TR 203 Service Manual

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CONTENTS

Intellectual Property Rights 4


Responsibilities of the Manufacturer 5
WARRANTY AND SERVICE 6
Preamble 8

1. SAFETY 10
1.1. SAFETY INFORMATION 10
1.1.1. Hazards 10
1.1.2. General Warnings 10
1.1.3. Usage warnings about patient health 11
1.1.4. Warnings for using the device 11
1.1.5. Other Precautions (Residual Risk) 11
1.2. SYMBOLS USED ON THE DEVICE 12
1.3. SEASONAL SAFETY CHECK 13

2. GENERAL 15
2.1. SCOPE OF USE 15
2.2. CONTRAINDICATIONS 15
2.3. PRODUCT DESCRIPTION 15
2.4. PRODUCT VIEW 15
2.5. ACCESSORIES 16
2.6. Side Effects 17
2.7. Lifetime, Patient Population and Target User 17

3. INSTALLATION 19
3.1. Unpacking 19
3.2. MOUNTING THE BODY TO THE FOOT 19
3.3. FITTING THE LOCATION WITH WHEEL BRAKES 20
3.4. CONNECTION TO EXTERNAL POWER SOURCES 22
3.5. BATTERY CHANGE 22
3.6. LAYOUT OF OXYGEN TUBES 23
3.7. OXYGEN MEASUREMENT SYSTEM CONNECTION 24
3.8. GENERAL OPERATION AND CONTROL OF FUNCTIONS 24
3.9. OPERATIONAL CHECKOUT PROCEDURE 24

4. DESCRIPTION OF THE FUNCTIONS 26


4.1. GENERAL FUNCTIONS 26
4.2. AIR TEMPERATURE MODE 26
4.3. SKIN TEMPERATURE MODE 26
4.4. AIR AND SKIN TEMPERATURE ALARMS 27
4.5. BODY 27
ALARMS ABOUT SYSTEMS 28

5. OPERATING 30
5.1. GENERAL 30
5.2. CONTROLS, INDICATORS AND CONNECTIONS 30
5.3. CONTROLS AND INDICATORS ON THE CONTROL UNIT 31
5.4. OPERATING CONTROL PROCEDURE 35
5.4.1. Checking the Tightness of the Wheels 35
5.4.2. Connecting the AC Power Cord to the Incubator and Checking the Power Failure Alarm 35
5.4.3. Operation Control - Body And Foot 36
5.4.4. Operating Control Control Unit 40

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5.5. GENERAL WORKING PROCEDURES 42
5.5.1. Air Temperature Mode 43
5.5.2. Skin Temperature Mode 43
5.5.1.Moistening 43
5.5.3.Oxygen Administration 44
5.5.4.Setting the Oxygen Limit Value 45
5.5.5.Oxygen Sensor Calibration 45
5.5.6.Use In Ambulant 47

6.CLEANING 48
6.1. GENERAL INFORMATION 48
6.2. CLEANING 48
6.2.1. Removing Parts for Cleaning 48
6.2.2. Cleaning After Removing Parts 50
A. Cleaning Agents 50
B.Skin Temperature Probe 50
C.Hose Access Sections, Access Window and Cuffs and Co 50
D.Control Unit, Dental Front and Moon 50
E.Body and Interior Walls 50
F. Mattress, Dampening Sponge, Mattress Tray and Main 50
G. Air Intake Microfilter 50
H. Transport Table 51
6.2.3. Post-Cleaning Installation 51

7.TECHNICAL INFORMATION 54
7.1. SPECIFICATION 54
7.1.2. TECHNICAL SPECIFICATIONS 54
7.2. EMC TEST REPORT 58
7.3. WORKING PRINCIPLE 62
7.3.1. General 62
7.3.2. Temperature Control 65
7.3.3. Alarms 65

8.MAINTENANCE 70
8.1. INTRODUCTION 70
8.2. REPLACEMENT OF INNER BATTERY AND INNER FUSE 70
8.3.REPLACEMENT OF ILLUMINATION LAMP AND OUTER FUSE 71
8.4. REPLACEMENT OF THE STORAGE BATTERY 71
8.5. Alarm code 72
8.6. Check Flow Chart 74
8.7. Troubleshooting 86

9. MAIN PARTS LIST AND PARTS NUMBER 88


9.1 GENERAL 88

10. DIAGRAMS 108


10.1 GENERAL 108

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TR203 SM-000-01-2020-EN
Document No: TR 203 SM-000-01-2020-EN
Release Date: 15.01.2020
Rev. Date/No: --/00

Notified Body:

KIWA Belgelendirme
Hizmetleri
1984

All rights reserved.

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Intellectual Property Rights

product and this manual. This user manual may contain information that is protected by copyright
or patents and does not bear any licenses in terms of patent rights or copyrights or other rights of

Okuman Medikal Sistemler aims to protect the contents of this user manual as
confidential information. The disclosure of the information contained in this manual is not permitted

The publication, modification, reproduction, distribution, lease, adaptation, translation or any


modifying act of any kind is not permitted without the written permission of Okuman Medikal Anonim

whether registered or not. All other trademarks mentioned in this user guide may be used for
informational or editorial purposes only. All mentioned trademarks are owned by their respective
owners.

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Responsibilities of the Manufacturer
The contents of this manual are subject to change without notice. All information contained in this

responsible for the errors found in this document or for any accidental or related damages related
to the provision, performance or use of this manual.

safety, security and performance of this product if:

If all installation procedures, developments, changes, changes and repairs of this product

The electrical installation of the relevant room complies with appropriate national and local
conditions and;

If the product has been used according to the instructions for use.
ATTENTION
It is important for the hospital or institution using this device to implement a reasonable
service / care plan. Failure to do so may result in machine malfunction or personal injury.
NOTE: This device should be operated by qualified / trained clinical professionals.

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WARRANTY AND SERVICE

Limited Warranty

given against labor and material defects for one (1) years from the date of delivery and cannot be
transferred. In addition, there is a 10 year warranty for all parts for a fee. The service life of the
device is 10 years.

This warranty does not cover consumables (eg LED lamps, etc.) or part breakage / deterioration
due to improper use. The only sanction of this warranty; Replacing or repairing damaged products
during the warranty period. Warranty will not be valid for product modifications made without the

be made by the user on the device, any broken or broken components should be replaced by the
Okuman Medikal Sistemler Authorized Service. In case of intervention by the customer, the seller
will not be responsible for the damages and injuries that may arise directly or indirectly.

Technical Service Support

Repairs of devices under warranty should be carried out at authorized repair centers. If necessary,
the customer can be contacted with local distributors or OKUMAN Technical Service. To get
service support, the model name and serial number of the device must be reported. Technical
Services representatives can be reached for fixations and are dispatched for required maintenance
by calling +90 312 384 05 20.

Note:
In order to improve the devices, the manufacturer reserves the right to make changes to the
product without notice.

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Technical Service Unit
Address: O
Head Office: Kazim Karabekir Caddesi Koyunlu Han 95/95 Iskitler, 06060 ANKARA-TURKEY
Mail: [email protected]
Telephone: +90 312 384 0520
Fax: +90 312 384 1975

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Preamble

Purpose of the Guide


This manual contains instructions for servicing the product safely and according to its function
and intended use. Following this guide is a prerequisite for proper product performance and
correct operation, and ensures the safety of the patient and the operator.
This guide is based on the maximum configuration, so some content may not fit your product. If
you have questions, please contact us.
This guide is an integral part of the product. It should always be kept close to the device so it
can be easily accessed if necessary.
Figures
All figures in this manual serve as examples only. It may not reflect the setups or data shown on
your device.
Writing Styles

In this manual, italic texts are used to transfer the referenced sections or parts.

[ ] is used to cover display texts.

is used to specify operating procedures.


Password
A technical service password is required to access some menus.

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FOR YOUR NOTES

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1. SAFETY
TR203 Transport Incubator is the brand of Okuman Medikal Sistemler and it is
designed to be used in situations where low-weight infants need to be transferred. The user is
responsible for the consequences arising from the use of the device outside of its usage areas.
1.1. SAFETY INFORMATION

DANGER
Indicates possible hazards that, if not avoided, will result in death, serious injury or property loss.
WARNINGS
Indicates potential hazards or unsafe operation that, if not avoided, will result in death, serious
injury or property loss.
WARNINGS
Indicates potential hazards or unsafe operations that, if not avoided, may result in minor worker
injuries and / or product / property damage.
NOTE: Emphasizes important measures to be taken and explicitly provides for better use of the
product.
1.1.1. Hazards

given in the relevant sections of this user manual.


1.1.2. General Warnings
Privacy Information: Intellectual Property Rights of any information contained in the User's
Guide belong to Okuman Medikal Sistemler This user manual may not be
reproduced in any way without the consent of Okuman Medikal Sistemler
Maintenance and Repair: Maintenance and repair of TR203 Transport Incubator will be
made only by Okuman Medikal Sistemler Okuman Medikal Sistemler Anonim
is not responsible for any injury or malfunction in the maintenance not performed by
Okuman Medikal Sistemler and the device is out of warranty.
User Responsibility: Using the device without fully understanding its features may cause
injury to the treated baby. For this reason, the user manual must be read carefully before
using the device.
Transport Incubator should only be used by appropriately trained personnel under the
supervision of qualified medical personnel who know the risks and advantages. Any user of
the incubator must be trained and familiar with the contents of the user manual before using
the device. For this reason, it should be ensured that the user manual is kept in a safe
environment, which can be accessed when necessary.
Since it is within the scope of hazardous waste such as accessories and materials that have
expired, it affects human health directly. According to the Regulation on Control of
Hazardous Wastes, it should be disposed of after the expiry date.

