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Anesthesia Machine - S6100 - Operation Manual - NML

The AN325-A Anesthesia System Operation Manual outlines the user responsibilities, safety warnings, and operational guidelines for the anesthesia equipment. It includes detailed sections on system components, preparation, checks before use, operation modes, maintenance, and troubleshooting. The manual emphasizes the importance of following instructions to ensure safe and effective use by trained medical personnel.

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0% found this document useful (0 votes)
59 views113 pages

Anesthesia Machine - S6100 - Operation Manual - NML

The AN325-A Anesthesia System Operation Manual outlines the user responsibilities, safety warnings, and operational guidelines for the anesthesia equipment. It includes detailed sections on system components, preparation, checks before use, operation modes, maintenance, and troubleshooting. The manual emphasizes the importance of following instructions to ensure safe and effective use by trained medical personnel.

Uploaded by

Gounteni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

AN325-A Anesthesia System

Operation Manual

NARANG MEDICAL USA CORPORATION


Contents
1. User’s responsibility .....................................................................................................1
2. Symbols used in this manual or on this equipment ......................................................2
3. Intended use ................................................................................................................ 7
4. Adaption disease ......................................................................................................... 7
5. Contraindication ...........................................................................................................7
6. EMC Information ..........................................................................................................8
7. Main structure, function and principle of system ........................................................12
7.1 System .............................................................................................................. 12
7.1.1 Components included ...............................................................................12
7.1.2 Components excluded ..............................................................................13
7.2 Structure of the whole machine ......................................................................... 14
7.3 Working principle ............................................................................................... 15
7.4 Flowmeter ..........................................................................................................16
7.4.1 Function ................................................................................................... 16
7.4.2 Structure ...................................................................................................16
7.5 Anaesthetic vaporizer ........................................................................................ 16
7.6 Anaesthetic breathing system ............................................................................17
7.6.1 Function ................................................................................................... 17
7.6.2 Structure ...................................................................................................17
7.6.3 Main control parts .....................................................................................18
7.7 Oxygen fault alarm and protection .........................................................20
7.7.1 Structure ...................................................................................................20
7.7.2 Working principle ......................................................................................20
7.8 Oxygen flush valve ............................................................................................ 20
7.9 System driving gas circuit ..................................................................................20
7.9.1 Gas supply ............................................................................................... 20
7.9.2 O2 supply ..................................................................................................20
7.9.3 N2O supply ............................................................................................... 21
7.9.4 Air supply(optional) ...................................................................................21
7.9.5 Fresh gas (common gas) ......................................................................... 21
7.9.6 Auxiliary common gas outlet (ACGO) .......................................................21
7.9.7 Anoxic alarm .............................................................................................21
7.9.8 Intake filter ................................................................................................21
7.10 Anesthesia ventilator ....................................................................................... 22
7.10.1 Function ................................................................................................. 22
7.10.2 Structure .................................................................................................22
7.11 Connection port ............................................................................................... 23
7.11.1 Rear panel of Anaesthesia System ........................................................ 23
7.11.2 Gas supply connector of the anesthesia system .................................... 23
7.12 Ventilation gas monitor (optional) .................................................................... 24
7.13 Transfer and receiving system of anaesthetic gas scavenging system(optional)24
7.14 Respiratory gas monitor .................................................................................. 24
8. Preparation ................................................................................................................ 25
8.1 Gas supply connection ...................................................................................... 25
8.2 Power supply ..................................................................................................... 26
8.2.1 Main power—AC mains ............................................................................26

i
8.2.2 Stand-by power ........................................................................................ 26
8.2.3 Main power supply -----Back-up battery transition ....................................26
8.2.4 Low voltage of back-up battery ................................................................ 27
8.2.5 Charge of back-up battery ........................................................................27
8.2.6 Discharge of back-up battery ................................................................... 27
8.2.7 Replacing of the back-up battery ..............................................................27
8.2.8 Installation or replace fuse ....................................................................... 28
8.3 Installation and arrangement of CO2 absorbent ................................................ 29
8.4 Installation and liquid medicine perfusion of vaporizer ...................................... 30
8.4.1 Installation ................................................................................................ 30
8.4.2 Liquid medicine perfusion .........................................................................30
8.5 Connection of reservoir bag .............................................................................. 30
8.6 Connection of breathing tube ............................................................................ 31
8.7 Installation and connection of O2 sensor and CO2 sensor ................................. 32
8.8 Installation and connection of anaesthetic gas scavenging system-transfer and
receiving system ......................................................................................................32
8.9 Installation and connection of respiratory gas monitor (optional) ...................... 32
8.10 Installation and operation of pressure regulator .............................................. 33
8.11 Connection of equipotential terminal ................................................................34
9. Check before use .......................................................................................................35
9.1 Check interval ....................................................................................................35
9.2 System check .................................................................................................... 35
9.3 Check power failure alarm .................................................................................35
9.4 Gas supply check .............................................................................................. 35
9.4.1 Air source check ....................................................................................... 35
9.4.2 Leakage check ......................................................................................... 36
9.4.3 Oxygen flush valve check .........................................................................36
9.4.4 Anoxic alarm and N2O truncation check ................................................... 36
9.4.5 Flow rate control check ............................................................................ 37
9.5 Anaesthetic breathing system check ................................................................. 38
9.5.1 Inhalation, exhalation flap check .............................................................. 38
9.5.2 Leakage check ......................................................................................... 38
9.5.3 “APL” valve check .................................................................................... 38
9.5.4 Breathing bellow check ............................................................................ 39
9.5.5 Manual ventilation check .......................................................................... 39
9.5.6 CO2 absorbent check ............................................................................... 39
9.6 Vaporizer check ................................................................................................. 40
9.7 Anesthesia ventilator check ............................................................................... 40
9.8 Alarm function check ......................................................................................... 41
10. Operation ................................................................................................................. 44
10.1 Start-up system ............................................................................................... 45
10.2 Manual mode ...................................................................................................46
10.2.1 Enter manual mode ................................................................................ 46
10.2.2 Manual ventilation .................................................................................. 46
10.3 Mechanical ventilation ..................................................................................... 47
10.4 Selection of Adult/Paed. mode ........................................................................ 48
10.5 Setting of ventilation mode and parameters .................................................... 49
10.6 Reset of alarm parameter ................................................................................52
10.7 Reset of system setting ................................................................................... 55
10.8 Operation of IPPV mode ..................................................................................61

ii
10.9 Operation of PCV mode .................................................................................. 62
10.10 Operation of A/C mode .................................................................................. 63
10.11 Operation of SIMV mode ............................................................................... 64
10.12 Operation of PSV mode .................................................................................65
10.13 Operation of apnea function .......................................................................... 66
10.14 Operation of SIGH function ........................................................................... 66
10.15 Operation of Audio paused function .............................................................. 66
10.16 Oxygen flush valve ........................................................................................ 66
10.17 Oxygen flow rate adjustment ......................................................................... 66
10.18 Auxiliary common gas outlet (optional) .......................................................... 67
10.19 Use of N2O .................................................................................................... 67
10.20 Anaesthesia ................................................................................................... 67
10.21 Pressure limit adjustment and discharge of manual ventilation .....................68
11. Operation of anaesthetic gas scavenging system-transfer and receiving
system(optional) ............................................................................................................ 69
12. The end of use .........................................................................................................69
13. Cleaning and disinfection .........................................................................................70
13.1 The methods of clean and disinfection ............................................................ 70
13.2 Cleaning and disinfecting agents and efficient disinfection methods ...............72
13.3 Using times for the reusable part .....................................................................72
14. Maintenance ............................................................................................................ 73
14.1 Before everyday operation .............................................................................. 73
14.2 After operation of every patient ........................................................................73
14.3 When needed .................................................................................................. 73
14.4 When Assembling after washing and disinfection ............................................73
14.5 Operation over 1200 hours or 6 months .......................................................... 74
14.6 Every year or operation over 2500 hours ........................................................ 74
14.7 Every two years or operation over 5000 hours ................................................ 74
14.8 Maintenance intervals table .............................................................................75
15. Alarm and solution system ....................................................................................... 77
16. Troubleshooting ....................................................................................................... 84
17. Main technical specification ..................................................................................... 86
17.1 Environment conditions ................................................................................... 86
17.2 Classification ................................................................................................... 86
17.3 Driving gas .......................................................................................................87
17.3.1 Gas circuit diagram ................................................................................ 87
17.3.2 Gas supply ............................................................................................. 88
17.3.3 Flow rate ................................................................................................ 88
17.3.4 Power supply ..........................................................................................88
17.4 Electromagnetic compatibility .......................................................................... 89
17.5 Anaesthetic breathing system ..........................................................................89
17.6 Anaesthetic gas discharge port ....................................................................... 89
17.7 Ventilation mode .............................................................................................. 89
17.8 Ventilation parameters .....................................................................................90
17.8.1 Specification ...........................................................................................90
17.8.2 Driven gas .............................................................................................. 91
17.8.3 Fresh gas compensation ........................................................................ 91
17.9 Ventilation parameter Monitoring .....................................................................92
17.10 Monitoring equipment should be equipped in using ...................................... 93
iii
17.11 Anaesthesia System Circuit diagram ............................................................. 94
17.12 Noise ............................................................................................................. 94
18. Installation, conveying and moving .......................................................................... 94
19. Storage and transportation ...................................................................................... 95
19.1 Storage ............................................................................................................ 95
19.2 Transportation ..................................................................................................95
20. Waste disposal .........................................................................................................96
20.1 Disposal of battery and O2 sensor ................................................................... 96
20.2 Disposal of electronic and plastic parts ........................................................... 96
20.3 Scrap disposal of medical equipment .............................................................. 96
20.4 Scrap disposal of packaging materials ............................................................ 97
21. Others ...................................................................................................................... 98
22. Check list ................................................................................................................. 99
23. Essential performance ........................................................................................... 106

iv
1. User’s responsibility
 Read the operation manual carefully and assemble, operate and maintain in strict accordance
with instructions in this manual.
 Performance of safety for the equipment shall be checked before the equipment is started each
time so as to ensure that the equipment is in sound operation condition in service. Please refer to
“Pre-use check” section in this operation manual.
 The equipment is to be operated by trained and authorized medical personnel only.
 Parts which are damaged, missing, wearing, deformed or polluted, should be replaced
immediately. If need to repair or replace, we recommend that you call or write to the recent
company's customer service center for help.
 Don’t make any change for the equipment unless authorized by our company. If any trouble
occurred with the equipment, service shall be made by special technical personnel authorized by
our Company or by trained and qualified technical personnel.
 If improper use, wrong maintenance and repairing, damage or changes made by any person not
in our company lead to product faults, the responsibility will be taken by users.
 If necessary, please contact our company for further information.
 Keep the Anaesthesia System stable and balance during operation, transportation or move. The
maximum tilt angle is not more than 10°.
Warning:
 Never use flammable or explosive anaesthetic agent with this equipment.
 The vaporizer only shall be filled with specified four kinds of anaesthetic agent Enflurane,
isoflurane, sevoflurane and halothane. Never mix them up.
 Only vaporizers provided or designated by anesthesia machine manufacturer that are in match
with the anesthesia machine shall be used. Otherwise, their performance will be degraded.
 Don’t use antistatic breathing tube (threaded pipe) and mask with this equipment. If this kind of
breathing tube (threaded pipe) and mask are used adjacent to HF electrical surgical equipment,
it will lead to fire.
 The equipment shall not be used in a hazardous environment containing inflammable and
explosive gases.
 The equipment shall not be used in the Nuclear Magnetic Resonance environment.
 When any alarm conditions occurred during operation, the equipment shall be checked and
trouble be removed immediately.
 If alarm occurs in use, please ensure patient’s safety at first, then carry out fault diagnosis or
necessary maintenance.
 If power supply is interrupted, manual vent should be immediately carried out.
 Although full consideration is given to clinic safety in the design of this equipment, its operator
still shall not neglect the observation of operation conditions of the equipment and monitoring of
patient. Only by so doing, any mistakes or functional abnormal may get corrected right away
once occurred.
 Breathing tube (threaded pipe) shall be placed carefully so as not to enwind or asphyxiate the
patient during operation.
 Moving or covering the equipment is not allowed during operation; nor is servicing of the
equipment allowed. Do not maintain the machine during operation.
 When N2O is used, its O2 concentration shall not be less than 25%.
 To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
 All parts of the Anaesthesia System must not be serviced or maintained while in use with the
patient.
 No modification of this machine is allowed.

1
 Do regular check (Refer to the chapter of maintenance) and replacement (Refer to of replacing of
the back-up battery) of the battery.
 Keep the distance between Anaesthesia System and obstruction more than 0.5m.
 Additional MULTIPLE SOCKET-OUTLET or extension cord is forbidden to be connected to the
ME SYSTEM.
 MULTIPLE SOCKET-OUTLETS provided with the ME SYSTEM must only be used for supplying
power to equipment that is intended to form part of the ME SYSTEM.

2. Symbols used in this manual or on this equipment


“ ” indicates you should refer to instruction manual/booklet.

“ Warning” and “ Note” indicate if the instruction is not followed, there will be some
emergencies, please read and keep to all the “ warning” and “note” items.
Warning: indicates that if the instruction is not followed, the machine may be damaged, you and your
patient may be injured.
Note: indicates that if the instruction is not followed, the machine may be damaged, and cannot work
normally.
Hint:indicate you should pay attention to the explanation.

In the machine and manual, the picture, sign, term and abbreviation are used to replace the language
remarks. However, all these picture, sign, term and abbreviation are not all involved in the machine
and manual.
Table A – Remarks of the picture, sign, term and abbreviation in the machine and manual
Graphs & Symbols Instructions

Refer to instruction manual/booklet

~ Alternating current

Type B applied part

General warning sign

Gas inlet

Gas outlet

Signal inlet

Reservoir bag

Anesthesia Ventilator

Read the top point of the float.

O2+ Oxygen flush valve

“OFF” for part of the equipment

“ON” for part of the equipment

Exhaust port

Central gas supply

2
Graphs & Symbols Instructions
300
600
900
1200
1500

Anaesthetic ventilation system

O2% O2 sensor connection port

CO2 sensor connection port

Audio Paused

Locking

Unlock

Main power supply indication

Battery supply indication

Indication for low voltage of battery

The battery is running out

Charging (mains power supply) indication

Backup battery failure

Backup battery indicator or backup battery

Inhale

Exhale

Upper limit

Lower limit

USB USB connector

Network connector

VGA connector

RS232 RS232 connector

Freeze

Protective earth

Equipotential terminal

Trigger mark

3
Graphs & Symbols Instructions

Standby

Parameters setting

System setting

Alarm setting

!!! High priority alarm

!! Medium priority alarm

! Low priority alarm

Maximum load 5kg

Maximum load 20kg

Date of manufacture

Manufacturer

The symbol indicating separate collection for EEE consists


of the crossed-out wheeled bin according to DIRECTIVE
2012/19/EU.

This way up

Fragile, Handle with care

Keep away from rain

Do not roll

4
Terms and abbreviation in this manual or on this equipment:
Terms and Abbreviation Explanation

IPPV Intermittent positive pressure ventilation

A/C Assistant/control ventilation

PCV Pressure control ventilation

PSV Pressure support ventilation

SIMV Synchronized intermittent mandatory ventilation

Manual Manual ventilation

Standby Standby mode

Adult Adult mode

Paed. Paediatric mode

FiO2 O2 concentration of inhalation

MV Minute volume

Vte Expiration tidal volume

Vt Tidal volume

Freq Frequency

Ppeak Airway peak pressure

PEEP Positive end-expiratory pressure

C Dynamic lung compliance

Tinsp Time of inspiration

Tramp Time of inspiration rise

ΔPs Pressure support level

Exp% Exhale sensitivity

etCO2 End-tidal Carbon Dioxide

I:E Inhalation/exhalation ratio

Tip Holding time (Platform time and Inhalation platform)


Sigh Sigh frequency

Pc Pressure control

PTr Pressure trigger

FTr Flow trigger

Pcon Continuous airway pressure alarm

Plimit Pressure limit

Psupp Pressure support

5
Terms and Abbreviation Explanation
Tapnea Apnea time

ACGO Auxiliary common gas outlet

Paw—t Waveform of airway pressure and time

Flow—t Waveform of flow and time

O2 Oxygen

BTPS Body temperature and pressure-saturated

DC Direct current

mL/cmH2O Milliliter/ Centimeter water column

% Percent

Vol.% Volume percent (Unit for concentration)

L/min Liter per minute (Unit for volume)

mL Milliliter (Unit for capability)

/min /minute (Unit for frequency)


cmH2O Centimeter water column (Unit for pressure)

mmHg millimeter of mercury(Unit for pressure)

s Second (Unit for time)

kg Kilogram (Unit for weight)

hPa HPa (Unit for pressure)

kPa KPa (Unit for pressure)

L Liter (Unit for capability)

V Voltage (Unit for voltage)

A Ampere (Unit for current)

Hz HZ (Unit for frequency)

db(A) Decibel (Unit for noise)

℃ Celsius (Unit for temperature)

6
3. Intended use
AN325-A Anesthesia System is intended to provide general Anaesthesia to the patients as well as
control patient’s breathing or assist breathing, monitor and display ventilation parameters of patients
in medical department. It applies to adults and children aged 3 years old and above.

4. Adaption disease
Patients in need of anesthesia surgery.

5. Contraindication
As to the anesthesia system, there is no absolute contraindication. But the operator should pay
attention to the relevant contraindication of mechanical ventilation. For example the patient with grave
lung disease should not use or use Anaesthesia System with great caution.

