Boaray 7006. MANUAL BOOKMANUAL BOOK

Product Information
Product name：Anesthesia Machine
Product Model：Boaray700
Factory Address: JinLiMei Factory Building, No.37, Yanshan Road, Nanshan District,
Shenzhen, P.R.China.
Product Executive Standard: YZB/State 0690-2010 (anesthesia machine)
Production Certificate No.: GDFDA for medical device production 20081586
Product Registration No.: SFDA for medical device (approval) 2010 3541137
Registered Address：JinLiMei Factory Building, No.37, Yanshan Road, Nanshan District,
Lifetime: 5 years
After Service
Department Name：Shenzhen PROBE Science & Technology co., Ltd.
Address: JinLiMei Factory Building, No.37, Yanshan Road, Nanshan District,
Post No.：518067
Tel：+86-755-26899782
After Service Tel: 4007-880-300
Fax：+86-755-26899789
Version Information
The version number of this user manual may be updated due to the software upgrades;
PROBE reserves the right to change it without giving prior notice.
The version information:
 Version：2.2
 Release date：November.2012
I
CE Mark
The product is marked with CE, as it conforms to European Council Directive for Medical
Devices (93/42/EEC), and meets basic requirements of appendix I in the directive.
This product is the TypeⅠ,Class B radio jamming protective equipment that complies with
the EN55011. It meets the requirements of EN60601-1-2 standard “Medical electrical
equipment-Electromagnetic compatibility”.
Declaration
The intellectual property of the product and its document belongs to Shenzhen PROBE
Science & Technology co.ltd (hereinafter referred to as the Company). The Company
reserves the final right of interpretation for this document. Any unauthorized copying,
storage, reproduction or translation of this document in any form is strictly prohibited
without the prior written permission from the Company.
Users can, if need, ask for other technical information separately from the Company in
order to understand, operate and maintenance the equipment, but should ensure the
information not obtained by the third party.
II
User’s Responsibility
Please check the product and accessories firstly when you receive the product, make sure
it conforms to the contract. If any damage of the package or the product is found before or
after you open the packing case, please contact the local office or the franchiser
immediately.
Users must perform the installation, operation, maintenance and carry out regular
inspection according to the instruction described in the manual. Replace the components
immediately if any damage, loss, distortion or contamination is found. Stop use when
malfunction occurs. Please contact the after service department of the Company for
repairing and replacing. Any change of the product is verboten without agreement of the
Company. Users must accept responsibility for any malfunction which results from
non-compliance with the servicing requirements detailed in this manual.
Free Maintenance
The user reserves the right to be served for free repairs and replacement within 12 months
from the order delivered date only in the event that the product is purchased from the
Company or the authorized distributor, it must be new product when purchased and it is
operated according to the “User’s Responsibility”. Otherwise, the Company has no
responsibility for any damages to the product.
Trademark
(TM)
is registered trademark of PROBE Company.
(TM)
is registered trademark of the anesthesia and ventilator
products of PROBE.
III
Preface
Description
This manual describes the intended use, function, installation, operation and maintenance
of the product. Please read and understand the contents carefully before use to ensure the
proper performance and patient safety. When you begin using the anesthesia machine, we
deem that you have read the manual carefully.
In order to use the equipment accurately, effectively and avoid the accident, please read
the manual carefully and comply with it strictly, especially pay attention to the “Warning”,
“Caution” and “Note”.
The optional features may not be completely included in the manual, if you have any
questions, please contact the Company.
Please read this manual carefully and keep within reach of the device.
Illustration
The illustration in the manual is only for reference. Some settings and data may not be
consistent with the real display, and please refer to the real product.
Conventions
 Bold Italic: The quoted section.
 【Character】：The character string on the user interface or on the control panel.
IV
Content
PRODUCT INFORMATION .................................................................................................................. I
VERSION INFORMATION ................................................................................................................... I
CE MARK ................................................................................................................................................II
DECLARATION .....................................................................................................................................II
USER’S RESPONSIBILITY ................................................................................................................ III
FREE MAINTENANCE ....................................................................................................................... III
TRADEMARK ...................................................................................................................................... III
PREFACE .............................................................................................................................................. IV
CONTENTS ............................................................................................................................................. V
CHAPTER 1 SAFETY INFORMATION ................................................................................................ 1
1.1 WARNINGS ................................................................................................................................. 2

1.2 CAUTIONS .................................................................................................................................. 7
CHAPTER 2 EQUIPMENT DESCRIPTION ...................................................................................... 10
2.1 BRIEF INTRODUCTION .............................................................................................................. 10

2.1.1 Intended use ...................................................................................................................... 10
2.1.2 Main features ..................................................................................................................... 10
2.2 SYSTEM OVERVIEW................................................................................................................... 11
2.2.1 External pipeline connection diagram ............................................................................ 12
2.2.2 Front view diagram ........................................................................................................... 13
2.2.3 Side view diagram ............................................................................................................ 14
2.2.4 Rear view ........................................................................................................................... 15
2.3 POWER SUPPLY ......................................................................................................................... 15
2.4 BATTERIES ................................................................................................................................ 16
2.5 GAS SUPPLY .............................................................................................................................. 17
2.6 SYSTEM SWITCH ....................................................................................................................... 18
2.7 FLOWMETER ............................................................................................................................. 19
2.8 OXYGEN FLUSH BUTTON........................................................................................................... 19
2.9 AUXILIARY COMMON GAS OUTLET（ACGO）....................................................................... 20
2.10 PATIENT ABSORBER AND BELLOWS ASSEMBLY .......................................................................... 20
2.11 ANAESTHETIC GAS SCAVENGING SYSTEM (AGSS)（OPTIONAL） .......................................... 22
2.12 VAPORIZER ............................................................................................................................... 23
2.13 ANAESTHETIC VENTILATOR ...................................................................................................... 23
2.13.1 Display ................................................................................................................................ 24
2.13.2 Membrane buttons ............................................................................................................. 25
2.13.3 User interface..................................................................................................................... 27
2.13.3.1 Power-up interface ................................................................................................................................ 27
V
2.13.3.2 manual mode leakage test..................................................................................................................... 28
2.13.3.3 Vent mode leakage test and compliance test ....................................................................................... 29
2.13.3.4 O2 sensor calibration ............................................................................................................................ 30
2.13.3.5 Start-up interface ................................................................................................................................... 31
2.13.3.6 Standby interface .................................................................................................................................. 32
2.13.3.7 Main interface ....................................................................................................................................... 33
2.13.3.8 Function interface ................................................................................................................................. 35
2.13.4 Ventilation modes .............................................................................................................. 39
2.13.4.1Manual ventilation mode ....................................................................................................................... 39
2.13.4.2Mechanical ventilation mode ................................................................................................................ 39
2.13.5 Compliance compensation .................................................................................................... 45
2.13.6 Fresh mixed gas compensation ............................................................................................. 45
2.13.7 Alarm system ..................................................................................................................... 45
2.13.7.1General Description ............................................................................................................................... 45
2.13.7.2Alarm limit settings ............................................................................................................................... 47
2.13.7.3Alarm silence ......................................................................................................................................... 47
CHAPTER 3 INSTALLATION AND CONNECTION ........................................................................ 49
3.1 POWER SUPPLY INTERFACE ....................................................................................................... 49

3.2 CONNECTING THE GAS SUPPLY ................................................................................................. 49
3.3 INSTALLING / REPLACING THE CYLINDERS ................................................................................ 50
3.4 INSTALLING THE CIRCLE ABSORBER ASSEMBLY ......................................................................... 51
3.5 INSTALLING THE FOLDING BAG AND THE BELLOWS HOUSING .................................................... 51
3.6 INSTALLING THE MICRO MANOMETER ....................................................................................... 52
3.7 INSTALLING THE OXYGEN BATTERY .......................................................................................... 53
3.8 INSTALLING THE CO2 CANISTER ............................................................................................... 53
3.8.1 Canned absorbent ............................................................................................................... 53
3.8.2 Installing the canister .......................................................................................................... 54
3.8.3 Replacing the absorbent .................................................................................................... 56
3.9 INSTALLING THE BREATHING HOSE AND THE Y CONNECTOR ..................................................... 57
3.10 INSTALLING THE MANUAL BREATHING BAG .............................................................................. 58
3.11 INSTALLING THE VAPORIZER ..................................................................................................... 58
3.11.1 Installing the vaporizer ...................................................................................................... 59
3.11.2 Adding the anesthetic........................................................................................................ 60
3.11.3 Discharging the anesthetic ............................................................................................... 60
3.12 INSTALLING AGSS ................................................................................................................... 61
3.12.1 Installation .......................................................................................................................... 61
3.12.2 Connection ......................................................................................................................... 61
3.12.3 Checking before usage ....................................................................................................... 61
3.12.4 Usage .................................................................................................................................. 61
CHAPTER 4 PRE-USE CHECK ......................................................................................................... 63
CHAPTER 5 OPERATIONS AND SETTINGS.................................................................................. 65
5.1 TOUCH KEY .............................................................................................................................. 65
VI
5.2 START-UP ................................................................................................................................. 65
5.3 PATIENT SETTINGS .................................................................................................................... 66
5.4 STANDBY.................................................................................................................................. 67
5.5 VENTILATION SETTINGS ........................................................................................................... 68
5.6 ALARM SETTINGS ..................................................................................................................... 69
5.7 SYSTEM SETTINGS .................................................................................................................... 70
5.8 SYSTEM SHUT OFF .................................................................................................................... 76
CHAPTER 6 PHASEIN MULTIGAS ANALYZERS (OPTIONAL) .................................................. 77
6.1 SUMMARIZE .................................................................................................................................... 77

6.2 ISA SIDESTREAM MULTIGAS ANALYZER........................................................................................... 78
6.2.1 Intended use ............................................................................................................................ 80
6.2.2 Patents and Trademarks .......................................................................................................... 81
6.2.3 Consumables ........................................................................................................................... 81
6.2.4 Adverse effects on performance............................................................................................... 82
6.2.4.1 Quantitative effects of barometric pressure........................................................................................... 82
6.2.4.2 Effects of humidity or condensate ......................................................................................................... 83
6.2.5 Analyzer system set-up ............................................................................................................ 84
6.2.6 Pre-use check .......................................................................................................................... 85
6.2.7 Zeroing .................................................................................................................................... 85
6.2.8 Alarms ..................................................................................................................................... 86
6.3 IRMA MAINSTREAM MULTIGAS ANALYZER ..................................................................................... 86
6.3.1 Intended use ............................................................................................................................ 88
6.3.2 System assembly instruction.................................................................................................... 89
6.3.3 Pre-use check .......................................................................................................................... 91
6.3.4 Zeroing procedure................................................................................................................... 91
6.3.5 Alarms ..................................................................................................................................... 92
CHAPTER 7 PHASEIN CO2 ANALYZER AND SPO2 MODULE (OPTIONAL) .......................... 93
7.1 PHASEIN CO2 ANALYZER ................................................................................................................. 93

7.1.1 Summarize............................................................................................................................... 93
7.1.2 Installation .............................................................................................................................. 93
7.1.3 Zeroing procedure ................................................................................................................... 93
7.1.4 Spectral broadening ................................................................................................................ 94
7.2 SPO2 MODULE................................................................................................................................. 94
7.2.1 Introduction ............................................................................................................................. 94
7.2.2Connecting and operating ........................................................................................................ 96
CHAPTER 8 USER MAINTENANCE ................................................................................................. 97
8.1 MAINTENANCE SCHEDULE ........................................................................................................ 99

8.2 CLEANING AND DISINFECTION .................................................................................................. 99
8.3 MAINTENANCE OF THE ANESTHESIA MACHINE SURFACE ........................................................ 101
8.4 MAINTENANCE OF RESPIRATION SYSTEM ............................................................................... 102
8.4.1 Breathing tube and manual bag ............................................................................... 103
8.4.2 Bellows assembly ....................................................................................................... 103
VII
8.4.3 Micro manometer and canister ................................................................................. 104
8.4.4 Pop-off valve assembly .............................................................................................. 104
8.4.5 Gas block and bellows covers .................................................................................. 105
8.4.6 BYPASS assembly ..................................................................................................... 105
8.4.7 Absorber upper cover and APL ................................................................................ 106
8.4.8 Heat plant and bag/ventilator assembly and non-return valve assembly ........... 107
8.4.9 Oxygen battery ............................................................................................................ 107
8.4.10 Expiratory and inspiratory connector and flow sensor .......................................... 108
8.5 ISA ANALYZER AND IRMA PROBE ......................................................................................... 108
CHAPTER 9 CONFIGURATION LIST ............................................................................................. 110
APPENDIX A WORKING PRINCIPLE ............................................................................................ 111
A.1 E LECTRICAL SCHEMATIC .............................................................................................................. 111
APPENDIX B PRODUCT SPECIFICATION ................................................................................... 113
B.1 SAFETY SPECIFICATION ................................................................................................................ 113

B.2 ENVIRONMENT SPECIFICATION ..................................................................................................... 114
B.3 POWER SUPPLY SPECIFICATION ..................................................................................................... 114
B.4 GAS SUPPLY SPECIFICATION ......................................................................................................... 115
B.5 SYSTEM SPECIFICATION ................................................................................................................ 115
B.6 SPECIFICATIONS OF PARAMETERS ................................................................................................. 117
B.6.1 Specification of setting parameters ................................................................................ 117
B.6.2 Specification of monitoring parameters ......................................................................... 117
B.6.3 Specification of alarm parameters .................................................................................. 118
B.7 SPECIFICATION OF HARDWARE ..................................................................................................... 119
B.8 PHASEIN CO2 ANALYZER（OPTIONAL） ................................................................................... 120
B.8.1 PHASEIN ISA CO2 analyzer ............................................................................................ 120
B.8.2 PHASEIN IRMA CO2 module （optional） ................................................................... 121
B.9 PHASEIN ISA ANALYZER（OPTIONAL）.................................................................................... 121
B.9.1 General specifications ...................................................................................................... 121
B.9.2 Interfering gas and vapor effects .................................................................................... 123
B.9.3 MAC (Minimum Alveolar Concentration) calculation ................................................... 124
B.9.4 Electromagnetic compatibility (EMC) ............................................................................. 124
B.10 PHASEIN IRMA MULTI-GAS ANALYZERS（OPTIONAL） ......................................................... 129
B.10.1 General Specifications ................................................................................................... 129
B.10.2 Interfering gas and vapour effects ................................................................................ 131
B.10.3 Electromagnetic compatibility (EMC) ........................................................................... 131
APPENDIX C ALARMS ..................................................................................................................... 137
APPENDIX D SYMBOLS AND GLOSSARY .................................................................................. 141
D.1 GLOSSARY .................................................................................................................................... 141

D.2 EQUIPMENT SYMBOLS .................................................................................................................. 142
D.3 PACKING SYMBOLS ....................................................................................................................... 145
APPENDIX E DEFAULT SETTINGS ............................................................................................... 147
VIII
E.1 PATIENT INFORMATION .................................................................................................................. 147
E.2 DEFAULT PARAMETERS ................................................................................................................. 147
E.3 ALARM DEFAULT SETTINGS ........................................................................................................... 147
APPENDIX F REFERENCE .............................................................................................................. 149
IX
Chapter 1 Safety Information

