Professional Documents
Culture Documents
Anesthetic machine
Practice 3200
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:
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:
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
DIXION is not responsible for the security; reliability and operating condition of this product in
case that:
Return
Follow the steps below in case that the product needs to be returned to DIXION:
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
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
P.C.: 40211
Tel.: +4921138838868
E-mail: info@dixion.de
User Manual
1. Product Description
This manual introduces Practice 3200 Anesthetic Machine.
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.
5
1.2. Symbols
The following table provides descriptions of symbols that are used on the device and/or within
this manual.
Dangerous voltage
Earth (ground)
Equipotentiality
Date of manufacture
User Manual
Do not reuse
Use by
Batch code
Temperature limitation
Type B equipment
Manufacturer
Catalogue number
Serial number
7
Rotation in two directions
Lock
Unlock
Insp. flow
Exp. flow
O2 flush O2+
Fuse
Recycle
Alarm icon
9
1.3. Abbreviations
Abbreviation Definition
C compliance
Des. Desflurane
Enf. Enflurane
Flow flow
Freq Frequency
User Manual
Hal. Halothane
Iso. Isoflurane
L iter
11
M
mL Mill Liter
MV minute volume
O2 oxygen
Pb plumbum
S
User Manual
Sev. Sevoflurane
VT tidal volume
ΔP Differential Pressure
13
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 Anesthetic machine must and can only be serviced by DIXION’s
WARNING: Do not use the machine if any test failures. Contact DIXION’s authorized
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
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
WARNING: Do not incline the machine at the angle of more than 10 degree.
WARNING:Do not service or maintain Practice 3200 Anesthesia machine while it is in use
WARNING: Remove all equipment on the top cover before moving the machine. Use the
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.
15
WARNING: Remove all the equipments attached at the flank of the machine before
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
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).
and isoflurane, which are compatible to other gas are allowed to use in anesthetic system.
User Manual
WARNING: Possible electric shock hazard. The machine may only be opened by DIXION
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
WARNING: Malfunction of the central gas supply system may cause more than one or
WARNING: Use a cleaning and disinfect schedule that confirms to your institution’s
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.
17
WARNING: All gas supplies should be of medical grade.
WARNING: After the device replacement is finished, all calibrations must be done again
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
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
CAUTION: If the machine does not function as described, it must be examined and repaired
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
CAUTION: After servicing, all calibrations must be performed again and only the
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,
19
2. Components
2.1. Configuration
Standard configuration: Mainframe,bellows, Breathing system, flow meter, anesthetic
ventilator, battery.
21
No. Name No. Name
1 Flowmeter 7 O2 flush
2 Bellows 8 AGSS
Counterclockwise rotation of
Flowmeter flowmeter rotary knob
3 Rotary increases the flow; clockwise
Knob rotation of flowmeter rotary
knob decreases the flow.
23
2.3. Side View
1 Slot 2 AGSS
User Manual
25
No. Name No. Name
CAUTION: Any adult anesthetic ventilator system used together with the
Mainly function: store anesthetic gas and O2, exhaust gas, absorb CO2, connect with breathing
airway directly and assist to operate breathing.
27
Figure3-4 the breathing system components function control
Figure 3-6C•G•O
29
2.5.3. Ventilating circulation
4 Pressure-relief valve
5 To patient circuit
User Manual
WARNING: Keep all inlets/cables away from the APL valve, and do not put lines/ cables
underneath the APL valve in order to adjust the APL valve smoothly.
CAUTION: The APL valve is automatically excluded from the breathing system whenever
APL valve has two functions; one is that it limits the maximum pressure during manual
ventilation; the other is that the airway pressure can be exhausted quickly by lifting the APL
valve.
The APL valve has a labeled knob for selecting between 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.
31
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
WARNING: Only dry gas of medical degree can be used on the vaporizer. Any improper
WARNING: The vaporizer should be placed vertically at the vaporizer mounting manifold.
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.
1 window 5 floater
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
33
CAUTION: If the AGSS used together with anesthesia system is produced by other
CAUTION: For more operating and maintaining information of AGSS, refer to AP1000 User
Manual.
2.8. O2 flush
Figure2-10
WARNING: The anesthesia breathing machine used together with anesthesia system
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
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:
Gas: O2.
CAUTION: The anesthesia ventilator which is used with the anesthetic system complies
37
3.1.1. The Interface layout without anesthesia gas monitoring
User Manual
monitoring
39
3.2. Information of the main interface
3.2.1.2. There are four states for mode button as shown below:
Name description 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:
41
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;
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).
43
3.2.5. Waveform display area
Waveform display area is located in the center of the screen, including waveform and breathing
loop.
Pressure-time
waveform(Paw-t)
Velocity-time waveform
(Flow-t)
(CO2-t)
Pressure-Volume
User Manual
Flow-Volume
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.
45
3.2.7. Patient parameter monitoring area
The shortcut key area includes shortcuts to alarm settings, system settings, calibration,
engineer mode, gas setting and breathing loop.
