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Beijing Aeonmed Co., Ltd. (Aeonmed for short) holds the copy rights to this manual, which is
non-public, published, and reserves the rights to keep it as a secure document. Refer to this
manual when operating, maintaining and repairing products only. Anyone other than
Aeonmed may not make it known to others.
Proprietary materials protected by the copyright law are included in this manual. Any section
of it cannot be reproduced, copied, or translated into other languages without any prior
written approval from Aeonmed who reserves the copyright.
Refer to this manual before the product is used. The manual includes operating procedures
which must be performed with cautiously, operations that may result in non-normal working
conditions and the dangers which may damage equipment or cause bodily harm. Aeonmed is
not responsible for the security, reliability and function of the equipments in case that the
dangers, damages and non-normal phenomenon mentioned in this manual happen. Free
repairs for these malfunctions will not be provided by Aeonmed.
Aeonmed has the rights to replace any content in this manual without notice.
Manufacturer Responsibility:
Aeonmed is responsible for the security; reliability and function of the equipments when to
following conditions are adhered to:
CAUTION: Malfunctioning equipment may become invalid and cause bodily injury if a
set of effective and approving repairing proposals cannot be submitted by the institution
which is responsible for using this equipment.
The paid theoretical framework diagram will be supplied according to customer requirements
by Aeonmed, plus calibrating method and other information to help the customer, under the
assistance of qualified technicians, repair the equipment parts where can be done by
customer himself based on the stipulation by Aeonmed.
Warranty:
For a period of one year from the date of original delivery, the components and assemblies of
this product is warranted to be free from defects manufacturing techniques and materials,
provided that the same is properly operated under the conditions of normal use and regular
maintenance. The warranty period for other parts is three months. Expendable parts are not
included. Our obligation under the above warranties is limited to repairing free of charge.
Free Obligations:
Our obligation under the above warranties does not include the freight and other fees;
Aeonmed is not responsible for any direct, indirect or final product broken and delay
which result from improper use, alteration by using the assemblies unratified and
maintenance by anyone other than Aeonmed;
Improper use
Aeonmed is not responsible for the security; reliability and operating condition of this product
in case that:
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This product is not operated correctly in accordance with the manual instruction.
The power supply used or operating environment does not follow the requirements in this
manual.
Return
Follow the steps below in case that the product needs to be returned to Aeonmed:
Contact our customer service by informing them the number and type of the product. The
number is marked on the surface of the product. Return is unacceptable if the number cannot
be identified. Enclose a statement of the number, type and the reason of return as well.
2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the
product to Aeonmed for repairing. (Customers charges are added with regard to the products
sold to non-Chinese mainland users).
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Use Notice
Welcome to use our products.
In order to correctly and effectively use this product, users must carefully read the manual
before using it. User must fully understand and strictly comply with this manual in using this
product.
This product is only applicable to the use stated in this manual. The repair and general survey
of this product can only be conducted by trained professional maintenance personnel. For
any situation in the use process, please contact with us. We will provide you with warm
service. Product specifications are subject to change without notification.
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CONTENTS
2. Components ..................................................................................................................................... 15
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5.9.2.3. Display................................................................................................................................................ 91
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8. Regular maintenance.......................................................................................................................161
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1. Product Description
The Aeon8300A Anesthesia machine is intended for use by licensed clinicians, for patients
requiring Anesthesia within a hospital. This product is suitable for infants, children and adults
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1.2. Symbols
The following table provides descriptions of symbols that are used on the device and/or within
this manual.
dangerous voltage
Earth (ground)
Equipotentiality
date of manufacture
manufacturer
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Catalogue number
serial number
lock
unlock
Insp. flow
Exp. flow
O2 flush O2+
fuse
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Recycle
alarm icon
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1.3. Abbreviations
Abbreviation Definition
C compliance
Des. Desflurane
Enf. Enflurane
Flow flow
Freq Frequency
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Hal. Halothane
Iso. Isoflurane
L liter
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mL Mill Liter
MV minute volume
O2 oxygen
Pb plumbum
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Sev. Sevoflurane
VT tidal volume
ΔP Differential Pressure
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The following WARNINGs and CAUTIONs are applicable to daily operation and
installation and operation for special parts will be described in relevant part of the manual.
WARNING: Aeon8300A anesthesia system must be and can only be maintained by the
WARNING: Before using Aeon8300A anesthesia machine, please carefully read the
WARNING: If the test fails, do not use this equipment. Please contact with Beijing
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WARNING: To avoid risk of electric shock, this equipment must only be connected to
module, water trap and sampling tube of sidestream module etc. disposal subassembly is not
permitted to reused to avoid cross-infection. Before using, the operator must check the
WARNING: The parts of machine contacted with the gas inhaled by patients don’t
WARNING: Check and replace the filter of suction when the suction can’t get adequate
flow.
WARNING: Flammable anesthetic cannot be used for anesthesia system, such as ethyl
sevoflurane, enflurane and isoflurane, which are compatible to other gas are allowed to use
in anesthesia system.
WARNING: Do not use antistatic or conductive respiratory siphon and mask. If such
respiratory siphon and mask are used near high frequency surgical equipment, burning might
occur.
WARNING: Accidental liquid leakage such as anesthetic etc into anesthesia system will
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WARNING: When anesthesia machine is in normal use, the angle of inclination shall not
WARNING: Before operating Aeon8300A anesthesia machine, one must conduct test
first.
WARNING: All gas volume, flow and leakage specifications have been tested under
STPD, except those associated with the anesthesia Breathing System, which be tested under
BTPS.
WARNING: Do not put pipeline and line near APL valve or put pipeline and line card
WARNING: Before cleaning and maintenance, ensure that the external supply is
disconnected.
Do not use this anesthesia system in the flammable and explosive area.
machine, stop using it immediately, turn off the power switch, and unplug the power socket
from AC outlet.
WARNING: Before moving anesthetic equipment, remove all patient monitors and
equipments from anesthesia machine roof through the push handle on it. Anesthesia
WARNING: Anesthesia machine shall not be inclined in fluctuation slope, turn, and over
the threshold (Such as door case and elevator). Do not try to push and pull anesthesia
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WARNING: Before transportation, all the monitoring devices at the side of anesthesia
machine shall be removed. If preventive measure is not taken, Anesthesia machine may tilt
WARNING: During application process, its front caster wheel shall keep tightly locked.
WARNING: Do not put the item over 25kg on the top shelf of Aeon8300A anesthesia
machine.
WARNING: Do not put the item over 12kg on the work table of Aeon8300A anesthesia
machine.
WARNING: The whole width of machine should be less than 0.8m when hanging some
stuff.
WARNING: Do the all calibrations after replacing the part of the machine, only by the
WARNING: The equipment must be used under the supervision of qualified medical
personnel, so as to ensure timely help for failure or when patient is lack of enough and timely
breathing.
WARNING: The medical gas pipeline system malfunction could cause one or more
devices connected to the system stopping their operation; this is not applicable to the
WARNING: If the anesthesia machine is equipped with Anesthetic Gas Delivery System,
Monitoring Equipment, Alarm System and Production Device, no matter the machine is
supplied by separate device or system assembly, the anesthesia machine checklist must be
provided.
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WARNING: Please follow local regulations for the discard anesthesia machine.
CAUTION: The anesthesia ventilator used together with anesthesia system conforms
to ISO 80601-2-13.
CAUTION: The anesthesia system is used together with the following monitoring device,
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2. Components
2.1. Configuration
Aeon8300A Anesthesia machine consists of mainframe, anesthetic ventilator, breathing
system, flowmeter and battery.
The optional parts consist of CO2 module,O2 concentration monitor module, anesthetic
agent module, auxiliary inspiration O2 device, air drive, anesthetic gas scavenging
system(AGSS) and vaporizer,Suction device,VP300(Enflurane,isoflurane,sevoflurane,
interface type:Selectatec,using double metal sheet to make temperature compensation,
Pour-fill infusion).
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table.
Counterclockwise rotation of
the flowmeter rotary knob
Flow Rotary
11 increases the flow; clockwise
Knob
rotation of the flowmeter rotary
knob decreases the flow.
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CAUTION:Breathing system used with Aeon8300A should comply with ISO 80601-2-13.
Breathing system is mainly used to store fresh gas including anesthetic gas, oxygen, and
absorb waste gas. It directly connects to airway to support patient’s respiration.
