Mindray SV300, SV350 Service Manual

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.

 Rev

 Release time:

© Copyright 2

reserved.

ision number: 5.0

2

021-08

014-2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights

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

Test ............................................................................... 3-5

3.7.12 ftotal Too High Alarm

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 Func

tion 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 ............................................................................ 5-5

5.2 System Test ..................................................................................................................... 5-6

5.2.1 System Check ..................................................................................................... 5-7

5.2.2 Check the Mechanical Ventilation State ............................................................. 5-9

5.2.3 Check the Correctness of Sensor Zero Point ..................................................... 5-11

5.2.4 Check the Accuracy of Flow Sensor ................................................................ 5-12

5.2.5 Check the Accuracy of Pressure Sensor ........................................................... 5-13

5.3 System Calibration ........................................................................................................ 5-15

5.3.1 Flow Calibration (User) ................................................................................... 5-19

5.3.2 Flow Calibration (Factory) ............................................................................... 5-20

5.3.3 O2% Calibration (User) ................................................................................... 5-24

5.3.4 O2% Calibration (Factory) ............................................................................... 5-25

5.3.5 Mainstream CO2 Zeroing (User) ..................................................................... 5-26

5.3.6 Sidestream CO2 Zeroing (User) ....................................................................... 5-27

5.3.7 Sidestream CO2 Calibration (User) ................................................................. 5-27

5.3.8 Pressure and Flow Zeroing (User) ................................................................... 5-28

5.3.9 Pressure and Flow Zeroing (Factory) ............................................................... 5-29

5.3.10 Pressure Calibration (Factory) ....................................................................... 5-32

5.3.11 Expiratory Valve Calibration (Factory) .......................................................... 5-45

5.3.12 Air and O2 Calibration (Factory) ................................................................... 5-48

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 Pre

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

parations before Using the Valve Test Tool ................................................. 6-19

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&SV350 Ventilator Main Unit Assembly ............................................................. 9-1

9.1.1 Exploded View ................................................................................................... 9-1

9.1.2 Parts List ............................................................................................................ 9-1

9.2 Display Front Housing Assembly ................................................................................... 9-1

9.2.1 Exploded View ................................................................................................... 9-2

9.2.2 Parts List ............................................................................................................ 9-2

9.3 Kernel Assembly ............................................................................................................. 9-3

9.3.1 Exploded View ................................................................................................... 9-3

t ............................................................................................................ 9-3

9.3.2 Parts

9.4 Main Unit Bracket Assembly .......................................................................................... 9-4

9.4.1 Exploded View ................................................................................................... 9-4

Lis

5

9.4.2 Parts List ............................................................................................................ 9-4

9.5 Main Unit Rear Housing Assembly ................................................................................ 9-4

9.5.1 Exploded View ................................................................................................... 9-5

9.5.2 Parts List ............................................................................................................ 9-5

9.6 O2 Inlet Assembly（NIST） .......................................................................................... 9-5

9.6.1 Exploded View ................................................................................................... 9-6

9.6.2 Parts List ............................................................................................................ 9-6

9.7 Expiration Valve Assembly ............................................................................................. 9-7

9.7.1 Exploded View ................................................................................................... 9-7

9.7.2 Parts List ............................................................................................................ 9-7

9.8 Safety Valve Assembly .................................................................................................... 9-8

9.8.1 Exploded View ................................................................................................... 9-8

9.8.2 Parts List ............................................................................................................ 9-8

9.9 Safety Valve Detachable Part .......................................................................................... 9-8

9.9.1 Exploded View ................................................................................................... 9-9

9.9.2 Parts List ............................................................................................................ 9-9

9.10 Expiration Valve Detachable Part ............................................................................... 9-10

9.10.1 Exploded View ............................................................................................... 9-10

9.10.2 Parts List ........................................................................................................ 9-10

9.11 Blower Box Assembly .................................................................................................. 9-11

9.11.1 Exploded View ................................................................................................ 9-11

9.11.2 Parts List .......................................................................................................... 9-11

9.12 Trolley Assembly ........................................................................................................ 9-12

9.12.1 Exploded View ............................................................................................... 9-12

9.12.2 Parts List ........................................................................................................ 9-12

9.13 Trolley Handle Assembly ............................................................................................ 9-13

9.13.1 Exploded View ............................................................................................... 9-13

9.13.2 Parts List ........................................................................................................ 9-13

9.14 Trolley Support Platform Assembly ............................................................................ 9-14

9.14.1 Exploded View ............................................................................................... 9-14

9.14.2 Parts List ........................................................................................................ 9-14

9.15 Trolley Base Assembly ................................................................................................ 9-15

9.15.1 Exploded View ............................................................................................... 9-15

9.15.2 Parts List ........................................................................................................ 9-15

9.16 Others .......................................................................................................................... 9-16

A Mindray SV300/350 Preventive Maintenance Report .................................................. A-1

A.1 Check before Preventive Maintenance ........................................................................... A-1

A.2 Preventive Maintenance ................................................................................................. A-2

est after Preventive Maintenance ................................................................................. A-3

A.3 T

A.4 Remarks ......................................................................................................................... A-5

6

1 Safety

1.1 Safety Information

DANGER

 Indicates an imminent hazard that, if not avoided, will result in death or serious injury.

