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DIXION VERTRIEB MEDIZINISCHER GERÄTE GMBH

Anesthetic machine
Practice 3200

Version No.: V1.5

Release Date: June 2020

Part No.: UM03-02-V1.5


Statement
DIXION VERTRIEB MEDIZINISCHER GERÄTE GMBH (DIXION 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 DIXION 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 DIXION who reserves the copyright.

Everything written in this manual is considered to be correct. DIXION is not legally responsible
for any mistakes printed within and any damages caused by incorrect installation and operation.
DIXION does not supply privileges endowed by the patent law to any other parties. DIXION is
not legally responsible for the results caused by patent law breaking and any rights of the third
party violating.

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. DIXION 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 DIXION.

DIXION has the rights to replace any content in this manual without notice.

Manufacturer Responsibility:

DIXION is responsible for the security; reliability and function of the equipments when to
following conditions are adhered to:

 Installation, adjustments, mending and repairs must be performed by individuals


authorized by DIXION;
 Necessary electrical equipment and the working environment must be in
accordance with the national standards, professional standards and the
requirements listed in this manual;
 Equipment must be used as instructed in the operating instructions.

CAUTION: This equipment is not for home use.


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
DIXION, 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 DIXION.

Warranty:

Manufacturing techniques and materials:

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;
 DIXION 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 DIXION;
 This warranty does not apply to the followings:

Improper use

Machines without maintenance or machines broken

The label of our original serial number or mark is removed or replaced

Other manufacturers’ product.


User Manual

Security, reliability and operating condition:

DIXION is not responsible for the security; reliability and operating condition of this product in
case that:

 The assemblies are disassembled, extended and readjusted


 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 DIXION:

1. Obtain the rights of return

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 DIXION for repairing.

Use Notice

Welcome to use our products.

To use this product correctly and effectively, the user must read this user manual carefully
before using this product.

When the user is using this product, this user manual must be understood totally and observe
strictly.

This product is only applied to the use this user manual described.

Only trained and professional service persons are allowed to repair and examine this product.

If there is any case happened in the process of use, please call us and intense service will be
provided.

If there is any change in product specification, another informs will not be given.

3
Manufacture: DIXION VERTRIEB MEDIZINISCHER GERÄTE GMBH

Address: Couvenstr. 6, 40211, Dusseldorf, Germany

P.C.: 40211

Tel.: +4921138838868

Web site: www.dixion.de

E-mail: info@dixion.de
User Manual

1. Product Description
This manual introduces Practice 3200 Anesthetic Machine.

Main function and parameter, please see “10 Appendix”.

1.1. General Information


Practice 3200 Anesthesia Machine is a continuous flow anesthesia system which offers manual
or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery,
ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems.

In terms of theory of operation, the Practice 3200 Anesthesia Machine driven by pneumatics
and controlled by electricity, is a device used to administer to a patient continuously or
intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation. The
integrated breathing system delivers the mixture of O2, N2O, AIR and anesthetic agents for
patient breathing control, while electrical control system functions as monitoring patient
parameters.

The Practice 3200 anesthetic machine is intended for use by licensed clinicians, for patients
requiring anesthesia within a hospital. This product is suitable for 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.

Symbol Description Symbol

CAUTION! Attention, consult accompanying documents. Refer


to user manual.

Turn on power switch ON

Turn off power switch OFF

"ON" for a part of equipment

"OFF" for a part of equipment

Alternating current (AC)

Direct current (DC)

Dangerous voltage

Earth (ground)

Protective earth (ground)

Equipotentiality

Date of manufacture
User Manual

Do not reuse

Use by

Batch code

Authorised representative in the European community

Temperature limitation

WEEE: Waste Electronic and Electrical Waste

Type B equipment

2: Protected against solid foreign objects of Φ12.5mm and


greater

1: Protection against vertically falling water drops

Manufacturer

Catalogue number

Serial number

7
Rotation in two directions

Rotate to adjust(increase counter-clockwise)

Lock

Unlock

Insp. flow

Exp. flow

O2 flush O2+

Breathing bag/manual ventilation

Fuse

Read the reading of the top floating-point

Outer power supply has been connected

Recycle

Battery charging condition


User Manual

Alarm mute icon

Alarm icon

Interference many occur in the vicinity of equipment marked with


this symbol

Refer to product instructions

Authorized representative in the European community

This device complies with the requirements of Medical Device


Directive, 93/42/EEC.

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1.3. Abbreviations
Abbreviation Definition

AGSS anesthetic gas scavenging system

APL adjustable pressure limiting

BDU basic data unit

C compliance

C·G·O common gas outlet

cmH2O Centimeters of Water

CO2 carbon oxide

Des. Desflurane

EEPROM electrically erasable programmable read only memory

Enf. Enflurane

eTCO2 End-expiratory CO2 concentration

FiO2 Fraction of Inspired Oxygen

Flow-t flow-time wave

Flow flow

Freq Frequency
User Manual

FreqMIN Minimum Frequency in PS mode

GUI Graphic user interface

Hal. Halothane

I:E Inspiratory to Expiratory Ratio

FiCO2 Inspiratory CO2 concentration

Iso. Isoflurane

IPPV Intermittent positive pressure ventilation

L/min liter per minute

L iter

11
M

MAC Minimum Alveolar Concentration

Manual manual ventilation

PMEAN mean pressure

mL Mill Liter

MRI Magnetic resonance imaging

MV minute volume

N2O nitro oxide

O2 oxygen

Paw airway pressure

Paw-t pressure-time wave

Pb plumbum

PLAT plat pressure

PCV Pressure Control Ventilation

PEEP Positive End Expiratory Pressure

PMEAN mean pressure

PPEAK Peak pressure

PS Pressure Support Ventilation

PTARGET Target Pressure

S
User Manual

SIMV Synchronized Intermittent Mandatory Ventilation

Sev. Sevoflurane

TINSP Inspiratory Time

TP Inspiratory Pause Time

Trigger flow trigger

TSLOPE Inspiratory Slope Time

VT tidal volume

WDT watch dog timer

ΔP Differential Pressure

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1.4. Warnings and Cautions
Please read and adhere to all warnings, CAUTIONs and NOTICEs listed here and in the
appropriate areas throughout this manual.

A WARNING statement gives important information that, if ignored, could lead directly to
personal injury.

A CAUTION statement gives important information that, if ignored, could lead directly to
equipment damage and indirectly to personal injury.

WARNING:Practice 3200 must only be operated by trained, skilled medical staff.

WARNING:Practice 3200 Anesthetic machine must and can only be serviced by DIXION’s

authorized service representatives.

WARNING: For a full understanding of the performance characteristics of this equipment,

the user should carefully read this manual before operating:

 All system connections.


 All WARNINGs and CAUTIONs.
 How to use the machine.
 How to test the machine.

WARNING: Do the following things before operating Practice 3200:

 Finish all the tests listed in Pre-use Preparation.


 Test other systematic parts.

WARNING: Do not use the machine if any test failures. Contact DIXION’s authorized

service representative for maintaining the machine.

WARNING:Practice 3200 is not suitable for use in a magnetic resonance imaging (MRI

)environment.

WARNING: To avoid the risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.


User Manual

WARNING: The highest attitude of Practice 3200 anesthesia machine is 4500m.

WARNING: The pipeline inlet pressure of Practice 3200 anesthesia machine must be

280-600kPa.

WARNING: Breathing tube, mask, SUCTION filter and so on, adapter of mainstream CO2

module, water trap of side stream CO2 module etc. are disposable accessories. Before using
check the pipeline to ensure the disposal subassembly is out of using .Check the tube which
will be used before use and avoid reusing.

WARNING: When the suction flow is insufficient, the suction port filter should be checked or

replaced.

WARNING: Do not use anti-static and/or electric breathing tubes or masks; otherwise, they

will be flammable near high frequent surgery equipment.

WARNING: Do not incline the machine at the angle of more than 10 degree.

WARNING:Do not position Practice 3200Anesthesia machine to make it difficult to operate

the disconnection device.

WARNING:Do not service or maintain Practice 3200 Anesthesia machine while it is in use

with the patient.

WARNING: Perform the pre-use checkout before operating Practice 3200.

WARNING: Remove all equipment on the top cover before moving the machine. Use the

handle on the machine to move the machine.

WARNING: Ensure that the machine does not incline when it is upgrading, downgrading,

turning around or getting across a threshold. Do not push the machine across pipelines, lines or
any barrier on the ground.

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WARNING: Remove all the equipments attached at the flank of the machine before

transportation, otherwise, incline of the machine will lead to personnel damage.

WARNING: Apply the castor brakes when the anesthetic machine is in use.

WARNING: Do not put the item over 25 kg on the top board of Practice 3200 anesthesia

machine.

WARNING: Do not put the item over 12 kg on the work table of Practice 3200 anesthesia

machine.

WARNING: The whole width of machine should be less than 0.8m when hanging some

stuff.

WARNING: In order to protect patients and users from electrical hazards, it is imperative

that all systems consisting of electrical medical devices and other electrical devices, such as
but not limited to PCs, priters, etc., be mounted exclusively by trained personnel.

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 anesthesia
machine that only uses cylinders for gas supply.

WARNING: The parts of machine in contact with gas to be inhaled by patients don’t contain

phthalates, which are known to be carcinogenic, mutagenic or toxic to reproduction.

WARNING: Possible explosion hazard. Do not operate machine near flammable anesthetic

agents or other flammable substances. Do not use flammable anesthetic agents (i.e., either or
cyclopropane).

WARNING: Only non-flammable anesthetics such as desflurane, sevoflurane, enflurane

and isoflurane, which are compatible to other gas are allowed to use in anesthetic system.
User Manual

WARNING: Possible fire hazard. Fuses(i.e., additional sockets)must only be replaced by

fuses of the same type and with the same rating.

WARNING: Possible electric shock hazard. The machine may only be opened by DIXION

qualified or DIXION authorized service engineer.

WARNING: Electric shock and fire hazard. Do not clean the machine while it is on and /or

plugged in.

WARNING: Disconnect the power plug from the mains supply before removing the rear

panels or servicing the machine.

WARNING: Independent means of ventilation(e.g. a self-inflating manually powered

resuscitator with mask) must be available whenever the machine is in use.

WARNING: Malfunction of the central gas supply system may cause more than one or

even all devices connected to it to stop their operation simultaneously.

WARNING: Use a cleaning and disinfect schedule that confirms to your institution’s

disinfect and risk-management policies.

 Refer to the material safety data as applicable.


 Refer to the operation and maintenance manuals of all disinfecting
equipment.
 A damaged oxygen sensor may lead to leakage of its highly caustic
contents that contain potassium chloride. Wear safety gloves and
safety googles per manufacturer’s recommendations.
 Do not inhale fumes that may result from any disinfectprocess.

WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.

WARNING: Use care in lifting and manipulating vaporizers during the mounting process as

their weight may be greater than expected, based on their size and shape.

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WARNING: All gas supplies should be of medical grade.

WARNING: To avoid endangering a patient, do not perform testing or maintenance when

the machine is in use.

WARNING: After the device replacement is finished, all calibrations must be done again

and only the service engineer is allowed to do this.

WARNING: All gas volume, flow and leakage specifications have been tested under STPD,

except those associated with the Anaesthetic Breathing System, which be tested under BTPS.

WARNING: If the anesthetic machine is equipped with Anesthetic Gas Delivery System,

Monitoring Equipment, Alarm System and Production Device, no mater the machine is supplied
by separate device or system assembly, the anesthetic machine checklist must be provided.

WARNING: The medical device connected to the anesthesia system must conform to IEC

60601-1:2005 and IEC 60601-1-2:2007.

CAUTION: For your safety and that of your patients, strictly follow this user manual.

CAUTION: Perform the tests specified on the Pre-use Preparation and ,in case of a fault,

do not operate the machine until the fault has been corrected.

CAUTION: Before starting the machine, users must be familiar with the information

contained in the User Manual.

CAUTION: If the machine does not function as described, it must be examined and repaired

as necessary by authorized service representative before being returned to use.

CAUTION: Handle the machine with care to prevent damage or functional faults.

CAUTION: Ensure that the gas supply of the machine always complies with the technical

specifications.
User Manual

CAUTION: Before clinical use, the machine must be correctly calibrated and the respective

tests must be performed, as described in the User Manual.

CAUTION: After servicing, all calibrations must be performed again and only the

professional service engineer can do this.

CAUTION: The anesthesia system conforms to ISO 80601-2-13:2011.

CAUTION: The anesthesia ventilator used together with anesthesia system conforms to

ISO 80601-2-13:2011.

CAUTION: The anesthesia system is used together with the following monitoring device,

alarm system and protection device:

 Conform to the pressure measurement of ISO 80601-2-13:2011;


 Pressure limit device in conformity with ISO 80601-2-13:2011;
 Conform to the exhale output monitor of ISO 80601-2-13:2011;
 Conform to the respiratory system with alarm system of ISO
80601-2-13:2011;
 Conform to the O2、CO2、anesthetic gas monitor of ISO
80601-2-55:2011;
 All parts contact with the gas conform to ASTM D5466-01.

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2. Components

2.1. Configuration
Standard configuration: Mainframe,bellows, Breathing system, flow meter, anesthetic
ventilator, battery.

Optional configuration: Touchscreen, O2 sensor, MAC, ACGO, AGSS (Anesthetic Gas


Scavenging System), VP300(Enflurane,isoflurane,sevoflurane,interface type: Selectatec,
using double metal sheet to make temperature compensation, Pour-fill infusion).
User Manual

2.2. Front View

Fig. 2-1 Practice 3200 Front View

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No. Name No. Name

1 Flowmeter 7 O2 flush

2 Bellows 8 AGSS

3 Flow Rotary Knob 9 Screen

4 Gas Supply Gauge 10 Vaporizer

5 Breathing System 11 Drawers Assembly

6 CGO 12 Caster(with brake)

Functional description of components is as follows.

Number Item Description Figure

Counterclockwise rotation of
Flowmeter flowmeter rotary knob
3 Rotary increases the flow; clockwise
Knob rotation of flowmeter rotary
knob decreases the flow.

Measure gauge gas supply


Gas supply pressure of N2O, AIR, O2
gauge flowing by airway.

Cylinder Cylinder gauges can measure


Gauges the pressure from N2O, AIR
and O2 respectively.
User Manual

It locates on the front of the


machine. It can provide oxygen
from 35L/min to 75L/min to
breathing system and
breathing bag.