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8 CO2
Absorber
It is used to absorb CO2 patient having
Canisters
exhaled.
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Inspiratory and expiratory valve guarantee the single direction of gas flow in the breathing
system. When the Anesthesia machine is working normally:
In the inspiratory phase, the inspiratory valve is acting and the expiratory valve is at rest; In
the expiratory phase, expiratory valve is acting and the inspiratory valve is at rest.
2.6.1.APL Valve
WARNING:Keep all inlets/cables away from the APL valve, and do not put lines/ cables
underneath the APL valve in order to adjust the APL valve smoothly.
CAUTION:The APL valve is automatically excluded from the breathing system whenever
APL valve has two functions; one is that it limits the maximum pressure during manual
ventilation; the other is that the airway pressure can be exhausted quickly by lifting the APL
valve.
The APL valve has a labeled knob for selecting between 0cmH2O to 70cmH2O and for
indicating approximate pressure settings. Click sound will be heard when adjusting the APL
valve. In manual mode, the APL valve knob can be rotated to change the pressure threshold
at which gas will flow through the pressure threshold at which gas will flow through the valve
and into AGSS. Clockwise rotation of the APL valve knob increases the pressure threshold,
and counterclockwise rotation of the APL valve knob decreases the pressure threshold.
Lifting the top of the APL valve knob will temporarily relieve pressure. The leakage from the
anesthetic breathing in all operational modes when tested at pressure of 3.0kPa (30cmH2O)
is 40ml.
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2.7. Vaporizer-VP300
The vaporizer delivers anesthetic agent of accurate concentration to breathing system.
Anesthetic agent of accurate concentration will be acquired by adjusting control knob on the
vaporizer. It has temperature compensation, flow compensation and pressure compensation.
The vaporizer cannot be used for patient with respiration because of the strong interior
resistance. The vaporizer can only use one specific anesthetic agent which can be identified
by the label.
Fig.2-7 Vaporizer
WARNING:Only dry gas of medical degree can be used on the vaporizer. Any improper
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CAUTION:The vaporizer used with Aeon8300A anesthesia machine should comply with
ISO 80601-2-13.
1 window 5 floater
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WARNING: Do not block the pressure relieve port on the top of the canister when using
AGSS.
WARNING: AGSS used together with Aeon8300A anesthesia system conforms to ISO
80601-2-13.
WARNING: If the AGSS used together with Aeon8300A anesthesia system is produced
by other manufacturer, make sure that the AGSS conforms to ISO 80601-2-13.
WARNING: For more information about operation and maintenance of AGSS, please
Before using SUCTION, adjust the negative pressure to a proper value, or it is easy to cause
mucosa broken. When using SUCTION, the gas inlet is advised to connect with Aeon8300A
auxiliary gas supply port. If the SUCTION is connected with other gas supplies, the pressure
of gas supply is smaller than 0.4MPa.
When the suction flow is insufficient, the suction port filter should be checked or replaced.
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CAUTION: The negative pressure suction device used together with Anesthesia system
CAUTION: If the negative pressure adjuster is expected to work, the negative pressure
control switch must be rotated within Range-OFF scope. Otherwise, when the negative
pressure control switch is in Full, output negative pressure is the maximum.
CAUTION: For more information about operation and maintenance of the negative
pressure suction device, please refer to the Instruction for Use provided with the negative
pressure suction device.
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3. User Interface
3.1.1.Front Panel
CAUTION: The Anesthesia ventilator which is used with the Anesthesia system should
The panel of the Anesthesia machine is composed of user interface, alternating current
indicator light, and function button and knob. See figure 3-1.
The operation of the user interface can be controlled by the knob (turn
and press) or function button.
2 AC Power When the power supply is the AC power, the AC power indicator light
Indicator Light is on;
When the power supply is battery, the AC power indicator light is off.
3 Function Button Open /Close each menu, the switch between manual and automatic
mode or mute the system can be realized by operating this button.
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4 Knob The knob is used to select and confirm the menu item or change the
setting. Turn the knob, the moving rectangle mark in the user interface
is called cursor. Where the cursor located means you can operate this
item. Turn the knob clockwise or counter-clockwise to select and
confirm the menu item or adjust the parameter.
follows:
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Function button area should include 6 buttons: manual/auto, alarm setting, mute, breathing
circle, menu, and user interface. No matter how long the button is pressed; pressing the
button one time only produces one command action.
Press this button, the Anesthesia machine is switched from the primary mode
to the manual mode;
Manual/Auto
Press this button again; the Anesthesia machine is switched from the manual
mode to the primary mode.
Alarm Press the button, open ―Alarm‖ window, see and adjust the alarm setting,
press the button again, close ―Alarm‖ window.
If there is an alarm now, press the mute button, the system will keep mute for
110s, press it again to cancel mute.
Mute
During the mute process, if there is a new alarm, the mute will be ineffective,
but alarm sound also exits. Cancel mute to renew sound alarm. No alarm now,
setting mute will be ineffective.
Press the breathing loop for the first time, the interface displays
―Pressure-Volume ―and ―Loop window‖.
Breathing Press it again, the interface displays ―Flow-Volume‖ loop window and the two
Loop former wave form display zone are covered by the breathing loop window.
Press for the third time; recede from breathing loop window to return to the
former wave form display interface.
Press the menu button to open the menu, the menu should include: alarm,
system, calibration, engineer and gas.
Menu After opening, press the menu for the first time, open the calibration menu O2
sensor calibration button is in bright green.
If the menu has been opened, press the menu button again, the menu will be
closed, then press it again, the menu opened last time will be opened.
Press the main interface button to close the menu and the breathing circle
Main
window and return to the F-flow wave interface.
Interface
If the menu and the breathing system window is not opened, press the main
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The ventilation parameter monitor, setup and message notice of the ventilator are all
displayed in the user interface. The parameter monitor is in the left and right side of the user
interface, the wave form in the middle. When there is a menu popping up, the wave area will
be covered. The upper section is message area, the middle section is monitor area, the under
is parameter area.
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(11)Patient Parameter 1
Wave Form 1
(8)Anesthetic Gas
(12)Patient Parameter 2
Monitor Display
Wave Form 2
(1) Alarm notice indicates that when there is an alarm, the alarm bell appears, whose color is
white . Press the mute button, an ―X‖ broken line appears on the alarm bell and lasts for
110s. Under the alarm bell, the counter down of the surplus time will be displayed as .
(2) Alarm message area is in the left up of the user interface providing system alarm notice
and patient ventilation malfunction alarm notice.
No more than 2 alarm messages are displayed in the user interface at the same time.
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(3) The display mode of Date has three types: MM/DD/YY, DD/MM/YY or YY/MM/DD.
(4) The display mode of Time has 2 types: 12 hour or 24 hour format.
(5) The power supply is in the left side of the patient type,having 2 icons: AC power and
battery. The 2 icons will always display. The AC power icons include 2 states: connected
and unconnected. If the AC power is not connected, the AC power is always glittering.
Battery icon includes 7 statues: full, 75%, 50%, 25%, low charging, unconnected.
When the battery is charging, a dynamic mark displaying electric quantity will be displayed
After the signal of low electric volume, the battery can still supply power for about 15 minutes.
(6) Adult/Child is displayed in the patient type area. When the patient type is highlighted,
pressing the knob can make the patient type switch between adult and child.
(7)The ventilation mode setting area is in the right up of the user interface.
The ventilation mode can be located and displayed highlighted by the knob (black word with
green background).When the ventilation mode is highlighted, press the knob, the current
ventilation mode is highlighted, but ―Mode‖ label still displays in black word with green
background. Turn the knob clockwise, the mode displays as follows: STANDBY,IPPV,PCV,
SIMV,PS and MANUAL. Turn the knob counter-clockwise, the modes displayed are
MANUAL, PS, SIMV, PCV, IPPV, and STANDBY.
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(8)The anesthetic gas monitor display is in the left side of the middle of the user interface
including 4 parameters: dominating anesthetic gas and suddominate anesthetic gas, N2O
and expiration MAC value.
Dominating anesthetic gas and suddominate anesthetic gas can monitor Insp and Exp ., the
gas type renews automatically at the same time.N2O can monitor Insp and Exp, MAC only
displays Exp. The unit of dominating anesthetic gas, suddominate anesthetic gas and N2O
is %, MAC has no unit. The data of dominating anesthetic gas and suddominate anesthetic
gas monitor value has one decimal. The data of N2O monitor value is no more than 3 integers
and changes automatically.