The safety information described in this chapter explains the unsafe conditions that may
occur if not performed correctly according to the manual. Please review all the Warning,
Caution and Note prior to operating the anesthesia machine.
This chapter contains important safety information of the anaesthesia machine, and some
other safety information throughout each chapter of the manual. Please read and
understand all the safety information before use to avoid security risks.
The ponderance of the safety requirements has no relation with the list order.
Warning:
Identify conditions or practices that could result in serious adverse reactions or
potential safety hazards.
Caution:
Identify conditions or practices that could result in damage to the anesthesia
machine or other equipment.
Note:
Identify supplemental information to help you better understand how the
anesthesia machine works.
Page 1 of 150
1.1 Warning
Warning
Preparing warning：
 Before using the device please ensures that all the connections of the pipelines are
accurate and reliable, not twisted, knotted, pressed or blocked.
 The auxiliary mains socket-outlet of this equipment can only be used for the specified
facilities; otherwise it may result in safety risks.
 Before using the equipment please make sure that the balanced terminal of the
potential has been connected to the spot grounded point, otherwise, unpredictable
risks may occur.
 This equipment can only be operated by the qualified personnel, please make sure the
operators have corresponding qualifications before using.
 Only the specified and with protective earthing power supply can be used. If you have
any questions about the installation of the external line, the equipment must be
operated by the internal power supply.
 The inflammable anesthetic agent such as aether and cyclopropane can not be used.
Only the anesthetic agent that according with the requirements about the
non-flammable anesthetic described in the appendix DD of the IEC-60601-2-13 can
be used in this anesthetic system.
 This equipment can only be used in the specified environment, should not be used in
the inflammable or explosive environment, magnetism resonance imaging (MRI)
environment, or in the environment with other strong electromagnetism interfere.
 Only those conform to the latest IEC-601-1 standard accessories and auxiliary
equipment can be connected to this anesthesia machine. If peripheral equipment such
as computer, monitor, and humidifier has been connected to the anaesthetic ventilator,
the whole system should meet the IEC-601-1 standard.
 Do not use flammable agent in the patient absorber.
 The container with water should not be placed on the equipment in order to prevent
Page 2 of 150
Warning
liquid entering the equipment and lead to malfunction.
 The equipment will produce some castoff such as the sodium- calcareousness, the
one-off parts or the damageable parts which will lead to serious pollute or cross
infection if discarded randomly, and should be managed and disposed according to
the relative regulations.
 Before operating please ensure that all the separate facilities that work with this
anesthesia machine such as the anesthesia gas monitoring apparatus and the
anesthesia gas purifying apparatus are in good condition.
 Before operating please ensure that the gas supply needed by the equipment is in
good condition, the malfunction may make the equipment unable to work if connected
to the central air feeding system.
 A malfunction of the central gas supply system may cause more than one or even all
devices connected to it to stop their operation simultaneously.
Operating warning：
 Once the abnormal alarms occur or it cannot start-up normally during the startup
process, please stop using the equipment and contact the maintaining personnel
immediately.
 Do not open the outer casing of the equipment so as to avoid electric shock.
 Do not touch the power supply so as to avoid electric shock.
 The volume of the alarm sound should be kept at an appropriate level, and it should
not disturb others or be ignored because of the inaudible volume.
 This equipment should only be used with the recommended accessories and
materials, otherwise unpredictable risks may occur.
 The machine must not be used if any of the alarm, monitoring devices is not
functioning correctly.
 When worked with the high frequency electrical surgical equipment, should avoid
mechanical damages to this equipment or its components that caused by the electrical
surgical equipment.
Page 3 of 150
Warning
 Those medical equipments that worked together with this anesthesia machine should
also conform to the corresponding safety requirements.
 Do not use the antistatic or conductive mask or breathing tubes.
 Additional equipment placed on the top shelf must be securely attached. Take care
when moving a fully loaded machine, particularly when negotiating ramps. Check that
hoses or power leads are not trailing on the floor.
 The exhausted gas should be discharged through the exhaust outlet and cannot be
discharged to the room, do not block the outlet.
 Do not replace the canister during the ventilation period, otherwise there may exist
risks.
 Prevent the absorbent turning dry; please replace the absorbent timely if it becomes
dry.
 The vent of the PEEP will discharge little air and oxygen continuously, so do not block
the vent, otherwise the anesthesia machine cannot work.
 During operation please ensure there is no testing plug or other foreign body in the
absorber.
 The expiratory valve of the anesthesia machine is with constantly open design, when
power failure or abnormal occurs, the valve is open and connected to the atmosphere
through the AGSS to ensure patient can breath freely. During use, please do not block
the AGSS to avoid suffocate the patient.
 If the system is connected to the peripheral equipment (such as VGA), it may increase
the leakage currents to the patient.
 If one or more devices are connected to the auxiliary mains socket-outlet, it will lead to
the increase of the leakage current risks, the leakage current should be checked
termly.
 Before using any additional electrical equipment powered by the auxiliary sockets on
the machine, check that the additional equipment is correctly wired and is earthed
through its plug. A missing or defective protective earth conductor may increase earth
Page 4 of 150
Warning
leakage currents to the patient to values exceeding the allowable limits, resulting in
ventricular fibrillation, or interference with the pumping action of the heart.
 Remember to do a circuit leak test after reinstalling the CO2 canister.
 When installing the oxygen sensor, please check if the sealed ring is in good condition,
replace a new oxygen sensor if the sealed ring is damaged or there is no sealed ring.
Maintenance Warning:
 Please clean and disinfect the parts that have been repeatedly used and contacted
with the patient according to the ways that recommended in the user manual every
time before use.
 Please shut off the equipment and the power supply while cleaning.
 While cleaning the parts of the equipment, users must be away from the equipment.
 While cleaning the outer casing, please make sure that no liquid enters into the
controlling components, and it cannot be connected to the AC power supply until the
parts have turned dry after cleaned.
 Cooling the equipment for at least half an hour before disassembling it.
 While disassembling the outer casing of the equipment, the supply must be cut off and
should only be operated by experienced personnel.
 Please dispose the wrapper according to the local regulations or the hospital waste
disposal system.
 Do not throw the batteries or the oxygen sensors to the fire so as to avoid exploder.
 The exhausted batteries should be replaced or discarded according to the local
regulations and should not be disposed in a normal way.
 The oxygen sensor and the flow sensor should not be dipped in the liquid or disposed
by high temperature and high pressure.
 The immersion time in hot water of the bellows components should be not more than
15 min, to prevent dissolving or aging.
 The heating accessories of the flow sensor are electriferous, so that it should be
cleaned with a soft cloth soaked in alcohol and should not be disinfected by way of
Page 5 of 150
Warning
dipping in the liquid.
 Do not use lube that contains oil or liquid.
 The moving parts and the knock-down components may lead to pinched or crushed
dangers please pay more attention when moving or replacing the parts of the system.
 Do not implement the calibration process when the system is connected to the patient.
 Please use the accessories provided by the Company in order to avoid the value
incorrect or the equipment failure.
 The one-off accessories can be used only once, repeated use may lead to
performance degradation or cross-infection.
 If there appear any problems about the accessory’s wrapping or the accessories, do
not use accessories.
Page 6 of 150
1.2 Caution
Caution
Preparation Caution:
 Please double-check the power cord before connected to the city electricity, make
sure it has no damage, scratch or other factors which will lead to the inside conductor
exposed issues.
 When the equipment or the accessories are about to exceed the limit time, they should
be disposed according to the local regulations or the hospital systems.
 The electromagnetic fields may affect the performance of this device, so the other
facilities used around this must meet the corresponding EMC requirements.
 This equipment complies with the electromagnetic compatibility regulations of the IEC
60601-1-2 standard. If the interfering grade exceeds the limit grade, it may lead to the
stop of the mechanical ventilation.
 Please install or transport the equipment appropriately to avoid falling, hitting, serious
vibrating or other outside forcing damages.
 The anesthetic gas delivering device that used together with the anesthesia system
must comply with the ISO 8835-4:2004 or ISO-8835-4 requirements.
 This equipment should be used together with the anesthesia gas monitoring apparatus
that comply with the ISO 11196:1996 requirements.
 Any of the anesthesia ventilation systems that used together with the anesthetic gas
delivery system should meet the requirements of the ISO 8835-2:1999
 The anesthesia ventilator that used together with the anesthesia system must comply
with the requirements of the ISO 8835-5:2005.
 The product itself Is not included with the anesthetic gas scavenging delivery or
receiving systems that used together with the anesthesia system, if need additional
equipped, please use the anesthetic gas scavenging apparatus that accorded with the
ISO 8835-3:1997 requirements to connect to the AGSS port.
 The measuring conditions shown in this user manual are the ambient temperature and
Page 7 of 150
Caution
pressure saturated (ATPS) conditions.
 The pressure in the medical gas pipeline keeps the original unchanged when the
anesthetic system stops delivering gas.
 When the pressure of the gas supply inlet is at twice the maximum rated inlet
pressure, the pipeline will not rupture or cause any security risk. But it is
recommended to keep the pressure in the specified range.
 Operation Caution
 In order to prolong the battery life, please use the battery at least once per month, and
charge or discharge it fully.
 Please open the device and check the battery if not been used for a period of time to
avoid the battery malfunctions.
 The battery life lies on the frequency and time of used. The lithium battery life is about
3 years if maintenance and used in a proper way.
 Please pay attention to the position of the gas pipeline so as to avoid falling off.
 Please make sure that the power supply cable exposed outside the equipment is not
twisted to the patients、operators、other personnel or objects(including tubes),
otherwise, dangers may occur.
 When installing the breathing tube, please hold the joints on the two ends of the tube
in order to avoid damages of the tube.
 This equipment can use three kinds of anesthetic agents: the enflurane, the isoflurane
and sevoflurane, only one anesthetic can be used at a time.
 This equipment may bring interference to other products.
 Do not use this equipment if it not passed the test before using, please contact the
after service department of the Company.
 Maintenance Caution:
 Please use the methods recommended in this manual to clean or disinfect this
equipment.
 Take care when transporting,moving or disassembling the equipment to avoid
Page 8 of 150
Caution
damages to the personnel.
 Do not use the abrasive detergents (such as the steel wool, silver polish or detergent).
 The display should be cleaned with a dry, soft and lint-free cloth; it should not be
cleaned by liquid.
 Please contact the repairing personnel or the Company if the calibration of the
equipment failed many times.
 Please use the parts that produced or sold by the Company to replace the damaged
parts. And have a test after replacing to ensure that the equipment accorded with the
specifications and requirements of the manufacturer.
Page 9 of 150
Chapter 2 Equipment Description

2.1 Brief Introduction
2.1.1 Intended use

This equipment is a pneumatic controlled anesthesia machine which is used to manage
and control the respiration and anesthesia of the single patient during the anesthesia
operation, it is suitable for both adult and Pediatric (Above 5Kg). This anesthesia machine
can provide controlled concentrations and flows of anesthesia gases into a patient
breathing system, (the concentration of oxygen is no less than 21%) and also provide the
respiratory support.
The anesthesia machine is intended to use only in the operating rooms and emergency
rooms, not suitable for other places, and it can only be operated by the professional
anesthetist.
Warning:
 This equipment should be operated by the professional anesthetist or under the
guidance of the professional anesthetist. Personnel not authorized or trained can not
carry out any operations.
 The clinical environment of this equipment is operating rooms and emergency rooms.
2.1.2 Main feature

This anesthesia machine consists of the anesthetic ventilator, patient absorber, CO2
canister, vaporizer assembly, flow meter assembly and gas connecting tubes.
This anesthesia machine has following functions and features:
1、 Use the touch screen to select setting parameters and functional buttons easily and
conveniently.
Page 10 of 150
2、 Automatically leakage compensation and compliance compensation.
3、 Make tidal volume compensation according to altitude.
4、 Electronic adjustable PEEP.
5、 The two-station vaporizer mounting systems with interlock function.
6、 Electronic flowmeters display on interface.
7、 With Cardio pulmonary bypass function.
8、 The accurate monitoring and displaying of the ventilation parameters.
9、 Clear and differentiable auditory and visual alarms.
10、With a top lighting system and a separately controlled small lamp on the top of the
machine.
11、Storing and reviewing the alarm events, recording the wrong status functions.
12、Optional high pressure cylinder.
13、Displaying the anesthesia parameters in big words.
14、With auxiliary oxygen configuration, the passive AGSS functions.
15、With the function of connecting to the monitor.
16、With the function of connecting to the tower crane.
2.2 System overview
Caution：
 The illustrations in this chapter are only for reference, due to the different
configurations, the illustrations may be not entirely consistent to the product.
Page 11 of 150
2.2.1 External pipeline connection diagram
1. Trolley 2. SpO2 probe(optional) 3. Patient system
4. Manual bag 5. Patient absorber 6. Display screen
7. Monitor (optional) 8. Plug-in box modules 9. Main power supply
10. Gas supply inlet
Page 12 of 150
2.2.2 Front view diagram
1. Auxiliary oxygen 2. Auxiliary oxygen flowmeter(optional) 3. Cylinder manometer
flowmeter knob(optional)
4. Electronic flowmeter 5. Micro manometer 6. Electronic flowmeter controlling
knob
7. Auxiliary oxygen outlet 8. Display screen 9. Anaesthetic ventilator
（optional） controlling buttons
10. Monitor(optional) 11. plug-in box modules (optional) 12. Vaporizer
13. Gas supply manometer 14. System switch 15. Caster brake
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2.2.3 Side view diagram
1. CO2 canister 2. Manual bag port 3. Oxygen battery
4. Inspiratory port hose interface /ACGO 5. Expiratory port hose 6. The non-return valve on the inspiratory
outlet interface limb
7. The non-return valve on the expiratory limb 8. Micro manometer 9. Bellows housing
10. Bag/Ventilator switch 11. APL valve 12. Oxygen flush button
13. ACGO switch
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2.2.4 Rear view
1. AGSS vent 2. Gas supply inlet 3. Rear panel
2.3 Power supply
1、 AC Power supply specification: 100～240VAC，50/60Hz；
2、 Auxiliary mains power supply: 100～240 VAC, 50/60Hz, 2A×3；
3、 Fuse specification：T10AL/250V；
4、 When AC power is connected, the AC indicator will be light; when AC power is
disconnected, the light will be off.
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1. Equipotential earthing pole 2. Filter 3. Communication interface
4. Network interface 5. RS232 interface 6. VGA interface
7. Auxiliary power outlet 8. T2AL/250V fuse 9. Monitor interface
Warning:
 If the system is connected to the peripheral equipment (such as VGA), the patient
leakage current may be increased.
 If one or more devices are connected to the auxiliary mains socket-outlet, it will lead
to the increasing of the leakage current risks, the leakage current should be checked
termly.
2.4 Batteries
The anesthesia machine is equipped with built-in rechargeable lithium batteries to ensure
that the anesthesia machine can still work when the power supply is cut off. When the
anesthesia machine is connected to the AC power and switched on, the batteries are
charging if not already full charged. When the power supply is cut off, the system will
automatically switch to the battery power supply, simultaneously, it will generate an AC
power supply failure alarm to prompt users, and will not lead to interruption of the
anesthesia ventilator work.
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The fill amount of the battery icon on the interface indicates the amount of battery power
remaining.
- The battery is working normally.
- Low battery capacity, it needs to be charged.
- The battery is exhausted and needs to be charged immediately.
- No battery.
When the battery power is low, the anesthesia machine will generate a medium alarm,
and the alarm message 【low battery capacity！

！】displays in the alarm area, it indicates
greater than 10 minutes of battery power remaining; when the battery is exhausted, there
will be a high alarm, and the alarm message 【the battery is exhausted！
！】displays in the
alarm area, it means greater than 3 minutes of battery power remaining, then the
anesthesia machine must be connected to the AC power supply.
Caution:
 The batteries can not be replaced by used, if need, contact the authorized equipment
maintenance personnel or the after service department of our company.
 The exhausted batteries should be replaced or discarded according to the local
regulations.
2.5 Gas supply
There are three kinds of gas input: oxygen, air and N2O. They can be connected to the
central gas supply system, and the required rated pressure range is 0.28～0.6Mpa,there
is a filter, manometer and a non-return valve installed in each pipeline of the gas. The
machine can also be connected to the O2 and N2O cylinder, the pressure inside the full O2
cylinder is about 15.0Mpa and it is about 8.0Mpa inside the full N2O cylinder, there is a
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filter, a manometer, a adjust pressure valve and a non-return valve installed in each
cylinder, if the output pressure of the cylinder exceeds 0.6Mpa, it will be regulated to
0.28 ～ 0.6Mpa by the adjust pressure valve. And there is a pressure-relief valve
connected to each of the gas supply, which is as a security role to prevent high pressure
of the gas supply, the releasing pressure is 758kPa（110psi), when the pressure is above
758Kpa, it begins to release the pressure, the pipeline will not rupture or cause any
security risk. But it is recommended to keep the pressure within the specified range.
The curve below displays the output pressure after the gas supply passes though the
pressure-relief valve.
2.6 System switch
There is a system switch designed in order to achieve the functions of opening and cutting
off the anesthesia circuit fresh gas and the system circuit at the same time. When the
system switch is turned on, users can adjust the gas flow by adjusting the electronic
flowmeter to make the fresh gas pass through the ACGO into the circuit, at the same time,
the system is connected to the power supply and begins to run according to the pre-set
state; when the system switch is turned off, the gas through the flowmeter is cut off, there
is no fresh gas output, the system is disconnected to the power supply, and the
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anesthesia machine can not be operated, but can be operated manually.
Turn the system switch to the position: the system is turned on.
Turn the system switch to the position: the system is turned off.
2.7 Flowmeter
The flowmeter displays the flow of the gas :O2，N2O and Air. Their flow can be read
directly. The unit is: L/min.
The user can adjust gases flow by the controlling knob, turn the flowmeter controlling knob
counterclockwise to increase the flow and clockwise to decrease.
 O2 and N2O knobs consist of a linkage device.( O2、N2O linkage device)；
 While counterclockwise rotation of N2O knob, and N2O flow is increased to a
certain extent, O2 knob would be rotated together with N2O knob, and the O2 flow
would be increased, such a system could ensure the O2 concentration in the
fresh gas over than 21%
 While clockwise rotation of O2 knob and O2 flow is decreased to a certain extent,
N2O knob would be rotated together with N2O knob, and the N2O flow would be
decreased, such a system could ensure the O2 concentration in the fresh gas
over than 21%.
There is a round float inside of the flowmeter, and the central plane scale of float is
indicates the current flow. See the graphic below:
2.8 Oxygen flush button

The oxygen flush supply is provided by the oxygen supply separately, it passes through
the oxygen flush button and the gas resistance then enters the patient absorber. Oxygen
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flow will rush into the gas path when the oxygen flush button” ” is pushed, and the
gas path is cut off when the button is released. The gas resistance is to reduce the impact
of the rapid oxygen flow on the patient and regulate the flow rate to the range of 25～
75L/min.
2.9 Auxiliary Common Gas Outlet（ACGO）

The inspiratory pipeline port and the ACGO share a common port.
- When the ACGO switch is activated, this outlet may be used to provide fresh gas to
atmosphere or an external manual breathing circuit. Mechanical ventilation is not available
when the auxiliary outlet is selected.
When the ACGO is closed, the breathing circuit is selected.
2.10 Patient absorber and bellows assembly

In this anesthesia machine, the patient absorber is integrated with the bellows assembly.
The patient absorber is used in conjunction with the anesthesia machine as a part of the
closed respiratory system, connected with the appropriate respiratory pipeline, gas
reservoir bag and patient port, and absorbs CO2. According to the different gas flow set by
the anesthetist, the expiratory gas can completely or partially circulates and enter the
inspiratory port, achieve the closed, semi-closed ventilation.
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The patient absorber and the bellows integrated system is connected to the anesthesia
machine by connecting the interface board on its side with the interface board on the side
of the host, after installed, lock the system by the locking device on the left front of the
anesthesia machine to prevent loosing or falling off and lead to gas leakage.
There is a Sodium lime canister at the bottom of the patient absorber, which is used to
absorb the exhalant CO2 and prevent the intraoperative excessive CO2 retentate which
may lead to hypercapnia. If you need to replace the sodium lime in use, remove the
sodium lime canister and the gas path will be closed automatically, it will not affect the
ventilation or use, but it is not recommended to undergo surgery using the anesthesia
machine in the case of the sodium lime canister absent and the sodium lime disabled.
The inspiratory non-return valve, inspiratory flow sensor and the expiratory non-return
valve, expiratory flow sensor are there installed respectively on the inspiratory limb and
the expiratory limb of the patient absorber, which are used to monitor the inspiratory and
expiratory flow rate, the airway pressure as well as achieve the gas circulating circuit.
The system is integrated with an oxygen sensor, it is connected to the anesthesia
ventilator through the cable, then displays the inspiratory oxygen concentration on the
user interface. It is accorded with the ISO 7767 standard.
There is also a micro-manometer installed above the patient absorber, it will display the
airway pressure, the display range is : -20～+100cmH2O.
The APL valve above the patient absorber is used to restrict the pressure during the
manual ventilation mode, the design range is 2～70cmH2O, when extruding the bag
manually, if the pressure exceeds the limited value, the gas will be vented from the valve
vent, and the exhausted gases are collected to the AGSS outlet and vented.
The system is integrated with the Bag/Ventilator switch valve, achieving the following
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functions:
1) Spontaneous respiration or manual ventilation in manual mode.
2) Using the anesthesia machine to ventilate in mechanical ventilation mode.
2.11 Anaesthetic Gas Scavenging System (AGSS)

（Optional）
The device is used in the operation room of hospital, and it is the system for collection and
delivery of exhausted gas from anesthesia machine to the hospital exhaust centralized
disposal system. This is the solution to avoid the pollution of anesthetic exhausted gas in
the operation room. The device is well-structured, simply-operated, safe and reliable.
AGSS consists of the exhaust port, float pump, float, cylinder, and inlet port.
AGSS has two models: Boaray 200A and Boaray 200B, there is difference between
Boaray200A and Boaray 200B, Boaray 200A cylinder with the metal material and
Boaray200B with the plastic material.
Anesthetic Gas Scavenging System (AGSS)(Top, Front, and Right Views)：
1. Exhaust port: it is a specified screw thread connecting port matched with the
specified corrugation hose which connects to the hospital’s waste gas disposal
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system.
2. Float pump: it is a transparent and plastic pump used for observing float” s
position, and marked the minimum scale line on the surface.
3. Float: it is a plastic disc that indicates AGSS’s intake flow.
4. Inlet port: it is the inner cone port (30mm) that complies with the standard of
YY1040.1-2003 and with a transfer hose connects to the anesthetic machine” s
exhaust gases outlet.
5. Cylinder: it is hollow cylinder that collects exhaust gases from the breathing
system.
2.12 Vaporizer
The vaporizer delivers the anesthetic agent to the patient respiratory system to
anesthetize the patient. Different anesthetic agent should be used with the corresponding
vaporizer, otherwise it will result in inaccurate output concentration.
The anesthesia machine adopts the imported PENLON vaporizer. The Halothane,
enflurane, isoflurane, sevoflurane and Desflurane vaporizers are available as option.
There are two vaporizer seatings, when the two vaporizers are installed, the interlocked
function makes it only output one kind of anesthetic at the same time.
The vaporizer used in this anesthesia machine should be accorded with the ISO-8835-4
requirements.
For the particular operation of the vaporizer please refer to the user manual provided by
the vaporizer manufacturer.
2.13 Anaesthesia ventilator

