Beruflich Dokumente
Kultur Dokumente
ii
1 Introduction
9.3
Troubleshooting ..................................................................................................................... 9-4
9.3.1
Anesthesia machine ...................................................................................................... 9-4
9.3.2
Anesthetic Ventilator ...................................................................................................... 9-5
10
iii
1 Introduction
1.1
The anesthetic machine anesthetic machine is face to medium or micro hospital which has
a succinct and handsome exterior, perfect and reliable performance, and convenient for
operation, easy to learn. Anesthetic ventilator(ventilator for short) attributes to pneumatic and
electric control continuous gas flow anesthetic system in principle. It is equipped with airway which
can transfer O 2 , N 2 O and inhalation anesthetic drug and circuit which can control respiration and
monitor patient respiratory parameters.
Not all the optional functions available may be included in the manual. For more information with
respect to the existing product, please feel free to contact the local representatives.
WARNING: The user of the anesthetic machine must be professional and trained.
WARNING: The anesthetic machine is unsuitable for use in a magnetic resonance
imaging (MRI) environment.
1.1.2 Contraindication
The anesthetic machine is not to be used with patients who have pneumothorax
1-1
1.2
Symbols
WARNING and
CAUTION indicate all the possible dangers in case of violation of
the stipulations in this manual. Refer to and follow them.
Type B equipment
equipment
OFF only used in part of
Attention!
consult
accompanying document
equipment
Alternating Current
O2+
1-2
SN
Serial Number
Direct Current
Dangerous Voltage
Oxygen flush
Input
Equipotentiality
Output
Inspiration flow
Expiration flow
Lock
Unlock
1 Introduction
1.3
Variability,
adjustment
rotational
Bag operate
Bag operate
Alarm Silence
Battery
Date of manufacture
Address of manufacture
Definition, abbreviation
Not all of the following definition or abbreviation may necessarily appear in the equipment and
manual.
AGSS
APL
bpm
cmH 2 O
Centimeters of Water
CO 2
Carbon Dioxide
FiO 2
Freq.
Breath frequency
Flow-t
Flow-time waveform
I:E
IPPV
SIMV
SIPPV
SPONT
spontaneous ventilation
Liter
L/min
1-3
mL
Milli Liter
Manual
Manual ventilation
MV
Minute volume
N2O
Nitrous Oxide
O2
Oxygen
Paw
Pressure of airway
P peak
Peak pressure
P plat
Plat pressure
Paw-t
Pressure-time waveform
PEEP
Tp
Trig.
Flow Trigger
VT
Tidal Volume
1-4
2 Work Principle
The anesthetic machine is a continuous flow anesthetic system. It is equipped with airway which
can transfer O 2 , N 2 O and inhalation anesthetic drug. Airway part can use O 2 , N 2 O ,select to using
two anesthetic drug: enflurane and isoflurane, and the O 2 and N 2 O which need reduce to
280kPa~600kPa can enter into machine through high pressure pipeline. After through the
protective pressure reducer in the machine, O 2 enter into flowmeter, while N 2 O-cut valve can only
open when the pressure of O 2 more than 0.2MPa, and the N 2 O can enter into flowmeter.
Otherwise, N 2 O can not enter airway of the machine. The flow of O 2 and N 2 O can be adjusted by
the knob of flowmeter. Adjust O 2 and N 2 O proportionally to ensure the O 2 concentration is no less
than 25%. O 2 and N 2 O are mixed in the flowmeter, and the mixer gas can take away part of
anesthetic drug through anesthetic drug vaporizer then be transferred to patient breathing circle.
The O 2 from O 2 flush is transferred to patient breathing circle directly without via flowmeter and
vaporizer. And the mixer gas or O 2 in patient breathing circle can maintain the breathing of patient
by the setted ventilation parameters and ventilation mode orderly by machine or manual. This
machine contains APL valve and pressure-relief valve.
2.1
Gas pipeline is used in supplying O 2 ,N 2 O and anesthetic gas for patient breathing circle, the
pressure must be kept in normal range so that ensure normal operating and securing patient.
Refer to figure 2-1.
2-1
2-2
1
2
3
N 2 O supply
O 2 supply
Filter
19
20
21
Safety Valve(8kPa)
Exhausting Valve(5kPa)
Pressure-relief valve
0.1~0.3kPa
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
2.2
Pressure Gauge
Check Valve
O 2 Regulator400kPa
Pressure Switch
N 2 O Cut Valve
N 2 O Flowmeter
O 2 Flowmeter
O 2 + Valve
Vaporizer 1
Vaporizer 2
Give into Atmosophere
Inspiratory
Electromagnetism Valve
Expiratory Control Valve
Throttle(control Vt)
Air and Oxygen Mixed Device
22
23
24
Bellows
Bag/Ventilator switch
Manual Reservoir Bag
25
26
27
28
29
30
31
32
33
APL Valve
Sode Lime Canister
Inhalation valve
Exhalation valve
Flow Sampling
Pressure Sampling
Patient End
Bag/Ventilator Control Valve
Gas resistance
34
35
Ventilator Principle
The high-pressure oxygen enters the pressure reduction valve, and the output pressure from the
pressure reduction valve is stabilized in 0.25MPa~0.28MPa and enters the electromagnetic valve
and throttle, the output gas is drive gas of bellows. The flow of input gas can be controlled by
adjust throttle. In order to secure patient, there is a safety valve in airway, which used for
stabilizing maximum airway pressure of patient at 8kPa. The safety valve opens to exhaust gas
when airway pressure higher than upper limit of safety pressure.
In inspiration, input gas drives anesthetic circuit gas entering into patient body through flow probe
by driving bellows circuit. At the same time, pressure sensor and flow sensor sample the gas by
sampling tube that connected with flow probe and then convert to monitoring parameter.
