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Rev. 4.2
Metrolab 2300 GL
CLINICAL ANALYZER
OPERATOR´S MANUAL
September 2008
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Manual de Uso Version 4.00 Rev. EAD 3/7/07 Rev. Gala 10/07/07 Rev. EAD 11/07/08 Versión de soft 4.1 Rev. EAD 16/07/08 C. Doc. No. 28 Referido a C.I No. 23 Cambio de soft y hard para equiparar al V4 CE Diatron EAD 27/10/08
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WARNINGS 1) Only connect instrument to a line complying with local or national rules and specifications. 2) Never use instrument for a purpose other than specified by manufacturer. (For purpose description, See Chapter 1). 3) Never turn instrument on without waiting at least 20 seconds after turning it off. 4) Do not connect monitors, printers or unauthorized cables in RS232 outputs of instrument. 5) Do not open rear or left cover of instrument before reading specific servicing situations described along the present manual. 6) To change lamps and other elements, follow directions included in the present manual. 7) The use of most screen savers can affect communication between PC and Metrolab 2300GL. Use only “Windows Curves and colors” at its minimum speed, if a screen saver must be utilized. 8) Maintain the cover down during operation to avoid danger from moving parts and to improve performance of the instrument. 9) This is a class A product. In a domestic environment, this product may cause radio interference in which case user may be required to take adequate measures. For technical assistance, please contact local representative or directly to factory.
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Safety symbols used in instrument: 7
Warning: Before using read instructions in Manual
Hazardous Voltage
Ground connection
Biological Risk
Warranty is subject to the following conditions: Trained personnel must perform installation. Installation Checklist and Test Report must be sent to manufacturer.
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WARNINGS on Instrument and Laboratory practices 1) Perform daily, weekly and quarterly maintenance procedures, as specified in user manual. Keep records on actions and dates. 2) Perform instrument tests as indicated in user manual. Any departure from specifications should be consulted with the Service Department. Keep records on tests and calibrations of instrument. Compare data with previous information. 3) Perform all maintenance repairs and replacements as required by manufacturer. Elements such as drying block and tubing must be inspected daily. 4) The use of standards in every run. Factor values can be used instead of standards if: a) Reagent belongs to the same lot for which factor was determined. b) Standard absorbance did not vary more than ¼ of the allowed method variation in the last few readings. c) Instrument did not suffer a major repair (change of filters, lamp or photometer).and photometer) since the last calibration. 5) To ensure adequate quality control, normal and abnormal control with assayed values should be run as unknown samples. a) At least every eight hours b) When a new container of reagent is used c) After preventative maintenance is performed, or a critical component is replaced. 6) Control results are considered valid if: a) Control values fall within the specified range. b) Results for controls run at the beginning and end differ by an acceptable level of variation. An acceptable level of variation is criteria determined by user, or control manufacturer. 7) Read all warning messages at the end of the run. Results can be totally or partially accepted or rejected if: a) Reagent initial absorbance values fall within specified range. b) Energy is within range. c) There are non-stopping instrument errors. 8) Open the error file and check for repetitive mechanical errors. If errors in Sample/Reagent tray or Reaction tray repeatedly occur, results must be under suspect and eventually discarded. 9) Immediately after the run check if cuvettes are dry. If not, results of previous run are under suspicion and should be carefully controlled and/or repeated. 10) Whenever a new reagent is introduced in the system cross-contamination must be studied. The study should be performed by using the same reaction cuvettes for both suspected reagents, in the interfering order: first the interfering, next the interfered reagent. Study should consist of running precision tests on new reagent alone and in contamination condition with other reagents. Acceptance criteria must meet normal laboratory practice.
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Table of Contents 1
DESCRIPTIO .......................................................................................................... 11 1.1 OVERVIEW ............................................................................................................. 11 1.2 OPERATING FEATURES .......................................................................................... 13 1.3 TECHNICAL SPECIFICATIONS ................................................................................. 15 1.4 MAIN MENU ........................................................................................................... 17 1.5 INSTALLATION ....................................................................................................... 19 1.5.1 Unpacking..................................................................................................... 19 1.5.2 Instrument Setup ........................................................................................... 20 1.5.3 Software Installation and Startup................................................................. 21 1.5.4 Software registration .................................................................................... 24 1.5.5 Database settings.......................................................................................... 24
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SYSTEM DESCRIPTIO A D DATA LOAD ...................................................... 25 2.1 METHOD SETUP ..................................................................................................... 25 2.1.1 Chemistry methods ....................................................................................... 27 2.1.1.1 Definition Page ......................................................................................... 27 2.1.1.2 Detail page................................................................................................ 32 2.1.1.3 Multipoint page ........................................................................................ 33 2.1.2 Coagulation methods.................................................................................... 35 2.1.2.1 Definition page ......................................................................................... 36 2.1.2.2 Detail page................................................................................................ 37 Multipoint page ........................................................................................................ 37 2.1.3 External methods .......................................................................................... 40 2.1.4 Calculated methods ...................................................................................... 41 2.1.5 Method development..................................................................................... 42 2.2 PRE-DILUTION ....................................................................................................... 42 2.3 TABLE OF METHODS IN USE .................................................................................. 43 2.4 REAGENT DATA INPUT .......................................................................................... 44 2.4.1 Loading individual reagents......................................................................... 44 2.4.2 Load from a tray........................................................................................... 44 2.4.3 Tray setup ..................................................................................................... 45 2.4.4 Tray modification ......................................................................................... 45 2.4.5 Reagent reservoirs........................................................................................ 46 2.5 TABLE OF PANELS: STANDARDS, CONTROLS AND PROFILES ................................. 47 2.6 LOAD OF SAMPLES, STANDARDS AND CONTROLS. .................................................. 49 2.6.1 Replicates of the same standard. .................................................................. 51 2.6.2 Load of standards for curve construction .................................................... 51 2.6.3 Additional data entry.................................................................................... 52 2.6.4 Pediatric samples ......................................................................................... 52 2.6.5 Conditional sample load............................................................................... 53 2.7 VERIFICATION OF PROGRAMMED REAGENTS AND SAMPLES.................................. 53 2.8 PARAMETERS ......................................................................................................... 55 2.8.1 Functionals ................................................................................................... 55 2.8.2 Instrumentals ................................................................................................ 56 2300GLlTIU Rev. 4.2
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2.8.3 Laboratory.................................................................................................... 57 2.8.4 Maintenance ................................................................................................. 58 2.8.5 Technical ...................................................................................................... 59 2.8.6 Optics............................................................................................................ 60 2.9 IMPORT AND EXPORT TO/FROM OTHER PROGRAMS................................................. 60 2.9.1 Exchange in ASCII protocol ......................................................................... 60 2.9.2 LIMS connection through Serial Port .......................................................... 61 2.9.2.1 ASTM structure of messages.................................................................... 63 2.9.2.2 Field lengths used by instrument .............................................................. 66 2.9.2.3 Messages in LIMS operation.................................................................... 66 2.10 HISTORIC FILE ....................................................................................................... 67 2.10.1 Statistics........................................................................................................ 68 2.10.2 Plots .............................................................................................................. 69 2.10.3 Exporting results .......................................................................................... 70 2.11 CALCULATIONS ..................................................................................................... 70 2.11.1 Absorbance reading...................................................................................... 70 2.11.2 Kinetics. ........................................................................................................ 71 2.12 ................................................................................................................................... 71 2.12.1 2-point Kinetics. ........................................................................................... 73 2.12.2 Color............................................................................................................. 74 2.12.3 End Point ...................................................................................................... 74 2.12.4 Times (Coagulation)..................................................................................... 74 3
DAILY STARTUP A D OPERATIO ................................................................... 77 3.1 STARTUP SEQUENCE .............................................................................................. 77 3.2 REGISTRATION....................................................................................................... 77 3.3 WASH SOLUTIONS .................................................................................................. 79 3.4 DAILY OPERATION ................................................................................................ 80 3.4.1 Daily sample loading procedure .................................................................. 80 3.5 MEASURING ........................................................................................................... 80 3.5.1 Volume check................................................................................................ 80 3.5.2 Temperature ................................................................................................. 82 3.5.3 Reagent Integrity check ................................................................................ 82 3.6 INTERFERENCES ..................................................................................................... 82 3.7 DILUTION AND REPETITION .................................................................................... 83 3.8 STAT PROCEDURE .................................................................................................. 84 3.9 PROCEDURE FOLLOW UP ........................................................................................ 85 3.9.1 From reaction tray ....................................................................................... 86 3.9.2 From the time table ...................................................................................... 87 3.9.3 From window of Operating Status ............................................................... 88 3.10 CHOICE OF OPTIMUM CALIBRATION CURVE ........................................................... 89
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MAI TE A CE ....................................................................................................... 91 4.1 PREVENTIVE MAINTENANCE PROGRAM................................................................. 91 4.1.1 Recommended daily care.............................................................................. 91 4.1.2 Weekly Care Recommendations ................................................................... 92 4.1.3 Quarterly Maintenance Recommendations .................................................. 92 4.1.4 Maintenance as needed ................................................................................ 93 2300GLlTIU Rev. 4.2
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4.2 REPLACEMENT AND CONTROL OF WASH SOLUTION................................................ 93 4.3 PUMP TUBING AND SYRINGE REPLACEMENT. ......................................................... 94 4.4 LAMP REPLACEMENT ............................................................................................. 95 4.5 SAMPLE PROBE CARE ............................................................................................. 95 4.5.1 Calibration procedure for probe arm (Only if required) ............................. 96 4.6 CONTROL AND MAINTENANCE OF HYDRAULIC CIRCUIT ......................................... 96 4.7 PHOTOMETER AND FILTER CLEANING .................................................................... 97 4.8 DETECTOR LENS CLEANING ................................................................................... 97 4.9 INFORMATION RECOVERY. .................................................................................... 97 4.10 CALIBRATION ........................................................................................................ 98 4.10.1 Photometer ................................................................................................... 98 4.10.2 Reference .................................................................................................... 100 4.10.3 Cuvette bottom............................................................................................ 100 4.11 MAINTENANCE FORM .......................................................................................... 100 5
TROUBLESHOOTI G........................................................................................... 103 5.1 OPERATION MALFUNCTION WITH WARNING ......................................................... 103 5.2 VISIBLE FAULTS ................................................................................................... 104 5.2.1 Drop formation on probe tip after dispensing............................................ 104 5.2.2 Drop formation after wash cycle. ............................................................... 105 5.2.3 Abnormal noises. ........................................................................................ 105 5.2.4 Inaccurate Temperature readings. ............................................................. 105 5.3 INCONSISTENT RESULTS ....................................................................................... 105 5.3.1 Colorimetric methods (one or more) .......................................................... 106 5.3.2 Symptom: Low linear range. ...................................................................... 107 5.3.3 Fast kinetics................................................................................................ 107 5.3.4 2-point kinetics ........................................................................................... 109 5.3.5 Inconsistent values in automatic repetition or dilution .............................. 110 5.3.6 Coagulation ................................................................................................ 110 5.4 MESSAGES AND WARNINGS................................................................................. 111 5.4.1 Messages while not operating instrument .................................................. 111 5.4.2 Run-time errors and messages ................................................................... 114
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VALIDATIO PROGRAM A D TESTS............................................................. 120 6.1 REQUIRED ELEMENTS. ......................................................................................... 120 6.2 DESCRIPTION OF TESTS ........................................................................................ 121 6.2.1 Energy......................................................................................................... 121 6.2.2 Cuvettes ...................................................................................................... 121 6.2.3 Cuvette dryer .............................................................................................. 121 6.2.4 ;oise ........................................................................................................... 121 6.2.5 Photometer Stability ................................................................................... 122 6.2.6 Dilution....................................................................................................... 122 6.2.7 Stray light ................................................................................................... 123 6.2.8 Simultaneous............................................................................................... 123 6.2.9 ISE dilution ................................................................................................. 123 6.2.10 Movements .................................................................................................. 124 6.2.11 Washer ........................................................................................................ 124 6.3 AUTOMATED VALIDATION TESTING .................................................................... 124 2300GLlTIU Rev. 4.2
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ILLUSTRATIO S ................................................................................................... 126 Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Figure 6. Figure 7. Figure 8. Figure 9. Figure 10. Figure 11. Figure 12. Figure 13.
Crating unpacking sequence. ........................................................... 128 Front view of instrument.................................................................. 129 Rear view of instrument. .................................................................. 130 Front Panel detail. ............................................................................ 131 Capillary probe heater connection. .................................................. 132 Syringe Replacement. ...................................................................... 133 Hydraulic input circuit. .................................................................... 134 Lateral cover removal for lamp replacement. .................................. 135 Lamp replacement............................................................................ 136 Pump tubing assembly. .................................................................. 137 View of reaction cuvettes when set in light path. .......................... 138 Sample detector unit....................................................................... 139 Peristaltic pump tube replacement ................................................. 140
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1 DESCRIPTION Autoanalyzer Metrolab 2300 Version 4 is a multitask system capable of performing 48 different tests to 48 samples in a walk-away manner. Its purpose is to perform Laboratory Chemistry Analysis in automated and selective form, either in routine or Stat mode. In Clinical analysis, it purpose is the In Vitro Diagnostics. Born as an improvement of the popular Metrolab 2300, it incorporates the latest in robotics, computer and communication technology to render simple and reliable long-term operation. The Metrolab 2300GL consists of a system of modules performing specific functions, computer controlled, and with bi-directional communication. 1.1 • • • • • • • • •
Overview The system supports the following modules: PC/IBM compatible computer, Pentium 233 or higher, 32 Mbytes minimum RAM memory, 20 Megs free space on hard drive, CD Rom. 80-column dot matrix or bubble jet printer. Cooled Sample/Reagent multiple tray. Reaction tray. Robot probe arm. Diluter. Photometer. Cleaning system. Level sensing systems.
Multiple Sample/Reagent Tray Loads 48 samples. Each sample can be positioned consecutively or in any position in the tray. The system processes the samples in increasing order, from 1 to 48. The same tray accommodates 48 reagents; therefore, 48 single tests or 24 double reagent tests, can be programmed for every sample. Reaction tray. 80 reaction well capacity. If the number of programmed reactions exceeds 80, the instrument will halt and demand reaction cuvette replacement for specific positions, then will resume operation. This routine repeats as necessary. The reaction cuvettes are disposable and come in strips of five units and they are available in 0.6 cm. of path length. Robot probe arm. The robot probe aspirates the reagent and sample, introducing a small air gap between them, then dispenses both in an identified reaction cuvette. The probe arm thermostats both sample and reagent before dispensing, at 0.5oC above the selected reaction chamber temperature. It has 4 work stages: (from right to left) 1. Dispensing position. 2. Wash position. 2300GLlTIU Rev. 4.2
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3. 4. 5. 6.
Sample aspiration position. Reagent aspiration position, reagents 1 to 24. Reagent aspiration position, reagents 25 to 48 (only split reagent vials) ISE delivery position
In the case of accidental probe arm collision, the system halts and signals an alarm until the problem is cleared. Diluter. A diluter with a 500-microliter syringe, aspirates reagent and sample consecutively. Air gaps separate liquids to prevent early mixing and contamination. Level sensors. When the probe aspirates samples or reagents, capacitive radio frequency system senses liquid level and stops probe tip at the surface. The tip penetrates the surface just enough to aspirate the required volume and minimizes the possibility of carryover, contamination and volumetric error. By the same means, the probe senses the level in all reagent vessels at the beginning of the working cycle to establish if enough reagent is present for the programmed assays. Samples in primary tubes are used by the system, eliminating the need and risk of sample transferring. Impact detector. Whenever the probe tip or arm impacts a mechanical obstruction in its path, it automatically halts, and visual and sound alarms are emitted. As soon as the problem is cleared, the system will resume the job. Photometer. The photometer is provided with 9-interference filters mounted in a filter wheel, and has a double beam reference system. Wavelengths are: 340,380, 405,450, 505, 550, 600, 650, and 700 nanometers. Light from a tungsten halogen source passes through the selected filter and a beam splitter. One beam traverses the reaction cuvette and the other is directed upon the reference detector. The reading is obtained as the ratio of both signals, and the system is therefore immune to source fluctuations, exact filter positioning or dirt accumulation on optical surfaces. This double beam design allows the detection of reaction cuvettes in the reaction tray, and sets alarms if cuvettes are missing or defective. Bichromatic mode is enabled by the system. This consists of reading the sample at two different wavelengths. The second wavelength is selected in a region where the chromogen of the sample does not absorb. This accounts for turbidity, hemolysis and intrinsic sample color, etc. Mixer. There are two mixing options that can be used in conjunction: Tray shake and mixer motor located on the head of the probe. The mixer motor has an eccentric head that introduces a circular motion to the probe tip. Cleaning system. In between sample aspiration, a programmable diaphragm pump flushes the probe with distilled or de-ionized water (DI water) with tensioactive addition. An alarm will flag when the DI water reservoir is almost empty, or when the waste reservoir is almost full. The consumption rate of the cleaning solution is very low. The cleaning of the probe is enhanced by an additional automatic cleaning routine accessed through the program with the aid of specific wash and soak solutions.