7
6. EMC Information
Important Note:
1) The AN325-A Anaesthesia System meets the requirement of electromagnetic compatibility in
IEC60601-1-2 and shall maintain basic safety and essential performance in regards to EMC.
2) The AN325-A Anaesthesia System is suitable for use in professional healthcare facility
environment. The customer or the user of the AN325-A should assure that it is used in such an
environment.
3) The user needs to install and use according to electromagnetic compatibility information which is
attached with it.
4) Portable, mobile RF and X-ray system communication devices may influence AN325-A
performance, so AN325-A should be kept away from them during using.
5) In addition to the cables sold by the equipment manufacturer as spare parts for internal
components, the use of non-prescribed accessories and cables may result in reduced interference to
the equipment or system;
6) Requirements for cables and other accessories:
AN325-A contains power supply cords, which are in compliance with requirements of IEC60601-1-2
when used with AN325-A. Manufacturer and model requirements for power supply cord:

No. Name Type Length,Shielded Manufacturer

Power supply cord H05VV-F 4.0m, unshielded


Zhenjiang Huayin Instrument and
Electrical Equipment
1 Mains plug 3VTJ2 ——

Mains connector 3VTJA ——

7) Essential performance of Anaesthesia System:


——Low O2 concentration alarm
——Low Airway pressure alarm
——Low MV alarm
——Power supply failure alarm
——Tidal volume monitoring range is 0 mL - 3000mL, >100 mL, and its accuracy is ±20 %, ≤
100 mL, ±20 mL;
— — Ppeak monitoring range is -20cmH2O - 120 cmH2O, and its accuracy is ± (4% full
scale+4%actual reading);
— — O2 concentration monitoring range is 15% - 100%, and its accuracy is ± (2.5v/v+2.5% gas
concentration)
8) When Essential Performance of Anaesthesia System is lost or degraded due to EM disturbances,
do not use the machine and contact our company.
9) The EMISSIONS characteristics of AN325-A make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is
normally required) AN325-A might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating or re-orienting the
equipment.

8
Warning:

1) AN325-A Anaesthesia System should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, AN325-A should be observed to verify normal operation
in the configuration in which it will be used;
2) Use of mobile phone or other RF radiating equipment near this machine may cause unexpected
problem or abnormity, they shall not be used no closer than 30 cm (12 inches) to any part of the
AN325-A, including cables specified by our company. In case RF radiating source exists nearby,
machine operating status shall be monitored.

Table 1
Guidance and manufacturer’s declaration –electromagnetic emissions
Emissions test Compliance
RF Conducted emissions
CISPR 11 Group 1 Class A
RF radiated emissions
CISPR 11 Group 1 Class A
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations / flicker emissions
Complies
IEC 61000-3-3

9
Table 2 ENCLOSURE PORT

Basic EMC standard IMMUNITY TEST LEVELS


Phenomenon
or test method Professional healthcare facility environment
ELECTROSTATIC ±8 kV contact
IEC 61000-4-2
DISCHARGE ±2 kV, ±4 kV, ± 8 kV, ±15 kV air
3 V/m
Radiated RF EM fields IEC 61000-4-3 80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximity fields from RF
IEC 61000-4-3
wireless communications See Table 4
equipment
RATED power frequency 30 A/m
IEC 61000-4-8
magnetic fields 50 Hz or 60 Hz

Table 3 Input a.c. power PORT

Basic EMC IMMUNITY TEST LEVELS


Phenomenon
standard Professional healthcare facility environment
3V
Conducted disturbances 0,15 MHz – 80 MHz
IEC 61000-4-6
induced by RF fields a) 6 V in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
IEC
Voltage dips 0 % UT; 1 cycle
61000-4-11
and
70 % UT ; 25/30 cycles
Single phase: at 0°
IEC
Voltage interruptions 0 % UT; 250/300 cycle
61000-4-11
Electrical fast transients /
IEC 61000-4-4 ±2 kV, 100 kHz repetition frequency
bursts
Line-to-line ±0.5 kV, ±1 kV
Surges IEC 61000-4-5
Line-to-ground ±0.5, ±1 kV, ±2 kV

10
Table 4 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment

IMMUNITY
Test Maximu
Band a) Distance TEST
frequency Service a)
Modulation b)
m power
(MHz) (m) LEVEL
(MHz) (W)
(V/m)
Pulse
385 380 –390 TETRA 400 modulation b) 1,8 0,3 27
18 Hz
FM c)
GMRS 460, ±5 kHz
450 430 – 470 2 0,3 28
FRS 460 deviation
1 kHz sine
710 Pulse
LTE Band 13,
745 704 – 787 modulation b) 0,2 0,3 9
17
780 217 Hz
810 GSM 800/900,
TETRA 800, Pulse
800 – 960 iDEN 820, modulation b) 2 0,3 28
870 CDMA 850, 18 Hz
930 LTE Band 5
GSM 1800;
1 720 CDMA 1900;
Pulse
1 700 – GSM 1900;
modulation b) 2 0,3 28
1 845 1 990 DECT;
217 Hz
LTE Band 1, 3,
1 970 4, 25; UMTS
Bluetooth,
WLAN, Pulse
2 400 –
2 450 802.11 b/g/n, modulation b) 2 0,3 28
2 570
RFID 2450, 217 Hz
LTE Band 7
5 240 5 100 – Pulse
WLAN 802.11
5500 5 800 modulation b) 0,2 0,3 9
a/n
5785 217 Hz

11
7. Main structure, function and principle of system
7.1 System
7.1.1 Components included
 AN325-A anesthesia system includes the following monitoring devices, alarm devices and
protection devices:

——monitoring for exhaling gas volume;

——monitoring for airway pressure;

——airway pressure limit;

——continuous pressure alarm for ventilation system;

——alarm for airway pressure high;

——alarm for MV high;

——apnea alarm;

——alarm for ventilation system integrity;

——oxygen fault alarm;

——oxygen fault protection;

——alarm for power supply fault;

——O2 monitor;

—— anaesthetic ventilator;

—— anaesthetic breathing system.

 The devices or components should all comply with the following relevant standards:

 IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and
essential performance

 ISO 80601-2-13 Medical electrical equipment — Part 2-13: Particular requirements for basic
safety and essential performance of an anaesthetic workstation

 ISO 80601-2-55 Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors

 IEC 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety
and essential performance- Collateral standard: General requirements, tests and guidance for
alarm systems in medical electrical equipment and medical electrical systems

12
7.1.2 Components excluded
 The following components are not equipped on AN325-A anesthesia system, but they can be
used with AN325-A.
——Ventilation gas monitor;
——Transfer and receiving systems of active anaesthetic gas scavenging systems.
 These components shall comply with the following international standards:
ISO 80601-2-55 Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors

ISO 80601-2-13 Medical electrical equipment — Part 2-13: Particular requirements for basic
safety and essential performance of an anaesthetic workstation
 When connect these components, the following aspects shall be paid attention to:
——Ventilation gas monitor should be connected with the inhalation port of the breathing system.
After assembling, leakage test shall be carried out.
——Transfer and receiving system of active anaesthetic gas scavenging system should be
connected with exhaust port of the breathing system. After assembling, leakage test shall be
carried out.

Warning:
Anesthesia system is used according to requirements of standard ISO 80601-2-13.
 It shall be used with the following monitors:
——CO2 monitor;
——O2 monitor;
——Exhalation gas volume monitor;
——Anaesthetic gas monitor(when using vaporizer).
 It shall also be used with transfer and receiving system of active anaesthetic gas scavenging
system.
 Breathing circuit equipped with this system should comply with the ISO 5367 standard.

Note:
When users connect the above equipment to the anesthesia system, the correspondent installation
operation instructions provided by the equipment manufacture must be complied with. Whoever
connect the single equipment to the anesthesia system, the guidance or instructions for the normal
operation of the separate equipment, which is requested by anesthesia system and standard shall all
be provided.

13
7.2 Structure of the whole machine
Anesthesia system comprises anaesthetic gas delivery system (include anaesthetic gas delivery
piping, flowmeter, oxygen fault alarm and protective device), anaesthetic breathing system,
anaesthetic gas scavenging system-transfer and receiving system(optional), anaesthetic
vaporizer(with some functions of pressure compensation, temperature compensation and flow
compensation, two models SE6A and SE6B, anaesthetic agents can be used have Enflurane,
Halothane, Isoflurane, Sevoflurane), anaesthetic ventilator, respiratory gas monitor (optional) and
main frame.

See figure 1 for the outline of whole machine.

1 Alarm indicator 2 Flowmeter


3 Screen and display zone 4 Anesthetic vaporizer
5 Airway pressure gauge 6 Adjusting knob of flowmeter
7 Oxygen flush valve 8 Anesthetic breathing system
9 O2 sensor cable connection port 10 CO2 sensor cable connection port
11 ACGO connection port 12 Mains switch
13 ACGO selector switch 14 Pressure gauge of gas supply
15 Drawer 16 Aluminum profile
17 Exhaust port
18 Anesthetic gas scavenging system-transfer and receiving system
19 Drawer handle 20 Castor
21 Central gas supply connection port 22 Mains power input port
23 EtCO2 module port 24 label

Fig.1 Outline of the whole machine

14
7.3 Working principle
Gas supply entered into the equipment shall be regulated to the required flow and proportion by flow
control valve of the flowmeter, then flow through drug vaporizer and be sent to ACGO selector valve.
Anaesthetic agent concentration is controlled by vaporizer. When concentration knob of the vaporizer
is adjusted to “0”, there will be no anaesthetic agent in the fresh gas output.
Part of O2 entered into the equipment is branched to oxygen flush valve, high flow oxygen coming
from oxygen flush outlet enters into ACGO selector valve.
There are another two branches of O2 entered into the equipment, one of them leading to oxygen
alarm device and the other leading to oxygen protection device (protection module for N2O cut off).
When O2 pressure is lower than 180 kPa, the equipment will cut off N2O supply at the same time.
In addition, another one branch of O2 becomes two after passing the reducing valve 1, one enter into
the flow control valve, the other flow through the reducing valve 2 and enter into
the exhalation control valve.
If "ACGO" is selected, the fresh gas flow from the ACGO. If "ventilation system" is selected, the gas
enter into ventilation system manual/mechanical selector valve.
If choose the manual control, fresh gas will be stored in the reservoir bag, and the breathing circuit
for patient is achieved by manual way. This time, the breathing of the patient is manually controlled by
squeezing the reservoir bag with a hand.
For inhalation, the gas and fresh gas outputted from reservoir bag will be sent into patient’s lung via
CO2 absorber, inhalation valve, inhalation gas connector, thread pipe and Y connector.
For exhalation, loosen the reservoir bag, expired gas will go through Y connector, thread pipe,
expiratory gas connector and expiratory valve and come back into the reservoir bag. The excessive
gas will be discharged through APL valve.
If choose the mechanical control, fresh gas will be stored in the bellow, the breathing circuit
for patient is achieved by anesthesia system .
For inhalation, the flow control valve and exhalation control valve open, O2 flow out of the bellow
via breathing control valve, squeeze the bellow so that fresh gas in the bellow will be sent into
patient’s lung via CO2 absorber, inhalation valve, inhalation gas connector, thread pipe and Y
connector.
For exhalation, the flow control valve and exhalation control valve close, expired gas will go through Y
connector, thread pipe, expiratory gas connector and expiratory valve and come back into the bellow,
squeeze the bellow to make the gas out of breathing valve(the circuit is complete).
The excessive gas will be discharged through the overflow valves via the breathing valve. When the
airway pressure reaches the set pressure of relief valve (not more than 12.5 kPa), pressure relief
valve opens automatically so as to prevent airway pressure being too high to hurt the patient's
airway .
The excessive gas coming from the breathing valve is discharged to outdoor atmosphere via gas
transfer and receiving system.
Anesthesia breathing control panel will work under the ventilation mode and parameters set on the
operation panel, and process airway pressure and tidal volume sampled from flow and pressure
sensor, then control inhaling time, breathing rate, and tidal volume, and display the monitored
ventilation parameters on the screen.
When the monitored ventilation parameters are beyond the set alarm limit, the anesthesia breathing
control panel will activate the sound and visible alarm.

15
7.4 Flowmeter
7.4.1 Function
 The flowmeter is provided with a flow control valve, which controls and indicates the flow rate of
fresh gas provided to the patients.

 The flowmeter is also provided with the proportion control unit of O2 and N2O , N2O shutoff valve,
the N2O will be shut off when oxygen pressure drop back to lower than 0.18MPa (29psi).

7.4.2 Structure
 The flow meter is five pipes rotary flow meter for O2, N2O, and AIR. The flow meter for O2 and
N2O consists of a thick tube and a slim tube separately. The process of slim tubes is low flow rate
process, and the process of thick tubes is high flow rate process.

 Flow rate is separately controlled by the corresponding flow rate control valve:

——counterclockwise rotation shall increase flow rate;

——clockwise rotation shall decrease flow rate.

 The flow rate control valve for O2 and N2O is additionally installed with proportional control device
for O2 and N2O to ensure the out O2 concentration is no less than 25%. When O2 pressure drops
back to lower than 0.18MPa (29psi), the device of N2O is automatically closed at the same time.

7.5 Anaesthetic vaporizer


Anaesthetic vaporizer is used for precisely controlling the concentration of anaesthetic gas which is
transmitted to the fresh gas.

The equipment may select enflurane or isoflurane or sevoflurane or halothane or desflurane


vaporizer with temperature and flow rate compensation function; and can be equipped with one or
two Anaesthetic vaporizers. The vaporizer mating with the anesthesia system nominated by our
company shall be used. Otherwise, the performance of them will be decreased.

There is the self-lock device on this vaporizer.

Turn the concentration-regulating-knob to adjust the required concentrations of anaesthetics.

See the manual for the detailed vaporizer instructions.

16
7.6 Anaesthetic breathing system
7.6.1 Function
 Transmit the fresh gas(mixed gases) with anaesthetic gas to the patients;

 The CO2 exhaled by the patient is absorbed;

 To provide path to control the inhalation and exhalation of patients;

 Discharge the surplus gas and waste.

7.6.2 Structure
 Anaesthetic breathing system mainly consists of breathing bellow, inhalation valve, exhalation
valve, CO2 absorber (circle absorber assembly),“bag/vent” selection valve, “APL” valve
(adjustable pressure limit valve, exhaust valve).
 See figure 2 for the outline of anaesthetic breathing system.

1 Breathing bellow 2 “APL” valve (adjustable pressure limit valve)

3 Inhalation gas connector 4 Exhalation gas connector

5 Reservoir bag connection port 6 CO2 absorber

7 O2 sensor port 8 Inhalation valve

9 Exhalation valve 10“bag/vent” selection knob

11 Water trap 12 Airway pressure gauge

Fig.2 Anaesthetic breathing system

17
7.6.3 Main control parts
 Inhalation valve and exhalation valve
The inhalation valve and exhalation valve are non-return valves
which controls the direction of breathing gas flow.
The inhalation valve and exhalation valve respectively consist of:
——Valve cover (1) and (2)
——Valve flap (3) and (4)
With breathing of patients, the inhalation valve flap(4) and the exhalation
valve flap (3) are opened and closed alternatively,
——When the patient inhales, the inhalation valve flap is opened,exhalation valve flap is closed,
the gas output by the anaesthetic breathing system is sent into patient airway through
breathing tube;
——When the patients exhales, the inhalation valve flap is closed, exhalation valve flap is
opened,the exhaled gas is sent to anaesthetic breathing system through breathing tube .
 CO2 absorber (circle absorber assembly)
——CO2 absorbent is put in the CO2 absorber. Absorbent can absorb the CO2 of the exhaled gas
of patients thoroughly, the produced O2 is transferred to patients.
——The CO2 absorber is installed on the lower part of anaesthetic breathing system, consisting
of absorber casing, screen cloth and inner housing.
——CO2 absorber has a capacity of about 1500 mL.
The structure of CO2 absorber see figure 3.
4

1. Screen cloth 2. Canister 3. Inner housing 4. Airflow direction

Fig.3 The structure of CO2 absorber

18
 “bag /vent” selection knob
Select manual ventilation (reservoir bag) or mechanical ventilation
(Anaesthesia System).
—— When the “bag /vent” selection knob revolves to “ ”,
the breathing of patients is controlled manually;
—— When the “bag /vent” selection knob revolves to “ ”,
the breathing of patients is controlled by Anaesthesia System.
 “APL” valve
When “APL” valve (adjustable pressure limit valve) is used for manual control ventilation, adjust
pressure limits of breathing system. When the pressure of breathing system exceeds the limit,
exhausting through the surplus gas outlet.
——Rotate the “APL” valve knob clockwise, increase the pressure of
breathing system. Rotate clockwise to the end to close the valve,
then the pressure limit is about 75 cmH2O;
——Rotate the “APL” valve knob counterclockwise, decrease the
pressure of breathing system. Rotate counterclockwise to the end APL
to open the valve fully, then the pressure limit is about 0 cmH2O, the
gas in breathing system exhaust directly through the surplus gas
outlet.
 Breathing bellow
During the starting of inhaling, the driving gas get into the folding bag and box cover, overflow valve
and exhale valve are closed; the mid-term of inhaling, the driving gas go on getting into, to increase
the pressure, then compress the folding bag, make it down, to force the intracapsular gas into the
breathing circuit; during the starting of exhaling, the gas (expiratory air and fresh air) of respiratory
system flow into the folding bag. Then the folding bag begin to rise up, to make the exhalation valve
open, the driving gas is discharged into the atmosphere; the final phase of exhaling, gas flow into
continuously, the positive pressure arise after the folding bag bulge completely, to make overflow
valve open, excess gas in the folding bag discharge into the exhaust system by the overflow valve.

19
7.7 Oxygen fault alarm and protection
7.7.1 Structure
O2 alarm device is composed of gas cylinder, slide valve and siren, etc. N2O cut-off module contains
cut off valve.

7.7.2 Working principle


—— When O2 source enters into the equipment, there is one steam entering into differential pressure
sensor to monitor the O2 inlet pressure. When the supply pressure of O2 is lower than 180kPa,
the Oxygen deficiency alarm is triggered.The display screen pops up the alarm prompt of "O2
supply low !!". When the supply pressure of O2 is greater than 180 kPa, the alarm stops.

——When O2 source enters into the equipment, there is another steam entering into N2O cut-off
device. When O2 supply pressure is greater than 180 kPa, N2O will output normally. When O2
supply pressure is lower than 180kpa, it will push the slide valve to its closed position. N2O input
will decrease to zero step by step. When O2 supply pressure is greater than 180 kPa and less
than 240 kPa, N2O cut-off device returns to normal.

7.8 Oxygen flush valve


Oxygen is used for providing high flow rate O2 to anaesthetic breathing system through fresh air
outlet:

 Press the switch of oxygen flush valve, output high flow rate O2;

 Loose the switch of oxygen flush valve, then the air flow will stop.