NOTICE: When ―Gas Module‖ in the ―Gas‖ menu is ―Forbidden‖ or the an aesthetic gas
function is not activated in the ―Activate Gas‖ submenu of ―Engineer‖ menu, the parameter
monitor area does not display and is covered fully.
The wave area of (9)、(10) is in the middle of the user interface,4 wave forms are allowed to
display: 1) Pressure-t wave form, Flow-t;2)Pressure-Volume loop,3)Flow-Volume Loop,4)
CO2 Concentration-t wave form, default waves: Pressure-t wave form and Flow-time wave
form.
In STANDBY ventilation mode, Pressure-t wave form and Flow-time wave form do not display
the real-time data.
The patient parameter area of (11)-(13) is in the right side of the user interface and can be
divided into 5 parameter groups: pressure, volume, O2 concentration, and compliance and
CO2 concentration.
(14) The user message area is in the low of the wave area. The user message is displayed in
the user message area, the word color is white. The main user messages displayed in this
area includes:
When the setup value has reached the high limit (or low limit) in the current situation, turn the
knob once or more time clockwise (or counter-clockwise), this alarm displays.
In manual mode, if the user has closed the manual alarm, the message displays.
When the system is in self-test, if the following mistakes occur, such as PEEP valve failure,
expiration sensor failure and inspiration valve failure, this alarm will display.
When the ventilation mode is glittering and not confirmed, the message displays and shows
the current running ventilation mode.
Press AUTO/MANUAL button directly, the ventilation mode switches from IPPV、PCV 、SIMV、
PS to MANUAL, the message will be displayed.
The parameter setup area of (15)-(22) should include 8 setup frames; the width and length of
every setup frame are fixed.
When the cursor falls on some setup frame, the setup frame is highlighted (black word with
green background).
When the setup frame is highlighted, the current parameter setup value is in white.
Turn the knob clockwise, the parameter value will increase, otherwise, it reduces.
Press the knob to select the setup parameter, it will display in white word with black
background. The setup value of the parameter displays in normal state, expect the
background frame has been selected or highlighted.
The background frame of the parameter should be set as the following table.
When it is needed to change parameter setting, the parameter setup will recede and revert to
the old parameter if the changed parameter setup has not been confirmed for more than
15s.When set ventilation mode, patient type and all the breathing parameter setup items, the
setup frame will recede automatically for overtime.
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STAND
--- --- --- --- --- --- --- ---
BY
MANUA
--- --- --- --- --- --- --- ---
L
When the cursor does not fall on the mode setting frame, the display state of the mode setting
When the cursor falls on the mode setting frame, the display state of the mode setting frame
When the mode setting frame is in state 2,press the knob , the display state of the mode
White word with black background. The display state labeled on ―Mode‖ is still in black word
with green background. Turn the knob clockwise to switch the breathing mode in turn:
STANDBY、IPPV、PCV、SIMV、PS 、MANUAL .
Turn the knob counter-clockwise to switch the breathing mode in turn: MANUAL, PS, SIMV,
PCV, IPPV, and STANDBY.
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When the mode setting frame is in state 3, if press the knob, the display state of the mode
setting frame is in preset state. The state as displays glitters in the preset
state of the state 4, the frequency is one time every second.
When in mode preset state, the parameter of the preset mode displays at the same time. One
message displays in the user interface area: the current ventilation mode is in preset. The
operator can adjust the parameter setting by turning the knob.
Having setting the parameter, turn the knob to make the cursor turn to the mode setting frame,
press the knob again to make the new selected ventilation mode take effect. The mode
preset state will last 15s. If the new selected ventilation mode is still not confirmed for more
than 15s, the ventilation mode will renew to the old one. All the parameter setting in preset
state will be ineffective.
STANDBY is the default ventilation mode after opening. The patient type and the alarm limit
will not change during the switch from the other ventilation mode to STANDBY mode.
All the parameter adopts default and all the parameter keeps the old setting when the mode
switches from STANDBY to IPPV、PCV、SIMV、PS.
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All the breathings are provided by the anesthesia machine, the patient cannot switch them by
self. The ventilation is managed by the predetermined ventilation volume, breathing
frequency and inspiration-expiration ratio to keep the tidal volume stable, thereby assure the
stable MV.
Vt、Freq、I:E、Tp、PEEP
The ventilation is managed by the setting target pressure, the ventilation volume and flow
rate are changed subsidiary and relate with the breathing system compliance and airway
resistance. The tidal volume is changed with the lung compliance and the airway resistance.
The flow rate is slowdown wave; the alveolus is turgor at the beginning of inspiratory which is
helpful for the gas communication in the lung.
SIMV is a ventilation mode which combines spontaneous breathing with control ventilation.
Within the trigger window, the patient can trigger the command positive pressure ventilation
synchronizing with the spontaneous breathing. Between the two command ventilation cycle,
the patient is allowed to breathe spontaneously. The command breathing follows the presets
volume. By setting frequency and tidal volume to assure the minimum MV, cooperating with
the patient’s spontaneous breathing to reduce the rivalry between patient and machine and
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negative effect of blood dynamics, and prevents the potential syndrome, such as air pressure
injury and so on.
By changing the presets frequency to change the breathing support level, in other words,
from entire support to partial support, the machine can be used for long-term patient to retreat
from machine.
The tidal volume is determined by the compliance and resistance of the breathing system.
△ P、FreqMIN、Trigger、PEEP、Expiration、Tslope
Fig.3-5 Waveform of PS
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4. Pre-operative Preparation
Step 1:
Fig.4-1
Step 2:
Fig.4-2
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Step 3:
Fig.4-3
Step 4:
Connect the other end of drive gas tube to the
interface marked ―Drive Gas‖ in the outlet
module.
Fig.4-4
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Step 1:
Fig.4-5
Step 2:
Fig.4-6
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Step 1:
Fig.4-7
Step 2:
Fig.4-8
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4.1.4.Connection of O2 sensor
Step 1:
Fig.4-9
Fig.4-10
Step 2:
Fig.4-11
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Fig.4-12
Step 3:
Connect O2 sensor to the inspiratory valve
cover.
Fig.4-13
Step 4:
Connect the other end of O2 sensor
connecting cable to the interface marked
―Oxygen‖.
Fig.4-14
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Step 1:
Snap the probe on top of the airway adapter. It
will click into place when properly seated.
Fig.4-15
Step 2:
Connect the RS232 interface of the adapter to
the RS232 interface on the back of the
displayed LED.
Fig.4-16
Step 3:
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Fig.4-17
Step 4:
Fig.4-18
CAUTION: Make sure AP1000 installs at a place where operator can get a clear view
of it.
WARNING: Make sure good connection in case of Anesthesia gas leaks to operating
room.
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Step 1:
Fig.4-19
Step 2:
Fig.4-20
Step 3:
Fig.4-21
Step 4:
Fig.4-22
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WARNING:Do not use the machine if any test failures. Contact Aeonmed’s authorized
WARNING:Make sure that the breathing system is in good connection and with no
damage.
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3. Make sure the breathing system is correctly connected and has no damage; the
absorber canister is fully filled with soda lime.
4. Make sure the vaporizer is well locked and is filled with adequate anesthetic agent.
5. Make sure the pipeline gas supply system is correctly connected and is at proper
pressure.
8. Make sure the castors are not loose and the forefront two castors are locked.
9. Make sure the Anesthesia machine is connected to power socket and power
indicator is light. There is no power supply if power indicator does not light.
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1. Turn on power switch; user interface is light, STANDBY interface displays after self-test
is finished.
2. After the Anesthesia machine operates under STANDBY mode for five minutes, pull out
power cord
3. Make sure power failure alarm occurs (alarm bell sounds or user interface displays
POWER FAILURE message).
CAUTION:Operator should make sure gas supplies are correctly connected during
WARNING: The malfunction of the center gas supply system may cause one or even all
1. Cut off pipeline gas supply. Perform the following steps if pipeline gauge does not read
zero:
2. Connect O2 supply.
6. Make sure O2 cylinder gauge reading restores to zero. Low gas source alarm occurs
when O2 pressure is decreasing.
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4.2.3.Vaporizer Test
4.2.4.Alarm Test
Ventilator Vt:700mL
Freq.:20
I:E:1:2
PAW-High:40cmH2O
4. Make sure:
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6. Make sure:
Disassemble O2 sensor, make sure that O2 takes up 21% of room air according to
the test result.