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1.2 Operating features Output Data File: The results remain in the Sample Table unless they are erased or sent to the History Table. Factors for each assay and results from control sera can also be saved in separate tables in the History Table. The History Table is automatically erased after a specified number of days, preset through Functional Parameters Menu. Printout of results: Metrolab 2300GL uses all Windows printing capabilities. If data are saved to disk, and no printout is required, set print batch parameter to zero. Analytical Methods: Metrolab 2300GL can store on hard disk an unlimited number of different analytical methods. Methods can be: chemistry, coagulation, external or calculated. Each chemistry method contains the following information: Name: Up to 15 characters. Test ID: 6 identification characters. Nomenclature: A code number for identification by external software. Brand: 15 characters for brand identification. Type of assay: Kinetics: Incubation and rate readings at intervals automatically pre-set. End Point: Performs a blank reading in the reaction cuvette before incubating the sample. Color: Uses reagent blank. (One for each method). Two point Kinetics: incubation and two readings at selected interval. ISE: Ion selective Na, K and Cl determinations (Optional) Reference: Single point or multipoint (curve). For single point factor and/or standard can be introduced. Wavelength Principal: Peak wavelength in clinical assays, wavelengths available in optic parameters. Bichromatic reference: For assays where serum color and turbidity interfere. Improves precision of readings. Sample volume: 2 to 100 microliters. (A parameter defines minimum allowed volume) First reagent volume: 0 to 700 µl (0.6 cm cuvettes). Second reagent volume: 0 to 450 µl. Use 0 for single reagent assays. The sum of sample and reagents volumes should not exceed the reaction cuvette capacity of 700 microliters. First incubation time. Second incubation time: Used in double reagent methods. If this time is zero, both reagents are loaded simultaneously. Concentration of standards Depending on the calculation type, system can operate with one or more standards. One standard is used with normal colorimetric methods. When a high measuring range is required in systems that do not obey Beer's Law; more standards can be used either in Curve, in non-linear mode a quadratic or multilinear adjust. 2300GLlTIU Rev. 4.2
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Factor: If working with one standard, it will indicate the calculated factor in accordance to concentration and absorbance of the standard. Not used in multipoint calibration. Initial absorbance Limits: Indicates reagent deterioration if limit is exceeded or is below or above a specified maximum and minimum. Used with the reagent intensity check option. Threshold: For time readings (coagulation), it indicates absorbance change. Limits Low Concentration: Indicates concentration value that determines analysis repetition when not reached. High Concentration: Indicates concentration value that determines dilution and repetition of analysis. Consumption: indicates allowed maximum initial absorbance rate. Values above it cause changes in the measuring interval and eventual repetition. Operates only in kinetic modes. Factor Calculation: Determines how the factor is handled. As options, a previously calculated factor may be used, or an average between previous and actual factor can be used, or simply use the actual factor. Multipoint requires the use of multiple standards. They always operate in replacement mode. Reagent Tray: Designates a group of 1 to 48 reagent sets in the tray. The order is an operator’s option. The position of each reagent in the tray, and the number present are saved to memory as a “Reagent Tray.” An unlimited number of tray configurations can be stored. It is not necessary to use all reagents in a tray. During a work cycle, select the tray containing the required reagents. Just select the tray number or name and its composition will appear on the screen. Table of methods in use: is a sub-set of all methods. With a double click, methods from this table go to selected entry in Sample Table. Panels: they consist of sets of methods stored on a separate table. The use of profiles saves time when data are introduced. When exported, all methods included in that profile are sent to the Sample Table. It is normal practice to prepare a “Hepatic profile”, a “Cardiac profile”, etc. In the Standard Table Profiles, Controls and Standards are pre-defined. STAT procedures: At any time, new samples can be input without interruption of incubation times. Data can be entered via the Sample Table as “Samples” or as “Stats.” When introduced as Samples, they are processed in the order that they occupy in the tray. When introduced as Stats, they acquire priority over all Samples already in the tray. Patient input: Patient data can be entered with their corresponding assay data of each sample. The protocol number is mandatory. The name, age, sex and terminal are optional. Data are: Protocol number Surname and name Age 2300GLlTIU Rev. 4.2
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Sex Terminal (used for selective output/input) Other optional demographic data. (See Section 2.6.3) Tests to be performed These data will be displayed in the final report together with the assay results. Statistics: Statistical analysis may be performed on samples, standards and controls. They are performed through the History Table only. Levy-Jennings diagrams are obtained and Westgard rules are applied. Output data: Various printout formats are available. They are printed as samples are completed. They include the Laboratory’s name, patient data, numerical data, units and diagnostics. The export file is in Paradox or Dbase format. Serial port communication: Data can be introduced and results returned from/to a host computer with LIMS capabilities, through a RS232C serial port. Transmission follows standards established in ASTM 1390 protocol. 1.3 Technical Specifications Samples 48 positions in rotary tray Use of primary tubes or pediatric vials. Optional bar code reader for sample identification with 16 characters. Sample volume programmable 2 – 100 µl Reagents 48 positions Reagent volume programmable: First reagent: 0 –700 ul Second reagent: 0 – 450 µl Typical volume: 200 µl . Total volume (Sample + Reagent 1 + Reagent 2) must not exceed 700 µl Reagents can be accommodated either in 50 ml. vials or double 30 ml. and 25 ml. vials for 2-reagent methods. System also accommodates large size vials of 70, 45 and 30 ml. Sampling system Pre-heater in probe to deliver reagent at preset temperature Capacitive sensor level Inner and outer probe washing system Klohen TM diluter with valve assembly Reaction tray Mixing system by probe vibration and tray shake. Admits 80 cuvettes of 0,6 cm of light pass Double beam, interferential filters Wavelengths: 340, 405, 450, 505, 550, 590, 650, 700 and 750 nm. Bandwidth: 10 nm Photometric range: -0.1 to 4.5 A with (referred to a 1 cm path light). Lamp: halogen, 6 volts, 20 watts. 2300GLlTIU Rev. 4.2
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Analysis modes End point with sample blank or reagent blank Factor or standard Priority programmable per sample (profile) or reagent (batch) Calibration curves with two up to 10 standards Automatic curve adjust Turbidimetry Coagulation time by turbidimetry Fast and two-point kinetics (0 and 1st order) Profiles, batches, STAT procedures. Automatic time adjust and dilution with high substrate consumption, Dilution for values above high limit. Pre-dilution of samples if method requires it. Automatic repetition on abnormal low values. Quality control: Levy Jennings plots, Westgard rules Data export and import to other programs and/or remote terminals. Automatic backup protection. Throughput 240 test/hour for an all end point mono-reagent profile. 190 test/hour for a profile including 40% double reagent and 40% kinetic assays. Measurement is defined on the basis of 150 tests and counting from the first intake to the last dilution. Data handling Computer required: PentiumTM or equivalent Minimum 256 Mb RAM (See Section 1.5.2) Two serial ports RS232C or 1 serial port RS232C and 1 mouse PS2 Port. One additional serial port for communication with external LIMS system. Color monitor SVGA Windows™ multitasking system version XP, Windows Vista CD Rom unit and 31/2” floppy disk Ink jet or 80-column printer. Communication Serial port standard communication according ASTM 1394 protocol. Supply 85 to 240 VAC +/-10% - 43/65 Hz – 400 VA Automatic set Fuses: 2.5 A – FF for 220 VAC 5.0 A - FF for 110 VAC µl Insulation: Class 1 Water consumption 1.5 ml/analysis, approximately 2300GLlTIU Rev. 4.2
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Operating conditions Temperature range: 15 – 35oC Relative humidity: < 80% Pressure: 750 – 1060 hPa. Dimensions Width: 85 cm Height: 47 cm Depth: 58 cm Weight Gross: 80 Kg, Net instrument alone: 60 Kg. Usage mode Continuous WARNING: Instrument is Installation Category II. Instrument requires protective ground connection. Verify ground connection before installing the instrument 1.4
Main menu
The main menu bar contains menu drop-downs for all system functions and icons for direct access the most important functions.
Data Methods: Analytical methods stored in memory Samples: Table where samples, standards and controls are loaded. Historic: All measured data can be sent to this table. Statistical calculations can be performed on them. Methods in Use: Table with a selected set of methods of daily use. Panels: Table where standards, controls and profiles are pre-defined Interferences: Sets of pairs of interfering reagents are defined. Trays in Memory: Sets of reagents are stored in tray for easy load. Check LIMS: Retrieval of external data. Memory: Instrument reconnection and servicing operations Exit: Close program. Trays Samples and reagents: Graphic representation of Samples and Reagents Tray. Allows operator to visualize programmed samples, reagents, volumes, etc. Movements 2300GLlTIU Rev. 4.2
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Manual Automatic: Start and stat options. Calibrate; Photometer, mechanics, water reference, cuvette bottom. For mechanical calibration, See the Service Manual. Cleaning: Automatic probe cleaning procedure, purge and filling Inspect Communications: Contains all the communications between PC and instrument for the last run. Coordinates: Instantaneous values for last position of the system (Trays, probe, read frequencies, etc) Status: Instantaneous status of error functions. Messages: Warnings and error condition for the system. Some of them are also shown in “ Operating conditions” and some are in the Error log file. Errors: Error log file. Opens in WordPad format. Filters: Gains, zeros, frequencies and status of the 9 optical filters. Calibrations: Gains, zeros and frequencies for all gains, not only those selected by the system. Volumes: Once the samples are programmed, details of needed volumes for all reagents. Error conditions also shown. Priorities: Order of analysis is established by instrument. It takes into account, highest priorities for blanks, next for standards, etc. Times: Table showing all measurements in the reaction cuvettes. Also collects information on actual measuring times, volumes, etc. It has an historic page where data are stored when cuvettes are blanked. Operating Conditions: Used cuvettes, samples to dilute, time to the next, reading, status messages. Parameters: (See Section 2.8). Miscellaneous Repeat Analysis: Data of last reading are erased and Sample Tray reloaded. Clean Samples: Sample Table is erased. Sample Tray must be empty. Clean Historic: Cleans Historic Table. Requires password. Clean Messages: Cleans the Table of Messages. Backup: Allows creation of backup files for Historic, Methods and Parameters. Save Desktop: Saves settings on sizes, positions and columns for every active window. Print Screen: Direct printout of the active window. Shift + Print Screen sends active window image to the clipboard. Translator: Multi-language dictionary for all messages and screens. Test: Instrument testing. See Chapter 7. Test Record: Information about the use of reagents. Help Users Manual: Access to PDF version of user's manual. What is new: version highlights. About: Software version and manufacturer information. 2300GLlTIU Rev. 4.2
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Icons. Most of them correspond to already defined menus. Table of Methods Table of Samples Samples and Reagents Tray Reaction Tray Barcode reading for samples and reagents Full initialization of system Trays are disabled to facilitate load of samples and new cuvettes. Manual movements Ends all procedures in progress. Start of automatic procedure. Volumes and priorities. Prints active window (To clipboard con shift + icon) Stops and resumes dispensing for Stat procedures
1.5
Installation
1.5.1 Unpacking Instrument should be moved preferably by mechanical aid. The instrument is packed fixed onto a wooden pallet, suitable for transportation. In case that instrument needs to be manually moved, at least two persons should take it from the lower wooden pallet. With reference to Figure 1: 1. Cut clamp rings that retain crating 2. Pull up the whole crate, but leaving instrument fixed to the base. 3. Remove all accessories 4. Remove four nuts that hold instrument to the base. 5. Carefully place instrument on desktop. If instrument is tested in distributor's premises, do not remove from base: hold on it and reinstall crate cover to send to customer. 2300GLlTIU Rev. 4.2
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1.5.2 Instrument Setup Refer to Figure 3 of this manual. There is one J 9 serial port type RS232C connector. Use the cable provided to connect the connector to Serial Port of the computer. If computer has J 25 type connector in Serial Port 2, use Serial Port 1 or a J 25 male to J 9 female adapter. If mouse is connected to PS-2 connector type, connect instrument to Serial Port 1. If mouse is connected to Serial Port 1, connect instrument to Serial Port 2. Tighten retaining screws. Connect level sensor tubing of DI water and waste reservoir as indicated in Figure 3. Sensor tubing is yellow color. The waste deposit stopper has three fittings: two for the waste hoses and one for level meter. One of them is the direct drainage of the probe wash station. The other collects contingent waste from the dispensing station in the reaction chamber. The wash solution reservoir must be located at less than 0.2 meters below or above the peristaltic pump of the instrument. The waste reservoir must be located below the instrument, and hose SHOULD NOT FORM BENDS that may impede drainage or overflow drain funnels. IMPORTANT: level metering is made by means of a pressure detector device. For proper operation, be sure that stopcock is firmly tightened. The Mains plug must be connected to 110/220 volts, 5/10 amperes installation, after ensuring proper fuses value of instrument that complies with local regulations (See Section 1.3). WARNING: Instrument is Installation Category II. Instrument requires protective ground connection. Verify ground connection before installing the instrument. Computer Setup Computer must be PC compatible, Pentium microprocessor, speed 233 MHz or higher. Hard and floppy disks and CD Rom must be installed. Minimum free space on hard drive must be 20 Mbytes. for mouse) and any PC compatible printer must be installed. Table shows OS compatibility. Operating system
Version 3.0
Previous versions
Sound requirements
Minimum RAM (Mb)
Windows 95 Windows 98 (1st. edition) Windows 98 (2nd. Edition)
No No
Yes Yes
PC speaker PC speaker
16 32
Recommen ded RAM (Mb) 32 64
Yes (No for Asiatic versions) Yes
Yes
PC speaker
32
64
Yes
Sound card and external
64
128
Windows Millennium
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Windows 2000 Yes
Yes
Windows XP
Yes
Yes
Windows Vista
Yes
Yes
speaker Sound card and external speaker Sound card and external speaker
64
128
128
256
2 Gb
4 Gb
1.5.3 Software Installation and Startup Install Windows Xp in the computer. Perform typical installation. M2300GL software for Windows is provided on one CD-Rom. Installation disk has Auto-run features that is will start installation automatically. Should not use the auto-run capability, follow the following instructions: Double click on My Computer on Windows desktop. Select drive D: (or E, or other drive designated as the CD drive) and double click on D:setup.exe Alternatively, select START menu, RUN and enter: D:setup.exe and click OK. The installation program will ask for operator’s name / company and then will automatically install in directory C:\Program Files\Autoanalyzer In the same folder, icons are located for Recover and Test programs. Install the program as follows: Open the Windows Explorer. Locate the directory Autoanalyzer where the program has been installed. You will find a Sub-directory with the instrument’s name main directory: Program Files
Autoanalyzer Data
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In this Autoanalyzer directory you will find direct access to the program and to the Backup option. Drag the icons of these files to the desk. To do that, press left button on the file icon and drag mouse until icon is outside the Windows Explorer’s window and on the desktop. Release button. In Data directory all required databases will be located. Once program is installed, specific calibration parameters for each instrument will automatically be installed. IMPORTANT: Before installation, verify that CD disk number coincides with instrument Serial Number. NOTE: Before proceeding with instrument startup, it is highly recommended to carefully go through the following chapters to become familiar with software and instrument operation. WARNING: If a dot matrix printer is used, a minimum configuration of 120 X 144 dots should be used. Otherwise printout could be incomplete. Start program by double clicking on the program icon. In Parameters, key-in default service password, select Technical and select desired Port.
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Verify that Movements are operative: Select Full Initialization and all trays, arm and diluter will move and acquire their startup positions.
Perform a CALIBRATION to the instrument (See Section 4.10). Edit the Functional Parameters. Modify the default password 12345 to any desired alphanumeric expression. Also modify the laboratory name, address, phone, etc. Insert authorization code and Serial Number parameter. Insert an empty vial in the sample tray, select Probe Down in Probe, Manual Movements (HORIZONTAL POSITION 3) and verify that the probe reaches the bottom of the vial. Make corrections as necessary. Verify that the probe does not collide with any vial as it moves to all positions. If adjustment is correct, probe should sense level with 100µl water in the vial. (See Section 4.5.1) Verify the 5 horizontal probe positions. Calibrate if necessary. Follow instructions included in Service Manual. Perform a “Fill” cycle and several dispensing cycles with diluter speed set to 15. 2300GLlTIU Rev. 4.2
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NOTE: When new cuvettes are installed, be sure that they are free from dust and packing material. Perform cuvette bottom calibration. To do this, select the option: Movements > Calibrate > Cuvette Bottom Perform validation tests. For instructions, please refer to Section 6. 1.5.4 Software registration For software registration follow instructions included in the Installation manual 1.5.5 Database settings Before starting operations, check settings in database. Using Windows Explorer, select directory: C:\Program Files\ Common Files \Borland Shared\ \BDE By double clicking on it execute program BDADMIN.EXE Select Tab of Configuration, then System > INIT Verify that Local Share is set to “False.” If not, change accordingly. Also, check if SharedMemSize is set to 8192. If not, change setting to 8192. Close the window. If modifications were made, confirm the changes by selecting Yes in the confirmation window. This window will not open unless changes are made. Alternatively, to execute database configuration program, in the Run menu execute: C:\Program Files\ Common Files \Borland Shared\ \BDE\ BDADMIN.EXE
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2 SYSTEM DESCRIPTION AND DATA LOAD 2.1
Method setup
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Methods are classified as follows: 1- Chemistry: These are the common clinical chemistry methods. 2- Coagulation: Turbidimetric time analysis 3- External: Methods whose results are directly keyed-in in the table of results for printing and statistics purposes. 4- Calculated: Methods whose result is a derivation of measured analysis. 5- Development: Continuous reading of sample. Absorbance plot for development purposes. The following options are available for all those methods: Test: Automatically generated when name and brand are entered. This is formed by the first three letters of reagent name, a dash and first two letters of Brand. The purpose of these test ID is to simplify reagent identification when entering data. Name: Up to 15 alphanumeric characters, designating reagent name. (Must always be present) Brand: Reagent manufacturer. Up to 12 alphanumeric characters. (Must always be present). (In calculated, at least one printable character must be introduced) Units: Up to 8 characters. Edit To modify method press Edit and enter password. Print Import
Printout of all methods in memory Input methods from files Next method Previous method
+ --
New method Erase method Confirm method
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2.1.1 Chemistry methods 2.1.1.1 Definition Page Wavelength (nm): Principal: from 340 to 767nm (See available wavelengths in the Optic parameters). Always must be present. Bichromatic: from 340 to 767 nm (See available wavelengths in the Optic parameters). The reading at this wavelength subtracts from reading at the principal wavelength. Reference values: Minimum: Input minimum reference values for men and women. Maximum: Input maximum reference values for men and women.
Validity (in days) Calibration This parameter defines the number of days for which the latest calibration is valid. The maximum allowed period is 60 days. If 0, no testing is performed. When automatic procedure starts, table of reagents and volumes will show the Expiration Date of each programmed reagent. Operator can choose either to eliminate the reagent with expired calibration or continue. Blank Defines expiration of blank in methods. Once expired, blank will be measured in next automatic cycle. If 0, blank will be measured in each run (default condition). Blank reading can be forced, even if valid, when reagent window is opened with mouse left button (See section 2.4) Type: End point: End point readings imply an initial reading after sample and reagent mixing in reaction cuvette, followed by a reading performed after the incubation time. The advantage of this type of measurement is that concentration is proportional to the absorbance difference between both readings and thus compensates cuvette irregularities, reagent color and sample turbidity. This type of measurement, combined with bichromatic reading, and the fact that the photometer is double beam, makes measurements strictly dependent on COLOR CHANGE as a function of time. This method is to be used when color generation in the reaction is gradual, and is not evidenced suddenly during sample and reagent mixing. Calculation is simple: Concentration = Factor * ( Afinal - Ainitial )
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The FACTOR is introduced directly in the method, (method with factor), or calculated by the instrument with the absorbance of a standard of known concentration, (Method with standard). The parameters are: TYPE: End point WAVELENGTH: According to method. Bichromatic reference can be chosen. ABSORBANCE LIMITS: Used for reagent integrity check. HIGH Conc.: Defines the CONCENTRATION above which automatic dilution as needed is to be performed. According to method. LOW Conc.: If this concentration limit is not reached, analysis is repeated, unless limit is set to zero. INCUBATION TIME: According to method. In two reagent methods, 1st and 2nd time must be defined. The 1st corresponds to the time interval between reagent dispensing and second reagent addition. The 2nd is the effective incubation time. VOLUMES: According to sample/reagent ratio established in the analytical method, adjust reagent volume between 0 and 700 µl, accounting for a minimum of 2µl for the sample. FACTOR: Assigned in accordance with method specification or previous calculations. If operating with a standard, the factor is automatically calculated when the standard is measured. DIRECTION: Always ascending. Color: For colorimetric measurements, a reagent blank is prepared for each sample tray (batch) or a blank reading is performed in each cuvette when reagent is added and before sample is delivered. The effective color measurement is obtained as the difference between sample reading and blank reading. This method is recommended when color is rapidly developed after sample and reagent mixing in the reaction cuvette Parameters: IMPORTANT: All parameters, times, volumes, of Colorimetric methods are identical to end point parameters, except for the blank origin (in cuvette or batch). If batch mode is selected, an additional vial is used in the sample tray and only one reagent blank is used for each analytical method for each sample batch.
