ADS IIAnesthesia Machine- New PDF
ADS IIAnesthesia Machine- New PDF
ADS IIAnesthesia Machine- New PDF
Product Information
Product name: Anesthesia Machine
CE Mark
The product is marked with CE, as it conforms to European Council Directive for Medical
Devices (93/42/EEC), and meets basic requirements of appendix I in the directive.
This product is Type,Class B radio jamming protective equipment that complies with the
EN55011. It meets the requirements of EN60601-1-2 standard Medical electrical
equipment-Electromagnetic compatibility.
Users Responsibility
Please check the product and accessories firstly when you receive the product, make sure
it conforms to the contract. If any damage of the package or the product is found before or
after you open the packing case, please contact the local office or the franchiser
immediately.
Users must perform the installation, operation, maintenance and carry out regular
inspection according to the instruction described in the manual. Replace the components
immediately if any damage, loss, distortion or contamination is found. Stop use when
malfunction occurs. Please contact the after service department of the Company for
repairing and replacing. Any change of the product is verboten without agreement of the
II
Company. Users must accept responsibility for any malfunction which results from
non-compliance with the servicing requirements detailed in this manual.
Preface
Description
This manual describes the intended use, function, installation, operation and maintenance
of the product. Please read and understand the contents carefully before use to ensure the
proper performance and patient safety. When you begin using the anesthesia machine, we
deem that you have read the manual carefully.
In order to use the equipment accurately, effectively and avoid the accident, please read
the manual carefully and comply with it strictly, especially pay attention to the Warning,
Caution and Note.
The optional features may not be completely included in the manual, if you have any
questions, please contact the Company.
Please read this manual carefully and keep within reach of the device.
Illustration
The illustration in the manual is only for reference. Some settings and data may not be
consistent with the real display, and please refer to the real product.
Conventions
III
Content
PRODUCT INFORMATION .................................................................................................................. I
CE MARK................................................................................................................................................II
USERS RESPONSIBILITY ..................................................................................................................II
PREFACE .............................................................................................................................................. III
CONTENT ............................................................................................................................................. IV
CHAPTER 1 SAFETY INFORMATION ................................................................................................ 1
1.1
WARNING ................................................................................................................................... 2
1.2
CAUTION .................................................................................................................................... 7
2.1.1
2.1.2
2.2
SYSTEM OVERVIEW................................................................................................................... 12
2.2.1
2.2.2
2.2.3
2.2.4
2.3
2.4
BATTERY .................................................................................................................................. 17
2.5
2.6
2.7
FLOWMETER ............................................................................................................................. 19
2.8
2.9
2.10
2.11
VAPORIZER ............................................................................................................................... 23
2.12
2.12.1
Display ............................................................................................................................ 25
2.12.2
Membrane button.......................................................................................................... 26
2.12.3
IV
2.12.4
2.12.4.1
2.12.4.2
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.10
3.11
5.2
START-UP ................................................................................................................................. 65
5.3
5.4
STANDBY.................................................................................................................................. 67
5.5
5.6
5.7
5.8
7.2
7.3
7.4
7.4.1
7.4.2
7.4.3
7.4.4
7.4.5
7.4.6
7.4.7
7.4.8
Heat plant and the Bag/Ventilator and non-return valve assembly ....................... 93
7.4.9
7.4.10
7.5
IRMA PROBE............................................................................................................................ 95
VI
VII
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This chapter contains important safety information of the anesthesia machine, and some
other safety information throughout each chapter of the manual. Please read and
understand all the safety information before use to avoid security risks.
The ponderance of the safety requirement has no relation with the list order.
Warning:
Identify conditions or practices that could result in serious adverse reactions or potential
safety hazards.
Caution:
Identify conditions or practices that could result in damage to the anesthesia machine or
other equipment.
Note
Identify supplemental information to help you better understand how the ventilator works.
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1.1
Warning
Warning:
Preparing warning
Before using the device, please ensure that all the connections of the pipelines are
accurate and reliable, not twisted, knotted, pressed or blocked.
The auxiliary mains socket-outlet of this equipment can only be used for the specified
facilities; otherwise it may result in safety risks.
Before using the equipment please make sure that the balanced terminal of the
potential has been connected to the spot grounded point, otherwise, unpredictable
risks may occur.
This equipment can only be operated by the qualified personnel, please make sure the
operators have corresponding qualifications before using.
Only the specified and with protective earthing power supply can be used. If you have
any questions about the installation of the external line, the equipment must be
operated by the internal power supply.
The inflammable anesthetic agent such as aether and cyclopropane can not be used.
Only the anesthetic agent that according with the requirements about the
non-flammable anesthetic described in the appendix DD of the IEC-60601-2-13 can
be used in this anesthetic system.
This equipment can only be used in the specified environment, should not be used in
the inflammable or explosive environment, magnetism resonance imaging (MRI)
environment, or in the environment with other strong electromagnetism interfere.
Only those conform to the latest IEC-601-1 standard accessories and auxiliary
equipment can be connected to this anesthesia machine. If peripheral equipment such
as computer
monitorhumidifier has been connected to the anaesthetic ventilator , the
whole system should meet the IEC-601-1 standard.
The container with water should not be placed on the equipment in order to prevent
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Warning:
liquid entering the equipment and lead to malfunction.
The equipment will produce some castoff such as the sodium- calcareousness, the
one-off parts or the damageable parts which will lead to serious pollute or cross
infection if discarded randomly, and should be managed and disposed according to
the relative regulations.
Before operating please ensure that all the separate facilities that work with this
anesthesia machine such as the anesthesia gas monitoring apparatus and the
anesthesia gas purifying apparatus are in good condition.
Before operating please ensure that the gas supply needed by the equipment is in
good condition, the malfunction may make the equipment unable to work if connected
to the central air feeding system.
A malfunction of the central gas supply system may cause more than one or even all
devices connected to it to stop their operation simultaneously.
Operating warning
Once the abnormal alarms occur or it cannot start-up normally during the startup
process, please stop using the equipment and contact the maintaining personnel
immediately.
Do not open the outer casing of the equipment so as to avoid electric shock.
The volume of the alarm sound should be kept at an appropriate level ,and it should
not disturb others or be ignored because of the inaudible volume.
This equipment should only be used with the recommended accessories and
materials, otherwise unpredictable risks may occur.
The machine must not be used if any of the alarm, monitoring device are not
functioning correctly.
When worked with the high frequency electrical surgical equipment, should avoid
mechanical damages to this equipment or its components that caused by the electrical
surgical equipment.
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Warning:
Those medical equipments that worked together with this anesthesia machine should
also conform to the corresponding safety requirements.
Additional equipment placed on the top shelf must be securely attached. Take care
when moving a fully loaded machine, particularly when negotiating ramps. Check that
hoses or power leads are not trailing on the floor.
The exhausted gas should be discharged through the exhaust outlet and cannot be
discharged to the room, do not block the outlet.
Do not replace the canister during the ventilation period, otherwise there may exist
risks.
Prevent the absorbent turning dry; please replace the absorbent timely if it becomes
dry.
The vent of the PEEP will discharge little air and oxygen continuously, so do not block
the vent, otherwise the anesthesia machine cannot work.
During operation please ensure there is no testing plug or other foreign body in the
absorber.
The expiratory valve of the anesthesia machine is with constantly open design, when
power failure or abnormal occurs, the valve is open and connected to the atmosphere
through the AGSS to ensure patient can breath freely. During use, please do not block
the AGSS to avoid suffocate the patient.
If one or more devices are connected to the auxiliary mains socket-outlet, it will lead to
the increase of the leakage current risks, the leakage current should be checked
termly.
Before using any additional electrical equipment powered by the auxiliary sockets on
the machine, check that the additional equipment is correctly wired and is earthed
through its plug. A missing or defective protective earth conductor may increase earth
leakage currents to the patient to values exceeding the allowable limits, resulting in
ventricular fibrillation, or interference with the pumping action of the heart.
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Warning:
When installing the oxygen sensor, please check if the sealed ring is in good condition,
replace a new oxygen sensor if the sealed ring is damaged or there is no sealed ring.
Maintenance Warning:
Please clean and disinfect the parts that have been repeatedly used and contacted
with the patient according to the ways that recommended in the user manual every
time before use.
Please shut off the equipment and the power supply while cleaning.
While cleaning the parts of the equipment, users must be away from the equipment.
While cleaning the outer casing, please make sure that no liquid enters into the
controlling components, and it cannot be connected to the AC power supply until the
parts have turned dry after cleaned.
Cooling the equipment for at least half an hour before disassembling it.
While disassembling the outer casing of the equipment, the supply must be cut off and
should only be operated by experienced personnel.
Please dispose the wrapper according to the local regulations or the hospital waste
disposal system.
Do not throw the batteries or the oxygen sensors to the fire so as to avoid exploder.
The oxygen sensor and the flow sensor should not be dipped in the liquid or disposed
by high temperature and high pressure.
The immersion time in hot water of the bellows components should be not more than
15 min, to prevent dissolving or aging.
The heating accessories of the flow sensor are electriferous, so that it should be
cleaned with a soft cloth soaked in alcohol and should not be disinfected by way of
dipping in the liquid.
