Mindray SV600 User manual

SV600

Ventilator

Operator’s Manual

© 2017-2018 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is December, 2018.

I

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

,andare the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

II

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product, only if:

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

the electrical installation of the relevant room complies with the applicable national and local requirements; and

the product is used in accordance with the instructions for use.

WARNING

It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.

NOTE

This equipment must be operated by skilled/trained clinical professionals.

III

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

Malfunction or damage caused by improper use or man-made failure.

Malfunction or damage caused by unstable or out-of-range power input.

Malfunction or damage caused by force majeure such as fire and earthquake.

Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

Malfunction of the instrument or part whose serial number is not legible enough.

Others not caused by instrument or part itself.

IV

Customer Service Department

Manufacturer:	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:	Mindray Building, Keji 12th Road South, High-tech industrial
	park, Nanshan, Shenzhen 518057, P.R. China
Website:	www.mindray.com
E-mail Address:	[e-mail]
Tel:	[phone]
Fax:	[phone]
EC-Representative:	Shanghai International Holding Corp. GmbH (Europe)
Address:	Eiffestraβe 80, 20537 Hamburg, GERMANY
Tel:	0049-40-2513175
Fax:	0049-40-255726

V

Preface

Manual Purpose

This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.

This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us.

This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.

Intended Audience

This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.

Illustrations

All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your ventilator.

Conventions

Italic text is used in this manual to quote the referenced chapters or sections.

[ ] is used to enclose screen texts.

→ is used to indicate operational procedures.

Password

A password is required to access different menus within the ventilator.

System menu: 1234

VI

Table of Contents

1 Safety.................................................................................................................................		1-1
1.1	Safety Information ..........................................................................................................	1-1
	1.1.1 DANGER ...........................................................................................................	1-2
	1.1.2 WARNING.........................................................................................................	1-2
	1.1.3 CAUTION..........................................................................................................	1-6
	1.1.4 NOTE .................................................................................................................	1-8
1.2	Equipment Symbols ........................................................................................................	1-8

2 The Basics .........................................................................................................................		2-1
2.1	System Description .........................................................................................................	2-1
	2.1.1 Intended Use.......................................................................................................	2-1
	2.1.2 Contraindications ...............................................................................................	2-1
	2.1.3 Components .......................................................................................................	2-1
2.2	Equipment Appearance ...................................................................................................	2-2
	2.2.1 Front View..........................................................................................................	2-2
	2.2.2 Rear View...........................................................................................................	2-4
	2.2.3 Air Compressor ..................................................................................................	2-6

3 Installations and Connections .........................................................................................		3-1
3.1	Connect the Power Supply ..............................................................................................	3-1
3.2	Connect the Pipeline Supply ...........................................................................................	3-2
3.3	Install the Gas Cylinder...................................................................................................	3-4
3.4	Install the Support Arm ...................................................................................................	3-5
3.5	Install the Patient Tubing ................................................................................................	3-7
	3.5.1 Install Adult/Pediatric Tubing ............................................................................	3-8
	3.5.2 Install Neonate Tubing .......................................................................................	3-9
3.6	Install the Humidifier .....................................................................................................	3-11
	3.6.1 Install the Humidifier onto the Ventilator..........................................................	3-11
	3.6.2 Install the Humidifier onto the Pendant ...........................................................	3-13
3.7	Install the Nebulizer ......................................................................................................	3-14
	3.7.1 Install Pneumatic Nebulizer .............................................................................	3-15
	3.7.2 Install Electronic Nebulizer..............................................................................	3-16
3.8	Install the Oxygen Sensor .............................................................................................	3-17
	3.8.1 O2 Cell..............................................................................................................	3-17
	3.8.2 Paramagnetic O2 Sensor...................................................................................	3-18
3.9	Install Module ...............................................................................................................	3-19

4 User Interface ...................................................................................................................	4-1
4.1 Display Controls .............................................................................................................	4-1
4.2 Waveforms Screen...........................................................................................................	4-5
	1