WARNING

 Indicates a potential hazard or unsafe practice that, if not avoided, could result in

death or serious injury.

CAUTION

 Indicates a potential hazard or unsafe practice that, if not avoided, could result in

minor personal injury or product/property damage.

NOTE

 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

 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.

 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.

 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.

 Use external power source (AC power or DC power) before the batteries are depleted.
 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.

 Do not place the ventilator adjacent to any barrier, which can prevent cold air from

flowing, resulting in equipment overheat.

 Do not open the equipment housings. All servicing and future upgrades must be

carried out by the personnel trained and authorized by us only.

 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.

 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.

 Dispose of the package material, observing the applicable waste control regulations

and keeping it out of children’s reach.

 All staff should be aware that disassembling or cleaning some parts of the ventilator

1-2

WARNING

can cause risk of infection.

 Maintenance mode can only be used when the equipment is disconnected from the

patient.

 Positive pressure breathing may be accompanied by some side effects such as

barotrauma, hypoventilation, hyperventilation etc.

 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.

 Do not use antistatic or conductive masks or breathing tubes. They can cause burns if

they are used near high frequency electrosurgical equipment.

 Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard due to

an oxygen-enriched environment.

 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.

 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.

 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.

 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.

 This equipment is not suitable for use in an MRI environment.

 When the ventilator gas supply input system fails or has faults, please contact us

immediately for specified personnel to service the ventilator.

 The ventilator shall not be used with helium or mixtures with Helium..

 Do not move the ventilator before removing the support arm from it, in order to avoid

the ventilator getting tilted during the movement.

 Do not block the air intake vent at the back of the ventilator.

 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

1-3

WARNING

necessary, verify the ventilator’s normal operation in the configuration in which it will

be used.

 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.

 To prevent possible equiment damage, avoid tipping over the ventilator when crossing

thresholds.

 To prevent possible equiment damage, step down the brake when parking the

ventilator.

 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.

 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.

 To prevent possible ventilator malfunction, do not spill liquid onto the ventilator.
 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.

 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.

 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.

 The ventilation accuracy can be affected by the gas added by use of a nebulizer.
 The ventilator shall not be used with nitric oxide.
 For non-invasive ventilation, the exhaled volume of the patient can differ from the

measured exhaled volume due to leaks around the mask.

 Check if the alarm limit settings are appropriate before taking measurement.
 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.

 No modification of this equipment is allowed.
 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.

 Stop using the ventilator and contact us immediately when the buzzer alarms.
 Under the ambient temperature of 40℃, the inspiratory pressure of the ventilator

exceeds 60cmH2O, and the maximum temperature on the surface of breathing mask

1-4

WARNING

may exceed 41℃ but does not exceed 43℃.

 When the ventilator is restalled, or main control board is repalced, perform flow

calibration (factory).

 Before the replacement of the main control board, please record the settings of the

service menu. After the replacement of the main control board, please restore the

settings of the service menu.

1.1.3 Cautions

CAUTION

 The ventilator must be inspected and serviced regularly by trained service personnel.

 To ensure patient safety, always prepare pulmotor for use.

 Always have a special person attend and monitor the operation of the equipment once

the ventilator is connected to the patient.

 During the operation of the ventilator, do not disassemble the inspiratory safety valve

and expiration valve unless in standby mode.

 To ensure patient safety, use only parts and accessories specified in this manual.

 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.

 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.

 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.

 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.

 Always install or carry the equipment properly to avoid damage caused by drop,

impact, strong vibration or other mechanical force.

 To electrically isolate the ventilator circuits from all poles of the supply mains

simultaneously, disconnect the mains plug.

1-5

CAUTION

 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.

 It is the clinician’s responsibility to ensure that all ventilator settings are appropriate.
 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.

 To prevent possible patient injury, make sure the ventilation parameters is set up

properly before ventilating the patient.

 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.

 A fan failure could result in oxygen enrichment inside the ventilator and a subsequent

fire hazard.