Fast kinetics: Incubation and next 7 readings at 30 seconds intervals. Slope is calculated by least squares. Linear fit and correlation factor are output. Absorption change vs. time is measured. It applies to first order kinetics where the concentration can be expressed as C =F *∆A/min Where F is a factor provided by the reagent manufacturer in a direct manner, or through a table. ∆A/min is the rate of change of the absorbance per minute obtained directly as the slope of A as a function of time through a correlation calculation. 2300GLlTIU Rev. 4.2
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Particular attention should be paid to manufacturer's indications as to the temperature for which the factor has been calculated. Some reagents have a constant factor and vary the normal limits as a function of temperature. As the reaction tray and the reagent pre-heater in the dispensing probe have the same temperature for each run, all analytical methods should be adjusted to this temperature. All methods should be adjusted to 37°C. Kinetic readings are performed in seven time intervals. The first measuring interval is 30 seconds. Consumption rate is monitored even during incubation time. If the rate of change of the absorbance exceeds the limit imposed by the method, the following time intervals are adjusted to variable intervals from 30 to 5 seconds; otherwise they remain 30 seconds. Result will always be expressed in terms of absorbance variation per minute. If sample concentration surpasses the High Concentration Limit, the sample is diluted to the required volume, multiplying the final result by the corresponding volume ratio. If sample concentration is below the Low Concentration limit, the dilution and measurement is repeated. The first and second readings are kept in the Sample Table. In the result plot, the correlation coefficient is printed. It indicates the degree of linearity of the reaction. A correlation coefficient of 0.9 to 1 will indicate a “linear” reaction; a value between 0.8 and 0.9 indicates a “suspect linearity”; under 0.8 the reaction is considered “non linear”. The Direction of the reaction must be specified according the method in use. IMPORTANT: A non-linear result is not infrequent in normal enzymatic values when time intervals are small, and therefore irregular. Method parameters that correspond to kinetic readings: TYPE: Fast Kinetics WAVELENGTH: According to method. CONSUMPTION LIMIT: (According to consumption of substrate, if exceeded, reading time is reduced accordingly. ABSORBANCE LIMITS: Minimum and maximum initial absorbance of substrate. LOW Conc.: Defines the concentration value at which automatic repetition will be performed (According to method), unless limit is set to zero. HIGH Conc: Defines the concentration value at which automatic dilution will be performed (According to method). INCUBATION TIME: Interval between dilution and first reading. It is eliminated if consumption exceeds three times the consumption rate. VOLUMES: According to the sample/reagent reaction imposed by reagent manufacturer, scaled to a reagent volume of 200 to 300 µl and a minimum sample volume of 2 µl. Second volume: it can be added at later time as starter. FACTOR: According to method and temperature. DIRECTION: Ascending or descending according method. 2300GLlTIU Rev. 4.2
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NOTE: The concentration limits can be used to generate automatic repetition of reading of all samples that surpass certain value chosen arbitrarily, even if it is within the linear limit. Two point kinetics: Incubation and two readings. The interval is the Kinetics 2 time. Absorbance change is measured at a fixed time interval. The first reading is performed after the first incubation period. The second reading is performed at a fixed incubation time, elapsed since the first reading. For maximum precision, if the incubation limit is greater than 0, the first reading is obtained by interpolating between two readings: one taken 6 second before the corresponding time and other immediately after the time. This method is used preferentially with nonlinear kinetics; for example, Creatinine and Urea (BUN). If consumption limit is set to zero, first reading is only one. IMPORTANT: Nonlinear kinetics does not closely relate volumes and concentrations. Therefore, the dilution of highly concentrated samples to one half will produce results higher than expected. To solve this analytical problem, reduce volumes of samples and standards. Parameters are: TYPE: 2-point kinetics or fixed time WAVELENGTH: In accordance with analytical method CONSUMPTION RATE: does not operate. BLANK/SUBSTRATE LIMIT: In accordance with method INCUBATION TIME: Fist incubation: time elapsed from dilution to first reading. Interval: time interval between readings. VOLUMES: Proportionality between reagent and sample volume must be in accordance with original method specification. Second volume: it can be added together the first one or at a later time. Volumes (microliters) M2300GL requires small reagent volumes compared to manual methods. It is advisable to take as reference, a reagent volume of 200 microliters, and adapt sample volume to the recommended dilution. For example if reagent manufacturer recommends 2 ml reagent and 50 µl of serum, to maintain proportion, for a reagent volume of 200 µl, only 5 µl serum will be required. If this ratio is altered, the linear range that the manufacturer indicates for that method will also be altered. It is not recommended to use sample volumes lower than 2 µl. It should be noted that if the sample exceeds the normal range, the instrument automatically dilutes the volume to one half. This implies that sample volume will be 2 µl, which is the minimum recommended volume, compatible with a good precision. 2300GLlTIU Rev. 4.2
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Sample: 3 to 100 microliters (minimum can be 2, 3 or 4 depending on Parameter setting) First reagent: to 700 microliters. Second reagent: to 450 microliters. Only used in two-reagent methods. The sum of sample and reagents volumes should not exceed the reaction cuvette capacity: 700 ul. Initial Absorbance: Minimum and maximum absorbance reading of reagent blanks. It generates check and warning messages (See Section 3.5.3) M2300GL permits methods with two reagents, for Colorimetric, Endpoint, Kinetic and Time Elapsed methods. The two reagents can be dispensed simultaneously or separately in time. Two parameters control the use of double reagents: 2nd volume and 2nd incubation time. 2nd Volume. If 2nd volume is zero, method is single reagent. If 2nd volume is greater than zero, it is two reagent. 2nd Incubation Time. When this is zero, the sample probe aspirates the first reagent, then the second reagent and then the sample. On the contrary, if the 2nd incubation time differs from zero; the first incubation time will be the time elapsed between dispensing of sample and 1st reagent, and dispensing of 2nd reagent. The second incubation time is the time elapsed since dispensing of second reagent and reading. SINGLE REAGENT *Dispensing of 1st Volume+ sample *1st Incubation *Measurement
TWO REAGENT (2nd Incubation = 0) *Dispensing of 1st volume + 2nd Volume + sample *1st Incubation *Measurement
TWO REAGENT 2nd incubation > 0) * Dispensing of 1st volume + sample * 1st incubation * Dispensing of 2nd volume * 2nd incubation * Measurement
For end point methods, first reading is after addition of first reagent but just before addition of second reagent. For kinetic and 2-point methods, first reading is after addition of second reagent. Times (sec) Second reagent: For two-reagent methods, time elapsed until second reagent is added (In end point methods, reading are immediately before 2nd. reagent addition). Incubation: Time interval from dilution/addition to reading. In two-reagent methods, incubation is the interval from addition of 2nd reagent to reading, in kinetic mode, interval is from dilution to first reading, in coagulation interval begins upon sample/reagent mixing and ends when final reading or when Wait interval is surpassed (clot not formed). Interval: time Interval between the two readings in two pint kinetics only. Limits: Low Concentration: Repeats analysis for values below this limit. 2300GLlTIU Rev. 4.2
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If Low Limit value is set to zero or left blank (empty) feature will not be activated for the method. High Concentration: Establishes automatic dilution value in Concentration units. In dilution, the new sample volume is automatically adjusted to enter linear range. The new factor is calculated using the volume change ratio. Consumption: (Only for fast and two-point kinetics). While incubating, the absorbance change in the 30 - 45 seconds interval is used to estimate substrate consumption (depletion). If the desired level is surpassed (in absorbance units), the reading interval is automatically varied between 30 and 5 seconds. This feature extends the reagent linear range. Reference: (Type of calculation) Single point Multipoint Single point Factor: In methods with factor, it can be entered directly. In methods with standard, the value is automatically calculated and set when a standard is measured. Not used in Multipoint and cutoff methods. Standard: Only used in methods with standard.
2.1.1.2 Detail page Calculation Slope Intercept The slope-intercept method affects the final result by multiplying all data with a factor (slope) or adding a constant value (intercept). This system allows expressing data in different units or comparing results with other instruments. Blank Absorbance Minimum Maximum The initial absorbance (blank or reagent) is used with the reagent integrity check option to warn user if reagent undergoes degradation. Once informed, operator can replace reagent, eliminate it or ignore the warning (See Section 3.5.3). Mixing: There are two different mixing operations: Reaction Tray shake and probe vibration by the use of a small motor provided with an eccentric head. Probe vibration can be used as normal, double time and triple time. Both types of mixing can be used together or separately. Tray shake can be adjusted by varying three Technical Parameters. Probe mixing does not require adjustment but can be inactive (No mixing) or with increasing length (Normal, X2 and X3). Strong action is recommended with method requires a low volume second reagent. Nomenclature: Numeric Method identifier for transfer purposes. 2300GLlTIU Rev. 4.2
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Decimals: Number of decimals for printout and transfer of results. Correlation minimum: acts only in kinetic methods. Defines value for automatic dilution and repetition of analysis. Linear Correlation coefficients lower than this parameter generate dilution and repetition. Discard volume (ul) First reagent Second reagent Reagent volume can be discarded in variable volumes from 0 to 200 microliters. Its purpose is to reduce carryover or avid reagent dilution with wash solution. Its use is only recommended in methods were no calibration with standard is performed or high linear range is required. Reagents Integrity When enabled, system delivers reagent blank alone and compares reading with Maximum and Minimum absorbance limits. If out of limits, system halts and requires further action. Blank (Color methods) This option allows discounting blank reagent in each cuvette. Procedure is as follows: Exact 200 microliters of reagent are dispensed; the absorbance is measured and next reagent and sample are dispensed in the same cuvette. The volume of this second reagent addition is to complete the total programmed volume. After incubation, absorbance is measured and initial absorbance blank, subtracted. Additional blank dispensing and measurement is performed only if reagent integrity check is selected. This blanking system does not support second reagent addition or sample pre-dilution. Minimum reagent volume is 300 µl (fixed initial 200 µl plus minimum additional 100 µl together with the sample). When this option is enabled, a blank is measured as a normal sample, including incubation times. For kinetic assays, time interval is fixed to 30 seconds. Dilution Samples can be prediluted in any method. Operator can choose the dilution ratio and if prediluent is either specific or generic. (See section 2.2 ) 2.1.1.3 Multipoint page When Multipoint is selected and password accepted, data on concentrations of up to ten different standards can be introduced in the second column. An identifier must be written in first column (Id). Calculated concentrations will appear in fourth column (Calc.). Optionally, absorbance data can be directly introduced in the third column. Values are updated when a new standard is read. When data are introduced by direct write, the fifth column (St.) is empty. By pressing Exc/Inc for EACH selected standard, it is enabled. Pressing again in the button, the standard is disabled. For the St. column possibilities are: 2300GLlTIU Rev. 4.2
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Standard disabled √ Standard enabled x Standard disabled Curve is automatically drawn and by pressing the Print button. Curve is drawn in a separate window and from there, printed out.. .
Multipoint selection is automatic when standards are measured. The least squares selection is made, provided equation has not multi-valued points, negative concentrations, infinite values, etc.
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The function selector window shows in the first column the type of function, the second indicates correlative number; the third one indicates the quality of the function: + * -
Acceptable function Best function Forbidden function
Colors are shown with the function number, together with the curve equation. The last column shows the correlation number: the lower the value, the better the fit. The + and – buttons allow to introduce new standards in the curve or erase them, permanently. IMPORTANT: Multilinear Function is those that joins adjacent standards by means of linear equations. It is the default equation after measuring standards. This is the best option if all the function fits are poor. Concentrations are calculated as follows: Conc. = a0 + a1* f(A) + a2 * f(A) * f(A) Where f(A) are the functions of absorbance numbered 1 to 10, and LOG( Conc.) = a0 + a1* f(A) + a2 * f(A) * f(A) Where f(A) are the functions of absorbance numbered 11 to 20. Linear function 21 corresponds to interpolation with the function Conc = a1 * A
2.1.2 Coagulation methods Coagulation is measured by the change of absorbance with time produced by clot turbidity. Absorbance is measured in short timed intervals. The time period in which the change in absorbance occurs is measured in seconds. In single reagent methods, measurement starts after the sample-reagent mixing and ends either when the absorbance reaches the threshold (successful reading) or when the wait interval is surpassed (clot not formed). In two reagent methods, above measurements start after the addition of second reagent. The second reagent time is the interval between the initial delivery and the second reagent addition.
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2.1.2.1 Definition page Wavelength Principal: 405 nm unless other value is recommended by reagent manufacturer. Bichromatic: Not used. Reference Correction (sec): additive time correction in final result to let data from turbidimetry and viscosity coincide. Can be positive or negative and is measured in seconds. All other parameters not used. Multipoint (See multipoint page) Volumes: according to method. Sample: up to 100 microliters. First reagent: up to 700 ul Second reagent: M2300GL permits methods with two reagents, for Colorimetric, Endpoint, Kinetic and Time elapsed methods. The two reagents can be dispensed simultaneously or separately in time. Two parameters control the use of double reagents: 2nd volume and 2nd incubation time. 2nd Volume. If 2nd volume is zero, method is single reagent. If 2nd volume is greater than zero, it is two reagent. 2nd Incubation Time. When this is zero, the sample probe aspirates the first reagent, then the second reagent and then the sample. On the contrary, if the 2nd incubation time differs from zero; the first incubation time will be the time elapsed between dispensing of sample and 1st reagent, and dispensing of 2nd reagent. The second incubation time is the time elapsed since dispensing of second reagent and reading. Times (sec) 2nd reagent: Recommended time interval until second reagent is delivered. Measured in minutes. Limits Low Concentration: Time at which determination is automatically repeated. Wait (sec): Maximum waiting time if clot is not formed and threshold not reached. Measured in seconds. Threshold (Abs): absorbance level that indicates coagulation. For most reagents, a value of 0,100 works very well. Variable threshold: Threshold can be variable with time, starting at a given initial value and linearly reducing its value to a given percent of original threshold. Search minimum: When this item is enabled, threshold is measured from the minimum measured absorbance. If not enabled, reference is set to the initial absorbance. This feature is useful because some reagents reduce turbidity after few seconds. From (sec.): Initial time from which threshold can linearly decrease with time. To: (% of threshold): This parameter indicates the % of initial thresholds when the wait time expires. If no variable threshold is desired, this parameter should be set to 100%. 2300GLlTIU Rev. 4.2
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100%
to (%) From
wait
time
2.1.2.2 Detail page Calculation Slope Intercept The slope-intercept method affects the final result by multiplying all data with a factor (slope) or adding a constant value (intercept). This system allows expressing data in different units or comparing results with other instruments. Blank Absorbance Minimum Maximum Nomenclature: Coded method definition (Selected countries) Decimals: in result printouts. Temperature: For printout reference only. It does not act on instrument. (See Functional parameters) Discard volume (ul) First reagent Second reagent Reagent volume can be discarded in variable volumes from 0 to 200 microliters. Its purpose is to reduce carryover or avoid reagent dilution with wash solution. Its use is only recommended in methods where no calibration with standard is performed or high linear range is required. Additional Shake When second reagent volume is small, (less than 40 microliters) the addition of second reagent can produce poor mixing. The shake option will enhance mixing. Parameters for shake are defined in Factory Parameters and should not be disturbed, unless serious positioning problems are observed in reaction tray. If parameters must be changed, utilize manual movements > Reactions > Shake for optimum determination. Integrity check. It is also applied to coagulation methods. Multipoint page Calibration curve in coagulation must be set in percent of Normal sample, pool or control. It is useful to establish dilutions, which represent some points between 100% and 10%. The number of dilutions can be up to 10 but normally with 5 points is enough to define a coagulation curve. Percent can be introduced in the second 2300GLlTIU Rev. 4.2
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column and an identifier must be written in first column (Id). Calculated percents will appear in fourth column (Calc.). Optionally, time data can be directly introduced in the third column. Values are updated when a new standard is read. When data are introduced by direct writing, the fifth column (St.) is empty. By pressing Exc/Inc for EACH selected standard, it is enabled. Pressing again in the button, the standard is disabled. For the St. column possibilities are: Standard disabled Standard √ enabled X Standard disabled Curve is automatically drawn and by pressing the Print button. Curve is drawn in a separate window and from there, printed out..
Plot scale can be enlarged by selecting area with mouse. Return to original scale is performed by drawing a line or a square that starts within the plot and ends in the left side of the plot.
Return to original drawing
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Multipoint selection is automatic when standards are measured. The least squares selection is made, provided equation has not multi-valued points, negative concentrations, infinite values, etc.
The function selector window shows in the first column the type of function, the second indicates correlative number; the third one indicates the quality of the function: + * -
Acceptable function Best function Forbidden function
Colors are shown with the function number, together with the curve equation. The last column shows the correlation number: the lower the value, the better the fit. The + and – buttons allow to introduce new standards in the curve or erase them, permanently.
IMPORTANT: Function 0 is multilinear, that is linear equations joining adjacent standards. This is the best option if all the function fits are poor. Concentrations are calculated as follows: Conc. = a0 + a1* f(A) + a2 * f(A) * f(A) Where f(A) are the functions of absorbance numbered 1 to 10, and LOG( Conc.) = a0 + a1* f(A) + a2 * f(A) * f(A) Where f(A) are the functions of absorbance numbered 11 to 20. Linear function 21 corresponds to interpolation with the function Conc = a1 * A
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Essentially, this is a parabolic type equation fit, with different functional substitutions. 2.1.3 External methods
Methods can be introduced directly on the system and results written in the sample. This enables to get results from other instruments and get a single printout included in the chemistry methods and also perform statistical analysis and storage of them.