	4.2.1	Graphic trend ......................................................................................................	4-6
	4.2.2 PulmoSight.........................................................................................................		4-6
4.3	Spirometry Screen...........................................................................................................		4-7
4.4	Measured Values Screen................................................................................................		4-10
4.5	Big Numeric Interface...................................................................................................		4-10
4.6	History	............................................................................................................................	4-11
	4.6.1 Graphic Trend....................................................................................................		4-11
	4.6.2 ...................................................................................................Tabular Trend		4-13
	4.6.3 ...................................................................................................Setting Trends		4-14
	4.6.4 .................................................................................................Event Logbook		4-15
4.7	Freeze............................................................................................................................		4-16
	4.7.1 ...........................................................................................Enter Freeze Status		4-16
	4.7.2 ..................................................................................View Frozen Waveforms		4-16
	4.7.3 ............................................................................................View Frozen Loop		4-17
	4.7.4 .............................................................................................Exit Freeze Status		4-17
4.8	Screen Capture ..............................................................................................................		4-18
4.9	Lock Screen...................................................................................................................		4-18
5 System Settings.................................................................................................................			5-1
5.1	Date & ......................................................................................................Time Settings		5-1
5.2	Export to .................................................................................................................USB		5-1
	5.2.1 .....................................................................................................Export Screen		5-1
	5.2.2 ........................................................................................................Export Data		5-1
	5.2.3 .................................................................................................Transfer Settings		5-2
5.3	Basic Settings..................................................................................................................		5-3
	5.3.1 ...........................................................................................Set Flow/Tpause(%)		5-3
	5.3.2 .......................................................................................................Set Tinsp/I:E		5-3
	5.3.3 ..................................................................................................Set IBW/Height		5-3
	5.3.4 .......................................................................................................Set TV/IBW		5-4
	5.3.5 ..................................................................................................Setup DuoLevel		5-4
	5.3.6 ...................................................................................Set Invasive Apnea Mode		5-4
	5.3.7 ............................................................Set O2% increment during O2↑ period		5-4
	5.3.8 ..........................................................................Set Oxygen Sensor Monitoring		5-5
5.4	Screen Settings................................................................................................................		5-6
	5.4.1 ...................................................................................Adjust Screen Brightness		5-6
	5.4.2 ............................................................................................Adjust Key Volume		5-6
	5.4.3 .......................................................................................................Screen Setup		5-6
	5.4.4 .....................................................................................................Color Settings		5-7
5.5	System ...............................................................................................................Settings		5-8
	5.5.1 ......................................................................................................Set Language		5-8
	5.5.2 ..............................................................................................................Set Unit		5-8
	5.5.3 .............................................................................Set Minimum Alarm Volume		5-8
	5.5.4 ..................................................................................................Default Settings		5-9
	5.5.5 ..................................................................................................Set Nurse Call		5-10
		2