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Warning:
The moving parts and the knock-down parts may lead to pinched or crushed
dangerous, please pay more attention when moving or replacing the parts of the
system.
Do not implement the calibration process when the system is connected to the patient.
Please use the accessories provided by the Company in order to avoid the value
incorrect or the equipment failure.
The one-off accessories can be used only once, repeated use may lead to
performance degradation or cross-infection.
If there appear any problems about the accessorys wrapping or the accessories, do
not use accessories.
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1.2
Caution
Caution:
Preparation Caution:
Please double-check the power cord before connected to the city electricity, make
sure it has no damage, scratch or other factors which will lead to the inside conductor
exposed issues.
When the equipment or the accessories are about to exceed the limit time, they should
be disposed according to the local regulations or the hospital systems.
The electromagnetic fields may affect the performance of this device, so the other
facilities used around this must meet the corresponding EMC requirements.
This equipment complies with the electromagnetic compatibility regulations of the IEC
60601-1-2 standard. If the interfering grade exceeds the limit grade, it may lead to the
stop of the mechanical ventilation.
Please install or transport the equipment appropriately to avoid falling, hitting, serious
vibrating or other outside forcing damages.
The anesthetic gas delivering device that used together with the anesthesia system
must comply with the ISO 8835-4:2004 or ISO-8835-4 requirements.
This equipment should be used together with the anesthesia gas monitoring
apparatus that comply with the ISO 11196:1996 requirements.
Any of the anesthesia ventilation systems that used together with the anesthetic
vapour delivery system should meet the requirements of the ISO 8835-2:1999
The anesthesia ventilator that used together with the anesthesia system must comply
with the requirements of the ISO 8835-5:2005.
The product itself Is not equipped with an anesthetic gas scavenging transfer or
receiving system that used together with the anesthesia system, if need additional
equipped, please use the anesthetic gas scavenging apparatus that accorded with the
ISO 8835-3:1997 requirements to connect to the AGSS port.
The measuring conditions shown in this user manual are the ambient temperature and
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Caution:
the ambient temperature and pressure saturated (ATPS) conditions.
The pressure in the medical gas pipeline keeps the original unchanged when the
anesthetic system stops delivering gas.
When the pressure of the gas supply inlet is at twice the maximum rated inlet
pressure, the pipeline will not rupture or cause any security risk. But it is
recommended to keep the pressure in the specified range.
Operation Caution
In order to prolong the battery life, please use the battery at least once per month, and
charge or discharge it fully.
Please open the device and check the battery if not been used for a period of time to
avoid the battery malfunctions.
The battery life lies on the frequency and time of used. The lithium battery life is about
3 years if maintenance and used in a proper way.
Please pay attention to the position of the gas pipeline so as to avoid falling off.
Please make sure that the power supply cable exposed outside the equipment is not
twisted to the patients, operators, other personnel or objects (including tubes),
otherwise, dangers may occur.
When installing the breathing tube, please hold the joints on the two ends of the tube
in order to avoid damages of the tube.
This equipment can use three kinds of anesthetic agents: the enflurane, the isoflurane
and the sevoflurane, only one anesthetic can be used at a time.
Do not use this equipment if it not passed the test before using, please contact the
after service department of the Company.
Maintenance Caution:
Please use the methods recommended in this manual to clean or disinfect this
equipment.
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Caution:
damages to the personnel.
Do not use the abrasive detergents (such as the steel wool, silver polish or detergent).
The display should be cleaned with a dry, soft and lint-free cloth; it should not be
cleaned by liquid.
Please contact the repairing personnel or the Company if the calibration of the
equipment failed many times.
Please use the parts that produced or sold by the Company to replace the damaged
parts. And have a test after replacing to ensure that the equipment accorded with the
specifications and requirements of the manufacturer.
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The anesthesia machine is intended to use only in the operating rooms and emergency
rooms, not suitable for other places, and it can only be operated by the professional
anesthetist.
The anesthesia machine has two models: D and C series, the differences of their
configurations are shown as below:
Configurations
D series
C series
Gas supply
O2,N2O / O2,N2O,Air
O2,N2O
LCD
10.1LCD
8LCD
Touch screen
Optional
NO
/Models
Manual ,VCV,PCV,
Manual ,VCV,PCV
Ventilation modes
SIMV(V)+PS,SIMV(P)+PS,
SIMV(V)+PS,SIMV(P)+PS,SPONT
SPONT
CO2 module
Optional
NO
SpO2 module
Optional
NO
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Warning:
The clinical environment of this equipment is operating rooms and emergency rooms.
Optional touch screen to select setting parameters and functional buttons easily and
conveniently.
2.
3.
4.
5.
6.
7.
With a top lighting system, and a separately controlled small lamp on the top of the
machine.
8.
Storing and reviewing the alarm events, recording the wrong status functions.
9.
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Illustrations in this chapter are only for reference, due to the different configurations,
the illustrations may be not entirely consistent to the product.
1. Trolley
2. Mask
6. Power jack
3. Manual bag
7. Host
4. Patient absorber
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2. CO2 canister
3. Manual bag
4. APL valve
7. System switch
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2.2.3
1. Vaporizer
2. Battery
3. User screen
5. Electronic flowmeter
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2.
3.
4.
1. Filter
4 .T2AL/250 fuse
5. Communication interface
6. RS232 Interface
Warning:
If one or more devices are connected to the auxiliary mains socket-outlet, it will lead
to the increasing of the leakage current risks, the leakage current should be checked
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termly.
2.4 Battery
The anesthesia machine is equipped with built-in rechargeable lithium battery to ensure
that the anesthesia machine can still work when the power supply is cut off. When the
anesthesia machine is connected to the AC power and switched on, the battery is
charging if not already full charged. When the power supply is cut off, the system will
automatically switch to the battery power supply, simultaneously, it will generate an AC
power supply failure alarm to prompt users, and will not lead to interruption of the
anaesthesia ventilator work.
The fill amount of the battery icon on the screen indicates the amount of battery power
remaining.
The battery is working normally; the solid part indicates the battery capacity.
No battery.
When the battery power is low, the anesthesia machine will generate a medium alarm,
and the alarm message low battery capacity
displays in the alarm area, it indicates
greater than 10 minutes of battery power remaining; when the battery is exhausted, there
will be a high level alarm, and the alarm message the battery is exhausted
displays
in the alarm area, it means greater than 3 minutes of battery power remaining, then the
anesthesia machine must be connected to the AC power supply.
Caution:
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The battery can not be replaced by users, if need, contact with the authorized
equipment maintenance personnel or the after service department of our company.
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2.7 Flowmeter
The flowmeter displays the flow of the gas: O2, N2O and Air. Their flow can be read
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directly.
The flowmeter range: 0~10L; Accuracy: 0.1L; The unit: L/min.
The user can adjust gases flow by the controlling knob, turn the flowmeter controlling knob
counterclockwise to increase the flow and clockwise to decrease.
There is a round float inside of the flowmeter, and the central plane scale of float is
indicates the current flow. See the graphic below:
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The patient absorber is used in conjunction with the anesthesia machine as a part of the
closed respiratory system, connected with the appropriate respiratory pipeline, gas
reservoir bag and patient port, and absorbs CO2. According to the different gas flow set by
the anesthetist, the expiratory gas can completely or partially circulate and enter the
inspiratory port, achieve the closedsemi-closed ventilation.
The patient absorber and the bellows integrated system is connected to the anesthesia
machine by connecting the interface board on its side with the interface boartd on the side
of the host, after installed, lock the system by the locking device on the left front of the
anesthesia machine to prevent loosing or falling off and lead to gas leakage.
There is a Sodium lime canister at the bottom of the patient absorber, which is used to
absorb the exhalant CO2 and prevent the intraoperative excessive CO2 retentate which
may lead to hypercapnia. If you need to replace the sodium lime in use, remove the
sodium lime canister and the gas path will be closed automatically, it will not affect the
ventilation or use, but it is not recommended to undergo surgery using the anesthesia
machine in the case of the sodium lime canister absent and the sodium lime disabled.
The inspiratory non-return valve,inspiratory flow sensor and the expiratory non-return
valve,expiratory flow sensor are there installed respectively on the inspiratory limb and the
expiratory limb of the patient absorber, which are used to monitor the inspiratory and
expiratory flow rate,the airway pressure as well as achieve the gas circulating circuit.
There is also a micro-manometer installed above the patient absorber, it will display the
airway pressure, the display range is : -20+100cmH2O.
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The APL valve above the patient absorber is used to restrict the pressure during the
manual ventilation mode, the design range is 270cmH2O, when extruding the bag
manually, if the pressure exceeds the limited value, the gas will be vented from the valve
vent, and the exhausted gases are collected to the AGSS outlet and vented.
The system is integrated with the Bag/Ventilator switch valve, achieving the following
functions:
a)
b)
AGSS consists of the exhaust port, float pump, float, cylinder, and inlet port.
AGSS has two models: 200A and 200B, there is difference between 200A and 200B, 200A
cylinder with the metal material and 200B with the plastic material.
Anesthetic Gas Scavenging System:
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Exhaust port: it is a specified screw thread connecting port matched with the specified
corrugation hose which connects to the hospitals waste gas disposal system.