 To reduce the risk of explosion, do not burn the O2 cell or force the cell open.
 When ventilating with a mask, avoid high airway pressures. High pressures may cause

gastric distension.

 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.

 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.

 To reduce the risk of fire, ensure adequate ventilation at the rear of the ventilator.
 To reduce the risk of fire, switch off the oxygen source when the ventilator is not in a

ventilating mode.

 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.

 Use the original packing materials to ship the ventilator.
 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.

 The ventilator is intended to be used in the patient environment.
 Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be connected

to the system.

 Before the ventilator is used for transfer, make sure its casters and brakes are in good

condition.

1-6

1.1.4 Notes
NOTE

 Put the ventilator and its accessories in a location where you can easily see the screen

and access the operating controls.

 Keep this manual close to the equipment so that it can be obtained conveniently when

needed.

 The software was developed in compliance with IEC 62304. The possibility of hazards

arising from software errors is minimized.

 This manual describes all features and options. Your equipment may not have all of

them.

1.2 Equipment Symbols

Battery

AC/DC power

indicator light

RS-232 connector

VGA output

connector

Network connector

Power switch

Lock

Fuse

Direct current input

port

Nebulizer connector

Oxygen sensor

connector

USB connector

Nurse call connector

Unlock

High-pressure

oxygen supply

connector

Ventilator gas outlet

1-7

Low-pressure

oxygen supply

connector

Flow sensor

Expiration

connector

AUDIO PAUSED

Date of manufacture

Serial number IP21

Caution

no pushing

SpO2 module

Inspiration

connector

CO2 module

Manufacturer

Degree of protection

provided by

enclosure

Protective earth

ground

Refer to the

operator's manual

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.

Nebulizing

subsytem

Insp.
limb

Gas supply

subsystem

Blower and flow control

subsystem

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

O2

Low-Pressure

Inlet

O2

High-Pressure

Inlet

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

F3 Filter

REG Regulator

PSOL Proportional solenoid valve

Q1 O2 flow sensor Monitors O2 flow

Low-pressure Air inlet Air inlet

Low-pressure O2 inlet

High-pressure O2 inlet

O2 connector, quick connector, compatible

with (CPC) PMC series

O2 connector, NIST/DISS optional, supply gas

pressure is 2.8-6bar

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.

Filters foreign substance in the high-pressure

O2 supply

Reduces and stabilizes the pressure of

high-pressure O2 supply to 2.0±0.1bar

High-pressure O2 proportional valve, output
peak flow≥120 L/min@6bar

2-2

Symbol Name Function and Index

F4 Filter screen Stabilizes gas flow

SD1

Blower Turbo blower

Tblower Temperature sensor Monitors the blower temperature

SD2

Heat

Exchanger

Inspiratory

valve

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

SV Safety valve

F7 Filter for pressure sensor Protects the pressure sensor

SOL1

PI Inspiratory pressure sensor Monitors the pressure in the inspiratory limb

F8 Inspiratory filter

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

F9 Expiratory filter

Noise reduction and Air&O2

mixed chamber

Noise reduction and Air&O2

mixed chamber

Heat exchanger Heat dissipating device of the blower

Inspiratory valve Controls the flow in the inspiratory limb

Inspiratory pressure zeroing

three-way valve

Air&O2 mixed channel, reduces the front-end

noise of the blower subsystem

Mixes the Air and O2 and improves the

pressure of mixed gas to the preset value

Further mixes the Air and O2 and reduces the

rear-end noise of the blower subsystem

Prevents gas from flowing in the reverse

direction

Pressure relief and spontaneous inspiratory

channel

Performs switchover between inspiratory

pressure measurement and zeroing

Prevents water vapor and bacteria inside the

patient tube from entering the ventilator

internal pneumatic circuit

Device which turns nebulized liquid medicine

into gaseous colloidal particles

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

SOL2

Pressure zeroing three-way

valve

Protects upstream limb from being polluted by

the exhaled gas

Expiratory pressure sensor zeroing and

pressure zeroing in the upstream of expiratory

2-3

r

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

Filter

Humidifier

WT

Gas supply

Water trap

Humidifie

Regulator

On-off valve (two-position

two-way solenoid valve)

O2

Nebulizer

O2 sensor

Check valve

Nebulizer

Two-position three-way

solenoid valve

P

R

Q

Pressure sensor

Resistor

Flow sensor

Proportional solenoid valve

Temperature sensor

Vacuum sensor at the Air

inlet

Turbo blower

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

Exp. assembly

Gas supply subsystem

Insp. assembly

Turbo blower subsystem

Flow control subsystem

Patient tube

Safety valve subsystem

Nebulizing 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.

