Ventilator

User Manual
Table of Contents

Announcement.......................................................................................6

1 Introduction........................................................................................9
1.1 Device brief description........................................................................................9
1.2 Designed usage.....................................................................................................9
1.3 Users......................................................................................................................9
1.4 Warnings, attention and important issues in the manual.................................9
1.5 Symbol.................................................................................................................10
1.6 System relevant reference material...................................................................13
1.6.1 User maual........................................................................................................13
1.6.2 Ventilator——basic information......................................................................14
1.7 General warning.................................................................................................14
1.8 General Notes.....................................................................................................15
1.9 Context-relevant warning..................................................................................17
1.10 Operation..........................................................................................................17

2 Ventilation..........................................................................................19
2.1 Ventilation Introduction......................................................................................19
2.1.1 Ventilation management.................................................................................19
2.1.2 Ventilation mechanism.....................................................................................19
2.1.3 How to achieve ventilation..............................................................................19
2.2 The ventilation mode..........................................................................................20
2.2.1 Control ventilation-Volume Control...............................................................20
2.2.2 Control ventilation-Pressure Control..............................................................21
2.2.3 Spontaneous respiration-CPAP........................................................................22
2.2.4 SIMV Ventilation..............................................................................................23
2.2.5 DUOPHASIC(Bi-level positive airway pressure)..............................................25
2.2.6 Support ventilation-Pressure Support.............................................................26
2.2.7 Trigger function................................................................................................27
2.3 Setting parameters Introduction........................................................................27
2.3.1 PEEP..................................................................................................................27
2.3.2 Inspiratory time/I:E...........................................................................................27
2.3.3 Control/support pressure value.......................................................................28
2.3.4 O2 Concentration............................................................................................28
2.3.5 Respiration frequency/SIMV frequency..........................................................28
2.3.6 Tidal Volume....................................................................................................28
2.3.7 Inspiratory Pause Time.....................................................................................28
2.3.8 High pressure level..........................................................................................29
2.3.9 Inspiratory time for High pressure level.........................................................29
2.3.10 Low pressure level.........................................................................................29
2.3.11 Pressure rising time........................................................................................29
2.4 Monitoring parameters introduction.................................................................29
2.5 Other features......................................................................................................31

3.
 2.5.1 Keys...................................................................................................................31 5.5 Replacement of fuse...........................................................................................67
2.5.2 Backup ventilation...........................................................................................31 5.6 Installation of trolley..........................................................................................68
2.5.3 Respiratory dynamics monitoring tools..........................................................31 5.7 Installation of Main unit....................................................................................69

3 Patient safety.....................................................................................33 6 Inspection before use........................................................................71

3.1 General instructions to alarm.............................................................................33 6.1 Requirements on equipment..............................................................................71
3.1.1 The high-priority alarm...................................................................................33 6.2 Pre-use check........................................................................................................72
3.1.2 The medium priority alarm.............................................................................33 6.2.1 Testing pre-use check function when power on.............................................72
3.1.3 The low priority alarm.....................................................................................34 6.2.2 Alarm test :.......................................................................................................75
3.1.4 Alarm signals....................................................................................................34
3.2 Alarm setting window.........................................................................................34 7 Operating...........................................................................................77
3.3 The present alarm status bar..............................................................................35
7.1 Getting started ....................................................................................................78
3.3.1 Visual alarm......................................................................................................35
7.2 Initial setting and operation..............................................................................78
3.3.2 Audible alarm..................................................................................................35
7.2.1 Start up ventilation...........................................................................................78
3.4 Alarm Silence.......................................................................................................36
7.2.2 set ventilation mode........................................................................................79
3.5 Alarm reset...........................................................................................................36
7.2.3 Set the alarm menu ........................................................................................80
3.6 Alarm log..............................................................................................................36
7.2.4 Set the system menu........................................................................................81
3.7 Built-in security preventive measures.................................................................36
7.3 Key.......................................................................................................................85
3.7.1 Apnea alarm.....................................................................................................37
7.4 Monitoring status...............................................................................................85
3.7.2 Back-up ventilation..........................................................................................37
3.7.3 Airway pressure safety valve...........................................................................37
3.7.4 Main power malfunction and battery............................................................37 8 Maintainance and cleaning...............................................................86
3.7.5 Gas supply failure............................................................................................37 8.1 General instruction.............................................................................................86
3.8 Alarm types..........................................................................................................38 8.2 Maintaining components instructions...............................................................86
8.2.1 O2 sensor..........................................................................................................86
4 Equipment description......................................................................41 8.2.2 Exhale channel expands cleaning...................................................................88
8.2.3 Battery maintenance........................................................................................91
4.1 System...................................................................................................................41
8.2.4 Recommended regular maintenance..............................................................93
4.1.1 R50 Ventilator..................................................................................................41
8.2.5 Cleaning of ventilator.....................................................................................95
4.1.2 Outline..............................................................................................................41
4.2 User’s interface....................................................................................................42
4.2.1 User’s interface general instructions..............................................................42 9 Trouble shotting................................................................................96
4.2.2 Detailed description of user interface.............................................................42 9.1 High priority alarm.............................................................................................96
4.3 Patient Device.....................................................................................................48 9.2 Middle priority alarm.........................................................................................98
4.3.1 Patient device outline......................................................................................48 9.3 Low priority alarm..............................................................................................98
4.3.2 Pneumatic system............................................................................................53
4.4 Electrical system..................................................................................................57 10 Technical Data..................................................................................99
4.5 Other Parts..........................................................................................................58
4.5.1 Trolley...............................................................................................................58 10.1 General technical description..........................................................................99
4.5.2 Hinged arm......................................................................................................58 10.2 Patient system parameter...............................................................................101
4.5.3 Filter..................................................................................................................59
4.5.4 Gas source piplines..........................................................................................60 11 CO2 module...................................................................................105
4.5.5 Ventilator overall unit.....................................................................................60 11.1 Product Description and Applications...........................................................105
4.6 Battery module...................................................................................................60 11.2 Performance indication...................................................................................105
4.7 Medical air compressor.......................................................................................61 11.3 Safety Guide.....................................................................................................106
4.8 System transshipment, transport and storage..................................................61 11.4 Connection.......................................................................................................107
4.8.1 Prior to the transshipment..............................................................................61
4.8.2 During the transport:......................................................................................61
12 Abbreviations and terms definition.............................................109
4.8.3 Storage.............................................................................................................62
Appendix I Electromagnetic Compatibility......................................111
5 Installation.........................................................................................63
Appendix II Accessories List...............................................................116
5.1 Installation of patient respiration system.........................................................63
5.2 Installation of expiratory valve..........................................................................63
AppendixIII Aftersales service unit...................................................117
5.3 Installation and replacement of oxygen cell.....................................................66
5.4 Installation of Battery module...........................................................................66

4. 5.
 Announcement Warning:
If the organization using the equipment cannot achieve a set of effective and
satisfactory maintenance plans, abnormal equipment failures may take place,
and human bodies may be harmed.

Warning:
Do not service the equipment without the authorization of the manufacturer!
Beijing Siriusmed Medical Device Co., Ltd. (hereinafter referred to as "the
Any fault or danger for modification of the ventilator by any person without
company") reserves the copyright of this unpublished manual, and has the
the authorization, the Company is not accountable.
right to treat it as confidential. It can be used as a reference for operation,
maintenance and repair only. Others are not allowed to disclose it to any third
party. Warning:
This manual contains proprietary information protected by the Copyright Law. If the eqiupment is serviced, it should be tested or calibrated for continuing
All rights reserved. Without the prior written consent of the company, the using the equipment safely.
manual shall not be copied by photos of any part of the manual, photocopied The company will provide principle block diagrams on demand, and explain
or translated into other languages. calibration methods and other information to users, so that they can have a
All the contents of this manual are considered correct. The company shall not technician to repair the part of the equipment that can be repaired by users
be held liable for the printing errors within the manual, and all the damages themselves as prescribed hereunder.
caused by the installation errors or improper operation. The company shall not
provide any privilege empowered by the patent law to other parties. Nor shall Warranty:
the company be held liable for any legal consequences caused by the violation
of the patent law or the third party's rights. Please read the service guarantees from our company or local dealer carefully.

Users must carefully read this manual before using the product. This manual zz The company's obligations under the guarantee do not include the freight
tells them the operation procedures they must carefully deal with, the and other expenses;
operation that possibly leads to exceptions and risks that are possibly harmful zz The company shall not be held accountable for direct, indirect or the final
to the equipment or the human body. The company shall not be held liable for damage and delay caused by misusing and replacing fittings without the
safety, reliability and performance guarantee for all the exceptions or damages company's permission, or maintenance by the personnel unauthorized by
or harms to the equipment or the human body caused by the operations that the company;
absolutely need to be avoided as prescribed here. Nor will the company give zz This guarantee shall not apply to the following:
free maintenance for such failures!
Improper use;
The contents of the manual can be changed without a prior notice.
Machines without maintenance or already damaged;
The manufacturer's responsibilities:
The original serial number tags or manufacturing marks of the company
The company shall be responsible for safety, reliability and performance of the havebeen torn or replaced;
equipment only in the following circumstances:
Products made by other manufacturers.
zz Assembly operation, expansion, re-adjusting, improvement and maintenance
are all handled by the personnel approved by the company; Product return
zz Supporting electrical equipment and application environment are up to the When the product needed to be returned back to the local dealer, please
national standards, the trade standards and the requirements inside this contact customer service department, and tell them the product type and
manual; series number, and tell the reason why you return the product. If the series
zz Equipment is operated according to the operation instruction. number on the product could not be see clearly, then product returning
application would not be accepted.
Caution: Safety, reliability and operation condition:
This equipment is not intended for family use. The company shall not be responsible for safety, reliability and operation
condition of the equipment if the following occurs:

6. 7.
 1 Introduction
zz A component is torn, stretched or readjusted.
zz The users do not operate according to the manual.
zz Equipment’s use environment or storage environment does not meet
therequirements herein.

Electromagnetic susceptibility

The Ventilator complies with the requirements of IEC 60601-1-2:2007 (EMC

Collateral Standard), including the E-field susceptibility requirements at a level
of 10 volts per meter, at frequencies from 80 MHz to 2.5 GHz, and the ESD 1.1 Device brief description
requirements of this standard.
However, even at this level of device immunity, certain transmitting devices This device includes a user’s interface, and also includes patient equipment
(cellular phones, walkie-talkies, cordless phones, paging transmitters, etc.) which is used for mixing and managing respiratory gas; user’s interface is used
emit radio frequencies that could interrupt ventilator operation if operated in for all settings, and respiration is monitored. Ventilator will send the gas to
a range too close to the ventilator. It is difficult to determine when the field patient in the way of continuous air flow or continuous pressuring; the air
strength of these devices becomes excessive. with right amount of oxygen will be received by patient.

Practitioners should be aware that radio frequency emissions are additive, 1.2 Designed usage
and that the ventilator must be located a sufficient distance from transmitting
devices to avoid interruption. Do not operate the ventilator in a magnetic This device design is used to cure and monitor children and adults who
resonance imaging (MRI) environment. suffured from Disordered breathing and Respiratory insufficiency diseases. This
ventilator system can only be used by medical staff in hospitals or Health care
Manufacture institutions, or it is used when patient is tranfering to diferent rooms inside
Company name: the hospital.
Beijing Siriusmed Medical Device Co., Ltd.
Registered Address:
Attention!
Room 201, Unit 6 of E6 Building, Beijing Yizhuang Biomedical Park, No,88 Any anesthesia reagents can not be applied in this device.
Kechuang sixth street, Yizhuang, 101111, Beijing, China
1.3 Users
Service Unit:
Beijing Siriusmed Medical Device Co., Ltd. This device is a ICU ventilator which is equipped with malti-advanced functions.
It is only designed for medical professionals who have experiences in curing
Service Address:
respiratory diseases.
Room 201, Unit 6 of E6 Building, Beijing Yizhuang Biomedical Park, No,88
Kechuang sixth street, Yizhuang, 101111, Beijing, China 1.4 Warnings, attention and important issues in the manual
Zip code: 101111
TEL: 010-87576012 Warning:
FAX: 010-87576012 Means that it can cause serious consequences for patients and users, please be
www.siriusmedica.com careful in using (High degree of vigilance).

Attention!
REP. : Shanghai International Holding Corp. GmbH (Europe) Means that users must follow the instructions and operating steps, to make
sure that device is used correctly.
TEL. : +49-40-2513175
Address: Eiffestrasse 80, 20537 Hamburg,Germany Important:
Means that help you simply and conveniently operate this device and
description information of its connecting equipment.

8. 9.
 1.5 Symbol
Reference Manual: when the
Table 1-1 Symbols and its description symbol appears in the product,
4 you must refere to manual 9 Connector of nebulizer
for more information
User’s interface (blue)

NO. symbol Symbol description NO. symbol Symbol description

5 Consult user manual

Buzzer silence
Waveform freeze symbols.
1 (means alarm mute) 5
(indicate that freeze function is activated )

Control back board

2 Auxiliary respiration symbol 6 Unlock Operation panel keys

NO. symbol Symbol description NO. symbol Symbol description

1 VGA VGA interface 11 RS 232 Ventilator expiratory port instructions

Alternating current power
3 Lock operation panel key 7
(indicates that main power is connected)

Calibration machine interface

2 USB interface 12 Cal. Port
specified by the manufacturer

Battery symbol Power switch position indication Power switch position indication
4 (indicating battery state, displaying 8 3 (indicates that power 13 (indicates that power
the present remaining power) switch is “off”) switch is “on”)

4 manufacturer 14 manufacturing date

Patient device

According to the WEEE directive, waste

CE Notified bodies
NO. symbol Symbol description NO. symbol Symbol description 5 15 equipment for recycling sites should be
(according to 93 /42 /EEC)
developed, not as a garbage discarded

Ventilator inspiratory
1 6 Ventilator expiratory port instructions
port instructions
6 Protective grounding 16 EU Authorized Representative

The correct installation The correct installation

2 7 7 IP21 Enclosure protection class 17 Serial number of the device
of flow sensor. position of diaphragm.

Identifying user needs to

Type BF Class I equipment Type B Class I equipment 8 perform the operation 18 Indicates a potentially hazardous
(According to IEC 60601- (According to IEC 60601-1 (Blue)
3 8
1 standard equipment standard equipment category)
category)

9 Shock hazard 19 Electrostatic sensitive devices

10. 11.
 The wasted old battery can not be discarded as normal wastes
(in some areas, some recycling and reusing facility are not available)
Equipotential
(Provides a means of connection
between the equipment and the
10 potential equalization busbar 20 Fuse mounting location Class II special waste
of the electrical connection. (the used O2 sensor must be replaced and discarded according to the local relevant
A common grounding point laws,the used O2 sensor can not be treated as the normal waste)
for the entire ventilator)

Dangerous waste(Infectious)
This device contains some components which can not be treated as normal waste.

Important:
21 The Port for Remote alarm
Not all of the symbols will be present on the device or in the user manual.

1.6 System relevant reference material

Refenrence materials include instructions and descriptions which are needed
Packing symbol
by medical staff to use the device. According to situation where informations
are used, reference materials are provided in several ways. If you have any
comments and suggestions, please let us know, so that we can improve. The
1 Fragile 6 pward <users’ manual> described function and usage of the divice, but this <users’
manual>can not be used as a universal guidence for all respiratory disease
complex treatment details and necessary information guidance document.
So, this<users’ manual> does not include diagnostic guidance or treatment
2 Keep away from rain 7 Relative humidity
programme. This system should be used by professional medical staffs who
are authorized and experienced, the diagnosis is done and system settings is
adjusted according to patient’s needs.
3 Stack layer 8 Transport temperature Please read the <users’ manual> carefully before device is used or operated.

1.6.1 User maual

4 Forbid roll 9 Use only once Informations in<users’ manual> can be applied to R50 ventilator.

User’s manual includes safety use system information. Including 6 main parts:
Contains or presence of
5 10 Not use after the date zz Introduction(must read information)
natural rubber latex
zz Ventilation and Patient safety
zz Equipment description,Operating, Installation and Inspection before use
zz Maintenance
Manual symbols zz Trouble shotting
Symbols Symbol description
zz Technical data
Suggested using methods:
Class I special waste
(the wasted aged battery must be handled and discarded according to the relevant local regulations)
This is the main document of the device, so it should be looked over in
everyday’s operating.
The words in instructions and on user’s interface are indicated in special fonts.

12. 13.
 1.6.2 Ventilator——basic information zz This device is not designed for the implementation of the drug reaction (MR)
examination MRI environment. Otherwise system will lost some functions,
and will possibly cause permanent damage to the device.
Attention! zz This device is not designed for anesthesia reagent on patients. To avoid the
This device may use the different softwere version. Please make sure that fire danger, flammable agents(such as ether, cyclopropane) are not allowed
software number indicated on screen fits version number in <user’s manual> to apply in device in any circumstances.
before use. zz To avoid fire danger, the device and oxygen hose should stay asway from fire
source. Do not fill the polluted oxygen hose with flammable liquids such as
1.7 General warning
oils and greases. Textiles,oils,and other flammable things start burning easily
in oxygen rich environment,if any burning odor is smelled, then oxygen
Abandoned ventilator shall be handled in accordance with local regulations.
supply, device power supply, spare resources must be cutted off immediately.
Can not handle the normal way of disposing of waste ventilator!
zz Do not position the ME EQUIPMENT so that it is difficult to operate the
Warning ! disconnection from POWER SUPPLY.
zz The Equipment cannot be used in oxygen-rich environment.
zz The device can only be operated and used by well-trained and authoriazed
medical staffs. Users must follow<user’s manual> strictly during the 1.8 General Notes
operation.
zz After opening the package, a routine cleaningand precheck must be done.
Attention!
zz The alarm limit is set to an appropriate value, to make sure the safety of the
relevant patient. zz You should not touch connector pins marked with ESD warning symbol (see
chapter 1.5 control panel symbol 19), and they should not form a connection
zz To avoide the risk of electric shock, device power calbe must be inserted into with these connectors.unless you use ESD precautions.
ground-protecting outlet on main power supply.
zz The divice is maintained and inspected by well-trained staffs. Maintainence
zz If abnormal situation takes place( such as irrelevant window pups out, time interval is listed in routine maintainence chapter. Any maintainence
abnormal sound from device, warning from patient device, high-priority
and inspection should be recorded in notes, to find the regulations.
technical alarm taking place), then ventilator must be inspected immediately,
and corresponding components should be replaced, if necessary. zz If the maintainence and repair is provided by professionals and authorized
people who are not from the device provider, then we will not be
zz Only accessories and ancillary equipment which fits the newest IEC 60601- responsible for the security of the device operating. It is suggested that
1 canbe connected to the device. If connected to external device (such as
maintaince and repair of the device must follow the rules on maintainence
computer, monitor, humidifier), then the whole system must fit IEC 60601-1
contract signed with provider.
standard.
zz If the device is used in other areas outside the <user’s manual> range, then
zz Ventilator must be placed and used vertically. we are not responsible for the consequences.
zz All staffs should realize that, some components have the infectiousf risk
zz To make sure the security, artificial respiration equipment should be
during disassembling or cleaning of the ventilator.
prepared.
zz Maintenance mode can only be used when device is not connected to
zz Once the system is connected to patient, the device operating should always
patient.
be watched and monitored by medical professionals.
zz Positive pressure respiration may have the following side effects:
zz When ventilator is being operated, please do not disassemble the respiratory
Barotrauma, hypoventilation, hyperventilation, or circulatory damage.
module.
zz Users have the responsibility to do the necessary measurement, to make sure
zz Heat and moisture exchanger or its relevant equipment should be used to
that treatment environment fits IEC60601-1-2 standard restrictive provision.
prevent the lung tissue dehydration.
Exceeding the limit to operate the equipment may damage the system
performance and affect the system security. Precautions may include(not zz If bacteria filter is added into inspiratory and expiratory channel, then that
limited to) the following aspects: will increase the inspiratory and expiratory resistance, this will increase
respiratory work.
zz Give special attention to relative humidity of the clothing and conductivity,
to make sure the lowest possibility of static electricity gathering. zz When assembling system or option (Attachment), please refer to installation
instructions to properly complete the mechanical assembly properly.
zz Radio radiation devices such as mobile phones and high-frequency devices
must stay away from ventilator system area. zz When lifting or moving ventilator system or some parts of the ventilators,

14. 15.
 please comply with the guidance of ergonomics, safety-related matters and some areas, Cycle re-use facilities are not available.
prepare relevant security matters in advance.
Class II special waste
zz In this ventilator system, the respiratory hose with antistatic properties or
conductive properties can not be used. Old used oxygen concentration sensor must be replaced and discarded
according to the relevant local regulations. Used old oxygen concentration
zz The value measured from the signal output of this device and data processed
sensor can not be treated as normal wastes.
by the ancillary equipment can not be used as the basis for the treatment or
diagnosis decision. Such decision can only be made by experienced medical Dangerous waste(Infectious)
staff, according to previous or recognized routine manner. When combined
this system with the ancillary equipment provided by non-equipment Some components of the device can not be treated as normal wastes.
providers, then we will not be responsible for the accuracy of the signal zz All discarded (disposable) parts must be processed in an environmentally
processing. safe manner, according to hospital rules and regulations.
zz If there is a deviation between information displayed on the ventilator zz Accumulation of excess fluid (such as during the cleaning and disinfection)
user's interface and relevant information displayed on ancillary equipment, can not stay in expiratory sensor probe, otherwise the function of the
the respiratory parameters displayed on user's interface should be regarded ventilator will be affected.
as the main reason of the displayed information. If this system is used
in conjunction with the other accessories or ancillary equipment which zz Do not let sharp tools touch the touch-screen.
is suggested by non-equipment provider, then user himself should be zz It is suggested that at least one battery is used in ventilator as back-up
responsible for complete consistency and security. To ensure the safety of power.
the electrical system, that is to fit IEC 60601-1 standards completely , only This device includes the following description document:
attachments and ancillary equipment that meet the latest the IEC 60601-1
standards can be connected to this device signal input and output ports. - User’s manual

zz The system must use the original parts. - Product and Attachment directory

zz The ventilator system can only use attachments, spare parts or auxiliary 1.9 Context-relevant warning
equipment provided by the equipment providers, using any other
accessories, spare parts or auxiliary equipment may damage the system's Note:General warning item is not listed here, but general warning words may
performance and security. appear repeatedly in manual text.