	5.5.6 Set Network......................................................................................................	5-10
	5.5.7 View System Information.................................................................................	5-10
5.6	Set Tool Shortcut Key ....................................................................................................	5-11
5.7	Set Gas Supply ...............................................................................................................	5-11
5.8	Factory Service Settings.................................................................................................	5-11
6 Start Ventilation................................................................................................................		6-1
6.1	Turn on the System .........................................................................................................	6-1
6.2	System Check..................................................................................................................	6-1
6.3	Circuit Test ......................................................................................................................	6-3
6.4	Select Patient...................................................................................................................	6-5
	6.4.1 Set Patient Information on the Ventilator ...........................................................	6-5
	6.4.2 Getting Patient Information from the ADT Server.............................................	6-5
6.5	Ventilation Type ..............................................................................................................	6-6
	6.5.1 Invasive Ventilation............................................................................................	6-6
	6.5.2 Non-Invasive Ventilation (NIV).........................................................................	6-7
	6.5.3 Set Ventilation Type ...........................................................................................	6-7
6.6	Ventilation Mode.............................................................................................................	6-8
	6.6.1 Ventilation Mode and Parameter Setup ..............................................................	6-8
	6.6.2 V-A/C ...............................................................................................................	6-10
	6.6.3 P-A/C ................................................................................................................	6-11
	6.6.4 V-SIMV............................................................................................................	6-12
	6.6.5 P-SIMV ............................................................................................................	6-13
	6.6.6 CPAP/PSV........................................................................................................	6-14
	6.6.7 PSV-S/T............................................................................................................	6-16
	6.6.8 PRVC................................................................................................................	6-17
	6.6.9 PRVC-SIMV ....................................................................................................	6-18
	6.6.10 DuoLevel........................................................................................................	6-20
	6.6.11 APRV..............................................................................................................	6-21
	6.6.12 VS...................................................................................................................	6-22
	6.6.13 AMV...............................................................................................................	6-23
	6.6.14 CPRV..............................................................................................................	6-25
	6.6.15 nCPAP ............................................................................................................	6-26
	6.6.16 Apnea Ventilation ...........................................................................................	6-27
6.7	Other Ventilation Settings .............................................................................................	6-28
	6.7.1 Sigh ..................................................................................................................	6-28
	6.7.2 Leak Compensation..........................................................................................	6-29
	6.7.3 Automatic Tube Resistance Compensation (ATRC) ........................................	6-31
	6.7.4 IntelliCycle.......................................................................................................	6-32
6.8 Alarm settings ...............................................................................................................		6-32
6.9	Start Ventilation.............................................................................................................	6-32
6.10 Ventilation Parameters.................................................................................................		6-33
6.11 Enter Standby Status ...................................................................................................		6-37
6.12 Turn the System off.....................................................................................................		6-37
	3

7 Neonatal Ventilation.........................................................................................................		7-1
7.1	Safety Information ..........................................................................................................	7-1
7.2	Connecting Patient Tubing to the Flow Sensor...............................................................	7-2
7.3	Circuit Test ......................................................................................................................	7-2
7.4	Start Ventilation...............................................................................................................	7-2
7.5	Backup Ventilation ..........................................................................................................	7-3
7.6	Set the Monitoring Switch ..............................................................................................	7-3
7.7	Neonatal Flow Sensor Zeroing........................................................................................	7-3

8 CO2 Monitoring................................................................................................................	8-1
8.1 Introduction.....................................................................................................................	8-1
8.2 CO2 Module ....................................................................................................................	8-4
8.3 Sidestream CO2 Module..................................................................................................	8-5
8.3.1 Preparation for Measurement .............................................................................	8-5
8.3.2 Make CO2 Settings.............................................................................................	8-6
8.3.3 Measurement Limitations...................................................................................	8-8
8.3.4 Troubleshooting..................................................................................................	8-8
8.3.5 Zero the Sensor ..................................................................................................	8-8
8.3.6 Calibrate the Sensor ...........................................................................................	8-8
8.4 Mainstream CO2 module.................................................................................................	8-9
8.4.1 Preparation for Measurement .............................................................................	8-9
8.4.2 Make CO2 Settings...........................................................................................	8-10
8.4.3 Measurement Limitations..................................................................................	8-11
8.4.4 Zero the Sensor .................................................................................................	8-11
8.4.5 Calibrate the Sensor .........................................................................................	8-12

9 SpO2 Monitoring ..............................................................................................................		9-1
9.1	Introduction.....................................................................................................................	9-1
9.2	Safety Information ..........................................................................................................	9-2
9.3 Applying the Sensor ........................................................................................................		9-3
9.4	Make SpO2 Settings ........................................................................................................	9-3
	9.4.1 Set SpO2 Monitoring ..........................................................................................	9-3
	9.4.2 Set Sensitivity.....................................................................................................	9-3
	9.4.3 Beat Volume .......................................................................................................	9-3
	9.4.4 Set CO2 Waveform .............................................................................................	9-3
9.5	Measurement Limitations................................................................................................	9-4