In expiration, the exhaust gas of patient enters anesthetic circuit through flow probe. At the same
time, pressure sensor and flow sensor sample the gas by sampling tube that connected with flow
probe and then convert to monitoring parameter.
During whole breathing process, oxygen sensor samples anesthetic circuit gas and convert to
pressure signal then be outputted to mainframe board. The mainframe board monitors oxygen
concentration of anesthetic circuit gas.
2-3
During the above procedures, it is the inhalation and exhalation electromagnetic valve that
controls the gas flowing directly. In inspiration, the inhalation electromagnetic valve will be opened
while the exhalation electromagnetic will be closed; In exhalation, the exhalation electromagnetic
valve will be opened while the inhalation electromagnetic will be closed. The whole process is
controlled by electricity. In the diagram the mainframe board supplies: inspiration time, expiration
time, exhalation valve control signal, collection and disposition of sensor signal. The
communication between mainframe board and display plate is finished through series-port.
Alarming, keyboard coding, LCD are displayed on display plate. The voltage stabilizing power
supply provides the circuit needed voltages and alarms when system haven`t connected with
power.
2-4
Anesthetic system
CAUTION:
WARNING: The incline angle should not exceed 10 degree whenever the anesthetic
system is in use. Don not put clog on the top of anesthetic machine,
otherwise it may make barycenter excursion.
Basic module :anesthetic ventilator frame, vaporizeranesthetic breathing system, flowmeter,
anesthetic ventilator.
Optional module: battery, CO 2 monitoring, AGSS.
3-1
3-2
Castor
Power Switch
O 2 flush button
Vaporizer
Breathing System
10
Bellows Assembly
11
Flowmeter
12
13
UI
14
Figure 3-1 each control function on the front view of the anesthetic machine:
Item
10
11
Diagram
Description
Oxygen Flush
Flow Control
Pressure
Gauge
Castor with
break
3-3
3-4
O 2 inlet connector
Power socket
Yoke
N 2 O inlet connector
3-5
3.2
Mainly function: store anesthetic gas and O 2 , exhaust gas, absorb CO 2 , connect with breathing
airway directly and assist to operate breathing.
Expiratory Port /
Patient circuit connector
Expiratory valve
APL valve
Inhalation Port /
Patient circuit connector
Bellows assembly
(auto ventilation)
3-6
Diagram
Description
Absorber
-----
APL valve
WARNING: Never connect exhaust gas port with sub-atmospheric system directly.
Or else leakage of breathing system generates.
3-7
1 Exhalation valve
6 Driving gas
2 Driving gas
3.3
Vaporizer
Be recommended to used together with the vaporizer: VP300 enflurane and isoflurane
high precision anesthetic vaporizer from our company.
More detailed information about vaporizer, please refer to the instruction for use of the vaporizer
used in this anesthetic system.
WARNING:
3-8
3.4
Anesthetic Ventilator
CAUTION:
CAUTION:
CAUTION:
3-9
3.4.2 Keys
Alarm silence key
Increase key
Decrease key
Confirmation key
Manual/automatic Key
IPPV-ventilation
SIMV-ventilation
SIPPV-ventilation
SPONT-ventilation
3-10
3.4.3 Indicators
AC Indicator
3.4.4 Knob
The user may use the rotary knob to select the menu item and modify the setup.
Tidal volume knob Set tidal volume by tidal volume knob on panel. Turn the knob
counterclockwise to increase the flow; turn the knob clockwise to decrease the flow.
3-11
Parameter setup area lies on the bottom left part of the screen. It includes Inspiration to expiration
time(I:E), Breaths frequency(Freq), Inspiratory pause time(Tp).Setup the parameters by the
parameter setup key, increase key, decrease key and confirmation key. Press the parameter setup
key then the parameter tile is highlighted(white text on blue background).Press the increase key
and decrease key to setup the setting required, then press the confirmation key to save it. When
the selection reaches its maximum or minimum setting, further rotation shall result in the minimum
or maximum setting being displayed. Parameter settings shall be in normal video unless the
parameter tile has been selected or highlighted.
3.4.5.2
Ventilation Mode
Ventilation Mode setup area lies on the top left part of the screen. Press the IPPV key to choose
the ventilation mode. There is only one automatic ventilation mode, that is IPPV.
3.4.5.3
Alarm Messages
Alarm message indication area lies on the top of the screen which indicate alarm messages and
patient ventilation failure alarmit can display all the alarm messages at the same time. More
details refer to Chapter 9.2.
3-12
3.4.5.4
Power Source
Located the right of Alarm message indication area, there are two icons: AC and Battery.
3.4.5.5
Monitoring Area
Monitoring area has two parts: Patient waveform and parameters. Patient parameter is fixedly
displayed in the right side of the screen. It monitors Paw-t,Flow-t,V T ,MV,
P peak, ,PEEP,P plat ,Pmean,FiO 2 ,Freq ,and so on.
Buzzer
Power Switch
O 2 sensor inconnector
Equipotential terminal
RS232 interface
3-13
Item
Description
Size: male 17 mm taper
Inspiratory
driving
Output
Use corrugated tubing to connect driving gas outlet with driven gas inlet
of bellows.
port
Gas Inspiratory phase: gas from ventilator drives bellows to make fresh gas
enter into the airway;
Expiratory phase: return gas from the airway drives bellows to make
gas from ventilator exhaust through exhaust port.
O2
sensor
inconnector
RS232 interface
Accessories
O 2 concentration sensor
Operation condition: 0.5 to 2.0 Bar (absolute pressure). More details
refer to section 8.4
3-14
4 Operating Guide
4.1
Starting System
Step 1
Press
Alarm
Settings key, then
display a menu
window on the
screen.