Important: Note:Context-related “attention”item and “importmant”item are not listed

here,but these warning words will appear on corresponding context of the
zz This symbol on components attracts your attention, and please refers to manual text.
instructions and guidance of the attached documents.
1.10 Operation
zz The supplied gas must be free from water, oil and particulate, these
impurities must be less than the following standards:
Air: . . . . . . . . . . H2O < 79 mg / m3 Attention:
Oil. . . . . . . . . . . .< 0.5 mg / m3 zz If any operation can cause any risks to patients, (such as replace O2 sensor,
disassemble components), then ventilator should be disconnected from
Oxygen:. . . . . . . . . . H2O < 20 mg / m3
patient.
zz Maintanence manual contains environment demands and insturctions.
zz If the trigger sensitivity is set too high, it may appear self-triggered
Air pressure data is in: (automatically triggered). If respiratory system leaks, such as the use of a
buckle collar hose with button, trigger also occurs. In this way, ventilation
1kPa = 10 cmH2O is triggered by system not by the patient. The occurrence of such cases is
100 kPa = lbar~latm avoided by decreasing the trigger sensitivity. This is also very important
during transport of patients, because the moving of patient's body and the
100 kPa = 15 psi
respiratory system will also cause an error trigger.
Class I special waste zz If functional malfunction is detected during the starting of the system,
please refer to chapter 11“Troubleshooting”.
The used old battery must be replaced and discarded according to the relevant
local regulations. Used old batteries can not be treated as normal wastes. In zz If some functional fault exists continuously, then do not connect ventilator
to patient.

16. 17.
 2 Ventilation
zz To protect patient from damage of high gas airway pressure, the upper
pressure limit must be set to appropriate value to make sure the safety of
patients.

Attention:
If the airway pressure rose to higher than the set pressure upper limit, the
expiratory valve opens. If the system pressure exceeds the maximum safe
pressure (not greater than 125 cmH2O), the safety valve also opens.
2.1 Ventilation Introduction

2.1.1 Ventilation management

This equipment is designed for the safe and efficient treatment.The

system could be set to operate according to patient’s respiration changing
continuously automatically adjusting in the way of assisting respiration and
manual controlling. And it’s system pressure, flow quantity and time length
control was achieved through different ventilation modes (the time was set in
control mode, and the valuve of patient related time length was set in support
mode).

Important:
zz To display all the installed ventilation modes, please refer to this manual
chapter “2.2 The ventilation mode”.
zz In all pressure-controlled ventilation modes, setting the alarm limit to the
appropriate level is very important.
2.1.2 Ventilation mechanism

This ventilator can be used as the following ventilation mechanism:

1) control ventilation
2) support ventilation
3) spontaneous respiration/CPAP
When necessary, all ventilations can use mandatory mode. Ventilator support
and monitor the patient's spontaneous respiration when the patient has their
own ability to breathe, and if necessary, ventilation can be controlled.

2.1.3 How to achieve ventilation

Ventilation can be managed and controlled according to the below factors:

A. Pressure
B. Flow rate/volume
C. Time
2.1.3.1 Ventilation according to pressure control.
In pressure-control ventilation mode, a pre-set constant steady pressure will
be maintained in the inspiratory period. (Pressure control ventilation, pressure
support ventilation)

18. 19.
 2.1.3.2 Ventilation according to flowrate/volume control If the patient is able to go beyond the pre-set trigger sensitivity, then the
patient can trigger extra respiration.
In flow rate-volume control ventilation mode, a constant and steady
Inspiratory capacity is maintained, inspiratory flowrate in every respiration 2.2.1.2 Detailed explationation of volumn control ventilation
remains constant and steady(volumn control ventilation)
Inspiration start:
2.1.3.3 Time
1) Volume control ventilation makes sure that: within pre-set inspiratory time,
In control ventilation mode, time and the pre-set value is related. In support and in preset frequency, ventilator provides pre-set tidal volume which has
ventilation mode, time is related to the patient trigger and inspiratory constant steady flowrate.
termination setting.
2) Inspiratory flowrate remains constant and steady, and this also depends on
2.2 The ventilation mode settings on user’s interface.
3) Inspiration starts according to the pre-set frequency or when patient
This device provides volume control ventilation (VCV), pressure control triggers.
ventilation (PCV), synchronized intermittent mandatory ventilation (SIMV),
spontaneous ventilation, bi-level positive airway pressure (Duophasic) and Expiration start:
other ventilation modes.
1) When pre-set tidal volume is transmitted and after the pre-set pause time,
But not every ventilation mode will appear on the device, the actual mode ventilator exhalation valve to start releasing the breath.
selected by the user configuration decisions. 2) In the supply process for patients, if the airway pressure exceeds the set
2.2.1 Control ventilation-Volume Control pressure limit values, the ventilator exhalation valve start releasing the breath
for the protection of patient safety.
2.2.1.1 Volume control ventilation Description
2.2.2 Control ventilation-Pressure Control
Volume control ventilation (also called fixed volume ventilation) is to make
sure that patient could receive a pre-set tidal volume.Mandatory ventilation 2.2.2.1 Pressure Control ventilation Description
in respiration period, in constant flow rate, the pre-set tidal volume, forced
Pressure controlled ventilation (PCV) is a control respiratory target pressure.
ventilation is given to patient. Meanwhile, in expiratory phase, monitoring
pressure condition in airway or airflow velocity condition (pressure trigger The inspiratory phase, mandatory ventilation is given according to the pre-
or flowrate trigger), when the trigger condition is reached, a "the same-set- set pressure, patient airway pressure was stabilized at the set-value in the
parameters" ventilation is given to patient. entire inspiratory cycle, the flow curve is going in downward trend. Pressure
control ventilation and volume controlled ventilation are the same, a "same-
The following parameters can be setted: parameters" forced ventilation can also be triggered by the patient during the
expiratory phase.
1) Tial volume(mL)
the following parameters can be set :
2) Respiration frequency(time/minute)
1) Pinsp (higher than PEEP control pressure)(cmH2O)
3) PEEP(Positive End-Expiratory Pressure)(cmH2O)
2) Respiration frequency(times/minute)
4) O2 concentration (%)
3) PEEP(Positive End-Expiratory Pressure)( cmH2O )
5) Inspiratory time(second)
4) O2 ncentration (%)
6) Pause time (%)
5) Inspiratory time(s)
7) Trigger flowrate/trigger pressure
6) Trigger flowrate/trigger pressure
Airway pressure depends on the tidal volume, inspiratory time, and resistance,
as well as the respiratory system compliance. Ventilator always send the setted The transmitted capacity depends the exceeded PEEP pressure, lung
tidal volume.Increased resistance and reduced compliance will increase airway compliance and patient airway system and the airway's resistance.This means
pressure. In order to protect the patient's lung from excessive pressure, it is that tidal volume may change.Pressure control ventilation mode is respiratory
very important to set an appropriate value for the upper pressure limit. When top-preferred mode when there is a leakage, such as when a inner-airway hose
the patient's airway pressure exceeds the setted pressure limit, the ventilator without mouth hoop is used. Or in the case where maximum airway pressure
will turn off the inspiratory diaphragm, and stop ventilation, and open must be controlled, also choose to use a pressure control mode.
expiratory diaphragm to release patient inner airway pressure.
During exhalation, the patient can trigger extra breathing.During the

20. 21.
 inspiratory period, flowrate is in decline trend. The patient can trigger extra The following parameters could be set:
respiration. If patient trys to exhale during the inspiratory period, then the
expiratory valve will allow contineous exhale, exhale can go on continually 1) PS above PEEP (higher than PEEP support pressure)( cmH2O )
as long as the pressure is 3 cmH2O higher than the pre-set pressure value. 2) PEEP(positive end-expiratory pressure)( cmH2O )
Due to the delivered tidal volume changes, it is very important that "minute
3) O2 concentration(% )
ventilation amount"-alarm-limit is set to the appropriate value.
4) Trigger flowrate/trigger pressure
2.2.2.2 Detailed explationation of Pressure Control
2.2.3.2 Spontaneous respiration/CPAP detailed explanation
Start inhale:
Start inhale:
1) Pressure control ventilation to ensure that the entire air intake to maintain
a preset suction pressure during Steady unchanged. By default ventilator 1) When patient attempting to inhale and reaches trigger level.
respiratory rate, inspiratory time, and lead to decreased inspiratory flow
2) When apnea alarm time setting is reached, back-up ventilation starts.
pressure transmission airflow.
Start exhale:
2) The default value is controlled by a pressure ventilator. The results depend
on the capacity of the set pressure value, inspiratory time, and structural 1) When the inspiratory flowrate decreased to the below 25% of the
characteristics of the patient's lungs, each breath during the traffic decline. inspiratory flowrate peak value.
3) According to the preset frequency or when the patient begins to inhale the 2) If upper pressure limit is exceeded.
trigger.
2.2.4 SIMV Ventilation
Start exhale:
2.2.4.1 SIMV function description
1) After the pre-set inspiration time terminate.
SIMV is a combined mode, according to the selected SIMV mode, patient
2) If the upper pressure limit is exceeded.
receives mandatory ventilation which trys to keep pace with patient’s
Activate expiratory valve: respiration. During mandatory respirations, the patient can breathe
spontaneously under pressure support ventilation mode. Mandatory
1) If patient trys to exhale during the inspiratory period, then pressure ventilation can be volume-controlled ventilation or pressure-controlled
increases. When pressure increase to 3cmH2O higher than pre-set inspiratory ventilation
pressure, expiratory valbe opens, and the pressure will be decreased to pre-set
inspiratory pressure value. zz SIMV (volume control) + Pressure Support

2) If pressure increases to the pre-set upper pressure limit (such as patient zz SIMV (Pressure Control) + Pressure Support
coughs),then expiratory valve opens, ventilator is switched to expiratory state. Mandatory respiration is defined through the following basic settings
(see Table 2-1): tidal volume, Pinsp, inspiratory time, pause time and SIMV
2.2.3 Spontaneous respiration-CPAP frequency.
2.2.3.1 Spontaneous respiration/CPAP function description Table 2-1 Mandatory respiration
Continuous Positive Airway Pressure (CPAP) mode is used during spontaneous
breathing. Ventilator continuously adjust ventilation mode according to the Setting requirements SIMV: (VC)+PS SIMV: (PC)+PS
patient’s ability to breathe, allowing patients more autonomy to control Pinsp(higher than PEEP control pressure) X
ventilation ventilator. PSV general use with pressure support. Tidal volume / minute volume X
In spontaneous breathing mode, in order to ensure patient safety, the apnea SIMV frenquency X X
alarm device configuration and backup ventilation function. Users should
Inspiratory time X X
address the specific circumstances of each patient, the apnea alarm time is set
to the appropriate value. If you pause to breathe alarm limit is reached, the Note: "X" indicates that the mode or function with this setting
ventilator will automatically switch to the backup mode. Suffocation alarm
Respiratory cycle time is the length of compulsory breath in seconds.
prompts the operator to take appropriate action.
For example: If breath rate of SIMV is 6, then the whole cycle of SIMV is 10
Back-up ventilation mode details, see section 2.5.2 backup ventilation.
seconds. During the cycle, the first 50% of the cycle is mandatory ventilation
phase (T1), the rest 50% of the cycle is spontaneous breath phase (T2). That

22. 23.
 is, if a patient triggers a ventilation during first 5 seconds of a SIMV cycle, Start exhale:
then the ventilator gives a ventilation to patient according to the preset
mandatory ventilation parameters. If the patient doesn’t trigger ventilation 1) Forced ventilation inspiratory time end;
during mandatory ventilation phase, then the ventilator automatically 2) Patient’s airway pressur exceeds pressure.
gives a ventilation to patient according to the preset mandatory ventilation
parameters. After mandatory ventilation finished, rest time of SIMV cycle is 2.2.5 DUOPHASIC(Bi-level positive airway pressure)
spontaneous ventilation time during which the patient can trigger pressure
2.2.5.1 Function description
support ventilation.
Duophasic mode simultaneously set two pressure values, by setting the time
and breathing frequency high voltage level to adjust the schedule . Assisted by
pressure support in patients with spontaneous breathing attempts.
Duophasic breathing pattern can set the following parameters:

T:SIMV breath cycle(includes T1 and T2); 1) Phigh: inspiratory pressure (cmH2O)

T1:Mandatory interval; T2:Spontaneous interval 2) Plow: low PEEP pressure (cmH2O)
Figure 2-1 SIMV cycle schematic diagram
3) O2 Concentration ( % )
“SIMV + pressure support” could set the following parameters: 4) F: Forced ventilation frequency
5) Thigh: inspiratory pressures of time ( in seconds )
1) PC above PEEP (above PEEP support pressure) (cmH2O) or tidal volume 6) Trigger flow / pressure trigger
2) SIMV frequency (times / min) 7) Psupp: Support during spontaneous breathing pressure
3) PEEP (positive end expiratory pressure) (cmH2O) In Duophasic ventilation mode , using two pressure ventilator transform
4) O2 concentration (%) each other , so that patients can be carried out at two pressure spontaneous
5) Inspiratory time (S) breathing . Since Duophasic essentially a controlled ventilation mode, so can
not be used to suspend breathing alarm and back- ventilation. Therefore,
6) Trigger flowrate / trigger pressure
setting the upper and lower alarm is very important for the minute ventilation.
7) Psupp(above PEEP support pressure) (cmH2O)
Each Duophasic cycles are independent happened, so most of the measured
2.2.4.2 SIMV-detailed explanation values in each Duophasic cycle will be updated , as minute ventilation ,
respiratory rate, mean pressure and PEEP . To meet this requirement , the
The SIMV’s content: associated alarm is also handled by each Duophasic cycle .
1) SIMV mode using the volume control and pressure control or pressure If you set a more extreme settings , the measured values and alarm updates are
support and spontaneous breathing pattern combination of features can mandatory and somewhat more frequently , even in the case of spontaneous
be achieved with the patient’s breathing to try to synchronize the default breathing also have this sign. Because switches between two different
mandatory breath. pressures , there may be significant changes in tidal volume respiration in
2) In the forced ventilation phase, the patient did not trigger breathing different.
attempts, after the forced ventilation zone, giving the patient a mandatory 2.2.5.2 DUOPHASIC(Bi-level positive airway pressure)detailed
ventilator to breathe.
explanation
3) Mandatory breath is defined by the basic settings (ventilation mode,
respiratory cycle time, breathing type and capacity / pressure). This function allows two different pressure values doing spontaneous
4) By setting the pressure support, you can define the trigger spontaneous respiration or pressure support ventilation respiration. The two basic pressure
breathing patients, given the pressure ventilator support level. values are set separately, and it is set by the frequency and high-pressure time,
each pressure time is set (in seconds) distributedly.
Start inhale:
Start inhale:
1) Patient attempting to respirate which reaches triggering level;
1) Patient trigger level reaches or exceedes the set value;
2) Within trigger window, patient have no spontaneous respiration or
spontaneous respiration does not reach the triggering level, after the end of 2) Start high-pressure ventilation time.
the triggering window, forced ventilation begins. 3) In synchronous time window, the trigger occurs.

24. 25.
 Start exhale: 2.2.7 Trigger function
1) Patient airway pressure reach or exceed the airway pressure upper-limit Triggers determine the extent which the patients try to breath, triggering the
alarm;
ventilator to assist patient inhaling.
2) High-pressure time end;
The trigger sensitivity can be set to flowrate trigger (trigger flowrate) or
3) The patient’s inspiratory flowrate decreases down to the set expiratory
pressure trigger (trigger pressure). Under normal circumstances, first priority
sensitivity level.
should be given to the flowrate trigger, because this will enable patient to get
2.2.6 Support ventilation-Pressure Support the ventilatory support by fewer respiratory effort.

2.2.6.1 Pressure support ventilation function description Sensitivity should be set as high as posible but the premise is that no self-
triggering take place. This not only ensures that the trigger is initiated by the
Pressure support ventilation (PSV) mode is a breathing pattern triggered by the patient, but also avoids the automatic cycle by the ventilator.
patient, the ventilator provides default Steady pressure support for patients.
When the initiative triggered by the patient, according to the preset ventilator
Steady pressure on the patient’s inspiratory be supported ventilation. In this Attention!
mode, the decision by the patient breathing frequency and duration, flow
curve downward trend. Inspiratory schedule is changed by the control patients If the trigger sensitivity is set too high, it may appear self-triggering
inspiratory flow. phenomenon.