2.
Float pump: it is a transparent and plastic pump used for observing float s position,
and marked the minimum scale line on the surface.
3.
4.
Inlet port: it is the inner cone port (30mm) that complies with the standard of
YY1040.1-2003 and with a transfer hose connects to the anesthetic machine s
exhaust gases outlet.
5.
Cylinder: it is hollow cylinder that collects exhaust gases from the breathing system.
2.11 Vaporizer
The vaporizer transmits the anesthetic to the patient respiratory system to anesthetize the
patient. Different anesthetic should be used with the corresponding vaporizer; otherwise it
will result in inaccurate output concentration.
The anesthesia machine adopts 80/60 vaporizer designed by the company, and also the
imported PENLON vaporizer. The enflurane, isoflurane and sevoflurane are optional. The
anesthesia machine is equipped with one vaporizer seating, and it can also support two
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vaporizer seatings. When installing two vaporizers, it will only output one kind of
anesthetic agent at the same time.
The vaporizer used in this anesthesia machine should be accorded with the standard
ISO8835-4.
For the particular operation of the vaporizer please refer to the user manual provided by
the vaporizer manufacturer.
In order to prevent the exceeding high pressure in the gas path which may bring dangers
to the patient or equipment, the anaesthesia ventilator monitors the pressure and flow
value of inspiratory and expiratory gas, and emits the auditory and visual alarms for the
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abnormal events, besides the design of the over-pressure valve to ensure the driving gas
not exceed the safe pressure.
2.12.1 Display
The anesthesia machine adopts the colour TFT LCD, which can display various
parameters and graphics clearly. The diagram below contains the main interface of the
anesthesia machine. For the information of the other interfaces, please refer to section
2.11.3 User screen.
D series:
C series:
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1.
No practical function. Response to the anesthetic ventilator alarms, the light is red for the
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high priority alarms and yellow for the medium and low priority alarms. please refer to
5.6 Alarm settings for more information
2.
Alarm Silence
1)
2)
When alarm sounds, push the key to mute the alarm, the duration is 100 seconds, the
alarm silence icon and the 100 seconds count down will display on the top right
corner of the interface.
3)
3.
Alarm Setting
Ventilation Setting:
Push the key to access the ventilation modes and parameters setting interface.
5.
System Setting:
Start/Standby:
Navigation wheel:
1)
Turn: to switch among the membrane buttons or the function options; turn it clockwise
to increase the parameter value, or anticlockwise to decrease the parameter value.
2)
8.
1)
2)
3)
9.
AC power indictor:
1)
The indicator light is on: the anesthesia machine is connected to the AC power;
2)
The indicator light is off: the anesthesia machine is disconnected to the AC power.
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According to different ventilation modes, the parameters setting keys are corresponding to
different parameters.
Caution
The user interface may be different due to the different configurations, please take
the material object as valid.
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2. APL valve.
Preparation for manual mode leakage test:
1. Set the Bag/Vent switch to Bag;
2. After install the Manual Bag and occlude the patient Y-piece in it;
3. Adjust APL valve to approximately 30cmH2O;
4. Shut off ACGO;
5. Shut off all the fresh gas controlling valve;
6. Push O2+ until Paw gauge value is between 25 cmH2O to 35 cmH2O;
7. After reading of pressure gauge reach setting range, take stock of the reading of
pressure gauge and the pressure waveform on the interface.If the pressure value
decreases less than 5 cmH2O within 15 seconds, and then it passes the test.
Otherwise it doesnt.
Remark: Choose Bypasskeyboard, the system enteres Start-up.
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If the system passes test, the interface displays the information of Test
passed; Leakage value;Compliance value.
b)
If the test fails, the interface displays the message such as Test failed;
Leakage value; Insufficient gas in the folding bag;Please shut off fresh
gas.
Warning
Small amount of leakage does not affect the function of this equipment; please
consider whether to continue using this equipment.
If you feel leakage is serious, please contact the after service dept. of the Company.
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Note
100% O2 sensor calibration must be carried out after 21% O2 sensor calibration.
Please perform the O2 sensor calibration if the measured O2 has obvious error or
after replacing O2 sensor.
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Caution:
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For more information about the operation , please refer to chapter 5 operations and
settings
In the start-up interface, the alarm function is normal if technical alarm occurs.
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C series:
1.
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1)
2)
3)
2.
1)
2)
3)
4.
Ventilation Setting;
2)
Measured Values;
3)
Alarm Settings;
4)
System Setting;
5)
System Log.
Ventilation Setting;
2)
Measured Values;
3)
Alarm Settings;
4)
System Setting;
5)
System Log;
6)
Exit Menu.
5.
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According to different configuration of models and different settings by users, it will display
the waveform or Loop.
7.
Except using the membrane button Ventilation settings, users can set the relative
ventilation parameter of the current ventilation mode in the main interface directly, the
gray touch key means the parameter has nothing to do with the current ventilation mode
and cannot be adjusted.
Ventilation setting
In the Modes setting interface, users can perform the following operations:
- Selecting the ventilation mode;
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Note
2.
Measured value
There is no user action in the measured value interface. It mainly displays the current
ventilation mode and the related setting parameters and measured value information.
- Real-time monitoring of ventilation parameters
- R-- real-time monitoring of gas resistance while setting breath holding time
- C-- real-time monitoring of dynamic compliance
3.
Alarm setting
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Users can set the alarm limit in this interface. The current measured value is between the
upper limit and the lower limit of the alarm value.
If no CO2 modules and SPO2 module are connected to the system, the alarm setting
interface will not display CO2 and SPO2 alarm limit settings.
4.
System setting
In the system setting interface, users can perform the following operations:
- Setting the current date and time;
- Setting the alarm volume;
- Setting the system language;
- Setting the waveform configuration of the interface;
- Setting the parameter area of the interface;
-
information display
Compensation setting;
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The super mode is non-user function, and it is used by trained engineers of the
System Log
There is no user action in the system log interface. It mainly displays the operation
information that the user have performed and the alarm information during operation. Use
the Navigation wheel to view more content.
Note
The anesthesia machine can store up to the latest 500 logs for your view.
position, the
Turn the controlling knob of the APL valve to adjust the pressure in the patient
absorber to an appropriate range.
In manual mode, the user can adjust peak pressure of the patient circuit and gas volume
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of the breathing bag by APL valve, when the pressure of the patient circuit exceeds the
limited value, APL valve will open to release superfluous gas.
Caution
In the manual ventilation mode, all the setting parameters are disabled.
Caution
2.12.4.2.1
1.
VCV mode
Principle description
VCV (volume control ventilation) mode is a basic completely mechanical ventilation mode.
Preset the tidal volumeVT, breathing frequency fand the expiratory and inspiratory
rate I:E. When the inspiration begins, the gas flow will enter the lung at a constant
speed and it will reach the preset tidal volume within the preset inspiratory time and then
expire.
In VCVmode, users can set the TIP:TI (inspiration hold) to improve the gas
distribution conditions in the patients lung; and set the PEEP(positive end-expiration
pressure) to improve the vent of CO2 in end-expiration and increase oxygen in the
breathing process.
When the peek pressure exceedsPlimit,the system will release the pressure and give an
alarm.
2.
1)
2)
Push the modes option frame and selectVCV mode in the drop-down menu;
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3)
When VCV mode is selected, the mode information display area will display
VCV.
3.
Principle description
In volume control mode, the user can set sigh by ventilation mode interface
range:OFF,10~100, the extra volume will be increase by 50% above the tidal volume
set by the user(1.5xset volume) in the next inspiration cycle of the sigh setting value.
Note that sigh function is canceled when the unit is powered off.
2.
Selecting Sigh
1)
Push the Ventilation Settings key, the modes setting interface will display;
Set the Sighparameter in the modes setting interface (only volume control mode);
2.12.4.2.3 PCV mode
1.
Principle description
In the PCVmode, users can also set the PEEP(positive end-expiratory pressure).
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2.
1)
2)
Push modes option frame and selectPCV mode in the drop-down menu;
3)
WhenPCV mode is selected, the mode information display area will display PCV.
3.
Principle description
In SIMV mode, the independent breathing frequency and the tidal volume is controlled by
the patient, and a synchronous control is activated at a certain interval of time; if the
trigger level (flow trigger) is met in the waiting trigger window, the anesthetic-ventilator will
provide a synchronized volume control ventilation for the patient; if the trigger level is not
achieved in the trigger window, at the end of the trigger window, the anesthetic-ventilator
will give a volume control ventilation.
2.
1)
Push the Ventilation Settings key, the modes setting interface will display;
2)
Push the modes option frame and select the SIMV(V)+PS mode in the drop-down
menu;
3)
When the SIMV(V)+PS mode is selected, the mode information display area will
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display SIMV(V)+PS.
3.
Principle description
In SIMV mode, the independent breathing frequency and tidal volume are controlled by
the patient, and a synchronous control is activated at a certain interval of time; if the
trigger level (flow trigger) is met in the waiting trigger window, the anaesthesia ventilator
will provide a synchronized pressure control ventilation for the patient; if the trigger level is
not achieved in the trigger window, at the end of the trigger window, the anaesthesia
ventilator will give a pressure control ventilation.
