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BC-6800 Auto Hematology Analyzer
Operator’s Manual
© 2011-2013 Shenzhen Mindray Bio-medical Electronics Co., Ltd.
All rights Reserved.
For this Operator’s Manual, the issued Date is 2013-12.
Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,
,
China and other countries.
are the trademarks, registered or otherwise, of Mindray in All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel.
the electrical installation of the relevant room complies with the applicable national and local requirements.
the product is used in accordance with the instructions for use.
I
It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health.
Be sure to operate the analyzer under the situation specified in this manual; otherwise, the analyzer will not work normally and the analysis results will be unreliable, which would damage the analyzer components and cause personal injury.
This equipment must be operated by skilled/trained clinical professionals.
II
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
III
Customer Service Department Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057,P.R.China
Website:
www.mindray.com
E-mail Address:
[email protected]
Tel:
+86 755 81888998
Fax:
+86 755 26582680
EC-Representative: Address:
Shanghai International Holding Corp. GmbH(Europe) Eiffestraβe 80, Hamburg 20537, Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Table of Contents 1
Using This Manual ............................................................................................... 1-1 1.1
Introduction ............................................................................................................ 1-1
1.2
Who Should Read This Manual ............................................................................. 1-2
1.3
How to Find Information ........................................................................................ 1-3
1.4
Conventions Used in This Manual ......................................................................... 1-4
1.5
Precautions, Limitations and Hazards ................................................................... 1-5
1.6
Symbols ................................................................................................................. 1-7
2
Understanding Your Analyzer ............................................................................ 2-1 2.1
Introduction ............................................................................................................ 2-1
2.2
Parameters ............................................................................................................ 2-2
2.3
Hardware ............................................................................................................... 2-6
2.4
2.5
2.3.1
Overview .................................................................................................. 2-6
2.3.2
Modules and Components ....................................................................... 2-7
2.3.3
External Equipment ................................................................................ 2-15
User Interface ...................................................................................................... 2-16 2.4.1
Of the SPU ............................................................................................. 2-16
2.4.2
Of the DMU ............................................................................................ 2-19
Software Operation .............................................................................................. 2-21 2.5.1
Of the SPU ............................................................................................. 2-21
2.5.2
Of the DMU ............................................................................................ 2-23
2.6
Help ..................................................................................................................... 2-31
2.7
Reagents, Controls and Calibrators .................................................................... 2-32
3
2.7.1
Reagent .................................................................................................. 2-32
2.7.2
Controls and Calibrators ........................................................................ 2-35
Understanding the System Principles ............................................................... 3-1 3.1
Introduction ............................................................................................................ 3-1
3.2
WBC Measurement ............................................................................................... 3-2
3.3
3.4
3.5
3.2.1
SF CUBE Cell Analysis Technology ......................................................... 3-2
3.2.2
Derivation of WBC-Related Parameters .................................................. 3-4
3.2.3
Derivation of NRBC Parameters .............................................................. 3-6
HGB Measurement ................................................................................................ 3-7 3.3.1
Colorimetric Method ................................................................................. 3-7
3.3.2
HGB .......................................................................................................... 3-7
RBC/PLT Measurement ......................................................................................... 3-8 3.4.1
Sheath Fluid Impedance Method ............................................................. 3-8
3.4.2
Derivation of RBC-Related Parameters ................................................... 3-8
3.4.3
Derivation of Reticulocyte-Related Parameters ....................................... 3-9
3.4.4
Derivation of PLT-Related Parameters................................................... 3-10
Wash .................................................................................................................... 3-12 1
Table of Contents 4
Installing Your Analyzer ...................................................................................... 4-1 4.1
Introduction ............................................................................................................ 4-1
4.2
Installation Requirements ...................................................................................... 4-2
4.3
5
4.2.1
Space Requirements ................................................................................ 4-2
4.2.2
Power Requirements ................................................................................ 4-3
4.2.3
General Environment ............................................................................... 4-4
4.2.4
Fuse Requirement .................................................................................... 4-5
4.2.5
Transportation and Installation ................................................................. 4-5
Connecting the Analyzer System .......................................................................... 4-6 4.3.1
Pneumatic unit.......................................................................................... 4-6
4.3.2
Reagents .................................................................................................. 4-7
4.3.3
Optional Equipment .................................................................................. 4-9
Customizing the Analyzer Software .................................................................. 5-1 5.1
Introduction ............................................................................................................ 5-1
5.2
Setting up the SPU ................................................................................................ 5-2 5.2.1
Date Setup ("Menu" > "Setup" > "Date") .................................................. 5-2
5.2.2
Auxiliary Setup ("Menu" > "Setup" > "Auxiliary Setup") ........................... 5-2
5.2.3
Reagent Setup ("Menu" > "Setup" > "Reagent") ...................................... 5-4
5.2.4
Maintenance Setup (Administrator) ("Menu" > "Setup" > "Maintenance")5-5
5.2.5
Autoloader Setup (Administrator) ("Menu" > "Setup" > "Autoloader") ..... 5-6
5.2.6
Barcode Setup (Administrator) ("Menu" > "Setup" > "Barcode") ............. 5-7
5.2.7
Communication
Setup
(Administrator)
("Menu"
>
"Setup"
>
"Communication") ................................................................................................... 5-9
5.3
6
5.2.8
Gain Setup (Administrator) ("Menu" > "Setup" > "Gain Setup") ............... 5-9
5.2.9
Algorithm Setup (Administrator) ("Menu" > "Setup" > "Alg") .................. 5-10
Setting up the DMU ............................................................................................. 5-11 5.3.1
General Setup ("Setup" > "General Setup") ........................................... 5-12
5.3.2
Para. Setup (Administrator) ("Setup" > "Para. Setup") .......................... 5-22
5.3.3
Access Setup ("Setup" > "Access Setup") ............................................. 5-27
5.3.4
Data Dictionary ("Setup" > "Data Dictionary") ........................................ 5-31
5.3.5
Para. Unit (Administrator) ("Setup" > "Para. Unit ") ............................... 5-33
5.3.6
Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") .............. 5-34
5.3.7
Reexam Rules (Administrator) ("Setup" > "Reexam Rules ") ................ 5-35
5.3.8
Flag Setup ("Setup" > "Flag Setup") ...................................................... 5-41
5.3.9
Screen Display ("Setup" > "Screen Display ") ........................................ 5-42
Operating Your Analyzer ..................................................................................... 6-1 6.1
Introduction ............................................................................................................ 6-1
6.2
Initial Checks ......................................................................................................... 6-2
6.3
Startup ................................................................................................................... 6-4
6.4
Daily Quality Control .............................................................................................. 6-9
6.5
Entering the “Count” Screen ................................................................................ 6-10
6.6
Preparing Samples .............................................................................................. 6-12 2
Table of Contents
6.7
6.8
6.9
6.6.1
Whole blood samples ............................................................................. 6-13
6.6.2
Prediluted samples ................................................................................. 6-13
6.6.3
Body fluid samples ................................................................................. 6-16
Sample Analysis in the OV Mode ........................................................................ 6-17 6.7.1
Selecting work mode .............................................................................. 6-17
6.7.2
Entering Worklist Information ................................................................. 6-19
6.7.3
Sample Analysis Procedure ................................................................... 6-22
6.7.4
Special Functions ................................................................................... 6-26
Sample Analysis in the Autoloading Mode .......................................................... 6-29 6.8.1
Enter Worklist Information ...................................................................... 6-29
6.8.2
Sample Analysis Procedure ................................................................... 6-32
6.8.3
Special Functions ................................................................................... 6-44
6.8.4
Barcode Labels ...................................................................................... 6-47
Working with the Worklist .................................................................................... 6-49 6.9.1
Introduction ............................................................................................. 6-49
6.9.2
Operations .............................................................................................. 6-49
6.10 Standby................................................................................................................ 6-53 6.11 Shutdown ............................................................................................................. 6-54 7
Reviewing Sample Results ................................................................................. 7-1 7.1
Introduction ............................................................................................................ 7-1
7.2
Reviewing Sample Results from SPU ................................................................... 7-2
7.3
7.4
7.5
8
7.2.1
Reviewing Blood Sample Results ............................................................ 7-2
7.2.2
Reviewing Body Fluid Sample Results .................................................. 7-11
Reviewing Sample Results from DMU ................................................................ 7-13 7.3.1
Introduction to the Screen ...................................................................... 7-13
7.3.2
Button Functions .................................................................................... 7-19
7.3.3
Right-Click Menu Functions ................................................................... 7-29
7.3.4
History Review (Administrator) ............................................................... 7-33
Report .................................................................................................................. 7-35 7.4.1
Introduction of the Screen ...................................................................... 7-35
7.4.2
Button Functions .................................................................................... 7-40
7.4.3
Right-Click Menu Functions ................................................................... 7-47
Statistics .............................................................................................................. 7-55 7.5.1
Workload Summary（"Statistics" > "Workload Summary"） ................. 7-55
7.5.2
Summary of Positive Samples ............................................................... 7-55
7.5.3
General Summary .................................................................................. 7-56
7.5.4
Print Summary........................................................................................ 7-57
Using the QC Programs ...................................................................................... 8-1 8.1
Introduction ............................................................................................................ 8-1
8.2
L-J QC Program .................................................................................................... 8-2 8.2.1
QC Setup (Administrator) ......................................................................... 8-2
8.2.2
L-J QC Run ............................................................................................ 8-10 3
Table of Contents 8.2.3 8.3
8.4
8.5
8.6
9
Review L-J QC Results .......................................................................... 8-22
X-B QC Program ................................................................................................. 8-41 8.3.1
Introduction to X-B QC Program ............................................................ 8-41
8.3.2
QC Setup (Administrator) ....................................................................... 8-41
8.3.3
Running Controls.................................................................................... 8-46
8.3.4
Reviewing X-B QC results ...................................................................... 8-46
X Mean QC Program ........................................................................................... 8-55 8.4.1
QC Setup (Administrator) ....................................................................... 8-55
8.4.2
Running Controls.................................................................................... 8-62
8.4.3
Reviewing X mean QC results ............................................................... 8-69
X Mean R QC Program ....................................................................................... 8-82 8.5.1
QC Setup (Administrator) ....................................................................... 8-82
8.5.2
Running Controls.................................................................................... 8-84
8.5.3
Reviewing X mean R QC results ............................................................ 8-90
X-M QC Program ............................................................................................... 8-104 8.6.1
X-M QC principle .................................................................................. 8-104
8.6.2
QC Setup (Administrator) ..................................................................... 8-104
8.6.3
Running Controls.................................................................................. 8-108
8.6.4
Reviewing X-M QC results ................................................................... 8-108
Calibrating Your Analyzer ................................................................................... 9-1 9.1
Introduction ............................................................................................................ 9-1
9.2
When to Calibrate .................................................................................................. 9-2
9.3
How to Calibrate .................................................................................................... 9-3 9.3.1
Preparation ............................................................................................... 9-3
9.3.2
Manual Calibration ("Menu" > "Calibration" > "Manual") .......................... 9-6
9.3.3
Calibration with Calibrator (Administrator) ("Menu" > "Calibration" >
"Calibrator") ............................................................................................................ 9-8 9.3.4
Calibration with Fresh Blood (Administrator) ("Menu" > "Calibration" >
"Fresh blood") ....................................................................................................... 9-12 9.3.5
10
Verifying calibration factors .................................................................... 9-16
9.4
Calibration History ("Menu" > "Calibration" > "History") ...................................... 9-17
9.5
Touch Screen Calibration ("Menu" > "Calibration" > "Touch Screen") ................ 9-18 Servicing Your Analyzer .................................................................................... 10-1
10.1 Introduction .......................................................................................................... 10-1 10.2 Reagent Management ......................................................................................... 10-2 10.3 Maintaining Your Analyzer Using the Service Program ....................................... 10-3 10.3.1
When and Why ............................................................................... 10-3
10.3.2
Replacing Reagent ("Menu" > "Service" > "Reagent" > "Replace
Reagent")
10-3
10.3.3
Reagent Priming ("Menu" > "Service" > "Reagent" > "Reagent priming") 10-5
10.3.4
Cleaning ("Menu" > "Service" > "Cleaning") ................................... 10-7 4
Table of Contents 10.3.5
Maintenance ("Menu" > "Service" > "Maintenance") ...................... 10-8
10.3.6
Servicing the Fluidics ("Menu" > "Service" > "Fluidics") ............... 10-10
10.3.7
Filter Discharging .......................................................................... 10-10
10.4 Checking the Analyzer Status Using the Status Program ................................. 10-11 10.4.1
Temp.&Pressure ("Menu" > "Status" > "Temp.&Pressure") .......... 10-11
10.4.2
Float Sensor ("Menu" > "Status" > "Float Sensor") ...................... 10-12
10.4.3
Version Info. ("Menu" > "Status" > "Version Info.") ....................... 10-12
10.5 Viewing History Logs ......................................................................................... 10-13 10.5.1
Viewing Logs ................................................................................ 10-13
10.5.2
Exporting Logs (Administrator) ..................................................... 10-14
10.6 Adjusting Pressure and Vacuum ....................................................................... 10-15 10.6.1
Introduction ................................................................................... 10-15
10.6.2
Adjusting Pressure and Vacuum .................................................. 10-16
10.7 Manual Cleaning ................................................................................................ 10-21 10.7.1
When, Why and Tools Needed ..................................................... 10-21
10.7.2
Opening and Closing the Front Cover .......................................... 10-21
10.7.3
Cleaning the Waste Collecting Trays ............................................ 10-22
10.7.4
Cleaning the SRV ......................................................................... 10-29
10.7.5
Cleaning the Probe Wipe of the Open-Vial Module ...................... 10-35
10.7.6
Sterilizing the Cover of the Analyzer............................................. 10-38
10.8 Replacing Containers or Components .............................................................. 10-39
11
10.8.1
When to Replace and Tools Needed ............................................ 10-39
10.8.2
Replacing the Reagent Containers............................................... 10-39
10.8.3
Replacing the Waste Container .................................................... 10-43
10.8.4
Replacing the Sample Probe of the Autoloading Module ............. 10-44
10.8.5
Replacing the Tube Clamp Assembly ........................................... 10-50
10.8.6
Replacing the Filter ....................................................................... 10-52
Troubleshooting ................................................................................................ 11-1 11.1 Introduction .......................................................................................................... 11-1 11.2 Error Information and Handling ........................................................................... 11-2
12
Customizing the Print Template ....................................................................... 12-1 12.1 Introduction .......................................................................................................... 12-1 12.2 Entering the Print Template Screen ..................................................................... 12-2 12.3 Editing the Template ............................................................................................ 12-4 12.3.1
Opening a Template........................................................................ 12-4
12.3.2
Editing the Template Property ........................................................ 12-4
12.3.3
Inserting Controls or Businesses .................................................... 12-4
12.3.4
Editing the Control(s) ...................................................................... 12-5
12.4 Managing the Templates ..................................................................................... 12-7 12.4.1
Importing a Template ...................................................................... 12-7
12.4.2
Exporting a Template ...................................................................... 12-8
12.4.3
Previewing a Template.................................................................... 12-9 5
Table of Contents 12.4.4
Printing a Template ......................................................................... 12-9
12.4.5
Deleting a Template ........................................................................ 12-9
12.5 Other Functions ................................................................................................. 12-10
13
12.5.1
Creating a New Business ............................................................. 12-10
12.5.2
Loading the Template Library ....................................................... 12-10
Appendices ..........................................................................................................A-1
6
1
Using This Manual
1.1 Introduction This chapter explains how to use your BC-6800 operation manual. This chapter explains how to use your operation manual, which is shipped with your Auto Hematology Analyzer and contains reference information about the BC-6800 and procedures for operating, troubleshooting and maintaining the analyzer. Read this manual carefully before operating your BC-6800 analyzer and operate your BC-6800 Auto Hematology Analyzer strictly as instructed in this manual.
NOTE
This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Please read this manual thoroughly before using the product.
This manual is based on the maximum configuration and therefore some contents may not apply to your product. It you have any questions, please contact us.
1-1
Using This Manual
1.2 Who Should Read This Manual This manual contains information written for clinical laboratory professionals to:
learn about the BC-6800 hardware and software.
customize system settings.
perform daily operating tasks.
perform system maintenance and troubleshooting.
1-2
Using This Manual
1.3 How to Find Information This operation manual comprises 12 chapters and 2 appendices. Refer to the table below to find the information you need. If you want to …
See …
learn about the intended use and parameters of the BC-6800
Chapter
2
Understanding
Your Analyzer Learn about the hardware, interface and software of the
Chapter
BC-6800
Your Analyzer
learn about how the BC-6800 works
Chapter 3 Understanding the
2
Understanding
System Principles learn about the installation requirements of the BC-6800
Chapter
4
Installing
Your
Analyzer learn about how to define/adjust system settings
Chapter 5 Customizing the Analyzer Software
Learn about the process of sample collection and analysis
Chapter 6 Operating Your Analyzer
learn about how to use the BC-6800 to perform your daily
Chapter 6 Operating Your
operating tasks
Analyzer
review sample results
Chapter 7 Reviewing Sample Results
learn about how to use the quality control programs of the
Chapter 8 Using the QC
BC-6800
Programs
learn about how to calibrate the BC-6800
Chapter 9 Calibrating Your Analyzer
learn about how to maintain/service the BC-6800
Chapter 10 Servicing Your Analyzer
Learn about how to solve the problems of the BC-6800
Chapter 11 Troubleshooting
Learn about how to customizing the print template of the
Chapter 12 Customizing the
BC-6800
Print Template
learn about the technical specifications of the BC-6800
Appendix B Specifications
1-3
Using This Manual
1.4 Conventions Used in This Manual This manual uses certain typographical conventions to clarify meaning in the text: form
meaning
[××]
all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the external keyboard), such as [ENTER].
“××”
bold letters included in " " indicate text you can find on the screen of the BC-6800
××
italic letters indicate chapter titles, such as Chapter 1 Using This Manual.
All illustrations in this manual are provided as examples only. They may not necessarily reflect your BC-6800 setup or data displayed.
1-4
Using This Manual
1.5 Precautions, Limitations and Hazards The following symbols are used to indicate danger and alert information in this manual. Symbols
Meaning read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is
WARNING
alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is
CAUTION
alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is
NOTE
alerting you to information that requires your attention.
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
If leakage happens to the analyzer, the leaked liquid is potentially biohazardous.
WARNING
Please check the firmness of all the doors and covers before running the analyzer.
Make sure all the safety measurements are adopted. Disabling any safety device or sensor is prohibited.
Please take action to any alarm and problem indication immediately.
Do not touch the moving parts.
Contact Mindray or Mindray-authorized distributors in time if any damaged part is found...
Be careful when opening/closing and removing/installing the doors, covers and boards of the analyzer.
Discard the analyzer according to government regulations. 1-5
Using This Manual
CAUTION
Please use the analyzer strictly as instructed by this manual.
Make sure only Mindray-authorized software is installed on the computer.
Please install the original edition software to prevent the computer from being infected by virus.
Please adopt proper measurements to prevent the reagents from being polluted.
It is recommended that you install anti-virus software on the computer and scan for viruses periodically.
1-6
Using This Manual
1.6 Symbols You will find the following symbols in this manual: Symbols
Meaning read the statement below the symbol. The statement is alerting you to a potentially biohazardous condition. read the statement below the symbol. The statement is
WARNING
alerting you to an operating hazard that can cause personnel injury. read the statement below the symbol. The statement is
CAUTION
alerting you to a possibility of analyzer damage or unreliable analysis results. read the statement below the symbol. The statement is
NOTE
alerting you to information that requires your attention.
You may find the following symbols of the analyzer system:
CAUTION
During the daily use of the analyzer, especially the cleaning process, the operator shall ensure the intactness of the labels.
Symbols
Meaning CAUTION, CONSULT ACCOMPANYING DOCUMENTS. Note: suggesting the users consult to accompanying documents to get important safety information.
BIOLOGICAL RISK
CAUTION, RISK OF ELECTRIC SHOCK
WARNING, LASER BEAM
CAUTION, HOT SURFACE
1-7
Using This Manual PROTECTIVE EARTH (GROUND)
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE
SERIAL NUMBER DATE OF MANUFACTURE
MANUFACTURER
THE FOLLOWING DEFINITION OF THE WEEE LABEL APPLIES TO EU MEMBER STATES ONLY: THE USE OF THIS SYMBOL INDICATES THAT THIS PRODUCT SHOULD NOT
BE
WASTE.
TREATED BY
AS
HOUSEHOLD
ENSURING
THAT
THIS
PRODUCT IS DISPOSED OF CORRECTLY, YOU WILL HELP PREVENT BRINGING POTENTIAL NEGATIVE CONSEQUENCES TO THE ENVIRONMENT AND HUMAN HEALTH.
FOR
INFORMATION RETURNING PRODUCT,
MORE WITH
AND
REGARD
TO
RECYCLING
THIS
CONSULT
THE
PLEASE
DISTRIBUTOR
DETAILED
FROM
WHOM
YOU
PURCHASED THE PRODUCT. THE DEVICE IS FULLY CONFORMANCE WITH
THE
CONCERNING
COUNCIL IN
VITRO
DIRECTIVE DIAGNOSTIC
MEDICAL DEVICES 98/79/EC. AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
1-8
Using This Manual
1
2 Figure 1-1 Back of the Analyzer
1
Connect only to a properly earth grounded outlet.
To avoid electric shock, disconnect power cord prior to removing or replacing fuse.
Replace fuse only with the type and rating specified.
2
1-9
Using This Manual
1 前板Panel Front
2 3
4 防护罩Cover Shielding Figure 1-2 Stop Bar Position (Front Cover Open)
1 To avoid personal injury, after you lift the cover, be sure to fix it with the stop bar exactly as the above figure shows.
2 Mechanical risk may exist if the protective cover is removed.
3
4 Notes 1. Please slide the tube into the autoloader. If you fail to do so, replace the tube barcode. 2. Please make sure the tube cap is secured. 1-10
Using This Manual 3. Please make sure the unloading tray is not full and the detecting photocoupler is not covered, and then start analysis.
1-11
Using This Manual
Figure 1-3 Right of the Analyzer
1 Caution: laser radiation when open, please avoid the laser beam
1-12
Using This Manual
Figure 1-4 Front of the Pneumatic Unit
1
1-13
Using This Manual
Figure 1-5 Back of the Pneumatic Unit
1 To avoid damaging the pneumatic unit, do not block the vent at its back.
2 Connect only to a properly earth grounded outlet。 To avoid electric shock, disconnect power cord prior to removing or replacing fuse. Replace fuse only with the type and rating specified. To avoid the compressor being damaged, wait at least 1 minute before restarting the pneumatic unit.
3 To avoid damaging the pneumatic unit, do not block the vent at its back.
1-14
2
Understanding Your Analyzer
2.1 Introduction BC-6800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte 5-part Differential, Hemoglobin Concentration Measurement, Reticulocyte and Nucleated Red Blood Cell Measurement for blood samples, as well as Body Fluid analysis.
CAUTION
The subtypes of body fluid supported
by
BC-6800 only include
cerebrospinal fluid and serous cavity fluid (pleural fluid and ascitic fluid). You may not get accurate results if you analyze body fluid samples other than specified above.
2-1
Understanding Your Analyzer
2.2 Parameters
NOTE
The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.
For blood sample analysis, BC-6800 provides:
37 basic parameters,
17 research parameters,
2 histograms,
6 scattergrams,
8 test panels.
Basic Parameters White Blood Cell count
WBC
Basophil number
Bas#
Basophil percentage
Bas%
Neutrophil number
Neu#
Neutrophil percentage
Neu%
Eosinophil number
Eos#
Eosinophil percentage
Eos%
Lymphocyte number
Lym#
Lymphocyte percentage
Lym%
Monocyte number
Mon#
Monocyte percentage
Mon%
Reticulocyte percentage
RET%
Reticulocyte number
RET#
Immature Reticulocyte Fraction
IRF
Reticulocyte Hemoglobin Expression
RHE
Low Fluorescent Ratio
LFR
Middle Fluorescent Ratio
MFR
High Fluorescent Ratio
HFR 2-2
Understanding Your Analyzer Red Blood Cell count
RBC
Hemoglobin Concentration
HGB
Mean Corpuscular Volume
MCV
Mean Corpuscular Hemoglobin
MCH
Mean Corpuscular Hemoglobin Concentration
MCHC
Red Blood Cell Distribution Width - Coefficient of Variation
RDW-CV
Red Blood Cell Distribution Width - Standard Deviation
RDW-SD
Hematocrit
HCT
Nucleated Red Blood Cell count
NRBC#
Nucleated Red Blood Cell percentage
NRBC%
Platelet count
PLT
Mean Platelet Volume
MPV
Platelet Distribution Width
PDW
Plateletcrit
PCT
Platelet-Large Cell Ratio
P-LCR
Platelet- Large Cell Count
P-LCC
Immature Granulocyte
IMG#
Immature Granulocyte percentage
IMG%
Immature Platelet Fraction
IPF
Research Use Only Parameters (RUO) High fluorescent Cell number
HFC#
High fluorescent Cell percentage
HFC%
Optical Red Blood Cell count
RBC-O
Optical Platelet count
PLT-O
Platelet count- Impedance
PLT-I
Optical White Blood Cell count
WBC-R
White Blood Cell count -DIFF
WBC-D
White Blood Cell count –BASO
WBC-B
White Blood Cell count-NRBC
WBC-N
Platelet Distribution Width – Standard Deviation
PDW-SD
Infected Red Blood Cell count
InR#
Infected Red Blood Cell permillage
InR‰
Microcyte count
Micro#
2-3
Understanding Your Analyzer Microcyte percentage
Micro%
Macrocyte count
Macro#
Macrocyte percentage
Macro%
Mean Reticulocyte Volume
MRV
Histogram Red Blood Cell Histogram
RBC Histogram
Platelet Histogram
PLT Histogram
Scattergram Differential Scattergram
DIFF Scattergram
Basophils Scattergram
BASO Scattergram
Reticulocyte Scattergram
RET Scattergram
Optical Platelet Scattergram
PLT-O Scattergram
Reticulocyte－Extension Scattergram
RET-EXT Scattergram
Nucleated Red Blood Cell-Scattergram
NRBC Scattergram
Test Panel 1.
CBC
2.
CBC+ DIFF
3.
CBC+DIFF+RETIC
4.
CBC+RETIC
5.
CBC+NRBC
6.
CBC+DIFF+NRBC
7.
CBC+DIFF+RET+NRBC
8.
RET
For body fluid sample analysis, BC-6800 provides:
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Understanding Your Analyzer
7 basic parameters,
7 research parameters,
1 histogram,
1 scattergram,
1 test panel. Basic Parameters
White Blood Cell count-body fluid
WBC-BF
Total nucleated cell counts-body fluid
TC-BF#
Mononuclear cell number
MN#
Mononuclear cell percentage
MN%
Polymorphonuclear cell number
PMN#
Polymorphonuclear cell percentage
PMN%
Red Blood Cell count-body fluid
RBC-BF
Research Use Only Parameters (RUO) Eosinophils number- body fluid
Eos-BF#
Eosinophils percentage- body fluid
Eos-BF%
Neutrophils number- body fluid
Neu-BF#
Neutrophils percentage- body fluid
Neu-BF%
High fluorescent cell number- body fluid
HF-BF#
High fluorescent cell percentage- body fluid
HF-BF%
Red Blood Cell count-body fluid
RBC-BF
Note: the RBC-BF for RUO has higher precision which is rounded down to the fourth decimal digit, while the basic parameter RBC-BF is rounded down to the third decimal digit.
Histogram Red Blood Cell Histogram
RBC Histogram
Scattergram Differential Scattergram
DIFF Scattergram
Test Panel 1.
CBC+ DIFF
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Understanding Your Analyzer
2.3 Hardware 2.3.1 Overview The BC-6800 Auto Hematology Analyzer includes the Sample Processing Unit (SPU), Data Managing Unit (DMU), Pneumatic Unit (PU) and accessories.
①
②
③
Component
Function
①Sample Processing Unit (SPU)
Processing patient samples and send original analysis results to the DMU
② Data Managing Unit (DMU)
Managing data, such as editing worklist, reviewing results, generating reports, communicating with LIS, etc.
③ Pneumatic Unit (PU)
Provide pressure and vacuum to the SPU
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Understanding Your Analyzer
2.3.2 Modules and Components
Figure 2-1 Front of the Analyzer 1 ---- Touch screen
2 --- Power indicator
3 ---- Sample probe
4 ---- Aspirate key
5 ---- Sample tube
6 ---- Tube rack
7 ---- Autoloader
8 ---- Fluorescent dye compartment door
Touch screen
The touch screen displays all alphanumeric and graphic data. You can use it to operate your analyzer
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Understanding Your Analyzer
CAUTION
Do not use anything sharp on the touch screen or strike on it.
Clean the touch screen with clean and soft cloth, as well as neutral cleanser or ethanol rather than chemical solution, acid or alkali solution.
Power indicator
The power indicator tells you about the status of the analyzer including ready, running, error, standby and on/off, etc.
Aspirate key
You can press the aspirate key to start sample analysis or dispense diluent.
Autoloader
The autoloader is located in the front of the analyzer. You can use it to load tubes automatically.
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Understanding Your Analyzer
Figure 2-2 Front of the analyzer (front cover open) 1 ---- Cover and touch screen module
2 ---- Cover stop bar
3 ---- Reaction bath module
4 ---- Manual sampling module
5 ---- HGB module
6 ---- Mix&pierce module
7 ---- Fluorescent reagent packages
8 ---- Fluorescent metering module
9 ---- RBC module
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Understanding Your Analyzer
Figure 2-3 Back of the Analyzer 1 ---- AC input
2
3 ---- Network interface**
4 ---- Waste sensor connector
5 ---- Waste outlet
6 ---- RET diluent inlet
7
8 ---- Diluent inlet
---- BASO lyse inlet
---- Pneumatic Unit Control Interface*
9 ---- Pressure interface
10 ---- Vacuum interface
11
---- HGB lyse inlet
12
13
---- NRBC lyse inlet
Pneumatic unit control interface
---- DIFF lyse inlet
You can use the pneumatic unit control interface to startup or shutdown the pneumatic unit.
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Understanding Your Analyzer
Network interface
You can use the network interface to connect the analyzer to the PC.
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Understanding Your Analyzer
Figure 2-4 Right side of the analyzer (right door open) 1 ---- Optical system
2 ---- Sheath fluid heating valves
3 ---- Bath-related module
4 ---- Fluidic valve module
5 ---- USB interfaces
6 ---- Reagent heating module
7 ---- Sheath fluid heating module
USB interface
You can use the 4 USB interfaces to connect external equipments (like keyboard, printer, etc.) to the analyzer.
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Understanding Your Analyzer
Figure 2-5 Left side of the analyzer (left door open, air valves presented) 1 ---- Boards integrating module
2 ---- Air valve module
3 ---- Pressure Filter
4 ---- Power module
5 ---- Power switch
Power switch
You can use the power switch to start up or shut down the analyzer
CAUTION
To avoid damage, do not turn on/off the power of the analyzer continually in a short time.
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Understanding Your Analyzer
Figure 2-6 Front of the pneumatic unit 1 --- Relief valve
2 --- Operation indicator
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Understanding Your Analyzer
Figure 2-7 Back of the pneumatic unit 1 --- Power switch
2 --- AC input
3 --- Pneumatic unit control interface
4 --- Vacuum interface
5 --- Pressure interface
2.3.3 External Equipment
Keyboard (Optional)
Mouse (Optional)
Bar-code scanner (optional)
NOTE
Do not adjust the pneumatic relief valve. Contact Mindray Customer Service Department if necessary.
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Understanding Your Analyzer
2.4 User Interface 2.4.1 Of the SPU System menu
Utility buttons
Auxiliary Information
Client area
Error message
System menu Menu Tree of the Analyzer Level 1
Level 2
Count
/
Table
/
QC
/
Level 1 Cleaning Service
Manual Calibration
Level 2
Maintenance Reagent Fluidics
Calibrator (administrator)
Status
Fresh Blood (administrator) 2-16
Statistics Temp.&Pressure
System time
Understanding Your Analyzer History (administrator)
Float Sensor (administrator)
Touch Screen (administrator)
Version Info.
Date
Function Config.
Auxiliary Setup Reagent
Logout
/
Shutdown
/
Maintenance (administrator) Setup
Autoloader (administrator) Barcode (administrator) Communication (administrator) Gain Setup (administrator) Alg (administrator)
Utility buttons
Name
Icon
Function
Count
Tap to enter the "Count" screen
Table
Tap to enter the "Table" Review screen
QC
Tap to enter the "QC" screen
Reagent
Tap to enter the "Reagent" Setup screen
Service
Tap to enter the "Service" screen
DILUENT
When the mode is OV-PD, tap "DILUENT" to dispense diluent
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Understanding Your Analyzer
Auxiliary information
The area displays auxiliary information of the current screen, like the next sample information in the “Count” screen.
Client area
The area displays contents of each screen
Auxiliary information
The area displays related auxiliary information of the current screen: E.g. At the "Count" screen, it displays the ID and analysis mode of the next sample; at the "Graph Review" screen, it displays position of the current sample and total number of samples
Error information area
When error occurs, this area displays the error message.
System time
It displays the current system time
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Understanding Your Analyzer
2.4.2 Of the DMU Sub-Menu Buttons Menu Area
User information area
Title Area
Function Buttons
Client area
Shortcut icon area
Status icon area
Title area
Show the title of the analyzer and the current screen.
Shortcut icon area Name
Icon
Function
Logout
Click to log out
Print Screen
Click to print the current screen
Help
Click to go to the software help screen
About
Click to check basic information of the software
Menu area Hierarchy of the menu Level 1
Level 2
Report
/
Review
/
Level 1 Setup
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Level 2 General Setup Para. setup
Understanding Your Analyzer Worklist
/
Access Setup
L-J
Data Dictionary
X-B
Para. Unit
X Mean
Ref. Ranges
X Mean R
Reexam Rules
X-M
Flag Setup
Workload Summary
Screen Display
QC
Statistics
Summary of Positive Samples
Log
General Summary
Shutdown/Exit
/
There DMU only shows the Level 1 menus, and you can enter the Level2 screens by using the sub-menu buttons in the button area.
Button area
It displays the available sub-menu buttons and function buttons of the current screen. If there are both types of buttons, they are separated by a vertical line in this area.
Client area
The area displays contents of each screen.
User information area
The area displays the access level, user ID and username of the current user.
Dynamic area
It displays information like error messages.
Status icons
Including the printer status icon and the instrument status icon, indicating whether the printer is idle and whether the instrument is connected to the PC.
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Understanding Your Analyzer
2.5 Software Operation 2.5.1 Of the SPU Pop-up keyboard Click any text box to activate the pop-up keyboard (full keyboard or numeric keyboard, depending on the contents to be entered into the text box), see the following figure. Click to close the pop-up keyboard.
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Understanding Your Analyzer
Table
You will see the table above on the "Review" screen. Click the buttons on the right and below the table to view information in the table. These buttons are: page),
(previous row), (left page),
(next row),
(right page),
(previous page),
(leftmost page),
(left column),
(next
(rightmost page),
(right column).
Besides, you can also view information in the table by pressing the buttons ([←], [→], [↑], [↓], [PgUp], [PgDn]) on the keyboard.
Date Text box The following figure is a date text box, and you can edit date per the preset date format in the text box. The default ranges allowed are: Year [0, 9999]; Month [1, 12]; Date [1, 31].
You can shift the cursor in the text box by pressing [Tab] and [Shift]+[Tab].
Time Text box The following figure is a time text box, you can edit time in the text box, and the valid range is: [00:00, 23:59].
Check Box Click the check box, a "√" mark appears in the frame, indicating the option is chosen. 2-22
Understanding Your Analyzer
Click the option again, the “√” disappeared, it means the option is not chosen as shown below.
2.5.2 Of the DMU Please make sure you fully understand the meaning of the following operations or interfaces before you start operating the software of the PC.
Move the pointer Move the pointer displayed on the interface by operating the mouse.
CLICK Move the pointer to the desired content, left click the mouse then release.
NOTE
Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately.
Double click Move the pointer to the desired content, left click the mouse twice rapidly then release.
NOTE
Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately.
Right click Move the pointer to the desired content, right click the mouse then release.
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Understanding Your Analyzer
NOTE
Repeat the operation if failed to choose the content; check the connection of the mouse if necessary. If the problem still exists, please contact Mindray or your local distributor immediately.
DRAG SCROLL BAR On some screens, the information can not be fully displayed in one page, then a scroll bar(horizontal/vertical) will appear. You can scroll the scroll bar in the following ways to check the rest of the information. A scroll bar is shown below:
Click the "arrow button" on the scroll bar.
Move the pointer to the slide bar, left click the mouse and hold, then scroll the bar at will.