Pressure support ventilation mode is usually not used alone, usually combined Pressure trigger settings range is between -20 to 0 cmH2O and (refer to setting
SIMV other modes combined. In this device, the pressure support mode with PEEP values).
CPAP, SIMV, Duophasic mode combination. Flow rate trigger setting rang is between 0.5 and 20LPM.
Pressure support ventilation The ventilator continued to send airflow during respiration period, this airflow
Pressure support ventilation mode can be set to the following parameters: is measured in the respiration channel.The bias flow of expiratory period: 2.5L/
min.
1) Psupp: support for higher PEEP pressure (cmH2O)
2) PEEP (positive end expiratory pressure) (cmH2O)
2.3 Setting parameters Introduction
3) O2 Concentration (%) 2.3.1 PEEP
4) Trigger flow / pressure trigger
During pressure support ventilation, provided by the patient self-regulating Positive end-expiratory pressure(PEEP) setting range is between 0~50 cmH2O.
respiratory rate and tidal volume, pressure with ventilator support. The suction Ventilator will maintain a positive end-expiratory pressure in the alveoli, and
pressure ventilator preset higher, the flow of air supplied to the patient will be prevent the possible abnormal airway collapse.
more.
2.3.2 Inspiratory time/I:E
2.2.6.2 Detailed explanation of pressure support ventilation
As shown in Figure2-2, on the ventilator’s “system” “setting” menu, the two
a) Pressure support ventilation ensures constant-steady pre-set inspiratory
pressure is according to patient respiration effort. alternative settings are available: Tinsp and I:E. The setting range of Tinsp is
0.1~12S, the setting range of I:E is 4:1~1:10, meanwhile, the settings depend
b) Pre-set pressure is controlled by ventilator, however respiration frequency
on the respiratory frequency and other factors’ changes.
and inspiratory time is decided by patient.
c) Inhale starts when patient triggers.
Start inhale:

When patient triggers one respiration, airflow comes into the lungs in a
constant-steady pressure. Due to a constant-steady pressure provided by
ventilator, flowrate will decrease, until pre-set inspiratory termination set
value is reached.
Start exhale:

zz When Inspiratory flowrate decreases to pre-set inspiratory termination

value.When upper pressure limit is exceeded.
zz When exceed longest time limit of pressure support inspiration.
zz Longest inspiratory time is 4s. Figure 2-2

26. 27.
 2.3.3 Control/support pressure value 2.3.10 Low pressure level

The set “Pinsp” (control pressure higher than the PEEP) is inpiratory pressure Low pressure level (Plow) setting means giving control of ventilation in
which is each mandatory respiration under “pressure control mode” and “SIMV patients with end-expiratory pressure under Duophasic mode. Low levels
(PC) + PS” control mode, it is also respiratory pressure which is backup period setting is in the range of 0 ~ 50cmH2O.
of “respiration pause” under “pressure support”.
2.3.11 Pressure rising time
The set“Psupp”( support pressure higher than PEEP)is inspiratory support
pressure which is trigger respiration under “pressure support, SIMV and Ventilator pressure rising time Tslope can be set. Tslope refers to the time that
DUOPHASIC(dual pressure)ventilation modes”. the ventilator pressure control or pressure support reach the target value given
to patient excpet VCV mode. The setting range is 0 ~ 1s.
2.3.4 O2 Concentration

The setting of FiO2 in ventilator is O2 Concentration of mixing gases. Setting

rang is between 21% O2 and 100% O2. 2.4 Monitoring parameters introduction
2.3.5 Respiration frequency/SIMV frequency When ventilator starts working, all monitoring parameters of ventilator
displays in the menu “Monitoring” column. Each monitoring parameters are
Respiration frequency is each minute mandatory respiration number which described in Table 2-2.
is except SIMV mode and under other control ventilation modes. It is set in
the range of 4 to 120 beats/min. SIMV frequency is per-minute mandatory But among them, the numbers 19 and 20 displays in the special features
respiration time which is under SIMV mode. It is set in the range of 1 to 40 monitoring area, a detailed description see section 4.2: user interface.
beats/min.
Table 2-2 Monitoring parameters
2.3.6 Tidal Volume
NO. Parameters Meaning Explanation

Ventilator tidal volume (Vt) setting means providing ventilation of each breath Volum that ventilator gives mixed
1 VTi Inspiratory tidal volume
to the patient at VCV, SIMV-V mode. The ventilation is a fixed value, according gas to patients every breath
which the ventilator forced providing tidal volume to the patient with
2 VTe Expiratory tidal volume Exhaled gas volum of patients
mechanical ventilation. Tidal volume setting range is 50 ~ 2500ml.

2.3.7 Inspiratory Pause Time Frequency of patients,including

3 f Total breathing frequency
Mandatory and Spontaneous
Inspiratory pause (Pause) time setting refers to breath-hold period at the end
of patient inspiratory at the VCV mode, and then release the patient to exhale.
Inspiratory pause (Pause) time setting range is 0 to 50%, that is inspiratory 4 fspn
Spontaneous breathing
Frequency triggered by patients
pause time is the percentage of actually setting inspiratory time. frequency

During the respiratory period, the inspiratory pause time occupies the time of
inspiratory time, i.e.: when pause is set, the actual time for ventilator supplying Minute ventilation of patients, including
5 MV Total minute ventilation
gas to patient (the time when there is inspiratory flow) shall be shorter. For Mandatory and Spontaneous
example, when inspiratory time is set as 1s and pause time is set as 50%, then
the time for ventilator supplying gas to patient is 0.5s and the rest 0.5s is
the time for patient inspiratory pause, which increases the time of alveolar 6 MVspn
Spontaneous minute Triggered by patient, support
oxygenation. ventilation minute ventilation by ventilator

2.3.8 High pressure level

In a respiratory cycle, the maximum
7 Ppeak Peak pressure
High pressure level (Phigh) setting is the pressure control ventilation patients pressure of the airway in patients

given in the Duophasic mode. High pressure level setting range is 5 ~

80cmH2O. In a respiratory cycle, the average
8 Pmean The average pressure
pressure of the airway in patients
2.3.9 Inspiratory time for High pressure level

Inspiratory time for High pressure level(Thigh) setting is inspiratory time of In a respiratory cycle, the Plateau
9 Pplat The Plateau pressure
pressure of the airway in patients
patient ventilation in Duophasic mode. Inspiratory time for High pressure level
setting range is 0.1 ~ 12S.

28. 29.
 patient according pre-set parameters. When patients recover spontaneously
positive end expiratory
In a respiratory cycle, the breathing capacity, and continuous trigger twice ventilation, the ventilator
10 PEEP positive end expiratory pressure stopped backup ventilation, and spontaneous breathing pattern continues.
pressure
of the airway in patients
Backup ventilation function has suffocation alarm time settings, and it is set in
the range of 10 ~ 60S with 5S a stall every set . At set alarm time , the patient
In a respiratory cycle, the minimum has no spontaneous breathing , the ventilator automatically switches to back-
11 Pmin The minimum pressure
pressure of the airway in patients up ventilation mode to ventilate for the patient , so the patient can effectively
be prevent from the risk of suffocation caused by apnea .
In a respiratory cycle, The actual Back-up ventilation mode is divided into volume control ventilation VCV and
The inspired oxygen PCV pressure control ventilation of ventilation mode . Setting and using of
12 FiO2 concentration of oxygen given
concentration
patients in a gas mixture these two modes are identical with the general volume control and pressure
control ventilation. During the back-up ventilation, preset ventilation
parameters will start and when the patient recovered spontaneous breathing
The static airway resistance and trigger two consecutive spontaneous breathing , the ventilator restores to
13 Rst Static resistance
of the respiratory system spontaneous ventilation mode.
2.5.3 Respiratory dynamics monitoring tools
The dynamic compliance of
14 Cdyn Dynamic compliance
the respiratory system
The device has a respiratory dynamics monitoring functions, namely the
pressure-volume loop and volume-flow loop. At “monitoring” menu of
Rapid shallow
ventilator, “waveform setting - Layout 2” can get two loops display.
15 RSBI Offline index of patients
breathing index P-V loop and V-F loopwaveform display as shown in Figure 2-3 and Figure 2-4.

16 ETCO2 End tidal CO2 concentration The concentration of CO2 in exhaled gas

17 SPO2 Oxygen saturation Actual Oxygen saturation of patients

18 Pulse Pulse rate The actual pulse rate of patients

Intrinsic positive end Intrinsic positive end expiratory

19 PEEPi
expiratory pressure pressure of patients

The Static compliance of

20 Cst Static compliance Figure 2-3 P-V loop schematic diagram
the respiratory system

2.5 Other features

2.5.1 Keys

Ventilator user interface includes fixed keys, each key has its corresponding
function. When using a fixed key ventilator work with the corresponding
function. Its detailed features found in chapter 4.2 “user interface”.

2.5.2 Backup ventilation

Backup ventilation is to ensure the safety of patients and prevent patients

suffocation.In sponotaneous mode (CPAP / PSV) of ventilator, user need to set
up backup ventilation mode, parameters and suffocation alarm time . Use see Figure 2-4 V-F loop schematic diagram
Chapter 7.
When using spontaneous ventilation mode and patients have no spontaneous
breathing within the setting suffocation alarm time, the device sends
suffocation alarm and immediately provide VCV or PCV ventilation to the

30. 31.
 3 Patient safety
alarm contacts to be dangerous original equipment before use.
The high-priority alarm is LATCHING ALARM.

3.1.2 The medium priority alarm

Medium priority alarms are precautions orange background display. The

degree of risk in priority alarms inferior to high-priority alarms, these alarms
are tips or suggestions nature, prompting the operator to pay attention to the
device or the patient’s condition, to operate when necessary to eliminate the
priority alarms.
The high-priority alarm is LATCHING ALARM.

3.1.3 The low priority alarm

3.1 General instructions to alarm Low priority alarms are precautions orange background display. The degree
of risk of inferior low priority alarm priority alarms, these alarms are tips or
To ensure patient safety during use of the device, the alarm system has taken suggestions nature, prompting the operator to pay attention to the device or
some measures to ensure the safety of the treatment and use. However, the patient’s condition, the operation when necessary in order to eliminate
these measures only calls attention to the real-time status of the patient or low-priority alarms.
equipment. When the alarm occurs, the device can not completely substitute
for the medical staff to protect patient safety. Therefore, even if the device has The low priority alarm is NON-LATCHING ALARM.
a certain security, but patients still need someone to care. 3.1.4 Alarm signals
The system uses three alarm priority: high priority alarm, the alarm priority
and low-priority alarms. Each has a different priority alarm, the device provides This device has two alarm signal, the alarm can be visual and sound alarms.
alarm type and priority in Table 3-4. Visual alarm means the alarm and warning lights warning text when an alarm
Alarm includes physiological alarm and technical alarm. occurs, the device will be displayed at the top of the interface displays the
actual alarm equipment problems, while the top of the alarm device will light
Physiological alarm is usually caused by a patient's physiological parameter up to alert the operator’s attention, see chapter 3.3.1.
exceeds the limit alarm level, or the patient physiological abnormalities.
Audible alarm is the speaker alarm. When an alarm is generated, the device
Technical Alarm is also known as the system error message, is the result of will “beep” sound generating alarm have different alarm sounds at different
improper operations or system failure which is caused by some functions of levels. See chapter 3.3.2.
the system can not run normally, or monitoring alarm is triggered when the
distortion. When an alarm is generated, the device will also be a visual and audible alarm
signal is issued to alert the user or equipment in the patient.
Warning! Alarm signal feature is the system default, in addition to the alarm volume,
user can not change or adjust it. The machine will save the alarm volume
zz To protect patients from harm of high airway pressure, pressure limit must setting, power will not be eliminated.
be set to the appropriate value, in order to ensure patient safety.
zz To ensure patient safety, alarm limits should be set to the appropriate value. 3.2 Alarm setting window

Important! Displayed in the user interface of the device, press the “Alarm” key to display
the lower and upper limits of all applicable alarms and settings. In this
zz To ensure safety, requiring the patient should always receive personal care. interface, respectively, Set 1, Set 2 and alarm logs are three options, shown in
Figure 7-6. Select the alarm to be set, turn the knob can be used to adjust the
3.1.1 The high-priority alarm
current alarm limits.
High priority is the warning alarm is displayed with a red background. Table 3-1 showed the alarm setting default values, these numbers were fixed
Advanced warning alarm is the most dangerous conditions to generate these values, the users could not modify them, the alarm limit would automatically
alarms may be caused by a very large patient injury or even endanger the lives restore these values when ventilator booted each time.
and safety of patients. So when the ventilator use this type of alarm occurs,
the user must be given immediate attention and resolve, if necessary, the
patient was transferred to the backup ventilation equipment or appliances,

32. 33.
 Table 3-1 alarm setting default values when there is a low priority alarm, the alarm indicator light is orange, Always
lighting without flashing, two alarm scale is a sequence of non-repetition.
Set valve Pressure MV F FiO2 VTe ETCO2 Pr SPO2
3.3.2 Audible alarm
Alarm up 40 40 100 100 1000 50 6.7 120 OFF In addition to visual alarm, the device offers sound alarm meet IEC60601-1-8
standard:
Alarm down 5 0 5 35 200 20 2.7 50 92 When the high-priority alarm, the ventilator issued ten “beep” continuous
alarm tone, in which the third and fourth alarm sound alarm sound slightly
kpa longer intervals.
Unit cmH2O L bpm % mL mmHg bpm %
or ％
When the medium priority alarm occurs, the ventilator issued three “beep”
continuous alarm tone.
Warning!
When the low priority alarm occurs, the ventilator issue two consecutive “beep”
Alarm display is the default boot device alarm settings that are not set up alarm sound.
correctly to ensure patient safety, the boot, the user should adjust settings to
suit the current patient. To prevent operator error of the adjustment, alarm 3.4 Alarm Silence
values to follow the requirements of internal algorithms.
The fixed buttons of the device provide alarm silence function.Press “Alarm
Warning! Silence” button and the alarm sounds of all alarms will be paused. Alarm
silence symbol will be displayed in the status display area in the upper right
When the alarm limit was set to OFF, then the relevant alarm function would of the display interface. the number under the alarm silence symbol is the
not work, so, please watch out patient’s condition. remaining time of alarm silence. The paused time is 120S.

3.3 The present alarm status bar When the alarm silence time is over or there is a new alarm occurring, an
audible alarm will be reactivated.
If one or more of the alarm is active, the current alarm status bar activated.
The bar shows only the highest level of alarm information, if necessary
3.5 Alarm reset
inquiries or other alarm existing alarm happened before, the user can press
Fixed button device provides alarm reset function.
the “Alarm” menu, select the alarm log, view all alarms that have occurred
over the current system believe that As shown in Figure 7-8. After the lifting device alarm condition, the audible alarm will be eliminated,
but the recent high-level or mid-level alarms generated information will be
When the same two priority alarms occur, only the relatively higher priority
latched to a black font on a blue background alarm status bar displays, such as
alarm displays in alarm status bar.
the user presses the “Alarm Reset” button in the There are currently no alarm
3.3.1 Visual alarm condition exists, you can eliminate the warning message text.

Visual alarm complies with IEC60601-1-8 standard,there are two effective 3.6 Alarm log
visual alarm forms:
The device provided alarm log function, when alarm was activated, ventilator
1) Displays alarm information currently occurring in the current alarm status system automatically recorded alarm types and the happening time of the
column of the upper part of the device’s user interface, and only shows alarm. You could conveniently check the recent 100 alarm events of the
the current highest priority alarm. Including high-priority alarm display ventilator. After 100 alarm events was saved, system would automatically cover
background is red, medium priority, low priority alarm display background is the oldest alarm information, the nearest records were displayed on most top.
orange. When ventilator power outaged or shutdown condition, the alarm log was still
2) At the top of the device, to provide users with an alarm indicator, alarm reserved, the alarm log would still display the most recent alarm condition at
indicator, there are two, namely, red and yellow, the more distant user can next boot.
view the current status of the alarm device at a distance. Among them, when There are exclamation marks after the alarm log. Three exclamation indicates
there is a high priority alarm, the alarm LED flashes red, and appears high that the alarm log is high priority alarm, two exclamation mark indicates that
frequency flashes(2 times per second), the alarm thread 10 is a sequence the alarm log is priority alarm, an exclamation mark indicates that the alarm
repeated every 10 seconds; when there is an medium priority alarm, the log is low priority alarm.
alarm indicator flashes orange, and appears low frequency flashes(1 times of
two seconds), the alarm thread 3 is a sequence repeated every 25 seconds; Alarm log shows in figure 7-8.

34. 35.
 3.7 Built-in security preventive measures 3.7.5 Gas supply failure

To ensure patient safety, this equipment has many built-in safety preventive If the air pressure is too low or gas supply failure, the device will send a high-
measures. level alarm, and emergency exhalation valve and suction valve opens, the
patient can breathe independently through two valve to prevent gas supply
caused no patients with inadequate ventilation or suffocation.
3.7.1 Apnea alarm 3.8 Alarm types
In spontaneous breathing mode, when the patient is no spontaneous
Table 3-1 lists all of the information provided by the equipment alarm, an
breathing suffocation alarm generated within the time set by the user, the
alarm condition and alarm priority. All the technical alarm,physiological alarm
device can emit suffocation alarm. This alarm is generated to prompt the
and alarm signal delay of ventilator have been preset, the user can’t change it.
user to the presence of a dangerous state, to prevent the patient’s ability to
breathe due to weakening caused by suffocation. Table 3-4 Alarm types
Suffocation alarm time can be set from 10 to 60 seconds. Use Chapter 7.

3.7.2 Back-up ventilation

Information Alarm conditions Alarm level Type

Backup ventilation exists in spontaneous breathing mode. The application of

spontaneous breathing mode at a time when the patient is not breathing, Apnea
Exceeding the set apnea
High priority
Physiological
choking device sends an alarm immediately after the pre-set fixed content or time , Spontaneous trigger didn’t occur. alarm

provide constant pressure ventilation to the patient. When patients recover

spontaneously breathing capacity, and continuous trigger twice ventilation,
the ventilator stopped backup ventilation, spontaneous breathing pattern Minute ventilation monitoring the value of three
Physiological
continues. MV High consecutive respiratory cycles or higher minute High priority
alarm
ventilation setpoint limit the time within 10 seconds.
Backup ventilation function described in “2.5.2 Backup ventilation” section.

3.7.3 Airway pressure safety valve

In order to prevent the patient’s airway pressure being too high and causing Minute ventilation monitoring the value of three
Physiological
MV low consecutive respiratory cycle or below the lower High priority
barotrauma, equipment configures airway pressure safety valve. If the pressure limit value of minute ventilation in 10 seconds.
alarm
of the patient airway pressure reaches or exceeds the upper limit value of
safety valve, the inspiration valve is closed, and the safety valve opens to
release the high airway pressures.
Three consecutive values of the peak pressure
3.7.4 Main power malfunction and battery Pressure high monitoring breathing cycle or upper airway pressure High priority
Physiological
alarm
greater than the set value in 10 seconds.
When an external power supply when the power fails, the ventilator will
automatically switch to battery-powered operation. Also, when this switch, the
device generates a low priority alarm to alert the operator’s attention. Peak pressure monitoring values for three consecutive
Physiological
In the lower right of the user interface to display the status bar of the power Pressure low respiratory cycle or within 10 seconds less than High priority
alarm
the lower limit value of airway pressure.
supply, the device switches to battery power supply mode, and displays the
remaining battery power consumption.
Ventilator running See Chapter 4 “Battery Module” section to switch to Continuous Airway pressure monitor for 15 seconds more Physiological
High priority
pressure high than the value of PEEP settings. alarm
battery-powered equipment after.

Attention! GAS SUPPLY FAILURE Air, and oxygen are insufficient at the for ten seconds. High priority Technical alarm

Internal battery-powered ventilator, when in use, disconnect the power supply,

the machine quickly replace the internal battery, the device can maintain the
current alarm setting, the alarm will not change the preset.