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1.1.3. Usage warnings about patient health
The skin temperature should be constantly monitored in case the baby's body temperature
rises.
Oxygen content should be constantly monitored
1.1.4. Warnings for using the device
The power cord should only be connected to the mains and grounded socket.
If it is not possible to ensure that some parts of the incubator are not working properly, the
device should not be used and in such a case, the technical service should be urgently
notified.
Original lamp should always be used within the knowledge of the manufacturer. Using
different lamps can change the light and temperature conditions.
Okuman Medikal Sistemler is not responsible for any damages that may occur
if parts other than accessories recommended by Okuman Medikal Sistemler
together with TR203 Transport Incubator are used. Only accessories recommended by
Okuman Medikal Sistemler should be used.
The device must be turned off before moving.
Radiation can damage the device. The device should be protected from radiation and should
not be exposed to sunlight.
Protect against electromagnetic waves.
Flammable solutions (antiseptic, cleaning agents, etc.) should not be used for cleaning the
incubator.
1.1.5. Other Precautions (Residual Risk)
1 ) Are there conflicting conditions for risk control of a single risk?
Conclusion: The current risk control has not been found to be contradictory yet.
2 ) Alarm review Are there too many alarms?
Result: The alarm message is clear, it conforms to the standard.
3 ) User Manual review
Is there some information that is contradictory or difficult to apply?
Result: The operating instructions of the device comply with the requirements of the general safety
standard; Security-related information is clear and easy to follow.
4 ) Comparison with similar or equivalent devices
Conclusion: The device was compared with similar products in the market with its clinical applications
and features, performance aspects; It is concluded that the device and similar product in the market have
similar features and performance.
Review Conclusion: After evaluating the above points, the review team accepts that general
residual risks are acceptable.

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1.2. SYMBOLS USED ON THE DEVICE

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1.3. SEASONAL SAFETY CHECK
1. Please clean the plug of power cord at least once a year. Too much dust on plug may cause the fire.
2. The air temperature sensor should be calibrated every 6 months, and only the authorized qualified
service personnel can calibrate the sensor.
3. The following safety checks should be performed at least every 12 months by a qualified person who
has adequate training, knowledge, and practical experience to perform these tests. The data should be
recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the
device has to be repaired.
1) Inspect the equipment and accessories for mechanical and functional damage.
2) Inspect the safety relevant labels for legibility.
3) Inspect the fuse to verify compliance with rated current and breaking characteristics.
4) Verify that the device functions properly as described in the instructions for use.
5) Test the protection earth resistance: Limit 0.1 .
6) Test the earth leakage current Limit: NC 5mA, SFC: 10mA.
7) Test the enclosure leakage current Limit: NC 10

8) Test the patient leakage current Limit: for a.c.: 100 (BF).

9) Test the patient leakage current under single fault condition with mains voltage on the applied

10) According to the test methods of IEC 60601-1:2005, the patient leakage current (net voltage
should be added on the applied part) of the testing device must
11) Test the patient auxiliary leakage current Limit: NC for a.c.:

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FOR YOUR NOTES

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2. GENERAL
Information about the general introduction, installation, transport and adjustment of the unit
before starting using TR203 transport is given in this section.

2.1. SCOPE OF USE


TR 203 Transport Incubator is designed for use in the transfer of low-weight, seriously ill or
newborn babies.

2.2. CONTRAINDICATIONS
Although there are no strict contraindications about the product, the following conditions can
inevitably be considered contraindications.
arily.

2.3. PRODUCT DESCRIPTION


TR 203 Transport Incubator is used for the transportation of low weight, seriously ill or newborn
babies. This guide is for the installation, operation, maintenance and troubleshooting of the TR
203 Transport Incubator made by Okuman. If the user does not comply with the maintenance
recommendations in this manual and does not operate the unit as shown, he will not be able to
hold our company responsible for the performance of the incubator or any consequences
caused by any unauthorized repairs.
Calibration and repair should only be done by authorized service personnel.

This manual should be read carefully from start to finish and should be available to all personnel
who will use the unit. The manual should be kept with the Incubator when incubator is not used.
If anything is not understood, please contact an Okuman representative or aftersales service
department for more detailed information.

2.4. PRODUCT VIEW


General view of TR203 transport incubator is given in Figure 2-1.

Serum Rack Handle


Battery Block Canopy

Control Module

Lock Mechanism

Wheel
Oxygen Cylinder
Chamber

-1. TR203 transport incubator general view

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Item Description
Serum rack Hanger used to hang the infusion bottle Max. Load: 2Kg.

Control module The buttons on the control panel provide power to the control panel,
change the operation mode, control the keypad lock, adjust the
temperature settings,> 37C, alarm mute and pulse oximetry features.
In this control panel, it is possible to monitor from which source the
power is supplied, the amount of heater operation, the operating
mode of the device, the battery charge rate, the battery charging
state, the temperature readings, the set temperature value, the alarm
states and the pulse oximeter functions.
Oxygen System It consists of the oxygen cylinder and oxygen inhaler expected to be
used in oxygen supply in clinical practice, further study details refer
to the attached oxygen equipment manual.
Canopy Acrylic headboard, baby bed etc. It is used to accommodate the

350mm.
Chassis It is an important part of the incubator and mainly consists of a
battery and air filter. The charge time of the battery is 10 hours when
fully discharged. After filling, when the temperature reaches steady
state, the temperature of the continuous working time is 90 minutes
(Ambient temperature 15 C, control temperature 36 C), fully charge
the battery service life discharge 200. 12V / 26AH. Battery size:

Lamp One of the lighting components for the incubator.


Stretcher Support part of an incubator. Ordinary type car is traditional
configuration; Ambulance trolley is an optional configuration.

2.5. ACCESSORIES
The accessories that can be used with TR 203 are listed below.

GEN PRESSURE METER

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2.6. Side Effects
Side effects may occur if the hygiene rules are not followed. Skin probes must be disinfected
before using. Prolonged skin temperature measurement may be sensitive to irritation at the
bottom.

2.7. Lifetime, Patient Population and Target User


Its service life is 10 years.
The target user of the device is professional healthcare professionals such as
doctors and nurses. The patient population is newborns under 10 kg.

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FOR YOUR NOTES

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3. INSTALLATION
3.1. Unpacking
Typically, the trolley and the hood are shipped in separate cartons. When taking out the equipment
from the cartons, take care not to damage the spare parts of the incubator.
This section describes the setup procedures of the trunk and foot. Typically, the foot and trunk are
loaded in separate boxes. When removing the device from the box, be careful not to scratch or
damage the unprotected surfaces. Take all packaging material out of the box and check all spare
parts according to the packing list.

WARNING: Do not raise this adjustable foot until the incubator is mounted on the foot;
there is a possibility of injury or damage to the foot part of the device.

3.2. MOUNTING THE BODY TO THE FOOT

A. Assemble the main body to the base part as shown in figure 3.3. Pull fixing lock in direction of
arrow 1; Release this lock from the foot according to the direction of arrow 2.

NOTE: Make sure the power socket and height adjustment arm are in the same direction
throughout the installation (see Figure 3.4).

WARNING: For safety reasons, transport incubator should always be carried by two people.
Chassis

Height adjustable foot

Figure 3-1. Correct positioning of the main body on the adjustable foot

Fixing lock

Figure 3-2. Clamp the main body and adjustable foot

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Locked state Open
Figure 3-3. Mounting of the main body on the adjustable foot

3.3. FITTING THE LOCATION WITH WHEEL BRAKES


B. See Figure 3.4. Pull the height adjustment latch in the direction of Arrow 1, at the same time,
raise the height-adjustable foot in the direction of Arrow 2. Lock the wheel of the foot when the
unit is raised.
WARNING: To avoid injury, keep your fingers away from wheels and other moving parts.
WARNING: To prevent it from slipping when you leave the incubator on a sloping surface,
the front wheels of the foot should face the slope and be locked.

Brake open Brake locked status


Figure 3-4. Raise the foot and lock the wheels

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NOTE: View of wheels locked in Arrow 3 direction and unlocked in Arrow 4 direction.
C. The AC power cord and External DC power cord should be properly wrapped and hung on the
protective rail, using the tape attached to the cable, as shown in figure 3.5.

Figure 3-5. Storage of ac and dc power cable when the device is not in use

D. Mount the serum hanger on the Foot and adjust the hanger to a suitable height and tighten the
fixing screw, as shown in Figure 3.6.

Figure 3-6. Install the serum rack

WARNING: Mounting of the incubator on the foot part should be done using the locking
mechanism. If it is not done this way, it may cause the incubator to leave the foot,
especially if it is shaken sufficiently during transport.

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3.4. CONNECTION TO EXTERNAL POWER SOURCES
A. The AC power cord socket (see Figure 5.1) can be connected to a standard 3-eyed hospital
outlet.
B. The External DC power cable that comes with the Incubator must be connected to the External
DC power cable socket (see Figure 5.1) and the voltage ratings must match the label values.

EXTERNAL DC
CONNECTOR

CAUTION: Before use, make sure that the grounding between the AC plug grounding tip
and the chassis of the battery is properly done. To ensure grounding, connect the AC
power cord only to a properly grounded 3-chamber hospital type or hospital use outlet
with proper voltage and frequency output. DO NOT USE THE EXTENSION CABLE.

3.5. BATTERY CHANGE


For battery replacement, firstly remove the screw on the metal layer and pull it out with the
help of the metal handle.

Remove the marked bolts and replace the battery.

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3.6. LAYOUT OF OXYGEN TUBES
WARNING: Oxygen cylinders can become dangerous rockets if there is a gas escape due to damage or
other reasons. Tubes must be securely fastened to prevent damage or movement.

A. Before attempting to insert the oxygen cylinders, make sure that the part used for the fastener gripper is in
the correct position for the width of the oxygen cylinders to be mounted on the Incubator.

B. Slide the oxygen cylinder into the chamber, after the cylinder lock button has passed the port, press the
locking lever in the direction indicated by the arrow to fix the cylinder. Tighten the ties on the oxygen cylinder
and make sure the tube is firmly seated (Figure 3.7).

C. Attach a suitable regulator and flow meter to the tube.


The tube must be tightened so that it does not move.

Hand Lock Tube

Hook

Figure 3-7. Tightly connecting the tube

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3.7. OXYGEN MEASUREMENT SYSTEM CONNECTION
See the figure; Connect the oxygen measuring system together with the oxygen cylinder
appropriately. After connection, the oxygen pressure gauge should be placed flat.
NOTE: Please read the oxygen measurement system manual before operating, operate
according to the manual.

Figure 3-8. Oxygen measurement system connection

3.8. GENERAL OPERATION AND CONTROL OF FUNCTIONS


Perform the function control procedure and general operating procedures given in 5.2 after
installation. Unless this is done, the incubator should remain in the service. After completion of the
procedure, the unit should be connected to an AC power source and the power switch (Figure 5.1)
should be turned ON. Thus, the batteries can be fully charged.

