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Statement

Beijing Aeonmed Co., Ltd. (Aeonmed for short) holds the copy rights to this manual, which is
non-public, published, and reserves the rights to keep it as a secure document. Refer to this
manual when operating, maintaining and repairing products only. Anyone other than
Aeonmed may not make it known to others.

Proprietary materials protected by the copyright law are included in this manual. Any section
of it cannot be reproduced, copied, or translated into other languages without any prior
written approval from Aeonmed who reserves the copyright.

Everything written in this manual is considered to be correct. Aeonmed is not legally


responsible for any mistakes printed within and any damages caused by incorrect installation
and operation. Aeonmed does not supply privileges endowed by the patent law to any other
parties. Aeonmed is not legally responsible for the results caused by patent law breaking and
any rights of the third party violating.

Refer to this manual before the product is used. The manual includes operating procedures
which must be performed with cautiously, operations that may result in non-normal working
conditions and the dangers which may damage equipment or cause bodily harm. Aeonmed is
not responsible for the security, reliability and function of the equipments in case that the
dangers, damages and non-normal phenomenon mentioned in this manual happen. Free
repairs for these malfunctions will not be provided by Aeonmed.

Aeonmed has the rights to replace any content in this manual without notice.

Manufacturer Responsibility:

Aeonmed is responsible for the security; reliability and function of the equipments when to
following conditions are adhered to:

 Installation, adjustments, mending and repairs must be performed by individuals


authorized by Aeonmed;
 Necessary electrical equipment and the working environment must be in
accordance with the national standards, professional standards and the
requirements listed in this manual;
 Equipment must be used as instructed in the operating instructions.

CAUTION: This equipment is not for family use.


User Manual

CAUTION: Malfunctioning equipment may become invalid and cause bodily injury if a

set of effective and approving repairing proposals cannot be submitted by the institution
which is responsible for using this equipment.

The paid theoretical framework diagram will be supplied according to customer requirements
by Aeonmed, plus calibrating method and other information to help the customer, under the
assistance of qualified technicians, repair the equipment parts where can be done by
customer himself based on the stipulation by Aeonmed.

Warranty:

Manufacturing techniques and materials:

For a period of one year from the date of original delivery, the components and assemblies of
this product is warranted to be free from defects manufacturing techniques and materials,
provided that the same is properly operated under the conditions of normal use and regular
maintenance. The warranty period for other parts is three months. Expendable parts are not
included. Our obligation under the above warranties is limited to repairing free of charge.

Free Obligations:

 Our obligation under the above warranties does not include the freight and other fees;

 Aeonmed is not responsible for any direct, indirect or final product broken and delay
which result from improper use, alteration by using the assemblies unratified and
maintenance by anyone other than Aeonmed;

 This warranty does not apply to the followings:

 Improper use

 Machines without maintenance or machines broken

 The label of our original serial number or mark is removed or replaced

 Other manufacturers’ product.

Security, reliability and operating condition:

Aeonmed is not responsible for the security; reliability and operating condition of this product
in case that:

 The assemblies are disassembled, extended and readjusted

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 This product is not operated correctly in accordance with the manual instruction.

 The power supply used or operating environment does not follow the requirements in this
manual.

Return

Follow the steps below in case that the product needs to be returned to Aeonmed:

1. Obtain the rights of return

Contact our customer service by informing them the number and type of the product. The
number is marked on the surface of the product. Return is unacceptable if the number cannot
be identified. Enclose a statement of the number, type and the reason of return as well.

2. Transportation charges

Transportation and insurance charges must be prepaid by the user for transporting the
product to Aeonmed for repairing. (Customers charges are added with regard to the products
sold to non-Chinese mainland users).

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Use Notice
Welcome to use our products.

In order to correctly and effectively use this product, users must carefully read the manual
before using it. User must fully understand and strictly comply with this manual in using this
product.

This product is only applicable to the use stated in this manual. The repair and general survey
of this product can only be conducted by trained professional maintenance personnel. For
any situation in the use process, please contact with us. We will provide you with warm
service. Product specifications are subject to change without notification.

Manufacture: Beijing Aeonmed Co., Ltd.


Registered Address: 11B2, Fengtai Science Park, Beijing, China
European Representative Shanghai International Holding Corp. GmbH(Europ)
Address: Eiffestrasse 80,20537 Hamburg Germany
Production No.10, Chaobai St., Yanjiao Development Zone, Sanhe,
address: Hebei Province, China
P.C.: 100070
Tel: +86-10-83681616
Fax: +86-10-63718989
Web site: Http://www.aeonmed.com/
Service Hotline: 800-810-8333
E-mail: service@aeonmed.com

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CONTENTS

1. Product Description ............................................................................................................................ 1

1.1. General Information ..........................................................................................................................1


1.2. Symbols .............................................................................................................................................2
1.3. Abbreviations.....................................................................................................................................5
1.4. Warnings and Cautions ......................................................................................................................9

2. Components ..................................................................................................................................... 15

2.1. Configuration ...................................................................................................................................15


2.2. Front View .......................................................................................................................................16
2.3. Side View .........................................................................................................................................19
2.4. Back View ........................................................................................................................................22
2.5. Accessories list .................................................................................................................................23
2.6. Breathing System .............................................................................................................................25
2.6.1. APL Valve .................................................................................................................................27
2.7. Vaporizer-VP300 ..............................................................................................................................29
2.8. Anesthetic Gas Scavenging System-AP1000 (Optional)...................................................................30
2.9. Negative pressure suction device (Optional)...................................................................................31

3. User Interface ................................................................................................................................... 33

3.1. Anesthesia ventilator .......................................................................................................................33


3.1.1. Front Panel ..............................................................................................................................33
3.1.1.1. Function Button ................................................................................................................................. 35

3.1.2. Main Interface Display ............................................................................................................36


3.2. Ventilation Mode .............................................................................................................................43
3.2.1. Intermittent Positive Pressure Ventilation (IPPV) ...................................................................43
3.2.2. Pressure control ventilation (PCV) ..........................................................................................44
3.2.3. Synchronized Intermittent Mandatory Ventilation (SIMV) .....................................................44
3.2.4. Pressure support ventilation (PS) ............................................................................................45

4. Pre-operative Preparation ................................................................................................................ 47

4.1. Installation and Connection .............................................................................................................47


4.1.1. Connection of Tubes and Cables .............................................................................................47
4.1.2. Installation of Breathing Bag ...................................................................................................49
4.1.3. Connection of test plug ...........................................................................................................50
4.1.4. Connection of O2 sensor..........................................................................................................51
4.1.5. Connection of Anesthetic gas monitor module (Optional) .....................................................53

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4.1.6. AGSS Installation and Connection (Optional) ..........................................................................54


4.2. Pre-operative Test ...........................................................................................................................56
4.2.1. Test before Operation .............................................................................................................56
4.2.1.1. System Check ..................................................................................................................................... 56

4.2.1.2. Power Failure Alarm Test ................................................................................................................... 58

4.2.2. Pipeline Gas Supply Test .........................................................................................................58


4.2.3. Vaporizer Test .........................................................................................................................59
4.2.4. Alarm Test ...............................................................................................................................59
4.2.5. Emergency treatment (electrical or pneumatic power supply failure) ...................................62

5. Operating guide ................................................................................................................................ 63

5.1. Opening ...........................................................................................................................................63


5.2. System Self–test ..............................................................................................................................64
5.3. Automatic Leak Test ........................................................................................................................65
5.4. Manual Test .....................................................................................................................................69
5.5. Patient Type Setting ........................................................................................................................72
5.6. Ventilation Mode Setting ................................................................................................................74
5.7. Breathing parameter setting ...........................................................................................................76
5.8. Breathing Loop ................................................................................................................................82
5.9. Menu setting ...................................................................................................................................84
5.9.1. Alarm setting ...........................................................................................................................84
5.9.1.1. Alarm parameter limit setting............................................................................................................ 84

5.9.1.2. Manual mode alarm setting ............................................................................................................... 85

5.9.1.3. Alarm volume..................................................................................................................................... 86

5.9.1.4. Alarm limits of anesthetic gas ............................................................................................................ 87

5.9.2. System setting .........................................................................................................................88


5.9.2.1. Pressure display ................................................................................................................................. 89

5.9.2.2. Language ............................................................................................................................................ 90

5.9.2.3. Display................................................................................................................................................ 91

5.9.2.4. Date setting........................................................................................................................................ 92

5.9.2.5. Time setting ....................................................................................................................................... 95

5.9.2.6. Restore defaults ................................................................................................................................. 98

5.9.2.7. The opening of O2 sensor ................................................................................................................... 99

5.9.2.8. Leak test result ................................................................................................................................. 100

5.9.2.9. Air drive (Optional) .......................................................................................................................... 101

5.9.3. Calibration .............................................................................................................................102


5.9.3.1. O2 sensor calibration ........................................................................................................................ 102

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5.9.3.2. CO2 sensor calibration...................................................................................................................... 104

5.9.3.3. Agents calibration ............................................................................................................................ 107

5.9.3.4. Leak Test .......................................................................................................................................... 109

5.9.3.5. Compliance Test ............................................................................................................................... 111

5.9.4. Gas setting .............................................................................................................................114


5.9.4.1. Open gas module ............................................................................................................................. 114

5.9.4.2. CO2 unit ............................................................................................................................................ 116

5.9.4.3. Wave display .................................................................................................................................... 117

5.9.4.4. Module version ................................................................................................................................ 118

5.10. Closing ...........................................................................................................................................119

6. Alarm and troubleshooting..............................................................................................................121

6.1. Brief introduction of alarm message .............................................................................................122


6.2. Alarm message ..............................................................................................................................123
6.2.1. Alarm default value and setting range ..................................................................................123
6.2.2. Technical alarm message table .............................................................................................124
6.2.3. Functional alarm message .....................................................................................................128
6.2.4. Self-test alarm .......................................................................................................................132
6.3. Failure diagnosis ............................................................................................................................134

7. Cleaning and Disinfecting ................................................................................................................141

7.1. General rule for cleaning and disinfection ....................................................................................141


7.2. User maintenance .........................................................................................................................144
7.3. Methods for cleaning and disinfecting ..........................................................................................144
7.4. Cleaning and disinfection of components .....................................................................................145
7.4.1. External Surfaces ...................................................................................................................145
7.4.2. Bellows ..................................................................................................................................145
7.4.2.1. Disassembly ..................................................................................................................................... 146

7.4.2.2. Cleaning ........................................................................................................................................... 147

7.4.2.3. Disinfection ...................................................................................................................................... 148

7.4.2.4. Assembly .......................................................................................................................................... 148

7.4.3. PAW gauge ............................................................................................................................148


7.4.3.1. Disassembly ..................................................................................................................................... 148

7.4.3.2. Cleaning ........................................................................................................................................... 148

7.4.3.3. Assembly .......................................................................................................................................... 149

7.4.4. Oxygen sensor .......................................................................................................................149


7.4.4.1. Disassembly ..................................................................................................................................... 149

7.4.4.2. Cleaning ........................................................................................................................................... 150


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7.4.4.3. Assembly .......................................................................................................................................... 150

7.4.5. Respiratory valves .................................................................................................................150


7.4.5.1. Disassembly ..................................................................................................................................... 150

7.4.5.2. Cleaning ........................................................................................................................................... 151

7.4.5.3. Disinfection ...................................................................................................................................... 151

7.4.5.4. Assembly .......................................................................................................................................... 151

7.4.6. Bag arm .................................................................................................................................152


7.4.6.1. Disassembly ..................................................................................................................................... 152

7.4.6.2. Cleaning ........................................................................................................................................... 152

7.4.6.3. Disinfection ...................................................................................................................................... 152

7.4.6.4. Assembly .......................................................................................................................................... 152

7.4.7. Absorber canister ..................................................................................................................153


7.4.7.1. Disassembly ..................................................................................................................................... 153

7.4.7.2. Cleaning ........................................................................................................................................... 154

7.4.7.3. Disinfection ...................................................................................................................................... 154

7.4.7.4. Assembly .......................................................................................................................................... 154

7.4.8. Breathing system disassembly ..............................................................................................155


7.4.8.1. Disassembly ..................................................................................................................................... 155

7.4.8.2. Cleaning ........................................................................................................................................... 158

7.4.8.3. Disinfection ...................................................................................................................................... 158

7.4.8.4. Assembly .......................................................................................................................................... 159

8. Regular maintenance.......................................................................................................................161

8.1. General principle of maintenance .................................................................................................162


8.2. Maintenance schedule ..................................................................................................................163
8.2.1. Appearance checklist ............................................................................................................163
8.3. Replacement of replaceable parts .................................................................................................164
8.4. Maintenance of O2 sensor .............................................................................................................165
8.5. Maintenance of fuse ......................................................................................................................166
8.6. Battery Maintenance .....................................................................................................................167
8.7. Consumptive components replacement .......................................................................................168

9. Technical Data .................................................................................................................................169

9.1. Pneumatic Diagram .......................................................................................................................169


9.2. System technical data ....................................................................................................................172
9.3. Electrical diagraph .........................................................................................................................172
9.4. Physical data ..................................................................................................................................174

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9.5. Environmental requirement ..........................................................................................................175


9.5.1. IEC60601-1:2005 classification ..............................................................................................176
9.6. Input and output ...........................................................................................................................176
9.6.1. Electrical ................................................................................................................................176
9.6.2. Pneumatic .............................................................................................................................177
9.7. Breathing system technical data ...................................................................................................178
9.8. Anesthetic ventilator technical specifications ...............................................................................180
9.8.1. Anesthesia ventilator performance ......................................................................................180
9.8.2. Ventilation parameter ...........................................................................................................181
9.8.3. Drive gas ................................................................................................................................182
9.8.4. Monitor performance ...........................................................................................................183
9.9. O2 sensor specification ..................................................................................................................185
9.10. Gas monitoring module technical specification ............................................................................187
9.11. Electromagnetic compatibility .......................................................................................................192
9.12. Recommended separation distances ............................................................................................199

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1. Product Description

1.1. General Information


The Aeon8300A Anesthesia machine is a continuous flow Anesthesia system which offers
manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent
delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems.

In terms of theory of operation, the Aeon8300A Anesthesia machine, driven by pneumatics


and controlled by electricity is a device used to administer to a patient continuously or
intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation. The
integrated breathing system delivers the mixture of O2, N2O, AIR and anesthetic agents for
patient breathing control, while electrical control system functions as monitoring patient
parameters.

The Aeon8300A Anesthesia machine is intended for use by licensed clinicians, for patients
requiring Anesthesia within a hospital. This product is suitable for infants, children and adults

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1.2. Symbols
The following table provides descriptions of symbols that are used on the device and/or within
this manual.

Symbol Description Symbol

CAUTION! Attention, consult accompanying documents.

Turn on power switch ON

Turn off power switch OFF

"ON" for a part of equipment

"OFF" for a part of equipment

alternating current (AC)

direct current (DC)

dangerous voltage

Earth (ground)

protective earth (ground)

Equipotentiality

date of manufacture

manufacturer

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Catalogue number

serial number

rotation in two directions

Rotate to adjust(increase counter-clockwise)

lock

unlock

Insp. flow

Exp. flow

O2 flush O2+

breathing bag/manual ventilation

fuse

Read the reading of the top floating-point

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draining valve operation guide

Outer power supply has been connected

Recycle

This mark means that pneumatic and electric device rubbish is


not allowed to be dealt as unclassified city rubbish and should be
collected separately.

battery charging condition

alarm mute icon

alarm icon

Refer to product instructions

interference many occur in the vicinity of equipment marked with


this symbol

Authorized representative in the European community

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1.3. Abbreviations
Abbreviation Definition

AGSS anesthetic gas scavenging system

APL adjustable pressure limiting

BDU basic data unit

C compliance

C·G·O common gas outlet

cmH2O Centimeters of Water

CO2 carbon oxide

Des. Desflurane

EEPROM electrically erasable programmable read only memory

Enf. Enflurane

etCO2 End-expiratory CO2 concentration

FiO2 Fraction of Inspired Oxygen

Flow-t flow-time wave

Flow flow

Freq Frequency

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FreqMIN Minimum Frequency in PS mode

GUI Graphic user interface

Hal. Halothane

I:E Inspiratory to Expiratory Ratio

FiCO2 Inspiratory CO2 concentration

Iso. Isoflurane

IPPV Intermittent positive pressure ventilation

L/min liter per minute

L liter

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MAC Minimum Alveolar Concentration

Manual manual ventilation

PMEAN mean pressure

mL Mill Liter

MRI Magnetic resonance imaging

MV minute volume

N2O nitro oxide

O2 oxygen

Paw airway pressure

Paw-t pressure-time wave

Pb plumbum

PIP Peak Inspiratory Pressure

PLAT plat pressure

PCV Pressure Control Ventilation

PEEP Positive End Expiratory Pressure

PMEAN mean pressure

PPEAK Peak pressure

PS Pressure Support Ventilation

PTARGET Target Pressure

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SIMV Synchronized Intermittent Mandatory Ventilation

Sev. Sevoflurane

TINSP Inspiratory Time

TP Inspiratory Pause Time

Trigger flow trigger

TSLOPE Inspiratory Slope Time

VT tidal volume

WDT watch dog timer

ΔP Differential Pressure

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1.4. Warnings and Cautions

The following WARNINGs and CAUTIONs are applicable to daily operation and

maintenance of Aeon8300A anesthesia machine. The WARNINGs and CAUTIONs about

installation and operation for special parts will be described in relevant part of the manual.

WARNING: The operator shall be medical personnel of relevant qualification and

accepting the operation training of Aeon8300A anesthesia machine.

WARNING: Aeon8300A anesthesia system must be and can only be maintained by the

representative authorized by customer service department of Aeonmed.

WARNING: Before using Aeon8300A anesthesia machine, please carefully read the

instructions, and learn the following contents:

 All system connected.

 All WARNINGs and CAUTIONs.

 Usage method of each system component.

 Test method of each system component.

WARNING: Before using Aeon8300A anesthesia machine:

 Complete all tests in chapter "Test before operation ".

 Test all other system components.

WARNING: If the test fails, do not use this equipment. Please contact with Beijing

Aeonmed Co., Ltd for service engineer trained to repair equipment.

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WARNING: Aeon8300A anesthesia machine is not suitable for use in magnetic

resonance imaging (MRI) environment.

WARNING: To avoid risk of electric shock, this equipment must only be connected to

supply mains with protective earth.

WARNING:The mask, breathing tubes, filter of the suction, adapter of mainstream

module, water trap and sampling tube of sidestream module etc. disposal subassembly is not

permitted to reused to avoid cross-infection. Before using, the operator must check the

pipeline to ensure the disposal subassembly is out of using.

WARNING: The parts of machine contacted with the gas inhaled by patients don’t

contain phthalates, which are known to be carcinogenic, mutagenic or toxic to reproduction.

WARNING: Check and replace the filter of suction when the suction can’t get adequate

flow.

