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Service Manual‐ V8800 Ventilator
V8800 Critical Care Ventilator Service Manual
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Service Manual‐ V8800 Critical Care Ventilator
VL9004 Rev 1
Service Manual‐ V8800 Ventilator
Contents
1 Safety Information ..................................................................... 6 2 Notices ......................................................................................... 9 2.1 2.2 2.3 2.4 2.5 2.6 2.7
Warranty Notice ........................................................................................................ 9 Copyright Notice ....................................................................................................... 9 EMC Notice ................................................................................................................ 9 MRI Notice ............................................................................................................... 10 Intended Use Notice ................................................................................................ 10 IEC Classification ...................................................................................................... 11 Declaration of Conformity Notice ........................................................................... 11
3 Equipment Symbols ................................................................. 12 4 Introduction ............................................................................. 15 4.1 4.2
General description ................................................................................................. 15 Abbreviations and Definitions ................................................................................. 16
5 Theory of Operation ................................................................. 18 5.1
Pneumatic System ................................................................................................... 18 5.1.1 Pneumatic Theory ........................................................................................... 18 5.1.2 Main Pneumatic Assemblies Overview ........................................................... 19 5.2 Electrical system ...................................................................................................... 26 5.2.1 Host inside View 1 ........................................................................................ 26 5.2.2 Host inside View 2 ........................................................................................ 28 5.2.3 Expiratory Valve heating Module view ....................................................... 29 5.2.4 Rear panel view ............................................................................................ 30 5.2.5 Display inside view .......................................................................................... 32 5.2.6 Monitor back plastic shell ............................................................................ 33 5.2.7 Power Management Supply board Components Overview ............................ 34 5.2.8 Ventilation Unit Motherboard Components Overview ................................ 35 5.2.9 Monitor Control Board Components Overview .............................................. 36 5.2.10 Monitor interface board Components Overview ............................................ 37 5.2.11 Stepper motor driver board Components Overview ...................................... 38 5.2.12 BDU Isolate Board Components Overview ...................................................... 39 5.2.13 Touch Screen control board ................................................................ 40 5.2.14 LCD Backlight inverter board .............................................................. 40 5.2.15 Single Board Computer Overview ................................................................... 41 5.2.16 System wiring diagram .................................................................................... 43 5.2.17 Main board ..................................................................................................... 50 5.2.18 Power supply board......................................................................................... 53 5.2.19 UIC board......................................................................................................... 55 5.3 Software System ...................................................................................................... 57 P a g e | 3
5.3.1 5.3.2 5.3.3
Service Manual‐ V8800 Critical Care Ventilator
Software Units and Their Relationship ............................................................ 57 Structure of the Software System ................................................................... 58 Hardware and Software Interface ................................................................... 59
6 Disassembling and assembling ............................................... 59 6.1 6.2
General .................................................................................................................... 59 Disassembling of the main assemblies .................................................................... 61 6.2.1 Disassembling of the display from the host ................................................. 61 6.2.2 Disassembling of the host from the trolley .................................................. 62 6.2.3 Disassembling of the air compressor from the trolley .................................... 63 6.2.4 Disassembling of the humidification assembly from the host ........................ 65 6.3 Disassembling of maintenance spare parts............................................................. 66 6.3.1 Disassembling of the gas supply inlet filter ..................................................... 66 6.3.2 Disassembling of oxygen sensor ...................................................................... 67 6.3.3 Disassembling of W15 cable ............................................................................ 68 6.3.4 Disassembling of pressure sensor board ......................................................... 69 6.3.5 Disassembling of W14 cable ............................................................................ 70 6.3.6 Disassembling of Stepper motor driving board ............................................... 72 6.3.7 Disassembling of TSI mass flow sensor ........................................................... 73 6.3.8 Disassembling of the W4 cable ....................................................................... 74 6.3.9 Disassembling of step motor ........................................................................... 74 6.3.10 Disassembling of PEEP valve ........................................................................... 76 6.3.11 Disassembling of diaphragm and scaleboard .................................................. 76 6.3.12 Disassembling of W24 cable ............................................................................ 79 6.3.13 Disassembling of W26 cable ............................................................................ 79 6.3.14 Disassembling of power supply AC/DC module .............................................. 80 6.3.15 Disassembling of components in the display .................................................. 81 6.3.16 Disassembling of electric panel assembly ....................................................... 82 6.3.17 Disassembling of BDU assembly...................................................................... 83
7 User maintenance ....................................................................... 84 7.1.1 Basic guidelines ............................................................................................... 85 7.1.2 Disinfection and Sterilization ........................................................................... 85 7.2 Regular Maintenance .............................................................................................. 87 7.2.1 Maintenance Principles ................................................................................... 87 7.2.2 User Maintenance ........................................................................................... 87 7.2.3 Service life of product/accessories .................................................................. 88 7.3 Maintenance in Operation and Transportation ....................................................... 89 7.3.1 Transportation ................................................................................................. 89 7.3.2 Storage ............................................................................................................ 90 7.4 Battery maintenance ............................................................................................... 90 7.4.1 Battery specification ........................................................................................ 90 7.4.2 Precautions ...................................................................................................... 91 7.4.3 Battery storage ................................................................................................ 91 P a g e | 4
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7.4.4 Battery replacement ....................................................................................... 91 Disposal ................................................................................................................... 92 Manufacturing techniques and materials: .............................................................. 92 Free Obligations: ..................................................................................................... 93 Security, reliability and operating condition: .......................................................... 93 Return ...................................................................................................................... 93
8 Pre‐Use Test and calibration ........................................................ 94 8.1.1 Technical Test .................................................................................................. 94 8.1.2 AC/Battery Test ................................................................................................ 94 8.1.3 Gas Supply Test ................................................................................................ 94 8.1.4 Oxygen Sensor Test ......................................................................................... 94 8.1.5 Leak Test .......................................................................................................... 95 8.1.6 Flow Sensor Test .............................................................................................. 95 8.1.7 Pressure Sensor Test ........................................................................................ 95 8.1.8 Safety Valve Test .............................................................................................. 95 8.1.9 Breath Circuit Test ........................................................................................... 95 8.1.10 etCO2 Sensor Test ........................................................................................... 95 8.2 Calibration ............................................................................................................... 96 8.2.1 Pressure Sensor ............................................................................................... 96 8.2.2 Flow Sensor ..................................................................................................... 96 8.2.3 O2 Sensor ........................................................................................................ 96 8.2.4 CO2 Sensor ...................................................................................................... 96 8.2.5 Inspiratory Valve .............................................................................................. 96 8.2.6 Expiratory Valve ............................................................................................... 97 8.2.7 Touch Screen ................................................................................................... 97
9 Troubleshooting .......................................................................... 97 9.1
Technical Error ......................................................................................................... 97 9.1.1 Technical Test Error Code ................................................................................ 97 9.1.2 Other Errors ................................................................................................... 100 9.1.3 Service Tools .................................................................................................. 101
10
Appendix A Contact & Ordering Information ........................ 102
11
Appendix B Diagrams and Schematics ............................... 103
12
Appendix C Specifications .................................................... 104
13
Appendix D spare parts ........................................................ 107
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Service Manual‐ V8800 Critical Care Ventilator
1 Safety Information The operator of this ventilator must recognize their full responsibility for choosing appropriate ventilation settings to ensure proper ventilation and patient safety. The responsibility for the selection of the appropriate level of patient monitoring depends solely on the equipment operator. All the monitoring information is for reference only; it should not be used as the sole basis for therapeutic or diagnostic decisions. Whenever a patient is connected to the ventilator, constant attention by qualified medical personnel is required in order to provide immediate corrective action in case of a malfunction and alarm occurrence. Terms This manual uses three special indicators to convey information of a specific nature. They include:
WARNING:
Identify conditions or practices that could result in serious adverse reactions or potential safety hazards.
CAUTION:
Identify conditions or practices that could result in damage to the ventilator or other equipment
NOTE:
Identify supplemental information to help you better understand how the ventilator works.
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Warnings, cautions, and notes Please take the time to familiarize yourself with the following safety considerations, special handling requirements, and regulations that govern the use of the V8800ventilator. To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel should attempt to service or make authorized modifications to the ventilator. The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Oricare. WARNING! Back‐up ventilation with an independent manual ventilation device If a fault is detected in the V8800ventilator so that its life-support functions are no longer assured, start ventilation using an independent ventilation device (resuscitation bag) without delay, if necessary with PEEP and / or increased inspiratory O2 concentration. To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches. To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics and/or heaters) away from V8800ventilator and oxygen hoses. Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. In case of fire or a burning smell, immediately disconnect the ventilator from the oxygen supply, facility power, and backup power source. Follow your hospital infection control guidelines for handling infectious material. Oricare recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. It is not possible for Oricare to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting. P a g e | 7
Service Manual‐ V8800 Critical Care Ventilator
Patients on life-support equipment should be appropriately monitored by competent medical personnel and suitable monitoring devices. V8800 ventilator is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients on life-support equipment. For a thorough understanding of ventilator operations, be sure to thoroughly read this manual before attempting to operate the system. Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run PUT (pre-use test) as described in this manual. Do not use sharp objects to make selections on the LCD touch screen or panel. Check the ventilator periodically as outlined in this manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated. An alternative source of ventilation should always be available when using V8800ventilator, such as manual respiratory equipment. Do not connect items which are not specified as part of the system. Do not place containers of liquids (such as humidifier water reservoirs) on top of or above ventilator. Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury. Do not use in conjunction with magnetic resonance imaging (MRI). Equipment malfunction with the risk of patient injury may result.
