Northern Meditec Crius V6 User manual

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Crius V6 Ventilator
Operator’s Manual

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© 2015-2017 ShenZhen Northern Meditec Co., Ltd.All rights Reserved. For this
Operator’s Manual, the issue date is Aug,2017.

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Intellectual Property Statement
The user manual and the corresponding products of intellectual property belongs to Shenzhen
Northern Meditec Co., Ltd. (hereinafter referred to as "Northern").
The User’s Manual contains exclusive data under the protection of law of copyright. All rights
reserved. Any individual or organization must not reproduce, amend or translate the any part of
the User’s Manual without prior written approval from our company.
However, Northerndoes not take any responsibilities by the error of User Manual or the actual
performance resulting from incidental or consequential damages cause by the user
manual.Northern promise not to offer concessions to other parties conferred by patent law.
Legal consequences for violation of patent law and the rights of any third party caused,
Northern does not take legal responsibility.

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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. Northern 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.
Northern 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 Northern 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.
\

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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.
In accordance with the conditions of storage and use, from the date of the factory 2 years, the
ventilator can not work properly, the company free of charge for the user repair, replacement
parts or products.
The design life of the ventilator is 10 years (batteries, folding bags and air bags and other
accessories are not included).
Exemptions
Northern'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 Northern or repairs by people other than Northern 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.

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Customer Service Department
Manufacturer: Shenzhen Northern Meditec Co., Ltd.
Address: Floor 4, Block C, Gold Power Industry Park, julongshan, Grand
industrial Zone, Pingshan New District, Shenzhen(518102), P.R.China
Website: www.northernmeditec.com
E-mail Address: [e-mail]
Tel: [phone]
Fax: [phone]
EC-Representative: Obelis S.A.
Address: Bd. General Wahis 53, 1030 Brussels, Belgium
Website: http://www.obelis.net
E-mail Address: [e-mail]
Tel: [phone]
Fax: [phone]

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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.
Factory Setting: 112358
Alarm Vol:8888

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Table of Contents
Chapter 1 Safety.......................................................................................................................16
1.1 SafetyInformation................................................................................................................16
1.1.1 Dangers ...................................................................................................................17
1.1.2 Warnings.................................................................................................................17
1.1.3 Cautions ..................................................................................................................19
1.1.4 Notes 21
1.2 Equipment Symbols .............................................................................................................21
1.3 Symbols and Abbreviations .................................................................................................23
1.3.1 Unit 23
1.3.2 Symbols...................................................................................................................23
1.3.3 Abbreviations..........................................................................................................24
Chapter 2 The Basics...............................................................................................................27
2.1.System Description ..............................................................................................................27
2.1.1 Intended Use ...........................................................................................................27
2.1.2 Contraindications ....................................................................................................27
2.1.3 Components ............................................................................................................27
2.2.Equipment Appearance........................................................................................................28
2.2.1 Front View ..............................................................................................................28
2.2.2 Rear View ...............................................................................................................30
Chapter 3 Installations and Connections...............................................................................33
3.1 Install the Main Unit.............................................................................................................33
3.2 Connect to the Power Supply...............................................................................................34
3.2.1 Connect to AC Power..............................................................................................34
3.3 Connect to the Gas Supply...................................................................................................35
3.4 Install the Support Arm........................................................................................................37
3.5 Install the Patient Tubing.....................................................................................................38
3.6 Install the Humidifier...........................................................................................................40
3.6.1 Install the Humidifier onto the Ventilator...............................................................40
3.7 Install the Nebulizer.............................................................................................................41
3.8 Install the O2 Sensor............................................................................................................43
Chapter 4 User Interface.........................................................................................................45
4.1 Display Controls ..................................................................................................................45
4.2 Syst.Check Screen................................................................................................................46
4.3 StandBy Screen....................................................................................................................47