Put O2 sensor in pure oxygen; make sure that O2 takes up 100% according to the
test result.
Set low minute volume alarm limit to 10.0L/min, make sure low minute volume alarm
is eliminated.
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Make sure continuous PAW alarm occurs when continuous pressure is at 10cmH2O
for 15 seconds.
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During the operation of the Anesthesia machine, when the electrical power supply fails and
the battery is dis-abled:
--- If the pneumatic power supply is normal, the manual ventilation should be carried out to
ensure the continued supply of fresh gas to the patient;
--- If the pneumatic power supply fails, the whole Anesthesia system is disabled; the manual
bag the patient to ensure the patients breathing.
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5. Operating guide
5.1. Opening
Use the AC power, connect the pipeline gas resource and auxiliary gas resource and open the
auxiliary cylinder valve, close O2, N2O, Air flow meter and the auxiliary O2 flow meter.
Fig.5-1
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Fig.5-2
After the system self-test:
1) Select and confirm ―Continue‖, the
Automatic Test begins.
Fig.5-3
2) Select and confirm ―Bypass‖, the
―Manual Test‖ interface appears.
Fig.5-4
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Fig.5-5
Select ―Continue‖, the system
enter into the Automatic Test
interface.
―Automatic Testing…‖ appears in
the user interface.
Fig.5-6
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2. Select “Continue” and press the knob ,the system begins to re-test, The interface
displays shown as above picture.
Fig.5-7
2. If the bellows is not full, the
message ―Push ―O2+‖ flush to
completely fill the Bellows‖
appears on the user interface.
1) Select ―Continue‖ to perform
Manual Test again.
2) Select ―Bypass‖ to proceed to
Manual Test.
Fig.5-8
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Fig.5-9
2. If the leakage is at the range of
100—400ml/min, the interface
shows as the picture on the right.
1) Select ―Retry‖ to perform the
Automatic Test again.
2) Select ―Bypass‖ to proceed to
the Manual Test.
Fig.5-10
3. If the leakage is more than
400ml/min, the interface shows
as the picture on the right.
1) Select ―Retry‖ to perform the
Automatic Test again.
2) Select ―Bypass‖ to proceed to
the Manual Test.
Fig.5-11
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Fig.5-12
5. Automatic Test failed
If the pressure sensor (Ambient
pressure sensor and Airway
pressure sensor) is disabled, the
automatic test will fail and the
prompt message will appear on
the user interface.
Please contact service
representative when the message
appears.
Fig.5-13
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Fig.5-14
If the automatic test success, the
system proceed to manual test,
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.
Fig.5-15
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Fig.5-16
2. If the PAW gauge value is bellow
20 cmH2O, the interface will display
as the picture on the right.
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.
Fig.5-17
3. If APL Valve adjustment is
improper
Follow the instructions on the user
interface.
Select ―Bypass‖, the system will
enter into normal interface.
Fig.5-18
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Fig.5-19
5. Manual test fails
If the manual test fails, the interface
displays as the picture on the right.
During 60s count time, do
according to the interface
message.
Select “Bypass”,the interface will
change to the Standby mode.
Fig.5-20
6. If the manual test fails three
times, the interface displays as the
picture on the right.
Select“Continue”
,the interface will
change to the Standby mode.
Fig.5-21
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CAUTION: The switch of the patient type is only allowed in STANDBY mode.
Fig.5-22
Press the knob and the green
cursor turns black, now select
the needed patient type.
Fig.5-23
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Fig.5-24
Press the knob, now the cursor
turns green and confirm your
setting.
Fig.5-25
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Fig.5-26
Press the knob and ―PCV‖
changes as the right
picture.
Fig.5-27
Turn the knob to select
―IPPV‖ mode, ―IPPV‖
changes as the right
picture.
Fig.5-28
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Fig.5-30
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Fig.5-31
Press the knob and Vt changes as the
right picture.
Fig.5-32
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Fig.5-33
Turn the knob and confirm your setting.
Fig.5-34
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Vt mL 20~1500 600 10
TP % Off,5~ 60 10 5
Vt mL 20~1500 120 10
TP % Off,5~ 60 10 5
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PTARGET cmH2O 5~ 70 20 1
PTARGET cmH2O 5~ 70 10 1
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Vt mL 20~1500 600 10
TP % Off,5~60 10 5
ΔP cmH2O 3~50 5 1
Vt mL 20~1500 120 10
TP % Off,5~60 10 5
ΔP cmH2O 3~50 5 1
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FreqMIN bpm 2 ~ 60 2 1
ΔP cmH2O 3~50 5 1
FreqMIN bpm 2 ~ 60 4 1
ΔP cmH2O 3~50 5 1
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―Save‖ is in the low right of the circle to save the next circle as a reference circle.
When a loop is going or no circle displays, press ―Save‖ to save the next entire circle
(inspiration and expiration) as a reference circle.
After pressing ―Save‖, Pressure-Volume circle and Flow-Volume circle are saved.
Press ―Save‖ again and the system will cancel the current saved Pressure-Volume and
Flow-Volume reference circles at once and save two new reference circles.
When recede from the function circle window, the saved reference is stored.
CAUTION;When the STANDBY mode is set as work mode, the two saved breathing
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5.9.1.Alarm setting
Now take the setup of the low and high limit of the minute volume for example, other
parameter settings are like this.
Fig.5-39
―MV‖ is the default option.
Fig.5-40
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Fig.5-41
Fig.5-42
Press the knob, the green cursor turns
black as the right picture. Turn the knob
to select the needed setting.
Fig.5-43
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Fig.5-44
Fig.5-45
Press the knob, the green cursor turns
black as the right picture.
Fig.5-46
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Now take the setup of the low and high limits of Iso. For example, other parameter settings
are like this.
Fig.5-47
The default option is Iso.
Fig.5-49
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Fig.5-50
5.9.2.System setting
Fig.5-51
The green cursor falls on the ―System‖.
Fig.5-52
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The wave of the main interface has two types: PLAT or MEAN.
Fig.5-53
Press the knob, and then cursor color
turns green, and confirm your setting.
Fig.5-54
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5.9.2.2. Language
The system has two languages to select: Chinese and English. The user can select the
needed one.
Fig.5-55
Press the knob, the green cursor turns
black.
Fig.5-56
Press the knob, the cursor turns green,
and confirm your setting.
Fig.5-57
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5.9.2.3. Display
Select the real-time display, the main interface will display the system’s live message and
wave.
Select the demo display; the main interface will display the standard default message and
wave of some breathing module.
NOTICE: Select demo, ―demo mode‖ in red is displayed in the alarm area which is in the
Fig.5-58
Press the knob and the green cursor
turns black,
Fig.5-59
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Fig.5-60
The date type has 3 types: MM/DD/YY, DD/MM/YY, and YY/MM/DD, select the needed one.
Fig.5-61
Press the knob, the cursor turns
black.
Fig.5-62
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Fig.5-63
Fig.5-64
Turn the knob and the green cursor falls
on ―Adjust Date‖.
Fig.5-65
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Fig.5-66
Turn the knob to ―Done‖, press the knob
to confirm the final date setting.
Fig.5-67
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The time format has 2 types: 12 hour and 24 hour. Select the needed one.
Fig.5-68
Press the knob and the cursor turns
black.
Fig.5-69
Press the knob and the cursor turns
black.
Fig.5-70
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Fig.5-71
Turn the knob and the green
cursor falls on ―Adjust Time‖.
Fig.5-72
Press the knob and the cursor
turns black.
Fig.5-73
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Fig.5-74
Turn the knob to ―Done‖,press
the knob and confirm the final
time setting.
Fig.5-75
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The setup value can be restored to system defaults by pressing ―Restore Defaults‖.
Fig.5-76
Press the knob, a ―Are you sure?‖
window appears in the right side
of the interface.
Fig.5-77
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Connect the O2 sensor to the system directly; enter into O2 sensor activation interface to open
O2 sensor. The main interface will display each value monitored by O2 sensor. Close O2
sensor, the values will not be displayed.
NOTICE: Connect 2 sensors before activating the system, after opening, the system will
If O2 sensor is connected during the system operating process, it is needed to enter the O2
sensor interface to open it, then the main interface can display each value monitored by O2
sensor.