7 O2 flush CAUTION: When central

gas supply or backup cylinder


is connected, press O2 flush
button will deliver oxygen to
breathing system and
breathing bag, even the
machine is powered off.

Castor(with Lock :Push down


11
brake) Unlock: Lift up

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2.3. Side View

Fig. 2-2 Practice 3200 Side View

No. Name No. Name

1 Slot 2 AGSS
User Manual

2.4. Back View

Fig. 2-3 Practice 3200 Back View

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No. Name No. Name

1 Power Switch 6 YOKE

2 RS-232 Interface 7 Battery

3 Fuse 8 Gas inlet

4 Auxiliary mains outlet socket 9 Exhaust

5 Power Cable 10 Drive Gas Interface

WARNING: The connection


Fuse of electrical equipment to the
auxiliary mains outlet socket
Auxiliary
3、4 may reduce the system safety
mains
level; therefore the equipment
outlet
connected to the auxiliary
socket
mains outlet socket must
conform to the IEC 60601-1.

Set power switch to “ON” to let


gas flow in and open an

Power aesthetic system.


11
Switch Set power switch to “OFF” and
close an aesthetic system to
prevent gas flowing in.
User Manual

2.5. The Breathing System module

CAUTION: Any adult anesthetic ventilator system used together with the

anesthetic gas supply system must be in accordance with ISO


8835-2.

Mainly function: store anesthetic gas and O2, exhaust gas, absorb CO2, connect with breathing
airway directly and assist to operate breathing.

Figure 3-4 breathing system module

1 Absorber (Carbon dioxide absorbent) 5 Inspiratory valve

2 Expiratory Port / Patient circuit 6 Expiratory valve


connector

3 Manual reservoir bag port 7 APL valve

4 Inhalation Port/ 8 Bellows assembly (auto ventilation)

Patient circuit connector

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Figure3-4 the breathing system components function control

Item Diagram Description

One soda lime canisters loaded can be continuously


1 Absorber ----- used for 6-8 hours at full load. The water from the
reaction is drained via the water collector underneath.

Used for setting peak pressure and deflating.


7 APL valve
Adjust range:0~70cmH2O.

2.5.1. Bellows Assembly Ports

Figure 3-5 Ports of bellows assembly

1 Driving gas connector

2 Exhaust gas port

3 Breathing system connector

WARNING: Neverconnectexhaust gas port with sub-atmospheric systemdirectly.

Or else leakage of breathingsystem generates.


User Manual

2.5.2. Common Gas Outlet

Figure 3-6C•G•O

Common gas outlet, abbreviated to C•G•O, is an optional part of Practice 3200Anesthetic


machine. Turn the hand valve clockwise to let the common gas flow through C•G•O, Turn the
hand valve counterclockwise, the common gas will flow within the Breathing System.

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2.5.3. Ventilating circulation

Inhalation primary phase: Exhalation primary phase: Exhalation end phase:

1 Exhalation valve 6 Driving gas 8 Excess gas of patient


circuit
2 Driving gas 7 From patient circuit

3 Gas of patient circuit

4 Pressure-relief valve

5 To patient circuit
User Manual

2.5.4. 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

an automatic ventilation mode is selected..

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 0cmH 2O 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.

Fig. 2-5 APL Valve

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2.6. Vaporizer-VP300/VP500(Optional)
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.2-6 Vaporizer

NO. Name NO. Name

1 Canister Body 6 Anesthetic tag

2 Interlock bolt 7 Screw cap

3 lock lever 8 Liquid level indicator

4 control dial 9 Drain valve

5 Release button 10 Drain hole

WARNING: Only dry gas of medical degree can be used on the vaporizer. Any improper

operation of the vaporizer will bring damage to patient.

WARNING: The vaporizer should be placed vertically at the vaporizer mounting manifold.

Turn the vaporizer to OFF when it is not used.


User Manual

CAUTION: The vaporizer used with Practice 3200 must comply with ISO 80601-2-13:2011.

CAUTION: For more operating and maintaining information of the vaporizer, refer to VP300

User Manual.

2.7. Anesthetic Gas Scavenging System-AP1000 (Optional)


Anesthetic gas scavenging system absorbs waste gas exhausted from breathing system and
delivers it to processing system.

Fig.2-7 Anesthetic Gas Scavenging System-AP1000

Number Name Number Name

1 window 5 floater

2 U-bracket 6 Patient inlet

3 canister 7 Pressure release port

4 Flow control knob

WARNING: Do not block the pressure relieve hole on top of the gas tank when using

AGSS.

CAUTION: The anesthetic gas scavenging system used with Practice 3200 Anesthetic

Machine complies with ISO 80601-2-13:2011.

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CAUTION: If the AGSS used together with anesthesia system is produced by other

manufacturer, make sure that the AGSS conforms to ISO 80601-2-13:2011.

CAUTION: For more operating and maintaining information of AGSS, refer to AP1000 User

Manual.

2.8. O2 flush

Figure2-10

As shown in Figure2-10, by pressing the button, high


flow of 35L/min--50L/min can be provided to fresh gas outlet. When “O2+” is pressed, between
35 L/min and 50 L/min of O2 flow will be delivered to the Breathing System. Flush is available at
all times when the machine is connected to a Central Gas Supply System or Back-up Cylinder.
3. User Interface

WARNING: The anesthesia breathing machine used together with anesthesia system

conforms to ISO 80601-2-13:2011.

For 12.1-inch display, the panel of the anesthetic machine is composed of user
interface,function keys and a knob. Shown in figure 3-1

Figure 3-1 User interface

No Name Description
1 Touch screen Touch screen.
The user interface can display real-time pressure and flow
waveforms, respiratory loop, monitoring data, ElectronicFlowmeter
settings and anesthesia System and provides both sound and visual
alarms to assist the user.
2 AC Indicator The indicator is lighted as AC power effectively;
The indicator is dark as AC power failure.
3-1 MANUAL/ In Standby mode, first press MANUAL/AUTO knob, the system switch
AUTO to Manual mode, then secondly switch to IPPV mode.
In automatic mode, first press MANUAL/AUTO knob, the system
switch to Manual mode, then secondly switch to the original mode.
When entering or exiting the Manual mode, the user information area
displays according to the original model.
3-2 MUTE If there is an alarm, press MUTE and the silence will keep for 110
seconds; press the key again, and the silence is cancelled. If the
alarm has a change but the silence less than 120s, the silence will be
cancelled.
4 Knob The user can set the parameter values by rotating the knob and
confirm set values by pressing the knob. Rotating the knob clockwise
increases values and rotating the knob counter-clockwise decreases
values.

CAUTION: The required circumstance of the monitoring of the breathing system as follows:

Circumstance temperature: 25℃;

Gas temperature: 25℃;

Gas tidal: 30%;

Gas: O2.

CAUTION: The anesthesia ventilator which is used with the anesthetic system complies

with ISO 80601-2-13:2011.


User Manual

3.1. Main interface display layout

NO. NAME NO. NAME

1 Parameter set and display area 6 Waveform display area

2 Anesthetic gas monitoring area 7 Patient message area

3 Ventilation mode set area 8 Machine information area

4 Ventilation mode display area 9 Shortcut key area

5 Alarm indication area 10 Patient parameter monitoring area

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3.1.1. The Interface layout without anesthesia gas monitoring
User Manual

3.1.2. The Interface layout with CO2 and anesthesia gas

monitoring

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3.2. Information of the main interface

3.2.1. Ventilation mode set and display area

3.2.1.1. Ventilation mode display


Name description
Ventilation mode display:Ventilation mode area shows current ventilation mode. The mode
setup menu will be open by clicking the ventilation mode area via touch screen.

3.2.1.2. There are four states for mode button as shown below:
Name description Diagram

The normal mode – without any operation to the mode button.

Focusing state – when rotating the knob to the purpose mode,

the corresponding button will display this state.

Pending state – this state is displayed when switching modes.

White state – means the current mode that is selected.


User Manual

3.2.2. Parameter Set and Display Area

3.2.2.1. Parameter display


Name description and Diagram

Parameter setting area is located at the bottom of the screen, which are applied for real-time
respiratory parameter adjustment, including 8 setting buttons.

The Ventilation parameters of all models are arranged from left to right, as shown in the chart
below:

Model Parameter1 Parameter2 Parameter3 Parameter4 Parameter5

Standby Patient Type Blank Blank Blank Blank

MANUAL ON/OFF Blank Blank Blank Blank

IPPV VT Freq I:E TP Blank

PLV VT Freq I:E Plimit Blank

SIMV VT Freq TINSP TP Trigger

SPONT FreqMIN Trigger Blank Blank Blank

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3.2.2.2. The button status when setting parameters
Name description Diagram
There are three display statuses in the process of parameter
setting:
1. The first status displays when no operation has been
performed to the button;
2. The second status displays when the button has been
selected by the rotation of the knob;
3. The second status displays when the button has been
selected by the rotation of the knob;

3.2.3. Alarm Indication area

Name description and Diagram

Alarm indication: when an alarm appears, an alarm bell icon shows in the warning area. For a
senior-level alarm, the alarm bell is red with white lettering. An intermediate-level alarm is
yellow with black lettering. A low-level alarm is blue-green with black lettering. At most,two
alarms can display on the screen at one time

By pressing MUTE button, an “X” shows on the alarm icon. Below the alarm bell a countdown
timer appears. The “X” and countdown second display the same color as the alarm bell.

CAUTION: The flickering frequency of higher priority alarm among all alarms indicates

all alarms, alarm bell and countdown seconds (if any). The alarm information text keeps
own color respectively (if any).

3.2.4. Machine Information Area

Name description Diagram


User Manual

Current date indicates at date display area, with format


“YYYY/MM/DD

Current date indicates at date display area, with format


“YYYY/MM/DD

NOTE: Time and date format and value can be set in

system setup menu.

The description of these icons is as follows.

Name description Diagram

Power status includes AC power and backup battery state,


which will be always shown. When AC power is normal, the
white plug icon shows consistently without flashing. When net
power is disconnected or fails, the white plug icon disappears.
Battery power 100%

Battery power 75%

Battery power 50%

Battery power 25%

Battery power low (≤10%)

Battery not connected

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3.2.5. Waveform display area

Waveform display area is located in the center of the screen, including waveform and breathing
loop.

Waveform name Diagram

Pressure-time

waveform(Paw-t)

Velocity-time waveform

(Flow-t)

Carbon dioxide-time waveform

(CO2-t)

Pressure-Volume
User Manual

Flow-Volume

3.2.6. Patient message area

Name description Diagram

The patient message area is to the right of the alarm zone,


and to the left of the information area. In this area, there are
two icon: patient type and trigger type.

The description of these icons is as follows.

Name description Diagram

Patient type shows adult or child.

CAUTION: Patient type setting is conducted under

standby mode.

When patient triggers, the trigger logo will show in the patient
information area, and disappear after 250ms. The background
color will restore the original color.

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3.2.7. Patient parameter monitoring area

Name description Diagram

The patient parameter monitoring area ison the right side of


the screen. There are at most four groups of parameters:
pressure group, capacity group, oxygen concentration group
and carbon dioxide concentration group.
User Manual

3.2.8. Shortcut key area

The shortcut key area includes shortcuts to alarm settings, system settings, calibration,
engineer mode, gas setting and breathing loop.

CAUTION: Shortcut keys are disabled during power up self-test.

Name description Diagram

Alarm setting: when user presses alarm setting key, alarm


menu appears. If this button is pressed in open state, alarm
setting menu closes, and returns to the main interface.

System setting: by pressing system setup key, the system


setup menu appears. If this menu is pressed in open state,
system setting menu disappears, and returns to main
interface.

Calibration: by pressing calibration key, the calibration menu


appears. If this button is pressed in open state, calibration
button disappears and returns to main interface.

Gas: by pressing gas setup key, the gas setup menu appears.
If this menu is pressed in open state, gas setting menu
disappears, and returns to main interface.

Loops: by pressing Loops key, the loops menu appears. If this


button is pressed in open state, the functional menu
disappears and returns to main interface.

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3.2.9. General menu layout

The background of the overall menu is gray with the menu title shown centered, at the top of
the window. Below the menu title there are a number of tabs containing a variety of content
within the menu. In the top, right corner of the window is an "x" button which closes the menu
when pressed. The menu elements include option key, button, label and indicative text, etc.
4. Pre-operative Preparation

4.1. Installation and Connection

4.1.1. Connection of Tubes and Cables

Step 1

Connect bellows and absorber cycle with one


corrugated tubing (Φ22).

Step 2

Connect bellows and driving gas output


connector on the rear panel with another tube
(Φ17).
Step 3

Get two repetitioussilica geltubes connect the


one at expiratory port of absorber cycle.

Step 4

Connect the other tubes at inspiratory port of


absorber cycle.

Step 5

The other end of the two tubes should be


connected with Y-piece and simulation lung
(reservoir bag).

The capacity of simulation lung is 3L.


User Manual

4.1.2. Installation of Breathing Bag

Connect the Manual reservoir bag onto bag arm of


breathing system.

4.2. Installing the Absorber Canister

WARNING: Follow the proper security measures:

 Do not use the absorber if the anesthetic is chloroform or


trichloroethylene.

 Avoid letting the skin or eyes touch the materials in the absorber.
Clean the affected part immediately and seek medical attention if
materials come in contact with skin or eyes.

 Do not replace absorber during the period of ventilating.

 Replace the absorbent often to prevent the deposition of


non-metabolism gas as the system is not on.

 Check the color of the absorbent after finishing each case. The
original color of the absorbent may be restored when not in use.
Refer to the labels of the absorbent for the details.

 Carbon monoxide is released if completely dried absorbent contact


with the anesthetic.Replace the absorbent for security.

 Perform leakage testing of breathing system in bag control mode


after disassembling the absorber.
51
The absorberin this system can be used repetitious.

The capacity of each absorber is 2000ml. It is recommended to use Medisorb absorbent.

Only air, oxygen, carbon monoxide, halothane, enflurane, isoflurane, sevoflurane and
desflurane can be used for the absorber.
User Manual

4.2.1. When to replace absorbent

Changed color of the soda lime in the absorbent indicates that it has absorbed the carbon
dioxide; however, this color is not 100% accurate. To decide whether to replace the absorbent,
use CO2 monitoring machine.

Remove the changed-color absorbent immediately. The soda lime will restore its original color
several hours later and that may mislead the operator.

4.2.2. Disassembling Absorber

The absorber is reusable. Follow the disassembling procedures:

Turn clockwise the absorber and then disconnected it according to the explanation on the
absorber.