Step 2
Press increase key or
decrease key to select
the item required, then
this item background as
shown, such as Paw_l
(cmH 2 O).
4-1
Step 3
Press the ENTER key,
the color of item changed.
Step 4
Press increase key and
decrease key to change
the number.
Step 5
Press
conformation
key to save the new
adjustment.
Go to next setup or exit
Alarm settings menu.
Step 6
Press
increase key
and decrease
key to select
Back
and
then
confirmation.
You can press NORMAL SCREEN to return normal screen.
4-2
IPPV mode
Step 1
Press IPPV Mode key, and then dispaly IPPV ventilation mode required.
Step 2
Press parameter setup key to setup correlate ventilation parameter.
Step 3
If require other ventilation mode, press other mode key, repeat the above steps.
4-3
4.2
Before getting started, make sure to set the patient circuit installing
and controlling correctly.
The following procedures assume that the system is in on position
and manual reservoir gas ventilating mode.
Step 1
Setup the ventilation parameter correctly before starting the auto ventilation. Make sure the control
settings according with the clinical settings.
Step 2
Press the manual/auto key to select auto ventilation.
Step 3
Select auto ventilation mode required. Refer to section 4.1.2.
Step 4
Fill the bellows with O 2 flush if necessary.
4.3
Step 1
Before stopping the auto ventilation, make sure the setting of manual ventilation is completepress
, and the setting of APL valve is correct.
the
CAUTION:
Step 2
Pressing the Manual/auto key, stop auto ventilation, you can use manual mode ventilation.
4-4
4.4
1
Waveform
Paw-t waveform
Y-Axis: airway pressure; X-Axis: time. More details refer to section 10.5.5.
Flow-t waveform
Time-Axis: Positive inspiratory direction above 0 L/min level; minus expiratory direction below
0L/min level; no gas flow on 0L/min level.
4-5
4-6
5 Preoperative Checkout
5.1
Test interval
System check:
Ventilator test:
WARNING:
Do not use this system before the operation and maintenance manual
are read and understood.
If test failure, do not use this system. Please contact service representative.
5-1
Make sure:
1 Equipment is in good condition.
2
The connection and pressure of pipeline gas supply system are correct.
The connected cylinder valve should be closed if there are backup cylinders.
WARNING:
Do not leave the cylinder valves open during pipeline gas supply
period; otherwise, cylinder gas supply will be used up and lead to
insufficient supply in case of pipeline malfunction.
7.
8.
The device for airway maintenance, organ cannula are ready and in good condition.
9.
10. Make sure the truckles are tight and locked and free of motion.
11. Connect the power cord to the AC power outlet. The power indicator light will light up
when power is connected.
If failure, that means no electric power supplying. Exchange other sockets, close breaker,
or replace power cord.
12. Make sure there is no seeper in Breathing pipeline and sampling probe.
5-2
Make sure that power off failure alarm occurs, it has the following characteristics:
Alarm sound;
To normal screen.
5.2
Disconnect all pipeline gas supply. If the readings of the pipeline pressure gauge is not zero.
Switch on O 2 supply.
5-3
5.3
Turn counterclockwise oxygen flow control valve slowly that the flowmeter floats can raise to
maximum, then close the flow control valve. Turn counterclockwise nitrous oxide flow control valve
slowly that oxygen flow control valve opened accordingly. When the oxygen flow indicator display
0.8L/min1.5L/min3L/min respectively, the corresponding nitrous oxide flow indicator`s display
range are 1.6L/min~2.1L/min3.0L/min~4.1L/min6.1L/min~8.1L/min. Try to decrease nitrous
oxide or increase oxygen separately, two gas shouldn`t occur interlocking.
5.4
Refer to User Manual of Vaporizer for installing and performance testing of vaporizer.
5.5
Testing alarm
IPPV mode
Ventilator:
Freq:12bpm
I:E: 1:2
Anesthetic machine:
5-4
Set bag / ventilator switch to bag control, and then set to ventilator control again. Make sure:
Make sure:
Test O 2 monitoring
Remove O 2 sensor, and confirm that O 2 concentration measured in the room air is about
21%.
Let O 2 sensor pass pure O 2 for 2 minutes, and conform that O 2 concentration measured
is about 100%.
Adjust lower limit of MV to 16L/min, and conform that Minute Volume Low alarm occurs.
Adjust lower limit of MV to 10L/min, and conform that the alarm eliminates.
Adjust higher limit of Paw to below P peak , and conform that Paw high alarm occurs.
5-5
5.6
WARNING: Objects in the breathing system can interrupt or disrupt the delivery of
breathing system gas, resulting in possible patient death or injury:
Do not use any testing plug small enough to slip completely into the
breathing system.
WARNING:
5-6
5.7
Testing Ventilator
IPPV mode
Ventilator:
Freq: 12bpm
I:E: 1:2
Anesthetic machine:
Ensure:
The bellows ascend and descend during the period of auto ventilation
Ensure:
The bellows inflate and scavenge during the period of auto ventilation.
10 Set the ventilator control and alarm limits to the proper clinical level.
5-7
11 Turn off mains supply and close all valves of gas cylinders if not to use the system.
12 Ensure that the things in the following table should be prepared completely.
Apparatus:
Airway maintenance
Manual ventilation
Organ cannula
5-8
CAUTION:
CAUTION:
WARNING: Be sure the gas pipeline supply hoses and the breathing circuit
components are non-poisonous, do not cause patient allergy, and do
not create dangerous by-product through reaction with the anesthesia
gas or the anesthetic.
WARNING: To prevent generating wrong data and malfunction, please use the
cables, hoses, and tubes from our company.