The anaesthesia ventilator is an auto-controlling equipment which replaces the traditional
manual ventilation, which adopts the pneumatic electronically controlling to achieve
different modes and parameters changes of the driving gas, and provides the monitoring
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of the corresponding physiological and ventilation parameters as well as the auditory and
visual alarms for the abnormal events.
In order to control the flow of the driving gas accurately, accurate pressure-regulation
valve is used to adjust the driving gas supply pressure to 0.2Mpa, and then solenoid
proportional valve is used to achieve the different flow rate adjustment through electrically
controlling. The output gas passes through the machinery over-pressure valve and the
bellows to achieve the automatically ventilation for the patients. The over-pressure valve
is to guarantee the pressure of the driving gas circuit less than the safe pressure, and its
release pressure is designed to be 10.8kPa (110cmH2O). The expiratory valve is closed
during inspiration, and during expiration, the gas inside the bellows passes through the
valve( the path is Ф18mm to the bellows interface andФ15mm to the PEEP valve gas
path interface) and enters the AGSS vent , to reduce the exhaust emission pollutions to
the operating environment.
In order to prevent the exceeding high pressure in the gas path which may bring dangers
to the patient or equipment, the anesthesia ventilator monitors the pressure and flow value
of inspiratory and expiratory gas, and emits the auditory and visual alarms for the
abnormal events, besides the design of the over-pressure valve to ensure the driving gas
not exceed the safe pressure.
2.13.1 Display
The anesthesia machine adopts the color TFT LCD, which can display various
parameters and graphics clearly. The diagram below contains the main interface of the
anesthesia machine.
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2.13.2 Membrane button
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1. Alarm indicator light:
No practical function. Response to the anesthetic ventilator alarms, the light is red for the
high priority alarm and yellow for the medium and low priority alarms. （please refer to 5.6
Alarm settings for more information）
2. Alarm Silence：
（1） The 【Alarm Silence】button is invalid when no alarm occurs;
（2） When alarm sounds, push this button to mute the alarm, the duration is 100
seconds, the alarm silence icon and 100 seconds count down will display
on the top right corner of the interface.
（3） Push this button again to resume the alarm sound.
（4） Alarm silence will be canceled when a new alarm occurs, it will generate the new
alarm.
3. Alarm Setting：
Push the 【Alarm Settings】button to access the alarm settings menu.
4. Lock：
Push the 【Lock】button to lock the screen, the icon “ ” will display on the
interface, push this button again to unlock the screen. The icon “ ” will display
on the interface.
5. Monitored Value:
Push the 【Monitored Values】button to access the respiratory parameters monitoring
interface.
6. Ventilation Setting:
Push the 【 Ventilation Settings 】 button to access the ventilation modes and
parameters setting interface.
7. System Setting:
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Push the 【System Settings】button to access the system settings interface.
8. System Log:
Push the 【System Log】button to access the system log interface.
9. Start/Standby:
Push the 【Start/Standby】button to access the Start/Standby interface.
10. Navigation wheel:
（1） Turn: to switch among the membrane buttons or the function options; turn it
clockwise to increase the parameter value, or anticlockwise to decrease the
parameter value.
（2） Push it down to confirm the settings.
11. Battery indicator light:
（1） The full battery power capacity: green;
（2） The insufficient battery power capacity: orange.
（3） Battery is not fitted or battery failure: OFF.
12. AC power indictor:
（1） The indicator light is on: the anesthesia machine is connected to the AC power;
（2） The indicator light is off: the anesthesia machine is disconnected to the AC power.
2.13.3 User interface
Caution：
 The user interface may be different due to the different configurations, please take
the material object as valid.
2.13.3.1 Power-up interface
Power-up interface is the first interface displayed on the screen when the anesthetic
ventilator is turned on; the interface is shown as below:
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The self-testing items include power (10V, 5V, 12V, -12V), inspiratory valve, expiratory
valve, sensors and so on.
The message in self-test process shows “Please wait, the system is staring self-testing”.
The system enters the next test interface, when self-testing is successful.
The message shows "Unit failure", when self-testing is failure, and system stop testing in
the Power-up interface. The system restarts until the failure is solved.
2.13.3.2 Manual mode leakage test
After the finish of self-testing, the system enters the manual mode leakage test, as
shown below:
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Manual mode leakage test is focus on the checking of below points:
1. The leakage value of system in the manual mode;
2. APL valve.
Preparation for manual mode leakage test:
1. Set the Bag/Vent switch to Bag；
2. After install the Manual Bag and occlude the patient Y-piece in it；
3. Adjust APL valve to approximately 30cmH2O；
4. Shut off ACGO；
5. Shut off all the fresh gas controlling valve;
6. Push O2+ until Paw gauge value is between 25 cmH2O to 35 cmH2O；
7. After reading of pressure gauge reach setting range, take stock of the reading of
pressure gauge and the pressure waveform on the interface. If the pressure value
decreases less than 5 cmH2O within 15 seconds, then it passes the test. Otherwise
it doesn’t.
Remark: Select【Bypass】, the system enters “Start-up” interface.
2.13.3.3 Vent mode leakage test and compliance test
After manual mode leakage test, select【Continue】, then the system enters Vent mode
leakage test and compliance test, as shown below:
The test is focus on below points:
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1. Test the system leakage value;
2. Check O2 valve and PPEP valve;
3. Check the compliance of circuit.
Preparations for Vent mode leakage test and compliance test:
1. Set the Bag/Vent switch to Vent;
2. Occlude the patient Y-piece;
3. Press O2+ to fill the bellows;
4. Shut off all fresh gas controlling valve.
After preparation of self-test, press【Start】 and navigation wheel, the system begins
self-testing.
a) If the system passes test, the interface displays the information of 【Test
passed】; 【Leakage value】;【Compliance value】.
b) If the test fails, the interface displays the message such as 【Test failed】;
【Leakage value】; 【Insufficient gas in the folding bag】;【 Please shut off fresh
gas】.
Remark: Select 【Bypass】, the system enters “Start-up” interface.
Warning：
 Please perform the system test before using the anesthesia unit and wait until the test
is completed. If system detects leak, please check connections of the patient
absorber assembly, if leaks still exist, please contact the after service dept. of the
company.
 Small amount of leakage does not affect the function of this equipment; please
consider whether to continue using this equipment.
 If you feel leakage is serious, please contact the after service dept. of the Company.
2.13.3.4 O2 sensor calibration
After finish of Vent mode leakage test and compliance test, select【Continue】, then the
system enter O2 sensor calibration, as shown below:
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O2 sensor calibration is focus on the checking of below points
1. 21% O2 sensor calibration;
2. 100% O2 sensor calibration;
Operate “Start 21% O2 sensor calibration” and “Start 100% O2 sensor calibration”,
according to the procedure of suggestive O2 concentration calibration in interface.
Warning：
 Never perform the O2 sensor calibration procedures when the anesthesia machine is
connected to patient.
Note：
 100% O2 sensor calibration must be carried out after 21% O2 sensor calibration.
 It is unnecessary to perform the O2 sensor calibration if O2 sensor is not fitted or not
used.
 Please perform the O2 sensor calibration if the measured O 2 has obvious error or
after replacing O2 sensor.
2.13.3.5 Start-up interface
After finish of self-test, the anaesthetic ventilator will enter the start-up screen, shown
as below:
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In the start-up interface, users can perform the following operations:
- Patient category (adult and pediatric) switch;
- The amendment of patient age;
- The amendment of Patient weight;
- Ventilation mode modification;
- Startup to enter working mode；
- Reset all setting parameters to default values.
Caution:
 For more information about the operation , please refer to chapter 5 “operations and
settings”
 In the start-up interface, buttons are invalid, except for【Alarm Silence】and 【Lock】
button.
 In the start-up interface, the alarm function is normal if technical alarm occurs.
2.13.3.6 Standby interface
When the standby mode is selected, the anaesthesia ventilator will enter the standby
mode, shown as below:
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2.13.3.7 Main interface
The main interface displays when the anesthesia machine works, it displays the setting
parameters, measured parameters, each type of information and operation function,
shown as below:
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1. Information display area:
1) Display the current ventilation mode;
2) Display the current patient category;
3) Display the CPAP icon;
4) Display the oxygen flush icon.
2. Alarm information display area:
Display the current alarm information.
3. Status information display area:
Display the battery power status.
Display the Lock/Unlock button;
Display the Alarm silence icon and count down time.
4. Anesthetic agents monitored parameters area:
Display the current monitored parameters of the anesthetic agents.
5. Module status display area:
Display the current connection status of the modules.
6. System time display area:
Display the current date and time.
7. Waveform display area:
According to different configuration of models and different settings by users, it will
display the waveform, Loop or the trend.
8. Flowmeter display area
Display oxygen, nitrous oxide, air, bar chart, scales, unit, and each flow numerical.
9. Monitored parameter area:
Display the current monitored parameters of the patient.
When PEEP is set to be OFF, the PEEP monitored parameters are not display in
the area of Monitored values and Big Font interface.
10. Key parameters setting area:
Besides using the membrane button 【Ventilation settings】, users can set the
relative ventilation parameters of the current ventilation mode in the main interface
directly, the gray touch key means the parameter has nothing to do with the current
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ventilation mode and cannot be adjusted.
Note:
◆ The module status display area indicates the connection status of CO2, anesthetic
agents, SPO2 modules.
◆ Modules are optional functions, the main interface above displays when the anesthetic
agents or CO2 module is connected; if no module connected, the anesthetic agents
monitored parameters area will display waveforms.
◆ The modules support plug-in and measure function.
2.13.3.8 Function interface
The function interface is the displayed interface when the membrane button is pushed; it
contains the detailed settings and operation of certain functions. The function interfaces
are described as below:
1. Ventilation settings
The ventilation settings interface is shown as below:
In the Modes setting interface, users can perform the following operations:
- Setting the ventilation mode;
- Setting the relative parameters in each ventilation mode.
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- Enable or disable “Cardio Pulmonary Bypass” in manual mode.
（If the absolute pressure sensor is installed in the pneumatic

- Setting Altitude；
control board, this setting would not be displayed.）
Note：
 The design of the anesthesia machine makes the parameters setting correspond with
the current ventilation mode, in other words, when you select a ventilation mode, the
interface will only display the parameters related to the current ventilation mode.
2. Measured values
The measured values interface is shown as below:
There is no user action in the measured value interface. It mainly displays the current
ventilation mode and the related setting parameters and measured value information.
- Real-time monitoring of ventilation parameters；
- 【R】-- real-time monitoring of gas resistance while setting breath holding time；
- 【C】-- real-time monitoring of dynamic compliance；
- 【T-Agent】Calculate and display of anesthetic agent consumption through
anesthetic agent concentration monitoring；
- 【MACAge】calculate and display corresponding MAC according to the patient
age.
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3. Alarm settings
The alarm settings view is shown as below:
Users can set the alarm limit in this interface. The current measured value is between the
upper limit and the lower limit of the alarm value.
If no anesthetic agent modules and SPO2 module are connected to the system, the alarm
setting interface will not display the anesthetic agent and SPO2 alarm limit settings.
4. System settings
The system settings interface is shown as below:
In the system setting interface, users can perform the following operations:
- Setting the current date and time;
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- Setting the alarm volume;
- Setting the system language;
- Setting the waveform configuration of the interface;
- Setting the parameter area of the interface;
- Information display；
- The super mode is non-user function, it is used by trained engineers of the
Company to calibrate, upgrade and do some other technical operations.
- Compensation setting;
5. System Log
The system log interface is shown as below:
There is no user action in the system log interface. It mainly displays the operation
information that the user have performed and the alarm information during operation.
Push 【Page up】 or 【Page down】 touch button to turn to the previous or the next page
and view more logs.
Note：
 The anesthesia machine can store up to the least 500 logs for your view.
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2.13.4 Ventilation modes
2.13.4.1Manual ventilation mode
1. Switch the Bag/Ventilator switch to manual position, the “Manual” will be

displayed in the ventilation modes display area.
2. Turn the controlling knob of the APL valve to adjust the pressure in the patient
absorber to an appropriate range.
Caution：
◆ In the manual ventilation mode, all the ventilation setting parameters are disabled.
2.13.4.2Mechanical ventilation mode
Caution：
 The default mechanical ventilation mode of the anesthesia machine is【VCV】mode.
Users can set other mechanical ventilation modes in the ventilation setting interface.
2.13.4.2.1VCV mode
1. Principle description
VCV (volume control ventilation) mode is a basic completely mechanical ventilation mode.
Preset the tidal volume【VT】,the breathing frequency【f】and the expiratory and inspiratory
rate 【I:E】. When the inspiration begins, the gas flow will enter the lung at a constant
speed and it will reach the preset tidal volume within the preset inspiratory time and then
expire.
In the 【VCV】mode, users can set the 【T IP:T I】(inspiratory hold) to improve the gas
distribution conditions in the patient’s lung; and set the 【PEEP】(positive end-expiratory
pressure) to improve the vent of CO2 in end-expiratory and increase oxygen in the
breathing process.
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When the peek pressure exceeds【Plimit】,the system will release the pressure and give an
alarm.
2. Selecting the VCV mode
1) Push the 【Ventilation Settings】 key, the modes setting interface will display;
2) Push the modes option frame and select the 【VCV】 mode in the drop-down
menu;
3) When the 【VCV】 mode is selected, the information display area will display
【VCV】.
3. Parameter need to be set
In VCV mode, following parameters need to be set::
- 【VT】
- 【f】
- 【I:E】
- 【TIP :T I】
- 【PEEP】
- 【Plimit】
- 【Sigh】
2.13.4.2.2 Sigh function（Optional）
In volume control mode, the user can set sigh by ventilation mode interface
（range:OFF,10~100）, the extra volume will be increase by 50% above the tidal volume
set by the user(1.5xset volume) in the next inspiration cycle of the sigh setting value.
Note that sigh function is canceled when the unit is powered off.
2. Selecting Sigh
2) Set the 【Sigh】parameter in the modes setting interface (only volume control
mode);
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2.13.4.2.3 PCV mode
PCV (pressure control ventilation) mode is a basic completely mechanical ventilation
mode. Preset the airway pressure 【Pinsp 】,the breathing frequency【f】and the expiratory
and inspiratory rate 【I:E】. When the inspiration begins, the gas flow will enter the
patient’s lung quickly, when it reaches the preset pressure level, it will reduce the flow rate
through the response system, and at the same time it will keep the airway pressure at the
preset pressure value till the end of the inspiratory and then expire.
In the 【PCV】mode, users can also set the 【PEEP】(positive end-expiratory pressure).
4. Selecting the PCV mode
2) Push the modes option frame and select the 【PCV】 mode in the drop-down
menu;
3) When the 【PCV】 mode is selected, the information display area will display
【PCV】.
In PCV mode, following parameters need to be set:
- 【Pinsp】
- 【f】
- 【I:E】
- 【PEEP】
2.13.4.2.4 SIMV (V) +PS mode
The SIMV (V) +PS mode is a mixed ventilation mode; it is the SIMV (synchronized
intermittent mandatory ventilation) mode under the volume controlling.
In the SIMV mode, the independent breathing frequency and tidal volume are controlled
by the patient, and a synchronous control is activated at a certain interval of time; if the
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trigger level (flow trigger) is met in the waiting trigger window, the anaesthetic ventilator
will provide a synchronized volume control ventilation for the patient; if the trigger level is
not achieved in the trigger window, at the end of the trigger window, the anaesthetic
ventilator will give a volume control ventilation.
2. Selecting the SIMV (V) +PS mode
1) Push【Ventilation Settings】 key, the modes setting interface will display;
2) Push the modes option frame and select【SIMV(V)+PS】 mode in the drop-down
menu;
3) When【SIMV(V)+PS】 mode is selected, the information display area will display
【SIMV(V)+PS】.
3. Parameters need to be set
In SIMV (V) +PS mode, following parameters need to be set:
- 【f】
- 【FTRIG】
- 【VT】
- 【TI】
- 【PEEP】
- 【Plimit】
- 【Psupp】
- 【Sigh】
2.13.4.2.5 SIMV (P) +PS mode
The SIMV (P) +PS mode is a mixed ventilation mode; it is the SIMV (synchronized
intermittent mandatory ventilation) mode under the pressure controlling.
In SIMV mode, the independent breathing frequency and tidal volume are controlled by
the patient, and a synchronous control is activated at a certain interval of time; if the
trigger level (flow trigger) is met in the waiting trigger window, the anaesthesia ventilator
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will provide a synchronized pressure control ventilation for the patient; if the trigger level is
not achieved in the trigger window, at the end of the trigger window, the anaesthesia
ventilator will give a pressure control ventilation.
2. Selecting the SIMV(P)+PS mode
1) Push the 【Ventilation Setting】 key, the modes setting interface will display;
2) Push the modes option frame and select the 【SIMV(P)+PS】 mode in the
drop-down menu;
3) When the 【SIMV(P)+PS】 mode is selected, the information display area will
display【SIMV(P)+PS】.
In【SIMV(P)+PS】mode, following parameters need to be set:
- 【Pinsp】
- 【f】
- 【FTRIG】
- 【TI】
- 【PEEP】
- 【Psupp】
2.13.4.2.6 SPONT mode（Optional）
1. principle description
SPONT (spontaneous ventilation mode). In the SPONT mode, the patients will control the
breathing rhythm themselves, when the triggered level is met, the ventilator will support
with the pre-set inspiratory pressure; keep the pressure till the inspiratory flow decreased
to the pre-set value and then enter the expiration phase.
2. Selecting the SPONT mode
2) Push the modes option frame and select the 【SPONT】 mode in the drop-down
menu;
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3) When the 【SPONT】 mode is selected, the information display area will display
【SPONT】.
In the【SPONT】mode, the following parameters need to be set:
- 【VT】
- 【f】
- 【Ti】
- 【Psupp】
- 【PEEP】
- 【Plimit】
- 【Sigh】
- 【FTRIG】
Users can set the backup ventilation in the SPONT mode, providing the mandatory
ventilation when the patient is asphyxial.
2.13.4.2.7 PRVC mode（Optional）
1. principle description
PRVC (Pressure Regulated Volume Control), in PRVC mode, inspiration is accomplished
at the pre-set tidal volume and respiratory rate within the pre-set inspiratory time, each
inspiration is automatically adapt to the controlled inspiratory pressure, which changes the
characteristic of the lung or thoracic to ensure using of the minimum pressure to deliver
the pre-set tidal volume and minute volume. The inspiratory pressure keeps constant
throughout the whole pre-set inspiratory time.
2. Selecting the PRVC mode
2) Push the modes option frame and select the 【PRVC】 mode in the drop-down
menu;
3) When the 【PRVC】 mode is selected, the information display area will display
【PRVC】.
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In 【PRVC】mode, the following parameters need to be set:
- 【Freq】
- 【Vt】
- 【PEEP】
- 【I:E】
- 【Plimit】
- 【Prate】
2.13.5 Compliance compensation
The anesthesia machine affords compliance compensation for resolving the pipeline
compliance loss in breathing system. The compliance compensation operates according
to the system testing the compliance data from the tidal volume.
Cautions: the system will compensate for tidal volume loss according to default
parameters, if the users do not carry out system testing.
2.13.6 Fresh mixed gas compensation
When the user changes the flow for O2，N2O and Air, the system will compensate for tidal
volume loss so as to keep the tidal volume of patient’s lung and the setting tidal volume
consistent.
2.13.7 Alarm system
2.13.7.1General Description
The anesthesia machine is designed with a perfect alarm system to help insure patient
safety. The anesthesia machine can signal 3 types of alarms according to different
potential risks during the alarm activated: High Priority, Medium Priority and Low Priority.
When alarm occurs, it will remind the user by the alarm indicator light, alarm sound and
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alarm messages, different grades of alarms have different manifestation patterns.
Alarm signals are grouped into physiological alarms and technical alarms, according to
their characters.
1) Physiological alarms: monitored gas parameters or patient physiological parameters
exceed the specified range.
2) Technical alarms: Due to the improper operations or malfunctions of the technical or
the equipment, the machine cannot monitor exactly.
According to the different risks when alarm activated, alarms are grouped into: High
Priority, Medium Priority and Low Priority alarm.
1) High priority: when the high priority alarm generates, it may endanger the patient’s
safety or the equipment cannot work normally, so users must stop operating to deal
with the malfunction.
2) Medium Priority: when the medium priority alarm generates, it may endanger the
patient’s safety if lasting a long time, or some reasonable settings, users should
adjust the parameters to clear the malfunction.
3) Low priority: when the low priority alarm generates, it will not endanger the patient’s
safety, there may be some unreasonable settings or some unimportant malfunctions,
users could adjust the setting parameters properly or clear up the malfunctions when
complete using the equipment.
When alarm generates, the ventilator will call users attention by following auditory and
visual signals.
1) High priority：
- Alarm indicator light:：red flashes;
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- Alarm tone:du- du - du -- du - du ---- du - du - du - du - du；
- Alarm message：red background , and displays “!!!” behind the alarm message;
2) Medium priority：
- Alarm indicator light:：yellow flashes;
- Alarm tone：du - du - du ----- du - du - du；
- Alarm message：yellow background , and displays”!!” behind the alarm message;
3) Low priority：
- Alarm indicator light:：yellow, static, not flashes
- Alarm tone：du-----du；
- Alarm message：yellow background , and displays “!” behind the alarm message;
Caution：
 When different priorities of alarms occur simultaneously, only the alarm with highest
priority will display.
2.13.7.2Alarm limit setting