3.9. OPERATIONAL CHECKOUT PROCEDURE

WARNING: Please stop using this model once some functions are lost or some spare
parts of front access panel are loose and repair by the qualified
personnel.
NOTE: 1. Please operate the Controller according to the Manual strictly.
Do not to press the key freely.
2. The checking of the temperature controller should be proceed in
the ambient temperature 25 , make sure the seal condition
of all doors during checking.
3. During the checking, use the mercury glass thermometer should
be used instead of the clinical thermometer.
The incubator is only allowed to use by the specially trained staff guided by
the qualified medical personnel who is familiar with the known risks and
advantages of incubator.
Please do the following checkout procedure each time before operation.
The operator should operate the device within 20cm aheat the specific
distance depends on the comfort when operating.

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3.9.1. CHECK THE INTEGRITY OF INCUBATOR
Make sure that the device has been sterilized;
Make sure that the hood are locked firmly;
Make sure that there is no crack or the sharp edge on the hood;
Make sure that the I.V. Pole is locked firmly;
Make sure that the bed is locked firmly;
Make sure that the needed accessories and other devices are available;
Make sure that the power cord is connected and is safe.
Make sure that the casters are installed well.
Check whether the caster can drop when lifting the incubator 2cm above
the ground. The drop of the caster will cause danger during transporting.

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4. DESCRIPTION OF THE FUNCTIONS
4.1. GENERAL FUNCTIONS
To show which parameter (air or skin) is controlled, the indicator lamp next to that button will light
up according to the selected control mode. The incubator air temperature will be monitored
through an air temperature sensor through an air temperature window; skin temperature will be
monitored through the skin temperature window via a skin temperature sensor. As a control
parameter, the temperature will be regulated using either the incubator's air or skin temperature;
The desired mode is selected with the keys on the front panel. Applying to both operating modes,
the heater output is proportional to the amount of temperature required to provide the desired
temperature. Each mode of operation is described below.

4.2. AIR TEMPERATURE MODE


Air temperature mode means that the temperature controller will be automatically controlled by
the temperature of the air in the Incubator, and shows the temperatures taken from the air sensor,
similar to the set value. In this operating mode, the air temperature can be adjusted from 25 to 37

The air temperature is monitored by a sensor located in the sensor module and compared with
the set air temperature value. The information from this sensor goes to the heater control circuit
that regulates the heater output to adjust the air temperature. In case of over temperature, the
heater stops its operation. In this control mode, the skin temperature display window will show the
temperature at the temperature sensor on the skin; If the skin temperature sensor is not attached,
the skin temperature display window will show "--.-".

4.3. SKIN TEMPERATURE MODE


Skin temperature mode means that the temperature controller will be automatically controlled by the
temperature of the air in the Incubator, and shows the temperatures taken from the skin sensor,
similar to the set value. In this operating mode, the infant's body temperature can be adjusted

A temperature sensor is attached to the skin of the infant, and the information from this sensor goes
to the heater control circuit that regulates the heater output to provide the set skin temperature value.
In skin temperature mode, skin temperature will be displayed in the skin temperature display window;
the air temperature display window will show the air temperature for information only. A second
sensor inside the air temperature sensor acts as a support to limit the highest incubator temperature.
In case of over temperature, the heater stops its operation.
In the event of a power failure in both control modes, the Incubator will continue to display the set
value for 10 minutes.
C, which is the factory set value. In other words, when you start the device for the first time, the set

failure alarm will work; If you turn off the unit and restart it within 10 minutes, the air temperature will

turning off the un

disconnecting the power or sounding the interrupt alarm.

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4.4. AIR AND SKIN TEMPERATURE ALARMS
High and low air or skin temperature alarms will work if the skin or air temperature deviates by the
following values:

-
-

An audible and illuminated alarm will sound if the air or skin temperature shown in the actual
temperature display window is below or above the set alarm limits.
If the alarm condition is corrected, the displayed alarm will be canceled automatically. The audible
alarm can be silenced by pressing the silence / reset key. When the alarm is silenced, the alarm
light will remain on until the condition is corrected. If the condition that caused the alarm is not
corrected within 5 minutes, the audible alarm will work again.

4.5. BODY
Double-walled body: Prevents loss of temperature, reduces the effect from external external heat
sources to the Incubator.
Hand access windows: Doctors can interfere with the baby thanks to the windows on the front of
the trunk. Hand entry points have a lock mechanism that opens with elbow contact.
Side door: Open the side door, remove the infant; Suitable for blood transfusion of the infant.
Hand inlet window sleeve: It prevents the air inside the incubator from mixing with the air outside
during operation. Hose access slot --- Enables the infusion hose to enter the incubator for infusion
infusion.

Hand entry latch: Silent touch latch design is used for all entrance windows in terms of being silent.

4.6. ALARM AND INSTANT MESSAGES


See Table 4.1 for alarm conditions in the incubator.
If 6 (or more) faults occur or individual faults occur, the audible and light alarm will appear on the
corresponding display.

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TABLE 4.1. ALARM AND SYSTEM MESSAGES

ALARMS ABOUT SYSTEMS


ALARM MESSAGE DESCRIPTION
A flashing audible alarm indicating an
Power Interrupt interruption in external power or battery
power.
Acoustic alarm that lights continuously,
showing that the incubator fan has failed; E05

Motor Failure Acoustic alarm indicating that the engine


speed is less than 1000rpm or the incubator
fan has stopped, the light is on continuously;

Air Temperature Sensor Malfunction In the Air mode, the air temperature appears
as an audible alarm that lights up
continuously when there is a communication
malfunction in the sensor module. E01 is read

Skin Temperature Sensor Malfunction In skin mode, the air temperature appears as
an audible alarm that lights up continuously
when there is a communication malfunction in
the sensor module. E02 is read at Skin Temp

Isolated Temperature Sensor Malfunction When the communication in the isolated


sensor is broken, this alarm sounds and the
alarm indicator lights up with the audible
alarm. E03 is
Skin Temperature Sensor Not In Place An audible alarm that lights continuously to
show that the skin temperature sensor is not

Overheating A flashing alarm with acoustic alarm when the


incubato

Low DC Flashing indicator light and intermittent alarm


due to 12V DC power supply supplying power
below 10.5V and / or 24V DC power supply

Temperature Control System Malfunction An internal malfunction. Along with an audible


alarm that sounds continuously, all illuminated
alarm indicators light up, E11 is read at Skin

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TABLE 4.2. ALARM AND SYSTEM MESSAGES (CONTINUED)

ALARMS ABOUT TEMPERATURE


ALARM MESSAGE DESCRIPTION
An audible and uninterrupted light alarm that
indicates the incubator air temperature

Air Temperature
Acoustic and uninterrupted light alarm that
Mode
indicates that the incubator air temperature

High / Low
Temperature An audible and continuous light alarm that
Alarms indicates the temperature of the infant skin

Skin Temperature
Mode Acoustic and continuous light alarm that
indicates that the skin temperature of the

NOTE: Except for power failure or system failure, the alarm can be silenced for 5 minutes

temperature. Except for the low temperature alarm condition, the heater is turned off.

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5.OPERATING
5.1. GENERAL
This section describes the operation of the incubator.

5.2. CONTROLS, INDICATORS AND CONNECTIONS


Controls, indicators and connections are shown in Figure 5.1., 5.2 and 5.3.
WARNING: To avoid electrical shock hazard, do not open the power supply cover.
Technical service should be provided by qualified personnel.

OXYGEN SENSOR CONNECTOR


SKIN PROBE
POWER

EXTERNAL DC
CONNECTOR
AC POWER
CONNECTOR

Figure 5-1. Unit connection sockets and switches

Battery Fixing
Screw

O2 Inlet Port

Figure 5-2. Oxygen inlet valve and battery handle

WARNING: To prevent damage to the electronic parts of the device, the device must not
be connected to the mains supply when you remove the battery tray.

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5.3. CONTROLS AND INDICATORS ON THE CONTROL UNIT

15 17 5 17 18 4 8 20 24 23 22 27 x

21
26 25

1 2 3 7 16 6 x 6 10 19 9 14 11 12 13

Figure 5-3. Controls and Indicators

Button Name Explanation


Opening It is used for turning the device on and off. The interface of
and the device is powered by this button.
1
closing
ON/OFF
LAMP It provides control of the examination lighting. While the
switch on the examination lamp is on, the inspection
2 illumination is turned on or off by pressing this button.

The led inspection light in the upper right corner of the


button shines when it is on.
Key Lock Control of key (Button) lock is provided. By pressing
this button, the keypad is activated or deactivated. When
3 the keypad is locked, the led in the upper right corner of
the button shines.

Air It provides control to put the device in air mode. If the


device is not in air mode, the led in the upper right corner
4 of this button cannot shine and the key lock is removed
and the operating mode of the device is set as air by
pressing this button and the led in the upper right corner
indicates that the working mode is illuminated by flashing.
Baby It provides control to put the device in baby mode. If the
device is not in baby mode, the led in the upper right
5 corner of this button cannot shine and the key lock is
removed and the operating mode of the device is set as
baby by pressing this button and the led in the upper
right corner indicates that the operating mode is
illuminated by changing the baby mode.
Set Tem- The buttons used to set the target temperature value that
perature the device will reach and remain constant.
6

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Button Name Explanation
>37 C
Button for adjusting the device temperature to more than 37 C. If the
7 desired target temperature is more than 37 C, the keypad is put into
use and after pressing this key, the target temperature is adjusted to
the desired temperature using the relevant buttons.

Alarm Button used for the Alarm Silence function.


8

Oxygen
By pressing this button, oxygen alarm limits are created. Creating
Alarm
9 oxygen alarm limits is described below.

Oxygen
By pressing this button, oxygen measurement can be activated or
10 deactivated. Oxygen sensor calibration is done by long pressing this
key. Oxygen calibration is described below.

SpO2 It is used to navigate pulse oximetry values. It is activated in order to


Menu change the values by pressing this button. The value to be changed on
11 the LCD screen can be noticed in a certain way by color change.