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2 Notices 2.1 Warranty Notice Do not make any service repairs on this equipment during the states warranty period. Any unauthorized work immediately voids the warranty. Oricare will not be liable for any repairs attempted by the owner. Any such attempted repairs other than specified no warranty repairs void the warranty.
2.2 Copyright Notice Copyright Notice: Inc. This work is protected the copyright law and is the sole property of the Company. No part of this document permitted to be copied or otherwise reproduced, translated into other languages, or stored in any electronic information retrieval system, without the prior written consent of the Company.
2.3 EMC Notice This equipment can radiate radio frequency energy ,as well can be interfered by electromagnetic If not installed and used in accordance with the instructions
mentioned
in the manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual. The ventilator has been tested to conform to the following specifications: MIL-STD-461D:
1993,
MIL-STD-462D:1993,
1000-4-2:1994, IEC 1000-4-3:1994, P a g e | 9
EN
55011:2007+A2:2007,
IEC
Service Manual‐ V8800 Critical Care Ventilator
IEC 1000‐4‐4:1994, IEC 1000‐4‐5:1994, QUASI‐STATIC:1993 This ventilator is also designed and manufactured to comply with the safety requirements of IEC 60601-1, IEC 60601‐2‐12, CAN/CSA C22.2 No. 601.1‐M90, and UL 60601‐1.
2.4 MRI Notice This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in a MRI environment or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the ventilator.
2.5 Intended Use Notice The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 5 kg for adult and 3.5 Kg for child (11 lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation. The V8800Critical Care Ventilator is intended for use in hospital and hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.
WARNING: The V8800 is not designed for use in an MRI environment. Do not use the V8800 near an MRI machine or injury or equipment damage could result.
WARNING: The user of the Ventilator must be professional and trained.
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2.6 IEC Classification Type of Equipment: Medical Equipment, Class 1 type B Adult/Pediatric Lung Ventilator
2.7 Declaration of Conformity Notice This medical equipment complies with the Medical Device Directive, 93/42/EEC, and the following Technical Standards, to which Conformity is declared: EN60601‐1 EN60601‐1‐2 ISO 9001, EN 46001
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Service Manual‐ V8800 Critical Care Ventilator
3 Equipment Symbols Warnings and
Cautions indicate all the possible dangers in case of violation
of the stipulations in this manual. Refer to and follow them.
Warnings Indicates potential hazards to operators or patients.
Cautions Indicates potential damage to equipment. Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear in the equipment and manual. The symbols include: Instead of illustrations, symbols may be utilized. Not all of these symbols may necessarily appear on the equipment or in this User manual. The symbols include:
On (Power)
Protection Class Type B
Attention: Please read Off (Power)
documents provided with the equipment
Attention: Please refer to Product Specifications and
Dangerous voltage
Relevant Standards
Protective earth ground
loudspeaker
EQUIPOTENTIAL Address of production connection
Lock
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Date of production
VL9004 Rev 1
Service Manual‐ V8800 Ventilator
Unlock
Serial Number
Inspiratory hold
Expiratory hold
Nebulization
Manual inspiration
Intelligent increase of Waveform freeze oxygen
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Standby
int.
Internal Battery
AC power
ext.
Extended Battery
USB device
Already online
Prompt message
Pressure trigger
Flow trigger
Manual trigger
Adult
Child
NIV modes
Invasive modes
Main Menu
Alarm Silence Key
Protection Class Type BF
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Disposal of Waste
Service Manual‐ V8800 Ventilator
4 Introduction 4.1 General description The V8800 Critical Care Ventilator System consists of two required Components: a Main Control Unit and a Graphical User Interface (GUI). Optional Components available for the V8800 Critical Care Ventilator system are: Ventilator Cart, Air Compressor, Drawer & Extended Battery Backup Assembly, Gas Cylinder Transport Cart, Patient Circuit Positioning Arm, and Hose Assemblies for O2 and Air, CO2 monitoring subsystem.
1
Main Control Unit
2
Humidifier
3
Air Compressor
4
connector
5
Nebulizer connector
6
Y‐piece
7
Patient Circuit Positioning Arm
8
Mask
9
Test Lung
11
Patient Circuit
12
Water trap
10 Nebulizer tube
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Service Manual‐ V8800 Critical Care Ventilator
4.2 Abbreviations and Definitions CPAP
Continuous Positive Airway Pressure (Set value, hereinafter “S”)
f
Breath rate (frequency) in bpm, i.e. ventilation times per minute (S)
fspont
ftotal
Patient’s spontaneous respiratory frequency (Measured value, hereinafter “M”) Total breath rate, i.e. the sum of breath rate f and spontaneous breath rate fspont (M)
O2
Inspiratory O2 concentration (S & M)
I : E
The ratio of Inspiration to Expiration (M)
MV
Expiratory minute volume (M)
MVspont
Spontaneously breathed minute volume (M)
MVleak
Leakage minute volume (M)
Paw
Patient airway pressure (M)
PEEP
Positive End‐Expiratory Pressure, which can improve the patient’s oxygenation (S & M)
PEEPi
Intrinsic Positive End‐Expiratory Pressure (M)
Pinsp
Upper pressure level in PCV mode (S)
Pmean
Mean airway pressure. This value is updated at the end of the last respiratory cycle, hence, is a continuous average (M)
Ppeak
Airway pressure peak value during one ventilatory cycle (M)
Pplat
End‐inspiratory airway pressure (M)
Pmin
Minimum airway pressure (M)
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Psens
Pressure sensitivity (S)
Psupp
Pressure support (S)
Phigh
Upper pressure level in BIVENT and APRV (S)
Plow
Lower pressure level in BIVENT and APRV (S)
T Imax
Maximum inspiratory time (S)
T insp
Inspiratory Time (S)
T pause
Inspiratory Pause Time, to increase the inspiratory time to improve the patient’s oxygenation (S) Trigger by flow rate (S)
VT
Tidal volume of mechanical ventilation (S)
VTE
Expiratory tidal volume (M)
VTI
Inspiratory tidal volume (M)
Esens
Expiratory trigger sensitivity (S)
ETCO2
End‐expiratory CO2 concentration (M)
WOB
Work of breathing (M)
R*C
Time constant (M)
Leak%
Leakage percentage (M)
Cdyn
Dynamic compliance (M)
Cstatic
Static compliance (M)
Rinsp
Inspiratory resistance (M)
Rexp
Expiratory resistance (M)
Elastic
Elastic resistance (M)
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Service Manual‐ V8800 Critical Care Ventilator
5 Theory of Operation 5.1 Pneumatic System 5.1.1 Pneumatic Theory
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Figure 6‐1 Pneumatic Theory
5.1.2 Main Pneumatic Assemblies Overview 5 6
4
7 8
3
2
1 Figure 6‐2 Main Airway Assemblies sketch view 1
Gas buffer module
2
Supply gas module
3
Pressure Regulator module
4
Inspiratory module
5
Electronic board module
6
Oxygen mixer module
7
PEEP valve
8
Expiratory module
The oxygen mixer module in this cell is different from the oxygen module in the airway theory. The oxygen mixer module in the airway theory includes the pressure regulator, the gas buffer module and the oxygen mixer module in this cell.
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Service Manual‐ V8800 Critical Care Ventilator
6.1.2.1 Pneumatic Connecting Diagram
Figure 6‐3 Pneumatic Connecting Diagram
PU tube￠10
φ3x1.5 silica gel tube
Vapor lock
φ2x1.5 silica gel tube
Three‐ entry connecting
1，2
Gas buffer module
3，6
Inspiratory module
4，7
Supply air module
5
Oxygen mixer module
8
Expiratory module
9
PEEP valve
10
Circuit module
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6.1.2.2 Supply Gas Module Overview
5 6 4 3 2
7
9
1
8
10 Figure 6‐4 Supply Gas Module item
Description Gas flow direction
1
Oxygen connector, connecting with oxygen supplies.
2
Air connector, connecting with external air supplies or air compressor.
3
Inlet filter, collecting any condensed water from the air or oxygen gas
4
Oxygen sensor, monitoring the oxygen density of mixed gas.
5
Pressure sensor, monitoring the pressure of inlet air or oxygen gas.
6
Solenoid valves (the W15 cable), carrying out self‐inspection in the start‐up of the ventilator.