O2 proportional valve

Nebulizer switch valve

High-pressure O2

connector compatible

with NIST/DISS

Low-pressure O2 CPC

quick connector

Regulator

O2 flow sensor

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.

2-9

Nebulizing nozzle

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 [Replace HEPA filter] 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

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.

Encapsulated

filter screen

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 diaphragm

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.

Safety valve knob

Safety valve plug

Safety valve

dust-proof pad

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 machine is powered off inadvertently, 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.

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.

The expiratory valve (EV) is an electronically controlled valve. The expiratory valve closing

2-15

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

p

The component structure of expiration module is as shown below.

Voice coil motor

Sampling seat assembly

Patient gas outlet

Disinfectable expiratory

iratory valve seat

Ex

valve assembly

Expiratory check

valve open

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.

Expiratory check

valve closed

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

input port

board

DC - DC

signal port

board

DC - DC

output port

power supply

Fan

2-25

Debugging portSerial 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

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

Input signal AC-DC outputs to

DC-DC

Rated current is 8.8A

1 DC-IN+

2 DC-IN+ /

3 DC-IN-

4 DC-IN-

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

3 GND Ground /

4 GND Ground /

5 BAT1

6 GND Ground /

7 BAT1

8 GND Ground /

9 GND Ground /

10 GND Ground /

11 BAT1

12 GND Ground /

Positive terminal of external DC

input signal

Negative terminal of external

DC input signal

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

/

/

/

/

/

/

/

2-26

Pin No. Signal name Signal description Remark

13 GND Ground /

14 BAT1

15 BAT1_BC In-place signal of battery 1

16 SMBC1 I2C clock signal of battery 1

17 SMBC2

Positive terminal of battery 1

input signal

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

23 GND Ground

24 GND Ground

25 BAT1

26 GND Ground

27 BAT1

28 GND Ground

29 GND Ground

30 GND Ground

31 BAT1

32 GND Ground

33 GND Ground

34 BAT1

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

Positive terminal of battery 1

input signal

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

4 5VA

12V power supply of monitoring

module main board

5V power supply of VCM of

monitoring module main board

2-27

/

/

Pin No. Signal name Signal description Remark

5 5VB

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

5 BAT_LED

6 TXD

7 KEY_ONOFF Power-on/off control signal

8 GND Ground

9 POWER_EN

10 RXD

11 GND Ground

12 IO1 Backup

13 GND Ground

14 GND Ground

5V power supply of GUI of

monitoring module main board

Control signal of AC indicator

light

Control signal of battery

indicator light

Serial port signal of power

board transmitting to main

control board

Control power signal of main

control board

Serial port signal of power

board receiving from main

control board

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

/

2-28

Battery adapter board:

Battery output

Battery adapter board

Battery input port

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+

8 BAT+

9 GND Ground

10 GND Ground

Positive terminal of battery input

signal

Positive terminal of battery input

signal

/

/

/

/

/

/

/

/

/

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+

3 GND Ground

4 BAT+

5 GND Ground

6 BAT+

7 GND Ground

8 BAT+

9 GND Ground

10 BAT+

11 GND Ground

12 BAT+

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

Positive terminal of battery input

signal

Positive terminal of battery input

signal

Positive terminal of battery input

signal

Positive terminal of battery input

signal

Positive terminal of battery input

signal

Positive terminal of battery input

signal

/

/

/

/

/

/

/

/

/

/

/

/

/

/

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

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

Turbine failure indicator light D1

Turbine connector

External temp.
sensor connector

Exp. Voice
coil motor

O2 proportional
valve

Insp. Failure
indicator light D2

Nebulizing
valve

Vacuum
sensor

Parameter module
connector

EV20 monitoring module main board

VCM failure indicator light D4

Nurse call RS232&CAL Net USB VGA

Sensor adapter board
connector

Exp. Failure indicator light D3

Backup(SPO2)

Display connector

Wireless wifi

Speaker
connector

Power
supply
connector
(power
board)

Signal
connector
(power
board)