CAUTION:
CAUTION:
CAUTION:
Put the electricity surgical conducting wire far from the place where the
breathing system and the O 2 sensor are put on.
Do not put the electricity surgical conducting wire on any parts of the
anesthetic system.
6-1
CAUTION:
6.1
Monitor and ensure that all the life supporting and monitoring
equipment are operated correctly.
Avoid to let the skin or eyes touch the materials in the absorber. Clean
the affected part immediately and seek medical attention if materials
come in contact with skin or eyes.
Check the color of the absorbent after finishing each case. The original
color of the absorbent may be restored when not in use. Refer to the
labels of the absorbent for the details.
the
deposition
of
6-2
Fill the absorber with fresh absorbent after dryness. Wipe soda lime fell on the edge of
absorber, and then install it back. Make sure the airtightness is well, and that no leakage and
spillage.
6-3
6.2
CAUTION: Anesthetic agent monitor (in accordance with ISO 21647:2004) should be
connected at T-piece installed inspiratory port.
6.2.1 Tubes
Step 1
Connect bellows and absorber cycle with one
corrugated tubing (22).
Step 2
Connect bellows and driving gas output
connector on the rear panel with another tube
(17).
Step 3
Get two repetitious silica gel tubes connect the
one at expiratory port of absorber cycle.
6-4
Step 4
Connect the other tubes at inspiratory port of
absorber cycle.
Step 5
The other end of the two tubes should be
connected with Y-piece and simulation
lung(reservoir bag).
The capacity of simulation lung is 3L.
6-5
Step 2:
Plug one end of the oxygen sensor line into the
bottom interface of the sensor.
Step 3:
The other end of the oxygen sensor line should
be plug into the "O 2 Sensor port on the rear
panel.
6.3
WARNING: The equipment connected to the power outlet will increase electric
current leakage. Test electric current leakage regularly.
WARNING: A malfunction of the central gas supply system may cause more than
one or even all devices connected to it to stop their operation
simultaneously.
6-6
CAUTION:
Disconnect the anesthetic workstation from the gas supply after use to
prevent contamination or pollution of the pipeline system.
CAUTION:
Only the medical gas supply should be used. Other types of gas supply
may contain water, oil or other pollutants.
WARNING: All connectors of gas supply have different dimensions and structures.
It can avoid wrong operation occurs.
6.3.1 AC inlet
AC Power:
100~240VAC 50/60Hz;
0.5A Max.
Fuse:
250V1A, 5X20T
Clasp can stop power cord breaking off.
CAUTION:
6-7
Signal Name
Signal Description
RXD
Receive Data
TXD
Transmit Data
GND
Signal Ground/Common
CAUTION:
6-8
6.4
Do not turn the cylinder valve on when the pipeline gas supply is being
used. The gas supply of the cylinder may be used out in case of pipeline
failure so that the backup supply may be insufficient.
1 Turn the handle T of the cylinder valve clockwise until it is tight. Close the valve of the cylinder to
be changed.
2 Release the yoke piece, then disassemble the cylinder.
3 Remove the valve cap from the new cylinder.
4 Keep the cylinder inlet away from all the objects which could be damaged by the release of high
pressure gas.
5 To clear the cylinder valve of any debris, use the cylinder wrench to briefly open, then close the
cylinder.
6 Install the cylinder.
Align index pin with the basic hole of the gas cylinder.
6-9
Close flowmeter.
If the pressure of the O 2 cylinder drops more than 5000 KPa after one minute, the high
pressure circuit has an unacceptable leak.
If the pressure of the N 2 O cylinder drops more than 690 KPa after one minute, the high
pressure circuit has an unacceptable leak.
6.5
Connect AGSS
CAUTION:
The Anesthetic gas scavenging transfer & receiving system used with
the anesthetic system shall comply with ISO8835-3.
There are two ports releasing exhaust gas in this system. One at bottom of APL valve, the other
one at bottom of bellows.
Connect the two ports to gas scavenging transfer and receiving system with tubes.
Connect exhausting port of bellows assembly with incepting system through commutator.
6-10
Wear safety gloves and safety goggles. The O2 sensor may leak and
burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.
CAUTION:
To prevent damage:
Refer to the data supplied by the manufacturer if there are any questions
about the agent.
Never use any organic, halogenate or oil base solvent, anesthetic, glass
agent, acestone or other irritant agents.
Never use any abrasive agent to clean any of the components (i.e. Steel
wool, silver polish or agent).
WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been used
to prevent tackiness could contaminate a patients lung or esophagus,
causing injury.
CAUTION:
7-1
7.1
Main unit
Clean the machines panel and all surfaces with soft cloth soaked
with the water soluble disinfecting agent.
Sterilize main unit with ultraviolet radiation. Do not use acetic hyctro
peroxide or formaldehyde steaming.
Breathing
components
system
Absorber cycle
Bellows assembly
7.2
Corrugated
(contacted with
reservoir bag
tubing
patient),
Washing to sterilize
T-piece
Washing to sterilize
Sampling
probe
parallel lines of flow
7.3
and
Clean with soap before use of each patient, and then washing in
disinfecting solution after airing.
Absorber
WARNING:
7-2
The dry absorber may be very dangerous with the presence of any
anesthetic. Take proper measures to avoid dry soda lime in the
absorbent. Switch off all gas supplies after use.
7-3
7.4
1.
Absorber assembly
Dismount the cover of the inspiration and expiratory valves by rotating it counter clockwise, then
clean all parts of them with the gauze soaked with water soluble disinfecting agent, after all parts
cleaned and dried recover it in original integration. Then one must check the leakage and the
movement of the inspiration and expiration valves in accordance with the required regulation and
checking procedure. Please handle all parts with care preventing any damage.