4.2.3. Filling Absorbent

1 Remove the absorbent of absorber.

2 Cleaning and disinfection refer to section 7.3.

3 Fill the absorber with fresh absorbent after dryness. Wipe soda lime fell on the edge of
absorber, and then install it back. Make sure the air tightness is well, and that no leakage
and spillage.

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4.2.4. Oxygen sensor connection

Step 1:

Plug one end of T-piece to the inspiratory port


of breathing system.

Step 2:

Plug the oxygen sensor to T-piece.


User Manual

Step 3:

Plug one end of the oxygen sensor line into the


bottom interface of the sensor. The other end
of the oxygen sensor line should be plug into
the “O2 Sensor port” on the rear panel.

4.2.5. Connection of the anesthetic gas/CO2 monitoring

module (optional)

CAUTION: The anesthetic gas/CO2 monitoring module has mainstream and side stream.

The two types can’t be used at the same time.

CAUTION: The anesthetic gas/CO2 monitoring module conforms to ISO 80601-2-55:2011.

4.2.5.1. Connection of the mainstream monitoring module

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Step 1:

Snap the probe on top of the airway adapter. It


will click into place when properly seated.

Step 2:

Connect the RS232 interface of the adapter to


the RS232 interface on the back of the
machine.

Step 3:

CAUTION: After powering on the system,

a green LED indicates that the probe is ready


for use.

Connect the smaller end of the adapter to the


Y-piece connector.
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Step 4:

Connect the other end of the adapter to the


face mask or breathing bag.

4.2.5.2. Connection of the sidestream monitoring module


Step 1:

Take out the sampling tube and elbow.

Sampling tube Elbow

Step 2:

Connect one end of the elbow to the Y-piece

Step 3:

Connect the other end of the elbow to the


breathing bag, or to patients through tube.

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Step 4:

Connect the other end of the elbow to the


sampling tube, and make a connection
between the sampling tube and the CO2 or
anesthesia gas water trap.

4.2.6. AGSS Installation and Connection

CAUTION: AP1000 cannot at an angle exceeding 5 degrees during normal operation.

CAUTION: Make sure AP1000 installs at a place where operator can get a clear view of

it.

CAUTION: Connect AP1000 according to the practical situation if no GCX rail is

available on the anesthetic machine.

CAUTION: Make sure good connection in case of anesthesia gas leaks to operating

room.

Step 1:

Connect the transfer connector to the one connector of


the AGSS.
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Step 2:

Connect two silica gel tubes to the connectors of the


transfer connector.

Step 3:

Connect the black connector of one silica gel tube to the


waste gas exhaust port on the bottom of the bellows
assembly.

Step 4:

Connect the black connector of the other silica gel tube


to the waste gas exhaust port on the breathing system.

4.3. Pre-operative Test

WARNING: For a full understanding of the performance characteristics of this equipment,

the user should carefully read this manual before operating:

 All system connections.


 All WARNINGs and CAUTIONs.
 How to use the machine.
 How to test the machine.

WARNING: Do the following things before operating Practice 3200:

59
 Finish all the tests listed in Pre-use Preparation.
 Test other systematic parts.

WARNING: Do not use the machine if any test failures. Contact DIXION’s authorized

service representative for maintaining the machine.

4.3.1. Test before Operation

Pre-use test should be performed under the following circumstances:

 Every day before used on the first patient.


 Before used on every patient.
 After maintenance or service.

4.3.1.1. System Check

WARNING: Make sure that the breathing system is in good connection and with no

damage.

1. Make sure the anesthetic machine has no damage.


2. Make sure all parts are correctly connected.
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.
6. Make sure backup equipments are available and functioning.
7. Make sure anesthetic agent and emergent medicine are available.
8. Make sure the castors are not loose and the forefront two castors are locked.
9. Make sure the anesthetic machine is connected to power socket and power
indicator is light. There is no power supply if power indicator does not light.

4.3.1.2. Power Failure Alarm Test


1. Turn on power switch; user interface is light, STANDBY interface displays after
self-test is finished.
2. After the anesthetic machine operates under STANDBY mode for five minutes,
pull out power cord
User Manual

3. Make sure power failure alarm occurs (alarm bell sounds or user interface
displays POWER FAILURE message).
4. Reconnect power cord.
5. Make sure alarm is eliminated.

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4.3.2. Pipeline Gas Supply Test

CAUTION: Operator should make sure gas supplies are correctly connected during

operation, there is no leak, wrong connection and damage in breathing circuit。 If something
abnormal occurs, check the connection.

WARNING: The malfunction of the center gas supply system may cause one or even all

connection equipment connected with it stopping work.

1. Cut off pipeline gas supply. Perform the following steps if pipeline gauge does
not read zero:
2. Connect O2 supply.
3. Set flow to the middle level.
4. Make sure N2O cylinder gauge reading restores to zero.
5. Cut off O2 supply.
6. Make sure O2 cylinder gauge reading restores to zero. Low gas source alarm
occurs when O2 pressure is decreasing

4.3.3. Vaporizer Test

CAUTION: For information of vaporizer’s function test, refer to VP300 User

Manual.(Material No.:13200)

 Make sure the vaporizer is steadily installed.


 Make sure the vaporizer is locked.
 Make sure only one vaporizer can be open at a time.
 Make sure the vaporizer is filled with adequate anesthetic agent.
User Manual

4.3.4. Alarm Test

1. Connect a test lung to Y-piece.


2. Turn on power switch.
3. Set the following items:

Ventilation Mode IPPV

Ventilator Vt:700mL

Freq.:20

I:E:1:2

PAW-High:40cmH2O

Anesthetic machine All gas flow: OFF

Push O2 flush to inflate bellows.

4. Make sure:
 Initiate mechanical ventilation.
 No low gas source pressure alarm occurs.
 Ventilator displays correct values.
 Bellows moves up and down during mechanical ventilation.
5. Set O2 flow at 5L/min.
6. Make sure:
 End respiratory pressure is approximately between 2cmH2O to
3cmH2O.
 Ventilator displays correct values.
 Bellows moves up and down during mechanical ventilation.
7. Test O2 monitoring and alarm:
 Disassemble O2 sensor, make sure that O2 takes up 21% of room
air according to the test result.
 Set low O2 alarm to 50%, make sure low O2 alarm occurs.
 Set low O2 alarm to 21%, make sure low O2 alarm is eliminated.
 Assemble O2 sensor in breathing system.
 Set high O2 alarm to 50%.
 Push O2 flush button to inflate bellows.
 Make sure high O2 alarm is initiated.
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 Set high O2 alarm to 100%, make sure high O2 alarm is eliminated.
 Put O2 sensor in pure oxygen; make sure that O2 takes up 100%
according to the test result.
8. Test low minute volume alarm:
 Return to alarm menu.
 Set low minute volume alarm limit to 16.0L/min.
 Make sure low minute volume alarm occurs.
 Return to alarm menu.
 Set low minute volume alarm limit to 10.0L/min, make sure low
minute volume alarm is eliminated.
9. Test high PAW alarm:
 Set high PAW below peak PAW.
 Make sure high PAW alarm occurs.
 Set high PAW alarm to 40cmH2O.
10. Test low PAW alarm:
 Disconnect test lung form breathing system.
 Other alarms occur, such as low minute volume alarm.
 Make sure low PAW alarm occurs.
11. Test continuous PAW alarm:
 Set control items:

APL valve: Adjust to the maximum value

Ventilation Mode: Manual

 Mechanical ventilation stops when the machine operates at Manual


ventilation mode.
 Block patient end and push O2 flush button.
 Make sure continuous PAW alarm occurs when continuous
pressure is at 10cmH2O for 15 seconds.
12. Turn off power switch.
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.

Turn the switch to “ON”. The user


interface is lighted, entering into the
system self-test interface.

5.2. System Self-test


Enter into the system self-test
interface after opening.
After the system self-test:
Select “Continue”, the interface will
change to the Standby mode.

5.3. Patient Type Setting


The patient type of Practice 3200 anesthesia system has 2 types: Child and Adult. The
user can select the needed one.

CAUTION: Adult is the default patient type after opening.

CAUTION: The switch of the patient type is only allowed in STANDBY mode.

Adult is the default type after


opening.
User Manual

Press the knob to select patient


type button in the bottom, left
corner of the screen. This button
will turn yellow when selected.

Turn the knob to change the patient


type to “Child”.

Press the knob to confirm the


setting and un-select the patient
button.

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5.4. Ventilation Mode

IPPV:Intermittent Positive Pressure Ventilation

PLV:Pressure Limited Ventilation

SIMV:Synchronized Intermittent Mandatory Ventilation

PS:Pressure Support Ventilation

5.4.1.1. Intermittent Positive Pressure Ventilation(IPPV):


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.

The setup parameters of IPPV mode:

VT, Freq, I:E, Tp

5.4.1.2. Pressure Limited Ventilation(PLV):


The setup parameters of PCV mode:

PTARGET, Freq, I:E, TSLOPE, Plimit

5.4.1.3. Synchronized Intermittent Mandatory Ventilation (SIMV):


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
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.
User Manual

The setup parameters of SIMV mode:

VT, Freq, Tins, Tp, Trigger

5.4.1.4. SPONT

The setup parameters of SIMV mode:

FreqMIN, Trigger,

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5.4.2. Parameter and adjustment scope of ventilation mode

Patient Type: Unit Range Default Stepping


Adult Valve

IPPV Mode VT mL 20~1500 500 10


Freq. bpm 4 ~100 12 1
I:E / 4:1 ~1:8 1:2 0.5
TP % OFF,5~ 60 10 5

Patient Type: Unit Range Default Stepping


Child Valve

IPPV Mode VT mL 20~300 120 10


Freq. bpm 4 ~100 20 1
I:E / 4:1 ~ 1:8 1:2 0.5
TP % OFF,5~ 60 10 5

Patient Type: Unit Range Default Stepping


Adult Valve

PLV Mode VT mL 20~1500 500 10


Freq. bpm 4~100 12 1
I:E / 4:1 ~ 1:8 1:2 0.5
Plimit cmH2O 5~70 20 1

Patient Type: Unit Range Default Stepping


Child Valve

PLV Mode VT mL 20~300 120 10


Freq. bpm 4~100 20 1
I:E / 4:1 ~1:8 1:2 0.5
Plimit cmH2O 5~70 10 1

Patient Type: Unit Range Default Stepping

SIMV Mode Adult Valve

VT mL 20~1500 500 10
User Manual

Freq. bpm 2~100 4 1

TINSP sec 0.2~5.0 2.0 0.1

TP % OFF,5~60 10 5

Trigger L/min 1~15 3 1

TSLOPE sec 0~2.0 0.5 0.1

Patient Type: Unit Range Default Stepping


Child Valve

VT mL 20~300 120 10

Freq. bpm 2~100 4 1


SIMV Mode
TINSP sec 0.2~5.0 1.0 0.1

TP % OFF,5~60 10 5

Trigger L/min 1~15 2 1

TSLOPE sec 0~2.0 0.5 0.1

Patient Type: Unit Range Default Stepping


Adult Valve
SPONT Mode
FreqMIN bpm 2~60 2 1

Trigger L/min 1~15 3 1

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5.4.3. Ventilation Mode Setting
The user can select the ventilation mode according to the patient’s actual situation.

The ventilation mode menus locate


on the left corner of screen. Click on
the ventilation menu to select the
corresponding ventilation mode.

If you wish to choose IPPV mode,


click the IPPV mode button. The
button will be at pre-selection state.

NOTE:
When the ventilation mode button is
at pre-selection state, the
corresponding ventilation
parameters that can be set appear
on the bottom of the screen.
User Manual

Click the IPPV button againto


confirm your selection.

5.4.4. Mode parameter setting


If the patient type and ventilation mode have been selected, the system will display default
parameters according to the ventilation mode. The user could set the needed breathing
parameter. VT of IPPV mode is used below as an example of how this is done. These
instructions also apply to other modes and parameters.

Click the parameter button to be set,


for example VT. The VT button will be at
pre-selection state.

73
Turn the knob to adjust the
wanted parameter value.

Click on VT button again the


setting.

5.5. Menu screens

CAUTION: The menu window covers two waveforms.

CAUTION: When selected, a short cut key will display the selected menu. When Normal is

selected the all menus will be removed.


User Manual

Menu screens are used to access most


functions in the anesthesia machine. All
menus open in specific menu windows.
Each menu opens or closes by touching
the screen or rotating the knob. Value
selection in the menu is accomplished
by touching the screen, rotating the
navigator knob and pressing the
navigator knob to confirm selection.

5.5.1. Menu operating logic

1. Open / close current menu by pressing the corresponding touch key.


2. An open menu can also be closed by clicking on the "X" key or “Normal" key.
3. Press the "Alarm" key to open / close the alarm setting menu. Press once to
open, and press again to close.
4. When the mode is in "pre-selection" status, closing or switching to another
menu will close pre-selection state.
5. If parameters are being set and not confirmed, the unconfirmed set values will
be lost and the original set values will be restored if the user closes the current
menu or switches to another menu.

75
5.5.2. Alarm setting
The alarm settings can be opened by touching the Alarm shortcut key. The alarm
setting menu includes four sub-options: Vent, Gas, Agent, and Volume. The default
alarm sub-option on start-up is Vent Alarm limits.

Vent:
Alarm limits for MV, PAW, Freq
can be set.

图 5-39

Gas: Alarm limits for FiO2、etCO2、


insCO2can be set.

图 5-40
User Manual

Agent: Alarm limits for


Sevoflurane(SEV),
Enflurane(ENF), and
Isoflurane(ISO) can be set.

Volume: The alarm volume can be


adjusted.

Press the knob, the alarm volume


turns yellow as the right picture.
Turn the knob to set the needed
alarm volume and press the knob
to confirm you setting.

图 5-42

5-43

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5.5.3. System setting

Pressure: two options: Mean and Plat.

Language: two options: Chinese and


English.

Demo: two sections, including OFF


and ON.

Data and Time:

Data: YYYY/MM/DD

Time: 24 hour format.

Vent: Used to monitor the ventilation


parameters.
User Manual

Default: Press the Default button,the


interface shown as the picture on the
right.
Select “Cancel”, the default will be
closed.
Select “OK”, will change the default
setting to the system defaults.

O2 Sensor: two sections, including


Enabled and Disabled.