WARNING: Flammable anesthetic cannot be used for anesthesia system, such as ethyl

ether and cyclopropane. Only those non-flammable anesthetics such as desflurane,

sevoflurane, enflurane and isoflurane, which are compatible to other gas are allowed to use

in anesthesia system.

WARNING: Independent ventilation mode (for example: manual boosting resuscitator

with mask) shall be applied for the anesthesia system in operation.

WARNING: Do not use antistatic or conductive respiratory siphon and mask. If such

respiratory siphon and mask are used near high frequency surgical equipment, burning might

occur.

WARNING: Accidental liquid leakage such as anesthetic etc into anesthesia system will

generate internal device malfunction or safety accident.

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WARNING: When anesthesia machine is in normal use, the angle of inclination shall not

be more than 10 degrees.

WARNING: Before operating Aeon8300A anesthesia machine, one must conduct test

first.

WARNING: All gas volume, flow and leakage specifications have been tested under

STPD, except those associated with the anesthesia Breathing System, which be tested under

BTPS.

WARNING: Do not put pipeline and line near APL valve or put pipeline and line card

below APL valve, so as to adjust APL valve smoothly.

WARNING: Before cleaning and maintenance, ensure that the external supply is

disconnected.

WARNING: Do not use Aeon8300A anesthesia machine in explosion hazardous area.

Do not use this anesthesia system in the flammable and explosive area.

WARNING: If the liquid accidentally leaks to the internal Aeon8300A anesthesia

machine, stop using it immediately, turn off the power switch, and unplug the power socket

from AC outlet.

WARNING: Before moving anesthetic equipment, remove all patient monitors and

equipments from anesthesia machine roof through the push handle on it. Anesthesia

machine can only be moved by personnel of enough physical strength.

WARNING: Anesthesia machine shall not be inclined in fluctuation slope, turn, and over

the threshold (Such as door case and elevator). Do not try to push and pull anesthesia

machine over any pipe, rope or obstacle on the floor.

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WARNING: Before transportation, all the monitoring devices at the side of anesthesia

machine shall be removed. If preventive measure is not taken, Anesthesia machine may tilt

and will cause security threats.

WARNING: During application process, its front caster wheel shall keep tightly locked.

WARNING: Do not put the item over 25kg on the top shelf of Aeon8300A anesthesia

machine.

WARNING: Do not put the item over 12kg on the work table of Aeon8300A anesthesia

machine.

WARNING: The whole width of machine should be less than 0.8m when hanging some

stuff.

WARNING: Do the all calibrations after replacing the part of the machine, only by the

authorized maintenance engineers.

WARNING: The equipment must be used under the supervision of qualified medical

personnel, so as to ensure timely help for failure or when patient is lack of enough and timely

breathing.

WARNING: The medical gas pipeline system malfunction could cause one or more

devices connected to the system stopping their operation; this is not applicable to the

Anesthesia machine that only uses cylinders for gas supply.

WARNING: If the anesthesia machine is equipped with Anesthetic Gas Delivery System,

Monitoring Equipment, Alarm System and Production Device, no matter the machine is

supplied by separate device or system assembly, the anesthesia machine checklist must be

provided.

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WARNING: Please follow local regulations for the discard anesthesia machine.

CAUTION: The anesthesia system conforms to ISO 10993-1.

CAUTION: The anesthesia ventilator used together with anesthesia system conforms

to ISO 80601-2-13.

CAUTION: The anesthesia system is used together with the following monitoring device,

alarm system and protection device:

 Conform to the pressure measurement of ISO 80601-2-13;

 Pressure limit device in conformity with ISO 80601-2-13;

 Conform to the exhale output monitor of ISO 80601-2-13;

 Conform to the respiratory system with alarm system of ISO 80601-2-13;

 Conform to the O2、CO2、anesthetic gas monitor of ISO 80601-2-55.

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2. Components

2.1. Configuration
Aeon8300A Anesthesia machine consists of mainframe, anesthetic ventilator, breathing
system, flowmeter and battery.

The optional parts consist of CO2 module,O2 concentration monitor module, anesthetic
agent module, auxiliary inspiration O2 device, air drive, anesthetic gas scavenging
system(AGSS) and vaporizer,Suction device,VP300(Enflurane,isoflurane,sevoflurane,
interface type:Selectatec,using double metal sheet to make temperature compensation,
Pour-fill infusion).

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2.2. Front View

Fig. 2-1 Aeon8300A Front View

No. Name No. Name

1 User Interface 7 Draws Assembly

2 Vaporizer Manifold 8 Built-in Work Table

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3 Cylinder gauge 9 Gas Supply Gauge

4 Breathing System 10 Power Switch

5 O2 Flush 11 Flow Rotary Knob

6 Caster(with brake) 12 Flowmeter

Functional description of components is as follows:

NO. Name Description Figure

It locates on the front of the


machine. It can provide
oxygen from 35L/min to
75L/min to breathing system
and breathing bag.

5 O2 Flush CAUTION: When central

gas supply or backup cylinder


is connected, pres suing O2
flush will deliver oxygen to
breathing system and
breathing bag, even the
machine is powered off.

Castor(with Lock :Push down


6 brake) Unlock: Lift up

The work table is built in the


machine. Pull it out when
being used and push it in not
Built-in Work
8 being used.
Table

CAUTION:Don’t put the

item over 20Kg on the work

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table.

Measure gauge gas supply


Gas supply
9 pressure of N2O, AIR, O2
gauge
flowing by airway.

Set power switch to ―ON‖ to


open the aesthesia system.

10 Power Switch Set power switch to ―OFF‖ and


close an aesthesia system to
prevent gas flowing in.

Counterclockwise rotation of
the flowmeter rotary knob
Flow Rotary
11 increases the flow; clockwise
Knob
rotation of the flowmeter rotary
knob decreases the flow.

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2.3. Side View

Fig. 2-2 Right Side View of Aeon8300A

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Fig. 2-2 Left Side View of Aeon8300A

No. Name No. Name


1 Slot 7 User interface cable socket
2 Auxiliary working Table 8 O2 sensor socket
3 Power plug 9 Breathing system heater cable
socket
4 YOKE Assembly 10 Gas Outlet Module

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5 Gas inlet 11 Caster(without brake)


6 Screen Arm

Functional description of components is as follows:

NO. Name Description Figure

The Gas inlet module


includes four ports, O2 inlet
5 Gas inlet
port, Air inlet port, N2O inlet
port and backup O2 inlet port.

Gas Outlet Module includes


CGO interface, Drive Gas

9 Gas Outlet Module outlet, Gas sampling


interface.

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2.4. Back View

Fig. 2-4 Aeon8300A Back View

No. Name No. Name


1 Fuse 4 YOKE bracket
2 Auxiliary mains outlet socket 5 Power Cable
3 YOKE Assembly

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2.5. Accessories list


NO. Part NO. Name Specification

1. 122002919 AGSS AP1000

2. 240000626 Suction 882VR-760-VGO-1000

3. 122000048 O2 Pipeline (white) M22×1.5 , Φ11.5 connecter

4. 122000049 N2O Pipeline(blue) M22×1.5 , Φ9.5 connecter

5. 122000050 Air Pipeline(black) M22×1.5 , Φ9 connecter

6. 122001476 Auxiliary O2 pipeline M14×1.5, Φ10 connecter

7. 122002613 Adult PVC Breathing Circuit package

8. 230000311 FACE MASK(PVC) XL(4#)

9. 230000312 Anesthesia Breathing Circuit ADULT

10. 230000075 Bag(3L) 3L

11. 230000076 Breathing Bag(2L) 2L

12. 121000065 Adult Silicon Breathing Circuit package

13. 230000538 Adult Silicon Hose package l=1000mm,Φ22

14. 230000163 Adult Silicon FACE MASK PN-0007AM(4#)

15. 230000113 Elbow Male and female cone Φ22

16. 230000101 Y Piece Φ22, Φ15 cone

17. 130000798 Straight connector Φ22 male cone

18. 240000415 IRMA_CO2 module IRMA CO2

19. 240000414 IRMA_AX+ gas module IRMA_AX+

20. 210001975 O2 sensor MOX-4

21. 122000831 Wean PVC Breathing Circuit package

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22. 240000028 Wean Anesthesia Breathing Circuit Wean

23. 122003285 Wean Silicon Breathing Circuit package

24. 230000066 FACE MASK ( PVC) HX.O11 M(2#)

25. 230000539 Wean Silicon Hose package l=1000mm,Φ15

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2.6. Breathing System

CAUTION:Breathing system used with Aeon8300A should comply with ISO 80601-2-13.

Breathing system is mainly used to store fresh gas including anesthetic gas, oxygen, and
absorb waste gas. It directly connects to airway to support patient’s respiration.

Fig.2-5 Breathing System

NO. Name NO. Name


1 Expiration Valve 8 Inspiratory Port
2 Bag Arm 9 Y-Piece Seal

3 APL 10 PAW Gauge


4 Expiratory Port 11 Inspiratory Valve

5 Hook 12 O2 cell plug


6 CO2 Absorber Canisters 13 Bellows Assembly(including
bellows)
7 CO2 Absorber Canisters 14 Bellows dome
Release Handle

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NO. Item Description Figure

It guarantees the single direction of gas flow


1 Exp. valve
in breathing system.

8 CO2
Absorber
It is used to absorb CO2 patient having
Canisters
exhaled.

10 PAW It can measure airway pressure through


gauge breathing system.

11 Insp. It guarantees the single direction of gas flow


valve in breathing system.

The bellows is made of neoprene, more


attention should be given when use.

Bellows NOTE: The graduation marks of bellows


13
Assembly dome are from 300 to 1500. These marks are
for qualitative purposes only. Tidal volume
(VT) should be read exclusively from the
display of the user interface.

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Description of inspiratory/expiratory valve:

Inspiratory and expiratory valve guarantee the single direction of gas flow in the breathing
system. When the Anesthesia machine is working normally:

In the inspiratory phase, the inspiratory valve is acting and the expiratory valve is at rest; In
the expiratory phase, expiratory valve is acting and the inspiratory valve is at rest.

2.6.1.APL Valve

WARNING:Keep all inlets/cables away from the APL valve, and do not put lines/ cables

underneath the APL valve in order to adjust the APL valve smoothly.

CAUTION:The APL valve is automatically excluded from the breathing system whenever

an automatic ventilation mode is selected.

APL valve has two functions; one is that it limits the maximum pressure during manual
ventilation; the other is that the airway pressure can be exhausted quickly by lifting the APL
valve.

The APL valve has a labeled knob for selecting between 0cmH2O to 70cmH2O and for
indicating approximate pressure settings. Click sound will be heard when adjusting the APL
valve. In manual mode, the APL valve knob can be rotated to change the pressure threshold
at which gas will flow through the pressure threshold at which gas will flow through the valve
and into AGSS. Clockwise rotation of the APL valve knob increases the pressure threshold,
and counterclockwise rotation of the APL valve knob decreases the pressure threshold.
Lifting the top of the APL valve knob will temporarily relieve pressure. The leakage from the
anesthetic breathing in all operational modes when tested at pressure of 3.0kPa (30cmH2O)
is 40ml.

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Fig. 2-6 APL Valve

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2.7. Vaporizer-VP300
The vaporizer delivers anesthetic agent of accurate concentration to breathing system.
Anesthetic agent of accurate concentration will be acquired by adjusting control knob on the
vaporizer. It has temperature compensation, flow compensation and pressure compensation.
The vaporizer cannot be used for patient with respiration because of the strong interior
resistance. The vaporizer can only use one specific anesthetic agent which can be identified
by the label.

Fig.2-7 Vaporizer

NO. Name NO. Name


1 Canister Body 6 Anesthetic tag
2 Interlock bolt 7 Screw cap
3 lock lever 8 Liquid level indicator
4 control dial 9 Drain valve
5 Release button 10 Drain hole

WARNING:Only dry gas of medical degree can be used on the vaporizer. Any improper

operation of the vaporizer will bring damage to patient.

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WARNING:The vaporizer should be placed vertically at the vaporizer mounting manifold.

Turn the vaporizer to OFF when it is not used.

CAUTION:The vaporizer used with Aeon8300A anesthesia machine should comply with

ISO 80601-2-13.

CAUTION:For more operating and maintaining information of the vaporizer, refer to

VP300 User Manual.

2.8. Anesthetic Gas Scavenging System-AP1000 (Optional)


Anesthetic gas scavenging system absorbs waste gas exhausted from breathing system and
delivers it to processing system.

Fig.2-8 Anesthetic Gas Scavenging System-AP1000

Number Name Number Name

1 window 5 floater

2 U-bracket 6 Patient inlet

3 canister 7 Pressure release port

4 Flow control knob

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WARNING: Do not block the pressure relieve port on the top of the canister when using

AGSS.

WARNING: AGSS used together with Aeon8300A anesthesia system conforms to ISO

80601-2-13.

WARNING: If the AGSS used together with Aeon8300A anesthesia system is produced

by other manufacturer, make sure that the AGSS conforms to ISO 80601-2-13.

WARNING: For more information about operation and maintenance of AGSS, please

refer to Instruction for use provided with AGSS.

2.9. Negative pressure suction device (Optional)


The suction device can be used for removing the sputum in the patient’s respiratory tract, and
also removing the bleeding and exudate during surgery.

Before using SUCTION, adjust the negative pressure to a proper value, or it is easy to cause
mucosa broken. When using SUCTION, the gas inlet is advised to connect with Aeon8300A
auxiliary gas supply port. If the SUCTION is connected with other gas supplies, the pressure
of gas supply is smaller than 0.4MPa.

When the suction flow is insufficient, the suction port filter should be checked or replaced.

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Figure 4-8 Negative pressure suction device

No. Name No. Name


1 Negative pressure control switch 4 Overfill protection device
2 Negative pressure indicator 5 Negative pressure connector
3 Negative pressure adjuster 6 Positive pressure input port

CAUTION: The negative pressure suction device used together with Anesthesia system

conforms to EN ISO 10079-3.

CAUTION: If the negative pressure adjuster is expected to work, the negative pressure

control switch must be rotated within Range-OFF scope. Otherwise, when the negative
pressure control switch is in Full, output negative pressure is the maximum.

CAUTION: For more information about operation and maintenance of the negative

pressure suction device, please refer to the Instruction for Use provided with the negative
pressure suction device.

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3. User Interface

3.1. Anesthesia ventilator

3.1.1.Front Panel

CAUTION: The Anesthesia ventilator which is used with the Anesthesia system should

comply with ISO 80601-2-13

The panel of the Anesthesia machine is composed of user interface, alternating current
indicator light, and function button and knob. See figure 3-1.

Figure 3-1 Front Panel

1 User Interface The user interface can display 1~2 wave.

The operation of the user interface can be controlled by the knob (turn
and press) or function button.

2 AC Power When the power supply is the AC power, the AC power indicator light
Indicator Light is on;

When the power supply is battery, the AC power indicator light is off.

3 Function Button Open /Close each menu, the switch between manual and automatic
mode or mute the system can be realized by operating this button.

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4 Knob The knob is used to select and confirm the menu item or change the
setting. Turn the knob, the moving rectangle mark in the user interface
is called cursor. Where the cursor located means you can operate this
item. Turn the knob clockwise or counter-clockwise to select and
confirm the menu item or adjust the parameter.

Press the knob to confirm the selected item or parameter.

CAUTION: The required circumstance of the monitoring of the breathing system as

follows:

 Circumstance temperature: 25℃;


 Gas temperature: 25℃;
 Gas tidal: 30%;
 Gas: O2.
.

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3.1.1.1. Function Button

Function button area should include 6 buttons: manual/auto, alarm setting, mute, breathing
circle, menu, and user interface. No matter how long the button is pressed; pressing the
button one time only produces one command action.

Press this button, the Anesthesia machine is switched from the primary mode
to the manual mode;
Manual/Auto
Press this button again; the Anesthesia machine is switched from the manual
mode to the primary mode.

Alarm Press the button, open ―Alarm‖ window, see and adjust the alarm setting,
press the button again, close ―Alarm‖ window.

If there is an alarm now, press the mute button, the system will keep mute for
110s, press it again to cancel mute.
Mute
During the mute process, if there is a new alarm, the mute will be ineffective,
but alarm sound also exits. Cancel mute to renew sound alarm. No alarm now,
setting mute will be ineffective.

Press the breathing loop for the first time, the interface displays
―Pressure-Volume ―and ―Loop window‖.

Breathing Press it again, the interface displays ―Flow-Volume‖ loop window and the two
Loop former wave form display zone are covered by the breathing loop window.

Press for the third time; recede from breathing loop window to return to the
former wave form display interface.

Press the menu button to open the menu, the menu should include: alarm,
system, calibration, engineer and gas.

Menu After opening, press the menu for the first time, open the calibration menu O2
sensor calibration button is in bright green.

If the menu has been opened, press the menu button again, the menu will be
closed, then press it again, the menu opened last time will be opened.

Press the main interface button to close the menu and the breathing circle
Main
window and return to the F-flow wave interface.
Interface
If the menu and the breathing system window is not opened, press the main

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interface button, there is no action to produce.

3.1.2.Main Interface Display

The ventilation parameter monitor, setup and message notice of the ventilator are all
displayed in the user interface. The parameter monitor is in the left and right side of the user
interface, the wave form in the middle. When there is a menu popping up, the wave area will
be covered. The upper section is message area, the middle section is monitor area, the under
is parameter area.

Fig 3-2 User Interface

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Alarm Date Patient Ventilation


Alarm Message Power
Indicator Time Type Mode

(11)Patient Parameter 1

Wave Form 1

(8)Anesthetic Gas
(12)Patient Parameter 2
Monitor Display

Wave Form 2

(13) Patient Parameter


3
(14)User Information

(15) (16) (17) (18) (19) (20) (21) (22)

Parameter Parameter Parameter Parameter Parameter Parameter Parameter Parameter

Setting 1 Setting 2 Setting 3 Setting 4 Setting 5 Setting 6 Setting 7 Setting 8

Fig 3-3 The Layout of the User Interface

(1) Alarm notice indicates that when there is an alarm, the alarm bell appears, whose color is

white . Press the mute button, an ―X‖ broken line appears on the alarm bell and lasts for

110s. Under the alarm bell, the counter down of the surplus time will be displayed as .

(2) Alarm message area is in the left up of the user interface providing system alarm notice
and patient ventilation malfunction alarm notice.

means high priority alarm, the color is red.

means low and medium priority, the color is yellow.

No more than 2 alarm messages are displayed in the user interface at the same time.

Every alarm message has its own icon correspondingly.

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(3) The display mode of Date has three types: MM/DD/YY, DD/MM/YY or YY/MM/DD.

(4) The display mode of Time has 2 types: 12 hour or 24 hour format.

(5) The power supply is in the left side of the patient type,having 2 icons: AC power and
battery. The 2 icons will always display. The AC power icons include 2 states: connected

and unconnected. If the AC power is not connected, the AC power is always glittering.