Refer to 5.6 alarm setting. push【Alarm Setting】membrane button to enter the alarm
setting interface and set alarm limit values.
Caution：
 Please always pay attention to the alarm limit parameter and make sure it is set at a
proper and reasonable level to avoid inaccurate alarms.
2.13.7.3Alarm silence
When alarm generates, push【Alarm silence】membrane button, the alarm will be muted,
meanwhile, the alarm silence icon and alarm silence 100 seconds count down
will display on the top right area of the interface.
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The alarm silence status lasts for 100 seconds, 100 seconds later, the alarm silence will
be disabled and the alarm tone resumes.
In alarm silence status, push 【Alarm silence】membrane button again to resume the
alarm tone.
Caution:
 In alarm silence status, alarm functions are working normally, except for the alarm
tone.
 In alarm silence status, if new alarms occur, the alarm silence will be disabled and
alarm tone will be activated according to the latest alarm.
 【Alarm silence】membrane button is invalid if no alarms occur.
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Chapter 3 Installation and connection
Warning:
 Always ensure that there is no toxicity in the gas supply hose or the breathing circuit,
will not cause allergic reactions in the patient's body, and will not react with the
anesthetic agent to produce dangerous substance.
 When the absorbent becomes dry, it may cause dangerous to patients if used
continuously. Appropriate preventive measures should be taken to prevent the
absorbent in the vaporizer becoming dry.
 Before using please make sure that the locking organs have been locked or it may
lead to unpredictable dangerous.
 Do not use antistatic or conductive mask or breathing hose.
 The installation of the equipment should be accomplished by engineers specified by
the manufacturer.
 This equipment has an exhaust vent; users should pay more attention to the disposal
of the exhalant residual gases.
 The operating environment and the power supply of this equipment must comply with
the requirements of the B.2 Environment specifications and B.3 Power supply
specifications.
3.1 Power supply interface
Warning：
 The facilities that connected to the power outlet will lead to increase of the leakage
current, so the leakage current should be tested regularly.
3.2 Connecting the gas supply
The anesthesia machine provides three gas supply inlet: O2、N2O and Air.
The following graphic indicates the tubes of the gas supply are connected correctly:
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Warning：
 Only the medical gas supply can be used. Other types of gas supply may contain
water, oil or other contaminations.
3.3 Installing / replacing the cylinder
The procedure of installing / replacing the gas cylinders is as below:
1. Rotate the handle of the cylinder clockwise, close the valve of the cylinder that to be
replaced, unscrew the T-handle anticlockwise;
2. Release the T-handle fully, break apart the door and remove the cylinder.
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3. Do not place any objects that may be damaged easily due to the releasing of high
pressure gas in front of the new cylinder mouth.
4. Open the cylinder valve and close it quickly, clear up the dust on the outlet of the
cylinder;
5. Make the cylinder position align with the indexing pin;
6. Close the door and tighten the T-handle;
7. Perform a cylinder testing.
Warning：
 When using gas supply from the pipeline, do not make the backup cylinder valve
open. Otherwise, when the gas supply of pipeline goes wrong, the gas of the cylinder
may be exhausted and lead to inadequate reserves.
3.4 Installing the circle absorber assembly
Put absorber inwards along with the lead rail, as followed figures. While it clicks, that
means it is all right.
Note: make sure the lock is open before installation. And lock it after installation.
3.5 Installing the folding bag and the bellows housing

1. Cover the bellows seating with the folding bag, make sure the bottom of the folding
bag can be nested tightly to the bellows seating. The graphic is shown as below;
2. Put the side with scale of the bellows housing to the front of the anesthesia machine,
note that the four block spaces should be pointed at the corresponding four gaps of
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the absorber assembly;
3. Push it down slightly, and rotate the bellows housing clockwise until it cannot be
moved.
Caution:
 Please make sure that the sealed ring inside the bellows cover can not be turned over
or extruded transmutative.
3.6 Installing the micro manometer

As shown below, firstly, press and hold the button in the direction of arrow, and then hold
the micro manometer and insert its head into the jack, when installation is completed,
adjust its surface to the front of the anesthesia machine.
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Caution：
 Before installing or removing the micro manometer, always press the button first so
as not to damage the micro manometer.
3.7 Installing the oxygen battery

Revolve the oxygen battery at the oxygen battery mounting hole clockwise. Hold the
crystal head of the connecting line and inset it at the jack of the oxygen battery.
3.8 Installing the CO2 canister

3.8.1 Canned absorbent
The structural graphic of the canister is as below:
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canister
Guiding
shelf
Guiding
tube
Filter plate
1. Spill the used absorbent from the canister to specified position, take out the filter plate
and the guiding shelf, clean away the dust and then put them back.(for the first time
please implement the step2 directly);
2. Defilade the top of the guiding shelf with a plastic lid or other objects to avoid dust
enter the guiding tube, dump the sodium lime (1) slowly to the CO 2 canister to the
specified position of the graphic below:
1
Shielding
cover
Sodium lime
filling line
3. Clean away the dust on the wall of the canister with paper or special cloth.
3.8.2 Installing the canister

1. Hold the bottom of the canister, push it upward to be directed at the screw thread and
align with silk-screen direction indicated by arrow.
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Silk-screen direction
indicated by arrow
2. Rotate it counterclockwise, it shown as below:
3. Rotate the canister anticlockwise until it is turned to limit position block of BYPASS
base, the following figure is shown as the installed canister.
Enlarge figure for

limit position block
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Caution：
 It is recommended to keep your hands clean and dry when installing the canister.
 Please take circuit leakage detection after reinstalling the canister.
 After installing or re-installing the canister, users must perform a system test (see
section 2.13.3.3 System Test) to ensure that canister is placed properly and there is
no leak, if system detects leak, please check the installation of the canister, and
re-install the canister .
3.8.3 Replacing the absorbent
The steps for replacing the absorbent is the same as the steps described in 3.8.1 Canned
absorbent.
Caution：
 There are two kinds of commonly used absorbent: sodium lime and barium lime, it is
recommended to use the sodium lime as absorbent.
 Before installing the canister, please check the color of the absorbent to decide
whether you need to replace the absorbent.
 The change of the absorbent color is just for reference. Please use the CO2 monitor
to decide whether you should replace the absorbent.
 Please discard the absorbent if the color is changed. If placed a few hours, it may turn
to its original color and lead to misusage.
 Appropriate defensive measures should be taken to ensure the absorbent not dry.
Please cut off the gas supply when completing using the system. When the absorbent
turns dry, if contacting with the anesthetic, it will emit carbon monoxide (CO) which
will bring hazards to patients. Therefore, please replace the absorbent in time for the
patients’ safety.
 In order to ensure the humidity of the sodium lime and avoid the emission of CO,
please pay attention to the following:
 Reduce the flow of fresh gas in the sealed absorber.
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 Replace the sodium lime at least once a week.
 Record the replacing date of sodium lime.
 Avoid gases flow through the sodium lime when the machine not being used.
 Users can add sodium lime temporarily in urgent conditions.
 During surgery or after a case, please check color of the absorbent and take
corresponding measures. For detailed information about the color change of the
absorbent, please refer to the instructions on the packaging of the absorbent.
3.9 Installing the breathing hose and the Y connector
Caution：
 When installing the breathing hose, please grab the two ends of the hose to avoid
damages.
1、 Connect ends of the two breathing hoses to expiratory connector and inspiratory
connector of the patient absorber;
2、 Connect the other end of the two breathing hoses to the two parallel interfaces of the
Y connector:
Caution：
 For disposable patient circuit accessories, the Y connector has been connected with
the breathing hose, so cancel this step.
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Note：
 It is recommended to install a bacteria filter to expiratory port of the breathing system.
3.10 Installing the manual breathing bag
Put the manual bag forcibly to the manual bag connector (marked”1” in the graphic
below):
Note:
 If you feel the manual bag is too close to the machine, an adapter breathing hose can
be connected to extend the distance between the machine and the manual bag,
which will help more convenient operation.
3.11 Installing the vaporizer
Warning：
 If the anesthesia machine and the vaporizer do not match, their performance will
depressed. Please use the vaporizer that matches the anesthesia machine.
Caution：
 For the detailed description of the installation and operation of the vaporizer, please
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refer to the manual of the corresponding vaporizer.
 When installing the vaporizer, make sure the vaporizer is locked well; otherwise it
may lead to leakage.
3.11.1 Installing the vaporizer
1. Hang the vaporizer to the fixing seating of the anesthesia machine;
2. Rotate the locking pole and press it, fix the vaporizer to the fixing seating;
3. Make sure the top of the vaporizer is flat, otherwise it should be removed and
installed again;
4. When re-installing the vaporizer, users should lift each of the vaporizer upward to let it
fall off the fixing seating instead of pulling it forward, be careful not to let the vaporizer
rotate on the fixing seating;
5. When the vaporizer is lifted off the fixing seating, install it again referring to the steps
1 to 3.
6. Try to open more than one vaporizer.
Test each possible combination. If the user is able to open more than one vaporizer at one
time, these vaporizers should be removed and installed again, then complete the steps 1
to 6.
A: Locking pole； B: Interlock bolt； C: Tighten hook;
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3.11.2 Adding the anesthetic
1. Check the controlling knob A and set it to Zero; check and tighten the screw C;
2. Unscrew the screw cap B;
3. Pour the anesthetic agent slowly to the vaporizer. During the process of pouring the
liquid, please pay attention to the height of the liquid inside the vaporizer, when it
reaches the maximum level, stop pouring the liquid;
4. Tighten the screw cap B, but not overly.
Caution：
 The maximum level of the anesthetic in the vaporizer is 250mL; and the minimum
level is 30 mL.
3.11.3 Discharging the anesthetic
1. Check the controlling knob A and set it to Zero;
2. Unscrew the screw cap B;
3. Place a bottle marked with the name of the corresponding anesthetic agent under the
vaporizer, put the mouth of the bottle at the tundish which is under the discharging
pipe, loosen screw C, ensure the anesthetic flow into the bottle. Make sure the
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anesthetic agent flow into the bottle.
3.12 Installing AGSS
3.12.1 Installation
Hang or fix AGSS tank to on the side of the machine and ensure that AGSS”s outlet port
is upward and vertical. There is a certain space in AGSS tank so as to be good for air
movement.
3.12.2 Connection
1. AGSS inlet port used with the specified transfer hose which connects to the
anesthetic machine” s exhaust gases outlet. The one end of the corrugated hose with
30mm connects onto AGSS inlet port, and the other end connects onto anesthetic
machine” s exhaust gases outlet.
2. AGSS exhaust port used with the specified transfer hose and connector connects to
the hospital’s waste gases scavenging system, and tightens with nut.
3.12.3 Checking before usage
Please check following items in steps before using machine:
1. Checking the negative pressure of waste gas processing system is enough or not.
Observe AGSS system buoy, if it is on the minimum scale, it means the negative
pressure is normal, and can work, but if the negative pressure is not enough, the
AGSS system can not work.
2. Checking the air inlet is jammed or not which is under the AGSS system cup. If it is
jammed, Use it till need clear the blockage.
3.12.4 Usage
After connection and check, AGSS system could be used normally.
Check the following items at any time during using:
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1. Check if float can rise and exceed the minimum scale line.
2. Check if cylinder’s inlet ports on the underneath are blocked.
3. Check if inlet and exhaust hoses are smooth.
If occurs the above malfunction, it must be solved immediately, otherwise AGSS will not
be used normally.
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Chapter 4 Pre-use check

Before using this equipment, please read the user manual and understand the operation
and maintenance of each part of the equipment, and make sure it meets the following
requirement:
1. The using environment should meet the relative requirements of the Appendix B;
2. The equipment is in good condition with no damages.
3. All the components are connected correctly.
4. The respiratory system is connected accurately with no damage.
5. The gas supplying system is connected accurately, the pressure is normal;
6. All emergency equipments are in ready and in good condition.
7. All equipments that used for the maintenance of pipeline and the intubatton of the
windpipe are available and in good condition.
8. Make sure there is no loose phenomenon on the truckle and the brake has been
locked and the anesthesia machine cannot be moved.
9. Connect the power cord to the AC power outlet, switch on the AC power supply, the
AC power indicator and the battery indicator will light, if not, that means the system
has no electricity.
10. The gas supply connection test:
1) Connect the O2、N2O and Air source ( please refer to the section 3.2 Connecting the
gas supply).
2) Connect the power supply and switch on the system.
3) View O2、N2O and Air manometers, make sure the reading of the each manometer is
in the range of 280~600kPa.
4) Cutoff the gas supply and discharge the gas in the pipeline view the manometers and
make sure the readings zero.
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Warning：
 Please always take pre-use check before the anesthesia machine is connected to the
patient.
 Please connect the power cord to a protective grounded power outlet in order to
avoid electric shock.
 If any functional failures detected, and the failures persist, the anesthesia machine
cannot be connected to the patient.
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Chapter 5 Operation and setting

5.1 Touch key
The touch keys will display different colors to indicate different status:
1. The blue key pad indicates the normal status; you can push it to operate. For
example:
2. The yellow key pad indicates the active status: the key is selected, and can be
operated directly. For example:
3. The dark blue key pad indicates the selected status; the parameter cannot be
adjusted currently. For example:
5.2 Start-up
1. Connect the power cable to the power outlet; make sure the power supply works
normally.
2. Turn on the system switch in front of the main unit.
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Warning：
 If abnormal alarms occur when the system starts up, please discontinue operation
and contact the authorized repaired personnel or the after service department of the
Company.
 Only the specified, protective grounded power supply can be used in this equipment.
5.3 Patient setting
1. According to the patient’s weight and age, the patient category is divided into two types:
；
-【Adult】
；
-【Pediatric】
Different patient categories decide different parameter setting and operation. In start-up
interface, user can set or change the patient categories.
1) In start-up interface, push the 【Adult】 or 【Pediatric】to select the patient
category.
2) Push the navigation wheel to confirm the selection.
1. Patient age setting:
The user could set the patient age in the start-up interface. The system calculates
corresponding MAC value based on the different ages.
Patient age range: 1-100 years old.
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1) Click patient age, the area would turn to be yellow.
2) Adjust the patient age through navigation wheel.
3) Press navigation wheel, the area turn to be light blue.
2. Weight setting:
User can set the patient’s weight in Start-up interface. The anesthesia machine calculates
the referenced tidal volume value in the volume ventilation mode according to different
weight of the patient.
For different patient categories, the setting ranges of the weight are different:
- Adult：20-150kg；
- Pediatric：5-20kg；
1) Push the patient’s weight area, the area turns light yellow.
2) Adjust the weight value by turning the navigation wheel.
3) Push the navigation wheel to confirm the setting, the area turns dark blue.
5.4 Standby
User can select the standby mode if need.
Enter the standby mode:
1) Push【Start/Standby】key.
2) Push【Standby】touch key in the pop-up window.
3) Push the navigation wheel to enter the standby mode.
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In the standby mode, push【default】touch key, then push the navigation wheel to
confirm, this returns all setting parameters to default values.
Exit the standby mode:
1) In the standby mode, push【start】touch key.
2) Push the navigation wheel to exit standby mode to the main menu.
5.5 Ventilation setting
1. Modes and parameters setting:

1) In ventilation status, push【Ventilation Setting】key.
2) Push【Mode】 option frame and select the ventilation mode in the drop-down menu.
3) Push the ventilation parameter that you need to set, turn the navigation wheel to
adjust the value and push the navigation wheel to confirm the setting.
4) Push【Exit】touch key to exit the current page.
2. Cardio pulmonary bypass
Cardio bypass mode could be started in the manual mode, and it is used for special
equipment that replaces the work of patient's heart and lungs for blood circulation and gas
exchange.
When Cardio pulmonary bypass is set, the following alarms will be disabled:
Apnea alarm;
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Tidal volume low alarm;
Minute volume low alarm;
Anaesthetic Agent low alarm;
CO2 (EtCO2 and FiCO2) low alarms;
Frequency low alarm;
Paw low alarm.
When the mechanical ventilation is turned back on, Cardiac pulmonary bypass returns to
“Disable”, and alarms become active.
3. Altitude
Altitude setting range: 100~5000 meter;
If the absolute pressure sensor is installed in the pneumatic control board, the system
could make tidal volume compensation automatically; otherwise, the tidal volume
compensation has to be realized by altitude setting.
5.6 Alarm setting
Users can use the alarm setting function to adjust the alarm parameters for the needs of
monitoring and protecting the patients.
For detailed alarm parameters and setting range, please refer to Appendix B.6.3
1. Push the upper limit or the lower limit parameter value, and the frame turns yellow.
2. Turn the navigation wheel to adjust the value.
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3. Push the navigation wheel to confirm the setting.
4. Push【default】touch key, all parameter values will resume to the system default value.
5.7 System setting
1. Common settings
Users can set the date/time, alarm volume and language of the system.
1) Push the parameter value that you desire to set, the frame turns yellow.
2) Turn the navigation wheel to adjust the value and push the navigation wheel to
confirm the setting.
2. View settings
Users can configure the waveform displayed on the interface; the system can display four
waveforms simultaneously.
1） The first waveform options:
- Paw-T;
- Flow-T;
- V-T;
- SpO2; (optional)
2） The second waveform options：
- Flow-T；
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- Paw-T；
- V-T;
- SpO2; (optional)
3） The third wave options：
- V-T；
- Paw-T；
- Flow-T；
- SpO2; (optional)
- CO2; (optional)
4） The fourth waveform options：
- CO2 (optional)；
- N2O；
- anesthetic agent (e.g.Enflurane)；
-O2
_ SPO2 (optional)
5）The display Font options：
- Normal；
- Wave+Loop；
- Big Font；
- Trend；
If you select 【 wave 】， the interface will only display the waveform, if you select
【wave+Loop】, the Loop will display on the right side of the interface, the Loop contains
following types:
- Flow-Pressure (F-P);
- Pressure-Volume (P-V);
-Flow-Volume (F-V);
- Volume-CO2 (V-CO2) (optional);
if you select 【Trend】, the time of the Trend can be set:
- 1 Hour;
- 4 Hours;
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- 8 Hours;
- 12 Hours;
- 24 Hours;
6）Parameter area
- electronic flowmeter;
- SPO2;
After the option is selected, it will be displayed in the Monitored Parameters Area in
the Main Interface
3. Special settings
1）Information
Select 【Information】, the system goes to the version information interface, as shown
in the following figure.
The system version, gas controller version, display control version, gas flowmeter
version, gas module version and SPO 2 module version are displayed in this interface.
2) Super mode
Push 【Super Mode】 to access the super mode interface.
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The “Super Mode” only supports the company’s engineers for operating the machine,
like calibrating, updating, configuration and so on, and needs to input the corresponding
password.
3) Compensation Setting
Push 【Compensation setting】key to access the compensation interface.
The O2 and N2O compensation settings
The presence of oxygen and nitrous oxide can cause some interference in the CO 2
measurement. So they should be compensated.
O2 compensation is performed automatically for ISA sidestream analyzers capable of O2
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measurements and all the IRMA probes with the oxygen sensor fitted. When using an ISA
sidestream gas analyzer without this capability or using an IRMA without an oxygen
sensor, i.e. when oxygen measurement is performed by the host equipment, SetO2
command should be applied to transmit current oxygen concentration to the IRMA probe
or the analyzer.
For most applications, sufficient accuracy in CO 2 measurement will be achieved by
dividing the oxygen concentration into three ranges: “high”, “medium” and “low”. By using
these ranges, the maximal relative CO 2 error will be limited to 1.2%.
Set O2 range:
0-30 vol%;
30-70 vol%;
70-100 vol%.
Setting N2Ocompensation:
N2O is measured and automatically compensated for the ISA sidestream analyzers
capable of N2O measurements and for all IRMA probes except for in IRMA CO 2.
When using an ISA sidestream gas analyzer without this capability, or using the IRMA CO2,
Set N2O command should be applied to transmit current N2O concentration to ISA gas
analyzer or IRMA Probe.
For most applications, sufficient accuracy in CO 2 measurement will be achieved by setting
N2O to one standard concentration used always with N 2O in use, as recommendation
span 30-70 vol% N2O. When N2O is not in use, set N2O range 0-30 vol%.
By using this range, the maximum CO 2 error with N2O compensation on (30-70%) will be
limited to 3.2% relative.
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Set N2O range:
- 0-30 vol%;
- 30-70 vol%;
By using this range, see table below, the maximum CO 2 error with N2O compensation on
(30-70%) will be limited to 3.2% relative.
Set-mode
For normal use, the ISA sensor has three operating modes: Self test, Sleep,
Measurement.
Self test:
The sensor performs a self test and does not respond to commands from the host.
Sleep：
Low-power standby state. The host can communicate with the sensor, but all functions are
disabled.
Measurement:
The sensor is measuring gas concentrations.
Set Apnea:
The apnea setting range is from 20 to 60 seconds.
Normal Zeroing:
For all IRMA mainstream multigas analyzers, they need to establish a zeroing every time
after replacing the adapter or you have any doubts about the accuracy of the measured
values.
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Push【Normal Zeroing】touch area, the analyzer will begin normal zeroing.
Unit:
For N2O and anesthetic agent gases, the gas unit is “%”
For CO2 gas, the following three can be set:
- %;
- kPa;
- mmHg.
5.8 System shut off
When you have completed using the system, please shut off the system as following
procedures:
1. Disconnect the pipeline that connected to the patient;
2. Turn off the system switch;
3. Shut off the AC power supply;
4. Clean the surface of the equipment if need.
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Chapter 6 PHASEIN multigas analyzers (optional)
Chapter 6 PHASEIN multigas analyzers