36. 37.
 Expiratory tidal volume monitoring the value of three
Medium Physiological
Total respiratory frequency monitor value for three VTE LOW consecutive respiratory cycle or are below the lower
Physiological priority alarm
RATE LOW consecutive breaths or within 10 seconds of the time limit High priority limit set tidal volume within 10 seconds of time.
alarm
set value lower than the frequency of respiratory.

When battery supplying time is less than 10 minutes,

BATTERY LOW High priority Technical alarm
the battery power indicatorshows 1 grid.
Total value of respiratory rate monitoring three consecutive
Medium Physiological
RATE HIGH breathing cycles, or within 10 seconds of the time limit
priority alarm
set value is higher than the respiratory frequency.

Medium
O2 SUPPLY DOWN Oxygen gas source pressure is lower than 0.28MPa for ten seconds. Technical alarm
priority
Battery power supplying time is less than 5 minutes.
BATTERY DISCHARGED High priority Technical alarm
Battery power indicating shows 0 grid
Medium
AIR SUPPLY DOWN Air gas source pressure is lower than 0.28MPa for ten seconds. Technical alarm
priority
Monitoring the oxygen concentration value of 3 consecutive
Physiological
FiO2 HIGH respiratory cycles or within 10 seconds of the time the oxygen High priority
alarm NEBULIZER ON Open nebulization Low priority Technical alarm
concentration is higher than the upper limit set value.

MAINS FAILURE Net power disconnected or malfunction Low priority Technical alarm

Monitoring the oxygen concentration value of 3 consecutive

Physiological
FiO2 LOW respiratory cycles or within 10 seconds of the time the High priority
alarm
oxygen concentration is below the lower limit value.

STANDBY ACTIVED Switched from working state into stand-by state. High priority Technical alarm

ETCO2 monitoring the value of three consecutive cycles or Physiological

ETCO2 HIGH High priority
higher than the upper limit set ETCO2 value within 10 seconds. alarm

ETCO2 monitor value three successive cycles ETCO2 Medium Physiological

ETCO2 LOW
limit set value or below within 10 seconds. priority alarm

When the peripheral module monitors the Medium

ETCO2 LINE OCCLUSION Technical alarm
carbon dioxide sampling tube is blocked. priority

ETCO2 OFF Option in the system settings, turn off the function ETCO2. Low priority Technical alarm

Expiratory tidal volume breathing monitor value for

Physiological
VTE HIGH three consecutive cycles or within 10 seconds of the High priority
alarm
time limit set value is higher than the tidal volume.

38. 39.
 4 Equipment description
through fixed keys.

Patients with device

Patient management and control means for the air flow, and a pneumatic
circuit including the control section. Patients with fixed displacement or
4.1 System
pressure means for the patient to provide a mixed gas oxygen concentration,
which is equipped with an internal battery module, the battery module to
4.1.1 R50 Ventilator provide backup AC power failure or during patient transport.

8 11 9
4.2 User’s interface

4.2.1 User’s interface general instructions

6
10 User interface using ergonomically designed.
5
7 Front of the device for the user interface, as shown in Figure 4-2, which consists
2 of display interface, fixed buttons, knobs and warning light components. All
4 the necessary functions and information equipment are concentrated in the
user interface area.

3
12-inch display screen color LCD display, touch operation can be used
to display the device status, monitoring parameters, waveforms. During
ventilation equipment, ventilation data in waveform or digital form curves
display interface display, parameter monitoring area always displays ventilator
1 parameters measured. Meanwhile, the display interface also displays alarm
status, power status and other functions.
Users can operate the device functions via the touch screen to achieve, knobs
and fixed buttons. Touch screen menu operation, to achieve ventilation mode
switching, ventilation parameter settings, alarm settings, and most functions.
Fixed keys for quick control operations can be achieved atomization, alarm
mute, keyboard lock and other functions. Knob is used to adjust and confirm
the ventilation parameters. Warning light is used to provide different levels of
User’s
visual alarm status.
1 Trolley 2 Expiratory entrance 3 Water collecting bottles 4 Patient system 5
interface
4.2.2 Detailed description of user interface
Patient
6 7 Air and O2 supply 8 Oxygen battery Cover 9 Inspiratory exit 10 CO2 module
device

Figure 4-1 Ventilator total drawing

4.1.2 Outline

Mainly composed of the ventilator and patient interface device user. Ventilator
can be assembled in a small car, easy to move or transport sick room.

User Interface

The user interface consists display interface, function keys for parameter
adjustment knobs and alarm lamp components.
Display interface can be displayed ventilator monitoring parameters and device
status. Touch display interface can operate most functions and ventilator
1 Alarm indicator 2 Display 3 Control instruction key 4 Knob
settings in this interface.
Some other functions such as breathing machines, etc. atomization achieved Figure 4-2 user interface

40. 41.
 each type of monitoring parameters, the central display monitoring parameter
values , the right side of the display unit of the parameter and alarm set upper
and lower limits.

4) Status Display :

The total area can display three states. The far left part of the display near
alarm status bar display alarm mute symbol (symbol 1 of section 1.5 user
interface symbol) and the remaining silent pause time; central area shows the
current state symbol of the keyboard , such as the user interface section 1.5
symbols 3and symbols 6 ; right side area displays the current system time.

5) Waveform display area :

This area is used to display the ventilation waveform , waveforms can be displayed
three kinds of curves , but also can display a waveform graph or two loop
waveforms. Each curve shows the waveform continues over time (x-axis ) of a
parameter measured . y-axis shows the magnitude of the change and measured
values. Squiggle different colors (manufacturer set the default color , change the
color can not be changed).
By default, the upper area shows the pressure - time waveform , the central
display flow - time waveform , the bottom of the display capacity - time
waveform . When you touch each display area , you can pop up the menu bar ,
Quick parameter the user can choose to display other types of waveforms in the region.
1 Mode display area 2 Alarm area 3 4 Status Display 5 Waveform area
monitoring area
6) Parameter setting area:
Power supply
Parameter Special function Prompt This area is used to set each parameter under different ventilation modes ,
6 7 8 Menu 9 status monitoring 10
setting area display area information area
area touch each parameter boxes, select boxes will turn yellow , then you can adjust
Figure 4-3 Interface function areas the knob to change the value of the parameter . After touching the frame
again, the color changes to blue background, parameter validation , device
parameters can be changed in accordance with aeration.
4.2.2.1 Display Interface
7) Special function display area:
Display interface is shown in Figure 4-3 , the entire interface is divided The area is used for the display of PEEPi , static compliance parameters , and
into nine different regions, each region has its own display or monitoring when using pure oxygen ventilation, oxygen supply in the area shows the
founction. Functions of each part show as follows : progress . Display function to achieve these operations, see description of key
“Insp Hold”, “Exp Hold”, “100% O2” on the “4.2.2.2 Fixed button “.
1) Mode display area :
8) Menu:
This area is used to display the ventilation mode currently in use. And when
The region is the main menu for ventilator operation. Mode selection, alarm
the breath is triggered by the patient ‘s ventilation, the right side of the mode
settings, system settings and other operations were completed operating in
character display spontaneous breathing symbol, the symbol is shown in this
this area . When standby, the menu bar displays three menu: mode , alarm,
manual section 1.5 user interface symbol 2.
system . Under working condition, the menu display four menu : mode ,alarm,
2) Alarm area : system and monitoring .

The area displays alarm information of device in the current. When no alarm , 9) Supply status monitoring area:
the regional background color is blue , when an alarm is caused, according to This area is used to display which power supply is used of the device.
the alarm level , will show red or yellow until the alarm is released .
When using the network for power supply , plug icon ( Section 1.5 User
3) Quick parameter monitoring area : Interface Symbol 7 ) on the left will display a green highlight; when using
battery power , the battery icon (Section 1.5 User Interface symbol 4 ) on the
This area is used to display the ventilator ventilation parameters , and it left will display a green highlights.
displays monitored pressure and expiratory tidal volume and other users of the
most commonly used parameters . The left column shows the parameters for When using the network power supply to charge the battery , the battery icon

42. 43.
 will scroll electricity , which means that the device is currently in charge of the 3) keyboard lock
internal battery .
Keyboard Lock key is mainly used for that user equipment has been set all
10) Prompt information area: the parameters, in order to prevent accidental touching leads to parameter
The area is used for displaying operating information of ventilator. For changes and endanger patient safety, use this key to lock operation interface.
example, as shown in Figure 4-3, when adjusing the inspiratory time, the Press this button, all ventilator operable features of user interface are locked,
system prompts user the I:E value under present setting. and the key indicator lights, while the unlock symbol at status display area
4.2.2.2 Knob in the display screen turns to lock. That indicates the user keypad is locked. If
need operating the ventilator, user needs to press the lock button again, then
Knob shown in Figure 4-2, and its main founction is to regulate the size of the the keyboard light is off, the lock indicator is converted to unlock icon.
selected parameters. When you select the parameters to adjust, the parameters
area turns yellow, then turn the knob clockwise to increase the parameter and 4) Inspiratory Hold
adjustment counter-clockwise, then reduce the parameters, press the knob In the process of the ventilation for patients , user keeps holding the button
again to confirm the adjusted parameters. to activate inspiratory hold at the end of inspiration, while the lamp is lit ;
Release the key to end the inspiratory hold , and the key indicator goes off.
4.2.2.3 Fixed Key
In order to protect patient safety , the longest time of inspiratory hold can go
User interface of the device also includes a fixed-key keyboard, shown in up to 15 seconds , that is,users has been keeping holding this key, the device
automatically turn the inspiratory phase into expiratory phase after 15s,
Figure 4-4. This keyboard constitutes of 11 keys, each key has a corresponding regardless of whether the user is still holding this key at this time.
function, the function of each key is described as follows:
When user uses this fouction , after the breath , the special function display
area will show the value of system static compliance (Cst) measurements.
Use this feature to accurately measure end-inspiratory lung pressure . During
X-ray , you can use this feature.
5) Expiratory Hold

In the process of the ventilation for patients , user keeps holding the Expiratory
Hold key, the key lamp is lit , the exhalation valve and inspiratory valves are
closed , ventilator keeps the expiratory phase state ; Release the button to end
the Expiratory Hold function , and key indicator goes off. In order to protect
patient safety , the longest time of Expiratory hold can go up to 15 seconds ,
that is, users has been holding down this key, the device automatically turns
the expiratory phase into the inspiratory phase after 15s, regardless of whether
1 Alarm Silent 4 Inspiratory hold 7 Power status indicating light
the case the user is still holding down the this key.
2 Alarm reset 5 Expiratory hold 8 Waveform freezing 10 Manual inspiration Expiratory hold feature allows you accurately measure the patient’s intrinsic
3 Keyboard locking 6 Pure oxygen ventilation 9 Neubilization 11 Start/Standby PEEP. After using this key special features will display the measured intrinsic
PEEP on the device display interface area .
Figure 4-4 Keyboard

1) Alarm Silent 6)100% O2

Pressing this button, you can achieve the alarm mute function and indicator at This key is oxygenated respiratory function keys, this feature allows the device
left corner of the keyboard lights, while status areaof the display screen will to supply 100% pure oxygen patients, duration of 2 minutes. Press this button
display mute symbol and the remaining time. Alarm Silent time is 120 seconds. to turn on respiratory function and oxygenation, the key indicator lights, while
progress is displayed ventilation equipment display interface special function
After the alarm silence time, the keyboard light is off, the mute symbol areas, the progress of the end, the light goes out, the concentration of oxygen
in display interface disappears. Or, when a new alarm occurs, the silence concentration restored to the default values.
immediately ends, keyboard light is off, and the display interface mute symbol
disappears, reappears alarm sounds. In the oxygenation ventilation process, if pressed again “100% O2” fixed keys,
then abort the oxygen supply.
2) Alarm reset

Press this button, enabling alarm reset, the alarm reset detailed description see
Attention!
section 3.5. In the process of oxygenation ventilation equipment to provide patients with
pure oxygen, the oxygen concentration is set temporarily disabled.

44. 45.
 7) Power status indicator

Power status indicator for power equipment category indicates that the user
is currently using. When using the network power supply, AC indicator lights
when using the internal battery-powered device, the green battery indicator
is illuminated. When using the network power supply to charge the battery,
orange and yellow light is on, which means that the device is currently in
charge of the internal battery.

8) Waveform freeze

Waveform freeze key provides the user interface to freeze the current
waveform display function. When you press this button, the button is lit, the
display interface mode display area freeze icon, while at the end of the screen
to freeze its ventilation waveform, the user can observe the detail screen 1 Display area 3 Handrail 5 Knob 7 Steppin
ventilation waveform. Press this button again, the light goes out, freeze icon 2 Key 4 Alarm indicator 6 Flow sensor
disappears, waveform thaw.
Figure 4-5 Main unit front
9) Spray function
Equipment for the duration of patient ventilation, press this button, the
atomization is enabled, the button is lit, the display interface alarm zone alarm
“atomization open.” Press this button again, the atomization is turned off, the
light goes off, the alarm eliminated.

Attention!
When using the spray function, since air or oxygen is introduced directly
into the patient through the proximal end of the atomizer, the real oxygen
concentration at this time the ventilator monitor the oxygen concentration is
not inhaled.

10) Manual suction

1 CO2 module 3 label 5 Exhalation valve
Manual key provides the user with the intake to the patient a manual
2 O2 sensor box 4 Inspiratory port 6 Cover
ventilation feature. In the ventilation expiratory phase, press this key, the
device immediately given a preset modes and parameters in accordance with Figure 4-6 Main unit left side
the ventilation.

11) Start / Standby

In the device during standby, press this button, the device started to provide
ventilation; during ventilation equipment, press this button, the device goes
into standby display interface prompts whether, after confirming the device
into standby mode, meanwhile, issued a standby alarm equipment.

4.3 Patient Device

4.3.1 Patient device outline

Patient device is a device to realize the ventilation management, and the

device has an external feature, prompt labels, internal circuit control system,
air system.

46. 47.
 1 Fan 6 Interface area Important!
2 Equipotential terminal 7 Back label
CO2 module for selecting components for perishable goods, module USES
3 Power switch (with switch protection) 8 Oxygen gas inlet
attention see chapter 11.
4 Power plug equipped fuse 9 Air gas inlet
5 Factory label 10 Battery cover 3) oxygen battery compartment

Figure 4-7 Back of main unit Oxygen breathing battery compartment configuration for the location of the
oxygen cell, which has a surface cover. Oxygen battery is a consumable item,
Warning! within a certain time need to re-check or replace the oxygen concentration of
oxygen batteries.
In order to cool the equipment normally, any covering or blocking is prohibit
Oxygen battery check and replacement of the manual method, see Chapter 8,
to the fan.
“Maintenance and cleaning.”
4.3.1.1 Ventilator Front view
4) side of the label
As shown in figure 4-4, the front view of the ventilator is mainly user interface, Side of the label as shown below, the label prompts the user before using the
the user operation on this screen. device, you need to read this manual to ensure correct use of a ventilator or
4.3.1.2 Ventilator side view properly installed components.
Meaning of each symbol on the label refer to this manual 1.5 “symbol.”
Patients with respiratory system connection mouth side breathing machine,
distribution of inspiratory interface, exhalation valve and some of the features.
Prompt tag is breathing machine side.
1) Inspiration port and expiration valve
The two interfaces to connect patients breathing circuit system, flow sensor
and the sensor sampling tube exhalation valve end connections, is used to
measure the tidal volume of patients breathe out.
Exhalation valve seat internal control of the breathing machine diaphragm
and diaphragm plunger, diaphragm plunger is a metal bar. Exhalation valve,
diaphragm, flow sensor are reusable components, the method of disinfection
using installation considerations, and please refer to chapter 8 of the present
manual maintenance and cleaning. Refer to user
1 2 CO2 label 3 Nebulizer 4 O2 sensor
manual
Attention! 5 Inspiratory port 6 Flow
sensor 7 Expiratiry port 8
Diaphragm installation
instructions
Exhalation valve through the pipeline and mask connected to the patient, for Figure 4-8 Side label
type B applied part.
4.3.1.3 Ventilator back view
Attention! Figure 4-9 shows the back of the ventilator. The back of the ventilator
breathing machine features such as air source inlet section .
To prevent damage to PEEP valve, rotating diaphragm plunger is prohibited.
1) nameplate affixed to the back of the ventilator , breathing on the
Attention! nameplate of the machine model, size, serial number, date of manufacture ,
manufacturer and other information for the user quick access .
In order to ensure the correct tidal volume measurement, flow sensor sampling
2) Power Inlet: No. 5 in Figure 4-6 , before breathing machine factory install
tube connection mode of connection as shown in the label, please.
the power cord to the power inlet , and additional protection frame , to
2) CO2 module prevent accidental removal of the power cord.
As shown in figure 4-6 serial number 1, the part for the CO2 module, which is Power entrance equipped with a fuse to protect the device or patient safety.
used to monitor patients at the end of the call of the CO2 partial pressure, the Fuses and replacement methods please refer to Chapter 8, “Maintenance and
need to connect the sampling tube to patients even when using outlet. cleaning.”
3) Switch: 4-6 No. 4 , when the ventilator , the switch opens as , otherwise, will

48. 49.
 switch off. External additional protection switch switch to prevent accidental
turn off the ventilator.
Warning!
4) And other potential terminal: No. 3 in Figure 4-6 , and other potential When the machine is working, Cal.port interface is not an external calibration
terminal can be connected to each other at the same time the use of multiple devices and other equipment.
medical devices to prevent electric shock.
5) Fan: back mounting ventilator fan , ventilator for cooling the heat inside
the heating devices , while preventing leakage of gas generated inside the
oxygen-rich environment.

Warning!
In order to cool the equipment normally, any covering or blocking is prohibit Figure 4-9 The Port label
to the fan. 7) Back label
6) Function Interface Zone: The device features an interface area for product Figure 4-8 for the back of the label on the label of the relevant part of the
maintenance or to provide additional functionality. There are four interfaces in features, specifications and warnings. Among them, fuses, spare battery will
the region, from left to right are the USB interface and Remote Alarm, check be described in detail in the appropriate sections.
port, RS232 port, VGA port, SPO2(optional).

Warning:
When the equipment is using with patient, The USB port does not connect to
the other equipments.

Remote Alarm:

The port for Remote Alarm.

USB:

Supply 5V voltage for other equipment.

Cal.port:
Figure 4-9 Back label
When the machine check external calibration device.
1. Refer to manual: To ensure safe use, please refer to the operating manual
VGA: before use.
When an external projector for teaching or demonstration. 2. Fuse: that here is the installation location of the fuse, the fuse for the two
specifications for T2AL/250V / 5X20. Its replacement methods detailed in this
RS232:
manual, please consult the Chapter 8, “Maintenance and cleaning.”
The RS232 port is used for updating software. 3. Battery: Indicates where a spare battery compartment, spare battery is a
nickel metal hydride batteries, its specifications, replace and Cautions please
SPO2:
refer to the manual Chapter 8, “Maintenance and cleaning.”
Optional. It is used for connecting SPO2 sensor.
4. Ventilator Caution:

Warning! Warning!
To prevent electrostatic damage to the equipment, prohibit hand touch
Disconnect power and gas supply before servicing.
function interface.

Warning! Warning!
Clean the fan filter every 500 hours.
Do not use an external VGA interface projector and other equipment while
the machine is working.

