SV300/350 Ventilator
Service Manual
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this product and this manual. This manual
may refer to information protected by copyrights or patents and does not convey any license
under the patent rights of Mindray, nor the rights of others. Mindray does not assume any
liability arising out of any infringements of patents or other rights of third parties.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution,
rent, adaption and translation of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
、
and
are the registered trademarks or trademarks owned by
Mindray in China and other countries. All other trademarks that appear in this manual are
used only for editorial purposes without the intention of improperly using them. They are the
property of their respective owners.
Contents of this manual are subject to changes without prior notice.
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject
to change without prior notice. Revision 1.0 is the initial release of the document.
„
Revision number: 3.0
„
Release time:
2016-07
© Copyright 2014-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights
reserved.
I
Preface
Manual Purpose
This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not
intended to be a comprehensive, in-depth explanation of the product architecture or technical
implementation. Observance of the manual is a prerequisite for proper equipment
maintenance and prevents equipment damage and personal injury.
This manual is based on the maximum configuration. Therefore, some contents may not
apply to your monitor. If you have any question, please contact our Customer Service
Department.
Intended Audience
This manual is geared for biomedical engineers, authorized technicians or service
representatives responsible for troubleshooting, repairing and maintaining the ventilator
machines.
Password
A password is required to access different modes within the ventilator machine.
„
User maintenance: 1234
„
Factory maintenance: 1118
II
Table of Contents
1 Safety ................................................................................................................................. 1-1
1.1 Safety Information .......................................................................................................... 1-1
1.1.1 Dangers .............................................................................................................. 1-2
1.1.2 Warnings ............................................................................................................ 1-2
1.1.3 Cautions ............................................................................................................. 1-5
1.1.4 Notes .................................................................................................................. 1-7
1.2 Equipment Symbols ........................................................................................................ 1-7
2 Theory of Operation ........................................................................................................ 2-1
2.1 Pneumatic Circuit ............................................................................................................ 2-1
2.1.1 Overview of the Pneumatic System ................................................................... 2-1
2.1.2 Pneumatic Circuit Diagram ................................................................................ 2-2
2.1.3 Theory of Operation of the Pneumatic Subsystem ............................................. 2-5
2.2 Electrical Circuit ........................................................................................................... 2-19
2.2.1 Overview of the Hardware Boards ................................................................... 2-19
2.2.2 Electrical Circuit Diagram ............................................................................... 2-21
2.2.3 Power Supply System ...................................................................................... 2-22
2.2.4 Board Function ................................................................................................. 2-24
3 Checkout and Test ............................................................................................................ 3-1
3.1 System Inspection ........................................................................................................... 3-1
3.2 Power Failure Alarm Test (External Power and Buzzer) ................................................ 3-1
3.3 O2 Pipeline Test .............................................................................................................. 3-2
3.4 System Test ..................................................................................................................... 3-2
3.5 Spontaneous Breathing Test ............................................................................................ 3-3
3.6 Humidifier Performance Test .......................................................................................... 3-3
3.7 Alarm Tests...................................................................................................................... 3-3
3.7.1 Prepare for Alarm Tests ...................................................................................... 3-3
3.7.2 Battery in Use Alarm Test .................................................................................. 3-3
3.7.3 Power Failure Alarm Test ................................................................................... 3-4
3.7.4 Paw Too High Alarm Test .................................................................................. 3-4
3.7.5 TVe Too High Alarm Test................................................................................... 3-4
3.7.6 TVe Too Low Alarm Test ................................................................................... 3-4
3.7.7 MV Too High Alarm Test ................................................................................... 3-4
3.7.8 MV Too Low Alarm Test ................................................................................... 3-5
3.7.9 PEEP Too Low Alarm Test ................................................................................. 3-5
3.7.10 Airway Obstructed Alarm Test ......................................................................... 3-5
3.7.11 Apnea Alarm Test ............................................................................................. 3-5
3.7.12 ftotal Too High Alarm Test ............................................................................... 3-5
3.7.13 FiO2 Too High Alarm Test ............................................................................... 3-6
3.7.14 FiO2 Too Low Alarm Test................................................................................ 3-6
1
3.7.15 EtCO2 Too High Alarm Test ............................................................................ 3-6
3.7.16 EtCO2 Too Low Alarm Test ............................................................................. 3-6
3.7.17 SpO2 Too High Alarm Test .............................................................................. 3-7
3.7.18 SpO2 Too Low Alarm Test ............................................................................... 3-7
3.7.19 PR Too High Alarm Test .................................................................................. 3-7
3.7.20 PR Too Low Alarm Test ................................................................................... 3-7
3.8 Function Tests ................................................................................................................. 3-8
3.8.1 Checking the Standard Working Mode .............................................................. 3-8
3.8.2 Checking the Tidal Volume ................................................................................ 3-8
3.8.3 Checking the Trigger Function........................................................................... 3-8
3.8.4 Checking Spontaneous Breathing in CPAP/PSV Mode ..................................... 3-8
3.8.5 Sidestream CO2 Test and Calibration ................................................................ 3-8
3.8.6 Mainstream CO2 Test....................................................................................... 3-10
3.8.7 SpO2 Test ..........................................................................................................3-11
3.8.8 Checking the Special Functions ........................................................................3-11
3.9 Electrical Safety Inspection........................................................................................... 3-12
3.9.1 Electrical Safety Inspection Test ...................................................................... 3-12
3.9.2 Electrical Safety Inspection Form .................................................................... 3-13
4 Maintenance Menu and Software Upgrade ................................................................... 4-1
4.1 User Maintenance ........................................................................................................... 4-1
4.1.1 Overview ............................................................................................................ 4-1
4.1.2 Setting ................................................................................................................ 4-1
4.1.3 Defaults Settings ................................................................................................ 4-2
4.1.4 Data Transfer ...................................................................................................... 4-2
4.1.5 Interface Setting ................................................................................................. 4-4
4.1.6 System Information ............................................................................................ 4-5
4.1.7 CO2 Maintenance............................................................................................... 4-6
4.2 Factory Maintenance ....................................................................................................... 4-7
4.2.1 Overview ............................................................................................................ 4-7
4.2.2 Factory Setup ..................................................................................................... 4-7
4.2.3 Factory Calibration........................................................................................... 4-13
4.2.4 Calibration Data ............................................................................................... 4-14
4.2.5 Data Monitoring ............................................................................................... 4-15
4.2.6 Diagnosis Test .................................................................................................. 4-16
4.2.7 Event Logbook ................................................................................................. 4-17
4.3 Software Upgrade and Software Function Activation ................................................... 4-18
4.3.1 Network Upgrade ............................................................................................. 4-18
4.3.2 USB Memory Upgrade .................................................................................... 4-28
4.3.3 Function Activation .......................................................................................... 4-31
4.3.4 Function Trial ................................................................................................... 4-35
5 Maintenance and Calibration ......................................................................................... 5-1
5.1 Equipment Maintenance.................................................................................................. 5-1
2
5.1.1 One-year Replaceable Parts ............................................................................... 5-2
5.1.2 Periodically-Maintained Parts ............................................................................ 5-6
5.2 System Test ..................................................................................................................... 5-7
5.2.1 System Check ..................................................................................................... 5-8
5.2.2 Check the Mechanical Ventilation State ........................................................... 5-10
5.2.3 Check the Correctness of Sensor Zero Point .................................................... 5-12
5.2.4 Check the Accuracy of Flow Sensor ................................................................ 5-13
5.2.5 Check the Accuracy of Pressure Sensor ........................................................... 5-14
5.3 System Calibration ........................................................................................................ 5-16
5.3.1 Flow Calibration (User) ................................................................................... 5-20
5.3.2 Flow Calibration (Factory) ............................................................................... 5-21
5.3.3 O2% Calibration (User) ................................................................................... 5-25
5.3.4 O2% Calibration (Factory) ............................................................................... 5-26
5.3.5 Mainstream CO2 Zeroing (User) ..................................................................... 5-27
5.3.6 Sidestream CO2 Zeroing (User)....................................................................... 5-28
5.3.7 Sidestream CO2 Calibration (User) ................................................................. 5-28
5.3.8 Pressure and Flow Zeroing (User) ................................................................... 5-29
5.3.9 Pressure and Flow Zeroing (Factory) ............................................................... 5-30
5.3.10 Pressure Calibration (Factory) ....................................................................... 5-33
5.3.11 Expiratory Valve Calibration (Factory) .......................................................... 5-46
5.3.12 Air and O2 Calibration (Factory) ................................................................... 5-49
6 Troubleshooting ................................................................................................................ 6-1
6.1 Introduction ..................................................................................................................... 6-1
6.2 Troubleshoot System Check Failures .............................................................................. 6-1
6.3 Technical Alarms and Diagnosis ..................................................................................... 6-4
6.3.1 Main Board Related Technical Alarms............................................................... 6-4
6.3.2 Keyboard Related Technical Alarms .................................................................. 6-5
6.3.3 VCM Related Technical Alarms......................................................................... 6-5
6.3.4 Auxiliary Monitor Board Related Technical Alarms .......................................... 6-9
6.3.5 Power Board Related Technical Alarms ........................................................... 6-10
6.3.6 CO2 Related Technical Alarms .........................................................................6-11
6.3.7 SpO2 Related Technical Alarms....................................................................... 6-12
6.4 Failure Code Table ........................................................................................................ 6-13
6.5 Error Information .......................................................................................................... 6-18
6.6 Diagnostic Test .............................................................................................................. 6-19
6.6.1 Preparations before Using the Valve Test Tool................................................. 6-19
6.6.2 Correspondence between the Sensors & Valves on the Valve Test Screen and the
Components .............................................................................................................. 6-19
6.6.3 Troubleshooting Methods by Using Valve Test Tool ....................................... 6-21
6.7 Pneumatic System Failures ........................................................................................... 6-25
6.7.1 Commonly Used Devices and Tools ................................................................ 6-25
6.7.2 Pneumatic Failures List .................................................................................... 6-26
6.7.3 Gas Supply Subsystem ..................................................................................... 6-29
3
6.7.4 Blower Fan and Flow Control Subsystem........................................................ 6-33
6.7.5 Safety Valve Assembly ..................................................................................... 6-36
6.7.6 Expiration Valve Assembly .............................................................................. 6-38
6.7.7 O2 Sensor Has Great Measurement Error ........................................................ 6-40
6.8 Hardware and Electrical System Failures ..................................................................... 6-41
7 Repair and Disassembly .................................................................................................. 7-1
7.1 Prepare for Disassembly ................................................................................................. 7-2
7.1.1 Tools ................................................................................................................... 7-2
7.1.2 Preparations ........................................................................................................ 7-2
7.2 Disassemble the Service Parts ......................................................................................... 7-3
7.2.1 Remove the Lithium Battery .............................................................................. 7-3
7.2.2 Replace the O2 Sensor ....................................................................................... 7-4
7.2.3 Remove the HEPA Filter and Fan Dust Screen .................................................. 7-4
7.2.4 Remove the Main Unit Dust Screen ................................................................... 7-5
7.2.5 Remove the Disinfectable Expiratory Valve Assembly and Safety Valve
Detachable Part ........................................................................................................... 7-6
7.2.6 Remove the Expiratory Valve Diaphragm and Expiratory Check Valve ............ 7-7
7.2.7 Remove the Parts of the Disinfectable Part of the Safety Valve ........................ 7-7
7.2.8 Remove the Upper Housing Assembly .............................................................. 7-8
7.2.9 Remove the Speaker........................................................................................... 7-9
7.2.10 Remove the WIFI Module (Optional) .............................................................. 7-9
7.2.11 Remove the SpO2 Module (optional)............................................................... 7-9
7.2.12 Remove the Display Assembly ...................................................................... 7-10
7.2.13 Remove the Main Unit Front Housing ........................................................... 7-10
7.2.14 Remove the Monitoring Board Assembly .......................................................7-11
7.2.15 Remove the Display Rear Housing and Key Control Board .......................... 7-12
7.2.16 Remove the Alarm Light Board ..................................................................... 7-13
7.2.17 Remove the Display Assembly ...................................................................... 7-14
7.2.18 Remove the Touchscreen ............................................................................... 7-14
7.2.19 Remove the Encoder ...................................................................................... 7-15
7.2.20 Replace the Pressure Sensor Filter ................................................................. 7-15
7.2.21 Remove the Safety Valve Seat Assembly ....................................................... 7-16
7.2.22 Remove the Electromagnet ............................................................................ 7-17
7.2.23 Remove the Air Flow Sensor ......................................................................... 7-17
7.2.24 Remove the Sensor Adapter Board ................................................................ 7-17
7.2.25 Remove the O2 Sensor Seat Assembly .......................................................... 7-18
7.2.26 Remove the Kernel Assembly ........................................................................ 7-18
7.2.27 Remove the AC-DC Power Board ................................................................. 7-20
7.2.28 Remove the DC-DC Power Board ................................................................. 7-21
7.2.29 Remove the Fan.............................................................................................. 7-22
7.2.30 Remove the AC Power Socket ....................................................................... 7-22
7.2.31 Remove the DC Input Socket ......................................................................... 7-23
7.2.32 Remove the Expiratory Valve Seat Assembly ................................................ 7-24
4
7.2.33 Remove the Expiratory Valve Voice Coil Motor ............................................ 7-24
7.2.34 Remove the Sidestream CO2 Module (optional) ........................................... 7-24
7.2.35 Remove the Blower Box Assembly ............................................................... 7-25
7.2.36 Remove the Vacuum Sensor Board ................................................................ 7-27
7.2.37 Remove the Inspiratory Valve Assembly ....................................................... 7-28
7.2.38 Remove the Filter Net for Inspiratory Valve .................................................. 7-29
7.2.39 Remove the O2 Inlet Assembly ...................................................................... 7-29
7.2.40 Remove the Proportional Valve and Nebulizer Valve .................................... 7-31
7.2.41 Remove the Pressure Regulator Assembly..................................................... 7-32
7.2.42 Remove the O2 Flow Sensor.......................................................................... 7-33
7.2.43 Remove the Low Pressure O2 Connector ...................................................... 7-34
7.2.44 Remove the Battery Adapter Board ............................................................... 7-34
7.2.45 Remove the Rear Housing Assembly ............................................................. 7-35
7.2.46 Remove the CO2 Parameter Connector Panel (optional) ............................... 7-36
7.2.47 Remove the WIFI Antenna (optional) ............................................................ 7-36
7.2.48 Remove the SpO2 Connector (optional) ........................................................ 7-37
7.2.49 Remove the Trolley Support Table Assembly ................................................ 7-38
7.2.50 Remove the Trolley Handle Assembly ........................................................... 7-38
7.2.51 Remove the Trolley Column .......................................................................... 7-39
7.2.52 Remove the Trolley Base Assembly............................................................... 7-39
7.2.53 Remove the Humidifier Fixing Assembly ...................................................... 7-40
7.2.54 Remove the Trolley Cylinder Fixing Assembly ............................................. 7-40
7.2.55 Remove the Trolley Lock Control Assembly ................................................. 7-41
8 Electrical and Pneumatic Connections........................................................................... 8-1
8.1 Pneumatic Connection .................................................................................................... 8-1
8.1.1 Pneumatic Connection Diagram......................................................................... 8-1
8.1.2 Tubes List ........................................................................................................... 8-2
8.2 Electrical Connection ...................................................................................................... 8-3
8.2.1 Electrical Connection Diagram .......................................................................... 8-3
8.2.2 Electrical Connection List .................................................................................. 8-4
9 Parts .................................................................................................................................. 9-1
9.1 SV300/350/SV350 Ventilator Main Unit Assembly ....................................................... 9-1
9.1.1 Exploded View ................................................................................................... 9-1
9.1.2 Parts List ............................................................................................................ 9-1
9.2 Display Assembly ........................................................................................................... 9-2
9.2.1 Exploded View ................................................................................................... 9-2
9.2.2 Parts List ............................................................................................................ 9-2
9.3 Display Front Housing Assembly ................................................................................... 9-3
9.3.1 Exploded View ................................................................................................... 9-3
9.3.2 Parts List ............................................................................................................ 9-3
9.4 Kernel Assembly ............................................................................................................. 9-4
9.4.1 Exploded View ................................................................................................... 9-4
5
9.4.2 Parts List ............................................................................................................ 9-5
9.5 Main Unit Bracket Assembly .......................................................................................... 9-6
9.5.1 Exploded View ................................................................................................... 9-6
9.5.2 Parts List ............................................................................................................ 9-6
9.6 Main Unit Rear Housing Assembly ................................................................................ 9-7
9.6.1 Exploded View ................................................................................................... 9-7
9.6.2 Parts List ............................................................................................................ 9-7
9.7 O2 Inlet Assembly（NIST） .......................................................................................... 9-8
9.7.1 Exploded View ................................................................................................... 9-8
9.7.2 Parts List ............................................................................................................ 9-8
9.8 O2 Inlet Assembly（DISS） .......................................................................................... 9-9
9.8.1 Exploded View ................................................................................................... 9-9
9.8.2 Parts List ............................................................................................................ 9-9
9.9 Expiration Valve Assembly ........................................................................................... 9-10
9.9.1 Exploded View ................................................................................................. 9-10
9.9.2 Parts List .......................................................................................................... 9-10
9.10 Safety Valve Assembly .................................................................................................9-11
9.10.1 Exploded View ................................................................................................9-11
9.10.2 Parts List .........................................................................................................9-11
9.11 Safety Valve Base Assembly ....................................................................................... 9-12
9.11.1 Exploded View ............................................................................................... 9-12
9.11.2 Parts List......................................................................................................... 9-12
9.12 Safety Valve Detachable Part ...................................................................................... 9-13
9.12.1 Exploded View ............................................................................................... 9-13
9.12.2 Parts List ........................................................................................................ 9-13
9.13 Exp. Flow Sensor Sampling Seat Assembly ............................................................... 9-14
9.13.1 Exploded View ............................................................................................... 9-14
9.13.2 Parts List ........................................................................................................ 9-14
9.14 Disinfectable Expiration Valve Assembly ................................................................... 9-15
9.14.1 Exploded View ............................................................................................... 9-15
9.14.2 Parts List ........................................................................................................ 9-15
9.15 Blower Box Assembly................................................................................................. 9-16
9.15.1 Exploded View ............................................................................................... 9-16
9.15.2 Parts List ........................................................................................................ 9-16
9.16 Inspiration Valve Assembly......................................................................................... 9-17
9.16.1 Exploded View ............................................................................................... 9-17
9.16.2 Parts List ........................................................................................................ 9-17
9.17 Trolley Assembly ........................................................................................................ 9-18
9.17.1 Exploded View ............................................................................................... 9-18
9.17.2 Parts List ........................................................................................................ 9-18
9.18 Trolley Handle Assembly ............................................................................................ 9-19
9.18.1 Exploded View ............................................................................................... 9-19
9.18.2 Parts List ........................................................................................................ 9-19
9.19 Trolley Support Platform Assembly ............................................................................ 9-20
6
9.19.1 Exploded View ............................................................................................... 9-20
9.19.2 Parts List ........................................................................................................ 9-20
9.20 Trolley Base Assembly................................................................................................ 9-21
9.20.1 Exploded View ............................................................................................... 9-21
9.20.2 Parts List ........................................................................................................ 9-21
9.21 Trolley Gas Cylinder Fixed Assembly ........................................................................ 9-22
9.21.1 Exploded View ............................................................................................... 9-22
9.21.2 Parts List ........................................................................................................ 9-22
A Mindray SV300/350 Preventive Maintenance Report..................................................A-1
A.1 Check before Preventive Maintenance ...........................................................................A-1
A.2 Preventive Maintenance .................................................................................................A-2
A.3 Test after Preventive Maintenance .................................................................................A-3
A.4 Remarks .........................................................................................................................A-5
7
FOR YOUR NOTES
8
1 Safety
1.1 Safety Information
DANGER
z
Indicates an imminent hazard that, if not avoided, will result in death or serious
injury.
WARNING
z
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
death or serious injury.
CAUTION
z
Indicates a potential hazard or unsafe practice that, if not avoided, could result in
minor personal injury or product/property damage.
NOTE
z
Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may
be given in the respective sections of this manual.
1.1.2 Warnings
WARNING
z
The ventilator must only be operated and used by authorized medical personnel
well trained in the use of this product. It must be operated strictly following the
Operator’s Manual.
z
Before putting the system into operation, the operator must verify that the
equipment, connecting cables and accessories are in correct working order and
operating condition.
z
To avoid the risk of electric shock, this equipment must be connected to a properly
installed power outlet with protective earth contacts only. If the installation does
not provide for a protective earth conductor, disconnect it from the power line.
z
Use external power source (AC power or DC power) before the batteries are
depleted.
z
To avoid explosion hazard, do not use the equipment in the presence of flammable
anesthetic agent, vapors or liquids. When O2 is used, keep the ventilator away
from any fire sources.
z
Do not place the ventilator adjacent to any barrier, which can prevent cold air
from flowing, resulting in equipment overheat.
z
Do not open the equipment housings. All servicing and future upgrades must be
carried out by the personnel trained and authorized by us only.
z
Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level may result in a hazard to the patient.
Remember that alarm settings should be customized according to different patient
situations and always keeping the patient under close surveillance is the most
reliable way for safe patient monitoring.
z
The physiological parameters and alarm messages displayed on the screen of the
equipment are for doctor’s reference only and cannot be directly used as the basis
for clinical treatment.
z
Dispose of the package material, observing the applicable waste control regulations
and keeping it out of children’s reach.
1-2
WARNING
z
All staff should be aware that disassembling or cleaning some parts of the
ventilator can cause risk of infection.
z
Maintenance mode can only be used when the equipment is disconnected from the
patient.
z
Positive pressure breathing may be accompanied by some side effects such as
barotrauma, hypoventilation, hyperventilation etc.
z
Using the ventilator in the vicinity of high-frequency electrosurgery units,
defibrillators or short-wave therapy equipment may impair correct functioning of
the ventilator and endanger the patient.
z
Do not use antistatic or conductive masks or breathing tubes. They can cause burns
if they are used near high frequency electrosurgical equipment.
z
Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard
due to an oxygen-enriched environment.
z
If the equipment internal monitoring system malfunctions, an alternative plan
must be available to ensure adequate level of monitoring. The operator of the
ventilator must be responsible for proper patient ventilation and safety under all
circumstances.
z
As required by the relevant rules and regulations, oxygen concentration should be
monitored when the equipment is used on the patient. If your ventilator is not
configured with such monitoring function or this function is turned off, use a
monitor which complies with the requirements of ISO 80601-2-55 for oxygen
concentration monitoring.
z
All analog or digital products connected to this system must be certified passing the
specified IEC standards (such as IEC 60950 for data processing equipment and
IEC 60601-1 for medical electrical equipment). All configurations shall comply
with the valid version of IEC 60601-1. The personnel who are responsible for
connecting the optional equipment to the I/O signal port shall be responsible for
medical system configuration and system compliance with IEC 60601-1 as well.
z
Do not touch the patient when connecting the peripheral equipment via the I/O
signal ports or replacing the oxygen cell to prevent patient leakage current from
exceeding the requirements specified by the standard.
z
This equipment is not suitable for use in an MRI environment.
z
When the ventilator gas supply input system fails or has faults, please contact us
immediately for specified personnel to service the ventilator.
z
The ventilator shall not be used with helium or mixtures with Helium..
z
Do not move the ventilator before removing the support arm from it, in order to
avoid the ventilator getting tilted during the movement.
z
Do not block the air intake vent at the back of the ventilator.
1-3
WARNING
z
To prevent interrupted operation of the ventilator due to electromagnetic
interference, avoid using it adjacent to or stacking other devices on it. If adjacent
or stacked use is necessary, verify the ventilator’s normal operation in the
configuration in which it will be used.
z
To prevent possible personal injury and equiment damage, make sure that the
ventilator is secured to the trolley or placed on the safe and smooth surface.
z
To prevent possible equiment damage, avoid tipping over the ventilator when
crossing thresholds.
z
To prevent possible equiment damage, step down the brake when parking the
ventilator.
z
Avoid use of polluted Air. When the equiment uses Air as gas source for
ventilation, if the Air is polluted, harmful substance may enter the patient tubes.
z
To prevent patient injury caused by equipmpment malfunction, when the alarm
[Technical Error**] occurs, remove the equipment immediately, record failure
code, and contact the Customer Service Department.
z
To prevent possible ventilator malfunction, do not spill liquid onto the ventilator.
z
A turbofan can cause gas to be heated. To reduce the temperature of gas inside the
tube and prevent patient injury accordingly, make sure that the lenght of patient
tube from the humidifier to Y piece is greater than 1.2m.
z
The internal electrical power source is to be used if the integrity of the protective
earth conductor or the protective earthing system in the installation is in doubt.
z
Nebulization or humidification can increase the resistance of breathing system
filters and that you need to monitor the filter frequently for increased resistance
and blockage.
z
The ventilation accuracy can be affected by the gas added by use of a nebulizer.
z
The ventilator shall not be used with nitric oxide.
z
For non-invasive ventilation, the exhaled volume of the patient can differ from the
measured exhaled volume due to leaks around the mask.
z
Check if the alarm limit settings are appropriate before taking measurement.
z
The mains plug is used to isolate the ventilator circuits electrically from the
SUPPLY MAINS，not to position the ventilator so that it is difficult to operate the
plug.
z
No modification of this equipment is allowed.
z
Failure to have an alternative means of ventilation such as a self-inflating,
manually-powered resuscitator(as specified in ISO 10651-4) with mask can result
in PATIENT death if the VENTILATOR fails.
z
Stop using the ventilator and contact us immediately when the buzzer alarms.
1-4
WARNING
z
Under the ambient temperature of 40℃, the inspiratory pressure of the ventilator
exceeds 60cmH2O, and the maximum temperature on the surface of breathing
mask may exceed 41℃ but does not exceed 43℃.
z
When the ventilator is restalled, or main control board is repalced, perform flow
calibration (factory).
1.1.3 Cautions
CAUTION
z
The ventilator must be inspected and serviced regularly by trained service
personnel.
z
To ensure patient safety, always prepare pulmotor for use.
z
Always have a special person attend and monitor the operation of the equipment
once the ventilator is connected to the patient.
z
During the operation of the ventilator, do not disassemble the inspiratory safety
valve and expiration valve unless in standby mode.
z
To ensure patient safety, use only parts and accessories specified in this manual.
z
At the end of its service life, the equipment, as well as its accessories, must be
disposed of in compliance with the guidelines regulating the disposal of such
products.
z
Magnetic and electrical fields are capable of interfering with the proper
performance of the equipment. For this reason make sure that all external devices
operated in the vicinity of the equipment comply with the relevant EMC
requirements. Mobile phone, X-ray equipment or MRI devices are a possible
source of interference as they may emit higher levels of electromagnetic radiation.
z
This system operates correctly at the electrical interference levels identified in this
manual. Higher levels can cause nuisance alarms that may stop mechanical
ventilation. Pay attention to false alarms caused by high-intensity electrical fields.
z
Before connecting the equipment to the power line, check that the voltage and
frequency ratings of the power line are the same as those indicated on the
equipment’s label or specified in this manual.
z
Always install or carry the equipment properly to avoid damage caused by drop,
impact, strong vibration or other mechanical force.
z
To electrically isolate the ventilator circuits from all poles of the supply mains
simultaneously, disconnect the mains plug.
1-5
CAUTION
z
To minimize the risk of fire, do not use low-pressure gas tubes that are worn or
contaminated with combustible materials like grease or oil.
z
It is the clinician’s responsibility to ensure that all ventilator settings are
appropriate.
z
To prevent possible patient injury, make sure the ventilator is set up for
appropriate patient type with the appropirate breathing tubes. Make sure the flow
sensor calibration and the system check are performed before you use the
ventilator.
z
To prevent possible patient injury, make sure the ventilation parameters is set up
properly before ventilating the patient.
z
To ensure the accuracy of oxygen monitoring, replace an exhausted oxygen cell as
soon as possible or use an external monitor that complies with ISO 80601-2-55.
z
A fan failure could result in oxygen enrichment inside the ventilator and a
subsequent fire hazard.
z
To reduce the risk of explosion, do not burn the O2 cell or force the cell open.
z
When ventilating with a mask, avoid high airway pressures. High pressures may
cause gastric distension.
z
Peak pressures exceeding 33 cmH2O may increase the risk of aspiration due to
gastric insufflation. When ventilating with such pressures, consider using an
invasive mode.
z
To reduce the risk of fire, use only tube systems approved for medical purposes
and for use with oxygen between the oxygen source and ventilator.
z
To reduce the risk of fire, ensure adequate ventilation at the rear of the ventilator.
z
To reduce the risk of fire, switch off the oxygen source when the ventilator is not in
a ventilating mode.
z
Avoid putting the ventilator in the storage environment of more than 50℃ for a
long time. Such enviroment may damage or shorten the battery life of internal
battery and oxygen sensor.
z
Use the original packing materials to ship the ventilator.
z
To prevent fire hazard, use only specified fuses or fuses with the same type, rated
voltage, and rated current to the existing fuses. When replacing fuses, contact the
Customer Service Department.
z
The ventilator is intended to be used in the patient environment.
z
Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be
connected to the system.
z
Before the ventilator is used for transfer, make sure its casters and brakes are in
good condition.
1-6
1.1.4 Notes
NOTE
z
Put the ventilator and its accessories in a location where you can easily see the
screen and access the operating controls.
z
Keep this manual close to the equipment so that it can be obtained conveniently
when needed.
z
The software was developed in compliance with IEC 62304. The possibility of
hazards arising from software errors is minimized.
z
This manual describes all features and options. Your equipment may not have all
of them.
1.2 Equipment Symbols
Battery
Fuse
AC/DC power
indicator light
Direct current input
port
RS-232 connector
Nebulizer connector
VGA output
connector
Oxygen sensor
connector
Network connector
USB connector
Power switch
Nurse call connector
Lock
Unlock
High-pressure
oxygen supply
connector
Low-pressure
oxygen supply
connector
Ventilator gas outlet
Flow sensor
1-7
Expiration
connector
Inspiration
connector
AUDIO PAUSED
CO2 module
Date of manufacture
Manufacturer
Serial number
Degree of protection
provided by
enclosure
IP21
Caution
Protective earth
ground
no pushing
Refer to the
operator's manual
SpO2 module
Disassemble the O2
sensor
Type BF applied part. Defibrillation-proof protection against electric
shock.
The following definition of the WEEE label applies to EU member
states only.
This symbol indicates that this product should not be treated as
household waste. By ensuring that this product is disposed of
correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more
detailed information with regard to returning and recycling this
product, please consult the distributor from whom you purchased it.
* For system products, this label may be attached to the main unit
only.
The product bears CE mark indicating its conformity with the
provisions of the Council Directive 93/42/EEC concerning medical
devices and fulfils the essential requirements of Annex I of this
directive.
Note：The product complies with the Council Directive 2011/65/EU.
1-8
2 Theory of Operation
2.1 Pneumatic Circuit
2.1.1 Overview of the Pneumatic System
The pneumatic system consists of three parts: inspiratory limb, patient tube, and expiratory
limb. The inspiratory limb can be further divided into gas supply and nebulizing subsystem,
blower and flow control subsystem, and safety valve subsystem.
Gas supply
subsystem
Nebulizing
subsytem
Insp. Blower and flow control
subsystem
limb
Patient
tube
Safety valve subsystem
Exp. limb
As shown above, the patient tube plays the role of bridge between the inspiratory limb and
the expiratory limb. The gas supply and nebulizing subsystem is connected with the patient
tube as required to implement the nebulizing function. These subsystems form a closed
circuit for the ventilator to implement the ventilation management function.
2-1
2.1.2 Pneumatic Circuit Diagram
2.1.2.1 Parts List
Symbol
Name
Function and Index
Air
Low-Pressure
Inlet
Low-pressure Air inlet
Air inlet
O2
Low-Pressure
Inlet
Low-pressure O2 inlet
O2 connector, quick connector, compatible
with (CPC) PMC series
O2
High-Pressure
Inlet
High-pressure O2 inlet
O2 connector, NIST/DISS optional, supply gas
pressure is 2.8-6bar
F1
Dust filter
Filters dust in the Air supply
F2
HEPA filter
Filters bacteria and viruses in the Air supply
Pfilter
Pressure sensor
Monitors vacuum at the Air inlet
CV1
Self-closing cut-off valve
Cuts off the connection between the
low-pressure O2 limb of the pneumatic system
and the outside environment when the
ventilator does not connect with the
low-pressure O2.
F3
Filter
Filters foreign substance in the high-pressure
O2 supply
REG
Regulator
Reduces and stabilizes the pressure of
high-pressure O2 supply to 2.0±0.1bar
PSOL
Proportional solenoid valve
High-pressure O2 proportional valve, output
peak flow≥120 L/min@6bar
Q1
O2 flow sensor
Monitors O2 flow
2-2
Symbol
Name
Function and Index
F4
Filter screen
Stabilizes gas flow
SD1
Noise reduction and Air&O2
mixed chamber
Air&O2 mixed channel, reduces the front-end
noise of the blower subsystem
Blower
Turbo blower
Mixes the Air and O2 and improves the
pressure of mixed gas to the preset value
Tblower
Temperature sensor
Monitors the blower temperature
SD2
Noise reduction and Air&O2
mixed chamber
Further mixes the Air and O2 and reduces the
rear-end noise of the blower subsystem
Heat
Exchanger
Heat exchanger
Heat dissipating device of the blower
Inspiratory
valve
Inspiratory valve
Controls the flow in the inspiratory limb
Q2
Flow sensor of the mixed gas
Monitors the flow of mixed gas
OS
O2 sensor
Monitors O2 concentration
F5
Filter screen
Stabilizes gas flow
CV2
Check valve
Prevents gas from flowing in the reverse
direction
SV
Safety valve
Pressure relief and spontaneous inspiratory
channel
F7
Filter for pressure sensor
Protects the pressure sensor
SOL1
Inspiratory pressure zeroing
three-way valve
Performs switchover between inspiratory
pressure measurement and zeroing
PI
Inspiratory pressure sensor
Monitors the pressure in the inspiratory limb
F8
Inspiratory filter
Prevents water vapor and bacteria inside the
patient tube from entering the ventilator
internal pneumatic circuit
Humidifier
Humidifier
Heats and humidifies the patient’s inspired gas
WT1/WT2
Water trap
Collects condensed water inside the tube
NCV
Nebulizer control valve
Controls the on-off of the nebulizer limb
R1
Nebulizer needle valve
Restricts the output flow of the nebulizer limb
Nebulizer
Nebulizer
Device which turns nebulized liquid medicine
into gaseous colloidal particles
F9
Expiratory filter
Prevents water vapor and bacteria inside the
patient tube from entering the expiratory
module
Q3
Expiratory flow sensor
Monitors expiratory gas flow
F10/F11
Filter
Protects pressure zeroing three-way valve
F12
Filter
Protects upstream limb from being polluted by
the exhaled gas
SOL2
Pressure zeroing three-way
valve
Expiratory pressure sensor zeroing and
pressure zeroing in the upstream of expiratory
2-3
Symbol
Name
Function and Index
flow sensor diaphragm
SOL3
Pressure zeroing three-way
valve
Pressure zeroing in the downstream of
expiratory flow sensor diaphragm
PQ3
Differential pressure sensor
Expiratory differential pressure sensor
PE
Expiratory pressure sensor
Expiratory pressure sensor
R2/R3
Flushing resistor
Restricts flushing flow
EV
Expiratory valve
Controls system PEEP or Plimit via voice coil
motor
CV3
Check valve
Ensures unidirectional gas flow
2.1.2.2 Symbols
Gas supply
WT
Filter
Water trap
Humidifier
On-off valve (two-position
two-way solenoid valve)
Regulator
O2
Nebulizer
Humidifier
O2 sensor
P
Pressure sensor
Check valve
R
Resistor
Nebulizer
Q
Flow sensor
Two-position three-way
solenoid valve
Proportional solenoid valve
Temperature sensor
Turbo blower
Vacuum sensor at the Air
inlet
Turbine heat exchanger
Inspiratory valve
/
2-4
/
2.1.3 Theory of Operation of the Pneumatic Subsystem
According to structural composition and function, the pneumatic system of the ventilator can
be broken down into 7 parts as shown below, which are gas supply subsystem, turbo blower
subsystem, flow control subsystem, safety valve subsystem, nebulizing subsystem, patient
tube and expiratory assembly.
Pneumatic system
Patient tube
Insp. assembly
Exp. assembly
Nebulizing subsystem
Safety valve subsystem
Flow control subsystem
Turbo blower subsystem
Gas supply subsystem
2.1.3.1 Gas Supply Subsystem
The schematic diagram of the gas supply subsystem is as shown below. The gas supply
subsystem includes three limbs: high-pressure O2, low-pressure O2, and low-pressure Air.
The room air enters the machine after passing through dust filter F1 and HEPA filer F2. O2
enters the machine after passing through high-pressure O2 limb or low-pressure O2 limb.
Flow sensor Q1 is placed at the outlet where low-pressure O2 and high-pressure O2 converge
to monitor O2 flow entering the machine.