10 Special Functions..........................................................................................................		10-1
10.1	Manual Breath.............................................................................................................	10-1
10.2	Expiration Hold...........................................................................................................	10-1
10.3	Inspiration Hold ..........................................................................................................	10-2
10.4	Nebulizer.....................................................................................................................	10-2
	10.4.1 Pneumatic Nebulizer ......................................................................................	10-3
	10.4.2 Electronic Nebulizer.......................................................................................	10-3
		4

10.5 O2↑(Oxygen Enrichment)..........................................................................................	10-4
10.6 Suction ........................................................................................................................	10-5
10.7 P0.1 .............................................................................................................................	10-6
10.8 PEEPi ..........................................................................................................................	10-6
10.9 NIF ..............................................................................................................................	10-7
10.10 Calculation of Alveolar Ventilation...........................................................................	10-7
10.11 P-V Tool ....................................................................................................................	10-8
10.12 Recruitment Tool SI .........................................................................................	10-10
10.12.1 History.........................................................................................................	10-11
10.13 Weaning Tools..........................................................................................................	10-11
10.13.1 Help Information Viewing..........................................................................	10-12
10.13.2 Spontaneous Breathing Trial (SBT) ...........................................................	10-12
10.13.3 History........................................................................................................	10-13
10.14 O2 Therapy ..............................................................................................................	10-14
10.14.1 Preparing for O2 Therapy ...........................................................................	10-14
10.14.2 Switching on O2 Therapy ...........................................................................	10-17
10.14.3 O2 Therapy Timing/Timer ..........................................................................	10-18
10.14.4 Switching off O2 Therapy...........................................................................	10-18
11 Alarms ............................................................................................................................	11-1
11.1 Introduction ..................................................................................................................	11-1
11.2 Alarm Categories..........................................................................................................	11-2
11.3 Alarm Priority Levels ...................................................................................................	11-2
11.4 Alarm Signals ...............................................................................................................	11-2
11.4.1 Alarm Lamp.....................................................................................................	11-3
11.4.2 Audible Alarm .................................................................................................	11-3
11.4.3 Alarm Messages ..............................................................................................	11-3
11.4.4 Flashing Alarm Numeric .................................................................................	11-3
11.4.5 Alarm Status Symbol.......................................................................................	11-4
11.5 Alarm Volume Settings.................................................................................................	11-4
11.6 Set Alarm Limits ..........................................................................................................	11-5
11.6.1 Auto Alarm Limits...........................................................................................	11-5
11.7 AUDIO PAUSED .........................................................................................................	11-6
11.7.1 Set AUDIO PAUSED ......................................................................................	11-6
11.7.2 Terminate AUDIO PAUSED ...........................................................................	11-6
11.8 Current Alarm...............................................................................................................	11-7
11.9 Alarm Chain .................................................................................................................	11-8
11.10 Recent Alarm..............................................................................................................	11-8
11.11 ALARM OFF .............................................................................................................	11-9
11.12 Alarm Tests...............................................................................................................	11-10
11.12.1 Battery in Use..............................................................................................	11-10
11.12.2 Loss of Power..............................................................................................	11-10
11.12.3 Paw Too High..............................................................................................	11-10
11.12.4 Paw Too Low...............................................................................................	11-11
5