Result of Leak Test: Press “Leak Test”


button, the “Result of leak test” window
appears in the right side of the
interface.
Leak voltage, test data and test time
will be displayed.
Press “Done” to recede from the
current interface.

79
Air drive: Open air drive, the drive
bellow’ gas is switched from O2 to air.

Trigger: two options: Flow and


Pressure.

Note: Have this function in PS and


SIMV mode.
User Manual

5.5.4. Calibration

The Calibration menu includes O2,


CO2, Agents, compliance test, leak
test, touch screen.

42

5.5.4.1. Oxygen sensor calibration

CAUTION:Remove the oxygen sensor from the breathing system and expose
the sensor to room air for at least three minutes before proceeding.

Note: A plug is provided on a chain attached to the side of the breathing system for

plugging the O2 sensor port on the inspiratory valve during this operation.

CAUTION:The alarm “O2 Cal Due” will be displayed when the oxygen sensor has not been

calibrated for over 72 hours.

81
The oxygen sensor calibration
calibrates the oxygen sensor at
21% oxygen concentration.

1. Press Oxygen button to enter


the Oxygen sensor calibration
window (see picture on the right).

42

2. The window displays a


countdown of 180s.

The “Start” button will be disabled


before the countdown ends.

1) After the countdown ends,


select “Start” button, the O2sensor
calibration begins.

2) Press , close the


O2sensor calibration.

On the calibration interface, there


is a voltage value. After
calibration, if the voltage value is
lower than 300mV, then the
sensor should be replaced; if the
voltage value is higher than
300mV, repeat calibration a
43
second time.
User Manual

When the calibration is successful,


the interface will display
“Calibration Successful”, press the
“OK” button close O2sensor
calibration.

44
If the calibration fails, the interface
will display “Calibration Failed”.

To perform the calibration again,


press the “Repeat” button.

45

5.5.4.2. Agents calibration


1. Press “Agents” button to enter the
agent calibration window (see picture
on the right).

图 5-55

83
2. Two notices appears, follow the
notice to operate.

The calibration of the anesthetic has two results:

1) If the anesthetic gas


calibration successes, the
interface will display” Calibration
Successful”,
User Manual

2) Anesthetic gas failures.

Follow the window notice to


examine the listed items step by
step.

Turn the knob to “Cancel”, press


the knob to return to and renew
the calibration.

Turn the knob to “Cancel”, press


the knob to return to the main
interface.

5.5.4.3. Compliance Test

NOTE: Perform the Leak Test prior to the Compliance Test when starting the system test.

85
5.5.4.4. CO2 module calibration

Press “CO 2 module calibration”,


and a “Please activate CO2
function first” notice appears.

Open the CO2, two notices


appears in the state area.
Follow the notice to operate.

Press “Start”, the calibration


begins.
User Manual

The result of CO2 module calibration has two types:

1)CO2 module calibration


succeeds, a word “CO2 module
calibration successful” appears
in the window.

2) CO2 module calibration


failures.

Follow the window notice to


examine step by step.

Select “Retry” to do the


Compliance Test again.

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5.5.4.5. Leak Test
Press “Leak Test” knob to enter
the calibration menu.

If the “Leak Test” window shows


as the picture on the right.

1)Follow the notice to operate.

2)Press“ to close leak test.

Select “Start” and a word


“Testing” appears in the window.
User Manual

1) If the Leak Test succeeds, a


word “Leak Test successful”
appears in the window.

2) If the Leak Test fails, a word


“Leak Test failed” appears in the
window.

5.5.4.6. Touch screen calibration

Click on “Touchscreen” sum-menu, the


screen seen as the right picture appears.

89
Press “Start”, the screen seen as the right
picture appears.

Click the “+” to complete the screen


calibration.

5.5.5. 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, and then the main interface can
display the parameters of CO2 or anesthetic gas.

Press “Gas” button to enter the


gas setting interface (see
picture on the right).

The gas setting include: gas


module, CO2 unit, wave display,
module information.
User Manual

5.5.5.1. Gas Module Setting

Select “Gas Module” button,


which will be at pre-selection
state.

Turn the knob to open the gas


module.

Press the button to confirm your


choice.

91
5.5.5.2. CO2 unit

CO2 monitor parameter and wave have two units: mmHg and %. The user can select the
needed one.

Press the “CO2 Unit” button,


which will be at pre-selection
state.

Turn the knob to select CO2 unit.

Press the knob to confirm CO2


unit.
User Manual

5.5.5.3. Wave display


The waves what the main interface displays have two types: CO2 wave and flow wave.The user
can select the needed one.

Press “Wave” button, which will


be at pre-selection state.

Turn the knob to select the


needed wave.

Press the knob to confirm the


selected wave.

93
5.5.5.4. Module version
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.

5.6. Breathing Loop


Press the breathing loop button in the right side of the user interface, the breathing loop
appears in the user interface.

“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 circle

will be canceled.
User Manual

Pressure-Volume (Before save reference)

Pressure-Volume (After save reference)

95
Flow-Volume (Before save reference)

Flow-Volume (Before save reference)


User Manual

5.7. Closing
The shutdown of the anesthesia system is as follows:
• Set the vaporizers to OFF;
• Turn OFF the gas supplies, until the gas in the system has gone out completely;
• Set all flowmeter settings to OFF;
• Set the auxiliary flowmeter to OFF;
• Turn the power switch to OFF to shut down the anesthesia system.
• If disconnect the power supply, unplug the power cord.

CAUTION: When the power switch is processing OFF state, the main power is
still available.

WARNING: After closing the power switch, the system is running continually
until the background light of the flow meter has gone out.

97
6. Alarm and troubleshooting

WARNING: Person without maintaining experience mustn’t mend the machine.

CAUTION: If alarm occurs, the patient’s safety must be protected firstly, then do

troubleshooting or necessary remedy.

CAUTION: Alarm presets will change with patient type automatically.

CAUTION: When several alarms occur at the same time, alarm message only displays the

front two in a sequence of “High” to “Low”.

CAUTION: When alarm silencing, the alarm bell has dashed “X” on itself. After
120s, the alarm bell renews to the old state; If the alarm is not dealt in time, alarm continues.

CAUTION: If alarm occurs when the anesthetic machine works normally, visible and

audible signals will delay a certain time.

WARNING: Do not set alarm limit exceeding the extremes, otherwise, alarm system will

failure.

WARNING:A potential hazard can exist if different alarm presets are used for the same or

similar equipment in any single area, such as ICU or cardio tic operating room.

WARNING: The operator should examine if the current alarm setting is suitable for every

patient.

WARNING: When power supply is interrupted, system will still renew the last alarm settings

when opening again.


User Manual

6.1. Brief introduction of alarm message


The alarm states have 3 priorities: high, medium, low. High alarm needs to be dealt in time.

The sound pressure level of alarm signal is no less than 60dB.

The operator can judge if the alarm system is functional by visible and audible alarm message.
The distance that the operator can hear the alarm sound or distinguish the priority of alarm is 4
meters at least. And the distance to see the alarm message is not less than 1 meter at the front
of the machine.

The top area of the user interface displays alarm message, see figure 6-1.

Table 6-1 Alarm message

Table 6-1

Priority Definition Alarm Tone Mute Notice Message

High Death or 10 alarm tones 120s Red background,”!!!”flickering,


irreversible including 2hurry, displaying frequency is 2Hz.
injury. alarm cycle is 8s.

Medium Reversible 120s Yellow background,”!!” flickering,


injury. displaying frequency is 0.5Hz.
3 alarm tones,
alarm cycle is 10s.

Low Slight injury or 2 alarm tones, no --- Yellow background,”!” flickering,


uncomfortable. repeat. long-term display.

99
6.2. Alarm message
The alarm method includes technical alarm and functional alarm; technical alarm includes
startup test list and alarm occurring during normal operation.

6.2.1. Alarm default value and setting range

High Low Setting range of high limit Setting range of


low limit
MV(Adult) 12 1 1~25 0~20
MV(Child) 6 1
PAW(Adult) 50 10 10~80 0~70
PAW(Child) 40 8
Freq(Adult) 18 --- 8~60 ---
Freq(Child) 30 ---
FiO2 100% 18% 21%~100% 18%~99%
Hal. 1.5 OFF 0.1%~8.4% OFF,0.1%~8.3%
Iso. 2.3 OFF 0.1%~8.4% OFF,
0.1%~8.3%
Enf. 3.4 OFF 0.1%~9.9% OFF,
0.1%~9.8%
Sev. 4.2 OFF 0.1%~9.9% OFF,
0.1%~9.8%
Des. 12.0 OFF 0.1%~21.9% OFF,
0.1%~21.8%
ETCO2 6.6% OFF 0.1%~9.9% OFF,
0.1%~9.8%
50mmHg OFF 1~75mmHg OFF,
1~74mmHg
INSCO2 0.7% --- 0.1~1.4% ---

5mmHg --- 1~10 ---


Other default items:

Manual Mode: Enabled

Alarm Volume: 2 tones

Patient type: Adult

Pressure:PLAT
User Manual

6.2.2. Technical alarm message table

Table 6-2

Alarm Name Priority Cause Remedy

Low gas supply High Drive gas pressure is less Check pipeline gas supply and
pressure than 2.9psi±15% replace pipeline.

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.

Switch to the manual mode,


backup battery begins to supply
power and assure battery capacity
is full.

101
Alarm Name Priority Cause Remedy

O2 sensor High Monitor O2 concentration<


Use exterior measurement system
failure 10%,the alarm occurs
or replace O2 sensor.
immediately.

Monitor O2
concentration≥10%, cancel
the alarm immediately.

When O2 sensor in the


system setting menu is
configured “Disable”, no
alarm occurs.

BDU
High GUI receives and sends Ventilator failure.
communication
data from BDU unit failure
failure Switch to manual mode and the
lasts for 2s
user interface is still available.
User interface switches to
STANDBY mode automatically.

Call service Rep.

Flowmeter
High GUI receives or sends data Switch to manual mode
failure from flowmeter sensor
Call service Rep.
failure lasts for 2s

Communication
High Communication between Switch to manual mode and call
between BDU
BDU and power supply service Rep.
and power
board is abnormal.
supply board
failure

Gas module
High When gas module
communication
communication is
failure
abnormal, if the cable is
interrupted, this abnormal
state will last 5s.
User Manual

Alarm Name Priority Cause Remedy

Gas module High Pull out adapter probe in Call service Rep.
probe failure gas module for several
seconds.

CAUTION: If the gas

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
failureappears, the alarm
will occur.

CAUTION: If the gas

module communication
failures, the alarm message
will not occur.

103
Alarm Name Priority Cause Remedy

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.

CAUTION: If the gas

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
User Manual

6.2.3. Functional alarm message

Table 6-3

Priorit
Alarm Name Condition Solution Remedy
y
1. In MANUAL mode, airway
pressure>10cmH2O, and
last more than 15s,this
1. Use manual
alarm occurs;
ventilation.
2. In other mode, airway
2.Check patient’s
pressure>PEEP setting After alarm
Continuos high expiratory
High values, and last more occurs, alarm
airway pressure passage ; if the
than 15s,this alarm lasts at least for alarm is not
occurs; 8s. canceled, call
3. In STANDBY mode, this
service Rep.
alarm will not appear;
4. In MANUAL mode, this
alarm will not be closed.
1.Switch to 1.Reset airway
expiratory high alarm
1. Airway Ppeak≥Ppeak;
phase, the timer limit;2.Detect if
2. In STANDBY mode, this
High airway 2. Alarm expiratory passage
High alarm will not appear;
pressure message lasts is blocked or not;
3. In MANUAL mode, this
for 8s after alarm 3. If Vt setting is too
alarm could be closed.
condition big; 4.If the patient’
disappears. airway is blocked.
1. Airway pressure≤SW883
-2cmH2O and lasts for
Do not block
Negative more than 4s.
High SUCTION exhaust
pressure In MANUAL mode, this
port
alarm, this alarm will not
be closed.
1. Monitor tidal volume
<10ml,or
2. Monitor average
APNEA High pressure<1cmH2O, in Alarm occurs.
MANUAL mode, it is not
determined, or
3. Monitor average pressure
105
equals to 1cmH2O,and
monitor PEEP≤0cmH2O,
in MANUAL mode, it is
not determined.
1. In MANUAL mode,airway
pressure is lower than
pressure alarm low
limit>30s;
2. In other mode,Freq≥4;
airway pressure is
Low airway Mediu 1. Ventilator
lowerthan alarm low Reset airway low
pressure m works as normal.
limit>15s,Freq<4,airway alarm limit
pressure is lower than
pressure alarm
lowlimit>30s;
3. In STANDBY mode, this
alarm will not appear.
APNEA backup Mediu SW425.2 in PS mode,
Alarm occurs.
ventilation m FreqMIN trigger ventilator.
1. Reduce alarm
setting;
2. Reduce air or
N2O compensation

1. Alarm value;

occurs. ; 3.Recalibrate O2
Low FiO2 High 1. FiO2≤Low FiO2 setting sensor;
2.Ventilator
works as normal. 4.O2 battery is
exhausted;
5. Call service
Rep.

1. Measured FiO2
value≥setting
When O2 sensor 1.Alarm occurs.;
Mediu 1.Increase FiO2
High FiO2 configuration in the 2.Ventilator
m and alarm setting
system menu is works as normal.
“Disabled”, this alarm will
not appear.
1. MV≥upper setting limit 1. Alarm
Mediu 1.Increase high MV
High MV In MANUAL mode, this occurs. ;
m alarm limit;
alarm could be closed. 2.Ventilator
User Manual

works as normal.
1.Reduce MV
1. MV≤lower alarm limit 1.Alarm occurs.;
Mediu alarm setting ;
Low MV In MANUAL mode, this 2.Ventilator
m 2.Check if there is
alarm could be closed. works as normal.
leak in patient end;
1. MV≥HighFreq setting 1.Alarm occurs.;
1.Check patient’s
2. The patient has 2.Ventilator
Mediu state and if there is
HighFreq spontaneous breathing. works as
m spontaneous
3. This alarm only applied to normal.(effective
breathing;
PS mode. in PS mode)
Expiratory CO2 concentration
HighETCO2conc
High exceeds high limit and lasts
entration
at least 2 continual breathes
Low ETCO2 concentration is lower
ETCO2concentr High than low alarm limit and lasts
ation at least 2 continual breaths.
HighINCO2 Alarm according to detected
High
concentration real-time data
Detected PEEP exceeds
PEEP setting +5cmH2O for 2
breaths or 30s (choose the
minimum one between the
Mediu
HighPEEP two).PEEP High alarm
m
occurs.
No this alarm
in STANDBY and MANUAL
mode.
When gas module
Gas module Check connection
communication is abnormal, Alarm occurs.
communication or replace gas
High such as unconnected, and Alarm occurs.
failure module
lasts for 5s.
Several seconds after pulling
up adapter of gas module
Gas module Check or replace
High CAUTION: If the gas module Alarm occurs.
probe failure adapter
communication failures, this
message will not appear.