2-5
The gas supply subsystem is the starting part of the ventilator’s pneumatic circuit. It
introduces external O2 and room air into the machine. A dust filter is necessary at the Air
inlet as there is dust and foreign substance inside the room air. Meanwhile, to filter the
bacteria and viruses inside the room air, HEPA filter is placed at the Air inlet to ensure the air
entering the machine is clean and aseptic. After the machine is used or placed for a period of
time, dust or foreign substance may be absorbed on the surfaces of the dust filter at the Air
inlet and HEPA filter. When the dust or foreign substance is accumulated to a certain extent,
occlusion occurs at the Air inlet, which may cause insufficient air intake of the machine. By
placing vacuum sensor Pfilter at the Air inlet, occlusion at the Air inlet can be effectively
monitored. If the Air inlet is occluded and the Air supply pressure is too low, vacuum sensor
Pfilter gives an alarm reminding the user to replace the HEPA filter.
2-6
The following picture shows the position of Air inlet and HEPA filter.
The connector of high-pressure O2 inlet is designed to be NIST/DISS as required by the
standard to prevent misconnection. The connector of low-pressure O2 inlet is designed to be
quick connector which is compatible with (CPC) PMC series and provides pneumatic cut-off
function to prevent gas error between the high-pressure O2 and low-pressure O2 inside the
ventilator. Air passes through the dust filter and HEPA filter to enter the machine. There is no
standard requirement for the type of Air connector and it is designed to be non-standard
connector. The regulator in the high-pressure O2 limb reduces the supply gas pressure and
stabilizes it at 2.0±0.1bar to ensure stable output and good repeatability of solenoid
proportional valve PSOL at the rear end.
2-7
The O2 inlet assembly is as shown below.
High-pressure O2
connector compatible
with NIST/DISS
O2 proportional valve
Nebulizer switch valve
Low-pressure O2 CPC
quick connector
O2 flow sensor
Regulator
Nebulizer outlet
2-8
2.1.3.2 Nebulizing Subsystem
The nebulizing control subsystem controls the on-off of nebulized gas flow via NCV, so as to
realize control of nebulizer by nebulized gas flow (nebulizer needs to be configured
separately and is independent of the ventilator main unit). When applying the nebulizer
function, note that the nebulizing subsystem is enabled only when the system is connected
with high-pressure O2 supply. Check if the machine is already connected with high-pressure
O2 supply before using this function.
The diagram of the nebulizing control subsystem is as shown below.
NCV is a solenoid two-way valve and it has two states: ON and OFF. R1 is a nebulizer
needle valve. It adjusts nebulized gas flow by adjusting the position of the needle valve.
When NCV is connected, O2 of 2.0-6.0bar is at its front end. By adjusting the position of the
needle valve in advance, there is continuous flow of 6-9 L/min at its rear end. Such flow
flows into the nebulizer via the nebulizing nozzle, takes away medicine and finally flows into
the patient. The external structure and size of the nebulizing nozzle comply with BS EN
13544-2_2002 standard.
Nebulizing nozzle
2-9
2.1.3.3 Turbo Blower Subsystem
The schematic diagram of the turbo blower subsystem is as shown below.
The turbo blower subsystem mixes Air and O2 and delivers the mixed gas to the lower level
assembly. The turbo blower subsystem is composed of blower, heat exchanger, oxygen
mixture outlet box assembly, HEPA filter, negative pressure sensor, labyrinth chamber
assembly, additional temperature sensor, shock-absorbent material, and silencing sponge.
The heat exchanger connects with the blower to conduct the heat produced by the blower
outside. Meanwhile, the mixed gas which flows through the blower carries away some heat
produced by the turbo blower subsystem. The temperature of the blower affects the service
life directly. Therefore, the working temperature of the blower is monitored by the additional
temperature sensor (Tblower). If the temperature exceeds the standard, the cooling fan is
speeded up to increase the heat-sinking capability of the blower.
Negative pressure sensor is used for monitoring the actual negative pressure at the inlet of the
turbine. If the negative pressure exceeds 8kPa, the alarm message [Technical Error 06] is
displayed on the screen. And then the HEPA filter must be replaced.
2-10
The structural components of the turbo blower subsystem are as shown below.
Turbine heat
exchanger
Mixed O2 outlet box
HEPA filter
2.1.3.4 Flow Control Subsystem
The chief component of the flow control subsystem is low-pressure large-diameter
inspiratory valve. It controls the opening and closing of the valve port via voice coil motor
and provides the required pressure and flow for the system. The large-diameter inspiratory
valve assembly also provides gas supply for monitoring O2 concentration. The schematic
diagram of the flow control subsystem is as shown below.
2-11
The component structure of the flow control subsystem is as shown below.
Inspiratory valve shell
Encapsulated
filter screen
Voice coil motor
2.1.3.5 Safety Valve Subsystem
The safety valve module is located in the downstream of the inspiratory flow sensor. As the
inspiratory channel of the system, it is connected with the external breathing tubes or other
medical accessories. This module has two functions. One is active pressure relief to prevent
the pressure of the pneumatic system from exceeding the preset pressure. The relief pressure
can be preset as required by the operator. The relief mechanism is controlled by software. The
other is to provide channel for patient’s spontaneous breathing when the system is powered
off or standby, to prevent patient apnea.
The safety valve module closes or opens the safety valve by controlling the power-on/-off of
the electromagnet.
The schematic diagram of the safety valve subsystem is as shown below.
2-12
The corresponding component structure is as shown below.
Safety valve
base assembly
Detachable part of
the safety valve
Electromagnet
Check valve
diaphragm
Safety valve plug
Safety valve
dust-proof pad
Safety valve diaphragm
Safety valve knob
The module has fixed part and detachable part. The fixed part includes electromagnet, safety
valve base, and floating mechanism. This part is fixed to the machine bracket via screws to
support the overall safety valve assembly. The detachable part includes safety valve
diaphragm, safety valve main body, check valve diaphragm, safety valve plug, and safety
valve knob. This part provides controlled breath and spontaneous breathing channel for the
patient. It can be detached without tools by the client for cleaning and disinfection.
The external output port of the safety valve subsystem is the outlet part of the gas reservoir.
This port complies with coaxial 22mm conical connector specified by ISO 5356-2：1987.
2-13
The gas flow of the safety valve includes the following cases:
1.
When the ventilator ventilates normally, the electromagnet is powered on and seals the
valve port. O2 enter the patient via safety valve channel. The gas flow is as shown
below.
2.
When the airway pressure is too high, the electromagnet is powered off and opens the
pressure relief channel actively to ensure patient safety. The gas flow is as shown below.
When the airway pressure returns to normal, the electromagnet is powered on. Gas
flow returns to that described in case 1.
2-14
3.
When the patient breathes spontaneously, the electromagnet is powered off and opens
the pressure relief channel. The patient obtains air from the atmosphere. The gas flow is
as shown below.
4.
When the machine is powered off inadvertently, the electromagnet is powered off and
opens the pressure relief channel to support patient spontaneous breathing. Refer to case
3 for gas flow.
2.1.3.6 Expiration Assembly
The expiration module implements pressure control, pressure monitoring, and flow
monitoring during the patient expiratory phase. It differs from the inspiration module in that
the gas that passes through it is the patient’s exhaled gas. This results in the need to clean and
disinfect the components of the expiration module before reuse. The diagram is as shown
below.
2-15
The expiratory valve (EV) is an electronically controlled valve. The expiratory valve closing
pressure is controlled by the voice coil motor. When the control current the system gives to
the voice coil motor is zero, the expiratory valve fully opens. When the system gives the
voice coil motor certain control current, the voice coil motor seals the diaphragm to the valve
port with certain pushing force. The patient’s exhaled gas must overcome the valve port
sealing force of the gas inside the expiratory valve cavity in order to pass the valve port. This
dynamic process finally guarantees that the airway pressure is a setting value (this value
corresponds to the control current of the voice coil motor).
During the inspiratory phase, the system gives the voice coil motor relatively large control
current to seal the valve. The corresponding valve closing pressure differs with the
parameters set under vent mode (Plimit in V-A/C mode, Pinsp+PEEP in P-A/C mode,
Psupp+PEEP in PSV mode). Gas enters the patient first. If the airway pressure is greater than
the valve closing pressure during the inspiratory phase, the expiratory valve diaphragm opens
to relieve pressure to ensure patient safety.
During the expiratory phase, the system gives the voice coil motor zero or relatively small
control current, which corresponds to expiratory valve fully open or forming certain valve
closing pressure. When the expiratory valve fully opens, it is equivalent to the case that the
patient’s exhaled gas is directly vented to the atmosphere (same to expiration by a normal
person). If the expiratory valve has certain valve closing pressure, it is equivalent to the case
that the patient’s exhaled gas is always kept above positive pressure; namely, the patient’s
expiratory pressure is the set PEEP value.
The expiratory flow sensor (Q3) is based on the principle of differential pressure. A
diaphragm-type sensor (metallic diaphragm flow sensor) is use, which is characterized by
high sensitivity. The expiration module uses metallic diaphragm flow sensor to support 134℃
autoclaving. The diaphragm will get distorted after long term of use. Therefore, it needs to be
calibrated periodically to maintain measurement accuracy.
When the gas flows through Q3, a pressure difference is produced on both sides of the Q3
diaphragm. Flow information is acquired through processing this pressure difference after it
is collected by differential pressure sensor PQ3. SOL2 and SOL3 are corresponding zeroing
three-way valve. Pressure sensor PE is the sensor measuring the pressure in the expiratory
limb. It uses front-end sampling line of Q3 to collect pressure signals.
In addition, there are two limbs passing through R2 and R3. They produce small flushing gas
flow in the pressure sampling line to prevent water vapor from condensing in the pressure
sampling line and affecting the accuracy of pressure measurement.
2-16
The component structure of expiration module is as shown below.
Sampling seat assembly
Disinfectable expiratory
valve assembly
Voice coil motor
Patient gas outlet
Expiratory check
valve open
Expiratory valve seat
Expiratory check
valve closed
2.1.3.7 Patient Tube
Patient tube is the peripheral pneumatic circuit of the ventilator, independent of the
ventilation main unit. It can be configured as needed. Patient tube connects the ventilator
with the patient and humidifies the patient’s inhaled gas. Its diagram is as shown below.
2-17
There are disposable and reusable patient tubes. Generally, disposable tubes integrate tube,
water trap, and Y piece, and are made of PVC material. They are of low cost and are
discarded after use. Reusable tubes, typically, are made of silicone which can be autoclaved
for many times. The water trap and Y piece can also be autoclaved. Despite the high cost,
reusable tubes reduce clinical cost since they can be used for many times.
Filters are placed at the inspiration port and expiration port of the ventilator. The filtering
accuracy is 5um. The filters can effectively prevent bacteria inside the patient tube from
entering the ventilator’s pneumatic circuit.
The humidifier is placed in the inspiratory tube. After passing through the humidifier, the
mixed dry gas the ventilator outputs become warm saturated gas and then enter the patient’s
respiratory tract, avoiding bring discomfort and complication to the patient.
The nebulizer is connected with the nebulizing nozzle on the front panel of the machine. It
turns nebulized liquid medicine into gaseous colloidal particles. During the patient’s
inspiration, the medicine is delivered to the patient’s respiratory tract and lungs together with
the nebulized gas to treat the patient.
2-18
2.2 Electrical Circuit
2.2.1 Overview of the Hardware Boards
The block diagram of SV300/350 hardware system is as shown below. The connection lines
in the diagram indicate the connection between hardware boards and that between modules.
2-19
The SV300/350 hardware system is divided into the following modules: power module, main
control&VPM module, monitoring module, display module, gas parameter module etc.
1.
Power module: includes AC input, cooling fan, AC-DC board, battery, DC-DC board,
battery adapter board; provides power supply for the whole ventilator system.
2.
Main control&VPM module: includes main control core board, peripheral drive
interface etc; fulfills man-machine interaction of the ventilator, data interaction with
other modules and subsystems; extends USB and network interfaces.
3.
Monitoring module: includes VCM module, inspiration module, expiration module,
vacuum sensor board, sensor adapter board etc.; fulfills pressure and flow monitoring,
valve control, O2 concentration collection, data interaction with the main control board.
4.
Display module: includes LCD screen, touchscreen, alarm light board, encoder board,
button control etc.
5.
Gas parameter module: includes sidestream CO2 module and mainstream CO2 module;
choose one from them.
2-20
2.2.2 Electrical Circuit Diagram
2-21
2.2.3 Power Supply System
2.2.3.1 Output of the Power Supply System
2-22
Pcon: system power-on/off button signal for SV300/350 ventilator.
Acon: power-off signal provided by the main control board; high level for not allowing to
power off and low level for allowing to power off.
2.2.3.2 Distribution of Power Supplies in the System
Power supplies for hardware boards and their parts
Monitoring module main board
+5V；+12V；+24V
Main control core board
+5V
Button control board
+3.3V；+5V；+12V
Alarm light board
+5V
Encoder board
+5V
Sensor adapter board
-5V；+3.3V；+5V；+10.5V；+12V
Touchscreen
+5V
Display
+3.3V；+12V
Cooling fan
+12V
O2 proportional valve
+12V
Inspiratory/expiratory voice coil motor
+7V
Nebulizing valve
+5V
Turbo blower
+5V；+24V
Mainstream CO2 module
+5V
Sidestream CO2 module
+12V
2-23
2.2.4 Board Function
For board connections, refer to 2.2.2Electrical Circuit Diagram.
2.2.4.1 Boards of the Power Module
The power module includes AC-DC board, DC-DC board, and battery adapter board. Their
functions are:
„
AC-DC board : transforms the external AC input power into DC power (nominal value
is 18.88V ) to be used by the DC-DC board.
„
DC-DC board : Controlled by the power-on/off circuit, transforms the DC power
outputted by AC-DC, external DC input, or intelligent battery power into DC power
which the system requires to produce 5V, 12V, 24V etc, and performs charging
management of the intelligent battery.
„
Battery adapter board : transfer battery signals.
AC-DC board:
AC input
AC-DC output
2-24
AC-DC board transforms external AC into internal DC. TB1 connector is AC input connector.
It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
L
AC input 1
AC signal
2
NC
No internal connection
/
3
N
AC input 2
AC signal
TB2 connector of AC-DC board is its DC output connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
+V
Positive terminal of AC-DC output
/
2
+V
Positive terminal of AC-DC output
/
3
+V
Positive terminal of AC-DC output
/
4
+V
Positive terminal of AC-DC output
/
5
GND
Ground
/
6
GND
Ground
/
7
GND
Ground
/
8
GND
Ground
/
DC-DC board:
External DC
input
Battery port
AC - DC board
input port
DC - DC board
signal port
DC - DC power supply
output port
Fan
Serial port
2-25
Debugging port
J3 connector of DC-DC board is connector with AC-DC. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
AC_DC_IN
2
AC_DC_IN
Input signal AC-DC outputs to
DC-DC
Rated current is 8.8A
3
AC_DC_IN
4
AC_DC_IN
5
GND
Ground
/
6
GND
Ground
/
7
GND
Ground
/
8
GND
Ground
/
J12 connector of DC-DC board is DC input connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
DC-IN+
/
2
DC-IN+
Positive terminal of external DC
input signal
3
DC-IN-
/
4
DC-IN-
Negative terminal of external
DC input signal
/
/
J11 connector of DC-DC board is the connector with battery adapter board. It is defined as
follows:
Pin No.
Signal name
Signal description
Remark
1
GND
Ground
/
2
BAT1
Positive terminal of battery 1
input signal
/
3
GND
Ground
/
4
GND
Ground
/
5
BAT1
Positive terminal of battery 1
input signal
/
6
GND
Ground
/
7
BAT1
Positive terminal of battery 1
input signal
/
8
GND
Ground
/
9
GND
Ground
/
10
GND
Ground
/
11
BAT1
Positive terminal of battery 1
input signal
/
12
GND
Ground
/
2-26
Pin No.
Signal name
Signal description
Remark
13
GND
Ground
/
14
BAT1
Positive terminal of battery 1
input signal
/
15
BAT1_BC
In-place signal of battery 1
/
16
SMBC1
I2C clock signal of battery 1
/
17
SMBC2
In-place clock signal of battery
2
/
18
SMBD1
I2C data signal of battery 1
/
19
SMBD2
I2C data signal of battery 2
/
20
BAT2_BC
In-place signal of battery 2
/
21
GND
Ground
/
22
BAT1
Positive terminal of battery 1
input signal
/
23
GND
Ground
/
24
GND
Ground
/
25
BAT1
Positive terminal of battery 1
input signal
/
26
GND
Ground
/
27
BAT1
Positive terminal of battery 1
input signal
/
28
GND
Ground
/
29
GND
Ground
/
30
GND
Ground
/
31
BAT1
Positive terminal of battery 1
input signal
/
32
GND
Ground
/
33
GND
Ground
/
34
BAT1
Positive terminal of battery 1
input signal
/
J13 connector of DC-DC board is the connector with monitoring module main board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
24VA
24V power supply of turbo blower
/
2
24VA
24V power supply of turbo blower
/
3
12VA
12V power supply of monitoring
module main board
/
4
5VA
5V power supply of VCM of
monitoring module main board
/
2-27
Pin No.
Signal name
Signal description
Remark
5
5VB
5V power supply of GUI of
monitoring module main board
/
6
GND
Ground
/
7
GND
Ground
/
8
GND
Ground
/
9
GND
Ground
/
10
GND
Ground
/
J1 connector of DC-DC board is the connector with monitoring module main board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VBUS
Power supply of buzzer
/
2
GND
Ground
/
3
BELL_CTRL
Control pin of buzzer
/
4
AC_LED
Control signal of AC indicator
light
/
5
BAT_LED
Control signal of battery
indicator light
/
/
6
TXD
Serial port signal of power
board transmitting to main
control board
7
KEY_ONOFF
Power-on/off control signal
/
8
GND
Ground
/
9
POWER_EN
Control power signal of main
control board
/
/
10
RXD
Serial port signal of power
board receiving from main
control board
11
GND
Ground
/
12
IO1
Backup
/
13
GND
Ground
/
14
GND
Ground
/
2-28
Battery adapter board:
Battery adapter board
Battery input port
Battery output
J1 connector of battery adapter board is the connector with battery. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
GND
Ground
/
2
GND
Ground
/
3
TEM
Battery temperature detection signal
/
4
PRT_BC
Battery in-place signal
/
5
SMBC
Clock signal of battery I2C interface
/
6
SMBD
Data signal of battery I2C interface
/
7
BAT+
Positive terminal of battery input
signal
/
8
BAT+
Positive terminal of battery input
signal
/
9
GND
Ground
/
10
GND
Ground
/
2-29
J2 connector of battery adapter board is the connector with DC-DC board. It is defined as
follows:
Pin No.
Signal name
Signal description
Remark
1
GND
Ground
/
2
BAT+
Positive terminal of battery input
signal
/
3
GND
Ground
/
4
BAT+
Positive terminal of battery input
signal
/
5
GND
Ground
/
6
BAT+
Positive terminal of battery input
signal
/
7
GND
Ground
/
8
BAT+
Positive terminal of battery input
signal
/
9
GND
Ground
/
10
BAT+
Positive terminal of battery input
signal
/
11
GND
Ground
/
12
BAT+
Positive terminal of battery input
signal
/
13
TEM
Battery temperature signal
14
SMBC
Clock signal of battery I2C interface
/
15
PRT_BC
Battery in-place signal
/
16
SMBD
Data signal of battery I2C interface
/
2.2.4.2 Main Control Core Board
Boards of the main control module include main control core board and peripheral interface
circuit (on the monitoring module main board). It is the control core of the ventilator and
implements man-machine interface (display screen, external key-in), control command
transfer, alarm, ventilator protection function, CO2 parameter module, and peripheral
interface circuit.
2-30
Main control core board: implements the minimum core system of the main control module;
leads out the pins of the minimum system to be connected to the monitoring main board.
Debu
ggin
g
JTAG
Serial port
debugging
2.2.4.3 Monitoring Module
The monitoring module includes the following boards: SV300/350 monitoring module main
board, SV300/350 sensor adapter board, and SV300/350 vacuum sensor board.
SV300/350 monitoring module main board:
The monitoring module main board fulfils the SV300/350 core board and ventilator
parameter functions. It includes DSP control module, inspiration module, expiration module,
and main control module peripheral interface circuit. It implements the following functions:
1. Control all valves and collect AD of analog quantity.
2. Drive and control the turbo blower.
3. Monitor turbine negative pressure and temperature.
4. Monitor pressure and flow signal input, transforms analog quantity into digital quantity.
5. Perform UART communication with the main control board.
6. Implement main control board peripheral interface circuit, such as wired network,
wireless network, USB, VGA, display interface etc.
2-31
EV20 monitoring module main board
Turbine failure indicator light D1
VCM failure indicator light D4
Turbine connector Nurse call RS232&CAL Net
USB
VGA
External temp.
sensor connector
Exp. Voice
coil motor
Speaker
connector
O2 proportional
valve
Power
supply
connector
(power
board)
Insp. Failure
indicator light D2
Nebulizing
valve
Signal
connector
(power
board)
Vacuum
sensor
Parameter module
connector
Sensor adapter board
Display connector Button board connector
Backup(SPO2)
connector
Wireless
wifi
Exp. Failure indicator light D3
The following table lists the indicator lights.
Item
Description
Turbine failure indicator light
D1
Lit: a failure occurs to the turbo blower or drive circuit is faulty.
Check if the cable for turbine connector is properly connected. If
not, the turbo blower or monitoring module main board itself is
faulty.
No lit: operate normally.
Insp. failure indicator light D2
Lit/not lit: if the inspiration module has software failure, restart
to see if the failure disappears. If the monitoring module main
board is damaged, replace the monitoring module main board. If
the power board is faulty, enter the AD channel to see if the
voltage value which the AD value samples has an error (if an
error occurs, the value is displayed in red).
Flashing: operate normally.
Exp. failure indicator light D3
Lit/not lit: if the expiration module has software failure, restart
to see if the failure disappears. If the monitoring module main
board is damaged, replace the monitoring module main board. If
the power board is faulty, enter the AD channel to see if the
voltage value which the AD value samples has an error (if an
error occurs, the value is displayed in red).
Flashing: operate normally.
2-32
Item
Description
VCM failure indictor light D4
Lit/not lit: if the VCM module has software failure, restart to see
if the failure disappears. If the monitoring module main board is
damaged, replace the monitoring module main board. If the
power board is faulty, enter the AD channel to see if the voltage
value which the AD value samples has an error.
Flashing: operate normally.
J22 connector of monitoring module main board power supply connector is the connector
with DC-DC board. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VBL
24V power supply of turbo blower
/
2
VBL
24V power supply of turbo blower
/
3
VPP
12V power supply of monitoring
module main board
/
4
VCCB
5V power supply of VCM of
monitoring module main board
/
5
VCCA
5V power supply of GUI of
monitoring module main board
/
6
GND
Ground
/
7
GND
Ground
/
8
GND
Ground
/
9
GND
Ground
/
10
GND
Ground
/
J38 connector of monitoring module main board is the connector with DC-DC board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VBUS
Power supply of buzzer
/
2
GND
Ground
/
3
BELL_CTRL
Control pin of buzzer
/
4
AC_LED
Control signal of AC indicator light
/
5
BAT_LED
Control signal of battery indicator
light
/
Serial port signal of main
control board receiving from
power board
/
6
UART4_335X_RXD
7
PCON
Power-on/off control signal
/
8
GND
Ground
/
2-33
Pin No.
Signal name
Signal description
Remark
9
POWER_EN
Control power signal of main
control board
/
/
10
UART4_335X_TXD
Serial port signal of main
control board transmitting to
power board
11
GND
Ground
/
12
BK
Backup
/
13
Blank
Blank
/
14
Blank
Blank
/
J9 is VGA connector of external display socket. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
R0
R signal of external display
/
2
G0
G signal of external display
/
3
B0
B signal of external display
/
4
NC
No internal connection
/
5
GND
Ground
/
6
GND
Ground
/
7
GND
Ground
/
8
GND
Ground
/
9
NC
No internal connection
/
10
GND
Ground
/
11
NC
No internal connection
/
12
NC
No internal connection
/
13
LCD_HS
Horizontal synchronization signal
of external display
/
14
LCD_VS
Vertical synchronization signal of
external display
/
15
NC
No internal connection
/
J11 is external USB connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
USB0_VBUS
USB0 power supply
5V
2
USB0_DM
USB0 signal cable
/
3
USB0_DP
USB0 signal cable
/
4
GND
Ground
/
2-34
J10 is external nurse call connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
NC1
Nurse call signal
/
2
GND
Ground
/
3
GND
Ground
/
4
GND
Ground
/
5
GND
Ground
/
J8 is network connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
TX+
Main control network transmitting
signal+
/
2
TX-
Main control network transmitting
signal-
/
3
RX+
Main control network receiving
signal+
/
4
GND
Ground
/
5
GND
Ground
/
6
RX-
Main control network receiving
signal-
/
7
GND
Ground
/
8
GND
Ground
/
J37 is nebulizing valve connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VCCBL
Nebulizing valve power supply, 5V
/
2
NCV-
Nebulizing valve control terminal
/
3
SW_O2+
Gas supply pressure switch signal,
reserved
Not used
4
GND
Ground
/
J29 is the connector between monitoring module main board and vacuum sensor board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
V_I2C
Vacuum sensor power supply, 3.3V
/
2
GND
Ground
/
2-35
Pin No.
Signal name
Signal description
Remark
3
AMBIENT_SDA_INSP
Data line for vacuum sensor I2C
connector
/
4
GND
Ground
/
5
AMBIENT_SCL_INSP
Clock line for vacuum sensor I2C
connector
/
J21 is CO2 module connector. It is defined as follows:
Pin No.
1
Signal name
EX_5V_TXA
Signal description
Remark
Extension serial port transmitting
Communicate with the
sidestream CO2
module
2
RS232_RXD
Extension serial port receiving
Communicate with the
mainstream CO2
module
3
GND
Ground
/
4
GND
Ground
/
5
EX_5V_RXA
Extension serial port receiving
Communicate with the
sidestream CO2
module
6
RS232_TXD
Extension serial port transmitting
Communicate with the
mainstream CO2
module
7
GND
Ground
/
8
VCCAC
Mainstream CO2 module power
supply, 5V
/
9
VCCAC
Mainstream CO2 module power
supply, 5V
/
10
PWR12V
Sidestream CO2 module power
supply,12V
/
11
GND
Ground
/
12
PWR12V
CO2 module power supply, 12V
/
J13 is the speaker connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VO-
Speaker drive signal-
/
2
VO+
Speaker drive signal +
/
2-36
J10 is the connector between monitoring module main board and display. It is defined as
follows:
Pin No.
Signal name
Signal description
Remark
1
GND
Ground
/
2
GND
Ground
/
3
GND
Ground
/
4
GND
Ground
/
5
GND
Ground
/
6
LVDS_0-
LVDS DIFFERENTIAL DATA
LINE0-
/
7
PWR12V
Display backlight power supply,
12V
/
8
LVDS_0+
LVDS DIFFERENTIAL DATA
LINE0+
/
9
PWR12V
Display backlight power supply,
12V
/
10
GND
Ground
/
11
PWR12V
Display backlight power supply,
12V
/
12
LVDS_1-
LVDS DIFFERENTIAL DATA
LINE1-
13
PWR12V
Display backlight power supply,
12V
/
14
LVDS_1+
LVDS DIFFERENTIAL DATA
LINE1+
/
15
GND
Ground
/
16
GND
Ground
/
17
GND
Ground
/
18
LVDS_CK-
Display differential data line-
/
19
VLCD
Display power supply, 3.3V
/
20
LVDS_CK+
Display differential data line-
/
21
VLCD
Display power supply, 3.3V
/
22
GND
Ground
/
23
VLCD
Display power supply, 3.3V
/
24
LVDS_2-
LVDS DIFFERENTIAL DATA
LINE2-
/
25
PWM1
Backlight brightness adjustment
signal
/
26
LVDS_2+
LVDS DIFFERENTIAL DATA
LINE2+
2-37
Pin No.
Signal name
Signal description
Remark
27
GND
Ground
/
28
GND
Ground
/
29
SET_6bit/8bit
Display bit color control
/
30
LVDS_3-
LVDS DIFFERENTIAL DATA
LINE3-
/
31
BACKLIGHT_EN
Display backlight enabled
/
32
LVDS_3+
LVDS DIFFERENTIAL DATA
LINE3+
33
NC
No internal connection
/
34
GND
Ground
/
35
NC
No internal connection
/
36
GND
Ground
/
37
NC
No internal connection
/
38
NC
No internal connection
/
39
NC
No internal connection
/
40
NC
No internal connection
/
J17 is the connector between monitoring module main board and button control board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
PWR12V
Button board power supply, 12V
/
2
VCCA
Button board power supply, 5V
/
3
GND
Ground
/
4
VDDA
Button board power supply, 3.3V
/
5
GND
Ground
6
UART2_335X_TXD
Button board communication serial
port, main control transmitting
/
7
GND
Ground
/
8
UART2_335X_RXD
Button board communication serial
port, main control receiving
/
9
AC_LED
AC indicator light
/
10
BAT_LED
Battery indicator light
/
11
PCON
Power-on signal
/
12
GND
Ground
/
2-38
J30 is the O2 proportional valve connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
O2_Valve+
Positive terminal of O2
proportional valve
/
2
O2_Valve-
Negative terminal of O2
proportional valve
/
J1 is the turbo blower connector. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
H2
Hall position signal H2
/
2
H1
Hall position signal H1
/
3
VCCB
Hall sensor power supply
/
4
MOTOR_A
Turbo blower drive signal A
/
5
NTC1
Thermistor
/
6
H3
Hall position signal H3
/
7
GND
Ground
/
8
MOTOR_C
Turbo blower drive signal C
/
9
MOTOR_B
Turbo blower drive signal B
/
10
NTC21
Ground
/
J2 is the connector for turbo blower external temperature sensor. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
NTC+
One terminal of temperature sensor
2
NTC+
The other terminal of temperature
sensor
No positive and
negative terminals are
differentiated.
J31 is the connector for proportional valve. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
Insp_Valve+
Positive terminal of inspiration
proportional valve
/
2
Insp_Valve+
Positive terminal of inspiration
proportional valve
/
3
/
/
Suspended
4
Insp_Valve-
Negative terminal of inspiration
proportional valve
/
2-39
Pin No.
Signal name
Signal description
Remark
5
Insp_Valve-
Negative terminal of inspiration
proportional valve
/
6
GND
Ground
Fix pad pin
7
GND
Ground
Fix pad pin
J32 is the connector for expiratory valve. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
Exp_Valve+
Positive terminal of expiration
proportional valve
/
2
Exp_Valve+
Positive terminal of expiration
proportional valve
/
3
NC
/
Suspended
4
Exp_Valve-
Negative terminal of expiration
proportional valve
/
5
Exp_Valve-
Negative terminal of expiration
proportional valve
/
6
GND
Ground
/
7
GND
Ground
/
J35 is the connector between monitoring module main board and sensor adapter board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
Safety_Valve-
Negative terminal of safety valve
/
2
Safety_Valve-
Negative terminal of safety valve
/
3
V_Safety_Valve
Safety valve power voltage
12V
4
V_Safety_Valve
Safety valve power voltage
12V
5
3Way_Purge_1_Exp-
Control signal of expiratory
purging 3-way valve 1
/
6
3Way_Purge_2_Exp-
Control signal of expiratory
purging 3-way valve 2
/
7
3Way_Zero_1_Exp-
Control signal of expiratory zeroing
3-way valve 1
/
8
3Way_Zero_2_Exp-
Control signal of expiratory zeroing
3-way valve 2
/
9
VCCBL
Power supply
5V
10
3Way_Zero_Insp-
Control signal of inspiratory
zeroing 3-way valve
/
11
VCCBL
Power supply
5V
2-40
Pin No.
Signal name
Signal description
Remark
12
GND
Ground
/
13
Blank
/
/
14
Blank
/
/
15
O2_TSI_SCL
Clock signal of O2 TSI sensor
/
16
GND
Ground
/
17
INSP_TSI_SCL
Clock signal of mixed gas TSI
sensor
/
18
O2_TSI_SDA
Data signal of O2 TSI sensor
/
19
GND
Ground
/
20
INSP_TSI_SDA
Data signal of mixed gas TSI
sensor
/
21
VDDB
Power supply
3.3V
22
GND
Ground
/
23
VCCBL
Power supply
5V
24
AVSS
Power supply
-5V
25
GND
Ground
/
26
AVCC
Power supply
5V
27
VC
Power supply
10.5V
28
GND
Ground
/
29
EXP_PIN
Expiratory pressure
/
30
EXP_FIN
Expiratory flow
/
31
GND
Ground
/
32
TEMP_O2_TSI
Temperature signal of O2 TSI
sensor
/
33
FLOW_O2_TSI
Flow signal of O2 TSI sensor
/
34
GND
Ground
/
35
FiO2
Inspired O2 concentration
/
36
INSP_PIN
Inspiratory pressure
/
37
GND
Ground
/
38
GND
Ground
/
39
FLOW_INSP_TSI
Flow signal of mixed gas TSI
sensor
/
40
TEMP_INSP_TSI
Temperature signal of mixed gas
TSI sensor
/
41
GND
Ground
Fix pad pin
42
GND
Ground
Fix pad pin
2-41
SV300/350 sensor adapter board:
The adapter board implements the following functions:
Monitor inspiratory pressure and expiratory pressure, output amplified signals.
Monitor expiratory flow and output amplified signals.
Monitor O2 concentration and output amplified signals.
Transfer O2 flow and inspiratory flow signals.
Transfer to 3-way valve.
Transfer to safety valve control signal.
J3 is the connector between sensor adapter board and monitoring module main board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
TEMP_INSP_TSI
Temperature signal of mixed gas TSI
sensor
/
2
FLOW_INSP_TSI
Flow signal of mixed gas TSI sensor
/
3
GND
Ground
/
4
GND
Ground
/
5
INSP_PIN
Inspiratory pressure
/
6
FiO2
O2 concentration
/
7
GND
Ground
/
8
FLOW_O2_TSI
Flow signal of O2 TSI sensor
/
9
TEMP_O2_TSI
Temperature signal of O2 TSI sensor
/
10
GND
Ground
/
11
EXP_FIN
Expiratory flow
/
12
EXP_PIN
Expiratory pressure
/
13
GND
Ground
/
14
VC
Power supply
10.5V
15
AVCC
Power supply
5V
16
GND
Ground
/
2-42
Pin No.
Signal name
Signal description
Remark
17
AVSS
Power supply
-5V
18
VCCBL
Power supply
5V
19
GND
Ground
/
20
VDDB
Power supply
3.3V
21
INSP_TSI_SDA
Data signal of mixed gas TSI sensor
/
22
GND
Ground
/
23
O2_TSI_SDA
Data signal of O2 TSI sensor
/
24
INSP_TSI_SCL
Clock signal of mixed gas TSI sensor
/
25
GND
Ground
/
26
O2_TSI_SCL
Clock signal of O2 TSI sensor
/
27
Blank
/
/
28
Blank
/
/
29
GND
Ground
/
30
VCCBL
Power supply
5V
31
3Way_Zero_Insp-
Control signal of inspiratory zeroing
3-way valve
/
32
VCCBL
Power supply
5V
33
3Way_Zero_2_Exp-
Control signal of expiratory zeroing
3-way valve 2
未用
34
3Way_Zero_1_Exp-
Control signal of expiratory zeroing
3-way valve 1
/
35
3Way_Purge_2_Exp-
Control signal of expiratory purging
3-way valve 2
/
36
3Way_Purge_1_Exp-
Control signal of expiratory purging
3-way valve 1
/
37
V_Safety_Valve
Safety valve power voltage
12V
38
V_Safety_Valve
Safety valve power voltage
/
39
Safety_Valve-
Negative terminal of safety valve
/
40
Safety_Valve-
Negative terminal of safety valve
/
41
GND
Ground
Fix pad pin
42
GND
Ground
Fix pad pin
J1 is connector for O2 concentration sensor. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
O2_SENSOR+
Positive terminal of O2
concentration sensor
/
2
O2_SENSOR-
Negative terminal of O2
concentration sensor
/
2-43
J4 is the connector for O2 flow sensor. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
O2_FLOW_TSI
Flow signal of O2 TSI sensor
/
2
O2_TEMP_TSI
Temperature signal of O2 TSI
sensor
/
3
GND
Ground
/
4
O2_SCL_I2C_TSI
Clock signal of O2 TSI sensor
/
5
O2_SDA_I2C_TSI
Data signal of O2 TSI sensor
/
6
VCCBL
Power supply
/
7
GND
Ground
/
8
VDDB
EEPROM power supply
/
J5 is the connector for mixed gas flow sensor. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
INSP_FLOW_TSI
Flow signal of mixed gas TSI
sensor
/
2
INSP_TEMP_TSI
Temperature signal of mixed
gas TSI sensor
/
3
GND
Ground
/
4
INSP_SCL_I2C_TSI
Clock signal of mixed gas TSI
sensor
/
5
INSP_SDA_I2C_TSI
Data signal of mixed gas TSI
sensor
/
6
VCCBL
Power supply
/
7
GND
Ground
/
8
VDDB
EEPROM power supply
/
J2 is the connector for safety valve. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
V_SAFE_VALVE
Positive terminal of safety valve
/
2
SAFE_VALVE-
Negative terminal of safety
valve
/
2-44
SV300/350 vacuum sensor board:
This board measures the negative pressure at the turbo blower. If the turbine inlet is occluded,
a relevant alarm is given.