7
Connector, connecting with gas drain tube
8
Connector, connecting with the inspiratory module
9
Gas drain connectors
10
Drain filter
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Service Manual‐ V8800 Critical Care Ventilator
6.1.2.3 Pressure Regulator Module Overview
1
Air
Oxygen gas
3
2
4
Figure 6‐4 Pressure Regulator Module item
Description Gas flow direction
1
Precision air pressure regulator, regulating gas pressure to 0.16MPa.
2
Inlet connector, connecting with the gas flow export of the supply air module.
3
Precision Air Relay, regulating gas pressure to 0.16MPa.
4
Export connector, connecting with the gas flow inlet of the oxygen mixer module.
6.1.2.3 Oxygen Mixer Module Overview
3
4 5
1 2 Figure 6‐5 Oxygen Mixer Module
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Service Manual‐ V8800 Ventilator
Description Gas flow direction
1
Gas flow inlet, connecting with gas flow export of the pressure regulator module
2
Export connector, connecting with the connector of the gas buffer module
3
Step motor driving board, controlling mixed gas oxygen density.
4
Step motor
5
Solenoid Valves (the W14 cable), controlling whether affording the mixed gas to nebulizer and supplying gas pressure to PEEP valve.
6
Connector, connecting with nebulizer pipe.
7
Connector, connecting with PEEP valve
6.1.2.4 Gas Buffer Module 4
3 2
1
5
Figure 6‐6 Gas Buffer Module item
Description
1
Connector, connecting with gas drain tube in the supply air module.
2
Solenoid Valves (the W13 cable), opening the connector for item 1 to exhaust when the pressure in the gas cylinder gets to the appointed value.
3
Safety valve, exhausting gas when the pressure in the gas cylinder gets to the appointed va
4
Pressure sensor, monitoring the pressure of the gas cylinder.
5
Connector, connecting with inspiratory module and oxygen mixer module
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Service Manual‐ V8800 Critical Care Ventilator
6.1.2.5 Inspiratory Module Overview
6 4
5
8
7
3
9 2 Figure 6‐7 Inspiratory Module 1 item
Description
Gas flow direction
1
Connector, connecting with the export connector in the supply gas module.
2
Connector, connecting with export in the gas buffer module.
3
Proportional valve(the W4 cable), adjusting the gas volume.
4
Flow sensor 1, monitoring the volume of the gas
5
Connector, connecting with the pressure sensor of circuit module
6
Low connector of flow circuit board
7
High connector of flow circuit board
8
Inspiratory connector, connecting with silica gel tube for patient.
9
Connector, connecting with the corresponding tubes of the oxygen mixer module and the PEEP valve module.
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6.1.2.6 Expiratory Module Overview
5
4 3 2
1
Figure 6‐8 Expiratory module
6 Figure 6‐9 Expiratory valve core component item
Description Movement direction, the component such as figure6‐9 can take off when turning the rod along the direction.
1
Connector, connecting with high connector of flow circuit board in the inspiratory module
2
Connector, connecting with export in the PEEP valve module.
3
Connector, connecting with high connector of flow circuit board in the inspiratory module
4
Nebulizer tube, connecting with the connector in the oxygen mixer module.
5
The rod, turned right along the direction and then it can come true to take off the component such as figure 6‐9
6
The cup collecting water,
6.1.2.7 PEEP Valve Module
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Service Manual‐ V8800 Critical Care Ventilator
4 2
3 Figure 6‐10 PEEP Valve item
Description
1
Valve bracket
2
Pressure control valve.
3
Connector, connecting with the export in the oxygen mixer module.
4
Connector, connecting with the export in the expiratory module.
5.2 Electrical system 5.2.1 Host inside View 1
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16
1
14 15
13
2
12
3
1 1
4
10 9
5 6
8 1．Display connector 2．Fan
3．Three Solenoid Valves 4．BDU Isolate board 5．pressure sensor board 6．One Solenoid Valve 7．Stepper motor Position Sensor 8．Stepper motor 9．Peep Valve 10. Stepper motor driver board 11. Two Solenoid Valves 12. Expiratory flow sensor
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13. Airway safety pressure monitoring switch 14. Inspiratory flow sensor 15. Inspiratory Valve 16. Ventilation Unit Motherboard 17. Two pressure sensor board (one for O2 Supply pressure, one for Air Supply pressure,) 18. Power Switch
5.2.2 Host inside View 2
12
11
1 10 9
8
2
3 4
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6
7
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1. Safety pressure monitoring switch
2. AC‐DC Switching power supply module 3. Battery charging board (Internal Battery) 4. Battery charging board (Extended battery) 5. Power Supply board 6. AC Power filter 7. AC power input circuit breaker 8. Internal Battery 9. pressure sensor board(O2 supply) 10. pressure sensor board(Air supply) 11. BDU board 12. Ventilation Unit Motherboard
5.2.3 Expiratory Valve heating Module view
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Service Manual‐ V8800 Critical Care Ventilator
1
1. Expiratory Valve heating Module(The above is temperature sensor, below is Heating resistor)
5.2.4 Rear panel view
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11
2
10
3 4 9
5
6
7
8
1.Fan 2.Monitor Connector 3. Power Switch 4.O2 sensor 5. AC power input circuit breaker 6. Equipotential terminal 7. AC power input socket 8. Standard Battery circuit breaker 9. Nurse Call Connector P a g e | 31
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10.RS232 Connector(Functional reserve) 11.CO2 Module Connector
5.2.5 Display inside view
12
11 10
9
7
8
7
1
2
1. Knob board
3
4
5
2. Knob LED & Mute Key Board 3. Monitor cable 4. Display connector
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5. USB connector 6. NET connector 7. Monitor interface board 8. Industrial control board 9. Alarm LED board 10. Touch Screen Control Board 11. Monitor Control Board 12. LCD Backlight inverter board 5.2.6
Monitor back plastic shell
1
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5.2.7 Power Management Supply board Components Overview 9
1
8
2
7
3
6
1. 2. 3. 4. 5. 6. 7. 8. 9.
4 5 P5 Connector Expiratory Valve heating connection J7 Connector Power indicator LED board(Installed on the front plastic panel) connection J3 Connector Software debugger connection J10,J11 Connector Battery charging board connection(Standard Battery) J12,J13 Connector Battery charging board connection(Extended battery) J6 Connector Power input （AC‐DC , Batteries）connection J9 Connector Power switch connection J8 Connector Fan connection J2 Connector Ventilation Unit Motherboard connection
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5.2.8 Ventilation Unit Motherboard Components Overview
19 16
1 2
15 14
3
13 4 5
12
6 7
11
8
10
18 9
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.
17
U11 Expiratory pressure sampling tube connection U15 pressure sampling tube connection JP4 Connector Inspiratory flow sensor(pin 5‐pin 10) connection JP6 Connector Inspiratory flow sensor(pin 1‐pin 4) connection JP2 Connector Expiratory flow sensor connection JP12 Connector Inspiratory Valve connection JP13 Connector Peep Controller connection JP16 Connector air way safety pressure monitor switch connection JP10 Connector Power Management Supply board connection JP1Connector O2 sensor connection JP11 Connector Three pressure sensor boards (O2 supply, Air supply , mixture Tank)connection
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Service Manual‐ V8800 Critical Care Ventilator
12. JP9 Connector Step motor control board(J1 Connector) connection 13. JP14 Connector six solenoids valves connection 14. JP18 Connector BDU isolate board connection 15 . JP19 Connector display monitor connection 16. Ventilation Unit Motherboard 17. Ventilation Unit daughter board 18. Ventilation Unit daughter board Software debugger connection
5.2.9 Monitor Control Board Components Overview
4
3
2
1
5 11 6
7
9
8
1. 2. 3. 4. 5. 6. 7. 8. 9.
P4 Connector Alarm LED board connection P1 Connector LCD Backlight inverter board connection P6 Connector knob LED & mute key board connection P2 Connector knob board connection P8 Connector monitor cable power connection P9 Connector monitor cable RS232 Signal connection P7 Connector Louder speaker connection P5 Connector Single Board Computer CN35 AUDIO‐OUT connection P12 Connector Single Board Computer CN38 Power Input connection
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10. P11 Connector Single Board Computer CN30 COM1/2/3/4Connection 11. P10 Connector Software debugger connection
5.2.10 Monitor interface board Components Overview 1
2
3
4
5
6
1. 2. 3. 4. 5. 6.