Battery icon includes 7 statues: full, 75%, 50%, 25%, low charging, unconnected.

For example: means 25% power.

means the power unconnected.

AC power supplies the power:

When the battery is charged fully, displaying 100% power, no glitter.

When the battery is charging, a dynamic mark displaying electric quantity will be displayed

AC power stops supplying the power:

The battery displays the actual electric volume.

After the signal of low electric volume, the battery can still supply power for about 15 minutes.

(6) Adult/Child is displayed in the patient type area. When the patient type is highlighted,
pressing the knob can make the patient type switch between adult and child.

The patient type can be changed only in STANDBY mode.

After opening, adult is the default patient type.

(7)The ventilation mode setting area is in the right up of the user interface.

The ventilation mode can be located and displayed highlighted by the knob (black word with
green background).When the ventilation mode is highlighted, press the knob, the current
ventilation mode is highlighted, but ―Mode‖ label still displays in black word with green
background. Turn the knob clockwise, the mode displays as follows: STANDBY,IPPV,PCV,
SIMV,PS and MANUAL. Turn the knob counter-clockwise, the modes displayed are
MANUAL, PS, SIMV, PCV, IPPV, and STANDBY.

STANDBY is the default ventilation mode after opening.

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(8)The anesthetic gas monitor display is in the left side of the middle of the user interface
including 4 parameters: dominating anesthetic gas and suddominate anesthetic gas, N2O
and expiration MAC value.

Dominating anesthetic gas and suddominate anesthetic gas can monitor Insp and Exp ., the
gas type renews automatically at the same time.N2O can monitor Insp and Exp, MAC only
displays Exp. The unit of dominating anesthetic gas, suddominate anesthetic gas and N2O
is %, MAC has no unit. The data of dominating anesthetic gas and suddominate anesthetic
gas monitor value has one decimal. The data of N2O monitor value is no more than 3 integers
and changes automatically.

NOTICE: When ―Gas Module‖ in the ―Gas‖ menu is ―Forbidden‖ or the an aesthetic gas

function is not activated in the ―Activate Gas‖ submenu of ―Engineer‖ menu, the parameter
monitor area does not display and is covered fully.

The wave area of (9)、(10) is in the middle of the user interface,4 wave forms are allowed to
display: 1) Pressure-t wave form, Flow-t;2)Pressure-Volume loop,3)Flow-Volume Loop,4)

CO2 Concentration-t wave form, default waves: Pressure-t wave form and Flow-time wave
form.

In STANDBY ventilation mode, Pressure-t wave form and Flow-time wave form do not display
the real-time data.

The patient parameter area of (11)-(13) is in the right side of the user interface and can be
divided into 5 parameter groups: pressure, volume, O2 concentration, and compliance and
CO2 concentration.

(14) The user message area is in the low of the wave area. The user message is displayed in
the user message area, the word color is white. The main user messages displayed in this
area includes:

The parameter is the parameter displayed in the preset mode.

Display when the mode selection is in preset situation.

The setup value can not be achieved.

When the setup value has reached the high limit (or low limit) in the current situation, turn the
knob once or more time clockwise (or counter-clockwise), this alarm displays.

Pressure, tidal volume and asphyxia alarm are closed.


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In manual mode, if the user has closed the manual alarm, the message displays.

Automatic ventilation is not available.

When the system is in self-test, if the following mistakes occur, such as PEEP valve failure,
expiration sensor failure and inspiration valve failure, this alarm will display.

When the ventilation mode is glittering and not confirmed, the message displays and shows
the current running ventilation mode.

Press AUTO/MANUAL button directly, the ventilation mode switches from IPPV、PCV 、SIMV、
PS to MANUAL, the message will be displayed.

The parameter setup area of (15)-(22) should include 8 setup frames; the width and length of
every setup frame are fixed.

When the cursor falls on some setup frame, the setup frame is highlighted (black word with
green background).

When the setup frame is highlighted, the current parameter setup value is in white.

Turn the knob clockwise, the parameter value will increase, otherwise, it reduces.

Press the knob to select the setup parameter, it will display in white word with black
background. The setup value of the parameter displays in normal state, expect the
background frame has been selected or highlighted.

The background frame of the parameter should be set as the following table.

When it is needed to change parameter setting, the parameter setup will recede and revert to
the old parameter if the changed parameter setup has not been confirmed for more than
15s.When set ventilation mode, patient type and all the breathing parameter setup items, the
setup frame will recede automatically for overtime.

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Paramet Paramet Paramet Paramet Paramet Paramet Paramet


Ventilati Parameter
er er er er er er er
on Setting
Setting Setting Setting Setting Setting Setting Setting
Mode 8
1 2 3 4 5 6 7

STAND
--- --- --- --- --- --- --- ---
BY

IPPV VT Freq. I:E TP PEEP --- --- ---

PCV PTARGET Freq. I:E --- PEEP --- --- TSLOPE

SIMV VT Freq. TINSP TP PEEP ΔP Trigger TSLOPE

PS --- FreqMIN --- --- PEEP ΔP Trigger TSLOPE

MANUA
--- --- --- --- --- --- --- ---
L

The mode setting frame displays the current ventilation mode.

When the cursor does not fall on the mode setting frame, the display state of the mode setting

frame is the state as Displays.

When the cursor falls on the mode setting frame, the display state of the mode setting frame

is the state as . WARNING:

The setting frame is highlighted (black words with green background).

When the mode setting frame is in state 2,press the knob , the display state of the mode

setting frame is the state as. .

White word with black background. The display state labeled on ―Mode‖ is still in black word
with green background. Turn the knob clockwise to switch the breathing mode in turn:
STANDBY、IPPV、PCV、SIMV、PS 、MANUAL .

Turn the knob counter-clockwise to switch the breathing mode in turn: MANUAL, PS, SIMV,
PCV, IPPV, and STANDBY.

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When the mode setting frame is in state 3, if press the knob, the display state of the mode

setting frame is in preset state. The state as displays glitters in the preset
state of the state 4, the frequency is one time every second.

When in mode preset state, the parameter of the preset mode displays at the same time. One
message displays in the user interface area: the current ventilation mode is in preset. The
operator can adjust the parameter setting by turning the knob.

Having setting the parameter, turn the knob to make the cursor turn to the mode setting frame,
press the knob again to make the new selected ventilation mode take effect. The mode
preset state will last 15s. If the new selected ventilation mode is still not confirmed for more
than 15s, the ventilation mode will renew to the old one. All the parameter setting in preset
state will be ineffective.

STANDBY is the default ventilation mode after opening. The patient type and the alarm limit
will not change during the switch from the other ventilation mode to STANDBY mode.

All the parameter adopts default and all the parameter keeps the old setting when the mode
switches from STANDBY to IPPV、PCV、SIMV、PS.

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3.2. Ventilation Mode


The system has 4 mechanical ventilation modes:

IPPV:Intermittent Positive Pressure Ventilation

PCV: Pressure Controlled Ventilation

SIMV:Synchronized Intermittent Mandatory Ventilation

PS: Pressure Support Ventilation

3.2.1.Intermittent Positive Pressure Ventilation (IPPV)

All the breathings are provided by the anesthesia machine, the patient cannot switch them by
self. The ventilation is managed by the predetermined ventilation volume, breathing
frequency and inspiration-expiration ratio to keep the tidal volume stable, thereby assure the
stable MV.

Method: time switch and pressure switch.

The setup parameters of IPPV mode:

Vt、Freq、I:E、Tp、PEEP

Fig.3-3 Waveform of IPPV


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3.2.2.Pressure control ventilation (PCV)

The ventilation is managed by the setting target pressure, the ventilation volume and flow
rate are changed subsidiary and relate with the breathing system compliance and airway
resistance. The tidal volume is changed with the lung compliance and the airway resistance.
The flow rate is slowdown wave; the alveolus is turgor at the beginning of inspiratory which is
helpful for the gas communication in the lung.

The setup parameters of PCV mode:Ptarget、Freq、I:E、Tslope、PEEP

Fig.3-4 Waveform of PCV

3.2.3.Synchronized Intermittent Mandatory Ventilation (SIMV)

SIMV is a ventilation mode which combines spontaneous breathing with control ventilation.
Within the trigger window, the patient can trigger the command positive pressure ventilation
synchronizing with the spontaneous breathing. Between the two command ventilation cycle,
the patient is allowed to breathe spontaneously. The command breathing follows the presets
volume. By setting frequency and tidal volume to assure the minimum MV, cooperating with
the patient’s spontaneous breathing to reduce the rivalry between patient and machine and

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negative effect of blood dynamics, and prevents the potential syndrome, such as air pressure
injury and so on.

By changing the presets frequency to change the breathing support level, in other words,
from entire support to partial support, the machine can be used for long-term patient to retreat
from machine.

The Setup Parameters of IPPV Mode: Vt、Freq、Tinsp、Tp、PEEP、Trigger、△P、Tslope

Fig.3-5 Waveform of SIMV

3.2.4.Pressure support ventilation (PS)

PS belongs to a partial ventilation support mode and is a auxiliary mechanical ventilation


mode of patient trigger, pressure target and flow switch. In other words, the patient triggers
ventilation and control the breathing frequency and tidal volume. When the airway pressure
has reached the presets pressure support level and the inspiration flow speed is lower than
the threshold level, the inspiration switches to the expiration. Setting appropriate level will
reduce human-machine rivalry and the breathing work effectively, adding the affectivity of the
patient breathing effort. Some studies thinks 5-8cmH2O PS can overcome the resistance of
the trachea in the airway and the circle of the ventilator, so PSV can apply to retreat from
machine.

The tidal volume is determined by the compliance and resistance of the breathing system.

The setup parameters of IPPV mode:


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△ P、FreqMIN、Trigger、PEEP、Expiration、Tslope

Fig.3-5 Waveform of PS

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4. Pre-operative Preparation

4.1. Installation and Connection

4.1.1.Connection of Tubes and Cables

Step 1:

Connect C·G·O connection cable of the


breathing system to C·G·O interface in the left
of Anesthesia machine.

Fig.4-1
Step 2:

Connect one end of heating cable to the


interface below the breathing system; the
other end connected to the interface marked
―Heater‖ in the outlet module.

Fig.4-2

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Step 3:

Connect one end of drive gas tube to the


interface below the breathing system.

Fig.4-3
Step 4:
Connect the other end of drive gas tube to the
interface marked ―Drive Gas‖ in the outlet
module.

Fig.4-4

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4.1.2.Installation of Breathing Bag

Step 1:

Hold the breathing bag to bag arm directly.

Fig.4-5
Step 2:

Connect breathing bag to the bag arm with an


upper force.

Fig.4-6

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4.1.3.Connection of test plug

Step 1:

Test plug is between inspiratory port and


expiratory port of the breathing system, ―T‖ is
marked above the plug.

Fig.4-7
Step 2:

Connect Y-piece to the Y-Piece seal.

Fig.4-8

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4.1.4.Connection of O2 sensor

Step 1:

Pull out O2 cell plug from inspiratory valve


cover.

Fig.4-9

Fig.4-10
Step 2:

Connect the transparent joint which connects


O2 sensor by cable to the top port of the O2
sensor.

Fig.4-11

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Fig.4-12
Step 3:
Connect O2 sensor to the inspiratory valve
cover.

Fig.4-13
Step 4:
Connect the other end of O2 sensor
connecting cable to the interface marked
―Oxygen‖.

Fig.4-14

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4.1.5.Connection of Anesthetic gas monitor module (Optional)

CAUTION: The anesthetic gas/CO2 monitoring module conforms to ISO 80601-2-55.

Step 1:
Snap the probe on top of the airway adapter. It
will click into place when properly seated.

Fig.4-15
Step 2:
Connect the RS232 interface of the adapter to
the RS232 interface on the back of the
displayed LED.

Fig.4-16
Step 3:

Connect the smaller end of the adapter to the


Y-piece connector.

CAUTION: After powering on the system,

a green LED indicates that the probe is ready


for use.

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Fig.4-17
Step 4:

Connect the other end of the adapter to the


face mask or breathing bag.

Fig.4-18

4.1.6.AGSS Installation and Connection (Optional)

CAUTION: AP1000 cannot at an angle exceeding 5 degrees during normal operation.

CAUTION: Make sure AP1000 installs at a place where operator can get a clear view

of it.

CAUTION: Connect AP1000 according to the practical situation if no GCX rail is

available on the Anesthesia machine.

WARNING: Make sure good connection in case of Anesthesia gas leaks to operating

room.

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Step 1:

There is an exposure slot specifically for

AGSS on the left side. Install AGSS in the slot.

Fig.4-19
Step 2:

Hold AGSS with hands, so that its fixed block


aligns with the exposure slot. Put AGSS into
rail in parallel and then slide AGSS to the limit
level of the fixed block.

Fig.4-20
Step 3:

Connect special screw pipe to the "Exhaust"


connector at the bottom of the respiratory
system and the connector on AGSS.

Fig.4-21
Step 4:

Connect AGSS exhaust pipe to AGSS outlet


(nipple), and tighten clockwise.

Fig.4-22

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4.2. Pre-operative Test

WARNING:Before using the Aeon8300A Anesthesia machine, please carefully read

manual and understand the following content:

 All system connections.

 All WARNINGs and CAUTIONs.

 Usage of each system component.

 Testing method of each system component.

WARNING:Do the following things before operating Aeon8300A:

 Finish all the tests listed in Pre-use Preparation.

 Test other systematic parts.

WARNING:Do not use the machine if any test failures. Contact Aeonmed’s authorized

service representative for maintaining the machine.

4.2.1.Test before Operation

Pre-use test should be performed under the following circumstances:

 Every day before used on the first patient.

 Before used on every patient.

 After maintenance or service.

4.2.1.1. System Check

WARNING:Make sure that the breathing system is in good connection and with no

damage.

1. Make sure the Anesthesia machine has no damage.

2. Make sure all parts are correctly connected.

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3. Make sure the breathing system is correctly connected and has no damage; the
absorber canister is fully filled with soda lime.

4. Make sure the vaporizer is well locked and is filled with adequate anesthetic agent.

5. Make sure the pipeline gas supply system is correctly connected and is at proper
pressure.

6. Make sure backup equipments are available and functioning.

7. Make sure anesthetic agent and emergent medicine are available.

8. Make sure the castors are not loose and the forefront two castors are locked.

9. Make sure the Anesthesia machine is connected to power socket and power
indicator is light. There is no power supply if power indicator does not light.

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4.2.1.2. Power Failure Alarm Test

1. Turn on power switch; user interface is light, STANDBY interface displays after self-test
is finished.

2. After the Anesthesia machine operates under STANDBY mode for five minutes, pull out
power cord

3. Make sure power failure alarm occurs (alarm bell sounds or user interface displays
POWER FAILURE message).

4. Reconnect power cord.

5. Make sure alarm is eliminated.

4.2.2.Pipeline Gas Supply Test

CAUTION:Operator should make sure gas supplies are correctly connected during

operation, there is no leak,wrong connection and damage in breathing circuit. If something


abnormal occurs, check the connection.

WARNING: The malfunction of the center gas supply system may cause one or even all

connection equipment connected with it stopping work.

1. Cut off pipeline gas supply. Perform the following steps if pipeline gauge does not read
zero:

2. Connect O2 supply.

3. Set flow to the middle level.

4. Make sure N2O cylinder gauge reading restores to zero.

5. Cut off O2 supply.

6. Make sure O2 cylinder gauge reading restores to zero. Low gas source alarm occurs
when O2 pressure is decreasing.

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4.2.3.Vaporizer Test

CAUTION:For information of vaporizer’s function test, refer to VP300 User Manual.

 Make sure the vaporizer is steadily installed.

 Make sure the vaporizer is locked.

 Make sure only one vaporizer can be open at a time.

 Make sure the vaporizer is filled with adequate anesthetic agent.

4.2.4.Alarm Test

1. Connect a test lung to Y-piece.

2. Turn on power switch.

3. Set the following items:

Ventilation Mode IPPV

Ventilator Vt:700mL

Freq.:20

I:E:1:2

PAW-High:40cmH2O

Anesthesia machine All gas flow:OFF

Push O2 flush to inflate bellows.

4. Make sure:

 Initiate mechanical ventilation.

 No low gas source pressure alarm occurs.

 Ventilator displays correct values.

 Bellows moves up and down during mechanical ventilation.

5. Set O2 flow at 5L/min.

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6. Make sure:

 End respiratory pressure is approximately between 2cmH2O to 3cmH2O.

 Ventilator displays correct values.

 Bellows moves up and down during mechanical ventilation.

7. Test O2 monitoring and alarm:

 Disassemble O2 sensor, make sure that O2 takes up 21% of room air according to
the test result.

 Set low O2 alarm to 50%, make sure low O2 alarm occurs.

 Set low O2 alarm to 21%, make sure low O2 alarm is eliminated.

 Assemble O2 sensor in breathing system.

 Set high O2 alarm to 50%.

 Push O2 flush button to inflate bellows.

 Make sure high O2 alarm is initiated.

 Set high O2 alarm to 100%, make sure high O2 alarm is eliminated.

 Put O2 sensor in pure oxygen; make sure that O2 takes up 100% according to the
test result.

8. Test low minute volume alarm:

 Return to alarm menu.

 Set low minute volume alarm limit to 16.0L/min.

 Make sure low minute volume alarm occurs.

 Return to alarm menu.

 Set low minute volume alarm limit to 10.0L/min, make sure low minute volume alarm
is eliminated.

9. Test high PAW alarm:

 Set high PAW below peak PAW.

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 Make sure high PAW alarm occurs.

 Set high PAW alarm to 40cmH2O.

10. Test low PAW alarm:

 Disconnect test lung from breathing system.

 Other alarms occur, such as low minute volume alarm.

 Make sure low PAW alarm occurs.

11. Test continuous PAW alarm:

 Set control items:

APL valve: Adjust to the maximum value

Ventilation Mode: Manual

 Mechanical ventilation stops when the machine operates at Manual ventilation


mode.

 Block patient end and push O2 flush button.

 Make sure continuous PAW alarm occurs when continuous pressure is at 10cmH2O
for 15 seconds.

 Turn off power switch.

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4.2.5.Emergency treatment (electrical or pneumatic power


supply failure)

During the operation of the Anesthesia machine, when the electrical power supply fails and
the battery is dis-abled:

--- If the pneumatic power supply is normal, the manual ventilation should be carried out to
ensure the continued supply of fresh gas to the patient;

--- If the pneumatic power supply fails, the whole Anesthesia system is disabled; the manual
bag the patient to ensure the patients breathing.

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5. Operating guide

5.1. Opening
Use the AC power, connect the pipeline gas resource and auxiliary gas resource and open the
auxiliary cylinder valve, close O2, N2O, Air flow meter and the auxiliary O2 flow meter.

Turn the switch to ―ON‖.


The user interface is lighted ,
entering into the system self-test
interface.

Fig.5-1

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5.2. System Self–test


Enter into the system self-test
interface after opening.
The current software version is
displayed.