J1 is the connector for vacuum sensor adapter board. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
V_I2C
Vacuum sensor power supply,
3.3V
/
2
GND
Ground
/
3
AMBIENT_SDA_INSP
Data line of vacuum sensor I2C
connector
/
4
GND
Ground
/
5
AMBIENT_SCL_INSP
Clock line of vacuum sensor
I2C connector
/
2.2.4.4 Display Module
Boards of the display part are responsible for man-machine interaction. They include button
control main board, alarm light board, and encoder board.
„
Button control main board
1.
Process button input and encoder input
2.
Drive alarm light and indicator light (battery and AC).
3.
Perform UART communication with the main control board.
4.
Process touchscreen input.
5.
Provide buttons for power-on/off and silence.
2-45
„
Alarm light board
Support alarm display in red and yellow.
„
Encoder board
1.
Select and confirm touch buttons on the SV300/350 ventilator display.
SV300/350 button control main board:
Alarm silence button
Power-on/off button
Power-on/off
backlight
AC and BAT indicator lights
Alarm silence indicator light
Encoder Alarm light Monitoring module
connector connector main board connector
Touchscreen input port
Button control board
J3 is the connector between button control board and monitoring module main board. It is
defined as follows:
Pin No.
Signal name
Signal description
Remark
1
VPP
12V power supply
Provide power supply for
alarm light and alarm
silence indicator light
2
VCC
5V power supply
Provide power supply for
touchscreen control IC and
encoder part
3
GND
Ground
/
4
VDD
3.3V power supply
Provide power supply for
button control CPU part
5
GND
Ground
/
6
TXD_MAIN
Button control serial port
receiving
TTL/LVTTL
7
GND
Ground
/
8
RXD_MAIN
Button control serial port
transmitting
TTL/LVTTL
9
LED_AC
Signal of AC indicator light
/
10
LED_BAT
Signal of battery indicator light
/
11
PCON
Signal of power-on/off button
/
2-46
12
GND
Ground
/
J1 is the connector between button control board and alarm light board. It is defined as
follows:
Pin No.
Signal name
Signal description
Remark
1
LED_RED
Control signal of red alarm light
/
2
LED_YELLOW
Control signal of yellow alarm
light
/
3
VPP
12V power supply
Alarm light 12V power
supply
4
GND
Ground
/
J1 is the connector between button control board and encoder board. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
GND
Ground
/
2
ES
Encoder press-down
/
3
EB
Encoder output B
/
4
EA
Encoder output A
/
5
VCC
5.0V power supply
Encoder power supply
5.0V
J4 is the connector between button control board and encoder board. It is defined as follows:
Pin No.
Signal name
Signal description
Remark
1
UR_HIN
Touchscreen RT signal
/
2
XR_XLIN
Touchscreen RL signal
/
3
AD3IN
Touchscreen SG signal
/
4
UL_YTIN
Touchscreen LT signal
/
5
LL_YBIN
Touchscreen LL signal
/
SV300/350 alarm light board:
2-47
J1 is the connector between alarm light board and button control board. It is defined as
follows:
Pin No.
Signal name
Signal description
Remark
1
LED_RED
Control signal of red alarm light
/
2
LED_YELLOW
Control signal of red alarm light
/
3
VPP
12V power supply
Alarm light 12V power
supply
2-48
3 Checkout and Test
WARNING
z
z
After servicing the equipment or replacing its components, compelete all the tests
in this section.
Before doing the tests in this section, completely reassemble the equipment and
refer to 5 Maintenance and Calibration to do necessary calibrations.
3.1 System Inspection
NOTE
z
Make sure that the breathing system is correctly connected and not damaged.
Make sure that:
1. The equipment is not damaged.
2. All components are correctly attached.
3. The breathing system (including the inspiratory safety valve, expiration valve,
humidifier, and nebulizer etc.) is correctly connected and the breathing tubes are not
damaged.
4. The gas supplies are correctly connected and the pressures are correct.
5. Cylinder valves are closed on models with cylinder supplies.
6. The casters are not loose and the brake (s) is set and prevents movement.
7. The power cord is correctly connected. The external power indicator and the battery
indicator work normally.
8. The ventilator is switched on or off normally.
3.2 Power Failure Alarm Test (External Power and
Buzzer)
1.
2.
3.
4.
5.
Connect the ventilator to the power supply. Both the power indicator and battery
indicator should come on. If the power indicator is not lit, check the fuse and power
board.
Depress the power switch to turn on the ventilator.
Disconnect the power socket with the system turned on. The prompt message [Battery
in Use] is displayed in the system alarm message area. Meanwhile, the power indicator
is extinguished and the battery indicator is flashing.
Reconnect the power supply and the prompt message [Battery in Use] disappears. The
power indicator is lit. The battery indicator stops flashing and stays on.
Remove the battery from the ventilator, and disconnect the power socket. The ventilator
will shut down and the buzzer buzz for more than 120 seconds. If the buzzer does not
respond, replace the monitoring board main board.
3-1
3.3 O2 Pipeline Test
1.
2.
3.
4.
5.
6.
7.
Connect the O2 pipeline supply.
Connect the test lungs.
Depress the system switch to turn on the ventilator.
Select [New Adult] in standby mode. Set ventilation type to [Non-invasive] and O2%
to 40%. Then select [Start Ventilation] to allow the ventilator to enter ventilation
status.
Make sure that the ventilator ventilates normally.
Disconnect the O2 pipeline supply.
As O2 pressure decreases, the high level alarm [O2 Supply Failure] is triggered.
3.4 System Test
1.
2.
3.
4.
Enter system check:
‹ Enter system check screen after power-on. Connect O2 supply and block the Y
piece as prompted. Then select [Continue] to start system check item by item.
‹ Push the [Standby] key. Standby screen appears after your confirmation. The
standby screen displays last system check time and result. Select [System Check].
Connect O2 supply and block the Y piece as prompted. Select [Continue] to start
system check item by item.
System check items include:
‹ Blower test: test the rotation speed of the blower ;
‹ O2 flow sensor test: test the flow sensor in O2 limb ;
‹ Insp. flow sensor test : test the inspiratory valve and flow sensor ;
‹ Exp. flow sensor test : test the expiratory flow sensor ;
‹ Pressure sensor test: test the pressure sensors at the inspiratory and expiratory
ports;
‹ Expiratory valve test ;
‹ Safety valve test;
‹ Leakage (mL/min) ;
‹ Compliance (mL/cmH2O) ;
‹ Circuit resistance (cmH2O/L/s) ;
‹ O2 sensor test.
System check result can be:
‹ Pass: indicates that check of this item is completed and is passed.
‹ Fail: indicates that check of this item is not completed and is failed.
‹ Cancel: indicates that check of this item is not completed;
‹ O2 Supply Failure : indicates that O2 supply is insufficient when O2 flow sensor
test and O2 sensor test are being carried out;
‹ Monitoring Off : indicates that O2 concentration monitoring function may not be
switched on when O2 sensor test is being carried out.
When system check is being performed, the system prompts [Running] on the right side
of the current check item. In this case, if you select [Skip], the system stops check of
this item immediately and displays [Cancel]. Check of the next item begins at the same
time. If you select [Stop], the system stops check of the current item and also check of
the remaining items, and displays [Cancel].
3-2
5.
6.
When checks of all items are completed, if you select [Retry], the system starts a new
round of check. When [Exit] is selected, the system exits check and enters standby
screen
Make sure that all the [Syst. Check] items pass the test.
3.5 Spontaneous Breathing Test
1.
2.
Turn off the ventilator and let the ventilator in OFF state. Wear a mask, and check if the
spontaneous breathing is smooth.
Turn on the ventilator and let the ventilator in Standby state. Wear a mask, and check if
the spontaneous breathing is smooth.
3.6 Humidifier Performance Test
For detailed performance test information, please refer to the Instructions for Use of the
humidifier. Make sure that the humidifier works normally.
3.7 Alarm Tests
3.7.1 Prepare for Alarm Tests
1.
2.
3.
Connect test lungs to the Y piece patient connection.
Turn on the ventilator. Select [New Adult] in standby mode. Set ventilation type to
[Invasive].
Set the ventilator controls as follows (in standard working state):
‹ Ventilator mode: [V-A/C]
‹ O2 concentration [O2%]: 40%
‹ Tidal volume [TV]: 500 ml
‹
Inspiration time [Tinsp]：2s，or Inspiration and expiration ratio [I :E]：1 :2
‹
Frequency [f]：10 bpm
Positive end-expiratory pressure [PEEP]: 3 cmH2O
Note: the working mode of the ventilator in this chapter refers to standard working state
unless specified otherwise.
4. Set the ventilator to exit standby state and enter working state.
5. Make sure of:
‹ Normal display of the ventilator monitored parameter data
‹ Periodical inspiraton and expiration of the test lungs.
‹
3.7.2 Battery in Use Alarm Test
1.
2.
3.
4.
5.
Connect the ventilator to AC power and depress the
hardkey.
Disconnect the AC power after the system starts up.
Verify that the [Battery in Use] alarm is activated and the ventilator is powered by the
battery.
Re-connect the AC power.
Verify that this alarm is automatically reset and the ventilator is AC powered.
3-3
3.7.3 Power Failure Alarm Test
1.
2.
3.
4.
5.
Connect the AC power and depress the
hardkey to start up the ventilator.
Disconnect the AC power after the battery is fully charged.
Connect the test lungs to let the ventilator keep normal ventilation.
For the ventilator configured with one battery, the ventilation time is approximately 2
hours (for the ventilator configured with two batteries, the ventilation time is
approximately 4 hours). When the battery capacity is to be depleted, verify that the
[System DOWN. Connect AC.] alarm is activated.
Re-connect the AC power. Verify that this alarm is automatically reset and the ventilator
is AC powered.
3.7.4 Paw Too High Alarm Test
1.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
2.
Set Paw high alarm limit to current peak pressure+5cmH2O。
3.
4.
Squeeze the test lungs forcibly in the inspiration phase.
Verify that the [Paw Too High] alarm is activated, breathing cycle enters expiration
phase, and Paw decreases to PEEP value.
3.7.5 TVe Too High Alarm Test
1.
2.
3.
After the ventilator system starts up normally, connect the ventilator to the test lungs and
set to pressure mode to start ventilation.
Set TVe high alarm limit to be less than the current TVe to verify that the [TVe Too
High] alarm is activated.
Set TVe high alarm limit to be greater than the current TVe to verify that this alarm is
automatically reset.
3.7.6 TVe Too Low Alarm Test
1.
2.
3.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set TVe low alarm limit to be greater than the current TVe to verify that the [TVe Too
Low] alarm is activated
Set TVe low alarm limit to be less than the current TVe to verify that this alarm is
automatically reset.
3.7.7 MV Too High Alarm Test
1.
2.
3.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set MV high alarm limit to be less than the current MV to verify that the [MV Too
High] alarm is activated.
Set MV high alarm limit to be greater than the current MV to verify that this alarm is
automatically reset.
3-4
3.7.8 MV Too Low Alarm Test
1.
2.
3.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set MV low alarm limit to be greater than the current MV to verify that the [MV Too
Low] alarm is activated.
Set MV low alarm limit to be less than the current MV to verify that this alarm is
automatically reset.
3.7.9 PEEP Too Low Alarm Test
1.
2.
3.
4.
5.
Remove the expiratory valve diaphragm of the ventilator and install the expiratory
valve.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set PEEP to 5cmH2O. Verify that the [PEEP Too Low] alarm is activated.
Re-install the expiratory valve diaphragm and install the expiratory valve.
Repeat steps 2 and 3. Verify that this alarm is automatically reset.
3.7.10 Airway Obstructed Alarm Test
1.
2.
3.
4.
After the ventilator system starts up normally, connect the ventilator to the test lungs and
set to pressure mode to start ventilation.
Nip the inspiration tube with the hands. Make sure the monitoring value of TVi is lower
than 10 ml.
After several breathing cycles, verify that the [Airway Obstructed?] alarm is activated.
Loosen the inspiration tube and verify that this alarm is automatically reset.
3.7.11 Apnea Alarm Test
1.
2.
3.
4.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set apnea alarm time to 15s.
Set breathing frequency to 3bpm. Verify that the [Apnea] alarm is activated.
Set breathing frequency to 10bpm. Verify that this alarm is automatically reset.
3.7.12 ftotal Too High Alarm Test
1.
2.
3.
After the ventilator system starts up normally, connect the ventilator to the test lungs to
start ventilation.
Set ftotal high alarm limit to be less than the current ftotal. Verify that the [ftotal Too
High] alarm is activated.
Set ftotal high alarm limit to be greater than the current ftotal. Verify that this alarm is
automatically reset.
3-5
3.7.13 FiO2 Too High Alarm Test
1. Connect the ventilator to low-pressure O2 supply. Select [Setup] →[Maintain]→[User]
→enter the required password→[Setting]→[Gas Supply] to set [O2 Supply Type] to
[LPO].
2. Connect the ventilator to the test lungs to start ventilation.
3. After ventilation is stable, set FiO2 high alarm limit to be less than the current O2
concentration monitored value.
4. Verify that the [FiO2 Too High] alarm is activated.
5. Set FiO2 high alarm limit to be greater than the current O2 concentration monitored
value. Verify that this alarm is automatically reset.
3.7.14 FiO2 Too Low Alarm Test
1.
2.
3.
4.
5.
Connect the ventilator to high-pressure O2 supply. Select [Setup] →[Maintain]→
[User]→enter the required password→[Setting]→[Gas Supply] to set [O2 Supply
Type] to [HPO].
Connect the ventilator to the test lungs to start ventilation.
After ventilation is stable, turn off high-pressure O2 supply.
Verify that the [FiO2 Too Low] alarm is activated.
Re-connect high-pressure O2 supply. Verify that this alarm is automatically reset.
3.7.15 EtCO2 Too High Alarm Test
1.
2.
3.
4.
5.
6.
Connect the CO2 test module. Set CO2 module to working mode.
Connect the ventilator to the test lungs to start ventilation.
After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to
sidestream CO2.
At the module sampling port or the airway adapter of mainstream CO2 module, set
EtCO2 high alarm limit to be less than the standard gas concentration.
Verify that the [EtCO2 Too High] alarm is activated.
Set EtCO2 high alarm limit to be greater than the standard gas concentration. Verify that
this alarm is automatically reset.
3.7.16 EtCO2 Too Low Alarm Test
1.
2.
3.
4.
5.
6.
Connect the ventilator to the test lungs to start ventilation.
Connect the CO2 test module. Set CO2 module to working mode.
After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to
sidestream CO2.
At the module sampling port or the airway adapter of mainstream CO2 module, set
EtCO2 low alarm limit to be greater than the standard gas concentration.
Verify that the [EtCO2 Too Low] alarm is activated.
Set EtCO2 low alarm limit to be less than the standard gas concentration. Verify that
this alarm is automatically reset.
3-6
3.7.17 SpO2 Too High Alarm Test
1.
Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator
patient type to [New Adult].
2.
Select [Setup]→[Sensor]→[SpO2] and set [Monitoring] to [On].
3.
Measure SpO2 at your finger (supposing you are in healthy state). Set the SpO2 high
alarm limit to 80% when the ventilator is stabilized.
Verify that the [SpO2 Too High] alarm is activated.
Set the SpO2 high alarm limit to 100%. Verify that this alarm is automatically reset.
4.
5.
3.7.18 SpO2 Too Low Alarm Test
1.
Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator
patient type to [New Adult].
2.
Select [Setup]→[Sensor]→[SpO2] and set [Monitoring] to [ON].
3.
Measure SpO2 at your finger (supposing you are in healthy state). Set the SpO2 low
alarm limit to 98% when the ventilator is stabilized.
Hold the wrist of the hand with sensor. Hold and press pulse until the SpO2 reading is
less than 98%. Verify that the [SpO2 Too Low] alarm is activated.
Stop pressing the pulse and set the SpO2 low alarm limit to 90%. Verify that this alarm
is automatically reset.
4.
5.
3.7.19 PR Too High Alarm Test
1.
Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator
patient type to [New Adult].
2.
Select [Setup]→[Sensor]→[SpO2] and set [Monitoring] to [ON].
3.
Measure SpO2 at your finger (supposing you are in healthy state). Set the PR high alarm
limit to 40 L/min when the ventilator is stabilized.
Verify that the [PR Too High] alarm is activated.
Set the PR high alarm limit to 120 L/min. Verify that this alarm is automatically reset.
4.
5.
3.7.20 PR Too Low Alarm Test
1.
Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator
patient type to [New Adult].
2.
Select [Setup]→[Sensor]→[SpO2] and set [Monitoring] to [ON].
3.
Measure SpO2 at your finger (supposing you are in healthy state). Set the PR low alarm
limit to 120 L/min when the ventilator is stabilized.
Verify that the [PR Too Low] alarm is activated.
Set the PR low alarm limit to 40 L/min. Verify that this alarm is automatically reset.
4.
5.
3-7
3.8 Function Tests
3.8.1 Checking the Standard Working Mode
Turn on the power switch and make sure that the ventilator is in working mode.
‹ Ventilator mode: [V-A/C]
‹
O2 concentration [O2%]：40 %
‹
Tidal volume [TV]：500 ml
‹
Inspiration time [Tinsp]：2s，or Inspiration and expiration ratio [I :E]：1 :2
‹
Frequency [f]：10 bpm
‹
Positive end-expiratory pressure [PEEP]：3 cmH2O
3.8.2 Checking the Tidal Volume
Turn on the ventilator and connect the test lungs. When the tidal volume output becomes
stable, observe the tidal volume displayed on the screen. Make sure that the displayed tidal
volume monitored value is stable and the monitored value is consistent with the set value.
3.8.3 Checking the Trigger Function
1.
2.
Set the pressure trigger sensibility to -2 cmH2O. Wear a mask and inspire gently. When
the airway pressure is a bit lower than this set value, starts inspiration and the trigger
flashes in the information bar of the screen.
icon
Set the flow trigger sensibility to 2 L/min. Wear a mask and inspire slightly. When the
inspiration flow is a bit lower than this set value, starts inspiration and the trigger icon
flashes in the information bar of the screen.
3.8.4 Checking Spontaneous Breathing in CPAP/PSV Mode
1.
2.
Set the ventilator to CPAP/PSV mode, flow trigger to 2 L/min, pressure support level to
10 cmH2O, and other parameters to their default values.
Wear a mask and inspire slightly. When the trigger sensitivity is reached, make sure that
inspiration starts and that the ventilator starts PSV ventilation.
3.8.5 Sidestream CO2 Test and Calibration
Leak test:
1. In standby mode, occlude the gas inlet of the module or watertrap with hand or other
object after CO2 warm-up is completed.
2. After occluding the gas inlet of the module or watertrap for a period of time, the screen
displays the alarm message [CO2 Sampleline Occluded], indicating that the module
has no leaks.
3-8
Module calibration:
Test tools:
„
CO2 with concentration of 6±0.05%,
„
T -connector
„
Gas tube
„
Flowmeter
cylinder with N2 as balance gas
1.
2.
Make sure that the sidestream CO2 module has already been warmed up or started.
Check the airway and leakage. Make sure that there is no leakage in the airway.
3.
Select [Setup]→[Maintain]→[User]→enter the required password→[CO2 In
Maintenance]→[Zero].
4.
Connect as shown below after successful zeroing.
5.
Turn on and adjust the regulator switch to make the flowmeter indicate flow of 10 to 50
mL/min and keep such flow.
Enter 6% (CO2 concentration value) in the [CO2%] text box in the [CO2 In
Maintenance] menu.
After the actually measured CO2 concentration is stable, select [Calibrate] to calibrate
the CO2 module. After successful calibration, the message [CO2 % Calibration
Completed!] is displayed. If the calibration fails, the message [Calibration Failure!
Try again!] is prompted. In this case, calibrate again.
6.
7.
3-9
3.8.6 Mainstream CO2 Test
Test tools:
„
CO2 with concentration of 6±0.05%,
„ Cylinder wtih 100% N2
„
T -connector
„
Gas tube
„
Flowmeter
cylinder with N2 as balance gas
1.
Make sure that the mainstream CO2 module has already been warmed up or started.
2.
Select [Setup]→[Calibrate]→[Zero]. Select the [Start] button corresponding to CO2
zeroing. The screen displays [CO2 Zeroing].
After successful zeroing, put the sensor before the mouth and breathe so that there is a
CO2 waveform on the screen. Then put the sensor in the air. Check that the ventilator
produces the alarm message [Apnea CO2].
Connect the test system as shown below.
3.
4.
5.
Open the N2 cylinder and CO2 cylinder regulators. Make sure that there is only one
cylinder connected with the T-connector at a time.
6.
Adjust the regulator switch to make the flowmeter indicate flow of 2～5L/min and
keep such flow.
Switch the cylinders connected with the T-connector at a time interval of 6-10s. Check
that the CO2 displayed value is 45±2mmHg.
7.
3-10
3.8.7 SpO2 Test
1.
2.
3.
4.
Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator
patient type to [New Adult].
Measure SpO2 at your finger (supposing you are in healthy state).
Check that the ventilator displays SpO2 Pleth waveform and PR value. And the
displayed SpO2 range should be 95-100%.
Remove the SpO2 sensor from the finger. Verify that the alarm [SpO2 Sensor Off] is
produced.
3.8.8 Checking the Special Functions
„
Inspiration Hold
1.
2.
Select the [Tools] key →[Functions] →[Insp. Hold]. Press and hold the [Insp. Hold]
key continuously. Make sure that the ventilator enters inspiration hold phase. The
ventilator automatically terminates the inspiration hold function if the [Insp. Hold] key
is pressed and held for continuous 30 seconds.
Release the [Insp. Hold] key, and make sure the ventilator enters expiration phase.
„
Expiration Hold
1.
Select the [Tools] key →[Functions] →[Exp. Hold]. Press and hold the [Exp. Hold]
key continuously. Make sure that the ventilator enters expiration hold phase. The
ventilator automatically terminates the expiration hold function if the [Exp. Hold] key is
pressed and held for continuous 30 seconds.
Release the [Exp. Hold] key, and make sure the ventilator enters inspiration phase.
2.
„
1.
2.
„
1.
2.
3.
„
1.
O2 Enrichment
When the ventilator is in working state, select Adult mode and press the [O2↑ Suction]
button. Make sure that the ventilator starts to deliver 100% O2.
Press the [O2↑ Suction] button again or maintain O2 enrichment function active for 2
minutes. Make sure that the ventilator restores to the working state before O2
enrichment.
Suction
Press the [O2↑ Suction] button to enter suction function. Make sure that suction enters
the first phase; namely, O2 enrichment is active.
Disconnect the patient. Make sure that suction enters the second phase; namely, O2
enrichment is not active. The message [The Patient is Disconnected! Reconnect
Patient after Suction Completed!] is prompted.
Re-connect the patient. Make sure that suction enters the third phase; namely, O2
enrichment is active.
Nebulizer
When the ventilator is in working state, press the [Nebulizer] key and set [Nebulizer
Time] in the accessed menu. Then select [Ok]. Make sure that the ventilator starts
nebulizer function that there is gas output at the nebulizer output port.
2. When the nebulizer time expires or the [Nebulizer] key is pressed again, make sure that
the ventilator terminates nebulizer function.
3-11
„
Manual Breath
When the ventilator is in working state, select the [Tools] key →[Functions] →
[Manual Breath]. Make sure that the ventilator delivers mechanical ventilation
immediately.
„
Sigh
1.
When the ventilator is in working state, select the
2.
Set ventilation parameters to their default values: [△int.PEEP] to 5cmH2O, [Interval]
to 1min, and [Cycles Sign] to 3.
Select [Ok]. Make sure that the ventilator activates sigh function once every minute and
that sigh is effective within continuous 3 ventilation cycles..
3.
key. Set [Sigh] to [ON].
3.9 Electrical Safety Inspection
NOTE
z
z
Perform electrical safety inspection after servicing or routine maintenance. Before
the electrical safety inspection, make sure all the covers, panels, and screws are
correctly installed.
The electrical safety inspection should be performed once a year.
3.9.1 Electrical Safety Inspection Test
1.
2.
3.
Perform protective earth resistance test:
a. Plug the probes of the safety analyzer into the protective earth terminal of AC power
cord and into the O2 connector.
b. Test the earth resistance with a current of 25 A.
c. Verify the resistance is not larger than 0.1ohms (100 mohms).
d. If the resistance is larger than 0.1ohms (100 mohms) but smaller than 0.2ohms (200
mohms), disconnect the AC power cord and plug the probe which is previously plugged
into the protective earth terminal of AC power cord into the protective earth contact of
the power outlet. Repeat steps a through c.
Perform the following earth leakage current tests:
‹ normal polarity;
‹ reverse polarity;
‹ normal polarity with open neutral; and
‹ reverse polarity with open neutral.
Verify that the maximum leakage current does not exceed 500 μA (0.5 mA) in the first
two tests. While for the last two tests, verify that the maximum leakage current does not
exceed 1000 μA (1 mA).
NOTE
z
Make sure the safety analyzer is authorized by certificate organizations (UL, CSA,
or AAMI etc.). Follow the instructions of the analyzer manufacturer.
3-12
3.9.2 Electrical Safety Inspection Form
Location:
Technician:
Equipment:
Control Number:
Manufacturer:
Model:
SN:
Measurement equipment /SN:
Date of Calibration:
INSPECTION AND TESTING
1
Protective Earth Resistance
Pass/Fail
2
Ω
Normal
condition(NC)
____μA
Single Fault
condition(SFC)
____μA
Limit
Max.：0.1 Ω
Max.：
NC：500μA
SFC：1000μA
Earth
Leakage
For periodically performance, all the test items included in the ELECTRICAL SAFETY
INSPECTION FORM shall be performed. After the equipment is repaired with main unit
disassembled, perform only test item 1 when the power supply PCBA is neither repaired nor
replaced, or perform all the test items when the power supply PCBA is repaired or replaced.
3-13
FOR YOUR NOTES
3-14
4 Maintenance Menu and Software Upgrade
4.1 User Maintenance
4.1.1 Overview
This section introduces the functions of user maintenance. User maintenance is mainly used
by the equipment maintenance personnel. It includes these functions: setup, defaults settings,
data transfer, interface setting, system information, and CO2 in maintenance.
4.1.2 Setting
Setting item
Description
Language
Set the screen display language.
Unit
Set Paw unit, weight unit, and CO2 unit.
Gas supply
Set O2 supply type. If the gas supply type is set incorrectly, use of partial
functions may be restricted (such as O2 enrichment etc.).
4-1
4.1.3 Defaults Settings
The ventilator settings can be adjusted as required. When [Use Current Settings] is selected,
the settings in Defaults Settings window will be replaced by the current settings. After the
ventilator is powered on and receives a new patient, it uploads the settings in Defaults
Settings window automatically.
When [Restore Factory Defaults] is selected, the settings in Defaults Settings window will
be restored to factory defaults. After the ventilator is powered on and receives a new patient,
it uploads the settings in Defaults Settings window automatically.
4.1.4 Data Transfer
When the department which the ventilator is used in needs to configure multiple ventilators,
the function of transferring settings is used to export or import the current settings and
defaults of the ventilator setting items. All USB memories have space of more than 10M
available and are in FAT32 or FAT format.
4-2
4.1.4.1 Export Settings
1.
Insert the USB memory into the USB connector of the ventilator.
2.
Select [Setup]→[Maintain]→[User]→enter the required password→[Data Transfer].
3.
Select [Export settings] to save the ventilator’s current settings and defaults to the USB
memory.
4.1.4.2 Import Settings
1.
Insert the USB memory into the USB connector of the ventilator.
2.
Select [Setup]→[Maintain]→[User]→enter the required password→[Data Transfer].
3.
Select [Import settings] to load the settings in the USB memory to the ventilator.
4.1.4.3 Export Data
This function is used for data export, which means to export patient demographics, current
setting parameters, current alarm limits, and trend data of the ventilator in the format of
“blg”.
To export data,
1.
Insert the USB memory into the USB connector of the ventilator.
2.
Select [Setup]→[Maintain]→[User]→enter the required password→[Data Transfer]
→[Export Data]. The system checks the availability of USB memory. If the USB
memory is available and has sufficient space, the system exports patient demographics,
current setting parameters, current alarm limits, tabular trend, graphic trend, PEEPi
measured value, P0.1 measured value, Vtrap measured value, NIF measured value,
calibration data, and event log.
3.
After data exporting is completed, select [Remove USB Memory] to remove the USB
memory.
4-3
4.1.5 Interface Setting
Interface setting includes nurse call.
4.1.5.1 Nurse Call
The nurse call function means that the ventilator outputs nurse call signals to the nurse call
system when an alarm which meets the user set requirements occurs.
The nurse call function is activated only when:
1.
The nurse call function is switched on;
2.
An alarm which meets the user set requirements occurs;
3.
The ventilator is not in Alarm AUDIO PAUSED status.
To set nurse call,
1.
Select [Setup]→[Maintain]→[User]→enter the required password→[Interface
Setting]→[Nurse Call].
2.
Select [Switch] and toggle between [ON] and [OFF].
„
[ON]: to switch on the nurse call function.
„
[OFF]: to switch off the nurse call function.
3.
Select [Signal Type] and toggle between [Pulse] and [Continuous].
„
[Pulse]: indicates that the nurse call signals outputted are pulse signals lasting for one
second. When multiple alarms occur simultaneously, only one pulse signal is outputted.
If a new alarm occurs while the ongoing alarm is not cleared yet, a new pulse signal will
be outputted.
„
[Continuous]: indicates that the nurse call signal lasts until the alarm ends, i.e. the
duration of a nurse call signal equals to that of the alarm.
4-4
4.
Select [Contact Type] and toggle between [Normally Open] and [Normally Closed].
„
[Normally Open]: normally open signals are used to trigger the nurse call function.
„
[Normally Closed]: normally closed signals are used to trigger the nurse call function.
5.
Select [Alarm Level] and set the alarm level for nurse call signals triggered alarm.
6.
Select [Alarm Type] and select the alarm type to which nurse call signals triggered
alarm belongs.
If no setting is made for [Alarm Level] or [Alarm Type], nurse call signals will not be
triggered whatever alarm occurs
WARNING
z
Do not rely exclusively on the nurse call system for alarm notification. Remember
that the most reliable alarm notification combines audible and visual alarm
indications with the patient’s clinical condition.
z
Use the specified nurse call cable when connecting with the hospital’s nurse call
system through the nurse call connection port. Failure to do so may burn the
machine and produce electric shock hazard.
z
Inspect the ventilator alarm signals periodically when using the nurse call function.
4.1.6 System Information
4-5
4.1.6.1 Version Information
The version information of the system software can be queries.
4.1.6.2 Configuration Information
The configuration information of the ventilator such as ventilation mode and special function
can be queries.
4.1.6.3 Maintenance Information
The system total running time, system startup time, CO2 last calibration time, O2 sensor last
calibration time, flow sensor last calibration time, time left for next blower maintenance and
time of last maintenance can be queried.
4.1.7 CO2 Maintenance
This setting item is available when the sidestream CO2 module is configured. For CO2
zeroing and CO2 calibration, refer to 5.3.5 Mainstream CO2 Zeroing (User) and 5.3.6
Sidestream CO2 Zeroing (User).
4-6
4.2 Factory Maintenance
4.2.1 Overview
Factory maintenance is used in such scenario as factory functional configuration, equipment
calibration, troubleshooting. The factory maintenance menu includes the following functions:
factory setup, factory calibration, calibration data, data monitoring, diagnosis test, event
logbook.
The factory maintenance password can be obtained in the preface chapter of this manual.
Warning: this menu can be operated only by Mindray authorized service engineers. Operating
the menu by unauthorized engineer may cause the machine unable to work normally.
4.2.2 Factory Setup
4.2.2.1 Overview
Factory setup includes: setup, functional activation, restore factory defaults, and versions.
4-7
4.2.2.2 Setup
The following table lists the setting items and their descriptions.
Setting item
Description
Update
Can be set to ON and OFF, to switch on or off the USB memory
update function.
Correction Mode
Can be set to ATPD and BTPS.
Apnea Reset
Can be set to ON and OFF.
Hide The Focus
Can be set to OFF, 15s, 30s, and 60s. When it is set to OFF, the
focus will not hide automatically. When it is set to other options, if
no operation is performed for corresponding period of time, the
focus will disappear automatically.
Hide The Menu
Can be set to OFF, 15s, 30s, and 60s. When it is set to OFF, the
menu will not hide automatically. When it is set to other options, if
no operation is performed for corresponding period of time, the
menu will disappear automatically.
Custom Parameter
Include two options: ON and OFF. When the factory locates a
failure, Custom Parameter can be switched on to view the trend of
corresponding parameter monitored value. After use, the option
needs to be set to OFF.
Altitude
Set altitude. When the atmospheric pressure sensor is faulty, the
atmospheric pressure can be calculated based on altitude.
Altitude Unit
Set altitude unit, including two options: m and ft.
CO2 Type
Set whether CO2 module is integrated based on the actual
configuration of the machine. If CO2 module is integrated, the type
of CO2 module needs to be set consistent with the actual one. Three
options are included: Mainstream, Sidestream, and No.
Blower Life Span
Set blower life span.
Clear Blower Running
Time
Click this button after replacing the blower to clear the blower
running time. Running time information is displayed next to the
button.
I:E
Can be set to ON and OFF. When it is set to ON, the system
displays the monitoring values of Tinsp and I:E. When it is set to
OFF, the system cannot display the monitoring values of the Tinsp
and I:E.
4.2.2.3 Functional Activation
In the Activate menu, payment configuration can be activated via activation code or USB
memory to use the corresponding function on trial. For details, refer to 4.3.3Function
Activation.
4-8
4.2.2.4 Restore Factory Defaults
Restoring factory defaults means to restore the values of setting items to factory default
values. The default values saved in the new patient default setting property page are also
restored to factory default values.
Restoring factory defaults will clear user log and saved spirometry loops (including reference
loop and P-V loop). Factory log will not be cleared.
The setting items which are not affected by restoring factory defaults include: inherent setting
items, power-on initialization items, menu entry initialization items, date and time setting
items, language and factory settings.
Language settings include:
Module
Position
Setting item
User
Setting
Language
4-9
Factory settings include:
Module
Position
Setting item
Service
Setup
Correction Mode
Setup
Blower Life Span
Setup
Update
Setup
Altitude Unit
Setup
Altitude
Setup
Custom Parameter
Setup
Apnea Reset
Setup
Hide the Focus
Setup
Hide the Menu
Inherent setting items: the values of setting items are not affected by transferring settings or
restoring factory defaults.
Module
Position
Inherent setting item
Service
Setup
CO2 Type
Setup
Blower Life Span
Activate
Preset item in ticked state on trial
Activate
Not activate preset item in ticked state
Power-on initialization items: restore to factory defaults each time after power-on; reserve the
latest preset item values each time after accessing the menu when not powered off.
Module
Procedure
Service
Screen
Layout
Position
Power-on initialization item
Nebulizer
Nebulizer Time
P-V Tools
Pstart
P-V Tools
Pmax
P-V Tools
Flow
P-V Tools
Vlimit
P-V Tools
History Loop
P-V Tools
Reference Loop
Calibration-Pressure
Calibration
Calibration Device
Calibration-Exp. Valve
Calibration Reference
Setup
Correction Mode
Setup
Update
Setup
Custom Parameter
Screen Layout
Waveforms
4-10
Menu entry initialization items: restore to factory defaults each time after accessing the
menu.
Module
Position
Menu entry initialization item
User
CO2 Calibration
CO2 Calibration Concentration
Data Monitor
Parts
Diagnosis
Blower speed
Diagnosis
Pressure
Diagnosis
Insp. valve
Diagnosis
Insp. valve
Diagnosis
O2 Insp. valve
Diagnosis
O2 Insp. valve
Diagnosis
Exp. valve
Diagnosis
Exp. valve
Diagnosis
Nebulizer valve
Diagnosis
Safety valve
Diagnosis
Activation code/USB
Service
Date and time setting items: neither being initialized nor being kept unchanged; displayed
following the ascending rules for time and date.
Module
Time setting
Position
Date and time setting items
Time and date
Date
Time and date
Time
4-11
4.2.2.5 Version Information
In [Versions] menu, you can view the version information of the software currently used by
each module.
4-12
4.2.3 Factory Calibration
The factory calibration menu provides access to the following: zeroing, flow calibration,
pressure calibration, Exp. valve calibration, O2 calibration, and Air-O2 calibration.