7.9 System driving gas circuit


7.9.1 Gas supply
 Gas enters the system through gas source input connector. Gas resource input connector
includes a set of central gas supply connector;
 The central gas supply connector includes an O2 inlet, a N2O inlet and an AIR inlet;
 Cylinder gas supply connector includes an O2 inlet, a N2O inlet and an AIR inlet ;
 All the gas resource input port have the marked connector ,filter and non-return valve;
 After gas resource enters the system, a relief valve (about 750kPa) is additionally connected to
prevent the system from bearing the over high pressure;
 Gas resource pressure gauge separately display the central gas supply pressure and gas
working pressure entering into the system.
7.9.2 O2 supply
After O2 enter the system, it reaches separately to:
 The O2 flow control valve of flowmeter:adjust O2 flow rate of the fresh gas (mixtures);
 Oxygen flush valve: press the oxygen flush valve and supply high flow O2 for the fresh gas outlet.
 Anoxic alarm and N2O cut protective device: when O2 Pressure is lower than 180kPa, equipment
deliver a sound alarm,at the same time cut N2O supply;
 Anaesthesia System:as Anaesthesia System’s driving gas.

20
7.9.3 N2O supply
When N2O enters the system, it separately reaches to:

 The N2O flow control valve of flowmeter: adjust N2O flow rate of the fresh gas (mixtures);

 When the intake pressure of O2 is lower than 180 kPa, N2O is blocked by truncation device;

 O2 and N2O flowmeter is equipped with O2 and N2O proportional control device, ensuring the
output O2 concentration is not less than 25%. When O2 pressure drop back to lower than
0.18MPa (29psi), N2O automatically closed at the same time.

7.9.4 Air supply(optional)


 Air reaches flow meter inlet and passes the flow rate control valve after entering system, adjust
the proportion of AIR in fresh gas (mixtures).

7.9.5 Fresh gas (common gas)


 Fresh gas from flowmeter outlet to fresh air outlet (inside the machine) through vaporizer, enters
anaesthetic breathing system.

 The outlet pressure for fresh gas is limited to 30kPa - 45 kPa by the pressure relief valve.

7.9.6 Auxiliary common gas outlet (ACGO)


 When switch on the switching of the auxiliary common gas outlet, fresh gas output via ACGO.

7.9.7 Anoxic alarm


 Function

When O2 pressure is lower than 180kPa, there will be a sound alarm for no less than 7 seconds.

 Structure

Anoxic alarm device consists of air container, sliding valve, alarm whistles, etc.

7.9.8 Intake filter


 Function
Preventing the dust and sundries with the size of over 100μm from entering equipment duct to affect
the normal operation of the equipment.
 Structure
Filter(1) is a cup shaped structure which is installed on the 1 2
back end of the gas input connector (2).

21
7.10 Anesthesia ventilator
7.10.1 Function
The anesthesia ventilator provides mechanical ventilation for patients in the operation and monitors
and displays the breathing parameters of patients.

7.10.2 Structure
Anesthesia ventilator main consists of breathing parameters adjusting and control part, display
window, sensor, etc.
The front panel of the Anesthesia ventilator sees figure 4.

1 Screen and display zone 2 Audio paused 3 Parameters setting key


4 System setting key 5 Alarm setting key 6 Standby key
7 Battery state indicator 8 Power supply state indicator
9 “Adjustment/ confirmation” knob

Fig. 4 The front panel of Anaesthesia System

22
7.11 Connection port
7.11.1 Rear panel of Anaesthesia System
See figure 5.

1 Power supply inlet socket with filter (include fuse)


2 Equipotential terminal
3 Fan
4 Mains switch
5 CO2 sensor cable connection port (optional)
Fig.5 The rear panel of Anaesthesia System

7.11.2 Gas supply connector of the anesthesia system


Gas supply connector of the Anesthesia system is at the rear end of the equipment, see Fig. 6.

1 O2 inlet 2 O2 inlet (reserve) 3 N2O inlet 4 AIR inlet


Fig.6 Gas supply connector of the anesthesia system

23
7.12 Ventilation gas monitor (optional)
See the operation manual of ventilation gas monitor.

7.13 Transfer and receiving system of anaesthetic gas


scavenging system(optional)
AGSS is used to transfer and receive exhaust gas which patients expire.
Connect exhaust port (Item 17 in Fig.1) to exhaust gas input port (Item 1 in Fig.7)with breathing
tube.

1 Exhaust gas input port


2 Negative pressure source connection port
3 Flow adjusting valve
4 Flow indicator

Fig. 7 Transfer and receiving system of anaesthetic gas scavenging system

7.14 Respiratory gas monitor


The respiratory gas monitor is mainly used to monitor and display the inhaled oxygen
concentration and alarm information.
 The range of adjustment of the alarm limits and the fixed limit for high inspired nitrous oxide
alarm condition is 0.5 - 100;
 The operators need to intervene the water-handling system based on a sample gas temperature
of 37 ℃ , a room temperature of 23 ℃ and sample relative humidity of 100 %. The specified
interval is about 5 h and 3 h at the maximum and minimum sample flowrates, respectively;
 The detection threshold for a single halogenated anaesthetic gas in a gas mixture is 0.5 - 8;
 The method for connecting the exhaust port of a diverting RGM to an anaesthetic gas
scavenging system (please refer to "Transfer and receiving system of anaesthetic gas
scavenging system");
 Quantitative effects of humidity or condensate: -0.03% relative humidity, 25 ℃;
 Due to leaks or internal venting of sampled gas, the periodic pressure rising to 10kPa
(100cmH2O) and the sampled gas returning to the respiratory system, there is no adverse effect
on the monitoring of oxygen concentration;
 The rated respiration rate is 1 /min - 100 /min, (Under SIMV:1 bpm - 40 bpm, All mode except
SIMV: Adult 4 bpm - 40 bpm;Paed. 20bpm - 100 bpm )
 Tidal volume is 0,20 mL - 1500 mL;(Adult: 250 mL - 1500 mL;Paed. :0,20 mL - 300 mL )
 Ambient temperature, atmospheric pressure and relative humidity during working and storage
environment (please refer to "Environment conditions");
 CO2 stability: drift less than 1 mmHg within 4 hours; long term drift does not affect nominal
accuracy;
 O2 drift: <1%Vol.% O2/month@air, averaged across 12 months;
 Total response time is less than 12s.
 After the supply mains has been interrupted, when the “on-off” switch remains in the ”on” position,
the RGM is restored after a period of time that is 30s or longer.
24
8. Preparation
8.1 Gas supply connection
 The gas resource of the equipment :
——Can be central gas supply system;
——Can be cylinder high-pressure O2, N2O and compressed air.
 The connection of central gas supply system and the equipment:
——In the first using, the connection plugs of the outlet connection of O2 , N2O , AIR central gas
supply system are separately installed on the corresponding high pressure gas hose of the
central gas supply.
——Check the supply pressure of the central gas supply system, it shall be 440 kPa±160 kPa
(280 kPa - 600 kPa);
——Connect the high pressure O2 , N2O , AIR hose:
a) Connect the corresponding inlet of air resource on the middle of the rear of the equipment
with one end;
b) Connect the corresponding air resource outlet on the air supply system with one end;
——And connection plug of O2, N2O, AIR central gas supply system is provided by central gas
supply system manufacturer. If the users need to be provided by the company, they should
put forward in ordering, and shall provide the technical data of the connection plug.
 If O2 and N2O cylinder is used, the pressure regulator must be used. Check and adjust the
pressure regulator for output pressure of 440 kPa±160 kPa (280 kPa - 600 kPa), then connect it
to O2 and N2O port on the rear of the machine by high pressure hose.
 If select compressed air as gas supply, the compressed air must be purification treatment to
make sure gas supply is oil free, no water, without impurities, and pressure is within 440
kPa±160 kPa (280 kPa - 600 kPa), then connect it to AIR inlet (Item 4 in Fig.6) by high pressure
AIR hose.

Warning:
Fault of central gas supply system may lead to that over one connecting units and even all the
connecting units stop working at the same time.

Note:
1. The rated work pressure of the system is 440 kPa(4.4 bar). The pressure range of central gas
supply system shall be 440 kPa±160 kPa (280 kPa - 600 kPa).
2. All gas resources all shall be medical use.
3. When taking central gas supply system as gas resource, the impurity of duct shall be prevented
from entering equipment.
4. Whether using central gas supply system to supply gas,or using gas cylinder to supply O2, all shall
be equipped with reserve gas cylinder which is full of O2.
5. The use of pressure regulator, please refer to “installation and use of pressure regulator” of this
manual.

25
8.2 Power supply
Warning:
Once the device loss power source, it must be connected to an appropriate power source that meet
the requirements of the device input power supply or transfer to manual ventilation immediately.

Note:
1.The supply voltage of mains power supply is100-240V ~, the frequency is 50/60 HZ.

2. Mains plug is intended to be used as isolation device from the supply mains. Please always make
mains plug easily to operate.

8.2.1 Main power—AC mains


 Plug the mains connector of power supply cord into AC power supply inlet socket (Item 1 in Fig. 5)
on the rear of equipment;

 Plug the mains plug of power supply cord into mains socket-outlet on the wall, then the power
supply state indicator (Item 8 in Fig.4) at the panel is on;
 When the power is supplied by AC, the power state indication place will display the signal of

" " or " ".

8.2.2 Stand-by power


 Back-up battery:
Model: SF-Y3S-8
Capacity: 6200mAh
Voltage: DC11.1V
 When the back-up battery is fully charged, the battery will supply power for the equipment about
2 hours.

 If the machine is powered by battery, the power state indication place will display the signal of
“ ”.

 When the power is changed from AC to back-up battery, the equipment will keep same functions
as working under AC.

8.2.3 Main power supply -----Back-up battery transition


 It will switch over to back-up battery automatically when the main power supply fails during
operation.

 When the back-up battery power the Anaesthesia System, there is sound indication from the
machine, and the power state indication place will display the signal of “ ”.

26
8.2.4 Low voltage of back-up battery
 When the voltage of back-up battery is low (10.6V±0.2V), the power state indication place will
display the signal of “ ”,and there will be a sound alarm.

 At this time, power supply should transit to AC or switch off the power of Anaesthesia System,
and charge the battery.

Warning:
Power supply should transit to AC when the battery is low voltage.

8.2.5 Charge of back-up battery


 When the equipment is supplied by AC power, the battery will be charged automatically, the
power state indication place will display the signal of “ ”. And the power state indication
place will display the signal of “ ”after charging fully.
 When the equipment is supplied by AC power and starting switch is off, power supply indicator
(Item 8 in Fig.4) lights (green for a long time), if battery is charging, battery state indicator (Item 7
in Fig.4) lights (green), if battery is fully charged, battery state indicator (Item 7 in Fig.4) is off.
 Charge can be carried out continually, or intermittently.
 In order to prolong the service life of battery, it should be used at least once a month. The
back-up battery should be charged in time after using, generally it should be charged for more
than 3 hours after using for one hour.
8.2.6 Discharge of back-up battery
 It should be discharged in regular time when no using for a long time.

 Discharge method: Do not connect the AC power, and supply the Anaesthesia System by
back-up battery till the power state indication place display the signal of “ ”.

 It should be charged in time after discharging.

 Intervals of discharge do not beyond 3 months.

8.2.7 Replacing of the back-up battery


 Usually, the battery can be used for 3- 6 years, if it is often used in over voltage state, or often
power cut or the environment temperature is excessive high, efficiency will become lower the
and life will be shorten, use time of the battery in fully charged is less than 1 hour, recommend
replacing this battery.
 The battery should be replaced when it fails.
 The battery should be replaced when the efficiency receded or shattered. Battery replacing
should be managed by service personnel. When replacing the battery, firstly switch off the AC,
and then open the cover to get the battery out. Pay attention to the specification of the battery
and do not overturn the polarity.

Warning:
1. Do not throw the battery into the fire in case of explosive; Do not open or destroy the battery,
because it contains injurant which may injure skin and eyes. Please dispose the battery under (by)
the local environment law.
2. The replacement of the battery by inadequately trained personnel could result in a hazard, such as
excessive temperatures, fire or explosion.

27
8.2.8 Installation or replace fuse
 Replacement of AC power supply fuse:
When AC input power supply is normal, power supply indicator (Item 8 in Fig.4) is not on. After
opening the starting mains switch (Item 4 in Fig.5), the backup battery works, at this time the
fuse of AC power supply inlet socket / fuse socket(Item 1 in Fig.5) shall be checked. Unplugging
the plug of power supply and poking fuse socket with screw driver, the fuse can be taken out. If it
has been damaged, the fuse with the same size and model shall be replaced.
 Replace stand-by power supply fuse:
When using standby power supply and the battery is already full, after pressing the starting
mains switch (Item 4 in Fig.5), no display is on the screen, at this time standby power supply
fuse shall be checked. Screwing off the cover of fuse box with screw driver, take out fuse to
check. If it has been damaged, the fuse with the same size and model shall be replaced.
 Size and model of fuse
—— AC power supply T2AH 250V
——Internal standby power supply T4AH 250V

Warning:
1. Before installing or replacing fuse, you must pull out the mains plug of power supply cord from the
mains-outlet.

2. When replacing fuse, it shall be noticed that the size and model is the same with the original one.

28
8.3 Installation and arrangement of CO2 absorbent
 When the color of CO2 absorber gradually changes, it shows that the carbon dioxide is absorbed,
the change of absorbent color only roughly display. Please use carbon dioxide monitor to decide
whether replacing absorbent or not.

 The replaced absorbent shall be discarded, for absorbent will recover to the original color after
placement for a while, instead, the misleading function will occurs.

 The placement of absorbent: (see Fig.3)

——Clockwise tilt CO2 absorber;

——Enclose appropriate amount of absorbent;

——Clean out the foreign matter attached on the sealing washer and sealing face;

——Put CO2 absorber on the fixed seat again;

——Counter clock wisely tilt and press CO2 absorber.

Warning:
1. Do not replace absorbent during ventilation.
2. Replace absorbent frequently to prevent the deposit of non metabolic gas when the system does
not work.
3. After complete each case, the color of absorbent shall be checked, when the system does not
work, the color of absorbent may recover to its original color. The detailed about color change sees
instructions of absorbent.
4. If the absorbent is completely dry, then it will release CO2 after contacting the anaesthetic gas. In
view of safety, please replace absorbent. The proper prevention measure shall be adopted to
ensure that absorbent can not change to be dry. After using the system, shut off all the air resource
is an important measure preventing absorbent from dry.
5. After replacing absorbent, air leakage test of anaesthetic breathing system shall be carried out.

Note:
1. CO2 absorbent can only use air, oxygen, nitrous oxide, halothane, enflurane, isoflurane and
sevoflurane;
2. The CO2 absorber shall be placed correctly, foreign matter must not exist between the sealing
washer and sealing face so as to avoid air leakage.

29
8.4 Installation and liquid medicine perfusion of vaporizer
8.4.1 Installation
 Counter clockwise rotate the lock bar of Anaesthetic vaporizer for 90°.
 Anaesthetic vaporizer is put into the vaporizer fixed seat block on the anesthesia system, when
placing, pay attention to the fast connection of vaporizer and fixed seat block.
 Clockwise rotate the lock bar of Anaesthetic vaporizer for 90°
 To check if vaporizer and fixed seat block is tightly connected.
 The installation of other model of vaporizer refers to the other instructions.
8.4.2 Liquid medicine perfusion
Vaporizer liquid medicine perfusion and the check before and after perfusion see the user manual
thereof.

Warning:
1. The equipment do not use inflammable and explosive anaesthetics!
2. Vaporizer can only be added the specified anaesthetics, do not mixed to add!

8.5 Connection of reservoir bag


Connect the reservoir bag (3) complying with ISO 5362 to the reservoir bag connection port (2)
of anaesthetic breathing system, see figure 8.

Note:
The reservoir bag shall comply with ISO 5362.

1 Anaesthetic breathing system 2 Breathing tube


3 Connector 4 Reservoir bag

Fig.8 Connection of reservoir bag

30
8.6 Connection of breathing tube
Connection of breathing tube see Fig. 9.

1 O2 sensor cable 2 O2 sensor

3 O2 concentration monitoring port 4 Inhalation gas connector

5 Exhalation gas connector 6 Breathing tube

7 “Y” connector 8 CO2 sensor (optional)

9 “L” connector 10 CO2 sensor cable (optional)

11 CO2 sensor connection port (optional) 12 O2 sensor connection port

Fig.9 Connection of breathing tube and O2 sensor cable

Note:
The breathing tubes should comply with the ISO 5367 standard.

 Breathing tube (6) is respectively connected with exhalation gas connector (5) and inhalation gas
connector (4) and “Y” connector (7);
 One end of “L” connector (9) is connected with “Y” connector (7);
 The other end of “L” connector (9) is connected with breathing mask or tracheal tube.

31
8.7 Installation and connection of O2 sensor and CO2 sensor
——Refer to Fig.9 for installation and connection of O2 sensor.
 Wrench O2 sensor (2) to O2 concentration monitoring port (3), pay attention to neither gas
leakage nor excessive exertion;
 Insert the input plug (thin plug) of O2 sensor cable (1) into the hole of the bottom of O2 sensor (2);
 Insert the input plug (thick plug) of O2 sensor cable (1) into O2 sensor connection port (12).
——Refer to Fig.9 for installation and connection of CO2 sensor.
 Wrench CO2 sensor (8) to “Y” connector (7), pay attention to neither gas leakage nor excessive
exertion;
 Insert the input plug (thick plug) of CO2 sensor cable (10) into CO2 sensor connection port (11).

8.8 Installation and connection of anaesthetic gas scavenging


system-transfer and receiving system
 Installation and connection of anaesthetic gas scavenging system refers to user’s manual;
 Connect the input connection tube of anaesthetic gas scavenging system-transfer and receiving
system to exhaust port (Item 17 in Fig.1) on the rear of anesthesia system.

Note:
Anaesthetic gas scavenging system-transfer and receiving system shall comply with ISO 80601-2-13.

8.9 Installation and connection of respiratory gas monitor


(optional)
 Installation and connection of respiratory gas monitor refers to user’s manual;
 CO2 monitor need to be connected with “Y” connector of anaesthetic breathing system. After
installation, a gas leakage test shall be performed;
 Respiratory gas monitor need to be connected with “Y” connector of anaesthetic breathing
system. After installation, a gas leakage test shall be performed;

Note:
Respiratory gas monitors shall comply with ISO 80601-2-55.