	11.12.5 TVe Too Low...............................................................................................	11-11
	11.12.6 TVe Too High ..............................................................................................	11-11
	11.12.7 MV Too Low ...............................................................................................	11-11
	11.12.8 Air Supply Pressure Low.............................................................................	11-11
	11.12.9 O2 Supply Pressure Low..............................................................................	11-12
	11.12.10 PEEP Too Low ..........................................................................................	11-12
	11.12.11 Airway Obstructed.....................................................................................	11-12
	11.12.12 FiO2 Too High ...........................................................................................	11-12
	11.12.13 FiO2 Too Low............................................................................................	11-13
	11.12.14 EtCO2 Too High ........................................................................................	11-13
	11.12.15 EtCO2 Too Low .........................................................................................	11-13
	11.12.16 SpO2 Too High ..........................................................................................	11-13
	11.12.17 SpO2 Too Low ...........................................................................................	11-14
	11.12.18 SpO2 Desat ................................................................................................	11-14
	11.12.19 PR Too High..............................................................................................	11-14
	11.12.20 PR Too LOW.............................................................................................	11-14
11.13 Nurse Call.................................................................................................................		11-15
11.14 When an Alarm Occurs ............................................................................................		11-16
12 Cleaning and Disinfection............................................................................................		12-1
12.1	Methods for Cleaning and Disinfection ......................................................................	12-2
12.2	Disassemble the Ventilator’s Cleanable and Disinfectable Parts ................................	12-5
	12.2.1 Expiration Valve Assembly and Membrane ...................................................	12-5
	12.2.2 Inspiration safety valve assembly ..................................................................	12-7
	12.2.3 HEPA Filter Components and Air Intake Dust Filter ...................................	12-10
	12.2.4 Back air supply cooling fan dust filter .........................................................	12-12
	12.2.5 Main Unit Air Outlet Dust Filter ..................................................................	12-13
	12.2.6 Patient Tubing ..............................................................................................	12-14
	12.2.7 Humidifier....................................................................................................	12-16
	12.2.8 Nebulizer......................................................................................................	12-19
	12.2.9 Mainstream CO2 Module .............................................................................	12-22
13 Maintenance .................................................................................................................		13-1
13.1	Repair Policy...............................................................................................................	13-1
13.2	Maintenance Schedule ................................................................................................	13-2
13.3 View Preventive Maintenance Items...........................................................................		13-4
13.4	Pressure and Flow Zeroing..........................................................................................	13-5
13.5	Neonatal Flow Sensor Zeroing....................................................................................	13-5
13.6	Flow Calibration .........................................................................................................	13-6
13.7	O2% Calibration ..........................................................................................................	13-7
13.8	CO2 Calibration...........................................................................................................	13-8
	13.8.1 Sidestream CO2 Module.................................................................................	13-8
	13.8.2 Mainstream CO2 Module ...............................................................................	13-9
13.9 Touch Screen Calibration ............................................................................................		13-9
	6

13.10 Battery Maintenance .................................................................................................		13-9
	13.10.1 Battery Guidelines.......................................................................................	13-11
	13.10.2 Battery Performance Conditioning..............................................................	13-11
	13.10.3 Battery Performance Checking ..................................................................	13-12
	13.10.4 Battery Storage...........................................................................................	13-12
	13.10.5 Battery Recycling.......................................................................................	13-13
13.11 Electrical Safety Inspection.....................................................................................		13-13
13.12 Water Build-up in the Flow Sensor .........................................................................		13-15
	13.12.1 Prevent Water Build-up ..............................................................................	13-15
	13.12.2 Clear Water Build-up..................................................................................	13-15
14 Accessories ....................................................................................................................		14-1
A Theory of Operation.......................................................................................................		A-1
A.1 Pneumatic Circuit Principle ..........................................................................................		A-1
	A.1.1 Pneumatic Circuit Diagram..............................................................................	A-1
	A.1.2 Parts List...........................................................................................................	A-2
	A.1.3 Definition of Symbols ......................................................................................	A-3
	A.1.4 Pneumatic System Overview............................................................................	A-4
A.2 Electrical System...........................................................................................................		A-7
	A.2.1 Electrical System Structure Diagram ...............................................................	A-7
	A.2.2 Parts List...........................................................................................................	A-8
B Product Specifications.....................................................................................................		B-1
B.1	Safety Specifications ......................................................................................................	B-1
B.2	Environmental Specifications.........................................................................................	B-2
B.3	Power Requirements.......................................................................................................	B-3
B.4	Physical Specifications...................................................................................................	B-4
B.5	Pneumatic System Specifications...................................................................................	B-5
B.6	Ventilator Specifications.................................................................................................	B-7
B.7	Ventilator Accuracy ......................................................................................................	B-10
B.8 Alarm............................................................................................................................		B-12
	B.8.1 Settable Alarms................................................................................................	B-12
	B.8.2 Internal Alarms ................................................................................................	B-13
B.9	Special Function ...........................................................................................................	B-13
B.10 CO2 Module Specifications ........................................................................................		B-14
	B.10.1 Sidestream CO2 Module ................................................................................	B-14
	B.10.2 Mainstream CO2 Module...............................................................................	B-15
B.11 SpO2 Module Specifications.......................................................................................		B-16
B.12 Air Compressor Specification.....................................................................................		B-18
B.13 Backup Air Supply .....................................................................................................		B-18
C EMC ................................................................................................................................		C-1