These values are respectively

mit

SpO2 When the desired value is changed with the Menu button, the value is
Down changed negatively with this button.
12

SpO2 Up When the desired value is changed with the Menu button, the value is
changed positively with this button.
13

SpO2 When this button is pressed, the power of the SpO2 LCD screen is cut
Power and its functions are stopped. When pressed again, the SpO2 LCD
14 screen is opened again.

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Indicator Name Explanation
15 Power It shows from which power source the device operates. BAT: Dahili
batarya

These LEDs are green.

16 Heater It shows the working power percentage of the heater. It shows the
Power percentage of power in 10% steps.
The led array here is also green.
Air Indicates whether the Air mode of the device is active. If LED is
4 active, it operates in air mode.

Baby Indicates whether the Baby mode of the device is active or not. If LED
5 is active, it works in Baby mode.

Key Lock Indicates whether the device's keypad lock is active. If the LED is de-
3 active, the keypad lock is active.

Lamp Indicates whether the Inspection Lamp is active.


2 Status

Oxygen It is observed whether the oxygen measurement is active or not.


10
Battery It shows the charge rate of the internal battery of the device. The
Capacity display has a 3 digit, 7-segment LED structure. Values range from 0 to
100.

17 Skin Tem- The temperature value that the device has read from the skin probes is
perature displayed on this screen with a sensitivity of 0.1C. The display is in 3-
digit, 7-segment LED structure.

18 Set Tem- Device temperature setting indicator. The temperature value is shown
perature
Error codes on the device are shown in this indicator. These error
codes are "H0.0" and "E0.0". These error codes are specified in the
alarms document.
The display is in 3-digit, 7-segment LED structure.

19 Oxygen The value that the device has read from the oxygen sensor is shown.
Values range from 0 to 100. The display is in 3-digit, 7-segment LED
structure.

Power Alarm indicator showing any power error. It is shown that an alarm has
20 Alarm occurred while the LED is active.
Fan Alarm Fan error status indicator. When LED is active, fan error occurs.
21

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Indicator Name Explanation
Sensor Sensor is an error status indicator. When LED is active, sensor error
22 Alarm occurs.

Over Alarm status indicator, where the measured temperature is too high
23 Alarm compared to the one set. When the LED is active, it is stated that the
alarm condition occurred.
Deviation Alarm indication of any deviation according to the measured
Alarm temperature and set temperature value. An alarm condition occurred
while the LED was active.
24
Low DC Low DC power alarm status indicator. An alarm condition occurred
25 Alarm while the LED was active.

>37 C > Indicator indicating whether a temperature above 37C can be done
status by pressing the 37 C button. When the LED is active, the temperature
7 can be set above 37C.
Alarm Indicator indicating whether an alarm condition has occurred. An
26 alarm has occurred while the LED is active or flashing.

27 Oxygen It is stated that the measured oxygen value is outside the set limit
Limit values.
Alarm

28 Alarm Whether the Alarm Silence function is active is shown.


Silence

Pulse Oxi- LCD display showing pulse oximetry values and alarm conditions.
meter

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5.4. OPERATING CONTROL PROCEDURE
Operation check must be carried out before the incubator's operation and after cleaning and
maintenance.
IMPORTANT: Please refer to section 5.2 before performing the
process.

WARNING

1. The infant must have been removed from the Incubator before the study control
procedures.
2. The incubator, which cannot be approved or has any malfunction in the control process,
should not be used. Repair should be done by qualified technical service personnel.
3. The control process is related to the temperature that can be used, the set temperature

5.4.1. Checking the Tightness of the Wheels


CAUTION: Before mounting the main body on the foot, the wheels must be checked as
shown below. The wheel should be checked regularly by the user.
Lift each corner of the incubator about 2 cm and check each wheel individually. A loose wheel
can cause the Incubator to become unstable and topple during transport. Do not use the Incubator
until the loose wheel has been replaced. IMPORTANT: Two people are required to perform the
test. One lifts the Incubator while the other controls the wheel. The weight of the incubator is
approximately 100 kg.
5.4.2. Connecting the AC Power Cord to the Incubator and Checking the Power Failure
Alarm
CAUTION: The check can be carried out when the power is supplied from the Incubator AC power
source, an external DC source, or internal batteries. Make sure that the building's power supplies match
the electrical characteristics shown on the Incubator. For proper grounding, connect the power cord only
to a properly grounded single-phase 3-wire outlet. Do not use an extension cord.
A. PRESS THE POWER SWITCH

Connect the AC power cord and DC power cord; Push the mains AC power switch and press the
power button on the temperature controller. The unit will test itself; a long beep should be heard and
the light of the indicators and displays should flash for a moment. At the end of the self-test phase,
the temperature indicator setting should stop flashing and the air temperature mode indicator and

indicator will show the capacity of the battery, skin temperature display and air temperature display
will show the actual temperature in the sensors. If the skin temperature sensor is not attached, the
skin temperature display will show "--.-". If the unit does not pass the self-test phase, an audible
alarm will sound and all alarm indicators will flash; E11 will be read on the skin temperature display.
The unit needs to be taken to the service.

NOTE: The AC power mode indicator will not light up if the unit is being tested while running
on DC power.

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B. CHECK THE SETTING RATE
While in air temperature control, press Set Temp button, Set Temp indicator light should be on.

rature, press and

indicator light is on, press the Skin Temp key until the skin temperature mode indicator lights up,
hold down the upper arrow button until the S

C. CHECK THE POWER SUPPLY MODE AND POWER INTERRUPT ALARM

With the temperature controller running, disconnect the AC power cord, the unit should start
receiving power from the DC power source. Disconnect the DC power supply, the unit should
start running on battery. Turn off the controller, loosen the nut of the battery tray (see figure 4.1),
and pull it out about 5 cm to detach the battery tray from the internal battery and run the
temperature controller again. The power failure indicator on the control unit should light up and a
continuous alarm sound should be heard. The alarm should stop automatically when the battery
is replaced. After self-test, the temperature control screen is as in figure 4.2. See paragraph

written below.

5.4.3. Operation Control - Body And Foot


Carry out this operation with the control for the control unit before incubator service and before
any maintenance or removal.
Control of the Transport Table
Pull the height adjustment latch in the direction of arrow 1 and at the same time press down on
the transport table, the table should slowly lower to the lowest position. Release the height
adjustment latch, it will lock automatically. The transport table should be adjustable in two steps
and should be lockable automatically.
NOTE: When the incubator is placed in the ambulance, the transport table should be set
at least in height.

Figure 5-4. Opening the latch

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TR203 SM-000-01-2020-EN
Control of the Front Access Panel
Pull the latches of the access panel in the same direction as Arrow 1 and Arrow 2 and turn the
lock to the unlocked position, open the access panel fully by hanging it down. Close the access
panel and rotate both latches until it is completely attached. Both latches must hold the panel
firmly against accidental opening.

Control of access window latches

Access window latch open

Access window latch is Locking latch


locked
Figure 5-5. Access window latches

Control of Access Window Latches and Gaskets


Press the opening button of each window with your elbow. The access window should open.
Check if the gaskets are airtight.

Figure 5-6. Access window locks

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TR203 SM-000-01-2020-EN
Iris Window Intrusion Control
Turn the outer ring of the iris window; The iris should open and close 360 degrees.

Figure 5-7. Iris Window

Control of Grippers and Latches


Check the retainers and latches. All four pegs and holders must be intact.

Not Locked Locked

Loose
Figure 5-8. Grippers And Pegs

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TR203 SM-000-01-2020-EN
Checking the Mattress Tray
Open the bedside access panel and pull the tray out of the Incubator until it opens fully into the
position indicated by the arrow. Check to see if it can remain still when force is applied when it is
open. As shown by the arrow, the mattress tray must be pulled out while pressing the stopper to
the side of the mattress tray. Push back the mattress tray and close the panels. Both latches
must be securely fastened to prevent the access panel from being opened accidentally.

Stoper

Figure 5-9. Checking the Mattress Tray


Control of the Air Intake Microfilter
Remove the cover by loosening the two screws on the air filter cover. Remove and inspect the
microfilter; replace it if it looks dirty.
WARNING: Dirty air intake microfilter may affect oxygen concentration and / or cause carbon
dioxide to accumulate. Make sure the filter is properly checked on a routine basis. It should
be changed every two months or when it looks dirty.

Micro Air Filter

Figure 5-10. Micro Air Filter

Control of the Oxygen System

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TR203 SM-000-01-2020-EN
Connect the oxygen inlet valve (Figure 4.1), install 10 lpm oxygen. Then check the level with an
adjusted oxygen analyzer to confirm whether the oxygen level in the body has reached the level
indicated in the oxygen concentration guide in the incubator.

Figure 5-11. Oxygen Inlet Port

Battery Tray Nut Check


After loosening the key nut of the battery tray as shown in Figure 4.1, the battery tray should be
pulled out. After pushing back the tray and tightening the nut, the tray must not be pulled out.

After these controls were achieved, the control of the body and foot was completed.

5.4.4. Operating Control Control Unit


WARNING: If the incubator does not work as described, it should not be used. Service should
be done by qualified personnel.
NOTE: Please use the control unit as in the manual. Do not press the keys randomly.
Operation control must be carried out before the incubator's operation and after cleaning and
maintenance, together with the control operation of the body.
A. Deviation Alarm Control (Air Mode)

status (see DESCRIPTIONS AND SYMBOLS TABLE). To control the high temperature alarm (+
the displayed air temperature (circulate hot air inside the body).

panel to control the low temperature alarm (-


deviation or low temperature deviation occurs, the alarm will work and E09 or E08 temperature
deviation alarms will appear on the skin temperature display along with the audible alarm.
NOTE: This alarm will not occur until the temperature is more or less than 3
set value. When controlling the low deviation alarm, the ambient temperature must be
lower than the set value or the air must be circulated inside the body, so the alarm will
occur.

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B. Dev ation Alarm Control (Skin Mode)
Plug the skin temperature sensor into the skin socket.
The arrow of the skin temperature sensor must be positioned towards the opening.

1. Grasp the sensor by the head or pull it out. Do not hang or remove the sensor cable.
2. Never place the skin temperature sensor under the infant or use it rectally.
3. Do not bend the sensor at the connection point..

will work and E09 or E08 temperature deviation alarms will appear on the skin temperature display
along with the audible alarm.
NOTE: The low deviation alarm will
the set value.