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.
47
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
Step 1
Step 2
Step 4
Step 5
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.
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.
Only air, oxygen, carbon monoxide, halothane, enflurane, isoflurane, sevoflurane and
desflurane can be used for the absorber.
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.
Turn clockwise the absorber and then disconnected it according to the explanation on the
absorber.
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.
53
4.2.4. Oxygen sensor connection
Step 1:
Step 2:
Step 3:
module (optional)
CAUTION: The anesthetic gas/CO2 monitoring module has mainstream and side stream.
55
Step 1:
Step 2:
Step 3:
Step 4:
Step 2:
Step 3:
57
Step 4:
CAUTION: Make sure AP1000 installs at a place where operator can get a clear view of
it.
CAUTION: Make sure good connection in case of anesthesia gas leaks to operating
room.
Step 1:
Step 2:
Step 3:
Step 4:
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
WARNING: Make sure that the breathing system is in good connection and with no
damage.
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.
61
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
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
Manual.(Material No.:13200)
Ventilator Vt:700mL
Freq.:20
I:E:1:2
PAW-High:40cmH2O
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.
63
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:
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.
CAUTION: The switch of the patient type is only allowed in STANDBY mode.
67
5.4. Ventilation Mode
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
5.4.1.4. SPONT
FreqMIN, Trigger,
69
5.4.2. Parameter and adjustment scope of ventilation mode
VT mL 20~1500 500 10
User Manual
TP % OFF,5~60 10 5
VT mL 20~300 120 10
TP % OFF,5~60 10 5
71
5.4.3. Ventilation Mode Setting
The user can select the ventilation mode according to the patient’s actual situation.
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
73
Turn the knob to adjust the
wanted parameter value.
CAUTION: When selected, a short cut key will display the selected menu. When Normal is
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
图 5-40
User Manual
图 5-42
5-43
77
5.5.3. System setting
Data: YYYY/MM/DD
79
Air drive: Open air drive, the drive
bellow’ gas is switched from O2 to air.
5.5.4. Calibration
42
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
81
The oxygen sensor calibration
calibrates the oxygen sensor at
21% oxygen concentration.
42
44
If the calibration fails, the interface
will display “Calibration Failed”.
45
图 5-55
83
2. Two notices appears, follow the
notice to operate.
NOTE: Perform the Leak Test prior to the Compliance Test when starting the system test.
85
5.5.4.4. CO2 module calibration
87
5.5.4.5. Leak Test
Press “Leak Test” knob to enter
the calibration menu.
89
Press “Start”, the screen seen as the right
picture appears.
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.
91
5.5.5.2. CO2 unit
CO2 monitor parameter and wave have two units: mmHg and %. The user can select the
needed one.
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.
“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
95
Flow-Volume (Before save reference)
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
CAUTION: If alarm occurs, the patient’s safety must be protected firstly, then do
CAUTION: When several alarms occur at the same time, alarm message only displays the
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
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
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
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.
Pressure:PLAT
User Manual
Table 6-2
Low gas supply High Drive gas pressure is less Check pipeline gas supply and
pressure than 2.9psi±15% replace pipeline.
101
Alarm Name Priority Cause Remedy
Monitor O2
concentration≥10%, cancel
the alarm immediately.
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.
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
Gas module High Pull out adapter probe in Call service Rep.
probe failure gas module for several
seconds.
module communication
failures or interior error in
gas module, the alarm
message will not occur.
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.
module communication
failures or interior error in
gas module or gas module
probe is disabling, the
alarm message will not
appear.
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
BDU EEPROM data fail Incorrect calibration in EEPROM Call service Rep.
check
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.
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.
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
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.
111
No. Message Cause Remedy
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.
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;
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
25. No air supply 1.Comm pressed air supply 1.Open optional backup air
has failed; supply;
26. No N2O supply 1.N2O supply has failed; 1. Open N2O backup cylinder;
113
No. Message Cause Remedy
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.
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.
2. Adequate substitute
monitoring must be ensured if
pressure and volume monitoring
has failed.
115
7. Cleaning and Disinfecting
Wear safety gloves and safety goggles. The O2 sensor may leak and
burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.
Never use any abrasive agent to clean any of the components (i.e.
Steel wool, silver polish or agent).
WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been used to
prevent tackiness could contaminate a patient’s lung or esophagus, causing
injury.
CAUTION: Never immerse the circuit O2 sensor or flow sensor connector in the
liquid.
Do not clean the inner surface of the flow sensor. Clean the outer
surface by using a damp cloth.
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.
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.
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
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
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.
Immerse the absorber completely in the sink with water and agent about three minutes at a
temperature of 40 ℃.
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
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.
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.
121
7.5.1. Disassembling
(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.
6 Push the locking spring to the center, and then remove the rim.
pressure relief valve. This can distort the seat or diaphragm and
cause injury to the patient.