7

D Alarm Messages..............................................................................................................	D-1
D.1 Physiological Alarm Messages......................................................................................	D-1
D.1.1 Ventilator Parameters .......................................................................................	D-1
D.1.2 CO2 Module......................................................................................................	D-2
D.1.3 SpO2 Module....................................................................................................	D-3
D.2 Technical Alarm Messages............................................................................................	D-4
D.2.1 Power Board.....................................................................................................	D-4
D.2.2 Main Control Board .........................................................................................	D-5
D.2.3 Monitor Board ..................................................................................................	D-5
D.2.4 CO2 Module......................................................................................................	D-9
D.2.5 SpO2 Module..................................................................................................	D-10
D.2.6 Neo. Module....................................................................................................	D-11

E Factory Defaults ..............................................................................................................		E-1
E.1 Ventilation Parameters ....................................................................................................		E-1
E.2	Setup ...............................................................................................................................	E-2
E.3	SystemSettings................................................................................................................	E-3
E.4 Alarms.............................................................................................................................		E-3
E.5	History ............................................................................................................................	E-4
E.6	Special Functions............................................................................................................	E-4
E.7	O2 Therapy......................................................................................................................	E-5
E.8 CO2 Module....................................................................................................................		E-6
E.9 SpO2 Module ..................................................................................................................		E-6
E.10 Other .............................................................................................................................		E-6

F Symbols and Abbreviations.............................................................................................		F-1
F.1	Unit..................................................................................................................................	F-1
F.2	Symbols...........................................................................................................................	F-2
F.3 Abbreviations ..................................................................................................................		F-2

8

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 and/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 DANGER

There are no dangers that refer to the product in general.

1.1.2 WARNING

WARNING

The ventilator must only be operated and used by authorized medical personnel well trained in the use of this product. Any unauthorized or untrained personnel should not perform any operations. 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. In this case, lithium ion batteries should be used temporarily to supply power to the equipment.

Use external power source (AC 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 case of the equipment, as you may suffer an electric shock. All servicing and future upgrades must be carried out by the personnel trained and authorized by us only.

Users should set alarm volume and alarm limits based on patients’ actual condition. 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. Always keep the patient under close surveillance.

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.

To dispose of the package material, observe the applicable waste control regulations. And keep the package material out of children’s reach.

All staff should be aware that disassembling or cleaning some parts of the ventilator can cause risk of infection.

1-2

WARNING

Maintenance menu can only be accessed when the equipment is disconnected from the patient.

Positive pressure ventilation may be accompanied by some side effects such as barotrauma, hypoventilation, hyperventilation, etc.

Using high frequency electrosurgery equipment, defibrillators, or short-wave treatment equipment in the vicinity of the ventilator may interfere with its operation and pose a risk of patient injury.

Do not use antistatic or conductive masks or patient tubing. They can cause burns if they are used near high frequency electrosurgery equipment.

Do not use the ventilator in a hyperbaric chamber.

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 patient’s proper 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 to 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 O2 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’s gas supply input system fails or has faults, please contact us immediately for service by specified personnel.