2. Absorber module
Either vapouring (not more than 50) or immersion disinfection can be used in practice, in case of
immersion all sterilized parts must be dried with the high pressure air or oxygen before reuse.
7.5
This section is about disassembling, assembling, cleaning and disinfecting the bellows assembly.
Read all content of this section before disassembling, assembling, cleaning and disinfecting the
bellows assembly to avoid equipment malfunction and patient injury.
7-4
7.5.1 Disassembling
To disassemble the bellows assembly:
(To assemble the bellows assembly, perform the steps in Disassembling the bellows assembly
in reverse order):
1
2
Loosen the screws from the mounting plate, then remove the mounting plate.
Turn counterclockwise and remove the bellows housing.
Push the locking spring to the center, and then remove the rim.
WARNING: Do not remove bellows assembly seat from diaphragm of the pressure
relief valve. This can distort the seat or diaphragm and cause injury to
the patient.
8
Do not use any object small enough to slip completely into the system
when occluding the breathing system for test purposes.
WARNING:
This test is to ensure all the components are installed correctly. It cannot replace the system test.
The bellows assembling can be installed in case they requirement testing. Otherwise, they need to
be disassembled to check and replace broken components, then reassembled and tested.
Hold the bellows assembly in hands vertically upwards to occlude the driving gas port before
installing.
7-5
Invert the bellows assembly. If the descending velocity of the bellows top is no more than 100
ml/min, this could be because the driving gas port is not properly sealed, bellows or seal is not
installed correctly or other component are broken and that the descending velocity exceeds the
limit.
Open the driving gas port to make the bellows fully spread, and then occludes the breathing
system connector.
Turn the bellows assembly so it faces vertically upwards. If the descending velocity of the bellows
top is no more than 100 ml/min this could be because the bellows or pressure-relief valve is not
installed correctly or other component are broken and the descending velocity exceeds the limit.
WARNING: Never separate the diaphragm and the valve seat in a pressure-relief
valve.
2) To prevent component damage, clean them lightly. Put the recommended nonenzyme mild
agent used for latex and plastic in hot water.
CAUTION:
CAUTION:
Dry by hanging while fully spread. If moisture is left in the bellows, they
may become tacky.
4) Check the components if they are broken or damp, then perform the assembling and function
test.
5) Connect the bellow assembly, ventilator and breathing system.
6) Perform the preoperative check.
7-6
2. Sterilizing
Cleaning and disinfecting must be performed at the same time. Follow instructions for the common
bellows assembly disinfection methods.
Sterilizing after general patient use:
Clean the inner and outer parts of the bellows assembly in a soap-and-water solution. Rinse
thoroughly in cold water, and dry with soft cloth. Immerse plastic and latex instruments in 70-80%
ethyl alcohol for half an hour. Take them out using the aseptically transmits pliers, then store in
clean containers. Repeat this step before next use. Components made of metal and glass can be
sterilized with high pressure steam. When the steam pressure is increased by the autoclave, the
rising temperature can concrete the bacterium protein rapidly to kill bacteria. In 1.05 KG/CM2
steam pressure, the temperature rises to 121C. All bacteria and most sorus can be killed if this
temperature is maintained for 15-25 minutes.
Sterilizing after special infection or infectious patient use:
Open pulmonary TB, pulmonary abscess, pseudomonas, tetanus aeruginosa infection, gas
gangrene or infectious hepatitis is included. Used bellows assembly components must be
completely sterilized according to preliminary and final disposal procedures.
1) Preliminary disposal: Perform in accordance with the isolated disposal stipulation. Collect and
leave all the used bellows assembly components during the operation process in the operating
room. Immerse the bellows assembly components in the 1:1000 benzalkonium bromide or 1-5%
cresol for 30 minutes after finishing the operation.
2) Final disposal: perform the final disinfecting disposal after the bellows assembly components
are processed by the above-mentioned preliminary disposal:
Scrub the bellows assembly in a soap-and-water solution. Thoroughly rinse in cold water,
and dry;
If conditions permit, suffocating the components directly contacted with patients with
formald or oxirane is preferred, or perform immersing disinfection respectively. For
example: the components used by open pulmonary TB patients must be immersed in 3%
cresol for 30 minutes; the components used by tetanus aeruginosa infection patients
must be immersed in 0.2% potassium permanganate for 30 minutes; the components
used by gas gangrene patients must be immersed in 0.1% chlorhexidine for 30 minutes;
the components used by pulmonary abscess patients must be immersed in 0.1%
benzalkonium bromide for 60 minutes; the components used by pseudomonas patients
must be immersed in 0.1% benzalkonium bromide for 120 minutes;
the components being immersed need to be rinsed by water and dried for next use;
scrub and rinse the components indirectly contacted with patients with 1-3% phenol
solution or soap-and-water solution and water. Irradiate them by using the ultraviolet ray
for 30 minutes if necessary.
7-7
WARNING:
Check each component carefully to check for cracks, distortion, dissolution, inflation and other
physical changes. Replace them if necessary.
Assemble the bellows assembly, and then perform the leak test.
7-8
8 User Maintenance
WARNING: To avoid fire:
All the covers or housings for the system use must be made of static
proof material, as static material may cause fire.
WARNING: Movable components and detachable parts can cause injury. Use
caution when system components and parts are being moved or
replaced.
8.1
Repair Policy
Do not use malfunctioning equipment. Make all necessary repairs, or have the equipment serviced
by our companys an authorized Service Representative. After repair, test the equipment to ensure
that it is functioning properly, in accordance with the manufacturers published specifications.