J3 Connector Single Board Computer CN27 CRT/VGA/LCD connection J6 Connector Single Board Computer CN15 USB1/2 connection J2 Connector Single Board Computer CN26 LAN connection J4 Connector VGA interface J5,J7 Connector USB interface J1 Connector NET interface
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5.2.11 Stepper motor driver board Components Overview
1
2
3
1. J1 Connector Ventilation Unit Motherboard (J9 Connector) connection 2. J3 Connector Stepper motor home position sensor connection 3. J2 Connector Stepper motor connection
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5.2.12 BDU Isolate Board Components Overview
1
3
2
1. P1 Connector Ventilation Unit Motherboard (J18 Connector) connection 2. P2Connector nurse call connection 3. P3 Connector CO2 module(upper) & reserve RS 232(lower)
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5.2.13 Touch Screen control board
1
2
1. JP1 Connector Touch Screen connection 2. J1 Connector Single Board Computer CN17 USB 3/4 connection
5.2.14 LCD Backlight inverter board
1 2 1. CN1 Connector Power Input 2. CN2, CN3 Connector LCD Backlight lamp
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5.2.15 Single Board Computer Overview
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Connector Table: CN4 TFT LCD I/F CN5 Inverter Power CN6 SMBus CN11 IDE CN15 USB1/2 CN17 USB 3/4 CN18 KB/MS CN19 Print Port CN20 RS422/485 CN23 ISA -5V & -12V Input CN26 LAN CN27 CRT/VGA/LCD CN30 COM1/2/3/4 CN32 Reset / Buzzer pin header CN34 AUDIO-IN CN35 AUDIO-OUT CN36 GPIO1 CN37 GPIO2 CN38 Power Input
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CN39 COM2 Setting CN40 DDR RAM Socket CN41 CF Socket CN42 LVDS LCD I/F CN43 Inverter Power (LVDS)
5.2.16 System wiring diagram Line BOM size and diagram： Line size
BOM size
Figure
W1
122004898 W2
122004899 W3
122004900 W4
122004901 W5
122004902
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W6
122004903
W7
122004904
W8
122004905
W9
122004906
W10
122004907
W11
122004908
W12
122004909
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W13
122004910
W14
122004911
W15
122004912
W16
122004913
W17
122004914
W18
122004915
W19
122004916
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Service Manual‐ V8800 Critical Care Ventilator
W20
122004917
W21
122004918
W22
122004919
W23
122004920
W24
122004921
W25
122004922
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W26
122004923
W27
122004924
W28
122004925
W29
122004926
W30
122004927
W31
122004928
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W32
122004929
W33
122004930
W34
122004931
W35
122004932
W36
122004933
W37
122004934
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W38
122004935
W39
122004936
W40
122004937
W41
122004938
W42
122004939
W43
122005313
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Service Manual‐ V8800 Critical Care Ventilator
Main board
Connection and Leading function function feet
Connection and function
Le ed in g fe et
JP4 TSI_FLOW_SEN SOR
+12V
function
1
TSI_SPI_MOSI
2
TSI_SPI_SCLK
3
TSI_SPI_SYNC
JP18 1 BDU ISOLATE 2 BOARD 3
4
TSI_SPI_MISO
4
GND
5
NC
5
NURSE CALL
6
GND
6
+3.3V
7
CO2 MOUDLE RXD
8
CO2 MOUDLE TXD
9
BDU_TXD2
GND +12V
10 BDU_RXD2 JP6 TSI_FLOW_SEN SOR
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1
TSI_FLOW（参数 范 ）
2
TSI_TEMP
3
+5V
JP19 DISPLAY MONITOR
VL9004 Rev 1
1
GND
2
+24V
3
GND
Service Manual‐ V8800 Ventilator
4
GND
4
+24V
JP2 EXP_FLOW_SE NSOR
1
EXP_FLOW
5
GND
2
GND
6
+24V
3
+5V
7
PS_RXD
JP12 INS_VALVE
1
INS VALE ‐
8
PS_TXD
9
BDU_RXD2
10 BDU_TXD2 11 BDU_RXD1 12 BDU_TXD1
JP13 EXP_VALVE
2
NC
3
1, 2, 3, 4
+12V
NC
5, 6, 7, 8
GND
4
INS VALE +
9
+3.3V
1
EXP VALE +
10 GND
2
NC
JP9 STEP_MOTOR _BOARD
11 MOTOR_STEP 12 MOTOR_DIR
3
EXP VALE ‐
13 MOTOR_HOME 14 MOTOR_SLP 15 GND 16 MOTOR_POS1 17 MOTOR_POS2 18 GND 19 SCL 20 SDA
JP16 1 SAFTY AIR PRESSURE SENSOR
SAFTY PRESSURE SIGNAL
AIR JP14 6 solenoids
1
Nebulizer solenoid Valve ‐
2
Nebulizer solenoid Valve +
3
Relief solenoid valve ‐
4
Relief solenoid Valve +
5
Peep solenoid Valve ‐
6
peep solenoid Valve +
7
O2 air choice solenoid Valve ‐
8
O2 air choice solenoid Valve +
9
21% 100% solenoid Valve ‐
10 21% 100% solenoid Valve + 11 O2 sensor check solenoid Valve ‐ P a g e | 51
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12 O2 sensor check solenoid Valve + 2
GND
JP1 O2 SENSOR
3
O2 SENSOR +
4
O2 SENSOR‐
Caution：check the tab of circuit board connection end
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5.2.18 Power supply board
Power supply board layout Connection and Leading function function feet
Connection and function
Le ed in g fe et
function
P5 Exp_valve_heat ing
P8 FAN
1
GND
2
FAN POWER
3
SPEED SIGNAL
1
SWITCH1
2
SWITCH1
3
SWITCH2
4
SWITCH2
1
EXTEND BATT POWER IN
2
GND
3
EXTEND BATT PLUG IN SIGNAL
P7 POWER INDICATION LED BOARD
1
GND
2
HEATING POWER
3
GND
4
DS18B20_DAT
5
+3.3V
1
AC_POWER_LED
2
CHANGING_LED
3
GND
S3 POWER SWITCH
P6
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4
GND
5
+24V POWER IN
6
STANDARD BATT PLUG IN SIGNAL
7
STANDARD BATT POWER IN
8
GND
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5.2.19 UIC board
Mouth function
and Leading function feet 1,2,3
+24V
4,5,6,7
GND
P9
1
PC_TXD3
RS232
2
PC_RXD3
3
PC_TXD2
4
PC_RXD2
5
PC_TXD1
M2
6
P7 SPEAKER
P8 POWER INPUT
PS-COM3, BDU-COM1,
Mouth function
and Leading function feet 1
+12
2
RED_ALARM_LED
3
YELLO_ALARM_LED
1
+12V
2
GND
3
BLACK ON/OFF
PC_RXD1
4
BRIGHTNESS_CONTR OL
1
SPEAKER +
5
+5V
2
SPEAKER ‐
CO2_module-CO
P4 ALARM_LED_BO ARD
P1 BRIGHTNESS_C ONTROL_BOAR D
LIGHT
P5 Audio input
1
Audio input_R
2
GND
3
Audio input_L
P6 1 MUTE & KNOB 2 LED_BOARD 3 4
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KEY KEY KNOB LED CONTROL +12V
P12 1 SCB POWER SUPPLY 2
P11 RS232
+5V +5V
Service Manual‐ V8800 Critical Care Ventilator
P2 KNOB_BOARD
1
2
KNOB_KEY
3
GND
3
TSB1
4
GND
4
TSA1
5
GND
5
+5V
6
GND
6
+12V
3
PC_RXD1
5
PC_TXD1
9
GND
13
PC_RXD2
14
PC_TXD2
19
GND
23
PC_RXD3
24
PC_TXD3
29
GND
33
PC_RXD3
34
PC_TXD3
39
GND
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5.3 Software System 5.3.1 Software Units and Their Relationship User Interface Software Unit bears the responsibility of user interface of the whole software system. It includes operation interface for the users, graphic interface for showing information of the device, communication with other units, etc. Breathing Delivery Software Unit bears the responsibility of ventilation control. User Interface Connection Software Unit bears the responsibility of controlling knob, hard key, alarm indicator and alarm speaker. Power Supply Software Unit bears the responsibility of power management. The relationship between these four units is as following:
Fig 1 Software Units of NVP System
In above figure, the orientation of arrow points to information is flowing to where. Furthermore, a bidirectional arrow means communication between SW units is bi‐ directional.
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5.3.2 Structure of the Software System
Fig 2 Structure of Software Units
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5.3.3 Hardware and Software Interface
Fig 3 Interface between Software and Hardware System
6 Disassembling and assembling 6.1 General The ventilator is mainly formed of the following components and some accessories. Disassembling of the main units and maintenance spare parts is described in this chapter. If not stated otherwise, the assembling procedure is the reverse of the described disassembling procedure.
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Fig 7‐1 Whole Shape 1
Display
4
Trolley assembly
2
Ventilator host
5
Arm assembly
3
Air Compressor
6
Arm assembly
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6.2 Disassembling of the main assemblies 6.2.1 Disassembling of the display from the host
Fig 7‐2 To separate the display from the host: a. Loose the screws (No.1) b. Drag out the spring lock(No.2) c. Pull out the display along the direction;
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6.2.2 Disassembling of the host from the trolley
Fig 7‐3
Fig 7‐4 Fig 7‐5
To separate the host machine from the trolley a. Drag out drawer(No.3),as fig.7‐4 shows; b. Screw off knurling bolts(No.2), as fig.7‐5 shows; c. Lift up the host machine(No.1); Note: when installing the host machine to the trolley, please take the plastic padding to aim at the holes，such as central line in Fig 7‐3.