WARNING: Do not use any object small enough to slip completely into the
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.
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.
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.
2. Disinfecting
Cleaning and disinfecting must be performed at the same time. Follow instructions for the
common bellows assembly disinfection methods.
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.
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:
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
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
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
WARNING: Moving part and removable elements is in danger of jamming hands or crush.
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
Ventilate the system, open flow meter, and make sure that
the float move up and down smoothly. It can prevent
blocking and clinging.
When cleaning and installing Check if any components are broken, and replace or repair
them if necessary.
CAUTION: Person without repair experience about such device must not repair this device.
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.
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
3. Connect new O2 sensor to cable connection port and install it on inspiratory valve of
breathing system.
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:
Interface form and definition: FCC-68 4 core telephone pin (RJ11-4), see the following
figure.
Range :0-1500mBar O2
Resolution :1mBar O2
ZERO signal(N2,+20℃):<200uV
Pressure range:0.5~2.0Bar
Long-term output excursion:<5%(in 100% O2 circumstance and use more than one year)
131
N2O resistance:100% N2O
Complied standard:EN12598/ISO7767
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,
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,
Replacement steps:
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
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.
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
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
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
Gas Supply
Table 9-1
Table 9-2
139
Fig.9-2 Electrical Diagraph
User Manual
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)
141
9.5. Environmental requirement
Table 9-4
Operation: 70~106kPa
Atmospheric pressure
Storage: 70~106kPa
Transport 70~106kPa
Power AC100-240V,50Hz/60Hz
Class I device
Common device/IP21
Mobile equipment
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.
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
3.When main power and internal battery both fails, the gas output is not affected.
9.6.1. Electrical
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,
WARNING:If the exterior protective grounded wire has questions during wiring, interior
Table 9-5
9.6.2. Pneumatic
Table 9-6
WARNING:Using cell phone or other radio radiant equipment near this product may cause
Using other electrical equipment in this system or nearby may cause interference. Check if the
equipment works normally in these conditions before using on a patient.
Do not put any object which is not in accordance with EN60601-1 in the 1.5M range of patients.
An isolated transformer must be used for alternating current supply (in accordance with
IEC60989), or additional protective ground wires are equipped if all the devices (for medical or
non-medical use) are connected to 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.
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.
Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3
147
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.
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.
70% UT 70% UT
<5% UT <5% UT
NOTICE UT is the a.c. mains voltage prior to application of the test level.
149
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.
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
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.
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.
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 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.
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
Table 9-8
155
9.7.2. Ventilation parameter
Table 9-9
Table 9-10
Label 1:Within rated outlet pressure range and under double maximum rated inlet pressure condition.
Table 9-11
According to ISO8835-2, test under peak flow 60L/min, fresh gas 10L/min.
Table 9-12
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.
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.
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
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.
Basic Configuration
38×37×34mm(1.49″×1.45″× 1.34″)
IRMA AX+:
IRMA AX+:
4.5-5.5VDC, Max1.4W
Max 50℃/122℉
Disposable infant:
NOTE 1: After being in a condensing atmosphere, this module shall be stored for more than
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.
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.
Table 9-18
Range1)
8-12
10-15
22-25
Table 9-19
Gas Accuracy
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
Table 9-20
Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants3)
monoxide) 3)
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.
167
9.9.3. Sidetream gas monitoring module
Table 9-21
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.
Table 9-22
Basic Configuration
23×62×38mm(0.9″×2.4″× 1.5″)
Weight 75g
Operating humidity
<4kPa H2O(no condensation)
(95%RH at 30℃)
169
ISA OR+/AX+:
Water handling Nomoline Family sampling line with proprietrary water removal
tubing.
NOTE 1: After condensation, the unit shall be stored for more than 24 hours in an
Table 9-23
Data Output
Fiand ET3 Fiand ET are displayed after one breath and have a continuously
updated breath average.
HAL
Table 9-24
Gas Analyzer
Sensor head 2-9 channel NDIR type gas analyzer measuring at 4-10 μm.
Rise time
≤200 ms
(@10L/min)
≤300 ms
HAL ≤500 ms
Table 9-25
The following accuracy specifications are valid for dry, single gases at 22±5℃ and 1013±40
hPa.
171
CO2 0-15% ± (0.2vol%+2% of reading)
15-25% Unspecified
8-25% Unspecified
Table 9-26
Gas Accuracy
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
Metered dose Not for use with metered dose inhaler propellants
inhaler
propellants4)
conditions” above.
NOTE 2: Negligible interference with N2O/O2 concentrations correctly set, effect included in
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
280kPa~600kPa
Vt(mL) 20mL~1500mL
Freq(BPM SPONT:2~60,
SIMV: 2~100
Other modes:4~100
I:E 4:1~1:8
Compliance 0mL/cmH2O~
monitor 100mL/cmH2O
Touch-screen Optional
Knob Standard
ACGO Optional
Loop Standard
AGSS Optional