107
6.2.4. Self-test alarm

Table 6-4

Alarm Name Probable Cause Remedy

BDU EEPROM data fail Incorrect calibration in EEPROM Call service Rep.
check

EEPROM IC fail EEPROM cannot read/write Call service Rep.

PAW sensor fail The data of the PAW pressure Call service Rep.
sensor is incorrect.

Ambient pressure sensor The data of the ambient pressure Call service Rep.
fail sensor is incorrect.

PEEP valve fail Incorrect PEEP valve data Call service Rep.

Inspiratory valve fail Incorrect monitor sensor ZERO state Call service Rep.

Vent/Manual fail Incorrect valve state Call service Rep.

Flow sensor fail Incorrect sensor data 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.
User Manual

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.

Alarm speaker fail Alarm speaker fails The ventilation machine


works as normal, the user
recedes or ignore, call
service Rep.

AC power fail AC power fails Check AC power supply,


check the fuse, replace it
when it is melt.

O2 sensor disconnect or O2 sensor fails or unconnected Replace O2 sensor or


fail connect O2 sensor; when
this alarm appears, the
setting of O2 sensor in the
system menu is disabled;
when there is no alarm,
the setting is Enabled.

Flowmeterfail
GUI receives or sends data from Switch to manual mode
flowmeter sensor failure lasts for 2s
Call service Rep.

109
6.3. Failure diagnosis
Table 6-5

No. Message Cause Remedy

1 O2 sensor The anesthetic gas 1. Use external gas measuring


failure measurement system has system.
failed
2.Call service Rep.

2 APNEA 1. Breathing or ventilation 1. Patient must immediately be


has stopped ventilated manually.

2. Check patient’s spontaneous


breathing ability.

3. Check ventilator settings.

4. Check fresh gas setting.

5. Check that everything is


connected.

6. Check hose system and tube.

3 Battery low The AC power failures and 1. Connect to main power.


the battery capacity of the
2. Check patient’s condition.
un-interruptible power
supply is almost 3. Prepare manual ventilation with
exhausted(﹤20%). 100% O2.

4 APL valve 1.The connection or setting 1.Check APL valve connection;


failures of APL valve is incorrect.
2.Select STANDBY mode and
return to the old ventilation mode;

3. Check APL valve setting.

5 High breathing 1. Breathing system is too 1.Check breathing system and


system high. breathing gas temperature;
temperature
2. Call service Rep.
User Manual

No. Message Cause Remedy

6 Gas monitoring 1. Sample line is blocked or 1. Check sample line, water trap
has no unconnected. and Y-piece filter.
sampling signal
2. Replace if necessary.

7 Breathing 1.Incorrect connection of 1. Check tube, sample line and


system leaks pipeline or line filter.

8 Close AIR 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

9 Close N2O 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

10 Close O2 1. Cylinder valve is open 1. Close cylinder valve to avoid


cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

11 CO2 sensor 1. CO2 gas measurement 1. Use external gas measuring


failure system has failed. system.

2. Call service Rep.

12 Continuous 1. The breathing pressure 1. Check ventilation and/or


high pressure exceeds the set limit for spontaneous breathing of the
more than 15s. patient.

2. Check breathing hoses,


breathing system, and gas
scavenging system for correct
functionality.

3. Check alarm limit for correct


setting.

13 ET CO2 high 1. The end-expiratory CO2 1. Check ventilation.


concentration has
exceeded the high alarm

111
No. Message Cause Remedy

limit for at least two breaths.

14 EXP.flow 1. Expiratory flow sensor 1. Replace flow sensor.


sensor failure has failed.

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 1. Fresh gas setting too low; 1.Increase fresh gad flow;
or leak
2. Leak. 2. Repair leak.

17 Gas sensor 1.Complete gas 1.Use external gas measuring


failure measurement system fails. system;

2. Call service Rep.

18. High airway 1. Hifh alarm limit for the 1.Check hose system and tube;
pressure airway pressure has been
2. Correct the ventilation
exceeded;
settings.
2.Ventilation hose kinked;

3. Ventilation settings are


not correct.

19. Inaccurate 1. Reduced accuracy of 1.Reduce fresh gas flow fo reach


fresh gas flow fresh gas flow gas to below 12L/min;
measurement.
2. Check to take flow meter.

3. Call service Rep.

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
system;
necessary;
3.High ventilation
4.Check ventilation settings;
frequencies;
User Manual

No. Message Cause Remedy

4.Dead space ventilation. 5. Replace flow sensor.

21. Inspiratory flow 1. Inspiratory flow sensor is 1. Replace flow sensor.


sensor failure faulty.

22. Inhaled N2O 1. Inhaled N2O 1. Check N2O concentration in


concentration concentration exceeds the the fresh gas flow.
high high alarm limit of 82%.

23. Inhaled O2 1. Inhaled O2 concentration 1. Check O2 concentration in the


concentration exceeds the high alarm fresh gas flow.
high limit.

24. Inhaled O2 1. Inhaled O2 concentration 1. Check O2 concentration and


concentration is below the low alarm limit. fresh gas setting.
low
2.Check O2 supply;

3.Check breathing system and


breathing bag.

25. No air supply 1.Comm pressed air supply 1.Open optional backup air
has failed; supply;

2. Pipeline supply hose not 2.Check connection to piped


connected or kinked. medical air supply;

3.Optional air cylinder is 3.Connect a full air cylinder or


empty or closed; open the cylinder valve;

4. Compressed air 4. Check compressor.


compressor has failed.

26. No N2O supply 1.N2O supply has failed; 1. Open N2O backup cylinder;

2.Pipeline supply hose not 2.Check central gas supply and


connected or kinked; connection to central gas supply;

113
No. Message Cause Remedy

3. N2O cylinder empty or 3. Connect a full N2O cylinder or


closed. open the cylinder valve.

27. No O2 supply 1.O2 supply has failed; 1.Open O2 backup cylinder;

2.Pipeline supply hose not 2.Check central supply and


connected or kinked; connection to central supply;

3. O2 cylinder empty or 3. Connect a full O2 cylinder or


closed. open the cylinder valve.

28. O2cylinder 1. Pressure has dropped 1. Use a new O2 backup cylinder


pressure low below the pressure limit set and the central gas supply.
for the O2 cylinder.

29. O2flow 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


5cmH2O above PEEP for 2 modes check the ventilation
breaths, or Expiratory parameters.
pressure 5cmH2O above
2. Check the anesthetic gas
PEEP in pressure support
scavenging line.
mode for more than 30s.

31. Power failure 1. Power failure. 1.Restore central supply and


observe battery capacity;
2. Short-circuit in one of the
devices connected to an 2. Prepare manual ventilation.
auxiliary outlet.
3. Call service Rep.

32. Pressure 1. Pressure sensor faulty. 1.Perform self test;


sensor failure
2. Call service Rep.
User Manual

No. Message Cause Remedy

33. Reinstall 1. Breathing system has 1.Check correct installation of


ventilator been installed incorrectly or breathing system;
in completely.
2. Breathing system 2. Check that upper diaphragm
defective. has been installed correctly.

3. Use a different breathing


system.

34. Setting can 1. The last setting has not 1. Repeat settings.
celled been accepted due to
2. Alarm can be reset by
temporary errors.
pressing “Mute” button.

35. Speaker failure 1. Speaker faulty. 1.No alarm tone;

2. Call service Rep.

36. Ventilator 1. Ventilator is no longer 1. Patient must immediately be


failure operational. ventilated manually.

2. Adequate substitute
monitoring must be ensured if
pressure and volume monitoring
has failed.

3. Call service Rep.

115
7. Cleaning and Disinfecting

WARNING: Use a cleaning and disinfecting schedule that conforms to your

institution’s disinfection and risk-management policies.

 Refer to the material safety data policy of each agent.

 Refer to the operating and maintaining manual of all the disinfecting


equipments.

 Wear safety gloves and safety goggles. The O2 sensor may leak and
burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.

 Do not inhale fume.

CAUTION: To prevent damage:

 Refer to the data supplied by the manufacturer if there are any


questions about the agent.

 Never use any organic, halogenate or oil base solvent, anesthetic,


glass agent, acestone or other irritant agents.

 Never use any abrasive agent to clean any of the components (i.e.
Steel wool, silver polish or agent).

 Keep liquids far from the electrical components.

 Prevent liquid from entering the equipment.

 Do not immerse the synthetic rubber components more than 15


minutes: any longer will cause inflation, or accelerating aging.

 Only the components marked 134℃ are pressure-resistant and


heat-resistant.

 The PH value of the cleaning solution must be from 7.0 to 10.5.


User Manual

WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been used to
prevent tackiness could contaminate a patient’s lung or esophagus, causing
injury.

CAUTION: Never immerse the circuit O2 sensor or flow sensor connector in the

liquid.

Never dispose the circuit O2 sensor connector by using hot press.

Do not clean the inner surface of the flow sensor. Clean the outer
surface by using a damp cloth.

Check if there is damage in the components. Replace if necessary.

117
7.1. Cleaning and disinfection of pre-use first

Main unit Clean the machine’s panel and all surfaces with soft cloth soaked
with the water soluble disinfecting agent.

Disinfect main unit with ultraviolet radiation. Do not use acetic hyctro
peroxide or formaldehyde steaming.

Breathingsystem Refer to section 7.2


components

Absorber cycle Washing, refer to section 7.4

Bellows assembly Washing refer to section 7.5.3

7.2. Cleanable Breathing System Components

Corrugated tubing Corrugated tubing and reservoir bag used by every patient
(contacted with patient), should be cleaned then air thehydrocele in tube and reservoir
reservoir bag bag. Finally put the tube and reservoir bag into disinfector for
disinfecting or select disinfectant methods of rubberproduces.

corrugated tubing and bag Washing to disinfect


(repetitious)

T-piece Washing to disinfect

Sampling probe and Clean with soap before use of each patient, and then washing
parallel lines of flow in disinfecting solution after airing.

7.3. Absorber

Refer to “Disassembling the Absorber” in the section 4.2.2


User Manual

Changed color of the soda lime in the absorbent indicates that it has absorbed the carbon
dioxide; however, this color is not 100% accurate. To decide whether to replace the absorbent,
use CO2 monitoring machine.

Remove the changed-color absorbent immediately. The soda lime will restore its original color
several hours later and that may mislead the operator.

WARNING: The dry absorber may be very dangerous with the presence of any

anesthetic. Take proper measures to avoid dry soda lime in the


absorbent. Switch off all gas supplies after use.

119
7.3.1. Auto cleaning with agent or disinfector

Clean the absorber in the agent or disinfector according to the cleaning procedure.

Put the absorber in the heat-up room with the maximum temperature as 80℃or with the room
temperature.

Higher-level disinfection is recommended if the agent and disinfector cannot disinfect


equipment.

7.3.2. Manual cleaning

Rinse the absorber.

Immerse the absorber completely in the sink with water and agent about three minutes at a
temperature of 40 ℃.

Rinse the absorber.

Higher-level disinfection must be performed after cleaning by hand.

7.3.3. Advanced Disinfecting

The absorber must be cleaned before advanced disinfecting.

The absorber can be placed in high temperature and high pressure conditions. The maximum
temperature recommended is 134℃.

Put the soda lime into the absorber after being dried, and then tighten the knob. Clear all soda
lime debris.
User Manual

7.4. Breathing system

1. Inhalation valve and exhalation valve

Dismount the cover of the inspiration and expiratory valves by rotating it counter clockwise,
then clean all parts of them with the gauze soaked with water soluble disinfecting agent, after
all parts cleaned and dried recover it in original integration. Then one must check the leakage
and the movement of the inspiration and expiration valves in accordance with the required
regulation and checking procedure. Please handle all parts with care preventing any damage.

2. Breathing system module


Either vapouring (not more than 50℃) or immersion disinfection can be used in practice, in case
of immersion all disinfected parts must be dried with the high pressure air or oxygen before
reuse.

7.5. The Bellows Assembly

This section is about disassembling, assembling, cleaning and disinfecting the bellows
assembly. Read all content of this section before disassembling, assembling, cleaning and
disinfecting the bellows assembly to avoid equipment malfunction and patient injury.

CAUTION: Only folding gasbag is made of latex.

121
7.5.1. Disassembling

To disassemble the bellows assembly:

(To assemble the bellows assembly, perform the steps in “Disassembling the bellows
assembly” in reverse order):

1 Loosen the screws from the mounting plate, and then remove the mounting plate.
2 Turn counterclockwise and remove the bellows housing.

3 Detach the folding gasbag from the rim.

4 Detach the top plate from the folding gasbag.

5 Remove inner ring from the top of folding gasbag.

6 Push the locking spring to the center, and then remove the rim.

7 Remove the pressure-relief valve diaphragm and the seat assembly.

WARNING: Do not remove bellows assembly seat from diaphragm of the

pressure relief valve. This can distort the seat or diaphragm and
cause injury to the patient.

8 Push to the center, and then remove the locking spring.

9 Remove the seal

7.5.2. Testing Function

WARNING: Do not use any object small enough to slip completely into the

system when occluding the breathing system for test purposes.

WARNING: Always check the breathing system components for foreign

objects before using on a patient.

This test is to ensure all the components are installed correctly. It cannot replace the system
test. The bellows assembling can be installed in case they requirement testing. Otherwise, they
need to be disassembled to check and replace broken components, then reassembled and
tested.
User Manual

Hold the bellows assembly in hands vertically upwards to occlude the driving gas port before
installing.

Invert the bellows assembly. If the descending velocity of the bellows top is no more than 100
ml/min, this could be because the driving gas port is not properly sealed, bellows or seal is not
installed correctly or other component are broken and that the descending velocity exceeds the
limit.

Open the driving gas port to make the bellows fully spread, and then occludes the breathing
system connector.

Turn the bellows assembly so it faces vertically upwards. If the descending velocity of the
bellows top is no more than 100 ml/min this could be because the bellows or pressure-relief
valve is not installed correctly or other component are broken and the descending velocity
exceeds the limit.