To ensure full reliability, have all repairs and service done by our companys an authorized
Representative. If this is not possible, replacement and maintenance of parts in this manual should
be performed by a competent, trained individual with experience in Anesthesia Systems repair,
and appropriate testing and calibration equipment.
CAUTION:
It is recommended that you replace damaged parts with components manufactured or sold by our
company. After any repair work, test the unit to ensure it complies with the manufacturers
published specifications.
Contact the nearest our companys Service Center for service assistance. In all cases, other than
where our companys warranty is applicable, repairs will be made in our companys current list
price for the replacement part(s) plus a reasonable labor charge.
8-1
8.2
The following schedule is a recommended minimum standard based upon normal usage and
environmental conditions. Frequency of maintenance for the equipment should be higher if your
actual schedule is more than the minimum standard.
Daily
weekly
monthly
As required
8-2
5 years
Components
5 years
Vaporizer
5 years
Absorb circle
5 years
8. User Maintenance
8.3
Parts that are broken, crushed, worn or distorted must be replaced immediately when cleaning the
breathing system.
Refer to the sections corresponding to reassembly and testing.
CAUTION:
Step 2
Press
the
decrease key to
select
pressure
calibration.
Press
the
confirmation
to
calibrate.
Pay attention to
the prompt on the
screen.
8-3
Step 3
In the process of
calibration,
the
word
Calibrating
displays
screen.
on
the
Step 4
Select Back and then press confirmation.
Step 1
Press
system
settings key, a menu
window appears on
the screen.
8-4
8. User Maintenance
Step 2
Press
the
decrease key to
select
flow
calibration.
Press
the
confirmation
to
calibrate.
Step 3
Select Start and
press the ENTER
to calibrate.
In the process of
calibration, the word
Calibrating.
displays
on
the
screen.
Cal. Ok! will be
displayed on the
window after the
calibration succeeds.
Step 4
Select Back and press confirmation.
8-5
8.3.4.1
Step 1
Press system setup
key, a menu window
appears
on
the
screen.
8-6
8. User Maintenance
Step 2
Press
decrease
key to select FiO 2
calibration .
Step 3
Press ENTER to
calibrate. In the
process
of
calibration,
the
word
Calibrating..
displays on the
screen.
Calibration
finished, screen
displays cal.ok!
then
connect
oxygen
sensor
onto
absorbor
circuit
and
calibrate oxygen
concentration
following
the
information.
8-7
If still failure, perform 100% oxygen sensor calibration. And then calibrate 21% O 2 sensor again
when the 100% calibration succeeded. If not, replace O 2 sensor and then recalibrate it.
8.3.4.2
WARNING:
Step 4
21% oxygen sensor
calibration
finished
then enter into 100%
oxygen
sensor
calibration interface.
Perform the operation
in accordance with
the prompt on the
window.
Step 5
Press the ENTER to
perform
the
calibration.
In the process of
calibration, the word
Calibrating
displays
on
the
screen.
8-8
8. User Maintenance
If 100% calibration
failure, the word Cal.
false! displays on the
window.
If
the
calibration
failure occurs:
Recalibrate it;
Reduce
airway
pressure and try it
again.
If failure still exists,
replace O 2 sensor
and perform 21%
calibration.
Step 6
Select Back and the press the confirmation key to exit.
8-9
Step 2
Press the decrease key
to
select
pressure
calibration.
Press the
calibrate.
ENTER to
Step 3
Press the decrease
key and decrease
key to select digit
which
need
to
change.
Step 4
Press the ENTER
key enters to digit
which
need
to
change. Then this
item background as
shown,
such
as
adjust kilobit.
8-10
8. User Maintenance
Step 5
Press
increase
key
or decrease key to
change
the
required
numbers.
Step 6
Press the ENTER key
then enters to next digit.
Adjust other digits using
the same steps.
8.4
8.5
Replacing fuses
WARNING:
WARNING:
Replace fuses with only those of the specified type and current rating,
otherwise that can damage the equipment.
CAUTION:
8-11
CAUTION:
8.6
Maintaining battery
Specification
Cautions
Charge: Connect mains supply; the system will maintain auto-charging battery. It is recommended
that charging time is better than 3 hours.
Discharge: It will last 120 minutes generally to use the battery supply.
The alarm Battery Low! should be displayed on the screen when the capacity of battery is not
enough until the system shut-off. The user/operator should connect mains supply to charge
battery in time and avoid the system shut-off abnormally.
Do not disassemble battery device without valid authorization.
Do not short-circuit between positive plate and negative plate of battery.
Storage
The battery should be charged full then conserve d if don`t use it in long time.
The maintenance of charging should be carried out with interval of 3 months at least if storage of
battery exceeds 3 months.
Stored environment should avoid dampness, high temperature.
If improper maintenance makes battery damage, replace it in time to avoid liquid of battery
corrading the apparatus. Replace the battery, please contact service representatives.
CAUTION:
8-12
9.1
About alarm
CAUTION:
If alarm occurs, protect patient safe firstly, and then go to diagnose fault
or service it necessarily.
1 Alarm bell
2 Alarm message
High
Volume
Silence
(seconds)
Prompt
Alarm bell
5 tones, 2 hurry;
Periods: 9s
120
Red background, 3 !
Displaying frequency: 2Hz
Red,
flickering
Medium
3 tones
Periods: 6s
120
Yellow background, 2 !
Displaying frequency: 0.5Hz
Yellow,
flickering
Low
2 tones
Periods: 27s
120
Yellow background, 1 !
Displaying all the time until
alarm disappears.
Yellow
CAUTION:
When alarm silencing, the alarm bell and sound will disappear. After 120
seconds, the alarm bell and sound will appear again.
CAUTION:
9-1
9.2
CAUTION:
Message
Priority
AC Power lost
Medium
Low Battery
Medium
Condition
Operator Action
Repair
Connection failure;
Power failure;
Fuses melted.