Fig.5-78
Press the knob and the
cursor turns black.
Fig.5-79
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Fig.5-80
Fig.5-81
Press the knob, and the leak test
result window appears in the right
side of the interface.
Fig.5-82
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Open air drive, the drive bellows gas is switched from O2 to air.
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5.9.3.Calibration
Fig.5-83
Turn the knob and the green cursor
falls on‖O2 Sensor Calibration‖.
Fig.5-84
Press the knob, the cursor turns
black.
Fig.5-85
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Fig.5-87
The calibration of O2 sensor succeeds.
The green cursor falls on ―Finish‖, press
the knob and return to the main
interface.
Fig.5-88
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Fig.5-89
Fig.5-90
Enter into CO2 sensor calibration
interface, Module OFF appears in the
state area, indicating CO2 sensor is
unopened.
Fig.5-91
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Fig.5-93
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Fig.5-94
Fig.5-95
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Fig.5-96
Enter into anesthetic gas calibration
interface, Module OFF appears in the
state area, indicating CO2 sensor is
unopened.
Fig.5-97
Open the anesthetic gas module.
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Fig.5-99
The calibration of the anesthetic gas has two results:
Fig.5-100
2) Anesthetic gas calibration failures.
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Fig.5-102
Adjust the knob to make the green cursor
fall on ―Leak Test‖.
Fig.5-103
Press the knob, the cursor turns black.
The ―Leak Test‖ window appears in the
right side of the interface.
If the ―Leak Test‖ window shows as the
picture on the right select ―Return‖ to main
interface and change the mode to
Standby, then perform Leak Test.
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Fig.5-105
Select ―Next‖ and a word ―Testing‖
appears in the window.
Fig.5-106
If the Leak Test succeeds. The green
cursor falls on ―Finish‖, press the knob and
return to the main interface.
Fig.5-107
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Fig.5-108
Fig.5-109
Adjust the knob to make the green
cursor fall on ―Compliance Test‖.
Fig.5-110
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Press the knob, the cursor turns black. The ―Compliance Test‖ window appears in the right side
of the interface.
Fig.5-111
If the ―Compliance Test‖ window
shows as the picture on the right
select ―Return‖ to main interface
and change the mode to Standby,
then perform Compliance Test.
Fig.5-113
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Fig.5-114
If the Compliance Test succeeds.
The green cursor falls on ―Finish‖,
press the knob and return to the
main interface.
Fig.5-115
If the Compliance Test fails, the
green cursor falls on ―Repeat Cal ‖,
press the knob and the system
begins to renew calibration;
Turn the knob to ―Cancel‖, press
the knob and returns to the main
interface.
Fig.5-116
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5.9.4.Gas setting
Monitor CO2 and anesthetic gas in real-time by opening or closing CO2 module and
anesthetic gas module.
NOTICE: Connect the gas module before startup the system; the gas module will be
defaulted to be open by the system after opening. If it is connected during the system running,
it is needed to enter into the gas module interface to open it, then the main interface can
display the parameters of CO2 or anesthetic gas.
Fig.5-117
After entering into this menu, the
green cursor falls on Gas Sensor.
Fig.5-118
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Fig.5-119
Press the knob to confirm your
choice.
Fig.5-120
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CO2 monitor parameter and wave have two units: mmHg and %. The user can select the
needed one.
Fig.5-121
Press the knob, the green
cursor turns black.
Fig.5-122
Press the knob to confirm CO2
unit.
Fig.5-123
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The waves what the main interface displays have two types: CO2 wave and flow wave. The
user can select the needed one.
Fig.5-124
Press the knob, the green cursor
turns black. Then turn the knob to
select the needed wave.
Fig.5-125
Press the knob to confirm the
selected wave.
Fig.5-126
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When the gas module is connected with the system and opened, the detailed version of the
gas module can be known through the module version.
Fig.5-127
Press the knob and the green
cursor turns black.
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5.10. Closing
Turn the power switch to ―OFF‖ to close the anesthesia system.
ALARM: After closing the power switch, the system is running continually until the
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WARNING: If alarm occurs, protect patient safety first, and then diagnose fault or service
if necessary
CAUTION: When more than one alarm occurs simultaneously, the alarm information will
CAUTION: For mute, "×" shape will appear on alarm bell. In white , alarm sound
disappears, and alarm bell restores less than 120s. If alarm is not timely processed, alarm
sound will continue.
CAUTION: If anesthesia machine produces alarm in running, alarm system will generate
certain time delay for sending visual signal and auditory signal.
WARNING: Do not set an alarm limit that exceeds limits, otherwise it will cause alarm
system failure.
WARNING: For the same or similar equipment used in any separate zone, if different
alarm preset values are used, there will be potential danger such as intensive care or cardiac
operating room.
WARNING: Operator shall check if the current alarm preset is suitable for each patient
before using.
WARNING: If the power is interrupted, the previously set alarm values will be recovered
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The operator can determine the alarm system role by a visual alarm signal and an auditory
alarm signal. Up to a distance of 4m, the anesthesia machine operator should be able to be
accurately and clearly aware of visual alarm signals. The visual indicator is located on the
display. At a distance of 1m from the front of the equipment, the acoustic pressure level of the
alarm signal shall not be less than 60dB.
The top area of the user interface displays alarm message, see figure 6-1.
Fig.6-1
Table 6-1 Alarm message
Low Slight injury or 2 alarm tones, no Less Yellow background, ―!‖ flickering,
uncomfortable. repeat. than long-term display.
120s
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Pressure:PLAT
Table 6-2
Low oxygen High Drive gas pressure is less Check pipeline gas supply and
supply than 2.9psi±15% replace pipeline.
pressure
AC power Low AC power failure alarm Check connection, AC power
failure when AC power supply supply and fuse;
failure
Replace fuse when it is melt.
Low battery Medium No AC power and the Connect AC power supply
capacity battery voltage lower than immediately;
22V.
When the alarm appears, the
battery capacity can last 10
minutes.
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Monitor O2 concentration≥
10%, cancel the alarm
immediately.
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Gas module High Pull out adapter probe in Call service Rep.
probe failure gas module for several
seconds.
module communication
failures or interior error in
gas module, the alarm
message will not occur.
Interior error in High Any case of software, Call service Rep.
gas module hardware, electric
―rotational speed― exceeds
limit, no factory calibration
or factory calibration failure,
O2 sensor error(only
by-pass flow) appears, the
alarm will occur.
module communication
failures, the alarm message
will not occur.
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Gas module High When any parameter of the Call service Rep.
monitor detected CO2,N2O, O2,
concentration anesthetic gas exceeds
exceed limit limit, the alarm message
appears.
module communication
failures or interior error in
gas module or gas module
probe is disabling, the
alarm message will not
appear.
Keyboard High No communication Switch to manual mode, Call
communication between UI and keyboard service Rep.
failure
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Table 6-3
timer expiratory
In STANDBY mode, this
High airway passage is
High alarm will not appear; 2. Alarm
pressure blocked or not;
In MANUAL mode, this message lasts
for 8s after 3. If Vt setting is
alarm could be closed.
alarm condition too big; 4.If the
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Monitor average
pressure<1cmH2O, in 1. Check the
MANUAL mode, it is not tube is
APNEA High determined, or Alarm occurs.
disconnected or
not.
Monitor average pressure
equals to 1cmH2O, and
monitor PEEP≤0cmH2O, in
MANUAL mode, it is not
determined.
In MANUAL mode, airway
pressure is lower than
pressure alarm low
limit>30s;
In other mode,Freq≥4;
airway pressure is lower 1. Ventilator
Low airway Reset airway low
Medium than alarm low works as
pressure alarm limit
limit>15s,Freq<4,airway normal.
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3.Recalibrate O2
sensor;
4. O2 battery is
exhausted;
5. Call service
Rep.
Measured FiO2
1. Alarm
value≥setting
occurs.;
1.Increase FiO2
High FiO2 Medium When O2 sensor 2.Ventilator
and alarm setting
configuration in the system works as
menu is ―Disabled‖, this normal.
alarm will not appear.
1. Alarm
MV≥upper setting limit
occurs.; 1.Increase high
High MV Medium In MANUAL mode, this 2.Ventilator MV alarm limit;
alarm could be closed. works as
normal.