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4.4 User Screen..........................................................................................................................47
4.5 Measured Values Screen......................................................................................................49
4.6 History Data.........................................................................................................................50
4.6.1 Tabular Trend..........................................................................................................50
4.6.2 Graphic Trend.........................................................................................................51
4.6.3 Event Log................................................................................................................53
4.7 Big Font Screen....................................................................................................................54
4.8 Big Loop Screen...................................................................................................................54
4.9 Freeze 55
4.8.1 Enter freeze status...................................................................................................55
4.8.2 Exit freeze status.....................................................................................................55
4.10Lock Screen.........................................................................................................................55
Chapter 5 System Settings.......................................................................................................57
5.1 Display Settings....................................................................................................................57
5.1.1 Interface ..................................................................................................................57
5.1.2 Waveforms..............................................................................................................57
5.2 Set Unit ................................................................................................................................57
5.12.1 Set Pressure Unit...........................................................................................57
5.12.2 Set Paw Unit .................................................................................................57
5.3 IBW/Height..........................................................................................................................57
5.4 Adjust ScreenBrightness .....................................................................................................58
5.5 Set Date and Time................................................................................................................58
5.6 Adjust Alarm Volume..........................................................................................................58
5.7 Adjust Alarm delay..............................................................................................................58
5.8 Screen Calibration................................................................................................................58
5.9 Defaults................................................................................................................................58
5.10Set Language.......................................................................................................................58
5.11Set 100%O2 Active Time ...................................................................................................59
5.12Set Protect Board Switch.....................................................................................................59
5.13Set Mexico Logo Switch.....................................................................................................59
5.14Module setup.......................................................................................................................59
5.12.1 Set CO2 module............................................................................................59
5.15Set CO2 Mode.....................................................................................................................59
5.14.1 Setting the working status.............................................................................59
5.14.2 Set CO2 Units...............................................................................................59
5.14.3 Set O2 compensation ....................................................................................60
5.14.4 Set N2O compensation .................................................................................60
5.14.5 Set CO2 suffocation......................................................................................60
5.16Select mode Calibration......................................................................................................60
5.17Set Mode Parameter............................................................................................................60
5.17.1 Set Pmax.......................................................................................................60
5.17.2 Set PEEP.......................................................................................................61
5.17.3 Set Vt ............................................................................................................61

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5.17.4 Set Psupp ......................................................................................................61
5.17.5 Set Pinsp .......................................................................................................61
5.17.6 Set Tinsp.......................................................................................................62
5.17.7 Set Rate.........................................................................................................62
5.17.8 Set Texp........................................................................................................62
5.17.9 Set Trigger ....................................................................................................63
5.17.10 Set Tslope .....................................................................................................63
5.17.11 Set Exp% ......................................................................................................63
5.17.12 Set Tpause.....................................................................................................64
5.17.13 Set I:E ...........................................................................................................64
5.17.14 Set Phigh.......................................................................................................64
5.17.15 Set Plow........................................................................................................64
5.17.16 Set Thigh.......................................................................................................65
5.17.17 Set Tlow........................................................................................................65
5.18Manage Default Settings.....................................................................................................65
5.18.1 Restore Factory Default Settings ..................................................................66
5.19View System Information ...................................................................................................66
5.19.1 Version Information......................................................................................66
5.19.2 Configuration Information............................................................................66
5.19.3 Maintenance Information..............................................................................66
Chapter 6 Ventilation ..............................................................................................................67
6.1 Turn on the System ..............................................................................................................67
6.2 System Check.......................................................................................................................67
6.3 Select Patient........................................................................................................................68
6.4 Ventilation Type ..................................................................................................................69
6.4.1 Invasive Ventilation................................................................................................69
6.4.2 Non-invasive Ventilation (NIV)..............................................................................69
6.4.3 Set Ventilation Type ...............................................................................................70
6.5 Ventilation Mode .................................................................................................................70
6.5.1 Ventilation Mode and Parameter Setup...................................................................70
6.5.2 Apnea Ventilation ...................................................................................................71
6.5.3 VC-ACV .................................................................................................................71
6.5.4 PC-ACV..................................................................................................................73
6.5.5 PVC-ACV...............................................................................................................74
6.5.6 VC-SIMV................................................................................................................76
6.5.7 PC-SIMV ................................................................................................................77
6.5.8 PVC-SIMV..............................................................................................................78
6.5.9 PC-Dual PAP ..........................................................................................................80
6.5.10 PC-APRV..............................................................................................................81
6.5.11 CPAP/PSV............................................................................................................82
6.5.12 CPAP-VG .............................................................................................................83
6.6 Set Alarm Limits..................................................................................................................83
6.7 Start Ventilation...................................................................................................................84