Button board connector

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

4 VCCB

5 VCCA

6 GND Ground

7 GND Ground

8 GND Ground

9 GND Ground /

10 GND Ground

12V power supply of monitoring

module main board

5V power supply of VCM of

monitoring module main board

5V power supply of GUI of

monitoring module main board

/

/

/

/

/

/

/

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

6 UART4_335X_RXD

7 PCON Power-on/off control signal

8 GND Ground

Control signal of battery indicator

light

Serial port signal of main

control board receiving from

power board

/

/

/

/

/

/

/

2-33

Pin No. Signal name Signal description Remark

9 POWER_EN

10 UART4_335X_TXD

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

7

8

9 NC No internal connection /

10 GND Ground /

11 NC No internal connection /

12 NC No internal connection /

13 LCD_HS

14 LCD_VS

15 NC No internal connection /

GND

GND

GND

Control power signal of main

control board

Serial port signal of main

control board transmitting to

power board

Ground /

Ground /

Ground /

Horizontal synchronization signal

of external display

Vertical synchronization signal of

external display

/

/

/

/

/

/

/

/

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+

2 TX-

3 RX+

4 GND Ground /

5 GND Ground /

6 RX-

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+

4 GND Ground /

Main control network transmitting

signal+

Main control network transmitting

signal-

Main control network receiving

signal+

Main control network receiving

signal-

Gas supply pressure switch signal,

reserved

/

/

/

/

Not used

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

4 GND Ground /

5 AMBIENT_SCL_INSP

J21 is CO2 module connector. It is defined as follows:

Pin No. Signal name Signal description Remark

1 EX_5V_TXA Extension serial port transmitting

2 RS232_RXD Extension serial port receiving

3 GND Ground /

4 GND Ground /

5 EX_5V_RXA Extension serial port receiving

6 RS232_TXD Extension serial port transmitting

7 GND Ground /

8 VCCAC

9 VCCAC

10 PWR12V

11 GND Ground /

12 PWR12V CO2 module power supply, 12V /

Data line for vacuum sensor I2C

connector

Clock line for vacuum sensor I2C

connector

Mainstream CO2 module power

supply, 5V

Mainstream CO2 module power

supply, 5V

Sidestream CO2 module power

supply,12V

/

/

Communicate with the

sidestream CO2

module

Communicate with the

mainstream CO2

module

Communicate with the

sidestream CO2

module

Communicate with the

mainstream CO2

module

/

/

/

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-

7 PWR12V

8 LVDS_0+

9 PWR12V

10 GND Ground /

11 PWR12V

12 LVDS_1-

13 PWR12V

14 LVDS_1+

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-

25 PWM1

26 LVDS_2+

LVDS DIFFERENTIAL DATA

LINE0-

Display backlight power supply,

12V

LVDS DIFFERENTIAL DATA

LINE0+

Display backlight power supply,

12V

Display backlight power supply,

12V

LVDS DIFFERENTIAL DATA

LINE1-

Display backlight power supply,

12V

LVDS DIFFERENTIAL DATA

LINE1+

LVDS DIFFERENTIAL DATA

LINE2-

Backlight brightness adjustment

signal

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-

31 BACKLIGHT_EN Display backlight enabled /

32 LVDS_3+

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 /

LVDS DIFFERENTIAL DATA

LINE3-

LVDS DIFFERENTIAL DATA

LINE3+

/

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

7 GND Ground /

8 UART2_335X_RXD

9 AC_LED AC indicator light /

10 BAT_LED Battery indicator light /

11 PCON Power-on signal /

12 GND Ground /

Button board communication serial

port, main control transmitting

Button board communication serial

port, main control receiving

/

/

2-38

J30 is the O2 proportional valve connector. It is defined as follows:

Pin No. Signal name Signal description Remark

1 O2_Valve+

2 O2_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

Positive terminal of O2

proportional valve

Negative terminal of O2

proportional valve

/

/

/

/

/

/

/

/

/

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+

J31 is the connector for proportional valve. It is defined as follows:

Pin No. Signal name Signal description Remark

1 Insp_Valve+

2 Insp_Valve+

3 / / Suspended

4 Insp_Valve-

The other terminal of temperature

sensor

Positive terminal of inspiration

proportional valve

Positive terminal of inspiration

proportional valve

Negative terminal of inspiration

proportional valve

No positive and

negative terminals are

differentiated.