7.5.3. Cleaning and Disinfecting

Follow the machine and disinfect manufacturer’s cleaning recommendations.

1. Cleaning
1) Disassembling.

WARNING: Never separate the diaphragm and the valve seat in a pressure-relief valve.

2) To prevent component damage, clean them lightly. Put the recommended non-enzyme mild
agent used for latex and plastic in hot water.

CAUTION: Do not immerse them more than 15 minutes to prevent inflation or aging.

3) Rinse using clean hot water, and then dry.

CAUTION: Dry by hanging while fully spread. If moisture is left in the bellows, they may
become tacky.

4) Check the components if they are broken or damp, then perform the assembling and
function test.
123
5) Connect the bellow assembly, ventilator and breathing system.

6) Perform the preoperative check.

2. Disinfecting
Cleaning and disinfecting must be performed at the same time. Follow instructions for the
common bellows assembly disinfection methods.

Disinfecting after general patient use:

Clean the inner and outer parts of the bellows assembly in a soap-and-water solution. Rinse
thoroughly in cold water, and dry with soft cloth. Immerse plastic and latex instruments in
70-80% ethyl alcohol for half an hour. Take them out using the aseptically transmits pliers, then
store in clean containers. Repeat this step before next use. Components made of metal and
glass can be disinfected with high pressure steam. When the steam pressure is increased by
the autoclave, the rising temperature can concrete the bacterium protein rapidly to kill bacteria.
In 1.05 KG/CM2 steam pressure, the temperature rises to 121C. All bacteria and most sorus
can be killed if this temperature is maintained for 15-25 minutes.

Disinfecting after special infection or infectious patient use:

Open pulmonary TB, pulmonary abscess, pseudomonas, tetanus aeruginosa infection, gas
gangrene or infectious hepatitis is included. Used bellows assembly components must be
completely disinfected according to preliminary and final disposal procedures.

1) Preliminary disposal: Perform in accordance with the isolated disposal stipulation. Collect
and leave all the used bellows assembly components during the operation process in the
operating room. Immerse the bellows assembly components in the 1:1000 benzalkonium
bromide or 1-5% cresol for 30 minutes after finishing the operation.

2) Final disposal: perform the final disinfecting disposal after the bellows assembly components
are processed by the above-mentioned preliminary disposal:

 Scrub the bellows assembly in a soap-and-water solution. Thoroughly rinse in cold


water, and dry;

 If conditions permit, suffocating the components directly contacted with patients with
formald or oxirane is preferred, or perform immersing disinfection respectively. For
example: the components used by open pulmonary TB patients must be immersed in
3% cresol for 30 minutes; the components used by tetanus aeruginosa infection
User Manual

patients must be immersed in 0.2% potassium permanganate for 30 minutes; the


components used by gas gangrene patients must be immersed in 0.1% chlorhexidine
for 30 minutes; the components used by pulmonary abscess patients must be
immersed in 0.1% benzalkonium bromide for 60 minutes; the components used by
pseudomonas patients must be immersed in 0.1% benzalkonium bromide for 120
minutes;

 the components being immersed need to be rinsed by water and dried for next use;

 scrub and rinse the components indirectly contacted with patients with 1-3% phenol
solution or soap-and-water solution and water. Irradiate them by using the ultraviolet
ray for 30 minutes if necessary.

125
7.5.4. Regular Maintenance

WARNING: Do not perform any tests and repairs when the equipment is being used to
avoid patient injury.

Perform the following check every 30 days to be sure that componentsworn by use and daily
cleaning are replaced in time.

 Test by eyes
 Separate the bellows assembly from anesthetic machine
 Disassemble the bellows assembly

WARNING: Never separate the diaphragm and the valve seat in a pressure-relief

valve

Check each component carefully to check for cracks, distortion, dissolution, inflation and other
physical changes. Replace them if necessary.

Assemble the bellows assembly, and then perform the leak test.
8. User maintenance

WARNING: To prevent fire:

 Please use admitted lubricant for anesthetic or O2 device.

 Do not use lubricant containing oil or lipin, because when O2 concentration reaches a
certain degree, burning or explosion may happen.

WARNING;Please observe disinfection control and safety regulation because the devices

having been used may contain blood and sap.

WARNING: Moving part and removable elements is in danger of jamming hands or crush.

More attention must be paid when moving or replacing system parts.

WARNING: In the process of removing product, strike and quiver must be avoided.

WARNING: Exhausted and old instruments (such as battery and LCD screen) harmful to

environment must be treated according to present local regulations.

Minimum maintaining Planned maintaining Standard


Standard

Daily Clean the outer surface.

weekly Perform 21% O2 sensor calibration.

Ventilate the system, open flow meter, and make sure that
the float move up and down smoothly. It can prevent
blocking and clinging.

monthly Perform 100% O2 sensor calibration.

Test leakage of bellows assembly. (refer to 6.5.2)

When cleaning and installing Check if any components are broken, and replace or repair
them if necessary.

As required Perform flow sensor calibration when flow waveform is


unusual.

Replace the filters in the gas inltet module (one year


generally).

Replace O2 sensor (one year generally).

8.1. General principle of maintenance


This chapter provides message needed by Practice 3200 anesthetic machine in term
maintenance. Replace or adjust some components before doing some calibration or
adjustment. If user uses improper components such as improper specification causes
malfunction, our company will not take responsibility. Do not use malfunction device.
Replacement and maintenance should be finished by authorized service engineer or qualified,
trained persons with repairmen experience. After maintenance, the device should be tested
and ensure its normal function and comply with the manufacture’s regulation. Use components
manufactured or sold by our company if replacement is needed, then test and ensure device
comply with the manufacture’s specification. If service support is needed, please call local
service engineer. In any case, the repairmen cost will include the current price and reasonable
personnel cost, but except repairmen items within DIXION company’s warranty.

8.2. Maintenance schedule


Table 8-1

Action After each repair Every 12 months Every 36 months


Check before use X X X
Check before operation √ X X
Check with eyes √ X X
Replace exhausted √ X X
component
Replace O2 sensor √ √ √
Replace/maintenance √ √ X
battery
Function test √ X X
User Manual

CAUTION: Person without repair experience about such device must not repair this device.

CAUTION:According to this schedule to do maintenance timely and replace corresponding

parts.

CAUTION: The recommended repair time interval is 5 years. Breathing system, vaporizer

and parts are recommended to have a comprehensive test and replacement every 5 year.

8.2.1. Appearance checklist

1. Assure the appearance of Practice 3200 no damage, the anesthetic machine can run
normally.
2. Assure absorbent canister install correctly and fill enough soda lime. Assure enough
anesthetic in vaporizer.
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).
6. Assure AC power cable no damage.

129
8.3. Maintenance of O2 sensor

WARNING: Exhausted and old O2 sensor must be treated according to the present local

regulation. Not burn or dispose the O2 sensor casually.

CAUTION: Calibration of O2 sensor please refers to Chapter 5.11.3.1.

8.3.1. Replacement of O2 sensor

Replacement steps of O2 sensor:

1. Pull out O2 sensor from inspiratory valve of breathing system.

2. Pull out O2 sensor cable connection port from O2 sensor.

3. Connect new O2 sensor to cable connection port and install it on inspiratory valve of
breathing system.

8.3.2. Main technical parameter of O2 sensor

CAUTION: Specific parameters refer to the latest published technical data by manufacture.

O2 sensor can be used to detect partial O2 concentration of the anesthetic machine. O2 sensor
belongs to consumptive products, so attentions should be paid to its useful-life.and use as the
characteristics and technical requirements provided by manufacture. Main technical
requirements of O2 sensor in Practice 3200 as follows:
User Manual

Performance parameters:

Maximum input range of interface: 0-500mV DC

Interface form and definition: FCC-68 4 core telephone pin (RJ11-4), see the following
figure.

Output :9-13mV(210mBar O2)

Range :0-1500mBar O2

Signal :100±1(100% O2)

Resolution :1mBar O2

Expected use life-span:1.5x106% O2 hour(in 20℃ circumstance);0.8x106% O2hour(in


40℃circumstance)

Total response time:T90<15s

ZERO signal(N2,+20℃):<200uV

Operation’s temperature range :-20℃~+50℃

Temperature compensation:within 0~40℃ is ±2%

Pressure range:0.5~2.0Bar

Relative humidity range :0~99%(no condensation)

Long-term output excursion:<5%(in 100% O2 circumstance and use more than one year)

Crust Material:White ABS

131
N2O resistance:100% N2O

Valid time:13 months

Complied standard:EN12598/ISO7767

Suggested type and main characteristic parameters


User Manual

8.4. Maintenance of fuse

WARNING: Disconnect AC power before fuse replacement, otherwise, it may cause injury

even death.

WARNING: When fuse replacement, fuse of the same type and size must be used,

otherwise, it can be harmful to the anesthetic machine.

CAUTION: Fuse belongs to damageable assembly, proper force must be used when

replacement.

CAUTION;Use screwdriver to swirl fuse and not use force largely and suddenly, otherwise,

it may cause fuse box broken.

Replacement steps:

Insert screwdriver into groove of the fuse box.

1. Rotate it about 45° counterclockwise, and then pull out fuse holder.
2. Take the fuse.
3. Install new fuse.
4. Pull new fuse to the original position.
5. Rotate it for about 45° with screwdriver clockwise to fix.
6. Connect AC power.

133
8.5. Battery Maintenance
CAUTION: Only service engineer authorized by our company can replace battery. If the
anesthetic machine is not used in a long time, please call service engineer to cut power supply
connection.

CAUTION: The exhausted and old battery must be treated according to present local
regulations.

 Battery configuration

DC24V,4AH,12V leadacid battery, 2 nodes in series.

Use time:8 hours and a half of an hour

 CAUTIONS when use

Charging: when the AC power is connected, the system will charge the battery
automatically, the recommended charging time is no less than 8 hours.

Discharging: when the device uses battery to supply power, normally the work time is 120
minutes.

When the battery’s electric capacity is insufficient, the device will display “Low power”
alarm until power off. When the “Low power” alarm occurs, the user should connect AC
power immediately and avoid the system closes (considering safety, manual startup
should be done to renew operation after the device closes automatically.)

Do not disassembly the battery causally and short battery connection line to avoid danger.

 Battery’s Preservation

If the battery is not used for a long time, it should be preserved after the battery is charged
fully.

When the preservation time exceeds 3 months, charge the battery at least every 3 months.

When preservation, humid and high temperature circumstances must be avoided.

Improper maintenance will cause battery broken, the battery should be replaced
immediately to avoid fluid leak erode device. Call manufacture when replace battery.

 Battery’ removal

Use screw driver to remove the screws of the back cover board, disconnect the battery
module with device to remove battery.
User Manual

8.6. Consumptive components replacement


Since installation, consumptive components names and code in every time dimension as the
table in below:
Consumptive components 6 months 12 months 48 months

Check /replace bellows assembly needless Check Replacement

Check /replace U sealed circuit needless Check Replacement

Check/replace AGSS transmission


needless Check Replacement
tube(optional)

Replace O2 sensor Check Replacement Replacement

135
9. Technical Data

CAUTION: All technical specifications should be updated based on the real state of

Practice 3200 anesthetic machine; no notification will be made if any change happens.

CAUTION:All display values are measured under dry environment and proper pressure.

WARNING: Cylinder valve should be closed during pipeline gas supply, so that gas

shortage can be avoided due to exhausted gas supply or pipeline problems.

9.1. Pneumatic Diagram


Pneumatic system plays the role of supplying O2, N2O, AIR and anesthetic agent to breathing
system, ensuring their pressures are within normal range respectively, so that normal operation
of anesthetic machine and patient’s safety can be guaranteed.
User Manual

Fig.9-1 Practice 3200 Pneumatic Diagram(V1.0)

137
1 Inlet filter 22 Safety valve
2 Pressure gauge 23 PEEP valve
3 Check valve 24 Ambient pressure
4 N2O Pressure regulator 25 Flow sensor
5 AIR Pressure regulator 26 Airway pressure
6 O2 Pressure regulator 27 Sensor board
7 Pressure sensor 28 AGSS
8 Pressure regulator 29 Exhaust valve
9 Pressure regulator 30 Pressure reversing valve
10 Auxiliary breathing O2 31 Bellows
11 Auxiliary supply O2 32 Reversing valve
12 ORC valve 33 APL valve
13 Flowmeter 34 Breathing bag
14 E-flowmeter 35 Flow sampling
15 O2 flush valve 36 Absorber container
16 Suction 37 O2 sensor
17 Check valve 38 Inspiration check valve
18 Vaporizer 39 Expiration check valve
19 Proportional solenoid valve 40 Ventilator
20 Solenoid valve 41 Breathing system
21 Throttle
User Manual

9.2. System technical data

CAUTION:All system gas supplies should be of medical degree.

Gas Supply

Table 9-1

Pipeline Gas O2, N2O,AIR


Pipeline Connection DISS-male,DISS-female,NIST(ISO 5359).
Connectors for each of the gas cannot be interchanged.
Pipeline Input Pressure 280-600kPa(2.8-6bar)
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

9.3. Electrical diagraph


Practice 3200 anesthesia machine can be divided into three parts: UI, drive control and circuit.
UI consists of computer system, auxiliary control circuit, power and etc, which mainly takes
charge of display, alarm, keyboard input and interface expansion. Drive control has BDU as its
core. Exterior sensor, signal processing, amplifier, power and battery are part of drive control
which mainly used for data acquisition and ventilation mode control. UI and drive control should
be connected by cables.

139
Fig.9-2 Electrical Diagraph
User Manual

9.4. Physical data

CAUTION:All physical specifications are of approximate values, no notice can be made if

any change happens.

CAUTION:Do not place Practice 3200 Anesthetic machine in vibrant environment.

CAUTION:Do not put heavy stuff on the top panel or in the drawers.

Table 9-3

Dimensions: 1356mm(H)×845mm(W)×620mm(D)
Weight: 110±5kg(not include vaporizer and
System
backup cylinder)
Top Panel Load: 25kg
Castor 125mm,each front castor with brake

Drawer 130mm(H)×360mm(W)×465mm(D)

Display 8’ 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

141
9.5. Environmental requirement

CAUTION:The anesthetic machine should be stored in draught room where there is no

caustic gas and storing magnetic field.

Table 9-4

Temperature Operation: 10~40℃

Storage: -20 ~ 55℃

Transport -20 ~ 55℃

Relative Humidity Operation: Not more than 80%, non-condensing.

Storage: Not more than 93%, non-condensing.