Fig.5-2
After the system self-test:
1) Select and confirm ―Continue‖, the
Automatic Test begins.

Fig.5-3
2) Select and confirm ―Bypass‖, the
―Manual Test‖ interface appears.

Fig.5-4

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User Manual

5.3. Automatic Leak Test

After System Self Test, the


automatic Test begins.
Follow instructions:
1) Select ―Continue‖ to perform
Automatic Test.
2) Select ―Bypass‖ to proceed to
Manual Test.

Fig.5-5
Select ―Continue‖, the system
enter into the Automatic Test
interface.
―Automatic Testing…‖ appears in
the user interface.

Fig.5-6

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User Manual

These situations may appear during the automatic test,

If these situations appear, please:

1. Do according to the message on the user interface.

2. Select “Continue” and press the knob ,the system begins to re-test, The interface
displays shown as above picture.

1. If the E-flowmeter isn’t closed,


the message ―Please close the
flowmeter‖ appears on the user
interface.

1) Select ―Continue‖ to perform


Automatic Test again.
2) Select ―Bypass‖ to proceed to
Manual Test.

Fig.5-7
2. If the bellows is not full, the
message ―Push ―O2+‖ flush to
completely fill the Bellows‖
appears on the user interface.
1) Select ―Continue‖ to perform
Manual Test again.
2) Select ―Bypass‖ to proceed to
Manual Test.

Fig.5-8

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Automatic Test results

1. If the safety valve is valid and


the leakage is less than
100ml/min, the automatic test is
passed and then the system
proceeds to the Manual Test.

Fig.5-9
2. If the leakage is at the range of
100—400ml/min, the interface
shows as the picture on the right.
1) Select ―Retry‖ to perform the
Automatic Test again.
2) Select ―Bypass‖ to proceed to
the Manual Test.

Fig.5-10
3. If the leakage is more than
400ml/min, the interface shows
as the picture on the right.
1) Select ―Retry‖ to perform the
Automatic Test again.
2) Select ―Bypass‖ to proceed to
the Manual Test.

Fig.5-11

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4. Automatic Test failed


If the safety valve in the gas
module is disabled the automatic
test will fail, and the interface as
the picture on the right appears.
Select ―Continue‖ to perform
Manual Test.

Fig.5-12
5. Automatic Test failed
If the pressure sensor (Ambient
pressure sensor and Airway
pressure sensor) is disabled, the
automatic test will fail and the
prompt message will appear on
the user interface.
Please contact service
representative when the message
appears.
Fig.5-13

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User Manual

5.4. Manual Test

Before performing the manual test,


if partial or none of the automatic
test is done, the user interface will
display as the picture on the right.
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.

Fig.5-14
If the automatic test success, the
system proceed to manual test,
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.

Fig.5-15

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Manual test results

1. Manual test success


If the manual test success, the
interface displays as the picture on
the right.
After 5s count time, the system will
change to Standby mode
automatically.

Fig.5-16
2. If the PAW gauge value is bellow
20 cmH2O, the interface will display
as the picture on the right.
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.

Fig.5-17
3. If APL Valve adjustment is
improper
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.

Fig.5-18

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User Manual

4. If no operation is done during the


two 60s count down after the
Manual test interface appears, the
interface displays shown as the
picture on the right.
Select“Continue”
,the interface will
change to the Standby mode.

Fig.5-19
5. Manual test fails
If the manual test fails, the interface
displays as the picture on the right.
During 60s count time, do
according to the interface
message.
Select “Bypass”,the interface will
change to the Standby mode.

Fig.5-20
6. If the manual test fails three
times, the interface displays as the
picture on the right.
Select“Continue”
,the interface will
change to the Standby mode.

Fig.5-21

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5.5. Patient Type Setting


The patient type of Aeon8300A anesthesia system has 2 types: Child and Adult. The user
can select the needed one.

CAUTION: Adult is the default patient type after opening.

CAUTION: The switch of the patient type is only allowed in STANDBY mode.

Adult is the default patient type


after opening.
Select and confirm ―Adult‖.

Fig.5-22
Press the knob and the green
cursor turns black, now select
the needed patient type.

Fig.5-23

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Turn the knob to ―Child‖, now


the green cursor changes as
the right picture.

Fig.5-24
Press the knob, now the cursor
turns green and confirm your
setting.

Fig.5-25

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5.6. Ventilation Mode Setting


The user can select the ventilation mode according to the patient’s actual situation. Take the
switch from PCV to IPPV for example.

Turn the knob, select and


confirm PCV mode.

Fig.5-26
Press the knob and ―PCV‖
changes as the right
picture.

Fig.5-27
Turn the knob to select
―IPPV‖ mode, ―IPPV‖
changes as the right
picture.

Fig.5-28

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User Manual

Press the knob, the cursor glitters


between yellow and green, now the
system is still in PCV mode.
Notice appears in the user message
area to remind the user the switch is
still going.

NOTICE: The mode preset state

lasts for 15s.If new ventilation mode is


still not confirmed for more than 15s,
the ventilation mode will renew to the
Fig.5-29
old mode, and all the setting parameter
in preset state will be invalid.
Press the knob again, now the cursor
turns green and confirm your setting.

Fig.5-30

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User Manual

5.7. Breathing parameter setting


If the patient type and ventilation mode have been selected, the system default the parameter
of the ventilation mode. The user can set the needed breathing parameter. Now take IPPV
mode for example; the setting methods of other modes and parameters can refer to this.

Turn the knob to the parameter setting


area in ―IPPV‖ mode, the green cursor
falls on Vt.

Fig.5-31
Press the knob and Vt changes as the
right picture.

Fig.5-32

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Turn the knob to adjust Vt parameter,


now Vt changes as the right picture.

Fig.5-33
Turn the knob and confirm your setting.

Fig.5-34

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Parameter and adjustment scope of the ventilation mode

IPPV Mode Patient Type: Unit Range Default Stepping


Valve
Adult

Vt mL 20~1500 600 10

Freq. bpm 4 ~100 8 1

I:E / 4:1 ~ 1:8 1:2 0.5

TP % Off,5~ 60 10 5

PEEP cmH2O Off,3 ~ 30 Off 1

IPPV Mode Patient Type: Unit Range Default Stepping


Valve
Child

Vt mL 20~1500 120 10

Freq. bpm 4 ~100 20 1

I:E / 4:1 ~ 1:8 1:2 0.5

TP % Off,5~ 60 10 5

PEEP cmH2O Off,3 ~ 30 Off 1

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PCV Mode Patient Type: Unit Range Default Stepping


Valve
Adult

PTARGET cmH2O 5~ 70 20 1

Freq. bpm 4~100 12 1

I:E / 4:1 ~ 1:8 1:2 0.5

PEEP cmH2O Off,3 ~ 30 Off 1

TSLOPE sec 0~2 0.5 0.1

PCV Mode Patient Type: Unit Range Default Stepping


Valve
Child

PTARGET cmH2O 5~ 70 10 1

Freq. bpm 4~100 20 1

I:E / 4:1 ~ 1:8 1:2 0.5

PEEP cmH2O Off,3 ~ 30 Off 1

TSLOPE sec 0~2 0.5 0.1

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SIMV Patient Type: Unit Range Default Stepping


Mode Valve
Adult

Vt mL 20~1500 600 10

Freq. bpm 4~100 4 1

TINSP sec 0.2~5.0 2 0.1

TP % Off,5~60 10 5

PEEP cmH2O Off,3~30 Off 1

ΔP cmH2O 3~50 5 1

Trigger L/min 1~15 3 1

TSLOPE sec 0~2 0.5 0.1

SIMV Patient Type: Unit Range Default Stepping


Mode Valve
Child

Vt mL 20~1500 120 10

Freq. bpm 4~100 4 1

TINSP sec 0.2~5.0 1 0.1

TP % Off,5~60 10 5

PEEP cmH2O Off,3~30 Off 1

ΔP cmH2O 3~50 5 1

Trigger L/min 1~15 2 1

TSLOPE sec 0~2 0.5 0.1

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PS Mode Patient Type: Unit Range Default Stepping


Valve
Adult

FreqMIN bpm 2 ~ 60 2 1

PEEP cmH2O Off,3~30 Off 1

ΔP cmH2O 3~50 5 1

Trigger L/min 1~15 3 1

TSLOPE sec 0~2 0.5 0.1

PS Mode Patient Type: Unit Range Default Stepping


Valve
Child

FreqMIN bpm 2 ~ 60 4 1

PEEP cmH2O Off,3~30 Off 1

ΔP cmH2O 3~50 5 1

Trigger L/min 1~15 2 1

TSLOPE sec 0~2 0.5 0.1

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5.8. Breathing Loop


Press the breathing loop button in the right side of the user interface, the breathing loop
appears in the user interface.

―Save‖ is in the low right of the circle to save the next circle as a reference circle.

When a loop is going or no circle displays, press ―Save‖ to save the next entire circle
(inspiration and expiration) as a reference circle.

After pressing ―Save‖, Pressure-Volume circle and Flow-Volume circle are saved.

Press ―Save‖ again and the system will cancel the current saved Pressure-Volume and
Flow-Volume reference circles at once and save two new reference circles.

When recede from the function circle window, the saved reference is stored.

CAUTION;When the STANDBY mode is set as work mode, the two saved breathing

circle will be canceled.

Fig.5-35 Pressure-Volume Big-scale Interface

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User Manual

Fig.5-36 Pressure-Volume Small-scale Interface

Fig.5-37 Flow-Volume Big-scale Interface

Fig.5-38 Flow-Volume Small-scale Interface

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User Manual

5.9. Menu setting

5.9.1.Alarm setting

5.9.1.1. Alarm parameter limit setting

Now take the setup of the low and high limit of the minute volume for example, other
parameter settings are like this.

The green cursor falls on the ―Alarm‖,


press the knob and enter into the alarm
setup menu.

Fig.5-39
―MV‖ is the default option.

NOTICE:‖Low‖ means the low setup

limit, ‖High‖ means the high setup limit.


Generally, the low setup can not exceed
the high setting. The setting of the setup
value is 1.

Fig.5-40

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User Manual

Press the knob, and the green cursor


turns black as the right picture .Turn the
knob to select the needed low limit of
minute volume.

Fig.5-41

5.9.1.2. Manual mode alarm setting

Manual alarm setup has two statues:


Open and Close. Now take the setup of
―Open‖ state for example.

Turn the knob to ―Manual Mode‖, the


green cursor falls on the ―Open‖.

Fig.5-42
Press the knob, the green cursor turns
black as the right picture. Turn the knob
to select the needed setting.

Fig.5-43

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User Manual

Press the knob to confirm your setting.

Fig.5-44

5.9.1.3. Alarm volume

Turn the knob to ―Alarm Volume‖, the


green cursor falls on the ―Alarm Volume‖
setup frame.

Fig.5-45
Press the knob, the green cursor turns
black as the right picture.

Turn the knob to set the needed alarm


volume and press the knob to confirm
your setting.

Fig.5-46

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User Manual

5.9.1.4. Alarm limits of anesthetic gas

Now take the setup of the low and high limits of Iso. For example, other parameter settings
are like this.

Turn the knob to ―Next‖ and press the


knob to enter into the next page.

Fig.5-47
The default option is Iso.

NOTICE: ―Low‖ means the low setup

limit. ―High‖ means the high setup limit.


Generally, the low setup cannot exceed
the high setting.‖OFF‖ is the default
option of the low limit. The setting of the
setup value is 0.1%.
Fig.5-48
Press the knob, the green cursor turns
black as the right picture.

Fig.5-49

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User Manual

1) Turn the knob to ―Previous‖, press the


knob to return to the previous interface.

2) Turn the knob to ―Return‖ and press


the knob to return to the main interface.

Fig.5-50

5.9.2.System setting

Turn the knob to make the green cursor


falls on the ―System‖.

Fig.5-51
The green cursor falls on the ―System‖.

Press the knob and enter into the system


setup menu. After entering into the
menu, the green cursor falls on the
―Pressure Display‖ setup frame as
defaulted by the system.

Fig.5-52

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User Manual

5.9.2.1. Pressure display

The wave of the main interface has two types: PLAT or MEAN.

Press the knob and the green cursor


turns black as the right picture.

Turn the knob to select the needed


pressure display.

Fig.5-53
Press the knob, and then cursor color
turns green, and confirm your setting.

Fig.5-54

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5.9.2.2. Language

The system has two languages to select: Chinese and English. The user can select the
needed one.

Turn the knob and the green cursor falls


on the language setup frame.

Fig.5-55
Press the knob, the green cursor turns
black.

Turn the knob to select the needed


language.

Fig.5-56
Press the knob, the cursor turns green,
and confirm your setting.

Fig.5-57

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5.9.2.3. Display

The display ways have two types: live and demo.

Select the real-time display, the main interface will display the system’s live message and
wave.

Select the demo display; the main interface will display the standard default message and
wave of some breathing module.

NOTICE: Select demo, ―demo mode‖ in red is displayed in the alarm area which is in the

left up side of the main interface.

Turn the knob and the green cursor


falls on the display setup frame.

Fig.5-58
Press the knob and the green cursor
turns black,

A password window appears in the


right side of the interface and input the
right password.

Fig.5-59

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Turn the knob to ―Done‖.

Press the knob to enter into the


display interface.

Fig.5-60

5.9.2.4. Date setting

The date type has 3 types: MM/DD/YY, DD/MM/YY, and YY/MM/DD, select the needed one.

Turn the knob and the green cursor


falls on the ―Edit Date‖.

Fig.5-61
Press the knob, the cursor turns
black.

The edit date window appears in the


right side of the interface.

Fig.5-62

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User Manual

Press the knob and the cursor in the


edit date window turns black.

Turn the knob to select the needed


date type.

Fig.5-63

Press the knob, the cursor turns green,


and confirm your setting.

Fig.5-64
Turn the knob and the green cursor falls
on ―Adjust Date‖.

Fig.5-65

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Press the knob and the cursor turns


black.

Turn the knob to select the needed date


and press the knob to confirm your
setting.

Fig.5-66
Turn the knob to ―Done‖, press the knob
to confirm the final date setting.

Fig.5-67

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5.9.2.5. Time setting

The time format has 2 types: 12 hour and 24 hour. Select the needed one.

Turn the knob, the green cursor falls


on the ―Edit Time‖.

Fig.5-68
Press the knob and the cursor turns
black.

An edit time window appears in the


right side of the interface.

Fig.5-69
Press the knob and the cursor turns
black.

Turn the knob to select the needed


time type.

Fig.5-70

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User Manual

Press the knob, the cursor turns


green and confirm your setting.

Fig.5-71
Turn the knob and the green
cursor falls on ―Adjust Time‖.

Fig.5-72
Press the knob and the cursor
turns black.

Turn the knob to select the


needed time and press the knob
to confirm your setting.

Fig.5-73

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Press the knob, the cursor turns


green and confirm your setting.

Fig.5-74
Turn the knob to ―Done‖,press
the knob and confirm the final
time setting.

Fig.5-75

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5.9.2.6. Restore defaults

The setup value can be restored to system defaults by pressing ―Restore Defaults‖.

Turn the knob, the green cursor


falls on ―Restore‖.

Fig.5-76
Press the knob, a ―Are you sure?‖
window appears in the right side
of the interface.

The green cursor falls on ―Done‖,


the system will restore default
option, otherwise, select ―Cancel‖.

Fig.5-77

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User Manual

5.9.2.7. The opening of O2 sensor

Connect the O2 sensor to the system directly; enter into O2 sensor activation interface to open
O2 sensor. The main interface will display each value monitored by O2 sensor. Close O2
sensor, the values will not be displayed.

NOTICE: Connect 2 sensors before activating the system, after opening, the system will

default the O2 sensor open.

If O2 sensor is connected during the system operating process, it is needed to enter the O2
sensor interface to open it, then the main interface can display each value monitored by O2
sensor.

Turn the knob, the green


cursor falls on the O2 Sensor
setup frame.

Fig.5-78
Press the knob and the
cursor turns black.

Fig.5-79

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Select the needed O2 sensor state and


confirm by pressing knob.

Fig.5-80

5.9.2.8. Leak test result

Turn the knob and the green cursor


falls on the leak test setup frame.

Fig.5-81
Press the knob, and the leak test
result window appears in the right
side of the interface.

Leak voltage, test date and test time


will be displayed.

Press ―Done‖ to recede from the


current interface.

Fig.5-82

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5.9.2.9. Air drive (Optional)

Air drive is an optional function of the system.

Open air drive, the drive bellows gas is switched from O2 to air.

Use password to open air drive.

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5.9.3.Calibration

5.9.3.1. O2 sensor calibration

Turn the knob to ―Calibrate‖.

Press the knob to enter into the


calibration menu.

Fig.5-83
Turn the knob and the green cursor
falls on‖O2 Sensor Calibration‖.

Fig.5-84
Press the knob, the cursor turns
black.

The ―O2 Sensor Calibration‖ window


appears in the right side of the
interface.

Follow the window notice to operate.

Fig.5-85

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The window displays a countdown of


180s.

Before the waiting time ends, select


―Continue‖, a ―Please waiting‖ notice
appears.

After the countdown ends, turn the knob


to ―Continue‖ and press the knob, the
calibration begins.
Fig.5-86
Turn the knob to ―Cancel‖, press the
knob and return to the main interface.

Select ―Continue‖ and A word


―Calibrating‖ appears in the window.

Fig.5-87
The calibration of O2 sensor succeeds.
The green cursor falls on ―Finish‖, press
the knob and return to the main
interface.

Fig.5-88

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The calibration of O2 sensor failures, the


green cursor falls on ―Repeat Cal ‖,
press the knob and the system begins to
renew calibration;

Turn the knob to ―Cancel‖, press the


knob and returns to the main interface.

Fig.5-89

5.9.3.2. CO2 sensor calibration

Turn the knob to ―CO2 Sensor


Calibration‖.

Press the knob and a ―Please activate


CO2 function first!‖notice appears.

Fig.5-90
Enter into CO2 sensor calibration
interface, Module OFF appears in the
state area, indicating CO2 sensor is
unopened.

Fig.5-91

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Open the CO2 sensor. Please Wait


appears in the state area.

Follow the notice to operate:

1) Turn the knob to ―Continue‖, press the


knob and the calibration begins;

2)Turn the knob to ―Cancel‖, press the


knob to return to the main interface.
Fig.5-92

The green cursor falls on ―Continue‖,


press the knob and a ―calibrating‖ notice
appears in the window.

Fig.5-93

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User Manual

The result of CO2 sensor calibration has two types:

CO2 sensor calibration succeeds.

Follow the window notice to operate, the


green cursor falls on ―Finish‖, press the
knob and return to the main interface.

Fig.5-94

2) CO2 sensor calibration failures.

Follow the window notice to examine


step by step.

Select ―Repeat Cal‖, press the knob and


return to renew the calibration.

Fig.5-95

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5.9.3.3. Agents calibration

Turn the knob to ―Anesthetic Gas


Calibration‖.