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6.8 Ventilation Parameters.........................................................................................................84
6.9 Enter Standby Status............................................................................................................87
6.10Turn the System off.............................................................................................................87
Chapter 7 CO2 Monitoring.....................................................................................................89
7.1 Summary..............................................................................................................................89
7.2 Monitoring ways ..................................................................................................................89
7.2.1 Main stream.............................................................................................................89
7.2.2 Side stream..............................................................................................................90
7.2.3 Set CO2...................................................................................................................91
7.3 Mainstream CO2 module.....................................................................................................91
7.3.1 Installation...............................................................................................................91
7.3.2 Checking before using.............................................................................................93
7.3.3 Affectingfactors of monitoring................................................................................93
7.3.4 Monitor calibration..................................................................................................94
7.3.5 Module LED status information..............................................................................94
7.3.6 Module cleanliness..................................................................................................95
7.4 Sidestream CO2 module ......................................................................................................95
7.4.1 Installation...............................................................................................................95
7.4.2 Checking before using.............................................................................................96
7.4.3 Affecting factors of monitoring...............................................................................97
7.4.4 Module calibration..................................................................................................98
7.4.5 Module LED status information..............................................................................98
7.4.6 Module cleanliness..................................................................................................98
7.5 Compensation.......................................................................................................................99
7.6 About Masimo......................................................................................................................99
Chapter 8 SpO2 (optional)....................................................................................................101
8.1 Overview...........................................................................................................................101
8.2 Safety Information...........................................................................................................101
8.3 Monitoring Steps..............................................................................................................102
8.4 Display102
8.5 Setting SpO2.....................................................................................................................103
8.5.1 Setting Wave Speed.............................................................................................103
10.5.1Setting Wave Mode............................................................................................103
10.5.2 Setting Average Time........................................................................................103
8.6 Measuring Influencing Factors.......................................................................................104
8.7 Alarm Setup......................................................................................................................104
Chapter 9 Special Functions .................................................................................................105
9.1 Manual Breath....................................................................................................................105
9.2 Expiration Hold..................................................................................................................105
9.3 Inspiration Hold .................................................................................................................105
9.4 Nebulizer............................................................................................................................106

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9.5 100%O2 (O2 enrichment)..................................................................................................106
9.6 P0.1………….. ..................................................................................................................107
9.7 O2 Therapy ........................................................................................................................107
9.7.1 Switching on O2 Therapy .....................................................................................108
9.7.3 O2 Therapy Timer.................................................................................................108
9.7.4 Switching off O2 Therapy ....................................................................................109
Chapter 10 Alarms.................................................................................................................110
10.1Summary...........................................................................................................................110
10.1.1 Alarm type ..................................................................................................110
10.1.2 Alarm level .................................................................................................111
10.2Alarm mode.......................................................................................................................111
10.2.1 Light alarm..................................................................................................111
10.2.2 Audible alarm .............................................................................................111
10.2.3 Alarm information ......................................................................................112
10.2.4 Parameters scintillation...............................................................................113
10.2.5 Alarm Audio Pause.....................................................................................113
10.2.6 Cancellation of Alarm Audio Pause............................................................113
10.3Flashing Alarm Numeric...................................................................................................113
10.4Set Alarm Volume.............................................................................................................113
10.5Set Alarm Limits...............................................................................................................113
10.6Alarm Tests.......................................................................................................................114
10.6.1 Loss of Power .............................................................................................114
10.6.2 Paw Too High.............................................................................................114
10.6.3 Paw Too Low..............................................................................................115
10.6.4 VTi mand Too Low ....................................................................................115
10.6.5 VTi mand Too High....................................................................................115
10.6.6 MVe Too High............................................................................................115
10.6.7 MVe Too Low ............................................................................................115
10.6.8 O2 Supply Failure.......................................................................................115
10.6.9 PEEP Too High...........................................................................................116
10.6.10 PEEP Too Low ...........................................................................................116
10.6.11 Rtotal Too High..........................................................................................116
10.6.12 Rtotal Too Low...........................................................................................116
10.6.13 Airway Obstructed......................................................................................116
10.6.14 FiO2 Too High............................................................................................116
10.6.15 FiO2 Too Low ............................................................................................117
10.6.16 EtCO2 Too High.........................................................................................117
10.6.17 EtCO2 Too Low..........................................................................................117
10.6.18 FiCO2 Too High.........................................................................................117
10.6.19 awRR Too High..........................................................................................118
10.6.20 awRR Too Low...........................................................................................118
10.6.21 SPO2 Too High...........................................................................................118
10.6.22 SPO2 Too Low ...........................................................................................118