For details, refer to 5.3 System Calibration.
4-13
4.2.4 Calibration Data
The calibration data menu provides the following functions: zero point data monitoring, user
calibration table and factory calibration table of all parts, and Air-O2 calibration data display.
4-14
4.2.5 Data Monitoring
The data monitor menu provides the following functions: VCM data monitoring, VPM data
monitoring, and power board data monitoring.
4-15
4.2.6 Diagnosis Test
Diagnosis test provides valve test device. For details, refer to 6.6Diagnostic Test.
4-16
4.2.7 Event Logbook
Event logbook can be viewed, including alarm logbook, operation logbook, error logbook,
maintenance information. You can select to view event logbook via filter, which is
configurable.
Setting item
Functional description
High Alarms
Display all high alarm events only.
Med Alarms
Display all medium alarm events only.
Low Alarms
Display all low alarm events only.
All Alarms
Display all alarm events only.
Operation
Information
Display all operation events only.
Error
Information
Display all error events only (only available in factory event
logbook and not available in user event logbook).
Maintenance
Information
Include maintenance operation such as zeroing and
calibration, and selftest operation (only available in factory
event logbook and not available in user event logbook).
All Events
Display all events.
4-17
4.3 Software Upgrade and Software Function
Activation
CAUTION
z
Software upgrade and configuration activation can be performed by Mindray
authorzied professional service personnel only.
You can perform software upgrade on the ventilator by downloading the upgrade software
through network or by using USB memory. You can also upgrade software supported optional
configuration through the activation code. Before activating the optional configuration, the
optional configuration can be applied for a maximum of 30 days on trial.
4.3.1 Network Upgrade
You can upgrade the following programs on the ventilator by downloading the upgrade
software through network:
„
BIOS (main board) software
„
Main board software
„
Multi-language library
„
Icon library
„
Start-up screen
„
Audio file
„
General configuration (requires password )
„
System functional configuration
„
Linux file system
„
Linux kernel
„
Protection module software
„
Control module software
„
Keyboard software
„
Power board software
„
Insp. module software
„
Exp. module software
„
M02C module software
„
SpO2 module software
4-18
CAUTION
z
Before software upgrade, disconnect the ventilator from the patient and back up
the important data.
NOTE
z
Make sure that the version of the upgrade package is the desired one. To obtain the
latest upgrade package, please contact us.
z
Before upgrading the system software, check the version information of the booting
software. If it is not the latest, upgrade the booting software to the latest version
first and make sure of software compatibility.
You can select the following operations to upgrade the corresponding software based on your
requirement. You must perform 4.3.1.1Network Connection before upgrading any software.
4.3.1.1 Network Connection
4.3.1.2 Network Connection
NOTE
z
Before upgrading any software, make sure that the network cable, Hub, and
notebook computer are connected correctly and reliably.
z
The recommended length of the network cable is not greater than 1 m.
4-19
Perform network connection as follows before software upgrade:
Connect the ventilator, Hub and notebook computer by using the straight through cable.
Connect the Hub to the power source and make sure that the network is connected.
2.
Set the IP address of the notebook computer. Make sure that the IP address of the
notebook computer is in the same IP segment with the ventilator and they do not repeat.
The IP address of the ventilator is fixed to the setting when delivered from the factory,
which is “192.168.23.250”. The IP address of the notebook is generally set to
“192.168.23.23”.
4.3.1.3 Booting Software Network Upgrade
CAUTION
z
Switching off or powering off the equipment during booting software upgrade can
cause system down.
NOTE
z
When selecting the upgrade package, make sure that the checksum and software
version are same to that provided by the factory.
4-20
To upgrade the booting software of the ventilator:
1.
Run the network upgrade downloading software on the notebook computer to access the
software upgrade screen.
2.
Click [Select Package] to enter the [Select Package] menu.
3.
Click [>>>]. Select the booting software of the ventilator (code: BIOS) in the dialog box
and then click [Open] to confirm.
4.
Check the checksum and software version of the booting software as shown below:
5.
If the checksum and version are correct, click [Ok].
6.
Click [Start (Single)] on the main screen.
7.
Re-start the ventilator to start to upgrade the booting software.
4-21
8.
The upgrade is successful when the screen prompts [Upgrading
BIOS…………………………Succeed], [Upgrade Completed！], and [Disconnect the
net wire，and restart this machine！]. Select [Setup]→[Maintain]→[Service]→enter the
required password→[Setup]→[Versions] to check the version information of the
booting software.
OTE
z
After completing booting software upgra e, turn on the ventilator to confirm
the corre tn ss of upgrade software version information.
4.3.1.4 System Software Network Upgrade
NOTE
z
Before upgrading the system software, check the version information of the booting
software. If it is not the latest, upgrade the booting software to the latest version
first and make sure of software compatibility.
z
Before upgrading the system software, record the current settings of the ventilator
so as to restore the pre-upgrade settings after software upgrade.
z
When selecting the upgrade package, make sure that the checksum and version are
same to those provided by the factory. You also need to check the machine code
corresponding to the ventilator to be upgraded.
Before upgrading the system software, note the matching between machine name and
machine code as listed below:
Machine name
Machine Code
Remarks
EV20
SV300/350
/
EV25
SV350
/
To upgrade the system software:
1.
Check and confirm that the booting software of the ventilator is of the latest version. If
not, refer to 4.3.1.3Booting Software Network Upgrade to upgrade to the latest version.
2.
When selecting the system software upgrade package, confirm the correctness of
checksum and software version. You also need to check the machine code, as shown
below:
4-22
3.
Other operations are similar to those for booting software upgrade. Refer to
4.3.1.3Booting Software Network Upgrade to complete the upgrade.
NOTE
z
After completing system software upgrade, turn on the ventilator to confirm the
correctness of upgrade software version information.
z
After completing system software upgrade, restore the pre-upgrade settings of the
system settings which are saved in case of power failure.
4.3.1.5 Protection Module Software Network Upgrade
NOTE
z
Before upgrading the protection module software, check the version information of
the booting software. If it is not the latest, upgrade the booting software to the
latest version first and make sure of software compatibility.
z
When selecting the upgrade package, make sure that the checksum and software
version are same to those provided by the factory.
To upgrade the protection module software:
1.
Check and confirm that the booting software of the ventilator is of the latest version. If
not, refer to 4.3.1.3Booting Software Network Upgrade to upgrade to the latest version.
2.
When selecting the protection module software upgrade package, confirm the
correctness of checksum and software version, as shown below.
4-23
3.
Other operations are similar to those for booting software upgrade. Refer to
4.3.1.3Booting Software Network Upgrade to complete the upgrade.
NOTE
z
After completing protection module software upgrade, turn on the ventilator to
confirm the correctness of upgrade software version information.
4.3.1.6 Module Software Network Upgrade
NOTE
z
When selecting the upgrade package, make sure that the checksum and software
version are same to those provided by the factory. You also need to check the
module sofware to be upgraded matches the corresponding module code.
The module software mentioned here includes monitor module software, inspiration module
software, expiration module software, keyboard software, power board software, M02C CO2
module software and SpO2 module software. Their upgrade procedures are similar to those
for booting software upgrade except that when selecting the upgrade package, apart from
making sure of the correctness of checksum and version, you also need to confirm the
module code corresponding to the module to be upgraded.
4-24
Before upgrading the module software, note the matching between module name and module
code as listed below:
Module name
Module code
Ventilator control module
VCM
Inspiration module
Insp. Module
Expiration module
Exp. Module
Power board
POWER
Keyboard
KEYBOARD
M02C CO2
0611-CO2-M02C
SpO2
SpO2
To upgrade the module software:
1.
When selecting the module software upgrade package, confirm the correctness of
checksum and software version. You also need to check the module code, as shown
below:
2.
Other operations are similar to those for booting software upgrade. Refer to
4.3.1.3Booting Software Network Upgrade to complete the upgrade.
z
NOTE
z
After completing module software upgrade, turn on the ventilator to confirm the
correctness of upgrade software version information.
4-25
4.3.1.7 Linux Platform Software Network Upgrade
NOTE
z
Linux platform software includes Linux file system and Linux kernel program.
There is no chronological order for upgrading Linux file system and Linux kernel
program.
z
When selecting the upgrade package for Linux kernel program, make sure that the
checksum and software version are same to those provided by the factory.
To upgrade the Linux kernel program:
1.
When selecting the upgrade package for Linux kernel program, confirm the correctness
of checksum and software version, as shown below.
2.
Other operations are similar to those for booting software upgrade. Refer to
4.3.1.3Booting Software Network Upgrade to complete the upgrade.
4-26
To upgrade the Linux file system:
1.
When selecting the upgrade package for Linux file system, confirm the correctness of
selected upgrade file, as shown below:
2.
Other operations are similar to those for booting software upgrade. Refer to
4.3.1.3Booting Software Network Upgrade to complete the upgrade.
NOTE
z
After completing Linux platform software upgrade, turn on the ventilator to
confirm the correctness of upgrade software version information.
4.3.1.8 Combination Package Network Upgrade
The operations to upgrade the combination package are the same with those for system
software upgrade. Please refer to related section.
NOTE
z
After completing combination package software upgrade, you need to confirm the
software version upgraded.
z
During combinatin package upgrade, if upgrade failure occurs due to abortion,
you need to upgrade again the software package in the combination package which
has not been upgraded successfully.
4-27
4.3.2 USB Memory Upgrade
The software programs supported by the ventilator USB memory are same to those by
network upgrade. They are omitted here.
4.3.2.1 Description of USB Memory Upgrade
NOTE
z
Make sure that the version of the upgrade package is the desired one. To obtain the
latest upgrade package, please contact us.
1.
Save the upgrade package and the configuration file of the same name under the
directory of UPGRADE of USB device. Name the upgrade package “USBUpgrade.pkg”
or “USBUpgrade.mpkg” and the configuration file “USBUpgrade.txt”.
2.
Set the upgrade mode of USB memory in the system software. Select [Setup]→
[Maintain]→[Service]→enter the required password→[Setting]→[System]. Set
[Update] to [On].
3.
Insert the USB memory into the USB port of the ventilator. Restart the ventilator and the
ventilator enters upgrade process.
4.
After upgrade is completed, remove the USB memory and restart the ventilator. Check if
the machine upgrade is completed.
NOTE
z
For USB memory to be upgraded, its file system must be in the format of FAT32
and the remaing space of USB memory must be at least 100M before upgrade to
ensure upgrade success.
z
The folder in which the upgrade package is kept can only be named UPGRADE in
capital letters. The upgrade package and configuration file can only be named
USBUpgrade.pkg or USBUpgrade.mpkg and USBUpgrade.txt, in which, USBU
must be in capital letters and other letters are lowercase.
z
When there are combination package and single upgrade package file in the USB
device, the combination package is upgraded by default. To upgrade a single
upgrade package, you need to delete the combination package from the USB device
first.
z
In case of USB memory upgrade, the configuration file can be shared when
upgrading different packages.
z
After upgrading an upgrade package, if it is necessary to continue USB memory
upgrade, restart the machine to set [Update] to [ON].
4-28
NOTE
z
When upgrading a single VCM module upgrade package, it is normal that the
buzzer sounds after a successful upgrade. Just turn off the machine and restart it.
4.3.2.2 Commonly-encountered Problems and Recommended Actions
Failure description
Possible cause
Recommended solution
Unable to enter upgrade
mode to activate upgrade.
Enter the system software
directly after power-on.
The IP address of the
computer is not correct.
Set the ventilator and PC
computer to a same IP
segment with different IP
address.
[Start] is not clicked for the
upgrade tool.
Click [Start].
Enable the firewall.
Close the firewall.
[Update] is not switched on.
Enter Setup→Maintain→
Service→enter the required
password→Setup→Setting
menu to set Update to ON.
USM memory is not inserted.
Insert the USB memory into
the USB port of the
ventilator.
USB memory is faulty.
Replace with a faultless USB
memory and try again.
The USB port of the
ventilator is damaged.
Return the VCM to the
factory for repair.
The name of folder, upgrade
package, or configuration file
does not comply with the
requirement.
Modify the name of folder,
upgrade package or
configuration file.
The upgrade package or
configuration file does not
exist.
Re-make the upgrade
package and configuration
file.
The upgrade package or
configuration file is wrong.
Re-make the upgrade
package and configuration
file.
The BIOS program of the
main control board is
damaged due to possible
power failure during upgrade
or upgrade failure.
Return the main control
board to factory for repair.
Unable to enter USB
memory upgrade. Enter
the system software
directly after power-on.
USB memory upgrade fails.
During upgrade, the buzzer
on the main control board
buzzes long, resulting in
upgrade failure.
4-29
Failure description
Possible cause
Recommended solution
In case of system software
upgrade, the upgrade screen
can be accessed but upgrade
is always failed.
The version of BIOS program
is incompatible with that of
system software.
The network is not stable.
1. Contact Mindray engineer
to confirm version
compatibility.
2. Check the network
connection between the
notebook computer, Hub and
ventilator to make sure that
the network cable is reliably
connected.
In case of control module,
inspiration module, and
expiration module upgrade,
the upgrade screen can be
accessed but upgrade is
always failed.
It is possible that the
corresponding parameter
software module BIOS
version is incompatible with
module software version.
It is possible that the
corresponding parameter
software module BIOS lacks.
1. Contact Mindray engineer
to confirm version
compatibility.
2. Check if the ventilator
version information contains
the BIOS version information
of the corresponding
parameter software module.
If not, return it to the factory
to upgrade the BIOS of the
corresponding parameter
software module.
The upgrade booting screen
is inaccessible.
The network may be not in
good condition.
1. Re-check the network
connection
between
the
notebook computer, Hub and
ventilator. Check that the
network cable is connected
correctly and reliably.
2. Make sure that Hub is
powered on.
After the system software or
XX module software is
upgraded,
XX
module
communication
stop
is
alarmed.
The version of system
software does not match that
of XX module software. Or,
the module is damaged.
4-30
Re-confirm
the
version
information of XX module
software and the module
code. If they are correct,
return the faulty module to
factory for repair.
4.3.3 Function Activation
The factory can activate all the functions listed in the following table through activation
codes. When the user wants to add any function listed in this table, the service engineer can
apply to the factory for activation code so as to activate the corresponding function.
Optional
configuration
Effect upon the software screen
Remarks
NIV
Not involved.
Paid configuration
PRVC
DuoLevel
APRV
PRVC-SIMV
P0.1
NIF
PEEPi
Not involved. If none of the functions is configured,
the special function property page is not displayed
in the main menu.
Suction
The Suction button is not displayed in the softkey
area on the right side of the main screen.
P-V tools
Not involved. When the function of P-V tools is not
configured, P-V tools property page is not
displayed in the special procedure menu.
ATRC
Not involved. When the function of ATRC is not
configured, ATRC property page is not displayed in
the parameter setting dialog box menu.
WOB
Not displayed.
RSBI
4-31
4.3.3.1 Apply for Software Function Activation Code
NOTE
z
To apply for activation code, you must provide the relevant information of the
ventilator whose configurations are to be activated, such as machine ID, existing
configuration and configuration to be activated.
z
One activation code can activate only one machine.
When the user wants to add any paid configuration listed in the above table, the service
engineer must place an order to the Service Department for the software function activation
code based on the user's need.
To apply for activation code:
1.
Record the serial number of the ventilator whose configurations are to be activated.
2.
Record the machine ID and the current configuration of the ventilator. Select [Setup]→
[Maintain]→[User]→enter the required password→[Syst. Info]→[Config Info.] to
open the configuration information menu.
3.
Record the configuration information the user wants to activate.
4.
Return the recorded information to the Service Department to purchase the
corresponding activation code.
4-32
4.3.3.2 How to Activate Software Function
NOTE
z
Before activation, check and record the user’s existing paid configurations and also
the paid configurations to be added.
z
After entering the activation code, make sure that the entered activation code is
same to that provided by the factory.
To activate software functions:
1.
Select [Setup]→ [Maintain]→[Service]→enter the required password→[Setup]→
[Activate] to open the [Activate] menu, as shown below.
2.
If you select to activate the function by [Code], enter the required activation code in the
[Activate] menu. If you select to activate the function by [USB Memory], inset the
USB memory with required activation code into the ventilator.
3.
Select [Activate]. If the entered activation code is correct, the prompt message
“Upgrade Completed! Please restart the ventilator.” is displayed.
4.
Click [Ok] to restart the ventilator so as to activate the new configuration.
4-33
NOTE
z
Do not power off the ventilator before the message [Upgrade Completed! Please
restart the ventilator.] is prompted. Otherwise, the BIOS program on the main
control board can be damaged.
z
After activation success is prompted, restart the ventilator to activate both the
existing and new paid configurations after software upgrade.
4.3.3.3 Commonly-encountered Problems and Recommended Actions
Failure description
Possible cause
Recommended solution
When restarting the ventilator
after activation, the main
control board buzzes long,
resulting in restart failure.
During activation, the ventilator
is powered off or turned off
before activation success is
prompted, which damages the
BIOS program on the main
control board.
Return the main control
board to factory for repair.
Invalid activation code is
prompted.
The activation code is entered
improperly or the activation code
itself is wrong.
1. Check that the activation
code entered is same to that
provided by the factory.
2. If the activation code is
entered correctly and invalid
activation code is still
prompted, send the machine
ID, existing configurations
and the configurations to be
added to the factory for
confirmation.
After system activation, the
activated functions are not
consistent with the user’s
configurations.
The factory activation code is
wrong.
Or,
the
existing
configurations
and
the
configurations to be added which
are provided for the factory are
not complete.
Check
the
existing
configurations
and
the
configurations to be added
again. Request the factory to
generate activation code
again.
“Activation Code File Not
Found” is prompt when
selecting
USB
memory
activation.
The activation code file is
damaged or does not exist in the
USB memory.
Re-apply for an activation
code.
“Activation Code File Error”
is prompt when selecting
USB memory activation.
The activation code file exists but
with incorrect contents, so that it
cannot be activated.
Re-apply for an activation
code.
4-34
4.3.4 Function Trial
You can use the optional function on trial and the longest trial period is 30 days.
To use the paid function on trial, select [Setup]→ [Maintain]→[Service]→enter the
required password→[Setup]→[Activate]. Select [Free Trial] in the Activate menu. Then
select the function items for trial use (multiple functional items can be selected). Select [Ok]
to pop up the [Trial Function] dialog box for confirmation. Restart the machine after your
confirmation to support trial use of the paid functions.
After starting to use the functions on trial, the corresponding paid functions can be used. The
longest trial period for each function is 30 days. Besides, you can cancel the selected ongoing
trial function to abort trial use of this function.
After the trial period expires, the corresponding trial use of the trial function comes to an end,
no longer supporting use of this function. If you want to continue use of this function, you
can purchase the software function activation code from use to activate this function.
NOTE
z
When starting trial use of a function, you must turn off the machine and then
restat it to activate the trial function.
z
After the end of trial period, the corresponding function cannot be used when
powered on the machine next time.
z
You can use each paid function on trial only once with the longest trial period of 30
days.
4-35
FOR YOUR NOTES
4-36
5 Maintenance and Calibration
WARNING
z
When it comes to test and maintain the equipment, make sure that the patient is
disconnected from the equipment.
z
The equipment may have been used on patients carrying infectious diseases. Before
testing or maintaining the equipment, wear sterile rubber gloves to reduce the risk
of being infected.
z
When the equipment to be maintained contains blood or other secretion, clean,
disinfect and sterilize the equipment by strictly following the control and safety
handling procedures for infectious diseases.
5.1 Equipment Maintenance
To ensure the long-term reliability and stability of the ventilator, periodical maintenance of
the equipment and replacement of its parts must be performed by authorized service
personnel. For details about parts replacement, refer to 7 Repair and Disassembly. Periodical
parts replacement is carried out every year after installation. Make records of the parts that
have been replaced before the periodical replacement. Lithium battery and blower box
assembly need to be maintained according to their working time. If it has reached the
maximum working time or the system gives an alarm, it is necessary to replace the part.
NOTE
z
These schedules are the minimum frequency based on typical usage of 5000 hours
per year. You should service the equipment more frequently if you use it more than
the typical yearly usage.
z
To avoid equipment damage or personal injury, replace the parts which need to be
replaced periodically even if they are not worn or damaged when the due date
arrives.
z
Before maintaining the ventilator, run system check to test the states of important
parts such as blower, sensors and valves, and circuit leakage or occlusion for a
basic understanding of the current state of the ventilator. Refer to 5.2.1System
Check.
5-1
5.1.1 One-year Replaceable Parts
One-year service list (115-028397-00) and tools.
S/N
P/N
Description
Qty.
Tool
1
049-000778-01
Expiratory valve diaphragm
1
No
2
045-001333-01
HEPA filter
1
No
3
045-001298-01
Air inlet dust screen
1
No
4
048-004133-00
Fan dust screen
1
No
082-001903-00
Pressure sensor filter PTFE
13mm
2
Cross
recessed
screwdriver
5
5.1.1.1 Parts Replacement
（1）Replace the expiratory valve diaphragm (049-000778-01) every 12 months as required.
As indicated by the expiratory valve handwheel silkscreen on the front panel of the
ventilator, rotate the expiratory valve handwheel counter clockwise to the limit position
and then take out the expiratory valve horizontally as shown below. Remove the
expiratory valve diaphragm at the tail with hand and replace with a new service part. Do
not damage the diaphragm during replacement. Note that the diaphragm is evenly
snapped in the ring recess of the expiratory valve plastic part.
Expiratory valve diaphragm
（049-000778-01）
5-2
（2）Replace the HEPA filter (045-001333-01) every 12 months as required. Remove the
baffle of main unit air inlet. Depress and grab the snap at the top of HEPA filter and pull
it out horizontally. When installing, push in the HEPA filter to the right position and
make sure it is installed in place.
HEPA filter（045-001333-01）
（3）Replace the air inlet dust screen (045-001298-01) every 12 months as required. Remove
the baffle of main unit air inlet. Remove the air inlet dust screen and replace with new
service part by hand.
Air inlet dust screen（045-001298-01）
5-3
（4）Replace the fan dust screen (048-004133-00) every 12 months as required. Remove the
main unit rear housing. Remove the fan dust screen and replace with new service part by
hand.
Fan dust screen（048-004133-00）
（5）Replace the small filter of expiratory flow sensor every 12 months as required. Its part
number and description is “082-001903-00 (pressure sensor filter PTFE 13mm)”.
Remove the main unit top cover, display, and front panel and then the two pressure
sensor filters can be seen as shown below. Refer to the figure below to replace the
pressure sensor filters.
5-4
Pressure sensor filter PTFE 13mm
（082-001903-00）
5-5
5.1.1.2 Ventilator Checkout and Test
After replacing the service kit, check and test the ventilator every 12 months: For details,
refer to 3Checkout and Test and 5.3 System Calibration.
5.1.2 Periodically-Maintained Parts
S/N
1
2
P/N
Description
022-000130-00
Lithium battery
Li-ion14.8V5800mAh
115-022516-00
Blower box assembly
5-6
Qty.
Remarks
1 or 2
Replace after two years or when the
system gives the alarm of “Battery
Failure”.
1
Replace after the blower has worked
for 20000 hours or when the system
gives the alarm of “Blower Need
Maintenance” or “Blower Failure”.
5.2 System Test
After maintaining the ventilator at the client end, some routine tests are required to check if
the current state of the ventilator is normal. The following table lists the routine tests.
S/N
1
Test item
System check
Functional description
1. Check if the blower, inspiratory flow sensor, O2 flow
sensor, expiratory flow sensor, pressure sensor,
expiration valve, safety valve, and O2 concentration
sensor are in good condition.
2. Check the leakage, compliance, and circuit resistance
of the system.
Test interval
After each
service or at
the time of
return visit
2
Check the
mechanical
ventilation
state
1. Check if the machine provides normal mechanical
ventilation and if there is an alarm triggered.
2. Check if the pressure or tidal volume measured
values are consistent with the preset values.
After each
service or at
the time of
return visit
3
Check the
correctness of
sensor zero
point
Check if the zero points of all the flow sensors and
pressure sensors inside the machine are within normal
ranges so as to determine whether to zero the sensors
again or replace the VCM board.
After each
service or at
the time of
return visit
4
5
Check the
accuracy of
flow sensor
Check the
accuracy of
pressure
sensor
Check if the measurements performed by the machine
internal flow sensors are consistent with each other.
Check if the measurement performed by any single flow
sensor inside the machine is accurate.
Check the effectiveness of flow calibration (factory)
result.
1. Check if the measurements performed by the machine
internal pressure sensors are consistent with each other.
2. Check if the measurement performed by any single
pressure sensor inside the machine is accurate.
3. Check the effectiveness of pressure calibration
(factory) result.
5-7
After each
service or at
the time of
return visit
After each
service or at
the time of
return visit
5.2.1 System Check
NOTE
z
Before maintaining the ventilator, run system check to test the states of important
parts such as blower, sensors and valves, and circuit leakage or occlusion for a
basic understanding of the current state of the ventilator.
System check includes tests on the working states of blower inspiration valve, O2
proportional valve, inspiratory flow sensor, O2 flow sensor, expiratory flow sensor, pressure
sensor, expiration valve, safety valve, and O2 concentration sensor, as well as the leakage and
resistance of the ventilator. The test items are listed below:
S/N
Calibration item
Functional description
Requirements to pass the test
1
Blower test
Test the speed of the
blower.
The deviation between the actual
speed of the monitored blower and
the control speed is less than ±10%
of the control speed.
2
O2 flow sensor test
Test the O2 proportional
valve and O2 flow
sensor.
The error between the O2 flow
sensor and the O2 proportional valve
opening speed is less than max
(2L/min, ±30% of the test flow).
3
Inspiratory flow sensor
test
Test the inspiration
valve and inspiratory
flow sensor.
The error between the inspiratory
flow sensor and the inspiration valve
opening speed is less than max
(2L/min, ±30% of the test flow).
4
Expiratory flow sensor
test
Test the expiratory flow
sensor.
The error between the expiratory
flow sensor and the inspiratory flow
sensor is less than max (2L/min,
±30% of the test flow).
5
Pressure sensor test
Test the inspiratory
pressure sensor and
expiratory pressure
sensor.
When the expiration valve is blocked
under different pressures, the change
of the readings on the inspiratory
pressure sensor and expiratory
pressure sensor are consistent with
that of the valve opening pressure.
The values measured by the
inspiratory pressure sensor and
expiratory pressure sensor shall not
deviate by 10cmH2O.
5-8
S/N
Calibration item
Functional description
Requirements to pass the test
6
Expiration valve test
Test the expiration
valve.
The same with the above one. One
judgment condition is added: the
auxiliary module controls to open the
expiration valve, and the readings of
both the inspiratory pressure sensor
and expiratory pressure sensor are
less than 10cmH2O.
7
Safety valve test
Test that the safety valve
can be opened and
closed normally.
The monitoring board and auxiliary
control board can control to open and
close the safety valve normally.
8
Leakage（ml/min）
Calculate the circuit
leakage.
Leakage when the airway pressure is
50cmH2O. The leakage is acceptable
within the range of 0~300ml/min.
The maximum range which the
machine can monitor is 0 to 10
L/min.
9
Compliance
（ml/cmH2O）
Calculate the circuit
compliance.
The measured compliance value is
0~20 ml/cmH2O.
10
Circuit resistance
（cmH2O/L/s）
Calculate the circuit
resistance; thus
reflecting if the circuit is
occluded.
The circuit resistance is 0 to 20
cmH2O/L/s when the flow is
60L/min.
11
O2 sensor test
Test the O2 sensor.
Under pure air environment, the
measured value is 18% to 23%.
Under pure O2 environment, the
measured value is 90% to 100%.
NOTE
z
If the system check fails, you need to troubleshoot the failed test items (refer to 6
Troubleshooting) and then run another system check until the system passes all the
tests.
5-9
5.2.2 Check the Mechanical Ventilation State
NOTE
z
The main function of the ventilator is to provide breathing support--mechanical
ventilation which complies with the doctor’s settings to the patient. The tests in this
section are performed aiming to ensure that the machine is able to provide normal
mechanical ventilation.
z
The tests can help to judge if the ventilator operates normally.
The tests are to check the consistency between the machine setting values and measured
values, the working state of the ventilator, and the alarms so as to determine if this ventilator
operates normally.
5.2.2.1 Check Volume Control Ventilation
This test is to check if the ventilator can provide volume control ventilation, including tidal
volume control, feedback and measurement, as well as correct ventilation alarms.
To check volume control ventilation,
1.
Make sure that the supply pressure is normal and that the tubes in the breathing circuit
are correctly connected as required for mechanical ventilation. Connect the test lung to
the Y piece in the patient circuit.
2.
Select V-A/C as the ventilation mode.
3.
Set the following combinations of TV and Rate respectively: (150 ml, 15 bpm), (300 ml,
15 bpm), (600 ml, 15 bpm) and (900 ml, 15 bpm). Set others to the defaults. Record the
TVi displayed value of each setting in stable state.
4.
Judge if the above measured data meet the following conditions:
‹
TV control and measurement are normal: the difference between the TVi displayed
value and the set value shall not exceed 10ml+10% of the setting value.
‹
No other ventilation failure occurs: the pressure and flow waveforms are displayed
normally and no technical alarms occur.
If the above test requirements are not met, perform subsequent checks and do the test again.
NOTE
z
If any errors are detected during volume control ventilation (V-A/C) test, perform
troubleshooting as per 6 Troubleshooting and do the test again until the system is
normal.
5-10
5.2.2.2 Check Pressure Control Ventilation
This test is to check if the ventilator can provide pressure control ventilation, including
pressure control, feedback and measurement, as well as correct ventilation alarms.
To check pressure control ventilation,
1.
Make sure that the supply pressure is normal and that the tubes in the breathing circuit
are correctly connected as required for mechanical ventilation. Connect a 2 L bag, which
is used as the test lung, to the Y piece in the patient circuit.
2.
Select P-A/C as the ventilation mode.
3.
Set the following combinations of △Pisnp, Rate and PEEP respectively: (10 cmH2O,
15 bpm, OFF), (15 cmH2O, 12 bpm, 5 cmH2O), (20 cmH2O, 10 bpm, 8 cmH2O). Set
others to the defaults. Record the displayed Ppeak and PEEP values of each setting in
stable state.
4.
Judge if the above measured data meet the following conditions:
‹
Pressure control and measurement are normal: the difference between the displayed
Ppeak value and Pinsp setting value (△Pisnp+PEEP) does not exceed
2cmH2O+5% of the setting value, the difference between the displayed PEEP
value and PEEP setting value does not exceed 2cmH2O+5% of the setting value.
‹
No other ventilation failure occurs: the pressure and flow waveforms are displayed
normally and no technical alarms occur.
If the above test requirements are not met, perform subsequent checks and do the test again.
NOTE
z
If any errors are detected during pressure control ventilation (P-A/C) test, perform
troubleshooting as per 6 Troubleshooting and do the test again until the system is
normal.
5-11
5.2.3 Check the Correctness of Sensor Zero Point
NOTE
z
If the zero point AD value of the pressure sensor has an error, in ventilation status
when PEEP is set to 0, the baseline of the pressure waveform is not at the zero
point.
z
If the zero point AD value of the expiratory flow sensor or the zero point value of
the inspiratory flow sensor has an error, in ventilation status, the baseline of the
flow waveform is not at the zero point.
z
If the zero point value of any sensor is outside of the normal range, and if it can not
be corrected, the monitoring board must be replaced.
z
The normal range of the zero point AD value of the inspiratory pressure sensor
and expiratory pressure sensor is 967~1875.
z
The normal range of the zero point AD value of the expiratory flow sensor is
365~910.
z
The normal range of the zero point of the inpiratory flow sensor and O2 flow
sensor is -0. 5~1L/min.
The test is to check if the zero points of all the flow sensors and pressure sensors inside the
ventilator are within normal range so as to determine whether to zero the sensors or replace
the monitoring board.
To check the correctness of sensor zero point,
1.
Disconnect all gas supplies and position the Y piece connector in the patient circuit to
the air.
2.
Make sure that the system is Standby. Select [Setup] → [Maintain] → [Service] →
enter the required password→ [Data Monitor]. Select [VCM] and [VPM] respectively.
Check the actual values of flow and pressure sensors.
3.
Make sure that the actual measured value of each sensor is close to “0” (zero). If the
measured value of any sensor is larger than 0.5, you need to calibrate the sensor. Record
the zero point value of each sensor and judge if the zero point falls within the normal
range. If not, zero the corresponding sensor. For details about zeroing, please refer to
5.3.9Pressure and Flow Zeroing (Factory).
5-12
5.2.4 Check the Accuracy of Flow Sensor
NOTE
z
If a great deviation of TV measured value occurs, test the measurement accuracy
of expiratory flow sensor so as to determine whether to perform flow calibration
again. This test can also validate the effectiveness of flow calibration.
This test is to check the consistency of measurement among the internal flow sensors and the
accuracy of measurement of each flow sensor, as well as validating the effectiveness of flow
calibration (factory).
To check the accuracy of flow sensor,
1.
Connect the inspiration port and expiration port of the ventilator with a hose, as shown
below.
2.
In standby mode, select [Setup] → [Maintain] → [Service] →enter the required
password→ [Diagnosis] to access the [Valve Test] menu.
3.
Set blower pressure to 80cmH2O. Increase the flow of inspiratory valve, causing the
valve opening flow to fall within the following ranges respectively: (3 ± 0.5) L/min, (10
± 1) L/min, (20 ± 1) L/min, (30 ± 2) L/min, (60 ± 3) L/min. Record the measured flow
values of the total flow sensor and expiratory sensor of each setting point under stable
state. Make sure that the deviation between the measured value of the expiratory flow
sensor and that of the total flow sensor shall be less than max (2L/min, measured value
of total flow sensor x 10%).
5-13
4.
Connect high pressure O2 supply and make sure that the gas supply is sufficient.
Increase the flow of O2 proportional valve, causing the valve opening flow to fall within
the following ranges respectively: （3±0.5）L/min,（10±1）L/min,（20±1）L/min,
（30±2）L/min,（60±3）L/min. Record the measured flow values of the O2 flow sensor
of each setting point under stable state. Make sure that the deviation between the
measured value of the O2 proportional valve and that of the O2 flow sensor shall be less
than max (2L/min, measured value of O2 flow sensor x 20%).
5.
If any of the sensors fails the test, perform flow calibration again as per 5.3.2Flow
Calibration (Factory). If the test still fails after calibration, replace the corresponding
flow sensor.
5.2.5 Check the Accuracy of Pressure Sensor
NOTE
z
If a great deviation of pressure measured value occurs, test the measurement
accuracy of pressure sensor so as to determine whether to perform pressure
calibration again. This test can also validate the effectiveness of pressure
calibration.
This test is to check the consistency of measurement among the internal pressure sensors and
the correctness of measurement of each pressure sensor, as well as validating the
effectiveness of pressure calibration (factory).
To check the accuracy of pressure sensor,
1.
Make sure that the pressure sampling line and calibration device (or other pressure
measurement device) are connected in parallel. Connect the Luer connector to the low
pressure port “+”of the calibration device using a pressure sample tube, as shown below.
Power cord
Pressure sampling port
Insp. port
Calibration device
Y- Piece connector
Exp. port
5-14
2.
In standby mode, select [Setup] → [Maintain] → [Service] →enter the required
password → [Diagnosis] to access the [Valve Test] menu.
3.
Set blower pressure to 80cmH2O and inspiratory valve opening flow to 10L/Min.
4.
Increase the pressure of expiratory valve, causing the expiratory valve closing pressure
to fall within the following ranges respectively: (5 ± 1) cm H2O, (20 ± 1) cm H2O, (50 ±
1) cm H2O, (70 ± 2) cm H2O. Record the measured values of the calibration device,
expiratory pressure sensor and inspiratory pressure sensor of each setting point under
stable state.
5.
Make sure that the deviation between the measured data of the expiratory pressure
sensor, inspiratory pressure sensor and calibration device shall be less than max
(1cmH2O, measured value of the calibration device x 4%). If not, perform calibration
again as per 5.3.10Pressure Calibration (Factory) and 5.3.11Expiratory Valve
Calibration (Factory). If the test still fails after calibration, replace the corresponding
pressure sensor.
6.
Make sure that the deviation between the measured data of the expiratory value and
calibration device (or expiratory/inspiratory pressure sensor) shall be less than max
(5cmH2O，valve opening setting value x 20%). If not, perform calibration again as per
5.3.11Expiratory Valve Calibration (Factory). If the test still fails after calibration,
replace the expiratory valve.
5-15
5.3 System Calibration
NOTE
z
Perform the corresponding calibration if any of the system tests described in
5.2System Test is failed.
z
After replacing the monitoring board, valve, or sensors, perform the corresponding
calibration as described in this chapter.
The ventilator provides the function of monitoring flow, pressure, volume, and inspiratory
oxygen concentration etc. When these measured values have great deviations, it is very likely
that measurement offset occurs to the relevant measurement parts. In this case, you need to
perform calibration again. After equipment service, such as replacing the monitoring board,
valve, or sensors, you need to calibrate the flow sensors or pressure sensors again.