Click the blank area on the scroll bar.
View indicating information The software provides the indicating information to the content displayed (e.g. buttons, titles, etc.)It will display automatically when the pointer is moved onto the certain area.
Tab screen Tag screen displays one page of the multipage information. For example, click the "Main", "WBC" and "RBC" tabs on the "Review" screen, you can enter the corresponding screens to view information.
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Understanding Your Analyzer
Button
Common buttons
After clicking the button, certain function will perform. For example, the system will print after clicking the "print" button as shown below.
Arrow buttons of the combo box
Click the button, a pull-down list of the combo box will appear as shown below. The options will be displayed in the combo list.
Hide the pull-down list by click the arrow button again:
Arrow button of the date text box
The date text box is shown below:
After clicking the arrow button on the date text box, a date box will pop up.
Choose the year: click the displayed year twice, there will be several years listed for you to select. If the desired year is not displayed, click the year range displayed on top to go to the year range list. Choose the desired year range and then the year. Choose the month: Operation 1: click the arrow button on the both sides of the date box to switch and choose the desired month. Operation 2: click the displayed month, then click the desired month from the list appeared as shown below. 2-25
Understanding Your Analyzer
Choose the date: click the desired date. When the date box pops up, you can hide it by pressing the [Esc] on the keyboard.
Radio button
Click the single choice button, a mark appears in the circle, indicating the option is chosen. For example, click "Network Interface" in the figure below to communicate through network interface.
NOTE
Only one radio button can be chosen for one setting.
Order adjusting buttons
You can see the Order adjusting buttons on some screens with tables. You can adjust the order of items in the table by clicking the order adjustment button. These buttons are: (to the top),
(move up),
(move down) and
(to the bottom).
Check Box Click the check box, a "√" mark appears in the frame, indicating the option is chosen.
Click the option again, the “√” disappeared, it means the option is not chosen as shown below.
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Understanding Your Analyzer
NOTE
More than one check box can be chosen at the same time in one setting option.
Text box Click the text box, and then you can start editing when the cursor appears. You can enter the characters from the location of the cursor and the cursor moves to the right at the time. A hospital name is entered into the text box as follows:
You can also proceed with the following operations in the text box:
Move the cursor to the left or right by using the [←], [→] keys on the keyboard.
Move the cursor to the left of the initial character or the right of the end character by pressing the [Home], [End] keys on the keyboard.
Delete the character on the right of the cursor by using the[Delete] on the keyboard.
Delete the character on the left of the cursor by using the[Backspace] key on the keyboard.
Switch to other text box by using the [Tab] key on the keyboard.
NOTE
Text boxes of different use require different input characters.
You don't have to enter the separators in the date box and the IP box.
The scroll bar (horizontal/vertical) will appear if the content of the text box can not be displayed in one sight. You can scroll or use the[↑], [↓] keys on the keyboard to view the information fully.
Combo box The combo box consists of a text box and an arrow button, which is shown below:
See "Arrow button of the combo box" for details about selecting. See "Text box" for details about editing if it is editable.
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Understanding Your Analyzer
Date Text box The date text box is shown below:
See "Arrow button of the date text box" for details to complete date selection, or see "Text box" for details to edit date in the date text boxes.
Form/Table The form contains several cells and check boxes (sometimes). Click a cell, it is chosen as shown below:
Then, you can proceed with the following operations:
Select the cell by using the [↑], [↓], [←], [→] keys on the keyboard.
Select the initial or end form unit of the current row by using the[Home], [End] keys on the keyboard.
For an editable form unit, a cursor will appear in it if it is double clicked. You can enter the characters from the location of the cursor and the cursor moves to the right at the time. See the following figure for the cell under editing status. 2-28
Understanding Your Analyzer
You can proceed with the following operations in the cell:
Move the cursor to the left or right in the form unit by using the[←], [→] keys on the keyboard.
Move the cursor to the left of the initial character or the right of the end character by pressing the [Home], [End] keys on the keyboard.
Delete the character on the right of the cursor by using the [Delete] on the keyboard.
Delete the character on the left of the cursor by using the [Backspace] key on the keyboard.
Hide the cursor and quit editing by using the [Enter] key on the keyboard.
In some forms/tables, you may perform the following operations:
Adjust the position of a column
Click and hold the title of the column, and then drag the column horizontally to the desired position.
Adjust the width of a column
Click and hold the boundary line between two columns, then drag the line to adjust the width of the columns.
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Understanding Your Analyzer
Sort
Click the title of a column, the rows will be sequenced by the condition of the column in ascending/descending order, click the title again to change to descending/ascending order.
Select more than one row
If you want to select some contiguous rows: 1.
Select the first row.
2.
Press and hold “Shift” on the keyboard, and select the last row. All rows between the first and last rows will be selected.
If you want to select some discontiguous rows: 1.
Select the one row.
2.
Press and hold “Ctrl” on the keyboard, and select other row(s).
Dialog box There are many types of dialog box with varied functional buttons, which are the "OK" dialog box, the "OK/Cancel" dialog box, the "Yes/No" dialog box, the "Yes/No/Cancel" dialog box, and other dialog boxes of special indication. A dialog box consists of the title area, information area and function button(s). Take the following "Yes/No/Cancel" dialog box for example:
After changing the settings, click to close the dialog box and save the change; or click "No" to close the dialog box without saving the change.
Click the
button on the right of the title area to close the dialog box without
performing any operation.
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Understanding Your Analyzer
2.6 Help Click the
icon to view the software help information.
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Understanding Your Analyzer
2.7 Reagents, Controls and Calibrators As the analyzer, reagents (diluent, rinse, lyses, probe cleanser and E-Z cleanser), controls, and calibrators are components of a system, performance of the system depends on the combined integrity of all components. You should only use the Mindray-specified reagents (see Appendix B Specifications), which are formulated specifically for the fluidic system of your analyzer in order to provide optimal system performance. Do not use the analyzer with reagents from multiple suppliers. In such use, the analyzer may not meet the performance specified in this manual and may provide unreliable results. All references related to reagents in this manual refer to the reagents specifically formulated for this analyzer. Each reagent package must be examined before use. Product integrity may be compromised in packages that have been damaged. Inspect the package for signs of leakage or moisture. If there is evidence of leakage or improper handling, do not use the reagent.
NOTE
Store and use the reagents as instructed by instructions for use of the reagents.
When you have changed the diluent, lyses or cleansers, run a background to see if the results meet the requirement.
Pay attention to the expiration dates and open-container stability days of all the reagents. Be sure not to use expired reagents.
After installing a new container of reagent, keep it still for a while before use.
2.7.1 Reagent
M-68DS DILUENT
The M-68DS DILUENT applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in the measurement of parameters related to RBC, PLT, WBC, RET and NRBC. The M-68DS DILUENT is an electric conducting solution formulated to dilute samples and form sheath fluid in the process of blood cell measurement. It participates in cell differentiation, counting and HGB measurement which are accomplished by using the impedance method, colorimetric method, and SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68DR DILUENT
The M-68DR DILUENT applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It 2-32
Understanding Your Analyzer participates in the measurement of RET-related parameters together with M-68FR DYE. The M-68DR DILUENT is formulated to lyse red blood cells in blood cell measurement, facilitate the dyeing effect of reticulocytes by M-68FR DYE. It participates in the measurement of RET-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68FR DYE
The M-68FR DYE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in the measurement of RET-related parameters together with M-68DR DILUENT. The M-68FR DYE is formulated to dye reticulocytes with the assist of M-68DR DILUENT. It participates in the measurement of RET-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68LD LYSE
The M-68LD LYSE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in WBC differentiation in the DIFF channel together with M-68FD DYE. The M-68LD LYSE is formulated to lyse red blood cells and process white blood cells in the blood cell measurement, amplify the differences among WBC sub-populations and facilitate the dyeing effect of white blood cells by M-68FD DYE. It participates in the measurement of WBC-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68FD DYE
The M-68FD DYE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in WBC differentiation in the DIFF channel together with M-68LD LYSE. The M-68FD DYE is formulated to dye the white blood cells with the assist of M-68LD LYSE. It participates in the measurement of WBC-related parameters in the DIFF channel which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68LN LYSE
The M-68LN LYSE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in the measurement of NRBC-related parameters together with M-68FN DYE. The M-68LN LYSE is formulated to lyse red blood cells in blood cell measurement, facilitate the dying effect of NRBCs by M-68FN DYE It participates in the measurement of NRBC-related parameters which is accomplished by using SF Cube cell analysis technology 2-33
Understanding Your Analyzer (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68FN DYE
The M-68FN DYE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in the measurement of NRBC-related parameters together with M-68LN LYSE. The M-68FN DYE is formulated to dye the NRBCs with the assist of M-68LN LYSE It participates in the measurement of NRBC-related parameters which is accomplished by using SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals).
M-68LB LYSE
The M-68LB LYSE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It participates in WBC counting and measurement of basophil-related parameters. The M-68LB LYSE is formulated for lysing of red blood cells and differential processing of white blood cells in blood cell measurement; it amplifies the differences between the basophils and other WBC sub-populations. It participates in the measurement of basophil-related parameters which is accomplished by using flow cytometry combining with laser scatter method.
M-68LH LYSE
The M-68LH LYSE applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It is formulated to measure the hemoglobin-related parameters. The M-68LH LYSE is formulated to lyse red blood cells, release hemoglobin in red blood cells and transform it into methemoglobin, which enables the measurement of hemoglobin-related parameters by using the colorimetric method.
PROBE CLEANSER
The PROBE CLEANSER applies to Mindray BC-6800/BC-6600 Auto Hematology Analyzer. It is used to clean the analyzer regularly. The PROBE CLEANSER is a cleaning solution which has sodium hypochlorite. It can clean the fluidic channels and tubing, and get rid of blood albumin and sediment.
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Understanding Your Analyzer
2.7.2 Controls and Calibrators The controls and calibrators are used to verify accurate operation of and calibrate the analyzer. The controls are commercially prepared whole-blood products used to verify that the analyzer is functioning properly. They are available in low, normal, and high levels. Daily use of all levels verifies the operation of the analyzer and ensures reliable results are obtained. The calibrators are commercially prepared whole-blood products used to calibrate the analyzer. Read and follow the instructions for use to use the controls and calibrators. All references related to controls and calibrators in this manual refer to the controls and calibrators specifically formulated for this analyzer by Mindray. You should buy those controls and calibrators from Mindray or Mindray-authorized distributors.
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3
Understanding the System Principles
3.1 Introduction The principles used by this analyzer for measurement are:
sheath flow impedance method, laser scatter and SF Cube cell analysis technology (3D analysis using information from scatter of laser light at two angles and fluorescence signals) for cell differentiation and counting;
the colorimetric method for HGB measurement.
3-1
Understanding the System Principles
3.2 WBC Measurement 3.2.1 SF CUBE Cell Analysis Technology SF Cube is a pathbreaking technology for reliable blood cell analysis, including WBC differential, Reticulocytes and NRBC with efficient flagging. After reaction with proprietory reagents, the targeted blood cells undergo 3D analysis using information from scatter of laser light at two angles and fluorescence signals. The 3D scattergram builds the power to better identify and differentiate blood cell populations, especially to reveal abnormal cell population undetected by other techniques.
Laser Flow Cytometry In normal peripheral blood, white blood cells can be classified into 5 categories: lymphocytes, monocytes, neutrophils, eosinophils and basophils. Analyzing all types of white blood cells will provide a great deal of useful information for the clinical diagnosis of diseases. Under the influence of certain diseases, the peripheral blood may contain various abnormal cells apart from the five subpopulations of normal cells, such as atypical lymphocytes, immature cells, etc. Most of these abnormal cells are different kinds of immature cells in the cell generation process. But what they have in common is they contain a great deal of nucleic acid (DNA and RNA), the content of which decreases as the cell gets maturer. Therefore, normal cells and immature cells can be differentiated by detecting the content of nucleic acid in the cells. Body fluid refers to the fluid in side body cavities except blood vessels. There are many sub-types of body fluid, among which the most commonly seen sub-types are cerebrospinal fluid and serous cavity fluid. Both cerebrospinal fluid and serous cavity fluid are colorless and transparent in normal case, but in abnormal cases, there could be increase of cells (including 3-2
Understanding the System Principles leukocytes and erythrocytes). Leukocytes in body fluid can be categorized into mononuclear cells (MN) and polymorphonuclear cells (PMN). The analysis of the cells in body fluid can provide useful information for clinical diagnosis. BC-6800 adopts the SF Cube cell analysis technology to recognize and detect the immature cells in blood accurately besides doing WBC 5-part differentiation, as well as identify the nucleated cells in body fluid.
Fluorescence
Beam
RNA/DNA content
Side scatter
splitter
Internal structure of a cell
Laser beam Forward scatter
SF Cube Technology In the DIFF channel of the auto hematology analyzer (BC-6800), the fluorescent staining technology is adopted after the sample is mixed with DIFF lyse. The RBCs are lysed and the WBC subpopulations are made different in size and complexity by the lyse; the nucleic acid substances in WBCs are marked by the new asymmetric cyanine fluorescent substance. Due to the different content of nucleic acid in different WBC subpopulations, maturity stages or abnormal development status, the volume of fluorescent dye staining the nucleic acid substances can be different; the low-angle light scatter reflects cell size, the high-angle light scatter reflects intracellular granularity, and the intensity of fluorescent signal reflects the degree that the cell is stained. By sensing the difference in signal in three dimensions of the cells processed with lyse, the DIFF channel differentiates the subpopulations of WBCs (lymphocytes, monocytes, neutrophil and eosinophils), as well as identifies and flags abnormal cells like immature granulocytes, abnormal lymphocytes and blast cells. The lymphocytes are smaller in size with the nucleus taking most part of them. Lymphocytes have a high nucleus-to-cytoplasm ratio, but their nucleic acid content is low, therefore they are at a lower position in the direction of fluorescence and side scatter. The monocytes are larger in size, with high nucleus-to-cytoplasm ratio and high nucleic acid content, and less complex in structure, therefore they are at a higher position in the direction of fluorescence, and have stronger side scatter. The neutrophils and basophils are larger in size, and have medium nucleus-to-cytoplasm ratio and low nucleic acid content, therefore they are at a lower position 3-3
Understanding the System Principles in the direction of fluorescence, but they have stronger side scatter. The characteristics of the eosinophils are similar to those of the neutrophils, but they contain a lot of alkaline grains, so they have very strong side scatter. The blast cells, atypical lymphocytes and immature granulocytes have high nucleic acid content, so they are at a higher position in the direction of fluorescence on the scattergram. In body fluid samples, the mononuclear cells (MN) are less complex in intracellular granularity, so the side scatter is weaker, while polymorphonuclear cells are more complex in intracellular granularity, so the side scatter is stronger.
3.2.2 Derivation of WBC-Related Parameters Based on the analysis of the BASO channel scattergram and Bas region, the analyzer gets the White Blood Cell count (WBC) and Basophil number (Bas#). The Basophil percentage (Bas%) is then calculated. Based on the analysis of the DIFF channel scattergram and the Lym region, Neu region (IMG region included), Mon region and Eos region, the analyzer gets the percentage of lymphocytes (Lym%), neutrophils (Neu%), monocytes (Mon%), eosinophils (Eos%), and immature granulocytes (IMG%, which is included in Neu%). The number of lymphocytes, (Lym#), neutrophils (Neu#), monocytes (Mon#), eosinophils (Eos#), and immature granulocytes (IMG#, which is included in Neu#) are then calculated based on the sub-population percentages together with the White Blood Cell count got from the BASO 9
channel. The cell numbers are all expressed in 10 /L. In body fluid analyses, the White Blood Cell count-body fluid (WBC-BF) and Total nucleated cell counts-body fluid (TC-BF#) are directly generated in DIFF channel. The mononuclear cell percentage (MN%) and polymorphonuclear cell percentage (PMN%) are obtained based on the analysis of the MN region, PMN region of the DIFF scattergram, and together with the White Blood Cell count-body fluid (WBC-BF), the mononuclear cell number (MN#) and polymorphonuclear cell number (PMN) are calculated. The unit of all the body fluid parameters 9
about cell number is 10 /L.
WBC count
WBC Sum of all particles in BAS channelexcept those in Ghost region
Basophil number
Bas# Particles in Bas region of BAS channel
Basophil percentage
Bas%
Bas# 100 % WBC
3-4
Understanding the System Principles
Lymphocyte percentage
Lym%
Neutrophil percentage
Neu%
Particles in Eos region of Diff channel 100％ Sum of all particles in Diff channelexcept those in Ghost region
Immature granulocyte percentage
IMG%
Particles in Mon region of Diff channel 100％ Sum of all particles in Diff channelexcept those in Ghost region
Eosinophil percentage
Eos%
Particles in Neu region of Diff channel 100％ Sum of all particles in Diff channelexcept those in Ghost region
Monocyte percentage
Mon%
Particles in Lym region of Diff channel 100％ Sum of all particles in Diff channelexcept those in Ghost region
Particles in IMG region of Diff channel 100％ Sum of all particles in Diff channelexcept those in Ghost region
Lymphocyte number
Lym# WBC Lym%
Neutrophil number
Neu# WBC Neu%
Monocyte number
Mon# WBC Mon%
Eosinophil number
Eos# WBC Eos%
Immature granulocyte
IMG # WBC IMG%
3-5
Understanding the System Principles
White Blood Cell count-body fluid
WBC − BF = The sum of all particles in Diff channel except those in ghost region and HFR region
Total nucleated cell counts-body fluid TC − BF = The sum of all particles in Diff channel except those in ghost region
Mononuclear cell percentage
MN %
Polymorphonuclear cell percentage
PMN%
Particles in MN region of Diff channel 100％ WBC - BF
Particles in PMN region of Diff channel 100％ WBC - BF
Mononuclear cell number MN# = WBC − BF × MN%
Polymorphonuclear cell number PMN# = WBC − BF × PMN%
3.2.3 Derivation of NRBC Parameters
Nucleated Red Blood Cell percentage
NRBC %
Particles in NRBC region of NRBC channel 100% Sum of all particles in WBC region of NRBC channel
Nucleated Red Blood Cell count
NRBC# WBC NRBC%
3-6
Understanding the System Principles
3.3 HGB Measurement 3.3.1 Colorimetric Method
According to the Lambert-Beer Principle, when a beam of monochromatic light passes through a well-proportioned non-scattering light-absorbing solution, the absorbance A is proportional to the product of the thickness L and the concentration C. The sample in the HGB channel acts as the light absorbing substance after being treated by reagent, therefore the HGB concentration can be measured by measuring the absorbance.
3.3.2 HGB The HGB is calculated per the following equation and expressed in g/L.
Blank Photocurrent HGB(g/L) Constant Ln Sample Photocurrent
3-7
Understanding the System Principles
3.4 RBC/PLT Measurement 3.4.1 Sheath Fluid Impedance Method
Sheath Fluid Impedance Method A sensor is designed to enable the RBCs and PLTs to pass through the aperture one by one in a queue under the "focusing" effect of fluid, during which process pulses will be generated according to the Coulter Principle. The backend processor amplifies the pulses and compares them with the voltage thresholds of the RBC/PLT channel, and then the number of pulses in the RBC/PLT channel is calculated. That is to say, the pulses collected are sorted per the voltage thresholds of different channels, the number of pulses falling in the range of the RBC/PLT channel is the number of RBC/PLT. The number of cells in each channel defines the volume distribution of cells. The analyzer presents the RBC/PLT histogram, whose x-coordinate represents the cell volume（fL）and y-coordinate represents the number of the cells. Comparing with the common impedance method, the sheath fluid impedance method is featured by higher efficiency, better signal quality, more accurate analysis results and lower consumption of reagents. The RBC count results of body fluid samples are also obtained from the impedance channel.
3.4.2 Derivation of RBC-Related Parameters
RBC
RBC is the number of erythrocytes measured directly by counting the erythrocytes passing 12
through the aperture, which is expressed in 10 /L.
RBC n 1012 / L
MCV
Based on the RBC histogram, this analyzer calculates the mean corpuscular volume (MCV) and expresses the result in fL. 3-8
Understanding the System Principles
HCT, MCH and MCHC
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows,
HCT
RBC MCV 10
MCH
HGB RBC
MCHC
HGB 100 HCT
12
where the RBC is expressed in 10 /L, MCV in fL and HGB in g/L.
RDW-CV
Based on the RBC histogram, this analyzer calculates the RDW-CV (Red Blood Cell Distribution Width – Coefficient of Variation). It is expressed in form of a percentage.
RDW-SD
RDW-SD (Red Blood Cell Distribution Width – Standard Deviation) is obtained by calculating the standard deviation of RBC distribution, which is expressed in fL.
RBC-BF
RBC-BF is the number of erythrocytes in body fluid measured directly by counting the 12
erythrocytes passing through the aperture, which is expressed in 10 /L. RBC − BF = n × 1012
3.4.3 Derivation of Reticulocyte-Related Parameters
Reticulocyte percentage:
RET %
Number of Cells in Reticulocyte Region 100% (Number of Cells in MatureRBC Region Number of Cells in RET Region)
Reticulocyte number:
RET #
RET % RBC 100 3-9
Understanding the System Principles
Low Fluorescent Ratio:
LFR 100－HFR - MFR
Reticulocyte Hemoglobin Expression:
Calculated based on the light scatter information of RET
Middle Fluorescent Ratio:
MFR
High Fluorescent Ratio:
HFR
Number of cells in MFR region 100% Number of cells in reticulocyte region
Number of cells in HFR region 100% Number of cells in reticulocyte region
Immature Reticulocyte Fraction:
IRF MFR HFR
3.4.4 Derivation of PLT-Related Parameters
PLT
PLT is measured directly by counting the platelets passing through the aperture, which is 9
expressed in 10 / L.
PLT n 109 / L
MPV
Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).
PDW
Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet size distribution. Each PDW result is derived from the platelet histogram data and is reported as 10 (GSD).
PCT
This analyzer calculates the PCT as follows and express it in ％
PCT
PLT MPV 10000
3-10
Understanding the System Principles 9
Where the PLT is expressed in 10 /L and the MPV in fL.
P-LCR
Platelet larger cell ratio (P-LCR) is the ratio of the larger platelet (larger than 12fL) count to the total PLT count. The analyzer calculates the P-LCR based on the PLT histogram and expresses the result in %. In the following figure, S2 represents the number of larger platelet cells, and S1+S2 represents the total PLT count.
P-LCC 9
This analyzer calculates the platelet large cell count (P-LCC) and expresses the result in 10 /L,
9
where the PLT is expressed in 10 /L and the P-LCR in %.
IPF
P-
The immature platelet fraction (IPF) is obtained from the optical PLT scattergram, and is expressed in %. IPF=𝐼𝑚𝑚𝑎𝑡𝑢𝑟𝑒
IPF
𝑝𝑙𝑎𝑡𝑒𝑙𝑒𝑡
𝑝𝑎𝑟𝑡𝑖𝑐𝑙𝑒
𝑛𝑢𝑚𝑏𝑒𝑟
Immature platelet number in opticalchannel 100% The sum of all platelet particles in opticalchannel
3-11
𝑡𝑖𝑐𝑎𝑙
𝑐ℎ𝑎𝑛𝑛𝑒𝑙
Understanding the System Principles
3.5 Wash After each analysis cycle, all elements of the analyzer that the sample runs through are washed to ensure no residue is left.
3-12
4
Installing Your Analyzer
4.1 Introduction WARNING
Installation by personnel not authorized or trained by Mindray may cause personal injury or damage your analyzer. Do not install your analyzer without the presence of -authorized personnel.
The installation, test, update, and modification of the software associated with the analyzer shall only be performed by personnel authorized by Mindray.
The analyzer is checked and packed with care before it is shipped from the factory. Inspect the carton carefully after arrival. If you see any sign of damage is found, contact Mindray or your local distributor immediately.
4-1
Installing Your Analyzer
4.2 Installation Requirements 4.2.1 Space Requirements While installing the analyzer, make sure there is enough space left for service and maintaining operations, as well as for the analyzer to dissipate heat and for the fluidic tubing to be properly placed without extrusion. Specific requirements shown as follows:
proper height to place the analyzer;
at least 500 mm to each side of the analyzer;
at least 600mm above the analyzer;
at least 150 mm to each side of the pneumatic unit;
at least 250 mm behind the analyzer and the pneumatic unit;
the diluent container must be placed within 1.0m above or below the analyzer, while the lyse containers must be placed on the same level with the analyzer or within 850mm below the analyzer.
The supporting table where the analyzer is placed shall be able to withstand at least 160kg of weight.
CAUTION
When installing or using the analyzer, make sure at least the two inside supporters of the autoloader are on the supporting table of the analyzer.
4-2
Installing Your Analyzer
600mm
0 50
25 0m m
mm
m 0m 50
150mm
mm 250
150mm
150mm
4.2.2 Power Requirements
WARNING
Make sure the analyzer is properly grounded.
Before turning on the analyzer, make sure the input voltage meets the requirements. 4-3
Installing Your Analyzer
CAUTION
Using pinboard may bring electrical interference and the analysis results may be unreliable. Please place the analyzer near the electrical outlet to avoid using pinboard.
Please use the original electrical wire shipped with the analyzer. Using other electrical wire may damage the analyzer or cause unreliable analysis results.
Analyzer
Compressor
Voltage
Frequency
Power
a.c. 110V/115V ±10%
50/60Hz ±2Hz
500VA
a.c. 220V/230V ±10%
50/60Hz ±2Hz
500VA
a.c. 110V/115V ±10%
60Hz ±2Hz
600VA
a.c. 220V/230V ±10%
50Hz ±2Hz
450VA
60Hz ±2Hz
300VA
4.2.3 General Environment Working
Storage
Operation
Environment
Environment
Environment
15℃-32℃
-10℃-40℃
5℃-40℃
Relative Humidity
30%-85%
10%-90%
10%-90%
Atmospheric
70kPa-106kPa
50kPa-106kPa
70kPa-106kPa
Ambient Temperature
Pressure
The environment should be as free as possible from dust, mechanical vibrations, loud noises, pollution and electrical interference.
It is advisable to evaluate the electromagnetic environment prior to operation of this analyzer.
Do not use this analyzer in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
Do not place the analyzer near brush-type motors, flickering fluorescent lights, and electrical contacts that regularly open and close.
Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.
The environment should be well-ventilated.
Do not place the analyzer on a slope. 4-4
Installing Your Analyzer
4.2.4 Fuse Requirement Fuse specification of the pneumatic unit: 250V T3A
WARNING
Only install fuses of specified specification on the analyzer.
4.2.5 Transportation and Installation
WARNING
Installation by personnel not authorized or trained by Mindray may cause personal injury or damage your analyzer. Do not install your analyzer without the presence of -authorized personnel.
The installation, test, update, and modification of the software associated with the analyzer shall only be performed by personnel authorized by Mindray.
CAUTION
After the autoloader is installed, do not lay to much pressure to it or transport the analyzer by holding the autoloader.
Installation of unrelated software on the DMU or other uses of the computer (e.g. play games, log on the internet, etc.) may cause system damage and/or data error. Therefore, please make sure the computer is used for the analysis system only.
The transportation and installation shall be conducted by Mindray-authorized personnel. Do not transport or install the analyzer without contacting Mindray or your local distributor.
4-5
Installing Your Analyzer
4.3 Connecting the Analyzer System 4.3.1 Pneumatic unit Connect the pneumatic unit to the analyzer as shown in the following figure. The operator shall make sure they are connected properly.
Figure 4-1 Connecting the Pneumatic Unit
4-6
Installing Your Analyzer
4.3.2 Reagents
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
There are two ways to discharge the waste: discharge to a waste container, or to directly to a waste disposal channel.
If the waste is directly discharged to a waste proposal channel, make sure the outlet of the waste piping is placed lower than the waste outlet of the analyzer
Connect the reagent containers to the analyzer as shown in the following figure. Be sure to keep all connecting lines isolated from anything electrical.
4-7
Installing Your Analyzer
Figure 4-2 Connecting the reagents 4-8
Installing Your Analyzer
4.3.3 Optional Equipment Connect the optional equipment to the analyzer as shown in the following figure, and make sure they are connected properly.
Figure 4-3 Connecting the Optional Equipment
4-9
5
Customizing the Analyzer Software
5.1 Introduction The BC-6800 is a flexible laboratory instrument that can be tailed to your work environment. You can use the “Setup” program to customize the software options as introduced in this chapter. For the security of the settings and data, two access levels are provided to the operator of the analyzer. The administrator access level provides the operator with access to more functions or settings, some of which can be configured to be accessible to operators. This chapter introduces how to customize the settings of the analyzer and the PC, some of which will be performed only occasionally.
5-1
Customizing the Analyzer Software
5.2 Setting up the SPU 5.2.1 Date Setup ("Menu" > "Setup" > "Date")
Click the corresponding radio button to select a date format.
5.2.2 Auxiliary Setup ("Menu" > "Setup" > "Auxiliary Setup") Operator access level
Predilute Mode Prompt
In the predilute mode, when you press the aspirate key at the sample analysis screen to start analysis, a dialog box will pop up to remind you that the current analysis mode is predilute. Tap on this option to enable or disable the function.
Pop-up Keyboard Open
Tap on the edit area of each screen, the pop-up keyboard will display for you to input information. Tap on this option to enable or disable the function.
Blood Sensor Open
Tap on this option to turn on or turn off the blood sensor. 5-2
Customizing the Analyzer Software
Waste Sensor Open
Tap on this option to turn on or turn off the waste sensor.
Enable Rotary Scan
During the barcode scanning in the autoloading mode, the analyzer can automatically rotate the tube to locate the barcode. Tap on this option to enable or disable the function.
Administrator access level
Besides the settings at the operator’s access level, an administrator can also set up the following items:
M68-FD, M68-FR, M68-FN Fluoreagent Sensor Open
Tap on this option to turn on or turn off the sensor of the fluorescent reagents.
Monitor Reagent Expiration Date
Tap on this check box to enable or disable or disable the reagent expiration date monitor function. When this function is enabled, an error will be reported once the instrument detects that the reagent is expired.
Set up the alarm volume
Tap the “Alarm Volume” pull-down list to select the volume of alarm sound.
Set up default test panel (a combination of analysis items)
Tap the “Default Test Panel” pull-down list to select the default test panel. For indications of 5-3
Customizing the Analyzer Software test panel abbreviations, see 6.7.1 Selecting work mode.
5.2.3 Reagent Setup ("Menu" > "Setup" > "Reagent")
1.
Tap “Setup”;
2.
Enter the barcode by typing or scanning, and then tap “Apply”. If the barcode is valid, the corresponding reagent information will automatically display;
3.
Tap “Exit” to exit the dialog box;
4.
Check the “Replace” box of the reagent in the “Reagent Setup” screen;
5.
Tap the “Replace” button to replace the reagent in fluidics.
5-4
Customizing the Analyzer Software
5.2.4 Maintenance Setup (Administrator) ("Menu" > "Setup" > "Maintenance")
Standby
Tap the text box in the "Standby" area and enter the waiting time before entering the standby status.
Probe cleanser maintenance
Tap the first text box in the "Probe Cleanser Maintenance" area to enter the time to start time-based probe cleanser maintenance. Tap the second text box in the "Probe Cleanser Maintenance" area to enter a time in the text box. Then when the operator cancels the time-based maintenance, a reminder dialog box will pop up after the defined minutes.
NOTE
Please make sure the numbers you enter are valid and in the required format.
5-5
Customizing the Analyzer Software
5.2.5 Autoloader Setup (Administrator) ("Menu" > "Setup" > "Autoloader")
Autoloader Stop Condition
Tap the check box in the "Autoloader Stop Condition" area to select one or more stop condition of the autoloader:
No Reagent
Waste Container Full
Sample ID Reading Error
Tube Rack No. Reading Error
Blood/Analysis Mode Inquiry Failed
Tap a radio button in the "Autoloader Stop Condition" area to select how to deal with the sample when the inquiry of its blood/analysis mode failed in the process of the autoloading analysis:
Use the mode of the previous sample
or
Skip after X second(s) (X can be configured by the operator)
Rule of Sample ID Increment
You can set the rule of sample ID increment in autoloading analysis. Tap the radio button to select the rule of sample ID increment when there is tube vacancy in the tube rack: 5-6
Customizing the Analyzer Software
increases
or
does not increase
Display summary after autoloading finished
Tap the check box to set whether to display the summary after autoloading completes.
Allow re-aspiration
Tap the check box to set whether allow re-aspiration (for once only) when the first aspiration is considered to be abnormal by the instrument.
5.2.6 Barcode Setup (Administrator) ("Menu" > "Setup" > "Barcode")
The analyzer supports 6 barcode types: CODE 128, CODE 39, IT, CODE 93, CODABAR and UPC/EAN/JAN.
Set barcode type and number of digits
1.
Tap one barcode type used on site to go to the corresponding setup screen.
2.
Check the “Apply” box to apply the code type.
3.
Select the number of digits used on site in the “Digits” area.
4.
Check the “check bit” box if the barcode in use has check bit.
5.
For CODE39, check “FULL ASCII” if needed.
6.
Set other code types if needed.
5-7
Customizing the Analyzer Software
For the length limits and check bit of different code types, see B.19 Barcode Specifications.
NOTE
If you are using ITF, CODE39 or CODABAR with check bit, the “Digits” shall be the sum of the length of the barcode and the check bit. E.g. If you are using barcodes with 9 digits, and select “check bit”, you shall select “10” as the number of “Digits”.
For barcode types supporting check bit, use check bit in barcode labels if possible to reduce the rate of misreading.
The code types and length limits set on the analyzer shall be those used in your laboratory. Do not select the code types that are not used, which may increase the rate of misreading.
Barcodes longer than 20 digits will not be read correctly.
Tap the check boxes to select one or more code systems and select the number of digits in the “Digits” pull-down lists or select “unlimited” for unlimited number of digits. For some code systems, there are “check bit” (for barcodes with check bit) and/or “FULL ASCII” (for full ASCII barcodes) check boxes. You can select as needed based on the barcodes you are using.
NOTE
Using “Unlimited” number of digits may lead to higher rate of incorrect scanning.
When “Unlimited” number of digits is selected, and the number of digits scanned is more than 20, the barcode will be displayed as “Invalid”.
5-8
Customizing the Analyzer Software
5.2.7 Communication Setup (Administrator) ("Menu" > "Setup" > "Communication")
Tap the text boxes to enter the IP address, subnet mask and default gateway of the analyzer.
5.2.8 Gain Setup (Administrator) ("Menu" > "Setup" > "Gain Setup")
You can view the gain values of different analyses in the “Gain Setup” screen at the operator access level, and modify the HGB gain at the administrator access level. When you modify the HGB default gain, the “Blank volt.” will change accordingly. If the entry is invalid, there will be a note of invalid entry when you try to save the change.
5-9
Customizing the Analyzer Software
5.2.9 Algorithm Setup (Administrator) ("Menu" > "Setup" > "Alg")
The algorithm setup screen shows the value to trigger the i-message flags. I-message is a collection of the flags with uncertainty to some extent. Administrator can modify the reference values of the i-message flags which indicating the degree of certainty (the higher the more probable). The “i-message” tab at the DMU (see graph area > i-message of 7.3.1) shows whether the values set here are met.
5-10
Customizing the Analyzer Software
5.3 Setting up the DMU The DMU provide the following setup configuration screens to users:
General Setup
Parameter Setup (Administrator)
Access Setup
Data Dictionary
Reference Range (Administrator)
Parameter Unit (Administrator)
Reexam Rules (Administrator)
Screen Display
Click “Setup” to go to the setup screen.
Saving your settings
In all the setup screens, if you want to save your changes, click the “Save” button in the button area to save, or when you leave the current setup screen a dialog box may pop up.
Click “Yes” to save the changes, close the dialog box, and go to the screen if specified. Click “No” to close the dialog box without saving the changes, and go to the screen if specified. Click “Cancel” to go back to the previous screen without saving the changes. 5-11
Customizing the Analyzer Software
5.3.1 General Setup ("Setup" > "General Setup") You can click the following tabs to go to the corresponding setup screens and complete the desired configurations.
Auxiliary setup (“Setup” > “General Setup” > “Auxiliary”) You can configure the following items from this screen:
Sample ID
Other
Color setup
Delta Check Setup
5-12
Customizing the Analyzer Software
Sample ID
Set how to enter the next sample ID Click the pull-down list after “Entry of Next Sample ID”, and select one of the two ways to enter the sample ID:
Auto Increase
Manual Entry
If you select “Auto Increase”, you only need to enter an ID for the first sample (you can choose not to enter and use the default one), and the subsequent sample IDs will automatically increase by 1 based on the previous one. If you select “Manual Entry”, you need to enter each sample ID manually. Set prefix for sample IDs You can use this function when you want to identify a certain batch of samples with a prefix. Type a desired prefix in the text box, and it will be applied to all sample IDs after the change is saved. Set the sample ID after startup Select “Reset Sample ID after Startup”, and enter the desired ID in the subsequent text box to define the ID you want to start with each time after startup (default to “1”); or Select “Sample ID increases based on the last ID before shutdown”, and the sample ID after start up will increase by 1 based on the last sample ID analyzed before shutdown.