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6.2.3 Disassembling of the air compressor from the trolley
Fig 7‐6 To separate the air compressor from the trolley (No.2) a. Screw off four bolts(No.3); b. Lift up the air compressor(No.1) 1) Disassembling of the arm assembly from the host
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Fig 7‐7
Service Manual‐ V8800 Critical Care Ventilator
To separate arm assembly from the host a. Loosen the knob(No.1); b. Open up the clasp(No.2) and take off arm assembly from handrail (No.3) of host;
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6.2.4 Disassembling of the humidification assembly from the host
Fig 7‐8 To separate the humidification assembly from the host a. Loosen the knob(No.1); b. Move the clasp(No. 2) along handrail(No.3) and take off it from the host Humidification (No.4) can been freely take off from the humidification assembly along the guide‐rail.
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6.3 Disassembling of maintenance spare parts 6.3.1 Disassembling of the gas supply inlet filter
Fig 7‐9 To separate the gas supply inlet filter from the host: a. Screw off four bolts(No.1) b. Remove the Inlet valve body (No.2); c. Drag out the gas supply inlet filter (No.3).
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6.3.2 Disassembling of oxygen sensor
Fig 7‐10 To separate the gas supply inlet filter from the host: a. Pull out oxygen sensor cover(No.1) b. Screw off the oxygen sensor(No.2)
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6.3.3 Disassembling of W15 cable
Fig 7‐11 To removal the W15 cable from the host: a. Screw off the four screw(No.1) ; b. Lift up covered component(No.2); c. Disconnect the cable connector; d. Screw off the six screw(No.3) on the solenoid valve; e. Pull out the W15 cable(No.4)
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6.3.4 Disassembling of pressure sensor board
Fig 7‐12 To removal the two pressure sensor board from the host: a. Screw off the four screw(No.1) ; b. Move the side panel(No.2) to a side; c. Disconnect the cable connector; d. Screw off the four screw(No.3) f. Pull out the two pressure sensor board(No.4)
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6.3.5 Disassembling of W14 cable
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Fig 7‐13 Fig 7‐14 To removal the W14 cable from the host: a. Screw off the four screw, No.2 in fig7‐13 ; b. Move the covered component to a side, No.1 in fig 7‐13; c. Disconnect the cable connector; d. Screw off the four screw (No.3 in fig 7‐14); e. Take out of the W14 cable (No.4 in fig 7‐14) ;
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6.3.6 Disassembling of Stepper motor driving board
Fig 7‐15 To remove Stepper motor driving board from the host: a. Screw off the four screw, No.2 in fig7‐13 ; b. Move the covered component to a side, No.1 in fig 7‐13; c. Disconnect the cable connector; d. Screw off the two screw, No.3 in fig7‐15; e. Take out of step motor driving board, No.4 in fig7‐15
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6.3.7 Disassembling of TSI mass flow sensor
Fig 7‐16 To removal TSI mass flow sensor from the host: a. Screw off the four screw, No.2 in fig7‐13; b. Move the covered component to a side, No.1 in fig 7‐13; c. Disconnect the cable connector; d. Screw off the two screw, No.3 in fig7‐16; e. Move the proportional valves component(No.4 in fig7‐16) to the left side; f. Drag out the TSI mass flow sensor (No.5 in fig 7‐16).
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6.3.8 Disassembling of the W4 cable
Fig 7‐17 To removal the W4 cable from the host: a. Screw off the four screw, No. 2 in fig7‐13; b. Move the covered component(No.1 in fig 7‐13) to a side; c. Disconnect the cable connector; d. Screw off the two screw, No.3 in fig7‐17; e. Lift up the proportional valve, No.4 in fig7‐17.
6.3.9 Disassembling of step motor
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Fig 7‐18 a. b. c. d.
To remove the step motor from the host: Screw off the four screw, No.2 in fig7‐13; Move the covered component to a side, No.1 in fig 7‐13; Screw off the four screw, No.1 in fig7‐18; Drag out the step motor, No. 2 in fig7‐18.
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6.3.10 Disassembling of PEEP valve
Fig 7‐19 To removal the PEEP valve from the host: a. Screw off the four screw, No.2 in fig7‐13 ; b. Move the covered component(No.1 in fig 7‐13) to a side; c. Pull out the plastic tube on the joints of PEEP valve(No.1 in fig 7‐19); d. Disconnect the cable connector; e. Screw off the four screw, No. 2 in fig7‐19; f. Take off the PEEP valve
6.3.11 Disassembling of diaphragm and scaleboard
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Fig 7‐20 The diaphragm and the scaleboard appear in the two components, expiratory module assembly and inspiratory module assembly. To removal the diaphragm and the scaleboard from inspiratory module assembly: a. Screw off the four screw, No.2 in fig7‐13; b. Move the covered component (No.1 in fig 7‐13) to a side, c. Pull out the plastic tube on the joints of safety valve; d. Screw off the safety valve cover, No. 1 in fig7‐20 e. Take off the diaphragm and the scaleboard, No. 2 and 3 in fig7‐20
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Fig 7‐21 Fig 7‐22 a. b. c. d.
To removal the diaphragm and the scaleboard from expiratory module assembly: Press the button(No.1 in fig7‐21); Pull out the expiratory valve core component (No.2 in fig 7‐21); Screw off the safety valve cover(No.1 in fig7‐22) Take off the diaphragm(No. 2 in fig 7‐22) and the scaleboard(No. 3 in fig7‐22)
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6.3.12 Disassembling of W24 cable
Fig 7‐23 To removal the W24 cable: a. Grasp the drawer handle(No.1 in fig 7‐23) and pull out battery box assembly; b. Disconnect the cable connector; c. Open up the spring slices, No.2 in fig7‐23; d. Take off the W24 cable, No. 3 in fig7‐23
6.3.13 Disassembling of W26 cable
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Fig 7‐24 Fig 7‐25 To removal the W26 cable: a. Pull out drawer, No.1 in fig7‐24 ; b. Disconnect the cable connector; c. Pull out the W26 cable(No.2 in fig 7‐25) along the lead‐rail(No.3 in fig 7‐25)
6.3.14 Disassembling of power supply AC/DC module
Fig 7‐26 To removal the power supply module: a. Screw off the four screws(No.1 in fig7‐26), and take down the side panel(No.2 in fig 7‐26) ; b. Screw off the screws(No.3 in fig7‐26), disconnect the correlative connectors, and take down the electronic board assembly (No.4 in fig7‐26); c. Take out the power supply module(No.5 in fig 7‐26) from host when screwing off the P a g e | 80
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four screws on the host pedestal;
6.3.15 Disassembling of components in the display Two screws
Four screws
Fig 7‐27 Fig 7‐28 a. Screw off the four screws in fig 7‐27 and take off the fixed board; b. Screw off the two screws in fig 7‐28;
Fig 7‐29 Fig 7‐30 c. Pry open the back‐shell of display with the tool. You can use the tool to prize the red circle signed places such as fig 7‐29. d. Open the back‐shell slowly and disassemble the two screws in the fig7‐30, move away the back‐shell. Screws PCB mask e. Screw off the eight screws, and then move away the PCB mask, such as fig 7‐30 f. Seeing fig7‐31, the components in the display can be easy to be taken away. Fig 7‐31 P a g e | 81
1
2
Service Manual‐ V8800 Critical Care Ventilator
3
4
12 11
5
10 9
Fig 7‐32
8
7
6
1. Alarm light panel 2. Display Control Panel 3. W36 cable 4. PC/104 single board computer suite, industrial grade CF card 5. Speaker Component 6. 1G memory card 7. Display interface panel 8. Touch screen control 9. Aperture and mute Panel 10. W31 cable 11. Inverter TPI‐02‐0606 12. Front shell component
6.3.16 Disassembling of electric panel assembly 1 2
3
4
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1. Main Control board 2. Main Control core board 3. Power Board 4. Charger Board a. Take down the side panel, such as fig 7‐26; b. The components on the electric panel assembly appear such as fig 7‐33, which can be easy to be taken away;
6.3.17 Disassembling of BDU assembly 1
2
Fig 7‐34 Fig 7‐35 a. Take down the side panel, such as fig 7‐34; b. Screw off the two screws (No.1 in fig7‐35); c. Take away the BDU assembly(No.1 in fig7‐35);
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7 User maintenance WARNING: Oricare recognizes that cleaning, disinfection, and sterilization practices vary widely among medical institutions. It is not possible to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting.
WARNING: Use a cleaning and disinfection schedule that conforms to your institution’s disinfection and risk-management policies. • Refer to the material safety data as applicable. • Refer to the operation and maintenance manuals of all disinfection equipment. • Do not inhale fumes that may result from any disinfection process.