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Once the method is defined, with the button of Results, they are written in the “Correction of results” window and from there, passed to the Sample table 2.1.4 Calculated methods Formula definition
Method assignment
Several calculations can be performed on the results. They can be combined in any formula, as desired. Terms in the formula are arbitrary: you can design Cholesterol as A, CHOL, Cholesterol or whatever you want, provided that the selected variable is assigned to a method stored in the Table of methods. The assigned methods can be combined in a formula. Examples are: A/G ratio: Albumin/(Total protein- Albumin) LDL: Cholesterol – HDL – (Trygliceride/5) Risk: Cholesterol/HDL Etc. Calculated method are assigned to a patient as a separated method. If all terms required in the formula are measured for a given sample, the calculation is performed, the result shown in the Table of Samples and printed out. 2300GLlTIU Rev. 4.2
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2.1.5 Method development This feature is used when a record of absorbance against plot is required. Method includes most of the parameters of any regular chemistry method, but its result is a set of plots shown in the multipoint page. Samples are listed in a table and when selected, plot is shown. Development method option will be visible only if option is enabled with corresponding Technical Parameter. 2.2 Pre-dilution Sample can be pre-diluted before analysis. This feature can be useful for any method but it is particularly important in turbidimetric and immunoenzimatic assays. In Details of methods the pre-diluted ratio is incorporated. Also, the diluents can be of generic type that is the same for several methods as is the case of physiologic solution or can be a specific diluent for a given method. If generic is used, the box labeled as exclusive should not be checked. Pre-dilution is performed in the first empty position in the reaction tray, with a total volume of 300 microliters. Intake of pre-diluted sample is performed immediately after pre-dilution. When generic pre-dilution is used, diluent is accommodated as reagent 24. If exclusive is used when reagent is loaded it will be loaded in the next available position, after second reagent, if present. Positions can be modified at will, except generic diluent. Dilution ratio 1+N
Check when specific diluent for the method is used
Generic diluent
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IMPORTANT: the pre-dilution 1:N means a total volume of 1+N = 300 Sample volume is 300/N . WARNING: Pre-dilution is a method feature. In consequence, it affect standards, controls, standards and stats. Therefore, factors calculated with non-diluted standards must be re-run. If pre-dilution is applied to methods without factor, multiply manufacturer’s factor by dilution ratio. 2.3 Table of Methods in Use This table contains methods currently in use. Its purpose is to save time loading methods to patients. There are two advantages for its use; first, it is a sub-set of all methods in memory; second, it is only necessary to double click to incorporate a method, without the need of pressing “+”, “Test” and Method selection, which is the normal procedure when loading directly from the method data base. To access the Table of Methods in Use proceed as follows:
For each new desired method, press the “+” key; next, click on the “Test” button. The method selection window will be displayed. Click on desired method. Press the “+” key and repeat procedure for all methods that are to be included in the table. At any later time methods can be added, replaced or removed. Use the symbols “+” and “- “to edit methods. When erasing methods a warning “Delete record?” will be displayed. 2300GLlTIU Rev. 4.2
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2.4 Reagent Data Input Loading of reagent data in the working tray can be individually entered or imported from a pre-defined tray already stored in memory. At any time, reagents can be entered, removed or replaced. If a Stat sample requires a reagent not previously loaded, it can be accommodated in any free position or replace any already used reagent. Reagents can be placed in single or double reservoir. If the double is not checked, it is assumed that the reagent will be single and will occupy the full position from 1 to 25 in the corresponding position from 25 to 45 will not be available. 2.4.1 Loading individual reagents
1) Select reagent position
3) Confirm 2) Double click on desired reagent 2.4.2 Load from a tray Select the desired tray, press Export to tray. For export procedure to take effect, the reagents in Sample and Reagent tray must be blanked.
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2.4.3 Tray setup The procedure for the definition of a tray is to enter all desired reagent data in Sample and Reagent tray as explained in 3.4. Next, select the tray menu and press Import from tray. Then chose a new name for the defined tray. You can use it at any time by the procedure illustrated above. From the tray menu you can modify, add, remove or replace reagents in any already defined tray. Notice: The number included in any tray is for internal use, and cannot be modified. When a tray is defined in the Sample and Reagent Tray Menu, the second reagent position in a two-reagent method is automatically defined.
2.4.4 Tray modification The way to modify a tray is to export it to Sample and Reagent Tray Menu, modify it as desired, and re-export. It returns as “Imported” tray, and can be renamed at will. To delete a reagent entry, locate the mouse pointer over it, hold down the Shift key and click the left mouse button. A pop-up dialogue box will appear. Left click in the 2300GLlTIU Rev. 4.2
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Test entry field. The reagent menu will drop down. Click again in the blank entry field (it will be highlighted in blue). Click OK and the reagent entry will be deleted.
Forcing Blank button
1) Select Reagent to eliminate
2) Press Shift + left button
3) Confirm
2.4.5 Reagent reservoirs Reagents can be accommodated in different vials: 1. Single vials, 50 ml volume. 2. Split vials: 20 ml which fits in positions 1 to 24 30 ml which fits in positions 25 to 48
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30 ml Pos. 25 to 48 20 ml Pos. 1 to 24
For use of split reservoirs, before introducing them, the position itself must be defined as “split”. To do that, left click on the desired position and check split box. Once split, reagents can be loaded in either one of the components. 3. Sample vials inserted in regular reagent vials with the neck previously cut. They admit up to 4 ml volume. A circle in the corresponding vial sector indicates the use of this option. The Full Size option must not be checked. If a double reagent is loaded in a split position, components 1 and 2 will be accommodated automatically the first in 30 ml vial and the second in 20 ml vial. Second reagent is marked with a black corner in the occupied position. NOTE: If double reagent method is loaded in a non-split position, the first reagent will occupy the selected position and the second reagent the first available position, starting from position number 1. 2.5 Table of Panels: Standards, Controls and Profiles This table contains the data of standard and control samples of current use in the M2300GL. The procedure for defining standards and controls in a separate table saves time, as the table has to be stored only once. If data are not reviewed, they are simply exported to the Sample Table and from there, to the tray. Tabs in the Table are color-coded as defined for samples: Green/red correspond to profiles, yellow to controls blue to standards. To enter data in the table, proceed as follows: Open it from main menu. (When opened from Sample Table, it is not in Edit mode)
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1) Define a name. This name can be changed in the sample table, but for Standards and Controls, it is advisable to always keep the same name because statistics will be performed in the Historic database over samples with equal name. When exporting profiles, name must be changed in sample table and replaced by the patient’s protocol number. 3) For each defined sample, load the corresponding methods. They can be loaded directly or using the Table of Methods in Use. For each new desired method, press the “+” key or the arrow down and open a new cell; next, click on the “test” cell. The method selector
will be visible. Click on it and select the desired method. Press the “+” key and repeat procedure for all methods that are to be performed to the sample. To load from Methods in Use, press the corresponding button, and double click on the desired methods. 4) For Standards, in the column “Concentration”, enter the assigned concentration value, in the same units that were defined in the method, EXCEPT IN MULTIPOINT METHODS. 5) For control samples define, in the Min and Max columns, the lower and upper target values, also in the units defined in the method. Include also Lot Number and Expiration Date. 6) For profiles, no value is introduced. All the samples exported to the Table of Samples can be modified there before they are sent to the tray. Also, methods can be eliminated or replaced. When transferred to the Sample Table, standards corresponding to a calibration Curve produce consecutive entries corresponding to all standards. They carry the same name but include a dash (“-“) followed by the standard identifier. It is useful to define, in a commercial control sample, all the methods included in it.
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When measuring, export to the Sample Table and erase all methods not being tested in the run. For multi-standards, i.e. commercial sera with defined concentrations, the same routine should be applied. IMPORTANT: When concentrations are defined within a method, it is not necessary to complete the corresponding columns in the Table of Standards. Nevertheless, if a value is written in the Table, this has higher priority and replaces the value included in the method. It is customary to introduce in the method the values of aqueous standards when they are part of a kit. If a serum calibrator is used, its values are introduced in the Table of Standards. 2.6 Load of samples, standards and controls. To input samples, proceed as follows:
Select with double click
Open Table of Methods in Use
+
1)
Enable new sample input.
2) Key in the protocol number, name, sex, age and terminal. Protocol number must always be present; other data are optional. M. in Use
3)
Open the table of Methods in Use combined with the Table of Panels.
Double click over all the desired methods in the table of Methods in Use or the Panels from the lower part of table. Alternatively, you can export profiles directly 2300GLlTIU Rev. 4.2
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from the Table of Panels. (See below the same procedure for controls and standards). 4) To input standards and controls, proceed as follows: Panels
When pressing this key, the correct tab selection will open.
Select the desired standard. 5) Repeat procedure 1 to 4 for all the samples. To tray
Once all desired samples are on table, press key “To tray” and samples will be sent to tray.
6) Select the desired standard/s and then press To Tray to send to tray.
Automatic select 7) Repeat procedure with control samples already defined in the Table of Panels. Press the button of Panels in the desired section (Samples, Standards, Controls). In Samples and Stats, Table of Panels opens in Profiles, in Standards opens in Standards and in Controls opens in controls. You can export as many samples as you desire, even repeating the same sample. Controls and Standards are automatically selected by double clicking on the Name and are transferred with its name. For samples, profiles are transferred without name and to a pre-selected sample name or protocol.
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When panels are selected, listing of components is shown. Default condition is with all components checked and all are selected. Operator can chose only part of the panel to be measured. 8) From the Table of Samples export standards and controls to tray. Pressing the button To Tray does this. Important: When samples are exported to tray, they occupy the first free positions starting from vial 1 position. If you export the samples first, they will occupy the first positions. If you export the standards first and then the controls, they will occupy the next free positions. Standards have the highest priority; therefore, they will be measured first regardless their positions. Samples and controls have the same priority; therefore, they will be measured in the order the positions they occupy in the tray. 2.6.1 Replicates of the same standard. The system admits up to 3 replicates of the same standard, all sipped from the same vial. In order to measure replicates, data must be loaded through the table of panels and not directly in the Table of Samples. When defining standards in the Table of Panels, the last column indicates the number of replicates. Options are nothing (null), 2 or 3. Nothing or null means just one measurement. Samples for all replicates are sipped from the same vial. The average of absorbances is used for calculation of the factor. Nevertheless, one or more replicates can be disabled and the factor is automatically re-calculated. When a method with replicated standard is selected, a window with all data pops up. If standards and samples are measured in the same run, averaged calculated factor will be applied. It is strongly recommended that if the replicate procedure is used, standards be run separately. This way, factors and replicates can be analyzed and outliers discarded. When a new run is started, the table of replicates is erased and it will not be for averaged absorbance correction.. 2.6.2 Load of standards for curve construction For Curve methods, the procedure for constructing a calibration curve is as follows: 1. Define calibration curve within the method as indicated in 2.1.1.3 and 0. Be sure to include for all standards the identifier (id) and concentration. Use numeric, increasing identifiers. Number of standards cannot be edited. If it must be varied, satart the lod of entire table again. 2. Open the Table of Panels in Edit mode (from Data in Main Menu) and select the Tab of Standards. Define for the calibration curve a Name and select method. DO NOT INTRODUCE CONCENTRATION. Close table. 2300GLlTIU Rev. 4.2
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3. Open the Table of Samples, select Standards, press the button Panels and double click on the desired Standard name. A set of entries, one for each standard will be generated. Each one will contain the corresponding concentration. In order to distinguish standards, the Id is added to the standard’s name In order to distinguish standards, the Id is added to the standard’s name. Id must be numeric. Introduce the desired number of replicates of each standard. 4. Transfer to the tray. IMPORTANT: If standards in multipoint calibration are defined in the Table of Samples instead of through panels, the instrument software might crash. 2.6.3 Additional data entry When arrow is pressed in Table of samples, additional data can be introduced. They refer to patient data, location, sample definition, status, etc. There are some fixed data but some variable fields. The variable fields Note and observations can be used for introduction of Inspector data, Diagnostic, and other references. Same data can be viewed in Historic file although cannot be modified.
2.6.4 Pediatric samples There are two types of samples: Normal and Pediatric. The normal samples are aspirated on the surface of a primary tube or any other vial. In that case, the needle touches the sample’s surface and penetrates a preset amount of steps. The sample is defined as pediatric by entering a “p” or a “P” in the first column of the sample table. When defined as pediatric, needle will not stop at 2300GLlTIU Rev. 4.2
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the sample surface but will descend all the way down to the position indicated by Technical parameter “Pediatric bottom”. This feature must be used when the liquid level does not exceed 5 mm, otherwise, the needle will become wet and contaminated. 2.6.5 Conditional sample load When transferring samples, standards or controls to tray, operator has the opportunity of selecting only those desired samples and not the whole table. After To Tray is pressed, selector will be visualized:
Selector is the correlative number and not the Sample ID. This way, there is full control on the desired samples and ordering. 2.7 Verification of Programmed Reagents and Samples When clicking the right mouse button while pointer is on a selected reagent, vial size can be reprogrammed, and reagent replaced even when instrument is operating. Left button displays required volume for all reactions and the measured volume in microliters. When left button is pressed on every colored sample vial, sample protocol identification is displayed. Sample can be replaced. With Shift + left button, sample can be erased. When right button is pressed, a list of programmed methods for selected sample is shown. Sample types (outer wheel) are color-coded: Green Sample Blue Standard Yellow Control Sample Red Stat
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Left button
Right button
Right button Left button
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2.8 Parameters Parameters are divided into two categories: those that are accessed by the user (Functional, Laboratory and Cycles), and those only accessible to technical service representatives (Factory, Technical and Internal). 2.8.1 Functionals Options: 1. Time priority for reagents: Order delivery is set so longer incubation times are delivered first and shorter delivery times last. 2. Enable cuvette washer: Not operative 3. Enable samples barcode reader Not operative 4. Enable reagents barcode reader: Not operative 5. Reagent integrity: enables/disables the use of reagent integrity check option. 6. Enable LIMS: allows using communication with host computer through serial port RS232C.
7. Enable ISE: Not operative 8. Tip wash notification: When this parameter is checked, instrument will stop before the tip wash operation at the end of the automatic cycle. If not checked, automatic cycle will proceed to the end. If this option is used, do 2300GLlTIU Rev. 4.2
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not put samples in the defined position for cleaning and rinsing solutions. In any case, if solution/s are not present, system will stop with warning. Various: 10. Print batch: Indicates how many samples are printed together when completed. If value is set to zero, no printout is produced; printout can be generated after run. If the value is one, every sample is printed in a separate sheet, when completed. 11. Samples expire: Samples are kept in the Sample Table this number of days. After that, measured valid data are passed to the historic file, and pending or questionable data are erased. 12. Historic expire: The historic file is kept in memory the number of days indicated by this parameter. Every day, the oldest data that exceeds this value are erased. 13. Abbreviation for Male: For other languages in which “Male” does not start with M, the initial letter must be introduced here. 19. Minimum absorbance for Standards: Whenever a standard is read, a factor is calculated, if the absorbance is too small or in kinetics the absorbance variation is too small, a considerable error can be generated. If absorbance or absorbance variation is smaller than this parameter, the factor stored in memory is used. The default value is set to 0.020. 20. Sample batch: Set of samples processed together. All methods are applied to this set before starting dilution of next batch. 2.8.2 Instrumentals Wash and diluent positions: 1. Wash (Sample 1 to 48) : position in which wash solution will be placed. Position corresponds to Sample vial position. 2. Rinse (Sample 1 to 48): position in which rinse solution will be placed. Position corresponds to Sample vial position. 3. ISE Urine diluent ( R: 1 to 24): Not operative 4. ISE cleaning ( R: 25 to 48) Not operative 5. Sample pre-diluent (R: 1 to 48): This is the Generic sample-pre diluent solution. Dilution of samples can be performed with a specific diluent or a generic, common to many or all methods which require pre-dilution. Temperature: 6. Overall working temperature can be fixed to Room, 30 or 37°C. Various: 10. Number washes in interferences: When an interfering sequence is detected, this is the number of additional intermediate washes. A value of zero produces intermediate wash with the interfered reagent. (For details, see 3.6) 11. Max. Eliminated Cuvettes: Parameter that defines how many dirty cuvettes can be discarded. 2300GLlTIU Rev. 4.2
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2.8.3 Laboratory 1. Language: Spanish, English, Portuguese, Chinese, Russian and Tai are the options. Use “English” for all other options. When selecting in Main menu > Miscellaneous > Translator, the table with all messages in Spanish, English, Portuguese, etc. are shown, divided in categories. By completing the corresponding column, the software will be automatically translated. Notice: In order for the translation to be effective, the program must be closed and re-started. 2. Key or password: Safety system to prevent general users from changing data, methods or parameters without owner’s authorization. To modify it, the original password must be introduced. Default factory value is 12345. 3. Laboratory: User data will be included in all printouts. 4. Terminal: For each different user or section, a Terminal number can be defined. This number is bound to patient data and allows printouts or exports by terminal. This is the basis of the multi-user function.
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5. Printout type The system has four printout options. In Functional Parameters the mode selection determines which printout is performed while system is operating: 1. Detailed for user, 2.simplified for patients, 3.Hospital I, 4.Hospitals II. Modes 1, 2 and 4 utilize the internal Printer report program. Mode 3 (Hospitals I) uses Microsoft WordPad program. Compact. Only names and results. The WordPad program must be configured according the printer being used. The margins should be between 5 and 10 mm for portrait orientation of paper and around 30 mm for landscape orientation of paper. The print batch is automatic set to 3 for Hospitals I option. If paper orientation is selected as landscape, print batch will be automatically set to 2. Other printing options follow the “Print Batch” parameter setting. If paper is selected in landscape orientation, print batch should be set to 2. 2.8.4 Maintenance For explanation and use of the pump, syringe and tubing counters, see Section 4.3.
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2.8.5 Technical
Options: 1. 2nd. Reagent Priority. When enabled, 2nd. reagent addition has higher priority than any other operation. 2. Show Development methods. Enables/disables access to development methodologies. Port: 3. Port: Serial Port to be used in computer. Usually, it can be 1 or 2. If PS2 Mouse port is used, instrument can be connected in port 1. Absorbance of cuvettes: 4. Dirty cuvette Absorbance: This value in absorbance units allows for distinguishing between empty reaction cuvettes, used and/or filled cuvettes. The value must be selected by taking readings of at least 80 cuvettes and adding 0.020 to the highest value. 5. Tolerance: Not operative
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2.8.6 Optics Filters. This table includes the definition of 9 filters. Preset wavelengths are 340, , 405, 450, 500, 550, 600, 650, 700 nm and 767 nm. They can be replaced by any wavelength in any position except for filter 0, which cannot be removed. It also includes absorption of water for each filter. It is used as reference for true absorbance reading. (See 4.10.2 )
Water absorbance. The value is automatically introduced in table when reference calibration is performed. (See Section 4.10.2). Data are adjusted to a 1cm path light. 2.9 Import and export to/from other programs The Metrolab 2300GL can exchange data with other programs with two different protocols. One is its own ASCII protocol. The other is a standard Paradox database system. With the last option, data can be exchanged between different terminals equipped with the same Metrolab 2300GL software, in a true Multi-user option. In addition, Serial Port communication allows receiving data and sending results to a Host computer equipped with LIMS capability. 2.9.1 Exchange in ASCII protocol Files to be imported in the ASCII option must have an extension “.ana” and the following structure: One line per patient. Fields are separated by semi-colons. A carriage return (CR) and line feed (LF) must be at the end of each patient (0D, 0A). 2300GLlTIU Rev. 4.2
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Each line must contain: Sample number or protocol: up to ten alphanumeric characters Sample type: One character: N: normal; P: pediatric. A blank is admissible. Patient name: Up to 30 alphanumeric characters. History number: Up to 12 alphanumeric characters Age: Three numeric characters. Sex: One character: M, F or blank Number of tests: One or two numeric characters. Test code: Six alphanumeric characters. The first character must be a letter. It corresponds to method Test ID. Also, three numeric characters are admissible. They must correspond to Nomenclature included in method. If code has less than six characters, system will match first three letters with first three letters of methods name included in “Methods in Use” table. Different types of tests can be mixed in the same input. Example: 2345;N;Cartell J.;1287645; 033;M;3;COL-Wi;GLU-Bi;URE (CR)(LF) 3;;Estevez;;;;5;GLU;174;AUR;GPT;GOT(CR)(LF) Notice: Sample number or protocol, number of test and test ID are mandatory; the others are optional but all the semi-colons must be present To import data, press import button in Sample Table and next select the desired .ana file. When file is imported, samples are shown in Sample Table and keep their original terminal number. Other data can be added manually. Import button is inactive in the Standards and Controls tables. Data are also exported in semicolon delimited ASCII files with res extension or comma delimited with CSV extension. 2.9.2 LIMS connection through Serial Port Host Computer
ANALYZER
Serial Port #2
Serial Port #1
Instrument Computer
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Lims connection is performed through a standard Serial Port RS232C. Serial port must be other additional to these used for connection with instrument. Communication parameters are defined in the parameter section of the Analyzer:
LIMS operation is enabled by checking the corresponding box in Functional Parameters. If LIMS is enabled and no Serial port device is present in the instrument PC, an error message will be visible:
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In this case, either install Serial Port or disable LIMS option until serial port is installed. All low-level communication, error detection and framing are strictly based on ASTM low-level communication protocol. High-level communication follows ASTM 1394 protocol in all what is pertinent. Communication components will be described later. System is established in such way that external host computer requests analysis and results. Instrument sends back results and error messages. The communication scheme is as follows:
Request of analysis Host Computer
Request of results
Buffer
Data are accepted ??