Others
5-13
Customizing the Analyzer Software Check box area Select one or more check boxes to enable the function(s); deselect to disable.
Prompt of using reference result in report
Automatically delete analyzed sample records from worklist
Auto Entry of Draw Time
Auto Entry of Order Time
Allow the sum of DIFF percentages not equal to 100%
Suspect flag Enter one character in the text box to define the suspect flag (default to “R”). High/low flag Enter one character in each combo box or select from the pull down list to define the high and low flags (default: “H” for high and “L” for low).
Color setting
Color of high/low flag You can set color for font and background of high/low flag. Click “Text color” or “Background color” radio button, and then click the corresponding “Setup” button to define the color. You can check the preview in the “Display Preview” box. Color of Printed Results Click the “Setup” button to select the background color of printed results. You can check the preview in the “Display Preview” box. Color of Validated Results Click the “Setup” button to select the background color of validated results. You can check the preview in the “Display Preview” box.
5-14
Customizing the Analyzer Software
Delta Check Setup
Delta Check (deviation control of patient results) calculates the deviation of two groups of analysis results of a patient. If the state of a patient is stable, the △ (delta) value shall be small. The report of the △ values exceeding the predefined limit may help remind the doctor of paying special attention to the patient status. 1.
Check the “Start Delta Check” check box to enable the delta check function.
2.
Define the maximal number of days between the two results of Delta Check in the “Max Days between two Results” box.
3.
Select parameters you want to include in the delta check in the “Criteria” table.
4.
If needed, edit the “Outlier Threshold” of the selected parameter(s) which defines the maximum deviation permitted for the delta check.
After you enable the delta check function and define the criteria, if the deviation of any selected parameter exceeds the defined limit (“Outlier Threshold (%)” or “Outlier Threshold (#)”), this sample will be reported as an outlier of delta check in the “Result Compare” tab of the “Review” screen. 5-15
Customizing the Analyzer Software
Print Setup (“Setup” > “General Setup” > “Print”) You can configure the following items from this screen:
Printer
Template setup
Print setup
Report
Printer
Click the pull-down list to select the default printer.
Template setup
Choose a report type 5-16
Customizing the Analyzer Software Click the pull-down list to select the report type from the following options:
Report
Worklist
L-J QC Graph
L-J QC Table
Parameter QC Graph
Monthly QC Graph
Trend Graph
Result Summary
Result List
General Summary
Summary of Positive Samples
Workload Summary
Microscopic Exam.
Annual Summary
Monthly Summary
Set the print template There is a table below the “Report Type” combo box showing all the templates available for the selected report type, and the default template is ticked. To change the default template, select the desired template in the table, and then click the “Set to Default Template” button to confirm your selection. You can also click “Template Preview” to check the preview of the template. If you want to customize the template, click “Customize”. For detailed instruction of template customization, see 12 Customizing the Print Template.
Print setup
Specify copies You can modify the number of copies (default to “1”) by clicking the up and down arrows or re-enter the number in the text box.
5-17
Customizing the Analyzer Software Adjust margins The numbers in the four boxes on top, bottom, left and right defines the margins to the top, bottom, left and right edges of the page respectively. Click the up and down arrows to modify the margins or enter the numbers in the text boxes.
Report
Define report title Modify the default report title or enter the desired one in the “Title” text box. Enable/Disable Autoprint Click the “On” radio button to enable autoprint once sample results get to the DMU; or click “Off” to disable autoprint.
NOTE
You cannot enable the autoprint if the “Print after Validation” check box is selected.
Check box area You can click the check boxes of the following options to enable the corresponding settings:
Print after Validation
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Customizing the Analyzer Software
Autoprint after validation
Half Page Report (A5)
Microscopic Report Print Prompt
Print Flags
Print Ref. Ranges
Print Result Edited Flags
Print Suspect Flag
Print & Flag
Print @ Flag
Print Out-of-Range Flags
Print Analyzer Temperature Abnormal Flags
NOTE
The “Autoprint after validation” check box can only be selected when the “Autoprint” function is “On”.
Communication Setup (“Setup” > “General Setup” > “Communication”) You can configure the following items from this screen:
Communicate through
Network Setup
Serial Port Setup
Protocol Setup
Transmission Mode
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Customizing the Analyzer Software
Communicate through
Click the radio button to select one of the following ways of communication:
Serial Port
Network Interface
When you select “Network Interface”, you can choose to check the “Terminal Software as the Server” check box if needed.
Network Setup
Enter the correct IP address and port into the “IP address” and “Port” text boxes.
Serial Port Setup
If you select to communicate through “Serial Port”, you can click the “Serial Port” pull-down list to choose the appropriate one. You can also view the baud rate configured for the serial port communication.
Protocol Setup
Select protocol type Click the “Protocol Type” pull-down list to select one of the following communication protocols:
HL7
15ID+GBK
15ID+UTF-8 5-20
Customizing the Analyzer Software
Select protocol version Click the “Version” pull-down list to select the desired version of communication protocol. Set ACK Synchronous Communication Click the “ACK Synchronous Communication” check box to activate the function. When the function is activated, you can click the up and down arrows to modify the default ACK Timeout value or re-enter it into the text box.
Transmission Mode
You can click the check boxes below to activate the corresponding communication settings:
2-Way LIS/HIS Communication
Auto Communication
Transmit after sample ID modified
Transmit after result modified
Do not transmit samples which need to be reexamined
Only communicate after validation
L-J QC result is communicated in the format of blood sample result
Transmit as Print Bitmap Data
Histogram/Scattergram Transmitted as You can click the pull-down list to select how to transmit histograms/scattergrams:
Not transmitted
Bitmap
Data 5-21
Customizing the Analyzer Software
Lab Info. Setup (“Setup” > “General Setup” > “Lab Info.”) An operator can view lab information from this screen, while an administrator can enter, save and view lab information.
The Lab Information includes: Information
Details
Hospital Name
Name of the hospital where the analyzer is installed
Lab Name
Name of the laboratory where the analyzer is installed
Supervisor
Name of the people in the laboratory who is in charge of the use of the instrument
Contact Info.
Contact information of the supervisor
Zip Code
Zip code of the hospital
Responsible Engineer
Name of the responsible service engineer
Service Contact Info.
Contact information of the responsible service engineer
Comments
You can enter any comments related to the laboratory
Analyzer Model
Model of the analyzer
Analyzer SN
Cannot be edited. The serial numbers of all analyzers that have been connected to this software are listed here by default
Date of Installation
The default installation date is the date on which software of the PC was installed, which cannot be later than the current system date
5.3.2 Para. Setup (Administrator) ("Setup" > "Para. Setup") You can click the following tabs to go to the corresponding setup screens and complete the desired configurations.
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Customizing the Analyzer Software
RUO Para. Setup (“Setup” > “Para. Setup” > “RUO Para. Setup”)
You can click the following check boxes to activate the corresponding RUO parameter settings:
Display "*" flags
Print "*" flags
Display Declaration
Print RUO Parameters
Edit declaration
The default declaration is:” * For research use only, not for diagnostic use.” You can edit the content of declaration in the “Print Declaration” if needed.
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Customizing the Analyzer Software
Define RUO parameters to be printed
After you select “Print RUO Parameters”, all the RUO parameters will be included by default when printing. You can change the default setting to select only desired parameters. In the “Test Panel” pull-down list, select the parameter type (“Blood” or “Body Fluid”), and then select/deselect desired parameter(s) to include/exclude them while printing.
NOTE
If the “Display “*” flags” check box is not selected, the “Display Declaration” check box will gray out and cannot be selected.
If the “Print RUO Parameters” check box is selected, it is recommended to select the “Display “*” flags” check box to ensure that the reader of the printout could identify the RUO parameters.
If the “Print RUO Parameters” check box is not selected, the “Print “*” flags” check box will gray out and cannot be selected.
The RUO-parameter-related settings apply to the display and print of RUO parameters of all samples, before or after the setup is completed.
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Customizing the Analyzer Software
Microscopic Para. Setup (“Setup” > “Para. Setup” > “Microscopic Para. Setup”)
Select sample type
You can click the “Sample Type” pull-down list to select the sample type you set in the “Data Dictionary” setup screen (see 5.3.4 Data Dictionary ("Setup" > "Data Dictionary")).
Add new parameter
Click the “New” button to add a new row in the table, and then you can enter the name of the parameter in the row.
Delete
Select a row in the table, click the “Delete” button to delete the parameter.
Adjust the order
Select a row in the table, click the Order adjusting buttons on the right to move it up/down or to the top/bottom.
Editing parameter name
Click a parameter name in the table to edit the name.
NOTE
You can add up to 40 microscopic parameters.
The reconfigured setup will not be applied to sample records which already have microscopic results saved, but only applied to sample records with unsaved microscopic results and records attained after the new setup is applied.
Custom Para. Setup (“Setup” > “Para. Setup” > “Custom Para. Setup”) If you want to print the parameter results obtained from other measuring device or through manual measurement together with the BC-6800 results, you can configure on the screen. 5-25
Customizing the Analyzer Software
Add a new parameter
1.
Click the “New” button to add a new row.
2.
Enter desired information, like “Abbreviation”, “Para. Name”, “Default”, “Para. Unit”, etc.
3.
If needed, tick the “Add to All Reports” box to add this new parameter to all reports.
NOTE
The abbreviations of custom parameters shall not be the same as any abbreviation of the report parameter of the analyzer. The “Analysis Parameters” are displayed at the bottom of the screen for your reference.
The abbreviation of a custom parameter cannot be null.
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Customizing the Analyzer Software
Set up reference value and upper/lower limits
You can set up to 15 reference groups and define the corresponding target and upper/lower limits. Click the corresponding cells to edit the settings.
Delete
Click to select a custom parameter in the table, and then click “Delete” to delete the parameter.
5.3.3 Access Setup ("Setup" > "Access Setup") The access setup provides different access levels with different functions.
Operator
Changing password
The current user logged in can modify his/her own password. 1.
Select the current user from the table, and then click “Change Password”.
2.
Enter the required information in the text boxes.
3.
Click “OK” to save the change and close the dialog box.
NOTE
The password can not be null and up to 12 characters can be entered.
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Customizing the Analyzer Software
Administrator
Change password
The current user logged in can modify his/her own password. 1.
Select the current user from the table, and then click “Change”.
2.
Enter the required information in the text boxes.
3.
Click “OK” to save the change and close the dialog box.
NOTE
The password can not be null and up to 12 characters can be entered.
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Customizing the Analyzer Software
Add a new user
1.
Click the “New” button.
2.
Enter the “User ID”, “Name”, “Password”, and “Confirm Password”.
3.
Select one of the following access levels from the “Access Level” pull-down list:
4.
Administrator
Operator
Click the “Yes” radio button to display the User ID on the login screen, or Click “No” not to display.
5.
Enter “Comments” if needed.
6.
Click “OK” to save and exit.
NOTE
1.
The user ID cannot be null and up to 12 characters can be entered.
The password can not be null and up to 12 characters can be entered.
The name cannot be null and up to 20 characters can be entered.
The comments can be null and up to 30 characters can be entered.
Edit user information Select a user, and then click “Edit”.
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Customizing the Analyzer Software
2.
Modify the “User ID”, “Name” and/or “Comments” by editing the text in the box(es) as needed.
NOTE
The default administrator user ID (“admin”) can not be edited.
3.
Reselect the “Access Level” if needed.
4.
Enable or disable “Login Screen Display” of the User ID if needed.
5.
Click “OK” to save the change and close the dialog box.
NOTE
The user ID cannot be null and up to 12 characters can be entered.
The name cannot be null and up to 20 characters can be entered.
The comments can be null and up to 30 characters can be entered.
Reset password
An administrator can reset the password (to be the same as the user ID) of all users at the operator and administrator access level Select a user and then click the “Reset Password” button to reset the password to be the same as its user ID.
Delete user
An administrator can delete all users at the operator and administrator access level. Select a user and then click “Delete” to delete it. 5-30
Customizing the Analyzer Software
NOTE
The current user logged in cannot be deleted.
Adjust the order
Select a user in the table, and click the Order adjusting buttons on the right to move it up/down or to the top/bottom.
Authorize functions/accesses
An administrator can authorize the users of the operator access level to perform certain operations or set up certain functions.
To authorize the access to an operator: Find the authority you want to authorize, and check the corresponding box(es) (“PC Workstation” (DMU) and/or “Analyzer End” (SPU)). E.g. if you tick both the “PC Workstation” and “Analyzer End” check boxes of the “Delete Sample” operation, all users of the operator access level are able to delete sample both at the PC and analyzer ends after the setting is saved.
5.3.4 Data Dictionary ("Setup" > "Data Dictionary") You can set up the information provided as options in the pull-down lists of patient information area of the “Report” screen (as for “Sample Type”, it also includes the pull-down lists in the “Microscopic Exam.” tab of the “Review” screen and in the “Microscopic Para. Setup” screen), in order to support quick entry. E.g. if there is a shortcut key of “Department” whose information are as follows: Code: 1; Department: Outpatient; Shortcut Code: OT When you are entering outpatient for the “Department” field of the worklist, you can select “Outpatient” from the pull-down list; or you can enter the code “1” or shortcut code “OT”, and the “Outpatient” option will be popped up in the pull-down list for you to select. The shortcut codes set up on this screen will be displayed in the pull-down lists of patient information text boxes.
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Customizing the Analyzer Software
Add a shortcut code
1.
Select the desired data dictionary item from the left.
2.
Click “Add Shortcut Key”, and a new row will be added in the list on the right.
3.
Enter the information needed for the new row. E.g. to enter the information of a shortcut key for the “Department”: 1) Enter a numeric “Code” (mandatory, up to 9 digits, and can not be the same with existed ones) 2) Enter the finial entry of the “Department” filed (mandatory, up to 20 characters, and can not be the same with existed ones) 3) Enter the “Shortcut code” (optional, up to 20 characters). 4) Enter the “Comments” if needed (optional).
Edit a shortcut code
1.
Select the desired data dictionary item from the left.
2.
Select the row of the shortcut code you want to edit.
3.
Click the column you want to edit one by one and modify
NOTE
You can only edit the “Shortcut Code” and “Comments” columns of the default items.
Delete shortcut code
1.
Select the desired data dictionary item from the left.
2.
Select the row of the shortcut code you want to delete.
3.
Click “Delete Shortcut Key” to delete it.
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Customizing the Analyzer Software
NOTE
You cannot delete the default items.
5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ")
Select one of the following “System of Units” from the pull-down list on top left:
Customize
China
International
US
Canada
Netherlands
UK
If "Customize" is selected, you can select the desired units from the pull-down lists of the “Unit” column. Click the "Restore" button to restore the default units for “Customize”.
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Customizing the Analyzer Software
5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") The “Ref. Ranges” screen provides 5 factory reference groups for your selection. In addition, you can set up to 10 custom reference groups.
Edit custom reference group
To edit a custom reference group, click the cells of custom reference groups in the table on the left and enter information like name of the reference group and age range directly and select the units for the age limits from the pull-down lists. Select a custom reference group; click the “Restore” button to the right of the “Set to Default” button to restore the age setting of the reference group.
NOTE
The information like name, upper/lower age limit and gender of the factory reference group cannot be changed.
The input range of age is [0,999].
Set default reference group
Select a reference group and then click “Set to Default” to set it as the default reference group.
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Customizing the Analyzer Software
Modify/Restore reference range(s)
To modify the reference range of a reference group, select the group from the reference group list on the left, and then click the cells of upper and lower limits in the table and re-enter the values. To restore the reference ranges to default, click the “Default” button on top right of the screen.
Automatic matching of custom reference groups
If you entered the age and/or gender information in the worklist, the analyzer will automatically find the matching reference group (first in the factory groups and then the custom groups) and use the corresponding reference ranges. If you want the analyzer to only find the appropriate reference group in the custom ones, check the “Only match custom ref. groups” check box.
5.3.7 Reexam Rules (Administrator) ("Setup" > "Reexam Rules ") Reexam means to reexamine the analyzed samples whose results match certain conditions. The way to reexam is determined by the laboratory procedure, which may include re-analyze on the analyzer, smear review, etc. You can set up a rule file of reexam rules in the "Reexam Rules” screen. The analyzer will check the sample results and information based on the applied rules to give reexam suggestions. The rule file of 31 default rules provided by the manufacturer is displayed on the "Reexam Rules” screen by default.
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Customizing the Analyzer Software
Introduction to the screen The reexam rule setup screen consists of the rule list area, rule file button area rule editing area and rule button area (from left to right and top to bottom).
Create a rule file 1.
Click the “New File” button on the right of the rule table.
2.
Click “OK”, the default rule table will be overwritten by a blank table.
Edit a rule file
Add a new rule
1.
Click the “Add” button at the bottom of the screen to add a new rule to the table.
2.
Enter the “Group Name” or select from the pull-down list if needed. Categorize the rules into groups can facilitate the check and management of rules.
3.
Enter the “Rule Name” in the rule editing area.
4.
Specify the “Gender” from the pull-down list if needed.
5.
Specify the age range by entering the ages and selecting the units if needed.
6.
Enter the desired rules in the “Parameter Rules” field; Or click the “Setup” button to the right of the “Parameter Rules” field, and then edit the rule in the pop-up box shown below.
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Customizing the Analyzer Software
Click “OK” after finish editing to close the dialog box. And the rule will be displayed in the “Parameter Rules” field. 7.
If you want to include “Flagging Rules”, you shall select “AND” or “OR” in the “Relation” pull-down list to define the relationship between flagging rules and other types of rules.
8.
Enter the desired rules in the “Flagging Rules” field; Or click the “Setup” button to the right of the “Flagging Rules” field, and then edit the rule in the pop-up box shown below.
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Customizing the Analyzer Software
Click “OK” after finish editing to close the dialog box. And the rule will be displayed in the “Flagging Rules” field. 9.
If you want to include “Delta check” rules, you shall select “AND” or “OR” in the “Relation” pull-down list to define the relationship between delta check rules and other types of rules.
10.
Enter the desired rules in the “Delta check” field; Or click the “Setup” button to the right of the “Delta check” field, and then edit the rule in the pop-up box shown below.
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Customizing the Analyzer Software
Click “OK” after finish editing to close the dialog box. And the rule will be displayed in the “Delta check” field. 11.
Click other rules in the rule list (if there are no other rules, click “Add” or “Copy”) to save the setup.
Apply rule(s)
Click the check box(es) in the “Apply” column of the rule list to apply the corresponding rule(s). You can also apply a group of rules by select the group name from the “Group Filter” pull-down list.
Adjust order of the rules
Select rules first and then click the buttons in the order adjusting area to move the rules up/down or to the top/bottom.
Edit a rule
Select the rule and edit its content in the box below. When editing completes, click other rules 5-39
Customizing the Analyzer Software in the rule list (if there are no other rules, click “Add” or “Copy”), the change will be saved automatically. 1.
Delete a rule Select the rule you want to delete and then click “Delete”, a dialog box below will pop up.
2.
Click “OK” to delete the rule and close the dialog box.
Copying rules
1.
Select the rule you want to copy and then click “Copy”, a dialog box below will pop up.
2.
Enter name of the new rule into the “Rule Name” field.
3.
Click “OK” to save the rule and close the dialog box.
Import a rule file You can also import custom rules per the following procedure: 1.
Click the “Import” button to the right of the rule table, a dialog box below will pop up.
2.
Click “OK” and browse to the rule file to be imported in the pop-up dialog box.
3.
Click “Open”, the rules of the new rule file will be displayed in the rule list area. 5-40
Customizing the Analyzer Software
Export a rule file 1.
Click the “Export” button to the right of the rule table.
2.
Browse to the directory you want to export the rule file in the pop-up dialog box.
3.
Click “Save” to export the rule file.
Restore the default rule file 1.
Click the “Restore Default Rules” button to the right of the rule table, a dialog box below will pop up.
2.
Click “OK”, the dialog box will be closed and the rules of the default rule file will be displayed in the rule list area.
5.3.8 Flag Setup ("Setup" > "Flag Setup") The flag setup screen provides a list of all flagging rules. When a result meets the requirement of the rule, the corresponding flag will be displayed. You can edit the flagging rules based on the needs and related procedure of your laboratory.
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Customizing the Analyzer Software 1.
Edit a flagging rule Click to select a rule from the flagging rule table, and the name and rule will be displayed under the table.
2.
If there is only one rule in the “Flagging Rules” field, click the value in the rule and edit. If there are more than one rule in the “Flagging Rules” field, tick to select one of the rules. Then click the value in the rule and edit.
3.
Click another rule in the table, a dialog box will pop up asking you whether to save the change. Click “Yes” to save the change.
Restore default rule
1.
Select a rule which has been edited from the table.
2.
Click the “Restore” button to restore the default value.
3.
Click another rule in the table, a dialog box will pop up asking you whether to save the change. Click “Yes” to save the change.
5.3.9 Screen Display ("Setup" > "Screen Display ") You can set up the style of screen display from this screen.
Click the radio buttons to select the way of menu display and font size.
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6
Operating Your Analyzer
6.1 Introduction This chapter provides step-by-step procedures for operating your analyzer on a daily basis. A flow chart presenting the common daily operating process is shown below.
Initial Checks Switch on the analzyer and open PC software
Power on
Daily Quality Control
Sample Collection and Handling
Run Samples
Switch off the analyzer and close PC software
Shutdown
6-1
Operating Your Analyzer
6.2 Initial Checks Perform the following checks before turning on the analyzer.
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Keep your clothes, hair and hands away from the moving parts to avoid injury.
NOTE
You should only use the Mindray-specified reagents. Store and use the reagents as instructed by instructions for use of the reagents.
Before using the analyzer, make sure reagents are properly connected.
After installing a new container of reagent, keep it still for a while before use.
Checking the waste container
Check and make sure the waste container is empty.
Checking tubing and power connections
Check and make sure the reagents, waste and pneumatic unit tubes are properly connected and not bent. Check and make sure the power cords of the analyzer and the pneumatic unit are properly 6-2
Operating Your Analyzer plugged into the power outlet.
Checking the printer (optional)
6-3
Operating Your Analyzer
6.3 Startup 1.
Start up the PU and SPU Place the power switch at the back of the PU in the ON position (I).
NOTE
Since the pneumatic unit is controlled by the analyzer, the power switch of the pneumatic unit can be kept in the ON position (I).
2.
Place the power switch at the left side of the SPU in the ON position (I). The power indicator light will be on.
3.
Press the power button to turn on the analyzer. The power indicator will turn from orange to green.
4.
The analyzer will automatically perform the self-test procedure, background cycle and initialize the systems.
NOTE
Time needed for initializing the fluidic systems depends on how the analyzer was previously shut down.
Background check of the analyzer measures the particle interference and electrical interference.
If the first background result obtained during the fluidic initialization process is out of the specified range, the analyzer will perform background check again.
The sample ID corresponds to background check result is “0”.
The analyzer does not flag background check result with H/L or suspect flag.
5
After the initialization process, you will go to the sample analysis screen.
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Operating Your Analyzer
NOTE
The system determines your access level (operator or administrator) base on the password you entered and provides different function on each screen per the access level.
To switch the access level, tap “Logout” from the main menu. Enter the desired password in the popup dialog box, and then tap “OK” to log in.
Switch user
1.
Tap “Menu” > “Logout”.
2.
Tap “Yes”.
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Operating Your Analyzer
3
Enter the correct password in the “Password” box, and then tap “OK”. Start up the external PC and run software of the PC:
1.
Power on the PC and the display.
2.
After entering the operation system, double click the icon “BC-6800 Auto Hematology Analyzer” to run the software installed.
3
When the following startup screen shows, select a desired user displayed on the screen and enter the password, or click “Other Users” to enter the “User ID” and “Password”.
6-6
Operating Your Analyzer 4. Click the
button or press “Enter”.
NOTE
If you fail to launch the software after tried for many times, please contact Mindray customer service department or your local distributor.
After the startup procedure completes, check if the date/time on the analyzer and the PC are correct.
1-12 characters are allowed for user name and password; Chinese characters are not allowed; neither user name nor password can be null.
5.
When initialization completes, if there is any sample not run or failed to be analyzed successfully in the worklist, a dialog box will pop up.
6-7
Operating Your Analyzer 6.
Click “Yes” to save the samples in the worklist; they will be analyzed later on; or click “No” to delete the samples from the worklist; they will not be analyzed.
NOTE
If error occurs during the initialization process (e.g. background result exceeds the specified range), the analyzer will send alarm, see Chapter 11 Troubleshooting for solutions.
Refer to Appendix B Specifications for the background range of each parameter.
The system determines your access level (operator or administrator) base on the password you entered and provides different function on each screen per the access level.
If user switching is necessary, CLICK the “Logout” icon at the “Main” screen. Enter the desired user name and the password into the popup dialog box and CLICK the “Ok” button to log in.
Running sample with the background abnormal error present will lead to unreliable results.
There is no restriction on the launching order of the analyzer software and PC software.
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Operating Your Analyzer
6.4 Daily Quality Control Before running any samples, run the controls. See Chapter 8 Using the QC Programs for details.
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Operating Your Analyzer
6.5 Entering the “Count” Screen Tap “Menu” →"Sample Analysis” to enter the screen below. Menu
Utility Buttons
Sample info.
Button
Analysis
Error
System
area
area
result area
message
time
NOTE
If the blood mode is switched from the “WB” to “PD” or the sampling mode is changed, the analyzer will switch modes automatically and give the prompt on the screen.
Menu button
Tap the MENU button on the top left of the screen to open the system menu. Tap a menu option to open the submenu or enter the corresponding screen or dialog box.
6-10
Operating Your Analyzer Utility buttons
Name
Icon
Function
Count
Tap to enter the "Count" screen
Table
Tap to enter the "Table" Review screen
QC
Tap to enter the "QC" screen
Reagent
Tap to enter the "Reagent" Setup screen
Service
Tap to enter the "Service" screen
DILUENT
When the mode is OV-PD, tap "Diluent" to dispense diluent
Analysis result area
This area displays the analysis result of the current sample (including flag messages, histograms, scattergrams, etc.).
Sample information area
This area displays the information of the current and the next sample.
Button area
Tap buttons in this area, the corresponding screen or dialog box will pop up, or the corresponding function will be realized.
Error information area
When error occurs, this area displays the error message.
System time
This area displays the current system time.
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Operating Your Analyzer
NOTE
Background check of the analyzer measures the particle interference and electrical interference.
The sample ID corresponds to background check result is “0”.
Running sample with the presence of the background abnormal error will lead to unreliable results.
If error occurs during the startup process, the error information will be displayed in the error information area after you log in. You should solve the error first before performing any operation. See Chapter 11 Troubleshooting for the way to clear the error.
6.6 Preparing Samples
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
Do not contact patients' sample blood directly.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Prepare
samples
per
the
procedure
recommended
by
the
tube
manufacturer.
The samples collected in capillary tubes must be analyzed with the tubes not capped under open vial mode.
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Operating Your Analyzer
NOTE
Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary tubes.
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
6.6.1 Whole blood samples 1.
Use clean K2EDTA (1.5 - 2.2mg/mL) anticoagulant collection tubes to collect venous blood samples.
2.
Mix the sample according to your laboratory's protocol.
CAUTION
To attain accurate analysis results, make sure the sample volume is no less than 1.0ml in the autoloading mode, and no less than 0.5ml in the open-vial mode (predilute not included).
Before running the refrigerated
(2℃ - 8℃) samples, warm them at room
temperature for at least 30 minutes.
Be sure to mix well any sample that has been prepared for a while before running it.
6.6.2 Prediluted samples 1.
Tap the “Mode” button at the “Count” screen.
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Operating Your Analyzer
2.
Select “OV-PD”, and then click “OK” to switch to the predilute mode.
3.
Tap the utility button “Diluent”.
NOTE
The number in the “Cancel” button shows the number of diluent dispensation after your last tapping of the “Diluent” button.
4.
Present a clean uncapped centrifugal tube to the sample probe and make sure the probe go deep into the bottom of the tube, as the figure shows, to avoid spills, hangings 6-14
Operating Your Analyzer and bubbles.
5
Press the Aspirate key to start dispensing the diluent.
6
Remove the centrifugal tube when the buzzer sounds.
7
Add 40μL of capillary blood to the diluent, close the tube cap and shake the tube to mix the sample.
8
After the prediluted sample is prepared, tap the “Cancel” button to quit dispensing the diluent.
9.
If more portions of diluent are needed, repeat the procedure 3-5.
NOTE
You can also aspirate 140μL of diluent by pipette into the tube.
Be sure to keep dust from the prepared diluent.
After mixing the capillary sample with the diluent, be sure to wait 3 minutes before running the sample.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Be sure to evaluate predilute stability based on your laboratory's sample population and sample collection techniques or methods. 6-15
Operating Your Analyzer
6.6.3 Body fluid samples 1.
Use clean EDTA anticoagulant collection tubes, centrifugal tubes or syringes to collect body fluid samples.
2.
Mix the sample according to your laboratory's protocol.
CAUTION
It is recommended to treat body fluid samples using EDTA anticoagulant.
No additional reagents, quality control or calibrator is required for body fluid sample analysis.
To attain accurate analysis results, make sure the body fluid sample volume is no less than 0.2ml. If the body fluid sample needs to be reexamined, the recommended sample volume is no less than 0.5ml.
To attain accurate analysis results, it is recommended to finish the analysis of body fluid samples within 1 hour after collection. If the body fluid sample can not be analyzed promptly, store it at 2~8℃, and finish the analysis within 4 hours.
Be sure to mix well any sample that has been prepared for a while before running it.
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Operating Your Analyzer
6.7 Sample Analysis in the OV Mode 6.7.1 Selecting work mode At the "Count” screen, tap the "Mode" button, the dialog box below will pop up.
Abbreviations used for modes: Abbreviation
Indication
OV
Open-Vial
AL
Autoloading
WB
Whole-Blood
PD
Predilute
BF
Body Fluid
C
CBC
D
DIFF
N
NRBC
R
RET
Running without following the worklist 1.
At the "Mode" screen, tap "OV-WB", "OV-PD" or "OV-BF" radio button to select the presentation mode and sample type.
2.
Tap any radio button in the analysis mode area at the bottom left of the screen to set the 6-17
Operating Your Analyzer analysis mode. 3.
If necessary, edit the sample ID of the next sample in the "Sample ID" box; the default ID will be used if you did not edit the sample ID. For details of setup related to the entry of sample ID, see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup").
4.
Tap "OK" button to save the data entered and return to the "Count” screen.
Running following the worklist 1.
At the "Mode" screen, tap "OV-WB", "OV-PD" or "OV-BF" radio button to select the presentation mode and sample type..
2.
Check the "Run as per Worklist" check box, the analyzer will search for the matched sample IDs automatically under OV mode.
If there are matching results, the analysis will be performed per the mode in the worklist.
If there are no matching results, and open vial analysis is performed for the first time, the analysis will be performed per the presentation mode you selected and the default analysis mode "C+D".
If there are no matching results, and open vial analysis is not performed for the first time, the analysis will be performed per the mode of the previous sample analyzed.
3.
Tap "OK" button to save the data entered and return to the "Count” screen.
NOTE
When analysis mode is shifted from "Whole Blood" to "Predilute" or sampling mode changes, the analyzer will switch mode automatically and pop-up message will be displayed.
25 characters are allowed for sample ID maximally (including prefix); the ID must end with a number, and must not be consisted of "0" only.
The default sample ID under open vial mode is determined by the setting of "Entry of next sample ID", see 5.3.1 General Setup ("Setup" > "General Setup") for the setup method.
When the analyzer is not connected with the PC, the "Run as per worklist" button is gray, the function is deactivated.
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Operating Your Analyzer
6.7.2 Entering Worklist Information You can enter the work list information for the next sample at the DMU before running it.
NOTE
If the analyzer is shut down abnormally, you will lose the worklist information of the samples that have not been saved yet.
If you want to enter the worklist information after the analysis, see Chapter 7 Reviewing Sample Results for details.
Click "Worklist" from the DMU software to enter the "Worklist" screen.
Click "New", a new entry will be built in the list area, and then you can enter the sample information (mandatory) and patient information (if needed) in the data entry area below.
Enter sample ID
Enter the sample ID in the “Sample ID” field. If the “Entry of Next Sample ID” is set to be “Auto Increase” (see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup")), the default "Sample ID" will increase by 1 when you add a new entry again.
NOTE
25 characters are allowed for sample ID maximally (including prefix); the ID must end with a number, and must not be consisted of "0" only.
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Operating Your Analyzer
Select mode
Click the pull-down lists to select the presentation mode, sample mode and test panel.
Enter patient ID
Enter the patient ID in the "Patient ID" field.
Enter patient name
Enter the patient name into the "First Name" and “Last Name” Fields.
Enter/Select patient gender
Enter the gender of the patient in the "Gender" field or select it from the "Gender" pull-down list.
Enter the patient's date of birth
Enter the patient's date of birth into the "Date of birth" field, or click the pull-down arrow to select the date of birth from the date control.
Enter patient age
The analyzer provides four ways for you to enter the patient's age: in years, in months, in days and in hours. The first way is designed for adults or pediatric patients older than one year; the second for infant patients who are one month to one year old; the third for neonatal patients no older than one month and the fourth the neonatal no older than 24 hours. You can choose only one of the four ways to enter the patient age. Select from “Year(s)”, “Month(s)”, “Day(s)” or “Hour(s)” in the “Age” pull-down list, and then define the corresponding value before the pull-down list.
NOTE
If the patient's date of birth is entered, his/her age will be calculated automatically, and the age field will gray out and cannot be edited
Select ref. group
Select the reference group for the sample from the "Ref. Group" pull-down list. Different reference groups have different reference ranges based on which the analyzer gives high and low flags of analysis results. See 5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") for details.
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Operating Your Analyzer
NOTE
If the patient's gender and age are entered, then the matching ref. group will be automatically displayed.
Enter/Select department name
Enter the name of the department into the “Department” field or select it from the “Department” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select ward name
Enter the name of the ward into the “Ward” field or select it from the “Ward” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select Bed No.
Enter the bed No. of the patient into the “Bed No.” field or select it from the “Bed No.” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select sample type
Enter the sample type into the “Sample Type” field or select it from the “Sample Type” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter draw time
Enter the date and time when the sample is drawn into the “Draw Time” field or click the pull-down arrow and select from the date control.
Enter order time
Enter the time when the analysis order is put into the "Order Time" field or click the pull-down arrow and select the time from the date control.
NOTE
The order time shall not be earlier than the draw time.
The draw time and order time shall not be later than the current system time.
Enter deliverer name
Enter the name of the person who deliver the test order to the laboratory into the "Delivered by" field or select it from the "Delivered by" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). 6-21
Operating Your Analyzer
Enter clinical diagnosis
Enter the clinical diagnosis result into the "Diagnosis" field or select it from the "Diagnosis" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much clinical diagnosis information to be entered, click the ">" button after the "Diagnosis" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
Enter comments
Enter comments into the "Comments" box or select it from the "Comments" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much information to be entered, click the ">" button after the "Comments" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
Save
After you finish editing the worklist, click "Save" button to save the information.
6.7.3 Sample Analysis Procedure
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
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Operating Your Analyzer
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Sample agglutination may result in inaccurate analysis result. Check if the sample is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory.
NOTE
After starting analysis, do not open the front cover of the analyzer.
The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may spill.
Proper reference range shall be selected at the "Setup" screen of the PC before analysis. Otherwise, the results may be flagged erroneously.
If you start sample analysis immediately after selecting work mode, then the default reference range is "General”. After the analysis finishes, the analyzer will flag results per the reference range "General".
Running whole blood samples 1.
Make sure that the presentation mode displayed in the "Next sample" information area of the count screen is shows OV-WB.
2.
Shake the tube of whole blood sample as instructed by the picture below to mix the sample thoroughly.
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Operating Your Analyzer 3.
When it is ready to run a sample (i.e. the analyzer indicator is green), present the whole blood sample to the sample probe.
4.
Press the aspirate key to start sample analysis.
5.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample, the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically.
6.
When the analysis finishes, the analyzer indicator return to green.
7.
Run the rest samples as instructed above.
Running prediluted samples 1.
Make sure the presentation mode displayed in "Next sample" information area of the count screen shows OV-PD.
2.
Shake the capped tube of the prediluted sample to mix it thoroughly.
3.
When it is ready to run a sample (i.e. the analyzer indicator is green), open the cap of the sample tube carefully and present the sample to the sample probe.