50. 51.
 Warning! user interface and stop breathing machine mechanical ventilation in order to
ensure patient safety.
Do not obstruct the fan filter.
Airflow control part is mainly composed of pressure reducing valve,
Warning! proportional valve, and sensors. This part of the module is the main module
Do not use in the presence of flammable anesthetics. of air flow control, pressure reducing valve can provide equipment with stable
gas pressure, so that the airflow into the subsequent control device to achieve
5. gas source identification: equipment required for gas supply gas type and a stable state. Through the adjustment of the proportional valve, breathing
specifications. machine can provide patients with constant rate or constant pressure air,
4.3.2 Pneumatic system airflow and the proportion of a certain concentration of gas, flow sensors flow
value, provide data for control and display.
4.3.2.1 Outline In addition, air flow control part supplies air flow for ventilator nebulization
function, and the flow is 6 ~ 10 l/min. Ventilator according to the setting of the
This ventilator belonged to pneumatically driven and electronically controlled
oxygen concentration choose nebulization gas source, when air pressure is low
ventilator, and pneumatic path was designed, accurately, efficiently, and
or air failure all the way, breathing machine automatically switch to another
intelligently.When it was working, the ventilator accomplished the required
along the atomizing air. So, breathing machine using atomizing function,
mechanical ventilation through all pheumatic modules according to the
patients with actual inhaled oxygen concentration may not be a breathing
preset value in control of oxygen and air flowrate. The ventilator pneumatic
machine monitoring of oxygen concentration, deviation of the real oxygen
path system can be devided into 3 parts according to its functions: inspiratory
concentration varies as the user parameter Settings, can’t accurate calculation,
module, expiratory module, and patient circuit:
the medical personnel should pay attention to the clinical situation at any
time.

O2
Inspiratory
Attention!
Control When using the spray function, the ventilator monitor inhaled oxygen
AIR control module
AIR concentration is not the true oxygen concentration.
module
Patient system Gas mixing and safety control part mainly constitute of mixer, the oxygen
concentration sensor, the valve, emergency valve. An oxygen gas flow control
Expiratory control module portion of the output air stream reaches the mixer after mixing, the intake
port delivered to the patient by mechanical ventilation. Concentration of the
Figure 4-10 ventilator gas path module drawing
mixed gas is monitored by a sensor and displayed on the user interface. In this
1) Inspiratory module: part of the airways, furnished with safety valves and emergency valves. Safety
valve is designed to protect patient safety and ensure patient airway pressure
As shown in figure 4-11, suction module is mainly composed of gas source
does not exceed a certain value set. When the patient’s airway pressure is too
access parts, flow control, safety control of gas mixing and parts. A variety of
large, the valve quickly opens, high pressure gas is released to ensure that
body to provide patients with gas, ventilation.
the patient is not crushed. Emergency valve is another measure to protect
Gas source monitor Safe valve patient safety ventilator, the ventilator when a fatal fault (eg power outage),
the emergency valve is opened, the patient can breathe freely from the
atmosphere.

Gas
source Gas inlet Flow control Mixer Patient
Attention!
When the patient’s airway pressure greater than 100 ± 10cmH2O, pressure
Figure 4-11 Inspiratory module diagram relief valve opens instantaneously.
Access part of the role of the gas source is the central source of supply or Expiratory control module
access ventilator gas cylinders by air pressure sensors to monitor and prevent
air pressure is too low to provide the required air flow for the device. As air Shown as figure 4-12, Expiratory control module mainly mainly constitute
pressure range to meet 2.8bar ~ 6.0bar, the ventilator work; such as detecting of PEEP valve, exhalation valve and sensors. This module is mainly used to
when the pressure is less than 2.8bar or pressure is too high, the ventilator will implement functions in patients with mechanical ventilation breath and inhale
bring unpredictable performance impact, or even damage the ventilator inside module with different mechanical ventilation mode.
the device, this when the ventilator alarm mode by displaying prompts the

52. 53.
 Breathing machine adopts electronic PEEP valve, electric control to achieve
precise PEEP function in order to achieve user preset PEEP level. Exhalation
Attention!
valve and exhalation valve includes a diaphragm breath control, for achieving When using wet or filtration device, the patient will increase the resistance of
patient breathe the breath of switching. Flow sensor is used to monitor the the pipeline.
patient’s exhaled gas flow.
4.3.2.2 Ventilator pneumatic principle drawing
Expiratory pressure monitoring module has a section for monitoring the
patient’s airway pressure. Principle of pneumatic equipment shown in Figure 4-13, it can be seen from
the diagram, the gas path of the device has two, one is used to control air,
oxygen is used to control all the way, two-way gas is mixed in a mixer at
provided to the patients. Inhale exhale part of the module is completed with
ventilation function.

Figure 4-12 Expiratory control module

Patients System

Patient ventilator system is used to connect with the patient, the ventilator
will provide airflow delivered to the patient, and the patient’s exhaled gas
emissions.
Patients systems including piping systems, water cup, Y-connector,
humidification devices simulate lung. Conduit piping system may be reusable,
disposable tubing may be, one cup of water generally contain the pipeline.

Attention!
When in use, in order to ensure safe and effective, the user select patients Figure 4-13 Ventilator pneumatic principle drawing
systems recommended by the manufacturer. 1 Watertrap 9 Gas mix room
2a 10 Inspiratory module
Warning! 2b
Pipeline pressure sensor
11 Oxygen battery
3a 12 Safety valve
To ensure patient safety, must be used with local regulations allow pipeline Filter
3b 13 Solenoid valve
connection system or component.
4a 14 Diaphragm one-way valve / stainless steel filtering net
One-way valve
Warning! 4b 15 Pressure sensor
5a 16 Expiratory module
Use pipe connection system or component does not meet the regulations will Pressure regulation valve
5b 17 PEEP valve
affect the basic performance of the device
6a 18 Expiratory flowrate sensor
Proportional valve
Warning! 6b
7a
19
20
Y-piece
Patient-end
Gas filter
On the ventilator system, do not use the breathing tube with a conductive 7b 21 Nebulizer
antistatic properties or characteristics 8a
Flowrate sensor
8b

Warning!
Use with local regulations allow humidification devices.

54. 55.
 Tray

4.4 Electrical system

Ventilator electrical system includes power supply module, controlling module Armrest
and display module. Figure 4-14 is electrical circuit system principle schematics.
Column
Switching power supplies and power supply board which main role is to
control the power of the ventilator and a spare battery. The main role is to
Hanging block
control the gas line control panel ventilator system. Showing some of the
major peripheral devices used to control and display section.

Chassis

Casters

Figure 4-15 Cart

4.5.2 Hinged arm

Hinged arm used to assist patients and fixed lines hanging. Double-joint robot
arm system at the top of the flexible section and hooks can bend freely at the
bottom of the shaft can rotate freely.
In use, the block is placed on the arm hanging left armrest ventilator, hanging
block rotation arm is fixed to the bottom of the handwheel, and in favor of
the patients can be placed in position.
Figure 4-14 electrical system principle schematic

4.5 Other Parts

Apart from some of these the parts introducing from several chapters above,
ventilator has some other user-friendly parts, such as moving cart, hinged arm
and so on.
4.5.1 Trolley

Mobile trolley is used to carry all the necessary user interface and a host of
optional equipment. Figure 4-15 ventilator moving car, by the pallet, handrails,
columns, hanging blocks, chassis and casters components.
Host ventilator installed in the tray, armrest for easy movement ventilator.
There are four mobile trolley casters, two front casters with brakes, when
necessary, depress the brake pedal can be fixed casters, when the car is no
longer able to move, to lift up the brake pedal, the brake is released.
Fixation hanging block provides a humidifier can be used to hang put suppliers Figure 4-16 Hinged arm
recommended humidifier.

56. 57.
 4.5.3 Filter

The part shown as Figure 4-17 is configured gas source filters for ventilator.
Filters for air intake end, as shown in Figure 4-16, it can be a source gas purge
most of the water in the supplied gas or dust. Filter filtration accuracy of 5
microns.
Filters require regular maintenance, the maintenance methods in Chapter 8 of
this booklet “Maintenance and cleaning.”

Figure 4-18 The whole machine

4.6 Battery module

Ventilator has a set of built-in NiMH battery module which can be used as
short-term backup power supply when there is no primary. In the fully charged
and a good working environment, the standard built-in battery module can be
powered in a common set of about 1.5 hours. Charging the battery status and
Figure 4-17 Filter
the situation is not always in the best condition.
4.5.4 Gas source piplines When the ventilator is connected to an appropriate AC power source, the
battery can trickle charge.
Gas supply pipeline for the gas supply pipeline connecting the device, shown
in Figure 4-16. Device has two air and oxygen gas, and therefore requires two The battery module is located on the back of the battery compartment
different lines. Inlet gas source equipment using NIST or DISS connectors, so ventilator, shown in Figure 4-19, consists of a protective cover, the cover will
the pipeline applicable NIST or DISS connectors can only be connected to this need to use a Phillips screwdriver for battery module can only be replaced
device. after its removal. Battery module is a battery pack, the installation of the
battery pack to Chapter 5, “Installation”, its specifications and precautions see
Attention! Chapter 8, “Maintenance and cleaning.

Gas supply pipe to withstand high pressure components shall comply with ISO
5359 or CGA-V5 standards choose to use the pipeline.

4.5.5 Ventilator overall unit

Under normal circumstances, the ventilator breathing machine from the host
machine, mobile car, robot arm and other components. Figure 4-18 followed
by the front, back and side views of the ventilator.

Figure 4-19 Battery module

58. 59.
 4.7 Medical air compressor the connection of the patient, to ensure not drag any pipes or no other
moving.
The medical air compressor is also known as compressor, when the center of 4.8.3 Storage
medical institutions can not provide gas and other gas source for the device, it
can be used as air supply ventilator. Further, it can also be used as an alternate During transport or storage devices need to meet certain environmental
air source of medical institutions. conditions, under this condition, the system can secure transport or storage.
Storage conditions of the system are as follows:
The company can provide customers with the air compressor, Model C30 and
C50. zz Storage temperature: -20℃ ~ +60℃
For users to buy other brands of air compressor as source, the compressor must zz Storage relative humidity: ≤95 %
meet international standard IEC60601-1: 2005 and local health regulations. zz Storage atmospheres :500 ~l060hPa
4.8 System transshipment, transport and storage
Attention!
4.8.1 Prior to the transshipment During storage, in order to maintain the effectiveness of the battery, the
battery pack every two months will be charged and discharged.
Prior to the ventilator connected or not connected to the patient for transport,
it should be ensured a fully comply with the following conditions:
zz Patient device and user interface were firmly connected and locked tightly.
zz All attachments were firmly connected and locked tightly.
zz Connecting to the battery and check the charged power supplying capacity
(when it was connected to patient, it should be fully charged), and check
whether the artificial respiration function is normal. Obey the related
instructions of the hospital.
zz Check to make sure that mobile trolley was intact.
4.8.2 During the transport:

During the ventilator connected or not connected to the patient for transport,
it should be ensured a fully comply with the following conditions:
zz Battery module was charged, artificial respiration device worked normally.
Obeying the relevant instructions of the hospital.
zz Ensured that when mobile trolley passed through the obstacles, no severe
shake occurred.

Warning!
If the trigger sensitivity is set too high, it may appear self-triggering
phenomenon (automatically triggered). If the respiratory system leak, such as
an inner gas tube hose without the mouth hoop, this case also occured. Thus,
ventilation was triggered by the system rather than by the patient, occurrence
of such cases should always be avoided by reducing the trigger sensitivity. It
was also important during the patient transport, because the patient’s body
shakes and the respiratory system trembles could also cause false triggering.

Attention!
zz In order to prevent ventilator accident triggering, the patient device should
be placed in its locked position during transportation.
zz When the mobile supporting arm changed its position, be alert to observe

60. 61.
 5 Installation
Exhalation valve installation steps are as follows:

1. The diaphragm assembly to the device, as shown in Figure 5-2, the

diaphragm plate toward the inside of the ventilator, will prevent the
formation of the diaphragm.
3. The exhalation valve seat aligned guide slots, forced under pressure after
exhalation valve clockwise, when you hear a “click” sound when a card pops
up, stuck exhalation valve, indicating exhalation valve installation place.
As shown in Figure 5-3,5-4,5-5. After installation, check whether expiratory
diaphragm remains flat.
5.1 Installation of patient respiration system 3. Shown in Figure 5-6, the expiratory flow sensor attached to the blue end
of the sampling tube exhalation valve exhaust port, the blue sampling tube
Typically, the patient with the system shown in FIG 5-1, which was a good connected to a device on the left side sampling ports, transparent sampling
connection shown in the figure, the conduit connecting the patient end of the tube connected to the right side of the device sampling port.
intake port to the device, and the other end connected to the exhalation port
device, the Y Three-way extension tube is connected to the port or terminal
patients, to connect to a complete patient respiratory system.
The humidifier can be fixed on a mobile trolley humidifier hanging blocks,
pipes can be placed on a robotic arm hook.

Figure 5-2 diaphragm assemble

1 Patient pipe 2 Humidfier 3 Water trap 4 Y pieces

Figure 5-1 Patient respiratory system connecting drawing

Important!
Patients system has many different types of accessories, such as adult /
infantile.
When standard, the device provides adult piping systems.

5.2 Installation of expiratory valve

When the equipment is provided to the user, exhalation valve diaphragm
expiratory flow sensor is installed on the device. However, these components
are sterilized using components, it needs to be disinfected properly installed
on the device. The method of installation shown in Figure 5-2 to 5-7.
Figure 5-3 expiratory valve position Figure 5-4 expiratory valve assemble
Important!
Disinfection, set apart expiratory diaphragm and the diaphragm plate were
disinfected way this booklet in Chapter 8, “Maintenance and cleaning.”

62. 63.
 5.3 Installation and replacement of oxygen cell
The oxygen concentration sensor is located on the side of the oxygen
ventilator battery compartment, the installation and replacement of the
oxygen concentration sensor (oxygen concentration sensor, also known
as oxygen battery), shown in Figure 5-9, pull open with your fingers snap,
take the cover Next, you can see the oxygen concentration sensor, connect
the sensor cable unplugged, pull out the connector (inside the enclosure to
prevent the connector is pulled), shown in Figure 5-10, will be placed on the
cable anchoring groove inside, with oxygen battery wrench into the oxygen
concentration sensor and removed. After replacing the cable connection is
good, then the cover into the slot, you can wear.
Figure 5-5 expiratory valve installation complete Figure 5-6 Flow sensor assemble The used O2 sensor must be replaced and discarded according to the
Exhalation valve removal procedure local relevant laws,the used O2 sensor can not be treated as the normal
oxygen battery cover
Demolition, with his left hand hold the exhalation valve, press and hold the waste.
right card, press down firmly until the card is in the underside of the following
exhalation valve, left hand firmly rotate counterclockwise, pull out the
exhalation valve. As shown in Figure 5-7.
The exhalation diaphragm removed from the device, shown in Figure 5-8.

Snap

Figure 5-9 O2 sensor box

Figure 5-7 expiratory valve disassembe

Figure 5-10 oxygen battery installation and replacement

5.4 Installation of Battery module

When installing a battery module, shown in Figure 5-11, the first host the
rear battery cover with a Phillips screwdriver to remove the battery into the
Figure 5-8 diaphragm disassembe slot, plug in the battery and battery-powered wire test line. After loading

64. 65.
 the battery, slide the battery cover back into the battery holder slot mouth,
aligned mounting holes, screws.
Warning!
Contrary to the battery removed. When replacing the fuse, patient must be disconnected.

The used battery must be replaced and discarded according to the

Warning!
local relevant laws,the used battery can not be treated as the normal
When replacing the fuse, AC supply must be disconnected.
waste.

Figure 5-12 Protection frame of plug Figure 5-13 Fuse notch

5.6 Installation of trolley

Under normal circumstances, available to customers, the mobile is installed in
the car. For installation, according to the following steps, shown in Figure 5-16.
1.Open the box to take the car chassis components and the introduction of
two casters with locking brakes (with brake castors attention install handrails
on one side), ready to install car.
2.Take the introduction of the car column, the column into the car fixed at the
base, and with a good four screws from the bottom locked trolley uprights.
Figure 5-11 Battery disassembe
3.The top of the pallet into the column and align the screw holes, lock the four
5.5 Replacement of fuse screws.
4.The bottom surface of the handrail on pallets, align screw holes for
Figure 4-7 and Figure 4-9, the fuse is located behind the ventilator power cord mounting screws.
plugs. When the device input current is too large, the fuse to disconnect the
power supply, protective equipment and patients. 5.Users should note that the two casters with brakes for breathing machine
forward, and the direction of the handrail installation.
1. We need to use the 2.5 hex wrench and flathead screwdriver when the
fuse replacement. The fuse specifications are T2AL250V.1, as shown in Figure
5-12, with a hex wrench to remove the protective frame screws, remove the
protective frame, unplug the power cord.
2. As shown in Figure 5-13 Use a slotted screwdriver to gently pry the power
cord socket fuse slot, remove the fuse after loosening the bracket, replace the
fuse.
3. Which will replace the fuse insertion slot bracket is completed, plug in the
power cord, you can install a protective frame.

Warning!
When replacing the fuse, to be used with the security certificate products.

66. 67.
 Figure 5-15 Main unit assemble

Figure 5-14 Cart

5.7 Installation of Main unit

Users to use, you need to install the mobile host small car, easy to use.
Installation steps are as follows:
1.The mobile car lock brakes, remove the breathing machine host, the host is
placed on the moving trolley tray, mounting holes and four mounting holes
on the bottom of the tray and the alignment of the host. The hosts will be
equipped with locking bolts from the bottom tray upward host box. As shown
in Figure 5-14.
2.The installation manipulator, the robotic arm into the armrest on the host
side of the host, the robotic arm lock bolts.
3.Install the humidifier, the humidifier assembly into the bracket trolley middle
column, the alignment slot seated.

Figure 5-16 Humidifier assemble

68. 69.
 6 Inspection before use
the functional failures continuously existed, then the ventilator could not be
connected to the patient.

Warning!
A gas supply path when the failure of the ventilator switch to another source
of gas path working, then the ventilator will not be set in accordance with the
oxygen concentration, oxygen concentration alarm may be generated.

6.1 Requirements on equipment 6.2 Pre-use check

User operate the equipment on the front and test it before use it. The
Attention! ventilator need to have already been connected before testing.

Before the device was used, please read this user’s manual first,and understand 1.Connect to gas supplies: Air and O2. Tighten the joint ensuring there is no
operatings and maintanences of each component, ensure that the following gas leakage.
requirements must be reached before use: 2.Ckeck if the expiration valve has been properly installed, ensure the gas
1. Devices were in intact condition. tightness.

2. Respiratory system were correctly connected, respiratory circuit was intact. 3.Connect with mains power, poke aside the baffle of power switch, turn the
power switch to “ON” position.
3. Check the diaphragm installation: flat patch installation should not have
distorted and so on 6.2.1 Testing pre-use check function when power on
4. Check the expiratory flow sensor: expiratory flow sensor sampling pipe 6.2.1.1 Effect of pre-use check function
connections are connected correctly, as shown in Figure 5-7, can not reverse.
The purpose of pre-use check function is to test the breathing circuit is in good
5. Gas supplying system was correctly connected, and pressure is normal. Gas
condition or not.
supplying pressure is between 0.28 ~ 0.6MPa. If air compressor is used, the air
supply inlet filter should be installed 6.2.1.2 Items of pre-use check
6. All required emergency devices were ready and in good condition. There are two items of pre-use check:
7. Devices used for airway maintanence and tracheal intubation were ready 1) Device test
and in good condition.
Devie test includes: Barometer check, Gas supply check, Internal leakage check,
8. Ensure that casters were not loosening and locked, so that the ventilator
Pressure sensor check, Safety valve check, Oxygen sensor check and Battery
could not be moved.
check. After finished checking it’ll display the test data and result to the
9. When powerline were connected to AC power. After AC power was testing interface.
connected, AC power indicator and battery indicator were lightening. If
indicators were not lightening, then there was no power in system. 2) Circuit test

Including “Circuit leakage test” and “Circuit compliance test”. After finished
Warning! checking it’ll display the test data and result the the testing interface.
Before ventilor were connected to patient, a pre-use inspection must always 6.2.1.3 Preparatory work
be done.
1) 0.4MPa Connect ventilator with Air and O2 gas supply source which pressure
is at 0.4MPa.
Warning! 2) Get ready for 2 pieces of standard corrugated tubes, one adapter and Y
To avoid the danger of electric shock, ventilator’s powerline cable should be piece.
inserted into the main power supply outlet with ground fault protection. 3) Connect machine with AC power supply.