Results are sent
Stand-by for delayed acceptance
No
Yes
Historic Table
Performed analysis
Table of Samples
2.9.2.1 ASTM structure of messages. The following tables contain the part of information included in ASTM 1394 adopted here. Host can send many fields but only those included in the present tables are processed. Header record (level 0) Field name ASTM Host ID Record type 1 X ID Delimiter 2 X definition Sender name 5 or ID 2300GLlTIU Rev. 4.2
Instr. X X X
Comment Always H. Starts every message. No delimiter between first and second field Field, repeat and escape delimiters. Instrument ID Software version 1.0 63
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Version No. Date and time of message
13 14
(X)
1394-97 From YYYYMMDDHHMMSS.
Message terminator record (level 0) Field name ASTM Host Instr. Comment ID Record type ID 1 X X Always L. Ends every message. No delimiter between first and second field Sequence 2 X X Always 1. One terminator per message. number Termination 3 (X) (X) N or missing: normal termination code E: unknown error I: no information available from last query Patient information record (level 1) Field name ASTM Host Instr. ID. Record type ID 1 X X Sequence 2 X X number Practice 3 (X) (X) assigned. Patient ID Patient Name 6 (X) (X)
Birth date Physician ID Patient known or suspected diagnosis Location
Always P Running number within message. Starts with 1 Patient ID. NULL patient is allowed.
Patient Name. The whole name should be given here as a string of up to 30 characters. All others will be ignored
8 14 19
(X) X X
X
Doctor. 30 characters. Diagnostic. 10 characters.
26
X
X
Section ^ Bed
Test order record (level 2) Field name ASTM Host ID Record type 1 X ID Sequence 2 X number Specimen ID 3 (X) Instrument specimen ID Universal Test
Comment
4 5
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Always O
X
Running number within patient information. Starts with 1 Sample protocol. If omitted, blank will be used. Internal correlative number used by instrument. ^^^Test ID. Will accept only those
(X) (X)
(X)
Comment
(X)
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ID
Specimen collection date Specimen descriptor
6
X
8
X
Result record (level 3) Field name ASTM Host ID Record type ID 1 Sequence 2 number Universal test 3 ID Data or Result 4
Units Result range flags Result status
Date/Time test is completed Instrument identification
identifiers as defined in the table of methods. Host MUST use these identifiers. Multiple ID, separated by identifier, are admitted. Structure YYYYMMDDHHMMSS Type 1: Serum, 2: plasma, 3: urine, 4:CSF, 5:other
Instr. X X X (X)
5 7
X X
9
X
13 14
(X)
(X) X
Request information record (level 1) Field name ASTM Host Instr. ID Record type 1 X ID Sequence 2 X number Starting 3 Range ID Universal test 5 (X) ID Beginning 7 (X) Request Results, Date 2300GLlTIU Rev. 4.2
Comment Always R Running number within test order. Starts with 1 ^^^Test code as defined in the Table of Methods in the instrument If result is not “Done”, no entry will be available in the Historic Table, from where data are retrieved. Units as defined in the Table of Methods. N: Normal A: Anormal P: Preliminary F: Final X: Cancelled P: Pending Structure YYYYMMDDHHMMSS. No value if test is not completed. Instrument ID as defined in the Translator entry that corresponds to “Autoanalyzer”
Comment Coded as Q. Always 1 Patient Id^Sample Id, or all ^^^Method ID or all Structure YYYYMMDDHHMMSS.
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and time Ending request of results, Date and time.
8
(X)
Structure YYYYMMDDHHMMSS.
2.9.2.2 Field lengths used by instrument Field Length in characters Instrument type Instrument ID Software version Date and time of message 14 Patient ID 10 Patient name 30 Date of birth 8 (?) Patient sex 2 Specimen ID 14 Instrument specimen ID 14 (?) Test ID 6 Specimen collection date and time 14 Clinical information 20 Section ID 18 Data of measurement 8 Units 8 Reference ranges Low 6, High 6 Data/time test completed 14 Date/time beginning request 14 Date/time ending request 14 2.9.2.3 Messages in LIMS operation Data transmission is fully independent from instrument operation. Operator’s attention is called only when data are pending from analysis in the buffer table and ready to be passed to the Sample Table:
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If the answer is yes, data are passed to the Table of Samples and will be ready for analysis. If the answer is NO, they will be on hold in the buffer for later retrieval. If one or more Test identifiers sent by host are not present in the table of Methods, a warning message will be generated:
All other analysis will be transmitted to buffer table If missing method/s are added to the Table of Method, the next host transmission will complete missing data. 2.10 Historic File Once samples are completed, they can be permanently stored in the Historic file. From the Sample Table, when the “To Historic” button is pressed, all completed data are transferred. They are also erased from the Sample Table at this time. Nevertheless, when tests from a patient are pending, these will remain in the Sample Table, whereas completed ones will be transferred to the Historic file. Data from patients, STATS, Standards and Controls are stored in different historic tables. Filter Data can be filtered following different criteria: Sample Id, Name, number range, date range, last samples. All these criteria are consecutive and exclusive. You can select name and from them a range number or the last number. For sample Id and name, simply click on it and it will be shown in selector window. Once the selection is chosen, press Filter button and the action will be performed. To de-select filtering, simply press the “un-filter” button or go out of the selected tab and return (for instance pass the controls to samples and return to controls).
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For names and Patient Id the selection can cover a range with dummy symbols: With exact name, selection is on all records that match name exactly. With a letter (or letters) followed by an asterisk, all records that start with that letter (or letters). If no name is selected, this field will not operate on the selection. If no range number is selected, selection will operate over the whole historic file. 2.10.1 Statistics Statistics is performed over the already filtered fields.
Statistics can be performed for different samples and periods: time interval, last data, and from one sample number to another. The sample number is an internal correlative number that is shown in a light green column. This number cannot be modified because it is used in all databases. The typical statistics report includes plot and data table: Average, SD and CV are included. Dotted lines indicate +/- 1SD and +/- 2 SD. For control samples, the prefixed range is displayed as a gray band. An arrow located in the lower part indicates data outside the Westgard rules.
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2.10.2 Plots Results corresponding to kinetic readings can be plotted on an absorbance vs. time diagram. This plot can be obtained either in the Historic Table, the Sample Table or in the Times Table. Information about linearity factor (linear correlation coefficient), initial substrate consumption, etc. is also provided.
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2.10.3 Exporting results According to different selection criteria, results can be exported. Menu is similar to the Statistics menu. In addition, results can be selected by terminal, user, section, operator, etc. IMPORTANT: In all data transfer, samples, STATS, controls and standards are considered as different categories. As an example, if the entire historic file is to be transferred, four different transfers must be performed. If results are modified, modifications only affect the opened table. 2.11 Calculations 2.11.1 Absorbance reading Absorbance is read from Photometer Status for both channels: Sample and Reference. Readings are either Monochromatic or Bichromatic. Additional required data are: Frequencies for each channel and filter, measured against air. Absorbances for water blank, measured for each filter. Abs = (Ref. Freq – 0_Ref) / (Sample Freq – 0_Sple) * Channel Ratio – Water Reference. Ref. Freq and Sample Freq.: Correspond to the actual measurement, as can bee seen in the table of communications.
Reading
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Channel ratio and Zero correspond to Filter calibration Water reference corresponds to Blank reference calibration. 2.11.2 Kinetics. The used calculation method is based on a least squares linear (0 order) fit. Data are taken at the following times Abs_0: Approximately 30 seconds after dilution Abs_1: 15 seconds after Abs_0 reading. Abs_2: Specified incubation time after dilution Abs_3: Nominal 30 seconds after Abs_2 reading Abs_4: Nominal 30 seconds after Abs_3 reading Abs_5: Nominal 30 seconds after Abs_4 reading Abs_6: Nominal 30 seconds after Abs_5 reading Abs_7: Nominal 30 seconds after Abs_6 reading 2.12 Actual reading times are recorded as To, T1, T2, T3, T4, T5, T6, T7. If a second reagent is delivered as starter, all times are recorded with origin in T2Reag time. For consumption or depletion limit, the following formulae apply: Abs_1 – Abs_0 Cons. = ----------------------- X 60 T1 – T0 If consumption is greater than Consumption Limit (CL) included in method, which is expressed per minute. then CL < Cons < 1.4 * CL 1.4 * CL < Cons < 1.7 * CL 1.7 * CL < Cons
Reading interval decreases linearly to 5 seconds. Incubation time is not respected and reading starts at 45 seconds Sample is diluted
If consumption is less than 0.015/min reading interval is increased to one minute. Between 0.015/min and 0.025/min reading interval is linearly decreased from 60 to 30 seconds. When dilution is required, there is an initial approximate result calculated as: C = Cons * Method Factor Analysis is repeated with a sample volume reduced with the volume factor. New method factor is: 2300GLlTIU Rev. 4.2
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Method Factor (Reagt. Vol. + Sple Vol) New method factor = -------------------- X ---------------------------------DF (Reagt. Vol. + Sple Vol/DF) If new consumption is still above CL, analysis is completed but error flag Cons. Limit is established and published in the Table of Samples. Samples with such condition cannot be passed to historic file. When complete analysis is performed, the following least square formulae apply: Sy =
ΣAbs_i
Sx =
ΣΤ_i
for i = 2 to i = 7
for i = 2 to i = 7
Sx2 =
Σ(Τ_i * T_I)
Sy2 =
Σ(Abs_I * Abs_I)
Sxy =
Σ(Abs_I *
for i = 2 to i = 7 for i = 2 to i = 7
Τ_i ) for i = 2 to i = 7
n = 6 (number of readings included in calculation) Regression slope A1 is: Sx * Sy - n * Sxy A1 = ------------------------Sx * Sx - n * Sx2 Calculated concentration is C = Method Factor * A1 For diluted samples: C = New Method Factor * A1 Linear regression coefficient (LRC) is evaluated as follows: Num# = n * Sxy – Sx * Sy Den1# = n * Sx2 – Sx * Sx Den2# = n * Sy2 – Sy * Sy Num# LRC = --------------------------2300GLlTIU Rev. 4.2
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SQR( Den1# * Den2#) This coefficient is published as “Linearity” in kinetic plot and compared with Correlation Min. (CM) in Functional parameters. Its value can vary from zero (total random distribution) to 1 for full linear correlation. If CM is set equal to zero, this dilution option becomes inactive; otherwise, the following dilution condition applies: CL/2 < LRC < CM LRC < CM/2
Dilution Factor = 2 (DF=2) Dilution Factor = 4 (DF=4)
New factor is calculated as above. 2.12.1 2-point Kinetics. The used calculation method is based on linear calculation. Data are taken at the following times Abs_0: 6 seconds before incubation expires Abs_1: when incubation expires. Abs_2: Nominal “Kinetics 2” value after Abs_2 reading, expressed in seconds. Actual reading times are recorded as To, T1, T2. If a second reagent is delivered as starter, all times are recorded with origin in T2Reag time. The following calculation applies: (Abs_2 – Abs_1*) C = Method Factor * ------------------------- * TKinetics_2 T2 – T1 Where Abs_1* is the result of interpolation between A1 and A0 to the exact time T1. The Method Factor can be given as part of the method or calculated with a standard. If measured with a standard of concentration Co, is
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2.12.2 Color Color readings are made by subtracting sample reading from reagent blank Concentration is calculated as follows: C = Method Factor * ( Abs_1 – Blk) Where Blk is the absorbance reading corresponding to reagent absorbance, measured in an independent cuvette or in the same cuvette, depending on the chosen method. The Method Factor can be given as part of the method or calculated with a standard. If measured with a standard of concentration Co, is Co Method Factor = -----------------------------( Abs_1 – Blk ) 2.12.3 End Point End point readings are made by subtracting sample reading after incubation period (Abs_1) from initial reading immediately after dilution (Abs_0). Concentration is calculated as follows: C = Method Factor * ( Abs_1 – Abs_0) The Method Factor can be given as part of the method or calculated with a standard. If measured with a standard of concentration Co, is Co Method Factor = -----------------------------( Abs_1 – Abs_0 ) Where Blk is the absorbance reading corresponding to reagent and absorbance, measured at the initial time. In two-reagent methods, Abs_0 is taken just before addition of second reagent 2.12.4 Times (Coagulation) After mixing or second reagent addition, sample is located in front of the light beam and absorbance measured every 1/10 of second. There are three parameters that define a coagulation method: Threshold, Wait and Correction. Reading scheme is as follows:
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Sample or starter reagent is delivered at time To
Absorbance is read Time is recorded: T-To
Yes
Is Abs > Threshold? Wait 1/10 second
Result is calculated as T - To + Correction
Yes
Reading is aborted. No coagulation and valid result.
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3 DAILY STARTUP AND OPERATION 3.1
Startup Sequence • Turn on instrument. • Turn on printer. • Turn on monitor. • Turn on computer. To turn off, close all applications and Windows, and then proceed in inverse order. To turn instrument on, set lever switch in front panel to position “1”. The switch lights up. Turn ON printer. Verify there is enough paper for the daily job. Turn ON monitor, green pilot light should be on. Finally turn ON computer. Verify no diskette is inserted. At the end of the cycle, monitor will display the Windows desktop screen. Double click on the Autoanalyzer icon. After a few seconds the optional Init menu will be displayed:
Init procedure will perform the following tasks: • Complete mechanical initialization • Temperature setting • Lamp test • System filling • Syringe purge IMPORTANT: Once software is registered, Registration form will not be shown anymore. For registration details and procedure, see Section 3.2. After initialization and eventual Registration, Main menu will be shown:
3.2
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Procedure is as follows: 1. Connect instrument first and next start program. The following window should appear
2. The red installation code will appear in the window, written in red color. 3. This code must be sent to factory by mail to:
[email protected] 4. In return, you will receive a registration code that must be introduced in the window, at the earliest opportunity. In the meantime, instrument can be freely operated for a trial period of 60 days by pressing the key Continue >>. 5. If instrument is not connected, the Registration window will not be shown and the program can be freely used in “off-line” condition. Status will be seen in the main menu title bar. The following remarks must be taken into consideration: 1. License is for one particular computer and one particular instrument. If computer is changed or instrument CPU replaced, a new Registration code will be necessary. Trial period starts again in 60 days. 2. Once the instrument is connected, trial period will start, regardless if instrument is used or not or software is used off-line only. 3. The number of re-installations for a given instrument is limited. Do not attempt to install and operate instrument from more than one computer. 4. The number of off-line installations is unlimited.
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WARNING: Be sure to transmit the license code correctly when using fax: use letters ARIAL BOLD size 24. To prevent errors, either write also number in words and replace 0 (zero) with # and O (letter O) with @. You will receive back an answer as follows (example):
A#1I-UKSE-L17K-#74@-F36I-XW97 This code only is formed by capital letters {A…Z}, numbers {1…9} and 3 special characters { @ # - } and must be introduced only once exactly as sent, without spaces and respecting capitals. Be aware that you should distinguish between 1 (one) and l (letter ). IMPORTANT: If Register window is not shown and operation is offline even with instrument connected, check communication parameters and re-start program. See section 2.8.5. 3.3
Wash solutions
Instrument requires a continuous supply of DI water with a tensioactive component added. This tensioactive is Triton X-100 or similar, in a concentration of 20 ppm v/v. For best results, utilize 2 ml per liter of Solution 3, Cat. No. VA0003SL For cleaning purposes, concentrated Cleaning and Rinsing solutions are required at the end of each run. Washing solution consists of a solution of 30 g/l of Sodium Hypochlorite in water and rinsing solution consists of tensioactive Triton X-100, 0, 2% v/v in water.
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For best results use Solutions 1 and 2 respectively, included in kit Cat. No. VA0000SL 3.4
Daily Operation
3.4.1 Daily sample loading procedure Before attempting to load samples, it is advisable to follow the following steps: 1) Define the set of reagents to be used. 2) Program all methods according to manufacturer's instructions and/or methods provided by M2300GL. 3) Define the set of standards to be used. 4) Define the control samples to be used. 5) Program the most common methods in the “Methods in Use” table as outlined in Section 0. 6) Calibrate the instrument. Calibration is automatic if not performed within 15 days. Follow the recommended directions (Section 4.10). Daily: In tables of data: 1) Load the Table of Samples with patient data. 2) Transfer to sample table the required standards and control samples. 3) Export all samples, standards and controls to the tray. In the instrument: 1) Perform daily preventive maintenance as indicated in section 4.1.1 2) Check all sample and reagent positions. Verify that reagents are uncapped and free of foam at surface. 3) Check for enough cleaning and rinsing solutions in positions 47 and 48. 4) Perform a manual filling. 5) Check if probe capillary tube is in proper shape. 6) Check if there is enough wash solution in container and if waste reservoir is empty. Table of Panels
Table of Samples To Tray
Table of Methods in Use
3.5
Measuring
3.5.1 Volume check. When automatic procedure is started, several tests are performed: reagent volumes, absorbances of reaction cuvettes and temperature. 2300GLlTIU Rev. 4.2
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Volumes are measured by touching the liquid surface with tip and calculating the stopping position. To avoid contamination, internal and external tip wash is performed. At start, the table of volumes will open showing required and previously measured volumes. At the end, if any error occurs, the window will open again showing reagent conditions. The operator can choose to remove the reagent from the tray by selecting and pressing corresponding button or to add a sufficient quantity of it. If error condition is not eliminated, test volume will be repeated.