1. Alarm 1.Reduce MV
MV≤lower alarm limit occurs.; alarm setting;
Low MV Medium In MANUAL mode, this 2.Ventilator 2.Check if there is
alarm could be closed. works as leak in patient
normal. end;
Expiratory CO2
High ETCO2 concentration exceeds Increase the Freq
High Alarm occurs;
concentration high limit and lasts at least valve and MV.
2 continual breathes
Low ETCO2 ETCO2 concentration is Decrease the Freq
High Alarm occurs;
concentration lower than low alarm limit valve and MV.
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6.2.4.Self-test alarm
Table 6-4
BDU EEPROM data fail Incorrect calibration in EEPROM Call service Rep.
check
PAW sensor fail The data of the pressure sensor is Call service Rep.
incorrect.
PEEP valve fail Incorrect PEEP valve data Call service Rep.
Inspiratory valve fail Incorrect monitor sensor ZERO state Call service Rep.
SW version fail BDU, GUI, KBD software version is Call service Rep.
not the same with the released one.
BDU Comm. fail If GUI cannot receive and send data All breathing functions fail,
from BDU unit for 0.5s. call service Rep.
KBD Comm. fail No communication between GUI and All breathing functions fail,
Keyboard. call service Rep.
Inspiration valve fail Incorrect voltage value the inspiratory The machine can
valve feedbacks continue to work, but
there is only manual mode
but automatic mode, the
monitor function is
effective, call service Rep.
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O2 supply fail The pressure of drive gas is lower Check if the pipeline
than 200kPa ± 15% supply is normal, connect
the backup gas supply.
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2. Replace if necessary.
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15 Fresh gas flow 1.Total fresh gas flow is 1. Reduce fresh gas flow;
too high above 19L/min.
2. Check vaporizer setting.
16 Fresh gas low or 1. Fresh gas setting too low; 1.Increase fresh gad flow;
leak
2. Leak. 2. Repair leak.
18. High airway 1. High alarm limit for the 1.Check hose system and tube;
pressure airway pressure has been
2. Correct the ventilation settings.
exceeded;
20. Inhaled CO2 1.Soda lime in circle system 1. Increase fresh gas flow;
high exhausted;
2.Replace breathing system;
2.Leak or fault in breathing
3.Adjust alarm limits if necessary;
system;
4.Check ventilation settings;
3.High ventilation
frequencies; 5. Replace flow sensor.
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22. Inhaled N2O 1. Inhaled N2O concentration 1. Check N2O concentration in the
concentration exceeds the high alarm limit fresh gas flow.
high of 82%.
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29. O2 flow 1. Fresh gas flow 1. Use only O2 as fresh gas and
measurement measurement for O2 has observe total flow meter.
failure failed.
2. Call service Rep.
30. PEEP high 1. Expiratory pressure 1. In automatic ventilation modes
5cmH2O above PEEP for 2 check the ventilation parameters.
breaths, or Expiratory
2. Check the anesthetic gas
pressure 5cmH2O above
scavenging line.
PEEP in pressure support
mode for more than 30s.
34. Setting can 1. The last setting has not 1. Repeat settings.
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After cleaning, disinfection and reinstallation the anesthesia machine must be calibrated
before using. For calibration details refer to the ―Preparation before operation‖.
CAUTION: The disinfection of the anesthesia machine must conform to the ISO 17664.
Please carefully read the operation and maintenance manual of all disinfection
equipment.
If the oxygen sensor damaged, leakage might occur and cause combustion
(containing potassium hydroxide).
Please wear safety gloves and glasses for cleaning and disinfection.
WARNING: Before cleaning the Aeon8300A anesthesia machine, disconnect the power
The breathing system must be cleaned after installation before the first usage
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The parts labeled ―134℃‖ can be disinfected with the method of high temperature
and pressure;
Except for the oxygen sensor and airway pressure gauge, the parts can be washed
in an automatic washer with mild detergent;
The only way of cleaning oxygen sensor and airway pressure gauge surface is
wiping.
All the cover and dome materials used in the system are made of anti-static
materials, because the static material could lead to fire.
Take necessary measures to keep the CO2 absorbent damp for the dry CO2
absorbent exploded to the anesthetic agent may lead to dangerous chemical
reaction.
Turn off all the gas supplies after using the anesthesia machine.
WARNING: Please comply with the disinfection controlling and safety regulation. The
WARNING: Ultraviolet light can be used to disinfect the whole machine. Peracetic acid
WARNING: Do not inhale any gas that is generated in cleaning and disinfection process.
WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar
materials for cleaning and disinfection. These materials may enter the patient's lung or airway
and cause irritation or injury.
CAUTION: Dismantle bellows integration for cleaning to reduce the drying time. Hang
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CAUTION: Wipe oxygen sensor with a damp cloth. Do not clean it in liquid.
CAUTION: Do not immerse oxygen sensor or airway pressure gauge in liquid. Do not
conduct autoclave or high temperature fumigation for oxygen sensor or airway pressure
gauge.
CAUTION: Regularly inspect the spare parts. If necessary replace it when the part is
damaged.
If you have any question about the cleaning agent, please refer to the message
provided by manufacturer.
Do not use abrasive detergent (such as steel wool, silver polish or cleaning agent)
Synthetic rubber parts cannot be soaked longer than 15 minutes. Doing so can
cause the materials to expand and, as well as accelerated aging of the material.
CAUTION: The part labeled with 134℃ is pressure and heat-resistant. It can be
washed by hand or machine (pH <10.5 mild detergent), and then dry thoroughly.
WARNING: After cleaning and disinfection,perform the leak test and compliance test
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Foundational
Action
maintenance
every day clean anesthesia machine’s surface
every week Ventilate for the system, open flow meter to make floating-point move in
order to flow meter pipe block or floating-point conglutination.
every month Leak test of bellow assembly; 100% O2 concentration calibration.
B: Machine washing: Automatic washing with washer and disinfecting with disinfection
machine.
D: High temperature and pressure disinfection: At 121℃ for max. 20 minutes, or at134℃ for
max. 8 minutes.
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Table 8-1
7.4.1.External Surfaces
Using ultraviolet light or a soft cloth with a water-soluble detergent or disinfectant wipes,
clean all outer surfaces, hoses and cables. If using disinfectant wipes follow the
manufacturer’s instructions for use.
7.4.2.Bellows
Read all content in this section before disassembling, cleaning, disinfecting, and
re-assembling the bellows to avoid equipment malfunction and patient injury.
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7.4.2.1. Disassembly
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7.4.2.2. Cleaning
a. To prevent damage, wash each component gently with hot water, using a mild,
non-enzyme detergent that is recommended for rubber and plastic. Ensure that all bellows
surfaces are cleaned.
NOTE: Dry the bellows by allowing it to hang so that it is fully expanded. This will facilitate
thorough drying and prevent it from sticking to itself.
CAUTION: If moisture remains in the bellows after cleaning, it may become tacky.
c. After all bellows components are completely dry, inspect them for damage before
disinfection or re-assembly and functional testing.
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7.4.2.3. Disinfection
NOTE: Ensure that all bellows components have been cleaned as described in 8.3.2.2 before
disinfecting.
Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of all bellows components while adhering to facility policies and
procedures.
7.4.2.4. Assembly
Connect the bellows to the breathing system by reassembling all components in the reverse
order.
7.4.3.PAW gauge
7.4.3.1. Disassembly
CAUTION: Do not immerse the PAW gauge in liquid. Do not conduct autoclave and high
7.4.3.2. Cleaning
Clean the PAW gauge with a soft, lint-free cloth soaked with a water-soluble detergent or
disinfectant.
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7.4.3.3. Assembly
7.4.4.Oxygen sensor
7.4.4.1. Disassembly
Unscrew O2 sensor
connector from O2 sensor
and put it on a safety place.
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WARNING: Do not immerse oxygen sensor in liquid. Do not conduct autoclave or high
WARNING: Do not clean the inner surface of oxygen sensor. Wipe oxygen sensor
7.4.4.2. Cleaning
Clean the oxygen sensor exterior with a soft, lint-free cloth soaked with a water-soluble
detergent or disinfectant. Allow to dry thoroughly.
7.4.4.3. Assembly
Inspect the oxygen sensor for damage and replace as necessary. Re-insert the oxygen
sensor.
7.4.5.Respiratory valves
The following procedure is written generically for a single, unspecified valve. It should apply
to both the inspiration and expiration valves.