Transport Not more than 93%, non-condensing.

Operation: 70~106kPa

Atmospheric pressure
Storage: 70~106kPa

Transport 70~106kPa

Power AC100-240V,50Hz/60Hz

Highest Attitude 3200m


User Manual

9.5.1. IEC60601-1:2005 classification

Practice 3200 belongs to this class:

 Class I device

 B type applied part

 Common device/IP21

 Mobile equipment

 not use flammable anesthetic

 Continuousoperation

NOTE:
The applied part of Practice 3200 anesthesia machine is the face mask.
The“quasi applied parts” of Practice 3200 anesthesia machine is IRMA module cable.

9.6. Input and output

NOTE:

1.When the anesthesia 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 all the

anesthesia machine components can work normally.

3.When main power and internal battery both fails, the gas output is not affected.

9.6.1. Electrical

WARNING: IEC60601-1 is applicable to the connections between medical devices, and 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
143
leakage current and temperature and other increased risk may exist, when the device is
connected to the auxiliary socket-outlet.

WARNING:When earth wire has failure, if the device connects with auxiliary power supply,

it may cause patient current leakage exceeding the permitted range

WARNING:If the exterior protective grounded wire has questions during wiring, interior

power supply must be used for device running.

Table 9-5

Supply Voltage 100-240VAC,50/60Hz


Maximum Input Current 8A
AC power fuse F10AH 250VAC,φ5X20(F)
Auxiliary AC power plug 4
Auxiliary AC power plug fuse T2AH 250VAC,φ5X20(T)
Maximum output valve of auxiliary 1.5A(single plug);6A(in total)
AC power plug
Grounded resistance Small than 0.1Ω
User Manual

9.6.2. Pneumatic

Table 9-6

Pipeline supply O2、AIR、N2O


Pipeline connection DISS-male, DISS-female, NIST (ISO 5359)
All fittings used to connect O2, N2O and Air pipeline gas
supply are already.
APL valve 250kPa
Vaporizer connection 2 Selected interfaces
Pressure display Color mark list
Pipeline inlet pressure 280-600kPa

9.6.3. Electromagnetic compatibility

Changing or reassembling this equipment without authorization may cause electromagnetic


compatibility problems. Contact with DIXION for assistance. Designing and testing this
equipment is in accordance with the following stipulations.

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.

Be careful of the following when Practice 3200 is connected:

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 Practice 3200 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.

145
Practice 3200 is equipped with all-purpose alternating current outlet for connecting other
medical equipment. 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.

WARNING: The medical electrical equipment operators contact non-medical electrical

equipment and patients at the same time. It is dangerous for patients or


operators.
User Manual

9.6.4. Guidance and manufacture’s declaration

Guidance and manufacture’s declaration – electromagnetic emissions

-for all equipment and systems

Guidance and manufacture’s declaration – electromagnetic emission

The Practice 3200 Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer of the user of the Practice 3200 Anesthetic machine should
assure that it is used in such and environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions The Practice 3200 anesthetic machine uses RF


energy only for its internal function. Therefore, its
CISPR 11
Group 1 RF emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.

RF emission The Practice 3200 Anesthetic machine is suitable


Class A for use in all establishments, other than domestic
CISPR 11
establishments and those directly connected to
Harmonic emissions the public low-voltage power supply network that
Class A supplies buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations/
flicker emissions Complies

IEC 61000-3-3

147
Guidance and manufacture’s declaration – electromagnetic immunity

–for all equipment and systems

Guidance and manufacture’s declaration – electromagnetic immunity

The Practice 3200 Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Practice 3200 Anesthetic machine should assure
that it is used in such an environment.

IEC 60601 test Electromagnetic


Immunity test Compliance level
level environment - guidance

Electrostatic 6 kV contact 6 kV contact Floors should be wood,


discharge (ESD) concrete or ceramic tile. If
8 kV air 8 kV air
floor are covered with
IEC 61000-4-2
synthetic material, the relative
humidity should be at least
30%.

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.

Surge 1 kV differential 1 kV differential Mains power quality should


mode mode be that of a typical
IEC 61000-4-5
commercial or hospital
2 kV common 2 kV common
environment.
mode mode

Voltage dips, <5% UT <5% UT Mains power quality should


short interruptions be that of a typical
(>95% dip in UT) (>95% dip in UT)
and voltage commercial or hospital
variations on for 0.5 cycle for 0.5 cycle environment. It should be that
power supply the Practice 3200
input lines Anestheticmachine be

40% UT 40% UT powered from an


IEC 61000-4-11
uninterrupted power supply or
(60% dip in UT) (60% dip in UT)
a battery.
User Manual

for 5 cycles for 5 cycles

70% UT 70% UT

(30% dip in UT) (30% dip in UT)

for 25 cycles for 25 cycles

<5% UT <5% UT

(>95% dip in UT) (>95% dip in UT)

for 5 sec for 5 sec

Power frequency 3A/m 3A/m Power frequency magnetic


fields
(50/60Hz)
magnetic field Should be at levels
characteristic of a typical
IEC61000-4-8
location in a typical
commercial or hospital
environment.

NOTICE UT is the a.c. mains voltage prior to application of the test level.

149
Guidance and manufacture’s declaration – electromagnetic immunity

–for equipment and systems that are life-supporting

Guidance and manufacture’s declaration – electromagnetic immunity

The Practice 3200 Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer or the user of Practice 3200 Anesthetic machine should assure
that it is used in such an environment.

Immunity IEC 60601 Compliance


Electromagnetic environment - guidance
test test level level

Portable and mobile RF communications


equipment should be used no closer to any part
of the Practice 3200 Anesthetic machine,
including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.

Recommended separation distance

 3.5 
d  P
 V1 

Conducted
3Vrms 3 Vrms
RF
12 
150 kHz to 80 d  P
IEC V 2 
MHz
61000-4-6
outside ISM
bands a
 12 
10 Vrms d    P 80 MHz to 800 MHz
 E1 

10 Vrms
 23 
d   P 800 MHz to 2.5 GHz
150 kHz to 80  E1 
MHz
Where P is the maximum output power rating of
in ISM bands 10 V/m
the transmitter in watts (W) according to the

Radiated transmitter manufacturer and d is the


User Manual

RF recommended separation distance in metres


(m). b
IEC 10 V/m
61000-4-3 Field strengths from fixed RF transmitters, as
80 MHz to 2.5
determined by an electromagnetic site
GHz c
survey, should be less than the compliance level
in each frequency range.d

Interference may occur in the vicinity of


equipment marked with the following symbol:

NOTICE 1At 80 MHz and 800 MHz, the higher frequency range applies.

NOTICE 2These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

aThe
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 Practice 3200
Anesthetic machine is used exceeds the applicable RF compliance level above, the
Practice 3200 Anesthetic machine should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Practice 3200 Anesthetic machine.

151
d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

9.6.5. Recommended separation distances

Recommended separation distances between portable and mobile

rf communications equipment and the equipment or system

–for equipment or system that are not life-supporting

Recommended separation distances between

portable and mobile RF communications equipment and the Practice 3200 Anesthetic
machine

The Practice 3200 Anesthetic machine is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the Practice 3200
Anesthetic machine can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
Practice 3200 Anesthetic machine as recommended below, according to the maximum output
power of the communications equipment.

Separation distance according to frequency of transmitter(m)

150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5


Rated
MHz MHz MHz GHz
maximum
output power outside ISM in ISM bands
 12   23 
of transmitter bands d   P d   P
 E1   E1 
12 
(W) d  P
 3.5  V 2 
d   P
 V1 

0.01 0.1167 0.1200 0.1200 0.2300

0.1 0.3689 0.3795 0.3795 0.7273

1 1.1667 1.2000 1.2000 2.3200

10 3.6893 3.7947 3.7947 7.2732


User Manual

100 11.6667 12.0000 12.0000 23.0000

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 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 3 An additional factor of 10/3 is used in calculating the recommended separation


distance for transmitters in the ISM frequency bands between 150kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas.

NOTICE 4 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

153
9.6.6. Compliance correction

In all of 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.

The anesthesia 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.

The VT set is delivered during the first breath.

ΔP is calculated from end-expiratory pressure (P1) and end-inspiratory pressure(P2).

Csys: the system compliance.

Figure11-3 Pressure values

Having the system compliance (Csys) and ΔP, Anesthesia machine can calculate which
volume (ΔV) has been "consumed" by the system, or, in other words, which volume has not
been delivered to patient.

ΔV = Csys x ΔP

The anesthesia machine increases the volume to be delivered by the value ΔV.

VTcorr = 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.
User Manual

9.7. Anesthetic ventilator technical specifications

9.7.1. Anesthetic ventilator performance

Table 9-8

Maximum Inspiratory 80cmH2O


Pressure
Noise of the Whole Work normally(not including alarm),no more than 60dB(A)
Machine
Warm-up Time ≥5min
MV Max 20L/min
Inspiratory Flow Max 75L/min
Pressure Transmission 5-80cmH2O
Range

155
9.7.2. Ventilation parameter

Table 9-9

Item Range Steppin Default Value Remark


g
Vt 20-1500mL 10mL 120mL ( Child 20-100mL,error is ±20mL;
); 100-1500mL,error is ±20%
500mL ( Adult

Freq. -100, 1bpm 20bpm ( Child error is ±1bpm or ±5% ,
2-100bpm(SIMV), ); choose the maximum one

2-60bpm(SPONT) 12bpm ( Adult



I:E 4:1-1:8 0.5 1:2 Have this function in IPPV,
PLV mode, error is ±15%
TINSP 0.2-5.0s 0.1sec 1sec(Child); Have this function in SIMV
2sec(Adult) mode,error is ±10% or 0.1s,
choose the maximum one
PEEP OFF,0-30cmH2O 1cmH2 OFF Monitoring error is ±2cmH2O
O or ±20% , choose the
maximum one.
FreqMIN 2-60bpm 1bpm 4bpm(Child) Have this function in SPONT
; mode
2bpm(Adult)
TP OFF,5%-60% 5% 10% Have this function in IPPV、
SIMV mode,error is ±30% of
the setting or ±0.05s,choose
the maximum one
Trigger 1-15L/min 1L/min 2L/min ( Child Have this function in SIMV、
); SPONT mode ,error is ±20%
3L/min ( Adult or ±1.3L/min , choose the
) maximum one
Plimit 5-70cmH2O 1cmH2 10cmH2O(Child Have this function in PLV.
O ); 20cmH2O
9.7.3. Gas dynamics

Table 9-10

Gas source Anesthetic system


Gas component O2
Rating supply pressure 400kPa
Inlet pressure range 280kPa ~ 600kPa
Flow valve range 5~75L/min
Output1 Pressure range: 0 ~ 8kPa;Flow range: 0 ~ 75L/min

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.

Item Standard Requirment Test Result


Expiratory impedence <0.6kPa 0.51
under manual condition

Inpiratoryimpedence <0.6kPa 0.39


under manual condition

Expiratory impedence <0.6kPa 0.57


under automatic condition

Inpiratoryimpedence <0.6kPa 0.22


under automatic condition
9.7.4. Monitor performance

Table 9-12

Item Range Stepping Accuracy


Vt 0 - 3200mL 1mL 20-100mL , error is ±20mL ;
100-3200mL,error is ±20%
Freq. 0 - 110bpm 1bpm 1bpm
PEAK -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
MEAN -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
PLAT -20 - 99cmH2O 1cmH2O ±5%,at least1cmH2O
FiO2 18 - 100% 1% Error is ±3 % ( concentration
value)
C 0-100mL/cmH2O 1mL/cmH2O Error is 20% or 5mL/ cmH2O,
0-99 mL/cmH2O choose the maximum one
(7600A)
PEEP -20 - 99cmH2O 1cmH2O 2cmH2O
PAW -20-99cmH2O 1cmH2O Error is±3cmH2O or ±10% ,
choose the maximum one
100%,75%,50%,25%,0%。
When battery is used to supply power, this sign displays available
Battery voltage state
remaining electric voltage.
display
When the vehicle is connected with AC power, this sign means
charging.
Pressure monitor range: 0 - 80cmH2O.According to different airway
pressure, gain the wave form displays is different.
0 ~ 10cmH2O,pressure axis gain: 5cmH2O
Paw-t wave form 0 ~30cmH2O,pressure axis gain: 10cmH2O
0 ~80cmH2O,pressure axis gain: 20cmH2O
Time axis is a fixed range.(the axises of Flow-t,Paw-t is same.):
When gas module is opened,0 ~15s;Gas module is closed, 0 ~20s.
Display range of flow rate: -90 - 90L/min,gain :45L/min. On time axis,
the positive axes stands for inspiratory direction; under the time axis,
Flow-t Wave form
the negative axes stands for expiratory direction. Flow rate is 0L/min,
which means no gas flow rate in airway.
CO2 display range is 0 - 76mmHg,gain is 38mmHg。
CO2 time wave form Time axis is a fixed range.
When gas module is opened,0 ~15s;Gas module is closed, 0 ~20s.
Horizontal abscissa displays Paw:fixed range :-20~ 80cmH2O,gain
P/V Loop is 20cmH2O。
Vertical abscissa displays tidal Volume:fixed range is 0~ 1500ml,gain
User Manual

is 250ml.
Horizontal abscissa displays tidal Volume: -1400 ~ 0mL,gain is
700mL.
F/V Loop Vertical abscissa stands for Flow:fixed range :-90 - 90L/min,gain is
45L/min ; The positive axes stands for aspiratory flow rate, the
negative axes stands for expiratory flow.

9.8. O2 sensor specification


Table 9-13

Response time No more than 15s.


Sensor type Chemical fuel battery
Antipated battery Normal operation period is 12 months.
life-span
O2 monitor monitors and displays O2 concentration in the patient
loop. O2 sensor accessory includes one O2 sensor. This sensor can
produce a voltage proportional with O2 partial pressure in its detected
surface and its metal electrode will exhaust gradually in the process
of oxidation.

O2 sensor is an electrochemical appliance (chemical battery). O2


diffuses into this device by penetrating a membrane to make the
metallic electrode oxidizing. In this process, electric current occurs,
Operating principle of which matches with partial pressure of oxygen displayed by electrode
O2 monitor sensor.

The sensor’s voltage is influenced by the temperature of monitoring


gas blender. The thermostat outside of the sensor can compensate
the temperature change in sensor.

O2 monitor uses signal to deal and analyze circuit, transforming the


sensor signal to corresponding oxygen percentage value.
The system displays this value and compares it with the saved alarm
extremes. If this value exceeds the extremes, the monitor will send
alarm.