By clicking the Key icon button or the Movement and Automatic tabs, the measuring process is started. All reagents in use are displayed in the Table of Volume Analysis. The table contains: Test ID: Method identification. Samples: Number of samples that use any particular reagent. VolNec1: Required volume for reagent 1 of method, in microliters (µl). VolNec2: Required volume for reagent 2 of method, in microliters (µl). Reag1: Tray position of reagent 1. Reag2: Tray position of reagent 2, when applicable. VolMeas1: Remaining reagent 1 volume, from previous analysis, in microliters (µl). VolMeas2: Remaining reagent 2, volume from previous analysis, in microliters (µl). Errors: (?): Reagent programmed in samples but not present in tray. If no corrective action is taken, tests will not be performed at this time but will remain in the sample table and in the tray. Observe that positions are not defined. (X): Reagent present in the tray but not necessary, or insufficient volume. No action should be taken at this time. The volume will be measured anyway, and corrective action can be taken at a later time, if necessary. To continue, press the Continue button. To eliminate entry, press the Eliminate Reagent button and once corrective actions have been taken, start the entire procedure again. 2300GLlTIU Rev. 4.2
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Integrity check is enabled by Functional Parameter “Integrity check”. 3.5.2 Temperature When system starts, temperature must be within specifications, otherwise the following message will be shown:
The read value indicates difference with pre-set value. When temperature reaches the correct range, message disappears and operation continues. If after 15 minutes temperature is still erroneous, a warning message will be shown and system halts. 3.5.3 Reagent Integrity check Once reagent blanks are delivered the following window may open:
Reagent blanks for tests with defined integrity check are delivered and absorbance evaluated against blank limits included in the corresponding method. Appropriate buttons can Eliminate, Ignore or Repeat reagents whose absorbance is out the specified limits. 3.6 Interferences M2300GL has the capability of handling reagent interference or incompatibilities. 2300GLlTIU Rev. 4.2
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This is done by defining in the Table of Interferences the two incompatible reagents, being the second, which interferes with the first. When both reagents are in the table, the system will try to prevent diluting in consecutive order and, if this is impossible, an additional probe wash will automatically be programmed. For each new interference data to enter, press the “+” key; next, click on the “first” cell. The method selector will be visible. Click on it and select the desired method. Click on the “Second” cell and repeat procedure. If other interferences are to be entered, press the key “+” and repeat the procedure.
At any later time interference data can be added, replaced or eliminated. Use the symbols “+” and “-“to include or exclude entries. When erasing data a warning “Delete record?” will be shown. IMPORTANT: If the Technical Parameter Number of washes in interference is set to zero, intermediate additional wash will be performed with the interfered reagent. The action of interference control system is threefold: 1. If two consecutive reagent deliveries match the restrictions included in the table of interferences, the ordering in delivery will be changed and non interfering reagents will be delivered consecutively. 2. For instruments with automatic cuvette wash system enabled, system will reorder delivery so no delivery will occur of an interfered reagent if interfering reagent was delivered in the same cuvette in previous use. 3. If there is no way to apply criteria established in 1, then extra washes described before will be applied. 3.7 Dilution and repetition M2300GL dilutes samples in any of the following situations: 1. For any method, if final result exceeds the High Concentration Limit which is part of the “limits” section in the Methods table. This limit is in concentration units and in general corresponds to the linear limit established 2300GLlTIU Rev. 4.2
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by the reagent’s manufacturer. When this limit is surpassed, the dilution is repeated but with a smaller amount of sample. This limit can be modified under two circumstances: if automatic result confirmation is required when result exceeds a given value and when the sample-to-reagent ratio is altered. In the sample table, the message “linear limit” will be displayed in the column corresponding to dilution status. This message is also shown in the time table. After dilution, the message will still be displayed, but the result will be replaced if the second reading is higher than first. If the second reading is lower than first more than 10%, a “questionable” message will be displayed. In this case result is not passed to the Historic file and must be repeated by user. 2.
For fast kinetic methods, if initial consumption rate exceeds about 1.7 times the consumption limit. This limit is part of the “limits” section in the Methods table. For consumptions between 0.9 and 1.7 times the consumption limit, the reading interval is linearly reduced between 30 and 5 seconds
3.
For two-point methods, when initial consumption rate exceeds the consumption limit if this is not set to zero.
4.
For fast kinetic methods, when linear regression coefficient is below the “Correlation Min.” parameter located in the Functional Parameters. Whenever the slope is calculated, a linear regression coefficient is also estimated. If all readings fall in a perfect straight line, the coefficient is 1. For random readings the coefficient is zero. Kinetic readings should exhibit a linearity better than 0.8. To leave this option inactive, set the parameter to zero. Instrument repeats without dilution if Concentration value falls below Low Conc. Limit except when its value is set to zero.
5.
3.8 Stat procedure The Metrolab 2300GL software is based on Windows multi-tasking system, taking full advantage of this operating system. Sample input while the instrument is operating, can be performed in four steps: 1) Enter patient and sample data in the Sample Table. 2) Export data to Tray. 3) Stop dilutions while physical samples are loaded to the Sample and Reagent tray. 4) Resume dilutions. Samples can be entered in the Table of Samples as Samples or as Stat Samples. The only difference is a matter of priority. Normal samples are read in increasing position order (except standards), from vial 1 to 48. 2300GLlTIU Rev. 4.2
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Stat samples are diluted with priority with respect to other samples but always after Standards. Before exporting to the Tray, it is advisable to inspect Tray and check for empty positions. Only samples with numbers that coincide with free positions will be exported; therefore, before exporting samples, you should free positions in the tray by erasing samples already completed. They are easily visualized in the tray as displayed on the screen, because they are marked with one diagonal black line. The order in which they are transferred, is the order of their increasing protocol numbers. They will occupy the free places in the increasing positions from 1 to 48.
Stop
Resume
Once the samples are exported, stop dispensing by pressing corresponding button. The dilution in progress will be completed, then the sample tray will be halted and the sample vials can be replaced and/or added. IMPORTANT: The Reaction tray will continue working and measurements and incubation times will be preserved. Before resuming dilutions, check the sample positions carefully. Click left button over each sample to verify protocol number. Samples introduced as Normal will be shown in green; samples introduced as Stat will be shown in red. When sample check is completed, press the Resume button. A new volume check will be performed. If new reagents are needed for the recently incorporated samples, they must be added to tray in an empty position. Also, if new reagents require blanking, it will be automatically performed at this time. Reagents already used and not required in future samples will not appear in the Table of Volumes. They can be replaced if more room is necessary. When a sample is pending for dilution, the required volume will still be in Table of Volumes. Stat samples are stored separately in the Table of Samples and in the Historic Table but they are printed out together with other samples. 3.9 Procedure follow up System operates in automatic mode but procedure can be followed from different windows.
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3.9.1 From reaction tray
When mouse is clicked over each cuvette, on the left side all data is displayed. Colors are coded according to wavelength. White is used for UV reactions. Dashes over the cuvettes correspond to the following situations: Reading is completed Sam
Sample with pending dilution
Clear
When measurements are to be started from cuvette 1, click on Clear and all samples will be erased.
Wash
While not in automatic operation, this button enables all used cuvettes in the tray to be washed.
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IMPORTANT: When 80 reactions are completed and/or new cuvettes are placed, reaction tray must be blanked. 3.9.2 From the time table Each new dilution generates a new entry in the table. It corresponds to the reaction cuvette whose number is located on the left column. Test, class, type and filter columns, etc., correspond to method in use for the selected dilution. Protocol ID corresponds to the sample being diluted.
Other columns give the following information: Class: Sample, standard, control. For blanks there is no indication of class. Repeat: Indicates cause of dilution when necessary: linear limit, linear regression, high substrate consumption. Volume: Is the sum of reagent and sample volume. In dilution is the only indication of the new used volume. Status: Done, In progress. Priority: Each sample has a priority. In absence of other condition, the higher the vial position (from 1 to 48), the lower the priority. This means that samples are processed in order from position 1 to 48. This order is altered by the following conditions: a) Order of samples: Blanks, Standards, Stats, Samples, Controls. b) If Batch is different from 1, the first batch is processed, then next batch, etc. c) If Time priority is chosen, the order of reaction is rearranged, in order to minimize measurement time. 2300GLlTIU Rev. 4.2
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Result: Absorbance units for Color and Endpoint reactions, and absorbance change per minute for Kinetics. Abs0, Ab1, Ab2, etc. In Color there is only one reading: Abs1 In Endpoint there are two readings: Abs0 (initial) and Abs1 (final). Concentration is related to the difference Abs1 – Abs0. In 2-point Kinetics there are four readings: Abs0, Abs1, Abs2 and Abs3. The interval Abs1 – Abs0 defines the consumption rate. The interval Ab3 – Abs2 defines the measurement rate. In Fast Kinetics there are seven readings: Abs0, ....Abs6. The interval Ab1 – Abs0 defines the substrate consumption rate; the readings Abs2, ...Abs6 are the readings used to calculate slope by least squares. T0, T1, T2, etc.: actual reading time. The zero is set to the dilution time. Button “Historic”: When cuvettes are blanked or washed, data are erased from the table and stored in the Historic cuvette table. Data are stored in this table for the amount of time indicated by the "Samples expire" parameter. 3.9.3 From window of Operating Status
Operative Status
Error and status display
This window shows current status: Reactions Pending: Number of reactions to be dispensed. Reactions in Progress: Indicates the number of samples already diluted but not read yet. Last reading also refers to samples already diluted. The status bar indicates if instrument is in automatic, manual, calibration or preparation mode, etc. The Message window indicates the last operational or error message. Bars indicate in graphic mode current status and number of used cuvettes.
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3.10 Choice of optimum calibration curve Single point methods does not require further analysis, except the acceptance or reject of replicates. For multi-point methods, analysis requires some additional detail. Once analysis is finished, absorbances should be written in the corresponding column in the Table included in method. The optimum function is indicated in the column adjacent to the function's name with an “O” symbol and blue color; other suitable functions are marked with a “+” symbol and green color. Non valid, multi-valued functions show no symbol and drawn in red color. Column to the right shows total least squares error. The smaller its value, the better is the curve fit. One or more curve points can be temporarily eliminated with Exc/Incl button. Recalculation is automatic. The following observations are important: 1. ID values must be correlative, increasing numbers. 2. Concentrations must be ordered in increasing way. 3. If the number of standards is varied, procedure must be repeated from the beginning. 4. It is recommended to measure curves one at a time. 5. If several curves are determined at the same time for different analytes, all must have the same number of standards. 6. It is recommended to measure standards not together with samples but rather in a previous run, otherwise system will select multi linear function as default.
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4 MAINTENANCE 4.1 Preventive Maintenance Program Scope: To familiarize operator with maintenance program of Metrolab 2300GL, as recommended by manufacturer. Applies to all instruments manufactured after 05/01/94, (see serial number). Some items are not present in instruments manufactured prior to 09/01/95, and should be incorporated by Manufacturer’s Technical Service when contacted by client. Requirements: The Maintenance program includes the following procedures: *Daily care. *Weekly care. *Quarterly care. *Maintenance as needed. Operator will also find in this section: *Cleaning and Adjustment procedures *Controls and Diagnostics *Quarterly Maintenance Form 4.1.1 Recommended daily care Recommended operations should be performed at the start of every shift or on demand. Purge hydraulic system by selecting Movements, Clean, and Fill. During process look for: *Presence of bubbles or air gaps in system. Air gaps and bubbles should be flushed, if present, during the filling operation. It is normal to find some bubbles in the peristaltic pump tubing. Repeat process if necessary. In case new bubbles generate in the process, determine the origin: Come from reservoir? Generate in pump connectors? Generate in syringe connectors? Are they visible only in probe tip? To solve problems, see Section 4.6: Control and maintenance of hydraulic system. *Leakage in peristaltic pump. 2300GLlTIU Rev. 4.2
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Replace pump tubing even if cycling time is not reached. See Figure 10 * Constant and uniform flow from probe tip. This indicates hydraulic system is operating normally. * No droplets hanging on probe tip. When system operates normally, no droplets should be present on outer part of tip. If tip is dirty, droplets will adhere to external surface. If obstructions are present in the system, flow will be intermittent and drops will continue to fall after pump has stopped, and eventually, one will remain hanging from the tip. When system operates normally, flow will stop instantaneously when pump stops. * Inspection and cleaning of probe Important: Perform all automatic cleaning cycles required by the instrument. *Remove solids from tip with a cotton swab soaked in Solution 1. Dry with lint-free tissue. 4.1.2 Weekly Care Recommendations * Repeat daily maintenance procedures. * Empty and clean waste reservoir, including stopper and tubing * Clean drain funnel in wash station. Use Sodium Hypo chlorite Solution 1 and rinse with water. * Clean reagent/sample tray by wiping it with mild detergent and water. Rinse with tap water and let dry. Do not heat to dry. If desired, dry with a towel or lint-free tissue. * Clean instrument table top with a moistened cloth. Do not use organic solvents or acids. * Refill DI water reservoir and eliminate leftover. * Execute a Wash cycle from the Cleaning menu. 4.1.3 Quarterly Maintenance Recommendations *Optical Filters cleaning. Before cleaning, perform a Calibration selecting the option from the Measuring Menu and entering security code. Keep a printout for data comparison. Proceed as in Sections 4.7 and 4.8. Perform the calibration cycle after any optics cleaning and/or adjust. 2300GLlTIU Rev. 4.2
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* Replace DI water aspiration tube. PVC tubing should be replaced, as fungus and algae formed may clog system. A quarterly basis for replacement may seem short, but microscopic formation may have already started. *Cleaning of DI water reservoir. Clean reservoir, stopper and electrodes with Sodium Hypo chlorite Solution 1. Rinse with abundant tap water followed by DI water. Replenish DI water reservoir and perform at least three filling cycles. 4.1.4 Maintenance as needed Must be performed when instrument indicates the need of corrective action, or when operation anomalies are encountered, relative to maintenance: *Hydraulic malfunction: droplet appearance on probe tip or bubbles in system. Proceed as in Section 4.6. *Message indicating pump tubing replacement. Replace tube and confirm with YES in the corresponding display. Section 4.3 * Message indicating syringe replacement. Replace syringe and enter YES on display. If syringe is replaced outside corresponding menu, the syringe counter should be reset to zero. Proceed as for tube replacement in pump, resetting the counter to zero. *Message indicating washer pump replacement. Replace pump at earliest opportunity 4.2 Replacement and control of wash solution The Metrolab 2300GL washes the sample probe between sample aspirations, requiring approximately 1 ml of DI water for each performed test. The DI water is pumped up from its reservoir and is disposed into the waste reservoir, both provided with the instrument. Both reservoirs have electronic level sensors. Wash reservoir EMPTY. Continue?
If volume is not sufficient, this message appears after initialization. It does not stop instrument operation. As enough DI water is still present, the run can be completed before refilling the reservoir. If no water is added, message reappears before next run. When the waste reservoir is full, a message is shown:
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The preceding paragraph applies to this case as well. 4.3 Pump tubing and syringe replacement. The pump tubing has a pre-fixed number of cycles for replacement. When that number is surpassed, a message will be shown:
This message means that operation will not necessarily be interrupted. At the earliest opportunity the replacement must be done.
Maximum number of cycles Latest replacement
Actual number of cycles
Reset button s
After replacement, select Parameters, then Cycles and press the reset button 0. This resets the counter; otherwise, the warning message will continue to be shown. 2300GLlTIU Rev. 4.2
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The same procedure is valid for syringe replacement. (See Figure 6). 4.4 Lamp replacement The user can easily perform lamp replacement by following these instructions: 1. Turn off and unplug instrument from Mains. Remove right lateral cover by removing the screw that hold it in place. (See Figure 8.) 2. Remove the four screws that hold protective grid. The lamp will be visible (See Figure 9). Remove the thumb screw that fix lamp holder to photometer body. Unplug lamp cable from connecting plug, (press small lever at side of plug to disengage). 3. Install a new lamp holder with pre-focused lamp in. Reset screws and tighten. Plug in lamp connector. Do not touch lamp bulb. If touched accidentally, clean with lint-free cloth or tissue paper and alcohol. 4. If lamp bulb has a protective envelope, remove it. Reinstall grid, lateral cover and fixing screws. 5. Start instrument in the order mentioned in Daily Startup and Operation. Perform a calibration cycle. To do so, enter Movements menu and then select Calibrate. 6. Open Inspect and then the Filters window. Compare obtained readings with previous calibrations. Take note of gain settings for each filter. If values differ from previous in 3 or more gain steps, contact Technical Support. Observe in the Status column if any Gain is too high or too low. 4.5 Sample probe care The sample probe is a delicate part of the instrument. Precision of results is essentially dependent on how well the sample probe is maintained. Probe tip must be kept clean. A cleaning cycle must be performed when indicated. If protein deposits are seen on the tip, remove gently with a tissue paper.
NEVER USE ABRASIVE MATERIAL: THE DELICATE PTFE COATING WILL BE DAMAGED.
If the probe tip is defective, remove cover of probe arm, loosen setscrew that retains the needle and pull it up. Install new probe. Tighten setscrew connector fitting and cable and repeat procedure outlined in 4.5.1.
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4.5.1 Calibration procedure for probe arm (Only if required) Probe arm calibration is made through: Movement > Calibrate > Mechanical Access is restricted to Service personnel and the description of procedure is in the Service Manual. 4.6 Control and maintenance of hydraulic circuit Correct hydraulic system operation is essential to obtain consistent and reproducible results. Malfunction symptoms are: 1) Erratic readings and low reproducibility. 2) Volume dispersion in reaction cuvettes for a same method. 3) Droplets or drop formation on probe tip after each wash cycle. 4) Leaks in the system produced by defective connections or capillary obstruction by kinks or solids. To verify, perform the following tests: 1) In the Result printout, the reaction cuvette number is printed. Identify cuvettes corresponding to a same method and compare volumes in each cuvette. 2) Repeat one same method at least 5 times and apply statistics. If percentile variation is greater than 5%, a problem in the hydraulic system is likely to be present. 3) Enter Test Program. Select Pump Operation, select 4000 steps. Retrieve liquid ejected by sample probe in a graduated cylinder. The total volume must exceed 2 ml. Tip should remain with no droplets adhered. Most common problems encountered in hydraulic system are: 1) Pump tubing wear introducing efficiency loss and eventual leaks. Replace tubing. 2) Hydraulic system obstruction. Particles present in DI water may clog filter in pump connector. This usually happens when metal distillers are used. 3) Kinks in probe arm heater tubing or defective connections. 4) Probe clogged by solids from samples or reagent aspiration. IMPORTANT: Clean peristaltic pump filter and replace pump tubing on a regular basis. To clean hydraulic system, proceed as follows: 1) Inspect malfunction by sections, start with pump filter, and then verify pump operation by disconnecting tube from syringe in diluter and verify dispensed volume. (Refer toFigure 7 and ¡Error! No se encuentra el origen de la referencia.) 2) Next disconnect at heater entrance in probe arm and verify dispensed volume to detect clogging. 3) Disconnect heater in probe arm from sampling capillary and repeat test. 2300GLlTIU Rev. 4.2
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4) If probe tube is clogged, flush with the aid of a syringe or replace. NORMALLY OBSTRUCTION WILL DISAPPEAR BY PUMP FLUSH ACTION WHEN DISCONNECTING AND DISPENSING AT THE MENTIONED POINTS.