4.
Press the aspirate key, a dialog box will pop up.
5.
Press the aspirate key to close the dialog box and start analysis.
NOTE
You can choose to disable the dialog box before predilute analysis. See 5.2.1Date Setup for the setup method.
6.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample, the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically.
7.
When the analysis finishes, the analyzer indicator return to green.
8.
Run the rest samples as instructed above.
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Operating Your Analyzer
Running body fluid samples 1.
Make sure that the presentation mode displayed in the "Next sample" information area of the count screen is shows OV-BF.
NOTE
Body fluid samples can only be analyzed in open-vial mode. Check whether the presentation mode is correct before analyzing body fluid samples.
2.
Shake the tube of sample as instructed by the picture below to mix it thoroughly.
3.
When it is ready to run the sample (i.e. the analyzer indicator is green), present it to the sample probe.
NOTE
Misleading results may occur if the body fluid sample has floccules, clots. cryoglobulin, leukocyte clumps, bacteria, or high protein. Follow your laboratory protocol to deal with such samples.
4.
Press the aspirate key to start sample analysis.
5.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample, the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically.
6.
When the analysis finishes, the analyzer indicator return to green.
7.
Run the rest samples as instructed above.
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Operating Your Analyzer
NOTE
During the analysis, you can perform any operation (including new, edit and cancel, etc.) to other "Ready" or "Error" samples in the work list.
When the analyzer is running, all the functions related to the fluidics sequence can not be used.
If you were not at the review screen, then when you switch to the review screen, the latest record information together with its results and graph will be displayed.
During the analysis process, if errors like clog or bubble occur, the analyzer will automatically display the results of related parameters as invalid, and alarm information will show on the error information area. See Chapter 11 Troubleshooting for the way to remove errors.
If the ambient temperature is outside the specified operating range, the analyzer will alarm you for abnormal ambient temperature and the analysis results may be unreliable. See Chapter 11 Troubleshooting for solutions.
6.7.4 Special Functions Automatic saving of analysis results This analyzer automatically saves sample results. When the maximum number of results that can be saved has been reached, the newest result will overwrite the oldest.
Parameter flags
If the parameter is followed by a high/low flag ("H"/"L" by default), it means the analysis result has exceeded the upper or lower limit of the reference range, but still within the display range.
If the parameter is follow by the suspect flag ("R" by default), it means the analysis result is suspicious.
If the parameter is followed by a "&", it means that the corresponding result is rectified by the algorithm of the instrument.
If the parameter is followed by an "@", it means that the result is out of the linearity range.
If a result is indicated by “*****”, it means the result is invalid.
If a result is indicated by “++++”, it means the result is out of the display range.
NOTE
The results of background check will not be flagged for abnormal
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Operating Your Analyzer parameters, abnormal blood cell differential or morphology.
You can change the default flags on the PC, see 5.3.1 General Setup ("Setup" > "General Setup") for reference.
Flags of Abnormal Blood Cell Differential or Morphology
CAUTION
Abnormal cells may not necessarily trigger the flags during the analysis process, it is recommended that reexamination is conducted per the operation instruction of your laboratory.
Flag Message
Indication
Criteria
WBC Scattergram
Abnormal distribution of
The distribution of DIFF scattergram and/or
Abn.
WBC scattergram
BASO scattergram is abnormal
NRBC Scattergram Abnormal distribution of
NRBC scattergram is abnormal
Abn.
NRBC scattergram
Neutropenia
Neu# low
Neu# < 1.00×10^9/L
Neutrophilia
Neu# high
Neu# > 11.00×10^9/L
Lymphopenia
Lym# low
Lym# < 0.80×10^9/L
Lymphocytosis
Lym# high
Lym# > 4.00×10^9/L
Monocytosis
Mon# high
Mon# > 1.50×10^9/L
Eosinophilia
Eos# high
Eos# > 0.70×10^9/L
Basophilia
Bas# high
Bas# > 0.20×10^9/L
Leukopenia
WBC low
WBC < 2.50×10^9/L
Leukocytosis
WBC high
WBC > 18.00×10^9/L
NRBC present
NRBC detected in the
NRBC% > 1% and NRBC# > 0.01
NRBC channel Blasts?
Possible presence of
Presence of excessive dots in blast sensitive
blasts
region of the scattergram
Abn Lympho/
Possible presence of
Presence of excessive dots in abnormal
Blasts？
abnormal lymphocytes or
lymphocyte/blast sensitive region of the
blasts
scattergram
Possible presence of
Presence of excessive dots in immature
immature granulocytes
granulocyte sensitive region of the
Immature Gran?
scattergram Left Shift?
Possibility of left shift
Presence of excessive dots in left shift sensitive region of the scattergram
Atypical Lymph?
Possible presence of
Presence of excessive dots in atypical
atypical lymphocytes
lymphocyte sensitive region of the scattergram 6-27
Operating Your Analyzer NRBC?
Possible presence of
Presence of excessive dots in NRBC sensitive
NRBC
region of the scattergram
RBC Lyse
Possibility of RBC lyse
Presence of abnormally distributed dots in
resistance?
resistance
WBC sensitive region of the WBC scattergram
RBC Histogram
Abnormal distribution of The distribution of RBC histogram is abnormal
Abn.
RBC histogram
RET Scattergram
Abnormal distribution of
The distribution of RET scattergram is
Abn.
RET scattergram
abnormal
Dimorphic
Two or more wave crests
Two or more wave crests in the RBC
Population
in the RBC histogram
histogram
Reticulocytosis
RET high
RET% > 5% or RET#>0.20×10^12/L
Anisocytosis
Anisocytosis
RDW-CV> 22 or RDW-SD > 64fL
Microcytosis
MCV low
MCV < 70fL
Macrocytosis
MCV high
MCV > 110fL
Hypochromia
Hypochromia
MCHC 6.5×10^12/L
RBC
RBC results possibly
Calculate and compare special parameters
Agglutination？
inaccurate
Turbidity/HGB
Hemoglobin abnormal or
Interference?
there is HGB interference
Iron Deficiency?
Possibility of iron
Calculate and compare special parameters Calculate and compare special parameters
deficiency Fragments?
Possible presence of RBC
Presence of abnormally distributed dots in
fragments
sensitive region of the RET channel
PLT Scattergram
Abnormal distribution of
The distribution of PLT scattergram is
Abn.
PLT scattergram
abnormal
PLT Histogram Abn. Abnormal distribution of The distribution of PLT histogram is abnormal PLT histogram Thrombopenia
PLT low
PLT600×10^9/L
PLT Clump?
Possibility of PLT clump
Calculate and compare special parameters
Pancytopenia
WBC, RBC and PLT low
WBC < 4.0 and RBC < 3.5 and PLT < 100
Lipid Particles?
Possible presence of lipid
Presence of excessive dots in lipid particle
particles
sensitive region of the scattergram
Possible presence of
Presence of excessive dots in infected RBC
infected RBC
sensitive region of the scattergram
Infected RBC?
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Operating Your Analyzer
6.8 Sample Analysis in the Autoloading Mode 6.8.1 Enter Worklist Information You can enter the work list information for the next sample at the DMU before running it.
NOTE
If the analyzer is shut down abnormally, you will lose the worklist information of the samples that have not been saved yet.
If you want to enter the worklist information after the analysis, see Chapter 7 Reviewing Sample Results for details.
Click "Worklist" from the DMU software to enter the "Worklist" screen.
Click "New", a new entry will be built in the list area, and then you can enter the sample information (mandatory) and patient information (if needed) in the data entry area below.
Enter sample ID
Enter the sample ID in the “Sample ID” box. If the “Entry of Next Sample ID” is set to be “Auto Increase” (see Auxiliary setup > Sample ID setup in 5.3.1 General Setup ("Setup" > "General Setup")),, the default "Sample ID" will increase by 1 when you add a new entry again.
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Operating Your Analyzer
NOTE
25 characters are allowed for sample ID maximally (including prefix); the ID must end with a number, and must not be consisted of "0" only.
Select mode
Click the pull-down lists to select the presentation mode, sample mode and test panel.
Enter rack number and tube number
Enter the rack number and tube number in the corresponding fields. When you add a new entry again, the default rack number-tube number will increase by 1 (if the previous rack number-tube number reaches the upper limit, then the numbers will both turn to be 1).
NOTE
The rack number shall be no greater than 100, while the tube number shall be no greater than 10.
Enter patient ID
Enter the patient ID in the "Patient ID" field.
Enter patient name
Enter the patient name into the "First Name" and “Last Name” Fields.
Enter/Select patient gender
Enter the gender of the patient in the "Gender" field or select it from the "Gender" pull-down list.
Enter the patient's date of birth
Enter the patient's date of birth into the "Date of birth" field, or click the pull-down arrow to select the date of birth from the date control.
Enter patient age
The analyzer provides four ways for you to enter the patient's age: in years, in months, in days and in hours. The first way is designed for adults or pediatric patients older than one year; the second for infant patients who are one month to one year old; the third for neonatal patients no older than one month and the fourth the neonatal no older than 24 hours. You can choose only one of the four ways to enter the patient age. 6-30
Operating Your Analyzer Select from “Year(s)”, “Month(s)”, “Day(s)” or “Hour(s)” in the “Age” pull-down list, and then define the corresponding value before the pull-down list.
NOTE
If the patient's date of birth is entered, his/her age will be calculated automatically, and the age field will gray out and cannot be edited
Select ref. group
Select the reference group for the sample from the "Ref. Group" pull-down list. Different reference groups have different reference ranges based on which the analyzer gives high and low flags of analysis results. See 5.3.6 Ref. Ranges (Administrator) ("Setup" > "Reference Ranges") for details.
NOTE
If the patient's gender and age are entered, then the matching ref. group will be automatically displayed.
Enter/Select department name
Enter the name of the department into the “Department” field or select it from the “Department” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select ward name
Enter the name of the ward into the “Ward” field or select it from the “Ward” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select Bed No.
Enter the bed No. of the patient into the “Bed No.” field or select it from the “Bed No.” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter/Select sample type
Enter the sample type into the “Sample Type” field or select it from the “Sample Type” pull-down list (if defined in data dictionary. See 5.3.4 for details).
Enter draw time
Enter the date and time when the sample is drawn into the “Draw Time” field or click the pull-down arrow and select from the date control.
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Operating Your Analyzer
Enter order time
Enter the when the analysis order is put into the "Order Time" field or click the pull-down arrow and select the time from the date control.
NOTE
The order time shall not be earlier than the draw time.
The draw time and order time shall not be later than the current system time.
Enter deliverer name
Enter the name of the person who deliver the test order to the laboratory into the "Delivered by" field or select it from the "Delivered by" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details).
Enter clinical diagnosis
Enter the clinical diagnosis result into the "Diagnosis" field or select it from the "Diagnosis" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much clinical diagnosis information to be entered, click the ">" button after the "Diagnosis" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
Enter comments
Enter comments into the "Comments" box or select it from the "Comments" pull-down list (if defined in data dictionary. See 5.3.4 Data Dictionary ("Setup" > "Data Dictionary") for details). If there is too much information to be entered, click the ">" button after the "Comments" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
Save
After you finish editing the worklist, click "Save" button to save the information.
6.8.2 Sample Analysis Procedure
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
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Operating Your Analyzer when handling them and the contacted areas in the laboratory.
WARNING
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Repeated piercing the cap of the evacuated blood collection tube may damage the cap, and the scraps produced may result in inaccurate analysis results. It is recommended that each tube is pierced for no more than 3 times.
Be sure that the entered sample ID, rack No., tube No. and the analysis mode are strictly in accordance with the sample to be run.
Do not run prediluted samples under the autoloading mode to ensure the correctness of analysis results.
Sample aggregation may result in inaccurate analysis result. Check if the sample is aggregated before analysis, if yes, handle per the operation requirements of your laboratory.
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Operating Your Analyzer
NOTE
Proper reference range shall be selected at the "Setup" screen before analysis. Otherwise, the results may be flagged erroneously.
If the 2-way LIS/HIS mode is selected, then after the sample ID is entered/scanned and saved, all the corresponding information will be obtained from the LIS/HIS, and then the analyzer starts running per the obtained information. Once the running is finished, the result, graph and sample/patient information will be uploaded to the LIS/HIS.
If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed.
Running without following the worklist and without automatic scan of sample ID and rack No. 1.
When it is ready to run a sample (i.e. the analyzer indicator is green), tap the "Mode" button at the “Count” screen, the "Mode" dialog box will pop up.
2.
Select "AL-WB"; do not select the following options: "Run as per worklist", “Auto-Scan rack No.” and "Auto-Scan sample ID".
NOTE
When the analyzer is not connected with the PC, the "Run as per
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Operating Your Analyzer worklist" button is gray, the function is deactivated.
The selection status of "2-Way LIS/HIS" check box is determine by the communication setup at the PC end, you cannot select/deselect it on the analyzer.
3.
Select the desired analysis mode, enter the starting sample ID, rack No. and tube No.
4.
Place the tubes into the corresponding tube positions according to the starting rack No. and tube No. entered.
5.
Place the racks with tubes on the right tray of the autoloader, with the back of the carrier (where the “MINDRAY” mark is located) facing the analyzer.
6.
Tap "OK" button to close the mode dialog box, and then tap the "Start Count" button on the “Count” screen, the analyzer will automatically start to run in order from the preset starting position. During this process, the analyzer indicator is flickering in green.
7.
After every analysis cycle, the results will be displayed on the analysis result area and saved to the sample database.
8.
When the analyses are finished, a statistical result dialog box will pop up.
NOTE
You can choose to select or deselect "Display statistics after autoloading finishes" at the "Autoloader" setup screen.
If the results of “Rack Vacancy” and/or “ID reading errors” on the statistical result dialog box are not 0, you can tap the "Detail…" button to check the sample ID, analysis time and sample position of the corresponding samples.
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Operating Your Analyzer 9.
Tap "OK" button to close the dialog box, the analyzer indicator will return to green.
10.
When the autoloading analyses are finished, all the tube racks are moved to the left tray of the autoloader automatically, and then you can remove the racks of tubes safely.
NOTE
If “Run as per worklist”, "Automatic scan of sample ID" and "Automatic scan of rack No." are not selected, then no running and other actions will be taken to the records in the worklist.
If more racks are needed when running the samples, you should load the rack from the right of the autoloader while removing the completed rack from the left of the autoloader in time.
Running following the worklist but without automatic scan of sample ID and rack No. 1.
Make sure the analyzer and the PC are properly connected.
2.
When it is ready to run a sample (i.e. the analyzer indicator is green), tap the "Mode" button at the “Count” screen, the "Mode" dialog box will pop up.
3.
Select "AL-WB", and select "Run as per worklist", do not select “Auto-Scan rack No.” or “Auto-Scan sample ID”.
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Operating Your Analyzer
NOTE
When the analyzer is not connected with the PC, the "Run as per worklist" button is gray, the function is deactivated.
The selection status of "2-Way LIS/HIS" check box is determine by the communication setup at the PC end, you cannot select/deselect it on the analyzer.
4.
Mark sample ID on the prepared sample tubes manually according to the sample information in the worklist, and place the tubes into the corresponding tube positions.
5.
Place the racks with tube on the right tray of the autoloader, with the back of the carrier (where the “MINDRAY” mark is located) facing the analyzer.
6.
Tap "OK" button to close the mode dialog box, and then tap the "Start Count" button on the “Count” screen, the analyzer will automatically start to run in order of the tube positions. During this process, the analyzer indicator is flickering in green.
7.
After every analysis cycle, the results will be displayed on the analysis result area and saved to the sample database.
8.
When the analyses are finished, a statistical result dialog box will pop up.
NOTE
You can choose to select or deselect "Display summary after autoloading finishes" at the "Autoloader" setup screen.
If the results of “Rack Vacancy” and/or “ID reading errors” on the statistical result dialog box are not 0, you can tap the "Detail…" button to check the sample ID, analysis time and sample position of the corresponding samples.
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Operating Your Analyzer 9.
Tap "OK" button to close the dialog box, the analyzer indicator will return to green.
10.
When the autoloading analyses are finished, all the tube racks are moved to the left tray of the autoloader automatically, and then you can remove the racks of tubes safely.
NOTE
For the unhidden samples whose status is “Ready” or “Error” in the worklist (of the autoloading sampling mode), the analyzer will run the samples according to the order of sample positions.
In the "Mode" dialog box, the entry of the grayed fields (sample ID, rack No., tube No. and analysis mode) comes from the first (tube position) unhidden sample in autoloading mode whose status is ready or error.
When "Run as per worklist", if the current tube is excluded in the worklist, the analyzer will still jump it without running.
If more racks are needed when running the samples, you should load the rack from the right of the autoloader while removing the completed rack from the left of the autoloader in time.
Running without following the worklist but with automatic scan of sample ID and rack No. 1.
When it is ready to run a sample (i.e. the analyzer indicator is green), tap the "Mode" button at the “Count” screen, the "Mode" dialog box will pop up.
6-38
Operating Your Analyzer 2.
Select "AL-WB" and select “Auto-Scan rack No.” and/or “Auto-Scan sample ID”, do not select "Run as per worklist".
NOTE
When the analyzer is not connected with the PC, the "Run as per worklist" button is gray, the function is deactivated.
The selection status of "2-Way LIS/HIS" check box is determine by the communication setup at the PC end, you cannot select/deselect it on the analyzer.
3.
Select analysis mode on the left, if “Auto-Scan sample ID” is not selected, enter the sample ID; if "automatically scan tube No." is not selected, enter the starting rack No. and tube No. of the sample to be run. If both options are selected, those data cannot be edited.
4.
If “Auto-Scan sample ID” is selected, place labels on the tubes properly (see 6.8.4 for how to place labels), and then place them into the corresponding tube positions properly as shown in the figure below.
5.
Place the racks with tubes on the right tray of the autoloader, with the back of the carrier (where the “MINDRAY” mark is located) facing the analyzer.
6.
Tap "OK" button to close the mode dialog box, and then tap the "Start Count" button on the “Count” screen, the analyzer will automatically scan sample ID and/or rack No. from the preset starting position. During this process, the analyzer indicator is flickering in green.
7.
After every analysis cycle, the results will be saved to the Review screen. 6-39
Operating Your Analyzer 8.
When the analyses are finished, a statistical result dialog box will pop up.
NOTE
You can choose to select or deselect "Display statistics after autoloading finishes" at the "Autoloader" setup screen.
If the results of “Rack Vacancy” and/or “ID reading errors” on the statistical result dialog box are not "0", you can click the "Detail…" button to check the sample ID, analysis time and sample position of the corresponding samples.
9.
Tap "OK" button to close the dialog box, the analyzer indicator will return to green.
6-40
Operating Your Analyzer 10.
When the autoloading analyses are finished, all the tube racks are moved to the left tray of the autoloader automatically, and then you can remove the racks of tubes safely.
NOTE
If “Auto-Scan sample ID” and/or “Auto-Scan rack No.” are selected, but "Run as per worklist" is not selected, then no running and other actions will be taken to the records in the worklist.
If “Auto-Scan sample ID” is selected, but the sample ID scanned is invalid, then "InvalidN" will be the sample ID, N starts from 1 and increases by one each time (starts from 1 again if the analyzer is restarted).
If “Auto-Scan rack No.” is selected and the tube No. scanned is invalid, then "??" will be the tube No..
If more racks are needed when running the samples, you should load the rack from the right of the autoloader while removing the completed rack from the left of the autoloader in time.
Running following the worklist and with automatic scan of sample ID and rack No. 1.
Make sure the analyzer and the PC are properly connected.
2.
When it is ready to run a sample (i.e. the analyzer indicator is green), tap the "Mode" button at the "Count" screen, the "Mode" dialog box will pop up.
6-41
Operating Your Analyzer 3.
Select the mode as "AL-WB", select “Auto-Scan rack No.” and/or “Auto-Scan sample ID”, and select "Run as per worklist".
NOTE
When the analyzer is not connected with the PC, the "Run as per worklist" button is gray, the function is deactivated.
The selection status of "2-Way LIS/HIS" check box is determine by the communication setup at the PC end, you cannot select/deselect it on the analyzer.
4.
If “Auto-Scan sample ID” is selected, place labels on the tubes properly (see 6.8.4 for how to place labels), and then place them into the corresponding tube positions properly as shown in the figure below.
5.
Place the racks with tubes on the right tray of the autoloader, with the back of the carrier (where the “MINDRAY” mark is located) facing the analyzer.
6.
Tap "OK" button to close the mode dialog box, then tap the "Start Count" button on the “Count” screen, the analyzer will automatically scan sample ID and/or rack No. from the preset starting position. During this process, the analyzer indicator is flickering in green.
7.
After every analysis cycle, the results will be saved to the Review screen.
8.
When the analyses are finished, a statistical result dialog box will pop up.
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Operating Your Analyzer
NOTE
You can choose to select or deselect "Display statistics after autoloading finishes" at the "Autoloader" setup screen.
If the results of “Rack Vacancy” and/or “ID reading errors” on the statistical result dialog box are not "0", you can click the "Detail…" button to check the sample ID, analysis time and sample position of the corresponding samples.
9.
Tap "OK" button to close the dialog box, the analyzer indicator will return to green.
10.
When the autoloading analyses are finished, all the tube racks are moved to the left tray of the autoloader automatically, and then you can remove the racks of tubes safely.
NOTE
If there is no record of AL-WB mode in the worklist, then the "Run as per worklist" button in the “Count” screen will be displayed in gray.
If “Auto-Scan rack No.” is not selected, the system will search for the matching record in the worklist according to the scanned sample ID, and then the rack No. and tube No. will be overwritten. The analysis status of the record will change from “Ready” to “Analyzing”.
If “Auto-Scan sample ID” is selected, but the sample ID scanned is invalid, then "InvalidN" will be the sample ID, N starts from 1 and increases by one each time (starts from 1 again if the analyzer is restarted).
If “Auto-Scan rack No.” is selected and the tube No. scanned is
6-43
Operating Your Analyzer invalid, then "??" will be the tube No..
If "Automatically delete analyzed sample records from worklist" is selected (Setup > General Setup > Auxiliary > Other), then the completed records will be deleted automatically from the worklist.
If more racks are needed when running the samples, you should load the rack from the right of the autoloader while removing the completed rack from the left of the autoloader in time.
6.8.3 Special Functions Stop Running During the analysis process, the "Start Count" button will turn into "Stop Count" button. Tap the "Stop Count" button, the analyzer will stop running after the current sample is analyzer, and the rack of the sample will move to the unloading tray one the left of the autoloader.
STAT During the analysis process, if there are STAT samples to be prioritized, tap the "STAT" button on the “Count” screen, and confirm the operation on the pop-up dialog box. After the current sample has been analyzed, the analyzer will stop the autoloading operation and covert AL to OV mode. When the analysis status icon turns yellow, run the STAT sample under OV mode as instructed in 6.7 Sample Analysis in the OV Mode. After the analysis completes, tap the "Exit STAT" button on the "Count" screen, the sample ID will restore to the next ID before the STAT analysis, then you can proceed with analysis under autoloader mode.
Automatic saving of analysis results This analyzer automatically saves sample results. When the maximum number of results that can be saved has been reached, the newest result will overwrite the oldest.
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Operating Your Analyzer
Parameter flags
If the parameter is followed by a high/low flag ("H"/"L" by default), it means the analysis result has exceeded the upper or lower limit of the reference range, but still within the display range.
If the parameter is follow by the suspect flag ("R" by default), it means the analysis result is suspicious.
If the parameter is followed by a "&", it means that the corresponding result is rectified by the algorithm of the instrument.
If the parameter is followed by an "@", it means that the result is out of the linearity range.If a result is indicated by “*****”, it means the result is invalid.
If a result is indicated by “++++”, it means the result is out of the display range.
NOTE
The results of background check will not be flagged for abnormal parameters, abnormal blood cell differential or morphology.
You can change the default flags on the PC. See 5.3.1 General Setup ("Setup" > "General Setup") for reference.
Flags of Abnormal Blood Cell Differential or Morphology
CAUTION
Abnormal cells may not necessarily trigger the flags during the analysis process, it is recommended that reexamination is conducted per the operation instruction of your laboratory.
Flag Message WBC Scattergram
Indication
Criteria
Abnormal distribution of The distribution of DIFF scattergram and/or
Abn.
WBC scattergram
BASO scattergram is abnormal
NRBC Scattergram
Abnormal distribution of
NRBC scattergram is abnormal
Abn.
NRBC scattergram
Neutropenia
Neu# low
Neu# < 1.00×10^9/L
Neutrophilia
Neu# high
Neu# > 11.00×10^9/L
Lymphopenia
Lym# low
Lym# < 0.80×10^9/L
Lymphocytosis
Lym# high
Lym# > 4.00×10^9/L
Monocytosis
Mon# high
Mon# > 1.50×10^9/L
Eosinophilia
Eos# high
Eos# > 0.70×10^9/L
Basophilia
Bas# high
Bas# > 0.20×10^9/L 6-45
Operating Your Analyzer Leukopenia
WBC low
WBC < 2.50×10^9/L
Leukocytosis
WBC high
WBC > 18.00×10^9/L
NRBC present
NRBC detected in the
NRBC% > 1% and NRBC# > 0.01
NRBC channel Blasts? Abn Lympho/ Blasts？
Immature Gran?
Possible presence of
Presence of excessive dots in blast sensitive
blasts
region of the scattergram
Possible presence of
Presence of excessive dots in abnormal
abnormal lymphocytes or
lymphocyte/blast sensitive region of the
blasts
scattergram
Possible presence of
Presence of excessive dots in immature
immature granulocytes
granulocyte sensitive region of the scattergram
Left Shift?
Possibility of left shift
Presence of excessive dots in left shift sensitive region of the scattergram
Atypical Lymph?
Possible presence of
Presence of excessive dots in atypical
atypical lymphocytes
lymphocyte sensitive region of the scattergram
NRBC?
Possible presence of
Presence of excessive dots in NRBC
NRBC
sensitive region of the scattergram
RBC Lyse resistance? Possibility of RBC lyse resistance
Presence of abnormally distributed dots in WBC sensitive region of the WBC scattergram
RBC Histogram Abn. Abnormal distribution of
The distribution of RBC histogram is
RBC histogram
abnormal
RET Scattergram
Abnormal distribution of
The distribution of RET scattergram is
Abn.
RET scattergram
abnormal
Dimorphic Population Two or more wave crests
Two or more wave crests in the RBC
in the RBC histogram
histogram
Reticulocytosis
RET high
RET% > 5% or RET#>0.20×10^12/L
Anisocytosis
Anisocytosis
RDW-CV> 22 or RDW-SD > 64fL
Microcytosis
MCV low
MCV < 70fL
Macrocytosis
MCV high
MCV > 110fL
Hypochromia
Hypochromia
MCHC 6.5×10^12/L
RBC Agglutination？
RBC results possibly
Calculate and compare special parameters
inaccurate Turbidity/HGB
Hemoglobin abnormal or Calculate and compare special parameters
Interference?
there is HGB interference
Iron Deficiency?
Possibility of iron
Calculate and compare special parameters
deficiency Fragments?
Possible presence of 6-46
Presence of abnormally distributed dots in
Operating Your Analyzer RBC fragments
sensitive region of the RET channel
PLT Scattergram Abn. Abnormal distribution of
The distribution of PLT scattergram is
PLT scattergram
abnormal
Abnormal distribution of
The distribution of PLT histogram is
PLT histogram
abnormal
Thrombopenia
PLT low
PLT600×10^9/L
PLT Histogram Abn.
PLT Clump?
Possibility of PLT clump Calculate and compare special parameters
Pancytopenia
WBC, RBC and PLT low
Lipid Particles? Infected RBC?
WBC < 4.0 and RBC < 3.5 and PLT < 100
Possible presence of lipid Presence of excessive dots in lipid particle particles
sensitive region of the scattergram
Possible presence of
Presence of excessive dots in infected RBC
infected RBC
sensitive region of the scattergram
6.8.4 Barcode Labels
CAUTION
The following errors may cause misreading of barcodes: The barcode is not stuck upright; Use of unqualified barcodes; There are blood, powder or other contaminators on the surface of the barcode.
To ensure good readability of barcodes, do as follows: Stick the barcode correctly, as shown in Figure 1. Use
qualified
barcodes
mentioned
in
Appendix
Specifications. Keep the surface of the barcode clean and free of dust.
6-47
B.19
Barcode
Operating Your Analyzer
NOTE
If several labels are stuck to one tube, or the label is misplaced, peeled or wrinkled, it may cause autoloading error. To avoid such error, the notes below shall be followed: The label shall be stuck properly, as shown in Figure 1. Do not stick several labels to one tube. The surface of the label shall not be wrinkled, Do not use barcode label which is easily peeled to prevent the label from peeling. Ensure that the tube with barcode label can be taken out from and placed back to the rack easily.
To ensure good readability of the barcode, you must place the label right on the region as shown in Figure 1, and place the label correctly as shown in Figure 2.
Figure 1 Where to place the barcode label
Figure 2 How to place the barcode label
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Operating Your Analyzer
6.9 Working with the Worklist The worklist enables users to create a list of samples, based on which the users can run these samples in batch. Click “Worklist” to go to the following screen.
6.9.1 Introduction The upper part of the screen under the buttons is the list area, while the lower part is information entry area including "Sample Info." and "Patient Info.".
NOTE
Up to 4000 records can be saved in the worklist.
All the information fields in the worklist are entered through the information entry area except the "No.", "Analysis Status" and "Time of Entry".
The information entry area displays data of the last selected record (the record marked with an arrow in the first column of the worklist).
6.9.2 Operations In the "Worklist" screen, you can perform the following operations to the worklist in the upper part of the screen.
Create sample records
You can click the "New" button to add a new sample record, see Enter Work List Information 6-49
Operating Your Analyzer section of this chapter for details.
Edit information
Click the desired record in the worklist to select it. Edit desired information of the sample in the information entry area.
NOTE
For the record whose "Analysis Status" is "Analyzing", you cannot edit its "Sample ID", "Mode", "Rack No." or "Tube No." (autoloading mode) in the information entry area.
For the record whose "Analysis Status" is "Finished", its information entry area grays out, and you cannot edit the information. You can go to the report screen to edit the information.
Delete sample results
1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select a radio button:
Selected Records
All Finished Records
All Records
NOTE
Make sure you have selected the desired record(s) if you want to delete the “Selected Records”.
3.
Click "OK" to perform the deletion and renew the worklist.
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Operating Your Analyzer
NOTE
The records whose "Analysis Status" are "Analyzing" cannot be deleted.
Search for record(s)
1.
Click the "Search" button, and a dialog box will pop up.
2.
Enter at least one condition (“Sample ID”, “Patient ID” and/or “Name”).
3.
Click the "Find Previous" or "Find Next" button to start searching upward/downward from the currently selected record. The matching record will be selected and highlighted.
4.
Continue to find more records by clicking "Find Previous" or "Find Next" if needed.
NOTE
If the first/last record is reached, then the searching cycle will start again from the last/first record upwards/downwards.
5.
Click “Close” to close the dialog box when you finish searching.
Copy records
1.
Select the desired record you want to copy in the worklist.
2.
Click the "Copy" button to add a new record in worklist. The sample ID of this newly added record is empty or will automatically increase by 1 based on the last sample ID in the worklist (if configured in “Auxiliary” setup), other information remains the same as that of the record you copy from. For the autoloading samples, the "Rack No. "-"Tube No." of this new record will increase by 1 based on the greatest "Rack No. "-"Tube No." existed in the worklist.
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Operating Your Analyzer
Import
If you have a file of worklist items, you can import the file so you don’t have to add them one by one. 1.
Click the "Import" button.
2.
Browse to the file to be imported in the pop-up dialog box.
3.
Click "Open" to import all the worklist items included in the file.
Export
You can export the items in the worklist to a file. 1.
Click the "Export" button.
2.
Specify the directory to save the exported file in the pop-up dialog box.
3.
Click "Save" to save the exported file.
Print
1.
Select the desired record(s) you want to print.
2.
Click the "Print" button to start printing.
Check print preview
1.
Select the desired record(s) you want to check the print preview.
2.
Click the "Preview" button to go to the print preview screen.
3.
Click the “Close” button to close print preview screen.
Save
After editing/adding information, you can click the "Save" button to save the changes.
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Operating Your Analyzer
6.10 Standby When the time for which the analyzer is free from fluidic operations reaches that you have set at the "Setup" screen of the analyzer, a dialog box will pop up, prompting "Entering standby status…". After the preparation, the dialog box closes automatically and the analyzer is in the auto-sleep status. The screen blacks out and prompts "Analyzer in standby status. Tap the screen or press the Aspirate Key to resume!".
NOTE
Refer to 5.2.4 Maintenance Setup (Administrator) ("Menu" > "Setup" > "Maintenance") for how to edit waiting time before entering the standby mode.
If it is time for standby, current operations will pause. After the analyzer entered the standby status, the operations will be continued.
To exit the standby status, press the aspirate key and a dialog box of "Exiting standby status..." will pop up. After exiting the standby status, the dialog box will close automatically.
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Operating Your Analyzer
6.11 Shutdown
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
CAUTION
Do not start up the analyzer immediately after shutdown. Wait at least 10 seconds.
NOTE
Be sure to shut down the analyzer strictly as instructed below.
Shut down the analyzer
1.
Tap "Shutdown" from the menu.
2.
Tap "Yes".
3.
A dialog box will pop up asking you to perform probe cleanser maintenance, present probe cleanser to the sample probe as instructed, and press the aspirate key to start probe cleanser maintenance.
4.
After probe cleanser maintenance completes, the touch screen will blacks out and message will be displayed instructing you to power off the analyzer, do accordingly.
6-54
Operating Your Analyzer 5
Empty the waste container and dispose of the waste properly.
Exit the terminal software
You can either log out and exit the software, or close the software directly. To log out and exit: 1.
2.
Click the logout icon
on top right of the screen, and a dialog box will pop up.
Click “OK” to go back to the login screen.
3. Click
on bottom right of the login screen to exit.
To close directly: 1.
Click
2.
Click “OK” to exit.
1.
on top right of the screen, and a dialog box will pop up.
Close the external computer Close the external computer according to the shutdown procedures of the operation system.
2.
Turn off the display.
6-55
Operating Your Analyzer
NOTE
You should first exit the terminal software, and then shut down the external computer according to the shutdown procedures of the operation system. Otherwise, the records in the sample database of the terminal software may be lost.
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7
Reviewing Sample Results
7.1 Introduction After every analysis cycle, the analyzer will save the analysis result automatically. Up to 100,000 analysis results can be stored in the DMU, including 33 report parameters, 14 RUO parameters, scattergrams and histograms. Up to 500 analysis results can be stored in the SPU. You can review all the analysis results, scattergrams and histograms either in table or graph mode.
7-1
Reviewing Sample Results
7.2 Reviewing Sample Results from SPU 7.2.1 Reviewing Blood Sample Results Table Review ("Menu" > "Table Review")
The current analysis result is marked with "*" in the first column as shown in the figure above. The position of the current sample result and the total sample results are shown in the form of "Position/Total" down to the screen. Browsing The sample results are sequentially displayed from left to right on the screen, the latest on the utmost right of the table. If the information cannot be displayed in one screen, use the arrow
keys below the table to browse. If you want to view the complete information of a sample result, use the arrow keys to the right of the table to browse. Selecting 1.
Select/Deselect a single result Tap the heading of the record that you want to select (or deselect). The selected record will be highlighted (see the record No. 6 below).
7-2
Reviewing Sample Results
2.
Tap the heading of the selected record again; the highlight will be canceled (see the No. 6 record below).
1.
Select/Deselect multiple results Tap the heading of the record that you want to select (or deselect). The selected records will be highlighted (see the record No.5 and No.6 below).The heading of record No.5 is marked with "*" for it's the last record being selected.
7-3
Reviewing Sample Results
2.
Tap the heading of the selected records again one by one, and the highlight will be canceled (see the record No.5 and No.6 below).
Searching You can use the search function to search for the desired sample record stored in the analyzer by defining conditions. 1.
Tap the "Search" button at the "Table Review" screen.
7-4
Reviewing Sample Results
2.
Define the Sample ID or range of Date of Analysis.
NOTE
You can leave the "Sample ID" or "Date of Analysis" in blank and start searching without one of the conditions.
3.
Tap "Search".
4.
Tap "OK".
5.
Tap the "Return" button to back to the "Table Review" screen.
7-5
Reviewing Sample Results
Exporting (Administrator) Users of administrator level can export the sample records to a USB flash drive. 1.
Tap the "Export" button at the "Table Review" screen.
2.
Select to export “Selected Records” or “All Records”. If you want to export “Selected Records”, make sure the desired records are selected.
3.
Make sure the USB flash drive is connected to the analyzer properly.