7.4.5.1. Disassembly
CAUTION: It is not necessary to remove the valve nut, the valve cover, the valve cage or
the valve disc to clean them. However, if removal is desired, follow the procedure below.
CAUTION: The valve disc is fragile and must, therefore, be handled with care when
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7.4.5.2. Cleaning
c. After all components are completely dry, verify that the valve disc and the prongs of the
valve cage are undamaged before disinfection or re-assembly and functional testing.
7.4.5.3. Disinfection
NOTE: Ensure that all valve components have been cleaned as described in 8.2.5.2 before
disinfecting.
Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of all valve components while adhering to facility policies and
procedures.
7.4.5.4. Assembly
Reassemble the valve components in the reverse order, noting any previously stated
CAUTION.
After installation, check air tightness of inspiratory and expiratory valve and movement of
valve disc.
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7.4.6.Bag arm
7.4.6.1. Disassembly
7.4.6.2. Cleaning
Clean the bag arm with a soft, lint-free cloth and a solution of mild detergent and water. Allow
it to dry thoroughly.
7.4.6.3. Disinfection
NOTE: Ensure that the bag arm has been cleaned as described in 8.2.6.2 before disinfecting.
Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of the bag arm while adhering to facility policies and procedures.
7.4.6.4. Assembly
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7.4.7.Absorber canister
7.4.7.1. Disassembly
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7.4.7.2. Cleaning
Clean the absorber canisters with a soft, lint-free cloth and a solution of mild detergent and
water. Allow them to dry thoroughly.
7.4.7.3. Disinfection
NOTE: Ensure that the Absorber Canisters have been cleaned as described in 8.2.7.2 before
disinfecting.
Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high
level disinfection and rinsing of the Absorber Canisters while adhering to facility policies and
procedures.
WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.
NOTE: Ensure that the absorber canisters are completely dry before adding absorbent.
7.4.7.4. Assembly
While noting the previous WARNING, add new pre-pak or loose fill absorbent to the absorber
canisters. Re-install the absorber canisters into the assembly. Rotate the locking mechanism
handle clockwise into the locked position.
Each time the absorbent is replaced, please check the sealing ability of the components by
performing the following operations:
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WARNING:Wear latex gloves during disassembly in case that operator’s hands get
damaged.
7.4.8.1. Disassembly
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WARNING: Use care in lifting and manipulating the breathing system block during
removal from its mounting arm as handling may be awkward due to its weight and shape.
7.4.8.2. Cleaning
Clean the breathing system block exterior with a soft, lint-free cloth and a mild detergent and
water solution. Allow to dry thoroughly.
7.4.8.3. Disinfection
NOTE: Ensure that the breathing system block has been cleaned as described in 7.4.8.2
before disinfecting. High level disinfection of the breathing system block can be performed
through steam autoclaving up to a maximum temperature of 134ºC (273 ºF).
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Using an autoclave, follow the manufacturer’s instructions for high level disinfection of the
breathing system block while adhering to facility policies and procedures.
7.4.8.4. Assembly
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CAUTION:For more cleaning and disinfecting information of AGSS, refer to AGSS User
Manual.
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8. Regular maintenance
Do not use lubricants containing oil or grease, as they will burn or explode
when oxygen reaches a certain concentration.
All the covers used in the system must be anti-static (conductive) materials,
because static electricity can cause a fire.
WARNING: Please follow disinfection control and safety procedures, because the used
WARNING: Moving parts and dismountable parts might pinch or crush hands. Pay
WARNING: In the process of transporting, be sure to prevent the flowmeter from shaking
WARNING: The disposal of equipment (batteries and LCDs, which may harm the
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WARNING: Person without such equipment maintenance experience can absolutely not
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accordance with current, local regulation requirements. If there is no regulation, put them in
the specified location. Do not throw away.
CAUTION: The ineffective CO2 absorbent has an obvious change in color when it
becomes ineffective.
CAUTION: Regularly maintain and replace corresponding parts for the Anesthesia
CAUTION: The maintenance interval of the Anesthesia machine is recommended for five
years. Comprehensive testing and part replacement is recommended every five years for the
respiratory system, vaporizer and parts.
8.2.1.Appearance checklist
1. Assure the appearance of Aeon8300A no damage, the Anesthesia machine can run
normally.
2. Assure absorbent canister install correctly and fill enough soda lime. Assure enough
anesthetic in vaporizer.
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3. Assure the exhaust gas absorber pipe connected with APL valve no damage and dry
inside.
4. Assure O2, N2O, AIR, VAC and EVAC connection pipe no damage.
5. Assure O2, N2O, AIR, VAC and EVAC flexible pipe no damage (if they are be used).
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mount)
NOTICE: The lifetime of all components above is the result in normal circumstance and
work condition.
WARNING: The disposal of oxygen sensors must be conducted in accordance with local
3. Connect new O2 sensor to cable connection port and install it on inspiratory valve of
breathing system.
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WARNING: Before replacing fuse, first disconnect AC power. Otherwise, it will cause
CAUTION: When replacing fuse, make sure the new fuse is the same type and size as
CAUTION: Fuse is a damageable part, which should be replaced with moderate force
and speed.
CAUTION: When screwing in the fuse with screwdriver, do not apply a lot of force;
7. Connect AC power.
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replace the battery. If the anesthesia machine is inactive for a long period of time, please
contact a customer service engineer to disconnect the battery.
CAUTION: The disposal of used batteries must be conducted in accordance with local
regulation requirements.
CAUTION: When experiencing a power failure, the system will switch to the internal
battery supply automatically, and all the subassemblies of the anesthesia machine should
work normally.
Battery specifications
Cautions
Charge: When network power supply is connected, the system will automatically charge the
battery for maintenance. The charging time is recommended to be at least eight hours.
For insufficient battery, the device will display the ―low battery‖ alarm, until automatic
shutdown. If the ―low battery‖ alarm appears, user should promptly connect mains supply
charge to avoid system shutdown.
Do not disassemble battery without permission. Short circuit connection between battery
cables is forbidden to avoid the danger.
Preservation of battery
If the battery is not used for a long time, the battery should be fully charged and then
preserved.
If the storage time is more than three months, charge the battery at least every three months.
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Replace the battery at once if the battery has a damage caused by the improper maintenance
to avoid liquid leakage corrosion.
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9. Technical Data
CAUTION:All displayed values are measured under dry environment and proper
pressure.
WARNING:Cylinder valve should be closed during pipeline gas supply, so that gas
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Gas Supply
Table 9-1
Flow Speed
Table 9-2
Gas Range Range
(thin flow tube) (thick flow tube)
O2 0.05-1L/min 1.1-10L/min
N2O 0.05-1L/min 1.1-10L/min
AIR 0.05-1L/min 1.1-12L/min
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CAUTION:Do not put heavy stuff on the top panel or in the drawers.
Table 9-3
Dimensions: 1403mm(H)×681mm(W)×855mm(D)
Weight: 100kg(excluding vaporizer and
System
backup cylinder)
Top Panel Load: 25kg
Caster 125mm,each front caster with brake
Drawer 142mm(H)×376.5mm(W)×438mm(D)
Display 10.9’ TFT LCD
Cylinder Gauge(AIR、O2、 Range:0-1MPa. Stepping:0.05MPa
N2O) Accuracy:±2.5% of full range
Range:-10 - 100cmH2O. Stepping:200Pa
PAW Gauge
Accuracy:±2.5% of full range
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Table 9-4
Operation: 70~106kPa
Atmospheric
Storage: 70~106kPa
pressure
Transport 70~106kPa
Power AC100-240V,50Hz/60Hz
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9.5.1.IEC60601-1:2005 classification
I type device
Common device/IP21
Traveling device
consecutive running
9.6.1.Electrical
to the connections between at least one medical device and one or more non-electrical
devices. Even if no functional connections between the single device, when using one
auxiliary power outlet, they forms a medical electrical system. User must be aware of the risk
of increased leakage current when the device is connected to the power outlet of the auxiliary
network.
outlet, the patient’s leakage current value might exceed the allowed range.
WARNING: If external protective grounding wire has a problem during installation, the
Table 9-5
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9.6.2.Pneumatic
Table 9-6
NOTE:
1. When the Anaesthesia system stops transferring, the pipeline supplying pressure should
be 280 to 600KPa.
2. When main power fails, the system switches to battery power automatically and,except for
the breathing system heating component, all the components of the anesthesia machine can
work normally.