/

/

/

2-39

Pin No. Signal name Signal description Remark

5 Insp_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+

2 Exp_Valve+

3 NC / Suspended

4 Exp_Valve-

5 Exp_Valve-

6 GND Ground /

7 GND Ground /

Negative terminal of inspiration

proportional valve

Positive terminal of expiration

proportional valve

Positive terminal of expiration

proportional valve

Negative terminal of expiration

proportional valve

Negative terminal of expiration

proportional valve

/

/

/

/

/

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-

6 3Way_Purge_2_Exp-

7 3Way_Zero_1_Exp-

8 3Way_Zero_2_Exp-

9 VCCBL Power supply 5V

10 3Way_Zero_Insp-

11 VCCBL Power supply 5V

Control signal of expiratory

purging 3-way valve 1

Control signal of expiratory

purging 3-way valve 2

Control signal of expiratory zeroing

3-way valve 1

Control signal of expiratory zeroing

3-way valve 2

Control signal of inspiratory

zeroing 3-way valve

/

/

/

/

/

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

18 O2_TSI_SDA Data signal of O2 TSI sensor /

19 GND Ground /

20 INSP_TSI_SDA

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

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

40 TEMP_INSP_TSI

41 GND Ground Fix pad pin

42 GND Ground Fix pad pin

Clock signal of mixed gas TSI

sensor

Data signal of mixed gas TSI

sensor

Temperature signal of O2 TSI

sensor

Flow signal of mixed gas TSI

sensor

Temperature signal of mixed gas

TSI sensor

/

/

/

/

/

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

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 /

Temperature signal of mixed gas TSI

sensor

/

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-

32 VCCBL Power supply 5V

33 3Way_Zero_2_Exp-

34 3Way_Zero_1_Exp-

35 3Way_Purge_2_Exp-

36 3Way_Purge_1_Exp-

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

Control signal of inspiratory zeroing

3-way valve

Control signal of expiratory zeroing

3-way valve 2

Control signal of expiratory zeroing

3-way valve 1

Control signal of expiratory purging

3-way valve 2

Control signal of expiratory purging

3-way valve 1

/

未用

/

/

/

J1 is connector for O2 concentration sensor. It is defined as follows:

Pin No. Signal name Signal description Remark

1 O2_SENSOR+

2 O2_SENSOR-

Positive terminal of O2

concentration 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

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

Temperature signal of O2 TSI

sensor

/

/

/

/

/

/

1 INSP_FLOW_TSI

2 INSP_TEMP_TSI

3 GND Ground

4 INSP_SCL_I2C_TSI

5 INSP_SDA_I2C_TSI

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-

Flow signal of mixed gas TSI

sensor

Temperature signal of mixed

gas TSI sensor

Clock signal of mixed gas TSI

sensor

Data signal of mixed gas TSI

sensor

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

2 GND Ground /

3 AMBIENT_SDA_INSP

4 GND Ground /

5 AMBIENT_SCL_INSP

Vacuum sensor power supply,

3.3V

Data line of vacuum sensor I2C

connector

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:

Power-on/off button

Power-on/off

backlight

AC and BAT indicator lights

Encoder

connector

Alarm light

connector

Monitoring module

main board connector

Button control board

Touchscreen input port

Alarm silence button

Alarm silence indicator light

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

Provide power supply for

1 VPP 12V power supply

alarm light and alarm

silence indicator light

Provide power supply for

2 VCC 5V power supply

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

3 VPP 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

J4 is the connector between button control board and encoder board. It is defined as follows:

Control signal of yellow alarm

light

/

/

Alarm light 12V power

supply

/

/

/

Encoder power supply

5.0V

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

 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

 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. 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.

2. Depress the power switch to turn on the ventilator.

3. 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.

4. 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.

5. 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. Connect the O2 pipeline supply.

2. Connect the test lungs.

3. Depress the system switch to turn on the ventilator.

4. 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.

5. Make sure that the ventilator ventilates normally.

6. Disconnect the O2 pipeline supply.

7. As O2 pressure decreases, the high level alarm [O2 Supply Failure] is triggered.

3.4 System Test

1. 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.

2. 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.

3. 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.

4. 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].

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5. 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

6. Make sure that all the [Syst. Check] items pass the test.

3.5 Spontaneous Breathing Test

1. Turn off the ventilator and let the ventilator in OFF state. Wear a mask, and check if the

spontaneous breathing is smooth.

2. 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. Connect test lungs to the Y piece patient connection.

2. Turn on the ventilator. Select [New Adult] in standby mode. Set ventilation type to

[Invasive].

3. 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. Connect the ventilator to AC power and depress the hardkey.

2. Disconnect the AC power after the system starts up.

3. Verify that the [Battery in Use] alarm is activated and the ventilator is powered by the

battery.

4. Re-connect the AC power.

5. Verify that this alarm is automatically reset and the ventilator is AC powered.

3-3

3.7.3 Power Failure Alarm Test

1. Connect the AC power and depress the hardkey to start up the ventilator.

2. Disconnect the AC power after the battery is fully charged.

3. Connect the test lungs to let the ventilator keep normal ventilation.

4. 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.

5. 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. Squeeze the test lungs forcibly in the inspiration phase.

4. 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. After the ventilator system starts up normally, connect the ventilator to the test lungs and

set to pressure mode to start ventilation.

2. Set TVe high alarm limit to be less than the current TVe to verify that the [TVe Too

High] alarm is activated.

3. 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. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

2. Set TVe low alarm limit to be greater than the current TVe to verify that the [TVe Too

Low] alarm is activated

3. 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. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

2. Set MV high alarm limit to be less than the current MV to verify that the [MV Too

High] alarm is activated.