If obstruction persists, call Technical Support. 4.7
Photometer and filter cleaning 1) Verify that the instrument is turned off and unplugged. 2) Remove right lateral cover as shown in Figure 8. 3) Provide adequate external illumination for the following operations. 4) Localize photometer and filter wheel. 5) Use cotton swabs to remove dirt from filters surface. Rub gently until opalescence is removed. 6) NOTICE: Filter No. 0 is an opaque dummy, and requires no cleaning. 7) After cleaning is complete, replace cover, turn the instrument on and allow it to warm up for 15 minutes. 8) Perform a Calibration. Normally, energy increases by 15% after cleaning.
4.8 Detector lens cleaning For photometer detail and light beam calibration, see Figure 11. Detector is accessed within the reaction chamber. Reaction tray must be removed for cleaning process. 1) Unplug instrument from Mains. 2) Remove 4 cross recessed screws from tray. Remove tray with caution, it is fragile and should be handled with care. 3) With a lint-free moistened cloth clean reaction chamber if spillages are visible. 4) Clean discharge funnel with Sodium Hypochlorite Solution 1 and soak with DI water. 5) Clean detector lens in slit with a cotton swab. 6) Replace reaction tray and screws. 4.9 Information recovery. One of the most important servicing tools included in Autoanalyzer Metrolab 2300GL is the storage and recovery of information of instrument program, data and parameters. There are two forms of getting backups: 1. In Miscellaneous, Backup, user can select to backup Historic file and Methods, calibrations and parameters, separately. These file are stored, as a first option in a floppy disk. But if a floppy disk is not present, user is prompted to store in any other place in the computer. In the same way, data are restored. 2. When exiting the program, user can choose to let system do automatic backup or cancel the operation. It is strongly recommended to let instrument do a backup at least once a day.
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This backup is stored in a file whose name is Bu_X.zip where X represent one day of the week: 1 is Monday, 2 is Tuesday, etc. This way, if previous day backup fails, there are still other usable backups available. When recover is activated, you will see:
You can recover from any available date by pressing the Recover button or from files by pressing Historic or Other Tables. Recovering can be performed from different floppy disks. 4.10 Calibration There are several calibrations available in the system. Some of them, photometer is automatically performed when required. Reference, Cuvette bottom are optional and some recommendations are included below.
4.10.1 Photometer Photometer calibration is a normal procedure that can be repeated as many times as desired. System performs it automatically every 15 days. It consists in finding the right amplifier gain for all filters in both channels. The procedure adjusts gains to get maximum number of counts per second for a given integration time, voltage to frequency converter and filter. Gains range from 0 to 31. Procedure can be followed in the Calibration Table and final values observed in the Table of Filters. 2300GLlTIU Rev. 4.2
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1. Num: First column indicates the number of filters (wavelengths in nanometers): 1 = 340 ; 2 = 380; 3 = 405; 4 = 450; 5 = 505: 6 = 550; 7 = 600; 8 = 650; 9 = 700. 2. GainSple: Sample channel gain. From 0 to 31. It is advisable not to have a gain of 0 or 31. 3. GainRef: Reference Channel gain. From 0 to 31. It is advisable not to have a gain of 0 or 31. 4. ZeroSample: Number of counts in absence of light for sample channel. (Reading of opaque filter number zero) 5. ZeroRef: Number of counts in absence of light for reference channel. (Reading of opaque filter number zero) 6. FreqSmple: Optimum reading for Sample channel. 7. FreqRef: Optimum reading for reference channel. 8. Ratio: Frequency ratio between channels. Value close to 1 indicates that system optics is clean. 9. Status: After calibration, indicates that values are within range. 10. Ref. Max and Min.: When system operates in normal measuring mode, reference channel monitors energy. The table shows minimum and maximum readings for each filter after the last calibration. If values differ more then 10% from calibrated reference value, a warning will be displayed in the message window. Table also shows the integration time and the limit of converter. Values should be read as follows: the limit of converter reads for 1 second. Multiply the limit for the integration time and you will get the maximum allowed reading. Gain is adjusted in 2300GLlTIU Rev. 4.2
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such way that a value is obtained as close as possible to the limit, without surpassing it. Example: if the converter limit is 440000 counts/sec and the integration time is 0.25 sec., the frequencies should be not greater than 110000. If value is surpassed, gain is diminished in one unit. IMPORTANT: When a calibration is performed, old calibration data will be placed in the error log file. Comparison of old and new data will give good idea on the instrument’s stability. 4.10.2 Reference Optionally, a water reference can be established and all absorbances will be referred to a cuvette filled with wash solution. This way, reagent integrity check will inform “true” absorbances and water and cuvette absorptions will be subtracted. When this option is selected, wash solution will be delivered in the next available cuvette and absorbances relative to air, recorded for each filter. If reference is not determined, all values in the table will be equal to zero and absorbances relative to air and to the gains in channels. This will not affect measurements and results. IMPORTANT: Prepare the wash solution as indicated in Section 3.3, otherwise bubbles in water can produce erroneous blank data. NOTE: Reference absorbance data are meaningless: they depend on the relative gains in sample and reference channels, but absorbances, once reference values are subtracted, are true absorbances with reference to water. Values are normalized to 1 cm. 4.10.3 Cuvette bottom This operation determines where reaction cuvette bottom is located and corresponding Technical Parameter, automatically updated. In this operation, system loads in a cuvette a fixed amount of water and next, level position is evaluated. No message is generated
4.11 Maintenance form
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5 TROUBLESHOOTING Problems can be classified into 3 major groups: 1. Operation malfunctions with visual, acoustic or printed warnings. 2. Visible faults or problems. 3. Measurement inconsistencies, (for example: GOT method with high dispersion). Definitions: DM: Daily maintenance procedures. WM: Weekly maintenance procedures. QM: Quarterly maintenance procedures. VT: Validation test. (See chapter 6) 5.1 Operation malfunction with warning Sometimes, an error is displayed in more than one way. Printed errors correspond to anomalous conditions found in samples and/or reagents and in no case stop the run. They are only displayed in the error File. To access it, use Microsoft WordPad:
WordPad error file
Errors are stored in file errors.log. It is stored in folder \Program Files\Autoanalyzer Older errors are kept in errors2.log and errors3.log files. They are text files that can be read with Notepad or WordPad programs. The error file keeps the last 10 operations before the error occurred. It also contains all start-up and instrument shutdown information.
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Errors shown in the display can be automatically overridden without halting the run. In Technical Parameters, the “Command Repeat” indicates the number of times an order is repeated before system is halted. The default value is 3. In some occasions, errors may be so serious as to force the operator to abort the run and take corrective actions. When the error does not affect the Reaction Tray and the photometric reading, only dilutions will be stopped. A message “Stop Dispensing.” will be displayed. By pressing the Resume button, dilutions will continue. If an error persists, even if corrective action solves the problem, Technical Support Department must be contacted. When a warning window opens:
Click to continue
Click to stop sound warning
5.2 Visible faults 1. Drop formation on probe tip after dispensing. 2. Drop formation on probe tip after wash cycle. 3. Abnormal noises. 5.2.1 Drop formation on probe tip after dispensing. Symptom Corrective Action Drops on probe tip Verify hydraulic system in accordance to user’s manual. Clean probe tip by submerging in Solution 1 for 5 minutes. Review “Air Volume” in Technical Parameters. Increase air volume only if preceding actions have been taken and problem persists.
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5.2.2 Drop formation after wash cycle. Symptom Corrective Action Drops on tip after wash cycle. Verify hydraulic system for leaks or obstructions. 5.2.3 Abnormal noises. Symptom Abnormal noises.
Corrective Action Defective fans. Moving parts blocked or frozen. Contact Technical Support.
5.2.4 Inaccurate Temperature readings. Symptom Corrective Action In “coordinates” temperature in reaction Room temperature too high, (should tray is too high. (Do not be concerned always be at least 4°C lower than about arm probe temperature) selected working temperature). Example: For 37°C incubation temperature, Room temperature should not exceed 33°C. For 30°C incubation temperature, ambient must be lower than 26°C. If Room temperature is within limits, and problem persists, call Technical Support. In “coordinates” temperature in reaction Room temperature excessively low. tray is too low. (Do not be concerned Verify instrument operating range, and about arm probe temperature) adequate the room temperature. If room temperature is within specified range and problem persists, call Technical Support. 5.3 Inconsistent results 1. All methods. 2. Only Colorimetric methods. 3. Fast Kinetics: all or some. 4. Only 2-point Kinetics. 5. Inconsistent automatic repetition values. 6. Coagulation. When these problems occur, proceed in the following sequence to solve: 1. Verify Main power supply and ground connections. Measure voltage of ground connection referred to neutral connector. 2300GLlTIU Rev. 4.2
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2. Use new reaction cuvettes. 3. Comply with Daily Maintenance Routines. 4. Perform a Validation Test VT to detect a module failure. (See Chapter 6).All Methods Symptom: Erratic readings. Possible Cause
Unstable lamp.
Validation Test Test Failed Number 6.2.1 and 6.2.4
Unstable photometer readings.
6.2.4 and 6.2.5
Low signal to noise ratio.
6.2.4 and 6.2.1
Hydraulic system obstruction.
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Hydraulic system leaks.
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Sample/reagent tray positioning error. Filter wheel position error. Main power fluctuations.
Poor reaction cuvettes.
6.2.5 and 6.2.6 6.2.5 --
6.2.2
5.3.1 Colorimetric methods (one or more) Symptom: High dispersion of results. Possible cause Validation Test Test Failed Number Low energy in filter (#). 6.2.1
Corrective Action
Replace lamp and perform CALIBRATION. Replace lamp and perform CALIBRATION. Call Technical Support. Calibrate. Replace lamp and calibrate. Perform quarterly maintenance. Call Technical Support. Perform daily maintenance. Inspect hydraulic system Perform daily maintenance. Verify hydraulic system. Perform daily maintenance. Call Technical Support. Call Technical Support. Verify. Use an Uninterrupted Power Supply unit if necessary. Replace with new reaction cuvettes.
Corrective Action
Perform CALIBRATION. If condition persists, change lamp and calibrate. Perform QM. Insufficient or defective 6.2.1 Centrifuge sample for a sample centrifugation. longer period of time and with a greater number of revolutions than for manual methods. Symptom: Normal values, having low dispersion, are too high or too low. 2300GLlTIU Rev. 4.2
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Possible Cause
Defective standard.
Contaminated standard. Standard crosscontaminated.
Method’s linear range exceeded.
Excessive sample volume. Stray light. Electronic linearity.
Validation Test Test Failed Number -
Corrective Action
Compare calculated factor with previous factors stored in the file. Perform calibration for that method. If problem persists, replace standard. Same as above. Change programmed order for standards. Change job mode (batch mode to profile mode or vice versa). Differences between Call Technical Support. readings and automatic repetitions Call Technical Support. 6.2.7 Call Technical Support. ¡Error! No se Call Technical Support. encuentra el origen de la referencia. and ¡Error! No se encuentra el origen de la referencia.
5.3.2 Symptom: Low linear range. Possible Cause Validation Test Test Failed Number Excessive sample volume. Poor reagent condition. -
Corrective Action
Call Technical Support. Change reagent. Repeat readings and compare.
5.3.3 Fast kinetics All Fast kinetics. Symptom: Erratic readings (High dispersion or low linearity). Possible Cause Validation Tests Corrective Action Test Failed Number Incubation time too short. Call Technical Support. Initial absorbance too high in Verify reagent preparation. decreasing kinetics. Replace if necessary. 2300GLlTIU Rev. 4.2
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Low energy in filter used.
6.2.1
Too high electronic noise. Low precision reaction tray positioning. Erroneous positioning of reaction tray. Bad reaction cuvettes. Reagent in bad condition.
6.2.4 6.2.2 and 6.2.5
Defective lamp. Lamp close to burnout.
6.2.4 and6.2.5 6.2.4 and6.2.5
6.2.2 and 6.2.5 6.2.2 -
Symptom: Normal values too high. Possible cause Validation Test Test Failed Number Electronic noise. 6.2.4 Low available energy. 6.2.1
Lamp close to burnout.
6.2.4 and6.2.5
Perform a Calibration. If problem persists, replace lamp and calibrate. Call Technical Support. Perform QM. Call Technical Support. Perform QM. Call Technical Support. Use new reaction cuvettes. Replace reagent. Compare results, if possible program simultaneously. Replace lamp and calibrate. Replace lamp and calibrate.
Corrective Action
Call Technical Support. Calibrate. If problem persists, replace lamp and calibrate. Call Technical Support. Replace lamp and calibrate.
Symptom: Normal and pathological values too high. Possible cause Validation Test Corrective Action Test Failed Number Incubation temperature too 6.2.10 Call Technical Support. high. Incorrect incubation Verify temperature setting temperature setting. and application. Error in factor. Verify if factor is correct for selected temperature setting. Symptom: Normal and pathological values too low. Possible Cause Validation Test Test Failed Number Incubation temperature too 6.2.10 low. Incorrect incubation temperature setting. Error in Factor. -
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Call Technical Support. Verify if factor is correct for selected temperature setting. Verify if factor is correct for selected temperature setting. 108
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Some Fast Kinetics Symptom: Erratic values. Possible Cause
Low energy with filter used.
Validation Test Test Failed Number 6.2.1
Incorrect wavelength setting. Sample volume too low.
---
Defective centrifugation.
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Too high initial absorbance for decreasing kinetics. Too low initial absorbance for increasing kinetics.
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Symptom: Normal values too high. Possible Cause Validation Test Test Failed Number Low signal to noise ratio for -the selected filter. Factor error for selected temperature and volumes.
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Symptom: High or low values for all the range. Possible Cause Validation Test Test Failed Number Factor error for selected temperature and volumes. 5.3.4 2-point kinetics Symptom: Erratic readings. Possible Cause 2300GLlTIU Rev. 4.2
Validation Test
Corrective Action
Calibrate. If problem persists, change lamp and calibrate. Call Technical Support. Review application. Use adequate sample volume. Use longer times and higher speed than for manual methods. Replace reagent. Compare results. Replace reagent. Compare results.
Corrective Action
Calibrate. If problem persists, replace lamp and calibrate. Call Technical Support. Call Technical Support.
Corrective Action
Call Technical Support.
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Absorbance of standard too low. Too high initial consumption rate.
Test fail Nr. ---
Poor reagent condition. Low signal to noise ratio for selected filter. Low sample volume. Elapsed time too short.
Review application. Call Technical Support. Verify with M2300GLvided by reagent manufacturer. Replace reagent. Replace reagent and compare results. Calibrate. If problem persists, replace lamp and recalibrate. Call Technical Support. Review application. Call Technical Support. Review application. Call Technical Support.
Symptom: All normal and pathological values high or low. Possible Cause Validation Test Corrective Action Test Failed Number Factor or standard error. Verify controls and method used. 5.3.5 Inconsistent values in automatic repetition or dilution Symptom: Colorimetric and kinetic reactions are not linear. Possible Cause Validation Test Corrective Action Test fail Nr. Sample volume too high. Review application. Verify reagent’s linear limit. Reagent in bad condition. Replace reagent and compare. Symptom: Non-linear 2-point method. Possible Cause Validation Test Test Failed Number Cannot be repeated because volume/absorbance ratio is not linear.
5.3.6 Coagulation Symptom: Erratic times. Possible Cause
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Validation Test Test Failed Number
Corrective Action
Call Technical Support.
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Poor reagent condition. Reagent insufficiently mixed.
-
Replace reagent. Mix reagents gently before use. If many tests are programmed, mix reagent every 15 minutes.
Symptom: Coagulation times too short in normal samples. Possible Cause Validation Test Corrective Action Test Failed Number Incorrect wavelength setting. Call Technical Support. Error in absorbance threshold Call Technical Support. setting. Symptom: Coagulation time excessive, or lack of coagulation. Possible Cause Validation Test Corrective Action Test Failed Number Threshold too high. Call Technical Support. Poor reagent condition. Replace reagent. 5.4
Messages and Warnings
5.4.1 Messages while not operating instrument Self-explanatory messages are not included in the present listing. Message Cause Action Incorrect Serial Number Introduce correct Serial Number Analysis to be performed. Attempt to edit a method Do not modify in use. method still in use. Change reaction cuvettes. All 80 cuvettes are used. Replace reaction cuvettes. Reaction tray not empty. Warning on the existence No action to be Continue? of used cuvettes. System taken. will use only clean cuvettes. Temperature is out of range. Not enough equilibration Abort startup and Continue? time wait 5 minutes. Replace syringe. Continue? Preset limit is surpassed. Replace at the earliest opportunity. Follow procedure outlined in Section 4.3
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Message Replace pump tubing. Continue?
Cause Preset limit is surpassed.
Replace wash pump. Continue? Place solutions in pos. 47 and 48.
Preset limit is surpassed.
Clear reaction cuvettes? Error: Sample already used. Error: Cannot put second reagent. Error: Reagent already used. Error: system in automatic mode.
Field ‘XXXX’ must have a value. (*) End of sample processing. Key violation.
When testing is finished, place solutions 1 and 2 in positions 47 and 48. When Clear button is pressed. Attempt to load a sample already in sample tray. No room in tray for second reagent. Attempt to load a reagent already in tray. Attempt to blank or wash cuvettes while sample reading is still in progress. Some data is missing.
Automatic mode is ended. Invalid or repeated value.
Invalid variant conversion type. Attempt to convert a null character into a number. When present dilution ends, Dilution has been load samples in tray and press stopped. Resume. Nothing to be transferred. There is no wash solution in position 47 or 48. Reaction still in progress. Repeated test ID.
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No data ready to be stored in historic file. One or both wash solutions are missing. Attempt to edit a method still in use. Only one test ID can be stored with a given name.
Action Replace at the earliest opportunity. Follow procedure outlined in Section 4.3 Replace at the earliest opportunity. Perform wash.
Confirms cuvette blanking. Load any sample only once. Remove reagents not in use. Load any reagent only once. Blank samples with system stopped.
Check for missing values. None. Check data and correct. Calibrate instrument. When probe is in standby place samples in tray and press Resume. None. Replace required wash solution. None.
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Message XX transferred samples YY transferred analysis.
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Cause Data transferred to historic file.
Action None.
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5.4.2 Run-time errors and messages Code
Error
Action
1Probe wet. Dry it.