159
9.9. Gas monitoring module technical specifications
The gas monitoring module is used to connect other medical devices, provide monitor data,
monitor and display CO2, N2O and 5 anaesthetic gases (halothane, isoflurane, enflurane,
sevoflurane, desflurane).

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.

CAUTION: Gas monitoring module complies with ISO 80601-2-55:2011.

9.9.1. MAC calculation of IRMA/ISA gas analyzer

Algorithms used in the host monitor to determine MAC values

Minimum alveolar concentration (MAC) is a standard for comparing the potency of inhalation
anesthetics. The MAC value represents the alveolar concentration of an anesthetic (at one
atmosphere) that, in 50 percent of a tested population, prevents gross muscular movement in
response to a painful, standardized stimulus.

If a mechanism to determine MAC values is implemented in the host device, the algorithms
used for this calculation must be adequately documented.

The MAC value may be calculated and displayed by using end-tidal (Et) gas concentrations
according to the following formula:
9.9.2. Mainstream gas monitoring module

Table 9-14

IRMA CO2 / AX+


Model

Interface type RS232,9600bps

Accessories Airway adapter, disposable.

Working principle of The gas module is a mainstream gas monitoring module, connecting
gas module to patient to monitor gas concentration of breath.

The gas module can be used for adults, children and infants.

The gas module uses infrared technology, which determines gas


concentrations by measuring 10 different wavelengths according to
different absorption of gases to different ray.
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 temperature IRMA CO2: 0-40℃, 32-104℉

IRMA AX+: 10-40℃, 50-104℉

Storage and -20-50℃,-4-122℉


transportation
IRMA CO2: -40-75℃, -40-167℉
temperature
IRMA AX+: -20-75℃, -4-167℉

Operating humidity 10-95%RH, no condensation

Storage and 5-100%RH, condensation1)


transportation humidity

Operating atmospheric IRMA CO2:


pressure
525-1200hPa(525 hPa corresponding to an altitude of
4572m/15000feet)

IRMA AX+:

700-1200hPa(700 hPa corresponding to an altitude of


3048m/10000feet )

Storage and 500-1200hPa


transportation pressure

Mechanical strength Withstands Repeated 1.8m drops on a hard surface.


User Manual

Complies with requirements for road ambulances according to


prEN1789 (clause 6.4) and requirements for shock and vibration
according to ISO 80601-2-55:2011 (clause 201.15.3.5.101,
transport).

Power supply IRMA CO2:

4.5-5.5VDC, Max 1.0W

(power on surge @ 5V less than 350mA during 200ms)

IRMA AX+:

4.5-5.5VDC, Max1.4W

(power on surge @ 5V less than 350mA during 200ms)

Surface temperature (at IRMA CO2:


ambient temperature
Max41℃/106℉
23℃)
IRMA AX+:

Max 50℃/122℉

Interface Modified RS-232 serial interface operating at 9600bps

Airway adapter Disposable adult/child:

Adds less than 6mL deadspace;

Pressure drop less than 0.3cmH2O @ 30LPM.

Disposable infant:

Adds less than 1mL deadspace;

Pressure drop less than 1.3cmH2O @ 10LPM.

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.

The humidity range 50-100% is valid for the temperature range -40 - 40℃.

Table 9-16

163
Data Output

Fiand 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;

IRMA CO2: within 10s;

IRMA 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
User Manual

Table 9-18

Accuracy specifications - standard conditions

Range1)

Gas CO2 AX+ Accuracy

CO2 0-15 0-10 ± (0.2vol%+2% of reading)

10-15 ± (0.3vol%+2% of reading)

15-25 15-25 Unspecified

N2O -- 0-100 ± (2vol%+2% of reading)

HAL,ISO,ENF -- 0-8 ± (0.15vol%+5% of reading)

8-12

SEV -- 0-10 ± (0.15vol%+5% of reading)

10-15

DES -- 0-22 ± (0.15vol%+5% of reading)

22-25

NOTE 1: Gas concentration reported in units of volume percent.

Table 9-19

Accuracy specifications –all conditions1)

Gas Accuracy

CO2 ± (0.3vol%+4% of reading)

N2O ± (2vol%+5% of reading)

Agents2) ± (0.2vol%+10% of reading)

165
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 more than two agents are

present in the gas mixture.

Table 9-20

Interference gas and vapor effects

Gas or vapor Gas CO2 Agents N2O


level
IRMA CO2 IRMA AX+

N2O3) 60 vol% --1) --1) --1) --1)

HAL3) 4vol% --1) --1) --1) --1)

ENF,ISO,SEV3) 5vol% +8% of reading2) --1) --1) --1)

DES3) 15vol% +12% of reading2) --1) --1) --1)

Xe(Xenon) 3) 80vol% -10% of reading2) --1) --1) --1)

Xe(Helium) 3) 50vol% -6% of reading2) --1) --1) --1)

Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants3)

C2H5OH(Ethanol) 3) 0.3vol% --1) --1) --1) --1)

C3H7OH(Isopropan 0.5 vol% --1) --1) --1) --1)


ol) 3)

CH3COCH3(Aceton 1 vol% --1) --1) --1) --1)


e) 3)

CH4(Methane) 3) 3 vol% --1) --1) --1) --1)

CO(Carbon 1 vol% --1) --1) --1) --1)


User Manual

monoxide) 3)

NO(Nitrogen 0.02 vol% --1) --1) --1) --1)


monoxide)3)

O23) 100 vol% --1) --1) --1) --1)

NOTE 1: Negligible interference, effect included in the specification “Accuracy, all

conditions” above.

NOTE 2: Interference at indicated gas level. For example, 50vol% helium typically

decreases the CO2 readings by 6%. This means that if measuring on 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.

NOTE 3: According to the ISO 80601-2-55:2011.

167
9.9.3. Sidetream gas monitoring module

Table 9-21

ISA CO2 / AX+


Model

Interface type RS232, 9600bps

Accessories Sampling tube, CO2 oranesthetic gas Water trap, disposable.

Working principle of The gas module is a sidestream gas monitoring module, connecting
gas module to patient to monitor gas concentration of breath by electrical
machine inhaling trace gas.

The gas module can be used for adults, children and infants.

The gas module uses infrared technology, which determines gas


concentrations by measuring 10 different wavelengths according to
different absorption of gases to different ray.
User Manual

Table 9-22

Basic Configuration

Description Ultra-compact, low-flow sidestream gas analyzers with integrated


pump, zeroing valve and flow controller.

Dimension(W×D×H) ISA CO2/ AX+:

23×62×38mm(0.9″×2.4″× 1.5″)

Weight 75g

Operating temprature ISA CO2: 0-50℃, 32-122℉

ISA AX+: 5-50℃, 41-122℉

Storage and -40-70℃,-40-158℉


transportation
temperature

Operating humidity
<4kPa H2O(no condensation)

(95%RH at 30℃)

Storage and 5-100%RH(condensation)1)


transportation humidity
(100%RH at 40℃)

Operating atmospheric 52.5-120kPa(corresponding to a max altitude of 5211m/17100feet)


pressure

Storage and 20-120 kPa (corresponding to a max altitude of 11760m/38600feet)


transportation pressure

Ambient CO2 ≤800ppm

Mechanical strength ISA CO2:

Meets the shock and vibration requirements for transport of ISO


80601-2-55:2011 (clause 201.15.3.5.101.2) and EN 1789-2007
(clause6.3.4.2).

169
ISA OR+/AX+:

Meets the shock and vibration requirements for transport of ISO


80601-2-55:2011 (clause 201.15.3.5.101.1)

Power supply 4.5-5.5VDC,

ISA CO2: <1.4W(normal op.), <1.8W(peak @5VDC)

ISA AX+: <1.6W(normal op.), <2.0W(peak @5VDC)

Interface Modified RS-232 serial interface.

Software upgrade possible using the RS-232 serial interface.

Water handling Nomoline Family sampling line with proprietrary water removal
tubing.

Sampling flow rate 50±10mL/min

NOTE 1: After condensation, the unit shall be stored for more than 24 hours in an

environment with relative moisture content below 95%RH (non-condensing).

Table 9-23

Data Output

Fiand ET3 Fiand ET are displayed after one breath and have a continuously
updated breath average.

ET will typically decrease below nominal value (ETnom) when


respiration rate (RR) exceeds the RR threshold (RRth) according to the
following formulas:

ET=ETnom×(125/RR) for RRth>125

N2O, O2, DES, ENF, ISO, SEV


User Manual

HAL

Automatic agent ISA OR+/AX+: Primary and secondary agent.


identification

Table 9-24

Gas Analyzer

Sensor head 2-9 channel NDIR type gas analyzer measuring at 4-10 μm.

Calibration No span calibration is required for the IR bench. An automatic zero


reference calibration is performed at startup and then every 24 hours1.

Warm-up Time ISA CO2: <10s(concentrations reported and full accuracy)

ISA AX+: <20s(concentrations reported, automatic agent identification


enabled and full accuracy)

Rise time
≤200 ms
(@10L/min)

≤300 ms

N2O, O2, ENF, ISO ,SEV, DES ≤400 ms

HAL ≤500 ms

Agent identification <20s (typically<10s)


time

Total system <3s(with 2m sampling line)


response time

Table 9-25

The following accuracy specifications are valid for dry, single gases at 22±5℃ and 1013±40
hPa.

Accuracy specifications - standard conditions

Gas Range Accuracy

171
CO2 0-15% ± (0.2vol%+2% of reading)

15-25% Unspecified

N2O 0-100% ± (2vol%+2% of reading)

HAL,ISO,ENF 0-8 % ± (0.15vol%+5% of reading)

8-25% Unspecified

SEV 0-10% ± (0.15vol%+5% of reading)


Unspecified
10-25%

DES 0-22% ± (0.15vol%+5% of reading)


Unspecified
22-25%

Table 9-26

Accuracy specifications – all conditions

Gas Accuracy

CO2 ± (0.3vol%+4% of reading)

N2O ± (2vol%+5% of reading)

Agents1) ± (0.2vol%+10% of reading)

NOTE 1: The accuracy specification is not valid if more than two agents are present in the

gas mixture. If more than two agents are present, an alarm will be set.

Table 9-27

Interference gas and vapor effects

Gas or vapor Gas CO2 Agents N2O


level
ISA CO2 ISA AX+

N2O4) 60 vol% --2) --1) --1) --1)

HAL4) 4vol% --1) --1) --1) --1)


User Manual

ENF,ISO,SEV4) 5vol% +8% of reading3) --1) --1) --1)

DES4) 15vol% +12% of reading3) --1) --1) --1)

Xe(Xenon) 4) 80vol% -10% of reading3) --1) --1) --1)

Xe(Helium) 4) 50vol% -6% of reading3) --1) --1) --1)

Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants4)

C2H5OH(Ethanol) 4) 0.3vol% --1) --1) --1) --1)

C3H7OH(Isopropan 0.5 vol% --1) --1) --1) --1)


ol) 4)

CH3COCH3(Aceton 1 vol% --1) --1) --1) --1)


e) 4)

CH4(Methane) 4) 3 vol% --1) --1) --1) --1)

CO(Carbon 1 vol% --1) --1) --1) --1)


monoxide) 4)

NO(Nitrogen 0.02 vol% --1) --1) --1) --1)


monoxide)4)

O24) 100 vol% --1) --1) --1) --1)

NOTE 1: Negligible interference, effect included in the specification “Accuracy, all

conditions” above.

NOTE 2: Negligible interference with N2O/O2 concentrations correctly set, effect included in

the specification “Accuracyspecifications- all conditions” above.

NOTE 3: Interference at indicated gas level. For example, 50vol% helium typically

decreases the CO2 readings by 6%. This means that if measuring on 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.

173
NOTE 4: According to the ISO 80601-2-55:2011.

10. Appendix
Function Type

&parameter Practice 3200

Gas supply O2 , N2O,Air

280kPa~600kPa

O2 flush 25 L/min~75 L/min

Vt(mL) 20mL~1500mL

Freq(BPM SPONT:2~60,

SIMV: 2~100

Other modes:4~100

I:E 4:1~1:8

Airway pressure Set 10cmH2O~


upper limit 100cmH2O
Alarm

Airway pressure Set: 0~70cmH2O


lower limit Alarm

Mode Standby, Manual, IPPV,


PLV, SIMV , SPONT

Compliance 0mL/cmH2O~
monitor 100mL/cmH2O

Touch-screen Optional

Flow trigger Standard


User Manual

Flow meter 6 tubes

Knob Standard

ACGO Optional

Loop Standard

AGSS Optional

10.1. Accessories List

No. Part No. Configuration Name Specification


1. 122002919 Optional AGSS AP1000
2. 122000048 Standard O2 Pipeline (white) M22×1.5 , Φ11.5
3. 122000049 Standard N2O Pipeline(blue) connecter , Φ9.5
M22×1.5
4. 122000050 Standard Air Pipeline(black) connecter , Φ9
M22×1.5
5. 232000311 Standard FACE MASK(PVC) XL(4#)
connecter
6. 232000312 Standard Anesthesia Breathing Circuit ADULT
7. 232000075 Standard Bag(3L) 3L
8. 232000076 Standard Breathing Bag(2L) 2L
9. 121000065 Optional Adult Silicon Breathing Circuit package
10. 232000538 Optional Adult Silicon Hose package l=1000mm,Φ22
11. 232000163 Optional Adult Silicon FACE MASK PN-0007AM(4#)
12. 232000113 Optional Elbow Male and female
13. 232000101 Optional Y Piece Φ22, Φ15cone
cone Φ22
14. 132000798 Optional Straight connector Φ22 male cone
15. 240000415 Optional IRMA_CO2 module IRMA CO2
16. 240000414 Optional IRMA_AX+ gas module IRMA_AX+
17. 210001975 Optional O2 sensor MOX-4
18. 122000831 Optional Wean PVC Breathing Circuit package

19. 240000028 Optional WeanAnesthesia Breathing Wean

20. 122003285 Optional Wean


Circuit Silicon Breathing Circuit package
21. 232000066 Optional FACE MASK ( PVC) HX.O11 M(2#)
175
22. 232000539 Optional Wean Silicon Hose package l=1000mm,Φ15

DIXION VERTRIEB MEDIZINISCHER GERÄTE GMBH


Couvenstr. 6, 40211, Dusseldorf, Germany

Tel: +4921138838868, Fax: +4921138838697

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