Warning! 6.2.1.4 Options when of pre-use test.

If any functional failures were detected during the system starting-up and 1) Selection interface when power on, as shown in figure 6-1, the machine
would ask if pre-use check need to be carried out and it provides two

70. 71.
 optionas: jThe machine would enter into STANDBY interface, shown as Figure 2).If operater need to carry out pre-use check again when it’s already in
6-2, if there is no operation for 5s or press “NO”. k The machine would enter STANDBY interface, then press “Device/Circuit Test” button (the button # 1
into pre-use check interface, shown as Figure 6-3, if press “Yes”. In pre-use shown as Figure 6-2) to enter into pre-use check interface.
interface, there are three press, Quit SST, Device test start, Circuit test start.
6.2.1.5 Testing procedures of “Device Test Start”
1. If user wants to carry out pre-use check, then press “Device Test Start”
button to enter into prompt interface before entering into pre-use check
interface (shown as in Figure 6-4), meanwhile connect pipelines (shown as in
Figure 6-5) according to the prompt message.
2. After the pipelines connections are confirmed all right, then press “Confirm”
button, enter into the interface shows as in Figure 6, to carry out pre-use check
3. The testing result will be shown in the left screen after finished testing.

Figure6-1

Figure 6-4 Prompt interface of machine self check

Figure6-2 STANDBY interface

Figure 6-5 Picture about corrugated hose connection for machine self check

1.Quit SST” 2.Device Test Start” 3.Circuit Test Start

Figure 6-3 Pre-use check interface

72. 73.
 PRESSURE Airway pressure alarm lower When the monitored value of peak-value pressure was lower than
LOW limit was set to 50cmH2O the set value for 3 cycle,then airway pressure low alarm occurred

GAS SUPPLY Cut off air and oxygen When air is insuffient alarm occurred, then
FAILURE gas sources GAS SUPPLY FAILURE alarm occurred.

When the monitored value of the oxygen concentration

Oxygen concentration upper
FIO2 HIGH is higher than the set value for 10 cycles in a row, then
limit alarm is set to 30%
oxygen concentration high alarm occurred.

When the monitored value of the oxygen concentration

Respiratory frequency lower
FIO2 low is lower than the set value for 10 cycles in a row, then
limit alarm is set to 50%
oxygen concentration low alarm occurred.

In continuously 15 seconds (±2 seconds),airway pressure

CIRCUIT PEEP/CPAP value is
Figure 6-6 machien seft test process interface is continuously high pressure(PEEP+15cmH2O),then
OCCLUSION set to 5cmH2O
continuous pressure high alarm was sent out.
6.2.1.6 Circuit test
We can choose "circuit test" shown as figure 6-3. The option is the same as
"Device test". The test result is displayed in the right screen.

6.2.2 Alarm test :

Equipment before use to check whether its alarm function to work properly,
the test, ventilator settings as a standard working condition. Alarm type and
alarm test checks the test method as shown in Table 6-1:

Standard working condition:

Mode: VCV; VT: 400 mL; TI:1s; FREQ:20 bpm;

Pause:0%; Psens:3 cmH2O; PEEP/CPAP:0 cmH2O; FiO2:40%

Attention!
If the alarm did not occur as the instructions, Please contact service personnel.
Table 6-1 Alarm inspections

Alarm type Testing conditions Alarm status

Minute volume alarm When monitored value of minute volume exceeded the set value for 10
MV HIGH
upper limit was set to 6L respiratory cycles in a row, then minute volume upper limit alarm occurred

Minute volume alarm lower When the monitored value of minute volume was lower than the set value
MV LOW
limit was set to 10L for 10 respiratory cycles in a row,then minute volume lower limit occurred

PRESSURE Airway pressure alarm upper When the monitored value of peak-value pressure was higher than the set
HIGH limit was set to 15cmH2O value for 2 cycles in a row,then the airway pressure high alarm occurred

74. 75.
 7 Operating
equipments suggested by the non-equipment providers, then the users
must be responsible to complete consistency and safety of the system
performance. To ensure the safety of the electrical system, that is to fit the
IEC 60601-1 standard totally, only accessories and auxiliary equipment which
fited the newest IEC standards can be connected onto this the signal input
and output ports of this device.
zz If there were differences between the information on ventilator’s user’s-
interface and the corresponding information displayed on auxiliary
equipment, then parameters on user’s interface of the ventilator should be
seen as main reason of the displayed information.
zz When a closed system inspiratory device was used:
zz If the inspiratory flowrate of the inspiratory device were higher than
inspiratory flowrate delievered by the ventilator,then a negative pressure
could be produced to
zz exert on the lung and respiratory system of the ventilator,the limited
pressure of the expiratory part would be -20cmH2O.
Important! zz When closed inspiratory devive was excuting ventilation, please do not use
inspiratory hold or expiratory hold function.
zz Before the ventilator is connected with the patient,a pre-use inspection
must always be done. zz When the device is stopping using, please first make the ventilator standby,
zz If any operation could cause the risk for the patient, such as replacing then turns off the ventilator, and then disconnect the power supply and air
oxygen sensor etc,then the connection between ventilator and patient supply.
should be cut off.
zz If any abnormal situation occurred, such as irrelevant window puted out on Important!
screen, abnormal sound from the device, alarm(s) from patient device,or
high priority level technical alarm occurred, then the ventilator must be When the start-up-status-humidifier was used, the measured expiratory
checked immediately, and the corresponding components must be replaced volume might be bigger than the inspiratory steam volume;this was because
if necessary. when steam was inhaled, its volume was in expanding status.
zz Check the patient pipeline,port and other components/devices often to 7.1 Getting started
make sure that they are connected correctly.
zz The design of this device could not be applied for all types of anesthetic This chapter describes the operation of the ventilator, please refer to the
regents to the patients. To avoid the fire risk, flammable reagents(such as user before using the contents of this section, in order to be able to skilled
ether,cyclopropane) are not allowed to be used in the device.
operators ventilator.
Attention! When boot mode ventilator, ventilation, alarms and other parameters to their
default values. Ventilation to the patient prior to treatment, the patient’s
zz Once the ventilator is connected to the patient, its operation should be
watched and monitored by professional staff. condition to the user follow the ventilation function of the ventilator settings.

zz During the operation, water collector should be checked regularly, and it Table 7-1 for the default boot ventilator ventilation parameters. The default
should be emptied if it is necessary. alarm parameters, see chapter 7.2.3 Table 7-2.
zz Please do not use the sharp tools to touch the screen. Table 7-1 default parameters of ventilator power on
zz To ensure the safety, the back-up artificial respiration device should always
be prepared. SPO2 on/
Mode Trigger ETCO2 on/off Volume Sigh interval ETCO2 Unit
off
zz During the ventilator’s operating, do not disassemble the expiratory sensor VCV Pressure Last Set Last Set Last Set 100 Last Set
probe.(but expiratory sensor probe could be checked under the back-up
Vt Ti f Pause Psense PEEP FiO2
condition)
500mL 1S 20 0 2 3 40%
zz The measured value at the signal output end of the device and the data
processed by auxiliary equipment, could not be used as the basis of treating
or diagnosing. This decision can only be made by experienced medical staffs Important!
according to the previous or recgnized routine manner. If this system is used
together with the auxiliary equipments provided by the other providers, To avoid injury to the patient before the ventilator used in patients with
then we are not responsible for the accuracy of the signal processing. ventilatory parameters and alarms should be set according to the patient’s
zz If this system will be used together with accessories and auxiliary condition parameters!

76. 77.
 7.2 Initial setting and operation 7.2.2 set ventilation mode

1.Pressed down “mode” button at menu area,going into mode selection

7.2.1 Start up ventilation interface.
Gas supply and the power switch on the device, the device behind the switch 2.Click on the desired breathing pattern (such as PCV), press the “OK” button
to “ON” position, the device starts a self-test, shown in Figure 7-1. After the to confirm (shown in Figure 7-4), confirmed the device returns to standby or
test is completed, the device goes into standby interface, shown in Figure 7-2. ventilation page.
Click Start / Stasndby button to start ventilation. As shown in Figure 7-3. 3.Click to select the-need-to-be-adjusted parameters on main page, rotate Jog
Dial to adjust the ventilation parameter value(shown as figure 7-5),press down
the knob confirm key, to confirm each setting.

Figure 7-1 Self-test

Figure 7-4 respiratory mode select schematic diagram

Figure 7-2 standby interface

Figure 7-5 Adjusting parameters

7.2.3 Set the alarm menu

1.Press “alarm”key to select alarm set page.

2.Click to select alarm parameters of“setting 1”or“setting 2”,select the need-
to-be-modified alarm parameters.
3.Rotate the knob to the right or the left, and adjust the knob to the desired
value, press down knob confirm button.
4.Repeat the above operations, confirm each seting.
Shown as figure 7-6.

Figure 7-3 Ventilation interface

78. 79.
 The interface can be set to sigh interval, language classes, trigger type, end-
tidal CO2 units, end-tidal CO2 switch, oxygen switches, alarm volume and
other functions.
Alarm volume settings: Tap the alarm volume, so turn the knob to adjust the
parameter values (a beep sounds when adjusting). Press the knob to confirm
parameter settings
Device currently supports Simplified Chinese, English, Spanish, Turkish, four
languages, but can only choose in English, Spanish or Chinese, English, earth
language configuration.
The device supports two kinds of trigger pressure and flow rate, pressure
trigger to set the value of the reference PEEP, flow trigger provides bias can
reduce the work of breathing.
Equipment with end-tidal CO2 monitoring function, its monitoring units
available in this interface options; When you do not use this feature, you can
Figure 7-6 Alarm limit setting schematic diagram choose to turn off in this interface.
Shown as figure 7-9:

Figure 7-7 Alarm record schematic diagram

7.2.4 Set the system menu

7.2.4.1 How to know the system information

Figure 7-9 system setting diagram
Press “system”button, select “system information” page.
The interface display the version information of each software, and machine’s 7.2.4.3 Date time setting
run time. Meanwhile, theinterface also display present barometric pressure Click to select “system” button, select“time&date” button.
and pressure of gas supply pressure currently used for user’s reference. Click to select the-needed-to-be-set option, adjusting the knob left of right,
Shown as figure 7-8: and press down knob for confirmation.(attention: during the adjustment, it
must be a single button adjustment, press the knob to confirm, otherwise
adjustment failed )
After adjustment completed, click application key.
Shown as figure 7-10:

Figure 7-8 System information

7.2.4.2 System settings

Press the "System" button, select "Settings" page. Figure 7-10 system date time diagram

80. 81.
 7.2.4.4 System calibration 7.2.4.6 Curve settings
The equipment can produce the certain error because environmental changes, This device provided configurable curve graphical display scheme, the users
so in order to keep the accuracy of equipment measurement(s) , the regular through configuration could select a different monitoring waveform displayed
calibration maintenance would be needed for this equipment. In additional, in the main interface.
in order to facilitate the maintenance, this equipment provided engineer’s
a.Press‘Standby/Start’button,to display waveform interface.
mode function, the coresponding operation could be done by staffs who were
given the authority by the equipment providers. b. In the graphical display page, click interface appeared curve display manner.
There are five types of curve combination manners to choose from.
a. enter into the standby mode, press “system”button, select “system
calibration” page. c. Select the set curve manner, and return to the main page, it could be
b. click to select the corresponding calibration item, to start calibration displayed according to the cure manner of new configuration.
operation. Shown as Figure 7-13:
Shown as figure 7-11:

Figure 7-13 display curve settings interface schematic diagram

Figure 7-11 system calibration schematic diagram
7.2.4.7 Monitoring
7.2.4.5 Engineer’s mode
In the ventilation states, you canchoose "monitoring" key at menu area right
Service engineer mode is used, the user is not entitled to use the model. of the LCD."Monitoring" can display all of the parameter of ventilator.
To avoid users using engineer’s operation mode randomly, which could affect a. Click “monitoring”button, select“monitoring number”,displaying all
monitored parameters and values of the present running machine.
the accuracy of the equipment, the authorized password was set, if the
relevant operation needed to be done, please contact the equipment provider.
When used, enter the password to authorize the use of engineer mode
functions.
Shown as figure 7-12:

Figure 7-14 monitored value schematic diagram

b. Click “monitoring”button, select “waveform setting”, click to select layout
1,click button, graphical interface was displayed as curve waveform (see
Figure 7-16), now the waveform parameters could be displayed, Paw-t, Flow-t,
Figure 7-12 engineer’s operating interface schematic digram
V-t, EtCO2-t waveform.

82. 83.
 Attention!
The coresponding conditions of all measured or displayed flowrate, volume or
ventilation quantity were all ATPD mode.

7.3 Key
Fixed function keys review this manual 4.2.2.3.

7.4 Monitoring status

This device provided status-display-bar-function, which was used to identify
work mode, type of power supply, keyboard lock status, alarm information,
Figure 7-15 waveform setting schematic diagram triggering, the system clock, mute status and prompt message.
Number 1,2,4,9 of the figure 4-3 is the display of monitoring status. Please
refer to 4.2.2 in this manual.

Figure 7-16 layout 1 schematic diagram

c. Click “monitoring” button, select “waveform setting”, click to select layout 2,
click “ד button, (see figure 7-17),the interface displays waveform for P-V and
F-V (Paw-t,Flow-t,V-t,EtCO2-t waveform, one of the curve displays could be
selected).

Figure 7-17 layout 2 schematic diagram

84. 85.
 8 Maintainance and cleaning Warning!
O2 sensor is a sealed component, which contains a strong corrosive liquid,
causing severe skin and eye burns. If someone accidentally contacted with
on the skin, then it should be immediately flushed with water for at least 15
minutes and treated by the doctor, especially when the eye contact with these
corrosive liquids.

Warning!
8.1 General instruction
The used O2 sensor must be replaced and discarded according to the local
It was suggested that the device was checked regularly, for the further relevant laws,the used O2 sensor can not be treated as the normal waste.
maintenance information, please refer to Service manual.
Important!
Attention! zz Ensure O2 sensor used city MOX-4 Model.
Only the trained and authorized maintaining technical staff could carry out zz Exchanging O2 sensor could only be operated by the trained qualified staffs.
R50 critical-care ventilator maintenance. The manufacturer would provide
qualified technical staffs, maintenance manual (including circuit diagram, zz If need to replace the O2 sensor, please contact the supplier to purchase,
such as replacing the vendor does not provide, or non-vendors to develop
parts lists, calibration instructions and other information) to assists the users
models of O2 sensor may cause ventilator parameters inaccurate or
maintain and repairer.
unknown cause damage and even endanger the patient.
Attention! 8.2.1.2 Use requirement

Special wastes Class I O2 sensor storage requirements

The aged and used old batteries must be replaced and discarded according to zz Under normal circumstances, such as customer demand, O2 sensor suppliers
the local regulations. The aged old used batteries could not be treated as the sealed packaging, such as not using, do not open the O2 sensor packaging,
normal wastes. In some areas, cycling and reuse facilities are not available. to prevent oxidation caused by reduced life.
Special wastes Class II zz O2 sensor requirements for the storage environment: Temperature: -20 ~
The wasted old O2 sensor must be replaced and discarded according to the 50℃ , Humidity: 0 to 99%.
local regulations. The aged old used O2 sensor could not be treated as the Notes O2 sensor
normal wastes.
zz O2 sensor is a sealed unit, do not use sharp objects to contact the battery
Dangerous wastes (Infectious)
casing oxygen.
The device contained some components which could not be treated as the
zz O2 sensor interior contains strong corrosive liquids, can cause severe burns to
normal wastes.
skin and eyes. If accidental contact with skin, wash immediately with water
Disposable components continuously for at least five minutes, for treatment by doctors, especially
when eye contact with these corrosive liquids.
Only manufacture’s replacement of disposable components and spare parts
are acceptable. The disposable components treated must according to the O2 sensor life
hospital’s regulations and considering about the environment safety. zz This product uses the O2 sensor life of 2 years.
8.2 Maintaining components instructions zz Ventilator after use for two years or when the O 2 sensor calibration
ventilator oxygen concentration can not play its due role in monitoring
8.2.1 O2 sensor accuracy, consider replacing the O2 sensor.
8.2.1.3 Replacement of O2 sensor
8.2.1.1 Generalstatement
zz Will be the key to open the back of the ventilator host switch to “off”
O2 sensor is a consuming product, because it has a certain life when it opened position, turn off the ventilator.
from of the sealed box. When oxygen monitoring inaccuracy or monitoring
date invalid appeared, please replace the O2 sensor. zz The ventilator is disconnected from the mains and gas equipment.

86. 87.
 zz Demolition oxygen concentration sensor please refer to Chapter 5.3. surfaces exhalation valve casing around it. Do not let the cleaning solution
zz After the replacement is completed, the air, the oxygen gas source splashed exhalation valve pressure sampling holes, shown in Figure 8-2.
connected to the device, and then turn the oxygen sensor for verification.
zz Oxygen sensor calibration steps: Select the user interface “System” menu,
Warning!
then select “System Check” - “the oxygen concentration sensor calibration”, If you accidentally spilled cleaning fluid sampling hole, the need to dry
the device starts checking, shown in Figure 8-1. naturally exhalation valve, pressure sampling holes before installation to
zz Important! When calibration gas source to ensure stable gas supply. confirm the presence of any liquid.

Pressure sampling
port

Figure 8-2 Pressure sampling port

Clean the exhalation valve, the diaphragm and exhalation flow sensor

1) immersed in the solution for 5 minutes Klenzyme. The solution can be

heated to a maximum Klenzyme 67℃ .
2) After cleaning the surface with distilled water. Ensure complete flushing
out the excess cleaning fluid, to prevent the residual fluid volume remaining.
Figure 8-1 O2 sensor calibration Finally, wipe with a soft cloth or dry naturally.
8.2.2 Exhale channel expands cleaning 8.2.2.3 disinfection / sterilization

Important! Exhalation valve and exhalation flow sensor diaphragm is the preferred
method of sterilization steam sterilization (autoclave). After 20 recommended
Before the preventative maintenance was executed, the patient circuit must be cleaning and disinfection cycle after replacing expiratory flow sensor
extending cleaning by trained qualified staffs. diaphragm breath, after 40 sterilization cycles exhalation valve replacement.
1) After cleaning the surface to ensure complete flushing out the excess
Important! cleaning fluid, to prevent the residual fluid volume remaining.
Before use for each patient exhalation channel need to be cleaning. 2) Using a high pressure steam sterilization method, the expiratory valve, a
flow sensor diaphragm and exhalation valve for disinfection, the minimum
Exhale channel includes exhalation valve, diaphragm, expiratory flow sensor,
temperature 132℃ , the maximum temperature of 134℃ .
this section describes the cleaning and disinfection of these components.
Removal and installation of these components please refer to the fifth chapter 3) Low flow gas source (<10L/min) the exhalation valve, a flow sensor,
of this manual. exhalation diaphragm dry to ensure a pressure sampling port in the exhalation
valve flow sensor sampling port and no moisture and debris.
8.2.2.1 Prepare
The breathing machine at the back of the system switch button switch to “off” Attention!
position, turn off the ventilator.
To avoid damaging the synthetic rubber component, the max. temp should
The ventilator is disconnected from the mains and gas equipment. under 135 °C and the time should less than 15 minutes.
Disconnect the device from the mains connection optional and breathing
machines. Attention!
The exhalation valve, diaphragm and expiratory flow sensor removed from the It’s better to avoid use ultrasonic cleaning also to avoid use the glutaraldehyde
device, please check the manual disassembly mode 5.3. disinfectant concentration > 2%. If it have to, made sure to thoroughly rinse
and dry the components to prevent residues accumulation. Otherwise residues
8.2.2.2 Cleaning
will lead sensor inaccuracy readings.
1.Use a clean, soft cloth dampened with isopropyl alcohol wipe all exposed

88. 89.
 process. If the instrument did not properly cleaned, it could not be effectively
Attention! disinfected or sterilized in high-temperature. Cleaning to remove most of the
Residues in sample will lead sensor inaccuracy readings. bacteria and dirt would be an important guarantee for the best sanitizing
effect.
Attention! Important!
Check the expiratory diaphragm before reinstall, if any attrited or damage,
replace it. Under normal circumstances, expiratory diaphragm sterilization was
not needed. The high pressure sterilizer would shorten the life-span of
Attention! the expiratory sensor probe and expiratory diaphragm, especially the
implementation of high temperature to 134 ℃ ( executing time > 3 minutes)
All personnel should be aware that during the disassembling or cleaning some sterilization in the autoclave.
parts of the ventilator would have the risk of infection.
Important!
Attention! Under the possible situation, the instrument should be immediately cleaned
All disposable(one-off)components must be treated environmentally friendly and disinfected after us. Dirt such as saliva or blood etc should not be left on
and safely according to the hospital regulations. the instrument.