The following table lists the possible calibration items and calibration time:
S/N
Calibration item
Functional description
Calibration time
1
Flow calibration (user)
Calibrate the expiratory
flow sensor, inspiratory
valve, and O2
proportional valve.
1. After the flow sensor has been
used for a long time, the values
measured by the flow sensor have
deviations, resulting in big difference
between TVi and TVe; for example,
the deviation exceeds 10ml+10% of
the setting value.
2. The expiratory flow sensor is
replaced.
2
Flow calibration
(factory)
Calibrate the expiratory
flow sensor, inspiratory
valve, and O2
proportional valve.
1. The deviation between the
inspiratory flow sensor and the
expiratory flow sensor exceeds 10%
of the reading or 2 L/min, whichever
is greater.
2. The inspiratory valve, TSI flow
sensor, or monitoring board, O2
proportional valve, sensor board is
replaced.
3
O2 concentration
calibration (user)
Calibrate the accuracy of
O2 cell at 21% O2 and
100% O2.
1. The measured value of the O2
sensor has a great deviation. The
value deviates by over 3% from 21%
in the Air and deviates by over 3%
from 100% in pure O2.
2. The O2 sensor is replaced.
5-16
S/N
Calibration item
Functional description
Calibration time
4
O2 concentration
calibration (factory)
Calibrate the accuracy of
O2 cell at 21% O2 and
100% O2.
1. The measured value of the O2
sensor has a great deviation. The
value deviates by over 3% from 21%
in the Air and deviates by over 3%
from 100% in pure O2.
2. The O2 sensor is replaced.
3. The monitoring board is replaced.
5
Mainstream CO2
zeroing (user)
Calibrate zero point
deviation of the CO2
module.
It is necessary to zero the sensor
under the following conditions:
1. Replace the adapter.
2. Re-connect the sensor to the
module.
3. The ventilator prompts [CO2 Zero
Required] when the sensor is not
under the best measure state. In this
case, check the airway adapter. Make
sure that the adapter window is not
occluded by mucus etc. If it is
occluded, clean or replace the
adapter.
6
Sidestream CO2 zeroing
(user)
Calibrate zero point
deviation of the CO2
module.
Zero point deviation of the CO2
module is manifested by CO2
waveform deviation from the
baseline when the CO2 module
sampling line is placed in the air until
the measured value is stable. It is
recommended to perform CO2
zeroing after the CO2 module has
zero point deviation or before
performing CO2 module calibration.
5-17
S/N
Calibration item
Functional description
Calibration time
7
Sidestream CO2
Calibration (User)
Make the module work
within the accuracy
range via the calibration
function.
It is necessary to calibrate the CO2
module when the module
measurement deviation is found to be
outside the accuracy range of the
specification:
The deviation exceeds 0.25 vol.% (±
2 mmHg) at the range of 0.0 to 5.0
vol.% (0 to 40mmHg);
The deviation exceeds ±5% of the
actual reading at the range of 5.0
vol.% (41mmHg) to 10.0 vol.%
(76mmHg) (not including 5 vol.%);
The deviation exceeds ±10% of the
actual reading at the range of 10.0
vol.% (77mmHg) to 13.0 vol.%
(99mmHg）(not including 10 vol.%).
8
Pressure and flow
zeroing (factory)
Calibrate the zero point
deviation of the pressure
sensor and flow sensor.
(the specific zero point
value can be seen in the
factory calibration
menu).
Pressure or flow waveform deviates
from the baseline.
9
Pressure and flow
zeroing (user)
Calibrate the zero point
deviation of the pressure
sensor and flow sensor.
Pressure or flow waveform deviates
from the baseline.
10
Pressure calibration
(factory)
Calibrate the inspiratory
pressure sensor,
expiratory pressure
sensor, and expiratory
valve.
1. The deviation between the
measured value of the ventilator
pressure sensor and that of the
standard pressure gauge exceeds
more than 2% of the reading or
1cmH2O, whichever is greater.
2. The expiratory valve or sensor
board is replaced.
3. The monitoring board is replaced.
5-18
S/N
Calibration item
Functional description
Calibration time
11
Expiratory valve
calibration (factory)
Calibrate the expiratory
valve after pressure
calibration is completed.
1. The deviation between the control
value of the ventilator expiratory
valve and the measured value of the
standard pressure gauge (or ventilator
inspiratory/expiratory pressure
sensor) exceeds more than 20% of
the reading or 5cmH2O, whichever is
greater.
2. Calibrate the expiratory valve after
performing pressure calibration when
the expiratory valve or sensor board
is replaced.
3. Calibrate the expiratory valve after
performing pressure calibration when
the monitoring board is replaced.
12
Air and O2 calibration
(factory)
Calibrate the coefficient
between the measured
value of Air flow sensor
and that of O2 flow
sensor.
1. The measured value of the O2
sensor has a great deviation after O2
centration calibration is completed.
The value deviates by over 3% from
21% in the Air and deviates by over
3% from 100% in pure O2.
2. The inspiratory flow sensor or O2
flow sensor is replaced.
5-19
5.3.1 Flow Calibration (User)
NOTE
z
The measurements performed by the flow sensors may be affected by the
environment where the sensors are used. After the sensors have been used for a
long time, great deviations may occur to the measurement results and tidal volume
control as well. This problem can be fixed through flow sensor calibration.
z
Perform flow calibration again after replacing the flow sensor.
z
Before calibration, perform system leak test first and make sure that the test is
passed and there is no tubing leakage.
z
During calibration, make sure that the ventilator is connected to high-pressure O2
supply with sufficient gas supply. Failure to do so may lead to calibration failure.
z
It is recommended to disconnect the ventilator from the humidifier before
calibration.
z
It is recommended to use adult hoses for calibration.
This calibration is intended to calibrate the expiratory flow sensor, inspiratory valve, and O2
proportional valve by using the ventilator inspiratory flow sensor and O2 flow sensor as
calibration devices.
After the flow sensors have been used for several months, for example, three months after
calibration, great deviations (more than 10% compared with the setting value) may occur to
tidal volume measurement due to sensor aging or environmental factors. Or, the user replaces
flow sensors. In this case, you need to re-calibrate the flow sensors.
To perform user flow calibration,
1.
Select [Setup] → [Calibrate] to access the [Calibrate] menu. Then select [Flow
Calibration]. Connect the high-pressure O2 supply and make sure that the gas supply is
sufficient.
2.
Connect the hoses and insert the Y piece into the leak test plug to close the breathing
circuit.
3.
Select [Start] to start user flow calibration.
NOTE
z
If measurement deviations are not corrected after multiple flow sensor
calibrations, the user is recommended to replace the flow sensor and then perform
calibration. If the problem persists, factory maintenance is necessary. After the
problem is fixed, perform calibration.
5-20
5.3.2 Flow Calibration (Factory)
NOTE
z
Factory flow calibration is necessary after replacing the monitoring module main
board, sensor adapter board, O2 proportional valve or inspiratory valve.
z
Factory flow calibration is necessary when a great deviatio (greater than 2L/min
and 10% of the measured value of calibration device) is detected between the
measured value of expiratory flow sensor and that of the calibration device.
z
When the altitude at which the ventilator is located changes, change the altitude
setting value in the setup menu and then perform factory flow calibration.
z
It is recommended to disconnect the ventilator from the humidifier before
calibration.
z
It is recommended to use adult hoses for calibration.
This calibration is intended to calibrate the expiratory flow sensor, inspiratory valve, and O2
proportional valve by using the ventilator inspiratory flow sensor and O2 flow sensor as
calibration devices.
5.3.2.1 Calibration Procedures
NOTE
z
Before calibration, perform system leak test first and make sure that the test is
passed and there is no tubing leakage.
z
Before calibration, make sure that no sensor, valve, or limb related technical
alarms occurred.
z
During calibration, make sure that the ventilator is connected to high-pressure O2
supply with sufficient gas supply. Failure to do so may lead to calibration failure.
z
Do not move or press the tubes during calibration.
To perform factory flow calibration,
1.
Select [Setup] → [Maintain] → [Service], and enter the required password to access
the [Service] menu. Select [Calibrate] and then select [Flow Calibration].
2.
Connect the high-pressure O2 supply and make sure that the gas supply is sufficient.
3.
Connect the hoses and insert the Y piece into the leak test plug to close the breathing
circuit (as shown below).
5-21
4.
Select [Start] to start factory flow calibration.
NOTE
z
After flow calibration, check the measurement accuracy of the flow sensors as per
5.2.4Check the Accuracy of Flow Sensor.
z
In case of calibration failure, first fix the problem and then perform calibration
again.
5.3.2.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt
message number [1]
Zero point flow error occurs to the
inspiratory flow sensor: when the
inspiratory valve is closed and the
blower stops rotation, the zero point
flow value of inspiratory flow sensor
is not within the normal range of [0，
0.2] L/min.
Replace the inspiratory flow
sensor.
5-22
Error code
Cause
Corrective Action
Failure prompt
message number [2]
The inspiratory valve has significant
leakage at 30cmH2O: when the
output pressure of blower is
30cmH2O and the inspiratory valve
is closed, the flow of inspiratory flow
sensor is greater than 2L/min.
Check the inspiratory valve port to
see if it is worn or polluted by
foreign matter. Clean or replace
the inspiratory valve.
Failure prompt
message number [3]
The inspiratory valve has significant
leakage at 80cmH2O: when the
output pressure of blower is
80cmH2O and the inspiratory valve
is closed, the flow of inspiratory flow
sensor is greater than 2L/min.
Check the inspiratory valve port to
see if it is worn or polluted by
foreign matter. Clean or replace
the inspiratory valve.
Failure prompt
message number [5]
Zero point flow error occurs to the
O2 flow sensor: when the O2
proportional valve is closed, the zero
point flow value of O2 flow sensor is
not within the range of [0，1]
L/min.
1. Disconnect the O2 supply,
including high-pressure O2 supply
and low-pressure O2 supply.
Check the A/D channel to see if
O2 flow is within the range of [0，
1] L/min. If yes, it indicates that
the O2 proportional valve is
unable to be fully closed. Replace
the O2 proportional valve.
2. Replace the O2 flow sensor.
Failure prompt
message number [6]
Reserved, not used temporarily.
/
Failure prompt
message number [7]
The output flow of O2 proportional
valve is low: the maximum output
flow of O2 proportional valve is a bit
low and the factory calibration is
110L/min.
1. Check if the high-pressure O2
supply is sufficient.
2. Connect the high-pressure O2
supply. On the Valve Test screen,
open the O2 proportional valve
with 500mA current to see if the
flow satisfies the threshold
requirement. If not, replace the O2
proportional valve.
Failure prompt
message number
[51]
Flow sensor type error
Failure prompt
message number
[53]
Three-way valve failure at the
high-pressure end of expiratory flow
sensor
Refer to 6.3Technical Alarms and
Diagnosis to fix the machine so
that the alarm will not occur. Then
perform calibration again.
Failure prompt
message number
[54]
Three-way valve failure at the
low-pressure end of expiratory flow
sensor
5-23
Error code
Cause
Corrective Action
Failure prompt
message number
[55]
Insp. Limb failure
Failure prompt
message number
[57]
Safety valve failure
Failure prompt
message number
[58]
Insp. module communication stop
Failure prompt
message number
[59]
Exp. module communication stop
Failure prompt
message number
[60]
Blower failure
Failure prompt
message number
[61]
Blower temperature too high
Failure prompt
message number
[64]
Standard table write EEPROM
timeout
Calibrate again after restart.
Failure prompt
message number
[104]
Flow non-monotonic: when
calibrating the O2 proportional valve,
the larger the O2 proportional valve
current, the smaller the flow
measured by O2 flow sensor.
1. Connect or replace the O2
supply to make sure that O2
supply pressure is normal.
2. Replace the O2 proportional
valve.
3. Replace the O2 flow sensor.
Failure prompt
message number
[106]
Current non-monotonic: when
calibrating the O2 proportional valve,
the larger the set control current, the
smaller the actual sampled current.
Replace the O2 proportional valve.
Failure prompt
message number
[107]
The maximum flow of O2
proportional valve table is too low.
1. Connect or replace the O2
supply to make sure that O2
supply pressure is normal.
2. Perform calibration again.
Failure prompt
message number
[108]
Inspiratory valve calibration table
current data is not humdrum.
Replace the inspiratory valve.
Failure prompt
message number
[115]
Error of saving table to insp. module
EEPROM
Calibrate again after restart.
5-24
Error code
Cause
Corrective Action
Failure prompt
message number
[204]
Expiratory flow sensor calibration
table flow data is not humdrum.
1. Check if the inspiratory valve is
faulty. If yes, replace it.
2. Check if the inspiratory flow
sensor is faulty. If yes, replace it.
Failure prompt
message number
[205]
Expiratory flow sensor calibration
table AD data is not humdrum.
1. Check if the sampling line of
expiratory flow sensor is correct.
2. Check if the tubes are normal
during calibration.
Failure prompt
message number
[208]
Expiratory flow sensor zero point
error
Perform zeroing.
Replace the expiratory flow
sensor.
Failure prompt
message number
[209]
Expiratory flow sensor resolution
error
Replace the expiratory flow
sensor.
Failure prompt
message number
[210]
Expiratory flow sensor range error
Replace the expiratory flow
sensor.
Failure prompt
message number
[213]
Error of saving table to exp. module
EEPROM
Calibrate again after restart.
5.3.3 O2% Calibration (User)
NOTE
z
Calibrate the O2 sensor when the O2 concentration monitored value has a great
deviation.
z
Before calibration, observe if FiO2 displays numerics on the measure screen. If not,
confirm that the O2 measure switch is turned on, check the O2 sensor connection
line, or replace the O2 cell until measure numerics are displayed.
You need to re-calibrate the O2 sensor when the measured value of O2 sensor has a great
deviation. The value deviates by over 3% from 21% in the Air and by over 3% from 100% in
pure O2.
To perform user O2% calibration,
1.
Select [Setup] → [Calibrate] to access the [Calibrate] menu. Then select [O2%].
2.
Make sure that high-pressure O2 supply is connected.
3.
Select [Start] to start user O2% calibration.
5-25
5.3.4 O2% Calibration (Factory)
NOTE
z
Calibrate O2 concentration when a great deviation of O2 concentration monitored
value occurs or when the O2 sensor or monitoring board is replaced.
z
Before calibration, observe if FiO2 displays numerics on the measure screen. If not,
confirm that the O2 measure switch is turned on, check the O2 sensor connection
line, or replace the O2 cell until measure numerics are displayed.
You need to re-calibrate the O2 sensor when the measured value of O2 sensor has a great
deviation. The value deviates by over 3% from 21% in the Air and by over 3% from 100% in
pure O2. You also need to re-calibrate the O2 sensor when replacing the O2 sensor or
monitoring board.
5.3.4.1 Calibration Procedures
To perform factory O2% calibration,
1.
Select [Setup] → [Maintain] → [Service], and enter the required password to access
the [Service] menu. Select [Calibrate] and then select [O2%].
2.
Make sure that high-pressure O2 supply is connected.
3.
Select [Start] to start factory O2% calibration. Perform O2% calibration at 21% first
before at 100%.
5.3.4.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt
message number [01]
O2 supply failure
Connect or replace the O2 supply
to make sure that O2 supply
pressure is normal.
Failure prompt
message number [21]
O2 sensor failure
Replace the O2 sensor.
Failure prompt
message number [36]
O2 cell disconnected during O2%
calibration
Check the O2 cell connection line
to make sure that it is properly
connected and then perform
calibration again.
Failure prompt
message number [45]
Insp. limb failure
Check the inspiratory valve in the
inspiratory limb and the
inspiratory flow sensor. Make sure
that the gas supply in the
inspiratory limb is normal.
5-26
Error code
Cause
Corrective Action
Failure prompt
message number [46]
Blower failure
Replace the blower.
Failure prompt
message number [48]
Insp. module communication stop
1. Restart the ventilator.
2. Upgrade the inspiratory module
software and monitoring module
software.
3. Replace the monitoring board.
Failure prompt
message number
[110]
O2 cell 21% sampling value exceeds
the lower limit; namely, the AD value
is less than 138.
Replace the O2 sensor.
Failure prompt
message number
[111]
O2 cell 21% standard sampling value
exceeds the upper limit; namely, the
AD value is greater than 542.
Failure prompt
message number
[112]
O2 cell 100% sampling value exceeds
the lower limit; namely, the AD value
is less than 774.
Failure prompt
message number
[113]
O2 cell 100% standard sampling value
exceeds the upper limit; namely, the
AD value is greater than 2458.
Failure prompt
message number
[114]
The difference between O2 cell 21%
and 100% standard AD sampling
values exceeds the threshold.
5.3.5 Mainstream CO2 Zeroing (User)
Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the
measurement so as to ensure measurement accuracy.
For mainstream CO2 module, zero the sensor when:
1.
The adapter is replaced.
2.
The sensor is re-connected to the module.
3.
The message [CO2 Zero Required] is displayed. In this case, check the airway adapter
for blockage. If a blockage is detected, clear or replace the adapter.
To zero the sensor, do as follows:
1.
Connect the sensor to the CO2 module.
2.
Select the [Setup] key→[Sensor]→[CO2] an set [Monitoring] to [ON].
3.
After warm-up is finished, connect the sensor to a clean, dry airway adapter. The adapter
should be vented to the air and isolated from CO2 sources, including ventilator, the
patient’s breathing and your own breathing.
4.
Select the [Setup] key→[Calibrate]→[Zero]. Select the [Start] button corresponding
to CO2 zeroing on the right side of the screen and the screen displays [CO2 Zeroing].
5-27
5.
A typical zeroing takes about 15 to 20 seconds. This message disappears after zeroing is
completed.
WARNING
z
When zeroing the sensor during the measurement, disconnect the sensor from the
breathing system first.
5.3.6 Sidestream CO2 Zeroing (User)
Zeroing the sensor aims to eliminate the effect of baseline drift upon the readings during the
measurement so as to ensure measurement accuracy.
For CO2 module, a zero calibration is carried out automatically when necessary. You can also
start a manual zero calibration when deemed necessary. You do not need to disconnect the
sensor from the breathing system when performing the zeroing.
To perform user CO2 zeroing,
1.
Select [Setup] →[Maintain]→[User]→enter the required password→[CO2 In
Maintenance].
2.
Select [Zero] to start user zeroing.
5.3.7 Sidestream CO2 Calibration (User)
NOTE
z
Make sure the system is in standby state. If not, select [Standby] and confirm to
enter the standby screen.
Only sidestream CO2 module supports calibration.
Prepare the following before doing the calibration:
„
Gas cylinder: filled with 3%～7% CO2
„
T-shape connector
„
Gas tranfer tube
CO2 leak test:
After CO2 warm-up is completed, enter vent mode. Fully occlude the module or watertrap
gas inlet with hand other object. Three seconds later, the screen displays alarm message
[CO2 Sampleline Occluded]. Select [Setup]→[Maintain]→[User]→enter the required
password→[CO2 In Maintenance]→[Calibrate]. Continue occluding the gas inlet for about
30s. Check the current CO2 flow is less than 10ml/min. If the screen displays alarm message
[CO2 Sampleline Occluded], it indicates that the module has no leaks.
5-28
Calibrate as follows:
1.
Check the airway and make sure that there are no occlusions or leaks. Make sure that the
CO2 module is already warmed up or started up.
2.
Select [Setup]→[Maintain]→[User]→enter the required password→[CO2 In
Maintenance]. Then select [Zero].
3.
After zeroing is completed, connect the gas cylinder to the sampling line using a
T-shape connector, as shown below. Check the airway and make sure that there are no
occlusions or leaks.
Open to the air
Gas transfer tube
Sampling line
Pressure relief valve
Ventilator
Gas cylinder
4.
Check the airway and make sure that there are no occlusions or leaks.
5.
Enter the vented CO2 concentration in the entry box on the screen.
6.
The measured CO2 concentration is displayed on the screen. After the measured CO2
concentration becomes stable, select [Calibrate] to calibrate the CO2 module. The
system displays prompt message [CO2 Cal. Running].
7.
If the calibration is passed, the system displays prompt message [CO2% Calibration
Completed!]. Otherwise, the prompt message [Calibration Failure! Try again!] is
displayed. In this case, you need to do the calibration again.
5.3.8 Pressure and Flow Zeroing (User)
Zeroing is necessary when pressure or flow waveform deviates from the baseline. During the
operation of the ventilator, pressure and flow are zeroed automatically at a specific interval.
Pressure and flow can also be zeroed manually in the user maintenance menu. Manual
zeroing can eliminate the measurement deviations caused by zero offset immediately.
To perform user pressure and flow zeroing,
1.
Select [Setup] → [Calibrate] to access the [Calibrate] menu. Then select [Zero].
2.
Select [Start] to start user zeroing.
5-29
5.3.9 Pressure and Flow Zeroing (Factory)
Zeroing is necessary when pressure or flow waveform deviates from the baseline. During the
operation of the ventilator, pressure and flow are zeroed automatically at a specific interval.
Pressure and flow can also be zeroed manually in the factory maintenance menu. Manual
zeroing can eliminate the measurement deviations caused by zero offset immediately.
5.3.9.1 Zeroing Procedures
1.
Select [Setup] → [Maintain] → [Service], and enter thee required password to enter
the [Service] menu. Select [Calibrate] and then select [Zero].
2.
Disconnect the O2 supply.
3.
Disconnect the breathing hoses from the patient.
4.
Select [Start] to start manual zeroing.
5.
If pressure and flow zeroing is passed, the prompt message [Zeroing Completed!] is
displayed. If pressure and flow zeroing is failed, the prompt message [Zeroing Failure!
Please try again.] is displayed.
NOTE
z
In case of zeroing failure, troubleshoot the problem first and then perform flow
calibration.
5.3.9.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt message
number [101]
The inspiratory module
zeroing result is not received.
1. Perform zeroing again.
2. If the problem persists after step 1
is performed, replace the monitoring
board.
Failure prompt message
number [102]
Error of inspiratory pressure
zeroing three-way valve status
voltage. It is not in the range
of ON.
Replace the inspiratory pressure
zeroing three-way valve.
Failure prompt message
number [103]
Error of inspiratory pressure
zeroing three-way valve status
voltage. It is not in the range
of OFF.
Replace the inspiratory pressure
zeroing three-way valve.
Failure prompt message
number [104]
Inspiratory pressure sensor
zero point too high (>1875)
1 Remove the sensor sampling line
to eliminate occlusion of sampling
5-30
Error code
Cause
Corrective Action
Failure prompt message
number [105]
Inspiratory pressure sensor
zero point too low (<967)
Failure prompt message
number [106]
The zero point of inspiratory
pressure sensor fluctuates
greatly in the course of
sampling.
Failure prompt message
number [107]
The zero point of inspiratory
pressure sensor is higher than
the threshold of previous zero
point.
Failure prompt message
number [108]
The zero point of inspiratory
pressure sensor is lower than
the threshold of previous zero
point.
Failure prompt message
number [201]
The expiratory module
zeroing result is not received.
Perform zeroing again.
If the problem persists after the
previous step is performed, replace
the monitoring board.
Failure prompt message
number [202]
Error of inspiratory flow
high-pressure end zeroing
three-way valve status
voltage. It is not in the range
of ON.
Replace the three-way valve.
Failure prompt message
number [203]
Error of inspiratory flow
high-pressure end zeroing
three-way valve status
voltage. It is not in the range
of OFF.
Failure prompt message
number [204]
Error of inspiratory flow
low-pressure end zeroing
three-way valve status
voltage. It is not in the range
of ON.
Failure prompt message
number [205]
Error of inspiratory flow
low-pressure end zeroing
three-way valve status
voltage. It is not in the range
of OFF.
5-31
Error code
Cause
Corrective Action
Failure prompt message
number [206]
Expiratory pressure sensor
zero point too high (>1875)
Failure prompt message
number [207]
Expiratory pressure sensor
zero point too low (<967)
Failure prompt message
number [208]
The zero point of expiratory
pressure sensor fluctuates
greatly in the course of
sampling.
Failure prompt message
number [209]
The zero point of expiratory
pressure sensor is higher than
the threshold of previous zero
point.
1 Remove the sensor sampling line
to eliminate occlusion of sampling
line or effect from three-way valve.
Then perform zeroing again.
2 Replace the corresponding sensor.
Then perform zeroing again.
3 If the zero point is still not correct,
it indicates that the monitoring board
is faulty. Replace the monitoring
board.
Failure prompt message
number [210]
The zero point of expiratory
pressure sensor is lower than
the threshold of previous zero
point.
Failure prompt message
number [211]
Expiratory flow sensor zero
point too high (>910)
Failure prompt message
number [212]
Expiratory flow sensor zero
point too low (<365)
Failure prompt message
number [213]
The zero point of expiratory
pressure sensor fluctuates
greatly in the course of
sampling.
Failure prompt message
number [214]
The zero point of expiratory
flow sensor is higher than the
threshold of previous zero
point.
Failure prompt message
number [215]
The zero point of expiratory
flow sensor is lower than the
threshold of previous zero
point.
5-32
5.3.10 Pressure Calibration (Factory)
NOTE
z
Factory pressure calibration is necessary when replacing the monitoring board,
sensor adapter board, or expiratory valve assembly.
z
When a great deviation (the deviation is larger than 2% of the reading or 1cmH2O)
is detected between the measured value of the machine built-in pressure sensor and
that of the standard pressure measurement device, you need to perform factory
pressure calibration.
z
It is recommended to disconnect the ventilator from the humidifier before
calibration.
This calibration is intended to calibrate the inspiratory pressure sensor, expiratory pressure
sensor and expiratory valve by using ventilator calibration device. The supported calibration
devices include VT Plus and PF300.
5.3.10.1 Calibration Procedures
NOTE
z
Before pressure calibration, make sure that the tubes are not leaky when
connected.
z
Do not move or press the tubes during calibration.
5-33
Perform pressure calibration by using PF300:
1.
Enter the pressure calibration screen.
Select [Setup] → [Maintain] → [Service], and enter the required password to access
the [Service] menu. Select [Calibration] and then select [Pressure Calibration]. Select
[PF300] as calibration device, as shown below.
2.
PF300 zeroing and setup
After PF300 is switched on and warms up for 5 minutes, press [Menu] button on the
front panel of PF300.
5-34
Press [Zero!] button to perform zeroing.
After zeroing is completed, press the button as shown below to enter P difference +
measure screen.
3.
Connect the calibration line.
The calibration fixture is as shown below. The two lines on the left are connected to the
USB port and RS-232 port at the back of the ventilator respectively. The communication
line (has PF300 mark) on the right is connected to the RS-232 port of PF300.
5-35
PF300 calibration fixture, as shown below.
Connect the calibration line at the back of the ventilator (PF300), as shown blow.
5-36
Connect PF300 calibration line as shown below.
4.
Connect the calibration pneumatic circuit, as shown below.
Connect the inspiratory port and expiratory port with hoses and occlude the Y piece end.
5-37
Connect the airway pressure sampling line to PF300 by using pneumatic connection
fixture.
5.
Select [Start] on the ventilator screen to start calibration.
Perform pressure calibration by using VT Plus:
1.
Enter the pressure calibration screen.
Select [Setup] → [Maintain] → [Service], and enter the required password to access
the [Service] menu. Select [Calibration] and then select [Pressure Calibration]. Select
[VT Plus] as calibration device.
2
VT Plus zeroing and setup
Zeroing: After VT Plus is switched on and warms up, press [PRESSURE] button to
enter pressure measure screen. Press the button corresponding to [Range] to switch to
“Low Pressure”. Press [Zero] button to perform zeroing.
5-38
Setup: press [SETUP]. Select “SYSTEM” and then select “Serial Mode”. Use
[MODIFY] to change mode to “OTIS Ctrl” mode.
3.
Connect the calibration line.
The calibration fixture is as shown below. The two lines on the left are connected to the
USB port and RS-232 port at the back of the ventilator respectively. The communication
line (has VT Plus mark) on the right is connected to the communication port of VT Plus.
The calibration fixture is as shown below.
5-39
Connect the calibration line at the back of the ventilator, as shown blow.
5-40
Connect VT Plus calibration line, as shown below.
4.
Pneumatic connection.
Connect the calibration pneumatic circuit, as shown below. Connect the inspiratory port
and expiratory port with hoses and occlude the Y piece end.
5-41
Connect the airway pressure sampling line to LOW PRESSURE “+” pressure sampling
port of VT Plus by using pneumatic connection fixture.
5.
Select [Start] on the ventilator screen to start calibration.
NOTE
z
After pressure calibration, check the measurement accuracy of the pressure sensor
as per 5.2.5Check the Accuracy of Pressure Sensor.
z
In case of calibration failure, troubleshoot the problem first and then perform
pressure calibration again.
5.3.10.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt
message number [1]
Calibration device communication
error
Check the calibration device setup
and communication cable
connection.
Failure prompt
message number [2]
Calibration device zero point
pressure error. The zero point
pressure of calibration device is not
within the range of [-0.3，
0.3]cmH2O.
Zero the calibration device
correctly before calibration.
5-42
Error code
Cause
Corrective Action
Failure prompt
message number [3]
The expiratory valve fails to produce
small pressure: when the blower
pressure is 80cmH2O, the expiratory
valve cannot find pressure of [10，
20]cmH2O within the current range
of [0，800]mA.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
Failure prompt
message number [4]
The expiratory valve fails to produce
large pressure: when the blower
pressure is 80cmH2O, the expiratory
valve cannot find pressure of [blower
maximum output pressure -15,
blower maximum output pressure
-5]cmH2O within the current range
of [0，800]mA. For definition of
blower maximum output pressure,
refer to “Failure prompt message
number [5]”.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
Failure prompt
message number [5]
Pneumatic maximum pressure low:
when blower pressure is 80cmH2O
and expiratory valve current is
800mA, the maximum pressure
(blower maximum output pressure)
produced is less than 45cmH2O.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
5-43
Error code
Cause
Corrective Action
Failure prompt
message number
[52]
Insp. Pressure three-way valve failure
Failure prompt
message number
[53]
Three-way valve failure at the
high-pressure end of expiratory flow
sensor
Refer to 6.3Technical Alarms and
Diagnosis to fix the machine so
that the alarm will not occur. Then
perform calibration again.
Failure prompt
message number
[55]
Insp. limb failure
Failure prompt
message number
[57]
Safety valve failure
Failure prompt
message number
[58]
Insp. module communication stop
Failure prompt
message number
[59]
Exp. module communication stop
Failure prompt
message number
[60]
Blower failure
Failure prompt
message number
[61]
Blower temperature too high
Failure prompt
message number
[64]
Standard table write EEPROM
timeout
Perform calibration again after
restart.
Failure prompt
message number
[103]
Insp. pressure sensor zero point error
1. Check the sampling line
connection of inspiratory pressure
sensor.
2. Perform calibration again.
3. Replace the inspiratory pressure
sensor.
Failure prompt
message number
[104]
Insp. pressure sensor calibration table
pressure is not humdrum: when
closing the expiratory valve with
larger current, the pressure measured
by the calibration device is smaller.
Check for leakage during
calibration.
5-44
Error code
Cause
Corrective Action
Failure prompt
message number
[105]
Insp. pressure sensor calibration table
AD is not humdrum: when closing
the expiratory valve with larger
current, the AD value of the insp.
pressure sensor is smaller.
1. Check for leakage during
calibration.
2. Check if the sampling line of
inspiratory pressure sensor is
properly connected.
3. Replace the inspiratory pressure
sensor.
Failure prompt
message number
[109]
The insp. pressure sensor calibration
curve is non-linear.
Perform calibration again.
Failure prompt
message number
[115]
Error of saving table to insp. module
EEPROM
Perform calibration again after
restart.
Failure prompt
message number
[203]
Exp. pressure sensor zero point error
1. Check the sampling line
connection of expiratory pressure
sensor.
2. Perform calibration again.。
3. Replace the monitoring board.
Failure prompt
message number
[204]
Exp. pressure sensor calibration table
pressure is not humdrum: when
closing the expiratory valve with
larger current, the pressure measured
by the calibration device is smaller.
Check for leakage during
calibration.
Failure prompt
message number
[206]
Exp. pressure sensor calibration table
AD is not humdrum: when closing
the expiratory valve with larger
current, the AD value of the exp.
pressure sensor is smaller.
1. Check for leakage during
calibration.
2. Check if the sampling line of
expiratory pressure sensor is
properly connected.
3. Replace the expiratory pressure
sensor.
Failure prompt
message number
[207]
Expiratory valve calibration table
non-monotonic: the larger the control
current, the smaller the actually
sampled current.
1. Perform calibration again.
2. If the problem persists, replace
the expiratory valve.
Failure prompt
message number
[212]
The exp. pressure sensor calibration
curve is non-linear.
Perform calibration again.
Failure prompt
message number
[213]
Error of saving table to exp. module
EEPROM
Perform calibration again after
restart.
5-45
5.3.11 Expiratory Valve Calibration (Factory)
NOTE
z
When a great deviation (5cmH2O and 20% of the valve opening settting value,
whichever is greater) is detected between the control effect of the machine
expiratory valve and the setting value, you need to perform expiratory valve
calibration (factory).
This calibration is intended to calibrate the expiratory valve by using the ventilator inside
pressure sensor onto which pressure calibration has been performed as the calibration
reference. Ventilator calibration device is not required.
5.3.11.1 Calibration Procedures
NOTE
z
Before expiratory valve calibration, make sure that the tubes are not leaky when
connected.
z
Do not move or press the tubes during calibration.
1.
Select [Setup] → [Maintain] → [Service], and enter thee required password to enter
the [Service] menu. Select [Calibrate] and then select [Exp. Valve Calibration].
2
Connect the hoses and insert the Y piece into the leak test plug to close the breathing
circuit.
3.
Select [Exp. Pressure Sensor] as the calibration reference.
4.
Select [Start] to start expiratory valve calibration.
NOTE
z
After expiratory valve calibration, check the measurement accuracy of the
pressure sensors as per 5.2.5Check the Accuracy of Pressure Sensor.
z
In case of calibration failure, troubleshoot the problem first and then perform
expiratory valve calibration.
5-46
5.3.11.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt
message number [1]
Pressure sensor zeroing error: before
expiratory valve calibration, an error
occurs to zeroing the corresponding
pressure sensor.
1. Call factory zeroing operation to
see if zeroing is successful.
2. If zeroing fails, handle
according to the zeroing error code
information.
Failure prompt
message number [2]
The expiratory valve fails to produce
small pressure: when the blower
pressure is 80cmH2O, the expiratory
valve cannot find pressure of [10，
20]cmH2O within the current range
of [0，800]mA.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
Failure prompt
message number [3]
The expiratory valve fails to produce
large pressure: when the blower
pressure is 80cmH2O, the expiratory
valve cannot find pressure of [blower
maximum output pressure -15,
blower maximum output pressure
-5]cmH2O within the current range
of [0，800]mA.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
Failure prompt
message number [4]
Pneumatic maximum pressure low:
when blower pressure is 80cmH2O
and expiratory valve current is
800mA, the maximum pressure
produced is less than 45cmH2O.
1. Check if the expiratory valve
diaphragm is normal.
2. During valve diagnostic test,
test if the safety valve can be
closed and opened normally.
5-47
Error code
Cause
Corrective Action
Failure prompt
message number
[52]
Insp. Pressure three-way valve failure
Failure prompt
message number
[53]
Three-way valve failure at the
high-pressure end of expiratory flow
sensor
Refer to 6.3Technical Alarms and
Diagnosis to fix the machine so
that the alarm will not occur. Then
perform calibration again.
Failure prompt
message number
[55]
Insp. limb failure
Failure prompt
message number
[57]
Safety valve failure
Failure prompt
message number
[58]
Insp. module communication stop
Failure prompt
message number
[59]
Exp. module communication stop
Failure prompt
message number
[60]
Blower failure
Failure prompt
message number
[61]
Blower temperature too high
Failure prompt
message number
[64]
Standard table write EEPROM
timeout
Perform calibration again after
restart.
Failure prompt
message number
[204]
Expiratory valve calibration table
pressure is not humdrum.
Check for leakage during
calibration.
Failure prompt
message number
[207]
Expiratory valve calibration table
current non-monotonic: the larger the
control current, the smaller the
actually sampled current.
1. Perform calibration again.
2. If the problem persists, replace
the expiratory valve.
Failure prompt
message number
[211]
The expiratory valve calibration
curve is non-linear.
1. Perform calibration again.
Failure prompt
message number
[213]
Error of saving table to exp. module
EEPROM
Perform calibration again after
restart.
5-48
5.3.12 Air and O2 Calibration (Factory)
NOTE
z
You need to perform Air and O2 calibration when:
‹
The measured value of the O2 sensor still has a great deviation after O2
concentration calibration is completed. The value deviates by over 3% from 21% in
the Air and deviates by over 3% from 100% in pure O2.
‹
Replacing the inspiratory flow sensor or O2 flow sensor.
This calibration is intended to calculate Air-OR factor by using the measured values of
ventilator internal O2 flow sensor and inspiratory flow sensor. Connecting with external
calibration device is not required.