(optional)
6.1 Summarize
The anesthesia machine adopts the PHASEIN multigas analyzer, it has the ability to
measure CO2, O2, N2O, anesthetic agents (Enflurane, Isoflurane, Sevoflurane), and
displays the real-time measuring value and waveform according to the settings; it can
provide automatic agent identification and are available in different configurations.
The anesthesia machine has two configurations: ISA sidestream gas analyzers and IRMA
mainstream analyzers. Users can select the following configurations:
Model Gases Description Interface
ISA AX+ CO2 ，N2O，anesthetic “Plug-in and RS-232
agents measure ”sidestream
multigas analyzer
ISA OR+ CO2, N2O, Anesthetic “Plug-in and measure” RS-232
agents，O2 sidestream multigas
analyzer with
paramagnetic oxygen
sensor
IRMA AX+ CO2 ，N2O，Anesthetic Mainstream multigas RS-232
agents analyzer
The PHASEIN multigas analyzer is shown as below:
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6.2 ISA sidestream multigas analyzer
Warning：
 The ISA sidestream gas analyzer is intended for use by authorized and trained
medical personnel only.
 Use only Nomoline sampling lines manufactured by PHASEIN.
 The ISA sidestream gas analyzer must not be used with flammable anesthetic
agents.
 Carefully route the sampling line to reduce the risk of patient entanglement or
strangulation.
 Do not re-use disposable sampling lines.
 Do not lift the ISA/host device by the sampling line as it could disconnect from the
ISA/host device, causing the ISA/host device to fall on the patient.
 Used disposable sampling lines shall be disposed of in accordance with local
regulations for medical waste.
 Do not use infant type sampling line configurations with adults, as this may cause
excessive flow resistance.
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 Do not use the ISA sidestream gas analyzer with metered-dose inhalers or nebulized
medications as this may clog the bacteria filter.
 Check that the gas sample flow is not too high for the present patient category.
 Since a successful zeroing requires the presence of ambient air (21% O 2 and 0%
CO2) in the gas analyzer; ensure that the ISA is placed in a well ventilated place.
Avoid breathing near the ISA sidestream gas analyzer before or during the zeroing
procedure.
 The Nomoline sampling line and its interfaces are non-sterile devices. To avoid
damage, do not autoclave any part of the sampling line.
 Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 Measurements can be affected by mobile and RF communications equipment. Make
sure that the ISA sidestream gas analyzer is used in the electromagnetic environment
specified in this manual.
 ISA sidestream gas analyzer is intended only as an adjunct in patient assessment. It
must be used in conjunction with other assessments of clinical signs and symptoms.
 Replace the sampling line if the sampling line input connector starts flashing red, or a
Nomoline occlusion message is displayed on the host.
 No modification of this equipment is allowed without authorization of the
manufacturer. If this equipment is modified, appropriate inspection and testing must
be conducted to ensure continued safe operation.
 ISA sidestream gas analyzers are not designed for MRI environments.
 During MRI scanning, the host device must be placed outside the MRI suite.
 Use of high frequency electrosurgical equipment in the vicinity of the ISA/host device
may produce interface and cause incorrect measurements.
 Do not use external ambient cooling of the ISA device.
 Do not apply negative pressure to the Nomoline (i.e. by a syringe) to remove
condensed water.
 Too strong positive or negative pressure in the patient circuit might affect the sample
flow.
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 Strong scavenging suction pressure might affect the sample flow.
 Exhaust gases should be returned to the patient circuit or a scavenging system.
 Always use a bacteria filter on the evac side if sampled gas is intended to be
re-breathed.
 Do not place the ISA gas analyzer in any position that might cause it to fall on the
patient.
Caution：
 The ISA “plug-in and measure” analyzers should be securely mounted in order to
avoid the risk of damage to the ISA.
 Do not apply tension to the ISA sidestream gas analyzer cable.
 Do not operate the ISA sidestream gas analyzer outside the specified operating
temperature environment.
6.2.1 Intended use
The ISA product family consists of different types of sidestream gas analyzers, intended to
be connected to other medical devices for display of real time and derived monitoring data
of a selection of CO2,N2O,O2 and the anesthetic agents （ Isaoflurane, Enflurane,
Sevoflurane）.
The ISA product family is intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It
may be used in the operating suit, intensive care unit, patient room and for applicable
versions emergency medicine/emergency transport settings for adult, pediatric and infant
patients.
The ISA product family is not intended to be used as the only means of monitoring a
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patient. They shall always be used in combination with other vital signs monitoring devices
and/or professional human judgments of patient condition. Products in the ISA product
family are intended to be used by trained and authorized health care professionals only.
They are only intended to be connected to medical devices approved by PHASEIN AB.
Note：
 An ISA sidestream gas analyzer should never be used as the only means of
monitoring a patient.
 An ISA sidestream gas analyzer shall only be connected to medical devices
approved by PHASEIN.
6.2.2 Patents and Trademarks
Patents
PHASEIN AB holds the following patents regarding products described in this manual:
SE519766; SE519779; SE523461; SE524086. Other patents pending.
Trademarks
PHASEIN IRMATM, PHASEIN ISA TM, PHASEIN XTPTM, Sigma Multigas TechnologyTM,
LEGITM, NomolineTM, IRMAEZ IntegratorTM, PHASEIN GasMasterTM and ISA
MaintenanceMasterTM are trademarks of PHASEIN AB.
Tygothane ○
R is a registered trademark of Saint-Gobain Performance Plastics
Corporation.
6.2.3 Consumables
The following sampling lines and other approved consumables can be ordered from
PHASEIN.
Product Description Catalog No.
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Sampling line with male Luer Lock connector.
Nomoline with Luer Lock For general use, with integrated water removal
108210
connector, 2m. Box of 25 and hydrophobic bacteria filter. Length 2
meters. Delivered in boxes of 25 pcs.
Sampling line with male Luer Lock connector.
Nomoline with Luer Lock For general use, with integrated water removal
108211
connector, 2m. 4 x Box of 25 and hydrophobic bacteria filter. Length 2
meters. Delivered as 4 boxes of 25 pcs.
Ordering information
To place an order for a PHASEIN product, please access www.phasein.com. You can get
detailed availability information for the products and order the products. Alternatively, you
can also contact our Company for information.
6.2.4 Adverse effects on performance
The performance of the ISO analyzer may be affected due to the following:
 Quantitative effects of humidity or condensate
 Quantitative effects of barometric pressure
 Interfering gases or vapors
 Other sources of interference
6.2.4.1 Quantitative effects of barometric pressure
Gas measurement units
Gas concentration is reported in units of volume percent. The concentration is defined as:
The total pressure of the gas mixture is measured by a cuvette pressure sensor in the ISA
gas analyzer.
For conversion to other units, the actual atmospheric pressure sent from the ISA
sidestream analyzer may be used, e.g.
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CO2 in mmHg= (CO2 concentration) × (atm.pressure value in kPa from ISA) ×
(750/100).
Example: 5.0 vol% [email protected] kPA → 0.05 × 101.3 × 750/100 = 38mmHg
6.2.4.2 Effects of humidity or condensate
The partial pressure and the volume percentage of CO 2, N2O, O2 and anesthetic agents
depend on the amount of water vapor in the measured gas. The O2 measurement will be
calibrated to show 20.8 vol% at actual ambient temperature and humidity level, instead of
showing actual partial pressure 20.8 vol% O 2 corresponds to the actual O 2 concentration
in room air with 0.7 vol% H2O concentration (at 1013 hPa this equals for example 25℃
and 23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g. all gases
measured by the IR-bench) will always show the actual partial pressure at the current
humidity level.
In the alveoli of the patient, the breathing gas is saturated with water vapor at body
temperature (BTPS).
When the breathing gas is sampled, and passing the sampling line, the gas temperature
will get close to the ambient temperature before reaching the ISA sidestream gas analyzer.
As the Nomoline removed all condensed water, no water will reach the ISA gas analyzer.
The relative humidity of the sampled gas will be about 95%.
If CO2 values at BTPS are required, the following equation can be used:
Where:
ETCO2=ETCO2 value sent from ISA [vol%]
Pamb=Ambient pressure sent from ISA [kPa]
3.8=Typical partial pressure of water vapor condensed between patient circuit and ISA
[kPa]
EtCO2 (BTPS) =EtCO2 gas concentration at BTPS [vol%]
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O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H 2O.
Spectral broadening
The present of oxygen and nitrous oxide can cause some interference in the CO 2
measurement. This is known as spectral broadening.
For the detailed information, please refer to the section 5.7 System settings.
Interfering gases and vapor
For the detailed information, please refer to the B.9.2 Interfering gas and vapor effects.
6.2.5 Analyzer system set-up
To set up the host device for gas analysis, follow these steps:
1. Connect the ISA analyzer interface cable to the host device.
2. Connect a Nomoline sampling line to the ISA analyzer input connector.
3. Connect the gas sample exhaust port to a scavenging system or return the gas
to the patient circuit.
4. Power up the host device.
5. A green LED indicates that the ISA analyzer is ready for use.
6. Perform a pre-use check as described in section 6.2.6pre-use check.
The installation of the sidestream analyzer is shown as the graphic below:
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SS
Exhaust gas AnesthesiaMulti- gasModule
And O Sensor
A irw ay adapter
Patient
6.2.6 Pre-use check
Before connecting the Nomoline sampling line to the breathing circuit, do the following:
1. Connect the sampling line to the ISA gas inlet connector (LEGI)
2. Check that the LEGI shows a steady green light (indicating that the system is ok)
3. For the ISA module with O 2 fitted: check that the O 2 reading on the monitor is correct
(21%)
4. Breathe into the sampling line and check that valid CO 2 waveforms and values are
displayed on the host device.
5. Occlude the sampling line with a fingertip and wait for 10 seconds.
6. Check that an occlusion alarm is displayed and that the LEGI shows a flashing red
light.
7. If applicable: perform a tightness check of the patient circuit with the sampling line
attached.
Note: LEGI is the abbreviation of “light emitting gas inlet”, which detects the
presence of a Nomoline sampling line and presents color-coded status information.
6.2.7 Zeroing
The infrared gas analyzer needs to establish a zero reference level for the CO 2,N2O and
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anesthetic agent gas measurement.
ISA sidestream gas analyzers perform zeroing automatically by switching the gas
sampling from the respiratory circuit to ambient air. The automatic zeroing is performed
every 24 hours, and takes less than 3 seconds for ISA CO 2 gas analyzers and less than
10 seconds for ISA multigas analyzers.
The ISA sidestream gas analyzer is fitted with an oxygen sensor, the automatic zeroing
will also include room air calibration of the oxygen sensor
Warning：
 Since a successful zeroing requires the presence of ambient air (21% O 2 and 0%
CO2) in the gas analyzer, ensure that the ISA is placed in a well ventilated place.
Avoid breathing near the ISA sidestream gas analyzer before or during the zeroing
procedure.
6.2.8 Alarms
The overview of the status indicated by the LEGI is described as the table below:
:
Indication Status
Steady green light System ok
Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check sampling line
6.3 IRMA mainstream multigas analyzer
Warning：
 The IRMA probe is intended for use by authorized and trained medical personnel
only.
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 The IRMA probe must not be used with flammable anesthetic agents.
 Disposable IRMA airway adapters shall not be reused. Reuse of the single use
adapter can cause cross infection.
 Used airway adapters shall be disposed of in accordance with local regulations for
medical waste.
 Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors
shall be disposed of in accordance with local regulations for batteries.
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds
6 ml dead space to the patient circuit.
 Do not use the IRMA infant airway adapter with adults as this may cause excessive
flow resistance.
 Measurements can be affected by mobile and RF communications equipment. It
should be assured that the IRMA probe is used in the electromagnetic environment
 Do not use the IRMA airway adapter with metered dose inhalers or nebulized
medications as this may affect the light transmission of the airway adapter windows.
 Do not place the IRMA airway adapter between the endotracheal tube and an elbow
as this may allow patient secretions to block the adapter windows and result in
incorrect operation.
 To keep secretions and moisture from pooling on the windows or oxygen sensor port,
always position the IRMA probe in a vertical position with the LED pointing upwards.
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 The IRMA probe is intended only as an adjunct in patient assessment. It must be
used in conjunction with other assessments of clinical signs and symptoms.
 Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable
product and contains a caustic electrolyte and lead.
 The IRMA probe is not intended to be in patient contact.
Caution：
 Never sterilize or immerse the IRMA probe in liquid.
 The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do
not autoclave the devices as this will damage them.
 Do not apply tension to the probe cable.
 Do not operate the IRMA probe outside the specified operating temperature
environment.
 Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe
is not in use.
6.3.1 Intended use
The IRMA main stream multi-gas probe is intended to be connected to other medical
devices for display of real time and derived monitoring data of CO 2, N2O, O 2, and the
anesthetic agents （Enflurane, Isoflurane, Sevoflurane ）.
It is intended to be connected to a patient breathing circuit for monitoring of
inspired/expired gases during anesthesia, recovery and respiratory care. It may be used
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in the operating suite, intensive care unit, patient room and emergency medicine settings
for adult, pediatric and infant patients.
It is not intended to be used as the only means of monitoring a patient. It shall always be
used in combination with other vital signs monitoring devices and /or professional human
judgments of patient condition. The IRMA probe is intended to be used by trained and
authorized health care professionals only.
6.3.2 System assembly instruction
Please follow the procedures below:
1. Plug the IRMA connector into the IRMA input of host device and switch the power on.
2. Snap the IRMA probe on top of the IRMA airway adapter. It will click into place when
properly seated.
3. A green LED indicates that the IRMA probe is ready for use.
4. Connect IRMA / airway adapter 15 mm male connector to the breathing circuit
Y-piece.
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5. Connect the IRMA / airway adapter 15mm female connector to the patient’s
endotracheal tube.
Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s
endotracheal tube and the IRMA probe. Placing an HME in front of the IRMA probe
protects the airway adapter from secretions and effects of water vapor and eliminates the
need of changing the adapter. It allows free positioning of the IRMA probe as well.
6. Unless the IRMA probe is protected with an HME always position the IRMA probe
with the status LED pointing upwards.
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Warning：
 The IRMA probe is not intended to be in patient contact.
6.3.3 Pre-use check
Prior to connecting the IRMA airway adapter to the breathing circuit, verify the O 2
calibration by checking that the O 2 reading on the monitor is correct (21%).
Always verify gas readings and waveforms on the monitor before connecting the airway
adapter to the patient circuit.
Perform the tightness check of the patient circuit with the IRMA probe snapped on the
IRMA airway adapter.
6.3.4 Zeroing procedure
Warning：
 Incorrect probe Zeroing will result in false gas readings.
In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe,
without connecting the airway adapter to the patient circuit, and then using the host
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instrument to transmit a zero reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during
the Zeroing procedure. The presence of ambient air (21% O 2 and 0% CO2) in the IRMA
airway adapter is of crucial importance for a successful Zeroing.
Always perform a pre-use check after zeroing the probe.
Zeroing should be performed every time the IRMA airway adapter is replaced, or
whenever an offset in gas values or an unspecified gas accuracy message is displayed.
Allow 30 seconds for warm up of the IRMA probe after power on and after changing the
IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED on
the probe will be blinking for approximately 5 seconds while zeroing is in progress.
6.3.5 Alarms
The description of the status LED situated on the IRMA probe is as below:
Steady green light System OK

Blinking green light Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adapter
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Chapter 7 PHASEIN CO2 analyzer and SPO2 module (optional)
Chapter 7 PHASEIN CO2 analyzer and