2.
Push the Ventilation Settings key, the modes setting interface will display;
2)
Push the modes option frame and select the SIMV(P)+PS mode in the
drop-down menu;
3)
When the SIMV(P)+PS mode is selected, the information display area will
displaySIMV(P)+PS.
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3.
principle description
SPONT (spontaneous ventilation mode). In the SPONT mode, the patients will control the
breathing rhythm themselves, when the triggered level is met, the ventilator will support
with the pre-set inspiratory pressure; keep the pressure till the inspiratory flow decreased
to the pre-set value and then enter the expiration phase.
2.
Push the Ventilation Settings key, the modes setting interface will display;
2)
Push the modes option frame and select the SPONT mode in the drop-down
menu;
3)
When the SPONT mode is selected, the information display area will display
SPONT.
3.
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- Sigh
- FTRIG
Users can set the backup ventilation in the SPONT mode, providing the mandatory
ventilation when the patient is asphyxial.
When alarm occurs, it will remind the user by the alarm indicator light, alarm sound and
alarm messages, different types of alarms have different alarm information.
The alarm signals and conditions are grouped into physiological alarm conditions and
technical alarm conditions.
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1)
2)
Technical alarms: Due to the improper operations or the malfunctions of the technical
or the equipment, the machine cannot monitor exactly.
According to the different risks when alarm activated, the alarms are grouped into: High
Priority, Medium Priority and Low Priority alarm.
1)
High priority: when the high priority alarm occurs, it may endanger the patients safety
or the equipment cannot work normally, users must stop operating to dealing with the
malfunction.
2)
Medium Priority: when the medium priority alarm occurs, it may endanger the
patients safety if lasting a long time, or some reasonable settings, users should
adjust the parameters to clear the malfunction.
3)
Low priority: when the low priority alarm occurs, it will not endanger the patients
safety, there may be some reasonable settings or some unimportant malfunction,
users could adjust the setting parameters properly or clear up the malfunction when
complete operating the equipment.
When alarm occurs, the anesthesia machine will remind users by the following
auditory and visual signals.
1)
High priority:
- Alarm indicator light:red flashes;
- Alarm sound:du- du - du -- du - du ---- du - du - du - du du ;
- Alarm messagered background , and displays
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2)
Medium priority:
- Alarm indicator light: yellow flashes;
- Alarm sound: du - du - du ----- du - du du;
- Alarm message: yellow background, and displays behind the alarm
message;
3)
Low priority:
- Alarm indicator light: yellow, static, not flashes
- Alarm sound: du-----du;
- Alarm message: yellow background, and displays behind the alarm message;
Caution
When different priorities of alarms occur simultaneously, only the alarm with highest
priority will display.
Warning
A HAZARD can exist if different ALARM PRESETS are used for the same or similar
equipment in any single area, e.g. an intensive care unit or cardiac operating theatre.
Caution
Please always pay attention to the alarm limit parameter and make sure it is set at a
proper and reasonable level to avoid inaccurate alarms.
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The alarm silence status lasts for 100 seconds, 100 seconds later, the alarm silence will
be disabled and the alarm sound resumes.
In the alarm silence status, pushAlarm silencemembrane button again to resume the
alarm sound.
Caution:
In alarm silence status, except for the alarm sound, the other alarm functions are
working normally.
In alarm silence status, if new alarms occur, the alarm silence will be disabled and
alarm sound will be activated according to the latest alarm.
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Always ensure that there is no toxicity in the gas supply hose or the absorber, will not
cause allergic reactions in the patient's body, and will not react with the anesthetic to
produce dangerous substance.
When the absorbent becomes dry, continuous using may cause dangerous to the
patient. Appropriate preventive measures should be taken to prevent the absorbent in
the vaporizer not becoming dry.
Before using please make sure that the locking organs have been locked or it may
lead to unpredictable dangerous.
This equipment has an exhaust emission vent, users should pay more attention to the
disposal of the vented residual gases.
The operating environment and the power supply of this equipment must comply with
the requirements of the B.2environment specifications and B.3power supply
specifications.
The facilities that connected to the power outlet will lead to increasing of the leakage
current, so the leakage current should be tested regularly.
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The following graphic indicates that the tubes of the three air source are connected
correctly.
Warning
Only the medical gas supply can be used. Other types of gas supply may contain
water, oil or other contaminations.
Turn the handle of the gas cylinder clockwise, close the valve of the cylinder that to
be replaced, unscrew the T-handle anticlockwise;
2.
Release the T-handle fully, break apart the door and remove the gas cylinder.
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3.
Do not place any objects that may be damaged easily due to the releasing of high
pressure gas in front of the new cylinder outlet.
4.
Open the gas cylinder valve quickly, eliminate the dust on the outlet of the cylinder;
5.
6.
7.
Warning
During the process of pipeline gas supplying, do not let the backup cylinder valve
open. Otherwise, when the gas supplying of the pipeline goes wrong, the gas of the
cylinder may be exhausted and lead to the inadequate supply of reserves.
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Cover the bellows base with the folding bag; make sure the bottom of the folding bag
can be nested tightly to the bellows base. The graphic is as below;
2.
Put the side that printed a scale of the bellows face to the front of the anesthesia
machine, note that the four block spaces should be pointed at the corresponding four
gaps of the patient absorber;
3.
Slightly push it down, and turn the bellows housing clockwise until you cannot turn it:
Caution:
Please make sure that the sealed ring inside the bellows cover can not be turned over
or extruded transmutative.
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Caution
Before installing or removing the micro manometer, always press the button first so
as not to damage the micro manometer.
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Filter plate
1.
Spill the used absorbent from the canister to the specified position, take out the filter
plate and the guiding shelf,clean away the dust and then put them back.(for the first
time please implement the step2 directly);
2.
Defilade the top of the guiding shelf with a plastic lid or other objects to avoid dust
enter the guiding tube, dump the sodium lime (1) slowly to the CO2 canister to the
specified position of the graphic below:
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1
Shielding
cover
Sodium lime
filling line
3.
Clean away the dust on the wall of the canister with paper or special cloth.
Hold the bottom of the canister, push it upward to be directed at the screw thread and
align with silk-screen direction indicated by arrow.
Silk-screen direction
indicated by arrow
2.
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3.
Rotate the canister anticlockwise until it is turned to limit position block of BYPASS
base, the following figure is shown as the installed canister.
Caution
Please check whether the installation of the canister is in place or not after
installation.
It is recommended to keep your hands clean and dry when installing the canister.
Caution
The commonly used absorbent are two types: sodium lime and barium lime, it is
recommended to use the sodium lime as absorbent.
Before installing the canister, please check the color of the absorbent to decide
whether you need to replace the absorbent.
The changes of the absorbent color are just shown in general. Please use the CO2
monitor to decide whether you should replace the absorbent.
Please discard the absorbent if the color is changed. If placed a few hours, it may
restore its original color and lead to misusage.
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Appropriate defensive measures should be taken to ensure the absorbent not turn
dry. Please cut off the gas supply when complete using the system. When the
absorbent turns dry, if contacting with the anesthetic, it will emit carbon monoxide
(CO) which will bring hazards to patients. Therefore, please replace the absorbent in
time for the patients safety.
In order to ensure the humidity of the sodium lime and avoid the emitting of CO,
please pay attention to the following:
Avoid gases flow through the sodium lime when the machine not being used.
During surgery or complete a case, please check the color of the absorbent and take
corresponding measures. For the detail information about the color change of the
absorbent, please refer to the instructions on the packaging of the absorbent.
When installing the breathing hose, please grab the two ends of the hose to avoid
damages to the hose.
1.
Connect the other end of the two breathing hoses to the two parallet intefaces of the
Y connector:
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Caution
For the one-off accessories, the Y connector has been connected with the breathing
hose, so cancel this step.
3.10
Put the manual bag forcibly to the manual bag connector (marked1 in the graphic
below):
If the anesthesia machine and the vaporizer do not match, their performance will
decrease. Please use the vaporizer that matches the anesthesia machine.
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Caution
For the detailed description of the installation and operation of the vaporizer, please
refer to the manual of the corresponding vaporizer.
When installing the vaporizer, make sure the vaporizer is locked well; otherwise it
may lead to leakage.
2.
Rotate the locking pole and push it, fix the vaporizer to the fixing socket;
3.
Make sure the top of the vaporizer is in parallel, otherwise it should be removed and
installed again;
4.
When re-installing the vaporizer, users should lift each of the vaporizer upward to let it
fall off the fixing socket instead of pulling it forward, be careful not to let the vaporizer
rotate on the fixing socket;
5.
When the vaporizer is lifted off the fixing socket, install it again and carry out the steps
1 to 3.
6.
Test each possible combination. If the user tries to open more than one vaporizer at one
time, these vaporizers should be removed and installed again, then complete the steps 1
to 6.
A:Locking pole;
B: Interlock bolt;
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C: Tighten hook;
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1.
Check the controlling knob A and set it to Zero; check and tighten the screw C;
2.
3.