32
8.10 Installation and operation of pressure regulator
Installation and operation in accordance with the following steps:
 Place the cylinder upright steadily;
 Stand at the side of cylinder and quickly open and close the cylinder valve so as to clean the
valve port;
 Confirm that the pressure regulator is in conformity with the gas in the cylinder;
 Clean up any oil stain and dirt at pressure regulator inlet and cylinder valve port;
 Install the pressure regulator on the corresponding cylinder and tighten with wrench;
 Turn the pressure adjusting knob anti-clockwise to release pressure adjusting spring;
 Connect the corresponding HP hose and tighten with wrench;
 The other end of HP hose is connected to the corresponding gas input port at rear of the
equipment;
 Open the cylinder valve slowly and adjust the pressure regulator to 440±50 kPa output pressure.

Warning:
1. The pressure regulator should be suitable to the gas-specific cylinder.
2. If there is grease on the O2 pressure regulator and the valve port of the O2 cylinder, explosion may
occur.

Note:
1. If a pressure regulator is connected to a gas cylinder, it shall be accordance with EN 738-1.
2. Before open the cylinder valve, the pressure adjusting knob of pressure regulator should be fully
loosened anti-clockwise, if not, the transient pressure may damage the diaphragm and will cause
invalidation of the pressure regulator and injury to person in extreme cases.
3. Don’t stand facing to or back to the cylinder valve port or the pressure regulator when opening the
cylinder valve.
4. Open the cylinder valve quickly, not for a long time, otherwise, the back pressure of discharged
gas will turn the cylinder over.

33
8.11 Connection of equipotential terminal
Warning:
When several medical devices are used together, ground all devices to the same external
equipotential grounding system by an equipotential grounding conductor. Any potential difference
between devices may cause electrical shock to the patient and operator.

 When more than one medical devices are used together, there may be electrical potential
difference between the devices .The electrical potential difference between devices may cause
current to flow to the patient connected to the devices, resulting electrical shock.
 Always perform equipotential grounding when required. It is often required in the operating
room ,ICU room and so on. Consult with a medical engineer to determine if it is required.
 When equipotential grounding is required to ensure patient safety, use the equipotential
grounding conductor to connect an external equipotential grounding system.
See the following figure for connection of equipotential terminal:

34
9. Check before use
Warning:
Do not use the equipment with fault.

Note:
The connection, safety characteristics and alarm characteristics of the equipment must be checked
before each use to ensure equipment is in good working condition.

9.1 Check interval


The check before use shall be carried out in the following conditions:
 Before the using of the first patient;
 Before the using of the every patient;
 After maintenance, servicing, cleaning and disinfection;
 After repairing.

9.2 System check


 Components are installed and connected tightly and correctly;
 Breathing tubes are in good condition and connection connected tightly and correctly;
 Vaporizer is locked to the position and filled with enough and correct vaporizer;
 Gas supply is correctly connected;
 When using central gas supply, the valve of reserve gas cylinder shall be closed;
 Plug the mains plug of power supply cord into mains socket-outlet on the wall tightly. Press
starting switch, Anaesthesia System screen shall be lighted.

9.3 Check power failure alarm


 Connect to mains power, power supply indicator is lighted, turn on the starting switch, the
Anaesthesia System runs. The power state indication place will display the signal of “ ”or
“ ”.
 Disconnect power supply cord from mains power. The Anaesthesia System is automatically
switched to the mode of operation with back-up battery. At this time, there will be a sound alarm
and the power state indication place will display the signal of “ ”.
 Reconnect to mains power, sound alarm disappears and the power state indication place will
display the signal of “ ” or “ ”.

9.4 Gas supply check


9.4.1 Air source check
 The gas supply pressure of central gas supply system shall be 440 kPa±160 kPa (280 kPa - 600
kPa);
 Gas cylinder in using and reserve gas cylinder all shall be full state;

35
 The reserve gas cylinder should be able to supply gas normally;
 Close the valve of reserve gas cylinder.
9.4.2 Leakage check
 Rotate the flow control knob of flowmeter clockwise, close O2 ,N2O and AIR flow;
 Switch on O2 , N2O and AIR resource respectively;
 After the indication value of corresponding O2, N2O and AIR pressure meter on the anesthesia
system is stabled, close air resource;
 Observe O2 , N2O and AIR pressure meter, the indication value thereof drops shall be no more
than 10 kPa in one minute;
 If the indication value thereof drops in one minute is greater than 10 kPa, it shows there is air
leakage, the air leakage position shall be checked and renovated;
 There may exist at air leakage position:
——Connection position between high pressure gas hose and pressure regulator;
——Connection position between high pressure gas hose and corresponding gas inlet port on
anesthesia system;
——Pressure regulator;
——High pressure gas hose;
——Flowmeter is not closed;
——Oxygen flush valve is not closed by itself.
Hint:
Air leakage may be at:
1. Connection ports of each breathing tube;
2. Each connection tube and port;
3. Breathing reservoir bag is broken;
4. Breathing tube is broken;
5. “APL”valve is not closed
6. CO2 absorber is leak.

9.4.3 Oxygen flush valve check


 Press oxygen flush switch, high flow gas shall outflow the fresh gas outlet.
 Loosen oxygen flush switch, the flow shall be stopped.
9.4.4 Anoxic alarm and N2O truncation check
 Adjust the flow rate of O2 and N2O to about 2 L/min;
 Alarm and N2O truncation:
——Cut off O2 supply ;
——Observe O2 pressure meter. When O2 pressure drops to about 220kPa, the alarm duration is
not less than 7 seconds;
——N2O pressure and flow rate reduces till it is shut off;
 Restore of O2 and N2O supply:
36
——Gradually increase O2 pressure;
——Observe O2 pressure meter. When O2 pressure raise to about 180kPa, sound alarm shall be
stopped;
——N2O pressure and flow rate recover to normal status.
9.4.5 Flow rate control check

Warning:

O2 and N2O proportion control can not substitute O2 monitor. Even if O2 ,N2O proportion control check
shows normal, the O2 monitoring device complying with the provision of EN ISO 80601-2-55 shall
also be used to monitor gas transmitted to patient.

 Adjust O2 and N2O flow rate control knob, flow rate shall can reach full range, buoy in the flow
rate tube shall move freely;
 When flow rate increase, O2 and N2O proportion control check is carried out:
——Rotate O2 and N2O flow rate control knob clockwise to the end, O2 and N2O flow rate all
are zero;
——Counter clockwise and slowly rotate N2O flow rate control knob;
——Adjust N2O flow rate respectively in accordance with flow rate in the following table, O2
flow rate shall be greater than corresponding the lowest limit;

N2O flow rate The lowest limit of O2 flow rate


(L/min) (L/min)

0.8 0.2

2.0 0.5

4.0 1.0

10 2.5

 When flow rate reduces, O2 , N2O proportion control check shall be carried out:
——Adjust N2O flow rate to 9 L/min;
——Adjust O2 flow rate to over 3 L/min;
——Clockwise and slowly rotate O2 flow rate control knob;
——Adjust O2 flow rate respectively in accordance with flow rate in the following table, N2O
flow rate shall be less than corresponding the highest limit;

N2O flow rate The highest limit of O2 flow rate


(L/min) (L/min)

2.0 8.0

1.0 4.0

0.2 0.8

37
9.5 Anaesthetic breathing system check
9.5.1 Inhalation, exhalation flap check
 Rotate selection knob of “bag/vent” to “ ”;
 Breathing reservoir bag connection port and patient connection port (“Y” connector) are all
connected with breathing reservoir bag;
 Press oxygen flush button to fill breathing reservoir bag;
 Repeatedly manually pinch the breathing reservoir bag to simulate the breathing status of
patients:
—— During exhalation, flap flake of exhalation flap rise, inhalation flap drop;
—— During inhalation, flap flake of inhalation flap rise, exhalation flap drop;
 Opening and closing of inhalation and exhalation flap shall be flexible, free.
9.5.2 Leakage check
 Rotate selection knob of “bag/vent” to “ ”;
 Close “APL” valve;
 Breathing reservoir bag connection port is connected with reservoir bag;
 Block up the patient connector (“Y” connector );
 Press oxygen flush button, breathing reservoir bag start to inflate;
 When indicated value of airway pressure gauge is 30 cmH2O, loosen oxygen flush button;
 Observe airway pressure gauge, the drop of pressure indicated value in one minute shall be no
more than 4 cmH2O;
 If the drop of pressure indicated value in one minute is greater than 4 cmH2O, it shows there is
air leakage, air leakage point shall be checked and renovated.
Hint:
Air leakage may be at:
1. Connection ports of each breathing tube;
2. Each connection tube and port;
3. Breathing reservoir bag is broken;
4. Breathing tube is broken;
5. “APL” valve is not closed;
6. CO2 absorber is leak.

9.5.3 “APL” valve check


 Rotate the “bag/vent” selection knob to“ ”;
 Block up the connection port of breathing reservoir bag;
 Block up patient connector(“Y” connector);
 “APL” valve is closed:
——Adjust gross flow rate of fresh gas to about 3 L/min;
——The indicated value of airway pressure gauge shall be no more than 85 cmH2O
(Pressure fluctuation belongs to normal phenomenon);

38
 “APL” valve is completely opened:
——Adjust gross flow rate of fresh gas to about 3 L/min;
——The indicated value of airway pressure gauge shall be about 0 cmH2O;
——Press oxygen flush button;
——The indicated value of airway pressure gauge shall be no more than 5 cmH2O.
9.5.4 Breathing bellow check
 Rotate “bag/vent” selection knob to“ ”;
 Block up patient connector (“Y” connector);
 Press oxygen flush button to fully fill breathing bellow;
 The indicated value of airway pressure gauge shall be no more than 2 cmH2O;
 Loosen oxygen flush button;
 Adjust gross flow rate of fresh gas to about 0.5 L/min;
 The buffer pocket of breathing bellow shall not drop;
 Any drop of the buffer pocket of breathing bellow shows there is air leakage and the air
leakage point shall be checked and renovated.
Hint:
Air leakage point may be at:
1. Connection ports of each breathing tube;
2. Each connection tube and port;
3. Breathing tube is broken;
4. Air leakage of CO2 absorber;
5. The bellows cover is not wrenched tightly;
6. Bellow and buffer pocket is broken.

9.5.5 Manual ventilation check


 Rotate “bag/vent” selection knob to“ ”;
 Close “APL” valve;
 The connection port of breathing reservoir bag and patient connection port (“Y” connector) are
respectively connected with reservoir bag;
 Press oxygen flush button to fill breathing reservoir bag;
 Press oxygen flush button to make two breathing reservoir bags inflated to about a half;
 Repeat manually pinch reservoir bag on the breathing reservoir bag connection port;
 The reservoir bag on the patient connector (“Y” connector) shall inflate or shrink.
9.5.6 CO2 absorbent check
 After completing each case, increase and check CO2 absorbent.
 The volume of discoloring absorbent do not exceed a half of volume.

39
9.6 Vaporizer check
 Before the perfusion of liquid medicine, check concentration adjust knob, it shall be with free
rotation, self locking and reliable interlocking unit;
 Observe fluid level gauge, perfused liquid medicine shall be between the highest and lowest fluid
level;
 Dosing knob, dosing screw shall be tightened without leakage.

9.7 Anesthesia ventilator check


 Rotate “bag/vent” selection knob to“ ”;
 Patient connector (“Y” connector) is connected with test lung;
 Adjust gross flow rate of fresh gas to 0.5L/min;
 Press oxygen flush button to fully fill breathing bellow;
 Open Anaesthesia System power supply;
 The parameters of Anaesthesia System ventilation is set as:
——tidal volume :500 mL
——frequency:12 /min;
——inspiratory to expiratory time ratio(I:E):1:2
 Start-up Anaesthesia System;
 The rise and drop of Anaesthesia System bellow shall be normal;
 The monitoring value display of ventilation parameters shall be correct;
 Adjust gross flow rate of fresh gas to 0.5 L/min;
 The monitoring value display of ventilation parameters shall be correct;
 The exhalation end pressure is about 2 cmH2O.

40
9.8 Alarm function check
 Rotate “bag/vent” selection knob to“ ”;
 Patient connector (“Y” connector) is connected with test lung;
 Adjust gross flow rate of fresh gas to 0.5 L/min;
 Press oxygen flush button to fully fill breathing bellow;
 Open Anaesthesia System power supply;
 Basic ventilation parameters set as:
——Tidal volume: 500 mL
—— Frequency: 12 /min;
——Inspiratory to expiratory time ratio(I:E):1:2
 Check the “MV high !!” alarm
——Set upper alarm limit value of MV as 8.0 L/min;
——Adjust tidal volume and frequency to ensure that the MV is slightly greater than or equal to
the set upper alarm limit value of MV;
——AN325-A displays the following medium priority alarm message “MV high !!”.
 Check the “MV low !! ”alarm
——Set the lower alarm limit value of MV as 6.0 L/min;
——Adjust tidal volume and frequency to ensure that the MV is slightly less than or equal to the
set lower alarm limit value of MV;
——AN325-A displays the following medium priority alarm message “ MV low !!” .
 Check the “PAW high !!! ”alarm
——Set the upper limit value of airway pressure as 20 cmH2O;
——Adjust tidal volume and airway resistance to ensure that airway pressure is slightly greater
than or equal to the set upper limit value of airway pressure;
——AN325-A displays the following high priority alarm message “PAW high !!!”;
——After the “PAW high !!!” alarm, inhalation state shall be switched to exhalation state and
airway pressure shall be no more than 100 cmH2O.
 Check the” PAW low !!!”alarm
——Set the lower limit value of airway pressure as 0 cmH2O:
——Adjust tidal volume and airway resistance to ensure that the airway pressure is slightly less
than or equal to the set lower limit value of airway pressure;
——AN325-A displays the following high priority alarm message “PAW low !!!”.
 Check “NO VT !!” alarm
——When beginning to expire, disconnect the breathing pipe and the flow sensor.
——Delay time is less than 6s, AN325-A displays the following medium priority alarm message
“NO VT !!”.
 Check “Apnea !!” alarm
——When beginning to expire, disconnect the breathing tube and the flow sensor.
——AN325-A displays the following medium priority alarm message “Apnea !!”, delay time
is about 30s, after 2 minutes, there will be a message “Apnea>2 minutes”.
 Check the continuous pressure alarm
41
——Set PEEP as 0 cmH2O;
——Observe airway pressure gauge, pinch flow sample tube to ensure airway pressure is more
than 15 cmH2O and delay16s;
——AN325-A displays the following high priority alarm message ” Pcon high !!!” .
 Check the “ FiO2 high !!!” alarm
——Put O2 sensor in air;
—— set upper limit value of O2 concentration as 20%;
——AN325-A displays the following high priority alarm message “FiO2 high !!! ” .
 Check “FiO2 low !!!” alarm
——Put O2 sensor in air;
——set lower limit value of O2 concentration as 22%;
——AN325-A displays the following high priority alarm message “FiO2 low !!!” .
 Check “O2 supply low !!” alarm
——Oxygen pressure regulation is lower than 180kPa;
——AN325-A displays the following medium priority alarm message “O2 supply low !!” .
 Check “Vte high!!” alarm
——Set upper alarm limit value of Vte as 500 mL;
——Reset Vte to make the Vte greater than or equal to the upper limit of Vte;
——AN325-A displays the following medium priority alarm message “Vte high!!”.
 Check “Vte low!!” alarm
——Set lower alarm limit value of Vte as 300 mL;
——Reset Vte to make the Vte less than or equal to the lower limit of Vte;
——AN325-A displays the following medium priority alarm message “Vte low!!”.
 Check “Freq high!!” alarm
——Set upper alarm limit value of frequency as 20/min;
——Reset frequency to make the frequency greater than or equal to the upper limit of frequency;
——AN325-A displays the following medium priority alarm message “Freq high!!”.
 Check “Freq low!!” alarm
——Set lower alarm limit value of frequency as 10/min;
——Reset frequency to make the frequency less than or equal to the lower limit of frequency;
——AN325-A displays the following medium priority alarm message “Freq low!!”.
 Check “etCO2 high!!” alarm
——Set upper alarm limit value of etCO2 as 100mmHg;
——Reset etCO2 to make the etCO2 greater than or equal to the upper limit of etCO2;
——AN325-A displays the following medium priority alarm message “etCO2 high!!”.
 Check “etCO2 low!!” alarm
——Set lower alarm limit value of etCO2 as 50mmHg;
——Reset etCO2 to make the etCO2 less than or equal to the lower limit of etCO2;
——AN325-A displays the following medium priority alarm message “etCO2 low!!”.
42
 Alarm shall be sound alarm and alarm hint;
 Check mute
——When an alarm occurs, the alarm will resume within 2 minutes by pressing audio paused key

“ ” (Item 2 in Fig. 4);


——If the alarm fault is not get rid of, then about 2 minutes later, this sound alarm continues;
—— When the sound alarm pause, alarm hint still exist unless fault is eliminated.

43
10. Operation
Warning:
1. At any time, the equipment shall has independent ventilation method in use (for example, be
equipped with simple breather with mask).
2. Before use and operation, please carefully read the user’s manual and strictly carry out use and
operation as specified.
3. If alarm occurs in use, it shall be treated. At first, protect the safety of patient, then carry out fault
diagnosis or necessary service.
4. In use, proper anesthesia, ventilation parameters and alarm parameters shall be set in accordance
with the conditions of patient.
5. Although the equipment has taken full consideration of the clinic security in design, operator still
must not neglect the observation for equipment’s work state and the monitoring for patient’s
psychological function parameters, only by this, once mistake or function abnormity occurs, it can
be rapidly correct.
6. In use, breathing tube (threaded pipe) shall be placed carefully, prevent duct from falling off ,
winding or suffocating patient .
7. In using anaesthetic gas, dry CO2 absorbent will be dangerous. Proper prevention measures shall
be adopted to ensure that absorbent will not run dry. After using the system, shuting off all the air
resource is an important measure of preventing absorbent run dry.
8. In use, the stability, equalizing of the equipment shall be paid attention to so as to prevent tilting.
9. According to requirements of IEC 60601-2-13 standards, when using anesthesia system, it shall be
used with the following monitoring:
——CO2 monitor;
——O2 monitor;
——Exhalation gas volume monitor;
——Anaesthetic gas monitor(when using vaporizer).
10. According to requirements of IEC 60601-2-13 standards, when using anesthesia system, it shall
be further used with anaesthetic gas scavenging system-transfer and receiving system.
 According to the different configuration of gas module and system function, the user interface will
be different, mainly reflected in the parameter and waveform display area.
 The user interface can be roughly divided into the following categories:
——Self-testing interface;
——Standby interface;
——Waveform interface;
——All parameter interface;

44
10.1 Start-up system
 Connect the power and gas source.
 Insert the power cord into the AC power supply inlet socket (Item 1 in Fig.5) and make sure that
the power supply indicator (Item 8 in Fig.4) lights;
 Switch on the Anaesthesia System, then the machine will enter the “Self-test” interface, Refer to
Fig.10.