SPO2 module (optional)
7.1 Phasein CO2 analyzer
7.1.1 Summarize
The anesthesia machine adopts the PHASEIN CO2 analyzers. Users can select IRMA
sidestream CO2 analyzer or ISA mainstream CO 2 analyzer to measure the CO 2
concentration.
The ISA CO2 analyzers are low-flow sidestream gas analyzers, designed for routine
clinical use in environments that place special demands on the product’s ruggedness. Its
low power consumption and fast rise-time makes ISA CO2 ideal for any application,
ranging from the OR and ICU to transport monitoring of adult, pediatric and infant patients,
7.1.2 Installation
1. The installation of ISA sidestream CO 2 analyzer, please refer to 6.2.5 Analyzer
system set-up.
2. The installation of IRMA mainstream CO2 analyzer, please refer to 6.3.2 system
assembly instruction.
7.1.3 Zeroing procedure
1. IRMA CO2 probe：
Zeroing needs to be performed ONLY when an offset in gas values is observed, or when
an unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO 2 probe after power on and after changing
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the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED
on the probe will be blinking for approximately 5 seconds while zeroing is in progress.
2. ISA CO2 analyzer：
ISA sidestream gas analyzers perform zeroing automatically by switching the gas
sampling from the respiratory circuit to ambient air. The automatic zeroing is performed
every 24 hours, and takes less than 3 seconds for the ISA CO 2 gas analyzers.
Warning：
 Incorrect probe Zeroing will result in false gas readings.
7.1.4 Spectral broadening
The presence of oxygen and nitrous oxide can cause some interference in the CO 2
measurement. This is known as spectral broadening, and must be compensated.
For the detailed information, please refer to the section 5.7 System settings.
7.2 SpO2 Module
7.2.1 Introduction
The detecting of SpO2 adopts Pulse Oximetry. That is a method of the durative and
untraumatic detecting HbO2 saturation (functional saturation). The process is that the light
from the emitter to the receiver across patient’s part of body like finger or ear. The quantity
of penetrable light is dependent on numerous factors, the much of light is constant. But
the arterial blood changes regularly with time, because it is pulsant. The module can get
HbO2 saturation, By means of detecting the receiving light in patient pulse time, moreover
can receive “volume drawing” waveform and pulse rate.
The SpO2 module is shown in the following figure.
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Warning:
 If there are carboxyhaemoglobin, methemoglobin or attenuant chemical medicine, the
SpO2 value occurs error probably.
 Need to clean the SpO2 probe before used.
 Don’t put the SpO2 probe and blood pressure bond on one arm together, because
that affects the SpO2 saturation reading.
 Environment light, movement, EMI, ornaments, hemoglobin dysfunction, blood
coloration and so on can cause interference probably.
 The SpO2 detecting has no preventing defibrillation function, and don’t use with the
defibrillation equipment. That can cause interference probably.
 Clip one patient’s part no more than 2 hours, for the skin needs to get some air.
 The probe sensor should avoid shinning from troubled light in the process of
detecting SpO2.
 Please choose the type SpO2 probe to the needs of the sick before used, otherwise
the SpO2 value occurs error probably.
 Check the sensor before used, if the sensor packing or itself is damaged, don’t use.
 Don’t make the cable and sensor cable twisting together.
 Don’t put together the SpO2 probe on the arm which has conduit or injection syringe.
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7.2.2Connecting and operating
Detecting steps:
The SpO2 module works using probe clamping down the adult’s finger or infant’s palm or
foot. Refer to the below steps:
1) Switch on the power.
2) put the SpO2 probe on the patient’s right place.
3) Connect the SpO2 probe cable and interface.
Be shown in the following figure.
Put the finger in the probe
Warning:
 Check the using status and skin every 2 hours in a long continuous detecting
process.
 Check the position of probe periodically in a long continuous detecting process,
avoid moving to cause error probably.
Attention:
 Choose right SpO2 probe to detect.
 Put the SpO2 probe cable on the hand, and make sure the nail face on the light
from lamp-house.
 If the detecting part can not face on the probe, that maybe cause error, even don’t
search the pulse and don’t detect, and now need to locate again.
 Move the detecting part can cause error probably, should make the patient quiet
and replace detecting part, to minimize this impact.
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Chapter 8 User maintenance
Warning：
 Please comply with the appropriate safety precautions.
 Please read all the operation and maintenance instructions of the disinfection devices
carefully.
 Please wear the safety gloves and glasses, the damages to the oxygen sensor may
result in leakage and lead to fire (contains the potassium hydroxide).
 After every disassembled cleaning or reinstallation, it can be used regularly only after
the pre-use check in chapter 4.
 In order to prevent the leakage of the patient absorber system, during disassembling
and re-installing process, please pay attention to avoid damages to the components
and make sure the correctness of the installation, especially note the installation of
the seal ring; during the process of cleaning and disinfecting, please make sure the
way to clean and disinfect is applicable and correct.
 The used devices may be polluted by blood or body fluid, please apply to the
disinfection controlling and safety regulations.
 The moveable parts and removable components may have pinching or crunching
dangers, please pay more attention to those parts when moving or replacing the
system components.
 Do not use the devices with malfunctions, the machine should be maintained、
dismantled or operated only by the qualified personnel.
 After repairing, the equipment should be tested to ensure the normal function of the
equipment.
 Everyone should realize that some parts of the anaesthetic ventilator may be in
danger of infection when dismantled and cleaned.
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Cautions：
 In order to prevent damages, if you have any problem about the cleanser, please see
the data provided by the manufacturer.
 Do not use abrasive cleanser. (such as steel wool, silver polish or detergent)
 Place the liquids far away from the electronic components.
 Do not let liquid penetrate into the equipment.
 The soaking time of the synthetic rubber can not exceed 15 minutes, or it will lead to
expansion or accelerated aging.
 Those personnel who don’t have the experiences of repairing such equipment should
not carry out the maintenance
 Use parts produced or sold by our company to replace those broken ones, and have
a test after replacement to assure that they correspond with the specification
requirements of the manufacturer.
 Certain parts of this equipment should not be disposed in a normal way.
 All the disposable (one –off) parts should be disposed in a safe and environmental
way according to the hospital regulations.
 When taking any parts from the anesthesia machine, you should abide by the hospital
rules and regulations about taking and disposing infectiousness materials. Because
the way of cleaning, sterilizing in the Medical institutions is very different from the
practice. Therefore the Company can not satisfy all the special needs and can not be
responsible for cleaning, sterilizing or other hygienic measure taken by the hospital
during therapeutic process. We suggest that you use the effective methods already
proven in this user manual, specific equipment and steps. Other methods may be just
as effectively, but we do not guaranteed unless the Company provides written
authorization.
 We suggest that when cleaning or sterilizing, you should use drinking water at least
or more healthful water, otherwise, the result may be affected.
 Cleaning is the most important step in cleaning and sterilizing process. If you clean
the instrument improperly, it would be impossible to sterilize or high temperature
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sterilize effectively. Eliminating most of bacterium and filth by cleaning is significant
guarantee for achieving the best sterilization.
 The instrument should be cleaned and sterilized immediately after using if possible.
Filth like saliva or blood should not remain in the instrument and turn dry.
 If you need service or support, please contact the after service department of the
Company.
8.1 Maintenance schedule

Maintenance
Maintenance
Frequency
Every patient Reusable breathing tube, manual bag, patient absorber.
Every day The anesthesia machine surface, the alarm system testing
The Pop-off valve assembly, BYPASS assembly, bellows assembly,
Every half year
flow sensor, batteries.
Every year The oxygen battery, vaporizer.
When cleaning
Check the parts intact or not, if necessary change or repair it
and installing
Reusable breathing tube, manual bag, patient absorber assembly,
Do as necessary
bellows assembly, flow sensor.
8.2 Cleaning and disinfection
Components marked with are pressure-resistant and heat-resistant
components, like metal、glass can be disinfected with the high-temperature and
high-pressure steam, the recommended temperature is 134ºC. Use the high-pressure
steam boiler to increase the steam pressure, and the temperature is also increased to
make the bacterial albumen solidify rapidly. This method is rapid and credible. If kept in
the conditions of 1.05 kg/cm 2 steam pressure and 121ºC temperature for 15 to 20 minutes,
all bacilluse and most sporangium will be killed. These kinds of components can also be
cleaned manually or by machines. Scrub the components of the patient absorber system
(except the oxygen sensor) by mild detergent of which the PH value is less than 10 and
make them dry.
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Warnings：
 Do not use the talc, zinc stearate calcium carbonate, corn flour or the similar
materials to avoid conglutination. These materials may enter the patient’s lung or air
channel, causing stimulation or damages.
 Do not soak the oxygen sensor in the liquid or dispose it by high-temperature and
high pressure.
4) Check if the parts have damages, replace them if necessary.
Each component on the absorber of the anesthesia machine can be cleaned and
disinfected. The methods of cleaning and disinfecting for different components are
different. Users should select the appropriate method according to the actual circs to
clean and disinfect each component of the absorber in the anesthesia machine to prevent
cross -infection of the patients while using the anesthesia machine.
AGSS is a corollary equipment of the anesthetic machine that must be cleaned and
serviced synchronously.
The methods of cleaning and disinfection described in the form below are recommended
by our company.
The
medium The high level disinfection
Components
disinfection
A* B* C*
The breathing hose and
√
Y-connector
The flow sensor √
The bellows assembly √
Pop-off valve components √ √
Bag/Ventilator switch √ √
assembly
The APL valve assembly √ √
The inspiratory and √
Page 100 of 150

expiratory non-return
valve assembly
oxygen battery √
The canister assembly √
The inspiratory and √ √
expiratory assembly
The patient absorber √ √
assembly
The reusable manual √ √
breathing bag
A*： Clean with the cloth that soaked in the mild cleanser and dry it by using a lint-free
cloth;
B*：Wash it with clean water firstly, and then soak it in the water mixed with cleanser
solution ( the recommended temperature is 40°C) for about 3 minutes, finally, clean up
with clean water and wipe it with 70% medical alcohol;
C*：The high-temperature and high-pressure steam sterilization (the maximum
temperature is 134°C).
Warning：
 The patient absorber assembly of the anesthesia machine has two optional
configurations, one can only allow general disinfection and another allows
high-temperature and high-pressure disinfection. Before disinfecting the patient
absorber assembly, users must confirm its configuration and select correct
disinfection method.
8.3 Maintenance of the anesthesia machine surface
1. Use the wet cloth that has been soaked in the mild cleanser solution (such as the
70% medical alcohol) to wipe the surface of the anesthesia machine;
2. After finish the clean of the surface, using dry, Lint-free clothe to wipe the residual
detergent.
Page 101 of 150

Warning：
 If the liquid dip into the controlling components, it will damage the equipments or
induce people in danger. So make sure there is no liquid dip into the controlling
components, and disconnect the equipment and the AC power in the process of
cleaning the surface. Reconnect the equipment to the AC power after all the parts
that have been cleaned are dry.
Caution：
 The screen must be cleaned by the cloth that is dry, soft and lint-free, can not be
cleaned by liquid.
8.4 Maintenance of respiration system
In order to clean and disinfect the respiration system, firstly disassemble the parts that can
be cleaned and disinfected. These parts are shown as below:
Page 102 of 150

1.Bellows assembly 2.Bellows seating assembly
3.Pop-off valve 4.Gas block
5.BYPASS adapter block 6.Canister component
7.The upper cover main parts of the 8.Heat plate (including the Bag/Ventilator
absorber(including the APL) and non-return valve)
9.The lower cover main parts of the 10.Oxygen battery
absorber(including the manual bag
connector)
11.Flow sensor 12.Inspiratory and expiratory connector
assembly
8.4.1 Breathing tube and manual bag
1、 Disassembling:
1） Pull out all the breathing tubes that connected to the patients.
2） Remove the manual bag and place it with the tubes to the specified position for
disinfection and depositary.
2、 Cleaning and disinfection: please refer to 8.2 Cleaning and disinfection.
Caution：
 When disassembling the breathing hoses, please grab the two ends of the hose to
prevent damages to the hose.
8.4.2 Bellows assembly
1. Disassembling: please refer to 3.5 Installing the folding bag and bellows housing.
The method of disassembling is contrary to the method of installing.
2. Cleaning and disinfecting: please refer to 8.2 Cleaning and disinfection.
Page 103 of 150

8.4.3 Micro manometer and canister
1. Disassembling: please refer to 3.6 Installing the micro manometer. The method of
disassembling is contrary to the method of installing.
2. Cleaning and disinfecting: please refer to 8.2 Cleaning and disinfecting.
Warning：
 The absorbent is strong corrosive substance which can irritate eyes、skins and
respiration system badly. If the skin is touched carelessly, please flush with clean
water for at least 15 minutes. If the irritating substance still remains after cleaning,
please seek for the doctor’s help.
Cautions：
 The airway manometer of absorber can not be disinfected, please take and place it
gently during the disassembling and installing process, cannot hit it violently.
 When disinfection of each component is completed, inset the manometer to its
original place separately, and a click sound will be heard.
8.4.4 Pop-off valve assembly
1、 Disassembling:
1） Unlock the absorber, and remove the patient absorber;
2） Unscrew the four screws 1 by hands or tools, take out the base 2 and the Pop-off
assembly 3, the diagram is shown as below:
Page 104 of 150

1 1
2
3
1 1
2、 Cleaning and disinfection: please refer to 8.2 Cleaning and disinfection.
Caution：
 The damages of Pop-off valve may lead to gas leakage or serious malfunction,
therefore, please take care to maintenance it.
8.4.5 Gas block and bellows cover
1. Disassembling:
1） Unscrew the four screws 1 and the six screws 6 , take out upper cover of the bellows
component 2 and the lower cover 4;
2） Take out the gas block 5 from the heat plate. The diagram is shown as below:
1 1 3
2 3
4
1
1
3 5
3
1
1
3
3
2. Cleaning and disinfection: please refer to 8.2 Cleaning and disinfection.
8.4.6 BYPASS assembly
1. Disassembling: unscrew the four screws 1 by tools, and take out BYPASS assembly
2.
Page 105 of 150

2 1
1
2. Cleaning and disinfecting: please refer to 8.2 Cleaning and disinfecting.
8.4.7 Absorber upper cover and APL
1. Disassembling: Unscrew the micro manometer 1 by a monkey wrench, and then take
out the nine screws 2. The diagram is shown as below:
5
2 3 2 2
2 2 2
4
2
1 2
Pull the manual/mechanical controlling handle 3 to the middle, and take out the upper
cover 4 with APL assembly 5.
Cautions：
 The APL assembly is fastened in the upper cover of the absorber; it can be
disinfected without being disassembled.
 If you need to disassemble it, please keep the dismantled parts to prevent loss.
Page 106 of 150

8.4.8 Heat plant and bag/ventilator assembly and non-return
valve assembly
1. Disassembling: Remove the upper cover t, and then you can easily take out the heat
plate 1 and the Bag/Ventilator assembly 2 (it is built in the heat plate, and not
recommended to be disassembled). Please see the diagram below:
2
1
3 3
Hold the non-return valve assembly 3 forcibly and pull out it upwards, then take out the
non-return valve.
8.4.9 Oxygen battery
1. Disassembling: please refer to 3.7 Installing the oxygen battery. The method of
disassembling is contrary to the method of installing.
Warnings:
 Do not soak the oxygen sensor to liquid or dispose it through high-temperature and
high- pressure.
 The vapor condensate on the surface of the oxygen battery will lead to failure of
oxygen concentration measurement. Should take out the oxygen battery and clean
away condensate on the surface and then install it to the absorber again.
Page 107 of 150

8.4.10 Expiratory and inspiratory connector and flow sensor
1. Disassembling:
1） Unscrew the connector nut 1 anticlockwise by hand, hold the expiratory and
inspiratory connector 2 and pull them out with the nut 1 from the lower cover unit. The
diagram is shown as below:
1 1
2 2
2） Fasten the two button ears A of the flow sensor assembly 1, and pull out the flow
sensor slightly. Shown as below:
1
A 1
A
8.5 ISA analyzer and IRMA probe

1. The cleaning of ISA sidestream gas analyzers
The “plug-in and measure” ISA sidestream gas analyzers should be cleaned on a
regular basis. Use a cloth moistened with max 70% ethanol or isopropyl to clean the
Page 108 of 150

analyzer. To prevent cleaning liquids and dust from entering the ISA gas analyzer
through its LEGI connector, keep the Nomoline sampling line connected while
cleaning the analyzer.
2. The replacement of sampling line
The Nomoline sampling line is non-reusable.
Every two weeks or whenever “sampling line clogged” appears, whichever comes
first, the Nomoline sampling line should be replaced.
3. The cleaning of IRMA probe
IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or
maximum 70% isopropyl alcohol.
Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe.
4. Gas span check
Gas readings should be verified at regular intervals with a reference instrument. If
great error of gas readings were found, please contact the manufacturers service
department for maintenance by the after service engineers.
Warnings:
 The Nomoline sampling lines are non-sterile devices. To avoid damage, do not
autoclave any part of the sampling line.
 Never sterilize or immerse the ISA sidestream gas analyzer in liquid.
 Never sterilize or immerse the IRMA probe in liquid.
Page 109 of 150

Chapter 9 Configuration list
Chapter 9 Configuration list
Warnings：
 Please use accessories provided by the Company in order to avoid the inaccurate
data or equipment failure.
 The disposable accessories can be used only once, repeated using may lead to
performance degradation or cross-infection.
 If you discover that the accessories package or the accessories are damaged, do not
use the accessories.
The recommended accessories, damageable parts list:
No. Name Specification/Model

1 Oxygen battery MOX-4
2 Mask Adult/Pediatric
Adult
3 Manual breathing bag
Pediatric（Optional）
The absorptivity is no less than
4 Sodium lime
25%
5 ISA CO2 800101 (optional)
6 IRMA CO2 200101 (optional)
7 ISA OR+（CO2、N2O、O2、Anesthetic agents） 800401 (optional)
8 ISA AX+ （CO2、N2O、、Anesthetic agents） 800601 (optional)
9 IRMA AX+ （CO2、N2O、、Anesthetic agents） 200601 (optional)
Caution：
 The accessories listed above are recommended by the Company, we have no
responsibilities for the result if accessories of other specification are used.
Page 110 of 150

Appendix A Working Principle

A.1 Electrical schematic
NO. Isolation Isolation type Isolation description

Name
1 A-f basic insulation Between parts of opposite polarity of the mains
part.
2 A-a1 basic insulation Between mains part and accessible metal parts
which are protectively earthed.
3 A-a1 basic insulation Between the internal power supply and
accessible metal parts which are protectively
earthed.
4 A-e double insulated between mains part and the signal input/output
5 A-a2 reinforced between mains part and the non-grounded
insulation protect enclosure
Page 111 of 150

Page 112 of 150

Appendix B Product specification

B.1 Safety specification
According to China's State Food and Drug Administration classification, this anesthesia
machine is Class III device.

ClassⅠ, Containing the inner power supply
Electric shock If you have any doubt about the integrality of the external protective
protection type grounding or the protective grounding cable, the device must be replaced
by: the internal power supply (batteries).
Electric shock
Type B
protection grade
Working mode Continuing working
Explosion protection Not providing the explosion protection (common device), do not use
grade flammable anesthetic agents.
Liquid protection grade Not providing the liquid protection (common device) －IPX0（IEC 529）.
The method of
The connection between the device and the patient is non-electrical
connecting the device
connection.
with the patient
Fixed devices: not including the anesthesia machine base and the truckle,
Moving grade including the fixed shelf;
Mobile devices: including the anesthesia machine base and truckle.
Use alcohol to clean the surface, some parts that contacted with the patient
Disinfecting method should be dipped in the ethylene oxide, and some parts can resist to the
high temperature and high pressure steam and can be disinfected.
After packed according to the designed method, the anesthesia machine
must meet the requirements of the test procedure 1A (requirements for
Transportation containerized cargo)of the ISTA(International Safe Transit Association).
The transporting carton must be marked with the allowable temperature、
humidity and the altitude conditions of storage.
frequency cycle range(Hz) 5~35~5
amplitude value(mm) 0.35
Frequency sweeping cycles frequency
Vibration test 15
(time)
frequency sweeping speed ≤1 octave/minute
working state Non-working state
2
acceleration (m/s ) 50
pulse duration(ms) 11±2
Collision test
collision frequency (time) 1000±10
pulse repetition frequency(Hz) 1.0~1.7
Page 113 of 150

pulse waveform half sine wave

working state non-working state
Falling test Meet the requirements of IEC 60601-1, clause:21.6 (rough handling)
Spilled and the Meet the requirements of IEC 60601-1, clause: 44.3, and the requirements
exudates of the non-protective devices (IPX0) in IEC 529.
Surface temperature Meet the requirements of clause:42.1,42.2 and 42.3 in IEC 60601-1
Mechanical stability Meet the requirements of the clause 24.1 in IEC 60601-1.
Meet the requirements of the clause 56.3 in IEC 60601-1 and FDA
Incompatibility of the
Reviewer Guidance for Premarket Notification Submission November1993，
external connector
i2
Shell stiffness and Meet the requirements of clause: 21a, 16a and 21b in IEC 60601-1
strength Meet the requirements of clause 55 in UL 2601-1.
Thermal conditions
Meet the requirements of clause 52.5.5 in IEC 60601-1.
deteriorate
Leakage current Meet the requirements of clause 19 in IEC 60601-1/EN 60601-1
Dielectric strength Meet the requirements of clause 20 in IEC 60601-1/EN 60601-1
Grounding impedance Meet the requirements of Clause 18 in IEC 60601-1
Protective earthing Meet the requirements of Clause 58 in IEC 60601-1
B.2 Environment specification

Climate environment
II using in the general environment
division
Mechanical environment II The devices that is allowed to general vibration and impact in use,
division generally refers to devices that are easy to move.
temperature -20℃～+55℃
Storage and transport
humidity ≤93%，non-condensation
environment
atmospheric pressure 50 kPa～106 kPa
temperature 10℃～40℃
Operating environment humidity ≤80%，non-condensation
atmospheric pressure 70 kPa～106 kPa
B.3 Power supply specification

Parameter Specification
External AC power supply
Input voltage 100～240 VAC
Input frequency 50/60Hz
Input power 10A
Auxiliary mains power 100～240 VAC, 50/60Hz, 2A×3
Internal battery
Page 114 of 150

Battery quantity 1
Rated battery voltage 18.5VDC
Battery capability 4Ah
It can be used for at least 10 minutes after the first alarm for low power
Shutdown delay
capability (using the new and fully charged battery).
The shortest supplying 60 min (using the new and fully charged battery, the ambient temperature
time is 25ºC).
Charging time The battery should be charged continuously for at least 10 hours for the
first time, and about 5 hours in the future.
B.4 Gas supply specification