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.

The oxygen and air gas mixer of the ventilator is without grease and thus no de-grease process is needed. Do not use lubricants that contain oil or grease, and rubber hose assembly should not be contaminated with grease. Lubricants will burn or explode when exposed to high O2 concentrations.

1-3

WARNING

The maximum pressure of hose is 1.4MPa@21 and please check whether gas supply pressure meets hose requirements before usage.

Hose connectors adopt standardized gas terminal connector with gas nature. Different types of gas and gas with different pressures shall not be exchanged with each other.

Hose may be aging quickly by long-term exposure to acidity, alkalinity or ultraviolet rays.

Don’t cascade two or more hose assemblies together.

The ventilator arm could bear 1kg maximally and don’t hang over 1kg goods.

After the ventilator is installed or the main control board is replaced, the altitude must be reset. After resetting the altitude value, please perform flow calibration (factory).

When disconnecting fast connectors, please operate by two hands to prevent potential injury caused by sudden pressure release.

Do not block the air intake on the side of the ventilator.

To prevent interrupted operation of the ventilator due to electromagnetic interference, avoid using the ventilator adjacent to or stack with other device. If adjacent or stacked use is necessary, verify the ventilator’s normal operation in the configuration in which it will be used.

To prevent possible personal injury and equipment damage, ensure that the ventilator is secured to the trolley or placed on the safe and smooth surface.

To prevent possible equipment damage, avoid tipping over the ventilator when crossing thresholds.

To prevent possible equipment damage, push the brake down when parking the ventilator.

Avoid the use of polluted air. When the equipment uses air as gas source for ventilation, if the air is polluted, harmful substance may enter the patient tubing.

To prevent patient injury caused by equipment 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.

Backup air supply could cause gas to be heated. To reduce the temperature of gas inside the tubing and prevent patient injury accordingly, ensure that the length of patient tubing from the humidifier to Y piece is greater than 1.2m.

The internal electrical power source is to be used temporarily if the integrity of the protective earth conductor or the protective grounding system in the installation is in doubt.

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WARNING

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.

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

When operating the unit with the power supply unit, always connect the unit to an easily accessible outlet so that it can be unplugged quickly in the event of a malfunction.

No modification of this equipment is allowed.

Stop using the ventilator and contact us immediately when the buzzer sounds.

Please place cables of neonatal flow sensor correctly, to avoid patients from becoming entangled or unplanned extubation.

System leakage, such as leakage caused by an uncuffed endotracheal tube, may influence airflow readings, including airflow parameters, pressure, dead space, and CO2 production.

When ventilator is connected to patient, do not remove or replace fuse, or perform any other maintenance tasks. Such tasks must be performed when the patient is not using the ventilator.

Please ensure that the AC power cord is disconnected before removing or replacing the fuse.

HAZARD can exist if different ALARM PRESETS are used for the same or similar equipment in any single area. Please read the manual and confirm the correct alarm pre-settings for the ventilator before using it.

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1.1.3 CAUTION

CAUTION

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

To ensure patient safety, always prepare resuscitator 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 inspiration safety valve and expiration valve unless in standby status.

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, ensure 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 dropping down, impact, strong vibration or other mechanical force.

Check whether the repetitive patient tubing is damaged or leaked before usage. If so, don’t use such tubing.

To electrically isolate the ventilator circuits from all poles of the supply mains simultaneously, disconnect the mains plug.

To minimize the risk of fire, do not use supply hose assembly that is 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, ensure the ventilator is set up for appropriate patient type with the appropriate patient tubing. Ensure that the System Check or

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CAUTION

tubing check is performed before each patient.

Perform Flow Sensor Calibration before the first use, or when the measured values have deviations.

To prevent possible patient injury, ensure the ventilation parameters are set up properly before ventilating the patient.

To ensure the accuracy of oxygen monitoring, replace an exhausted O2 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 force the chemical O2 cell open or place it close to a source of heat.