Press the knob and a ―Please activate


agents function first!‖notice appears.
Activate the monitor function of the
anesthetic gas.

Fig.5-96
Enter into anesthetic gas calibration
interface, Module OFF appears in the
state area, indicating CO2 sensor is
unopened.

Fig.5-97
Open the anesthetic gas module.

Please Wait appears in the state area.

Follow the notice to operate:

1) Turn the knob to ―Continue‖, press the


knob and the calibration begins;

2)Turn the knob to ―Cancel‖, press the


knob to return to the main interface.
Fig.5-98

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User Manual

The green cursor falls on ―Continue‖ press


the knob and an ―Anesthetic gas is
calibrating‖ notice appears in the window.

Fig.5-99
The calibration of the anesthetic gas has two results:

Anesthetic gas calibration succeeds.

Follow the window notice to operate, the


green cursor falls on ―Finish‖, press the
knob and return to the main interface.

Fig.5-100
2) Anesthetic gas calibration failures.

Follow the window notice to examine the


listed items step by step.

Select ―Repeat Cal‖, press the knob to


return and renew the calibration.

Turn the knob to ―Cancel‖, press the knob


to return to the main interface.
Fig.5-101

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5.9.3.4. Leak Test

Turn the knob to ―Calibrate‖.


Press the knob to enter into the calibration
menu.

Fig.5-102
Adjust the knob to make the green cursor
fall on ―Leak Test‖.

Fig.5-103
Press the knob, the cursor turns black.
The ―Leak Test‖ window appears in the
right side of the interface.
If the ―Leak Test‖ window shows as the
picture on the right select ―Return‖ to main
interface and change the mode to
Standby, then perform Leak Test.

CAUTION: Leak Test is valid only in

Standby mode. Fig.5-104

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If the ―Leak Test‖ window shows as the


picture on the right:
Select ―Next‖ to perform the leak test.
Select ―Cancel‖ to enter into main
interface.

Fig.5-105
Select ―Next‖ and a word ―Testing‖
appears in the window.

Fig.5-106
If the Leak Test succeeds. The green
cursor falls on ―Finish‖, press the knob and
return to the main interface.

Fig.5-107

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If he Leak Test fails, the green cursor falls


on ―Repeat Cal ‖,press the knob and the
system begins to renew calibration;
Turn the knob to ―Cancel‖, press the knob
and returns to the main interface.

Fig.5-108

5.9.3.5. Compliance Test

Turn the knob to ―Calibrate‖.


Press the knob to enter into the
calibration menu.

Fig.5-109
Adjust the knob to make the green
cursor fall on ―Compliance Test‖.

Fig.5-110

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Press the knob, the cursor turns black. The ―Compliance Test‖ window appears in the right side
of the interface.

If the ―Compliance Test‖ window


shows as the picture on the right
Select ―Next‖ to perform Leak Test

NOTE: In general, do the leak

test before performing the


compliance test

Fig.5-111
If the ―Compliance Test‖ window
shows as the picture on the right
select ―Return‖ to main interface
and change the mode to Standby,
then perform Compliance Test.

CAUTION: Leak Test is valid

only in Standby mode.


Fig.5-112
If the ―Compliance Test‖ window
shows as the picture on the right:

Select ―Next‖ to perform the


compliance test.

Select ―Cancel‖ to enter into main


interface.

Fig.5-113

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Select ―Next‖ and a word ―Testing‖


appears in the window.

Fig.5-114
If the Compliance Test succeeds.
The green cursor falls on ―Finish‖,
press the knob and return to the
main interface.

Fig.5-115
If the Compliance Test fails, the
green cursor falls on ―Repeat Cal ‖,
press the knob and the system
begins to renew calibration;
Turn the knob to ―Cancel‖, press
the knob and returns to the main
interface.

Fig.5-116

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5.9.4.Gas setting

5.9.4.1. Open gas module

Monitor CO2 and anesthetic gas in real-time by opening or closing CO2 module and
anesthetic gas module.

NOTICE: Connect the gas module before startup the system; the gas module will be

defaulted to be open by the system after opening. If it is connected during the system running,
it is needed to enter into the gas module interface to open it, then the main interface can
display the parameters of CO2 or anesthetic gas.

Select and confirm ―Gas‖.

Press the knob to enter into this


menu.

Fig.5-117
After entering into this menu, the
green cursor falls on Gas Sensor.

Fig.5-118

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Press the knob, the green cursor


turns black.

Turn the knob to open the gas


module.

Fig.5-119
Press the knob to confirm your
choice.

Fig.5-120

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5.9.4.2. CO2 unit

CO2 monitor parameter and wave have two units: mmHg and %. The user can select the
needed one.

Turn the knob and the green


cursor falls on ―CO2 Unit‖.

Fig.5-121
Press the knob, the green
cursor turns black.

Turn the knob to select CO2


unit.

Fig.5-122
Press the knob to confirm CO2
unit.

Fig.5-123

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5.9.4.3. Wave display

The waves what the main interface displays have two types: CO2 wave and flow wave. The
user can select the needed one.

Turn the knob and the green


cursor falls on ―Wave Display‖.

Fig.5-124
Press the knob, the green cursor
turns black. Then turn the knob to
select the needed wave.

Fig.5-125
Press the knob to confirm the
selected wave.

Fig.5-126

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5.9.4.4. Module version

When the gas module is connected with the system and opened, the detailed version of the
gas module can be known through the module version.

Turn the knob and the green


cursor falls on ―Module Version‖.

Fig.5-127
Press the knob and the green
cursor turns black.

A ―Gas Module Version‖ window


appears in the right side of the
interface.

The gas module type, software


version, hardware version and
number will be displayed.
Fig.5-128

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5.10. Closing
Turn the power switch to ―OFF‖ to close the anesthesia system.

ALARM: After closing the power switch, the system is running continually until the

background light of the flow meter has gone out.

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6. Alarm and troubleshooting

WARNING: Personnel without experience in the maintenance of such equipment must

not be engaged in maintenance work.

WARNING: If alarm occurs, protect patient safety first, and then diagnose fault or service

if necessary

CAUTION: When more than one alarm occurs simultaneously, the alarm information will

display from highest to lowest priority

CAUTION: For mute, "×" shape will appear on alarm bell. In white , alarm sound
disappears, and alarm bell restores less than 120s. If alarm is not timely processed, alarm
sound will continue.

CAUTION: If anesthesia machine produces alarm in running, alarm system will generate

certain time delay for sending visual signal and auditory signal.

WARNING: Do not set an alarm limit that exceeds limits, otherwise it will cause alarm

system failure.

WARNING: For the same or similar equipment used in any separate zone, if different

alarm preset values are used, there will be potential danger such as intensive care or cardiac
operating room.

WARNING: Operator shall check if the current alarm preset is suitable for each patient

before using.

WARNING: If the power is interrupted, the previously set alarm values will be recovered

at the next boot-up of the system.

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6.1. Brief introduction of alarm message


Alarm state is divided into three priorities: high priority, medium priority and low priority.
High-priority alarms needs to be addressed immediately.

The operator can determine the alarm system role by a visual alarm signal and an auditory
alarm signal. Up to a distance of 4m, the anesthesia machine operator should be able to be
accurately and clearly aware of visual alarm signals. The visual indicator is located on the
display. At a distance of 1m from the front of the equipment, the acoustic pressure level of the
alarm signal shall not be less than 60dB.

The top area of the user interface displays alarm message, see figure 6-1.

Fig.6-1
Table 6-1 Alarm message

Priority Definition Alarm Tone Mute Notice Message

High Death or 10 alarm tones Less Red background, ―!!!‖flickering,


irreversible including 2 hurry, than displaying frequency is 2Hz.
injury. alarm cycle is 8s. 120s

Medium Reversible 3 alarm tones, Less Yellow background, ―!!‖ flickering,


injury. alarm cycle is 10s. than displaying frequency is 0.5Hz.
120s

Low Slight injury or 2 alarm tones, no Less Yellow background, ―!‖ flickering,
uncomfortable. repeat. than long-term display.
120s

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6.2. Alarm message


Alarm types include technical alarms and functional alarms. Technical alarms include boot
detection alarms and alarms during the normal operation process.

6.2.1.Alarm default value and setting range

High Low Setting range of high limit Setting range of


low limit
MV(Adult) 12 1 1~25 0~20
MV(Child) 6 1
PAW(Adult) 50 10 10~80 0~70
PAW(Child) 40 8
Freq(Adult) 18 --- 8~60 ---
Freq(Child) 30 ---
FiO2 100% 18% 21%~100% 18%~99%
Hal. 1.5 OFF 0.1%~8.4% OFF,0.1%~8.3%
Iso. 2.3 OFF 0.1%~8.4% OFF,
0.1%~8.3%
Enf. 3.4 OFF 0.1%~9.9% OFF,
0.1%~9.8%
Sev. 4.2 OFF 0.1%~9.9% OFF,
0.1%~9.8%
Des. 12.0 OFF 0.1%~21.9% OFF,
0.1%~21.8%
etCO2 6.6% OFF 0.1%~9.9% OFF,
0.1%~9.8%
50mmHg OFF 1~75mmHg OFF,
1~74mmHg
FiCO2 0.7% --- 0.1~1.4% ---
5mmHg --- 1~10 ---

Other default items:


Manual Mode: Enabled
Alarm Volume: 2 tones
Patient type: Adult
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Pressure:PLAT

6.2.2.Technical alarm message table

Table 6-2

Alarm Name Priority Cause Remedy

Low oxygen High Drive gas pressure is less Check pipeline gas supply and
supply than 2.9psi±15% replace pipeline.
pressure
AC power Low AC power failure alarm Check connection, AC power
failure when AC power supply supply and fuse;
failure
Replace fuse when it is melt.
Low battery Medium No AC power and the Connect AC power supply
capacity battery voltage lower than immediately;
22V.
When the alarm appears, the
battery capacity can last 10
minutes.

Switch to the manual mode,


backup battery begins to supply
power and assure battery capacity
is full.

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Alarm Name Priority Cause Remedy

O2 sensor High Monitor O2 concentration< Use exterior measurement system


failure 10%,the alarm occurs or replace O2 sensor.
immediately.

Monitor O2 concentration≥
10%, cancel the alarm
immediately.

The alarm is produced by


epigynous machine.

When O2 sensor in the


system setting menu is
configured ―Disable‖, no
alarm occurs.
BDU High GUI receives and sends Ventilator failure.
communication data from BDU unit failure
Switch to manual mode and the
failure lasts for 2s
user interface is still available.
User interface switches to
STANDBY mode automatically.

Call service Rep.


Communication High Communication between Switch to manual mode and call
between BDU BDU and power supply service Rep.
and power board is abnormal.
supply board
failure
Gas module High When gas module Check cable connection or replace
communication communication is gas module
failure abnormal, if the cable is
interrupted, this abnormal
state will last 5s.

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Alarm Name Priority Cause Remedy

Gas module High Pull out adapter probe in Call service Rep.
probe failure gas module for several
seconds.

NOTICE: If the gas

module communication
failures or interior error in
gas module, the alarm
message will not occur.
Interior error in High Any case of software, Call service Rep.
gas module hardware, electric
―rotational speed― exceeds
limit, no factory calibration
or factory calibration failure,
O2 sensor error(only
by-pass flow) appears, the
alarm will occur.

NOTICE: If the gas

module communication
failures, the alarm message
will not occur.

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Alarm Name Priority Cause Remedy

Gas module High When any parameter of the Call service Rep.
monitor detected CO2,N2O, O2,
concentration anesthetic gas exceeds
exceed limit limit, the alarm message
appears.

NOTICE: If the gas

module communication
failures or interior error in
gas module or gas module
probe is disabling, the
alarm message will not
appear.
Keyboard High No communication Switch to manual mode, Call
communication between UI and keyboard service Rep.
failure

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6.2.3.Functional alarm message

Table 6-3

Alarm Name Priority Condition Solution Remedy

In MANUAL mode, airway


pressure>10cmH2O, and
last more than 15s,this 1. Use manual
alarm occurs; ventilation.

In other mode, airway After alarm 2.Check patient’s


Continuous
pressure>PEEP setting occurs, alarm expiratory
high airway High
values, and last more than lasts at least for passage;if the
pressure
15s,this alarm occurs; 8s. alarm is not

In STANDBY mode, this canceled, call

alarm will not appear; service Rep.

In MANUAL mode, this


alarm will not be closed.

1.Switch to 1.Reset airway

expiratory high alarm


Airway Ppeak≥Ppeak; phase, the limit;2.Detect if

timer expiratory
In STANDBY mode, this
High airway passage is
High alarm will not appear; 2. Alarm
pressure blocked or not;
In MANUAL mode, this message lasts
for 8s after 3. If Vt setting is
alarm could be closed.
alarm condition too big; 4.If the

disappears. patient’ airway is


blocked.
Current monitoring airway
pressure ≤-2cmH2O and
Do not block
Negative lasts for more than 1s.
High SUCTION exhaust
pressure
In MANUAL mode, this port
alarm, this alarm will not be
closed.

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Monitor tidal volume


<10ml,or

Monitor average
pressure<1cmH2O, in 1. Check the
MANUAL mode, it is not tube is
APNEA High determined, or Alarm occurs.
disconnected or
not.
Monitor average pressure
equals to 1cmH2O, and
monitor PEEP≤0cmH2O, in
MANUAL mode, it is not
determined.
In MANUAL mode, airway
pressure is lower than
pressure alarm low
limit>30s;

In other mode,Freq≥4;
airway pressure is lower 1. Ventilator
Low airway Reset airway low
Medium than alarm low works as
pressure alarm limit
limit>15s,Freq<4,airway normal.

pressure is lower than


pressure alarm low
limit>30s;

In STANDBY mode, this


alarm will not appear.

APNEA The patient has no


SW425.2 in PS mode, spontaneous
backup Medium Alarm occurs.
FreqMIN trigger ventilator. ventilation, check
ventilation
the patient state.
1. Reduce alarm
1. Alarm
setting;
occurs.;
Low FiO2 High 1. FiO2≤Low FiO2 setting 2.Ventilator 2. Reduce air or
works as N2O
normal. compensation
value;

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3.Recalibrate O2
sensor;

4. O2 battery is
exhausted;

5. Call service
Rep.
Measured FiO2
1. Alarm
value≥setting
occurs.;
1.Increase FiO2
High FiO2 Medium When O2 sensor 2.Ventilator
and alarm setting
configuration in the system works as
menu is ―Disabled‖, this normal.
alarm will not appear.
1. Alarm
MV≥upper setting limit
occurs.; 1.Increase high
High MV Medium In MANUAL mode, this 2.Ventilator MV alarm limit;
alarm could be closed. works as
normal.
1. Alarm 1.Reduce MV
MV≤lower alarm limit occurs.; alarm setting;
Low MV Medium In MANUAL mode, this 2.Ventilator 2.Check if there is
alarm could be closed. works as leak in patient
normal. end;

MV≥High Freq setting 1.Alarm


occurs.; 1.Check patient’s
The patient has 2.Ventilator state and if there
High Freq Medium spontaneous breathing. works as is spontaneous
normal.(effectiv breathing;
This alarm only applied to
e in PS mode)
PS mode.

Expiratory CO2
High ETCO2 concentration exceeds Increase the Freq
High Alarm occurs;
concentration high limit and lasts at least valve and MV.

2 continual breathes
Low ETCO2 ETCO2 concentration is Decrease the Freq
High Alarm occurs;
concentration lower than low alarm limit valve and MV.

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and lasts at least 2


continual breaths.
1. Replace the
CO2 Absorbent.
High INCO2 Alarm according to
High Alarm occurs; 2. Check the
concentration detected real-time data
unidirectional
characteristic of
Insp./Exp. disc.
Detected PEEP exceeds
PEEP setting +5cmH2O for
2 breaths or 30s (choose
the minimum one between Switch to Manual
High PEEP Medium Alarm occurs;
the two).PEEP High alarm Mode.
occurs.

No this alarm in STANDBY


and MANUAL mode.
No alarm in STANDBY
mode.
High Insp. ISO.
Inspiratory anesthetic gas 1. Check the
High Insp. concentration>alarm alarm upper limit
ENF. High upper limit and lasts for 2 Alarm occurs;
and the anesthetic
breathing cycles. gas concentration.
High Insp.
SEV.• When not content with the
condition, the alarm is
disappears automatically.
No alarm in STANDBY
mode.
Low Insp. ISO.
Inspiratory anesthetic gas
1. Check the
Low Insp. concentration< alarm lower
alarm lower limit
ENF. High limit and lasts for 2 Alarm occurs;
and the anesthetic
breathing cycles.
Low Insp. gas concentration.
When not content with the
SEV.•
condition, the alarm is
disappears automatically.

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6.2.4.Self-test alarm

Table 6-4

Alarm Name Probable Cause Remedy

BDU EEPROM data fail Incorrect calibration in EEPROM Call service Rep.
check

EEPROM IC fail EEPROM cannot read/write Call service Rep.

PAW sensor fail The data of the pressure sensor is Call service Rep.
incorrect.

PEEP valve fail Incorrect PEEP valve data Call service Rep.

Inspiratory valve fail Incorrect monitor sensor ZERO state Call service Rep.

Vent/Manual fail Incorrect valve state Call service Rep.

Flow sensor fail Incorrect sensor data Call service Rep.

SW version fail BDU, GUI, KBD software version is Call service Rep.
not the same with the released one.

BDU Comm. fail If GUI cannot receive and send data All breathing functions fail,
from BDU unit for 0.5s. call service Rep.

KBD Comm. fail No communication between GUI and All breathing functions fail,
Keyboard. call service Rep.

Inspiration valve fail Incorrect voltage value the inspiratory The machine can
valve feedbacks continue to work, but
there is only manual mode
but automatic mode, the
monitor function is
effective, call service Rep.

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O2 supply fail The pressure of drive gas is lower Check if the pipeline
than 200kPa ± 15% supply is normal, connect
the backup gas supply.

Alarm speaker fail Alarm speaker fails The ventilation machine


works as normal, the user
recedes or ignore, call
service Rep.

AC power fail AC power fails Check AC power supply,


check the fuse, replace it
when it is melt.

O2 sensor disconnect or O2 sensor fails or unconnected Replace O2 sensor or


fail connect O2 sensor; when
this alarm appears, the
setting of O2 sensor in the
system menu is disabled;
when there is no alarm,
the setting is Enabled.

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6.3. Failure diagnosis


Table 6-5

No. Message Cause Remedy

1 O2 sensor The anesthetic gas 1. Use external gas measuring


failure measurement system has system.
failed
2.Call service Rep.

2 APNEA 1. Breathing or ventilation 1. Patient must immediately be


has stopped ventilated manually.

2. Check patient’s spontaneous


breathing ability.

3. Check ventilator settings.

4. Check fresh gas setting.

5. Check that everything is


connected.