3. When main power and internal battery both fails, the gas output is not affected.
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Compliance correction
In all software version, the anesthesia machine is able to carry out a compliance correction
which compensates for volume "lost" in hoses and in the breathing system.
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The Anaesthesia machine determines the system compliance (hoses and breathing system)
and required later for compliance correction during the self test or standby leak test. The hose
of standard equipped compliance has a fixed value of 11mL/kPa.
Having the system compliance (Csys) and ΔP, the Anesthesia machine can calculate the
volume (ΔV) which has been "consumed" by the system, in other words, the volume has not
been delivered to patient.
ΔV = Csys x ΔP
VT corr = VT + ΔV
The anesthesia machine repeats this procedure during each breathing phase so that the VT
delivered to the patient gradually approaches the set VT. This procedure is completed as
soon as the plateau value stops changing (±0.5 cmH2O).The displayed flow and the resulting
values (for example, MV) are updated accordingly.
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Table 9-8
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9.8.2.Ventilation parameter
Table 9-9
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9.8.3.Drive gas
Table 9-10
Label 1:Within rated outlet pressure range and under double maximum rated inlet pressure
condition.
Table 9-11
According to ISO8835-2, test under peak flow 60L/min, fresh gas 10L/min.
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9.8.4.Monitor performance
Table 9-12
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CAUTION: Specific parameters are subject to the latest technical data released by the
manufacturer.
The oxygen sensor can be used to measure the local oxygen concentration of the Anesthesia
machine. Since it’s a consumptive item, user should pay attention to the validity of the sensor,
and use it according to the features and technical requirements provided by the manufacturer.
The following is main technical parameters of the oxygen sensor for the Aeon8300A
Anesthesia machine.
Table 9-13
Performance parameters
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range
Temperature When the temperature is between 0~40℃,the compensation is
compensation ±2%.
Pressure range 0.5~2.0Bar
Relative humidity range 0~99%(no condensation)
Long-term output drift <5%(in 100% O2 environment, used more than one year)
Shell material White ABS
Nitrous oxide resistance 100% N2O
Period of validity 13 months
Meet standard EN12598/ISO7767
The O2 monitor surveys and displays the O2 concentration in the
patient loop. The oxygen sensor component contains an oxygen
sensor, which can produce the voltage proportional to the
oxygen partial pressure (concentration) on its detection surface.
The oxygen sensor is an electrochemical device (chemical
battery). Oxygen expands in this device through a layer of film
and oxidize base metal electrode. The oxidation process
produces a current with an amplitude proportional to the oxygen
partial pressure indicated by the electrode sensor. The base
Working principle of O2 metal electrode is gradually exhausted during the oxidation
monitor process.
The voltage of the sensor is influenced by the temperature of the
monitoring gas mixture. The surgical thermosensitive resistor of
the sensor automatically compensates fot the temperature
change in the sensor.
The O2 monitor converts the sensor signal into the corresponding
oxygen percentage value by using signal processing and circuit
analysis. The system displays the value and compares it with the
stored alarm limit value. If the value exceeds the threshold, the
monitor will alarm.
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The gas monitoring module is connected to the patient’s breathing pipeline to monitor the
inspiratory and expiratory gas and can be applied to Adult/Child and Infant.
Table 9-14
Table 9-15
Basic Configuration
Description Extremely compact infrared mainstream multi-gas module.
Available in various parameter configurations.
Dimension(W×D×H) IRMA CO2/ AX+:
38×37×34mm(1.49‖×1.45‖× 1.34‖)
Cable length 2.50m±0.02m
Weight <25g(except cable)
Operating temprature IRMA CO2: 0-40℃, 32-104℉
IRMA AX+: 10-40℃, 50-104℉
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NOTE 1: After being in a condensing atmosphere, this module shall be stored for more than
24 hours in an environment equivalent to operating humidity.
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The humidity range 50-100% is valid for the temperature range -40 - 40℃.
Table 9-16
Data Output
Fi and ET The newest breathing value (Fi and ET) is continually displayed after
one breath.
Gas monitor module CO2:CO2
Automatic agent IRMA AX+: Primary and secondary agent.
identification
Table 9-17
Gas Analyzer
Probe 2-9 channel NDIR type gas analyzer measuring at 4-10 μm. Pressure,
temperature and full spectral interference correction.
Calibration When the detected value is offset;
When alarm occurs because ―gas module monitor concentration
exceeding the limits‖;
After replacing gas circuit adapter of gas monitor module.
Warm-up Time Record concentration and full-range accuracy identified automatically
by anesthetic gas in 10s;
Gas monitor module CO2: within 10s;
Gas monitor module AX+: within 1 minute.
Rise time CO2≤90ms
(@10L/min) N2O≤300ms
HAL,ISO,ENF,SEV,DES≤300ms
Agent identification <20s (Typically<10s)
time
Total system <1s
response time
Table 9-18
Range1)
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Table 9-19
Gas Accuracy
NOTE 1: The accuracy specification is valid for the operating temperature and humidity
conditions specified, except for interference specified in the table ―Interfering gas and vapor
effects‖ below.
NOTE 2: The accuracy specification for IRMA AX+ is not valid if two or more than agents are
present in the gas mixture.
Table 9-20
N2O3) 60
--1) --1) --1) --1)
vol%
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Metered dose Not for use with metered dose inhaler propellants
inhaler propellants3)
l)3)
CH3COCH3(Aceton 1 vol%
--1) --1) --1) --1)
3)
e)
CO(Carbon 1 vol%
--1) --1) --1) --1)
3)
monoxide)
NOTE 1: Confirm that parameters are effective in all special circumstances except referred in
―interference gas and vapor effect‖.
NOTE 2: Interference at indicated gas level. For example,50vol% helium typically decreases
the CO2 readings by 6%. This means that, if measuring a mixture containing 5.0vol% CO2
and 50vol% helium,the measured CO2 concentration will typically be (1-0.06)*5.0vol%=4.7
vol% CO2.
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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.
Do not put any object which is not in accordance with EN60601-1 in the 1.5M range of
patients.
An isolated transformer must be used for alternating current supply (in accordance with
IEC60989), or additional protective ground wires are equipped if all the devices (for medical
or non-medical use) are connected to Aeon8300A by using signal input/signal output cable.
Do not connect the non-medical equipment directly to the alternating current outlet on the
wall. Only the alternating current supply of the isolated transformer can be used. Otherwise,
the surface leaking current may exceed the range permitted by EN60601-1 under the normal
conditions, and disoperation may cause injury to patients or operators.
Aeon8300A is equipped with all-purpose alternating current outlet for connecting other
medical equipments. Do not connect non-medical equipment to these outlets. Otherwise, the
surface leaking current may exceed the range permitted by EN60601-1 under normal
conditions and disoperation may be dangerous to patients or operators.
A complete system current leaking test (according to EN60601-1) must be performed after
any equipment is connected to these outlets.
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equipment and patients at the same time. It is dangerous for patients or operators.
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The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer of the user of the Aeon8300A anesthesia machine should
assure that it is used in such and environment.
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
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The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Aeon8300A anesthesia machine should assure
that it is used in such an environment.
Electromagnetic environment
Immunity test IEC 60601 test level Compliance level
- guidance
Electrical fast 2 kV for power 2kV for power Mains power quality should
transient/burst supply lines supply lines be that of a typical
commercial or hospital
IEC 61000-4-4
environment.
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70% UT 70% UT
<5% UT <5% UT
NOTICE UT is the a.c. mains voltage prior to application of the test level.
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The Aeon8300A anesthesia machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Aeon8300A anesthesia machine should assure
that it is used in such an environment.
3.5
d P
V1
23
150 kHz to 80 d P 800 MHz to 2.5 GHz
MHz
E1
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NOTICE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTICE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are
6.765MHz to 6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in
the frequency range 80 MHz to 2.5GHz are intended to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Aeon8300A anesthesia
machine is used exceeds the applicable RF compliance level above, the Aeon8300A
anesthesia machine should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the
Aeon8300A anesthesia machine.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10
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V/m.
portable and mobile RF communications equipment and the Aeon8300A anesthesia machine
Rated 150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5
maximum MHz MHz MHz GHz
output power
outside ISM bands in ISM bands
of transmitter 12 23
d P d P
E1 E1
(W) 3.5 12
d P d P
V1 V2
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
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frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTICE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTICE 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are
6.765MHz to 6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.
NOTICE 4 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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