Pour the anesthetic liquid slowly to the vaporizer. During the process of pouring the
liquid, please pay attention to the height of the liquid inside the vaporizer, when it
reaches the maximum level, stop pouring the liquid;
4.
Caution
The maximum level of the anesthetic in the vaporizer is 250mL; and the minimum
level is 35mL.
1.
2.
3.
Place a bottle marked with the name of the corresponding anesthetic under the
vaporizer, put the mouth of the bottle at the tundish that under the discharging pipe,
loosen the screw C, ensure the anesthetic flow into the bottle. Make sure the
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3.12.2 Connection
1.
AGSS inlet port used with the specified transfer hose which connects to the
anesthetic machine s exhaust gases outlet. The one end of the corrugated hose with
30mm connects onto AGSS inlet port, and the other end connects onto anesthetic
machine s exhaust gases outlet.
2.
AGSS exhaust port used with the specified transfer hose and connector connects to
the hospitals waste gases scavenging system, and tightens with nut.
3.12.3 Usage
After connection and check, AGSS system could be used normally.
Check if float can rise and exceed the minimum scale line.
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2.
3.
If occurs the above malfunction, it must be solved immediately, otherwise AGSS will not
be used normally.
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The using environment should meet the relative requirements of the Appendix B;
2.
3.
4.
5.
6.
7.
All the equipment that used for the maintenance of the pipeline and the intubatton of
the windpipe are available and in good condition.
8.
Make sure there is no loose phenomenon on the truckle and the brake has been
locked and the anesthesia machine cannot be moved.
9.
Connect the power cord to the AC power outlet, switch on the AC power supply, the
AC power indicator and the battery indicator will light, if not, that means the system
has no electricity.
10. Checking the negative pressure of waste gas processing system is enough or not.
Observe AGSS system buoy, if it is on the minimum scale, it means the negative
pressure is normal, and can work, but if the negative pressure is not enough, the
AGSS system can not work.
11. Checking the air inlet is jammed or not which is under the AGSS system cup. If it is
jammed, Use it till need clear the blockage.
12. The gas supply connection test:
1)
Connect the O2; N2O and Air source (please refer to the section 3.2 connecting the
gas supply).
2)
3)
View O2, N2O and Air manometers, make sure the reading of the each manometer is
in the range of 280~600kPa.
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4)
Cutoff the gas supply and discharge the gas in the pipeline, view the manometers
and make sure the readings zero.
5)
Check if waste gas disposal systems negative pressure is enough, and observe
AGSSs float, if the float can rise and exceed the minimum scale line, it means the
negative pressure system is normal, otherwise the negative pressure is deficiency
and AGSS system could not be used normally.
6)
Check that cylinders inlet ports are blocked or not; if any blockage, please dispose
blockage existed before using.
Warnings
Please always do a pre-use check before the anesthesia machine is connected to the
patient.
Please connect the power cord to a protective grounded power outlet in order to
avoid electric shock.
If any functional failures detected, and the failures persist, the anesthesia machine
cannot be connected to the patient.
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1.
The blue key pad indicates the normal status; you can push it to operate. For
example:
2.
The yellow key pad indicates the active status: the key is selected, and can be
operated directly. For example:
3.
The dark blue key pad indicates the selected status; the parameter cannot be
adjusted currently. For example:
4.
The gray key pad indicates the invalid status, the key is disabled, and the
parameter cannot be adjusted currently. For example:
5.2 Start-up
1.
Connect the power cable to the power outlet; make sure the power supply works
normally.
2.
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Warning
If abnormal alarms occur when the system starts up, please discontinue operation
and contact the authorized repaired personnel or the after service department of the
Company.
Only the specified, protective grounded power supply can be used in this equipment.
1.
1)
2)
The user could set the patient age in the start-up interface. The system calculates
corresponding MAC value based on the different ages when there is anesthetic agent in
machine.
Patient age range: 1-100 years old.
1)
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2.
2)
3)
Weight setting:
User can set the patients weight in Start-up interface. The anesthesia machine calculates
the referenced tidal volume value in the volume ventilation mode according to different
weight of the patient.
For different patient categories, the setting ranges of the weight are different:
- Adult: 20-150kg;
- Pediatric: 5-20kg;
1)
Push the patients weight area, the area turns light yellow.
2)
3)
Push the navigation wheel to confirm the setting, the area turns dark blue.
5.4 Standby
User can select the standby mode if need.
PushStart/Standbykey.
2)
3)
In the standby mode, pushdefaulttouch key, then push the navigation wheel to
confirm, this returns all setting parameters to default values.
Exit the standby mode:
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1)
1)
Push the navigation wheel to exit standby mode to the main menu.
2)
Push Mode option frame and select the ventilation mode in the drop-down menu.
3)
Push the ventilation parameter that you need to set, turn the navigation wheel to
adjust the value and push the navigation wheel to confirm the setting.
4)
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Users can use the alarm setting function to adjust the alarm parameters for the needs of
monitoring and protecting the patients.
For the detail alarm parameters and setting range, please refer to the Appendix B.6.3
1)
Push the upper limit or the lower limit parameter value, the frame turns yellow.
2)
3)
4)
Pushdefaulttouch key, all the parameter value will resume to the system default
value.
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1. Common settings
Users can set the date/time, alarm volume and language of the system.
1)
Push the parameter value that you desire to set, the frame turns yellow.
2)
Turn the navigation wheel to adjust the value and push the navigation wheel to
confirm the setting.
2. View settings
Users can configure the waveform displayed on the interface; the system can display
three waveforms simultaneously.
1 The first waveform options:
- Airway Pressure(Paw);
2 The second waveform options:
- Flow;
- Volume
3 The third waveform options:
- SpO2; Optional
- CO2; Optional
- Volume;
- Airway pressure(Paw);
- Flow
4The display format options:
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- Normal;
- Wave+Loop
If you select wave, the interface will only display the waveform, if you select
wave+Loop, the Loop will display on the right side of the interface, the Loop contains
the following types:
- Flow-Pressure (F-P);
- Pressure-Volume (P-V);
5Parameter area
- Electronic flowmeter;
- SPO2;
- Measured values;
After the option is selected, it will be displayed in the Monitored Parameters Area in
the Main Interface.
3. Special settings
1information
The system version, gas controller version, display control version, gas flowmeter version,
gas module version, SPO2 module version, and SN are in this interface.
2) Super mode
Push Super Modekey to access the super mode interface.
Functions of the super mode are only for trained engineers of the Company to calibrate
or upgrade the system, and a password is required.
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3) Compensation Setting
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these ranges, the maximal relative CO2 error will be limited to 1.2%.
Set O2 range:
0-30 vol%;
30-70 vol%;
70-100 vol%.
When using the IRMA CO2, the current N2O concentration should be transmitted to the
ISA gas analyzer or the Probe using the SetN2O command.
For most applications, sufficient accuracy in CO2 measurement will be achieved by setting
N2O to one standard concentration used always with N2O in use, as recommendation
span 30-70 vol% N2O. when N2O is not in use, set N2O range 0-30 vol%.
By using this range, the maximum CO2 error with N2O compensation on (30-70%) will be
limited to 3.2% relative.
Set-mode
For normal use, the ISA sensor has three operating modes: Self test, Sleep,
Measurement.
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Self test:
The sensor performs a self test and does not respond to commands from the host.
Sleep Mode
Low-power standby state. The host can communicate with the sensor, but all functions are
disabled.
Measurement Mode:
The sensor is measuring gas concentrations.
SetApnea:
The apnea setting range is from 20 to 60 seconds.
Normal Zeroing:
For all IRMA mainstream multigas analyzers, they need to establish a zeroing every time
after replacing the adapter or you have any doubts about the accuracy of the measured
values.
PushNormal Zeroingtouch area, the analyzer will begin normal zeroing.
Unit:
Three units can be selected:
- %;
- kPa;
- mmHg.
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2)
3)
4)
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It is not intended to be used as the only means of monitoring a patient. It shall always be
used in combination with other vital signs monitoring devices and / or professional human
judgments of patient condition. The IRMA probe is intended to be used by trained and
authorized health care professionals only.
Warning
The IRMA probe is intended for use by authorized and trained medical personnel
only.
The IRMA probe must not be used with flammable anesthetic agents.
Disposable IRMA airway adapters shall not be reused. Reuse of the single use
adapter can cause cross infection.
Used airway adapters shall be disposed of in accordance with local regulations for
medical waste.
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Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors
shall be disposed of in accordance with local regulations for batteries.
Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds
6 ml dead space to the patient circuit.
Do not use the IRMA infant airway adapter with adults as this may cause excessive
flow resistance.
Do not place the IRMA airway adapter between the endotracheal tube and an elbow
as this may allow patient secretions to block the adapter windows and result in
incorrect operation.
To keep secretions and moisture from pooling on the windows or oxygen sensor port,
always position the IRMA probe in a vertical position with the LED pointing upwards.
Do not use the IRMA airway adapter with metered dose inhalers or nebulized
medications as this may affect the light transmission of the airway adapter windows.
Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable
product and contains a caustic electrolyte and lead.
Caution
The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do
not autoclave the devices as this will damage them.
Do not operate the IRMA probe outside the specified operating temperature
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environment.
Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe
is not in use.
Plug the IRMA connector into the IRMA input of host device and switch the power on.
2.
Snap the IRMA probe on top of the IRMA airway adapter. It will click into place when
properly seated.
3.
A green LED indicates that the IRMA probe is ready for use.
4.
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5.
Connect the IRMA / airway adapter 15mm female connector to the patients
endotracheal tube.
6.
Unless the IRMA probe is protected with an HME always position the IRMA probe
with the status LED pointing upwards.
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Warning
Perform the tightness check of the patient circuit with the IRMA probe snapped on the
IRMA airway adapter.
In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe,
without connecting the airway adapter to the patient circuit, and then using the host
instrument to transmit a Zero reference command to the IRMA probe.
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Special care should be taken to avoid breathing near the airway adapter before or during
the Zeroing procedure. The presence of ambient air (21% O2 and 0% CO2) in the IRMA
airway adapter is of crucial importance for a successful Zeroing.
Always perform a pre-use check after zeroing the probe.
Zeroing needs to be performed ONLY when an offset in gas values is observed, or when
an unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probe after power on and after changing
the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED
on the probe will be blinking for approximately 5 seconds while zeroing is in progress.
6.1.5 Alarms
The description of the status LED situated on the IRMA probe is as below:
Steady green light
System OK
Zeroing in progress
Check adapter
Warning:
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Dont put the SpO2 probe and blood pressure bond on one arm together, because
that affects the SpO2 saturation reading.
The SpO2 detecting has no preventing defibrillation function, and dont use with the
defibrillation equipment. That can cause interference probably.
Clip one patients part no more than 2 hours, for the skin needs to get some air.
The probe sensor should avoid shinning from troubled light in the process of
detecting SpO2.
Please choose the type SpO2 probe to the needs of the sick before used, otherwise
the SpO2 value occurs error probably.
Check the sensor before used, if the sensor packing or itself is damaged, dont use.
Dont put together the SpO2 probe on the arm which has conduit or injection syringe.
2)
3)
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Warning:
Check the using status and skin every 2 hours in a long continuous detecting
process.
Check the position of probe periodically in a long continuous detecting process, avoid
moving to cause error probably.
Attention:
Put the SpO2 probe cable on the hand, and make sure the nail face on the light from
lamp-house.
If the detecting part can not face on the probe, that maybe cause error, even dont
search the pulse and dont detect, and now need to locate again.
Move the detecting part can cause error probably, should make the patient quiet and
replace detecting part, to minimize this impact.
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Chapter 7 Maintenance
Warning
Please read all the operation and maintenance instructions of the disinfection devices
carefully.
Please wear the safety gloves and glasses, the damages to the oxygen sensor may
result in leakage and lead to fire (contains potassium hydroxide).
After every disassembled cleaning or reinstallation, it can be used regularly only after
the pre-use check in chapter 4.
In order to prevent the leakage of the patient absorber system, during disassembling
and re-installing process, please pay attention to avoid damages to the components
and make sure the correctness of the installation, especially note the installation of
the seal ring; during the process of cleaning and disinfecting, please make sure the
way to clean and disinfect is applicable and correct.
The used devices may be polluted by blood or body fluid, please apply to the
disinfection controlling and safety regulations.
The moveable parts and removable components may have pinching or crunching
dangers, please pay more attention to those parts when moving or replacing the
system components.
Do not use the devices with malfunctions, the machine should be maintained
dismantled or operated only by the qualified personnel.
After repairing, the equipment should be tested to ensure the normal function of the
equipment.
Everyone should realize that some parts of the anesthetic-ventilator may be in danger
of infection when dismantled and cleaned.
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Caution
In order to prevent damages, if you have any problem about the cleanser, please see
the data provided by the manufacturer.
Don no use abrasive cleanser. (like steel wool, silver polish or detergent)
The soaking time of the synthetic rubber can not exceed 15 minutes, or it will lead to
expansion or accelerated aging.
Those personnel who dont have the experiences of repairing such equipment should
not carry out the maintenance
Use parts produced or sold by our company to replace those broken ones, and have
a test after replacement to assure that they correspond with the specification
requirements of the manufacturer.
All the disposable (one off) parts should be disposed in a safe and environmental
way according to the hospital regulations.
When taking any parts from the anesthesia machine, you should abide by the
hospital rules and regulations about taking and disposing infectiousness materials.
Because the way of cleaning, sterilizing in the Medical institutions is very different
from the practice. Therefore the Company can not satisfy all the special needs and
can not be responsible for cleaning, sterilizing or other hygienic measure taken by the
hospital during therapeutic process. We suggest that you use the effective methods
already proven in this user manual, specific equipment and steps. Other methods
may be just as effectively, but we do not guaranteed unless the Company provides
written authorization.
We suggest that when cleaning or sterilizing, you should use drinking water at least
or more healthful water, otherwise, the result may be affected.
Cleaning is the most important step in cleaning and sterilizing process. If you clean
the instrument improperly, it would be impossible to sterilize or high temperature
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The instrument should be cleaned and sterilized immediately after using if possible.
Filth like saliva or blood should not remain in the instrument and turn dry.
If you need service or support, please contact with the after service department of the
Company.
Maintenance
Every patient
Every day
Every year
When
cleaning
and installing
Perform based on
requirement
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Warning
Do not use the talczinc stearate, calcium carbonate, corn flour or the similar
materials to avoid conglutination. These materials may enter the patients lung or air
channel, causing stimulation or damages.
Do not soak the oxygen sensor in the liquid or dispose it by high-temperature and
high pressure.
Each component on the absorber of the anesthesia machine can be cleaned and
disinfected. The methods of cleaning and disinfecting for different components are
different. Users should select the appropriate method according to the actual circs to
clean and disinfect each component of the absorber in the anesthesia machine to prevent
cross -infection of the patients while using the anesthesia machine.
AGSS is a corollary equipment of the anesthetic machine that must be cleaned and
serviced synchronously.
The methods of cleaning and disinfecting described in the form below are recommended
by our company.
Components
The medium
disinfection
A*
C*
Y-connector
The flow sensor
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oxygen sensor
assembly
A* Clean with a cloth that soaked in the mild cleanser and dry it by using a lint-free cloth;
B*Wash it with clean water firstly, and then soak it in the water and the cleanser solution
(the recommended temperature is 40C) for about 3 minutes, finally, clean up with clean
water and wipe it with 70% medical alcohol;
C*The high-temperature and high-pressure steam sterilization (the maximum
temperature is 134C).
Use a wet cloth that has been soaked in the mild cleanser solution (such as the 70%
medical alcohol) to wipe the surface of the anesthesia machine;
2.
After finish clean of the surface, using dry, Lint-free clothe to wipe the residual
detergent.
Warning
If liquid dip into the controlling components, it will damage the equipments or induce
people in danger, in the process of cleaning the surface, please make sure there is
no liquid dip into the controlling components, and disconnect the equipment and the
AC power. Reconnect the equipment to the AC power after all the parts that have
been cleaned are dry.
Caution
The screen must be cleaned by the cloth that is dry, soft and lint-free, can not be
cleaned by liquid.
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1. Bellows assembly
3. Pop-off valve
4. Gas block
6. Canister assembly
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Disassembling:
1 Pull out all the breathing tubes that connected to the patients.
2 Remove the manual bag and place it with the tubes to the specified position for
disinfecting and depositing.
2.
Caution
When disassembling breathing hoses, please grab the two ends of the hose to
prevent damages to the hose.
Disassembling: please refer to 3.5 Installing the folding bag and bellows housing,.
The method of disassembling is contrary to the method of installing.
2.
Disassembling: please refer to 3.6 Installing the micro manometer. The method of
disassembling is contrary to the method of installing.
2.
Warning
The absorbent is strong corrosive substance which can irritate the eyesskins and
the respiration system badly. If touches the skins carelessly, please flush with clean
water for at least 15 minutes. If the irritating substance still remains after cleaning,
please seek for the doctors help.
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Cautions
The manometer of the absorber airway can not be disinfected, please take and place
it gently during the disassembling and installing process, cannot hit it violently.
Disassembling:
2
3
1
2.
Caution
The damages of the Pop-off valve may lead to the gas leakage or serious
malfunction, therefore, please be careful to maintenance it.
Disassembling:
1 Unscrew the four screws 1 and the six screws 6 , take out the upper cover of the
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4
1
1
1
3
1
3
2.
Disassembling: unscrew the four screws 1 by tools, and take out the BYPASS
assembly 2.
2
1
1
1
2.
Disassembling: Unscrew the micro manometer 1 by a monkey wrench, and then take
out the nine screws 2. The diagram is shown as below:
5
2
2
1
4
2
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Pull the Bag/Ventilator handle 3 to the middle, and take out the upper cover 4 with the APL
assembly 5.
2.
Caution
The APL assembly is fastened in the upper cover of the absorber; it can be
disinfected without being disassembled.
If you need to disassemble it, please keep the dismantled parts to prevent loss.
Disassembling: Remove the upper cover main unit, then you can easily take out the
heat plate 1 and the Bag/Ventilator assembly 2 (it is built in the heat plate, advise not
to dismantle it). Please see the diagram below:
2
1
3
Hold the non-return valve assembly 3 forcibly and pull out it upwards, then take out the
non-return valve.