6. Check hose system and tube.

3 Battery low The AC power failures and 1. Connect to main power.


the battery capacity of the
2. Check patient’s condition.
un-interruptible power supply
is almost exhausted(﹤20%). 3. Prepare manual ventilation with
100% O2.

4 APL valve 1. The connection or setting 1.Check APL valve connection;


failures of APL valve is incorrect.
2.Select STANDBY mode and
return to the old ventilation mode;

3. Check APL valve setting.

5 No sampling 1. Sample line is blocked or 1. Check sample line, water trap


signal unconnected. and Y-piece filter.

2. Replace if necessary.

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No. Message Cause Remedy

6 Breathing 1.Incorrect connection of 1. Check tube, sample line and


system leaks pipeline or line filter.

7 Close AIR 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

8 Close N2O 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

9 Close O2 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

10 CO2 sensor 1. CO2 gas measurement 1. Use external gas measuring


failure system has failed. system.

2. Call service Rep.

11 Continuous high 1. The breathing pressure 1. Check ventilation and/or


pressure exceeds the set limit for spontaneous breathing of the
more than 15s. patient.

2. Check breathing hoses,


breathing system, and gas
scavenging system for correct
functionality.

3. Check alarm limit for correct


setting.
13 ET CO2 high 1. The end-expiratory CO2 1. Check ventilation.
concentration has exceeded
the high alarm limit for at
least two breaths.

14 EXP.flow sensor 1. Expiratory flow sensor has 1. Replace flow sensor.


failure failed.

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No. Message Cause Remedy

15 Fresh gas flow 1.Total fresh gas flow is 1. Reduce fresh gas flow;
too high above 19L/min.
2. Check vaporizer setting.

16 Fresh gas low or 1. Fresh gas setting too low; 1.Increase fresh gad flow;
leak
2. Leak. 2. Repair leak.

17 Gas sensor 1. Complete gas 1.Use external gas measuring


failure measurement system fails. system;

2. Call service Rep.

18. High airway 1. High alarm limit for the 1.Check hose system and tube;
pressure airway pressure has been
2. Correct the ventilation settings.
exceeded;

2.Ventilation hose kinked;

3. Ventilation settings are not


correct.
19. Inaccurate fresh 1. Reduced accuracy of 1.Reduce fresh gas flow fo reach
gas flow fresh gas flow measurement. gas to below 12L/min;

2. Check to take flow meter.

3. Call service Rep.

20. Inhaled CO2 1.Soda lime in circle system 1. Increase fresh gas flow;
high exhausted;
2.Replace breathing system;
2.Leak or fault in breathing
3.Adjust alarm limits if necessary;
system;
4.Check ventilation settings;
3.High ventilation
frequencies; 5. Replace flow sensor.

4. Dead space ventilation.

21. Inspiratory flow 1. Inspiratory flow sensor is 1. Replace flow sensor.


sensor failure faulty.

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No. Message Cause Remedy

22. Inhaled N2O 1. Inhaled N2O concentration 1. Check N2O concentration in the
concentration exceeds the high alarm limit fresh gas flow.
high of 82%.

23. Inhaled O2 1. Inhaled O2 concentration 1. Check O2 concentration in the


concentration exceeds the high alarm limit. fresh gas flow.
high

24. Inhaled O2 1. Inhaled O2 concentration 1. Check O2 concentration and


concentration is below the low alarm limit. fresh gas setting.
low
2. Check O2 supply;

3. Check breathing system and


breathing bag.
25. No air supply 1.Comm pressed air supply 1.Open optional backup air
has failed; supply;

2. Pipeline supply hose not 2.Check connection to piped


connected or kinked. medical air supply;

3.Optional air cylinder is 3.Connect a full air cylinder or


empty or closed; open the cylinder valve;

4. Compressed air 4. Check compressor.


compressor has failed.
26. No N2O supply 1.N2O supply has failed; 1. Open N2O backup cylinder;

2.Pipeline supply hose not 2.Check central gas supply and


connected or kinked; connection to central gas supply;

3. N2O cylinder empty or 3. Connect a full N2O cylinder or


closed. open the cylinder valve.

27. No O2 supply 1.O2 supply has failed; 1.Open O2 backup cylinder;

2.Pipeline supply hose not 2.Check central supply and


connected or kinked; connection to central supply;

3. O2 cylinder empty or 3. Connect a full O2 cylinder or

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No. Message Cause Remedy

closed. open the cylinder valve.

28. O2 cylinder 1. Pressure has dropped 1. Use a new O2 backup cylinder


pressure low below the pressure limit set and the central gas supply.
for the O2 cylinder.

29. O2 flow 1. Fresh gas flow 1. Use only O2 as fresh gas and
measurement measurement for O2 has observe total flow meter.
failure failed.
2. Call service Rep.
30. PEEP high 1. Expiratory pressure 1. In automatic ventilation modes
5cmH2O above PEEP for 2 check the ventilation parameters.
breaths, or Expiratory
2. Check the anesthetic gas
pressure 5cmH2O above
scavenging line.
PEEP in pressure support
mode for more than 30s.

31. Power failure 1. Power failure. 1.Restore central supply and


observe battery capacity;
2. Short-circuit in one of the
devices connected to an 2. Prepare manual ventilation.
auxiliary outlet.
3. Call service Rep.
32. Pressure sensor 1. Pressure sensor faulty. 1.Perform self test;
failure
2. Call service Rep.

33. Reinstall 1. Breathing system has 1.Check correct installation of


ventilator been installed incorrectly or breathing system;
in completely.
2. Check that upper diaphragm
2. Breathing system has been installed correctly.
defective.
3. Use a different breathing
system.

34. Setting can 1. The last setting has not 1. Repeat settings.

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No. Message Cause Remedy

celled been accepted due to 2. Alarm can be reset by pressing


temporary errors. ―Mute‖ button.

35. Speaker failure 1. Speaker faulty. 1.No alarm tone;

2. Call service Rep.

36. Ventilator failure 1. Ventilator is no longer 1. Patient must immediately be


operational. ventilated manually.

2. Adequate substitute monitoring


must be ensured if pressure and
volume monitoring has failed.

3. Call service Rep.

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7. Cleaning and Disinfecting

7.1. General rule for cleaning and disinfection


When cleaning and disinfecting the Aeon8300A anesthesia machine, please strictly follow the
WARNINGs and pre CAUTIONs in this chapter. Different parts of the anesthesia machine
have their respective cleaning and disinfection methods. The parts need to be disinfected,
cleaned and thoroughly dry.

After cleaning, disinfection and reinstallation the anesthesia machine must be calibrated
before using. For calibration details refer to the ―Preparation before operation‖.

CAUTION: The disinfection of the anesthesia machine must conform to the ISO 17664.

WARNING: Please comply with applicable security regulations:

 Please carefully read the safety data for each detergent.

 Please carefully read the operation and maintenance manual of all disinfection
equipment.

 If the oxygen sensor damaged, leakage might occur and cause combustion
(containing potassium hydroxide).

 Please wear safety gloves and glasses for cleaning and disinfection.

 Do not breathe the fumes.

WARNING: Before cleaning the Aeon8300A anesthesia machine, disconnect the power

and turn off the main switch.

CAUTION: Cleaning message:

 The breathing system must be cleaned after installation before the first usage

 If there is a potentially infectious object on the breathing system, such as blood or


secretion, please wipe with disposable cloth or proper disinfectant;

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 The parts labeled ―134℃‖ can be disinfected with the method of high temperature
and pressure;

 Except for the oxygen sensor and airway pressure gauge, the parts can be washed
in an automatic washer with mild detergent;

 The only way of cleaning oxygen sensor and airway pressure gauge surface is
wiping.

WARNING: In case of fire:

 All the cover and dome materials used in the system are made of anti-static
materials, because the static material could lead to fire.

 Take necessary measures to keep the CO2 absorbent damp for the dry CO2
absorbent exploded to the anesthetic agent may lead to dangerous chemical
reaction.

 Turn off all the gas supplies after using the anesthesia machine.

WARNING: Please comply with the disinfection controlling and safety regulation. The

system after using may have blood and body liquid.

WARNING: Be careful when moving or replacing components. Moving pars and

removing components could injure fingers.

WARNING: Ultraviolet light can be used to disinfect the whole machine. Peracetic acid

and formaldehyde is forbidden for fumigation.

WARNING: Do not inhale any gas that is generated in cleaning and disinfection process.

WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar

materials for cleaning and disinfection. These materials may enter the patient's lung or airway
and cause irritation or injury.

CAUTION: Dismantle bellows integration for cleaning to reduce the drying time. Hang

bladder upside down (expand) for drying to avoid adhesion.

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CAUTION: Wipe oxygen sensor with a damp cloth. Do not clean it in liquid.

CAUTION: Do not immerse oxygen sensor or airway pressure gauge in liquid. Do not

conduct autoclave or high temperature fumigation for oxygen sensor or airway pressure
gauge.

CAUTION: Do not clean the inner surface of the oxygen sensor.

CAUTION: Regularly inspect the spare parts. If necessary replace it when the part is

damaged.

WARNING: To prevent damage:

 If you have any question about the cleaning agent, please refer to the message
provided by manufacturer.

 Do not use organic, halogenated or petroleum based solvents, anesthetics, glass


cleaner, acetone, or other irritating detergents.

 Do not use abrasive detergent (such as steel wool, silver polish or cleaning agent)

 Keep liquids far away from electronic components.

 Do not allow liquid to flow into device housing.

 Synthetic rubber parts cannot be soaked longer than 15 minutes. Doing so can
cause the materials to expand and, as well as accelerated aging of the material.

 Only the part labeled with 134℃ is pressure and heat-resistant.

 The pH value of cleaning solution must be between 7.0 and 10.5.

CAUTION: The part labeled with 134℃ is pressure and heat-resistant. It can be

washed by hand or machine (pH <10.5 mild detergent), and then dry thoroughly.

WARNING: After cleaning and disinfection,perform the leak test and compliance test

before using the Aeon8300A anesthesia machine.

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7.2. User maintenance

Foundational
Action
maintenance
every day clean anesthesia machine’s surface
every week Ventilate for the system, open flow meter to make floating-point move in
order to flow meter pipe block or floating-point conglutination.
every month Leak test of bellow assembly; 100% O2 concentration calibration.

Cleanness and Check if assembly is damaged, replace or repair if necessary.


installation
According to actual Open drain valve to replace soda lime.
situation Pipeline replacement: User replaces breathing pipeline in time according
to actual situation to ensure normal running (no gas leak in breathing
pipeline‖) after breathing pipeline is used for a certain time.

7.3. Methods for cleaning and disinfecting


A: Wipe: with a soft, lint-free cloth soaked with water-soluble disinfecting agent.

B: Machine washing: Automatic washing with washer and disinfecting with disinfection
machine.

C: Immersion disinfection: Soak in glutaraldehyde-based solutions of 2%.

D: High temperature and pressure disinfection: At 121℃ for max. 20 minutes, or at134℃ for
max. 8 minutes.

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Table 8-1

Part name Cleaning and disinfection methods


A B C D
Anesthesia machine (outer √
surface)
Connecting cables √
Breathing bag, reusable tube √
Breathing system (after √ √ √ √
diassembly)
Inspiratory/expiratory valve disc √ √ √
Inspiratory/expiratory valve cage √ √ √ √
Inspiratory/expiratory valve cover, √ √ √ √
valve nut
APL Valve √ √ √ √
Airway pressure gauge √
Oxygen sensor √
Integration silicone glue hose √ √ √ √
Absorber canister √ √ √ √
Bellows dome √ √ √
Bellows √ √
Top plate √ √ √ √
Bellows adapter ring √ √ √ √
U-ring √ √ √ √

7.4. Cleaning and disinfection of components

7.4.1.External Surfaces

Using ultraviolet light or a soft cloth with a water-soluble detergent or disinfectant wipes,
clean all outer surfaces, hoses and cables. If using disinfectant wipes follow the
manufacturer’s instructions for use.

7.4.2.Bellows

Read all content in this section before disassembling, cleaning, disinfecting, and
re-assembling the bellows to avoid equipment malfunction and patient injury.

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7.4.2.1. Disassembly

The bellows dome is a transparent cover with


graduation marks from 300 to 1500.

Remove the bellows dome by turning it


counterclockwise and lifting it away from the breathing
system.

Detach the bellows from the base plate.

Detach the top plate from the bellows.

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Remove the bellows adapter ring from inside the


bellows.

Remove the bellows dome U-ring.

7.4.2.2. Cleaning

a. To prevent damage, wash each component gently with hot water, using a mild,
non-enzyme detergent that is recommended for rubber and plastic. Ensure that all bellows
surfaces are cleaned.

b. Rinse with clean, hot water, and allow to dry.

NOTE: Dry the bellows by allowing it to hang so that it is fully expanded. This will facilitate
thorough drying and prevent it from sticking to itself.

CAUTION: Do not soak longer than 15 minutes to prevent swelling or aging.

CAUTION: If moisture remains in the bellows after cleaning, it may become tacky.

c. After all bellows components are completely dry, inspect them for damage before
disinfection or re-assembly and functional testing.

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7.4.2.3. Disinfection

NOTE: Ensure that all bellows components have been cleaned as described in 8.3.2.2 before
disinfecting.

Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of all bellows components while adhering to facility policies and
procedures.

7.4.2.4. Assembly

Connect the bellows to the breathing system by reassembling all components in the reverse
order.

7.4.3.PAW gauge

7.4.3.1. Disassembly

Hold lower part of PAW


gauge, pull upward, and then
remove PAW gauge.

CAUTION: Do not immerse the PAW gauge in liquid. Do not conduct autoclave and high

temperature fumigation for the PAW gauge.

7.4.3.2. Cleaning

Clean the PAW gauge with a soft, lint-free cloth soaked with a water-soluble detergent or
disinfectant.

Allow it to dry thoroughly.

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7.4.3.3. Assembly

Re-insert the PAW gauge.

7.4.4.Oxygen sensor

7.4.4.1. Disassembly

Disconnect one end of the


O2 sensor cable from the O2
sensor socket.

Hold O2 sensor, and unplug


it from the inspiratory valve
cover with force.

Unscrew O2 sensor
connector from O2 sensor
and put it on a safety place.

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WARNING: Do not immerse oxygen sensor in liquid. Do not conduct autoclave or high

temperature fumigation on oxygen sensor.

WARNING: Do not clean the inner surface of oxygen sensor. Wipe oxygen sensor

exterior with a damp cloth.

7.4.4.2. Cleaning

Clean the oxygen sensor exterior with a soft, lint-free cloth soaked with a water-soluble
detergent or disinfectant. Allow to dry thoroughly.

7.4.4.3. Assembly

Inspect the oxygen sensor for damage and replace as necessary. Re-insert the oxygen
sensor.

7.4.5.Respiratory valves

The following procedure is written generically for a single, unspecified valve. It should apply
to both the inspiration and expiration valves.

7.4.5.1. Disassembly

CAUTION: It is not necessary to remove the valve nut, the valve cover, the valve cage or

the valve disc to clean them. However, if removal is desired, follow the procedure below.

CAUTION: The valve disc is fragile and must, therefore, be handled with care when

removing it from the valve cage.

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Rotate valve nut


counterclockwise to loosen
it.

Remove the valve nut,


valve cover, valve cage and
valve disc from the
inspiratory valve.

7.4.5.2. Cleaning

a. Wash each component using a mild detergent and water solution.

b. Rinse with clean, hot water and allow to dry.

c. After all components are completely dry, verify that the valve disc and the prongs of the
valve cage are undamaged before disinfection or re-assembly and functional testing.

7.4.5.3. Disinfection

NOTE: Ensure that all valve components have been cleaned as described in 8.2.5.2 before
disinfecting.

Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of all valve components while adhering to facility policies and
procedures.

7.4.5.4. Assembly

Reassemble the valve components in the reverse order, noting any previously stated
CAUTION.

After installation, check air tightness of inspiratory and expiratory valve and movement of
valve disc.

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7.4.6.Bag arm

7.4.6.1. Disassembly

It is not necessary to remove the bag arm to


clean it, However, if removal is desired, turn it
counterclockwise, loosen the fixing nut and
then remove the bag arm from the breathing
system block.

7.4.6.2. Cleaning

Clean the bag arm with a soft, lint-free cloth and a solution of mild detergent and water. Allow
it to dry thoroughly.

7.4.6.3. Disinfection

NOTE: Ensure that the bag arm has been cleaned as described in 8.2.6.2 before disinfecting.

Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of the bag arm while adhering to facility policies and procedures.

7.4.6.4. Assembly

Reassemble the bag arm to the breathing system.

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7.4.7.Absorber canister

7.4.7.1. Disassembly

Push the handle according to the label to release


absorber canister.

Hold the two-tier absorber canister and remove it


from the bracket at an inclined angle.

Pull up the drain valve to drain the residual


moisture in breathing system.

WARNING: After the breathing system is

cleaned, open the drain valve to drain off the water


from the internal breathing system.

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7.4.7.2. Cleaning

Clean the absorber canisters with a soft, lint-free cloth and a solution of mild detergent and
water. Allow them to dry thoroughly.

7.4.7.3. Disinfection

NOTE: Ensure that the Absorber Canisters have been cleaned as described in 8.2.7.2 before
disinfecting.

Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of the Absorber Canisters while adhering to facility policies and
procedures.

WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.

NOTE: Ensure that the absorber canisters are completely dry before adding absorbent.

7.4.7.4. Assembly

While noting the previous WARNING, add new pre-pak or loose fill absorbent to the absorber
canisters. Re-install the absorber canisters into the assembly. Rotate the locking mechanism
handle clockwise into the locked position.

Each time the absorbent is replaced, please check the sealing ability of the components by
performing the following operations:

 Connect breathing system and breathing bag to the anesthesia machine;

 Set the Manual/Auto switch to manual state;

 Set the APL Valve to 70cmH2O;

 Block the Y-piece;

 Press the O2 flush(O2+)until the airway pressure up to 40 cmH2O;

Verify whether or not the airway pressure can continue 10s.

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7.4.8.Breathing system disassembly

WARNING:Wear latex gloves during disassembly in case that operator’s hands get

damaged.

CAUTION:The assembly sequence of the breathing system is contrary to the

disassembly sequence, referring to this chapter.

7.4.8.1. Disassembly

Take C•G•O assembly from the C•G•O.


interface

Remove the O2 sensor from breathing


system. Refer to chapter 7.4.4.1

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Remove the heater cable from the outlet


module.

Take the heater cable from the heater port in


the breathing system.

Take the screwed pipe from the outlet


module.

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Take the screwed pipe from the breathing


system and store safely.

Take the integrated gas sampling pipe from


the outlet module.

One hand holds the bracket, the other hand


holds the other side of the breathing system,
and lift the breathing system vertically, take
the breathing system from the anesthesia
machine.

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Remove bellows assembly and PAW gauge


form the breathing system, shown as in the
right figure. Autoclave sterilize the
disassembled breathing system.

WARNING: Use care in lifting and manipulating the breathing system block during

removal from its mounting arm as handling may be awkward due to its weight and shape.