Attention! Important!
In the expiratory end, there might contain bacteria exhaled by the patient. We About humidifier routine cleaning methods, please refer to the separate
suggest use bacterial filter, filtering the airflow between expiratory channel to operating manual.
expiratory sensor probe, thereby reducing the spread of germs, we suggest use
8.2.2.4 Installation
the bacteria filter, thus reducing the number of daily cleaning and could also
extend the life-span of the expiratory sensor probe. Periodic replacement of Breath channel can be installed components after disinfection is completed,
the bacteria filter, could reduce the bacterial infection risk of crossing-infection the installation method fifth chapter of this booklet.
between patients and medical staffs.
Attention!
Important!
Before installation, the exhalation valve,flow sensor, exhalation diaphragm
Use the bacteria filter would increase the expiratory channel resistance, so that must be checked.
would increases the patient respiratory work.
zz Check the plastic connector was not damaged and cracked;
Important! zz Check the sealing circle and silicone diaphragm was no damaged deformed;
zz After cleaning, all parts are dry and free of stains residual;
zz Disinfection and sterilization must comply with the processes of regulations.
zz When cleaning or replacement of any components of the ventilator system, Attention!
you should always abide by the hospital relevant rules and regulations of
cleaning, replacing and handling of infectious materials. Various medical After exhalation diaphragm to be installed together with the cover they are
institutions had different standards on the implementation manner of the loaded diaphragm mounting groove.
cleaning, disinfection, sanitation and sterilization and on routine practice,
so this equipment would not be able to meet all those needs and special 8.2.2.5 After installation
requirements, also we would not be responsible for effectiveness of
cleaning disinfection and other health measures used by hospitals during zz Connected patient pipeline and accessories.
the patents’ treatment. It was recommend that you should use a proven
zz The ventilator pre-use inspection.
effective method described in this manual, and use the specific equipment
and follow procedures described. Other methods may be equally effective, 8.2.3 Battery maintenance
but unless this equipment provided written permission, otherwise we would
not guarantee this. The R50 critical-care ventilator has a built-in Nickel-Hydrogen battery set which
can be used as short-term back-up power supply when the main power failure.
Important!
Under the condition of adequate power and a good working environment, the
The cleaning would be the most important step in the cleaning / disinfection new built-in battery set could supply about 1.5 hours in the general settings.

90. 91.
 When the ventilator is connected to the appropriate AC power, the battery product technical support representative, see Appendix “After sales service
could be charged continuously and complementarily. unit”.
The R50 critical-care ventilator should be executed a preventive maintenance
Important! services every 5000 hours. Call to the company’s customer service department,
zz The life of built-in battery provided by manufacture is about tow years or contact qualified technical staff for maintains, for the phone number, please
discharge up to 500 times in good maintain condition. see Appendix.
zz The ventilator would slowly consume electric quantity of battery when the After continuous running for 5000 hours need to maintain and the content
ventilator is off. such as shown in table 8-3.
Please disconect the cable of batterywhen ventilator is not in use and the If needed any more maintenance and technical information, we could provide
battery would be charged every two months. a circuit diagram, parts lists, legend, calibration details or provide necessary-
repairable-equipment-components materials specified by manufacturer.
The interval should be short when storage temprature is too high.The
Ventilator daily need to maintain the content as shown in table 8-4.
recommended temprature is under 27℃ .
Table 8-3 Preventive maintenance
zz Ventilator will cut off the power supply when battery was completely
discharged.Please charge the battery in time.
NO. Part name Action Remark
8.2.3.1 Specifications of battery
This product use batteries for nickel metal hydride batteries, rated voltage 1 Air inlet filter Clean or replace
DC12V, rated capacity is 4200 mah, the battery through the CE certification,
under the condition of the breathing machine using the environment, have
2 O2 inlet filter Clean or replace
the safety requirements.
If the customer need to replace the battery, please contact manufacture to buy
3 Fresh gas inlet filter Clean or replace
the battery specifications, such as replacement battery, not manufacture may
cause unknown damage of breathing machine, and even endanger the patient
or the operator. 4 Ventilator The performance test

8.2.3.2 Battery maintenance and storage requirements

Table 8-4 Daily maintenance list
When customers buy separate battery as backup, in order to ensure the battery
life, please place the battery in as shown in table 8-2 of the environmental NO. Part name Period Action Remark
conditions.
Clean or
Table 8-2 storage requirements 1 Fan filter cotton 500 hours
replace

Project Temperature Relative humidity

2 Battery storage exceed for 60days Charge

The ventilator continue

Condition 10℃ ~+30℃ 10%~90%
working for 30days and
3 O2sensor Calibration
the calibration or selftest
is not performed.
The ventilator continue
The wasted aged battery must be handled and discarded according to the working for 30days and
4 Flow sensor Calibration
relevant local regulations the calibration or selftest
is not performed.
In some areas, may not provide recycling facilities.
Table 8-5 list use for a long time to maintain
The battery discarded directly may cause environmental pollution.
NO. Part name Period Action Remark

1 Air filter 10000 hours replace

8.2.4 Recommended regular maintenance
2 CO2moudule 50000 hours Calibration or replace
The company is committed to providing product support services. If you have
any questions about ventilator’s operation or maintenance, please contact

92. 93.
 8.2.4.1 Fan filter cotton
Attention!
Fan is located on the back of breathing machine, as shown in figure 8-3, the
outer shield, shield placed within filter cotton. Remove the fan cover must be Other equipment is prohibited placed under the filter.
wafer, sufficiently will filter cotton are taken from the fan cover.
Fan cover

Figure 8-3 Air filter

Figure 8-3 Fan
Fan filter cotton should be checked every 500 hours, when it is necessary to 8.2.5 Cleaning of ventilator
be clean. When cleaning, should be taken from the fan cover, soak in hot,
soapy water. After washing and drying thoroughly filter cotton, reinstall the 8.2.5.1 Outer surface cleaning
breathing machine. All the outer surface of the ventilator should wiped clean with isopropanol
Filter cotton to black, size of 60 * 60 * 15 mm square. Usually, only need dipped soft cloth.
cleaning, filter cotton when unable to filter impurities in cotton to clean clean,
need to change. Warning!
Warning! Never immerse ventilator in the cleaning fluid or spill the inside.
8.2.5.2 Cleaning and disinfection of other accessories
Block or cover is prohibited.
For not provided by the manufacturer, but by outsourcing any attachments
Attention! used in the treatment of respiratory R50 machine, shall comply with the
manufacturer’s recommended method for cleaning and disinfection.
When it is necessary to replace filter cotton.
8.2.4.2 Air filter
Air filter for the air inlet end of breathing machine air filters, as shown in
figure 8 and 4, its main role is filter out the dust in the air and moisture,
prevent moisture damage inside the equipment parts, prevent the dust into
the patients’ lungs.
Air filter filtration precision is 5 microns, in general, can be used not less than
10000 hours. If the air condition is bad, when the filter pressure drop more
than 0.1 MPa, need to change the filter.
Air filter for drainage filter automatically, when the water in the cup reaches
to a certain extent, the drain valve opens, the water is within the cup.

Important!
When using the water cup of filter towards the ground.

94. 95.
 9 Trouble shotting RATE LOW
Respiratory frequency was too low. Triggering
device sensitivity was set uncorrected.
Observed and took care of the patient.
Check triggering device setting. Check
inspiratory termination setting.

Connecting main power, the fully

charged battery module was
BATTERY
Battery module remaining power supply inserted.(the ventilator was
DISCHARGED
capacity was less than 5 minutes. connected to main power to charge
the battery module again.)

The measured oxygen (O2) concentration exceeded

9.1 High priority alarm the pre-set value or higher. Gas supplying equipment
or air pipeline disconnected. There were no air in
the wall gas supplying pipeline. Check if the air gas-
Diagram 9-1 High priority alarm question and correcting methods FIO2 HIGH source pressure were too low. Air module connection Check air supplying equipment
was cut off. If gas could not be supplied, then both
expiratory valve and safety valve should be opened.
Question Possible reasons Correcting methods

Exceeded the preset or default alarm limit. The time between Check the patient and respiration system. The measured (O2) concentration was lower than the pre-set
Apnea
two continuous inspiratory efforts longer than the set alarm limit. And check the ventilator’s settings. value or lower. The gas supplied in oxygen supplying pipeline
FIO2 LOW was not oxygen. Oxygen(O2) sensor failed or became invalid. Check oxygen(O2)supplying pipeline
Oxygen(O2) sensor was not calibrated. Oxygen gas module failure.
Exceeded the preset or default alarm limit. The patient’s Check the patient and the
MV HIGH independent respiratory activities increased. The ventilator self- respiratory system.
triggered (automatic cycle). Alarm limit setting improperly. Check alarm limit settings.
Check if there were condensate in expiratory
Condensation existed on expiratory sensor, which caused sensor. The value-limit-setting was done
Check patient and respiratory system. VTE HIGH expiratory resistance increase. The setting was improper. according to the current tidal volume.
Check pipeline orifice pressure.
Exceeded the preset or default alarm limit.
Check patient respiratory system(doing
Note: this alarm was also used as patient disconnecting
the leakage testing when necessary). Battery module remaining power supplying New battery module was inserted
alarm. The patient’s spontaneous respiratory activity BATTERY LOW
MV LOW Check the pause time and the capacity was less than 10 minutes. or connecting the main power.
decreased. Pipeline orifice surrounding leaked. Patient
graphical display for verification.
respiratory system leaked. Alarm was set improperly.
Consider let the ventilator increase
patient respiratory support.
Observed and took care of the patient.

Airway pressure exceeded the pre-set pressure upper limit. The

pipeline twisted or blocked. mucilage or secretions clogged Lungs ventilation was insufficient, alarm
ETCO2 high parameters settings were low
the tube inside the air hose or airway. The patient cough or
PRESSURE HIGH respiratory rhythm is inconsistent with the ventilator. The alrm was Check the patient and respiratory system. Checked the ventilator’s settings.
set improperly. Expiratory bacteria filtering device was blocked.

Airway peak pressure was lower than The ventilator entered into standby mode,
pre-set pressure lower limit. Check patient and respiratory system. Standby activated Observed and took care of the patient(s).
and terminated ventilation
Tidal volume was set too Check ventilator’s setting and alarm limit.
PRESSURE LOW low. pipeline fell off. Severe gas leakage.
Alarm was set improperly.

CIRCUIT Airway pressure continued to be high pressure(PEEP

Checking patient and respiratory system.
Check ventilator settings. If the problem
Important!
OCCLUSION +15 cmH2O )over 15 second(±2 s). still existed, then please contact the
maintaining technical personnel. If the airway pressure increased and exceeded the set pressure upper limit,
then expiratory valve would open. If the system air pressure exceeded
GAS SUPPLY Air and oxygen pressure were both lower than 280kPa Check air and oxygen supplying pipeline. maximum safety pressure, then the safety valve shall open.
DOWN or air and oxygen supply pipeline were disconnected. If the questions still existed, then please
contacted maintaining technical personnel.

96. 97.
 9.2 Middle priority alarm
10 Technical Data
Diagram 9-2 middle priority alarm questions and correcting methods

Question Possible reasons Correcting methods

Observed and took care of the patient.

Respiration frequency was too high.
RATE HIGH Check the triggering device setting. Check if
Automatic triggered. Pipeline leaked.
the patient tube path connection were normal.

Oxygen(O2)supplying pressure Check oxygen supplying pipeline. If the

O2 SUPPLY DOWN was lower than280 kPa. Oxygen problem still existed, then please contact 10.1 General technical description
supply pipeline disconnected. the maintaining technical personnel.

System:
Checked and connected air supplying pipeline
Air SUPPLY DOWN
Air supplying pressure was lower than 280
well. If the problem still exited, then please
zz General instruction:
kPa. Air supplying pipeline disconnected.
contact the maintaining technical personnel. zz The device met medical equipment starndard requirements 93/42/EEC
zz Standard:
Pipeline fell off. Gas leakage was Check patient and respiration system. zz IEC 60601-1( Classl , TypeB )
VTE LOW
severe. The alarm was set improperly. Check ventilator setting and alarm limit.
zz IEC 60601-2-12

Hyperventilation zz Degrees of protection providedby enclosures: IP21(according to IEC 60529).

Observed and took care of the patient.
ETCO2 low Alarm parameter setting were high.
Check ventilator setting. Power:

Please check if the CO2 sampling tube zz Automatic arrange transform AC: 100 ~ 240V, frequency 50/60 Hz.
ETCO2 sampling tube blockage CO2 module sampling tube blockage
were blocked by sputum or etc. zz Battery: Ni-MH, DC12V, 4200mAh.
zz Charging time would be about 4 hours, power supplying time: 1.5 hour.

9.3 Low priority alarm Attention!

Diagram 9-3 Low priority alarm questions and correcting methods. Isolation from SUPPLY MAINS / POWER SUPPLY by disconnection of POWER
SUPPLY CORD / PLUG.
Question Possible reasons Correcting methods
Electromagnetic compatibility(EMC):
Power cable fell off Observed and took care of the patient.
zz Radiation: Conform IEC 60601-1-2
MAINS FAILURE Net power failure Check if power cable were well
Switch power damage connected.Replaced switch power. zz Anti-interference performance: Conform IEC 60601-1-2

NEBULIZOR ON Nebulization function switched on Switched off nebulization

Critical-care ventilator:

zz General instruction: patient device:length 455mm x width 400mm x height

ETCO2 OFF Switch off the ETCO2 in the system setting Switch on the ETCO2
300mm
zz weight would be appximately 12.5kg.
zz Triggering manner: flowrate trigger and pressure trigger.
Gas supply: the supplied gas must be fresh gas which is water-free, oil-free or

no impurity particles, and its contents must be belwo the following standards:
3 3
zz Air: H2O < 79mg / m , oil < 0.5 mg / m
3
zz Oxygen: H2O < 20mg / m
zz Inlet pressure: 0.28~0.6 MPa

98. 99.
 zz Connecting standard NIST or DISS standard could be used. zz Expiratory resistance: 3cmH2O @ 60L/min
zz Patient system gas transporting connector: zz Expiratory flowrate measuring: Flowrate arrange: 0~200L/Min.
zz Cone port: male connector 22mm;
zz female connector 15mm.Conform ISO 5356-1:2008. 10.2 Patient system parameter
zz Exhaust port: male connector 22mm Cone
Table 10-1 technical parameters
Suitable patient arrange:
Parameters Description
zz Infant(>5Kg), child, adult patient.
Operation condition:
Type Phematically driven electrically controlled.

zz Operating temperature range: 10℃ ~40℃ .

zz Relative humidity: 5%~95%, Non-condensing. Display screen 12 inches,TFT display screen.

zz Atmosphere pressure: 500 - 1060hPa

Battery Nickel hydrogen battery,supplying power for 1.5 hour.
zz Altitude: ≤5000m
Non-operating status condition: VCV,PCV,SIMV-VC+ PSV,SIMV-PC+PSV,SIMV-PRVC(optional)
Respiratory mode SPONT(CPAP/PSV),DUOPHASIC/APRV, PRVC(optional),NIV-
zz Anti-collision: peak acceleration: 15g PC(optional),NIV-CPAP(optional)

zz Pulse duration: 6 ms
Waveform：pressure-time,flowrate-time,volume-time,
zz The number of collisions: 1000 Graphical display CO2-time,pulse rate-time
zz Temperature: from -20℃ to +55℃ Loop graph：pressure-volume,flowrate-volume

zz Relative humidity ≤95 %

zz Atmosphere pressure: 500 - l060hPa Pneumatic path system safety pressure ≤125cmH2O.

zz Altitude: ≤5000m
Data communication port Serial port RS232,VGA
Testing mode:

The flowrate measurement of this ventilator used ATP manner, that is: The
gas flowrate and flow quantity were transformed into the volume flow Table 10-2 main seting parameters
quantity under the current environment(current atmosphere pressure,current
temperature and current humidity). Parameters Description

Inspiratory channel:
Tidal volume Range: 50~2500 mL;Increment: 10mL; 20mL(optional)
zz Pressure decreasing:
zz When flowrate was 60L/min, the maximum would be 6cmH2O. Respiratory frequency Range:4~120 bpm; Increment: 1 bpm; SIMV: 1~40bmp

zz When flowrate was 30L/min, the maximum would be 3cmH2O.

Inspiratory time Range: 0.1~12s; Increment: 0.1s;
zz When flowrate was 5L/min, the maximum would be 1cmH2O.
zz Inspiratory resistance: 6cmH2O @ 60L/min
Range: 0~50%,relative to percentage
zz Gas transportation: Flowrate arrange:0~180L/Min.
Breath-holdtime
Expiratory channel: of inspiratory time;

zz Pressure decreasing:
Pressure triggering Range:(PEEP-20cmH2O); PEEP 0 cmH2O: Increment:1 cmH2O;
zz When flowrate would be 60L/Min, the maximum < 2cmH2O.
zz When flowrate would be 30L/Min, the maximum < 1cmH2O.
Flowrate triggering Range: 0.5~20 L/min; Increment: 0.1 L/min;
zz When flowrate was 5L/min, the maximum <0.5cmH2O.

100. 101.
 PEEP Range: 0~50 cmH2O;Increment: 1cmH2O; Spontaneous respiration frequency Range: 0~120 bpm; Resolution: 1 bpm;

Pressure support Range: 0~80 cmH2O; Increment: 1 cmH2O; PEEP Range: 0~50 cmH2O; Resolution: 1 cmH2O;

Pressure control Range: 5~80 cmH2O; Increment: 1 cmH2O; Airway peak pressure Range: 0~100 cmH2O; Resolution: 1 cmH2O;

High pressure level Range: 5~80 cmH2O; Increment: 1 cmH2O; Mean airway pressure Range: 0~100 cmH2O; Resolution: 1 cmH2O;

Low pressurelevel Range: 0~50 cmH2O; Increment: 1 cmH2O; Inspiratory platform pressure Range: 0~100 cmH2O; Resolution:1 cmH2O;

Oxygen concentration Range: 21~100%; Increment: 1%; Minimium airway pressure Range: -20~100 cmH2O; Resolution: 1 cmH2O;

Pure oxygen
Pure oxygen ventilation 2min; Airway resistance Range: 0~600 cmH2O/(L/S); Resolution: 1 cmH2O/(L/S);
ventilation

When this button is pressed and hold,after the ventilator switched into expiratory status, closed
Expiratory hold Compliance Range: 0~300 mL/cmH2O; Resolution: 1 mL/cmH2O;
inspiratory expiratory valve, until releasing the button or the longest time was less than 15 seconds.