2.
Disassembling: please refer to 3.7 Installing the oxygen sensor. The method of
disassembling is contrary to the method of installing.
2.
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Warning:
Do not soak the oxygen sensor to liquid or dispose it by high-temperature and highpressure.
The vapor condensate on the surface of the oxygen sensor will lead to failure of the
oxygen concentration measurement. Should take out the oxygen sensor and clean
way the condensate on the surface and then install it to the absorber again.
Disassembling:
1 Unscrew the connector nut 1 anticlockwise by hand, hold the expiratory and
inspiratory connector 2 and pull them out with the nut 1 from the lower cover unit. The
diagram is shown as below:
2 Fasten the two button ears A of the flow sensor assembly 1, and pull out the flow
sensor slightly. Shown as below:
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1
A
2.
Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe.
Warning:
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Please use accessories provided by the Company in order to avoid the inaccurate
data or equipment failure.
The disposable accessories can be used only once, repeated using may lead to
performance degradation or cross-infection.
If you discover that the accessories package or the accessories are damaged, do not
use the accessories.
Name
Specification/Model
Oxygen sensor
MOX-4
Mask
Adult/Pediatric
Manual bag
Adult
PediatricOptional
Sodium lime
200101 (optional)
Caution
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NO.
Isolation Name
Isolation type
Isolation description
A-f
basic insulation
A-a1
basic insulation
A-a1
basic insulation
A-e
double insulated
A-a2
reinforced
insulation
protect enclosure
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shock
protection type
If you have any doubt about the integrality of the external protective grounding
or the protective grounding cable, the device must be replaced by: the internal
power supply (batteries).
Electric
shock
protection grade
Type B
Working mode
Continuing working
Explosion
protection
grade
The
method
of
Moving grade
Disinfecting method
should be dipped in the ethylene oxide, and some parts can resist to the
Vibration test
5~35~5
amplitude value(mm)
0.35
Frequency sweeping
cycles
(time)
frequency
15
1 octave/minute
working state
Non-working state
2
acceleration (m/s )
50
pulse duration(ms)
112
Collision test
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Falling test
100010
1.0~1.7
pulse waveform
working state
non-working state
Surface temperature
Mechanical stability
Incompatibility
of
the
external connector
Shell
stiffness
strength
Thermal
Meet the requirements of the clause 56.3 in IEC 60601-1 and FDA Reviewer
Meet the requirements of clause: 21a, 16a and 21b in IEC 60601-1
Meet the requirements of clause 55 in UL 2601-1.
conditions
deteriorate
Leakage current
Dielectric strength
Grounding impedance
Protective earthing
environment
division
Mechanical environment
division
Storage environment
Operating environment
temperature
-20+55
humidity
10%93%, non-condensation
atmospheric pressure
50 kPa106 kPa
temperature
1040
humidity
15%95 %, non-condensation
atmospheric pressure
70 kPa106 kPa
Specification
100240 VAC
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Input frequency
50/60Hz
Input power
8.5A
Internal battery
Battery quantity
18.5VDC
Battery capability
4 Ah
Shutdown delay
It can be used for at least 10 minutes after the first alarm for low power
capability (using the new and fully charged battery).
60 min (using the new and fully charged battery, the ambient temperature is
time
25C).
Charging time
The battery should be charged continuously for at least 10 hours for the first
time, and about 5 hours in the future.
Specification
Oxygen supply(O2)
Air supply
Flow rate
100L/min
Specification
Host
Rapid oxygen supplying flow rate
2575L/min
Supplementary oxygen
60dB
1200kPa
25mL/min
mL/min.
Under the pressure of 3 kPa, the leakage is not more than 150
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mL/min.
Inspiratory impedance
Expiratory impedance
Anesthetic ventilator
Driving mode
Driving gas
oxygen
0.280.6 Mpa
120 L/min
Ventilation mode
PCV,VCV,SIMV(V)+PS, SIMV(P)+PS,SPONT,Manual
Pressure-time;
Graph
flow-time;
volume-time;
CO2-time(optional);
Alarms
Alarm sound
>65dB
100mL below is20mL;
Tidal volume
Breathing frequency
Positive
error
pressure
2cmH2O or 10% of the set value, take those with the largest
Pressure control
error
Controlling
Pressure support
0.1s or 5% of the set value, take those with the largest error
holding
percent
expiratory rate
Flow trigger
error
error
Inspiratory time
Inspiratory
2cmH2O or 10% of the set value, take those with the largest
2cmH2O or 10% of the set value, take those with the largest
Pressure limit
Inspiratory
error
2cmH2O or 10% of the set value, take those with the largest
end-expiratory
accuracy
2bpm or 10% of the set value, take those with the largest
and
System
The losing gas capacity caused by the system compliance (gasbag mode): adult
compliance
Breathing
system
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resistance
Flowmeter
The oxygen Nitrous oxide, air electrical flowmeter, 1
10L/min (20).
Anesthetic vaporizer
Two-station vaporizer mounting systems with interlock function.
three anesthetic vaporizer can be selected :enflurane, isoflurane, sevoflurane
Ambient
temperature
Capability
Minimum capability 30 ml
Remnants capability6010 ml
Pressure
Scale
Pediatric
20
adult
40
300mL
Working mode
20100mL
300mL
5mL;
(Boaray 700D)
Tidal volume:VT
step
1001500ml
(Boaray 700C)
100 1000
10mL
1000 1500
VCV
SIMV(V)+PS
SPONT
50mL
Pinsp
570 cmH2O
570 cmH2O
1cmH2O
460 bpm
460 bpm
1 bpm
PCV
SIMV(P)+PS
VCV,PCV
SIMV(V)+PS
SIMV frequency
140 bpm
140 bpm
1bpm
SIMV(P)+PS
SPONT
I:E
PEEP
3:11:6
3:11:6
Boaray 700D:
Boaray 700D:
OFF 4 30
OFF 4 30
cmH2O
cmH2O
0.5
PCVVCV
1cmH2O
All modes
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Inspiration pause
Boaray 700C:
Boaray 700C:
OFF 4 20
OFF 4 20
cmH2O
cmH2O
OFF5%50%
OFF5%50%
2%
VCV
SIMV(V)+PS
Inspiration time
0.110.0 s
0.110.0 s
0.1s
SIMV(P)+PS
SPONT
SIMV(V)+PS
FTRIG
115 L/min
115 L/min
1 L/min
SIMV(P)+PS
SPONT
SIMV(V)+PS
Psupp
560 cmH2O
560 cmH2O
1cmH2O
SIMV(P)+PS
SPONT
VCV
PEEP+5100
Plimit
PEEP+5100
SIMV(V)+PS
1cmH2O
SPONT
range
resolution
02000 mL
1mL
02000 mL
1mL
Minute ventilation
060 L
0.1L
060 L
0.1L
Breathing frequency
0100bpm
1bpm
099 bpm
1bpm
I:E
3:11:6
0.1
0100cmH2O
1cmH2O
PEEP
070cmH2O
1cmH2O
0100cmH2O
1cmH2O
-12100 cmH2O
1cmH2O
0100 cmH2O
1cmH2O
21%100%
1%
Airway resistance
0200cmH2O/(L/S)
1 cmH2O/(L/S)
Compliance
0200mL/cmH2O
1mL/cmH2O
End-expiratory CO2(optional)
099mmHg
1mmHg
Inspiratory CO2(optional)
099mmHg
1mmHg
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Range
alarm
of
the
end-expiratory CO2(optional)
Lower-limit
alarm
of
the
end-expiratory CO2(optional)
Suffocation alarm
Lower-limit
alarm
of
the
SPO2(optional)
Continuous airway pressure
Step
1100cmH2O
1 cm H2O
099cmH2O
1 cm H2O
21100%
1%
OFF21100%
1%
401500mLOFF
10mL
201500mL
140LOFF
1L
OFF, 140L
1L
160 bpm
1 bpm
060bpm
1 bpm
199mmHgOFF
1mmHg
099mmHg
1mmHg
1040s
5s
7099%
1%
Oxygen
supplying
malfunction
alarm
B.7Hardware specification
Parameter
Specification
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Size
1575840725 mm HWD
Weight(net weight)
About 85kg
34 kg75lb
shelf
Display
Type
Size
Resolution
800600 Pixels
LED indicate
Alarm indicator light
one yellow, red. If the high priority alarms and medium priority alarms happen at
the same time, only the red light flashes.
AC power indicator
One
Batery indicator
One
Audio indicating
Speaker
Buzzer
Alarm sound, key tone, the alarm sound meets the requirements of ISO
9703-2:1992 standard.
It gives an alarm when the system is out of order.
Controlling
Knob
keys
Interface
Power supply
Network
Equipotential
Serial port
One
PS2 interface
One
Mobile devices
Trolleys
Four trolleysdiameter:12.5 cm
Brake
Braking board
On the two front truckles, with the function of braking when trodden.