7.4.8.2. Cleaning

Clean the breathing system block exterior with a soft, lint-free cloth and a mild detergent and
water solution. Allow to dry thoroughly.

7.4.8.3. Disinfection

NOTE: Ensure that the breathing system block has been cleaned as described in 7.4.8.2

before disinfecting. High level disinfection of the breathing system block can be performed
through steam autoclaving up to a maximum temperature of 134ºC (273 ºF).

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Using an autoclave, follow the manufacturer’s instructions for high level disinfection of the
breathing system block while adhering to facility policies and procedures.

7.4.8.4. Assembly

Reassemble the breathing system components in reverse order.

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7.4.9.Cleaning and disinfecting for AGSS

CAUTION:For more cleaning and disinfecting information of AGSS, refer to AGSS User

Manual.

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8. Regular maintenance

WARNING: To prevent fire:

 Please use the approved lubricant for anesthetic or oxygen equipment.

 Do not use lubricants containing oil or grease, as they will burn or explode
when oxygen reaches a certain concentration.

 All the covers used in the system must be anti-static (conductive) materials,
because static electricity can cause a fire.

WARNING: Please follow disinfection control and safety procedures, because the used

equipment may contain blood and body fluid.

WARNING: Moving parts and dismountable parts might pinch or crush hands. Pay

careful attention when moving or replacing system components.

WARNING: In the process of transporting, be sure to prevent the flowmeter from shaking

and vibrating. Otherwise, glass tube might break.

WARNING: The disposal of equipment (batteries and LCDs, which may harm the

environment) must be conducted in accordance with local regulation requirements.

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8.1. General principle of maintenance


This section provides information on regular maintenance of the Aeon8300A anesthesia
machine. For correction or adjustment, one shall replace or adjust some parts. Aeonmed will
not assume responsibility for the use of improper spare parts leading to equipment failure. Do
not use faulty equipment. The customer service engineer authorized by our company or
qualified, competent, well-trained with such equipment repair experience is allowed to
replace and repair the spare parts listed in the manual. After maintenance, the machine shall
be tested to ensure normal function and conformity to manufacturer specifications. The spare
parts produced or sold by Aeonmed can be replaced for damaged one, and then tested to
ensure specification compliance. If you need support services, please contact local customer
service engineers. In all cases, maintenance costs will be charged. This cost will be the
current price of the replacement parts plus a reasonable labor cost. This does not apply for
items that are within the warranty period.

WARNING: Person without such equipment maintenance experience can absolutely not

be engaged in maintenance work.

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8.2. Maintenance schedule


Table 8-1

Action After each repair Every 12 months Every 36 months


Check before use X X X
Check before operation √ X X
Check with eyes √ X X
Replace exhausted √ X X
component
Replace O2 sensor √ √ √
Replace/maintenance √ √ X
battery
Function test √ X X

WARNING: The processing of ineffective CO2 absorbent must be conducted in

accordance with current, local regulation requirements. If there is no regulation, put them in
the specified location. Do not throw away.

CAUTION: The ineffective CO2 absorbent has an obvious change in color when it

becomes ineffective.

CAUTION: Regularly maintain and replace corresponding parts for the Anesthesia

machine according to this schedule.

CAUTION: The maintenance interval of the Anesthesia machine is recommended for five

years. Comprehensive testing and part replacement is recommended every five years for the
respiratory system, vaporizer and parts.

8.2.1.Appearance checklist

1. Assure the appearance of Aeon8300A no damage, the Anesthesia machine can run
normally.

2. Assure absorbent canister install correctly and fill enough soda lime. Assure enough
anesthetic in vaporizer.

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3. Assure the exhaust gas absorber pipe connected with APL valve no damage and dry
inside.

4. Assure O2, N2O, AIR, VAC and EVAC connection pipe no damage.

5. Assure O2, N2O, AIR, VAC and EVAC flexible pipe no damage (if they are be used).

6. Assure AC power cable no damage.

8.3. Replacement of replaceable parts

No. Replaceable part Every 6 Every 12 Every 36 Part Number


month month month
1. Replace O2 sensor No Replace Replace 210001975
2. Replace O-ring in No Replace Replace 304000101
O2 sensor
3. Check /Replace No Check Replace 210002830
battery
4. Clean/Replace Clean Clean Replace 230000318
latex screwed pipe
φ17
5. Check /Replace No Check Replace 122005548
bellows assembly
6. Check /Replace No Check Replace 130004091
U-type sealing ring
7. Check /Replace No Check Replace 122001806
AGSS transmitted
pipe
8. Check /Replace No Check Replace 130004147
valve sealing
gasket
9. Check /Replace Check Replace Replace 304000096
O-ringφ9×1.8
(Pressure gauge)
10. Check /Replace Check Replace Replace 304000044
O-ring 14×2.65
(on vaporizer

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mount)

NOTICE: The lifetime of all components above is the result in normal circumstance and

work condition.

8.4. Maintenance of O2 sensor

WARNING: The disposal of oxygen sensors must be conducted in accordance with local

current regulation requirements. Do not burn or throw away oxygen sensors.

CAUTION: For oxygen sensors calibration, refer to Chapter 5.11.3.1.

Replacement steps of O2 sensor:

1. Pull out O2 sensor from inspiratory valve of breathing system.

2. Pull out O2 sensor cable connection port from O2 sensor.

3. Connect new O2 sensor to cable connection port and install it on inspiratory valve of
breathing system.

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8.5. Maintenance of fuse

WARNING: Before replacing fuse, first disconnect AC power. Otherwise, it will cause

injury or even death.

CAUTION: When replacing fuse, make sure the new fuse is the same type and size as

the old one; otherwise, anesthesia machine will be damaged.

CAUTION: Fuse is a damageable part, which should be replaced with moderate force

and speed.

CAUTION: When screwing in the fuse with screwdriver, do not apply a lot of force;

otherwise, fuse box will be damaged.

Fuse replacement steps:

1. Insert screwdriver into the trench of end of fuse box.

2. Rotate it about 45°counterclockwise, and then pull out fuse holder.

3. Remove the fuse.

4. Load new fuse.

5. Push the fuse into the original position gently.

6. Rotate it for about 45°with screwdriver clockwise to fix.

7. Connect AC power.

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8.6. Battery Maintenance

WARNING: Only the customer service engineer authorized by Aeonmed is allowed to

replace the battery. If the anesthesia machine is inactive for a long period of time, please
contact a customer service engineer to disconnect the battery.

CAUTION: The disposal of used batteries must be conducted in accordance with local

regulation requirements.

CAUTION: When experiencing a power failure, the system will switch to the internal

battery supply automatically, and all the subassemblies of the anesthesia machine should
work normally.

 Battery specifications

Expected lifetime: 5 years.

DC24V, 4AH, 12V lead-acid battery, 2 in series.

 Cautions

Charge: When network power supply is connected, the system will automatically charge the
battery for maintenance. The charging time is recommended to be at least eight hours.

Discharge: General working time is 120 minutes.

For insufficient battery, the device will display the ―low battery‖ alarm, until automatic
shutdown. If the ―low battery‖ alarm appears, user should promptly connect mains supply
charge to avoid system shutdown.

Do not disassemble battery without permission. Short circuit connection between battery
cables is forbidden to avoid the danger.

 Preservation of battery

If the battery is not used for a long time, the battery should be fully charged and then
preserved.

If the storage time is more than three months, charge the battery at least every three months.

Store the battery in a dry place with low temperature.

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Replace the battery at once if the battery has a damage caused by the improper maintenance
to avoid liquid leakage corrosion.

To replace battery, please contact the manufacturer.

8.7. Consumptive components replacement


Since installation, consumptive components names and code in every time dimension as the
table in below:

Consumptive components 6 months 12 months 48 months

Check /replace bellows assembly needless Check Replacement

Check /replace U sealed circuit needless Check Replacement

Check/replace AGSS transmission


needless Check Replacement
tube(optional)

Replace O2 sensor Check Replacement Replacement

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9. Technical Data

CAUTION:All technical specifications should be updated based on the real state of

Aeon8300A anesthesia machine; no notification will be made if any change happens.

CAUTION:All displayed values are measured under dry environment and proper

pressure.

WARNING:Cylinder valve should be closed during pipeline gas supply, so that gas

shortage can be avoided due to exhausted gas supply or pipeline problems.

9.1. Pneumatic Diagram


Pneumatic system plays the role of supplying O2, N2O, AIR and anesthetic agent to breathing
system, ensuring their pressures are within normal range respectively, so that normal
operation of anesthesia machine and patient’s safety can be guaranteed.

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Fig.9-1 Aeon8300A Pneumatic Diagram(V1.0)

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1 Inlet filter 22 Safety valve


2 Pressure gauge 23 PEEP valve
3 Check valve 24 Ambient pressure
4 N2O Pressure regulator 25 Flow sensor
5 AIR Pressure regulator 26 Airway pressure
6 O2 Pressure regulator 27 Sensor board
7 Pressure sensor 28 AGSS
8 Pressure regulator(2.5 bar) 29 Exhaust valve
9 Pressure regulator (1.8 bar) 30 Pressure reversing valve
10 Auxiliary breathing O2 31 Bellows
11 Auxiliary supply O2 32 Reversing valve
12 ORC valve 33 APL valve
13 Flowmeter 34 Breathing bag
14 E-flowmeter 35 Flow sampling
15 O2 flush valve 36 Absorber container
16 Suction 37 O2 sensor
17 Check valve 38 Inspiration check valve
18 Vaporizer 39 Expiration check valve
19 Proportional solenoid valve 40 Ventilator
20 Solenoid valve 41 Breathing system
21 Throttle 42

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9.2. System technical data

CAUTION:All system gas supplies should be of medical degree.

WARNING: All supply gas must be dry.

Gas Supply

Table 9-1

Pipeline Gas O2, N2O,AIR


Pipeline Connection DISS-male,DISS-female,NIST(ISO 5359).
Connectors for each of the gas cannot be interchanged.
Pipeline Input Pressure 280-600kPa(2.8-6bar)

Flow Speed
Table 9-2
Gas Range Range
(thin flow tube) (thick flow tube)
O2 0.05-1L/min 1.1-10L/min
N2O 0.05-1L/min 1.1-10L/min
AIR 0.05-1L/min 1.1-12L/min

9.3. Electrical diagraph


Aeon8300A anesthesia machine can be divided into three parts: UI, drive control and circuit.
UI consists of computer system, auxiliary control circuit, power and etc, which mainly takes
charge of display, alarm, keyboard input and interface expansion. Drive control has BDU as
its core. Exterior sensor, signal processing, amplifier, power and battery are part of drive
control which mainly used for data acquisition and ventilation mode control. UI and drive
control should be connected by cables.

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Fig.9-2 Electrical Diagram

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9.4. Physical data

CAUTION:All physical specifications are of approximate values, no notice can be made

if any change happens.

CAUTION:Do not place Aeon8300A anesthesia machine in vibrant environment.

CAUTION:Do not put heavy stuff on the top panel or in the drawers.

Table 9-3
Dimensions: 1403mm(H)×681mm(W)×855mm(D)
Weight: 100kg(excluding vaporizer and
System
backup cylinder)
Top Panel Load: 25kg
Caster 125mm,each front caster with brake
Drawer 142mm(H)×376.5mm(W)×438mm(D)
Display 10.9’ TFT LCD
Cylinder Gauge(AIR、O2、 Range:0-1MPa. Stepping:0.05MPa
N2O) Accuracy:±2.5% of full range
Range:-10 - 100cmH2O. Stepping:200Pa
PAW Gauge
Accuracy:±2.5% of full range

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9.5. Environmental requirement

CAUTION:The anesthesia machine should be stored in draught room where there is no

caustic gas and storing magnetic field.

Table 9-4

Temperature Operation: 10~40℃

Storage: -20 ~ 55℃

Transport -20 ~ 55℃

Relative Humidity Operation: Not more than 80%, non-condensing.

Storage: Not more than 93%, non-condensing.

Transport Not more than 93%, non-condensing.

Operation: 70~106kPa
Atmospheric
Storage: 70~106kPa
pressure
Transport 70~106kPa

Power AC100-240V,50Hz/60Hz

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9.5.1.IEC60601-1:2005 classification

Aeon8300A belongs to this class:

 I type device

 B type applied part

 Common device/IP21

 Traveling device

 not use flammable anesthetic

 consecutive running

9.6. Input and output

9.6.1.Electrical

WARNING: IEC60601-1 is applicable to the connections between medical devices, and

to the connections between at least one medical device and one or more non-electrical
devices. Even if no functional connections between the single device, when using one
auxiliary power outlet, they forms a medical electrical system. User must be aware of the risk
of increased leakage current when the device is connected to the power outlet of the auxiliary
network.

WARNING: In case of defective ground, if equipment is connected to the main power

outlet, the patient’s leakage current value might exceed the allowed range.

WARNING: If external protective grounding wire has a problem during installation, the

equipment must be run by internal power supply.

Table 9-5

Supply Voltage 100-240VAC,50/60Hz


Maximum Input Current 8A
AC power fuse F10AH 250VAC,φ5X20(F)
Auxiliary AC power plug 4

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Auxiliary AC power plug fuse T2AH 250VAC,φ5X20(T)


Maximum output valve of auxiliary 1.5A(single plug);6A(in total)
AC power plug
Grounded resistance Small than 0.2Ω

9.6.2.Pneumatic

Table 9-6

Pipeline supply O2、AIR、N2O


Pipeline connection DISS-male, DISS-female, NIST (ISO 5359)
All fittings used to connect O2, N2O and Air pipeline gas
supply are all ready.
APL valve 250kPa
Vaporizer connection 2 Selected interfaces
Pressure display Color code table
Pipeline inlet pressure 280-600kPa

WARNING: All the supply gas must be medical grade.

NOTE:
1. When the Anaesthesia system stops transferring, the pipeline supplying pressure should
be 280 to 600KPa.
2. When main power fails, the system switches to battery power automatically and,except for
the breathing system heating component, all the components of the anesthesia machine can
work normally.

3. When main power and internal battery both fails, the gas output is not affected.

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9.7. Breathing system technical data


Table 9-7

Flow compensation range:1-20L/min


Fresh gas compensation
Gases:O2、N2O、AIR、anesthetic agent
Absorbent 1500mL(for each absorber canister)
Connection C·G·O:ISO5356 connector(standard 22mm exterior diameter or
15mm interior diameter)
Breathing system leak These data ensures the continuous pressure is higher than the
anticipated pressure during mechanical ventilation.
Pressure: 3kPa,leak volume≤150ml/min
Breathings system Use a two-way sine wave test breathing system: Freq:20/min,
resistance Vt=1L:
Expiratory. resistance≤0.6kPa;Inspiratory resistance≤0.6kPa.
Breathing system with small patient resistance should be selected
in order to be accordance with standards.
APL valve resistance Flow speed:3L/min,flow resistance:0.05 - 3kPa
Flow speed:30L/min,flow resistance:0.1 - 0.5kPa
Connector leak Under 30hPa and APL valve fully closed, the leakage rate ≤
50ml/min.
Check valve resistance In dry environment:≤0.15kPa
Pressure generated from <0.14kPa
moist check valve
Pressure of opening moist <0.1kPa
check valve
System compliance <150ml/30KPa,use standard pipeline
(Csys)
Internal capacity 7.6L±0.1L
O2 flush 25-75L/min
O2 supply failure alarm <200kPa
O2 concentration Not less than 19%

Compliance correction

In all software version, the anesthesia machine is able to carry out a compliance correction
which compensates for volume "lost" in hoses and in the breathing system.

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The Anaesthesia machine determines the system compliance (hoses and breathing system)
and required later for compliance correction during the self test or standby leak test. The hose
of standard equipped compliance has a fixed value of 11mL/kPa.

The VT set is delivered during the first breath.

ΔP is calculated from end-expiratory pressure (P1) and end-inspiratory pressure (P2).

Csys: the system compliance.

Figure 10-3 Pressure values

Having the system compliance (Csys) and ΔP, the Anesthesia machine can calculate the
volume (ΔV) which has been "consumed" by the system, in other words, the volume has not
been delivered to patient.

ΔV = Csys x ΔP

Anesthesia machine increases the volume to be delivered by the value ΔV.

VT corr = VT + ΔV

The anesthesia machine repeats this procedure during each breathing phase so that the VT
delivered to the patient gradually approaches the set VT. This procedure is completed as
soon as the plateau value stops changing (±0.5 cmH2O).The displayed flow and the resulting
values (for example, MV) are updated accordingly.

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9.8. Anesthetic ventilator technical specifications

9.8.1.Anesthesia ventilator performance

Table 9-8

Maximum Inspiratory 80cmH2O


Pressure
Noise of the Whole Work normally(not including alarm),no more than 60dB(A)
Machine
Warm-up Time ≥5min
MV Max 20L/min
Inspiratory Flow Max 75L/min
Pressure Transmission 5-80cmH2O
Range

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9.8.2.Ventilation parameter

Table 9-9

Parameter Range Stepping Default Value Remark


Vt 20-1500mL 10mL 120mL 20-100mL,error is ±20mL;
(Child); 100-1500mL,error is ±20%
500mL(Adult)
Freq. 4-100bpm, 1bpm 20bpm error is ±1bpm or ±5%,
2-60bpm(PS (Child); whichever is greater
mode) 12bpm(Adult)
I:E 4:1-1:8 0.5 1:2 error is ±15%
TINSP 0.2-5.0s 0.1sec 1sec(Child); Have this function in SIMV
2sec(Adult) mode,error is ±10% or 0.1s,
whichever is greater
PEEP OFF,3-30cmH2O 1cmH2O OFF When it is OFF,PEEP value
is 1-3cmH2O;when
3-30cmH2O,
error is ±2cmH2O
or ±15%,whichever is
greater.
FreqMIN 2-60bpm 1bpm 4bpm(Child); Have this function in PS mode
2bpm(Adult)
TP OFF,5%-60% 5% 10% Have this function in IPPV、
SIMV mode,error is ±30% of
the setting or ±0.05s,
whichever is greater
Trigger 1-15L/min 1L/min 2L/min Have this function in SIMV、
(Child); PS mode ,error is ±20% or
3L/min(Adult) ±1.3L/min,whichever is
greater
PTARGET 5-70cmH2O 1cmH2O 10cmH2O Have this function in PCV
(Child); mode
20cmH2O
(Adult)
ΔP 3-50cmH2O 1cmH2O 5cmH2O Have this function in SIMV、
PS mode ,setting

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range :5-70 cmH2O。error is


±4 cmH2O or ±20%,
whichever is greater
TSLOPE 0-2s 0.1sec 0.5sec error is ±1s

9.8.3.Drive gas

Table 9-10

Gas source Anaesthesia system


Gas component O2
Rating supply pressure 400kPa
Inlet pressure range 280kPa ~ 600kPa
Flow valve range 5~75L/min
Output1 Pressure range: 0 ~ 8kPa;Flow range: 0 ~ 75L/min

Label 1:Within rated outlet pressure range and under double maximum rated inlet pressure
condition.