3. Set MV high alarm limit to be greater than the current MV to verify that this alarm is

automatically reset.

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3.7.8 MV Too Low Alarm Test

1. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

2. Set MV low alarm limit to be greater than the current MV to verify that the [MV Too

Low] alarm is activated.

3. 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. Remove the expiratory valve diaphragm of the ventilator and install the expiratory

valve.

2. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

3. Set PEEP to 5cmH2O. Verify that the [PEEP Too Low] alarm is activated.

4. Re-install the expiratory valve diaphragm and install the expiratory valve.

5. Repeat steps 2 and 3. Verify that this alarm is automatically reset.

3.7.10 Airway Obstructed Alarm Test

1. After the ventilator system starts up normally, connect the ventilator to the test lungs and

set to pressure mode to start ventilation.

2. Nip the inspiration tube with the hands. Make sure the monitoring value of TVi is lower

than 10 ml.

3. After several breathing cycles, verify that the [Airway Obstructed?] alarm is activated.

4. Loosen the inspiration tube and verify that this alarm is automatically reset.

3.7.11 Apnea Alarm Test

1. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

2. Set apnea alarm time to 15s.

3. Set breathing frequency to 3bpm. Verify that the [Apnea] alarm is activated.

4. Set breathing frequency to 10bpm. Verify that this alarm is automatically reset.

3.7.12 ftotal Too High Alarm Test

1. After the ventilator system starts up normally, connect the ventilator to the test lungs to

start ventilation.

2. Set ftotal high alarm limit to be less than the current ftotal. Verify that the [ftotal Too

High] alarm is activated.

3. Set ftotal high alarm limit to be greater than the current ftotal. Verify that this alarm is

automatically reset.

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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. 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].

2. Connect the ventilator to the test lungs to start ventilation.

3. After ventilation is stable, turn off high-pressure O2 supply.

4. Verify that the [FiO2 Too Low] alarm is activated.

5. Re-connect high-pressure O2 supply. Verify that this alarm is automatically reset.

3.7.15 EtCO2 Too High Alarm Test

1. Connect the CO2 test module. Set CO2 module to working mode.

2. Connect the ventilator to the test lungs to start ventilation.

3. After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to

sidestream CO2.

4. 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.

5. Verify that the [EtCO2 Too High] alarm is activated.

6. 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. Connect the ventilator to the test lungs to start ventilation.

2. Connect the CO2 test module. Set CO2 module to working mode.

3. After CO2 completes warm-up and enters working mode, vent 3%-7% standard CO2 to

sidestream CO2.

4. 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.

5. Verify that the [EtCO2 Too Low] alarm is activated.

6. Set EtCO2 low alarm limit to be less than the standard gas concentration. Verify that

this alarm is automatically reset.

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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.

4. Verify that the [SpO2 Too High] alarm is activated.

5. Set the SpO2 high alarm limit to 100%. Verify that this alarm is automatically reset.

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.

4. 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.

5. Stop pressing the pulse and set the SpO2 low alarm limit to 90%. Verify that this alarm

is automatically reset.

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.

4. Verify that the [PR Too High] alarm is activated.

5. Set the PR high alarm limit to 120 L/min. Verify that this alarm is automatically reset.

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.

4. Verify that the [PR Too Low] alarm is activated.

5. Set the PR low alarm limit to 40 L/min. Verify that this alarm is automatically reset.

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. 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

icon

2. 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.

flashes in the information bar of the screen.

3.8.4 Checking Spontaneous Breathing in CPAP/PSV Mode

1. Set the ventilator to CPAP/PSV mode, flow trigger to 2 L/min, pressure support level to

10 cmH

2. Wear a mask and inspire slightly. When the trigger sensitivity is reached, make sure that

inspiration starts and that the ventilator starts PSV ventilation.

O, and other parameters to their default values.

2

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%, cylinder with N2 as balance gas
 T -connector
 Gas tube
 Flowmeter

1. Make sure that the sidestream CO2 module has already been warmed up or started.

2. 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.

6. Enter 6% (CO2 concentration value) in the [CO

2%] text box in the [CO2 In

Maintenance] menu.

7. 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.

3-9

3.8.6 Mainstream CO2 Test

Test tools:

 CO2 with concentration of 6±0.05%, cylinder with N2 as balance gas
 Cylinder wtih 100% N2
 T -connector
 Gas tube
 Flowmeter

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].

3. 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].

4. Connect the test system as shown below.

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.

7. Switch the cylinders connected with the T-connector at a time interval of 6-10s. Check

that the CO2 displayed value is 45±2mmHg.