5.3.12.1 Calibration Procedures
NOTE
z
Before Air and O2 calibration, make sure that the main unit air inlet is not
occluded and there is no leakage.
z
During calibration, make sure that the ventilator is connected to high-pressure O2
supply with sufficient gas supply. Failure to do so may lead to calibration failure.
1.
Select [Setup] → [Maintain] → [Service], and enter thee required password to enter
the [Service] menu. Select [Calibrate] and then select [Air O2 Calibration].
2
Connect high pressure O2 supply and make sure that the gas supply is sufficient
Cover plate for main
unit air inlet
Connect to high
pressure gas supply
5-49
3.
Remove the baffle of main unit air inlet and HEPA filter.
HEPA filter
Remove
Baffle for main unit
air inlet
4.
Put the special clamp into the air inlet to make pneumatic obturate.
Special clamp
Insert
5.
Select [Start] to start Air and O2 calibration.
NOTE
z
After successful Air and O2 calibration, check the measurement accuracy of O2
concentration to make sure that the deviation between the O2 concentration
measured by O2 sensor and the O2 concentration setting value does not exceed 3%.
z
In case of calibration failure, troubleshoot the problem first and then perform Air
and O2 calibration.
5-50
5.3.12.2 Error Codes and Corrective Actions
Error code
Cause
Corrective Action
Failure prompt
message number [1]
Zero point flow error occurs to the
inspiratory flow sensor: when the
inspiratory valve is closed and the
blower stops rotation, the zero point
flow value of inspiratory flow sensor
is not within the normal range of [0，
0.2] L/min.
Replace the inspiratory flow
sensor.
Failure prompt
message number [5]
Zero point flow error occurs to the
O2 flow sensor: when the O2
proportional valve is closed, the zero
point flow value of O2 flow sensor is
not within the range of [0，1]
L/min.
1. Disconnect the O2 supply,
including high pressure O2 supply
and low pressure O2 supply.
Check in the A/D channel to see if
O2 flow is within the range of [0，
1] L/min. If yes, it indicates that
the O2 proportional valve cannot
be fully closed. Replace the O2
proportional valve.
2. Replace the O2 flow sensor.
Failure prompt
message number [7]
The output flow of O2 proportional
valve is low: the maximum output
flow of O2 proportional valve is a bit
low and the factory calibration is
100L/min.
1. Check if the high pressure O2
supply is sufficient.
2. Connect the high pressure O2
supply. On the valve test screen,
open the O2 proportional valve
with 500mA current. Check if the
flow satisfies the threshold
requirement. If not, replace the O2
proportional valve.
Failure prompt
message number
[55]
Insp. limb failure
Failure prompt
message number
[58]
Insp. module communication stop
Refer to 6.3Technical Alarms and
Diagnosis to fix the machine so
that the alarm will not occur. Then
perform calibration again.
Failure prompt
message number
[64]
Standard table write EEPROM
timeout
Perform calibration again after
restart.
Failure prompt
message number
[104]
Flow non-monotonic: during Air and
O2 calibration, the larger the current
of O2 proportional valve, the smaller
the flow measured by the inspiratory
flow sensor.
1. Check if the blower gas inlet is
fully occluded.
2. Perform calibration again.
5-51
Error code
Cause
Corrective Action
Failure prompt
message number
[115]
Error of saving table to insp. module
EEPROM
Perform calibration again after
restart.
Failure prompt
message number
[116]
TSI Air-O2 conversion factor is too
large.
1. Check if the clamp and Air inlet
are sealed. Re-plug the clamp.
2. Perform leakage test of system
check and make sure that the test
is passed.
3. Perform calibration again. If the
problem persists, replace the
inspiratory flow sensor and O2
flow sensor.
4. Perform calibration again. If the
problem persists, check the parts
of the machine (such as blower
box assembly, inspiration
valve,flow sensor, O2 inlet
assembly) whether there are some
installation errors.
Failure prompt
message number
[117]
TSI Air-O2 conversion factor is too
small.
Perform calibration again. If the
problem persists, replace the
inspiratory flow sensor and O2
flow sensor.
5-52
6 Troubleshooting
6.1 Introduction
In this chapter, ventilator failures are listed along with possible causes and recommended
actions. Refer to the tables below to check the ventilator, isolate and eliminate the failures.
Once isolating the part you suspect defective, refer to 7Repair and Disassembly to
disassemble the equipment, and repair and replace the defective part.
6.2 Troubleshoot System Check Failures
Troubleshoot by referring to the table below if there are failed items during system check.
Failed item
Possible cause
Recommended action
Blower test
1. Blower power supply
connection line is disconnected.
2. Blower failure.
1. Make sure of the correct connection of
blower power cable.
2. Replace the blower.
O2 flow sensor
test
1. High pressure O2 supply
insufficiency.
2. Low pressure O2 ventilation.
3. The deviation between O2
proportional valve and O2 flow
sensor is a bit large.
4. O2 proportional valve failure.
5. O2 flow sensor failure.
1. Check if high-pressure O2 supply is
connected and is sufficient.
2. Check in [Setup] →[Maintain]→[User]
→enter the required password→[Setting]→
[Gas Supply] →[O2 Supply Type] to see
if low pressure O2 is selected. If yes, switch
to high pressure O2.
3. Re-do flow calibration. Refer to
5.3.2Flow Calibration (Factory).
4. Diagnose if the O2 proportional valve is
abnormal on the valve diagnostic screen
(refer to 6.6.3.3Insp. Valve and O2
Proportional Valve Satus Error). If yes,
replace the O2 proportional valve and re-do
system check.
5. Check if O2 flow sensor is correctly
connected. If the failure persists, replace the
O2 flow sensor and re-do system check.
6. Replace the VCM.
6-1
Failed item
Possible cause
Recommended action
Insp. flow sensor
test
1. The deviation of valve opening
flow between insp. flow sensor
and insp. valve is a bit large.
2. Insp. valve failure.
3. Insp. flow sensor failure.
1. Re-do flow calibration. Refer to
5.3.2Flow Calibration (Factory).
2. Diagnose if the insp. valve is abnormal
on the valve diagnostic screen (refer to
6.6.3.3Insp. Valve and O2 Proportional
Valve Satus Error). If yes, replace the insp.
valve and re-do system check.
3. Check if insp. flow sensor is correctly
connected. If the failure persists, replace the
insp. flow sensor and re-do system check.
4. Replace the VCM.
Exp. flow sensor
test
1. Y piece is not occluded or the
tube is not connected.
2. The deviation of measured
flow between exp. flow sensor
and insp. flow sensor is a bit
large.
3. Exp. flow sensor failure.
1. Check if the Y piece is occluded or the
tube is connected.
2. Re-do flow calibration. Refer to
5.3.2Flow Calibration (Factory).
3. Check if exp. flow sensor is correctly
connected. If the failure persists, replace the
exp. flow sensor and re-do flow calibration
and system check.
4. Replace the VCM.
Pressure sensor
test
1. Y piece is not occluded or the
tube is not connected.
2. The deviation between insp.
pressure sensor, exp. pressure
sensor measured pressures and
exp. valve opening pressure is a
bit large.
3. Insp. pressure and exp.
pressure sensor sampling lines
are not connected or are leaky.
4. Exp. valve is not installed or
has power supply error.
5. Exp. valve error.
1. Check if the Y piece is occluded or the
tube is connected.
2. Re-do pressure calibration.
3. Make sure that the insp. pressure and exp.
pressure sensor sampling lines are in good
condition (not broken) and are properly
connected.
4. Make sure that the exp. power cable is
correctly connected and the exp. valve is
correctly installed. Re-do system check.
5. Diagnose if the exp. valve has an error on
the valve diagnostic screen (refer to
6.6.3.4Exp. Valve Status Error. If yes,
replace the exp. valve and re-do system
check.
6. Replace the VCM.
Exp. valve test
Same to “Pressure sensor test”.
Same to “Pressure sensor test”.
6-2
Failed item
Possible cause
Recommended action
Safety valve test
1. Y piece is not occluded or the
tube is not connected.
2. Safety valve power supply
error.
3. Safety valve error.
1. Check if the Y piece is occluded or the
tube is connected.
2. Make sure of the normal connection of
safety valve power cable.
3. Diagnose if the safety valve has an error
on the valve diagnostic screen (refer to
6.6.3.5Safety Valve Status Error. If yes,
replace the safety valve and re-do system
check.
4. Replace the VCM.
Leakage
（mL/min）
1. Y piece is not occluded or the
tube is not connected.
2. Insp. flow sensor test or
pressure sensor test is failed.
1. Check if the Y piece is occluded or the
tube is connected.
2. Do leak test after successful insp. flow
sensor test and pressure sensor test.
Compliance
（mL/cmH2O）
Same to“Leakage test”.
Same to“Leakage test”.
Circuit resistance
（cmH2O/L/s）
1. Y piece is not occluded or the
tube is not connected.
2. Exp. flow sensor test or
pressure sensor test is failed.
1. Check if the Y piece is occluded or the
tube is connected.
2. Do circuit resistance test after successful
exp. flow sensor test and pressure sensor
test.
O2 sensor test
1. The on-screen O2 monitoring
function is turned off.
2. The O2 sensor is no not
connected or is ineffective.
3. Blower test, or O2 flow sensor
test, or insp. flow sensor test is
failed.
1. Turn on O2 monitoring function.
2. Make sure that O2 sensor is correctly
connected and there is no O2 sensor related
alarm on the screen. Re-do O2 sensor test.
3. Perform O2 sensor test after successful
blower test, O2 flow sensor test, and insp.
flow sensor test.
4. Perform O2 sensor calibration.
5. Replace the VCM.
6-3
6.3 Technical Alarms and Diagnosis
Before troubleshooting the ventilator, check for technical alarm message. If an alarm message
is presented, eliminate the technical alarm first.
The following sections detail how to troubleshoot technical alarms related to the ventilator.
For detailed information on possible causes and recommended actions for technical alarm
messages of other modules, refer to the Operator’s Manual.
In the “Level” column of the following table, the default alarm level is indicated: H for high,
M for medium, L for low and P for prompt message.
6.3.1 Main Board Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
Please reset
date and time
L
The system has no
button cell or the
cell has no
capacity.
1. Replace the button cell and reset date and
time.
2. If the failure persists, replace the main
board.
Technology
event
M
Alarm of technical
error occurs:
keyboard
communication
stop.
Refer to 6.4Failure Code Table.
Machine
failure
H
Alarm of machine
failure occurs:
control module
initialization error,
VCM, power
board, SpO2, and
protection module
communication
stop.
Refer to 6.4Failure Code Table.
6-4
6.3.2 Keyboard Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
Key error
L
Key pressing
timeout; control
knob or hard key is
broken, or the
contact is not
good.
1. Key pressing times out. Correct the
operation.
2. Replace the keyboard.
3. Replace the main board.
Technology
event
M
Alarm of technical
error occurs:
keyboard selftest
error
Refer to 6.4Failure Code Table.
6.3.3 VCM Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
PEEP too high
H
PEEP is too high.
PEEP monitored
value is greater
than PEEP setting
value+5cmH2O.
Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Check parameter settings.
PEEP too low
M
PEEP is too low.
PEEP monitored
value is less than
PEEP setting value
by a certain value
which is decided
by the software.
1. Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
2. Check if the exp. valve is installed
correctly.
3. Check parameter settings.
Airway
obstructed?
H
Patient tube is
obstructed.
1 .Check if the patient tube is obstructed. If
yes, dredge it.
2. Refer to 5.2.4Check the Accuracy of
Flow Sensor to check the flow sensor. If it is
inaccurate, perform calibration again.
3. Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
6-5
Alarm
Level
Possible cause
Recommended action
Insp. limb
airway
obstructed?
H
During O2 therapy,
patient tube is bent
or obstructed.
Check if the patient tube is obstructed. If
yes, dredge it.
Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the insp. pressure
sensor. If it is inaccurate, perform calibration
again.
Sustained
airway
pressure
H
The patient airway
pressure is
sustained at a high
level.
Check parameter settings.
Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Airway leak?
L
Patient tube is
leaky.
1. Check if the patient tube is leaky. If yes,
replace the tube.
2. Refer to 5.2.4Check the Accuracy of
Flow Sensor to check the flow sensor. If it is
inaccurate, perform calibration again.
3. Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Tube
disconnected?
H
Patient tube is
disconnected.
1. Check if the patient tube is disconnected
or loose. If yes, re-connect it.
2. Refer to 5.2.4Check the Accuracy of
Flow Sensor to check the flow sensor. If it is
inaccurate, perform calibration again.
3. Refer to5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Pressure
limited
L
Pressure reaches
pressure high
alarm
limit-5cmH2O.
Check parameter settings, including pressure
high alarm limit setting.
Check if there is pressure sensor failure
alarm (corresponding to strings “Device
Failure 09” and “Device Failure 21”). If it is
faulty, replace it.
If the failure persists, replace the VCM.
Volume limited
L
In pressure mode,
delivered gas
exceeds the upper
limit of set TV and
expiration is
switched to in
advance.
Check parameter settings, including TVe
high alarm limit setting.
Check if there is “Please check exp. flow
sensor” alarm. If yes, eliminate this alarm.
If the failure persists, replace the VCM.
6-6
Alarm
Level
Possible cause
Recommended action
Pinsp not
achieved
L
Ppeak fails to
reach the set value.
Check if the tube is leaky. If yes, re-connect.
Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Check parameter settings.
TV not
achieved
L
TV fails to reach
the set value.
Check if the tube is leaky. If yes, re-connect.
Refer to 5.2.4Check the Accuracy of Flow
Sensor to check the flow sensor. If it is
inaccurate, perform calibration again.
Check if parameter settings are reasonable.
Pressure
limited in sigh
cycle
L
After sigh function
is activated, the
pressure in sigh
cycle reaches
pressure high
alarm
limit-5cmH2O.
Check parameter settings, including pressure
alarm high limit setting.
Check if there is pressure sensor failure
alarm (corresponding to strings “Device
Failure 09” and “Device Failure 21”). If it is
faulty, replace it.
If the failure persists, replace the VCM.
O2 supply
failure
H
O2 supply is
insufficient.
Check if high pressure is connected and is
sufficient.
Diagnose if the O2 proportional valve is
abnormal on the valve diagnostic screen
(refer to 6.6.3.3 Insp. Valve and O2
Proportional Valve Satus Error). If yes,
replace the O2 proportional valve.
Replace the VCM.
Tinsp too long
L
Spontaneous
breathing in PSV
mode fails to
satisfy the exp.
sensitivity all the
time so that
expiration is
unable to end.
Check parameter settings.
Check and replace pressure and flow
sensors.
Please check
exp. flow
sensor
H
Exp. flow sensor is
faulty.
Perform zeroing. Refer to 5.3.9Pressure and
Flow Zeroing (Factory).
Calibrate the exp. flow sensor. Refer to
5.3.2Flow Calibration (Factory).
Replace the exp. flow sensor.
6-7
Alarm
Level
Possible cause
Recommended action
Insp. gas temp.
too high
H
Insp. gas
temperature
exceeds the limit.
1. Check if the temperature of machine
working environment exceeds the factory
specified maximum working temperature,
which is 40℃.
2. Check if the fan air intake vent and air
exhaust vent are occluded. If yes, clear the
foreign matter and dust. Check the operation
of the fan. If it is abnormal (such as
abnormal sound, abnormal rotation speed
etc.), replace the fan.
3. In the A/D channel, check if the insp. gas
temperature and insp. O2 temperature
measured values exceed the range provided
by the A/D channel. Replace the flow sensor
(mixed gas flow sensor or O2 flow sensor)
whose corresponding temperature exceeds
the limit.
Replace HEPA
filter
L
The HEPA filter is
occluded.
Replace the HEPA filter.
O2 sensor
unconnected
L
O2 sensor is not
connected.
1. Check if the O2 sensor cable is
disconnected. If yes, re-connect it.
2. If the failure persists, replace the O2
sensor.
Please replace
O2 sensor
M
O2 sensor is used
up.
Replace the O2 sensor.
Please
calibrate O2
sensor
L
O2 sensor is not
calibrated (not
calibrated by both
the factory and the
user).
Perform 21% and 100% O2 sensor
calibration again. Refer to 5.3.4O2%
Calibration (Factory).
Please perform
pressure
calibration
H
Pressure sensor is
not calibrated
(factory
calibration).
1. Perform pressure sensor calibration. Refer
to 5.3.10Pressure Calibration (Factory).
2. Replace the VCM.
Please perform
flow
calibration
H
Flow sensor and
insp. valve are not
calibrated (not
calibrated by both
the factory and the
user).
1. Perform flow sensor and insp. valve
calibration. Refer to 5.3.2Flow Calibration
(Factory).
2. Replace the VCM.
6-8
Alarm
Level
Possible cause
Recommended action
Flow sensor
type error
H
Air flow sensor
type or O2 flow
sensor type is
wrong.
1. Check the mixed gas flow sensor to see if
it is Air flow sensor. If not, replace it.
2. Check the flow sensor in O2 limb to see if
it is O2 flow sensor. If not, replace it.
Blower
temperature
high
H
The blower
temperature
exceeds the
threshold.
1. Check if the temperature of machine
working environment exceeds the factory
specified maximum working temperature,
which is 40℃.
2. Check if the fan air intake vent and air
exhaust vent are occluded. If yes, clear the
foreign matter and dust. Check the operation
of the fan. If it is abnormal (such as
abnormal sound, abnormal rotation speed
etc.), replace the fan.
Technology
event
M
Alarm of technical
error occurs.
Refer to 6.4Failure Code Table.
Machine
failure
H
Alarm of machine
failure occurs.
Refer to6.4Failure Code Table.
6.3.4 Auxiliary Monitor Board Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
Sustained
airway
pressure
H
The patient airway
pressure is
sustained at a high
level.
Check parameter settings.
Refer to 5.2.5Check the Accuracy of
Pressure Sensor to check the pressure
sensor. If it is inaccurate, perform calibration
again.
Machine
failure
H
The machine
internal voltage is
abnormal. Or, the
communication
between insp.
module and
auxiliary monitor
board stops. Or the
communication
between exp.
module and
auxiliary monitor
board stops.
Refer to 6.4Failure Code Table.
6-9
6.3.5 Power Board Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
Battery 1
failure
H
Failure type of
alarm occurs to
battery 1.
Replace battery 1.
Battery 2
failure
H
Failure type of
alarm occurs to
battery 2.
Replace battery 2.
Battery temp.
high. Connect
external power
supply.
M
Battery
temperature is a bit
high during
discharging.
System maybe
down for
battery temp.
high
H
Battery
temperature is too
high during
discharging.
1. Make sure if the environmental
temperature is too high, for example,
exceeding 35℃. If exceeding 35℃,
recommend the user to use the machine at
lower temperature and make sure that there is
no heat source around the machine.
2. Check if the fan air intake vent and air
exhaust vent are occluded. If yes, clear the
foreign matter and dust. Check the operation
of the fan. If it is abnormal (such as abnormal
sound, abnormal rotation speed etc.), replace
the fan.
3. If the above two items are eliminated,
check if the battery is normal.
4. If the failure persists, replace the DC-DC
board.
Battery in use
L
Battery is being
used.
Check the external power connection.
If the external power supply is normally
connected and the voltage is normal, check
the connection between external power
supply and power board, socket, and fuse.
If the failure persists, replace the DC-DC
board.
Low battery.
Connect
external power
supply.
M
The battery
remaining capacity
is lower than the
threshold.
System down.
Connect
external power
supply.
H
Battery capacity is
to be depleted.
1. The system is operable. Connect external
power supply immediately.
2. Check if the battery can be normally
charged. If it cannot be charged, replace the
DC-DC board.
3. Perform battery conditioning once: fully
charged, completely discharged, and fully
charged again. Make sure battery
charging/power supply time is normal. If
charging or power supply time is
distinguishingly shortened, consider to
replace the battery.
6-10
Alarm
Level
Possible cause
Recommended action
Battery
undetected
H
No battery is
installed. Or, the
connection line
between the
battery and the
power module is
not connected.
1. Check if the battery is normal. If there is a
problem with the battery, replace the battery.
2. If the battery is normal, check if the cable
between battery adapter board and DC-DC
board is normal.
3. If the failure persists, replace the DC-DC
board.
Fan failure
M
Fan hardware
failure.
1. Replace the fan.
2. If the failure persists, replace the DC-DC
board.
Machine
failure
H
Power board
self-test error.
See section 6.4 Failure Code Table.
6.3.6 CO2 Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
CO2 sensor
high temp.
L
The CO2 sensor
assembly
temperature is too
high.
Replace the CO2 module.
CO2
sampleline
occluded
L
The sampling line
has an error or is
occluded.
1. Replace the sampling line.
2. Replace the CO2 module.
CO2 no
watertrap
L
The watertrap is
disconnected or is
connected
improperly.
1. Re-install the CO2 watertrap.
2. If the failure persists, replace the CO2
module.
EtCO2
overrange
L
The parameter
measured value
exceeds the
measurement
range.
1. Check if the measure mode is correct.
2. Replace the CO2 module.
Please replace
CO2 sensor
M
Mainstream CO2
module sensor is
faulty.
Replace the mainstream CO2 module sensor.
CO2 no sensor
L
Mainstream CO2
module sensor is
not connected.
1. Check the connection of mainstream CO2
module.
2. If the failure persists, replace the
mainstream CO2 module sensor.
CO2 module
failure
M
CO2 module is
faulty.
Refer to 6.4Failure Code Table.
6-11
6.3.7 SpO2 Related Technical Alarms
Alarm
Level
Possible cause
Recommended action
SpO2 sensor
off
L
SpO2 sensor
changes from
connected state to
disconnected state
at the patient side.
Check the sensor placement part. Check the
sensor for damage. Re-connect the sensor and
use a new sensor.
Please replace
SpO2 sensor
M
SpO2 sensor
failure
L
Connection
between the main
cable and the
module changes
from connected
state to
disconnected state.
Move the sensor to part with weak light or
cover the probe.
L
The sensor
ambient light is
too strong. The
photoelectric
detection end of
the sensor absorbs
ambient light.
L
SpO2 sensor is
unable to acquired
pulsation signals.
Check the patient condition. Re-install the
sensor to a proper part. If the failure persists,
replace the sensor.
1. Check if the measure mode is correct.
2. Replace the SpO2 module.
L
The parameter
measured value
exceeds the
measurement
range.
1. Check if the measure mode is correct.
2. Replace the SpO2 module.
PR overrange
L
The parameter
measured value
exceeds the
measurement
range.
SpO2 module
failure
M
SpO2 module is
faulty.
Replace the SpO2 module.
SpO2 no
sensor
SpO2 too
much light
SpO2 no
pulsatile
SpO2
overrange
6-12
6.4 Failure Code Table
Alarm
Failure code
Possible cause
Recommended action
Technology
event
Technical
error 01
Keyboard
communication
stop
1. Check if the keyboard and main board are
not in good contact. If yes, re-plug or
replace the communication cable.
2. If the failure persists, check the
correctness of keyboard software.
3. If the failure persists, replace the
keyboard.
4. If the failure persists, replace the main
board.
Technical
error 02
Keyboard selftest
error
1. Restart the machine.
2. Replace the keyboard software.
3. If the failure persists, replace the
keyboard.
Technical
error 03
Blower temp.
sensor failure
In the A/D channel, check the blower
internal temperature and blower external
temperature. If the internal temperature (or
external temperature) exceeds the limit,
replace the temperature sensor.
Technical
error 05
Atmospheric
pressure sensor
failure
1. Check if “Technical error 06”exists at
the same time. If yes, in the A/D channel,
check which of “Pfilter pressure sensor
measured pressure value” and “Atmospheric
pressure sensor measured atmospheric
pressure” is closer to the atmospheric
pressure in the current environment.
Replace the sensor with greater deviation.
2. Replace the VCM.
Technical
error 06
HEPA pressure
sensor failure
1. Check if “Technical error 05”exists at
the same time. If yes, in the A/D channel,
check which of “Pfilter pressure sensor
measured pressure value” and “Atmospheric
pressure sensor measured atmospheric
pressure” is closer to the atmospheric
pressure in the current environment.
Replace the sensor with greater deviation.
2. Replace the VCM.
Technical
error 07
3-way valve
failure
Check and replace the 3-way valve.
Technical
error 08
Nebulizer valve
failure
Check and replace the nebulizer valve.
6-13
Alarm
Machine
failure
Failure code
Possible cause
Recommended action
Technical
error 09
Insp. temp. sensor
failure
1. In the A/D channel, check if the insp.
mixed gas and insp. O2 temperature
measured values are too large or too small.
Replace the temperature sensor which has
some problem.
2. Replace the insp. mixed gas temp. sensor
and insp. O2 temp. sensor.
Device failure
01
Power supply
voltage error
1. Measure the voltage of corresponding test
point.
2. If the failure persists, replace the power
board.
Device failure
02
Memory error
1. Restart the ventilator.
2. If the failure persists, replace the VCM.
Device failure
03
Power board
selftest error
1. Restart the ventilator.
2. Replace the power board software.
3. If the failure cannot be fixed, replace the
power board.
Device failure
04
Control module
initialization error
Check the VCM hardware. If it is faulty,
replace it.
Device failure
05
Control module
communication
stop
1. Check if the VCM and main board are
not in good contact. If yes, re-plug or
replace the communication cable.
2. Check if the control module is damaged.
If yes, replace the control module.
3. Check if the main board is damaged. If
yes, replace the main board.
4. Check if the software version is
compatible. If not, upgrade the correct
software version.
Device failure
06
Control module
selftest error
1. Restart the ventilator.
2. Check and replace the control module.
Device failure
07
Insp. module
communication
stop
1. Restart the ventilator.
2. Upgrade the insp. module software and
control module software.
Device failure
08
Exp. module
communication
stop
1. Restart the ventilator.
2. Upgrade the exp. module software and
control module software.
Device failure
09
Pressure sensor
failure
1. Replace the insp. pressure sensor.
2. Replace the exp. pressure sensor.
Device failure
10
Safety valve
failure
Check and replace the safety valve.
6-14
Alarm
Failure code
Possible cause
Recommended action
Device failure
12
Insp. limb failure
1. Check if the insp. valve works normally.
If not, replace the insp. valve.
2. Check the insp. flow sensor.
3. Replace the insp. valve or insp. flow
sensor and perform calibration.
Device failure
13
O2 limb failure
1. Check if the O2 proportional valve works
normally. If not, replace the O2 proportional
valve.
2. Check the O2 flow sensor.
3. Replace the O2 proportional valve or O2
flow sensor and perform calibration.
Device failure
14
Blower failure
Replace the blower.
Device failure
15
Blower
temperature too
high
1. Check if the temperature of machine
working environment exceeds the working
temperature.
2. Check if the fan air intake vent and air
exhaust vent are occluded. If yes, clear the
foreign matter and dust. Check the
operation of the fan. If it is abnormal (such
as abnormal sound, abnormal rotation speed
etc.), replace the fan.
Device failure
16
Insp. valve
disconnected
1. Check the connection of insp. valve.
2. Replace the insp. valve.
Device failure
17
Insp. module
selftest error
1. Restart the ventilator.
2. Replace the VCM.
Device failure
18
Exp. module
selftest error
1. Restart the ventilator.
2. Replace the VCM.
Device failure
19
Power board
communication
stop
1. Check if the power board and main board
are not in good contact. If yes, re-plug or
replace the communication cable.
2. Check if the power board is damaged. If
yes, replace the power board.
3. Check if the main board is damaged. If
yes, replace the main board.
4. Check if the software version is
compatible. If not, upgrade the correct
software version.
Device failure
20
SpO2
communication
stop
1. Check if the SpO2 module and main
board are not in good contact. If yes, re-plug
or replace the communication cable.
6-15
Alarm
Failure code
Possible cause
Recommended action
2. Check if the SpO2 module and main
board are damaged. If yes, replace them.
3. Check if the software version is
compatible. If not, upgrade the correct
software version.
Battery 1
failure
Battery 2
failure
Device failure
21
Pressure sensor
zero point error
1. Replace the insp. pressure sensor.
2. Replace the exp. pressure sensor.
Device failure
22
Protection module
communication
stop
1. Check if the main board is damaged. If
yes, replace the main board.
2. Check if the software version is
compatible. If not, upgrade the correct
software version.
Battery 1
failure 01
Battery 1 temp.
error. Unable to
charge.
Replace battery 1.
Battery 1
failure 02
Battery 1 charge
failure
Battery 1
failure 03
Battery 1 aging
Battery 1
failure 04
Battery 1
communication
error
Battery 1
failure 05
Battery 1 failure
Battery 2
failure 01
Battery 2 temp.
error. Unable to
charge.
Battery 2
failure 02
Battery 2 charge
failure
Battery 2
failure 03
Battery 2 aging
Battery 2
failure 04
Battery 2
communication
error
Battery 2
failure 05
Battery 2 failure
6-16
Replace battery 2.
Alarm
Failure code
Possible cause
Recommended action
CO2
module
failure
CO2 module
failure 01
CO2 zero failure
1. Check if the connection between sensor
and tubes is normal, and zero the module
again;
2. If the failure persists, replace the CO2
module.
CO2 module
failure 02
CO2 initialization
error
1. Re-install the CO2 module;
2. Replace the CO2 module.
CO2 module
failure 03
CO2 self-test error
1. Re-install the CO2 module;
2. Replace the CO2 module.
CO2 module
failure 04
CO2 hardware
error
1. Check if the connection of the sensor is
correct;
2. If the failure persists, replace the CO2
module.
CO2 module
failure 05
CO2
communication
stop
1. Check if the connection between CO2
module and main board is normal. If not,
plug in the communication line again, or
replace the communication line.
2. Check if the CO2 module or main board
is damaged. If yes, replace the CO2 module
or main board.
CO2 module
failure 06
CO2 zero error
1. Check if the zero procedure is correct
according to the prompt on the zeroing
window. If not, zero the mainstream CO2
module again according to the prompt.
2. Check if the mainstream CO2 module is
damaged. If yes, replace the module.
6-17
6.5 Error Information
Error information does not prompt to user as alarms, they only be record in log.
Error
Possible Cause
Recommended action
Ventilator
Reset Error
1.UI task of the main board
software crashes so that the
watch dog resets;
2. The power is unstable, or
in bad contact.
1. Update the software of the main board again;
2. Check if the power or power cord is damaged. If
yes, replace it.
Keyboard
Comm Error
1. The communication line
between the keyboard and
the main board is in bad
contact;
2. The temperature of the
ventilator is too high.
1. Check and plug in the communication line
again.
2. Ensure that the ventilator runs at the normal
temperature.
Ctrl Module
Comm Error
The software version of
VCM is not compatible with
that of main board.
Update the correct software of VCM and the main
board.
Power Board
Comm Error
1. The communication line
between the power board and
the main board is in bad
contact;
2. The temperature of the
ventilator is too high.
1. Check and plug in the communication line
again.
2. Ensure that the ventilator runs at the normal
temperature.
Protection
Module Comm
Error
The software version of
protection module is not
compatible with that of main
board.
Update the correct software of protection module
and the main board.
SpO2 Comm
Error
1. The SpO2 communication
line is in bad contact;
2. The SpO2 module error.
1. Check and plug in the SpO2 communication line
again.
2. Replace the SpO2 module.
CO2 Comm
Error
1. The CO2 communication
line is in bad contact;
2. The CO2 module error.
1. Check and plug in the CO2 communication line
again.
2. Replace the CO2 module.
6-18
6.6 Diagnostic Test
6.6.1 Preparations before Using the Valve Test Tool
Make the following preparations before using the valve test tool to locate the valve or sensor
related failures.
1
Connect the pneumatic circuit according to the type of sensor or valve to be checked.
‹
Constant-flow connection method: connect the ventialtor tubes by following the
constant-flow connection method to check the flow sensors and inspiratory valve.
For details, refer to 5.2.4Check the Accuracy of Flow Sensor.
‹
Constant-pressure connection method: connect the ventilator tubes by following the
constant-pressure connection method to check the pressure sensors and expiratory
valve. For details, refer to 5.2.5Check the Accuracy of Pressure Sensor.
2.
If checking the O2 limb, make sure that high pressure O2 supply pressure is normal.
3.
When the system is Standby, select the Setup key and then select [Maintain] →
[Service] → enter the required password→ [Diagnosis] to access the [Valve Test]
menu.
6.6.2 Correspondence between the Sensors & Valves on the
Valve Test Screen and the Components
To troubleshoot the sensors or valves related failures by using the valve test tool, you must be
familiar with the correspondence between the menu options on the valve test tool screen and
the actual pneumatic circuit and hardware components.
6.6.2.1 Correspondence with Pneumatic Components
The following diagram shows the correspondence between the sensors & valves on the valve
test tool screen and the actual components in the pneumatic circuit diagram.
6-19
List of critical sensors or valves:
Symbol
Name
Inspiratory valve
Low pressure insp. valve
PSOL
Solenoid proportional valve (O2
proportional valve)
Q1
O2 flow sensor
Q2
Mixed gas flow sensor (insp. flow
sensor)
Q3
Exp. flow sensor
PI
Insp. pressure sensor
PE
Exp. pressure sensor
EV
Exp. valve
SV
Safety valve
6.6.2.2 Correspondence with Hardware Components
The following picture shows the actual sampling line connections of the sensors.
6-20
6.6.3 Troubleshooting Methods by Using Valve Test Tool
By using the valve test tool, you can troubleshoot the problems related to:
„
Sensor zero point
„
Sensor sampling line connection
„
Insp. valve and O2 proportional valve satus
„
Exp. valve status
„
Safety valve status
6.6.3.1 Sensor Zero Point Error
By using the valve test tool, you can easily detect if the zero points of all the pressure and
flow sensors of the ventilator are abnormal.
To diagnose sensor zero point error:
1.
Disconnect all gas supplies. Stop the blower. Disconnect the patient from the tubes.
Make sure that the pressure and flow sensors are in the zero point environment.
2.
Check the actual measured value of each sensor in the valve test menu. If the actual
value is greater than “0.5”, it indicates that this sensor requires zeroing.
3.
If the actual measured value of each sensor nears “0”, check its zero point AD value. If
the zero point AD value of a sensor is outside the normal range, it indicates that this
sensor is faulty. You need to replace this sensor. After replacing the faulty sensor,
perform zeroing again. If the zero point AD value of the sensor is still outside the
normal range, it indicates that the VCM is faulty. You need to replace or maintain the
VCM.
NOTE
z
Zero point normal range of each sensor :
‹
Exp. pressure sensor zero point AD : 967 ~ 1875AD
‹
Insp. pressure sensor zero point AD : 967 ~ 1875AD
‹
Exp. flow sensor zero point AD : 365~910AD
‹
Insp. flow sensor and O2 flow sensor zero point : -0. 5~1L/min
6.6.3.2 Sensor Sampling Line Connection Error
The expiratory flow sensor has two sampling lines. Generally, connection error can be:
‹
Two sampling lines are connected reversely;
‹
One sampling line is not connected;
‹
Two sampling lines are not connected.
6-21
The pressure sensor has one sampling line. Generally, connection error can be:
‹
The sampling line is not connected;
‹
The sampling line is not correctly connected.
By using the valve test tool, you can detect if the sensor sampling lines are connected
normally.
„
To diagnose the sampling line connection error of expiratory flow sensor:
1.
Enter the valve test menu and set blower pressure to 80cmH2O.
2.
Increase the DA setting of the inspiratory valve gradually (open inspiration valve flow to
10L/Min). The AD value of the flow sensor should also increase. With the gradual
increase of gas supplied,
‹
If the AD value of one flow sensor decreases gradually, it is possible that the two
sampling lines of the flow sensor are connected reversely.
‹
If the AD value of one flow sensor nears zero point and keeps unchanged, it is
possible that the two sampling lines of the flow sensor are not connected or the
sampling line at the high pressure end is not connected.
‹
If the low pressure end of the flow sensor is not connected, the AD value of the
flow sensor cannot help judgment of this situation. Disassemble the machine for
inspection when necessary.
3.
If sensor sampling line connection error is detected, re-connect the sampling lines by
referring to 6.6.2.2Correspondence with Hardware Components and make sure of
connection correctness following the above method.
„
To diagnose the sampling line connection error of pressure sensor:
1.
Enter the valve test menu. Set blower pressure to 80cmH2O and open insp. valve flow to
10L/min.
2.
Increase the DA setting of the expiratory valve gradually. Check if the AD values of
expiratory pressure sensor and inspiratory pressure sensor also increase.
‹
3.
If the AD value of one pressure sensor has very small change (less than 100AD), it
is possible that the sampling line of the pressure sensor is not connected.
If sensor sampling line connection error is detected, re-connect the sampling lines by
referring to6.6.2.2Correspondence with Hardware Components and make sure of
connection correctness following the above method.
6-22
6.6.3.3 Insp. Valve and O2 Proportional Valve Satus Error
By using the valve test tool, you can check if the working status of inspiratory valve is
abnormal.
1.