Arrow Claw
Direction

Sensor Plug

Figure 5-12. Skin probe connection


C. Skin Temperature Sensor Alarm Control
Select Skin Mode Control, disconnect the skin sensor from the port. An audible and light alarm
will work. E02 will appear on the skin temperature screen. The Incubator will return to normal
operation when the skin sensor is attached.

When the incubator temperature alarm enters the control state (see related symbols and
explanations), audible and light alarms will operate. The skin temperature screen will show E04.
When the skin sensor is in the correct state, the Incubator will return to its normal operation.
D. Overheating Alarm Control

Press the UP and / or Down key quickly, the space will appear on the setting screen, the overheat
indicator lights will light up after the temperature controller is set to overheat test mode (Over
Temperature Test Mode). After approximately 10-12 minutes, the overheat alarm indicator will
work and the audible and light alarm will appear. The skin temperature display will show E07.
Press the Reset / Silence key, the alarm will silence and the controller will return to the set state.

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E. Fan Motor Failure Alarm Control
See Figure 5.2; lift the body and remove the mattress tray. Keep the fan in mind, run the
temperature controller, the alarm should sound. While the fan alarm indicator is flashing, the Skin
temperature display will show E06. Release the fan, the alarm will automatically silence when the
fan is in place. After pressing the Reset / Silence key, the fan will continue normal operation.
NOTE: For the risk of burns, perform this check at least 45 minutes after turning off the
incubator.

Figure 5-13. Fan Control

5.5. GENERAL WORKING PROCEDURES


WARNING: Before operating the incubator, see also precautions to be taken during
operation in this manual and paragraph 4.2 Controls and Indicators.
If the incubator is closed and not operated for cleaning and maintenance, operation control
operations must be carried out before using the incubator again. Do not use the incubator without
performing general operation and function check procedures.
The incubator must be preheated to the temperature set by the doctor or care rules. In order to
provide the most benefit from the battery during transportation, it must be preheated depending
on the mains voltage before using the incubator with a battery..
WARNING
1. Improper use of the incubator can damage infants. The incubator should only be used by trained
personnel guided by a qualified physician who knows the benefits and harms.

2. While the infant is in incubator, it is necessary not to raise the body of the incubator. Access panels
can be used for all necessary interventions to be infused.

3. High temperature alarm works only with air temperature. Daylight or heat from other sources can
cause the baby to overheat without triggering the alarm. Do not place the incubator in direct sunlight
or near a heat source.

4. Phototherapy units placed very close to the incubator can affect the body wall temperature, the
incubator temperature, and the infant's skin temperature.

5. To prevent accidental overturning of the incubator during transportation, do not place materials on
the accessory shelf and do not move the carrying table sideways or from an angle.
IMPORTANT: Temperature control mode and temperature settings must be determined by
a doctor. The rectal and / or armpit temperature of the infant should be routinely monitored
and recorded according to the demands of the attending physician or the rules of care.

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5.5.1. Air Temperature Mode
Press the Set button to select the air temperature mode control, use the Up / Down arrow keys to

If it is necessary to change the set temperature value while the incubator is running, press the Set
button, the adjustment indicator lights will come on,

press the Set key directly to reach the control state or do not press any key for 10 seconds, the
controller will automatically come to the control state. The air temperature display shows the
temperature received from the air sensor, and the skin temperature sensor shows the temperature
received
screen.
5.5.2. Skin Temperature Mode
Attach the skin temperature sensor to the sensor connection. Before placing the skin sensor on
the skin, the skin area where the sensor will settle must be completely clean and dry. If the infant
lies on his back or side, place the sensor between the abdomen, the xaphoid and the navel. To
fix the probe, stick tape on the probe cable, about 1 cm from the sensor tip.
CAUTION: If the infant lies prone, place the sensor in an area determined by the doctor.
WARNING

1. Do not place the skin temperature sensor under the infant or use it rectally.
2. The skin temperature sensor must be in direct contact with the skin to accurately monitor
the infant's skin temperature. Failure to provide this contact may result in error and danger.
Check the condition of the baby every 15 minutes for the sensor to stop properly and follow
the signs of the baby's skin overheating.
3. If the temperature of the infant rises or fever, the temperature of the Incubator will drop or
another bad effect will occur.
4. If the skin temperature sensor gets wet, the skin temperature will not be controlled
correctly..
If it is necessary to change the set temperature value while the incubator is running, press the Set

C. After selecting the appropriate temperature, press the Set key directly to reach the control state
or do not press any key for 10 seconds, the controller will automatically come to the control state.
The skin temperature display shows the temperature received from the skin sensor, the air
temperature display shows the temperature received from the air sensor. The set temperature

5.5.1. Moistening
NOTE: Adding the moisturizer is an issue determined by the attending physician.
Pull out the mattress tray, add sterile distilled water to the sponge on both sides of the main body.
Do not pour the water, it is enough to wet the sponge thoroughly. The wet sponge used for one
infant is not used for another infant. To get the most out of humidification, do the Incubator preheating
while the sponge is dry.

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TR203 SM-000-01-2020-EN
Figure 5-14. Canopy Interior View

5.5.2. Placing the Infant in Incubator


Open the front access panel, place the infant on the Incubator. Secure the infant with fastening
tapes. Tapes should be placed on the infant and their ends should be pressed tightly. Be careful
not to over tighten the tapes. Close the access panel, the access panel latches must be securely
closed to prevent accidental opening.

Figure 5-15. Fixing Tapes

WARNING:
1. A control mode must be selected on the incubator and the Incubator must be warmed up 2
hours before placing the infant.
2. Do not keep the access panels open for longer than necessary. The value read on the air
temperature indicator when the access panels are open does not reflect the incubator
temperature precisely. Under these conditions, the Incubator temperature may be
significantly lower than the temperature shown.
3. For the safety of the infant, do not leave the infant alone while the access panels are open.
5.5.3. Oxygen Administration
Connect the oxygen cylinder to the oxygen valve (Figure 4.1) and install the oxygen measuring system. Adjust
the oxygen concentration with the oxygen reducer. The guide table for concentration is on the next page. This
manual is also located on the body of the Incubator. The value that appears in the table is the oxygen
concentration that keeps the incubator in balance. The value in the table is for reference only. Oxygen
concentrations should be measured intermittently with an adjustable analyzer. The optimum oxygen
concentration value should be determined by the attending physician based on the oxygen pressure in the
blood.

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TR203 SM-000-01-2020-EN
OXYGEN CONCENTRATION TABLE

OXYGEN SOURCE

2 lpm 22-34

4 lpm 30-42

6 lpm 38-50

8 lpm 46-58

10 lpm 54-66

Ensure that oxygen concentrations are stable.

5.5.4. Setting the Oxygen Limit Value


Oxygen limit values of the device are made by following the steps below.

If the oxygen measurement of the device is not active firstly, pressing the button starts

the oxygen measurement and the led above the oxygen / calibration key shines.
The oxygen concentration value measured on the screen is written.

key is pressed and the current oxygen limit value is written. This value is stated in the
table below.

By pressing the button again, the desired oxygen limit value is set. Oxygen limit values
are shown in the table below. The values specified in this table are brought to the level set from
the regulator connected to the oxygen cylinder.
Oxygen alarm is given when the measured oxygen concentration value differs from the set value
by 5%.

If the button is not pressed again for 10s after the necessary adjustment, the last set value
is taken as the limit values.
5.5.5. Oxygen Sensor Calibration
Oxygen sensor calibration is done by following the steps below.

If the oxygen measurement of the device is not active firstly, pressing the button starts

the oxygen measurement and the led above the oxygen / calibration key shines.

Again, button is pressed for 3s and oxygen calibration is started. In this case, CAL is written

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TR203 SM-000-01-2020-EN
on the screen. At any step of the calibration, button is pressed to end the calibration process
and the calibration process is terminated.
CAL will appear on the screen when calibration is started. The sensor is taken outside (outside
the incubator) and kept in the external environment for at least 3 minutes.

After the sensor is kept in the external environment for at least 3 minutes, button is pressed
and 21% calibration of the oxygen sensor is expected. Upon completion of the calibration, a
voice warning is made 3 times and then 100 text appears on the oxygen screen.
Oxygen is given by connecting to the sensor calibration apparatus.

key. During the calibration, the sensor does


not leave the calibration apparatus and the oxygen supply is not turned off.

the measured oxygen concentration is displayed on the screen.


screen and the calibration
is terminated.
WARNING
1. Before continuing, review the operating measures in this manual. Oxygen concentration
should be managed by the attending physician.
2. Too high oxygen concentration will cause great damage to infants. The operation should
be done by the attending physician and use the monitor to monitor the concentration and
flow rate set by the physician. The oxygen concentration should be monitored
continuously with a regulated oxygen monitor, and the table above should only be used as
a reference.

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TR203 SM-000-01-2020-EN
5.5.6.USE IN AMBULANT
The incubator carrying table must be placed in the lowest position and the wheels must be locked
before being placed in the ambulance. For proper use of the DC power supply, the DC power
supply of the incubator socket must face the direction of the DC power output.
NOTE: When the latch and carrying table shaft are separated, the table and the body are
locked.

Figure 5-16. Making adjustments for use in ambulance

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6. CLEANING
6.1. GENERAL INFORMATION
This section is about what to do with cleaning and maintenance. If necessary, instructions for
disassembling are also included. Maintenance other than those described in this section should
only be performed by qualified service personnel. The patient department should be routinely
examined to determine if there are signs of breakage and parts should be replaced before
leaving the incubator for service.
WARNING: Before cleaning and maintenance, make sure all connections of the Incubator,
especially the oxygen source, have been removed. There is a risk of fire or explosion
when performing maintenance and / or cleaning operations in an oxygen-rich
environment.

6.2. CLEANING
It is recommended to clean and sterilize the Incubator thoroughly after a baby leaves the
Incubator or once a week. Since the incubator is not sold as disinfected, cleaning and sterilization
should be done before first use. All relevant parts should be removed before cleaning, and should
be grouped according to the cleaning method. The battery should be replaced every three years.
WARNING: The infant should be removed from the Incubator before cleaning.