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10.6.23 PR Too High...............................................................................................118
10.6.24 PRToo Low.................................................................................................119
10.7When an Alarm Occurs.....................................................................................................119
10.8Alarm information table....................................................................................................120
10.8.1 Physiological alarm.....................................................................................120
10.8.2 Technical alarm...........................................................................................122
Chapter 11Cleaning and Disinfection...................................................................................126
11.1Methods for Cleaning and Disinfection ............................................................................127
11.2Disassemble the Ventilator’s Cleanable and Disinfectable Parts......................................129
11.2.1 Expiration Valve Assembly and Membrane...............................................129
11.2.2 Inspiration Safety Valve Assembly ............................................................130
11.2.3 High Efficiency Particle Air (HEPA) Filter Assembly and Dust Filter......132
11.2.4 Patient Tubing.............................................................................................133
11.2.5 Nebulizer.....................................................................................................134
11.2.6 Humidifier...................................................................................................136
11.2.7 Mainstream CO2 Sensor.............................................................................138
Chapter 12 Maintenance.......................................................................................................139
12.1Repair Policy.....................................................................................................................139
12.2Maintenance Schedule.......................................................................................................139
12.3Pressure and Flow Zeroing................................................................................................141
12.4Flow Calibration................................................................................................................141
12.5Oxygen Concentration Calibration....................................................................................142
12.6CO2 Calibration ................................................................................................................143
12.7Touch Screen Calibration..................................................................................................143
12.8Battery Maintenance .........................................................................................................144
12.8.1 Battery Performance Conditioning .............................................................145
12.8.2 Battery Performance Checking...................................................................146
12.8.3 Battery Storage ...........................................................................................146
12.8.4 Battery Recycling .......................................................................................147
12.9Electrical Safety Inspection...............................................................................................147
12.10Water Build-up in the Flow Sensor.................................................................................148
12.10.1 Prevent Water Build-up ..............................................................................148
12.10.2 Clear Water Build-up..................................................................................148
Chapter 13 Accessories..........................................................................................................150
Chapter 14 Theory of Operation ..........................................................................................152
14.1Pneumatic System.............................................................................................................152
14.1.1 Pneumatic Circuit Diagram.........................................................................152
14.1.2 Parts List.....................................................................................................152
14.1.3 Theory.........................................................................................................153

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Chapter 15 Product Specifications .......................................................................................157
15.1Environmental Specifications ...........................................................................................157
15.2Safety Specifications.........................................................................................................157
15.3Power Requirements .........................................................................................................158
15.4Physical Specifications......................................................................................................159
15.5Pneumatic System Specifications......................................................................................160
15.6Ventilator Specifications...................................................................................................162
15.7Special Functions ..............................................................................................................165
15.8CO2 Module Specifications..............................................................................................166
15.9O2 Sensor Specifications ..................................................................................................168
15.10SpO2 Specifications(optional) ........................................................................................169
15.11Factory Defaults..............................................................................................................170
15.11.1 Ventilation Mode........................................................................................170
15.11.2 Wave Color.................................................................................................172
15.11.3 Setup...........................................................................................................173
15.11.4 CO2 Module ...............................................................................................173
15.11.5 History Data................................................................................................173
15.11.6 Therapy.......................................................................................................174
15.12EMC and Radio Regulatory Compliance........................................................................174
15.12.1 EMC............................................................................................................174

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FOR YOUR NOTES

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Chapter 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.

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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 thismanual.
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 over heat.
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.
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.
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 the ventilator in the vicinity of high frequency electrosurgery equipment,
defibrillators or short-wave therapy equipment may impair correct functioning of the

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ventilator and endanger the patient.
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 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 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 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’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.
Do not block the air intake at the rear 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.
A turbine can 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 if the integrity of the protective earth
conductor or the protective grounding system in the installation is in doubt.

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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.
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.
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 sounds.
Under the ambient temperature of 40ºC, the inspiratory pressure of the ventilator
exceeds 60 cmH2O, and the maximum temperature on the surface of breathing mask may
exceed 41ºC but does not exceed 43ºC
1.1.3 Cautions
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.

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CAUTION
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.
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 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, ensure the ventilator is set up for appropriate patient
type with the appropriate patient tubing. Ensure the System 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 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 environment may damage or shorten the battery lives 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 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 SOCKET- OUTLET 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.