In the [Valve Test] menu, set the blower pressure to 80cmH2O and DA value of
inspiratory valve to “0”. If the measured values of total flow sensor, expiratory flow
sensor, and standard device are all greater than 1 L/min, it indicates that the inspiratory
valve cannot be fully closed or that the valve drive circuit has an error.
2.
In the [Valve Test] menu, gradually increase the opening of inspiratory valve (increase
flow setting value). If all the measured values of total flow sensor, expiratory flow
sensor, and standard device do not change much and that small gas flow is felt at the
expiratory port, it indicates that the inspiratory valve is faulty or that the valve drive
circuit has an error.
3.
To locate if there is a problem with the valve drive circuit, you can check the status
values of inspiratory valve in the [Valve Test] menu. With the increase of DA value, the
status current sampling value of inspiratory valve should also increase. Besides, when
the inspiratory valve control DA value is adjusted to “4000”, its status current sampling
value should be 300mA~1100mA. Otherwise, it indicates that the valve drive circuit has
an error.
4.
After replacing the inspiratory valve or VCM board, you can check if the problem is
fixed using the same method.
By using the valve test tool, you can check if the working status of O2 proportional valve is
abnormal.
1.
Connect high pressure O2. In the [Valve Test] menu, set the DA value of O2
proportional valve to “0”. If the measured value of O2 flow sensor is greater than 1
L/min, it indicates that the O2 proportional valve cannot be fully closed or that the valve
drive circuit has an error.
2.
In the [Valve Test] menu, gradually increase the opening of O2 proportional valve
(increase flow setting value). If the measured value of O2 flow sensor does not change
much, it indicates that the O2 proportional valve is faulty or that the valve drive circuit
has an error.
3.
To locate if there is a problem with the valve drive circuit, you can check the status
values of O2 proportional valve in the [Valve Test] menu. With the increase of DA
value, the status current sampling value of O2 proportional valve should also increase.
Besides, when the O2 proportional valve control DA value is adjusted to “1000”, its
status current sampling value should be 100mA~330mA. Otherwise, it indicates that the
valve drive circuit has an error.
4.
After replacing the O2 proportional valve or VCM board, you can check if the problem
is fixed using the same method.
6-23
6.6.3.4 Exp. Valve Status Error
By using the valve test tool, you can check if the working status of expiratory valve is
abnormal.
1.
Enter the valve test menu. Set blower pressure to 80cmH2O and open insp. valve flow to
10L/min.
2.
Set DA value of expiratory valve to “0”. If the measured values of exp. pressure sensor,
insp. pressure sensor, and standard device are all greater than 11cmH2O, it indicates that
the expiratory valve is faulty or that the valve drive circuit has an error.
3.
Gradually increase the pressure setting value of expiratory valve, the measured value of
exp. pressure sensor (and the connected ventilator calibration device) also increases. If
the measured values of exp. pressure sensor and standard device do not change much, it
is possible that the expiratory valve is faulty, the sampling line is disconnected, or the
valve drive circuit has an error.
4.
Note that there is a non-response area for the expiratory valve when the DA value is
relatively small (less than “21000”). When the DA value is less than this area, the
expiratory valve may be unable to open and the output is “0” continuously. When the
DA value exceeds this area, the output increases with the increase of DA value.
5.
To locate if there is a problem with the valve drive circuit, you can check the status
value of expiratory valve in the [Valve Test] menu. With the increase of DA value, the
status current sampling value of expiratory valve should also increase. Besides, when
the expiratory valve control DA value is adjusted to “2000”, its status current sampling
value should be 300mA~1100mA. Otherwise, it indicates that the valve drive circuit has
an error.
6.
After replacing the expiratory valve or VCM board, you can check if the problem is
fixed using the same method.
6.6.3.5 Safety Valve Status Error
There is safety risk when the safety valve cannot be opened (namely, always closed). The
ventilator cannot perform normal mechanical ventilation when the safety valve cannot be
closed (namely, always opened).
By using the valve test tool, you can check if the safety vale can be opened or closed
normally.
1.
Enter the valve test menu. Set blower pressure to 80cmH2O.
2.
Set the status of safety valve to ON and you can hear a subtle click.
3.
Set expiratory valve pressure to 50 cmH2O and inspiratory valve opening flow to 5
L/min. Check the actual measured values of expiratory flow sensor and expiratory
pressure sensor, both of which should near “0” (less than “0.5”).Otherwise, it indicates
that the safety valve cannot be opened normally.
6-24
4.
Based on the above operations, set the status of safety valve to OFF. Then, the measured
value of expiratory flow sensor will near that of inspiratory flow sensor. The measured
value of expiratory pressure sensor will near the expiratory valve opening pressure.
Otherwise, it indicates that the safety valve cannot be closed normally.
5.
If safety valve control error is found, it is possible that there is some problem with the
drive voltage of safety valve. You can check the status value of safety valve in the valve
test menu. When the safety valve control is OFF, its status voltage value should be
0V~0.5V. When the safety valve control is ON, its status voltage value should be about
9.5V~14.85V. Otherwise, it indicates that valve drive circuit has an error.
6.
If the safety valve is faulty, replace the safety valve assembly. After replacing the safety
valve assembly, you can check if the problem is fixed using the same method.
6.7 Pneumatic System Failures
The pneumatic system is mainly composed of gas supply subsystem, nebulizer subsystem,
blower fan and flow control subsystem, safety valve subsystem, and expiration module. This
section details possible failures regarding the pneumatic system and how to troubleshoot
them.
6.7.1 Commonly Used Devices and Tools
The commonly used tools and devices for troubleshooting pneumatic failures are as listed
below.
S/N
P/N
Description
1
2
M6Q-030068--M6Q-0300659--
Connector. tube-to-tube straight connector 3106-04-06
Connector. tube-to-tube straight connector 3106-06-00
3
M6Q-030025---
Connector. tube-to-tube Y piece 3140-08-00
4
082-000021-00
Tube plug 3126-04-00
5
M6Q-120001---
Tube plug 3126-06-00
6
M6G-020046---
Tube. precision soft PU(polyether) tube 4mmX2.5mm
transparent
7
M6G-020026---
Tube. precision soft PU (polyether) tube 4mmX6mm transparent
8
A21-000007---
Tube .Silicone,3/32"X7/32"X100ft
9
M6G-020017---
Tube. Adult silicone tube 450mm
10
115-002454-00
Tube adapter
11
/
Hexagonal wrench
12
/
Ventilator analyzer VT-PLUS
6-25
6.7.2 Pneumatic Failures List
The pneumatic system failures are as listed below.
Failure description
The output pressure of
regulator is not accurate.
The output exceeds the
range of 190~210Kpa.
Nebulizer ineffective
Nebulizer flow is a bit
small or large. The output
exceeds the range of
6~9L/min.
The maximum flow output
value of high pressure O2
limb is a bit small, flow
output <120L/min.
Low pressure O2 connector
is loose, resulting in
leakage.
The flow measured by the
O2 flow sensor fluctuates
greatly.
Possible cause
Troubleshooting
The output pressure
setting of regulator
is inaccurate.
Re-set the regulator
output pressure.
The internal
components are
aged and ineffective
(such as pressure
drift caused by
spring aging
/leakage caused by
sealing ring aging
etc.)
Re-set the pressure
by following the
correct method. If it
still fails to satisfy
the requirement,
replace the
regulator.
The nebulizer tube
is occluded.
Clean or replace the
nebulizer tube.
The nebulizer switch
valve is faulty.
Replace the
nebulizer switch
valve.
The nebulizer needle
valve is occluded.
Replace the O2 inlet
assembly.
The O2 proportional
valve is faulty.
Replace the O2
proportional valve
The sintered copper
filter at the high
pressure O2 inlet is
occluded.
Replace the sintered
copper filter.
The low pressure O2
connector is
damaged.
Replace the low
pressure O2
connector.
Filter net is
damaged.
Replace the filter
net.
The O2 flow sensor
is damaged.
Replace the O2 flow
sensor.
6-26
Reference
6.7.3.1Regulator
Output Pressure Is
Inaccurate
6.7.3.2Nebulizer Is
Faulty or Flow Is
Abnormal
6.7.3.2Nebulizer Is
Faulty or Flow Is
Abnormal
6.7.3.3Maximum
Flow Output Value
in the High
Pressuer O2 Limb
Is Small
/
6.7.3.4Measured
Flow Value by the
O2 Flow Sensor
Fluctuates Greatly
Failure description
Possible cause
Troubleshooting
The blower is faulty.
Maximum output flow is a
bit low, <180L/min.
O2 concentration is
inaccurate,
deviation >(3%+1%*setting
value)
Leakage of insp. valve
exceeds the limit.
Insp. valve responds too
slowly.
Sponge aging results
in airway occlusion.
Replace the blower
box assembly.
The insp. valve filter
screen is occluded.
Replace the insp.
valve filter screen.
The voice coil motor
is faulty.
Replace the insp.
valve assembly.
The Air/O2 flow
sensor is damaged.
Replace the flow
sensor.
Other parts are leaky
(such as connection
part between the
blower box and insp.
valve, flushing limb,
O2 sensor sampling
limb etc.)
Check the leaky
point and
troubleshoot. If
replacing the sealing
ring, check if it is
assembled properly.
The blower box is
leaky.
Replace the blower
box assembly.
Spring aging
Replace the insp.
valve assembly.
The insp. valve
diaphragm is aged
or damaged.
Replace the insp.
valve assembly.
The sealing part of
insp. valve
diaphragm has
debris.
Wash the insp. valve
diaphragm.
The sealing cover
assembly of insp.
valve is stuck.
Replace the insp.
valve assembly.
The valve port of
insp. valve is
damaged.
Replace the insp.
valve assembly.
The voice coil motor
is faulty.
Replace the insp.
valve assembly.
The insp. valve
diaphragm is aged
and sticky.
Replace the insp.
valve assembly.
6-27
Reference
6.7.4.1Maximum
Output Flow Is
Small
6.7.4.2O2
Concentration Is
Inaccurate
6.7.4.3Leakage of
Insp. Valve Exceeds
the Standard
6.7.4.4Insp. Valve
Response Time Is
Long
Failure description
Possible cause
Troubleshooting
Reference
Replace the
damaged sealing
ring or re-assembly
the sealing ring.
6.7.5.1Safety Valve
Is Leak
The safety valve
diaphragm
049-000654-00 is
damaged or is not
correctly installed.
The sealing ring
082-000223-00 in
the main channel of
safety valve main
body is damaged or
lost.
Safety valve leakage
The sealing ring
082-000739-00 in
the sampling limb of
safety valve main
body is damaged or
lost.
The sealing ring
082-001510-00 of
safety valve plug is
damaged or lost.
The sealing ring
082-000324-00 of
floating mechanism
is damaged or lost.
The electromagnet is
faulty.
Pressure relief is slow in
the safety valve pressure
relief channel. Safety valve
selftest fails.
Exp. valve leakage
Replace the
electromagnet.
The safety valve
diaphragm
049-000654-00 is
not fully reset or the
electromagnet is not
fully reset.
Replace the safety
valve diaphragm or
electromagnet.
The exp. valve
diaphragm is
damaged.
Replace the exp.
valve diaphragm
The exp. valve port
is damaged.
Replace the
disinfectable exp.
valve assembly.
The voice coil motor
is faulty.
Replace the voice
coil motor.
6-28
6.7.5.2Pressure
Relief Speed of
Safety Valve
Pressure Relief
Channel is Slow
6.7.6.1Exp. Valve Is
Leaky
Failure description
Exp. flow has no measured
value or has great
measurement deviation.
O2 sensor has great
measurement deviation.
Possible cause
Troubleshooting
The diaphragm is
ineffective or
broken.
Replace the
disinfectable exp.
valve assembly.
The sampling line or
pressure sensor filter
is occluded.
Replace the
sampling line or
pressure sensor
filter.
The flushing limb is
occluded.
Replace the needle
valve of flushing
limb.
The O2 sensor is
faulty.
Replace the O2
sensor.
The O2 sensor
sampling limb is
occluded.
Clear the O2 sensor
sampling limb.
Reference
6.7.6.2Exp. Valve
Flow Test Has an
Error
6.7.7O2 Sensor Has
Great Measurement
Error
6.7.3 Gas Supply Subsystem
6.7.3.1 Regulator Output Pressure Is Inaccurate
The regulator reduces supply gas pressure and stabilizes the effect of supply gas pressure
fluctuation upon the rear end. After long term of use, the output pressure of the ventilator
regulator may be inaccurate. Generally, you need to check the regulator output pressure under
the following situations:
1.
Perform machine inspection at the client end.
2.
The ventilator is faulty; for example, serious drift occurs to flow control.
The commonly used tools required for checking and adjusting the regulator output pressure
are as follows:
1.
400KPa gas supply (high pressure cylinder with pressure regulating function)
2.
Φ6 PU tube and quick connector
3.
Ventilator analyzer VT-PLUS
4.
Sleeve wrench and hexagon wrench
6-29
The regulator is as shown below.
Regulator
Nebulizer nozzle
6-30
To adjust the output pressure at the rear end of regulator,
1.
Connect to the O2 cylinder supply. Adjust supply gas pressure to 400±10KPa.
2.
Connect ventilator analyzer VT-PLUS high pressure port to the nebulizer connector via
PU tube and quick connector.
3.
Turn on nebulizer switch valve in the valve test tool under the ventilator service mode.
Adjust the O2 proportional valve to flow of approximately 5L/Min.
4.
Observe the readings on the VT-PLUS, which should be 200±10KPa. It the reading is
outside the range, adjust the regulator.
5.
To adjust the regulator, loosen the hexagonal nut on the front side of the regulator by
using the sleeve wrench. Adjust the plastic screws by using M3x20 hexagonal wrench
clockwise to increase pressure and counter clockwise to decrease pressure. While
adjusting, pay attention to the readings on the pressure gauge. When the pressure value
satisfies the requirement, tighten the hexagonal nut. When tightening the hexagonal nut,
pay attention to the values on the pressure gauge too. Generally, the pressure will drop.
This indicates that a margin should be reserved when adjusting pressure at the
beginning.
6.
If re-setting pressure detection by following the correct methods still fails to satisfy the
requirement, it is possible that some parts of the regulator are already faulty. In this case,
replace the regulator.
6.7.3.2 Nebulizer Is Faulty or Flow Is Abnormal
Nebulizer switch valve
6-31
The nebulizer switch valve controls ON/OFF of nebulized gas flow. To judge if the nebulizer
function is normal,
1.
Connect to the high pressure O2 supply or cylinder. Make sure that the pressure of
external gas supply satisfies the ventilator requirements and that gas supply is sufficient.
2
Control the nebulizer switch in the valve test tool under the service mode. Connect the
ventilator analyzer VT-PLUS at the nebulizer nozzle via PU tube to test if the nebulized
gas flow is normal. If there is no nebulized gas flow available and the failure still
persists after replacing the nebulizer tube, it is possible that the nebulizer switch valve is
faulty. Replace the valve. Control the nebulizer switch in the valve test tool under the
service mode for multiple times (3 times recommended) to see if obvious click can be
heard. If not, it is possible that the nebulizer switch valve is faulty. Replace the valve. If
the nebulizer switch valve is normal, it is possible that the nebulizer needle valve is
occluded, replace the O2 inlet assembly.
3.
If nebulized gas flow is available but is abnormal, exceeding the range of 6~9L/min, it is
possible that the nebulizer needle valve is occluded, replace the O2 inlet assembly.
6.7.3.3 Maximum Flow Output Value in the High Pressuer O2 Limb Is
Small
O2 proportional valve
Sintered copper filter
The maximum flow output of O2 inlet assembly is closely related to the performance of O2
proportional valve. The possible failure of this valve is that the maximum flow output value
in the high pressure O2 limb is small. To troubleshoot this failure,
1.
Check if the sintered copper filter is occluded. If yes, replace it.
2
Connect to the external gas supply or O2 cylinder. Make sure that the pressure of
external gas supply satisfies the requirement of the ventilator and that the gas supply is
sufficient.
6-32
3.
In diagnosis mode, adjust DA of O2 proportional valve to 4095 to let the O2
proportional valve fully open. Observe if the reading of O2 flow sensor is ≥120L/min.
If the maximum flow output value is small, generally, it is caused by the internal failure
of proportional valve. In this case, replace it.
6.7.3.4 Measured Flow Value by the O2 Flow Sensor Fluctuates Greatly
Filter net
If the measured flow value by the O2 flow sensor fluctuates greatly, troubleshoot as follows,
1.
Troubleshoot by using the machine selftest function. If O2 flow sensor selftest fails, it is
possible that the flow sensor is faulty. In this case, replace the O2 flow sensor.
2
Check if the filter net assembly (049-000702-00) at the front end of the flow sensor is
normal. If not, replace it. Then re-do the test to see if the measured data are improved.
6.7.4 Blower Fan and Flow Control Subsystem
The blower fan and flow control subsystem is the core part of the machine. It is mainly
composed of blower box assembly and insp. valve.
6.7.4.1 Maximum Output Flow Is Small
Enter the valve diagnostic function under service mode. Adjust insp. valve control DA to
4095 and adjust the blower rotation speed to the maximum (44000-45000 rotation/min).
Observe the reading of total flow sensor. If the reading deviates from 180L/min greatly, it
indicates that the blower box assembly and insp. valve may be faulty. This problem is
complicated. Troubleshoot as follows,
6-33
1.
Close the insp. valve. Adjust the blower rotation speed to 39600 rotations and adjust
pressure to 80cmH20. Observe “Blower rotation speed”, “Blower internal temperature”
and “blower external temperature” displayed on the screen. If the blower rotation speed
is far less than 39600 rotations, or if the blower temperature is higher than 85℃, it
indicates that the blower may be faulty. Replace the whole blower box assembly.
2.
If both blower rotation speed and working temperature are normal, remove the blower
box assembly and do test. The test principle is as shown below. Connect the outlet of
blower box assembly to the ventilator analyzer VT-PLUS or other flow test device via
hose. By using the valve diagnostic function under service mode, adjust the blower
rotation speed to the maximum (44000-45000 rotation/min). If the reading on the flow
device is greater than 250L/min, it indicates that the blower box assembly is normal and
that the failure lies in the insp. valve assembly. Then troubleshoot the insp. valve
assembly. If the flow reading is less than 250L/min, it indicates that the blower box
assembly is faulty. Replace the blower box assembly.
3.
If the insp. valve assembly is located to be faulty, troubleshoot as follows. Check the
filter net at the gas outlet of the insp. valve assembly. If the filter net is occluded, clean
or replace the filter net (049-0007020-00). If the problem persists after replacing the
filter net (049-0007020-00), it indicates that the insp. valve is faulty. Replace the insp.
valve assembly.
Filter net
6-34
6.7.4.2 O2 Concentration Is Inaccurate
If the defect of inaccurate O2 concentration occurs to the machine, troubleshoot as follows.
1.
Use the system check function to check the Air/O2 flow sensor. If “O2 Flow Sensor
Test” and “Insp. Flow Sensor Test” fail, it indicates that the Air/O2 flow sensor may be
faulty. Replace the Air/O2 flow sensor.
2
Check the leakage of other assemblies except the blower box assembly, focusing on the
connection part between the blower box and insp. valve, leakage in the flushing limb,
and leakage in the O2 sensor sampling limb. If leakage is detected, re-assemble the parts
or replace the sealing components.
3
If tube disconnected or loose is found out, troubleshoot the exp. valve flushing limb and
O2 sensor sampling limb. Re-connect the disconnected or loose tube.
4.
If the problem persists after the above three steps, it is possible that the blower box
assembly is leaky. Replace the blower box assembly.
6.7.4.3 Leakage of Insp. Valve Exceeds the Standard
The leak test method for the insp. valve is as follows:
Enter the valve diagnostic mode under service mode. Adjust DA of insp. valve to “0”
and set the rotation speed of the blower to 39600 rotations. Observe the reading on the
total flow sensor. If the reading is greater than 0. 1L/min, it indicates that the leakage of
insp. valve exceeds the standard.
Troubleshoot as follows,
1.
Remove the insp. valve shell and check if there is debris at the insp. valve diaphragm. If
the sealing part of insp. valve diaphragm has debris, wipe or clean the diaphragm. Do
not leave out the filter net when re-installing the insp. valve shell.
2.
If the problem persists after cleaning the insp. valve diaphragm, it is possible that the
insp. valve assembly is faulty. Replace the insp. valve assembly.
Insp. valve diaphragm
Filter net
6-35
6.7.4.4 Insp. Valve Response Time Is Long
There are two reasons if the insp. valve response time is long:
1.
The voice coil motor is faulty;
2.
The insp. valve diaphragm is damaged or polluted, so that it is sticky to the valve port
and affects valve port to open.
If the insp. valve response time is long, troubleshoot as follows.
1.
Remove the insp. valve shell and check if there is debris at the insp. valve diaphragm. If
the sealing part of insp. valve diaphragm is polluted, wipe or clean the diaphragm. Do
not leave out the filter net when re-installing the insp. valve shell.
2.
If the problem persists after cleaning the insp. valve diaphragm, it is possible that the
insp. valve assembly is faulty. Replace the insp. valve assembly.
6.7.5 Safety Valve Assembly
6.7.5.1 Safety Valve Is Leaky
If the safety valve is leaky, troubleshoot as follows.
1.
If clear leakage sound is heard, listen to find the leakage so as to confirm the faulty part.
2.
Remove the safety valve detachable part. Perform visual inspection to see if the sealing
ring on the safety valve is lost or damaged. If yes, replace it. For the position of sealing
ring, refer to the explosive view of the safety valve detachable part.
Sealing ring
3.
Install the safety valve detachable part back to the machine. Open and close it for
multiple times (three times recommended) in the valve test tool under the service mode
to see if clear click can be heard. If not, it is possible that the solenoid is faulty. Replace
the electromagnet.
6-36
4.
Disconnect the safety valve power cord. When doing the leak test, depress the tail of the
electromagnet to close the pressure relief channel. If leak test satisfies the requirement
by using this method, it is possible that electromagnet is faulty. Replace the
electromagnet.
6.7.5.2 Pressure Relief Speed of Safety Valve Pressure Relief Channel is
Slow
Diaphragm fixing knob
If “Safety Valve Test” during system check fails, troubleshoot as follows.
1.
Check if the safety valve is leaky. Refer to 6.7.5.1Safety Valve Is Leaky.
2.
Check if the dustproof pad of safety valve is occluded. If yes, replace it.
3.
Remove the safety valve detachable part. Observe the safety valve diaphragm
049-000654-00. Push the safety valve diaphragm and with fingers and then loosen the
fingers to see if the safety valve diaphragm rebounds normally. If not, replace it.
4.
Disassemble the diaphragm fixing knob and take out the safety valve diaphragm.
Observe if the safety valve diaphragm is correctly installed. If not, re-install it.
5.
Push the tail of the electromagnet in case of power failure and then loosen the fingers.
Observe if the solenoid valve stem is reset with the help of spring. If not, the
electromagnet is faulty, replace it.
6-37
6.7.6 Expiration Valve Assembly
6.7.6.1 Exp. Valve Is Leaky
Exp. valve diaphragm
Exp. valve port
6-38
If the exp. valve is leaky, troubleshoot as follows.
1.
If clear leakage sound is heard, listen to find the leakage so as to confirm the faulty part.
2.
Remove the disinfectable exp. valve assembly. Perform visual inspection on the exp.
valve diaphragm to see if the exp. valve diaphragm is damaged. If yes, replace it.
3.
Remove the exp. valve diaphragm. Perform visual inspection on the exp. valve port. If
there is breach on the valve port, replace it.
4.
Install the disinfectable exp. valve assembly back to the machine. Connect the exp. valve
outlet with the safety valve outlet via a tube. In the valve test tool under the service
mode, adjust the blower assembly and insp. valve to produce output flow of 2L/min.
Adjust the exp. valve pressure to 80cmH20. Observe if the pressure reading in the exp.
valve limb reaches 80cmH20. If not, it is possible that the voice coil motor is faulty.
Replace the voice coil motor.
6.7.6.2 Exp. Valve Flow Test Has an Error
If exp. valve flow test has an error, and there is no flow sampling data in the sampling limb or
there is great deviation, troubleshoot as follows.
1.
Observe if the flow sensor metal diaphragm is normal. If it is broken or damaged,
replace it. If it cannot be replaced separately, replace the whole disinfectable exp. valve
assembly.
Damaged
diaphragm
2.
Normal diaphragm
Check if the flushing limb and flushing needle valve are occluded. If yes, clean or
replace it. To check if the flushing limb is occluded, disconnect the silicone tube from
the exp. valve sampling port to enter the valve diagnostic function under the service
mode. Adjust the blower rotation speed to 39600 rotations. Place one end of the tube
into a container filled with water. If there is bubble at the tube, it indicates that the
flushing limb is normal. If there is no bubble at the tube, it indicates that the flushing
limb is occluded or not connected, clean or replace it. This method can be used to test if
tube occlusion or disconnection occurs at the exp. valve sampling port, pressure sensor
connector etc.
6-39
6.7.7 O2 Sensor Has Great Measurement Error
O2 sensor
Position of O2 sensor
The O2 sensor detects the concentration of O2. Possible failure which can occur to this
assembly is O2 sensor failure. This problem can be judged preliminarily by replacing the O2
sensor once a year. If the replacement time interval is short and O2 concentration detection is
inaccurate, O2 concentration calibration is necessary. If O2 concentration detection is still
inaccurate, judge if the O2 sensor is faulty. Judge as follows.
1.
Connect to the high pressure O2 supply. Check if the HEPA filter at the Air inlet is
occluded. If the high pressure O2 supply is not connected, or if the HEPA filter is
occluded, it is possible that O2 sensor test is failed.
2.
By using the system check function, if the result of “O2 Sensor Test” is “Pass”, it
indicates that the O2 sensor is not damaged. If the result is “Fail”, it indicates that the
O2 sensor is damaged. Replace the O2 sensor.
6-40
3.
If the problem persists after replacing the O2 sensor, it is possible that the O2 sensor
sampling line is occluded. Cleaning or replacing the sampling tube is recommended.
6.8 Hardware and Electrical System Failures
Failure description
Possible cause
Recommended action
At startup, the
operational indicator
light, AC indicator light,
and the battery indicator
light are not lit and there
is no screen display
available. Namely, the
ventilator fails to start
up.
The AC power supply is not
connected and the battery capacity is
not sufficient.
Check and make sure of the
correct connection of AC power
supply.
The fuse of the AC mains inlet is
burned out and the battery capacity is
insufficient.
Replace the fuse. If the problem
persists, it indicates that the
machine is internally short
circuited.
The display cable (at the
motherboard or the main unit
external connector) is disconnected
or is not reliably connected.
Check and make sure of reliable
cable connection. Make sure that
the cable captive screws are
tightened.
The cable related to power switch is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
There is no 18.8V power output and
insufficient battery capacity is not
sufficient due to AC-DC board
hardware circuit failure.
Replace the AC-DC board.
There is no 5V, 3.3V, 7V, and 12V
power output due to DC-DC board
hardware circuit failure.
Replace the DC-DC board.
At startup, the AC
indicator light and
battery indicator light are
lit while the operational
indicator light is not lit.
There is no screen
display available.
6-41
Failure description
Possible cause
Recommended action
There is no screen
display available (black
screen).
The inverter connection lines
(including the inverter input line and
output line) are disconnected or are
not reliably connected.
Check and make sure of reliable
cable connection.
The inverter is damaged.
Replace the inverter.
The main board hardware failure
causes the backlight enable signals to
output invalid level.
Replace the main board.
The main board software failure
causes the backlight enable signals to
output invalid level.
Upgrade the main board
software.
The LCD is damaged.
Replace the LCD.
The display cable (at the LCD) is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The main board hardware failure
causes no 3.3V output or output
error.
Replace the main board
The LCD is damaged.
Replace the LCD.
There is screen display
available but there is
color error displayed
(screen blurred).
The display cable (at the LCD) is
disconnected or is not reliably
connected, which causes loss of some
color signals.
Check and make sure of reliable
cable connection.
Screen brightness cannot
be adjusted.
The DC-DC board hardware failure
causes the backlight brightness
adjustment signals unable to output
normal signals.
Replace the DC-DC board.
The main board hardware failure
causes the backlight brightness
adjustment signals unable to output
normal signals.
Replace the main board.
The inverter connection lines
(including the inverter input line and
output line) are disconnected or are
not reliably connected.
Check and make sure of reliable
cable connection.
The inverter is damaged.
Replace the inverter.
There is no screen
display available (white
screen).
6-42
Failure description
Possible cause
Recommended action
The alarm indicator light
is not lit.
The display cable is disconnected or
is not reliably connected
Check and make sure of reliable
cable connection.
The alarm light board connection line
is disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The main board hardware failure
causes failure to output normal alarm
light control signals.
Replace the main board.
The alarm light board hardware
failure causes failure to drive the
alarm light.
Replace the alarm light board.
The key related connection line is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The key control board hardware
failure causes failure to respond to
key input information.
Replace the key control board.
The encoder board connection line is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The rotary encoder is damaged.
Replace the rotary encoder.
The key control board hardware
failure causes failure to respond to
rotary encoder input information.
Replace the key control board.
The touchscreen related cable is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The key control board hardware
failure causes failure to respond to
touchscreen input information.
Replace the key control board.
The touchscreen is damaged.
Replace the touchscreen.
The speaker related cable is
disconnected or is not reliably
connected.
Check and make sure of reliable
cable connection.
The main board hardware failure
causes failure to output normal
speaker drive signals.
Replace the main board.
The speaker is damaged.
Replace the speaker.
Key failure
Rotary encoder failure
Touchscreen failure
Speaker failure
6-43
Failure description
Possible cause
Recommended action
Wifi module error
Wifi antenna is disconnected or
broken.
Re-plug the wifi antenna or
replace the antenna.
Wifi module is damaged.
Replace the wifi module.
Failure occurs to monitoring main
board.
Replace the monitoring board
assembly.
SpO2 module cable is disconnected.
Re-plug the cables, including
machine internal SpO2 module
related cables.
SpO2 module failure
Replace the SpO2 board
assembly.
Communication error between the
SpO2 module and monitoring
module main board occurs.
Replace the monitoring module
board assembly.
The connection line between the CO2
module and monitoring main board is
disconnected.
Re-plug or replace the relevant
cables.
CO2 module failure.
Replace the CO2 module.
Serial port communication error
occurs to the monitoring module
main board.
Replace the monitoring module
main board assembly.
The fan is occluded.
Check fan occlusion and clear the
obstacles.
The fan connection line is
disconnected or the fan is failed.
Re-plug the fan connection line
or replace the fan.
12V power supply for the fan
provided by the DC-DC board is
damaged.
Replace the DC-DC board.
The turbofan is damaged.
Replace the turbofan assembly.
Blower drive circuit error
Replace the monitoring module
main board assembly.
DC-DC board is failed.
Replace the DC-DC board.
SpO2 module error
Mainstream CO2 or
sidestream module error
The cooling fan does not
work.
The turbofan does not
work..
6-44
7 Repair and Disassembly
WARNING
z
To help prevent fires, only use lubricants approved for ventilator or O2 equipment.
z
Do not use lubricants that contain oil or grease. They burn or explode in high O2
concentrations.
z
Obey infection control and safety procedures. Used equipment may contain blood
and body fluids.
z
Movable parts and removable components may present a pinch or a crush hazard.
Use care when moving or replacing system parts and components.
z
Use care when disassembling the parts with sharp edges to avoid cuts.
z
Pay attention to the screws during the disassembly to prevent screws from falling
into the inside of the equipment. Failure to do so may cause short circuit.
z
Make sure to bleed gas pressure before disassembling pneumatic fittings to avoid
personal injury caused by high pressure gas.
NOTE
z
When re-assembling, inspect all parts for deterioration. Replace them if necessary.
Use appropriate screws and parts.
z
After repairs are completed or parts replaced, refer to 3Checkout and Test to
perform the checkout procedure.
7-1
7.1 Prepare for Disassembly
7.1.1 Tools
During parts disassembling and replacing, the following tools may be required:
„
Metric Allen wrench (2.5#, 3#, 4#, 5#, 6#)
„
Phillips screwdriver
„
Diagonal pliers
„
Flathead screwdriver
„
Metric M3 and M4 socket screwdriver
„
Adjustable wrench
„
Tweezers
7.1.2 Preparations
Before disassembling the ventilator, do the following:
„
Make sure that the ventilator is already turned off and that the ventilator is disconnected
from AC power supply and backup battery.
„
Remove all the accessories connected to the ventilator.
„
Disconnect pipeline and cylinder gas supply connections.
„
Prepare the tools required for disassembly.
„
Wear antistatic gloves or hand rings when removing the boards.
„
Maneuver the ventilator to an appropriate location and then step down the caster brake
(cart configured) fixing the ventilator.
CAUTION
z
The internal parts may be contaminated during long-term use of the equipment.
Wear special gloves during disassembling and inspecting.
7-2
7.2 Disassemble the Service Parts
7.2.1 Remove the Lithium Battery
1.
Lay down the machine. Remove the 4 M3X8 self-locking screws on the main unit
battery compartment door from the bottom to remove the battery compartment door.
Battery
compartment
door
2.
Pull out the slice on the battery to remove the lithium battery.
Pull out the slice at here.
7-3
7.2.2 Replace the O2 Sensor
1.
Pry the O2 sensor cover to pull out the O2 sensor holder.
2.
Pull out the O2 sensor connection line from the O2 sensor. Then remove the O2 sensor
by rotating it counter clockwise.
3.
Re-install the O2 sensor by following the relevant steps.
Pull out, remove the line, and
remove the O2 sensor
Pry open from here
7.2.3 Remove the HEPA Filter and Fan Dust Screen
1.
Depress the snap on the baffle of main unit air inlet to remove the baffle.
Snap
Baffle of main unit air
inlet
7-4
2.
Depress the snap of HEPA filter to remove the filter. If the fan dust screen is to be
replaced, remove the fan dust filter for replacement.
Fan dust screen
HEPA filter
7.2.4 Remove the Main Unit Dust Screen
Remove the baffle of main unit air inlet as described in 7.2.3. Pull out the main unit dust
screen from the bottom.
Main unit dust screen with protruding
block facing outward
7-5
7.2.5 Remove the Disinfectable Expiratory Valve Assembly and
Safety Valve Detachable Part
1.
Rotate the expiratory valve knob counter clockwise from the front of the machine to
take out the disinfectable expiratory valve assembly.
2.
Rotate the safety valve knob counter clockwise from the front of the machine to take out
the safety valve detachable part.
Disinfectable
expiratory
valve assembly
Safety valve
detachable
part
Note: The knob cannot be taken out until it has come to the corresponding unlock position.
7-6
7.2.6 Remove the Expiratory Valve Diaphragm and Expiratory
Check Valve
1.
Remove the disinfectable expiratory valve assembly as described in 7.2.5.
2.
Pull out the expiratory valve diaphragm and expiratory check valve from the back of the
disinfectable expiratory valve assembly.
Expiratory valve diaphragm
Expiratory check valve
7.2.7 Remove the Parts of the Disinfectable Part of the Safety
Valve
1.
Remove the disinfectable part of the safety valve as described in 7.2.5.
2.
Remove the parts of the disinfectable part of the safety valve as shown below.
7-7
7.2.8 Remove the Upper Housing Assembly
1.
Remove the lithium battery as described in 7.2.1.
2.
Pry up the screw cover of the main unit upper housing with flathead screwdriver.
3.
Remove the 4 M3X8 combination screws fixing the upper housing to remove the upper
housing assembly.
7-8
7.2.9 Remove the Speaker
1.
Remove the upper housing assembly as described in 7.2.8.
2.
Disconnect the cables from the speaker and monitoring board and remove the speaker
from the bottom up.
Speaker connection line
7.2.10 Remove the WIFI Module (Optional)
1.
Remove the upper housing assembly as described in 7.2.8
2.
Disconnect the antenna from the WIFI module. Depress the two snaps on both sides of
the board to remove the WIFI module.
WIFI module
WIFI antenna
7.2.11 Remove the SpO2 Module (optional)
1.
Remove the upper housing assembly as described in 7.2.8
2.
Disconnect the two cables from the SpO2 module. Remove the 3 M3X6 pan head
screws fixing the SpO2 module to remove the SpO2 module.
7-9
7.2.12 Remove the Display Assembly
After removing the upper housing assembly as described in 7.2.8, remove the 4 M4X12
combination screws fixing the display assembly. Disconnect the display connection line and
keyboard connection line so as to remove the display assembly from the front.
7.2.13 Remove the Main Unit Front Housing
1.
Remove the lithium battery as described in 7.2.1and the display assembly as described
in 7.2.12.
2.
Remove the disinfectable expiratory valve assembly and safety valve detachable part as
described in 7.2.5.
3.
Pry up the 4 screw covers on the main unit front housing to remove the 4 M3X8
combination screws on the front housing to remove the main unit front housing.
7-10
7.2.14 Remove the Monitoring Board Assembly
1.
Remove the main unit front housing as described in 7.2.13.
2.
Disconnect the cables from the monitoring board. Remove the 6 M3X8 combination
screws fixing the monitoring board assembly.