WARNING: Movable and removable parts may clamp or even crush your hand. Use caution when moving or replacing system components.
CAUTION: The disposal of environmentally harmful devices (such as batteries and LCD display) must be in accordance with local regulations. WARNING: Use a cleaning and disinfection schedule that conforms to your institution’s disinfection and risk-management policies. • Refer to the material safety data as applicable. • Refer to the operation and maintenance manuals of all disinfection equipment. • Do not inhale fumes that may result from any disinfection process. WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch or similar material to prevent sticking of the bellows, as these materials may enter the patient’s lungs or airway, causing irritation or injury. CAUTION:
To prevent system damage:
• Refer to the literature supplied by the manufacturer of the cleaning agent. • Never use organic, halogenated or petroleum-based solvents, anesthetic, glass cleaning agents, acetone or other irritant agents. • Never use abrasive agents (i.e. steel wool or silver polish) to clean components. P a g e | 84
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• Keep all liquids away from electronic components. • Prevent liquid from entering the equipment. • All cleaning solutions used must have a pH between 7.0 and 10.5. CAUTION: Never immerse the oxygen sensor or its connector in any type of liquid. • Dispose of the oxygen sensor per the manufacturer’s specification. CAUTION: Do not wash the inner surface of the oxygen sensor. CAUTION: Prior to use after cleaning or disinfecting, power up the system as described in section 6 and follow the on-screen Pre-Use test prompts to perform the Leak Test and Circuit Compliance Test.
7.1.1 Basic guidelines Discard one time use components after using. Don’t use hard brushes or other sharp tools in cleaning to avoid damage to parts. Clean components with warm water and light detergent. Dry the components after rinsing with water. Check each component when cleaning and replace damaged ones. After a component is replaced, test the ventilator first prior to putting the ventilator into service. CAUTION: Follow the instructions of detergent manufacturer. Concentrated detergent may hurt some components. Detergent residue may cause spots and cracks, especially in high temperature disinfection.
7.1.2 Disinfection and Sterilization Discard one time use components after using. Using an FDA cleared Gluteraldehyde disinfection solution; follow the manufacturer’s instructions for high level disinfection and rinsing of the part while adhering to facility policies and procedures. Ensure that the part has been cleaned as described before disinfecting. Alternative method to disinfection solution is steam autoclaving. High level disinfection of the part is accomplished, through steam autoclaving up to a maximum temperature of 134 ºC (273 ºF). When using an autoclave,
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follow the manufacturer’s instructions for high level disinfection. Table 8‐1 Guidelines for cleaning and disinfection Item
How Often
Procedure
Note
External
After every
Wipe clean with a damp cloth and
Be careful not to let
surface of
patient
water-soluble mild soap or with one
disinfectant into the
of the chemicals listed below or its
machine or power
equivalent. Apply soap or chemical
supply plug.
ventilator (including
LCD)
to damp cloth and directly to the equipment. If necessary use damp
cloth and water to rinse off chemical residue. • Mild dishwashing detergent • Isopropyl alcohol (70% solution) • Window cleaning solution (with isopropyl alcohol and ammonia) • Ammonia (15% solution) • Bleach (10% solution) • Hydrogen peroxide (3% solution)
Expiratory
After each
Remove Expiratory module from
Reinstall the
module
patient/
ventilator and remove diaphragm
module after
weekly
and water trap. Clean the shell,
cleaning and
diaphragm and water trap
drying. Pay
separately. Using an approved
attention to assure
Gluteraldehyde disinfection solution,
connections are
follow the manufacturer’s instruction
gas tight.
for high level disinfection and rinsing of the diaphragm, water trap and shell. Note: The shell and water trap can also be high level disinfected through steam autoclaving up to a maximum temperature of 134°C (273°F). Using an autoclave, follow the manufacturer’s instruction for high level disinfection of the shell and water trap while adhering to facility procedures. Note: autoclaving should not be used for high level disinfection of the diaphragm.
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7.2 Regular Maintenance 7.2.1 Maintenance Principles Don’t use a faulty machine. Ask an authorized agent of our company to carry out all necessary maintenance tasks. Test the machine after maintenance for normal operation. Every parameter should meet requirement in specification. In order to ensure the reliability of the machine, all maintenance and repair work should be carried out by an authorized agent of our company. In case such person is unavailable, a qualified person with similar maintenance experience is acceptable for the work. CAUTION: Person with no sufficient experiences is strictly prohibited to perform maintenance.
Use products of our company to replace damaged ones and test, ensuring all specifications met. Contact local service agent of our company in case support is needed. In all cases, maintenance fee is the current component price plus reasonable labor cost, except for those within guarantee period.
7.2.2 User Maintenance Minimum maintenance
Task
interval Daily
Drain water in gas supply inlet filter, check liquid
in
expiratory
module
water
trap(collected liquid volume cannot be more than half of the bottle) 1‐3 month(s)
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Calibrate flow and pressure sensors; Calibrate inspiratory valve and expiratory valve (if necessary)
Every year or after calibration Replace the O2 sensor(actual life depends on temperature and O2 concentration) When cleaning and installing
Check components and replace or repair when necessary.
Notes related to User Maintenance: To change the Oxygen sensor, remove the Oxygen sensor cover on the rear of the machine, replace the installed Oxygen sensor with a new Oxygen sensor supplied by Oricare. Use care to assure connections and installation are complete. Replace Oxygen sensor cover. Note: V8800Ventilator performs an O2 sensor calibration automatically, every 24 hours, no operator intervention is needed. WARNING: If the V8800 Ventilator will not be in use for a period of more than 6 months, the internal batteries must be disconnected or removed to prevent possible damage to the equipment or risk to users or service personnel.
WARNING:The ventilator must not use, nor be connected to, any anti‐static or electrically conductive hoses and tubing.
7.2.3 Service life of product/accessories Caution：The service life of the following items is based on normal operating conditions.
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Power supply cable, gas supply pipe
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8 years
Battery
1 year
7.3 Maintenance in Operation and Transportation The location of machine should be proper so that it cannot obstruct or be disturbed by medical care personnel. Fix power supply cable well to avoid failure. Use caution not to touch accidental keys on the panel, which may make tidal volume setting wrong. During transportation of the ventilator with or without a patient connected, make sure that the following conditions are fulfilled; Gas cylinders are connected with a sufficient amount of gas, the Battery module is functioning. Follow the hospital guidelines. Use the handles on the Mobile Cart. Transport the bed and the ventilator slowly, and watch the patient connection carefully to see that no pulling or other movement occurs. Be careful not to tip the Mobile Cart when crossing an obstacle such as a doorstep
7.3.1 Transportation Use care when moving machine within hospital or clinical environment. WARNING: If Control Unit of Ventilator is dropped or damaged during transportation, equipment failure could result in patient injury. WARNING: Tip over hazard – use care when moving Ventilator mounted to Cart as device could tip over leading to injury or damage to the equipment and possible subsequent patient injury. User can carry packaged machine while riding vehicle, plane and train. Impact, severe shock and damp should be avoided during transportation (other conditions should accord with P a g e | 89
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purchase contract), with ambient temperature ‐20°C‐+60°C and relative humidity not more than 95%. In case transportation conditions don’t agree, put the machine in normal operating environment at least 24h before using.
7.3.2 Storage CAUTION: Do not put ventilator into the shock environment. CAUTION: Do not lay the heavy on the top. The machine should be stored in a room with temperature ‐20°C ‐+60°C and relative humidity 5 ‐ 95% non‐condensating, with ventilation and no corrosive gas. WARNING: If the storage environment conditions don’t agree, put the machine in normal operating environment at least 24h before using. CAUTION: The device should be stored at the room that is drafty and no corrosion gas exists. CAUTION: When the storage conditions are beyond the requirements of operational environment, and the storage state is transferred into operation state, the product only can be used after being stored in environment for over 24 hours.
7.4 Battery maintenance 7.4.1 Battery specification Internal battery module -
DC12V, 2.3AH, lead‐acid battery, 2 in series
-
Typical charge time: 4h
-
Typical discharge time: 1h
Extended battery module -
DC12V, 5.0AH, lead‐acid battery, 2 in series
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7.4.2 Precautions Charge: When operating with AC power supply on, the system will maintain the battery automatically. Charge time is less than 4h. Discharge: Extended battery module (if installed) will supply power prior to the internal battery module when machine is operating on battery. In case of low battery condition, an alarm message “Low battery” will appear, notifying the user to restore AC power supply to charge batteries, otherwise the batteries will be depleted and alarm “Limited Battery Capacity” will be displayed, and eventually the system will be shut down (for safety reason, manual power‐on is required to start the machines again after an automatic shutdown).