.
Fig.10 Self-test interface
 When Self-test is finished, the machine will enter “Standby” interface. Refer to Fig.11.

Fig.11 Standby interface

45
10.2 Manual mode
10.2.1 Enter manual mode 300
600
900
1200
1500

 Turn the ACGO selection knob to position " ".


 Enter manual mode, turn the "bag/vent" selection knob (Item 10 in Fig.2) on the anaesthetic
breathing system to position " ", the equipment automatically enters manual mode.
 See Fig.12 for interface of manual mode.

Fig.12 Manual mode interface


10.2.2 Manual ventilation
 Turn the “bag/vent” selection knob to position " ";
 Adjust O2 flow rate valve for required flow rate;
 Push the oxygen flush valve to ensure that the reservoir bag is moderately inflated;
 Adjust “APL” valve(adjustable pressure limit valve) to proper pressure limit value;
 Manually squeeze the bag frequently to execute manual ventilation for patient.

Note:
In manual ventilation, “bag/vent” selection knob of anaesthetic breathing system must be turned to
position “ ”.

46
10.3 Mechanical ventilation

 “ACGO” selection knob is turned to position “ ”.


 When “bag/vent” selection knob is turned to position “ ”, Anaesthesia System automatically
enters mechanical-controlled mode;
——If it is the first time to operate the mechanical-controlled mode, then operates in accordance
with the default ventilation mode(includes default ventilation parameters);
——If it is from standby, it shall also operate according to default IPPV mode;
——If it has operated the mechanical-controlled mode and it switched from manual mode, then it
shall operate according to the original mode;
 Enter such mechanical ventilation mode as IPPV,A/C, SIMV, PCV, PSV, etc.:
——Ventilation mode can be selected under the mechanical-controlled mode. Or ventilation
mode can be preset under the manual-controlled mode;
——Enter corresponding mechanical ventilation mode according to the steps of “select
ventilation mode” and press the adjustment/confirmation knob to conform. Refer to Fig.13.

Fig.13 Operation interface

1 Exhaled/inhaled status 2 Alarm display area 3 Function status display


display area area

4 Waveform display area 5 Adult/Paed. mode and ventilation 6 Gas intake pressure
parameters display area monitoring area

7 Parameter monitoring area 8 Power indication, date setting area 9 Standby key

10 System Setting key 11 Freeze key 12 Audio paused key

13 Graph display area 14 Ventilation parameter setting area

47
10.4 Selection of Adult/Paed. mode
 Enter the surface of Adult/Paed. mode selection
——Switch on the anesthesia system, the machine enters Adult/Paed. mode selection surface
after finishing self-test;

——Press ” ” key (Item 6 in Fig.4) on the operation panel about 4s, and the machine enters
Adult/Paed. mode selection surface.
——See Fig.11 for interface of Adult/Paed. mode selection.
 Choose Adult/Paed. mode
——Turn the knob (Item 9 in Fig.4) to Adult/Paed. button and press the knob (Item 9 in Fig.4) to
choose Adult/Paed. mode.
——After the item selected, turn the knob (Item 9 in Fig.4) to confirm button and press the knob
(Item 9 in Fig.4) to enter Adult/Paed. mode.
——Then the machine will work under chosen mode.

Note:
The item selected is in opposite color.

48
10.5 Setting of ventilation mode and parameters
 Enter the surface of setting of ventilation mode and parameters
——Switch on the anesthesia system, choose Adult/Paed. mode and press the knob(Item 9 in
Fig.4) to enter the surface ;

——After start-up system, press the " " key (Item 3 in Fig.4) to enter to reset the ventilation
mode and parameters.
 Ventilation mode selection:
——Turn the knob (Item 9 in Fig.4) to IPPV or A/C or SIMV or PCV or PSV button and press the
knob (Item 9 in Fig.4) to choose required mode;
——The setting of Paed. ventilation mode and parameters are same as adult, Fig.14,15,16,17,
18 are the ventilation mode and parameters setting surfaces under IPPV, A/C, SIMV , PCV,
PSV mode.
——After the item selected, turn the knob (Item 9 in Fig.4) to confirm button and press the knob
(Item 9 in Fig.4) to enter the required mode surface.
 Setting of parameter:
——Under the required mode, turn the knob (Item 9 in Fig.4) to the required parameter and
press the knob (Item 9 in Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) for setting (The parameter value
increases in the clockwise direction and decreases in the counterclockwise direction.);
——Press the knob (Item 9 in Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) to confirm button and press the knob
(Item 9 in Fig.4) to enter relevant mode surface.
——The machine will work under the set mode and parameters.

Note:
The machine will work under the former ventilation mode and parameters when make the settings.

Fig.14 Setting of mode and parameter under IPPV

49
Fig.15 Setting of mode and parameter under A/C

Fig.16 Setting of mode and parameter under SIMV

50
Fig.17 Setting of mode and parameter under PCV

Fig.18 Setting of mode and parameter under PSV

51
10.6 Reset of alarm parameter
 Reset of alarm parameter:
——Enter the relevant surface of ventilation mode, if you don’t want to use the previous alarm
parameters or default alarm parameters, you can reset alarm parameters;

——In operation, if it is necessary to change the alarm parameters, press the " " key (Item 5
in Fig.4) to enter the alarm setting surface, and then the parameters can be set again, as
shown in figure 19.
 Setting alarm parameters:
——Turn the knob (Item 9 in Fig.4) to the required alarm parameter and press the knob (Item 9 in
Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) for setting (The parameter value
increases in the clockwise direction and decreases in the counterclockwise direction.);
——Press the knob (Item 9 in Fig.4) for confirmation;
——Repeat the previous step if next alarm value need to be adjusted;
——Turn the knob (Item 9 in Fig.4) to confirm button and press the knob (Item 9 in Fig.4) to exit
the setting surface;
——The machine will work under the set alarm parameters.

Fig.19 Setting of alarm parameter surface (IPPV、A/C、PCV)(1)

Fig.19 Setting of alarm parameter surface (SIMV、PSV)(2)

52
 Current alarm information

——In operation, if you want to view the alarm information, press the " " key (Item 5 in Fig.4)
to enter the alarm setting surface, as shown in Fig.19;
——Turn the knob (Item 9 in Fig.4) to Curr. Alm and press the knob (Item 9 in Fig.4) to enter the
current alarm information surface. Refer to Fig.20;

——Turn the knob (Item 9 in Fig.4) to“ ”or“ ”button and press the knob (Item 9 in Fig.4)
check current alarm information;
——After checking current alarm information, turn the knob (Item 9 in Fig.4) to Exit button and
press the knob (Item 9 in Fig.4) to exit the setting surface.

Fig.20 Setting of current alarm information surface


 Recent alarm information

——In operation, if you want to view the alarm information, press the " " key (Item 5 in Fig.4)
to enter the alarm setting surface, as shown in Fig.19;
——Turn the knob (Item 9 in Fig.4) to Rec. Alm and press the knob (Item 9 in Fig.4) to enter the
recent alarm information surface. Refer to Fig.21;

——Turn the knob (Item 9 in Fig.4) to“ ”or“ ”button and press the knob (Item 9 in Fig.4)
check recent alarm information;
——After checking recent alarm information, turn the knob (Item 9 in Fig.4) to Exit button and
press the knob (Item 9 in Fig.4) to exit the setting surface.

Fig.21 Setting of recent alarm information surface

53
 Alarm log information

——In operation, if you want to view the alarm information, press the " " key (Item 5 in Fig.4)
to enter the alarm setting surface, as shown in Fig.19;
——Turn the knob (Item 9 in Fig.4) to Info and press the knob (Item 9 in Fig.4) to enter the alarm
log information surface. Refer to Fig.22;

——Turn the knob (Item 9 in Fig.4) to“ ”or“ ”button and press the knob (Item 9 in Fig.4)
check alarm log information;
——After checking alarm log information, turn the knob (Item 9 in Fig.4) to Exit button and press
the knob (Item 9 in Fig.4) to exit the setting surface.

Fig.22 Setting of alarm log information surface

Note:
1. The system can store up to 1000 records of alarm log. When a new alarm log occurs after 1000
events are already stored, the new alarm log overwrites the earliest one.
2. Alarm log displays the most recent record at the top.
3. The alarm log can be maintained after power failure, and the time of power failure can be captured
by the alarm log.
4. If both AC power and battery are powered off , the alarm logs will not be lost.

54
10.7 Reset of system setting
 Reset of system setting:
——Enter the relevant surface of ventilation mode, if you don’t want to use the previous mode or
default system setting, you can reset system setting;

——If need to change system setting, press the " " key (Item 4 in Fig.4) to enter system
setting surface, and then the system can be set again, see Fig.23.

Fig.23 System setting surface(Graph)


 Operation of all parameter function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Loop button and press the knob (Item 9 in Fig.4) to select
the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose ON or OFF;
——Press the knob (Item 9 in Fig.4) for confirmation;
——Turn the knob (Item 9 in Fig.4) to Exit button and press the knob (Item 9 in Fig.4) to exit the
setting surface, the machine will work with the chosen loop display. The display zone of the
loop of the machine surface is switched to all parameter display.
 Operation of Graph function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Graph button and press the knob (Item 9 in Fig.4) to
select the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “CO2-T” or “V-T”;
——Press the knob (Item 9 in Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface, the machine operates with the chosen graph
display.

55
 Operation of language function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to ENV button and press the knob (Item 9 in Fig.4) to enter
setting surface see Fig.24;
——Turn the knob (Item 9 in Fig.4) to Lang button and press the knob (Item 9 in Fig.4) to select
the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose required Lang;
——Press the knob (Item 9 in Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface, The machine operates in the adjusted working
environment.
 Operation of day and night function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to ENV button and press the knob (Item 9 in Fig.4) to enter
setting surface see Fig.24;
——Turn the knob (Item 9 in Fig.4) to DayNight parameter box and press the knob (Item 9 in
Fig.4) to confirm;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “Day” or “Night”;
——Press the knob (Item 9 in Fig.4) for confirmation;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface. The machine operates in the adjusted working
environment.

Fig.24 System setting surface(working environment)

56
 Operation of O2 concentration calibration function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to FiO2 cal. button and press the knob (Item 9 in Fig.4) to
enter O2 concentration calibration surface, see Fig. 25;
——Put the O2 sensor in air;
——Turn the knob (Item 9 in Fig.4) to 21% button and press the knob (Item 9 in Fig.4) to
calibrate O2, until the screen displays "Complete ";
——Take out the reservoir bag and install the O2 sensor;
——The “bag/vent” selection knob is revolved to “ ”position;
——Remove breathing tube (Item 6 in Fig.9) ;
——Adjust O2 flow valve to 10 L/min;
—— Push oxygen flush valve about 10s;
——Turn the knob (Item 9 in Fig.4) to 100% button and press the knob (Item 9 in Fig.4) to
calibrate O2, until the screen displays "Complete”;
——After calibration, turn the knob (Item 9 in Fig.4) to Exit button and press the knob (Item 9 in
Fig.4) to exit the oxygen concentration calibration surface.

Fig.25 System setting surface(O2 concentration calibration)


 Operation of CO2 Module setting function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to CO2 Module parameter box and press the knob (Item 9 in
Fig.4) to select the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “ON” or “OFF”;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface.
 Operation of CO2 Unit setting function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to CO2 Unit parameter box and press the knob (Item 9 in
Fig.4) to select the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “mmHg” or “Vol.%”;

57
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface.
 Operation of CO2 Zero setting function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to CO2 Zero parameter box and press the knob (Item 9 in
Fig.4) to select the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “CO2 Zero”;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface.
 Operation of locking/unlock setting function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to LockSta parameter box and press the knob (Item 9 in
Fig.4) to select the parameter box;
——After parameter box selected, turn the knob (Item 9 in Fig.4) to choose “Locking” or
“Unlock”;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the setting surface.

Fig.26 System setting surface(Other)


 Operation of Graphic
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to Data button and press the knob (Item 9 in Fig.4) to enter
the graphic in the data page, see Fig.27;

58
Fig.27 Data page (Graphic)

59
 Operation of Tabular
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Other button and press the knob (Item 9 in Fig.4) to enter
other settings page, see Fig.26;
——Turn the knob (Item 9 in Fig.4) to Data button and press the knob (Item 9 in Fig.4) to enter
the tabular in the data page, see Fig.28;

Fig.28 Data page (Tabular)


 Operation of Patient information setting function
——Enter system setting surface, see Fig.23;
——Turn the knob (Item 9 in Fig.4) to Pati Info button and press the knob (Item 9 in Fig.4) to
enter the surface, see Fig.29;
——Turn the knob (Item 9 in Fig.4) to Age or Weight or Bed Num. parameter box and press the
knob (Item 9 in Fig.4) to select the parameter box;
——After the item selected, turn the knob (Item 9 in Fig.4) to the required parameter;
——Press the knob (Item 9 in Fig.4) to select the adjusted parameters;
——After the item selected, turn the knob (Item 9 in Fig.4) to Exit button and press the knob
(Item 9 in Fig.4) to exit the surface.

Fig.29 System setting surface(Patient information)

60
10.8 Operation of IPPV mode
 Enter IPPV mode:
——Enter the setting of mode and parameter under IPPV, see Fig.14;
——Turn the knob (Item 9 in Fig.4) to Confirm button and press the knob (Item 9 in Fig.4) to
enter surface of IPPV mode, see Fig.30.

Fig.30 Surface of IPPV mode

Note:
When the Anaesthesia System is working, the “bag/vent” selection knob must be turned to “ ”
position, “ACGO” selection knob must be turned to “ ” position.
300
600
900
1200
1500

61
10.9 Operation of PCV mode
 Enter the mode of PCV:
——Enter the setting of mode and parameter under PCV, see Fig.17;
——Turn the knob (Item 9 in Fig.4) to Confirm button and press the knob (Item 9 in Fig.4) to
enter surface of PCV mode, see Fig.31.

Fig. 31-1 Surface of PCV-PC mode

Fig. 31-2 Surface of PCV-VG mode

62
10.10 Operation of A/C mode
 Enter the mode of A/C:
——Enter the setting of mode and parameter under A/C, see Fig.15;
——Turn the knob (Item 9 in Fig.4) to Confirm button and press the knob (Item 9 in Fig.4) to
enter surface of A/C mode, see Fig.32.

Fig.32-1 Surface of V-A/C mode

Fig.32-2 Surface of P-A/C mode

63
10.11 Operation of SIMV mode
 Enter the mode of SIMV
——Enter the setting of mode and parameter under SIMV, see Fig.16;
——Turn the knob (Item 9 in Fig.4) to Confirm button and press the knob (Item 9 in Fig.4) to
enter surface of SIMV mode, see Fig.33.

Fig.33-1 Surface of V-SIMV mode

Fig.33-2 Surface of P-SIMV mode

64
10.12 Operation of PSV mode
 Enter the mode of PSV:
——Enter the setting of mode and parameter under PSV, see Fig.18;
——Turn the knob (Item 9 in Fig.4) to Confirm button and press the knob (Item 9 in Fig.4) to
enter surface of PCV mode, see Fig.34.

Fig. 34 Surface of PSV mode

65
10.13 Operation of apnea function
Note:
Only under the mode of SIMV and PSV, apnea time can be set.

 Before choose of apnea mode, please set the proper ventilation parameters under the mode of
A/C.
 Enter the alarm setting surface and set the apnea time under mode of SIMV and PSV.
 If there is no spontaneous or assisted ventilation during apnea time, the mode will change to A/C,
and there is alarm indication of Apnea!!! (Red color).
 If there are 3 times of Spontaneous ventilation after change mode to A/C, the mode will change
to the former ventilation mode, and there is alarm indication of Apnea!!!.

Note:
When apnea time is set to OFF, there will be no apnea ventilation or apnea alarm indication.

10.14 Operation of SIGH function


 Under the mode of IPPV, choose sigh function and set times of sigh.

10.15 Operation of Audio paused function


 When an alarm occurs, the alarm will resume within 2 minutes by pressing audio paused “ ”
(Item 2 in Fig.4), after mute time (2 minutes), alarm will remain unless the problem is solved
properly.

 When the sound alarm is muted, the alarm indication “ ” on the screen will remain unless the
problem is solved properly.

10.16 Oxygen flush valve


 Press the oxygen flush valve (Item 7 in Fig.1) to provide high flow rate of O2 to anaesthetic
breathing system or ACGO;
 Loosen the oxygen flush valve, oxygen flow stops.

Note:
When open the oxygen flush valve, pay attention that airway pressure cannot be too high.

10.17 Oxygen flow rate adjustment


 The volume of oxygen flow rate is decided by consumption of patient and leakage volume of
whole breathing circuit ,etc;
 In mechanical ventilation:
——The buffer pocket of breathing bellow shall inflate to the top at the end of each breathing;
——If the buffer pocket of breathing bellow falls at the end of each breathing, then the oxygen
flow rate shall be increased.

66
10.18 Auxiliary common gas outlet (optional)
 Screw the selection knob to the position of "ACGO".

 Deliver fresh gas via "ACGO".

 The screen displays “ACGO” when using under ACGO. All of the monitoring parameters
disappear.

 When “ACGO” selection knob returns to the position of “ ”, the ventilator will do the
Self-testing again, and come back to the standby mode.

10.19 Use of N2O


When using N2O:
 Open N2O flow rate valve to maximum at first;
 Then adjust O2 flow rate valve to the needed flow rate and proportion of O2 and N2O.