4.
Tap “OK” to export to the USB flash drive.
Deleting (Administrator) Users of administrator level can delete records at the “Table Review” screen. 1.
Tap the "Delete" button at the "Table Review" screen.
2.
Select to export “Selected Records” or “All Records”.
3.
Tap “OK”.
7-6
Reviewing Sample Results
4.
Tap “Yes” to deleted the records and close the dialog box.
Trend Graph Select one or more samples at the “Table Review” screen, and click the “Trend Graph” button, the following screen will pop up.
The Trend graph displays the trend of all parameters of the selected samples. The data points of each parameter display from left to right. In the trend graph, black points represent sample data that are within upper and lower limits, while red points represent sample data that are outside upper or lower limits. Click the arrow buttons on the right to view the trend graph of all parameters. If there are more that 25 points in the trend graph, click the arrow button under the graph to view all points.
Setting up the limit
1.
Click the “Setup” button at the trend graph screen, the following dialog box will pop up for you to set up the limit of each parameter.
7-7
Reviewing Sample Results
2.
After setting up the limit, click “OK” to save the change and close the dialog box; or click “Cancel” to close the dialog box without save the change.
Returning to the graph review screen
Click the “Return” button at the trend graph screen to return to the graph review screen. Transmit When the SPU is connected with the DMU, the “Transmit” button is activated. You can click it to transmit selected sample records to the DMU.
Graph Review Tap the "Graph Review" button at the “Table Review” screen to enter the "Graph Review" screen of blood samples.
7-8
Reviewing Sample Results The position of the current sample result and the total sample results are shown in the form of "Position/Total" down to the screen. Browsing Tap "Previous" or "Next" button to browse each sample result. Reviewing RUO Parameters (Administrator) 1.
Tap the "RUO Parameters" button.
2.
Tap "OK" to go back to the “Graph Review” screen.
Reviewing the Special Info. Click the “Special Info.” button at the graph review screen, the following screen will pop up. You can view special information, including error information (number of error messages, error codes and names) at the screen.
7-9
Reviewing Sample Results
Switching Screens Tap the "Table Review" button to switch to the “Table Review” screen.
7-10
Reviewing Sample Results
7.2.2 Reviewing Body Fluid Sample Results Table Review ("Menu" > "Review-BF")
The functions of the body fluid sample table review screen are the same with corresponding functions of blood sample table review screen. Refer to 7.2.1 for details.
Graph Review Tap the "Graph Review" button at the “Review-BF” screen to enter the "Graph Review" screen of body fluid samples.
7-11
Reviewing Sample Results
The functions of the body fluid sample graph review screen are the same with corresponding functions of blood sample graph review screen. Refer to 7.2.1 for details.
7-12
Reviewing Sample Results
7.3 Reviewing Sample Results from DMU From the “Review” screen, an operator can send, view, print and search sample records, and an administrator can validate records, cancel validation, delete records, export data, archive records lock/unlock the screen view except from using the functions available to operators. Click "Review" to enter the "Review" screen.
NOTE
Some tabs are not displayed in the default layout. You can use the “View” button to find it and click to display.
7.3.1 Introduction to the Screen Table Area The table displays a list of analyzed samples with basic sample information like sample ID, patient name, date of analysis, time of analysis, patient ID, validation, print and communication status, flag, error, rack no., tube no., analyzer SN, sample mode, test panel and presentation mode.
7-13
Reviewing Sample Results
Column lock setup
You can lock one or more most frequently used columns in this area to make it fixed on the left of the table while dragging the horizontal scroll bar. 1.
Right click the heading of any column, and a menu pops up.
2.
Select "Column Lock", and a dialog box below will pop up.
3.
Select the desired item(s) from the “Available Items” list, and then click “Add” to add it to the “Selected Items” list; Or, Select the desired item(s) from the “Selected Items” list, and then click “Delete” to delete it from the “Selected Items” list.
4.
Adjust the order of the columns using the order adjusting buttons if necessary.
5.
Click “OK”.
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Reviewing Sample Results
Switch to Report
To switch to the “Report” screen of a selected record, right click and select “Switch to report”, or double click the desired record.
Graph Area Graph area provides different tabs where you can view different groups or types of results. The tabs include General, WBC, RBC, Result Compare, Microscopic Exam, RUO Parameters, Intraday repeated results, and Patient Info.
NOTE
You can click on any scattergram or histogram for a zoom-in view of it, and then click elsewhere to exit.
General
This screen displays all the report parameter results, flag messages, 4 scattergrams (DIFF, BASO, RET, and NRBC) and 2 histograms (RBC and PLT).
WBC
You can review WBC-related parameter results, WBC flag messages, and 4 scattergrams (DIFF, BASO, RET, and NRBC) from this screen.
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RBC
You can review the RBC-related parameter results, RBC/RET flag messages and PLT flag messages, 4 scattergrams (RET-EXT, PLT-O, RET and NRBC) and 2 histograms (RBC and PLT) from this screen.
Result Compare
You can compare the results with the same Patient ID and patient name attained within 6 months. Select "Parameter Compare" (comparative review of all report parameter results), "Trend
Graph"
(parameter-by-parameter
trend
graphs)
or
"Scattergram/Histogram
Compare" (comparative review of all histograms and scattergrams) for comparative reviews in different dimensions.
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NOTE
The “Outliers” message displayed in Delta check area on the right means the delta check function is enabled and the corresponding parameter result is out of the set limit. For Delta check setup, see Auxiliary setup > Delta check setup in 5.3.1 General Setup ("Setup" > "General Setup").
Print You can print the “Parameter Compare” and “Trend Graph” screens by clicking the “Print” button in the corresponding screen. Print Preview You can check the print preview of the “Parameter Compare” and “Trend Graph” screens by clicking the “Print” button in the corresponding screen. Parameter Order To adjust the order of parameters displayed in the “Parameter Compare” and “Trend Graph” screens, click the “Para. Order” button in the corresponding screen, and adjust the order of desired parameter(s) in the pop-up dialog box.
Microscopic Exam.
You can review information including Time of Microscopic Exam., Microscopic Description, comments, and etc. from this screen.
RUO Parameters
You can review the results of RUO parameters, WBC, RBC/RET and PLT flag messages, as well as 4 scattergrams (DIFF, BASO, PLT-O, and NRBC) from this screen.
Reference results
You can view the reference results (raw data) of all parameters in this tab.
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I-message
I-message is a collection of the flags with uncertainty to some extent. This tab shows the degree of certainty of these flags.
The values in the “Value” column and along the red vertical lines are the reference values of certainty which can be modified at the algorithm setup screen of the SPU (see 5.2.9 Algorithm Setup (Administrator) ("Menu" > "Setup" > "Alg")). The larger the values is, the more probable of the flagging message. Those larger than the reference values will be displayed in red.
Intraday repeated results
If a sample (the records with same sample IDs will be regarded as results of the same sample) is analyzed for several times on the same day, you can review these records from this screen.
Detailed parameter results are listed on the left, and you can click the “Reported Parameter” or “RUO Para” to view the corresponding parameter results. The table on the right is a list of the sample records, among which the ticked one is the one to be reported. You can select a record in this table, right-click and select to report (by clicking “Match repeated results”) or transmit this record (by clicking “Transmit repeated results”).
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Patient Info.
You can browse the patient information including Date of Analysis, Sample ID, Patient ID, Gender, Date of Birth, Age, Reference Group, Department, Ward, Bed No., Sample Type, Draw Time, Order Time, Ordered by, Operated by, Validated by, Time of Report, Clinical, Comments, etc.
7.3.2 Button Functions Data Communication
To communicate selected data:
1.
Select one or more sample records you want to transmit from the “Table”.
2.
Click the “Communication” button, a dialog box below will pop up.
3.
Select the “Selected Data” radio button.
4.
Click “Start” to close the dialog box and start the communication.
1.
To communicate specified data: Click the “Communication” button, a dialog box below will pop up.
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2.
Select the “Specified Data” radio button.
3.
Specify desired starting and ending date.
4.
Click “Start” to close the dialog box and start the communication of records in the specified date range.
Validate/Cancel (Administrator)
To validate sample record(s)
Select the sample record(s) to be validated from the “Table”, and then click the "Validate" button to validate. The check boxes of validated sample(s) will be ticked and the record(s) will be highlighted. A dialog box will pop up asking for Administrator ID and password if the current user is of operator level.
To cancel the validation of sample record(s)
Select the validated sample record(s) from the “Table” and then click the "Cancel" button to remove the validation check mark(s) and cancel the highlight.
Delete Sample Record(s) (Administrator) 1.
Select the sample result(s) to be deleted from the “Table”.
2.
Click the “Delete” button, and the following dialog box will pop up.
3.
Click “OK” to close the dialog box and delete the record(s). 7-20
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Check the Print Preview 1.
Select a record you want to check the print preview from the “Table”.
2.
Click the “Preview” button to go to the preview screen.
3.
Click “Close” to exit the preview screen.
Batch Validation (Administrator) 1.
Click the “Batch Validation” button and the following dialog box will pop up.
2.
Specify the date on which the sample records you want to validate.
3.
Specify the range of the “Sample ID” to be validated if needed.
4.
Click “Validate” to validate the specified records and close the dialog box.
Batch Print 1.
Click the “Batch Print” button and the following dialog box will pop up.
2.
Specify the date on which the sample records you want to print.
3.
Specify the range of the “Sample ID” to be printed if needed.
4.
Select a radio button to print as “Report” or “Table”. 7-21
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Click “Print” to print the specified records and close the dialog box.
Print
To print based on default print template
Select the sample record(s) you want to print from the “Table”, and then click the "Print" button to print.
To print result summary/list
1.
Select the sample record(s) you want to print from the “Table”.
2.
Click the arrow on bottom of the “Print” button.
3.
Select “Print Result Summary” or “Print Result List”.
To check print preview
1.
Select the sample record you want to check the print preview from the “Table”.
2.
Click the arrow on bottom of the “Print” button.
3.
Select “Result Summary Preview” or “Result List Preview”.
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Search Sample Record(s) 1.
Click the “Search” button, and then the following dialog box will pop up.
2.
Specify the searching condition(s) by entering or selecting from pull-down list.
3.
If you want to filter the searched results, click the "Filter".
4.
“Add” “General Parameter Condition” and/or “Custom Parameter Condition” if needed. If more than one condition is added to either group, define the relation between two conditions by selecting “AND” or “OR” in the “Relations” column.
5.
If both “General Parameter Condition” and “Custom Parameter Condition” are specified, select “AND” or “OR” from the pull-down list between the two tables to define the logic relation between the two group of conditions.
6.
Click the "OK" button to start searching and close the dialog box. The Searching results will be displayed in the table area.
NOTE
You can delete any condition in the “General Parameter Condition” or “Custom Parameter Condition” by clicking the “Delete” button under the corresponding table.
Display All Samples The table area on the review screen displays the sample record of the day by default, if you 7-23
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Lock Record When connection is established between the SPU and the DMU, the Review Screen of the DMU will display the latest sample result received from the analyzer. You can click the "Lock Record" button to lock the review screen at the current sample result, and the screen will not be refreshed after new sample records come.
Data Export (Administrator) 1.
Click the “Data Export” button, and the following dialog box will pop up.
2.
In the “Export records” area,
select “Selected Records”;
select “Specified Records”, and then define the starting and ending of “Date
or
of Analysis”. 3.
If needed, select the types of information to be exported in the “Options” area. These may include:
Patient Info.
Sample Info.
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4.
Reported Parameter
Other Parameter
Graph-Related Flag
If needed, you can customize parameters included in Reported Parameters and RUO Parameters. To customize reported parameters Click “Customize”, and a dialog box will pop up.
Check or uncheck the corresponding check boxes in the “Export?” column to specify whether to export the reported parameters. To customize RUO parameters Click “Customize RUO”, and a dialog box will pop up.
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Check or uncheck the corresponding check boxes in the “Export?” column to specify whether to export the reported parameters. 5.
Click “Browse” to specify the directory to save the exported file.
6.
Click “OK” to start the export and close the dialog box.
Archive Sample Records (Administrator) Users at the administrator access level can archive the sample records of a specified period (including both the numeric and graphic data), in order to:
Make a backup of data;
Release space in the disk (need to select “Delete the records after archiving”).
Since the DMU can store 100,000 sample records at most, and the oldest records will be overwritten after this limit is reached. Therefore, the manufacturer recommend that users archive data periodically on a reasonable basis to avoid data loss. You can archive sample records by doing as follows: 1.
Click the “Archive” button, and the following dialog box will pop up.
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2.
Specify the starting and ending date of the data to be archived.
3.
Click “Browse” to specify the directory to save the archive.
4.
If needed, select to “Delete the records after archiving”. If you check this box, all the archived records (including both the numeric and graphic data) will be deleted after the archiving is finished.
5.
Click “Archive” to start archiving and close the dialog box.
By archiving, the system will create a folder in the directory specified named by the date of archiving. The archived data can be reviewed in the “History” review screen (see 7.3.4 History Review).
Adjust View Click the “View” button, and then the following menu will pop up.
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To switch to another tab
Click “Table”, General", "WBC", "RBC", "Result Compare", "Microscopic Exam.", “RUO Para.”, “Intraday repeated results” or “Patient Info.” to switch to the corresponding tab.
To restore default layout
Click "Restore default layout" to restore the screen layout to default.
To lock/unlock layout (administrator)
The layout of the “Review” screen is locked by default. You can click "Unlock Layout" to unlock the layout. When the layout is unlocked, you can adjust the location of any module by dragging it to the destination, or close the modules you don’t need to simplify the view. When the layout is unlocked, the “Unlock Layout” menu option will automatically change into “Lock Layout”. Click “Lock Layout” to disable the layout change function.
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7.3.3 Right-Click Menu Functions Table Tab Select one or more records from the “Table” area, and then right click. The following menu will pop up.
Print
Click “Print” to print the selected record(s).
Validate/Cancel (administrator)
If the selected record(s) is/are not validated, click “Validate” to validate. If the selected record(s) is/are validated, click “Cancel” to cancel the validation.
Delete (administrator)
Click “Delete” to delete the selected record(s).
Data Communication
Click “Communication” to communicate the selected record(s).
Error Alarm (operator)/Special Info. (administrator)
The operator can check the error messages reported during the analysis of the selected sample by clicking “Error Alarm”; the administrator can check the error messages, as well as other special information in the process of sample analysis (like the HGB blank voltage, aperture voltage, etc.) by clicking “Special Info.”.
Switch to report
Click “Switch to report” switch to the report screen of the last selected record.
Refresh
Click “Refresh” to refresh the “Table” area.
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General Tab Right click in the “Parameter” area of the “General” tab, the following menu will pop up.
Change the property
Click “Property”, and a dialog box consisting of 2 tabs will pop up. “Parameter” tab:
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Introduction There are two tables in the “Parameter”/”Column” tab: “Available Items” and “Selected Item”. The “Selected Item” table shows the parameters currently displayed in the “General” tab, while the “Available Items” table shows the parameters currently not in but can be added to the “General” tab. Insert item 1.
Select the desired item from the “Available Items” table.
2.
Click the “Insert” button.
3.
The selected item will be inserted in front of the current item in the “Selected Item” table.
4.
Click “OK” to save the change and close the dialog box.
Add Item 1.
Select the desired item from the “Available Items” table.
2.
Click the “Add” button.
3.
The selected item will be added on the bottom of the “Selected Item” table. 7-31
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Click “OK” to save the change and close the dialog box.
Delete parameter 1.
Select the desired item from the “Selected Item” table.
2.
Click the “Delete” button.
3.
The selected item will be deleted from the “Selected Item” table and displayed in the “Available Items” table.
4.
Click “OK” to save the change and close the dialog box.
Adjust item order 1.
Select desired parameter from the “Selected Item” table.
2.
Use the order adjusting buttons to adjust its position.
3.
Click “OK” to save the change and close the dialog box.
Adjust message order
There are 3 types of flag messages displayed in the “General” tab: WBC Message, RBC message and PLT message. Right click on the desired message type, the following menu will pop up.
Click “Message Order”, and the “Message Order” dialog box will pop up (see the WBC message order adjust dialog box below).
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Adjust message order 1.
Select desired message from the table.
2.
Use the order adjusting buttons to adjust its position.
3.
Click “OK” to save the change and close the dialog box.
Restore Defaults Click the “Restore Defaults” button, and then click “OK” to restore default order.
7.3.4 History Review (Administrator) If you have archived sample records use the “Archive” function (see 7.3.2 Button Functions > Archive Sample Records), you can review the archived history data in the “History” review screen. Click the “History” button in the “Review” screen to go to the “History” review screen.
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Load History Data You need to load history data before review. Do as follows: 1.
Click the “Load History Data” button.
2.
Browse to the desired folder of history data in the message box, and then click “OK”.
NOTE
You can only load one folder of history data at one time.
If there are already data displayed in the “History” review screen before loading, only the newly loaded data can be displayed after the loading is finished.
Unload History Data After reviewing the history data, you can click the “Unload History Data” button to unload the currently displayed data. Other buttons on the “History” review screen function in the same way as those in the “Review” screen.
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7.4 Report You can edit patient information, review and validate analysis results and print analysis report on the "Report" screen of the DMU. Click "Report" to enter the "Report" screen.
7.4.1 Introduction of the Screen The "Report" screen consists of the patient information area, result display area and result table area (from left to right in default layout). Some tabs are hidden in the default display. You can use the "View" button to display and switch to these tabs (see 7.4.2 Button Functions > Adjust View).
Patient information area This area displays the patient information of the sample selected in the table.
Switch to desired sample
The first 2 fields are highlighted and used to switch to desired sample. If you specify a “Date of Analysis”, all the sample records will be displayed in the result table area, and the results of the first sample that day will be displayed in the result display area. If you specify a “Sample ID”, the corresponding records of that day will be highlighted in the result table area, and the results of this sample will be displayed in the result display area. If there is no matching sample on that day, a new item will be added in the result table area.
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Edit patient information
You can edit the patient information of the samples, if the sample exists, the changes will be saved in real time; if the sample is newly added, the changes will be saved when you switch to another sample record.
NOTE
The patient information of the background results (sample ID: 0) cannot be edited.
Result display area The result display area consists of the "Para.", "Microscopic Exam.", "RUO" and "Reference Results" tab screens, which display the parameter results, microscopic exam results, results of RUO parameters and raw results of all basic parameters respectively. The "Para." tab and “Microscopic Exam” tab are displayed by default; while the “RUO” tab can be displayed from the “View” button.
Para.
You can view the results of all report parameters, flags, and the 3 recent history records (if there is any). The history records refers to the previous analysis results which has the same Patient ID with the currently selected one, and they are displayed in “Third”, “Second” and “First” columns from the latest to earlier.
Microscopic Exam
If the sample type of the current sample is set in the data dictionary setup ("Setup" > “Data Dictionary”) and this sample type has predefined microscopic parameters ("Setup" > “Para. Setup” > “Microscopic Para. Setup”), you can edit the microscopic examination results of this sample in the "Microscopic Exam" tab.
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1.
Modify the default “Time of Microscopic Exam.” If needed by entering from keyboard or select from the date text box.
2.
If needed, enter the "Microscopic Description" in the text box. If there is too much information to be entered, click the ">" button after the "Microscopic Description" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
3.
If needed, enter the "Comments" in the text box. If there is too much information to be entered, click the ">" button after the "Comments" field, and enter the information in the pop-up dialog box. After you finish entering, click “OK” to save the entry and close the dialog box.
4.
Enter the results of the microscopic parameters in the corresponding text boxes if needed.
Reference results
You can view the reference results (raw data) of all parameters in this tab.
RUO Para.
You can review the results of RUO parameters and 4 scattergrams (DIFF, BASO, PLT-O, and NRBC) from this screen.
Result table area The result table area consists of the "Table", "Graph" and "Intraday repeated results" tab screens, which display the sample table of the day, graphs of the selected samples and information of the repeated results of the day.
Table
The "Table" displays a list of all analysis result records attained in a day. You can click the 7-37
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Graph
The "Graph" tab displays WBC, RBC, and PLT flag messages, 4 scattergrams (DIFF, BASO, RET, and NRBC) and 2 histograms (RBC and PLT).
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NOTE
You can click on any scattergram or histogram for a zoom-in view of it, and then click elsewhere to exit.
Intraday repeated results
If a sample (the records with same sample IDs will be regarded as results of the same sample) is analyzed for several times on the same day, you can review these records from this screen. The upper part is the record table area showing the repeated sample records, among which the ticked one is to be reported; the lower part is the result display area showing all parameter results of the record selected in the list, and you can click the “Reported Parameter” or “RUO Para” to view the corresponding parameter results.
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7.4.2 Button Functions Edit result (Administrator) 1.
Select the desired record from the “Table” or by specifying the “Date of Analysis” and “Sample ID”.
2.
Click the "Edit Result" button, and all results that can be edited will be highlighted in pink in the “Parameter” tab of the result display area.
3.
Select the desired parameter result and edit one by one.
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NOTE
If the result of one parameter is modified, the result of other related parameter(s) will be changed accordingly and the high/low flags and suspect flags will also be renewed.
Only the results of the measured parameters (WBC, RBC, HGB, HCT, PLT, RET and NRBC) and the WBC subpopulations can be edited.
After editing and saving the WBC differential parameters (%), the absolute values of the WBC differential parameters will be recalculated and renewed.
Make sure the sum of the WBC differential parameters (%) edited is 100.00%.
No matter the sample result is validated or not, as long as it is edited, the edited parameter result will be flagged with an "E". If any parameter result is changed due to the manual change of a parameter result, it will be flagged with an “e”. ("E" or "e" flags will be displayed in the “Flag” column.)
You cannot edit the results of the background.
Restore result (administrator) 1.
Select the edited record from the “Table” or by specifying the “Date of Analysis” and “Sample ID”.
2.
Click the "Restore Result" button, all edited results will be changed back into the initial values.
NOTE
The original measurement results of up to 2000 lately edited sample results can be saved by the analyzer.
You cannot restore results of the background.
Entry Option You can set the property of items displayed in the patient information area and how the information shall be entered by using the “Entry Option” button. Click the “Entry Option” button, and a dialog box will pop up.
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1.
Set up the patient information items Select/Deselect the “Unhidden” check box to display/not display the item in the patient information area.
2.
Enter or select the “Default” if needed.
3.
Select the “Memory” check box if needed, and then the patient information of the next sample will remain the same as the previous selected sample.
4.
Click the “Text Display” and modify if needed.
5.
Select the “Only get from dictionary” check box if needed, and then the entry of this item shall only come from the options set in data dictionary.
Adjust the order of the items
Select an item from the table on the left, and then use the order adjusting buttons to adjust the display order of the items in the patient information area.
Selecting entry options
You can select from the following options:
Only enter bed No. for inpatients (which makes the entry of bed No. only enabled for inpatients)
Double Validation Control (sample results must be operated and validated by 7-42
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Operator can be modified (enable the modification of the “Operated by” field)
Use the time of first print as the time of report
Use the time when the report is printed as the time of report
Switch to next sample after validation
Communication 1.
Select desired record(s) from the “Table”.
2.
Click the "Communication" button to start transmitting the selected sample(s).
Validate/Cancel (Administrator)
To validate sample record(s)
Select the sample record(s) to be validated from the “Table”, and then click the "Validate" button to validate. The validated record(s) will be highlighted. A dialog box will pop up asking for Administrator ID and password if the current user is of operator level.
To cancel the validation of sample record(s)
Select the validated sample record(s) from the “Table” and then click the "Cancel" button to cancel the validation and the highlight.
Delete Sample Record(s) (Administrator) 1.
Select the sample result(s) to be deleted from the “Table”.
2.
Click the “Delete” button, and the following dialog box will pop up.
3.
Click “OK” to close the dialog box and delete the record(s).
New Para. If you have defined custom parameters in the custom parameter setup screen (“Setup” > “Para. Setup” > “Custom Para. Setup”), you can edit the results of these parameters and add them to the reported results. 1.
Select the desired sample result(s) from the “Table”. 7-43
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Click the “New Para.” button or [F6] on the keyboard, and the following dialog box will pop up.
3.
Enter the results of custom parameters to the corresponding cell in the “Result” column.
4.
If you want to add any of these parameters to the report parameters, select the corresponding check box in the “Add” column.
5.
Click “OK” and the added custom parameters will be displayed at the end of the “Para.” Tab.
Check the Print Preview 1.
Select a record you want to check the print preview from the “Table”.
2.
Click the “Preview” button to go to the preview screen.
3.
Click “Close” to exit the preview screen.
Batch Validation (administrator) 1.
Click the “Batch Validation” button and the following dialog box will pop up.
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2.
Specify the date on which the sample records you want to validate.
3.
Specify the range of the “Sample ID” to be validated if needed.
4.
Click “Validate” to validate the specified records and close the dialog box.
Batch Print 1.
Click the “Batch Print” button and the following dialog box will pop up.
2.
Specify the date on which the sample records you want to print.
3.
Specify the range of the “Sample ID” to be printed if needed.
4.
Select a radio button to print as “Report” or “Table”.
5.
Click “Print” to print the specified records and close the dialog box.
Result compare You can compare the results with the same Patient ID and patient name attained within 6 months. 1.
Select the record you want to do a comparative study from the “Table”.
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NOTE
If there are records of the same sample, the “Result Compare” button will turn to red.
2.
Click "Result Compare", a dialog box will pop up.
3.
If needed, specify the range of “Date of Analysis” and then click “Search” to search for the records of the same sample within that period of time.
4.
Select from “Parameter Compare”, “Trend Graph” and “Scattergram/Histogram” radio buttons for different comparative view of the samples.
5.
If needed, check the print preview and print the “Parameter Compare” and “Trend Graph” by using the “Print” and “Print Preview” buttons.
6.
If needed, adjust the display order of the parameters in “Parameter Compare” and “Trend Graph” screens. Click the “Para. Order” button in the corresponding screen, and adjust the order of desired parameter(s) in the pop-up dialog box.
Print Select the sample record(s) you want to print from the “Table”, and then click the "Print" button to print.
Adjust View Click the “View” button, and then the following dialog box will pop up. 7-46
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To switch to another tab
Click “Patient Info.”, Parameter", "Microscopic Exam.", "RUO Para.", "Table", “Intraday repeated results", or “Graphics” to switch to the corresponding tab.
To restore default layout
Click "Restore default layout" to restore the screen layout to default.
To lock/unlock layout (administrator)
The layout of the Review Screen is locked as default. You can click "Unlock Layout" to unlock the layout. When the layout is unlocked, you can adjust the location of any module by dragging it to the destination, or close the modules you don’t need to simplify the view. When the layout is unlocked, the “Unlock Layout” menu option will automatically change into “Lock Layout”. Click “Lock Layout” to disable the layout change function.
7.4.3 Right-Click Menu Functions Patient info. Area Right click in non-editable area of the patient info. area, the following menu will pop up.
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Set up the property
Click “Property”, and a dialog box will pop up. You can set the property of items displayed in the patient information area and how the information shall be entered. See Entry Option of 7.4.2 Button Functions for details.
Result display area “Para.” tab Right click in the “Para.” tab of the result display area, the following menu will pop up.
Add custom parameter results
If you have defined custom parameters in the custom parameter setup screen (“Setup” > “Para. Setup” > “Custom Para. Setup”), you can edit the results of these parameters and add them to the reported results. 1.
Click “Add”, and the following dialog box will pop up.
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2.
Enter the results of custom parameters to the corresponding cell in the “Result” column.
3.
If you want to add any of these parameters to the report parameters, select the corresponding check box in the “Add” column.
4.
Click “OK” and the added custom parameters will be displayed at the end of the “Para.” Tab.
Delete sample record(s)
1.
Click “Delete”, and the following dialog box will pop up.
2.
Click “OK” to close the dialog box and delete the record(s).
“Reference Results” tab (administrator) Right click in the “Reference Results” tab of the result display area, the following menu will pop up.
1.
Click “Report Ref. Results”, and then select the parameters you want to apply reference results in the report.
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2.
Click “OK” to close the dialog box, and the reference results of the selected parameters will be applied in the report.
Result table Area “Table” tab Select one or more records from the “Table” tab, and then right click. The following menu will pop up.
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Print
Click “Print” to print the selected record(s).
Validate/Cancel (administrator)
If the selected record(s) is/are not validated, click “Validate” to validate. If the selected record(s) is/are validated, click “Cancel” to cancel the validation.
Delete (administrator)
Click “Delete” to delete the selected record(s).
Data Communication
Click “Communication” to communicate the selected record(s).
Edit Sample ID (administrator)
1.
Click "Edit Sample ID", the "Sample ID Edit" dialog box will pop up.
2.
Modify the sample ID, and then click “OK” to save the change and close the dialog box.
1.
Report reference results Click “Report Ref. Results”, and then select the parameters you want to apply reference results in the report.
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2.
Click “OK” to close the dialog box, and the reference results of the selected parameters will be applied in the report.
1.
Apply reexam rules Click "Apply reexam rules", the software will automatically apply current reexam rules (configured in “Setup” > “Reexam Rules”) to the selected record(s).
2.
For records suggested to be reexamined, the text color in the “Table” will change into red and there will be a
message on top of the screen.
NOTE
Before performing the "Apply reexam rules" function, make sure the rules are enabled on the reexam rules setup screen.
For the samples that are required to be reexamined, reexamine them according to laboratory procedures.
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Reviewing Sample Results Error Alarm (operator)/Special Info. (administrator)
The operator can check the error messages reported during the analysis of the selected sample by clicking “Error Alarm”; the administrator can check the error messages, as well as other special information in the process of sample analysis (like the HGB blank voltage, aperture voltage, etc.) by clicking “Special Info.”.
Switch to review
Click “Switch to review” switch to the review screen of the last selected record. Refresh
Click “Refresh” to refresh the “Table” area.
“Intraday repeated results” tab Select a record in the record table area, and then right-click.
Set the report record
You can set any record in the list to be the report record. 1.
Select the desired record from the record table area.
2.
Right click in the record table area, and select “Match repeated results”, and then the selected record will be ticked.
Delete repeated results
1.
Select the desired record from the record table area.
2.
Right click in the record table area, and select “Delete repeated results”, and then a dialog box will pop up asking you to confirm the deletion.
3.
Click “OK” to delete the selected record and exit.
Transmit repeated results
1.
Select the desired record from the record table area.
2.
Right click in the record table area, and select “Transmit repeated results” to transmit the results of the selected record. 7-53
Reviewing Sample Results
Print repeated results
1.
Select the desired record from the record table area.
2.
Right click in the record table area, and select “Print repeated results” to print the results of the selected record.
Edit sample ID
1.
Select the desired record from the record table area.
2.
Right click in the record table area, and select “Edit sample ID”, and then a dialog box will pop up.
3.
Edit the sample ID in the text box and click “OK” to save the change. Since the previously selected sample ID has been changed, it will be excluded in the repeated results.
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Reviewing Sample Results
7.5 Statistics You can check and print the following summaries from the "Statistics" screen of the DMU:
Workload Summary
Summary of Positive Samples
General Summary
7.5.1 Workload Summary（"Statistics" > "Workload Summary"）
1.
2.
Specify one or more conditions to generate the "Workload Summary":
Analyzer
Date of Analysis
Department
Ward
Operated by
Validated by
Sample Type
Delivered by
Click "OK", and then the matching results will be displayed in the summary area below the conditions.
7.5.2 Summary of Positive Samples
1.
Specify one or more conditions to filter the records: 7-55
Reviewing Sample Results
2.
Analyzer Name
Date of Analysis
Item (parameter)
Sample Type
Department
Select one of the following radio buttons:
Identify Positive Samples Based on Reexam Rules
Custom Rules for Positive Samples
If you want to "Identify Positive Samples Based on Reexam Rules", make sure the desired reexam rules are "Applied" in the reexam rule setup screen. If "Custom Rules for Positive Samples" is selected, edit the conditions of positive samples in the custom area below. 3.
Click "OK", the matching results will be displayed in the summary area below the conditions.
7.5.3 General Summary
1.
Specify one or more conditions:
Analyzer
Sample ID
Date of Analysis
Name
Patient ID
Gender
Ref. Group
Sample Type
Department
Ward
Delivered by 7-56
Reviewing Sample Results
2.
Operated by
Validated by
Specify one or two statistical items from the pull down list(s). The statistical item is used by system to categorize the results meeting the filtering conditions set in Step 1. E.g. if you select “Gender” as "Statistical Item 1", and the “Gender” filtering condition is not defined, the table below will list the filtered records in different genders.
3.
Click "OK", the matching results will be displayed in the summary area below the conditions.
7.5.4 Print Summary Print Preview Click the "Preview" button, the "Print Preview" window will pop up displaying the preview of the summary results. Click the “Close” button to close the window.
Print Click the "Print" button to print the summary results.
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8
Using the QC Programs
8.1 Introduction Quality Control (QC) consists of strategies and procedures that measure the precision and stability of the analyzer. The results reflect the reliability of the sample results. QC involves measuring materials with known, stable characteristics at frequent intervals. Analysis of the results with statistical methods allows the inference that sample results are reliable. Mindray recommends you run the QC program daily with low, normal and high level controls. A new lot of controls should be analyzed in parallel with the current lot prior to their expiration dates. This may be accomplished by running the new lot of controls twice a day for five days using any empty QC file. The QC files calculate the mean, standard deviation and coefficient of variation for each selected parameter. The instrument-calculated means of these ten runs should be within the expected ranges published by the manufacturer. The BC-6800 analyzer provides 5 QC programs: L-J QC, X QC, X -R QC, X-B QC and X-M QC. You can only perform QC analysis on the analyzer, the QC setup and QC result review operations must be done on the PC.
8-1
Using the QC Programs
8.2 L-J QC Program 8.2.1 QC Setup (Administrator)
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
NOTE
If the "In Use" check box of a QC file is ticked, the QC information will be transmitted to the SPU when the connection is built up, and the matching QC results will be saved in this file.
Before analyzing a new batch of controls with the L-J program, you should set a QC file for each lot of controls. 1.
Click "QC”, and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the L-J QC setup screen.
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Using the QC Programs
To set up the QC file, you shall enter the required “File Info.” and “Target/Limit” using one of the following ways:
Reading the information provided by the manufacturer
Manual entry
Reading the saved preset values.
There are 3 columns which cannot be edited in the “File Info.” table:
File No. (Sequence number of the QC file)
Editor (the information of the user who edited the file, in the format of “User ID(User Name)”)
Existing Data/Capacity (number of existing records for the file/the maximum records that can be saved in the file)
Reading the information provided by the manufacturer 1.
Click "QC”, and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the L-J QC setup screen.
3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
Click the “Read File” button, a message box will pop up. 8-3
Using the QC Programs
5.
Click the "Browse" button, and then select the path to read QC information.
6.
Click "OK" to close the box, the dialog box below will display.
NOTE
The QC files for selection are displayed in the format of "Batch No. (level)".
7.
Select a QC file and click "OK" to close the dialog box and return to the "Read File" dialog box. The path selected will be displayed.
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Using the QC Programs
8.
Select "Read Target/Limit", and then click "OK" to import the QC information into the current QC file.
NOTE
If the “Read Target/Limits” is not selected, you have to enter the target and limits manually.
9.
Select the source of control from the pull-down list.
10.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
11
Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID.
NOTE
Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0".Chinese and other languages are not supported (e.g. Japanese, Korean, etc.)
12.
Tick the “In Use” box if needed.
NOTE
For files having the same “Level”, presentation mode (OV or AL) and
8-5
Using the QC Programs “QC Sample ID”, only one of them can be “In Use”. 13.
Click the “Save” button to save the QC information.
NOTE
The expiration date shall not be earlier than the current system date.
Manual entry 1.
Click "QC”, and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the L-J QC setup screen.
3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
Enter the lot No. of the controls by one of the following ways:
Manual entry
Using external barcode scanner
NOTE
The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters.
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Using the QC Programs 5.
Select the control level from the pull-down list (L for low level, N for normal level and H for high level).
6.
Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
NOTE
The format of the expiration date is determined by the configuration of the PC.
The expiration date shall not be earlier than the current system date.
7.
Select the source of control from the pull-down list.
8.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
9.
Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID.
NOTE
Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0" .Chinese and other languages are not supported (e.g. Japanese, Korean, etc.)
10
Tick the “In Use” box if needed.
NOTE
For files having the same “Level”, presentation mode (OV or AL) and “QC Sample ID”, only one of them can be “In Use”.
11.
Enter the targets and limits manually according to the package insert for the batch of controls.
12.
Click the “Save” button to save the QC information.
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Using the QC Programs
Reading the saved preset values
NOTE
If there are the saved preset values (Target and Limits) for the current level, you can read-in the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.2.3 Review L-J QC Results.
1.
Click "QC”, and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the L-J QC setup screen.