Toolbox
Drawer
150338308 mm HeightWidthDepth
Breathing system
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Bellows capacity
About 1500 mL
Canister capacity
1.5L
Inspiratory/ACGO port: standard outside diameter 22 mm, inner diameter 15mm,
Connections
Absorber leakage
The absorber pressure under 3 kPa, then the leakage is not more than 150
mL/min
Respiration system
resistance
Year 200000:00:00209923:59:59
Accuracy
1 minute/monthcondition: 213
Display resolution
One second
Power supply
Specifications
Measuring mode
Mainstream
Operating temperature
0-40/ 32-104
-40-75/ -40-167
temperature
Operating humidity
10-95% RH non-condensing
5-100 % RHcondensing
humidity
Operating atmospheric
pressure
feet)
5001200 hPa
pressure
1 second
Accuracy specifications-during
standard conditions
Accuracy specifications-during
all
conditions
Range
Accuracy
015
1525
Unspecified
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Gas
level
CO2
IRMA
CO2
IRMA
AX+/OR+
Agent
N2O
N2O 4)
60 vol%
_1&2)
_1&2)
_1)
_1)
HAL4)
4 vol%
_1)
_1)
_1)
_1)
5 vol%
+8%
of
3)
reading
_1)
_1)
_1)
Xe (Xenon) 4)
80 vol%
-10% of reading3)
_1)
_1)
He(Helium) 4)
50 vol%
-6% of reading3)
_1)
_1)
Metered dose
propellants4)
inhaler
C2H5OH (Ethanol) 4)
0.3
vol%
_1)
_1)
_1)
C3H7OH (Isopropanol) 4)
0.5
vol%
_1)
_1)
_1)
CH3COCH3(Acetone) 4)
1 vol%
_1)
_1)
_1)
CH4 (Methane) 4)
3 vol%
_1)
_1)
_1)
CO(Carbon monoxide)5)
1 vol%
_1)
_1)
_1)
NO(Nitrogen monoxide)
0.02
vol%
_1)
_1)
_1)
100
vol%
_2)
_2)
_1)
5)
O25)
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Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CLSPR 11
Harmonic emissions
N/A
IEC 61000-3-2
Voltage
fluctuations/flicker
N/A
Electromagnetic immunity
The IRMA probe is intended for use in the electromagnetic environment specified below.
Customers or end users of ISA gas analyzers should assure that they are used in such an
environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic discharge
6 kV contact
6 kV contact
(ESD)
8 kV air
8 kV air
IEC
61000-4-2
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Electrical
fast
2 kV for power
transient/burst
supply lines
IEC 61000-4-4
kV
N/A
for
commercial
or
hospital
environment.
input/output
lines
Surge IEC 61000-4-5
1 kV line(s) to
N/A
line(s)
typical
commercial
2 kV line(s) to
environment.
or
hospital
earth
Voltage
dips,
short
5% UT
N/A
and
( 95% dip in
voltage variations on
power
40%
UT (60%
cycles
interruptions
supply
input
70%
UT (30%
Power
(50/60Hz)
frequency
3 A/m
3 A/m
magnetic
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
3 Vrms 150kHz
10 Vrms
to 80 MHz
20 V/m
3 Vrms 80 MHz
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61000-4-3
to 2.5 GHz
cables,
than
the
recommended
d=0.18
d=0.35
800MHz to 2.5GHz
to
the
transmitter
strengths
transmitters,
from
as
fixed
determined
by
RF
an
range.
interference
may
Note1At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guideline may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
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Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
V/m.
ISA gas analyzers are intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the IRMA probe can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment(transmitters) and the IRMA probe as
recommended below, according to the maximum output power of the communications
equipment.
Rated
output
maximum
power
of
d=0.35 P
d=0.18 P
d=0.34 P
0.01
0.035
0.018
0.035
0.1
0.11
0.057
0.11
0.35
018
0.35
10
1.1
0.57
1.1
100
3.5
1.8
3.5
transmitter[W]
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters(m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
Page 111 of 122
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Note 1: At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
Warning:
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Appendix C Alarm
This chapter lists some of the most important parameters and technical alarm information,
some information may not be listed.
Note that in this chapter:
- The L is the default alarm level: H for the high priority; M for the medium; L for
the low;
- For each of the alarm information, there lists the corresponding solutions. If the
problem persists after operated in accordance with the solutions, please
contact with the maintenance man.
Alarm
information
High minute
ventilation
Decrease the set tidal volume or the respiratory frequency or increase the
alarm upper limit.
The minute ventilation volume is less than the lower limit of the alarm
Low minute
ventilation
settings.
Increase the set tidal volume or the respiratory frequency or decrease the
alarm lower limit.
High breathing
frequency
Low breathing
frequency
High inspiratory
oxygen
The ventilation frequency exceeds the upper limit of the alarm settings.
Decrease the set respiratory frequency or increase the alarm upper limit.
The ventilation frequency is less than the lower limit of the alarm settings.
Decrease the set respiratory frequency or decrease the alarm lower limit.
The FiO2 exceeds the upper limit of the alarm settings.
Decrease the oxygen volume of the fresh gas or increase the alarm upper
concentration
limit.
Low inspiratory
oxygen
concentration
Increase the oxygen volume of the fresh gas or decrease the alarm lower
limit.
The airway peek pressure exceeds the upper limit of the alarm settings.
High airway
pressure
Check if the ventilation pipeline bent or plugged up, if the pipeline connection
is normal, the inspiratory pressure or the tidal volume should be decreased
or increase the alarm upper limit.
Low airway
pressure
The airway pressure ( pressure waveform data) is less than the lower limit of
the alarm settings.
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Check if the ventilation pipeline leak or fall off, if the pipeline connection is
normal, the inspiratory pressure or the tidal volume should be increase or
decrease the alarm lower limit.
High
end-expiratory
The measuring value is more or less than the upper or lower limit of the
CO2
alarm settings.
Low
Check the patients physical conditionsmake sure if the patient type and the
end-expiratory
CO2
continuous high
airway pressure
The patient absorber airway pressure has been above the PEEP+15
H
Negative
pressure alarm
Check if the patient is breathing spontaneously. Increase the fresh gas flow.
H
Observe whether there is high speed flow passing through the residual gas
purging system. If there is, check the negative pressure releasing valve on
the receiver.
In the Settings Tapnea time, no mechanical ventilation and manual
Suffocation
breathing;
Increase the settings of the tidal volume and respiratory frequency or begin
manual ventilation.
Low O2 supply
Low battery
power
If the power supply is cutoff, please use manual ventilation to support the
patient breath.
If the batteries can not be charged fully within 24 hours, please contact with
the specified maintenance men.
The battery power is too low, and the system will shut off within three
minutes.
Exhausted
battery power
If the power supply is cutoff, please use manual ventilation to support the
patient breath.
If the batteries can not be charged fully within 24 hours, please contact with
the specified maintenance men.
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Define
AA
Anesthetic agent
AGSS
ACGO
APL
ENF
Enflurane
ISO
Isoflurane
SEV
Sevoflurane
BPM
BTPS
ATPD
Manual
Manual ventilation
PCV
PSV
SIMV
VCV
N2O
N2O
O2
Oxygen
Compliance Cdyn
Paw
Airway pressure
TI
Inspiratory time
PEEP
Pinsp
Pmean
Ppeak
Peak pressure
Pplat
Plateau pressure
Pmin
Minimum pressure
Plimit
Limit pressure
Frequency
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InCO2
Inspiratory CO2
EtCO2
End-Tidal CO2
Psupp
Resistance
FiO2
TIP:TI
VT
Tidal volume
I:E
MV
Minute ventilation
MVspn
VTE
VTI
see
accompanying
the
document
(this manual)
Alternating current
Fuse
Battery
Equipotential pole
Alarm settings
Ventilation settings
Start / Standby
System settings
Manual ventilation
Manual bag
Lock
Unlock
Earthing
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Network interface
Flowmeter knob
Cylinder
pipeline
Light
O2 supply connector
Flowmeter backlight
mechanical ventilation
The
maximum
load
CO2 canister
arm
Oxygen
Vaporizer
Class
cylinder
manometer
AGSS vent
Classequipment
CE mark
TYPE B equipment
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THIS WAY UP
FRAGILE
DO NOT STACK
KEEP
DO NOT ROLL
AWAY
FROM
SUNLIGHT
Caution:
Due to the different configuration, some symbols may be not entirely consistent to the
equipment, please take the equipment as valid.
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Patient type
adult
Pediatric
Weight
65kg
7.5 kg
adult
Pediatric
1.7
0.7
460
50
14
30
OFF
OFF
I:E
1:2.0
1:2.0
PEEPcmH2O
OFF
OFF
20
15
20
15
40
20
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Upper limit:20,
Lower limit: 0
Lower limit: 30
Lower limit:3
Lower limit: 0
Upper limit: 20
Appendix F Reference
EN 60601-1/IEC60601-1 Medical electrical equipment Part I: General requirements for
safety
IEC 60601-2-13:2003 Medical electrical equipment Part 2: Particular requirements for the
safety and essential performance of anaesthetic systems
ISO 8835-4:2004 Inhalational anaesthetic systems- Part 3: Anaesthetic vapour delivery
devices.
EN 740 Anaesthetic workstations and their modules - Particular requirements