Warning:
1. In using N2O, O2 concentration should not be lower than 25%.
2. O2 and N2O proportion control cannot substitute the O2 monitor .

10.20 Anaesthesia
 In accordance with requirements, adjust flow rate of fresh gas (generally, flow rate is 0.5 L/min
-1L/min);
 Turn the concentration adjustment knob to required concentration;
 After using, turn the concentration adjustment knob clockwise to position “0”.

Warning:
Concentration adjustment of the vaporizer shall not be less than 0.2%. If it is less than 0.2%, output
concentration of anaesthetics is unstable.

Note:
See user’s manual for use of vaporizer.

67
10.21 Pressure limit adjustment and discharge of manual
ventilation
During manual control ventilation,
 When it is needed to adjust pressure limit value of anaesthetic breathing system:
——Observe the airway pressure gauge (Item 5 in Fig.1);
——As manually pinches breathing reservoir bag, rotate “APL” valve(adjustable pressure limit
valve) knob:
a)rotate clockwise to increase pressure limit value of breathing system;
b)counter clockwise rotate to reduce pressure limit value of breathing system
Until airway pressure reached the needed value, then the equipment starts to discharge.
 When the equipment need to completely discharge:
——Counter clockwise rotate “APL” valve knob to completely open;
——After completion of discharge, rotate clockwise knob, adjust “ APL” valve to required
pressure limit value or completely close.

68
11. Operation of anaesthetic gas scavenging
system-transfer and receiving system(optional)
Warning:
1. The largest continuous or intermittent flow of ventilation system used with exhaust gas transfer
and receiving system shall not be over 60L/min, otherwise it will overflow.
2. The suction flow rate of processing system used with exhaust gas transfer and receiving system
shall not be less than 75L/min.
 Connect the negative pressure air supply properly;
 Adjust the flow regulating valve so that the suction flow rate is between the high and low flow
signs.

12. The end of use


It shall be carried out according to the following procedures after completion of use:
 Rotate vaporizer concentration adjustment knob to “0”;
 Close the flowmeter:
—— at first close N2O flowmeter;
——secondly, close O2 flowmeter;
 Close power supply of anesthesia ventilator;
 Remove power cord;
 Close air resource, remove high pressure gas hose;
 Pressure relief of anesthesia system:
——Revolves “ bag/vent” breathing selection knob to “ ” position;
—— counter clockwise rotate “APL” valve (adjustable pressure limit valve) knob to completely
open, carry out discharge (sound alarm is given in discharge process is normal
phenomenon );
——After completion of discharge, rotate clockwise knob, adjust “APL” valve to required
pressure limit value or completely close .

69
13. Cleaning and disinfection
Warning:
1. Do not use talc, zinc stearate, CaCO3, cornstarch or similar material, which will enter the lung or
Respiratory tract of the patient.
2. Seeping liquid into the control assembly can damage the equipment or cause personal injury.
When cleaning the housing, ensure that no liquid flows into the control assemblies and always
disconnect the equipment from the AC mains. Reconnect the AC mains after the cleaned parts are
fully dry.

Note:
1. Read the application scope and operation manual of the cleaning agent.
2. Read the operation manual of the disinfections equipment.
3. Do not use irritation cleaning agent of organic, halogenated, or petroleum Solvent, anesthesia
agent, detergent for glass, acetone.
4. Please wear necessary protective equipment, such as work clothes, masks, hats, splash screens,
safety gloves and glasses. A damaged O2 sensor can leak and cause burns(contains potassium
hydroxide).
5. Reuse of undisinfected reusable accessories or components may cause cross-contamination.
6. Do not use abrasive cleaning agents (such as steel wool, sliver polish or cleaner).
7. Put the liquid from the electronic parts.
8. No liquid into the inner of machine.
9. Do not flush or blow the inner cylinder of the flow sensor with rapid water or high-pressure gas;
10. The pH value of cleaning agent must be between 7.0 and 10.5.
11. Do not sterilize the flow sensor with high temperature steam.
12. After Clean and disinfection, check the machine according to the Chapter of Check before
operation.

13.1 The methods of clean and disinfection


 Some of the machine's parts can be cleaned and disinfected. Different parts of the machine
should be disinfected using different methods. You need to select the appropriate method to
clean and disinfect the parts based on the actual situations to avoid cross-contamination
between the user and the patient.
 On the premise of ensuring the safety of operators, the procedures of thorough cleaning and
disinfection should be followed. The following table is our recommended clean and disinfection
methods for the parts.

70
Clean Disinfection
Part Frequency ① ②
A Wipe B Immersion
Wipe Immersion
Equipment enclosure
External
machine
Before the
surface
using of the
Touch screen
first patient
External ① A
and after the
anesthesia
using of the
respiratory
every patient
system
surface
Gas supply
High pressure
air hose
Before the
High pressure
using of the ② B
N2O hose
first patient
High pressure
O2 hose
Anesthesia respiratory system
Reservoir bag ② B
Silicone
② B
bellow
CO2 absorber Before the ② B
using of the
Inhalation,
first patient
exhalation ① A
and after the
flap
using of the
Breathing
every patient ② B
bellow
Water trap ② B
Folding bag ② B
Others
Before the Refer to the cleaning and disinfection methods provided by the
O2 sensor
using of the O2 sensor manufacturer
first patient
and after the Refer to the cleaning and disinfection methods provided by the
CO2 sensor
using of the CO2 sensor manufacturer
every patient
Clean methods:
1 Wipe: wipe with a damp cloth immersed in alkalescent detergent (soapy water, etc.) or
alcohol solution, and then wipe off the remaining detergent with a dry lint free cloth.
2 Inmmersion: flush with water first and then immerse it in alkalescent detergent(soapy
water, etc., water temperature of 40℃ recommended) for approximately three minutes.
Finally, clean with water and dry completely. When the breathing tube is immersed in the
detergent, there should be no dead bend in the tube, and there should be no bubbles in the
cavity of hollow articles.
Methods for disinfection:
A Wipe:wipe with a damp cloth immersed in medium or high efficiency detergent and then wipe
off the remaining detergent with a dry lint free cloth.
B Immersion: immerse it in medium or high efficiency detergent for more than 30minutes. Then
clean with water and dry completely. When the breathing tube is immersed in the detergent,
there should be no dead bend in the tube, and there should be no bubbles in the cavity of
hollow articles.

71
13.2 Cleaning and disinfecting agents and efficient
disinfection methods
 The table below lists the cleaning and disinfecting agents and efficient disinfection methods that
may be used on the machine.

Item Explanation
Ethanol (75%) Moderately efficient disinfectant
Soapy water (The pH value is 7.0 - 10.5) Rinsing agent
Pure water Rinsing agent

13.3 Using times for the reusable part


In normal use, without damage:
 Inhalation connector, exhalation connector, high-pressure tube, reservoir bag, inhalation flap,
exhalation flap, CO2 absorber, pressure relief valve, folding bag, exhalation valve (except gasket
and "O" ring), exhaled tidal volume sampling tube and water trap can be used with unlimited
times.
 Exhalation valve (gasket and "O" ring) and silicone bellow can be replaced every year or
operation over 2500 hours.

72
14. Maintenance
Warning:
1. Do not use the equipment with fault.
2. If fault occurs in equipment, then it shall be serviced by authorized professional technicians of our
Company. If users need to service by themselves, the service shall be carried out by trained,
qualified and competent technicians. If necessary, our company may provide necessary information.
3. Calibration of components of equipment shall be carried out by authorized professional
technicians of our Company, or by trained, qualified and competent technicians.
4. Do not throw away the replaced battery into fire in maintenance and servicing so as to avoid
blasting; do not open or destroy battery, since it contain hazard substance and may damage skin
and eyes; nor throw away freely so as to avoid polluting the environment. It shall be sent to
manufacturer to recover or disposed according to the requirements of local environmental laws and
regulations.
5. Do not throw away the replaced electric and plastic parts freely in maintenance and servicing so
as to avoid polluting the environment. It shall be handled according to the requirements of local
environmental laws and regulations.
6. Our company will provide circuit diagrams, component part lists, descriptions, calibration
instructions to assist service personnel, to repair those parts of the equipment that are designated
by our company as repairable by SERVICE PERSONNEL.

Note:
After maintenance and servicing, the equipment check shall be carried out according to the steps of
“check before use".

14.1 Before everyday operation


 Before first operation, clean the surface of the machine everyday.

 Pour out the water in the water trap (Item 11 in Fig.2) of the machine.

14.2 After operation of every patient


 Do disinfection after operation of every patient.

14.3 When needed


 Calibrate the O2 sensor, see subclause 10.7.

 CO2 sensor zero calibration, see subclause 10.7.

 Check the equipotential terminal.

 Charge the backup battery, see subclause 8.2.5.

14.4 When Assembling after washing and disinfection


Check the folding bag, gasket of exhalation valve and “O” ring and other part when doing assemble
after disinfection. If any part is broken, replace it immediately.

73
14.5 Operation over 1200 hours or 6 months
 Every 6 months or over 1200 hours, take out the filter. Assemble it after removing the dust and
other things.

14.6 Every year or operation over 2500 hours


 Maintain, and check the machine completely;
 Replace the gasket, O type circle, silicone tube and PU tube;
 Check and calibrate:
——Vaporizer;
—— Flow meter;
—— Pressure gauge;
—— Exhalation gas volume(tidal volume , minute MV) monitor;
—— Pressure monitor.
 To ensure continued safe use of this equipment, open the top cover by tools, then touch the
protective earth by a screwdriver to check its connection reliability every year. Pull out the
appliance plug from the mains supply socket-outlet firstly.

14.7 Every two years or operation over 5000 hours


Every two years or operation over 5000 hours, check and calibrate every pressure limit valves.

74
14.8 Maintenance intervals table
The following table provides an overview of the maintenance intervals for AN325-A.
NO. Frequency Content Personnel Method
Before the using of
1 Check before use Operator See clause 9
the first patient
Before the using of Check before use
2 Operator See clause 9
the every patient
After maintenance, Check before use See clause 9
3 servicing , cleaning Operator
folding bag, gasket and “O” ring See clause 14.4
disinfection
4 After repairing Check before use Operator See clause 9
Cleaning and disinfection for high See subclause
5 Used for the first time Operator
pressure O2, N2O and Air hose 13.1
Before the using of Equipment enclosure
the first patient and External anesthesia respiratory See subclause
6 Operator
after the using of the system surface 13.1
every patient O2 sensor and CO2 sensor
Before everyday See subclause
7 Cleaning for equipment surface Operator
operation 13.1
Cleaning and disinfection for
equipment surface, “Y” connector,
inhalation connector, exhalation
connector, high pressure tube,
reservoir bag, Inhalation, exhalation See subclause
8 After each use Operator
flap, CO2 absorber, pressure relief 13.3
valve,exhalation valve (except
gasket and "O" ring), exhalation tidal
volume sampling tube and water
trap.
The backup battery should be See subclause
Operator
charged 8.2.5
See subclause
Calibrate the O2 sensor Operator
10.7
9 When needed
See subclause
CO2 sensor zero calibration Operator
10.7
Check connection reliability of the Service See subclause
equipotential terminal personnel 14.3
Every 6 months or Remove the dust and other things of Service See subclause
10
over 1200 hours the filter personnel 14.5
Check connection of protective Service See subclause
11 Every year
earth reliability personnel 14.6
Maintain, and check the machine Service See subclause
completely personnel 14.6
Replace the gasket, O type circle, Service See subclause
Every year or
silicone tube and PU tube personnel 14.6
12 operation over 2500
Check and calibrate vaporizer, flow
hours
meter, pressure gauge, exhalation Service See subclause
gas volume(tidal volume , minute personnel 14.6
MV)monitor and pressure monitor
Every two years or
Check and calibrate every pressure Service See subclause
13 operation over 5000
limit valves personnel 14.7
hours
Service See subclause
14 Every 3 ~ 6 years Replace Li-ion battery
personnel 8.2.7

75
Use time of the
battery in fully Service See subclause
15 Replace Li-ion battery
charged is less than 1 personnel 8.2.7
hour or when it fails
No using for a long It should be discharged in regular Service See subclause
16
time time personnel 8.2.6

Note:

1. Operator is a trained and qualified medical professional who operates this equipment.

2. Service personnel is an individual or entity who is trained by manufacturer and obtain


corresponding written authorization.

76
15. Alarm and solution system
Warning:
1. If there is alarm during the operation, safeguard the patient firstly, then check immediately to fix the
fault.
2. If power fails during operation, and the machine stop working, please do manual ventilation to the
patient.
3. When the alarm for under-voltage of the backup power battery is activated, indicating that the
backup power is running out, the system shall be immediately switched to be powered through AC
utility power. If it is impossible to switch to supply power through AC utility, turn off the Anaesthesia
System and conduct manual ventilation for the patient.
 If there is alarm during the operation, safeguard the patient firstly, then check immediately to fix
the fault.
——Revolves the “bag/vent” selection knob of anaesthetic breathing system to“ ”;
——Adjust O2 flow rate valve to the needed flow rate;
——Push oxygen flush button to ensure that manually controlled breathing reservoir bag is
moderately inflated;
——Adjust the “APL” valve (adjustable pressure limiting valve) to proper pressure limiting value;
——Manually pinching breathing reservoir bag may conduct manual ventilation to patients;
—— Or use the simple breather with mask to directly conduct manual ventilation.
 When the alarm condition occurs, the alarm should be actived immediately.
 When there are two or more alarms occur at the same time, the alarm is the high priority alarm.
 The position of the operators:
—— Visual alarm: The operator should be at a distance of 1 m from the display screen (in the
cone which is 30 ° against the center of the screen plane level);
—— Auditory alarm: The operator should be at a distance of 1 m from the front of equipment .
 Before and after the interruption of power supply, alarm default values will not change.
 Alarm default values must do with access change or storage change by a special tool.
 The volume of the auditory alarm signal:
high priority: 68 db middle priority: 68 db low priority: 68 db
 Alarm indicator: yellow, 0.625 Hz flashing frequency, 50% duty cycle.
 The alarm priority is classified by the risk level to the patient.
 The high priority alarm should be disposed immediately.
 When an ALARM CONDITION is short duration, high priority, medium priority and low priority
auditory ALARM SIGNAL completes one full BURST.
 Alarm priority:

Priority Alarm way

High Continuous and repeated ten tones and with 7 second interval

Medium Continuous and repeated three tones and with 23 second interval

Low Odd tune

77
 Alarm categories:

Physiological alarms: It also called patient status alarms, are triggered by a monitored parameter
value that violates set alarm limits or an abnormal patient condition.

Technical alarms: It also called system status alarms, are triggered by a device malfunction or a
patient data distortion due to proper operation or mechanical problems.

Prompt messages: As a matter of fact, prompt messages are not alarm messages. Apart from the
physiological and technical alarm messages, the S9130 will show some messages telling the
system status.
 Physiological alarm messages:

Default
Alarm Priority Setting range Alarming way
value

When the monitoring value is


greater than or equal to the
2 cmH2O - 100
High Ppeak alarm High 50 cmH2O upper limit of Ppeak, there will
cmH2O
be a sound alarm and display
“PAW high!!!”.

When the monitoring value is


less than or equal to low limit
Low Ppeak alarm High 0cmH2O - 98 cmH2O 10 cmH2O of Ppeak, there will be a sound
alarm and display “ PAW
low!!!”.

When the monitoring value is


0.2 L/min, greater than or equal to upper
High MV alarm Medium 0.5 L/min - 100 20 L/min limit of MV, there will be a
L/min sound alarm and display “MV
high!!”.

When the monitoring value is


less than or equal to low limit
Low MV alarm Medium 0 L/min - 99 L/min 0 L/min
of MV, there will sound alarm
and display “MV low!!”.
If there is no tidal volume (≤5
No tidal volume mL) in 6 seconds, there will be
Medium -- --
alarm a sound alarm and display “No
Vt!!”.
When the monitoring value of
O2 concentration is greater
than or equal to the upper limit
High O2 alarm High OFF, 19%-100% 100%
of O2, there will be a sound
alarm and display “FiO2
high!!!”.

78
Default
Alarm Priority Setting range Alarming way
value

When the monitoring value of


O2 concentration is less than
or equal to low limit of O2
Low O2 alarm High 18%-99% 18%
concentration, there will be a
sound alarm and display “FiO2
low!!!”.

When the monitoring value of


Vte is greater than or equal to
High Vte alarm Medium 5 mL - 1600 mL 1000mL the upper limit of Vte, there will
be a sound alarm and display
“Vte high!!”.

When the monitoring value of


Vte is less than or equal to low
Low Vte alarm Medium 0 mL - 1595 mL 50mL limit of Vte, there will be a
sound alarm and display “Vte
low!!”.

When the monitoring value of


etCO2 is greater than or equal
OFF, 22 mmHg - 99
High etCO2 alarm Medium 60 mmHg to the upper limit of etCO2,
mmHg
there will be a sound alarm
and display “etCO2 high!!”.

When the monitoring value of


etCO2 is less than or equal to
OFF, 1 mmHg - 60
Low etCO2 alarm Medium OFF low limit of etCO2, there will be
mmHg
a sound alarm and display
“etCO2 low!!”.

When the monitoring value is


greater than or equal to upper
High Freq alarm Medium 4 /min - 100 /min 40 /min limit of Freq, there will be a
sound alarm and display “Freq
High !!!”.

When the monitoring value is


less than or equal to low limit
Low Freq alarm Medium 2 /min - 98 /min 2 /min
of Freq, there will sound alarm
and display “Freq Low !!!”.

If the airway pressure


(PEEP+1.5kPa) over or under
the set upper or low limit of
Continuous
High -- -- continuous pressure alarm in
pressure alarm
16 seconds, there will be a
sound alarm and display “Pcon
high!!!”.

79
Default
Alarm Priority Setting range Alarming way
value

If there is no spontaneous or
assisted ventilation during
Apnea time, the mode will
change to AC, and there is
alarm indication “ Apnea !!!”
(Red color).
Apnea alarm Medium 5s - 60s OFF
If there are 3 times of
Spontaneous ventilation after
change mode to AC, the mode
will change to the former
ventilation mode, and there is
alarm indication “ Apnea !!!