Table 9-11

According to ISO8835-2, test under peak flow 60L/min, fresh gas 10L/min.

Item Standard Requirement Test Result


Expiratory resistance <0.6kPa 0.51
under manual condition

Inpiratory resistance <0.6kPa 0.39


under manual condition

Expiratory resistance <0.6kPa 0.57


under automatic condition

Inpiratory resistance <0.6kPa 0.22


under automatic condition

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9.8.4.Monitor performance

Table 9-12

Item Range Stepping Accuracy


Vt 0 - 3000mL 1mL 20-100mL,error is ±20mL;
100-3000mL,error is ±20%
Freq. 0 - 110bpm 1bpm 1bpm
PEAK -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
MEAN -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
PLAT -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
FiO2 18 - 100% 1% Error is ±3%(concentration
value)
C 0-100mL/cmH2O 1mL/cmH2O Error is 20% or 5mL/ cmH2O,
whichever is greater
PEEP -20 - 99cmH2O 1cmH2O 2cmH2O
PAW -20-99cmH2O 1cmH2O Error is±3cmH2O or ±10%,
whichever is greater
100%,75%,50%,25%,0%。
When battery is used to supply power, this sign displays available
Battery voltage state
remaining electric voltage.
display
When the vehicle is connected with AC power, this sign means
charging.
Pressure monitor range: 0 - 80cmH2O.According to different airway
pressure, gain the wave form displays is different.
0 ~ 10cmH2O,pressure axis gain: 5cmH2O
Paw-t wave form 0 ~30cmH2O,pressure axis gain: 10cmH2O
0 ~80cmH2O,pressure axis gain: 20cmH2O
Time axis is a fixed range.(the axises of Flow-t,Paw-t is same.):
When gas module is opened,0 ~15s;Gas module is closed, 0 ~20s.
Display range of flow rate: -90 - 90L/min, gain :45L/min. On time axis,
the positive axes stands for inspiratory direction; under the time axis,
Flow-t Wave form
the negative axes stands for expiratory direction. Flow rate is 0L/min,
which means no gas flow rate in airway.
CO2 display range is 0 - 76mmHg,gain is 38mmHg。
CO2 time wave form Time axis is a fixed range.
When gas module is opened,0 ~15s;Gas module is closed, 0 ~20s.

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Horizontal abscissa displays Paw:fixed range :-20 ~ 80cmH2O,gain


is 20cmH2O。
P/V Loop
Vertical abscissa displays tidal Volume:fixed range is 0 ~ 1500ml,gain
is 250ml.
Horizontal abscissa displays tidal Volume: -1400 ~ 0mL,gain is
700mL.
F/V Loop Vertical abscissa stands for Flow:fixed range :-90 - 90L/min,gain is
45L/min;The positive axes stands for aspiratory flow rate, the negative
axes stands for expiratory flow.

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9.9. O2 sensor specification

CAUTION: Specific parameters are subject to the latest technical data released by the

manufacturer.

The oxygen sensor can be used to measure the local oxygen concentration of the Anesthesia
machine. Since it’s a consumptive item, user should pay attention to the validity of the sensor,
and use it according to the features and technical requirements provided by the manufacturer.
The following is main technical parameters of the oxygen sensor for the Aeon8300A
Anesthesia machine.

Fig.9-3 Oxygen sensor

Table 9-13

Performance parameters

Interface form and FCC-68 4 core telephone adapter(RJ11-4)


definition
Output 9-13mV(210mBar O2)
Range 0-1500mBar O2
Signal 100±1(100% O2)
Resolution 1mBar O2
Life expectancy 0.94x106% O2 hour(at 20℃);0.6x106% O2 hour (at 40℃)
Total system response time T90<15s
Zero signal(N2, +20℃) <200uV
Operating temperature -20℃~+50℃

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range
Temperature When the temperature is between 0~40℃,the compensation is
compensation ±2%.
Pressure range 0.5~2.0Bar
Relative humidity range 0~99%(no condensation)
Long-term output drift <5%(in 100% O2 environment, used more than one year)
Shell material White ABS
Nitrous oxide resistance 100% N2O
Period of validity 13 months
Meet standard EN12598/ISO7767
The O2 monitor surveys and displays the O2 concentration in the
patient loop. The oxygen sensor component contains an oxygen
sensor, which can produce the voltage proportional to the
oxygen partial pressure (concentration) on its detection surface.
The oxygen sensor is an electrochemical device (chemical
battery). Oxygen expands in this device through a layer of film
and oxidize base metal electrode. The oxidation process
produces a current with an amplitude proportional to the oxygen
partial pressure indicated by the electrode sensor. The base
Working principle of O2 metal electrode is gradually exhausted during the oxidation
monitor process.
The voltage of the sensor is influenced by the temperature of the
monitoring gas mixture. The surgical thermosensitive resistor of
the sensor automatically compensates fot the temperature
change in the sensor.
The O2 monitor converts the sensor signal into the corresponding
oxygen percentage value by using signal processing and circuit
analysis. The system displays the value and compares it with the
stored alarm limit value. If the value exceeds the threshold, the
monitor will alarm.

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9.10. Gas monitoring module technical specification


The gas monitoring module is used to connect other medical devices, provide monitor data,
monitor and display CO2,N2O and 5 anesthetic gases (halothane, isoflurane, enflurane,
sevoflurane, desflurane).

The gas monitoring module is connected to the patient’s breathing pipeline to monitor the
inspiratory and expiratory gas and can be applied to Adult/Child and Infant.

CAUTION: Gas monitoring module complies with ISO 80601-2-55 standard.

Table 9-14

Model IRMA CO2 / AX+


Interface type RS232,9600bps
Accessories Airway adapter, disposable.
Working principle of The gas module is a mainstream gas monitoring module, connected
gas module to the patient to monitor gas concentration of breath.
The gas module can be used for adults, children and infants.
The gas module uses infrared technology, which determines gas
concentrations by measuring 10 different wavelengths according to
different absorption of gases to different ray.

Table 9-15

Basic Configuration
Description Extremely compact infrared mainstream multi-gas module.
Available in various parameter configurations.
Dimension(W×D×H) IRMA CO2/ AX+:
38×37×34mm(1.49‖×1.45‖× 1.34‖)
Cable length 2.50m±0.02m
Weight <25g(except cable)
Operating temprature IRMA CO2: 0-40℃, 32-104℉
IRMA AX+: 10-40℃, 50-104℉

Storage and -20-50℃,-4-122℉


transportation IRMA CO2: -40-75℃, -40-167℉

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temperature IRMA AX+: -20-75℃, -4-167℉


Operating humidity 10-95%RH, no condensation
Storage and 5-100%RH, condensation1)
transportation humidity
Operating atmospheric IRMA CO2:
pressure 525-1200hPa(525 hPa corresponding to an altitude of
4572m/15000feet)
IRMA AX+:
700-1200hPa(700 hPa corresponding to an altitude of
3048m/10000feet )
Storage and 500-1200hPa 5-100%RH, condensation1)
transportation pressure
Mechanical strength Withstands Repeated 1.8m drops on a hard surface.
Complies with requirements for road ambulances according to
prEN1789 (clause 6.4) and requirements for shock and vibration
according to ISO 80601-2-55 (clause 201.15.3.5.101, transport).
Power supply IRMA CO2:
4.5-5.5VDC, Max 1.0W
(power on surge @ 5V less than 350mA during 200ms)
IRMA AX+:
4.5-5.5VDC, Max1.4W
(power on surge @ 5V less than 350mA during 200ms)
Surface temperature (at IRMA CO2:
ambient temperature Max41℃/106℉
23℃) IRMA AX+:
Max 50℃/122℉
Interface Modified RS-232 serial interface operating at 9600bps
Airway adapter Disposable adult/child:
Adds less than 6mL deadspace;
Pressure drop less than 0.3cmH2O @ 30LPM.
Disposable infant:
Adds less than 1mL deadspace;
Pressure drop less than 1.3cmH2O @ 10LPM.

NOTE 1: After being in a condensing atmosphere, this module shall be stored for more than
24 hours in an environment equivalent to operating humidity.

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The humidity range 50-100% is valid for the temperature range -40 - 40℃.

Table 9-16

Data Output

Fi and ET The newest breathing value (Fi and ET) is continually displayed after
one breath.
Gas monitor module CO2:CO2
Automatic agent IRMA AX+: Primary and secondary agent.
identification

Table 9-17

Gas Analyzer

Probe 2-9 channel NDIR type gas analyzer measuring at 4-10 μm. Pressure,
temperature and full spectral interference correction.
Calibration When the detected value is offset;
When alarm occurs because ―gas module monitor concentration
exceeding the limits‖;
After replacing gas circuit adapter of gas monitor module.
Warm-up Time Record concentration and full-range accuracy identified automatically
by anesthetic gas in 10s;
Gas monitor module CO2: within 10s;
Gas monitor module AX+: within 1 minute.
Rise time CO2≤90ms
(@10L/min) N2O≤300ms
HAL,ISO,ENF,SEV,DES≤300ms
Agent identification <20s (Typically<10s)
time
Total system <1s
response time

Table 9-18

Accuracy specifications - during standard conditions

Range1)

Gas CO2 AX+ Accuracy


CO2 0-15 0-10 ±(0.2vol%+2% of reading)

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10-15 ±(0.3vol%+2% of reading)


15-25 15-25 Unspecified
N2O -- 0-100 ±(2vol%+2% of reading)

HAL,ISO,ENF -- 0-8 ±(0.15vol%+5% of reading)


8-12
SEV -- 0-10 ±(0.15vol%+5% of reading)
10-15
DES -- 0-22 ±(0.15vol%+5% of reading)
22-25

NOTE 1: Gas concentration reported in units of volume percent.

Table 9-19

Accuracy specifications – during all conditions1)

Gas Accuracy

CO2 ±(0.3vol%+4% of reading)

N2O ±(2vol%+5% of reading)

Agents2) ±(0.2vol%+10% of reading)

NOTE 1: The accuracy specification is valid for the operating temperature and humidity
conditions specified, except for interference specified in the table ―Interfering gas and vapor
effects‖ below.

NOTE 2: The accuracy specification for IRMA AX+ is not valid if two or more than agents are
present in the gas mixture.

Table 9-20

Interference gas and vapor effects

Gas or vapor Gas CO2 Agents N2O

level IRMA CO2 IRMA AX+

N2O3) 60
--1) --1) --1) --1)

vol%

HAL3) 4vol% --1) --1) --1) --1)

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ENF,ISO,SEV3) 5vol% +8% of reading2) --1) --1) --1)

DES3) 15vol% +12% of reading2) --1) --1) --1)

Xe(Xenon)3) 80vol% -10% of reading2) --1) --1) --1)

Xe(Helium)3) 50vol% -6% of reading2) --1) --1) --1)

Metered dose Not for use with metered dose inhaler propellants

inhaler propellants3)

C2H5OH(Ethanol)3) 0.3vol% --1) --1) --1) --1)

--1) --1) --1) --1)


C3H7OH(Isopropano 0.5 vol%

l)3)

CH3COCH3(Aceton 1 vol%
--1) --1) --1) --1)
3)
e)

CH4(Methane)3) 3 vol% --1) --1) --1) --1)

CO(Carbon 1 vol%
--1) --1) --1) --1)
3)
monoxide)

NO(Nitrogen 0.02 vol%


--1) --1) --1) --1)
3)
monoxide)

O23) 100 vol% --1) --1) --1) --1)

NOTE 1: Confirm that parameters are effective in all special circumstances except referred in
―interference gas and vapor effect‖.

NOTE 2: Interference at indicated gas level. For example,50vol% helium typically decreases
the CO2 readings by 6%. This means that, if measuring a mixture containing 5.0vol% CO2
and 50vol% helium,the measured CO2 concentration will typically be (1-0.06)*5.0vol%=4.7
vol% CO2.

NOTE 3: According to the ISO 80601-2-55 standard.

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9.11. Electromagnetic compatibility


Changing or reassembling this equipment without authorization may cause electromagnetic
compatibility problems. Contact with Aeonmed for assistance. Designing and testing this
equipment is in accordance with the following stipulations.

WARNING:Using cell phone or other radio radiant equipment near this product may

cause malfunction. Closely monitor the working condition of this equipment if there is any
radio radiant supply nearby.

Using other electrical equipment in this system or nearby may cause interference. Check if
the equipment works normally in these conditions before using on a patient.

Be careful of the following when Aeon8300A is connected:

Do not put any object which is not in accordance with EN60601-1 in the 1.5M range of
patients.

An isolated transformer must be used for alternating current supply (in accordance with
IEC60989), or additional protective ground wires are equipped if all the devices (for medical
or non-medical use) are connected to Aeon8300A by using signal input/signal output cable.

If a portable all-purpose outlet is used as the alternating current supply, it must be in


accordance with EN60601-1-1 and cannot be put on the floor. Using another portable
all-purpose outlet is not recommended.

Do not connect the non-medical equipment directly to the alternating current outlet on the
wall. Only the alternating current supply of the isolated transformer can be used. Otherwise,
the surface leaking current may exceed the range permitted by EN60601-1 under the normal
conditions, and disoperation may cause injury to patients or operators.

Aeon8300A is equipped with all-purpose alternating current outlet for connecting other
medical equipments. Do not connect non-medical equipment to these outlets. Otherwise, the
surface leaking current may exceed the range permitted by EN60601-1 under normal
conditions and disoperation may be dangerous to patients or operators.

A complete system current leaking test (according to EN60601-1) must be performed after
any equipment is connected to these outlets.

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WARNING: The medical electrical equipment operators contact non-medical electrical

equipment and patients at the same time. It is dangerous for patients or operators.

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Guidance and manufacture’s declaration

Guidance and manufacture’s declaration – electromagnetic emissions

-for all equipment and systems

Guidance and manufacture’s declaration – electromagnetic emission

The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer of the user of the Aeon8300A anesthesia machine should
assure that it is used in such and environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions The Aeon8300A anesthesia machine uses RF


energy only for its internal function. Therefore, its
CISPR 11
Group 1 RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.

RF emission The Aeon8300A anesthesia machine is suitable


Class A for use in all establishments, other than domestic
CISPR 11
establishments and those directly connected to
Harmonic emissions the public low-voltage power supply network that
Class A supplies buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations/
flicker emissions Complies

IEC 61000-3-3

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Guidance and manufacture’s declaration – electromagnetic immunity

–for all equipment and systems

Guidance and manufacture’s declaration – electromagnetic immunity

The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Aeon8300A anesthesia machine should assure
that it is used in such an environment.

Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
- guidance

Electrostatic 6 kV contact 6 kV contact Floors should be wood,


discharge (ESD) concrete or ceramic tile. If
8 kV air 8 kV air
floor are covered with
IEC 61000-4-2
synthetic material, the relative
humidity should be at least
30%.

Electrical fast 2 kV for power 2kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
commercial or hospital
IEC 61000-4-4
environment.

Surge 1 kV differential 1 kV differential Mains power quality should


mode mode be that of a typical
IEC 61000-4-5
commercial or hospital
2 kV common 2 kV common
environment.
mode mode

Voltage dips, <5% UT <5% UT Mains power quality should


short interruptions be that of a typical
(>95% dip in UT) (>95% dip in UT)
and voltage commercial or hospital
variations on for 0.5 cycle for 0.5 cycle environment. It should be that
power supply the Aeon8300A anesthesia
input lines machine be powered from an

40% UT 40% UT uninterrupted power supply or


IEC 61000-4-11
a battery.
(60% dip in UT) (60% dip in UT)

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for 5 cycles for 5 cycles

70% UT 70% UT

(30% dip in UT) (30% dip in UT)

for 25 cycles for 25 cycles

<5% UT <5% UT

(>95% dip in UT) (>95% dip in UT)

for 5 sec for 5 sec

Power frequency 3A/m 3A/m Power frequency magnetic


fields
(50/60Hz)
magnetic field Should be at levels
characteristic of a typical
IEC61000-4-8
location in a typical
commercial or hospital
environment.

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

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Guidance and manufacture’s declaration – electromagnetic immunity

–for equipment and systems that are life-supporting

Guidance and manufacture’s declaration – electromagnetic immunity

The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Aeon8300A anesthesia machine should assure
that it is used in such an environment.

Immunity IEC 60601 Compliance


Electromagnetic environment - guidance
test test level level

Portable and mobile RF communications


equipment should be used no closer to any part
of the Aeon8300A anesthesia machine, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.

Recommended separation distance

 3.5 
d   P
 V1 

Conducted 3Vrms 3 Vrms


RF
150 kHz to 80 12 
d  P
IEC MHz  V2 
61000-4-6
outside ISM
bands a
10 Vrms  12 
d    P 80 MHz to 800 MHz
 E1 
10 Vrms

 23 
150 kHz to 80 d   P 800 MHz to 2.5 GHz
MHz
 E1 

in ISM bands 10 V/m Where P is the maximum output power rating of


the transmitter in watts (W) according to the

Radiated transmitter manufacturer and d is the

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RF 10 V/m recommended separation distance in metres


(m). b
IEC 80 MHz to 2.5
61000-4-3 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,c
should be less than the compliance level in each
frequency range.d

Interference may occur in the vicinity of


equipment marked with the following symbol:

NOTICE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTICE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are
6.765MHz to 6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in
the frequency range 80 MHz to 2.5GHz are intended to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency ranges.

c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Aeon8300A anesthesia
machine is used exceeds the applicable RF compliance level above, the Aeon8300A
anesthesia machine should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the
Aeon8300A anesthesia machine.

d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10

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V/m.

9.12. Recommended separation distances


Recommended separation distances between portable and mobile

rf communications equipment and the equipment or system

–for equipment or system that are not life-supporting

Recommended separation distances between

portable and mobile RF communications equipment and the Aeon8300A anesthesia machine

The Aeon8300A anesthesia machine is intended for use in an electromagnetic environment in


which radiated RF disturbances are controlled. The customer or the user of the Aeon8300A
anesthesia machine can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
Aeon8300A anesthesia machine as recommended below, according to the maximum output
power of the communications equipment.

Separation distance according to frequency of transmitter(m)

Rated 150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
maximum MHz MHz MHz GHz
output power
outside ISM bands in ISM bands
of transmitter  12   23 
d   P d   P
 E1   E1 
(W)  3.5  12 
d   P d  P
 V1   V2 

0.01 0.1167 0.1200 0.1200 0.2300

0.1 0.3689 0.3795 0.3795 0.7273

1 1.1667 1.2000 1.2000 2.3000

10 3.6893 3.7947 3.7947 7.2732

100 11.6667 12.0000 12.0000 23.0000

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

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frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.

NOTICE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTICE 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are
6.765MHz to 6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

NOTICE 3 An additional factor of 10/3 is used in calculating the recommended separation


distance for transmitters in the ISM frequency bands between 150kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas.

NOTICE 4 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

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