7.4.3 Battery storage In case the battery is to be stored for a long time, charge it fully prior to storage. In case storage time exceeds 3 months, charge battery every 3 months. High humidity and high temperature environments should be avoided for storage. If battery is damaged due to improper maintenance, replace promptly, otherwise liquid leakage may corrupt the machine. Contact the manufacturer when replacing battery.
7.4.4 Battery replacement Same model battery with CE certification is suggested. Make sure AC power supply is disconnected before replacing. CAUTION: An authorized Oricare services representative can replace battery. If not to use the battery for long‐time, please contact Oricare service representatives to disconnect P a g e | 91
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battery. The waste battery should be disposed in accordance with the local policies. CAUTION: When ‘battery low’ alarm occurs, charging should be done immediately. Or else, the Shangrila590 Ventilator System will shut off in several minutes automatically.
7.5 Disposal Correct Disposal of Batteries and O2 Sensors
WARNING: Treatment of batteries and O2-sensor capsules: • Do not throw into fire! Risk of explosion. • Do not force open! Danger of bodily injury. • Follow all local regulations with respect to environmental protection when disposing of batteries and O2-sensor capsules.
This product must not be disposed of with your other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment, or by returning it to Medical Illumination International, Inc for reprocessing. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your waste equipment for recycling, please contact your local city office, your waste disposal service, or your product distributor or retailer.
7.6 Manufacturing techniques and materials: For a period of one year from the date of original delivery, the components and assemblies of this product are warranted to be free from defects manufacturing techniques and materials, provided that the same is properly operated under the conditions of normal use and regular maintenance. The warranty period for other parts is three months. Expendable parts are not included. Oricare’s obligation under the above warranties is limited to repairing free of charge.
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7.7 Free Obligations: • Oricare’s obligation under the above warranties does not include the freight and other fees; • Oricare is not responsible for any direct, indirect or final product broken and delay which result from improper use, alteration by using unapproved assemblies and maintenance by anyone other than Oricare; • This warranty does not apply to the followings: Improper use; Machines without maintenance or machines broken; The label of Oricare original serial number or mark is removed or replaced; Other manufacturers’ products.
7.8 Security, reliability and operating condition: Oricare is not responsible for the security; reliability and operating condition of this product in case that: • The assemblies are disassembled, extended and readjusted • This product is not operated correctly in accordance with the manual instruction. The power supply used or operating environment does not follow the requirements in this manual.
7.9 Return Follow the steps in case that the product needs to be returned to Oricare: 1、Obtain the rights of return Contact with the customer service of Oricare by informing them the number and type of the product. The number is marked on the surface of the product. Return is unacceptable if the number cannot be identified. Enclose a statement of the number, type and the reason of return as well. 2、Transportation charges Transportation and insurance charges must be prepaid by the user for transporting the product to Oricare for repairing.
NOTE: Each Oricare product has a serial number, such as V8800 xx xx xxx. This serial number should be referenced in all correspondence. Where: V8800 = machine model number xx xx xxx: equipment number 1st two ‘xx’ digits – last two digits of current year 2nd two ‘xx’ digits indicate month product was manufactured
rd
Z=O,Y=1,X=2,W=3,V=4,U=5,T=6,S=7,R=8,K=9.
3 group of ‘xxx’ digits indicates the number unit shipping in a current month.
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Product serial number appears at nameplate and on equipment packaging. Manufacturer
Oricare Inc
Address
1900 AM Drive Quakertown, PA 18951 USA
EC Representative
Obelis SA
Address
Bd General Wahis 53, 103D Brussels, Belgium
Tel.
+(32) 2732‐59 54
Fax
+(32) 2732‐60 03
Web site
www.oricaremed.com
Email
[email protected]
8 Pre‐Use Test and calibration 8.1.1 Technical Test Possible reason and recommended action if failed: See the Technical Test Error Code below.
8.1.2 AC/Battery Test Possible reason and recommended action if failed: Make sure the internal battery is installed and charged. Make sure the AC supply is OK.
8.1.3 Gas Supply Test Possible reason and recommended action if failed: 1. Make sure the two gas supplies are connected, and the pressure is in the spec
8.1.4 Oxygen Sensor Test Possible reason and recommended action if failed: 1. Perform 21% and 100% oxygen sensor test at first, and try again. 2. Make sure the two gas supplies are connected, and the pressure is in the spec. 3. Make sure the oxygen sensor is valid and connected to the main box. 4. Make sure the oxygen auto calibration valve is connected right and no leak.
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8.1.5 Leak Test Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve at first, and try again; 2. Make sure machine and connected tube have no leak.
8.1.6 Flow Sensor Test Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve at first, and try again; 2. Make sure machine and connected tube have no leak; 3. Make sure inspiratory flow sensor and expiratory flow sensor work fine.
8.1.7 Pressure Sensor Test Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve at first, and try again; 2. Make sure machine and connected tube have no leak; 3. Make sure inspiratory pressure sensor and expiratory pressure sensor work fine.
8.1.8 Safety Valve Test Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve at first, and try again; 2. Make sure safety valve works fine; 3. Make sure machine and connected tube have no leak; 4. Make sure expiratory pressure sensor works fine.
8.1.9 Breath Circuit Test Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve and Expiratory valve at first, and try again. 2. Make sure machine and connected tube have no leak; 3. Make sure expiratory pressure sensor works fine.
8.1.10 etCO2 Sensor Test Possible reason and recommended action if failed: 1. Take off the CO2 sensor from the breath circuit, and put it in the air. 2. Make sure the CO2 sensor has warmed up. The LED indicator in the sensor turns green. P a g e | 95
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3. Make sure the adapter is installed into the sensor.
8.2 Calibration 8.2.1 Pressure Sensor Possible reason and recommended action if failed: 1． Make sure inspiratory pressure sensor and expiratory pressure sensor work fine; 2． Make sure no gas flow pass inspiratory pressure sensor and expiratory pressure sensor.
8.2.2 Flow Sensor Possible reason and recommended action if failed: 1. Make sure inspiratory flow sensor and expiratory flow sensor work fine; 3． Make sure no gas flow pass inspiratory flow sensor and expiratory flow sensor.
8.2.3 O2 Sensor Possible reason and recommended action if failed: 1. Calibrate Inspiratory valve and Expiratory valve at first, and try again; 2. Make sure the two gas supplies are connected, and the pressure is in the spec; 3. Make sure the oxygen sensor is valid and connected to the main box; 4. Make sure the mixer works fine; 5. Make sure regulators wok fine.
8.2.4 CO2 Sensor Possible reason and recommended action if failed: See Section 9.2.10.
8.2.5 Inspiratory Valve Possible reason and recommended action if failed: 1. Make sure the two gas supplies are connected and work normal; 2. Make sure machine and connected tube have no leak; 3. Make sure inspiratory flow sensor and expiratory flow sensor work fine. 4. Make sure inspiratory valve works fine; P a g e | 96
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8.2.6 Expiratory Valve Possible reason and recommended action if failed: 1. Make sure the two gas supplies are connected and work normal; 2. Make sure machine and connected tube and lung have no leak; 3. Make sure inspiratory pressure sensor and expiratory pressure sensor work fine; 4. Make sure inspiratory valve and expiratory valve work fine;
8.2.7 Touch Screen Possible reason and recommended action if failed: 1. Trying the fewest test points calibration (4 points). 2. Make sure press the center of each test point (the red region). 3. Make sure the plastic frame of screen doesn’t constrict the touching area of touch screen.
9 Troubleshooting 9.1 Technical Error 9.1.1 Technical Test Error Code The error code is made up by 8 digits hexadecimal numbers, which are four byte using binary system. The highest two bytes are internal AD test result flag, the lowest byte are external AD test result flag. The meaning of each bit is shown in the below table. External AD##(0xF FFF00xx)
Test Point
Bit 1
Zero point of expiratory 1. Remove the test lung and breath circuits, flow rate perform the test again. 2. Don’s start PUT too quickly after quit from ventilation. 3. Calibrate the pressure, flow rate sensor, Insp. valve and Exp valve. 4. Proportional solenoid valve can’t close completely. Replace proportional solenoid valve.
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5. Replace expiratory flow rate sensor. Bit 2
Zero point of inspiratory 1. Remove the test lung, connect Insp. port and flow rate Exp. port directly with a tube. 2. Don’s start PUT too quickly after quit from ventilation. 3. Calibrate the pressure, flow rate sensor, Insp. valve and Exp valve. 4. Proportional solenoid valve can’t close completely. Replace proportional solenoid valve. 5. Replace mother board.
Bit 3
Inspiratory temperature
1. 2. 3.
4.
Check the cable between the mother board to the temperature sensor The interface IC on the mother board is broken. Replace mother board. The input port of external AD chip on the mother board is broken. Replace mother board. Replace temperature sensor.