3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
Enter the lot No. of the controls by one of the following ways:
Manual entry
Using external barcode scanner
NOTE
The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed.
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Using the QC Programs 5.
Select the control level from the pull-down list (L for low level, N for normal level and H for high level).
6.
Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
NOTE
The format of the expiration date is determined by the configuration of the PC.
The expiration date shall not be earlier than the current system date.
7.
Select the source of control from the pull-down list.
8.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
9.
Set QC sample ID: if you are used to analyze control together with blood samples, you can set a unique ID for the control. The analyzer will recognize the sample as control when it reads the unique ID. After the analysis completes, the results will be saved into the QC file of the QC sample ID.
NOTE
Letters, numbers and all characters that can be entered with the keyboard are allowed for the special ID, but the ID must end with a number except "0" .Chinese and other languages are not supported (e.g. Japanese, Korean, etc.)
10.
Tick the “In Use” box if needed.
NOTE
For files having the same “Level”, presentation mode (OV or AL) and “QC Sample ID”, only one of them can be “In Use”.
11.
Click the “Get Preset Values” button to read in the saved preset targets and limits (corresponding to the current level) into the current QC file.
NOTE
If some parameters to be included in the QC run have no preset values, you should enter the target and limits for them manually; if you don't want some parameters with preset values to be included in the QC run, you can delete the target and limits of those parameters
8-9
Using the QC Programs manually after read-in the preset values. 12.
Click the “Save” button to save the QC information.
Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1.
Click the “Set Limits” button, and then the following dialog box will pop up.
2.
Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage.
3.
If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits.
4.
Click the “OK” button to save and close the dialog box.
8.2.2 L-J QC Run You can select one of the two ways below to run controls:
Run controls under the "QC" screen
Put controls together with normal samples, and run the controls under the sample analysis screen.
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Using the QC Programs
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Under open vial mode, make sure the volume of the control is no less than 0.5mL; under autoloader mode, make sure the volume of the control is no less than 1mL.
Running controls with errors occurred may lead to incorrect analysis results. If errors occur during the QC analysis process, be sure to remove the errors first and then proceed with the QC run.
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
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Using the QC Programs
NOTE
When analysis mode is shifted from "Whole Blood" to "Predilute" or sampling mode changes, the analyzer will switch mode automatically and pop-up message will be displayed.
Only the controls specified by Mindray can be used. Using controls of other manufacturers may lead to incorrect QC results.
Store and use the controls as instructed by instructions for use of the controls.
Be sure to keep dust from the prepared diluent.
After mixing the control with the diluent, be sure to wait 3 minutes before running.
Be sure to run the prediluted samples within 30 minutes after the mixing.
Be sure to mix any sample that has been prepared for a while before running it.
Run controls under the "QC Run" screen After editing the QC information, you can start QC analysis by one of the following ways according to the selected QC mode.
OV-WB
OV-PD
AL-WB (Without Built-in Barcode Scanner)
AL-WB (With Built-in Barcode Scanner)
NOTE
After starting analysis, do not open the front cover of the analyzer.
The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may spill.
8-12
Using the QC Programs OV-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
1.
Tap the MENU button on the screen, and then select "QC" on the pop-up menu.
8-13
Using the QC Programs
2.
Tap "Setup" button, the QC setup dialog box will pop up.
3.
Select “QC Type” as "L-J QC" and select the QC file of the control to be run, and then tap "OK" to return to the QC screen.
NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
The expiration date of expired controls is displayed in red.
8-14
Using the QC Programs 4.
Prepare the control as instructed by instructions for use of the controls.
5.
Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Shake the vial of the whole blood sample as instructed by the picture below to mix the sample thoroughly.
3) Tap "Start Count" button. 4) Present the whole blood sample to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 6.
When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause 8-15
Using the QC Programs biohazard. Exercise caution to the uncapped collection tubes.
Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes.
The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
After starting analysis, do not open the front cover of the analyzer.
If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed.
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
1.
Tap the MENU button on the screen, and then select "QC" on the pop-up menu.
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Using the QC Programs
2.
Tap "Setup" button, the QC setup dialog box will pop up.
3.
Select “QC Type” as "L-J QC" and select the QC file of the control to be run, and then tap "OK" to return to the QC screen.
NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
The expiration date of expired controls is displayed in red.
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Using the QC Programs Prepare the control as instructed by instructions for use of the controls, and paste
4.
barcode labels to the control vials (for details about pasting barcodes, see 6.8.4 Barcode Labels). 5.
Run QC analysis: 1) Make sure the QC mode is "AL-WB" and the analysis status icon and analyzer indicator is green. 2) Make sure the barcode labels are well pasted to the containers of the controls. 3) Accommodate the prepared control into the rack. 4) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 5) Tap the "Start Count" button on the dialog box to start running. 6) When finish running, you can remove the racks from the left of the autoloader.
When finish running, the newest QC results will be displayed in the current screen and
6.
be saved in the QC file automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
Put controls together with normal samples, and run the controls under the sample analysis screen. After setting special "QC Sample ID" for a control under the QC setup screen, you can put the control together with normal samples, and run it under the “Count” screen. Based on the QC mode selected, you can choose to run QC analysis from one of the following ways:
OV-WB
AL-WB
NOTE
Worklist is not supported in QC sample analyses.
8-18
Using the QC Programs OV-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
1.
Prepare the control as instructed by instructions for use of the controls.
8-19
Using the QC Programs 2.
When it is ready to run a sample (i.e. the status icon and the analyzer indicator is green), shake the vial the control as instructed by the picture below to mix the sample thoroughly.
3.
When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is green), present the whole blood sample to the sample probe.
4.
Press the aspirate key to start the analysis.
5.
The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample; the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically.
6.
When the analysis is finished, the status icon and the analyzer indicator will return to green, and the results will be saved into the QC file of the QC sample ID automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution 8-20
Using the QC Programs to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes.
The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
1.
Prepare the control as instructed by instructions for use of the controls.
2.
Paste the barcode to the vial of the control (for details about pasting barcodes, see 6.8.4 Barcode Labels).
8-21
Using the QC Programs 3.
Make sure the QC mode is “AL-WB” and the analysis status icon and analyzer indicator is green.
4.
Make sure the barcode labels are well pasted to the containers of the controls.
5.
Accommodate the prepared control into the rack.
6.
Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer.
7.
Tap the "Start Count" button on the dialog box to start running.
8.
When finish running, you can remove the racks from the left of the autoloader.
NOTE
If nothing is scanned or no matching lot No. is found, the analyzer will jump over the certain control without analyzing, and proceed with barcode scanning and QC analyzing of other controls.
9.
After the analysis finishes, the QC results will be saved into the QC file of the QC sample ID automatically.
NOTE
If any control is jumped over without being analyzed, a prompt will pop up when the analysis cycle is completed. Tap the "OK" button to close the prompt.
10.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running the QC analysis if necessary.
8.2.3 Review L-J QC Results After QC analysis, you can review the QC results in the following ways from the PC:
QC Graph
QC Table
Parameter QC Graph
Monthly QC Graph
L-J QC graph review 1.
Click "QC", and then select "L-J QC" from the "QC Program" pull-down list to enter the L-J QC graph screen.
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Using the QC Programs
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph.
3.
You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
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Using the QC Programs
Introduction to the "Graph" screen
1 2 3 4 6 5 7 8
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points saved currently.
NOTE
The outliers are excluded from the calculation of Mean, SD and CV%.
For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow.
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Using the QC Programs Delete (administrator) You can delete the QC graph data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2.
To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button
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Using the QC Programs Data Compare You can compare the QC graphs of the same parameter obtained by running different batches of control. 1.
Click the “Data Compare” button to go to the data compare screen.
2.
Select the parameter you want to compare from the “Para.” pull-down list.
3.
Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed.
4.
Use the arrow buttons at the bottom to move to the first/previous/next/last QC point.
5.
Click “Print” to print the screen if needed.
6.
Click “Close” to exit.
NOTE
The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level).
Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. 8-26
Using the QC Programs Do as follows to adjust the sequence of parameters displayed in the QC graph screen. 1.
Click the "Sequence" button, and a dialog box will pop up.
2.
Select the parameter that you want to adjust.
3.
Use the order adjusting buttons to move it upwards/downwards/to top/to bottom.
4.
Click the "OK" button to save the change and close the dialog box.
Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1.
Click the "Calculate Preset Values" button, and then two black lines are displayed to
2.
Click and drag the two lines respectively to locate them at the beginning and the end of
locate the range for calculating the preset values. the range for calculating the preset values.
3.
The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range.
4.
If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels 8-27
Using the QC Programs (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
NOTE
The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty.
Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all.
Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1.
After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceeding the limit will be displayed in red) and enter the reasons for the outliers.
2.
You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters).
3.
Click “OK” to save and exit.
NOTE
If you enter the outlier reason for the group of QC points whose results are
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Using the QC Programs actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black if you cancel the outlier reason and then save the changes.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview 1.
Click the "Preview" button, and a dialog box will pop up.
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2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
L-J QC table review 1.
Click "QC", and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the "Table" tab to enter the L-J QC table screen.
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Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table.
4.
You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
Introduction to the "Table" screen
1
2
3 4
5 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently.
NOTE
For the QC files with saved QC results, if any change is made to the target or the limits, the changed data will be highlighted in yellow.
Delete (administrator) You can delete the QC table data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
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2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed. 8-32
Using the QC Programs 3.
Click “OK” to start printing and close the dialog box.
Print preview 1.
Click the "Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1.
Click the "Communication" button, and a dialog box will pop up.
2.
Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you
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Using the QC Programs want to transmit. 3.
Click the "Start" button to start transmitting data.
NOTE
If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start.
The QC data saved in the process of transmission will not be transmitted.
If you need to transmit the L-J QC data in the format of sample data, configure it in the communication setup of DMU (see 5.3.1 General Setup > Communication)
Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1.
Click the "Data Export" button, a dialog box will pop up.
2.
Select the export directory in the pop up box.
3.
Edit the file name of the data to be exported if needed.
4.
Select the format of the data to be exported. (default format:
5.
Click the "Save" button to start the export.
“.csv”)
NOTE
You can modify the exported data if needed but cannot check the data at the "History" screen.
You can click the "Cancel" button to cancel exporting when it is in process.
Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1.
Click the "Restore" button.
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2.
Select to restore “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to restore the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
Parameter QC graph 1.
Click "QC", and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the "Parameter QC Graph" tab to enter the parameter QC graph screen.
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Introduction to the “Parameter QC Graph” screen The parameter QC graph screen consists of the file information area, QC graph area and the comments area.
File information area
You can select among all valid QC file No. from the “File No.” pull-down list. The default file No. is the L-J QC file used by the current operator, and the file No. cannot be null. The lot No, level, exp. date, source of control QC test panel, editor and QC sample ID will be displayed automatically after you select the QC file No..
QC graph area
You can select the parameter to plot QC graph from the “Parameter” pull-down list, and select the QC point plotting mode from the “QC Point” pull down list: “By Date of QC”, “1 per day Sequential”, “All”. The default values of the “X Mean” and “SD” boxes are the latest calculate values (null if no calculation has done before). You can edit the values manually or recalculate. Calculate Target 1.
Click the “Calculate Target” button, the following screen will pop up.
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After selecting the date range, the X mean, SD and CV will be calculated and displayed
2.
in to the corresponding boxes automatically. 3.
Click “Apply” to enter the calculated target into the parameter QC graph screen.
4.
Click “OK” to save the target and close the dialog box.
If there are no data in the selected date range, a prompt will be displayed asking you to reselect a date range and make sure there are more than 5 groups of valid data.”
If you select “By QC Date” or “1 per Day sequential” plotting mode, and there are more than 1 QC point in one day, the points will all be displayed in the graph, but only the latest one will be the connecting point of the plot.
Drag the scroll bar after setting up all the information, and the QC graph will be plotted automatically and the analysis results and operator information will be displayed under the graph. Save Click “Save” to save the mean and SD currently displayed.
QC analysis and flag area
This area displays the conclusion drawn based on the preset rule of outliers (see Set rule of outliers in this section for details). New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
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Using the QC Programs 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2.
To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button Set rule of outliers 1.
Click the “Rule of Outliers” button, and a dialog box will pop up.
2.
Tick the “Effective” check box of the desired rules.
3.
Click “OK” to save and exit.
Print Click the "Print" button to print all the QC file information and graphs of the QC parameters.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
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Monthly QC graph 1.
Click "QC", and then select "L-J QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the "Monthly QC Graph" tab to enter the monthly QC graph screen.
Introduction to the “Monthly QC Graph” screen The monthly QC graph screen consists of the file information area and QC graph area.
File information area
You can select the desired year and month of QC analyses from the “QC Year” and “QC Month” pull-down lists, and the parameter you want to plot, level of control, and way of plotting the QC points from the “Para.”, “Level” and “QC Point” pull-down lists. After you set the above conditions, the matching QC files will be acquired and the Lot No., exp. Date, X mean and SD will be displayed in the area of the corresponding QC levels. If no data is acquired, the boxes will be null. The QC graph can only display the data of 2 batches for each control level of the same month. If there are more than 2 batches of controls, select the desired one(s) from the “Lot No.” pull-down list(s). If the “X Mean” and “SD” boxes are both null, their values cannot be edited, otherwise you can edit the values of X mean and SD, then click “Save” to save the change.
QC graph area
Drag the scroll bar after setting up all the information, the QC graph will be plotted 8-39
Using the QC Programs automatically and the QC point No., analysis results and operator information will be displayed under the QC graph. If there are QC points in the graph, the Lot No., X mean, SD and CV% will be displayed above the graph. Each screen of the QC graph can display 31 groups of QC data. To view more QC data, drag the horizontal scroll bar. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
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8.3 X-B QC Program 8.3.1 Introduction to X-B QC Program The X-B analysis is a weighted moving average analysis that uses values obtained from patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC to indicate the hematology instrument performance. Effective use of X-B requires randomization of samples and a normal cross section of patients to prevent skewing of indices. It is recommended the X-B analysis be activated when the sample volume of your laboratory is greater than 100 samples per day. The analyzer implement X-B QC on the 3 parameters: MCV, MCH and MCHC, each group of samples for X-B analysis consists of 20-200 sample results obtained from normal analysis of both WB and PD modes. The analyzer can save up to 1000 X-B QC results. When the saved QC results have reached the maximum number, the newest result will overwrite the oldest.
8.3.2 QC Setup (Administrator)
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
1.
Click "QC”, and then select "X-B QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X-B QC setup screen.
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At the X-B QC setting screen, you can configure the “X-B QC” information, “Target/Limit” and “Sample Validity Setup”.
QC information setup 1.
In the "Samples/Batch" text box of the X-B QC setup screen, you can enter the amount of samples (shall be within the range from 20 (default) to 200) to be included in calculating for an X-B QC point.
2.
Select “On” to enable the X-B QC, and then all samples compliant with the sample validity setup will be included in the X-B QC calculation; or Select “Close” to disable the X-B QC.
Target/Limit setup Before the X-B QC analysis, you shall set up the target and limit for each parameter at the X-B QC setup screen using one of the following ways:
Manual entry
Reading the saved preset values.
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NOTE
The units for the targets and limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
Manual Entry 1.
In the “Target/Limit” area of the X-B QC setup screen, specify the targets and limits in the “Target/Limit” table by entering manually.
NOTE
Do not leave any of the targets and limits for the QC parameters blank.
When first use, the default setting will provide the initial values for the targets and limits of all QC parameters.
2.
Click the "Save" button to save the changes.
Reading the Saved Preset Values
NOTE
If there are saved preset values (Target and Limits) for the X-B QC, you can read the preset values into the X-B QC setup screen. For details of calculating and saving the preset values, see Section 8.3.4 Reviewing X-B QC results.
1.
In the X-B QC setup screen, click the "Get Preset Values" button to read the saved preset target and limits into the X-B QC setup screen.
NOTE
Do not leave any of the targets and limits for the QC parameters blank.
If some of the parameters do not have preset values, you shall enter them manually.
2.
Click the "Save" button to save the changes.
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Using the QC Programs Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1.
In the X-B QC setup screen, click the “Set Limits” button, and then the following dialog box will pop up.
2.
Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage.
3.
If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits.
4.
Click the “OK” button to save and close the dialog box.
Restoring defaults If needed, you can restore the targets and limits to the default values by clicking the "Restore Defaults" button to read the defaults to the X-B QC setup screen. The default target for each parameter: Parameter
Target
Limit (#)
MCV
89.5
2.7
MCH
30.5
0.9
MCHC
340
10
Sample validity setup In X-B QC, sample results conforming to any of the following conditions will be considered as invalid and cannot be used in the QC calculation. 8-44
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Sample results exceeding the linearity range;
Background results;
Sample results not conforming to the "Sample Validity Setup";
QC data for L-J, X mean and X mean R QC;
Calibration data;
Results generated while there are errors which could affect the accuracy of the results (insufficient aspiration volume or clogging for example).
"Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results. Only when the results of all these four parameters are within the specified ranges, the sample results can be used for X-B QC calculation. Do as follows to set the sample validity: 1.
In the "Sample Validity Setup" of the X-B QC setup screen, set the upper and lower limits of the 4 parameters in the sample validity setup area. The default validity range of each parameter is shown in the following figure.
2.
Click "Save" to save the setup.
NOTE
In the sample validity setup, the upper limit shall be no smaller than the lower limit. Otherwise, there will be prompted message asking you to revise.
The valid ranges of the RBC parameters are their linearity ranges; the valid ranges of other parameters are their display ranges.
All the entries shall be numbers with only one decimal point. The length of the number entered cannot be longer than the length of the text box.
Once the validity range is changed, the previous results will not be used in the QC calculation as valid results. For example, if 20 valid samples are needed for the X-B QC calculation, when you change the validity range after 10 groups of valid sample results have been acquired, these 10 groups of results will be discarded, and only valid sample results generated afterwards will be used in the QC calculation.
The units for the lower and upper limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
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8.3.3 Running Controls
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
After editing X-B setup, the system will start X-B run automatically. After every 20~200 results (determined by the setting) are obtained, the system will perform the X-B calculation once automatically. You can review the result in X-B QC graph or X-B QC table.
8.3.4 Reviewing X-B QC results After QC analysis, you can review the QC results in the following two ways:
QC Graph
QC Table
X-B QC graph review 1.
Click "QC”, and then "X-B QC" from the "QC Program" pull-down list to enter the X-B QC graph screen.
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NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
Introduction to the "Graph" screen
1 2
5 3 4 6 7 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The QC result corresponding to the QC point on the green line. 4- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 5- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 6- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 7- The sequence number of the QC points on the green line and the total groups of QC points saved currently.
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NOTE
The outliers are excluded from the calculation of Mean, SD and CV%.
Delete (administrator) You can delete the QC graph data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The delete operation will be recorded in the log.
Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1.
Click the "Calculate Preset Values" button, and then two black lines are displayed to
2.
Click and drag the two lines respectively to locate them at the beginning and the end of
locate the range for calculating the preset values. the range for calculating the preset values. 8-48
Using the QC Programs 3.
The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range.
4.
If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
NOTE
The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty.
Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
NOTE
The green line and the corresponding values of the QC points will not be printed.
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Click the "Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
X-B QC table review 1.
Click "QC”, and then select "X-B QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Table” button to go to the X-B QC table review screen.
3.
You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse 8-50
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Introduction to the "Table" screen
1 2
3 4
5 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. Delete (Administrator) You can delete the QC table data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
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Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The delete operation will be recorded in the log.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
Print preview 1.
Click the "Print Preview" button, and a dialog box will pop up.
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2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1.
Click the "Communication" button, and a dialog box will pop up.
2.
Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit.
3.
Click the "Start" button to start transmitting data.
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NOTE
If auto communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start.
The QC data saved in the process of transmission will not be transmitted.
Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1.
Click the "Data Export" button, a dialog box will pop up.
2.
Select the export directory in the pop up box.
3.
Enter the file name of the data to be exported.
4.
Select the format of the data to be exported. (default format: “.csv”)
5.
Click the "Save" button to start the export.
NOTE
You can modify the exported data if needed but cannot check the data at the "History" screen.
You can click the "Cancel" button to cancel exporting when it is in process.
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8.4 X Mean QC Program 8.4.1 QC Setup (Administrator)
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
NOTE
If the "In Use" check box of a QC file is ticked, the QC information will be transmitted to the SPU when the connection is built up, and the matching QC results will be saved in this file.
Before analyzing a new batch of controls with the X mean program, you should set up a QC file for each lot of controls. 1.
Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X mean QC setup screen.
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To set up the QC file, you shall enter the required “File Info.” and “Target/Limit” using one of the following ways:
Reading the information provided by the manufacturer
Manual entry
Reading the saved preset values.
There are 3 columns which cannot be edited in the “File Info.” table:
File No. (Sequence number of the QC file)
Editor (the information of the user who edited the file, in the format of “User ID(User Name)”)
Existing Data/Capacity (number of existing records for the file/the maximum records that can be saved in the file)
Reading the information provided by the manufacturer 1.
Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X mean QC setup screen.
3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
Click the “Read File” button, a message box will pop up.
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5.
Click the "Browse" button, and then select the path to read QC information.
6.
Click "OK" to close the box, the dialog box below will display.
NOTE
The QC files for selection are displayed in the format of "Batch No. (level)".
7.
Select a QC file and click "OK" to close the dialog box and return to the "Read File" dialog box. The path selected will be displayed.
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8.
Select "Read Target/Limit", and then click "OK" to import the QC information into the current QC file.
NOTE
If the “Read Target/Limits” is not selected, you have to enter the target and limits manually.
9.
Select the source of control from the pull-down list.
10.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
11.
Tick the “In Use” box if needed.
12.
Click the “Save” button to save the QC information.
NOTE
The expiration date shall not be earlier than the current system date.
Manual entry 1.
Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X mean QC setup screen.
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3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
You can enter the lot No. of the controls by one of the following ways:
Manual entry
Using external barcode scanner
NOTE
The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed.
5.
Select the control level from the pull-down list (L for low level, N for normal level and H for high level).
6.
Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
NOTE
The format of the expiration date is determined by the configuration of the PC.
The expiration date shall not be earlier than the current system date.
7.
Select the source of control from the pull-down list.
8.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
9.
Tick the “In Use” box if needed. 8-59
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Enter the targets and limits manually according to the package insert for the batch of controls.
11.
Click the “Save” button to save the QC information.
Reading the saved preset values
NOTE
If there are the saved preset values (Target and Limits) for the current level, you can read-in the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.4.3 Reviewing X mean QC results.
1.
Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X mean QC setup screen.
3.
Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
4.
You can enter the lot No. of the controls by one of the following ways:
Manual entry
Using external barcode scanner
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NOTE
The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed.
5.
Select the control level from the pull-down list (L for low level, N for normal level and H for high level).
6.
Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
NOTE
The format of the expiration date is determined by the configuration of the PC.
The expiration date shall not be earlier than the current system date.
7.
Select the source of control from the pull-down list.
8.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
9.
Tick the “In Use” box if needed.
10.
Click the “Get Preset Values” button to read-in the saved preset targets and limits (corresponding to the current level) into the current QC file.
NOTE
If some parameters to be included in the QC run have no preset values, you should enter the target and limits for them manually; if you don't want some parameters with preset values to be included in the QC run, you can delete the target and limits of those parameters manually after read-in the preset values.
11.
Click the “Save” button to save the QC information.
Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1.
Click the “Set Limits” button, and then the following dialog box will pop up.
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2.
Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage.
3.
If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits.
4.
Click the “OK” button to save and close the dialog box.
8.4.2 Running Controls After editing the QC information, you can start QC analysis by one of the following ways in the selected QC mode.
OV-WB
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Sample aggregation may result in inaccurate analysis result. Check if the control is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory.
NOTE
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
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OV-WB
NOTE
After starting analysis, do not open the front cover of the analyzer.
The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may spill.
1.
Click the MENU button on the screen, and then select "QC" on the pop-up menu.
2.
Click "Setup" button, the QC setup dialog box will pop up.
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3.
Select “QC Type” as "X mean QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen.
NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
The expiration date of expired controls is displayed in red.
4.
Prepare the control as instructed by instructions for use of the controls.
5.
Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Wave the whole blood sample as instructed by below picture to mix the sample thoroughly.
3) Click "Start Count" button. 4) Present the whole blood sample to the sample probe. 5) Press the aspirate key to start QC run. 8-65
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When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes.
The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
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If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
After starting analysis, do not open the front cover of the analyzer.
If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed.
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
1.
Click the MENU button on the screen, and then select "QC" on the pop-up menu.
2.
Click "Setup" button, the QC setup dialog box will pop up.
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3.
Select “QC Type” as "X mean QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen.
NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
4.
The expiration date of expired controls is displayed in red.
Prepare the control as instructed by instructions for use of the controls, and paste barcode labels to the control vials (for details about pasting barcodes, see 6.8.4 Barcode Labels).
5.
Run QC analysis: 1) Make sure the QC mode is "AL-WB" and the analysis status icon and analyzer indicator is green. 2) Make sure the barcode labels are well pasted to the containers of the controls. 3) Click "Start Count" button. 4) Present the prepared control into the rack. 5) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 6) Press the [Count] key or click the "Count" button on the dialog box to start running. 7) When the running completes, you can remove the racks from the left of the autoloader.
6.
When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
NOTE
Up to 372 QC results can be saved in each QC file. 8-68
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Do the above procedures to continue running QC analysis if necessary.
8.4.3 Reviewing X mean QC results After QC analysis, you can review the QC results in the following two ways:
QC Graph
QC Table
X mean QC graph review 1.
Click "QC", and then "X Mean QC" from the "QC Program" pull-down list to enter the X mean QC graph screen.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph.
3.
You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
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2 1
3 4
6 5 7 8
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points saved currently.
NOTE
The outliers are excluded from the calculation of Mean, SD and CV%.
For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow.
Delete (administrator) You can delete the QC graph data at the administrator level. 8-70
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Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2.
To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button
Data Compare You can compare the QC graphs of the same parameter obtained by running different batches 8-71
Using the QC Programs of control. 1.
Click the “Data Compare” button to go to the data compare screen.
2.
Select the parameter you want to compare from the “Parameter” pull-down list.
3.
Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed.
4.
Use the arrow buttons at the bottom to move to the first/previous/next/last QC point.
5.
Click “Print” to print the screen if needed.
6.
Click “Close” to exit.
NOTE
The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level).
Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. Do as follows to adjust the sequence of parameters displayed in the QC graph screen.
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Click the "Sequence" button, and a dialog box will pop up.
2.
Select the parameter that you want to adjust.
3.
Use the order adjusting buttons to move it upwards/downwards/to top/to bottom.
4.
Click the "OK" button to save the change and close the dialog box.
Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1.
Click the "Calculate Preset Values" button, and then two black lines are displayed to
2.
Click and drag the two lines respectively to locate them at the beginning and the end of
locate the range for calculating the preset values. the range for calculating the preset values.
3.
The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range.
4.
If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results. 8-73
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NOTE
The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty.
Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all.
Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1.
After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
2.
You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters).
3.
Click “OK” to save and exit.
NOTE
If you enter the outlier reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black 8-74
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Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview 1.
Click the "Preview" button, and a dialog box will pop up.
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2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
X mean QC table review 1.
Click "QC", and then select "X Mean QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the "Table" tab to enter the X mean QC table screen.
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3.
Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table.
4.
You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
Introduction to the "Table" screen
1
2 3
4
5
1- The sequence number of the QC results saved in the QC file (earliest to the latest from left 8-77
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NOTE
For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow.
Delete (administrator) You can delete the QC table data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
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Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
Print preview 1.
Click the "Print Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
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Using the QC Programs Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1.
Click the "Communication" button, and a dialog box will pop up.
2.
Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit.
3.
Click the "Start" button to start transmitting data.
NOTE
If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start.
The QC data saved in the process of transmission will not be transmitted.
Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1.
Click the "Data Export" button, a dialog box will pop up.
2.
Select the export directory in the pop up box.
3.
Edit the file name of the data to be exported if needed.
4.
Select the format of the data to be exported. (default format: “.csv”)
5.
Click the "Save" button to start the export.
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NOTE
You can modify the exported data if needed but cannot check the data at the "History" screen.
You can click the "Cancel" button to cancel exporting when it is in process.
Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1.
Click the "Restore" button.
2.
Select to restore “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to restore the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
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8.5 X Mean R QC Program 8.5.1 QC Setup (Administrator)
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
NOTE
If the "In Use" check box of a QC file is ticked, the QC information will be transmitted to the SPU when the connection is built up, and the matching QC results will be saved in this file.
Before analyzing a new batch of controls with the X mean R program, you should set up a QC file for each lot of controls. 1.
Click "QC”, and then select "X mean R QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X mean R QC setup screen.
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Select an empty QC file (ranging from 1 to 60) from the “File Info.” table.
There are 3 columns which cannot be edited in the “File Info.” table:
File No. (Sequence number of the QC file)
Editor (the information of the user who edited the file, in the format of “User ID(User Name)”)
Existing Data/Capacity (number of existing records for the file/the maximum records that can be saved in the file)
To set up the QC file, you shall enter the required “File Info.” as follows: 1.
You can enter the lot No. of the controls by one of the following ways:
Manual entry
Using external barcode scanner
NOTE
The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed.
2.
Select the control level from the pull-down list (L for low level, N for normal level and H for high level).
3.
Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control.
NOTE
The format of the expiration date is determined by the configuration of the PC.
The expiration date shall not be earlier than the current system date
4.
Select the source of control from the pull-down list.
5.
Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations).
6.
Tick the “In Use” box if needed.
7.
Click the “Save” button to save the QC information.
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NOTE
The "In Use" check box of a QC file is ticked automatically when you save the setup for the file.
For QC files having the same lot no., QC test panel and QC sample ID, only the last saved one will be “In Use”.
8.5.2 Running Controls After editing the QC information, you can start QC analysis by one of the following ways in the selected QC mode.
OV-WB
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe is shape and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor. 8-84
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CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
Sample aggregation may result in inaccurate analysis result. Check if the control is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory.
NOTE
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
OV-WB
NOTE
After starting analysis, do not open the front cover of the analyzer.
The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise.
The probe tip should not contact the sample tube. Otherwise, the blood may spill.
1.
Click the MENU button on the screen, and then select "QC" on the pop-up menu.
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2.
Click "Setup" button, the QC setup dialog box will pop up.
3.
Select “QC Type” as "X mean R QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen.
NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
The expiration date of expired controls is displayed in red.
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Prepare the control as instructed by instructions for use of the controls.
5.
Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Wave the whole blood sample as instructed by below picture to mix the sample thoroughly.
3) Click "Start Count" button. 4) Present the whole blood sample to the sample probe. 5) Press the aspirate key to start QC run. 6) When you hear the beep, remove the control. 6.
When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
AL-WB
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
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WARNING
The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it.
The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes.
Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes.
The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes.
The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
After starting analysis, do not open the front cover of the analyzer.
If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed.
Be sure to use the Mindray-specified disposable products including 8-88
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1.
Click the MENU button on the screen, and then select "QC" on the pop-up menu.
2.
Click "Setup" button, the QC setup dialog box will pop up.
3.
Select “QC Type” as "X mean R QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen.
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NOTE
Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired.
4.
The expiration date of expired controls is displayed in red.
Prepare the control as instructed by instructions for use of the controls, and paste barcode labels to the control vials (for details about pasting barcodes, see 6.8.4 Barcode Labels).
5.
Run QC analysis: 1) Make sure the QC mode is "AL-WB" and the analysis status icon and analyzer indicator is green. 2) Make sure the barcode labels are well pasted to the containers of the controls. 3) Click "Start Count" button. 4) Present the prepared control into the rack. 5) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 6) Press the [Count] key or click the "Count" button on the dialog box to start running. 7) When the running completes, you can remove the racks from the left of the autoloader.
6.
When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically.
NOTE 7.
Up to 372 QC results can be saved in each QC file.
Do the above procedures to continue running QC analysis if necessary.
8.5.3 Reviewing X mean R QC results After QC analysis, you can review the QC results in the following two ways:
QC Graph
QC Table
X mean R QC graph review 1.
Click "QC", and then select "X Mean R QC" from the "QC Program" pull-down list to enter the X mean R QC graph screen.
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NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph.
3.
You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
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1
2 3
6 4 5 7
8
1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points saved currently.
NOTE
The outliers are excluded from the calculation of Mean, SD and CV%.
For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow.
Delete (administrator) You can delete the QC graph data at the administrator level.
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Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old. 1.
Move the green line to the first QC point of the new vial.
2.
Click the “New Vial” button, and then a blue line appears at the QC point of the new vial.
3.
After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2.
To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button
Data Compare You can compare the QC graphs of the same parameter obtained by running different batches 8-93
Using the QC Programs of control. 1.
Click the “Data Compare” button to go to the data compare screen.
2.
Select the parameter you want to compare from the “Para.” pull-down list.
3.
Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed.
4.
Use the arrow buttons at the bottom to move to the first/previous/next/last QC point.
5.
Click “Print” to print the screen if needed.
6.
Click “Close” to exit.
NOTE
The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level).
Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. Do as follows to adjust the sequence of parameters displayed in the QC graph screen.
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Click the "Sequence" button, and a dialog box will pop up.
2.
Select the parameter that you want to adjust.
3.
Use the order adjusting buttons to move it upwards/downwards/to top/to bottom.
4.
Click the "OK" button to save the change and close the dialog box.
Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1.
After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceed the limit will be displayed in red) and enter the reasons for the outliers.
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2.
You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters).
3.
Click “OK” to save and exit.
NOTE
If you enter the outlier reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black if you cancel the outlier reason and then save the changes.
Print 1.
Click the "Print" button, and a dialog box will pop up.
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2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview 1.
Click the "Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
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Click the “Close” button to close the window.
X mean R QC table review 1.
Click "QC", and then select "X Mean R QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the "Table" tab to enter the X mean R QC table screen.
3.
Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table.
4.
You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
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1
2 3
4
5 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently.
NOTE
For the QC files with saved QC results, if any change is made to the target or the limits, the changed data will be highlighted in yellow.
Delete (administrator) You can delete the QC table data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
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2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The operation of deletion will be recorded in the log.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed. 8-100
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Click “OK” to start printing and close the dialog box.
Print preview 1.
Click the "Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1.
Click the "Communication" button, and a dialog box will pop up.
2.
Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit.
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Click the "Start" button to start transmitting data.
NOTE
If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start.
The QC data saved in the process of transmission will not be transmitted.
Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1.
Click the "Data Export" button, a dialog box will pop up.
2.
Select the export directory in the pop up box.
3.
Edit the file name of the data to be exported if needed.
4.
Select the format of the data to be exported. (default format: “.csv”)
5.
Click the "Save" button to start the export.
NOTE
You can modify the exported data if needed but cannot check the data at the "History" screen.
You can click the "Cancel" button to cancel exporting when it is in process.
Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1.
Click the "Restore" button.
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2.
Select to restore “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to restore the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
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8.6 X-M QC Program 8.6.1 X-M QC principle The X-M analysis is a weighted moving average analysis that uses values obtained from patient samples. It uses the parameters of CBC, DIFF, NRBC and RET to indicate the hematology instrument performance. Effective use of X-M requires randomization of samples and a normal cross section of patients to prevent skewing of indices. The analyzer implement X-M QC on all the reported parameters (expect the RUO parameters), each group of samples for X-M analysis consists of 2-500 sample results obtained from normal analysis of both WB and PD modes. The analyzer can save up to 1000 X-M QC results. When the saved QC results have reached the maximum number, the newest result will overwrite the oldest.
8.6.2 QC Setup (Administrator)
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
1.
Click "QC”, and then select "X-M QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Setup” button to go to the X-M QC setup screen.
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At the X-M QC setting screen, you can configure the “X-M QC” information, “Target/Limit” and “Sample Validity Setup”.
QC information setup 1.
In the "Samples/Batch" text box of the X-M QC setup screen, you can enter the amount of samples (shall be within the range from 2 (default) to 500) to be included in calculating for an X-M QC point.
2.
Select “On” to enable the X-M QC, and then all samples compliant with the sample validity setup will be included in the X-M QC calculation; or Select “Close” to disable the X-M QC.
Target/Limit setup Before the X-M QC analysis, you shall set up the target and limit for each parameter at the X-M QC setup screen using one of the following ways:
Manual entry
Reading the saved preset values.
NOTE
The units for the targets and limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
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In the X-M QC setup screen, specify the targets and limits in the “Target/Limit” table by entering manually.
NOTE
Do not leave any of the targets and limits for the QC parameters blank.
When first use, the default setting will provide the initial values for the targets and limits of all QC parameters.
2.
Click the "Save" button to save the changes.
Reading the Saved Preset Values
NOTE
If there are saved preset values (Target and Limits) for the X-M QC, you can read the preset values into the X-M QC setup screen. For details of calculating and saving the preset values, see Section 8.6.4 Reviewing X-M QC results.