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 Technical alarm messages

Default
Alarm Priority Setting range Alarming way
value

When Main power is not


connected or fails, the back-up
Power failure
Low -- -- battery is working, there will be
alarm
a sound alarm and display the
signal of “ ”.

When the voltage of back-up


The battery is
battery is low (10V±0.3V), the
running out High -- --
display shows "The battery is
alarm
running out!!!.

When the voltage of back-up


battery is low (10.6V ± 0.2V),
Low voltage the power state indication
Medium -- --
alarm place will display the signal of
“ ” , and there will be a
sound alarm.
When the fan doesn't work, the
screen will display the signal
Fan failure Medium -- --
of "Fan failure!!", and there will
be a sound alarm.
When the input pressure of the
gas supply is less than
Oxygen deficiency ncy 180kpa, the screen will display
Medium -- 180 kPa
alarm the signal of "O2 supply low !!",
and there will be a sound
alarm.

When the absorber is not


connected or the absorber is
No absorber not locked, the screen will
High -- --
canister alarm display the signal of "No
absorber canister!!!", and there
will be a sound alarm.

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 Cause of alarm and solution of the alarm:

Alarm Cause Solution of alarm

1 Block of breathing circuit pipe


1 Check the breathing circuit pipe
2 Block of patient airway.
High Ppeak 2 Check the patient status
alarm 3 Upper limit of alarm is too low.
3 Re-set the upper limit of alarm.
4 Ventilation parameters are set
4 Reset ventilation parameters.
improperly.

1 Leakage or disconnection of
breathing circuit pipe 1 Check and reconnect the pipe.
Low Ppeak
2 Low limit of alarm is too high. 2 Reset the low limit of alarm
alarm
3 The compliance of patient 3 Check the patient status.
changes.

1 Upper limit of MV alarm is too


low. 1 Reset the upper limit of MV alarm.
High MV alarm
2 High frequency or High tidal 2 Reset frequency or tidal volume
volume

1 Low limit of MV is too high.


2 Leakage or disconnection of 1 Reset the low limit of MV.
breathing circuit pipe 2 Check and reconnect the pipe.
Low MV alarm 3 Low frequency or Low tidal 3 Reset frequency or tidal volume
volume 4 Check the input gas supply
4 No input gas 5 Check the flow sensor
5 Problem with flow sensor

High O2
1 Upper limit of alarm is too low. 1 Reset the upper limit of O2.
concentration
2 Problem with O2 sensor 2 Re-adjust the O2 sensor.
alarm

Low O2
1 Low limit of alarm is too high. 1 Reset the low limit of O2 alarm.
concentration
2 problem with O2 sensor. 2 Calibrate the O2 sensor.
alarm

High etCO2 1 Upper limit of alarm is too low. 1 Reset the upper limit of etCO2.
alarm 2 problem with CO2 sensor. 2 Check the CO2 sensor.

Low etCO2 1 Low limit of alarm is too high. 1 Reset the low limit of etCO2 alarm.
alarm 2 problem with CO2 sensor. 2 Check the CO2 sensor.

1 Upper limit of alarm is too low.


1 Reset the upper limit of Vte
High Vte alarm 2 Flow sensor sampling tube
2 Check the flow sensor sampling tube
failure

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Alarm Cause Solution of alarm

1 Low limit of alarm is too high.


1 Reset the low limit of Vte.
2 Problem with breathing tube
2 Check the breathing tube
Low Vte alarm 3 Block of patient airway
3 Check the patient status
4 Flow sensor sampling tube
4 Check the flow sensor sampling tube
failure

1 Upper limit of alarm is too low. 1 Reset the upper limit of Freq
High Freq alarm
2 Change of patient's condition 2 Check the patient status

1 Low limit of alarm is too high. 1 Reset the low limit of Freq.
Low Freq alarm
2 Change of patient's condition 2 Check the patient status

1 gas supply pressure is too low 1 Adjust gas supply pressure within
Oxygen 440 kPa± 160 kPa
deficiency 2 The output pressure of the
alarm pressure reducing valve of the gas 2 Adjust pressure regulator to make sure
cylinder is too low that the output pressure is 440 kPa

1 Problem with breathing circuit


pipe 1 Check and reconnect the pipe

Continuous 2 Block of patient airway 2 Check the patient status


pressure alarm 3 Alarm limit of is too low 3 Reset the alarm limit
4 Ventilation parameters are set 4 Reset the ventilation parameters
improperly.

1 Main power disconnection or


Power 1Check the main power supply
problem
failure alarm 2 Replace the fuse
2 Problem with fuse

The battery is
1 The system shall be switched to AC in
running out 1 The battery is running out
time and the battery shall be charged.
alarm

1 Change the power supply to main


Alarm of low
power. If you cannot switch to AC power,
voltage of 1 Low voltage of battery
please turn off the anesthesia system and
battery
turn on the manual mode for the patient.

Fan failure 1 Fan doesn’t work. 1 Change the fan.

1 Absorber canister is unlocked


No absorber 1 Check the absorber canister
2 Absorber canister is
canister alarm 2 Install the absorber canister
disconnected

83
16. Troubleshooting
Fault Cause Solution way

There is no 1 The main power is off 1 Check the power supply in the
display on screen 2 Power line disconnection working place
and Anaesthesia 2 Connect the power line
System do not 3 The switch of Anaesthesia System
work. is off. 3 Switch on the Anaesthesia
4 Fuse is broken System
4 Change the fuse

Abnormal display 1 Leakage of breathing circuit pipe 1 Re-connect or change pipe


of tidal volume 2 Leakage of exhalation valve 2 Check exhalation valve

Air leakage of 1 “APL” valve is not closed 1 Close “APL” valve


anaesthetic 2 CO2 absorber is not tightly 2 Reinstall and clean out foreign
breathing system installed matter of seal washer of CO2
3 Breathing tube damage or absorber
connector is loosened 3 Replace new tube or reinstall
4 Damage of breathing reservoir 4 Replace air bag
bag 5 Replace new flap cover or
5 Inhalation, exhalation flap cover is repressed
damaged or unpressed

At the end of 1 Over fast selected breathing rate 1 Reset proper breathing rate
exhalation, at the bigger tidal volume 2 Open flow rate control valve
breathing buffer 2 Flow rate control valve is not switch or adjust proper flow rate
pocket of bellow opened or flow rate is too small 3 According to the method of “air
can not expand 3 Air leakage of breathing circuit leakage of anaesthetic breathing
to top or 4 Buffer pocket of bellow is system” to check and treat
gradually drop damaged or detached 4 Check and replace buffer pocket
of bellow

During inhalation, 1 “bag/vent” selection knob is still 1 Switch the selection knob to
buffer pocket of at position “bag” “ventilator”
breathing bellow 2 Airway blocking 2 Check and get rid of
is not
compressed or
compress range
is not enough

Difficult drench of 1 Evaporation concentration 1 Evaporation concentration


vaporizer adjustment knob did not adjustment knob revolves to 0 or
revolve to“0”, or drenching is drenching is carried out 2 minute
carried out at once after the knob after drenching
revolved to “0”. 2 The perfusion port’s screw is not
2 The perfusion port’s screw is not loosened
loosened

84
Fault Cause Solution way

Without 1 Flow rate control valve is not 1 Adjust flow rate control valve
concentration opened, without flow rate output 2 Dosing
output of 2 No liquid medicine
vaporizer

85
17. Main technical specification
17.1 Environment conditions
 Working environment
Ambient temperature 5℃- 40 ℃
Relative humidity ≤80 %
Atmospheric pressure 860 hPa - 1060 hPa
 Storage environment
Ambient temperature -20 ℃ - +50 ℃
Relative humidity ≤93%
Atmospheric pressure 500 hPa - 1060 hPa

17.2 Classification
Classified according to IEC 60601-1, AN325-A belong to:
 Class I equipment, internally powered equipment;
 Typed B equipment, the breathing tubes are the applied parts of AN325-A;
 Common equipment;
 No use flammable anaesthetic;
 Continuous operation;
 please refer to the Chapter “Cleaning and disinfection”
 Steam and high heat pressure resistant or may be sterilized(please refer to“ cleaning and
disinfection ”of the user’s manual).

86
17.3 Driving gas
17.3.1 Gas circuit diagram
Fig. 35 is gas circuit diagram of system

Fig.35 Gas circuit diagram

87
17.3.2 Gas supply
 Gas source O2 Vmax=120L/min (For medical use)
N2O Vmax=20L/min (For medical use)
Air Vmax=20L/min (For medical use)
 Rated working pressure 440 kPa
 Input pressure range 280 kPa - 600 kPa
 Output pressure of regulator
(gas cylinder supply) less than 440 kPa
 Safety valve 750kPa
 Negative pressure air source ≥75 L/min

17.3.3 Flow rate


 Adjust range of flow meter
O2 0 L/min - 15 L/min
N2 O 0 L/min - 12 L/min
AIR 0 L/min - 15 L/min
 Precision (20℃ 101.3kPa, supply pressure 440 kPa)
The precision from 10 % of full scale to full scale is ±10 % of indicated value
The precision lower than 10 % of full scale is class 4.
 Linkage control of O2 and N2O flow rate
Adjust O2 concentration to no less than 25 % according to proportion.
 Flow rate of oxygen flush valve 25 L/min - 75 L/min
 Output pressure for fresh valve 30 kPa - 45 kPa
17.3.4 Power supply
 Voltage 100-240 V ~
 Frequency 50/60 HZ
 Input power 38VA
 Fuse
——Main power T2AH 250V
——Internal power T4AH 250V

88
17.4 Electromagnetic compatibility
Warning:
1.Cell phone and other radiation equipment used near the machine will cause unexpected problem to
the Anaesthesia System. If there is radio frequency radiation source nearby, working status of the
equipment should be monitored.
2. The other equipment added to Anaesthesia System will lead to disturbance to the machine. Before
used to the patient, check if the machine work normally under the set values.

Note:
1. Without our company agreement to change the equipment, may cause electromagnetic
compatibility problem of this equipment or other equipment.
2. Design and test of this equipment comply with regulations of electromagnetic compatibility.

17.5 Anaesthetic breathing system


 Volume 3500 mL(includes bellow and CO2 absorber)
 CO2 absorber 1500 mL/piece
 System compliance 2.2 mL/cmH2O
 Resistance

30 L/min 60 L/min

Inhalation 2 cmH2O 4 cmH2O


resistance
Exhalation
2.5 cmH2O 5 cmH2O
resistance

 Exhalation flap(damp non-return valve)resistance 1 cmH2O(60 L/min , 35 ℃)


 Exhalation flap(damp non-return valve)open pressure 0.8 cmH2O(20 mL/min 35 ℃)
17.6 Anaesthetic gas discharge port
Anaesthetic gas discharge port is a 30mm outer cone connector complying with ISO 5356-1, which is
used to be connected with the anaesthetic gas scavenging system - transfer and receiving system
complying with ISO 80601-2-13.

17.7 Ventilation mode


——Intermittent positive pressure ventilation (IPPV)
——Pressure control- assistant/control ventilation(P-A/C)
——Volume control- assistant/control ventilation(V-A/C)
——Pressure control- Synchronized intermittent mandatory ventilation(P-SIMV)
——Volume control- Synchronized intermittent mandatory ventilation(V-SIMV)
——Pressure control ventilation - pressure control(PCV-PC)
——Pressure control ventilation - volume guaranteed(PCV-VG)
——Pressure support ventilation(PSV)

89
17.8 Ventilation parameters
17.8.1 Specification
Parameter Setting range Step Allowable error
0,20 mL - 1500 mL
Tidal volume And: Adult:10 mL ±(10 mL +10% setting
(VT) Adult:300 mL - 1500 mL Paed:5 mL value)
Paed:0,20 mL - 300 mL
Sigh OFF, 1 (/100) - 5 (/100) 1 /100
Apnea time OFF, 5 s - 60 s 1s
1 /min - 100 /min
And:
Under SIMV :1 /min - 40
Frequency /min 1/min ±1 /min or ±10 %
All mode except SIMV:
Adult:4 /min - 40 /min
Paed:10 /min - 100 /min;
Inhalation time(I:E) ±15 % or ±0.1 s, whichever
4:1 - 1:8(0.2s - 12s)
(Tinsp) is the greater.
OFF, 5 % - 60 %
Holding time
inhalation time
(Inhalation platform) 0.1 s ±8 %
(TIP)
±2.5 cmH2O or ±7 %
10 cmH2O - 100 cmH2O
Pressure limit 1 cmH2O setting value, whichever is
(1 kPa - 10 kPa)
the greater
±2.5 cmH2O or ±7 %
Pressure control 5 cmH2O - 70 cmH2O
1 cmH2O setting value, whichever is
(Pc) (0.5 kPa - 7.0 kPa)
the greater
±2.5 cmH2O or ±7 %
0 cmH2O - 30 cmH2O
PEEP 1 cmH2O setting value, whichever is
(0 kPa - 3 kPa)
the greater
Pressure support ±2.5 cmH2O or ±7 %
5 cmH2O - 70 cmH2O
(Ps) 1 cmH2O setting value, whichever is
(0.5 kPa - 7.0 kPa)
the greater
Pressure support ±2.5 cmH2O or ±7 %
5 cmH2O - 70 cmH2O
level 1 cmH2O setting value, whichever is
(0.5 kPa - 7.0 kPa)
(ΔPs) the greater
﹣20 cmH2O - 0 cmH2O
(﹣2.0 kPa - 0 kPa)
Pressure trigger ±(1 cmH2O +10% setting
Under PEEP :﹣20 1 cmH2O
(PTr) value)
cmH2O - 0 cmH2O(﹣2.0
kPa - 0 kPa)

Flow trigger OFF, 0.5 L/min~30 L/min 0.5 L/min >3.0 L/min,±20 %;
≤3.0 L/min,±0.6 L/min
±0.1or ±(10% setting
Rise time 0.1 s - 2 s 0.1 s
value)
Expiratory trigger 10 % - 85 % 1% ±(1% +10% setting value )
Maximum limit
≤12.5 kPa
pressure

90
Explanation:
1. Set pressure limit value to produce maximum working pressure (the upper limit of high airway
pressure alarm).
2. Do not use negative pressure at exhalation.
3. Maximum limit pressure is pressure of the safety valve.

17.8.2 Driven gas


 Gas source O2 (For medical use)
 Rated working pressure 440 kPa
 Input pressure range 280 kPa - 600 kPa
17.8.3 Fresh gas compensation
 Compensation range 0L/min - 15 L/min
 Gas composition O2, N2O, AIR and anaesthetic

91
17.9 Ventilation parameter Monitoring
 The following are monitoring parameters under the environment of body temperature and
pressure-saturated.
 Minimum exhalation volume maybe monitored is 50 mL/min.
 Figure display:

Parameter Range Resolution Accuracy

Frequency(Freq) 0 /min - 120 /min 1 /min ±15 %

>100 mL:±20%
Tidal volume(VT) 0 mL - 3000 mL 10 mL
≤100 mL:±20mL
>1 L/min:±20%
Minute ventilation(MV) 0 mL-100L/min 0.1 L/min ≤1 L/min:±0.1 L/min or ±15%,
whichever is the greater

-20cmH2O -120 ±(4% full scale+4% actual


Ppeak 1 cmH2O
cmH2O reading)

±[2.5%(v/v)+2.5%
O2 concentration 15 % - 100 % 0.1 %
(concentration level)]

0.0 mmHg-114 ±[0.43%(v/v)+8%


etCO2 0.1 mmHg
mmHg (concentration level)]

1mL/ cmH2O
Compliance 1mL/ cmH2O
-1000mL/ cmH2O

 Waveform display:
——Time- airway pressure(under all modes)
——Time—flow(under all modes)
——Time—Volume or etCO2(under all modes)
——Pressure-volume loop, flow-volume loop, flow-pressure loop(all modes)
Remarks:The machine cannot record all the adjusting and monitoring values.

92
 The purpose and sensor position, type and sampling method of control, measurement and
display device

The purpose Sensor position Type Sampling method

Pressure- voltage and Choose average value


Airway pressure Exhaling end
simulated data from multiple sampling

Pressure- voltage and Choose average value


PEEP Exhaling end
simulated data from multiple sampling

Continuous Pressure- voltage and Choose average value


Exhaling end
pressure simulated data from multiple sampling

Choose average value


Freq Built-in Time and simulated data
from multiple sampling

Choose average value


Inhalation time Built-in Time and simulated data
from multiple sampling

Choose average value


Holding time Built-in Time and simulated data
from multiple sampling

Flow- voltage and Choose average value


Tidal volume Exhaling end
simulated data from multiple sampling

Exhaling end and Flow-voltage and Choose average value


Flow
inhaling end simulated data from multiple sampling

O2 concentration-voltage Choose average value


O2 concentration Inhaling end
and simulated data from multiple sampling

17.10 Monitoring equipment should be equipped in using


According to international standard, the equipment shall be used with the following monitoring
equipment:
 CO2 monitor (comply with requirements of ISO 80601-2-55);
 O2 monitoring device (comply with requirements of ISO 80601-2-55);
 Anaesthetic gas monitoring device (when using vaporizer)(comply with requirements of ISO
80601-2-55).

93
17.11 Anaesthesia System Circuit diagram
Fig.36 is Anaesthesia System’s circuit diagram.
1 Control panel of anesthesia ventilator
2 Display panel
3 Switch power supply
4 Oxygen concentration sensor
5 Loudspeaker
6 Proportional electromagnetic valve
7 Proportional electromagnetic valve
8 Fan 9 Battery 10 Starting switch
11 Socket with fuse and power filter
12 Display screen 13 Inverter
14 Key-press panel 15 Switch Panel

Fig.36 Anaesthesia System circuit diagram


17.12 Noise
 Noise under normal working condition is not more than 65dB(A).

18. Installation, conveying and moving


 The equipment shall be steady when installing, conveying or moving, in installation, the tilting of
the equipment shall not be greater than 5°.
 Before the anesthesia system is conveyed or moved, it shall:
——Dismantle all power wires, cables, pipe etc.
——Drawer shall be pushed to close.
 The mass of anesthesia system including its safe working load is 80kg.

Note:
1. When the anesthesia system is conveyed or moved, it shall:
——pay attention to keep steady to prevent from unbalanced.
2. Before the anesthesia system is conveyed or moved, it shall:
——dismantle all power wire, cable, pipe etc;
——drawer shall be pushed to close.