Check connection;
Check
mains
supply;
Check fuses.
Replace
fuses
when melted.
capacity
of
exhaust;
battery failure.
Resume AC power
immediately;
Charge the battery;
switch to Bag mode;
Maintain battery
periodically, and
ensure it full
charged.
battery
Self-check
failure
low
Recalibrate
valve.
Paw High
High
Paw Low
High
No driven gas;
Sampling lines fall off or
blocked;
Respiratory
frequency
lower.
__
High
V T monitored is zero
beyond 20 seconds.
Check patient.
Check
tubing
connections.
__
High
No
volume
MV High
9-2
Tidal
flow Please
contact
eligible
service
representative.
High
High FiO 2
High
Low FiO 2
Continuous
Pressure High
Communicatio
n
Malfunction
High
High
High
__
__
Ventilator
software
malfunction;
Connection incorrect.
__
Please
contact
eligible
service
representative.
9-3
9.3
Troubleshooting
Possible Cause
Recommended Action
APL valve is on
Replace or reinstall
valves loosen
Tighten them
APL
valve
incorrectly
Adjust it properly
Leakage occurs
ventilator switch
Manual
tube
incorrect..
Patient breathing
gas leak
9-4
circuit
is
adjusted
at
bag
connection
Possible Cause
Power supply cable is unplugged or
broken;
Power switch is off;
Fuse is burned .
Patient circuit is occluded;
Patients respiratory tract is
occluded;
Maximum pressure setting is too
low;
Ventilator parameters changed.
Patient circuit leaks;
Alarm settings is too high;
Patients compliance changes;
Pressure
sampling
pipe
is
disconnected or broken.
No gas flow through pressure
gauge;
Pressure
sampling
pipe
is
disconnected;
Gas supply exhausted.
Flow sensor is unplugged;
The inner and outer O rings of
bellows base are broken;
Bellows is broken;
Pressure-relief valve is broken.
Gas scavenging port is occluded;
Malfunctioning
waste
gas
scavenging
system
creates
excessive resistance or vacuum
Breathing resorption interface is
unplugged;
Bellows base is broken;
Tear or leak in the bellows;
Exhalation diaphragm is broken;
O rings are broken
Recommended Action
Plug in power supply cable or
replace power cable;
Turn on power switch;
Replace with a new fuse.
Check and adjust patient
circuit;
Check the patient;
Readjust the alarm setting;
Recalculate
the
ventilator
parameter.
Check the pipeline leak part;
Reset the alarm settings;
Check the patient;
Check the pressure sampling
pipe.
Calibrate pressure gauge;
Reconnect
the
pressure
sampling pipe;
Replace the gas supply.
Plug in the flow sensor;
Check the bellows and replace
the
broken
parts,
then
reassemble it ;
Replace pressure-relief valve.
Remove the occlusion;
Repair waste gas scavenging
system
Reconnect
breathing
resorption interface;
Check and replace a bellows
base;
Check and replace a bellows;
Check
and
replace
an
exhalation diaphragm;
Check and replace O rings
9-5
9-6
10 Specifications
10.1 Physical specification
All specifications are approximately, maybe changed at any moment without notice.
CAUTION:
CAUTION:
System
Dimensions:
Weight:
85kg
Castor
Display
Pipeline gauge
Airway gauge
Relative Humidity
Atmospheric pressure
Operation
10~40
80%no condensation
70~106kPa
Storage/Transportation:
-20~55
93%no condensation
50~106kPa
CAUTION:
CAUTION:
10-1
WARNING: using cell phone or other radio radiant equipment near this product may
cause malfunction. Closely monitor the working condition of this
equipment if there is any radio radiant supply nearby.
Using other electrical equipment in this system or nearby may cause interference. Check if the
equipment works normally in these conditions before using on a patient.
Power cable and Oxygen sensor cable are the mainly cables which used with the anesthetic
machine.
WARNING: Don not use the other cables and if it is necessary, the selected cable
must be in accordance with IEC 60601-1-2,2007.
WARNING: the equipment should not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, the equipment
should be observed to verify normal operation in configuration in which
it will be used.
10-2
10. Specifications
Emission test
RF emissions
CISPR 11
Compliance
Group 1
RF emission
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
10-3
Immunity test
Electromagnetic
environment - guidance
Floors should be wood,
6 kV contact
concrete or ceramic tile. If floor
8 kV air
are covered with synthetic
material, the relative humidity
should be at least 30%.
2kV for power Mains power quality should be
that of a typical commercial or
supply lines
hospital environment.
Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
Electrical
fast
transient/burst
IEC 61000-4-4
2 kV for
supply lines
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
<5% U T
(>95% dip in U T )
for 0.5 cycle
1 kV differential
mode
2 kV common
mode
<5% U T
(>95% dip in U T )
for 0.5 cycle
40% U T
(60% dip in U T )
for 5 cycles
40% U T
(60% dip in U T )
for 5 cycles
70% U T
(30% dip in U T )
for 25 cycles
70% U T
(30% dip in U T )
for 25 cycles
<5% U T
(>95% dip in U T )
for 5 sec
3A/m
<5% U T
(>95% dip in U T )
for 5 sec
3A/m
Power frequency
(50/60Hz)
magnetic field
IEC61000-4-8
NOTE
10-4
8 kV air
power
10. Specifications
Immunity
test
IEC 60601
test level
Compliance
level
Conducted
RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3
3V rms
150 kHz to 80
MHz
outside
ISM
a
bands
3 V rms
d = 1.17 p
10 V rms
150 kHz to 80
MHz
in ISM bands
10 V rms
d = 1.2 p
10 V/m
80 MHz to 2.5
GHz
10 V/m
d = 1.2 p
d = 2.3 p
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz;
13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range
80 MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the Anesthetic
machine is used exceeds the applicable RF compliance level above, the Anesthetic machine should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Anesthetic machine.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
10-5
d = 1.17 P
d = 1.2 P
d = 1.2 P
d = 2.3 P
0.12
0.12
0.12
0.23
0.01
0.37
0.38
0.38
0.73
0.1
1.17
1.2
1.2
2.3
1
3.69
3.8
3.8
7.28
10
11.67
12
12
23
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to
6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
NoTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could couse interference if it is
inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
10-6
10. Specifications
Absorbent
Connection
Leakage
system
of
breathing
Resistance of breathing
system
At flow of 60L/min:
Resistance of exhalation: 0.6 kPa;
Resistance of inhalation: 0.6 kPa.