Stop
2 Dirty probe. Clean tip 9 Error in diluter.
Stop Repeat and Abort
10 Error in level sensor 11Waste flooded
Stop
12Probe impact. Check Tip and Stop
Generator bit Origin and frequency level ST1-7 (E11) With resistive sensor, drop between electrodes. With capacitive sensor, wet inner core ST1-7 (E11) ST1-0 (E22) Errors 52, 53 ó 54
Dry electrodes. With capacitive probe, warm it to dry. Verify for leaks in upper connector. If leak persists, replace probe
ST1-7
In old models verify that waste funnel is not flooded ST1-1, ST1-4, Stopcock in reagent or sample. Check and uncap reagents and samples. ST1-5 (E11) Stacked movement Check for mechanical obstructions. Verify arm led function ST1-3 (E11) Dirty sensor. Check sensor. Clean, if necessary. Check Sensor touches lid. belt tension. Check for mechanical Defective sensor. malfunctioning. Check power supply. With Power supply motors off, check if motion is smooth. ST1-2 (E11) Dirty sensor. Check sensor. Clean, if necessary. Check Sensor touches lid. belt tension. Check for mechanical Defective sensor. malfunctioning. Check power supply. With Power supply motors off, check if motion is smooth.
14 Error in Sample Tray
Repeat and Abort
15 Error in Reaction Tray
Repeat and Abort
16 Error in pump
Message
ST1-6 (E11)
17 Error in Horizontal
Repeat and Abort
ST1-4 (E11)
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Possible solution
Sensor position1, dirty or Check sensors. Clean, if necessary. defective. Mechanical Check for mechanical malfunctioning. problem in arm Check power supply. With motors off, check if motion is smooth.
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18Error in Vertical
Repeat and Abort
20 Cover open sensor error
Message
ST0-3
21Module busy
Repeat
ST0-2
22Module inoperative
23Time Out
30CTS Time Out
31Error in temperature SPI
ST1-5 (E11)
Upper or lower sensor defective. Mechanical problem. When level must be detected: a) Stop at lower sensor: Reagent or sample missing. b) Different number of steps: vertical movement problem Sensor dirty, blocked or deteriorated Overloaded computer
Eliminate unnecessary programs. Leave at least 50 MB free memory. Remove all screen savers and power savers Abort Overloaded computer Eliminate unnecessary programs. Leave at least 50 MB free memory. Remove all screen savers and power savers Abort No answer from Instrument off. Instrument is not Check connections, parameters and serial Autoanalyzer connected to PC. ports Error in communication parameters. Defective Serial Port, either in computer or instrument. Abort CTS line not Instrument off. Instrument is not Check connections, parameters and serial enabled by connected to PC. ports Autoanalyzer Error in communication parameters. Defective Serial Port, either in computer or instrument. Message Temperature External noise halted SPI Turn instrument off and re-start operation controller temperature control
32Warning: Low free disk Message Less than free capacity 50 Mb in disk 34Sample channel low on filter Message In calibration, Defective Filter gain 31 and less than 25000 counts, sample channel
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Check sensors. Clean, if necessary. Check belt and gears. Check for mechanical malfunctioning. Check power supply. With motors off, check if motion is smooth.
Check filter. Check lamp voltage. Check filter wheel malfunctioning
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35 Sample channel saturated on Message In calibration, gain 31 and less filter than 25000 counts, reference channel 36 Reference channel low on Message In calibration, filter gain 0 and more than 80000 counts, sample channel 37Reference channel saturated Message In calibration, on filter gain 0 and more than 80000 counts, reference channel 38Error in 0%T. When run ends, Message Read frequency recalibrate. 50 counts less than zero 39Error in Photometer Repeat Errors 60 or 61 and Abort 40Error in filters or photometer Repeat and Abort 41Excessive energy in filter
42Burn Out Lamp or defective photometer
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Abort
Defective Filter
Check filter. Check lamp voltage. Check filter wheel malfunctioning
Defective Filter
Check filter. Check lamp voltage. Check filter wheel malfunctioning
Defective Filter
Check filter. Check lamp voltage. Check filter wheel malfunctioning
Zero setting or calibration, changed
Calibrate. If persists, check noise stability and power supplies
Reference Lamp intensity changed. channel, more Usually this is a symptom that than 110% of lamp is close to burning-out reference frequency Reference Burned out lamp. Change lamp. Verify if failure occurs frequency less Light is not reaching sensors. always at a given filter than 2 times zero Defective photometer level for a given filter
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44Low energy in filter X
46Error in calibration
Message Reference frequency 50% to 90% of calibration value Repeat Reference and frequency Abort between 2 times noise level and 50% of calibration value Message
47Internal error 1 in dilution 48Internal error 2 in dilution 49Internal error 3 in dilution 50Internal Error
Abort Abort Abort Abort
45Insufficient energy in filter X
51Error, table 52Syringe jammed
Normal lamp intensity variation None. Calibrate at the end of the run along its life
Unusual lamp intensity variation
Calibrate. Change lamp. Check photometer aligning
Inconsistent parameter values. No. 5. Parameter Pasos_CommMA (service manual, 3.11) doesn't coincide with twice Air gap volume in Internal Use Parameters. Default: 10 and 5, respectively No. 7 Parameter “Optimize reading” in “Internal Use” must be modified.
Repeat and Abort
ST1-3 (E22)
Stops before completing the required volume
Check screw, lubricate, if necessary. Check motor and belt.
53No Answer
Repeat and Abort
ST1-2 (E22)
No answer from syringe module
Inspect Klohen module connections. Replace, if necessary
54Wrong parameters
Repeat and Abort Repeat and Abort
ST0-6
Attempt to go beyond syringe limit. (Manual operations)
ST0-7
Defective communication. Reception not equal to transmission.
57Wrong CRC
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Check connectors, serial ports, cables
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58Wrong CRC Memory
Abort
ST0-4
59 Inexistent command 60 Error Converter
Abort Repeat and Abort Repeat and Abort
ST0-5 ST1-3
Repeat and Abort
ST1-1
61Error Filter wheel
62Internal Parameters
Defective parameters in the With auxiliary board, modify any instrument boards (COMU and parameter. This resets all CRC's. Next, CARRU) return to the original parameter. Wrong model selection
ST1-2
Message: Only in Operating conditions and Messages windows Stop: Big message in screen waiting for operator's action Abort: operation permanently stops after a number of retrays
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6 VALIDATION PROGRAM AND TESTS The TEST program is used to check Autoanalyzer M2300GL operating parameters. When performed by authorized personnel, it will be an official validation of instrument’s specifications. The access to it is through Miscellaneous > Test. There are two sets of tests, labeled Service and Group B. User must use the Service Set, only. They are selected by pressing Options button. Group B are reserved for Factory adjustments. This validation test should be performed after installation, after servicing, by client request, or periodically, approximately every 6 months.
6.1
Required elements.
Solution a: Potassium chromate, Reagent grade, diluted in water to 5 gr/l, in water Solution b: Potassium chromate, Reagent grade, diluted in water to 2 gr/l, in water Solution c: Potassium chromate, Reagent grade, diluted in water to 0,150 gr/l, in water Solution d: Sodium Nitrite, Reagent grade, 50 gr/l in water Solution e: This solution is the wash solution described in 3.3, with tensioactive Triton X-100 or similar, in a concentration of 20 ppm v/v. For best results, utilize 2 ml per liter of Solution 3, Cat. No. VA0003SL Solutions a, b and d are included in Calibration Set
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6.2
Description of tests
6.2.1 Energy Description: This test performs a calibration of photometer zeros and gains and verifies if all of them are within range. Previous and present calibration is published. Materials: Sample: none Reagent: none Parameters: Compliance: Errors: 0 6.2.2 Cuvettes Description: This test measures all 80 new empty cuvettes in reaction tray and establishes the minimum and maximum absorbance value, with a tolerance for the allowed maximum difference. Materials: Sample: none Reagent: none Reaction tray: 80 new cuvettes Parameters: Empty: 0 Normal: 0.300 Tolerance: 0.040 Compliance: Difference: Target Min.: 0 Target Max: 0.040 6.2.3 Cuvette dryer Not operative. 6.2.4 Noise Description: This test measures noise of 0%T, static noise at high absorbance and noise when measurements are made and the reaction tray is randomly moved. Do not use absorbances above 1,600. Dilution is performed by the instrument. Materials: Sample: Solution b Reagent: Solution e Reaction tray: clean cuvettes Parameters: 2300GLlTIU Rev. 4.2
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Cuvette: any Filter: 1 Measurements: at least 30 Min.Absorbance: 1.300 Absorbance units Compliance: 0%T_SD: 5 counts Dynamic_SD: 0,003 Absorbance Unit Static_SD: 0.002 Absorbance units. 6.2.5 Photometer Stability Description: This test measures photometer stability for any filter and any number of readings. To have a confidence interval of 95%, a minimum of 30 readings must be made. The test has two parts: first part filter wheel is rotated but measurements are all consecutive, without interval. In this part two consecutive readings are made each time. Second reading is labeled with bis identifier. Differences between readings and accumulated difference are recorded. This allows to determine photometer stabilization time. Second part, filter wheel is kept fixed and readings are spaced the programmed time interval. This will determine long term stability. Dilution is automatically performed. Materials: Sample: Solution b Reagent: Solution e Reaction tray: clean cuvettes Parameters: Filter: 1 Measurements: at least 30 Min.Absorbance: 1.300 Absorbance units Time interval: at least 30 seconds between readings. Compliance: Filter_Move_Diference : 0 to 0.005 AU Filter_Move_Diference_2: 0 to 0.005 AU Filter_Move_Mean_Dif : +/- 0.003 AU Long_Term_Dif: +/- 0.01 AU Long_Term_Dif_2: +/- 0.01 AU Long_Term_Mean_Dif: +/- 0.003 AU 6.2.6 Dilution Description: This test allows determination of precision in dilution by repeating dilutions and readings from the same reagent and sample vial. Standard test is with Concentrated Potassium chromate, 5 g/l as sample and water with 0,02% of Triton x-100 added. Complete test with a commonly used end point method: Glucose, Cholesterol, etc. and any fresh serum sample. Parameters: 2300GLlTIU Rev. 4.2
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Incubation Time: 1 minute Lambda_1: (Wavelength) 340 nm Lambda_2: (Bichromatic reference): 0 Reagent description: K2CrO4 (Potassium Chromate, 5 g/l) Reagent position: Any Sample Position: Any Reagent volume: 400 µl Sample Volume: 4 µl Replicates: 10 (minimum) Materials: Sample: Solution a: Concentrated Potassium chromate, 5 g/l as Reagent: Solution e: water with 0,02% of Triton x-100 added. Reaction tray: Clean cuvettes Compliance: SD: 0.02 CV: 2,5% 6.2.7 Stray light Description: This test determines percent of light measured at 340 nm, which does not correspond to radiation of 340 nm. It is measured by comparing readings of delivered Sodium Chromate 5 g/l (Solution a) with Sodium Nitrite (Solution d) at 340 nm. Samples are automatically delivered. Materials: Sample: Solution a, Solution d Reagent: Solution e Reaction tray: empty cuvettes. Parameters: Positions for solutions a and d Position for Reagent e Wavelength: 340 nm Compliance: Chromate Solution a: 0,1 % Sodium Nitrite blocking: 0,3% 6.2.8 Simultaneous Description: This test makes readings with simultaneous movements and compares with single reading. Materials: As in 6.2.4 Compliance: Within 10 mA units. 6.2.9 ISE dilution Not operative 2300GLlTIU Rev. 4.2
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6.2.10 Movements Description: This is a general procedure to test the operation of mechanical and electrical parts. Put sample at any position and reagent at any position. Reagent is taken, sample level measured but sample is not aspirated, reagent is returned to its reservoir and temperature measured. Error log will accumulate any detected error. No error should be visible in at least 100 cycles and an ideal condition of 3000 cycles. Materials: Sample: water Reagent: water Parameters Measurements: at least 100, get as many as possible Reagent: any position between 1 and 24. Sample: any position from 1 to 48 Steps tolerance (steps in level detection): 10 Temperature tolerance: 0.5 oC. Compliance: Level_errors: must be 0 Status_errors: must be 0 Temp_Errors: must be 0 6.2.11 Washer Not operative 6.3 Automated Validation Testing By pressing button of Batch, all tests will be performed in sequence. To do that, solutions must be located at the following recommended positions:
Position 1: Position 2: Position 3: Position 23: Reagent Position 1:
Solution b Solution a Solution d Distilled water Solution e
Minimum required 250 µl 400 µl 300 µl 1 ml 35 ml
(See section 6.1) Operation: 1. Put 80 NEW cuvettes in reaction tray 2. Put solutions b, a, d and e in the specified positions 3. At the end, get the generated report. Methods included in the batch can be enabled/disabled by selecting Options > Batch options 2300GLlTIU Rev. 4.2
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7 ILLUSTRATIONS
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Figure 1.
Crating unpacking sequence.
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PRO B E A RM
PRO B E A RM P R O TE C T IO N (R O T A R Y )
R E A C T IO N C H A M B E R C O V ER
PRO B E
W A S H S T A T IO N M A IN S S W IT C H
S A M PL E A N D R EA G E N T T R A Y
R EM O V A B L E C O V ER . A C C E S S TO D IL U T ER A N D P E R IS TA L T IC P U M P
Figure 2.
2 3 G L V 4 F i- r0
Front view of instrument.
2300GLlTIU Rev. 4.2
129
Rev. 4.2
C O O L IN G F A N S O U T L E T ( K EEP U N O B S TRU C TED )
FU SE H O LD ER M A IN S C O N N E C T IO N
L A M P H O U S IN G S E R IA L P O R T C O N N EC T TO PC T O W A IS T B O T T L E T O W A IS T B O T T L E L EV EL SEN SO R (Y E L L O W T U B E )
Figure 3.
T O W A S H S O L U T IO N L EV EL SEN SO R (Y E L L O W T U B E ) W A S H S O L U T IO N IN T A K E 2 3 G L V 4 T i- V 0
Rear view of instrument.
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130
Rev. 4.2
M ES H FIL TER A N D C O N N EC TO R IN TA K E TU B E
D IL U TER C O N N EC TIO N S
TO PRO B E
D IL U TER S Y RIN GE
Z ER O V O L U M E A D J . W H EEL PU M P B ED S Y STEM PU M P RO TO R
M A IN S S W ITC H
2 3 G L V 4 D i- v0
Figure 4.
Front Panel detail.
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131
Rev. 4.2
REAGENT HEATER PROBE LIQUID CONNECTION MIXER MOTOR PROBE ELECTRIC CONNECTION
COLLISION SENSORS
PROBE M400BC23W
TO REPLACE PROBE DISCONNECT ELECTRICAL AND LIQUID CONNECTIONS. UNSCREW PROBE BY THE KNURLED COLLAR BELOW MIXER MOTOR. INSERT NEW PROBE AND REPEAT STEPS IN OPPOSITE ORDER. REPLACE COVER AND FIXING SCREWS. M24V4 PROBE CONNECTIONS REV.0
Figure 5.
Capillary probe heater connection.
2300GLlTIU Rev. 4.2
132
Rev. 4.2
A B C D
Diluter unit, no syringe 3 way valve Syringe Diluter belt drive (not shown
Part Nr.
Order Nr.
VOSB1200 VOSB1200 VOSB1203 VOSB1203 VOSB1202 VOSB1202 CO973982
CO973982
Unscrew syringe and pull gently downwards to disengage.
4
3 Remove plunger head fixing screw and disengage.
Component
2
1 Activate diluter, move plunger downwards.
Nr.
Remove syringe. To replace new syringe proceed in inverse order. SYRINGE REPLACEMENT M24A19, rev.1
Figure 6.
Syringe Replacement.
2300GLlTIU Rev. 4.2
133
Rev. 4.2
# This tube connects to the cuvette washing system. See schematics M24A30.
#
2 4
3
Nr.
Component
Part Nr.
Order Nr.
1 2 3 4 5
Intake tube, PVC Ø6xØ3x1400mm Peristaltic pump tubing Pump-Diluter tube with fittings Diluter-Heater tube with fittings Diluter syringe, CAVRO725030
MGPV0306 M24M64 M24H17A M24H17B VOSB1202
MGPV0306 M24M64 M24H17A M24H17B VOSB1202
6 7 8 9 10
Probe drain funnel Reaction chamber funnels (Qty:2) 1/4"Y barbed connector Drain hoses Ø11xØ6x3m Drain reservoir with stopper
M24H01 M24H19 VACOP06Y MGS10611 M24H08W
M24H01 M24H19 VACOP06Y MGS10611 M24H08W
11 Wash solution reservoir with stopper M24H07W 12 Reservoir mesh filter replacement M24H03
M24H07W M24H03
PROBE ARM PUMP
5 1
6
DILUTER 8
7
9 11 12
10
NOTE: Avoid loops in drain hoses to prevent funnel flooding
Layout of sample handling system. M24A28, rev.3
Figure 7.
Hydraulic input circuit.
2300GLlTIU Rev. 4.2
134
Rev. 4.2
REM O V E SC REW S REM O V E C O V ER
A C C ES S TO L A M P L O D G IN G 2 3 G L V 4 L i- v 0
Figure 8.
Lateral cover removal for lamp replacement.
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135
Rev. 4.2
LAMP ASSEMBLY Part Nr. VA000LAM
KNURLED NUT Part Nr. M24F28 Order Nr. PHOTOMETER
1
REMOVE KNURLED NUT AND REMOVE LAMP ASSEMBLY
2
UNPLUG LAMP CONNECTOR
3
REINSTALL NEW LAMP ASSEMBLY
4
PLUG-IN LAMP CONNECTOR
5
SCEW LAMP COVER IN PLACE AND REPLACE SIDE PANEL
REMOVED LAMP COVER
23GLV4LAi-v0
Figure 9.
Lamp replacement.
2300GLlTIU Rev. 4.2
136
Rev. 4.2
TO DILUTER
Nr.
Component
1 2 3 4
Pump-Diluter tubing w. fittings M24H17A Female union M24H14 Male connector M24H30A O-rings OR-201200
M24H17A M24H14 M24H30A OR-201200
5 6 7 8 9
Peristaltic pump mesh filter M24H30D Filter housing M24H30B Pump tubing M24M64 Reservoir to pump barbed fitting VAX06365 Intake tube MGPV0306
M24H30D M24H30B M24M64 VAX06365 MGPV0306
2
3
6 5 4 7 1 9
8
PUMP TUBING ASSEMBLY.
Figure 10.
Pump tubing assembly.
2300GLlTIU Rev. 4.2
137
Part #
Order Nr.
Rev. 4.2
Figure 11.
View of reaction cuvettes when set in light path.
2300GLlTIU Rev. 4.2
138
Rev. 4.2
Figure 12.
Sample detector unit.
2300GLlTIU Rev. 4.2
139
Rev. 4.2
3
1
2 1 Release tension to bed disengaging spring system. 2 Rotate bed to free tube. 3 Pull fittings up and out of bracket. Remove old tube from barbed fittings and insert new tube. Install in inverse order.
PERISTALTIC PUMP TUBE REPLACEMENT
Figure 13.
Peristaltic pump tube replacement
2300GLlTIU Rev. 4.2
140
Rev. 4.2
2300GLlTIU Rev. 4.2
141