94
19. Storage and transportation
19.1 Storage
 The Anaesthesia System shall be stored indoors with ambient temperature of - 20℃ - 50℃,
relative humidity not exceeding 93% and atmospheric pressure at 500 hPa - 1060 hPa, free of
corrosive gases and not affected by strong magnetic field, and with good ventilation.
 When the anesthesia system is stored, the anaesthetics of vaporizer shall be drained and the
vaporizer shall be purged according to user’s manual of vaporizer.

19.2 Transportation
 Anaesthesia System to be transported shall be packed in package. Each set of machine shall be
secured in its package and soft material of adequate thickness shall be inserted in between the
package and product to protect against movement and rubbing against each other during
transportation. The package shall be protected from damp and rain to ensure that the product will
not be damaged in natural condition.
 The packed Anaesthesia System can be transported by general means. The product shall be
protected from rain, damp, corrosion and against strong vibration, turn over at handling is
forbidden.
 The Anesthesia System shall be transported at ambient temperature of -20℃ - 50℃, relative
humidity not exceeding 93% and atmospheric pressure at 500 hPa - 1060 hPa.
 Maximum load: top:20 kg, drawer:5 kg, workbench face:5 kg.

95
20. Waste disposal
20.1 Disposal of battery and O2 sensor
Warning:
1. Do not throw the battery or O2 sensor into the fire in case of explosive.
2. Do not open or destroy the battery and O2 sensor, because it contains injurant which may injure
skin and eyes.
3. Please dispose the battery and O2 sensor under the local environment law.
 For there is polluting material in battery, please dispose battery according to local environment
law.

 O2 sensor is special waste, do dispose it according to local environment law.

 Please refer to Environmental Protection Agency or government or waste disposal company for
relevant environment law.

20.2 Disposal of electronic and plastic parts


Warning:
Do not discard the broken electronic and plastic parts ignorantly for environment protection.
 Do not discard the broken electronic and plastic parts ignorantly for environment protection.
Please dispose them under the environment law.

20.3 Scrap disposal of medical equipment


When service life is over, do not dispose it as household waste, and dispose it separately.

 Please abide the local environment law for waste disposal.

 Please refer to Environmental Protection Agency or government or waste disposal company for
waste disposal.

96
20.4 Scrap disposal of packaging materials
Warning:
Don't discard packaging materials to avoid polluting the environment.

 Please abide the local environment law for waste disposal.

 Please refer to Environmental Protection Agency or government or waste disposal company for
waste disposal.

Table Disposal of packaging material

Method of disposal
Recycling Final disposal
Parts Material
Reusable Material Energy
Biodegradation Landfill Incineration
recycling recycling
Outer
packing Plywood √ √ √
box
Dust
HPPE √ √
cover
Tube
packing HPPE √
bag
Gasket EPE √ √ √

97
21. Others
 If complying with the rules of storage and transport and use, and the equipment can work
normally ,our company will repair it freely within one year from leaving factory.
 Please do not dismantle the equipment without authorization If faults occur on the equipment, it
shall be repaired by professional technical person authorized by our company .If users need to
repair by yourselves, it shall be carried out by trained, qualified and competent technical. IF
necessary, our company can provide necessary data.
 If AN325-A Anesthesia System and its accessories are at the end of their expected service life,
please do not use them and dispose them according to the requirements of local environmental
laws and regulations, AN325-A Anesthesia System expected service life is 8 years after delivery,
its accessories expected service life see their accompanying documents.

98
22. Check list
Warning:
If any check did not pass through, then the equipment shall not be used.
 Every day before use of the first patient and every patient, and after maintenance, service,
cleaning, disinfection and repairing, all the items shall be checked by experienced personnel
who are familiar with the equipment.
 The list can be copied as records of daily check, each function shall be marked after being
checked and passed.
System check
□ The installation and connection of components are well done;
□ Breathing tube are in good condition, and connection is secure and correct;
□ Vaporizer is well locked and is provided with enough and correct anaesthetic;
□ Gas supply connection is correct;
□ When using central gas supply, the cylinder valve shall be closed;
□ The plug of power cord is firmly connected with the power socket on the wall.

Check of power supply fault alarm


□ Connect mains power supply, the power indicator lights; switch on the starting switch, start-up the
Anaesthesia System. The symbol “ ” and “ ” will display on the screen.
□ Pull down the power cord from the socket, the equipment shall automatically switch to work with
battery, there will be a sound alarm and the symbol “ ” will display on the screen.

□ Reconnect mains power supply, sound alarm stops, “ ”or“ ” will display on the screen.

Gas supply check


 Gas supply check
□ Pressure of the central gas supply system is 440 kPa±160 kPa(280 kPa - 600 kPa);
□ The pressure of O2 cylinder shall be greater than 7000 kPa;
□ The pressure of N2O cylinder shall be greater than 4300 kPa;
□ The reserved cylinder shall be able to well supply gas;
Close the gas cylinder valve.

 Leakage check
□ Leakage check
——Close the flow rate of O2, N2O and AIR;
——Connect gas supply of O2 ,N2O and AIR step by step;
——After the indicated value of pressure gauge of O2, N2O and AIR on the anesthesia system are
stable, switch off the gas supply;
——Observe O2 or N2O pressure gauge, the indicated value shall drop not more than 10 kPa in 1
minute;

99
——If the drop of the indicated value is greater than 10 kPa, it indicates there is gas leakage, gas
leakage position shall be checked and restored.

 Check of oxygen flush valve


□ Press the oxygen flush valve switch, high gas flow shall flow from the fresh gas outlet;
□ Loosen the oxygen flush valve switch, gas flow shall stop.

 Check of flow rate control


□ Adjust the flow rate control knob of O2 ,N2O and AIR step by step, flow rate shall be able to reach
full scale, the floater in the flow meter tube shall float freely;
□ When flow rate increases, O2 and N2O proportion control check shall be carried out:
——Rotate O2 and N2O flow rate control knob clockwise to the end , flow rate of O2 and N2O are
both 0;
——Slowly rotate N2O flow rate control knob anticlockwise;
——Adjust N2O flow rate according to the following table respectively, O2 flow rate shall be greater
than corresponding lowest limit;

lowest limit of O2 flow rate


N2O flow rate L/min L/min

0.8 0.2

2.0 0.5

4.0 1.0

10 2.5

□ When flow rate decreases, O2 and N2O proportion control check shall be carried out:
——Adjust N2O flow rate to 9 L/min;
——Adjust O2 flow rate to more than 3 L/min;
——Clockwise and slowly rotate O2 flow rate control knob;
——Adjust O2 flow rate according to the following table respectively, N2O flow rate shall be lower
than corresponding highest limit;

highest limit of N2O flow rate


O2 flow rate L/min L/min

2.0 8.0

1.0 4.0

0.2 0.8

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 O2 deficiency alarm and N2O cut check
Adjust flow rate of both O2 and N2O to about 2 L/min;
□ alarm and N2O cut:
——Cut off O2 supply ;
——Observe O2 pressure gauge. When O2 Pressure drops to about 200kPa, sound alarm shall be
given with the continuous time of no less than 7 seconds ;
——Pressure and flow rate of N2O are reduced correspondingly until to be cut off;
□ Recovery of O2 and N2O supply :
—— Gradually increase O2 Pressure;
—— Observe O2 pressure gauge. When O2 Pressure rise to about 280kPa,sound alarm shall be
stop;
——Pressure and flow rate of N2O recover to normal state.

Vaporizer check

□ Check the concentration adjustment knob before perfusion of liquid medicine, the knob shall be
rotated freely, self-locking and Interlocking device shall be reliable;

□ Observe the fluid level gauge, perfused liquid medicine shall be between the highest and the lowest
level;

□ Dosing knob and dosing screw shall be tightened, leakage phenomenon shall not exist.

Anaesthetic breathing system check


□ Inhalation and exhalation valve check
—— Rotate “bag/vent” selection knob to “ ”;
—— Patient connector(“Y” connector )is connected with the breathing reservoir bag;
—— Press oxygen flush valve to ensure breathing reservoir bag full;
—— Repeatedly squeeze the breathing reservoir bag by hand to simulate the breathing state of
patients:
During exhalation, the flap of exhalation valve rises and the flap of inhalation valve drops;
During inhalation, the flap of inhalation valve rises and the flap of exhalation valve drops;
——Rise and drop of inhalation and exhalation flap shall move freely.
□ Leakage check
—— Rotate “bag/vent” selection knob to “ ”;
—— Close “APL” valve;
——The breathing reservoir bag connection port is connected with the reservoir bag;
—— Block off patient connector(“Y” connector);
——Press oxygen flush valve,the breathing reservoir bag starts to inflate;
——when the indicated value of airway pressure gauge is 30 cmH2O, loosen oxygen flush valve;
——Observe airway pressure gauge, drop of indicated value shall be no more than 4 cmH2O in 1
minute;
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——If the drop of indicated value is greater than 4 cmH2O, it indicates there is leakage, the
leakage position shall be checked and restored.
□ “APL” valve check
—— Rotate“ bag/vent” selection knob to “ ”;
——Block off the breathing reservoir bag connection port ;
——Block off the patient connector (“Y” connector);
——“APL” valve is closed:
Adjust gross flow rate of fresh gas to about 3 L/min;
The indicated value of airway pressure gauge shall be no more than 85cmH2O(pressure
fluctuation belongs to normal phenomenon );
——“APL” valve is completely opened:
Adjust gross flow rate of fresh gas to about 3 L/min;
The indicated value of airway pressure gauge shall be about 0 cmH2O;
Press oxygen flush valve;
The indicated value of airway pressure gauge shall be no more than 5 cmH2O.
□ Breathing bellow check
——Rotate “bag/vent” selection knob to “ ”;
——Block off the patient connector(“Y” connector);
—— Press oxygen flush valve to ensure that breathing bellow is filled;
——The indicated value of airway pressure gauge shall be no more than 2 cmH2O;
—— Loosen oxygen flush valve;
—— Adjust gross flow rate of fresh gas to about 0.5 L/min;
——Buffer pocket of breathing bellow shall not drop;
——If the buffer pocket of breathing bellow drop, it indicates there is gas leakage, the leakage
position shall be checked and restored .
□ Manual ventilation check
——Rotate “bag/vent” selection knob to “ ”;
—— Close “APL” valve ;
——The breathing reservoir bag connection port and patient connector (“Y” connector) are
respectively connected with the reservoir bag;
—— Press oxygen flush valve,the reservoir bag starts to be inflated;
—— Press oxygen flush valve to ensure that the two breathing reservoir bags are inflated to
about half;
——Repeatedly squeeze the reservoir bag on the reservoir bag connection port by hand;
——The reservoir bag on the patient connector(“Y” connector)shall inflate or shrink accordingly.
□ CO2 absorbent check(After each patient using,do check.)
The volume of discoloring absorbent shall not exceed a half.

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Anesthesia ventilator check
□ Anesthesia ventilator check
——Rotate “bag/vent” selection knob to “ ”;
—— Patient connector(“Y” connector)is connected with simulating lung;
——Adjust gross flow rate of fresh gas to 0.5L/min;
—— Press oxygen flush valve to ensure that breathing bellow is filled;
—— Open Anaesthesia System power supply;
——Anaesthesia System ventilation parameters are set as:
Tidal volume:500 mL
Frequency :12 /min;
inspiratory to expiratory time ratio:1:2
—— Start-up Anaesthesia System;
—— Rise and drop of Anaesthesia System bellow shall be normal ;
——Monitoring value of ventilation parameters shall correctly display;
——Adjust gross flow rate of fresh gas to 0.5 L/min;
——Monitoring value of ventilation parameters shall correctly display;
——The pressure at the end of exhalation is about 0 cmH2O.

Alarm function check


——Rotate “bag/vent” selection knob to “ ”;
——Connect the Y connector with simulating lung;
——Adjust gross flow rate of fresh gas to 0.5L/min;
—— Press oxygen flush valve to ensure that breathing bellow is filled;
——Switch on the Anaesthesia System;
——Set the ventilation parameters to the following value under mode IPPV (Adult);
Tidal volume:0.50 L
Frequency:12 /min;
I:E:1:2
□ Check for high MV alarm:
——Set the upper limit of MV to 8.0 L/min;
——Reset tidal volume and frequency to make the MV greater than or equal to upper limit of MV;
——When the MV is greater than or equal to 8.0 L/min, there will be an alarm for high MV alarm.
□ Check for low MV alarm:
——Set the lower limit of MV to 6.0 L/min;
——Reset tidal volume and frequency to make MV less than or equal to the lower limit of MV;
——When the MV is less than or equal to 6.0 L/min, there will be an alarm for low MV alarm.
□ Check for High Ppeak alarm:
——Set the upper limit of Ppeak to 20 cmH2O;

103
——Adjust tidal volume and airway resistance to make the Ppeak greater than or equal to the
upper limit;
——There will be alarm for High Ppeak alarm.
——When alarm for High Ppeak occurs, inhalation status should be turned to exhalation status
and airway pressure should be not more than 100 cmH2O.
□ Check for low Ppeak alarm:
——Set PEEP to 0 cmH2O;
——Squeeze the flow sampling tube, observe airway pressure and make it more than 15 cmH2O,
delay 16s, alarm for continuous pressure should occur.
□ Apnea alarm
——When start exhalation, disconnect breathing circuit pipe from the flow sensor.
——There will be alarm for apnea lasting for 30 seconds.
□ Check for continuous pressure alarm:
——When start exhalation, disconnect breathing circuit pipe from the flow sensor.
——After two respiratory cycles, there should be alarm for continuous pressure.
□ Check for High O2 concentration alarm:
——Put O2 sensor in air ;
——Set the upper limit of O2 concentration to 20%;
——There will be an alarm for high O2 concentration.
□ Check for low O2 concentration alarm:
——Put O2 sensor in air;
——Set lower limit of O2 concentration to 22%;
——There will be an alarm for low O2 concentration.
□ Check for no Vt alarm:
——When start exhalation, disconnect breathing circuit pipe from the flow sensor.
——Delay time is less than 6s. Alarm for no tidal volume shall occur.
□ Audio alarm and visual alarm shall be available.
□ Check for audio paused alarm:
——Press the audio paused key (Item 2 in Fig.4)when any sound alarm occurs, then the sound
alarm will pause about 2 minutes;
——If alarm condition does not disappear, the sound alarm will continue after 2 minutes;
——When sound alarm pauses, indicator alarm still exist, unless fault disappears.
□ Check for high Vte alarm:
——Set the upper limit of Vte to 500 mL;
——Reset Vte to make the Vte greater than or equal to the upper limit of Vte;
——When the Vte is greater than or equal to 500 mL, there will be an alarm for high Vte alarm.
□ Check for low Vte alarm:
——Set the lower limit of Vte to 300 mL;
——Reset Vte to make the Vte less than or equal to the lower limit of Vte;

104
——When the Vte is less than or equal to 300mL, there will be an alarm for low Vte alarm.
□ Check for high Frequency alarm:
——Set the upper limit of Frequency to 20/min;
——Reset frequency to make the frequency greater than or equal to the upper limit of frequency;
——When the frequency is greater than or equal to 20/min, there will be an alarm for high
frequency alarm.
□ Check for low Freq alarm:

——Set the lower limit of Frequency to 10/min;


——Reset frequency to make frequency less than or equal to the lower limit of frequency;
——When the frequency is less than or equal to 10/min, there will be an alarm for low frequency
alarm.
□ Check for high etCO2 alarm:
——Set the upper limit of etCO2 to 100mmHg;
——Exhale to the breathing tube;
——There will be an alarm for high etCO2 alarm.
□ Check for low etCO2 alarm:
——Set the lower limit of etCO2 to 50mmHg;
——Exhale to the breathing tube;
——There will be an alarm for low etCO2 alarm.
□ Check for low O2 supply alarm:
——Oxygen pressure regulation is lower than 180kPa;
——There will be an alarm for low O2 supply alarm.

105
23. Essential performance
Table 5 Distributed essential performance requirements
NO. Description for essential performance Test method Tester Recommended frequency
1. Anoxic alarm and N2O truncation protection
See sub-clause 9.4.4
against hazardous
2. “bag/vent” selection protection against hazardous See sub-clause 9.5.5
3. oxygen flush valve function See sub-clause 9.4.3
4. Power failure alarm See sub-clause 9.3
5. Low Paw alarm protection against hazardous See sub-clause 9.8 Every day before use of the first
6. High Paw alarm protection against hazardous See sub-clause 9.8 patient;
7. Maximum limited pressure protection against Every patient;
See sub-clause 17.8.1 Operator
hazardous After maintenance;
8. Adjustable pressure limitation protection against After cleaning and disinfection;
See sub-clause 9.5.3
hazardous After repairing.
9. Tidal volume protection against hazardous See sub-clause 9.8
10. Continuous pressure alarm protection against
See sub-clause 9.8
hazardous
11. High MV alarm protection against hazardous See sub-clause 9.8
12. Low MV alarm protection against hazardous See sub-clause 9.8
13. Accuracy of tidal volume(VT)( ±20% (>100 mL)
and ±0.02 L (≤100 mL) ) check protection
against hazardous
14. Accuracy of minute ventilation(MV)(±20% (>
1L/min) and ±0.1 L/min or ±15%, whichever is
the greater (≤1L/min) check protection against
hazardous Every year;
Manufacturer
15. O2 concentration monitoring range is 15 - After maintenance;
See sub-clause 17.9 or qualified
100 % ,and its accuracy is ±[2.5%(v/v)+2.5% After repairing.
third
(concentration level)]
16. CO2 concentration monitoring range is 0.0 mmHg
- 114 mmHg ,and its accuracy is ±[0.43%(v/v)+
8%(concentration level)]
17. Ppeak monitoring range is -20 cmH2O - 120
cmH2O ,and its accuracy is ±(4%full scale+4%
actual reading)

106
Thank you for using AN325-A Anesthesia System.
Please read the manual carefully before operation, and keep the manual properly
for reference.

Manufacturer: NARANG MEDICAL USA CORPORATION

Address: 3190 Willow In., Weston, Florida, 33331, USA

EMAIL: [email protected]

Phone: +1(754)9003330

Web: www.narang-usa.com

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