6.2.1. Removing Parts for Cleaning


NOTE: The body does not need to be removed for routine cleaning. If it needs to be removed,
see the installation section.
1. Turn off the incubator and unplug it. Remove the access window sleeves, seals, iris inlet
window sleeves and the part for IV.
2. Disconnect the cables from the sensor module and take the IV pole. Open the body holders,
take the body and inner wall as shown in figure 6.1.
CAUTION: Before lifting the incubator body for cleaning, make sure all accessories are
removed. Otherwise, they may get confused when lifting the trunk.

Cabin

Inner Wall

Figure 6-1. Cabin and Inner Wall

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TR203 SM-000-01-2020-EN
1. Remove the mattress tray and remove the dampening sponge.
2. Open the main body latches and lift the main body. In order for the heater to cool, it is necessary
to wait 30 after unplugging the Incubator and be careful against the danger of burns.
3. Loosen the two screws of the air filter cover and remove the air filter.

Inner Wall

Figure 6-2. Removing the inner wall and bearing part

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TR203 SM-000-01-2020-EN
6.2.2. Cleaning After Removing Parts
A. Cleaning Agents
With the incubator empty and disassembled as described, use a medium-level detergent /
disinfectant. When using any cleaning agent, follow the instructions regarding the use of that
substance. After removing all solid waste and dirt, clean the parts of the Incubator as follows.
B. Skin Temperature Probe
Use a certain detergent / disinfectant manufacturer to clean all surfaces. Dry with a clean cloth
or paper towel. Do not put the probe in detergent / disinfectant.
C. Hose Access Sections, Access Window and Cuffs and Co
Place in a container filled with detergent / disinfectant. Follow the instructions for use on the
detergent / disinfectant.
Then remove it and rinse it with distilled water and dry it completely with a clean cloth or paper
towel.
D. Control Unit, Dental Front and Moon
CAUTION: When cleaning the outer surface of the incubator, care must be taken so that liquids
do not leak in.
Clean any strand formation on the heater radiator flange. Use a certain detergent / disinfectant
manufacturer to clean all surfaces. Dry with a clean cloth or paper towel. Be especially careful when
cleaning the fan, heater and the surface of the air temperature sensor. Then dry them with a clean cloth.
CAUTION: Some chemicals may be conductive and / or leave a residue that allows the
formation of dust or dirt that may be conductive. Do not allow the cleaning agent to come into
contact with electrical circuit components. Do not apply cleaning spray on any of these
surfaces.
Failure to clean the fan can result in dust lumps that will reduce air flow. This will affect
temperature control and cause high carbon dioxide concentration.
E. Body and Interior Walls
Use a manufacturer-specific detergent / disinfectant to clean all surfaces of the body, including
the recesses and projections, access windows, and access panel. Dry with a clean cloth or
paper towel.
CAUTION: Do not use alcohol for cleaning, as alcohol can cause the acrylic body to
crack. Never expose the body to direct ultraviolet light. This can cause the gaskets to
crack, discolour, and crack the acrylic body.
F. Mattress, Dampening Sponge, Mattress Tray and Main
Use a certain detergent / disinfectant manufacturer to clean all surfaces, including ridges. Dry
with a clean cloth or paper towel. Take the mattress and sponge, wash the manufacturer with a
certain detergent / disinfectant and rinse with clean water and let it dry in the daylight.
G. Air Intake Microfilter
Do not try to clean the microfilter or vice versa. If it looks dirty or replace it every 2 months.
Before installing a new filter, clean the microfilter chamber and the cover with detergent /
disinfectant.

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TR203 SM-000-01-2020-EN
WARNING: A dirty filter can affect oxygen concentration and / or cause carbon dioxide build-
up. Make sure the filter is checked routinely.

H. Transport Table
Use detergent / disinfectant to clean all surfaces. Dry with a clean cloth or paper towel.
CAUTION: Do not lubricate the mattress tray holder with oil and other flammable
substances.
6.2.3. Post-Cleaning Installation
NOTE: Install all cleaned parts after checking for cracks or defects. Hard cleaning agents can
damage some plastic parts used in the patient compartment.
A. Place the main body, mattress tray, mattress and body.
B. Check for any holes or cuts in the mat that could cause liquids to pass into the inner sponge. If
the mattress is damaged, replace it.
C. Install access window gasket and sleeve as shown in Figure 6.3.

Figure 6-3. Installing the gaskets


NOTE: If the incubator is sterilized with gas, install the new cuffs after sterilization. If the
access window seal is too tight and difficult to locate, soak it in warm water before
installing it.
D. Fit the hose access part as shown in figure 6.4. If it is damaged, replace it with a new one
(NOTE: The flat surface of the hose access section is outside).

E. Fit the iris inlet section plastic sleeves and gaskets (see Figure 6.5). Replace if damaged.
Fit the smaller diameter elastic band of the new sleeve over the inner ring of the chamber. Fold
back and slide the elastic band over the outer ring of the chamber.

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TR203 SM-000-01-2020-EN
Figure 6-4. Installing the hose access part

Figure 6-5. Installing plastic sleeves

Turn the outer ring to close. If you have placed it correctly, the sleeve will open when you turn
the ring to the opposite side.
F. Install Air Microfilter.
See paragraph 4.3.3H, place the air intake microfilter on the cap and tighten it with two screws.
Install the air intake microfilter. WARNING: To use the Incubator after disassembly, cleaning and
installation, the operation control process must be performed. If there is any malfunction,
technical service should be provided by qualified personnel.

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FOR YOUR NOTES

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7. TECHNICAL INFORMATION
7.1. SPECIFICATION

By the electric shock protection type classification: Type I equipment.


By the degree of shock proof classification: Type BF application part
By the specified of IEC60529 for liquid protection degree classification: IPX0.
By the manufacturers recommended disinfection and sterilization method classification:
Use neutral disinfection solvents or solution to clean.
By the air mixer of flammable gas or with oxygen or nitrous oxide mixture of flammable
anaesthetic gas safety degree classification: It should not use in air mixer of flammable
gas or with oxygen or nitrous oxide mixture of flammable anaesthetic gas.
By operational mode classification: Continuous operation.
Specifications for the Incubators are provided in Table 3.1. All specifications maybe
subject to change without advance notice. Open Access Doors and Front Panel or use the
supplies, the other equipment inside the incubator, which can alter the air flow pattern, may
affect temperature uniformity, temperature variability, the correlation of the Incubator
temperature reading to center mattress temperature and infant skin temperature.

7.1.2. TECHNICAL SPECIFICATIONS


The characteristics of the incubators are shown in Table A.1. All features are reserved without
notice.

EXTERNAL POWER REQUIREMENT


AC 220 V-230V/110V-120V, 50-60Hz
max 200VA or less.
DC 12 V, max 150VA or less
24 V, max 150VA or less
CHASSIS LEAKAGE CURRENT NC: <0.5mA, SFC: <1mA
According to IEC-60601-1, it is a class 1, BF type, internal power source device.
INTERNAL BATTERY FEATURES
Type -26 Battery
Piece One; two on request
Voltage 12V/26AH
Charging time (after full discharge) Single battery _10 hours
Two batteries_20 hours
Life 200 full charge / discharge
90 min (single battery)
180min (two batteries)
Battery length 17.5 cm
Battery width 16.6 cm
Battery height 12.6 cm

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Battery weight 9.1 kg
ENVIRONMENTAL TEMPERATURE (NORMAL)
Working range (normal) -
The incubator setting should be at least

temperature.
Working range (limited) -
Storage temperature range - -
ENVIRONMENTAL HUMIDITY
Working range %30 -%75 RH Mist-free
Storage humidity range < %95 RH Mist-free
ATMOSPHERIC PRESSURE
Atmospheric pressure range of loading and 500hPa 1060hPa
storage
Working atmospheric pressure range 700hPa 1060hPa

AIR FLOW RATE


Ambient air flow rate <1.0 m/s
TEMPERATURE CONTROL RANGE AND RELATED FEATURES
Air Mode Control 25.0
Skin Mode Control 34.0
Temperature < 30 min
Temperature Deviation **
Temperature Integrity ** (mattress level)
Difference between the displayed air temperature and
the actual temperature of the incubator ** (after the
incubator reaches the temperature balance **)
Skin temperature sensor accuracy **
ALARMS
Power failure alarm It works in AC power failure, DC power
shortage or when the battery is exhausted.
Engine failure alarm Engine failure, engine running speed too
low, or airflow stopped.
Low DC External DC12V or battery operates when
DC drops below 10.5V External DC24V or
battery operates when DC drops below
22.5V.

Sensor alarm It works in case of sensor failure or when the


skin sensor is not in place.
Temperature deviation alarm It works when the air or skin temperature is
higher or lower than the set limits.

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High temperature alarm Operates when incubator temperature is too
high when in air control mode or skin control
mode.
E2ROM disorder alarm It works when there is an internal defect in
temperature control.

DIMENSIONS
Height (highest position on the carriage table) 128cm
Height (lowest position on the carrying desk) 100cm
Length 170cm
Width 50cm
Main body weight (including incubator and two batteries) 80kg
Height adjustable carrying table weight 25kg
Serum rack maximum load carrying capacity 20N
Infant mattress maximum load carrying capacity 98N
Infant mattress length 63cm
Infant mattress width 35cm

A. STANDARDS
TR203 transport incubator meets the standards in the table below.
TS 60601-1
TS 60601-2
IEC 62304
IEC 62366
EN 60601-2-20

B. PRODUCT LABEL

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C. VERSIONS
TR203 Transport is available in 4 versions, incubator A, B, C and D.

TR203 A: Base Version.

TR203 B: Base version + O2


measurement module

TR203 C: Base version + SPO2


measurement module

TR203 D: Base version + O2


measurement module + SPO2
measurement module

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7.2. EMC TEST REPORT

GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS

This TR203 Transport Incubator has been developed for use in the following environment. The customer or user
must ensure that the TR203 Transport Incubator is used in the specified type of environment.

Emission test Compatibility Electromagnetic Environment - Guidance


RF (radio frequency emissions) Group 1 RF energy TR203 Transport Incubator is used
CISPR 11 only for internal operation. For this reason, RF
emissions are very low and it is unlikely to
interfere (interfere) with nearby electronic devices.