When this button is pressed and hold, ventilator finished this inspiration then it switched into
Inspiratory hold RSBI respiration index Range: 0~9999 bpm/L;Resolution: 1 bpm/L;
breath-hold section, until releasing this button or the longest time was less than 15 seconds.

Manual inspiration This key is pressed and hold during the expiratory part, the ventilator automatically triggered inspiration once. Inhaled oxygen concentration monitoring Range: 15% ~100 %;Resolution:1 %;

Freeze After pressing this key, waveform stopped refreshing , press again toactivate. SPO2 Range: 0 ~ 100 %;Resolution:1 %;

Pluse Rate Range: 30~250 bpm;Resolution: 1 bpm;

Table 10-3 back-up ventilation setting parameters

Back-up ventilation volume mode seting item andrange Vt:50 -2500 ml/20mL(optional) TI :0.1-12.0 s FREQ:4-120 bpm EtCO2 Range: 0~100 mmHg;Resolution: 1 mmHg;

Back-up ventilation pressure mode seting item andrange Pinsp:5-80 cmH­2O TI: 0.1-12.0 s FREQ:4-120 bpm
Table 10-5 Alarm parameter

Alarm items Description

Table 10-4 monitoring parameters

Parameters Description Upper limit 20~3000 mL

Tidal volume
Inspiratory tidal volume Range: 0~4000 mL; Resolution: 1 mL; Lower limit OFF,20~2990 mL

Expiratory tidal volume Range: 0~4000 mL; Resolution: 1 mL; Upper limit 1~99 L

Minute volume
Minute volume Range: 0~99 L; Resolution: 0.1 L; Lower limit 0~98 L

Spontaneous minute volume Range: 0~99 L/min; Resolution: 0.1 L/min; Upper limit 22~100%,OFF

Oxygen concentration
Total respiration frequency Range: 0~120 bpm; Resolution: 1 bpm; Lower limit 20~99%

102. 103.
 Upper limit 1~99 cmH2O
11 CO2 module
Airway pressure
Lower limit 0~98 cmH2O

Upper limit 1~120 bpm

Respiratory frequency
Lower limit OFF, 1~99 bpm

Upper limit 50~99%,OFF CO2 modules, components and packaging must be carried out in accordance
with local regulations concerning replacement and discarded. Can not handle
SPO2 the normal way of handling waste CO2 modules, components and packaging
Lower limit 49~99%;
waste.

Upper limit 1~100 mmHg;

11.1 Product Description and Applications
ETCO2 In the EU and North America, as the conventional end-tidal CO2 monitor
Lower limit 0~99 mmHg; parameters essential parameters, while the majority of high-end ventilators
and Anesthesia Workstations are also equipped with this feature.
Upper limit 31~250 bpm;
End-tidal CO2 module can monitor exhaled air concentration of CO2, end-tidal
Pulse rate CO2 concentration, inhaled CO2 concentration and respiratory rate, inspiratory
Lower limit 30~249 bpm; time and expiratory time. This module can be used for intubated patients (via
a three-way sampling) and bedside patient (via nasal sampling tube sampling).
The module can be used for newborns, children and adults.
Circuit occlusion When airway pressure exceeded (PEEP+15)cmH2O forcontinuously 15 seconds.

Caution!
Apnea alarm The set time was 15~60s, Increment was 5s; This module has been calibrated at the factory, does not recommend the user
to calibrate. If the user finds a significant deviation from the measurement
O2 SUPPLY DOWN alarm Oxygen supply pressure was less than 0.28 MPa; results, the need to return to factory calibration. The module also with
automatic zero calibration function be zero in the course of automatic
calibration drift. Boot heat 10 minutes at least, shall not be cleared clogged
O2 SUPPLY DOWN alarm Oxygen supply pressure was less than 0.28 MPa;
pipe, not in the clear tube near the CO2 gas emissions, must be replaced after
plugging off the bottle. This module is less than the offset measurement
Mains failure alarm Automatically switched into battery power supplying; 1mmHg.

11.2 Performance indication

Battery power low alarm After alarm battery supplying time would be no less than10 min;

Power requirements 5 .0 V ± 0.2V DC

Battery discharged alarm After alarm battery supplying time would be no less than5 min;
Power General 80mA, 300mA extreme circumstances

Operating Temperature 5 ~ 50℃

Alarm silence ≤120 s
Storage Temperature -20~ +70℃
Moveable trolley: Relative humidity 0-85% (non-condensing)

zz Weight : 20kg Size 77 × 50 × 30mm

zz Size : Length565mm x Width535mm x Height910mm CO2 measurement range 0 - 20% by volume of (0 - 150mmHg @ BTPS)

<5.0% CO2 (ATPS) Time: 2mmHg

CO2 measurement accuracy (see Note 2)
> 5.0% CO2 (ATPS) Time: <5% of reading

104. 105.
 Respiratory rate 2 ~ 150BPM can not be shared between patients, or they may cause cross-infection.

Respiratory rate measurement accuracy 1% @ ± 1BPM zz All can be discarded (disposable) components must be according to hospital
regulations and in an environmentally safe manner.
Warm-up time 10S
zz To prevent damage to the module in the water off the bottle is nearly full
Detector 28mS, system response time depends on the bottle sure to remove and replace the off, or out of water suction module
Response Time implementation, flow settings and dehydration technology
will cause the module to measure serious inaccuracies. Recommended use,
Automatically according to the time and one week at least once cup water puddles. In other cases, the operator
Automatic offset calibration
temperature, or under instruction discretion to increase or decrease the number of inspections.
zz Please ensure smooth flow of sampling tube, sample tube bending die and
Port Programmable serial, TTL, RS232 optional
so is not smooth conditions will lead to a long period of work overload
pump status, which will affect the life of the pump and the module as well
Automatically according to the time and
Fully automatic deviationcalibration temperature,or according to the instructions as the accuracy of measurement.
zz Repair or validated only by specially trained personnel. Recommended in
most cases return to factory repair.
Interfering gases and steam to CO2 measurement accuracy
zz If the module because the user or the operator's incorrect use or use
Gases or anesthetic agents Gas concentration CO2 contrary to the way the design, manufacturers will not be held responsible.
Nitrous oxide Volume percentage of 60% 1) zz The module can only be in the technical specification operation and storage
Halothane Volume percentage of 4% 1) under ambient conditions.

Enflurane Volume percentage of 5% +10% Of reading zz Missed off the bottle in the case do not use the module for the
measurement of exhaled gases, exhaled moisture may cause measurement
Isoflurane Volume percentage of 5% +10% Of reading
errors, but also easy to damage the moisture accumulation module life.
Sevoflurane Volume percentage of 5% +10% Of reading
zz Boot the case without heat, the reading will be minor deviations.
Desflurane Volume percentage of 15% +14% Of reading
zz Dramatic changes in temperature environments using the module may
1) the module allows normal operating conditions, the interference and can be neglected. cause the measured data is not accurate, so should be relatively stable over
temperature environments.
Warning! zz Any obstacles circulation of the sample gas, such as sampling tubes severely
This module is a non-mobile device, therefore, when the ventilator was being bent, contaminants blocking the sampling tube, bottle filters or severely
moved, the CO2 module accuracy would be affected. blocked off, may be both inaccurate measurements damage module life.
When the system clogging and lasts 20 seconds is not canceled, the module
will shut down the pump.
11.3 Safety Guide zz Error generated by the software has been reduced to the minimum risk, risk
detection has been met EN1441: 1997 and EN62366:2008.
For your safety reasons, please read the following contents and follow the
medical equipment products instruction requirements. zz Whatever causes pipeline leak occurs, it will seriously affect the accuracy of
measurement data and waveform shape.
Warning! zz Excess humidity in the range of use of standard operating state, the module
zz This module provides only exhaled CO2 and respiration rate data, only play will be affected by a greater impact on measurement accuracy, then please
a supporting role in the diagnosis, a doctor with clinical signs and symptoms use caution.
to make a diagnosis.
11.4 Connection
zz Disposable sampling pipes shall be reused to avoid cross-infection.

Caution! CO2 module was fitted The left side of external ventilator, water accumulating
cup was a detachable parts, water accumulating cup should be hold by hand
zz This module is used by trained professionals or professional medical center. when disassembling, it should be gently pull down, if the upper part of the
Operator before using the module must be familiar with the contents of the water accumulating cup fell off the bracket, then the accumulating cup should
manual. be removed for replacement, shown in Figure 11-3.
zz Single-use water bottles off (water control) can not be reused, otherwise it When using the CO2 module function, sampling tube should be connected
will lead to inaccurate readings or even damage the module. Off the bottle
to sampling orifice of the water collecting cup, threaded pipe should be

106. 107.
 12 Abbreviations and terms definition
respectively connected to the inspiratory orifice and the expiratory orifice of
the ventilator; among which right-angle connector should be connected to the
patient. Shown in Figure 11-3.

Bpm: The times of respiration per minute

Bias flow: The continuous flowrate during the expiratory period.
Breath cycle time: The total cycle time of a mandatory respiration under
SIMV mode(inspiratory time + pause time + expiratory time). Unit setting was
in second.
CMV: Mechanical controlled ventilation
CPAP: Continuous airway positive pressure.
Expiratory hold: Used in closing inspiratory and expiration valve after
expiration, during the key was pressed the respiration was hold(as long as 30
seconds). Measuring total PEEP value.
HME: Heat and moisture exchanger.
I:E: The ratio between inspiratory and expiratory time(which was set during
controlled ventilation period).
Inspiratory hold: Used in closing inspiratory and expiratory valve after
inspiration, the respiration was hold during the key was pressed (as long as 15
seconds). Measuring platform pressure.
Inspiratory cycle-off: The percentage of peak value flow rate(%), inspiration
Figure 11-3 CO2 module external connections schematic diagram was switched into expiration when this value was reached.
Minute volume: Inspiration capacity per minute or target capacity.
MV: Expiratory capacity per minute
MVspn: Spontaneous expiratory capacity per minute
O2: Oxygen concentration, unit vol.
O2 Suction: Providing 100% pure oxygen for 2 minutes. if the button was
press in 2 minutes, then pure oxygen supply would be stopped.
Pause time: The time when stop to deliver gas flow or no pressure exerting.
PC: Pressure control
PEEP: Positive end-expiratory pressure, unit(cmH2O)
Paw: Airway pressure
Ppeak: Maximum inspiratory pressure.
Phigh: Relatively high pressure.
Pmean: Mean airway pressure.

108. 109.
 Appendix I
Pplat: End inspiration pause period gas pressure.
PS: Pressure support ventilation.
PS above PEEP: Under the DUOPHASIC ventilation mode, TPEEP
period(cmH2O). Electromagnetic Compatibility
Respiratory Rate: Controlled mandatory respiratory frequency, or used in
calculating target capacity(times/minute).
Rate: Respiration frequency.
SIMV: Synchronized intermittent mandatory ventilation.
SIMV Rate: The controlled mandatory respiration frequency(times/minute).
Changing or reassembling this equipment without Siriusmed’s authorization
Manual Insp: Used in manually starting up respiration.
may cause electromagnetic compatibility problems. Contact with Siriusmed
Tidal volume: The volume of each respiration or target capacity(ml). for assistance. Designing and testing this equipment is in accordance with the
following stipulations.
Thigh: Under DUOPHASIC or APRV ventilation mode, the time in relatively
high pressure (Phigh) status(second).
Warning!
Tlow: Under the APRV ventilation mode, the time in the PEEP status(second). The devices need to be installed and used in compliance with the
VC: Volume controlled(volume fixed) ventilation. electromagnetic environment.

Warning!
Portable and mobile RF communications equipment can affect The equipment.

Warning!
Pins of connectors identified with the ESD warning symbol should not be
touched and that connections should not be made to these connectors unless
ESD precautionary procedures are used;

Warning!
The use of accessories, sensor and cables other than those specified, with
the exception of transducers and cables sold by the manufacturer of the
equipment as replacement parts for internal components, may result in
increased emissions or decreased immunity of The equipment.

Warning!
The equipment should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in the configuration in which it
will be used.

Warning!
The equipment can not be used magnetic resonance (MRI) environment.

Important!
Staff that could touch connectors identified with the ESD warning symbol
should receive this explanation and training. This includes clinical/biomedical
engineering and health-care staff.

Important!
ESD training should include an introduction to the physics of electrostatic

110. 111.
 charge, the voltagelevels that can occur in normal practice and the damage
that can be done to electroniccomponents if equipment are touched by an Recommended
OPERATOR who is electrostatically charged.
IEC 60601test
Immunitytest level Compliancelevel Electromagnetic environment guidance
separation
Guidance and manufacture’s declaration – electromagnetic emissions - for all distance
EQUIPMENT and SYSTEMS.

Portable and mobile RF communications

Conducted equipment should be used no closer
Guidance and manufacture’s declaration – electromagnetic emission RF
3Vrms to any part of the R50 VENTILATOR,
150kHz to including cables, than the recommended
IEC 3V d=1.17
80MHz separation distance calculated
61000-4-6
from the equation applicable to the
The R50 VENTILATOR is intended for use in the electromagnetic environment specified below. The frequency of the transmitter. where P is
customer or the user of R50 VENTILATOR should assure that it is used in such an environment. the maximum output power rating of
the transmitter in watts (W) according
to the transmitter manufacturer and d
is the recommended separation distance
Emission test Compliance Electromagnetic environment – guidance in metres (m).b Field strengths from
fixed RF transmitters, as determined by
an electromagnetic site survey,c should
The R50 VENTILATOR uses RF energy only for d=1.17 be less than the compliance level in
its internal function. Therefore, its RF emissions 80MHz to each frequency range.d Interference
RF emissionsCISPR 11 Group 1 Radiated
are very low and are not likely to cause any 3V/m 800MHz may occur in the vicinity of equipment
interference in nearby electronic equipment. RF
80 MHz to 3V/m marked with the following symbol:
IEC
2.5 GHz d=1.17
61000-4-3
800MHz to
RF emissionCISPR 11 Class A 2.5GHz

The R50 VENTILATOR is suitable for use in all establishments

Harmonic emissionsIEC other than domestic and those directly connected to
Class A
61000-3-2 the public low-voltage power supply network that
supplies buildings used for domestic purposes.
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is
Voltage fluctuations/flicker affected by absorption and reflection from structures, objects and people.
Complies
emissionsIEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity for all

EQUIPMENT and SYSTEMS
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795
MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
Guidance and manufacturer’s declaration – electromagnetic immunity 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference
if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into
the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges.
c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
The R50 VENTILATOR is intended for use in the electromagnetic environment specified below. The
customer or the user of R50 VENTILATOR should assure that it is used in such an environment. assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the R50 VENTILATOR is used exceeds the applicable RF compliance
level above, the R50 VENTILATOR should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM].
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

112. 113.
 Guidance and manufacture’s declaration – electromagnetic immunity –for all
EQUIPMENT and SYSTEMS 0.01 0.117 0.12 0.12 0.23

Guidance and manufacture’s declaration – electromagnetic immunity

0.1 0.37 0.38 0.38 0.72
The R50 VENTILATOR is intended for use in the electromagnetic environment specified below. The
customer or the user of R50 VENTILATOR should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Floors should be wood,concrete or 1 1.17 1.2 1.2 2.3
Electrostaticdischarge
±6 kV contact ±6 kV contact ceramic tile. Iffloors are covered
(ESD)
±8 kV air ±8 kV air withsynthetic material, therelative
IEC 61000-4-2
humidity should beat least 30%.
±2 kV for power 10 3.68 3.8 3.8 7.2
Electrical fast
supply lines ±2kV for power Mains power quality should be that of a
transient/burst
±1 kV for supply lines typical commercial or hospital environment.
IEC 61000-4-4
input/output lines
Surge ±1 kV line(s) line(s) 100 11.7 12 12 23
±1 kV line(s) line(s) Mains power quality should be that of a
IEC 61000-4-5 ±2 kV line(s) to earth
±2 kV line(s) to earth typical commercial or hospital environment.

<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT) For transmitters rated at a maximum output power not listed above, the recommended
for 0.5 cycle for 0.5 cycle separation distance d in metres (m) can be determined using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating
40% UT 40% UT Mains power quality should be that of a
Voltage dips, short of the transmitter in watts (W) according to the transmitter manufacturer.
(60% dip in UT) (60% dip in UT) typical commercial or hospital environment.
interruptions and
for 5 cycles for 5 cycles If the user of the R50 Ventilator requires NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
voltage variations on
continued operation during power mains
power supply input lines
70% UT 70% UT interruptions, it is recommended that NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz
IEC 61000-4-11
(30% dip in UT) (30% dip in UT) the R50 Ventilator be powered from an to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
for 25 cycles for 25 cycles uninterruptible power supply or a battery.
NOTE 3: An additional factor of 10/3 has been incorporated into the formulae used in calculating the
<5% UT <5% UT recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and
(>95% dip in UT) (>95% dip in UT) 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that mobile/portable
for 5 sec for 5 sec
communications equipment could cause interference if it is inadvertently brought into patient areas.
Power frequency magnetic fields
Power frequency should be at levels characteristic NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation
3A/m 3A/m
(50Hz) magnetic field of a typical location in a typical is affected by absorption and reflection from structures, objects and people.
commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

Recommended separation distances between portable and mobile RF communications equipment

and the R50 VENTILATOR

The R50 VENTILATOR is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the R50 VENTILATOR can help
preventele ctromagnetic interference by maintaining a minimum distance between portable
andmobile RF communications equipment (transmitters) and the R50 VENTILATOR as recommended
below,according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter /m

Rated
maximumoutput 150 kHz to 80MHz
150 kHz to 80MHz 80Mhz to 800MHz to
power oftransmitter outside ISM bands
in ISMbands 800MHz 2.5GHz
W d=1.17
d=1.17 d=1.17 d=1.17

114. 115.
 Appendix II Accessories List AppendixIII Aftersales service unit

Service unit
N.O. Name Specification Quality Remark
Name: Beijing Siriusmed Medical Device Co., Ltd.
Address: Room 201, Unit 6 of E6 Building, Beijing Yizhuang Biomedical Park,
1 Ventilation breathing circuits PVC 1set
No,88 Kechuang sixth street, Yizhuang, 101111, Beijing, China

ZIP: 101111
2 Bacteria/viral filter PVC, F22/M22 1 optional Telephone: 010-87576012
Fax: 010-87576012
3 Humidifier SH330 1 optional www.siriusmedica.com
Product Type: R50
4 Breathing bag 3L 1 Product name: Ventilator
Manufacturing adress: Room 201, Unit 6 of E6 Building, Beijing Yizhuang
Biomedical Park, No,88 Kechuang sixth street, Yizhuang, 101111, Beijing, China
5 Ventilation breathing circuits Silicon 1set optional
Using period: 8 years

6 Low-pressure air hose assembly 34E-Air 1 optional

7 Low-pressure O2 hose assembly 34E-Oxy 1 optional

8 Face Mask — 1 optional

9 User Manual — 1

116.
 Ventilator Users Manual
R50
V1.1
Written: 06. 2015
Beijing Siriusmed Medical Device Co., Ltd.