7-11
7.2.15 Remove the Display Rear Housing and Key Control
Board
1.
After removing the display assembly as described in 7.2.12, pry up the 7 display screw
covers with flathead screwdriver.
2.
Remove the 7 M3X8 combination screws fixing the display rear housing assembly and
the M3X8 combination screw fixing the cable cover to remove the rear housing
assembly.
7-12
3.
Remove the 4 M3X8 combination screws fixing the key control board. Disconnect the
cables from the key control board to remove the key control board.
7.2.16 Remove the Alarm Light Board
After removing the display rear housing assembly as described in 7.2.15, remove the 2 M3X8
combination screws fixing the alarm light board. Disconnect the connection lines from the
alarm light board to remove the alarm light board.
7-13
7.2.17 Remove the Display Assembly
After removing the key control board as described in 7.2.15, remove the 4 M3X8
combination screws fixing the display assembly to remove the display assembly.
7.2.18 Remove the Touchscreen
1.
Remove the display assembly as described in 7.2.17.
2.
Remove the touchscreen. Pay attention to the direction of the touchscreen as shown
below.
Touchscreen signal line, led out rightward
The surface of the touchscreen which can
see metal wiring is placed in the front.
7-14
7.2.19 Remove the Encoder
1.
Remove the rear housing assembly as described in 7.2.15.
2.
Disconnect the encoder connection line from the key board.
3.
Use the small-sized hexagonal wrench to knock put the knob from the inside through the
hole. Use the adjustable wrench to remove the nut fixing the encoder to remove the
encoder (note to support the encoder board with hand when removing the nut to prevent
damage caused by board rotation).
Pass from this hole out of the knob
Encoder
Nut
Knob
7.2.20 Replace the Pressure Sensor Filter
1.
Remove the main unit front housing as described in 7.2.13.
2.
Disconnect the tubes from the filter. Remove the filter from the Luer fitting.
3.
Replace with a new filter and then connect the tubes properly following the tube
connection diagram.
7-15
Luer fitting
Pressure sensor filter
7.2.21 Remove the Safety Valve Seat Assembly
1.
Remove the main unit front housing as described in 7.2.13.
2.
Remove the 4 M3X8 combination screws fixing the safety valve seat to remove the
safety valve seat assembly.
3.
Remove the solenoid connection line and inspiratory pressure sampling line.
Solenoid connection line
Inspiratory pressure sampling line
7-16
7.2.22 Remove the Electromagnet
1.
Remove the safety valve seat assembly as described in 7.2.21.
2.
Remove the 4 M3X8 combination screws fixing the electromagnet to remove the
electromagnet.
electromagnet
7.2.23 Remove the Air Flow Sensor
After removing the safety valve seat assembly as described in 7.2.21, pull out the Air flow
sensor on the safety valve seat and cut the tape to remove the sensor connection line.
Air flow sensor
7.2.24 Remove the Sensor Adapter Board
1.
Remove the main unit front housing as described in 7.2.13.
2.
Remove the three tubes from the sensor adapter board. Remove the connection lines
from the sensor adapter board.
3.
Remove the 3 M3X8 combination screws fixing the sensor adapter board to remove the
sensor adapter board.
Remove the three tubes
7-17
7.2.25 Remove the O2 Sensor Seat Assembly
1.
Remove the main unit front housing as described in 7.2.13.
2.
Remove the cables and tubes from the O2 sensor seat assembly (the tubes are properly
connected when assembled following the tube number on the tube connection diagram).
Remove the 2 M3X8 combination screws fixing the assembly to remove the O2 sensor
seat assembly.
O2 sensor seat assembly
7.2.26 Remove the Kernel Assembly
Note: sort out cables and tubes after removing the kernel to prevent them from being hooked.
1.
Remove the main unit front housing as described in 7.2.13.
2.
Depress the snap on the baffle of main unit air inlet to remove the baffle.
Baffle of main
unit air inlet
7-18
3.
Remove the expiratory valve external slide from the left side of the machine.
Expiratory valve
external slide
4.
Remove the 4 M3X8 combination screws fixing the kernel assembly from the back of
the machine.
5.
Remove the 4 M3X8 combination screws fixing the kernel assembly from the front of
the machine. If CO2 module is configured, remove the tubes and cables from the CO2
module (only mainstream CO2 module has cables). If SpO2 module is configured,
remove the SpO2 module connection line.
7-19
6.
Remove the speaker connection line from the top of the kernel. If WIFI is configured,
remove the WIFI antenna to pull out the kernel assembly from the front.
WIFI antenna
Speaker connection line
7.2.27 Remove the AC-DC Power Board
1.
Remove the kernel assembly as described in 7.2.26.
2.
Remove the 4 M3X8 combination screws fixing the AC-DC power bracket from the
front side and left side of the kernel.
7-20
3.
After disconnecting the connected cables, remove the AC-DC power bracket and
AC-DC power board. Remove the 4 M3X8 combination screws fixing the AC-DC
power board to remove the AC-DC power board.
7.2.28 Remove the DC-DC Power Board
1.
Remove the AC-DC power bracket as described in 7.2.27.
2.
Remove the 5 M3X8 combination screws fixing the DC-DC power board. Disconnect
the connected cables to remove the DC-DC power board.
7-21
7.2.29 Remove the Fan
1.
Remove the DC-DC power board as described in 7.2.28.
2.
Remove the 4 M3X8 combination screws fixing the fan from the back of the kernel.
Disconnect the fan connection line to remove the fan.
Fan
7.2.30 Remove the AC Power Socket
1.
Remove the AC-DC power bracket as described in 7.2.27.
2.
Remove the 2 M3X8 countersunk screws fixing the AC power socket and the M4 nut
fixing the grounding cable so as to remove the AC power socket.
3.
Pry up the fuse cover from the AC power socket to replace the fuse (note: if only fuse is
to be replaced, do not disassemble the machine. Replace from the outside of the machine
directly).
7-22
Socket with accompanying fuse
Fuse of
T3.15AH
Spring
washer
M4 nut
Earth soldering lug
Plain
washer
Kernel
bracket
Grounding cable fixing mode
7.2.31 Remove the DC Input Socket
1.
Remove the AC-DC power bracket as described in 7.2.27.
2.
Remove the 4 screws fixing the DC input socket. Disconnect the DC input line from the
DC-DC power board so as to remove the DC input socket from the outside of the
machine.
Remove the plug
7-23
7.2.32 Remove the Expiratory Valve Seat Assembly
1.
Remove the kernel assembly as described in 7.2.26.
2.
Remove the 4 M3X8 combination screws fixing the expiratory valve seat assembly front
the front face and side face of the kernel assembly. Disconnect the connection line of
voice coil motor to remove the expiratory valve seat assembly. Re-fix and sort out the
cables, as shown below.
7.2.33 Remove the Expiratory Valve Voice Coil Motor
1.
Remove the expiratory valve seat assembly as described in 7.2.32.
2.
Remove the 4 M3X8 combination screws fixing the voice coil motor from the inside of
the valve seat.
7.2.34 Remove the Sidestream CO2 Module (optional)
1.
Remove the kernel assembly as described in 7.2.26.
2.
Remove the 4 M3X6 screws fixing the CO2 module from the side face of the machine.
Disconnect the cables connecting the CO2 module to remove the CO2 module.
7-24
7.2.35 Remove the Blower Box Assembly
1.
Remove the kernel assembly as described in 7.2.26.
2.
Disconnect all the cables connecting the monitoring main board.
Note: You need to reset the blower running time in factory service menu after changing the
blower.
7-25
3.
Remove the 4 M3X8 combination screws fixing the bracket top plate to remove the
bracket top plate.
Remove the two
screws from the
side face
4.
Remove the 4 step screws fixing the blower box assembly by using 5# hexagonal
wrench (note: do not remove other screws on the blower box assembly).
NOTE
z
Note that when installing, the connector underneath the blower box assembly shall
be placed inside the silicone tube and inspiratory valve connector.
7-26
Fully placed inside the
inspiratory valve connector
Fully placed inside the silicone tube
5.
Disconnect the cables from the vacuum sensor board on the blower box assembly so as
to remove the blower box assembly.
Vacuum sensor
connection line
7.2.36 Remove the Vacuum Sensor Board
1.
Remove the sidestream CO2 module as described in 7.2.34.
2.
Disconnect the board connected cables. Remove the 2 M3X8 combination screws fixing
the board so as to remove the board.
7-27
7.2.37 Remove the Inspiratory Valve Assembly
1.
Remove the blower box assembly as described in 7.2.35.
2.
Remove the 4 M3X8 combination screws fixing the inspiratory valve assembly (note not
to remove the screws fixing the plastic parts). Disconnect the tubes. Remove the
inspiratory valve assembly upward after the whole assembly retracts.
3.
Sort out the tubes and cables as shown below during re-installation.
Tube No. 10 are led out
from underneath the sensor
Tubes Nos. 5 and 7 are led out on the solenoid and both
are located on the right side of the solenoid cable.
7-28
7.2.38 Remove the Filter Net for Inspiratory Valve
1.
Remove the blower box assembly as described in 7.2.35.
2.
Take out the filter net from the valve outlet by using the tweezers. During re-installation,
note to align the filter breach with the gas inlet
Align the breath with the gas inlet
7.2.39 Remove the O2 Inlet Assembly
1.
Remove the blower box assembly as described in 7.2.35.
2.
Remove the 4 M3X8 combination screws fixing the O2 inlet assembly from the back
and left side of the machine to pull out the O2 inlet assembly.
Cables are lead out from
the sheet metal breach
7-29
3.
Disconnect the tubes and cables connecting the O2 inlet assembly.
Cables on the
O2 inlet
assembly
φ4PU tube, routing from the O2
inlet accompanying tube, routing
underneath φ6PU tube
4.
Disconnect the cables from the O2 flow sensor from the front of the machine to pull out
the O2 sensor assembly.
O2 flow sensor connection line at the O2 inlet
7-30
5.
Cable as shown below during re-installation.
The cable goes through the sheet metal from
here and is pull out forward.
Sensor fully placed inside the silicone tube
7.2.40 Remove the Proportional Valve and Nebulizer Valve
1.
Remove the O2 inlet assembly as described in 7.2.39.
2.
Remove the 4 M3X20 hexagonal screws fixing the proportional valve and nebulizer
valve by using 2.5# hexagonal wrench. Disconnect the connection line between the
valve and monitoring board to take out the proportional valve and nebulizer valve.
7-31
3.
Re-install by following the requirements below.
Proportional
valve, this side
up
Nebulizer valve, this side up
Lay the two connectors flat before installing the two valves
7.2.41 Remove the Pressure Regulator Assembly
1.
Remove the O2 inlet assembly as described in 7.2.39.
2.
Remove the 2 M3X20 screws fixing the pressure regulator assembly (note: do not
remove the other two screws accompanying the pressure regulator).
7-32
3.
Re-install by referring to the following requirements
Align the pin holes with the pin columns
7.2.42 Remove the O2 Flow Sensor
1.
Remove the O2 inlet assembly as described in 7.2.39.
2.
Remove the 2 M3X20 combination screws fixing the O2 flow sensor anchor plate.
Remove the O2 sensor and filter net.
Two gas flow arrows are in the
same direction
Fixing sheet metal
Filter net
7-33
7.2.43 Remove the Low Pressure O2 Connector
1.
Remove the O2 inlet assembly as described in 7.2.39.
2.
Disconnect the tubes connecting the low pressure O2 connector. Remove the fixing nut
of low pressure O2 with adjustable wrench so as to take out the low pressure O2
connector.
Low pressure O 2 connector
M6Q-030107---
7.2.44 Remove the Battery Adapter Board
1.
Remove the kernel assembly as described in 7.2.26.
2.
Remove the 4 M3X8 countersunk screws fixing the lithium battery box from the bottom
of the machine to remove the lithium battery box.
3.
Remove the two nuts fixing the battery adapter board to take out the battery adapter
board.
7-34
7.2.45 Remove the Rear Housing Assembly
1.
Remove the kernel assembly as described in 7.2.26.
2.
The rear housing assembly is left after the kernel assembly is removed.
7-35
7.2.46 Remove the CO2 Parameter Connector Panel (optional)
1.
Remove the rear housing assembly as described in 7.2.45.
2.
Remove the 2 M2X6 tapping screws fixing the CO2 parameter connector panel from the
outside. Disconnect the cables inside the cable tie so as to take out the CO2 parameter
connector panel assembly from the outside.
7.2.47 Remove the WIFI Antenna (optional)
1.
Remove the rear housing assembly as described in 7.2.45.
2.
Remove the 4 M3X8 combination screws fixing the main unit handle to take out the
main unit handle.
7-36
3.
Tear out the WIFI antenna.
7.2.48 Remove the SpO2 Connector (optional)
1.
Remove the rear housing assembly as described in 7.2.45.
2.
Depress the cable tie on both sides of the SpO2 connector. Take out the SpO2 connector
and installation box from the outside.
7-37
7.2.49 Remove the Trolley Support Table Assembly
Remove the 4 M4X12 screws fixing the trolley support table assembly from the bottom up to
take out the support table assembly.
Trolley support table assembly
7.2.50 Remove the Trolley Handle Assembly
1.
Remove the trolley support table assembly as described in 7.2.49.
2.
Remove the 4 M8X25 hexagonal screws fixing the trolley handle to take out the trolley
handle assembly.
7-38
7.2.51 Remove the Trolley Column
1.
Remove the trolley handle assembly as described in 7.2.50.
2.
Lay down the trolley. Remove the 4 M8X25 hexagonal screws fixing the trolley column
from the bottom of the base to take out the trolley column.
7.2.52 Remove the Trolley Base Assembly
1.
Lay down the trolley. Remove the 4 M8X25 hexagonal screws fixing the trolley base
assembly from the bottom.
2.
Remove the trolley base assembly.
7-39
7.2.53 Remove the Humidifier Fixing Assembly
Remove the two set screws fixing the humidifier fixing assembly. Slide down along the
column guide and remove from the breach.
7.2.54 Remove the Trolley Cylinder Fixing Assembly
Remove the 2 M4X12 combination screws fixing the trolley cylinder fixing assembly to
remove the trolley cylinder fixing assembly.
7-40
7.2.55 Remove the Trolley Lock Control Assembly
1.
Remove the trolley support table assembly as described in 7.2.49.
2.
Remove the 4 M4X8 combination screws fixing the trolley lock control assembly to
remove the trolley lock control assembly.
7-41
FOR YOUR NOTES
7-42
8 Electrical and Pneumatic Connections
8.1 Pneumatic Connection
8.1.1 Pneumatic Connection Diagram
8-1
8.1.2 Tubes List
Pneumatic assembly、Unit material
No.
Name
Diameter
Assembly
Qty
.
Length
(mm)
P/N
5
Silicone tube
4.0x2.5
Integrated equipment
1
40±2
A21-000007---
6
Silicone tube
4.0x2.5
Integrated equipment
1
180±5
A21-000007---
7
Silicone tube
4.0x2.5
Integrated equipment
1
80±3
A21-000007---
8
Silicone tube
4.0x2.5
Integrated equipment
1
40±2
A21-000007---
9
Silicone tube
4.0x2.5
Integrated equipment
1
185±5
A21-000007---
10
Silicone tube
4.0x2.5
Integrated equipment
1
215±5·
A21-000007---
12
Silicone tube
4.0x2.5
Integrated equipment
4
45±2
A21-000007---
13
Silicone tube
4.0x2.5
Integrated equipment
2
70±3
A21-000007---
14
Silicone tube
4.0x2.5
Integrated equipment
2
30±2
A21-000007---
15
L-shaped
silicone tube
/
Integrated equipment
1
L1=10±1
L2=30±2
049-000831-00
16
L-shaped
silicone tube
/
Integrated equipment
1
L1=10±1
L2=30±2
049-000831-00
17
PU tube
6.0x4.0
O2 inlet assembly
1
150±5
M6G-020026---
18
PU tube
4.0x2.5
Main unit bracket
assembly
1
270±5
M6G-020046---
Y
T-shaped
connector
1/8"ID
Integrated equipment
1
/
M90-100030---
T
T-shaped
connector
3/32"ID
Integrated equipment
2
/
S1-0103-00-05
11
V
Metal needle
valve
Resistor
adjustable
Integrated equipment
2
/
082-000571-00
F
Filter
/
Integrated equipment
4
/
082-001903-00
Sensor board material
1
L-shaped
silicone tube
/
Sensor board
1
L1=13±1
L2=43±2
049-000831-00
2
Silicone tube
1/16"X3/1
6"
Sensor board
1
48±2
M6G-020006---
3
Silicone tube
1/16"X3/1
6"
Sensor board
1
70±3
M6G-020006---
4
Silicone tube
1/16"X3/1
6"
Sensor board
1
52±3
M6G-020006---
11
L-shaped
silicone tube
/
Sensor board
1
L1=13±1
L2=13±1
049-000831-00
T
T-shaped
connector
3/32"ID
Sensor board
1
/
S1-0103-00-05
11
8-2
Notes:
Dimensions L1 and L2 of L-shaped silicone tube are as shown below.
8.2 Electrical Connection
8.2.1 Electrical Connection Diagram
S5
S1
#1
S2
#2
#18
#17
#3
S3
B2
S4
B1
S4
B1
Purchased
material/
connector
Hardware board
#5/#6
S18
S17
S16
#4
#16
#15
#4
S15
B10
S14
B3
S13
S6
S7
#13
B7
#7
#14
S8
S12
S11
B9
#12
S10
#12
B4
S9
#8
B6
#10
#9
#11
B5
8-3
B8
Notes:
„
A hollow arrow indicates connection via board-board connectors while a solid arrow
indicates connection via cables.
„
“Bxx” indicates self-made board and “Sxx” indicates purchased material.
„
“#xx” indicates cable material.
8.2.2 Electrical Connection List
S/N
Description
P/N
#1
EV20 AC-DC board AC input connection line
009-004076-00
#2
EV20 AC-DC board to DC-DC board connection line
009-004027-00
#3
EV20 external DC input connection line (inside the machine)
009-004077-00
#4
EV20 battery input connection line
009-004028-00
#5
EV20 DC-DC board and monitoring board communication cable
009-004344-00
#6
EV20 monitoring main board power input line
009-004029-00
#7
EV20 Sharp screen connection line
009-004548-00
#8
EV20 alarm light connection line
009-004032-00
#9
EV20 encoder connection line
009-004033-00
#10
EV20 key control board connection line
009-004031-00
EV20 sidestream CO2 module connection line
009-004034-00
EV20 mainstream CO2 module connection line
009-004035-00
#12
EV20 flow sensor connection line
009-004040-00
#13
EV20 O2 concentration sensor connection line
009-004041-00
#14
EV20 sensor adapter board connection line
009-004036-00
#15
EV20 vacuum sensor connection line
009-004042-00
#16
EV20 blower temperature sensor connection line
009-004043-00
#17
EV20 O2 proportional valve and connection line
009-004173-00
#18
EV20 nebulizer valve and connection line
009-004174-00
S1
AC input socket
009-004076-00
S2
AC-DC power board
022-000163-00
S3
DC input socket
009-004077-00
S4
Intelligent battery
115-025022-00
S5
Cooling fan
115-028052-00
S6
Speaker
115-028050-00
S7
Display
115-022782-00
S8
Touchscreen
021-000149-00
S9
O2 flow sensor
012-000019-00
S10
Total flow sensor
012-000018-00
S11
Safety valve
024-000566-00
S12
O2 sensor
040-001275-00
#11
8-4
S/N
Description
P/N
S13
Inspiratory valve
115-020420-00
S14
Exp. proportional valve
024-000565-00
S15
Temperature sensor
009-004043-00
S16
Blower fan
115-028051-00
S17
O2 proportional valve
009-004173-00
S18
Nebulizer valve
009-004174-00
B1
EV20 battery adapter board PCBA
051-001551-00
EV20 DC-DC power board PCBA (without DC-IN)
051-001481-00
EV20 DC-DC power board PCBA (with DC-IN)
051-001777-00
EV20 main control board PCBA(configured with VGA and nurse
call)
051-001780-01
EV20 main control board PCBA(standard configuration)
051-001779-01
B4
EV20 alarm light board PCBA
051-001554-00
B5
Copper shaft encoder fixing board
DA8K-30-27114
B6
EV20 key control board PCBA
051-001552-00
EV20 monitoring module main board PCBA (configured with
VGA and nurse call)
051-001780-01
EV20 monitoring module main board (standard
configuration)PCBA
051-00177901
CO2 module (mainstream)
9211-20-87275
CO2 module (sidestream)
115-010077-00
B9
EV20 sensor adapter board PCBA
051-001555-00
B10
EV20 vacuum sensor board PCBA
051-001556-00
B2
B3
B7
B8
Notes:
For cable material which contains the corresponding purchased component, P/N is the P/N of
the cable material.
„
EV20 AC-DC board AC input connection line “#1” is outsourced cable with material.
Its incoming material already contains material “S1”.
„
EV20 exterma DC input connection line (inside the machine)”3” is purchased cable. Its
incoming material already contains material “S3”.
„
EV20 vacuum sensor connection line “#16” is outsourced cable with material. Its
incoming material already contains material “S15”.
„
EV20 O2 proportional valve and connection line “#17” is outsourced cable with
material. Its incoming material already contains material “S17”.
„
EV20 nebulizer valve and connection line “#18” is outsourced cable with material. Its
incoming material already contains material “S18”.
8-5
FOR YOUR NOTES
8-6
9 Parts
9.1 SV300/350/SV350 Ventilator Main Unit Assembly
9.1.1 Exploded View
9.1.2 Parts List
S/N
P/N
Description
Qty
1
049-000657-00
EV20 host front cover screw cap
4
2
115-028045-00
Front cover FRU (CE)
1
3
115-028049-00
Battery door FRU
1
4
115-025022-00
Li-ion battery kit
1
5
042-010558-00
EV20 power fixer
1
6
048-004133-00
Dustproof net
1
7
115-028048-00
Host inlet fence FRU(CE)
1
8
049-000656-00
EV20 host top cover screw cap
2
9
115-021483-00
EV20 host top cover assembly
1
10
115-028046-00
Host back cover FRU(CE)
1
9-1
S/N
P/N
Description
Qty
11
043-004014-00
Outside guide slot of expiration valve
1
9.2 Display Assembly
9.2.1 Exploded View
9.2.2 Parts List
S/N
P/N
Description
Qty
1
049-000660-00
EV20 display screw cap
7
2
043-004019-00
EV20 display back cover
1
3
043-004020-00
EV20 display back cover cable Plate
1
4
045-001157-00
Right hinge assembly
1
5
045-001160-00
Left hinge assembly
1
9-2
9.3 Display Front Housing Assembly
9.3.1 Exploded View
9.3.2 Parts List
S/N
P/N
Description
Qty
115-028053-00
Display front cover FRU(SV300/350)
1
115-028054-00
Display front cover FRU(SV350)
1
2
043-005358-00
Alarm light cover
1
3
6200-30-09774
Encoder
1
4
043-004516-00
EV20 knob
1
5
049-000745-00
EV20 silence key(silkscreen)
1
6
049-000744-00
EV20 power key(silkscreen)
1
7
051-001554-00
EV20 Alarm LED PCBA
1
8
021-000149-00
Touch-panel resistive 12.1" 5-line wide
1
9
115-022782-00
EV20 Sharp display material package
1
10
115-028055-00
Key control PCBA FRU
1
1
9-3
9.4 Kernel Assembly
9.4.1 Exploded View
9-4
9.4.2 Parts List
S/N
P/N
Description
Qty
051-001780-01
EV20 control assembly(VGA&nurse call)
1
051-001779-01
EV20 control assembly(classic)
1
2
115-028051-00
Blower box FRU
1
3
115-020420-00
Inspiration valve
1
4
115-010077-00
CO2 Module Unit(M02C)
1
5
051-001555-00
EV20 Sensor Interface PCBA
1
6
082-001903-00
PTFE Syringe Filter 13mm 5.0µm
2
7
115-021480-00
O2 Mount of EV20
1
8
012-000018-00
SENSOR Flow Air 300slpm
1
9
M05-010R03---
Button cell Lithium 3V35mAh D12.5*2.0
1
10
051-000811-00
Cyberlink module PCBA
1
11
024-000188-00
Antenna 2400-2500MHz 2.15dBI
1
9-5
IPEX-II
1
9.5 Main Unit Bracket Assembly
9.5.1 Exploded View
9.5.2 Parts List
S/N
P/N
Description
Qty
1
051-001551-01
EV20 Battery Interface PCBA
2
2
041-010201-00
Case used for the post of EV20
2
051-001777-00
EV20 DC-DC power board PCBA(DC-IN)
1
051-001481-00
EV20 DC-DC power board PCBA（without DC-IN）
1
4
022-000163-00
POWER SUPPLY BOARD 18.8V 160W
1
5
0509-20-00098
Equipotential stud / lug
1
6
M07-00130F---
FUSE Time-lag 250V 3.15AD5X20
1
7
115-028052-00
Fan FRU
1
3
9-6
9.6 Main Unit Rear Housing Assembly
9.6.1 Exploded View
9.6.2 Parts List
S/N
P/N
Description
Qty
1
115-028050-00
Speaker FRU
1
2
043-004111-00
Fence for dustproof of EV20
1
043-004975-00
Cover of the CO2
043-005204-00
CO2 cover(mainstream CO2)(silkscreen)
043-005205-00
CO2 cover(sidestream CO2)(silkscreen)
043-005203-00
CO2 cover(SpO2)(silkscreen)
043-005206-00
CO2 cover(SpO2+mainstream
CO2)(silkscreen)
043-005207-00
CO2 cover(SpO2+sidestream
CO2)(silkscreen)
4
040-000119-00
Dryline receptacle Mindray 60-13510-01
1
5
9200-10-10591
Mounting Frame.DRYLINE,Flush
1
3
9-7
1(different
configuration
corresponds to
differed material）
9.7 O2 Inlet Assembly（NIST）
9.7.1 Exploded View
9.7.2 Parts List
S/N
P/N
Description
Qty
1
009-004173-00
EV20 O2 proportional value with cable
1
2
009-004174-00
EV20 Nebulizer value with cable
1
3
M6M-010069---
Seal, O ring 3X1.5 fluorine rubber black A50
2
4
049-000702-00
Filter net
1
5
012-000019-00
SENSOR Flow Oxygen 300slpm
1
6
115-011292-00
Main body of regulator
1
7
M6M-010032---
Seal, O ring 18X2.5 silicone red A50
1
8
0611-20-45600
Filter
1
9
M6Q-030107---
PP Panel mount hose barb PMCD160212
1
9-8
9.8 O2 Inlet Assembly（DISS）
9.8.1 Exploded View
9.8.2 Parts List
S/N
P/N
Description
Qty
1
009-004173-00
EV20 O2 proportional value with cable
1
2
009-004174-00
EV20 Nebulizer value with cable
1
3
M6M-010069---
Seal, O ring 3X1.5 fluorine rubber black A50
2
4
049-000702-00
Filter net
1
5
012-000019-00
SENSOR Flow Oxygen 300slpm
1
6
115-011292-00
Main body of regulator
1
7
M6M-010032---
Seal, O ring 18X2.5 silicone red A50
1
8
0611-20-45600
Filter
1
9
M6Q-030107---
Panel mount hose barb PMCD160212
1
9-9
9.9 Expiration Valve Assembly
9.9.1 Exploded View
9.9.2 Parts List
S/N
P/N
Description
Qty
1
024-000565-00
Voice coil motor
1
2
043-004013-00
Exp. valve seat
1
3
115-021461-00
Disinfectable exp. valve assembly
1
9-10
9.10 Safety Valve Assembly
9.10.1 Exploded View
9.10.2 Parts List
S/N
P/N
Description
Qty
1
115-021478-00
Detachable part of safety valve
1
9-11
9.11 Safety Valve Base Assembly
9.11.1 Exploded View
9.11.2 Parts List
S/N
P/N
Description
Qty
1
082-001510-00
O-RING. 36.17X2.62 Silicone, transparent, A50
1
2
024-000566-00
Electromagnet 12V 48Ohm 4.8mm
1
9-12
9.12 Safety Valve Detachable Part
9.12.1 Exploded View
9.12.2 Parts List
Note: The P/N of this assembly is 115-021478-00。
S/N
P/N
Description
Qty
1
043-005276-00
Safety valve main body (silkscreen)
1
2
049-000693-00
Membrane of check valve
1
3
082-000649-00
O-RING.25X1.8 Silicone, transparent, A50
1
4
043-004062-00
Body of check valve
1
5
082-000739-00
O-RING. 6.5X1.5 fluorine rubber black A75
1
6
049-000654-00
Membrane of safety valve
1
7
041-010186-00
Supporting of membrane
1
8
043-004061-00
Fixing nut of membrane
1
9
043-005277-00
Fixing nut of safety valve (silkscreen)
1
10
043-004059-00
Safety valve plug
1
11
082-000223-00
O-RING.29.87X1.78 Silicone, black, A60
2
9-13
9.13 Exp. Flow Sensor Sampling Seat Assembly
9.13.1 Exploded View
9.13.2 Parts List
S/N
P/N
Description
Qty
1
M90-100060---
O-RING. 6.5X1.5 fluorine rubber black A75
2
9-14
9.14 Disinfectable Expiration Valve Assembly
9.14.1 Exploded View
9.14.2 Parts List
Note: The P/N of this assembly is 115-021461-00。
S/N
P/N
Description
Qty
1
049-000778-01
Exp. valve membrane
1
2
049-000684-00
Exp. check valve
1
9-15
9.15 Blower Box Assembly
9.15.1 Exploded View
9.15.2 Parts List
S/N
P/N
Description
Qty
1
045-001333-01
HEPA filter
1
2
051-001556-00
EV20 negative pressure sensor PCBA
1
9-16
9.16 Inspiration Valve Assembly
9.16.1 Exploded View
9.16.2 Parts List
Note: The P/N of this assembly is 115-020420-00.
S/N
P/N
Description
Qty
1
024-000565-00
Voice coil motor
1
2
082-000223-00
O-RING.29.87X1.78 Silicone, black, A60
1
3
049-000700-00
Mesh cushion of insp. valve
1
4
082-001498-00
O-Ring 17.17X1.78 SIL A50 Crystal
1
9-17
9.17 Trolley Assembly
9.17.1 Exploded View
9.17.2 Parts List
S/N
P/N
Description
Qty
1
115-022676-00
EV2O trolley humidifier fixed assembly
1
2
115-022677-00
EV20 trolley gas cylinder fixed assembly
1
9-18
9.18 Trolley Handle Assembly
9.18.1 Exploded View
9.18.2 Parts List
S/N
P/N
Description
Qty
1
044-000454-00
EV20 trolley front handle
1
2
042-011007-00
EV20 trolley arm support
1
3
115-028057-00
Trolley rear handle FRU
1
9-19
9.19 Trolley Support Platform Assembly
9.19.1 Exploded View
9.19.2 Parts List
S/N
P/N
Description
Qty
1
115-022678-00
EV20 trolley push-button assembly
1
9-20
9.20 Trolley Base Assembly
9.20.1 Exploded View
9.20.2 Parts List
S/N
P/N
Description
Qty
1
0020-10-12509
Caster.4" white, with brakes (FRU)
4
2
115-028056-00
Trolley base cover FRU
1
9-21
9.21 Trolley Gas Cylinder Fixed Assembly
9.21.1 Exploded View
9.21.2 Parts List
S/N
P/N
Description
Qty
1
040-001966-00
EV20 trolley magic tape
1
9-22
A Mindray SV300/350 Preventive Maintenance
Report
Customer Name
Service Company
Service Date (YYYY/MM/DD)
A.1 Check before Preventive Maintenance
System Total Running
Time (hrs)
（Syst. info->Maintain）
S/N of Ventilator
Software Ver.
（Maintain->Servi
ce->Setup->Versio
ns）
Main Board Software
Items
Operations
Result
Data Export
Export log data from service
menu via USB stick.
□Yes
□No
System Self
Test
Check if machine pass all
system check items and record
leakage value
□Pass
（Leak
□Fail
Ventilation Check
Check if machine pass
ventilation test and no alarm
□Pass
□Fail
（Alarm
Check for any damage of the
appearance.
□Pass
Visual check
Ventilator Protection Module
Ventilator Control Module
A-1
）
□Fail
）
A.2 Preventive Maintenance
Items
Operations
Result
Parts Replacement (Chapter 5.2.1)
1
Expiration valve
membrane
Replace as required.
□Yes
□No
2
HEPA filter
Replace as required.
□Yes
□No
3
Fan dust filter
Replace as required.
□Yes
□No
4
PTFE Syringe Filter
13mm 5.0µm
Replace as required.
□Yes
□No
5
Touch screen
calibration (Operator’s
manual 11.7)
Calibrate successfully.
□Yes
□No
6
Zero
Calibrate successfully.
□Yes
□No
7
Flow calibration
(factory)
Calibrate successfully.
□Yes
□No
8
Pressure calibration
(factory)
Calibrate successfully.
□Yes
□No
9
O2 % calibration
(factory)
Calibrate successfully and
record the AD value.
□Yes
□No
(21% ______ 100% ______)
10
Air O2 calibration
Calibrate successfully.
□Yes
□No
11
Expiration valve
calibration (factory)
Calibrate successfully.
□Yes
□No
Calibrations (Chapter 5.3)
A-2
A.3 Test after Preventive Maintenance
A.3.1 System Self-Test
No.
Items
Result
Remarks
1
Blower test
□Pass
□Fail
2
O2 Flow Sensor Test
□Pass
□Fail
3
Total Flow Sensor Test
□Pass
□Fail
4
Exp. Flow Sensor Test
□Pass
□Fail
5
Pressure Sensor Test
□Pass
□Fail
6
Exp. Valve Test
□Pass
□Fail
7
Safety Valve Test
□Pass
□Fail
8
Leakage（mL/min）
9
Compliance（mL/cmH2O）
10
Circuit Resistance（cmH2O/L/s）
11
O2 Sensor Test
<300ml/min acceptable
□Pass
□Fail
A.3.2 Mechanical Ventilation Test (Chapter 5.1.2)
Ventilation
Mode
V-A/C
Groups
Settings
Measured Data
Result
1
TV
150 ml
TVi
□Pass
□Fail
2
TV
300 ml
TVi
□Pass
□Fail
3
TV
600 ml
TVi
□Pass
□Fail
4
TV
900 ml
TVi
□Pass
□Fail
△Pinsp
10 cmH2O
Ppeak
□Pass
□Fail
PEEP
OFF
PEEP
□Pass
□Fail
△Pinsp
15 cmH2O
Ppeak
□Pass
□Fail
PEEP
5 cmH2O
PEEP
□Pass
□Fail
△Pinsp
20 cmH2O
Ppeak
□Pass
□Fail
PEEP
8 cmH2O
PEEP
□Pass
□Fail
5
P-A/C
6
7
A-3
A.3.3 Zero Point Accuracy Test (Chapter 5.1.3)
Items
Sensor Name
1
Counts
Actual
Counts Range
Result
Total flow sensor
-0.5~1L/min
□Pass
□Fail
2
O2 flow sensor
-0.5~1L/min
□Pass
□Fail
3
Exp. Flow sensor
365~910
□Pass
□Fail
3
Insp. pressure
sensor
967~1875
□Pass
□Fail
4
Exp. Pressure
sensor
967~1875
□Pass
□Fail
A.3.4 Flow Sensor Accuracy Test (Chapter 5.1.4)
Items
Insp. Valve Settings
（L/min）
Total Flow
Sensor Data
Exp. Flow Sensor
Data
Result
Air
1
3±0.5
□Pass
□Fail
2
10±1
□Pass
□Fail
3
20±1
□Pass
□Fail
4
30±2
□Pass
□Fail
5
60±3
□Pass
□Fail
Items
O2 Proportional
Valve Settings
（L/min）
O2 Flow Sensor
Data
/
Result
High Pressure O2
1
3±0.5
/
□Pass
□Fail
2
10±1
/
□Pass
□Fail
3
20±1
/
□Pass
□Fail
4
30±2
/
□Pass
□Fail
5
60±3
/
□Pass
□Fail
A-4
A.3.5 Pressure Sensor Accuracy Test (Chapter 5.1.5)
Items
Exp. Valve
Settings
（cmH2O）
Benchmark
Device Data
Insp. Pressure
Sensor Data
Exp. Pressure
Sensor Data
Result
1
5±1
□Pass
□Fail
2
20±1
□Pass
□Fail
3
50±1
□Pass
□Fail
4
70±2
□Pass
□Fail
A.3.6 Electrical Safety Test (Chapter 3.9)
Items
Measured Data
Pass Criteria
Result
<=0.1
□Pass
□Fail
Normal status(uA)
<=500
□Pass
□Fail
Single Fault(uA)
<=1000
□Pass
□Fail
Protective Earth Resistance (Ω)
Earth Leakage
Current
A.4 Remarks
Engineer Signature：
Date：
A-5
FOR YOUR NOTES
A-6
PN：046-006348-00（3.0）