RF (radio frequency emissions) Class A


CISPR 11 types of facilities, except for those directly
connected to low-voltage public networks that
Harmonic emissions TS - provide electricity for domestic and domestic
EN 61000 3 2 purposes.

Voltage fluctuations / flicker emissions TS EN -


61000 3 3
GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY

This TR203 Transport Incubator has been developed for use in the following environment. The customer or user
must ensure that the TR203 Transport Incubator is used in the specified type of environment.

Immunity test TS EN 60601 test Compliance level Electromagnetic


level environment - guidance
Electrostatic discharge Floors should be wood, concrete or
(ESD) TS EN 61000 4 ceramic tiles. If floors are covered
2 with synthetic material, the relative
humidity should be at least 10%.

Electrical fast transient / Mains electricity will be suitable


regime burst TS EN for general commercial and
61000 4 4 output lines output lines hospital environments.

Wave Mains electricity will be suitable


TS EN 61000 4 5 for general commercial and
common mode mode hospital environments.

Sudden voltage drops, <5% UT in 0.5 cycles <5% UT in 0.5 cycles Mains electricity will be suitable
short interruptions and (drop in UT> 95%) 40% (drop in UT> 95%) 40% for general commercial and
voltage changes in the UT in 5 cycles (drop in hospital environments. If the user
UT in 5 cycles (drop in
electricity supply input UT = 60%) 70% UT in needs to use the incubator to be
lines TS EN 61000 4 11 UT = 60%) 70% UT in
25 cycles (30% exposed to power outages, from
25 cycles (30% decrease in UT) <5% the incubator's uninterruptible
decrease in UT) <5% UT in 5 seconds (Drop power supply
UT in 5 seconds (Drop in UT> 95%) or battery is recommended.
in UT> 95%)

Electric frequency (50/60 3 A / m electric 3 A / m electric frequency Magnetic fields will be at a level
Hz) magnetic field TS EN frequency suitable for general commercial
61000 4 8 and hospital environments.

Note: The alternating current before the UT test level is applied is the mains voltage.

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GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY

This TR203 Transport Incubator has been developed for use in the following environment. The customer
or user must ensure that the TR203 Transport Incubator is used in the specified type of environment.

Immunity test TS EN 60601 test Compliance level Electromagnetic


level environment - guidance
Portable and mobile RF
communication devices should
not be used closer than the
recommended separation
distance calculated according to
the transmitting frequency of any
3 average square part of the incubator, including
Conducted RF 150 kHz to 80 MHz root volts
TS EN 61000 4 6 apart from 3 average its cables.
square root volts of Recommended separation
EBT bands distance
10 average square
root volts
Out of 10 average
square root volts of
EBT bands 150 kHz to
80 MHz 10 V/m

10 V/m
Sprawling RF 80 MHz to 2,5 GHz
TS EN 61000 4 3
Here; P is the maximum rated
output power of the transmitter
in watts (W) according to the
manufacturer; d is the
recommended separation
distance in meters (m) b field
strengths arising from the fixed
RF transmitter determined by
an electromagnetic field survey
c carried out should be less
than the compatibility level of
each frequency range.
Interference may occur near
equipment carrying the symbol
below.
NOTE 1: The higher frequency range from 80 MHz to 800 MHz is applied.
NOTE 2: This general information may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.

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a. EBT (industrial, scientific and medical) bands between 150 kHz and 80 MHz from 6,765
MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

b. Compatibility levels in EBT bands between 150 kHz and 80 MHz and frequency ranges
from 80 MHz to 2.5 GHz are intended to reduce the likelihood of interference from mobile /
portable communication devices brought to the patient area unintentionally. Therefore, an
additional factor of 10/3 was used to calculate the recommended separation distance for
transmitters in this frequency domain.

c. Field strengths from fixed transmitters such as cordless telephone base stations (cellular /
wireless) and terrestrial mobile radios, amateur radios, AM and FM radio broadcasts and TV
broadcasts cannot be predicted theoretically precisely. The results of the electromagnetic
field survey conducted to evaluate the electromagnetic environment caused by fixed RF
transmitters should be taken into consideration. If the field intensity measured at the location
where the incubator is used exceeds the applicable RF compliance level stated above, it
should be checked if the incubator is operating normally. In the event of an abnormality in
his work, additional measures may be required, such as changing the orientation or location
of the incubator.

d. Field strengths above the frequency range of 150 KHz to 80 MHz should be less than 3 V /
m.

RECOMMENDED DISTANCE DISTANCES REQUIRED BETWEEN PORTABLE AND MOBILE RF


COMMUNICATION DEVICES AND TR203 TRANSPORT INCUBATOR
This TR203 Transport Incubator is designed for use in electromagnetic environments where
RF emission disturbances are kept under control. In order to contribute to the prevention of
electromagnetic interference, the customer or user should maintain a minimum distance
between the TR203 Transport Incubator and the portable and mobile communication devices
(transmitters), which are determined according to the maximum output power of these devices,
as follows.
Maximum rated Separation distance according to the frequency of the transmitter (m)
output power of 150 kHz to 80 Mhz 150 kHz to 80 80 MHz to 800 MHz 800 MHz to
the transmitter (W) Mhz in EBT 2,5 GHz
EBT bands bands
0,01 0,12 0,12 0,12 0,23
0,1 0,38 0,38 0,38 0,73
1 1,2 1,2 1,2 2,3
10 3,8 3,8 3,8 7,3
100 12 12 12 23

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The maximum rated output power can be determined for transmitters not mentioned above, in
meters (m), the recommended separation distance (d) using the equation that applies to the
frequency of the transmitter. Here; The maximum rated output power of the transmitter in watts
(W), according to the manufacturer P.

NOTE 1: The higher frequency range from 80 MHz to 800 MHz is applied.

NOTE 2: EBT (industrial, scientific and medical) bands between 150 kHz and 80 MHz from
6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26.957 MHz to 27.283 MHz; and 40.66
MHz to 40.70 MHz.

NOTE 3: In the calculation of the recommended separation distance for transmitters in the
EBT bands between 150 kHz and 80 MHz and in the frequency ranges from 80 MHz to 2.5
GHz, in order to reduce the likelihood of interference from mobile / portable communication
devices brought to the patient area unintentionally. Additional factor was used.

NOTE 4: This general information may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
All Rights Reserved.

Technical specifications can be changed by OKUMAN without prior notice.

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7.3. WORKING PRINCIPLE
7.3.1. General
This section contains a functional description and detailed theory of operation of the
equipment. A system block diagram of the Controller is shown in Figure 3.2 and 3.3.
Temperature control can carry through the air-circulation system as figure 3.1. After the air
outside is purified and is filtrated, it can go into the constant temperature hood from the air-
intake of the incubator through the fan driving, and then recycle to the fan by place with a
draught. All fresh and recycling air are led through nearby the airflow sensor and heater.
The air can pass through the sensor equipped with probe of temperature sensor, which
includes themistor of air temperature control and themistor of over-air-temp alarm.

FIGURE 3.1 AIR CIRCULATION SYSTEM

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FIGURE 3.2 CONTROL DIAGRAM

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FIGURE 3.3 FLOW CHART OF PROGRAMME

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7.3.2. Temperature Control
Temperature is regulated using either incubator Air or Skin temperature as the controlling
parameter; the desired mode is selected by the front panel keys.
In either mode of operation, the heater output is proportional to the amount of heat required
to maintain the desired temperature. In air mode the air temperature can be maintained

-ride mode: 37 38 ). A sensor located in the Sensor Module and


compared with Air Set Temperature setting monitors air temperature. The information from
this sensor is supplied to heater control circuitry which regulates the heater output to
maintain the Air Temperature setting. In the event that over temperature limit is activated,
the heater is shut off. Under this control mode, skin display window will display the
temperature on the skin te
--. -
In baby mode -ride
mode: 37 37.5 ) .A temperature sensor is attached directly to the skin; the
information from the sensor is supplied to the heater control circuitry, which proportions
the heater output to maintain the Skin Set Temperature. In Skin Temperature Mode, the
Skin Temperature will be displayed on Skin Temperature Display Window; the Air
Temperature Display Window will display the Air Temperature for information only. A
second sensor within the air temperature sensor serves as a backup to limit the maximum
Incubator temperature. In the event that over temperature limit is activated, the heater is
shut off.

7.3.3. Alarms
1. Alarm information
High priority: the most urgent information, red alarm light flashing, alarm sounds more than 65dB(A).
Five tones order alarm, ring twice, and every 2.5 seconds to repeat again
Note: the sound of power failure alarm is different from the other high priority alarm
which sound source is a single buzzle.
Medium priority: medium priority information, yellow alarm light flashing, alarm sounds more
than 65 dB(A).
Three tones order alarm, and every 7.5 seconds to repeat again.
2. The alarm preference is arranged according to the alarm serial number, the bigger the serial
number is, the lower level is. When various failures appear, the alarm prompts according to
the priority, the sound is different too.