Parameters Specification
Oxygen supply(O2) 280 kPa~600 kPa，dry and clean
Nitrous oxide supply(N2O) 280 kPa~600 kPa，dry and clean
Air supply 280 kPa~600 kPa，dry and clean
Flow rate ＞100L/min
B.5 System specification

Technical parameter Specification
Host
O2 flush flow 25～75L/min
Auxiliary oxygen supply Non-pressure compensation, flow rate: 0～15L/min
Pneumatic system safety pressure Not above 12.5kPa
the noise of the whole device ≤65dB
The pressure resistance of the
≥1200kPa
ventilation airway.
The leakage between the inlet and
≤25mL/min
the flow controlling valve
The leakage between the flow
Under the pressure of 3 kPa, the leakage is not more than 50
controlling valve and the common
mL/min.
gas outlet
Under the pressure of 3 kPa, the leakage is not more than 150
Non-return valve pressure
mL/min.
Inspiratory resistance Not above 0.4 kPa
Expiratory resistance Not above 0.4 kPa
The pressure generated by a dry

≤0.15kPa
non-return valve
Anaesthetic ventilator
Driving mode Pneumatic electronically control
Driving gas Oxygen
Page 115 of 150

Driving gas pressure 0.28～0.6 Mpa

Driving gas flow rate ≤120 L/min
Ventilation mode PCV,VCV,SIMV,Manual
Pressure-time; flow-time; volume-time; CO2-time(optional);
Graph
pressure-volume loop; flow-pressure loop,SpO2
Inspiratory oxygen concentration, tidal volume, airway pressure, breathing
Alarms frequency, minute ventilation, suffocation, negative pressure, continuous high
pressure, end-inspiratory CO2 concentration(optional).
Alarm sound >65dB
100mL below is：±20mL；

Tidal volume
100mL above is：±20mL or 15% of the set value, take the
largest error
Breathing
±2bpm or ±10% of the set value, take the largest error
frequency
Positive
end-expiratory ±2cmH2O or ±10% of the set value, take the largest error
pressure
Controlling
Pressure control ±2cmH2O or ±10% of the set value, take the largest error
accuracy
Pressure support ±2cmH2O or ±10% of the set value, take the largest error
Pressure limit ±2cmH2O or ±10% of the set value, take the largest error
Inspiratory time ±0.1s or ±5% of the set value, take the largest error
Inspiratory holding
±10% of the set value
percent
Inspiratory and
±15% of the set value
expiratory rate
Flow trigger ±1L/min or ±10% of the set value, take the largest error
System The losing gas volume caused by the system compliance (bag mode): adult
compliance mode≤3 mL/cmH2O, Pediatric mode≤2 mL/cmH2O
Breathing
system Inspiratory resistance:≤0.4kPa, expiratory resistance:≤0.4kPa
resistance
Flowmeter
The oxygen, Nitrous oxide, air electrical flowmeter, 1 ～
Three kinds of gas supplies
10L/min (20℃)
Anesthetic vaporizer
Two-station vaporizer mounting systems with interlock function.
three anesthetic vaporizers can be selected :enflurane, isoflurane, sevoflurane

Ambient working：15～35℃；storage：-20～50℃；transport（not exceed 7 days）：-40～
temperature 60℃
Maximum capability：250 ml
Capability
Minimum capability： 30 ml
Page 116 of 150

Remnants capability：60±10 ml
Safety releasing pressure：38 kPa

Pressure
Working pressure：0～5kPa
0～2% vol, 0.2% vol
Scale 2～max, 0.5% vol
off status mark “0”.
B.6 Specifications of parameters
B.6.1 Specification of setting parameter
parameters Pediatric adult step Working mode
20～100：mL；5mL
100 ～ 1000 ：
VCV
Tidal volume:VT 20～300mL 100～1500ml 10mL；
SIMV(V)+PS
1000 ～ 1500 ：
50mL
PCV
Pinsp 5～70 cmH2O 5～70 cmH2O 1cmH2O
SIMV(P)+PS
VCV
Plimit 5～100cmH2O 5～100cmH2O 1cmH2O
SIMV(V)+PS
f 4～100 bpm 4～100 bpm 1 bpm PCV，VCV

SIMV(V)+PS
SIMV frequency 1～40 bpm 1～40 bpm 1bpm
SIMV(P)+PS
I:E 4:1～1:10 4:1～1:10 0.5 PCV，VCV
OFF ， 4 ～ 30 OFF ， 4 ～ 30
PEEP 1cmH2O PCV，VCV
cmH2O cmH2O
Inspiration pause OFF，5%～50% OFF，5%～50% 5% VCV
SIMV(V)+PS
Inspiration time 0.1～10.0 s 0.1～10.0 s 0.1s
SIMV(P)+PS
SIMV(V)+PS
FTRIG 1～15 L/min 1～15 L/min 1 L/min
SIMV(P)+PS
SIMV(V)+PS
Psupp 5～60 cmH2O 5～60 cmH2O 1cmH2O
SIMV(P)+PS
B.6.2 Specification of monitoring parameter
parameter range resolution

Inspiratory tidal volume 0～2500 mL 1mL
Expiratory tidal volume 0～2500 mL 1mL
Page 117 of 150

Minute ventilation 0～60 L 0.1L

Spontaneous minute ventilation 0～60 L 0.1L
Breathing frequency 0～100bpm 1bpm
Spontaneous breathing 0～99 bpm 1bpm
Frequency
I:E 4:1～1:10 0.1
The average airway pressure 0～100cmH2O 1cmH2O
PEEP 0～70cmH2O 1cmH2O
Inspiration platform pressure 0～100cmH2O 1cmH2O
Airway peek pressure 0～100 cmH2O 1cmH2O
Minimum airway pressure 0～100 cmH2O 1cmH2O
Inspiratory oxygen concentration 21%～100% 1%
Airway resistance 0～200cmH2O/(L/S) 1 cmH2O/(L/S)
Compliance 0～200mL/cmH2O 1mL/cmH2O
End-expiratory CO2(optional) 0～99mmHg 1mmHg
Inspiratory CO2(optional) 0～99mmHg 1mmHg
B.6.3 Specification of alarm parameters
Parameters Range Step
Upper-limit alarm of the airway

1～100cmH2O 1 cm H2O
pressure
Lower-limit alarm of the airway
0～99cmH2O 1 cm H2O
pressure
Upper-limit alarm of the oxygen
21～100% 1%
concentration
Lower-limit alarm of the oxygen
OFF，21～99% 1%
concentration
Upper-limit alarm of the tidal
30～1500mL，OFF
volume
10mL；
Lower-limit alarm of the tidal
20～1500mL
volume
Upper-limit alarm of the minute
1～40L，OFF 1L
ventilation
Lower-limit alarm of the minute
0～40L 1L
ventilation
Upper-limit alarm of the breathing
1～100 bpm 1 bpm
frequency
Lower-limit alarm of the breathing
0～99bpm 1 bpm
frequency
Upper-limit alarm of the
1～99mmHg，OFF 1mmHg
end-expiratory CO2(optional)
Lower-limit alarm of the 0～99mmHg 1mmHg
Page 118 of 150

end-expiratory CO2(optional)
Suffocation alarm 10～40s 5s
Lower-limit alarm of the SPO2
70～99% 1%
(optional)
When the airway pressure is continuous above （PEEP+15）
Continuous airway pressure
cmH2O for 15 seconds
Negative pressure alarm When the airway pressure is less than（-10）cmH2O。
Oxygen supplying malfunction When the oxygen supplying pressure is less than 0.28Mpa, The
alarm alarm sound is no less than 65dB.
The insufficient battery power The battery working time is 10 minutes after alarm
The exhausted battery power The battery working time is 3 minutes after alarm
B.7 Specification of hardware

Complete unit
Dimension 1450×1000×1330 mm （ H×W×D）
Weight(net weight) About 108 kg
The maximum load
capacity of the top 34 kg（75lb）
shelf
Screen
Type Colour TFT LCD
Size 15 inch
Resolution 1024×768 Pixels
LED indication
Alarm indicator one （yellow、red. If the high priority alarms and medium priority alarms happen
light at the same time, only the red light flashes.）
AC power indicator One （the indicator light is green when connected to the AC power supply）
Battery indicator One （green: the battery is full；yellow：the battery is not full）
Audio indication
Alarm sound, key tone, the alarm sound meets the requirements of ISO
Speaker
9703-2 :1992 standard.
Buzzer It gives an alarm when the system is out of order.
Controlling
One navigation wheel, it can be turned clockwise / anticlockwise and pressed
Navigation wheel
down
Eight keys: Alarm Silence, Alarm Settings, Lock, Monitored values, Ventilation
Keys
Settings, System Settings, System Log, Start/Standby
Interface
Power supply One AC power interface and three assistant output power interface
Network One Ethernet interface
Monitor One standard color VGA monitor interface, 15-PIN D-sub jacks.
Page 119 of 150

Equipotential One equipotential grounding terminal

RS232 interface One
PS2 interface One
Mobile devices
Trolleys Four trolleys，diameter:12.5 cm
Brake
Braking board On the two front truckles, with the function of braking when trodden.
Toolbox
Drawer 150×338×308 mm （Height×Width×Depth）
Breathing system
Bellows capacity About 1500 mL
Canister capacity 1.5L（about 1.3kg）
Inspiratory/ACGO port: standard outside diameter 22 mm, inner diameter
15mm, cone-shaped connector; expiratory port: standard outside diameter 22
Connections
mm, inner diameter 15mm, cone-shaped connector; manual breathing bag:
outside diameter 22 mm.
The absorber pressure under 3 kPa, then the leakage is not more than 50
Absorber leakage
mL/min
Respiration system Inspiratory impedance：not more than 0.6 kPa ; expiratory impedance：not more
resistance than 0.6 kPa
Real time clock
Range Year 2000（00:00:00）～2099（23:59:59）
Accuracy ±1 minute/month（condition: 21±3º）
Display resolution One second
Power supply Independent power supply
B.8 PHASEIN CO2 analyzer（optional）
B.8.1 PHASEIN ISA CO2 analyzer
Measuring mode sidestream

Operation temperature 0 to 50 ºC
Storage temperature -40 to 70 ºC
Operation atmospheric 52.5 to 120kPa (corresponding to a max altitude of 4572 m/ 15000
pressure feet)
Measuring range Accuracy
measuring range and
0 to 15 vol% ±2 (0.2 vol%+2% of reading)
accuracy
15 to 25 vol% unspecified
Total system response time ＜3 seconds (with 2 m sampling line)
Page 120 of 150

B.8.2 PHASEIN IRMA CO2 module（optional）
parameter specification
Measuring mode Mainstream

Operation temperature 0-40℃/ 32-104 ℉
Storage and transportation
-40-75℃/ -40-167 ℉
temperature
Operating humidity 10-95% RH， non-condensing
5-100 % RH，condensing
humidity
Operation atmospheric 525-1200 hPa (525hPa corresponding to an altitude of 4572
pressure m/15000 feet)
500 to1200 hPa
pressure
Total system response time ＜1 second
Accuracy Range accuracy
specifications(during 0～15 ± （0.2 vol%+ 2%of reading）
standard conditions） 15～25 unspecified
Accuracy specifications
± （0.3 vol%+ 4% of reading）
（during all conditions）
B.9 PHASEIN ISA analyzer（optional）
B.9.1 General specifications
parameters specification
Operating Storage
temperature 5 to 50℃ (41 to 122 ℉) -40 to 70℃(-40 to 158℉)
<4 Kpa H2O
5 to 100%RH(condensing)
humidity (non-condensing) (95% RH at
(100% RH at 40℃)
Using environment 30℃)
52.5 to 120kPa
Operating
(corresponding to a max
atmospheric 20 to 120kPa
altitude of 4572 m/ 15000
pressure
feet)
Sampling lines 2±0.1 m and 3±0.1 m versions
Sampling flow rate 50±10 ml/min
Power supply 4.5 to 5.5 VDC, <2.0W(normal op.), <2.4W(Peak@5 VDC)
Interface USB or RS-232 serial interface.
Page 121 of 150

Software upgrade possible using the RS-232 serial interface.
<20 seconds(Concentrations reported, automatic agent identification enabled and

Warm-up time
full accuracy)
CO2 ≤250 ms
Typical rise time at
N2O ≤350 ms
50 ml/min sample
Agents ≤350 ms
flow
O2≤ 450ms
Primary agent 0.15 vol%. When an agent is identified, concentration will be reported even below
threshold 0.15 vol%
Secondary agent
0.2 vol% + 10% of total agent concentration
threshold
Agent
<20 seconds(typically<10 seconds)
identification time
Total system
<3 seconds(with 2 m sampling line)
response time
Gas Range Accuracy
±(0.2 vol%+2% of
0 to 15 vol%
reading)
CO2
±(0.2 vol%+2% of
N2O 0 to 100 vol%
reading)
Accuracy-standard
±(0.15 vol%+5% of
conditions (the 0 to 8vol%
reading)
accuracy HAL,ENF,ISO
specifications are 8 to 25 vol% unspecified
valid for single
±(0.15 vol%+5% of
gases at 22±5℃ 0 to 10 vol%
reading)
SEV
and 1013±40 hPa)
±(0.15 vol%+5% of
0 to 22 vol%
reading)
DES
±(1 vol%+2% of
O2 0 to 100 vol%
reading)
Accuracy – all Gas Accuracy
conditions (the
accuracy CO2 ±(0.3 kPa+4% of reading)
specifications are
N2O ±(2 kPa+5% of reading)
valid for all
specified Agents ±(0.2 kPa+10% of reading)
environmental
O2 ±(2kPa+2% of reading)
conditions)
Page 122 of 150

Note：
5) The accuracy specification is not valid if more than one anesthetic agents are
present in the gas mixture. If more than two anesthetic agents are present, there
will be an alarm.
B.9.2 Interfering gas and vapor effect
Gas CO2
Gas or vapor Agent N2 O
level ISA CO2 ISA AX+
N2O 4) 60 vol% _2) _1) _1) _1)
HAL4) 4 vol% _1) _1) _1) _1)
5 vol% +8% of _1)
ENF, ISO, SEV4) 3) _1) _1)
reading
Xe (Xenon) 4) 80 vol% -10% of reading3) _1) _1)
He(Helium) 4) 50 vol% -6% of reading3) _1) _1)
Metered dose inhaler Not for use with metered dose inhaler propellants
4)
propellants
C2H5OH (Ethanol) 4) 0.3 vol% _1) _1) _1)
C3H7OH (Isopropanol) 4) 0.5 vol% _1) _1) _1)
CH3COCH3(Acetone) 4) 1 vol% _1) _1) _1)
CH4 (Methane) 4) 3 vol% _1) _1) _1)
CO(Carbon monoxide)5) 1 vol% _1) _1) _1)
0.02
NO(Nitrogen monoxide) 5) _1) _1) _1)
vol%
100
O25) _2) _2) _1)
vol%
Note 1: Negligible interference, effect included in the specification “Accuracy, all
conditions” above.
Note 2: Negligible interference with N2O/O2 concentrations correctly set, effect included in
the specification “Accuracy, all conditions” above.
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically
decreases the CO2 readings by 6%. This means that if measuring on a mixture containing
5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically
be (1-0.06)*5.0 vol%=4.7 vol% CO2
Page 123 of 150

Note 4: According to the EN ISO 21647:2004 standard.
Note 5: In addition to the EN ISO 21647:2004 standard.
B.9.3 MAC (Minimum Alveolar Concentration) calculation
Minimum alveolar concentration (MAC) is a standard for comparing the potency of
inhalation anesthetics. The MAC value represents the alveolar concentration of an
anesthetic (at one atmosphere) that, in 50 percent of a tested population, prevents gross
muscular movement in response to a painful, standardized stimulus.
If a mechanism to determine MAC values is implemented in the host device, the
algorithms used for this calculation must be adequately documented.
The MAC value may be calculated and displayed by using end-tidal(Et)gas concentrations
according to the following formula:
X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%,DES=6.0%.
Note：
6) Altitude, patient age and other individual factors are not considered in the formula
above.
B.9.4 Electromagnetic compatibility (EMC)
Electromagnetic emission
This section constitutes the guidance and PHASEIN’s declaration regarding
electromagnetic emissions for the ISA gas analyzers.
Page 124 of 150

Isa gas analyzers are intended for use in the electromagnetic environment specified in the
table below. Customers can end users of ISA gas analyzers should assure that they are
used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions Group 1 The ISA sensor uses RF energy only for its
CISPR 11 internal function. Therefore, Its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The ISA sensor is suitable for use in all
CLSPR 11 establishments including domestic and those
Harmonic emissions N/A directly connected to the public low-voltage
IEC 61000-3-2 power supply network that supplies buildings
Voltage fluctuations/flicker N/A used for domestic purposes.
emissions IEC 61000-3-3
Electromagnetic immunity
This section constitutes the guidance and PHASEIN’s declaration regarding
electromagnetic immunity for the ISA gas analyzers.
Isa gas analyzers are intended for use in the electromagnetic environment specified below.
Customers or end users of ISA gas analyzers should assure that they are used in such an
environment.
Immunity test IEC 60601 Compliance Electromagnetic
test level level environment-guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or
(ESD) IEC 61000-4-2 ±8 kV air ±8 kV air ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Page 125 of 150

Electrical fast ±2 kV for power N/A AC power quality should be that of a
transient/burst supply lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for environment.
input/output lines
Surge IEC 61000-4-5 ±1 kV line(s) to N/A AC power quality should be that of a
line(s) typical commercial or hospital
±2 kV line(s) to environment.
earth
1
Voltage dips, short ＜5% UT N/A The power supply quality should be the
interruptions and ( ＞ 95% dip in same as in a typical commercial or
voltage variations on UT) for 0.5 cycle hospital environment. If the user of the ISA
power supply input 40% UT (60% dip sensor requires continued operation
lines IEC 61000-4-11 in UT) for 5 during power outages, the ISA sensor
cycles should be powered by an uninterruptible
70% UT (30% dip power supply or a battery.
in UT) for 25
cycles
＜5% UT
( ＞ 95% dip in
UT) for 5 Sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.
Conducted RF IEC 3 Vrms 150kHz 10 Vrms Portable and mobile RF communications
61000-4-6 to 80 MHz 20 V/m equipment should be used no closer to
Radiated RF IEC 3 Vrms 80 MHz any part of the ISA sensor, including
61000-4-3 to 2.5 GHz cables, than the recommended separation
Page 126 of 150

distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
d=0.35 P
d=0.18 P 80MHz to 800 MHz
d=0.35 P 800MHz to 2.5GHz
where P is the maximum output power
rating of the transmitter in watts(W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
a
survey, should be less than the
compliance level in each frequency
b
range. interference may occur in the
vicinity of equipment marked with the
following symbol.
Note1：At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guideline may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a
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 assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
Page 127 of 150

considered. If the measured field strength in the location in which ISA is used exceeds the
applicable RF compliance level above, ISA should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating ISA.