Bit 4
‐‐
Bit 5
Zero point of inspiratory 1. Remove the test lung, connect Insp. port and pressure Exp. port directly with a tube. 2. Don’s start PUT too quickly after quit from ventilation. 3. Calibrate the pressure, flow rate sensor, Insp. valve and Exp valve. 4. Proportional solenoid valve can’t close completely. Replace proportional solenoid valve. 5. The amplifier on the mother board is broken. Replace mother board. 6. The input port of external AD chip on the mother board is broken. Replace mother board. 7. The sensor is broken. Replace mother board.
Bit 6
Zero point of expiratory 1. Remove the test lung, connect Insp. port and pressure Exp. port directly with a tube. 2. Don’s start PUT too quickly after quit from ventilation. 3. Calibrate the pressure, flow rate sensor, Insp. valve and Exp valve. 4. Proportional solenoid valve can’t close completely. Replace proportional solenoid valve.
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5. The amplifier on the mother board is broken. Replace mother board. 6. The input port of external AD chip on the mother board is broken. Replace mother board. 7. The sensor is broken. Replace mother board. Bit 7
Barometric pressure
1. Proportional solenoid valve can’t close completely. Replace proportional solenoid valve. 2. The amplifier on the mother board is broken. Replace mother board. 3. The input port of external AD chip on the mother board is broken. Replace mother board. The sensor is broken. Replace mother board.
Bit 8
‐‐
‐‐
Internal AD(0xxxxx 00FF)
Bit 1
‐‐
‐‐
Bit 2
‐‐
‐‐
Bit 3
‐‐
‐‐
Bit 4
‐‐
‐‐
Bit 5 Bit 8
Inspiratory valve AD/DA 1. Poor connection between the mother board sample and daughter board. Re‐plug the daughter board. 2. The daughter board is broken. Replace daughter board.
Bit 6 Bit 7
Expiratory valve AD/DA 1. Poor connection between the mother board sample and daughter board. Re‐plug the daughter board. 2. The driver chip of expiratory valve on the mother board is broken. Replace mother board. 3. The daughter board is broken. Replace daughter board.
Bit 9
‐‐
‐‐
Bit 10
‐‐
‐‐
Bit 11
‐‐
‐‐
Bit 12
‐‐
‐‐
Bit 13
‐‐
‐‐
Bit 14
‐‐
‐‐
Bit 15
‐‐
‐‐
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1. Error Codes in the Log Error Code
Test Point
Possible Reason and Recommended Action
1000
PS board 7.5V DC
The 7.5 V out is out of range. Replace PS board.
PS board LDO3.3V DC
The 3.3V LDO output is out of range. Replace PS board.
PS board 12V DC
The 12V output is out of range. Replace PS board.
PS board Analog 3.3V DC
The 3.3V output is out of range. Replace PS board.
1001 1002 1004
1013
Temperature sensor in the PS board 1. Sensor failed. Replace W17. (Malfunction) 2. PS board failed. Replace PS board.
2000
12V DC on UIC board
The 12V out is out of range. Replace PS board.
2001
5V DC on UIC board
The 5V out is out of range. Replace PS board.
2003
Alarm Speaker in the UIC Check if the alarm speaker in the screen is board short disconnected or short.
2004
Alarm Speaker in the UIC board open Data check
3000
Data files are broken in the embedded computer of UI. Configurations, previous patient’s data, logs, trends data may be lost, and the manufactory default settings will be applied. Check these data and re‐configure them if necessary.
Communication failure Check if the MCU of BDU, PS and UIC are working. between BDU to UI Make sure cables linking to the BDU, PS and UIC Communication failure are OK. 3005: Replace the daughter board between PS board to UI Communication failure 3006: Replace the PS board between UIC board to UI 3007: Replace the UIC board
3005 3006 3007
9.1.2 Other Errors Alarm 1) Communication Check if the UI are working. sound failure between UI to Make sure the cable linking to the PS board is OK. from PS board Replace power supply board. buzzer in 2) No AC and battery the PS connected board
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9.1.3 Service Tools Service tools are listed underside: Sequence number
Name
Quantity
Remark
1
Metric hex driver set
One set
2
#2cross screwdriver
One entries
Staff width is about 5mm
3
Multi‐meter
One block
4
V8800 checkout frock and its attachments for ESD (Electro‐Static Discharge) protection)
One desk
If anyone of the electric machine, electric machine driver and the main board is replaced
5
Breath pipeline cover bag
One set
6
Simulated lung
One entries
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10 Appendix A Contact & Ordering Information How to Call for Service This service manual provides procedures for testing and maintaining the Ventilator V8800. It is not intended to be a complete maintenance document; therefore, it contains no disassembly or reassembly instructions. Refer any repairs or adjustments that exceed the scope of this manual to the Service Center of Oricare Inc., by calling 800‐810‐8333. This manual contains proprietary information. It is intended for use only by individuals qualified in the installation and maintenance of the Oricare anesthetic machine. Receipt, purchase, or possession of this document in no way confers or transfers any other rights for the use of this information. Disclosure or reproduction of the enclosed, without the written permission of Oricare Inc. is prohibited. This manual is intended for use only by technicians who have successfully completed Oricare, Inc. training on this product. Oricare, Inc. believes the information herein is accurate but accepts no responsibility for errors, omissions, or misrepresentation.
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11 Appendix B Diagrams and Schematics
Pneumatic diagram P a g e | 103
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12 Appendix C Specifications System Operating Conditions Operating Temperature Range: +10 to +40 C Relative Humidity: 15 to 95% non‐condensing Atmospheric Pressure: 500 to 1060 hPa Non‐operating Conditions Storage Temperature Range: ‐20 to +60 C Storage Relative Humidity: 5 to 95% non‐condensing Storage Atmospheric Pressure: 500 to 1060 hPa Power Supply Power Supply, Automatic Range Selection Battery Backup, Internal (Standard) Battery Backup, Extended (Optional) Maximum Power Consumption 100‐120 +/‐ 10%, 220‐240 +/‐ 10% VAC 50/60 Hz Two rechargeable battery modules, 12 V, 2.3 Ah each. Recharge time approximately 4 hours. Battery backup time of 60 minutes minimum with only standard internal battery. Two rechargeable battery modules 12 V, 5 Ah each. Recharge time approximately 12 hours for both the Internal and Extended batteries together. Battery backup time of 3 hours minimum for both the internal and external batteries. At 110‐120 VAC: 2A, 150VA (Ventilator only); 15 A (Ventilator plus Auxiliary Outlets) At 220‐240 VAC: 1A, 150VA (Ventilator only); 7.5 A (Ventilator plus Auxiliary Outlets) CAUTION: The Power Supply should meet the above specifications.
Ventilator General Dimensions User Interface: 406 wide x 70 deep x 289 high (mm) Ventilation Delivery Unit: 460 wide x 504 deep x 669 high (mm) System with Cart (optional): 774 wide x 624 deep x 1410 high (mm) Weight : Total: 60 kg (Approximate) User Interface: 3 kg Ventilation Delivery Unit: 27 kg Cart: 30 kg Trigger: Flow and Pressure Method Maximum 110 cm H2O Limited pressure Maximum 100 cm H2O, ensured by high pressure limit Working pressure 90 cm H2O, pressure ventilation Sub‐atmospheric pressure：In the expiratory phase (‐40 cm H2O) P a g e | 104
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Gas Supply Supplied gases must be free of water, oil and particles Inlet Gas Pressure : O2, Air: 200 kPa to 650 kPa (29 – 94 PSI) Connection Standards Available DISS, NIST Patient System Connectors Male 22 mm Conical Fittings in accordance with ISO 5356‐1 User Interface Attaches to the cart, a rail, or other mounting system. Standard Conditions Specifications Error ranges in this document assume the following standard conditions: Ambient pressure: 101.3 kPa (1 atmosphere) Room temperature: 20 C Dry gases in patient system Inlet pressure: 345 kPa (50 PSI) Inspiratory Channel Pressure Drop : Maximum 5 cm H2O at a flow of 60 liters/min without CO2 airway adapter. Compliance : Maximum 2 ml/cm H2O (with Fisher & Paykel MR 810 humidifier and reusable silicone adult patient circuit) Gas Delivery System Microprocessor controlled valves Gas Delivery Device Flow Range: 1 to 180 liters/min. (Adult) 0 to 60 liters/min. (Child) Maximum Pressure Setting: 90 cm H2O NIV Max leakage compensation level Adult: 30 liters/min Child: 15 liters/min Expiratory Channel Pressure Drop (Resistance) Maximum 5 cm H2O at a flow of 60 liters/min without CO2 airway adapter. Compliance Maximum 2 ml/cm H2O (with Fisher & Paykel MR 810 humidifier and reusable silicone adult patient circuit) PEEP Regulation Microprocessor controlled valve PEEP Setting Range : 0 – 50 cm H2O Expiratory Flow Measurements Range: 0 – 180 liters/min. Monitoring Expiratory Minute Volume Range: 0 – 60 liters/min. Accuracy: +/‐ 0.5 LPM or +/‐ 8% of measured value (whichever is greater)
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Resolution: 0.1 liters > 1 liter/min, 0.001 liters
