Anesthesia Machine - S6100 - Operation Manual - NML
Anesthesia Machine - S6100 - Operation Manual - NML
Operation Manual
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
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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
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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
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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.
“ 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
~ Alternating current
Gas inlet
Gas outlet
Signal inlet
Reservoir bag
Anesthesia Ventilator
Exhaust port
2
Graphs & Symbols Instructions
300
600
900
1200
1500
Audio Paused
Locking
Unlock
Inhale
Exhale
Upper limit
Lower limit
Network connector
VGA connector
Freeze
Protective earth
Equipotential terminal
Trigger mark
3
Graphs & Symbols Instructions
Standby
Parameters setting
System setting
Alarm setting
Date of manufacture
Manufacturer
This way up
Do not roll
4
Terms and abbreviation in this manual or on this equipment:
Terms and Abbreviation Explanation
MV Minute volume
Vt Tidal volume
Freq Frequency
Pc Pressure control
5
Terms and Abbreviation Explanation
Tapnea Apnea time
O2 Oxygen
DC Direct current
% Percent
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.
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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:
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
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
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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:
——apnea alarm;
——O2 monitor;
—— anaesthetic ventilator;
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.
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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.
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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:
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.
16
7.6 Anaesthetic breathing system
7.6.1 Function
Transmit the fresh gas(mixed gases) with anaesthetic gas to the patients;
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.
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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
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.
——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.
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.
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.
The outlet pressure for fresh gas is limited to 30kPa - 45 kPa by the pressure relief valve.
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.
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.
22
7.11 Connection port
7.11.1 Rear panel of Anaesthesia System
See figure 5.
23
7.12 Ventilation gas monitor (optional)
See the operation manual of ventilation gas monitor.
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.
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
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.
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.
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 “ ”.
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.
——Clean out the foreign matter attached on the sealing washer and sealing face;
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!
Note:
The reservoir bag shall comply with ISO 5362.
30
8.6 Connection of breathing tube
Connection of breathing tube see Fig. 9.
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).
Note:
Anaesthetic gas scavenging system-transfer and receiving system shall comply with ISO 80601-2-13.
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.
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.
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;
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;
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.
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.
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.
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
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.
45
10.2 Manual mode
10.2.1 Enter manual mode 300
600
900
1200
1500
Note:
In manual ventilation, “bag/vent” selection knob of anaesthetic breathing system must be turned to
position “ ”.
46
10.3 Mechanical ventilation
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
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.
49
Fig.15 Setting of mode and parameter under A/C
50
Fig.17 Setting of mode and parameter under PCV
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.
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.
——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.
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.
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.
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.
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.
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.
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;
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.
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.
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.
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.
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.
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.
When the sound alarm is muted, the alarm indication “ ” on the screen will remain unless the
problem is solved properly.
Note:
When open the oxygen flush valve, pay attention that airway pressure cannot be too high.
66
10.18 Auxiliary common gas outlet (optional)
Screw the selection knob to the position of "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.
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.
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.
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
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".
Pour out the water in the water trap (Item 11 in Fig.2) of the machine.
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.
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.
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:
High Continuous and repeated ten tones and with 7 second interval
Medium Continuous and repeated three tones and with 23 second interval
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
78
Default
Alarm Priority Setting range Alarming way
value
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 !!!
80
Technical alarm messages
Default
Alarm Priority Setting range Alarming way
value
81
Cause of alarm and solution of the alarm:
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.
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.
82
Alarm Cause Solution of alarm
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
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
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
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
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
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
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.
30 L/min 60 L/min
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.
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:
>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
±[2.5%(v/v)+2.5%
O2 concentration 15 % - 100 % 0.1 %
(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
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
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.
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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.
Please refer to Environmental Protection Agency or government or waste disposal company for
relevant environment law.
Please refer to Environmental Protection Agency or government or waste disposal company for
waste disposal.
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20.4 Scrap disposal of packaging materials
Warning:
Don't discard packaging materials to avoid polluting the environment.
Please refer to Environmental Protection Agency or government or waste disposal company for
waste disposal.
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 √ √ √
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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.
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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.
□ Reconnect mains power supply, sound alarm stops, “ ”or“ ” will display on the screen.
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;
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——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.
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;
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.
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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.
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——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;
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——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:
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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)
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Thank you for using AN325-A Anesthesia System.
Please read the manual carefully before operation, and keep the manual properly
for reference.
EMAIL: [email protected]
Phone: +1(754)9003330
Web: www.narang-usa.com