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
V/m.
Separation distance to RF communications equipment

In this section the recommended separation distances between portable and mobile RF
communications equipment and the ISA gas analyzers are specified.
ISA gas analyzers are intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the ISA gas
analyzers can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment(transmitters) and
the ISA gas analyzer as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum Separation distance according to frequency of transmitter [m]
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter[W]
d=0.35 P d=0.18 P d=0.34 P
0.01 0.035 0.018 0.035
0.1 0.11 0.057 0.11
1 0.35 018 0.35
10 1.1 0.57 1.1
100 3.5 1.8 3.5
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters(m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts(W) according to the transmitter manufacturer.
Page 128 of 150

Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
Warning
7) Measurements can be affected by mobile and RF communications equipment.
Make sure that the ISA gas analyzer is used in the electromagnetic environment
B.10 PHASEIN IRMA multi-gas analyzers（optional）
B.10.1 General Specifications
parameters specification
Operating Storage
Temperature 10 to 40℃ (50 to 104 ℉) -20 to 75℃(-4 to 167℉)
Humidity 10-95% RH， non-condensing 5-100%， condensing

Using environment
525-1200 hPa (corresponding

Operating
atmospheric to an altitude of 4572 m/ 15000 500-1200 hPa
pressure
feet)
4.5~ 5.5 VDC, max1.4W(power on surge @ 5 V less than 350mA during 200
Power supply
ms)
Interface Modified RS-232serial interface operating at 9600 bps
Automatic agent
Primary and secondary agent.
identification
Warm-up time <20 sec (concentrations are reported and the automatic agent identification is
Page 129 of 150

running within 20 seconds).
Primary agent
0.15 vol%. when an agent is identified, concentrations
threshold
Secondary agent
0.2 vol% + 10% of total agent concentration
threshold
Agent
<20 seconds(Typically＜10 seconds)
identification time
Total system
<1 second
response time
Gas Range Accuracy
0 ~ 10 ±(0.2 vol%+ 2% of reading )
CO2 10 ~ 15 ±(0.3 vol%+ 2% of reading)
15 ~ 25 Unspecified
N2O 0 ~ 10 ±(0.2 vol%+ 2% of reading)

Accuracy
0~8 ±(0.15 vol%+ 5% of reading)
specifications HAL,ENF,ISO
8 ~ 25 Unspecified
（during standard
0 ~ 10 ±(0.15 vol%+ 5% of reading)
conditions） SEV
10 ~ 25 Unspecified
0 ~ 22 ±(0.15 vol%+5% of reading)

DES
22 ~ 25 Unspecified
O2 0 ~ 100 ±(1vol%+ 2% of reading)
Gas Accuracy
CO2 ±(0.3 vol%+ 4% of reading)

Accuracy （ during
N2O ±(2 vol%+ 5% of reading)
all conditions）
Agents ±(0.2 vol%+ 10% of reading)
O2 ±(2vol%+ 2% of reading)
Page 130 of 150

B.10.2 Interfering gas and vapour effect
CO2
Gas
Gas or vapor IRMA IRMA Agent N2 O
level
CO2 AX+/OR+
4) 1&2)
N2 O 60 vol% _ _1&2) _1) _1)
HAL4) 4 vol% _1) _1) _1) _1)
5 vol% +8% of _1)
ENF, ISO, SEV4) 3) _1) _1)
reading
Xe (Xenon) 4) 80 vol% -10% of reading3) _1) _1)
He(Helium) 4) 50 vol% -6% of reading3) _1) _1)
Metered dose inhaler Not for use with metered dose inhaler propellants
4)
propellants
C2H5OH (Ethanol) 4) 0.3 vol% _1) _1) _1)
C3H7OH (Isopropanol) 4) 0.5 vol% _1) _1) _1)
CH3COCH3(Acetone) 4) 1 vol% _1) _1) _1)
CH4 (Methane) 4) 3 vol% _1) _1) _1)
CO(Carbon monoxide)5) 1 vol% _1) _1) _1)
0.02
NO(Nitrogen monoxide) 5) _1) _1) _1)
vol%
100
O25) _2) _2) _1)
vol%
Note 1: Negligible interference, effect included in the specification “Accuracy, all
conditions” above.
Note 2: For probes not measuring N2O and / or O2 the concentrations shall be set from
host according to the instructions in section 5.7 System setting (SetN2O/SetO2)
Note 3: Interference at indicated gas level. For example, 50 vol% Helium typically
decreases the CO2 readings by 6%. This means that if measuring on a mixture containing
5.0 vol% CO2 and 50 vol% Helium, the actual measured CO 2 concentration will typically
be (1-0.06)*5.0 vol%=4.7 vol% CO 2
Note 4: According to the EN ISO 21647:2004 standard.
Note 5: In addition to the EN ISO 21647:2004 standard.
B.10.3 Electromagnetic compatibility (EMC)
Electromagnetic emission
The IRMA probe is intended for use in the electromagnetic environment specified below.
Page 131 of 150

The customer or the user of the IRMA probe should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions Group 1 The IRMA probe uses RF energy only for its
CISPR 11 internal function. Therefore, Its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class B The IRMA probe is suitable for use in all
CLSPR 11 establishments including domestic and those
Harmonic emissions N/A directly connected to the public low-voltage
IEC 61000-3-2 power supply network that supplies buildings
Voltage fluctuations/flicker N/A used for domestic purposes.
emissions IEC 61000-3-3
Electromagnetic immunity
The IRMA probe is intended for use in the electromagnetic environment specified below.
Customers or end users of ISA gas analyzers should assure that they are used in such an
environment.
Immunity test IEC 60601 Compliance Electromagnetic
test level level environment-guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or
(ESD) IEC 61000-4-2 ±8 kV air ±8 kV air ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%
Electrical fast ±2 kV for power N/A AC power quality should be that of a
transient/burst supply lines typical commercial or hospital
IEC 61000-4-4 ±1 kV for environment.
input/output lines
Page 132 of 150

Surge IEC 61000-4-5 ±1 kV line(s) to N/A AC power quality should be that of a
line(s) typical commercial or hospital
±2 kV line(s) to environment.
earth
1
Voltage dips, short ＜5% UT N/A The power supply quality should be the
interruptions and ( ＞ 95% dip in same as in a typical commercial or
voltage variations on UT) for 0.5 cycle hospital environment. If the user of the
power supply input 40% UT (60% dip IRMA probe requires continued operation
lines IEC 61000-4-11 in UT) for 5 during power outages, the IRMA probe
cycles should be powered by an uninterruptible
70% UT (30% dip power supply or a battery.
in UT) for 25
cycles
＜5% UT
( ＞ 95% dip in
UT) for 5 Sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60Hz) magnetic be at levels characteristic of a typical
field IEC 61000-4-8 location in a typical commercial or hospital
environment.
Conducted RF IEC 3 Vrms 150kHz 10 Vrms Portable and mobile RF communications
61000-4-6 to 80 MHz 20 V/m equipment should be used no closer to
Radiated RF IEC 3 Vrms 80 MHz any part of the IRMA probe, including
61000-4-3 to 2.5 GHz cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Page 133 of 150

d=0.35 P
d=0.18 P 80MHz to 800 MHz
d=0.35 P 800MHz to 2.5GHz
where P is the maximum output power
rating of the transmitter in watts(W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
a
survey, should be less than the
compliance level in each frequency
b
range. interference may occur in the
vicinity of equipment marked with the
following symbol.
Note1：At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guideline may not apply in all situations. Electromagnetic propagation is

a
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 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 ISA is used exceeds the
applicable RF compliance level above, ISA should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the IRMA probe.
Page 134 of 150

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
V/m.
Separation distance to RF communications equipment

In this section the recommended separation distances between portable and mobile RF
communications equipment and the IRMA probe are specified.
ISA gas analyzers are intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the IRMA probe can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the IRMA probe as
recommended below, according to the maximum output power of the communications
equipment.
Rated maximum Separation distance according to frequency of transmitter [m]
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter[W]
d=0.35 P d=0.18 P d=0.34 P
0.01 0.035 0.018 0.035
0.1 0.11 0.057 0.11
1 0.35 018 0.35
10 1.1 0.57 1.1
100 3.5 1.8 3.5
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters(m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts(W) according to the transmitter manufacturer.
Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
Page 135 of 150

Warning:
8) Measurements can be affected by mobile and RF communications equipment.
Make sure that the IRMA probe is used in the electromagnetic environment
Page 136 of 150

Appendix C Alarm
Appendix C Alarm
This chapter lists some of the most important parameters and technical alarm information,
some information may not be listed.
Note that in this chapter:
- The “L” is the default alarm level: H for the high priority; M for the medium; L for
the low;
- For each of the alarm information, there lists the corresponding solutions. If the
problem persists after operated in accordance with the solutions, please
contact the maintenance man.
Alarm
L Reasons and solution
information
High tidal The expiratory tidal volume exceeds the upper limit of the alarm settings.
M
volume Decrease the set tidal volume or increase the alarm upper limit
The expiratory tidal volume is less than the lower limit of the alarm
Low tidal
M settings.
volume
Increase the set tidal volume or decrease the alarm lower limit.
The minute ventilation volume exceeds the upper limit of the alarm
High minute settings.
M
ventilation Decrease the set tidal volume or the respiratory frequency or increase
the alarm upper limit.
The minute ventilation volume is less than the lower limit of the alarm
Low minute settings.
M
ventilation Increase the set tidal volume or the respiratory frequency or decrease
the alarm lower limit.
High breathing The ventilation frequency exceeds the upper limit of the alarm settings.
L
frequency Decrease the set respiratory frequency or increase the alarm upper limit.
The ventilation frequency is less than the lower limit of the alarm
Low breathing settings.
L
frequency Decrease the set respiratory frequency or decrease the alarm lower
limit.
High inspiratory The FiO2 exceeds the upper limit of the alarm settings.
oxygen M Decrease the oxygen volume of the fresh gas or increase the alarm
concentration upper limit.
Low inspiratory The FiO2 is less than the lower limit of the alarm settings.
H
oxygen Increase the oxygen volume of the fresh gas or decrease the alarm
Page 137 of 150

Appendix C Alarm
concentration lower limit.

The airway peek pressure exceeds the upper limit of the alarm settings.
High airway Check if the ventilation pipeline bent or plugged up, if the pipeline
H
pressure connection is normal, the inspiratory pressure or the tidal volume should
be decreased or increase the alarm upper limit.
The airway pressure (pressure waveform data) is less than the lower
limit of the alarm settings.
Low airway
H Check if the ventilation pipeline leak or fall off, if the pipeline connection
pressure
is normal, the inspiratory pressure or the tidal volume should be increase
or decrease the alarm lower limit.
High
end-expiratory M The measuring value is more or less than the upper or lower limit of the
CO2 alarm settings.
Low Check the patient’s physical conditions、make sure if the patient type
end-expiratory M and the set alarm limit applicable to the patient.
CO2
The patient absorber airway pressure has been above the （PEEP+15）
continuous high
H cmH2O more than 15 seconds.
airway pressure
Check if the pipeline bent, plugged up or disconnected.
Lower than the atmospheric pressure 10cmH2O.
Check if the patient is breathing spontaneously. Increase the fresh gas
Negative
H flow. Observe whether there is high speed flow passing through the
pressure alarm
residual gas purging system. If there is, check the negative
pressure-relief valve on the receiver.
In the Settings Tapnea time, no mechanical ventilation and manual
breathing;
Suffocation H
Increase the settings of the tidal volume and respiratory frequency or
begin manual ventilation.
The oxygen source pressure is low.
Low O2 supply H
Should use or replace the backup cylinder immediately.
The battery power is low.
The system is operable, connect it to the AC power at once.
Low battery If the power supply is cutoff, please use manual ventilation to support
M
power the patient breath.
If the batteries can not be charged fully within 24 hours, please contact
the specified maintenance man.
The battery power is too low, and the system will shut off within three
minutes.
Please connect it to the AC power at once.
Exhausted
H If the power supply is cutoff, please use manual ventilation to support
battery power
patient breath.
If the batteries can not be charged fully within 24 hours, please contact
the specified maintenance man.
AC Power M Please check the AC Power.
Page 138 of 150

Appendix C Alarm
Failure!!
Page 139 of 150

Appendix C Alarm
Page 140 of 150

Appendix D Symbol and glossary

D.1 Glossary
Abbreviation Define
AA Anesthetic agent
AGSS Anesthesia Gas Scavenging System
ACGO Auxiliary Common Gas Outlet
APL Adjustable pressure-limiting valve
ENF Enflurane
ISO Isoflurane
SEV Sevoflurane
BPM Breaths per minute
BTPS body temperature and pressure，Saturated
ATPD Ambient temperature and pressure
Manual Manual ventilation
PCV Pressure control ventilation
SIMV Synchronized intermittent mandatory ventilation
VCV Volume control ventilation
N2O N2O
O2 Oxygen
C Compliance （Cdyn）
Paw Airway pressure
TI Inspiratory time
PEEP Positive end-expiratory pressure
Pinsp Pressure control level of inspiration
Pmean Mean airway pressure
Ppeak Peak pressure
Pplat Plateau pressure
Pmin Minimum pressure
Plimit Limit pressure
f Frequency
InCO2 Inspiratory CO2
Page 141 of 150

EtCO2 End-Tidal CO2
Psupp Pressure support level
R Resistance
FiO2 Fractional concentration of O2 in inspired gas
TIP:TI Percentage of inspiratory plateau time in inspiratory time
VT Tidal volume
I:E Inspiratory time: Expiratory time ratio
MV Minute ventilation
PR Pulse Rate
MVspn Spontaneously breathed minute volume
VTE Expired tidal volume
VTI Inspired tidal volume
T-Flow Total Flow
MAC Minimum Alveolar Concentration
CON indicate the module is connected
DISC indicate the module is not connected or disconnected
BTPS Body Temperature and Pressure Saturated
D.2 Equipment symbol

Attention, see the
accompanying document (this High pressure warning
manual)
Alternating current Fuse
Battery Equipotential pole
System settings Alarm settings
Alarm Silence Debug serial port
The device is switched on The device is switched off
Ventilation settings Start / Standby
Alarm silence Oxygen flush button
Page 142 of 150

Manual ventilation Manual bag
Lock Unlock
Monitor interface pipeline
Network interface Flowmeter knob
Light Oxygen sensor interface
Flowmeter backlight N2O supply connector
VGA interface Air supply connector
Mouse interface O2 supply connector
Cylinder Earthing
The maximum pressure at the The maximum pressure at

oxygen cylinder inlet the N2O cylinder inlet
The maximum load

CO2 canister capacity of the monitor
arm
The maximum load

Vaporizer capacity of the information
system
Oxygen cylinder
N2O cylinder manometer
manometer
Page 143 of 150

mechanical ventilation AGSS vent
TYPE B equipment ClassⅠ ClassⅠequipment
Consult instructions for use Catalog number
Consult instructions for use of

Serial number
ISA
Use by
date[YYYY-MM-DD]
The device should not be
Batch code
taken into operation after
the date accompanying
the symbol
Temperature limitation Pressure limitation
Humidity limitation Do not re-use
Waste Electrical and Electronic

CE mark
Equipment(WEEE)
Splash-proof Rx only
ISA equipped to measure CO2 ISA equipped to measure

only multiple gases
Connection to patient
Sigma Multigas Technology
circuit
Non-sterile,
Connection to ISA
Latex free
Proper disposal of products
Page 144 of 150

D.3 Packing symbol
THIS WAY UP FRAGILE
KEEP AWAY FROM RAIN DO NOT STACK
KEEP AWAY FROM

DO NOT ROLL
SUNLIGHT
Caution:
 Due to the different configuration, some symbols may be not entirely consistent to the
equipment, please take the equipment as valid.
Page 145 of 150

Page 146 of 150

Appendix E Default setting

This chapter lists some of the most important default settings of the anesthesia machine.
Users can not change the factory settings, but can reset the anesthesia machine to the
default settings when necessary.
E.1 Patient information
Patient information Factory default setting
Patient category adult Pediatric
Weight 65kg 7.5 kg
E.2 Default parameter
Factory default setting
Patient category adult Pediatric
Respiratory parameter settings
Tidal volume VT（mL） 460 50
Breathing frequency f（bpm） 12 30
Inspiratory pause TIP:TI(%) OFF OFF
I:E 1:2.0 1:2.0
TI（S） 1.7 0.7
PEEP（cmH2O） OFF OFF
Pressure limit Plimit（cmH2O） 40 20
Pressure controlling level Pinsp（cmH2O） 5 5
Pressure supporting level Psupp（cmH2O） 5 5
E.3 Alarm default setting
Alarm default setting
Tidal volume (mL) Upper limit: OFF,
Page 147 of 150

lower limit: Adult:300; Pediatric:30
Minute ventilation volume (L) Upper limit:20, Lower limit:3
Respiratory frequency (bpm) Upper limit: 40, Lower limit: 0
Inspiratory oxygen concentration (%) Upper limit: OFF, Lower limit: 21
Airway pressure (cmH2O) Upper limit: 40, Lower limit: 0
End expiratory CO2 (mmHg) Upper limit: 60, Lower limit: 30
The airway pressure is >（PEEP+15）cmH2O for

Continuous airway pressure (cmH2O)
15 seconds.
Suffocation (s) Upper limit: 20
Page 148 of 150

Appendix F Reference
Appendix F Reference
EN 60601-1/IEC60601-1 Medical electrical equipment Part I: General requirements for
safety
IEC 60601-2-13:2003 Medical electrical equipment Part 2: Particular requirements for the
safety and essential performance of anesthetic systems
ISO 8835-4:2004 Inhalational anaesthetic systems- Part 3: Anesthetic vapour delivery
devices.
EN 740 Anesthetic workstations and their modules - Particular requirements
Page 149 of 150

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What standards and regulations does the anesthesia machine comply with?

Product Information

Product name：Anesthesia Machine

Product Executive Standard: YZB/State 0690-2010 (anesthesia machine)

Production Certificate No.: GDFDA for medical device production 20081586

Registered Address：JinLiMei Factory Building, No.37, Yanshan Road, Nanshan District,

Address: JinLiMei Factory Building, No.37, Yanshan Road, Nanshan District,

After Service Tel: 4007-880-300

PROBE reserves the right to change it without giving prior notice.

The version information:

Devices (93/42/EEC), and meets basic requirements of appendix I in the directive.

the EN55011. It meets the requirements of EN60601-1-2 standard “Medical electrical

storage, reproduction or translation of this document in any form is strictly prohibited

without the prior written permission from the Company.

information not obtained by the third party.

non-compliance with the servicing requirements detailed in this manual.

operated according to the “User’s Responsibility”. Otherwise, the Company has no

responsibility for any damages to the product.

deem that you have read the manual carefully.

“Caution” and “Note”.

questions, please contact the Company.

 Bold Italic: The quoted section.

 【Character】：The character string on the user interface or on the control panel.

VERSION INFORMATION ................................................................................................................... I

USER’S RESPONSIBILITY ................................................................................................................ III

FREE MAINTENANCE ....................................................................................................................... III

TRADEMARK ...................................................................................................................................... III

CHAPTER 1 SAFETY INFORMATION ................................................................................................ 1

1.1 WARNINGS ................................................................................................................................. 2

CHAPTER 2 EQUIPMENT DESCRIPTION ...................................................................................... 10

2.1 BRIEF INTRODUCTION .............................................................................................................. 10

CHAPTER 3 INSTALLATION AND CONNECTION ........................................................................ 49

3.1 POWER SUPPLY INTERFACE ....................................................................................................... 49

CHAPTER 4 PRE-USE CHECK ......................................................................................................... 63

CHAPTER 5 OPERATIONS AND SETTINGS.................................................................................. 65

5.1 TOUCH KEY .............................................................................................................................. 65

CHAPTER 6 PHASEIN MULTIGAS ANALYZERS (OPTIONAL) .................................................. 77

6.1 SUMMARIZE .................................................................................................................................... 77

CHAPTER 7 PHASEIN CO2 ANALYZER AND SPO2 MODULE (OPTIONAL) .......................... 93

7.1 PHASEIN CO2 ANALYZER ................................................................................................................. 93

CHAPTER 8 USER MAINTENANCE ................................................................................................. 97

8.1 MAINTENANCE SCHEDULE ........................................................................................................ 99

CHAPTER 9 CONFIGURATION LIST ............................................................................................. 110

APPENDIX A WORKING PRINCIPLE ............................................................................................ 111

A.1 E LECTRICAL SCHEMATIC .............................................................................................................. 111

APPENDIX B PRODUCT SPECIFICATION ................................................................................... 113

B.1 SAFETY SPECIFICATION ................................................................................................................ 113

APPENDIX C ALARMS ..................................................................................................................... 137

APPENDIX D SYMBOLS AND GLOSSARY .................................................................................. 141

D.1 GLOSSARY .................................................................................................................................... 141

APPENDIX E DEFAULT SETTINGS ............................................................................................... 147

APPENDIX F REFERENCE .............................................................................................................. 149

Chapter 1 Safety Information

Caution and Note prior to operating the anesthesia machine.

potential safety hazards.

machine or other equipment.