1.
In the X-M QC setup screen, click the "Get Preset Values" button to read the saved preset target and limits into the X-M QC setup screen.
NOTE
Do not leave any of the targets and limits for the QC parameters blank.
If some of the parameters do not have preset values, you shall enter them manually.
2.
Click the "Save" button to save the changes.
Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1.
In the X-M QC setup screen, click the “Set Limits” button, and then the following dialog box will pop up.
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2.
Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage.
3.
If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits.
4.
Click the “OK” button to save and close the dialog box.
Setting sample validity In X-M QC, sample results conforming to any of the following conditions will be considered as invalid and cannot be used in the QC calculation.
Sample results exceeding the linearity range;
Background results;
Sample results not conforming to the "Sample Validity Setup";
QC data for L-J, X mean and X mean R QC;
Calibration data;
Results generated while there are errors which could affect the accuracy of the results (insufficient aspiration volume or clogging for example).
"Sample Validity Setup" is to set up the ranges of valid X-M QC results. Only when the results of all these parameters are within the specified ranges, the sample results can be used for X-M QC calculation. Do as follows to set the sample validity: 1.
In the X-M QC setup screen, set the upper and lower limits of the parameters in the
2.
Click "Save" to save the setup.
sample validity setup area.
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NOTE
In the sample validity setup, the upper limit shall be greater than the lower limit. Otherwise, there will be prompted message asking you to revise.
The valid ranges of the parameters are their display ranges.
All the entries shall be numbers with only one decimal point. The length of the number entered cannot be longer than the length of the text box.
Once the validity range is changed, the previous results will not be used in the QC calculation as valid results. For example, if 20 valid samples are needed for the X-M QC calculation, when you change the validity range after 10 groups of valid sample results have been acquired, these 10 groups of results will be discarded, and only valid sample results generated afterwards will be used in the QC calculation.
The units for the lower and upper limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
8.6.3 Running Controls
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
After editing X-M setup, the system will start X-M run automatically. After every 2-500 results (determined by the setting) are obtained, the system will perform the X-M calculation once automatically. You can review the result in X-M QC graph or X-M QC table.
8.6.4 Reviewing X-M QC results X-M QC graph review 1.
Click "QC”, and then "X-M QC" from the "QC Program" pull-down list to enter the X-M QC graph screen.
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NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
Introduction to the "Graph" screen
2 1 3
4 5 6
7
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NOTE
The outliers are excluded from the calculation of Mean, SD and CV%.
Delete (administrator) You can delete the QC graph data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”.
NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
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NOTE
The delete operation will be recorded in the log.
Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1.
Click the "Calculate Preset Values" button, and then two black lines are displayed to
2.
Click and drag the two lines respectively to locate them at the beginning and the end of
locate the range for calculating the preset values. the range for calculating the preset values.
3.
The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range.
4.
If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results.
NOTE
The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty.
Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all.
Print 1.
Click the "Print" button, and a dialog box will pop up.
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2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
NOTE
The green line and the corresponding values of the QC points will not be printed.
Print Preview 1.
Click the "Preview" button, and a dialog box will pop up.
2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
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Click the “Close” button to close the window.
X-M QC table review 1.
Click "QC”, and then select "X-M QC" from the "QC Program" pull-down list.
NOTE
If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen.
2.
Click the “Table” button to go to the X-M QC table review screen.
3.
You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
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1
2 3
4
5
1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. Delete (administrator) You can delete the QC table data at the administrator level. 1.
Click the "Delete" button, and a dialog box will pop up.
2.
Select to delete “Current Data” or “All Data”. 8-114
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NOTE
Make sure you select the desired data if you choose to delete the “Current Data”.
3.
Click the "OK" button to delete specified data and close the dialog box.
NOTE
The delete operation will be recorded in the log.
Print 1.
Click the "Print" button, and a dialog box will pop up.
2.
Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
3.
Click “OK” to start printing and close the dialog box.
Print preview 1.
Click the "Preview" button, and a dialog box will pop up.
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2.
Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview.
3.
Click “OK” to go to the print preview window.
4.
Click the “Close” button to close the window.
Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1.
Click the "Communication" button, and a dialog box will pop up.
2.
Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit.
3.
Click the "Start" button to start transmitting data.
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NOTE
If auto communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start.
The QC data saved in the process of transmission will not be transmitted.
Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1.
Click the "Data Export" button, a dialog box will pop up.
2.
Select the export directory in the pop up box.
3.
Edit the file name of the data to be exported if needed.
4.
Select the format of the data to be exported. (default format: “.csv”)
5.
Click the "Save" button to start the export.
NOTE
You can modify the exported data if needed but cannot check the data at the "History" screen.
You can click the "Cancel" button to cancel exporting when it is in process.
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9
Calibrating Your Analyzer
9.1 Introduction Calibration is a procedure to standardize the analyzer by determining its deviation under certain specified conditions. In order to get accurate sample analysis results, you should calibrate the analyzer per the procedure below when necessary. There are three calibration programs available on this analyzer: manual calibration, auto calibration using calibrators and auto calibration using fresh blood samples. All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be calibrated by the calibration programs.
NOTE z
Calibration
procedures
can
only
be
performed
by
users
of
the
administrator-level.
z
You should only use the Mindray-specified calibrators and reagents. Store and use the calibrations and reagents as instructed by instructions for use of the calibrators and reagents.
z
The analyzer identifies a sample as a calibration sample only if the analysis is started from the "Calibration" screen.
z
Calculation of reproducibility is included in the calibration procedure.
9-1
Calibrating Your Analyzer
9.2 When to Calibrate This analyzer is calibrated at the factory just before shipment. It is electronically stable and does not require frequent recalibration if you operate and maintain it as instructed by this manual. You only need to recalibrate this analyzer if:
you are going to use this analyzer for the first time (usually done by a Mindray-authorized representative when installing the analyzer).
an analytical component has been changed.
you are going to re-use the analyzer after a long-term storage.
the quality control results indicate there may be a problem.
NOTE
All of the measured parameters must be calibrated before readings of this analyzer can be used as valid analysis results.
9-2
Calibrating Your Analyzer
9.3 How to Calibrate 9.3.1 Preparation Do the following pre-calibration procedures before calibration. If problems are detected during these checks, do not attempt to calibrate the analyzer. If necessary, call Mindray Customer Service Department or your local distributor for assistance. 1.
Check and make sure enough reagents have been prepared for the calibration. You need to start over the calibration if the reagents run out during the process.
2.
Check the background (for calibration right after startup) or blank count results. If the analyzer alarms for abnormal background results, see 11 Troubleshooting for solutions.
3.
Enter the "Count" screen and run a vial of blood sample consecutively for 10 times. Enter the "Table" review screen to check the reproducibility of the ten runs and make sure they meet the following requirements. Parameter
Range
Whole Blood
Predilute
Reproducibility CV% /
Reproducibility CV% /
absolute deviation (d)
absolute deviation (d)
WBC
≥ 4×10 /L
≤ 2.5%
≤ 4.0%
RBC
≥3.5×10 /L
12
≤ 1.5%
≤ 2.0%
9
HGB
(110-180) g/L
MCV
(80-100) fL
PLT
≥100×10 /L
9
≤ 1.0% Range**≤3.0
≤ 2.0%
≤ 1.0%
≤ 3.0%
≤ 4.0%
≤ 8.0%
NOTE
If you are using fresh blood to perform the reproducibility test, make sure the volume of sample is adequate (suggested sample volume: no less than 3.0ml in open-vial mode; no less than 3.5ml in autoloading mode).
If you are using fresh blood in AL-WB mode to perform the reproducibility test, be aware that the number of times that the tube is pierced may affect the accuracy of the test results.
9-3
Calibrating Your Analyzer 4.
Run a vial of high level control consecutively for 3 times and then immediately run the diluent consecutively for 3 times. Calculate the carryover per the following equation.
Carryover(%)
First low - level sample result－Third low - level sample result 100％ Third high - level sample result－Third low - level sample result
The calculated carryovers shall meet the requirements in the following table. Parameter
Carryover
WBC
≤1.0％
RBC
≤1.0％
HGB
≤1.0％
HCT
≤1.0％
PLT
≤1.0％
9-4
Calibrating Your Analyzer 5.
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid contact with the probe when working around it.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
Keep you clothes, hairs and hands away from the moving parts to avoid injury.
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
CAUTION
Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc.
NOTE
You should only use the Mindray-specified controls and reagents. Store and use the controls and reagents as instructed by instructions for use of the controls and reagents.
Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc.
9-5
Calibrating Your Analyzer
9.3.2 Manual Calibration ("Menu" > "Calibration" > "Manual")
NOTE
If you log in at the operator access level, you can only view the calibration factors. To perform calibration, please log out and then log in at the administrator access level.
Do as follows to calibrate the analyzer: 1.
At the "Manual” calibration screen, check the calibration factors and calculate the new factors per the following equation.
New calibration factor＝
Current calibration factor Reference value Mean
For example: Suppose the WBC reference value of a calibrator is 8.4, and the current calibration factor of the whole blood mode is 98.9％. Run the calibrator under the whole blood mode for 10 consecutive times and take the WBC results of the 10 runs to calculate: 8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3. The obtained CV is 1.5% and Mean is 8.16, which meet the requirements. The new calibration factor is obtained:
New calibration factor＝
98.90% 8.4 ＝101 .81% 8.16
The calculated calibration factors shall be between 75.00％ - 125.00％.In case of an invalid calibration factor, try to find out the reason (e.g. calibration material not thoroughly mixed, misoperation, etc.).Then recalibrate the analyzer and recalculate the calibration factors.
9-6
Calibrating Your Analyzer
NOTE
The entered calibration factors shall be between 75.00％～125.00％ (accurate to the second decimal place).
2.
Enter the new calibration factors into the factor cell of the parameter that requires calibration.
3.
When you switch screen after entering the new calibration factor, a prompt will display.
If the entered calibration factors are valid, a dialog box will pop up when you are exiting the screen.
Tap “Yes” to save the new calibration factors and the calibration date of the corresponding parameter changes to current system date and is recorded in the calibration history; then, close the dialog box and switch to another screen.
If the entered calibration factors are invalid, a dialog box will pop up when you are switching to another screen.
Tap "Yes" to close the dialog box and switch to another screen without saving the changes; the original calibration factors and dates will remain the same.
9-7
Calibrating Your Analyzer
9.3.3 Calibration with Calibrator (Administrator) ("Menu" > "Calibration" > "Calibrator")
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
NOTE
The calibrator calibration can only be performed under whole blood mode.
Only Mindray-specified calibrators shall be used. Mindray will not be responsible for any erroneous result caused by using other calibrators.
Do as follows to calibrate the analyzer with calibrators. 1.
Enter the lot No. of the calibrator into the "Lot No." box.
NOTE
See the instruction for use of the calibrators for the lot No., expiration
9-8
Calibrating Your Analyzer date and the target.
2.
The lot No. must be entered.
Enter the “Expiration date”.
NOTE
3.
The expiration date defaults to the current system date.
The expiration date shall not be earlier than the current system date.
Enter the targets into the "Target" cells.
NOTE
The entered expiration date should be either the expiration date printed on the labeling or the open-container expiration date, whichever is earlier. The open-container expiration date is calculated as follows: the date that container is opened + the open-container stability days.
4.
Prepare the calibrator as instructed by instructions for use of the calibrators.
5.
Press the aspirate key to start calibration, the message box will close automatically, and then a progress bar will pop up.
6.
After the analysis, the calibration progress bar will close automatically and the analyzer will have different responses to different analysis results.
When the current running is done, if there is a parameter whose calibration data is out of its linearity range but still within the display range, then the calibration data will be displayed in the list and a message box will also pop up.
Tap “OK” to close the message box, and the data will be deleted from the table without saving automatically.
When the running is done, if there is a parameter whose calibration data is out of the display range, then the non-numeric parameter values "***" will be displayed in the list and a message box will pop up.
9-9
Calibrating Your Analyzer
Tap “OK” to close the message box, and the data will be deleted from the table without saving automatically.
The valid results within the linearity range will be displayed directly.
NOTE
Valid calibration results will be highlighted per the default setting, and will be taken to calculate calibration factors.
7.
If the calibration factors have not been calculated but you switch to another screen, then a message box will pop up.
Tap "Yes" to switch to another screen while discarding the calibration data and closing the message box. The original calibration factors remain. 8.
When calibration count has been performed to a sample for n times (n≥5), the analyzer will calculate the Mean, CV% and calibration factors of all the highlighted calibration data automatically. You can select several data to calculate the calibration factors, but only after at least 5 groups of the data are selected can you get the calibration factors.
NOTE
The out-of-range CV% does not influence the display of calibration factors.
When the amount of valid calibration data in the list reaches 10, a message box "Calibration done!" will pop up. Then, if you press the 9-10
Calibrating Your Analyzer aspirate key again, the analyzer will beep without starting analysis. 9.
There may be two cases when you are switching to another screen:
If the calibration factors of any parameter is out of the range [75%-125%] or the CV% of any parameter exceeds the reproducibility standard, then the calculated calibration factors of all parameters will not be saved and a message box will also pop up.
Tap "Yes" to close the dialog box and switch to another screen. The calibration factors and date of all parameters will not be changed.
If the calculated calibration factors of all parameter are within the range [75%-125%] and the CV% of all parameter are also within the reproducibility standard, then a message box will pop up.
Tap "Yes" to save the new calibration factors while closing the message box and switching to another screen.
9-11
Calibrating Your Analyzer
9.3.4 Calibration with Fresh Blood (Administrator) ("Menu" > "Calibration" > "Fresh blood")
Do as follows to calibrate the analyzer with fresh blood samples. 1.
Prepare 3 to 5 normal fresh blood samples as instructed by 6.6 Preparing Samples.
2.
Run each of the prepared samples on the reference instrument (or by the reference method) three times at least. Calculate the mean values and use them as the targets.
3.
Select the ID of current sample from the box "Sample 1- Sample 5" on the left of the screen.
4.
Enter the targets into the "Target" text boxes.
5.
Prepare fresh blood sample.
6.
Press the aspirate key to start the calibration and the dialog box will close automatically, then a progress bar will pop up.
7.
After the analysis, the calibration progress bar will close automatically and the analyzer will have different responses to different analysis results.
If the results are out of the linearity range but still within the display range, a dialog box will pop up when the results are displayed in the table.
9-12
Calibrating Your Analyzer
Tap "OK" to close the dialog box and the results will be deleted from the table without saving automatically.
If the results are out of the display rage, the non-numeric parameter values "***" are obtained and a dialog box will pop up.
Tap "OK" to close the dialog box and the results will be deleted from the table without saving automatically.
The valid results within the linearity range will be displayed directly.
NOTE
Valid calibration results will be highlighted per the default setting, and will be taken to calculate calibration factors.
8.
When calibration count has been performed to a sample for n times (n≥5), the analyzer will calculate the Mean, CV% and calibration factors of all the highlighted calibration data automatically. You can select several groups of data (at least 5) to calculate the calibration factors.
NOTE
The out-of-range CV% does not influence the display of the calibration factors.
When the amount of valid calibration data in the table reaches 10, a dialog box of "Fresh blood calibration done!" will pop up; if you
9-13
Calibrating Your Analyzer press the aspirate key again, the analyzer will beep without starting analysis. 9.
Select other calibration sample ID, analyze other samples according to Step 6-8 above to obtain the calibration factors of all samples.
10.
There may be several cases when switching to another blood sample:
If the calibration factors of the blood sample are invalid or the CV% of any parameter exceeds the reproducibility standard, a dialog box will pop up when switching to another blood sample.
Tap "Yes" to empty the entered target of the current sample, all the calibration data obtained and each calculated value including calibration factors, then close the dialog box and switch to another blood sample.
If the calibration factors have not been calculated, a dialog box will pop up.
Tap “Yes” to empty the entered target of the current sample and all the calibration data obtained, then close the dialog box and switch to another blood sample. If the calibration factors of the sample are valid and the CV% of all the parameters do not exceed the reproducibility standard, you can switch to another blood sample directly. 11.
After calibration factors of at least 3 fresh blood samples are obtained, tap the "Calculate" button to enter the screen of calibration calculation.
9-14
Calibrating Your Analyzer
12.
Select or deselect the calibration factors of a blood sample for the calculation of the Mean calibration factors by tapping the corresponding calibration factors. The selected calibration factors will be highlighted, and when 3 or more groups of factors are selected, CV% will be re-calculated automatically base on the selected calibration factors.
NOTE
The out-of-range CV% does not influence the display of calibration factors.
When 3 or more groups of calibration factors are selected, the mean calibration factor will be re-calculated automatically base on the selected calibration factors. The mean calibration factors are regarded as invalid if the deviation of absolute value between the calibration factors included in calculating the mean and the original calibration factors reaches or exceeds 5%; a dialog box will pop up when you exit the current fresh blood calibration screen.
Tap "Yes" to close the dialog box and exit with the current calibration data emptied, and 9-15
Calibrating Your Analyzer then switch to another screen. Tap "No" to return to the current screen. Invalid mean calibration factors are displayed in red and followed with a "?". 13.
If the mean calibration factors have not been calculated, when you exit the fresh blood screen or switch to another calibration mode, a dialog box will pop up.
Tap "Yes" to discard the calibration data, close the dialog box, and switch to another screen or calibration mode. The original calibration factors and date remain the same. 14.
If the calculated mean calibration factors are valid, when exiting the fresh blood calibration screen or switching to another calibration mode, a dialog box will pop up.
Tap "Yes" to save the current mean calibration factors and refresh the calibration factors and date in the table at the "Calibration Factors" screen. Then, you can switch to another screen or calibration mode. Tap "No" to close the dialog box and switch to another screen or calibration mode without saving the mean calibration factors and all the calibration data.
9.3.5 Verifying calibration factors It is recommended that you take the following steps to verify the calibration factors: 1. Run the calibrator at least three times and check whether the means of the obtained results are within the expected ranges. 2. Run the low, normal and high level controls, each for three times at least, and check whether the means of the obtained results are within the expected ranges. 3. Run at least three fresh blood samples with known reference values, each for six times at least, and check whether the means of the obtained results are within the expected ranges. 9-16
Calibrating Your Analyzer
9.4 Calibration History ("Menu" > "Calibration" > "History")
The date, operator of calibration, calibration method and calibration mode of the latest 100 calibrations will be displayed in the table on the screen with the latest on the top (No. 1). If more than 100 calibrations were performed, the earliest result will be overwritten. You can click the arrow buttons to view the entire table. You are not allowed to modify or delete contents in the table.
9-17
Calibrating Your Analyzer
9.5 Touch Screen Calibration ("Menu" > "Calibration" > "Touch Screen")
CAUTION
Do not use anything sharp on the touch screen or strike on it.
NOTE
Do not click with the mouse to calibrate the touch screen.
1.
Tap the “Touch Screen Cal.” button in the middle of the screen.
2.
Tap the red dot at the upper left corner of the screen as instructed by the screen display to start the calibration.
3.
Then tap the red dot at the lower right corner of the screen.
4.
Tap the blue rectangular area in the middle of the screen, and the calibration will be finished and the screen will resume after 1 second.
9-18
10 Servicing Your Analyzer 10.1 Introduction Preventive and corrective maintenance procedures are required to keep the analyzer in a good operating condition. This analyzer provides multiple maintenance functions for this purpose. This chapter introduces how to use the provided functions to maintain and troubleshoot your analyzer.
z
All the analyzer components and surfaces are potentially infectious, take proper protective measures for operation or maintenance.
CAUTION z
Performing unauthorized maintenance procedures can damage your analyzer. Do not perform any maintenance procedures that are not described in this chapter.
z
In case of problems not specified in this manual, contact Mindray Customer Service Department or your local distributor for assistance.
z
Only Mindray-supplied parts can be used for maintenance. For any questions, contact Mindray Customer Service Department or your local distributor.
z
Exercise caution to avoid contact with the sharp sample probe when performing maintenance.
10-1
Servicing Your Analyzer
10.2 Reagent Management
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
Do not mix the new container of reagent with the residue in the replaced container to ensure accurate measurement.
NOTE
Please keep the diluent container from severe shock or crashing against other object. Otherwise, the alarming would be unreliable.
You need to replace reagents promptly when it is low, depleted, expired, or required to remove an error. Do as follows:
Replace with a new container of desired reagent (see 10.8.2 for details);
Finish reagent setup on the SPU. (see 5.2.3 for details)
You can also check the reagent information (like expiration date, residual volume, etc.) of the reagents at the reagent setup screen of the SPU.
10-2
Servicing Your Analyzer
10.3 Maintaining Your Analyzer Using the Service Program 10.3.1 When and Why Procedure Reagent Replacing Reagent Priming
Flow Cell Bubble Removal Fluidics Cleaning
When to Clean
Why to Clean
After replacing a new container of
Replace the old reagent in
reagent
fluidics
the reagent is contaminated
Replace the old reagent in
WBC/RBC bubbles are reported
fluidics;
When abnormal distribution is found
To remove bubbles from the
in scattergrams
flow cell
When all the blank count results
To clean the fluidic system
exceed their limits Probe Maintenance
Cleanser (of
As needed
To clean and soak specified
fluidic
components
system, flow cell, SRV, and/or aperture) Aperture Unclogging
When aperture clogging is reported
Unclog the aperture
Pack-up
When the analyzer is to be left idle for
Drain the residual reagent
a long time (more than 10 days)
from fluidics
10.3.2 Replacing Reagent ("Menu" > "Service" > "Reagent" > "Replace Reagent") The operator can use this program to replace the reagent in fluidics after replacing a new container of reagent or as needed.
10-3
Servicing Your Analyzer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
You can replace the following reagents in the fluidics at this screen:
M-68DS DILUENT
M-68LH LYSE
M-68LB LYSE
M-68LN LYSE
M-68LD LYSE
M-68DR DILUENT
M-68FN DYE
M-68FD DYE
M-68FR DYE 10-4
Servicing Your Analyzer
NOTE
Please keep the diluent container from severe shock or crashing against other object. Otherwise, the alarming would be unreliable.
Do as follows to replace the reagent(s): 1.
Tap the reagent you want to replace to start replacing.
2.
A prompt will pop up when the replacing is finished.
3.
Tap “OK” to close the dialog box.
4.
Perform the procedures above to replace other reagents if necessary.
10.3.3 Reagent Priming ("Menu" > "Service" > "Reagent" > "Reagent priming")
10-5
Servicing Your Analyzer
WARNING
The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
You can prime with the following reagents at this screen:
M-68DS DILUENT
M-68LH LYSE
M-68LB LYSE
M-68LN LYSE
M-68LD LYSE
M-68DR DILUENT
M-68FN DYE
M-68FD DYE
M-68FR DYE
NOTE
Please keep the diluent container from severe shock or crashing against other object. Otherwise, the alarming would be unreliable.
Do as follows to prime the reagent(s): 1.
Tap the reagent you want to prime to start priming.
2.
A prompt will pop up when the priming is finished.
3.
Tap “OK” to close the dialog box.
4.
Perform the procedures above to prime other reagents if necessary.
10-6
Servicing Your Analyzer
10.3.4 Cleaning ("Menu" > "Service" > "Cleaning")
Do as follows to clean: 1.
Tap the button of the component you want to clean.
2.
A prompt will pop up when the cleaning is completed.
3.
Tap “OK” to close the dialog box.
4.
Perform the procedures above to clean other components if necessary.
10-7
Servicing Your Analyzer
10.3.5 Maintenance ("Menu" > "Service" > "Maintenance")
Maintenance with Probe Cleanser You can use the probe cleanser to clean and soak the following components:
Fluidic system
Flow cell
Sample rotary valve (SRV)
Aperture
Do as follows to maintain: 1.
At the "Maintenance" screen, tap the icon of the component you want to maintain.
2.
Tap "Yes" and operate as prompted by the dialog box until the count down box of maintenance appears.
10-8
Servicing Your Analyzer
3.
When the maintenance is finished, the dialog box "Maintaining finished!" will pop up. Tap “OK” to close the dialog box.
Maintaining Apertures Unclogging Do as follows to unclog: 1.
Tap the "Unclog" button at the "Maintenance" screen.
2.
A prompt will pop up when the unclogging is finished.
3.
Tap “OK” to close the dialog box.
10-9
Servicing Your Analyzer
10.3.6 Servicing the Fluidics ("Menu" > "Service" > "Fluidics") Pack-up
Do as follows to pack up: 1.
Tap “Pack-up”.
2.
Tap "Yes" to perform the pack-up procedure as instructed by the pop-up screens.
3.
When the pack-up is finished, shut down the analyzer as prompted.
10.3.7 Filter Discharging The analyzer will perform automatic filter discharging periodically for the proper functioning. When the time comes, a prompt shown below will pop up.
The prompt will disappear after the maintenance is finished. 10-10
Servicing Your Analyzer
10.4 Checking the Analyzer Status Using the Status Program The Status Screen displays the current status of the analyzer. You can check the status including:
Statistics
Temperature&Pressure
Version Info.
You cannot modify but only browse the status information at the Status Screen. To check the status information at the Status Screen is significant for you to locate and remove errors of the analyzer.
10.4.1 Temp.&Pressure ("Menu" > "Status" > "Temp.&Pressure")
You can check the temperature and pressure values of different components of the analyzer. The screen displays the current value of each item and the corresponding normal range, which is significant for you to judge and locate errors of the analyzer.
10-11
Servicing Your Analyzer
10.4.2 Float Sensor ("Menu" > "Status" > "Float Sensor")
After you enter the “Float Sensor” screen, wait a few seconds, and the status of the cisterns and waste container will be displayed.
10.4.3 Version Info. ("Menu" > "Status" > "Version Info.")
You can check the current version information of the analyzer software and hardware.
10-12
Servicing Your Analyzer
10.5 Viewing History Logs The log records the key operations performed on the analyzer. It provides the operators an access to review the operating history and service personnel the facilitation of troubleshooting. The DMU can save logs of the recent two years. If number of logs exceeds the upper limit, the latest log will overwrite the oldest one. You can browse and print logs, but cannot delete them. Click “Log” to enter the following screen.
10.5.1 Viewing Logs Defining the date range Enter or select the starting and ending dates to define a desired date range of logs.
Selecting the source of logs Select the desired source of logs from the pull-down list, where you can select all logs, logs on the PC workstation, or logs about the SPUs which used to connect to the DMU.
Selecting the log type Select the desired log type from the buttons on the left:
10-13
Servicing Your Analyzer
All Logs
Setup Adjustment (administrator)
Error Info. (administrator)
Other Logs
10.5.2 Exporting Logs (Administrator) 1.
Click the "Export" button, and a dialog box will pop up.
2.
Select one of the following:
Select Date Range
All Records
Selected Records
If you select the first radio button (to export the records of selected date range, you should specify the starting and ending date. 3.
Click the “Browse” button to specify the directory to save the exported logs.
4.
Click “OK” to start exporting.
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Servicing Your Analyzer
10.6 Adjusting Pressure and Vacuum 10.6.1 Introduction Adjusting pressure and vacuum of the pneumatic unit is important in daily use of the analyzer. Once a pressure or vacuum error is reported, do as instructed by the troubleshooting information to adjust pressure or vacuum. Pressure/Vacuum
Function
0.25MPa
drives the cylinders and pinch valves of the analyzer.
0.16MPa
drives the sheath fluid of optical system
0.07MPa
drives the waste emptying process of the analyzer and reagent dispensing from volumetric pump
0.04MPa
drives the sheath fluid of the impedance measurement module
-0.04MPa
drives the waste emptying process of baths
The location of the pressure and vacuum regulators:
0.25Mpa
10-15
Servicing Your Analyzer
0.16Mpa 0.07Mpa
0.04Mpa -0.04Mpa
10.6.2 Adjusting Pressure and Vacuum You need to go to the “Temperature&Pressure” screen before adjusting the pressure or vacuum, Tap "Menu" > "Status" > "Temperature&Pressure"
10-16
Servicing Your Analyzer
Adjusting the 0.25MPa pressure 1.
Loosen the fixing screw of 0.25MPa pressure regulator with a cross-headed screwdriver.
Fixing screw
10-17
Servicing Your Analyzer 2.
Check the pressure value in the “PS1 (250)” column at the “Temperature&Pressure” screen, and then turn the adjustment knob (clockwise to increase the pressure, counterclockwise to decrease) until the value fall in the expected range ((250±10)Kpa).
NOTE
If the pressure is too high while adjusting, adjust it to the lowest level before readjusting it to the desired level.
3.
Tighten the lock screw of the 0.25MPa pressure regulator after the adjustment is finished.
Adjusting the 0.16MPa pressure 1.
Pull the 0.16MPa pressure regulator outwards.
2.
Check the pressure value in the “PS2 (160)” column at the “Temperature&Pressure” screen, and then turn the adjustment knob (clockwise to increase the pressure, counterclockwise to decrease) until the value fall in the expected range ((160±1)Kpa).
10-18
Servicing Your Analyzer 3.
Push the regulator inwards after the adjustment is finished.
NOTE
If the regulator can not be pushed back, turn it a little bit and then push.
Adjusting the 0.07MPa pressure 1.
Pull the 0.07MPa pressure regulator outwards.
2.
Check the pressure value in the “PS3 (70)” column at the “Temperature&Pressure” screen, and then turn the adjustment knob (clockwise to increase the pressure, counterclockwise to decrease) until the value fall in the expected range ((70±1)Kpa).
3.
Push the regulator inwards after the adjustment is finished.
NOTE
If the regulator cannot be pushed back, turn it a little bit and then push.
Adjusting the 0.04MPa pressure 1.
Pull the 0.04MPa pressure regulator outwards.
10-19
Servicing Your Analyzer
2.
Check the pressure value in the “PS4 (40)” column at the “Temperature&Pressure” screen, and then turn the adjustment knob (clockwise to increase the pressure, counterclockwise to decrease) until the value fall in the expected range ((40±1)Kpa).
3.
Push the regulator inwards after the adjustment is finished.
NOTE
If the regulator cannot be pushed back, turn it a little bit and then push.
Adjusting the -0.04MPa vacuum 1.
Turn the locknut of the relief valve counterclockwise to loosen it.
Locknut
2.
Check the pressure value in the “PS5 (-40)” column at the “Temperature&Pressure” screen, and then turn the adjustment knob (clockwise to increase the vacuum, counterclockwise to decrease) until the value fall in the expected range ((-40±1)Kpa).
3.
Secure the locknut by turning it clockwise after the adjustment is finished. 10-20
Servicing Your Analyzer
10.7 Manual Cleaning 10.7.1 When, Why and Tools Needed Procedure
When to
Why to Clean
Clean Cleaning the waste
As needed
Tools You May Need To remove the buildup in the
Distilled water, dry
trays
cloth
Every 2
To remove blood residue or
Distilled water, dry
months (of
other buildup in the SRV
cloth, syringe, clean
collecting trays Cleaning the SRV
Consumables and
operation)
toothbrush, clean lint-free wet cloth
Cleaning the probe
As needed
wipe of the open-vial
To remove blood residue or
Distilled water, dry
other buildup in the probe wipe
cloth
To remove the contaminants on
Disinfectant (see 10.7.6
the coverr of the analyzer
for recommended
module Sterilizing the cover
As needed
of the analyzer
disinfectants)
10.7.2 Opening and Closing the Front Cover You may need to open and close the front cover in some manual cleaning procedures. Be sure to perform strictly according the standard procedures stated below.
Opening the front cover 1.
Hold the sides of the front cover and lift it upwards.
10-21
Servicing Your Analyzer 2.
Fix the opened front cover with the stop bar.
Stop Bar
Closing the front cover 1.
Hold the front cover steadily, and then release the stop bar.
2.
Move the front cover downwards and close it.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10.7.3 Cleaning the Waste Collecting Trays
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
10-22
Servicing Your Analyzer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The waste collecting trays may contain biohazardous materials. Exercise caution to avoid direct contact with the trays.
CAUTION
After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer.
Cleaning the waste collecting tray of the open-vial module 1.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
2.
Pull out the waste collecting tray under the open-vial sample probe.
10-23
Servicing Your Analyzer
3.
Wash the tray with clean water.
4.
Wipe up the water left in the tray.
5
Install the tray back properly.
6.
Close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10-24
Servicing Your Analyzer
Cleaning the SRV waste collecting tray
CAUTION
When removing the SRV waste collecting tray, do not make the screw thread of the connecting part on top of the sample probe loose, which may bring air in the sample probe and lead to unreliable results.
NOTE
Reassemble the SRV waste collecting tray by facing the side with the groove up.
1.
Shut down the analyzer, and wait several minutes after power-off.
2.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Pull out the waste collecting tray under the SRV.
10-25
Servicing Your Analyzer
4.
Wash the tray with clean water.
5.
Wipe up the water left in the tray.
6.
Install the tray back properly.
10-26
Servicing Your Analyzer
7.
Close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
Cleaning the waste collecting tray of the autoloading module 1.
Shut down the analyzer, and wait several minutes after power-off.
10-27
Servicing Your Analyzer 2.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Pull out the waste collecting tray under the autoloading piercing unit.
4.
Wash the tray with clean water.
5.
Wipe up the water left in the tray.
6.
Install the tray back properly.
7.
Close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10-28
Servicing Your Analyzer
10.7.4 Cleaning the SRV
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The sample probe and the SRV may contain biohazardous materials. Exercise caution to avoid direct contact with the probe and the SRV when working around them.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer.
The SRV is so fragile that any knock or drop may damage it. Exercise caution when disassembling/assembling or cleaning the SRV. Do not loosen or bend the tiny steel tubes at sides of the SRV.
Do not loosen or deform the sample probe when disassembling, cleaning and reassembling the SRV.
1.
Shut down the analyzer, and wait several minutes after power-off.
10-29
Servicing Your Analyzer 2.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Remove the SRV waste collecting tray (see 10.7.3) and pull the probe wipe assembly down to the lowest position.
10-30
Servicing Your Analyzer 4.
Remove the probe wipe from the sample probe.
CAUTION
The sample probe should be completely separated from the probe wipe when the SRV is disassembled. Otherwise, the probe may be deformed or the probe wipe may be damaged.
5.
Remove the pressure screw by turning it counterclockwise.
10-31
Servicing Your Analyzer
6.
Remove the sampling valve (the outer piece) and the rotor valve (the middle piece) of the SRV respectively.
CAUTION
When the SRV is disassembled, reagent may leak from the tubes.
10-32
Servicing Your Analyzer Place a dry cloth or tissue under the SRV to absorb any reagent.
Do not remove the rear fixed valve of the SRV.
Do not use too much force to pull tubes on sides of the SRV when disassembling the SRV. Otherwise, the tubes may be disconnected and the leakage may be caused.
7.
Inject some probe cleanser into holes and grooves of the sampling valve, rotor valve and rear fixed valve respectively. You can also clean the holes and grooves gently with a brush dampened with probe cleanser.
8.
Use clean lint-free tissues dampened with probe cleanser to wipe the contact surfaces of the valves. Then wash the valves with distilled water.
CAUTION
Make sure no dust should be found in the holes and grooves and on the contact surfaces after the cleaning. Unclean surface(s) may lead to leakage from the SRV and unreliable analysis results.
10-33
Servicing Your Analyzer 9.
Install the rotor valve and sampling valve back properly.
CAUTION
While installing the rotor valve of the SRV, the plane part shall be placed horizontally on the top, and the metal knob shall be placed between the two stoppers. Otherwise, the SRV will not be able to work properly.
NOTE
The valve contact surfaces must be damp when the SRV is reassembled.
Be sure the sampling valve, rotor valve and rear fixed valve of the SRV attach well after the reassembly.
10.
Install the pressure screw by turning it clockwise, and then secure it.
11.
Put the sample probe through the center of the probe wipe, lift the probe wipe assembly back to the original position when the analyzer is turned off.
CAUTION
Make sure the sample probe is properly installed through the probe wipe and the probe wipe is at its original position. Otherwise the wipe may be stuck and unable to work properly.
12.
Install the SRV waste collecting tray back properly, and then close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
After the SRV tray is reassembled, check whether the connection between the SRV and the top of the sample probe is fixed. If not, tighten it to prevent air from coming into the probe and lead to unreliable analysis result.
To avoid damage to the components of the analyzer, close the front cover gently.
10-34
Servicing Your Analyzer
CAUTION
Once reagents spill on the surface of the analyzer, wipe them off with a damp cloth or tissue as soon as possible.
13.
Run a blank count after startup. Be sure the results are within required ranges.
10.7.5 Cleaning the Probe Wipe of the Open-Vial Module
Samples, controls, calibrators and waste are potentially infectious. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The sample probe and the SRV may contain biohazardous materials. Exercise caution to avoid direct contact with the probe and the SRV when working around them.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
CAUTION
After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer.