Leakage of connector
Resistance of checkvalve
Internal volume
2.5L approximately
Rotation
50 degree max.
10-7
O2, N2O
All fittings used to connect O 2 and N 2 O pipeline gas supply are
all ready.
10.4.2 flowmeter
Flow rate:
Gas component
O2
N2O
CAUTION:
Accuracy: With regard to the flow between 10% of full scale or 300 mL/min (higher is preferred)
and full scale under the condition of 20, 101.3kPa, flow meter precision is within the 10% of
indicated values. The precision is 4 degree when the flow is lower than 10% of full scale or
300ml/min (higher is preferred).
O2 flush: 25 to 75 L/min.
O2 failure alarm and the associate cut-off device
O 2 pressure
O 2 failure alarm:
200kPa
N 2 O cut-off:
50kPa
10-8
10. Specifications
10.4.3 Classification
According to IEC60601-1, The anesthetic machine belongs to the following classifications:
Class I equipment
Type B equipment
General equipment
Mobile equipment
Operate continuously
10.5 Input/output
10.5.1 Electrical
Voltage:
Input power:
Maximum input current:
Fuse at mains supply inlet:
Earth resistance:
WARNING: The connection of equipment to the auxiliary mains socket outlets can
increase the patient leakage currents to values exceeding the allowable
limits in the event of a defective protective earth conductor.
10-9
10.5.2 Pneumatic
Pipeline supply:
O2, N2O
Cylinder supply:
O2, N2O
280 to 600kPa
2.5 to 12MPa
Reducer:
250kPa
Gas regulator:
250kPa~400kPa
Display pressure:
Connect vaporizer:
10-10
10. Specifications
Compliance:
Electrical safety:
Alarming sound:
Maximum MV
Warm-up time:
IPPV mode
Manual mode
----
Range
Remark
4~100bpm
I:E
4:1~1:8
Error 15%
TP
OFF~60%
20%
PEEP
0~2kPa
optional
10-11
Item
Range
Resolution
Accuracy
V TI
0~2000mL
1mL
MV
0~25L/min
1L/min
Freq.
0~100bpm
1bpm
P peak
-20~100cmH 2 O
1cmH 2 O
P plat
-20~100cmH 2 O
1cmH 2 O
P mean
-20~100cmH 2 O
1cmH 2 O
FiO 2
18~100
1%
PEEP
0~20cmH 2 O
1cmH 2 O
Paw
-20~100cmH 2 O
Paw-t waveform:
Flow-t waveform:
10-12
10. Specifications
Range
Windows default
Error
MV High
1~25L/min
20L/min
1L
Remark
(Less
than
-----
than
-----
5L/min)
20% (other)
MV Low
0~20L/min
0L/min
1L
(Less
5L/min)
20% (other)
Paw High
20~80cmH 2 O
35cmH 2 O
10%
Paw Low
0~20cmH 2 O
4cmH 2 O
2cmH 2 O
FiO 2 High
21%~100%
95%
3%
-----
FiO 2 Low
OFF
21%
3%
-----
(Less
21%~99%
No
tidal
volume
alarm
20s
-----
20%
alternating
current
failure
alarm
-----
-----
-----
Battery
low
alarm
-----
-----
-----
continuous
airway
pressure
high
-----
-----
0.5s
AC lost
-----
-----
-----
AC failure.
alarming 120s.
10-13
CAUTION:
All low limits of parameters in above table may not be set up the high
limits, nor may the high limits be set below the low limits.
Type of O 2 sensor:
Useful life:
Operational principle:
10-14
10. Specifications
10.7.5 Cross-sensitivity
Test gas
50% He/50% O 2
80% N 2 O/20% O 2
4% Halothane/28.8% O 2 /67.2% N 2 O
5% Sevoflurane/28.5% O 2 /66.5% N 2 O
5% Enflurane/28.5% O 2 /66.5% N 2 O
5% Isoflurane/28.5% O 2 /66.5% N 2 O
5% CO 2 /28.5% O 2 /66.5% N 2 O
Error(%O 2 )
<1%
+1 to +1.5%
+1.5 to +2%
+1 to +1.5%
+1.2 to +1.8%
+1.2 to +1.8%
<1%
resolution
Expected operating life
1mBar O 2
1001%
6
1.5X10 % O 2 hours at 20
6
0.8X10 % O 2 hours at 40
Response time(air to 100% O 2 )
linearity
T 90 <15s
Linear-100% O 2
Zero signal in N 2 at 20
<200V
Operating temp.range
-20 to +50
Temp. compensation
Pressure range
Relative humidity range
Long term output drift in 100% O 2
N 2 O resistance
Cross-sensitivity
Warranty period
0.5-2.0Bar
0 to 99% non-condensing
Typically >5% over 1year
Resistant to 100% N 2 O
Meets EN12598 requirements
13 months from date of despatch
10-15
10-16