3-10

3.8.7 SpO2 Test

1. Connect the adult SpO2 sensor to the ventilator SpO2 connector. Set the ventilator

patient type to [New Adult].

2. Measure SpO2 at your finger (supposing you are in healthy state).

3. Check that the ventilator displays SpO2 Pleth waveform and PR value. And the

displayed SpO2 range should be 95-100%.

4. 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. 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.

2. 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.

2. Release the [Exp. Hold] key, and make sure the ventilator enters inspiration phase.

 O2 Enrichment

1. When the ventilator is in working state, select Adult mode and press the [O

button. Make sure that the ventilator starts to deliver 100% O2.

2. 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

1. Press the [O

the first phase; namely, O2 enrichment is active.

2. 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.

3. Re-connect the patient. Make sure that suction enters the third phase; namely, O2

enrichment is active.

 Nebulizer

1. 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.

↑ Suction] button to enter suction function. Make sure that suction enters

2

↑ Suction]

2

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.

3. Select [Ok]. Make sure that the ventilator activates sigh function once every minute and

that sigh is effective within continuous 3 ventilation cycles..

key. Set [Sigh] to [ON].

3.9 Electrical Safety Inspection

NOTE

 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. 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.

2. Perform the following earth leakage current tests:

 normal polarity;
 reverse polarity;
 normal polarity with open neutral; and
 reverse polarity with open neutral.

3. 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

 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 Pass/Fail Limit

1 Protective Earth Resistance Ω Max.：0.1 Ω

Normal
condition(NC)

2

Earth
Leakage

Single Fault
condition(SFC)

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.

____μA

Max.：
NC：500μA
SFC：1000μA

____μA

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

 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.

 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.

 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).

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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.

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4.2.2.2 Setup

The following table lists the setting items and their descriptions.

Setting item Description

Update

Correction Mode Can be set to ATPD and BTPS.

Apnea Reset Can be set to ON and OFF.

Hide The Focus

Hide The Menu

Custom Parameter

Altitude

Altitude Unit Set altitude unit, including two options: m and ft.

CO2 Type

Blower Life Span Set blower life span.

Clear Blower Running

Time

I:E

Can be set to ON and OFF, to switch on or off the USB memory

update function.

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.

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.

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.

Set altitude. When the atmospheric pressure sensor is faulty, the

atmospheric pressure can be calculated based on altitude.

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.

Click this button after replacing the blower to clear the blower

running time. Running time information is displayed next to the

button.

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.

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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

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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 Position Power-on initialization item

Nebulizer Nebulizer Time

P-V Tools Pstart

P-V Tools Pmax

Procedure

Service

Screen

Layout

P-V Tools Flow

P-V Tools Vlimit

P-V Tools History Loop

P-V Tools Reference Loop

Calibration-Pressure

Calibration

Calibration-Exp. Valve Calibration Reference

Setup Correction Mode

Setup Update

Setup Custom Parameter

Screen Layout Waveforms

Calibration Device

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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

Service

Date and time setting items: neither being initialized nor being kept unchanged; displayed

following the ascending rules for time and date.

Diagnosis O2 Insp. valve

Diagnosis O2 Insp. valve

Diagnosis Exp. valve

Diagnosis Exp. valve

Diagnosis Nebulizer valve

Diagnosis Safety valve

Diagnosis Activation code/USB

Module Position Date and time setting items

Time setting

Time and date Date

Time and date Time

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4.2.2.5 Version Information

In [Ver si o ns ] menu, you can view the version information of the software currently used by

each module.

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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.

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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.

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4.2.5 Data Monitoring

The data monitor menu provides the following functions: VCM data monitoring, VPM data

monitoring, and power board data monitoring.

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4.2.6 Diagnosis Test

Diagnosis test provides valve test device. For details, refer to 6.6Diagnostic Test.

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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

Error

Information

Maintenance

Information

All Events Display all events.

Display all operation events only.

Display all error events only (only available in factory event

logbook and not available in user event logbook).

Include maintenance operation such as zeroing and

calibration, and selftest operation (only available in factory

event logbook and not available in user event logbook).

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4.3 Software Upgrade and Software Function

Activation

CAUTION

 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

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CAUTION

 Before software upgrade, disconnect the ventilator from the patient and back up the

important data.

NOTE

 Make sure that the version of the upgrade package is the desired one. To obtain the

latest upgrade package, please contact us.

 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

 Before upgrading any software, make sure that the network cable, Hub, and notebook

computer are connected correctly and reliably.

 The recommended length of the network cable is not greater than 1 m.

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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

 Switching off or powering off the equipment during booting software upgrade can

cause system down.

NOTE

 When selecting the upgrade package, make sure that the checksum and software

version are same to that provided by the factory.

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