When disassembling, cleaning and reassembling the probe wipe of the open-vial module, do not use too much force. Otherwise, the probe wipe may be damaged.
1.
Shut down the analyzer, and wait several minutes after power-off.
10-35
Servicing Your Analyzer 2.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Pull the probe wipe assembly down to the lowest position, and then remove it from the sample probe.
4.
Separate the probe wipe from the probe wipe assembly. Disconnect the tubing from the probe wipe.
10-36
Servicing Your Analyzer
5.
Wash the probe wipe with clean water, wipe it dry and install it back properly. Place the probe wipe assembly to the original position when the analyzer is turned off.
CAUTION
Disconnect the tubes by pinching the connecting ends, swaying them while pulling them outward. Do not use too much force while disconnecting the tubes. Otherwise, the probe wipe of the open vial sampling unit may be damaged.
Make sure the sample probe is properly installed through the probe wipe and the probe wipe is at its original position. Otherwise the wipe may be stuck and unable to work properly.
6.
Close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10-37
Servicing Your Analyzer
10.7.6 Sterilizing the Cover of the Analyzer The user shall perform daily cleaning and sterilization to the cover of the analyzer. Use the specified materials to sterilize the equipment only. For any damage to the instrument or other accidents caused by using materials other than specified, Mindray will not provide any warranty. Mindray does not claim the validity of the listed chemicals in infection control. For effective control of infection, please consult the Infection Prevention Department of the hospital or the epidemic professionals. The sterilization may damage the analyzer to some extent. It is recommended to perform sterilization only when necessary according to your laboratory protocol. Remember to clean the equipment before sterilizing. Recommended disinfectant: 70% ethanol, 70％ isopropyl alcohol and Cidex 2% Glutaral + Activator. Prohibited disinfectant: 3% hydrogen peroxide, Aerodesin 2000, Cidex OPA.
10-38
Servicing Your Analyzer
10.8 Replacing Containers or Components 10.8.1 When to Replace and Tools Needed Procedure Replacing the reagent containers
When to Replace
/
As needed
Replacing the waste
When the current waste
container
container is full
Replacing the sample probe of the autoloading
Tools You May Need
/ Cross-headed screwdriver,
Sample probe is damaged
hexagonal wrench
module Replacing the tube clamp assembly
Tube dropping from the clamp
Cross-headed screwdriver
Pressure-related errors are Replacing the filter
/
reported, and the auto draining module cannot work properly
10.8.2 Replacing the Reagent Containers
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
10-39
Servicing Your Analyzer
CAUTION
After replacing the reagent container, check the tubing connected to the cap assembly and make sure it is not bent over.
Replacing the M-68DS DILUENT container 1.
Get a new container of M-68DS DILUENT, open the cap, and put the container next to the one to be replaced.
2.
Remove the supporting board under the cap of the old container.
3.
Turn the cap of the old container counterclockwise, and then take out the cap assembly with caution.
4.
Insert the pickup tube of the cap assembly vertically into the new container, and then turn the cap clockwise until it is secured.
5.
Install the supporting board under the cap as instructed below.
6.
Cap the old container with the cap of the new container and propose of the container properly.
Replace the fluorescent dye bag 1.
Open the fluorescent dye compartment door.
10-40
Servicing Your Analyzer
2.
Get a new bag of fluorescent dye, open the cap and the aluminium film sealing the bag.
3.
Take out the bag to be replaced along the direction of the supporting rack.
4.
Turn the cap of the old bag counterclockwise, and then take out the cap assembly with caution.
10-41
Servicing Your Analyzer
5.
Insert the pickup tube of the cap assembly vertically into the new container, and then turn the cap clockwise until it is secured.
6.
Put the new bag back to the supporting rack, making sure the bag is securely accommodated.
7.
Cap the old bag with the cap of the new bag and dispose of the bag properly.
10-42
Servicing Your Analyzer
WARNING
While replacing the fluorescent dye bag, hold the upper corners of the bag or the part under the bag mouth (where the interior tube is located), in order not to extrude the reagent out.
CAUTION
While replacing the fluorescent dye bag, make sure the name on the bag label and that on the label of the exterior tubing of the cap assembly are the same.
When you take out the pickup tube of the cap assembly from the fluorescent dye bag, if the tube is stuck, move it slightly and try to take it out again. Do not pull it violently.
Do not insert the pickup tube of the cap assembly down to the bottom the fluorescent dye bag to ensure proper aspiration.
Replacing other reagent (except M-68DS DILUENT and fluorescent dyes) containers 1.
Get a new container of desired reagent, remove the cap and place it next to the one to be replaced.
2.
Turn the cap counterclockwise and remove the cap assembly from the container with caution.
3.
Insert the pickup tube of the cap assembly into the new container, and secure the cap by turning it clockwise.
4.
Cap the old container with the cap of the new one, and then dispose of it properly.
10.8.3 Replacing the Waste Container
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
10-43
Servicing Your Analyzer
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
Remove the waste container cap and replace the waste container only when the power indicator is not flickering, in order not to make the waste overflow from the container.
1.
Get an empty waste container, remove the cap and place it next to the one to be replaced.
2.
Turn the cap counterclockwise and remove the cap assembly from the container with caution.
3.
Insert the pickup tube of the cap assembly into the new container, and secure the cap by turning it clockwise.
4.
Cap the old container with the cap of the new one, and then dispose of the waste properly.
10.8.4 Replacing the Sample Probe of the Autoloading Module
All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
WARNING
Be sure to dispose of reagents, waste, samples, consumables, etc. according to government regulations.
The sample probe may contain biohazardous materials. Exercise caution to avoid direct contact with the probe when working around them.
If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor.
10-44
Servicing Your Analyzer
CAUTION
After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer.
NOTE
To ensure that the analyzer functions normally, check the sample probe of the autoloading module periodically and replace it in time.
1.
Shut down the analyzer, and wait several minutes after power-off.
2.
Open the front cover.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Loosen the fixing screws to remove the protective cover of the autoloading piercing unit.
10-45
Servicing Your Analyzer
4.
Disconnect all tubes connected to the probe and probe wipe.
5.
Loosen the fixing nut at the end of the probe.
10-46
Servicing Your Analyzer
6.
Remove the 2 fixing screws securing the fixing block.
10-47
Servicing Your Analyzer
7.
Remove the fixing block, and then the sample probe.
10-48
Servicing Your Analyzer
8.
Take a new sample probe from the accessory kit, insert it through the probe wipe, and install the fixing block to fix the new probe.
9.
Reconnect the tubes to the probe and probe wipe properly, and install the protective cover.
10-49
Servicing Your Analyzer 10
Close the front cover.
.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10.8.5 Replacing the Tube Clamp Assembly
CAUTION
After the analyzer is turned off, wait at least 30 seconds to release the pressure and vacuum accumulated in the pneumatic lines. Do not perform any maintenance or replacing procedure immediately after you turn off the analyzer.
1.
Shut down the analyzer, and wait several minutes after power-off.
2.
Open the front cover, and you can find the tube clamp assembly.
WARNING
To avoid personal injury, after you lift the front cover, be sure to fix it with the stop bar properly.
3.
Loosen the fixing screws to remove the protective cover of the tube clamp assembly.
10-50
Servicing Your Analyzer
4.
Remove the fixing screws securing the tube clamp assembly.
5.
Install a new tube clamp assembly.
NOTE 6.
Make sure the installed tube clamp assembly does not slant.
Install the protective cover.
10-51
Servicing Your Analyzer 7.
Close the front cover.
WARNING
To avoid personal injury, when you close the front cover, be sure to hold it steadily before releasing the stop bar.
CAUTION
To avoid damage to the components of the analyzer, close the front cover gently.
10.8.6 Replacing the Filter After a long period of running, the filter may be blocked by dust, which may cause pressure / vacuum error or malfunction of the auto drainage. In such case, contact Mindray Service Department or your local distributor to clean or replace the filter.
10-52
11
Troubleshooting
11.1 Introduction This chapter contains information that is helpful in locating and correcting problems that may occur during operation of your analyzer.
NOTE
This chapter is not a complete service manual and is limited to problems that are readily diagnosed and/or corrected by the user of the analyzer. If the recommended solution fails to solve the problem, contact Mindray or your local distributor.
11-1
Troubleshooting
11.2 Error Information and Handling During the operation, if error(s) is detected, the analyzer will beep and display the corresponding error message in the pop-up dialog box. You can see the error name(s) and the corresponding troubleshooting information in the pop-up dialog box. The error names are displayed in order. You can click the error name in the dialog box to select (highlight) it and check the corresponding troubleshooting information in the “Troubleshooting” list under the dialog box. The troubleshooting information of the first error will display (default). Follow the instructions in the dialog box to remove the error(s)
The following functions are provided in the current dialog box.
Removing Error
Press the "Remove error" button, then the system will remove the error automatically if possible. If the error(s) still exists, you should follow the instructions of the troubleshooting to remove the error(s).
Muting
Press the “Mute” button to mute the alarm.
Closing Error Dialog Box
Click the “Close” button to close the “Error” dialog box, but the corresponding error message will display in the error message area. If you click the error message again, the “Error” dialog box will be re-opened.
11-2
12 Customizing the Print Template 12.1 Introduction You can modify the print template based on the default one provided by the software in order to customize the format of the report. After customizing and saving a template, you can select the newly customized one in the print setup. And then, the report will be printed in the customized template.
Users of common level have no authority to customize report.
12-1
Customizing the Print Template
12.2 Entering the Print Template Screen Log in as an administrator, and then click "Menu" "Setup" "Print" to go to the print setup screen.
1. Click the “Customize” button to enter the “PrintTemplate” screen, and the following message box will pop up.
2. Enter the correct user name and password in the message box, and go to the print template screen shown as follows.
12-2
Customizing the Print Template
1 --- Main screen
2 --- Menu bar
3 --- Toolbar
4 --- Working area
5 --- Toolbar
6 --- Status bar
7 --- Property tab
8 --- Report tab
12-3
Customizing the Print Template
12.3 Editing the Template 12.3.1 Opening a Template You can open a template by one of the following ways:
Click on the "Report" tab in the "ProjectProperty" area to display all existing templates in the current template library. Click one of the template names and the corresponding template will be displayed in the working area.
Click "File" "Open" on the menu bar or the
button on the toolbar, and then
specify the directory and select the template file. Click "Open" to open the template.
12.3.2 Editing the Template Property After you open a template, the properties of this template will be displayed under the "Property" tab on the left of the screen. Click the cell to the right of the property name box to edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down list, choose the desired value in the list.
12.3.3 Inserting Controls or Businesses Inserting a Control Click "Insert" on the menu bar and choose the control you want to insert; or select a control in the tool bar on the bottom left, and drag it to the desired place in the working area.
You can click the
button (line control) to draw a straight line or an oblique line in the
working area.
You can click the
button (title control) to add a title in the working area.
You can click the
button (label control) to add the fixed text information in the working
area.
You can click the
button (edit control) to add details associated with the print template
and the changeable information in the working area.
You can click the
button (picture control) to arrange the location and size of the graph
in the working area.
You can click the
button (table control) to add a table in the working area. 12-4
Customizing the Print Template
Inserting a Business A business is a set of controls which can be inserted in the template to facilitate the editing process. Do as follows to insert a business: 1. Click "Insert" on the menu bar and choose "Head", "Body" or "Tail". The following message box will pop up.
2. Select the desired business name in the pull-down list. Click the "Ok" button to close the message box and insert the selected business.
12.3.4 Editing the Control(s) You should select the control(s) you want to edit before start editing. Click on the control to select it. You can select multiple controls by one of the following ways:
Press and hold the "Ctrl" key on the keyboard, and at the same time, click on the controls you want to select.
Click on the template in the working area and drag the mouse to enclose the controls you want to select in the rectangular box displayed.
Moving the Control(s) You can move the control(s) by one of the following ways:
Select the control(s) you want to move. Left click and hold the mouse, and then move the control to the destination and release.
Select the control(s) you want to move. Press and hold the "Ctrl" key, and move the control using the arrow keys on the keyboard.
Aligning the Control(s) Select the control(s), and select the desired alignment options in the "Format" menu or the corresponding button on the toolbar on the bottom left. 12-5
Customizing the Print Template
Modifying the Size of a Control Select the control you want to edit, and then drag the borders to modify the size.
Editing the Property of the Control(s) Select the control(s) you want to edit, and the properties will be displayed under the "Property" tab on the left of the screen. Click the cell to the right of the property name box to edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down list, choose the desired value in the list.
12-6
Customizing the Print Template
12.4 Managing the Templates 12.4.1 Importing a Template When you enter the main screen, you can see all the imported templates under the "Report" tab in the "ProjectProperty" area. Do as follows to import a new template to the current template library: 1. On the menu bar, click "File" "Import", and the following message box will pop up.
2. Choose the import type and click "Ok". Then the following message box will pop up.
3. Select the template file you want to import and click "Open" to import the template into the current library. The name of the imported template will be displayed under the "Report" tab, shown as follows.
12-7
Customizing the Print Template
12.4.2 Exporting a Template 1. Click on the "Report" tab in the "ProjectProperty" area to display all the templates in the current template library. 2. Double click the template you want to export to open it in the working area. 3. On the menu bar, click "File" "Export", and the following message box will pop up.
12-8
Customizing the Print Template
4. Specify the directory you want to save the template and enter the file name. Click "Save" to save the template.
12.4.3 Previewing a Template Click "File" "Preview" on the menu bar or the
button on the toolbar to preview the
current template.
12.4.4 Printing a Template Click "File" "Print" on the menu bar or the
button on the toolbar to print the current
template.
12.4.5 Deleting a Template Click "File" "Delete" on the menu bar or the current template.
12-9
button on the toolbar to delete the
Customizing the Print Template
12.5 Other Functions 12.5.1 Creating a New Business 1. Click "Business" "New" on the menu bar to open a blank template. 2. Insert the desired controls and modify their properties. 3. Click "Business" "Save" on the menu bar, and the following message box will pop up. Enter the information of the business in corresponding boxes and click "Ok" to save the business.
12.5.2 Loading the Template Library 1. Click "Setting" "LoadTemplateLib" on the menu bar, and the following message box will pop up.
2. Select the right machine model and click "Ok" to load the template library for this model. 3. When the loading is completed, all the templates in the loaded library will be displayed under the "Report" tab.
12-10
13 A
Appendices
Index Eos% formula, 3-5, 3-6
A
External Equipment, 2-15 Analyzer, 2-1
H B HCT formula, 3-9
Background, B-5 Barcode Labels, 6-47
Help, 2-31
Bas#
HFR formula, 3-10
formula, 3-4
HGB
Bas%
formula, 3-7
formula, 3-4
Histogram
Blank Count, B-4, B-5, B-6, B-7, B-8
PLT Histogram, 2-4 RBC Histogram, 2-4, 2-5
C
History Log, 10-13
Calibration, 9-1
I
Calibrator, 9-8 Fresh Blood, 9-12
IFR
Manual, 9-6
formula, 3-10
Carryover, B-7
Interfaces, B-9
Compatibility, B-6 Controls and Calibrators, 2-35
L
Correlation, B-8
LFR
D
formula, 3-10 Data Managing Unit (DMU), 2-6
Linearity Range, B-5, B-6, B-7, B-8
Display range, B-4
Lym# formula, 3-5 Lym%
E
formula, 3-5
EMC, B-10 Eos# formula, 3-5
A-1
Index Lym%, 2-2
M
MCH, 2-3 MCHC, 2-3
Manual Cleaning, 10-21
MCV, 2-3
MCH
MFR, 2-2
formula, 3-9
Mon#, 2-2
MCHC
Mon%, 2-2
formula, 3-9
MPV, 2-3
MCV
Neu#, 2-2
formula, 3-8
Neu%, 2-2
MFR
NRBC#, 2-3
formula, 3-10
NRBC%, 2-3
Mode Abbreviations, 6-17
PCT, 2-3
Mon#
PDW, 2-3
formula, 3-5
P-LCC, 2-3
Mon%
P-LCR, 2-3
formula, 3-5
PLT, 2-3
MPV
RBC, 2-3
formula, 3-10
RDW-CV, 2-3 RDW-SD, 2-3
N
RET#, 2-2 RET%, 2-2
Neu#
WBC, 2-2
formula, 3-5
PCT
Neu%
formula, 3-10
formula, 3-5
PDW
NRBC#
formula, 3-10
formula, 3-6
P-LCC
NRBC%
formula, 3-11
formula, 3-6
P-LCR formula, 3-11
P
PLT formula, 3-10
Pack-up, 10-10
Pneumatic Unit (PU), 2-6
Parameters
print template, 12-1
Bas#, 2-2 Bas%, 2-2
Q
Eos#, 2-2 Eos%, 2-2
QC Program
HCT, 2-3
L-J QC, 8-2
HFR, 2-2
X Mean QC, 8-55
HGB, 2-3
X Mean R QC, 8-82
IRF, 2-2
X-B QC, 8-41
LFR, 2-2
X-M QC, 8-104
Lym#, 2-2
A-2
Index Quality Control, 8-1
S
R
Sample Processing Unit (SPU), 2-6 Scattergram
RBC
BASO Scattergram, 2-4
formula, 3-8
DIFF Scattergram, 2-4, 2-5
RDW-CV
NRBC Scattergram, 2-4
formula, 3-9
PLT-O Scattergram, 2-4
RDW-SD
RET Scattergram, 2-4
formula, 3-9
RET-EXT Scattergram, 2-4
Reagent
Shutdown, 6-54
M-68DR DILUENT, 2-32
Standby, 6-53
M-68DS DILUENT, 2-32
Startup, 6-4
M-68FD DYE, 2-33
Symbols, 1-7
M-68FN DYE, 2-34 M-68FR DYE, 2-33
T
M-68LB LYSE, 2-34 M-68LD LYSE, 2-33
Test Panel, 2-4, 2-5
M-68LH LYSE, 2-34
Throughput, B-3
M-68LN LYSE, 2-33
troubleshooting, 11-1
PROBE CLEANSER, 2-34
Tubes, B-1
Reproducibility, B-6 Research Use Only Parameters (RUO)
U
IMG#, 2-3 IMG%, 2-3
Unclogging, 10-9
PLT-I, 2-3
User Interface, 2-16
PLT-O, 2-3 RBC-O, 2-3
W
WBC-B, 2-3 WBC-D, 2-3
WBC
WBC-N, 2-3
formula, 3-4
WBC-O, 2-3
Measurement, 3-2
RET#
WBC Differential Accuracy, B-6
formula, 3-9
Worklist, 6-49
RET% formula, 3-9
A-3
B B.1
Specifications and Performance Classification
According to the CE classification, the BC-6800 belongs to In vitro diagnostic medical devices other than those covered by Annex II and devices for performance evaluation.
B.2
B.3
Calibrator
Blood samples with known values.
Specified by manufacturer.
Controls
Specified by manufacturer.
B.4
Reagents Diluent
M-68DS DILUENT M-68DR DILUENT M-68LD LYSE
Lyse
M-68LN LYSE M-68LB LYSE M-68LH LYSE
Probe Cleanser
PROBE CLEANSER M-68FN DYE
Dye
M-68FR DYE M-68FD DYE
B.5
Applicable Tubes
Size of applicable tubes in the autoloading mode: 11-13mm (external diameter) ×65-78mm/80-83mm (height without cap/with cap) Recommended tubes for analysis on BC-6800 in the autoloading mode:
B-1
Specifications and Performance
NOTE
Some tubes may not adapt to the analyzer or tube rack (e.g. tubes with unique caps). Contact Mindray or your local distributor in this case.
B.6
Parameters Name
Abbreviation
Default Unit 9
White Blood Cell count
WBC
10 /L
Basophil number
Bas#
10 /L
Basophil percentage
Bas%
%
Neutrophil number
Neu#
10 /L
Neutrophil percentage
Neu%
%
Eosinophil number
Eos#
10 /L
Eosinophil percentage
Eos%
%
Lymphocyte number
Lym#
10 /L
Lymphocyte percentage
Lym%
%
Monocyte number
Mon#
10 /L
Monocyte percentage
Mon%
%
Reticulocyte percentage
RET%
%
Reticulocyte number
RET#
10 /uL
Immature Reticulocyte Fraction
IRF
%
Reticulocyte Hemoglobin Expression
RHE
pg
Low Fluorescent Ratio
LFR
%
Middle Fluorescent Ratio
MFR
%
High Fluorescent Ratio
HFR
%
Red Blood Cell count
RBC
10 /L
Hemoglobin Concentration
HGB
g/L
Mean Corpuscular Volume
MCV
fL
Mean Corpuscular Hemoglobin
MCH
pg
Mean Corpuscular Hemoglobin Concentration
MCHC
g/L
Red Blood Cell Distribution Width - Coefficient
RDW-CV
%
RDW-SD
fL
9
9
9
9
9
6
12
of Variation Red Blood Cell Distribution Width - Standard Deviation B-2
Specifications and Performance Hematocrit
HCT
Nucleated Red Blood Cell count
NRBC#
10 /uL
Nucleated Red Blood Cell percentage
NRBC%
/100WBC
Platelet count
PLT
10 /L
Mean Platelet Volume
MPV
fL
Platelet Distribution Width
PDW
None
Plateletcrit
PCT
%
Platelet-Large Cell Ratio
P-LCR
%
Platelet- Large Cell Count
P-LCC
10 /L
Immature Granulocyte
IMG#
10 /L
Immature Granulocyte percentage
IMG%
%
Immature Platelet Fraction
IPF
%
White Blood Cell count-body fluid
WBC-BF
10 /L
Total nucleated cell counts-body fluid
TC-BF#
10 /L
Mononuclear cell number
MN#
10 /L
Mononuclear cell percentage
MN%
%
Polymorphonuclear cell number
PMN#
10 /L
Polymorphonuclear cell percentage
PMN%
%
Red Blood Cell count-body fluid
RBC-BF
B.7
% 3
9
9 9
9 9 9
9
12
10 /L
Sampling Features
B.7.1 Sample volumes required for each analysis AL Mode
≤200μl
OV-WB Mode
≤150μl
OV-PD Mode
≤40μl
OV-BF Mode
≤150μl
B.7.2 Throughput Throughput of Blood Sample Analysis in Different Modes Analysis mode
Whole Blood
Predilute
(analyses per hour)
(analyses per hour)
CBC
125
36
CBC+ DIFF
125
36
CBC+DIFF+RET
90
30 B-3
Specifications and Performance CBC+RET
90
30
CBC+NRBC
125
36
CBC+DIFF+NRBC
125
36
CBC+DIFF+RET+NRBC
90
30
RET
90
30
Throughput of Body Fluid Sample Analysis Mode
Throughput (analyses per hour)
CBC+ DIFF
40
B.8
Performance specifications
B.8.1 Display range Display Ranges for Blood Samples Parameter
Display range 9
WBC
0.00~999.99×10 /L
Neu%/ Lym%/ Mon%/ Eos%/ Bas%
0~100%
RBC
0.00~99.99×10 /L
HGB
0~300g/L
PLT
0~9999×10 /L
HCT
0.0~100.0%
MCV
0.0~250.0 fL
RET%
0~100.00%
RET＃
0.0000~9.9999×10 /L
NRBC%
0~9999.99%
NRBC＃
0-9999.99×10 /L
12
9
12
9
Display Ranges for Body Fluid Samples Parameter
Display range
WBC-BF/ TC-BF
0.000~999.999×10 /L
RBC-BF
0.000~99.999×10 /L
MN#
0.000~999.999×10 /L
MN%
0.0~100.0%
PMN#
0.000~999.999×10 /L
PMN%
0.0~100.0%
9
12
9
9
B-4
Specifications and Performance
B.8.2 Background/Blank Count Background/Blank Count Requirements for Blood Samples Parameter
Requirement 9
WBC
≤ 0.1 10 / L
WBC-D
≤ 0.2 10 / L
WBC-N
≤ 0.2 109 / L
9
12
RBC
≤ 0.02 10 / L
RBC-O
≤ 0.02 10 / L
12
HGB
≤1g/L
PLT
≤ 5 109 / L
PLT-O
≤ 5 109 / L Background/Blank Count Requirements for Body Fluid Samples Parameter
Requirement 9
WBC-BF/TC-BF
≤ 0.003 10 / L
RBC-BF
≤ 0.003 10 / L
12
B.8.3 Linearity Range Linearity Requirements for Blood Samples Parameter
Linearity range 9
Deviation Range
(Whole Blood)
(Predilute)
9
(0 ~ 100.00)×10 /L WBC
Deviation Range
9
(100.01 ~ 350.00)×10 /L 9
(350.01 ~ 500)×10 /L
±0.50×10 /L or ±5％
±6 ％
±6 ％
±11％
12
9
±0.20×10 /L or ±2％
±11％ 12
12
RBC
(0 ~ 8.00)×10 /L
±0.03×10 /L or ±2％
±0.05×10 /L or ±5％
HGB
(0 ~ 250) g/L
±2g/L or ±2％
±2g/L or ±3％
HCT
(0 ~ 75)%
±1 .0 (HCT value) or ±2
(deviation
％
percent) 9
PLT
9
(0 ~ 1000)×10 /L 9
(1001 ~ 5000)×10 /L
±2.0
(HCT
value)
±4 ％ (deviation percent) 9
±10×10 /L or ±5％
±10×10 /L or ±10％
±6 ％
±10％
±0.3 (RET value) or RET%
(0 ~ 30)%
±20 ％
(deviation
/
±0.015×10 /L or ±20％
/
percent) RET#
12
12
(0~0.8)×10 /L
Linearity Requirements for Body Fluid Samples Parameter
Linearity range 9
WBC-BF/TC-BF
Deviation Range 9
(0 ~ 0.050)×10 /L
±0.01×10 /L 9
(0.050 ~ 1.000)×10 /L
±20％
9
(1.000 ~ 10.000)×10 /L
±20％ B-5
or
Specifications and Performance 12
±0.010×10 /L or ±5％
12
12
±0.03×10 /L or±2％
(0.000 ~ 0.100)×10 /L
RBC-BF
12
(0.100 ~ 5.000)×10 /L
B.8.4 Compatibility Deviation range compared with the reference instrument: WBC≤±3%, RBC≤±2%, HGB≤±2%, PLT≤±5%, HCT/MCV≤±2%.
B.8.5 WBC Differential Accuracy The differential results for neutrophils, lymphocytes, monocytes, eosinophils and basophils should fall in the permissible ranges of the results acquired by using the reference method (confidence interval: 99%).
B.8.6 Reproducibility Reproducibility Requirements for Blood Samples Parameter WBC
Condition 9
Whole Blood
Predilute
Reproducibility CV% /
Reproducibility CV% /
absolute deviation (d*)
absolute deviation (d)
≥ 4×10 /L
≤ 2.5%
≤ 4.0%
12
≤ 1.5%
≤ 2.0%
RBC
≥3.5×10 /L
HGB
(110～180) g/L
MCV
(80～100) fL
≤ 1.0%
≤ 3.0%
HCT
(30～50)%
≤ 1.5%
≤ 3.0%
MCH
/
≤ 1.5%
/
MCHC
/
≤ 1.5%
/
RDW-SD
/
≤ 2.0%
/
RDW-CV
/
≤ 2.0%
/
9
≤ 1.0% range**≤ 3
≤ 2.0%
PLT
≥100×10 /L
≤ 4.0%
≤ 8.0%
PDW
/
≤ 10.0%
/
MPV
/
≤ 3.0%
/
P-LCR
/
≤ 15.0%
/
P-LCC
/
≤ 15.0%
/
PCT
/
≤ 5.0%
/
≤6.0%
≤12.0%
≤6.0%
≤12.0%
≤16.0%
≤32.0%
9
≤20.0% or ±1.5% (d)
≤40.0% or ±3.0% (d)
9
≤30.0% or ±1.0% (d)
≤60.0% or ±2.0% (d)
9
≤20.0% or ±1.5% (d)
/
Neu% Lym% Mon% Eos% Bas% NRBC%
Neu%≥30.0% 9
WBC≥ 4×10 /L Lym %≥15.0% 9
WBC≥ 4×10 /L Mon %≥5.0% 9
WBC≥ 4×10 /L WBC≥ 4×10 /L WBC≥ 4×10 /L WBC≥ 4×10 /L
B-6
Specifications and Performance Neu# Lym# Mon#
9
≤6.0%
≤12.0%
9
≤6.0%
≤12.0%
≥1.20×10 /L ≥0.60×10 /L 9
≥0.20×10 /L
≤16.0%
≤32.0%
9
≤20.0% or ±0.12×10 /L (d)
9
Eos#
WBC≥ 4×10 /L
Bas#
WBC≥ 4×10 /L
9
≤40.0% or ±0.24×10 /L (d)
9
≤30.0% or ±0.06×10 /L (d)
9
≤60.0% or ±0.12×10 /L (d)
≤25.0% or ±1.5% (d)
/
9
9
IMG% IMG# NRBC#
WBC≥ 4×10 /L IG%≥2% 9
≥ 0.10×10 /L
9
/
9
≤20.0% or ±0.12×10 /L (d)
/
≤ 15%
≤ 30%
≤ 15%
≤ 30%
≤ 5%
/
≤ 30%
/
≤ 50%
/
≤ 100% or ±2.0% (d)
/
≤ 30%
/
≤ 25%
/
≤25.0% or ±0.12×10 /L (d)
9
WBC≥ 4×10 /L 12
RET#
RBC≥ 3×10 /L RET%1%～4% 12
RET% RHE
RBC≥ 3×10 /L RET%1%～4% 12
RET#≥ 0.02×10 /L 12
RBC≥ 3×10 /L LFR
RET%1%～4% LFR≥20% 12
RBC≥ 3×10 /L MFR
RET%1%～4% MFR≥20% 12
HFR
RBC≥ 3×10 /L RET%1%～4% 12
RBC≥ 3×10 /L IRF
RET%1%～4% IRF≥20% 9
IPF
PLT ≥ 50×10 /L IPF≥3%
Note: * absolute deviation (d*)=measured value – mean of measured value ** range=max of measured value – min of measured value Reproducibility Requirements for Body Fluid Samples Parameter WBC-BF/TC-BF RBC-BF
Condition
Reproducibility CV% / absolute deviation (d) 9
≤30%
12
≤40% or ≤7000/μL
(0.015-0.100)×10 /L (0.003-0.050)×10 /L
B.8.7 Carryover Carryover Requirements for Blood Samples Parameter
Carryover
WBC
≤1.0％
RBC
≤1.0％
HGB
≤1.0％ B-7
Specifications and Performance HCT
≤1.0％
PLT
≤1.0％
RBC-O
≤1.5％
WBC-D
≤1.0％
WBC-N
≤1.5％ Carryover Requirements for Body Fluid Samples Parameter
Carryover 9
WBC-BF/TC-BF
≤0.3% or ≤0.003×10 /L
RBC-BF
≤0.3% or ≤0.003×10 /L
12
B.8.8 Correlation Correlation Requirements for Blood Samples Parameter
Correlation Coefficient
WBC
≥ 0.99
RBC
≥ 0.99
HGB
≥ 0.98
MCV
≥ 0.98
PLT
≥ 0.95
NRBC#/NRBC%
≥ 0.90
RET#/RET%
≥ 0.90
RHE
≥ 0.80
IMG#/IMG%
≥ 0.80
IPF
≥ 0.80 Correlation Requirements for Body Fluid Samples Parameter
Correlation Coefficient/Gradient
WBC-BF/TC-BF
≥0.90 and gradient between 0.7-1.3
RBC-BF
≥0.80 and gradient between 0.7-1.3
MN%
≥0.90
MN#
≥0.70
PMN%
≥0.90
PMN#
≥0.70
Input/Output Devices
B.9
NOTE
Be sure to use the specified devices only.
B-8
Specifications and Performance
B.9.1
External Computer
PC (IBM compatible)
CPU: Intel® 2.6GHz or above
RAM: 2GB or above
Hard disk: 320GB or above
CD-ROM: DVD-RW
At least 2 network adapters
Operating system: Microsoft Windows Vista or above, Microsoft Windows 7 32bit Home Basic, Microsoft Windows 7 32bit Ultimate, or Microsoft Windows 8 64bit Professional
Recommended screen size: no smaller than 22’’; recommended resolution: 1680*1050
B.9.2
Keyboard (Optional)
USB keyboard
B.9.3
Mouse (Optional)
USB mouse
B.9.4
External Barcode Scanner (Optional)
USB hand-held barcode scanner
B.9.5
Printer (Optional)
B.9.6
USB Flash Disk
B.10 Interfaces
NOTE
The USB interfaces on the back of the analyzer shall only be used to connect the peripheral devices specified in this manual. See Section B.9 Input/output device for details about supported devices and models.
1 network interface
1 pneumatic unit interface
4 USB interfaces
B.11 Power Supply Analyzer
Voltage
Frequency
Power
a.c. 110V/115V ±10%
50/60Hz ±2Hz
500VA
B-9
Specifications and Performance
Compressor
a.c. 220V/230V ±10%
50/60Hz ±2Hz
500VA
a.c. 110V/115V ±10%
60Hz ±2Hz
600VA
a.c. 220V/230V ±10%
50Hz ±2Hz
450VA
60Hz ±2Hz
300VA
B.12 EMC Description
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as these may interfere with the proper operation.
This equipment complies with the emission and immunity requirements of the EN 61326-1:2006 and EN 61326-2-6:2006.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference.
NOTE
It is the manufacturer's responsibility to provide equipment electromagnetic compatibility information to the customer or user.
It is the user's responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.
B.13 Sound Pressure Maximal sound pressure: 65db
NOTE
Be sure to use and store the analyzer in the specified environment.
B-10
Specifications and Performance
B.14 Operating environment
Ambient temperature: 15 ℃ - 32 ℃
Optimal operating humidity: 30% - 85%
Atmospheric pressure: 70 kPa - 106 kPa
B.15 Storage Environment
Ambient temperature: -10 ℃ - 40 ℃
Relative humidity: 10% - 90%
Atmospheric pressure: 50 kPa - 106 kPa
B.16 Running Environment
Ambient temperature: 5 ℃ - 40 ℃
Relative humidity: 10% - 90%
Atmospheric pressure: 70 kPa - 106 kPa
B.17 Dimensions and Weight
Height Depth Width Analyzer
Compressor
Width (mm)
≤680
≤310
Depth (mm)
≤850
≤480
Height (mm)
≤700
≤430
Weight (Kg)
≤125
≤20
B-11
Specifications and Performance
B.18 Contraindication None.
B.19 Barcode Specifications The BC-6800 can read barcodes that are stuck to the test tubes. The sample ID read from the barcode will be stored and used as the only identification of the sample. The barcodes used shall meet the specifications stated in this section. 1.
Supported barcode types
All code types and check digit supported by BC-6800 are listed as follows. Barcodes Supported by BC-6800 Code Type
Check Digit
Number of Digits
CODE128
Self-checking(check digit is always included)
No more than 20 digits (sample ID)
CODE93
Self-checking(check digit is always included)
No more than 20 digits (sample ID)
UPC/EAN
Self-checking(check digit is always included)
Fixed length: 8 or 13 digits
Not use check digit
No more than 20 digits (sample ID) No more than 19 digits (sample
ITF Use Check digit
ID)+1 digit (check digit) = no more than 20 digits
Not use check digit
No more than 20 digits (sample ID) No more than 19 digits (sample
CODE39 Use Check digit
ID)+1 digit (check digit) = no more than 20 digits
Not use check digit
No more than 20 digits (sample ID) No more than 19 digits (sample
CODABAR Use Check digit
ID)+1 digit (check digit) = no more than 20 digits
NOTE
The manufacturer suggest you use check digit to reduce the possibility
of misreading.
B-12
Specifications and Performance 2.
Barcode label dimensions
Barcode height: A≥10mm Label width: B≤45mm Clear area width: C≥5mm
Wide-to-narrow ratio: between 2.5: 1 and 3.0: 1 Width of the narrowest bar: above 0.127mm Code quality: According to ANSI MH10.8M standard, the code quality shall be Level C or above.
3. Samples of valid and invalid barcode labels: Use of invalid barcode labels will increase the possibility of misreading. To ensure good readability, use valid labels as shown in the figure below.
B-13
Specifications and Performance
B.20 Safety Classification Level of transient overvoltage: Category II. Rated pollution degree: 2.
B-14
C
Communication
The LIS/HIS communication function of BC-6800 enabled the communication between the analyzer and the PC in laboratory through Ethernet, including sending analysis results to and receiving worklist from PC. There are 3 types of communication protocol involved in the LIS/HIS communication process of BC-6800: 15ID protocol, HL7 protocol, and ASTM protocol. For details about the connection control, and the introduction, message definition and examples, please contact Mindray Customer Service Department or your local distributor.
C-1
P/N: 046-001725-00 (10.0)