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 gastric insufflation when the ventilation type is non-invasive. 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 environment may damage or shorten the battery lives of internal battery and O2 cell.

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 as the existing fuses. When it is necessary to replace fuses, contact the Customer Service Department.

The ventilator is suitable for use within the PATIENT ENVIRONMENT.

Additional MULTIPLE SOCKETOUTLET or extension cord shall not be connected to the system.

Before moving the ventilator, ensure that the casters and brakes can work properly, and the main unit is locked on the trolley.

Please use dry and clean medical compressed air and oxygen as gas supply. Water in gas supply can cause equipment malfunction.

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1.1.4 NOTE

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.

When the oxygen supply is insufficient, the ventilator will automatically switch to air supply. When the air supply is insufficient, the ventilator will automatically switch to oxygen supply.

The ventilator is equipped with barometric pressure sensors, and has the function of barometric pressure compensation.

1.2Equipment Symbols

	AUDIO PAUSED		ALARM OFF
	Recent Alarm		Clear alarm
	Alarm settings		O2↑key
	Nebulizer		Tools key
	Setup		Standby key
	Preventive		Screen Capture
	maintenance

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History

Backup Air Supply

Freeze

Invasive Ventilation

Inspiratory trigger

Non-Invasive

icon

Ventilation

Adult (male)

Adult (female)

Pediatric (male)

Pediatric (female)

Adjust screen

Neonate

brightness/volume to

night mode

Adjust screen

Start O2 therapy timer

brightness/volume to

day mode

Stop O2 therapy timer

Reset O2 therapy

timer

Caution

Equipotentiality

Fuse

Protective earth

ground

Battery LED

AC power

RS-232 connector

VGA output

connector

USB connector

Network connector

Display connector

Nurse call connector

Oxygen sensor

Pneumatic nebulizer

connector

connector

Lock

Unlock

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	Power switch	Neonatal flow sensor
		connector
	Expiration connector	Inspiration connector
	Oxygen supply	Air supply connector
	connector
	Date of manufacture	Manufacturer
	Serial number	European community
		representative
	Keep dry	Temperature
		limitation
	Humidity limitation	Atmospheric pressure
		limitation
	This way up	Fragile, handle with
		care
	Recyclable	Stacking limit by
		number
	Degree of protection	Not suitable for use
IP21	against harmful	in an MRI
	ingress of water	environment
	High Efficiency
	Particle Air (HEPA)	Water trap indicator
	installation instruction
	Refer to the operator's	Ventilator gas outlet
	manual
	Defibrillation-proof	DEFIBRILLATION-
		PROOF TYPE CF
	BF application part
		APPLIED PART
	1-10

Reset the paramagnetic oxygen sensor (NOTE: This operation can be performed only by the Customer Service Department or authorized personnel.)

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 fulfills the essential requirements of Annex I of this directive.

Unified circulation mark indicates that products marked them passed all specified in the technical regulations of the Customs Union of the procedure for the assessment (confirmation) of conformity and complies with the requirements applicable to all the products technical regulations of the Customs Union.

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FOR YOUR NOTES

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2 The Basics

2.1 System Description

2.1.1 Intended Use

This product is intended to be used in intensive care situations within a professional healthcare facility, or during transport within a professional healthcare facility. This product is intended to provide ventilation assistance and breathing support for adult, paediatric and neonate patients. The product should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

2.1.2 Contraindications

There are no absolute contraindications for this product. For some special diseases, however, some necessary treatments shall be taken for ventilator mechanical ventilation, or special ventilation modes shall be adopted to prevent possible patient injury.

2.1.3 Components

The ventilator consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), backup air supply, air compressor (model: C3), trolley, and support arm.

The ventilator is suitable for use within the PATIENT ENVIRONMENT. Connect the patient to the ventilator via the patient breathing circuit. The applied part of the ventilator is breathing masks.

2-1

2.2 Equipment Appearance

2.2.1 Front View

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5

4

3

2

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