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Alarm Introduction

Alarm Alarm Alarm activate Control The state Alarm Alarm


No. information Alarm character condition mode of level delay
heater time
Power failure on red Turn on the switch

alarm alarm light flashes sound without power supply High


1 All Off <5s
alarm start priority
Main machine MCU
Main machine Red alarm light flashes, set
internal ROM failure
ROM failure
High
2 alarm sound alarm All Off <5s
priority
start
Main machine MCU
Main machine Red alarm light flashes, set
internal system failure
internal system
High
3 failure alarm sound alarm All Off <5s
priority
start
Communication Red alarm light flashes, set communication failure
failure alarm between main machine
and slave machine A High
4 sound alarm All Off <5s
priority
start
Slave machine Red alarm light flashes, set Salve machine
internal ROM failure
ROM failure
High
5 alarm sound alarm All Off <5s
priority
start
Slave machine system
Slave machine Red alarm light flashes, set
failure
internal system
High
6 failure alarm sound alarm All Off <5s
priority
start

Red alarm light flashes, set Main machine internal


FLASH failure FLASH failure
alarm High
7 sound alarm start All Off <5s
priority

Main machine ADC


Main machine
Red alarm light flashes, set failure for example
ADC failure
slave machine system
alarm TLV2548 including High
sound alarm start All Off <5s
8
priority
sampling error, chip
damage,
no reaction, etc

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Alarm introduction continued

Alarm Alarm Alarm activate Control The state Alarm Alarm


No. information Alarm character condition mode of level delay
heater time
Heating circuit fault
Red alarm light flashes, set (for example the
Heating system
heater, solid-state High
9 failure alarm All Off <5s
sound alarm start relay, priority
mechanical relay and
the circuits controlled
by
them failure

Short circuit, open


red alarm light flashes, set
Air sensor failure circuit or bad High
10
alarm connection occurs All Off
priority
<5s
sound alarm start
inside the air
temperature sensor

Short circuit, open


Isolated sensor red alarm light flashes, set
circuit or bad High
11 failure alarm All Off <5s
connection occurs priority
sound alarm start
inside the isolated
temperature sensor

Air sensor red alarm light flashes, set The difference


High
12 difference failure between air sensor All Off <40s
priority
alarm sound alarm start and isolated sensor
above 0.8

red alarm light flashes, set Short circuit, open


Skin sensor failure circuit or bad High
13
alarm connection occurs Baby Off
priority
<5s
sound inside the skin
alarm start temperature sensor

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Alarm introduction continued

Alarm Alarm information Alarm activate Control The state Alarm Alarm delay
No. Alarm character condition mode of level time
heater
The temperature of the
incubator is not over 38
Over temperature on red alarm light
set temperature is less High
alarm flashes, set indicator than 37
14 or not over 39 All Off
priority
<10s
set temperature is
alarm start more than 37
DC 12V the voltage of
power supply or storage
battery is less than 10.5V

on red alarm light DC 24V the


Low DC alarm High
15 flashes, set indicator voltage of power supply All Off <10s
is less than 22.5V or output priority

alarm start voltage of the switching


power supply is less than
14V
Cell box connection failure
Red alarm light
Cell box (the connection part
flashes, set indicator High
connection failure between the storage All Off <5s
16
priority
battery and cell box
alarm start
failure)

red alarm light


High
flashes, set indicator Fan stop rotating All Off <15s
s priority

alarm start
Fan failure alarm
17
red alarm light
High
flashes, set indicator The rotate speed is slow All Off <5s
priority

alarm start

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Alarm introduction continued

Alarm Alarm Alarm activate Control The state Alarm Alarm


No. information Alarm character condition mode of level delay
heater time
The displayed air
red High
temperature is Air Off <5s
alarm light flashes, set priority
higher
than set temperature
start 1
The displayed
Deviation alarm High
18 skin temperature Baby Off <5s
priority
is higher
than set temperature
1
red The displayed air High
temperature is Air On <5s
alarm light flashes, set priority
lower
than set temperature
1
start The displayed
High
skin temperature Baby On <5s
priority
is lower
than set temperature
1
Yellow alarm light flashes,

Keyboard alarm Medium


19 sound alarm Keyboard failure All Off <5s
priority
start

Yellow alarm light flashes, Short circuit, open


s
Battery alarm circuit or bad Medium
20 sound alarm All Off <5s
connection occurs priority
start
inside the
rechargeable
battery

Note 1.all the above alarms except the skin over temperature alarm in baby mode
are belong to physiological alarm status, the power failure alarm belongs to other
alarm status; The others are all technology alarm status.
2. except for the power failure alarm, the other alarms are all can silence by pressing
silence/reset key, the time for silence is 5 mins. When the silence time is over, if the alarm
condition is still not solved, the alarm will have to activate. If occur multiple alarm at the
same time, the device will give an alarm firstly for the higher grade.

4. The power failure alarm lasts at least 10 mins, when power supply recover before the
alarm indication, the equipment will back to the setting before power failure alarm.

Warning: when using the incubator in any independent place, if use different alarm
preset, there will be the potential risk.

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8. MAINTENANCE
8.1. INTRODUCTION
This section provides the replacement of the inner battery, the set procedure of the control and
the procedure of trouble-shooting.
8.2. REPLACEMENT OF INNER BATTERY AND INNER FUSE
See figure 5.1, unscrew the bolts on the cover of the power board and the fixing bolt on the
power board, take out the upper cover, disconnect all the wiring plugs on the control board, take out
the temperature control. You can replace the inner battery and inner fuse.
Skin temp Sensor Plug of Power Switch for Control 1AL/250V T Fuse Plug of Fan Motor Power

Air temp Sensor 15AL/32V F Fuse 500mAL/250V T Fuse Heater Plug Plug of Illumination lamp

FIGURE 5.1

Battery fastener Internal charing battery Baffle


FIGURE 5.2 NOTE
. During replacing the internal battery, the plastic washer should be placed the original position,
and keep correct connection between the anode/ cathode of battery and its fastener; the faulty
connection will cause the damage to the battery and no hont for power failure alarm.
. Please replace the internal battery after using it for three years.
. Battery will be automatically charged when the temperature controller works, charging the battery
outside of the incubator is forbidden.
. The charging battery inside the wartmer is GP17R8H Ni-MH8.4V/170mAh, to ensure safety, do not
disassemble battery. Connect the battery correctly, do not use other type battery.
. Please do not throw the old battery into fire or water to avoid explosion or leakage.
. When install the temperature controller, please push the controller back to the original position,
then connect all receptacle.

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8.3. REPLACEMENT OF ILLUMINATION LAMP AND OUTER FUSE
A.Replacement Outer Fuse

FUSE COVER

Figure 5.3, open the cover of fuse to replace the fuse.

FIGURE 5.3
Note: The fuse only can be replaced by authorized qualified maintenance personnel. Please cut off the
power supply and do not touch the metal parts and patients at the same time before replacing the
fuse according to the stipulated specification.
B. Replacement Of Illumination Lamp
If the illumination lamp is not on, please check whether the voltage of illumination lamp is
DC12V, if good, then check the connecting condition of illumination lamp socket and power output
condition.
8.4. REPLACEMENT OF THE STORAGE BATTERY

Storage battery tray Storage battery power socket

Negative connection bolt

Positive connection bolt

Storage battery

Turn out positive and negative connection bolt of the storage battery to replace it.
FIGURE 5.4

NOTE:
1. The replacement of storage battery shoud be done by the professions personnel.
2. Reconnect positive and negative wire of the storage batter, the brown wire should be
connected to positive of the storage battery and the blue wire to negative.
3. The damage of the socket of storage battery electricity-offer is forbidden. We suggest to
use type -26 and storage battery electricity-offer 12V/26AH.

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4. The storage battery can only recharge when the temperature control is working, you
should not take it out to recharge by yourself.
5. Recharge it when the storage battery is full (turn on the switch of the temperature control),
it will not affect the capacity of the storage battery.
6. Throwing the useless battery into the fair or water is forbidden to avoid of explosion or
liquid leaking.
7. The useless battery should not discard at will, should be dealt with according to the law of
the nation.
8. When the device enters into the battery protection mode, ( the power failure light is
on, any other light will not give any indication and audible tips), the user must recharge it or turn
off the device at once to avoid affecting the life-span of the storage battery.

8.5. Alarm code


Other alarm have the relative alarm code except for the power failure alarm, see table 5.1.
TABLE 5.1 CLASSIFICATION OF ALARM CODE

Alarm code Classification Cause and method

E0.1 Air temperature sensor failure alarm See flow chart 5.2

E0.2 Isolated temperature sensor alarm See flow chart 5.3

Air temperature deviation failure alarm


E0.3 See flow chart 5.4

Skin temperature sensor failure


E0.4 alarm See flow chart 5.5

E0.5 Over temperature failure alarm Refer to Flow chart 5.6

E0.6 Fan motor stop alarm Check the connecting wire of the fan

Check whether the fan stops working or the low


E0.7 Fan motor retard alarm speed

E0.8 Wrong position of skin sensor alarm Check the position of skin sensor

1. Check whether there is heat source nearby, if


yes, please leave far away from the heat source.
High deviation temperature failure 2. Check the close condition of all doors and
E0.9 alarm panels

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Low deviation temperature failure
E1.0 alarm The same as high deviation alarm

E1.1 Low voltage alarm See flow chart 5.7

Power failure alarm See flow chart 5.8

TABLE 5.1 CLASSIFICATION OF ALARM CODE CONTINUE

Alarm code Classification Cause and method

ROM failure alarm inside auxiliary MCU


H0.1 Replace the control card

Internal system failure alarm inside main


H0.2 MCU Replace the control card

H0.3 Communication Failure Replace the control card

H0.4 ROM malfunction alarm inside of Replace the control card


auxiliary MCU

Internal system failure alarm inside


H0.5 auxiliary MCU Replace the control card

H0.6 FLASH failure alarm Replace the control card

H0.7 Main ADC failure alarm Replace the control card.

H0.8 Auxiliary ADC failure alarm Replace the control card

1. Check the heating control relay


K3 on the power board, triode Q2 and
other controlling circuit.
2. Check the MOS Q4, Q5 on the
H0.9 Heating control relay malfunction alarm power board to see whether they're
damaged or not.
3. Check the electronic parts U5 and
its relative circuit.
4. Check the heater to see whether
it's broken or bad connected.

H1.0 Power voltage overlarge failure See flow chart 5.9

H1.1 Keyboard fault alarm Replace the control panel

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H1.2 Battery failure alarm Replace the inner storage battery

Connecting parts between the storage Check the connecting socket


H1.3 battery and the power box fault alarm between the battery and the power
box, ans check the connection of the
socket J9 in the power board.

8.6. Check Flow Chart


Before inspection, first, open the power cover box, while ensuring control device +5V and
+12V power supply is normal, normal components and wires. In working condition, while pressing
the upper button and the air temperature key, air temperature display window shows air temperature
sensor temperature or no display, skin temperature display shows vehicle power supply voltage or
no display, battery capacity display window shows the charge voltage or battery voltage and set
temperature display window shows the fan speed or power supply switch voltage. These display
contents can be useful for maintance staff to find the cause of the malfunction.

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FLOW CHART 5.2 AIR TEMPERATURE SENSOR ALARM

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FLOW CHART 5.3 ISOLATED TEMPERATURE SENSOR ALARM

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FLOW CHART 5.4 AIR TEMPERATURE DEVIATION FAILURE
ALARM

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FLOW CHART 5.5 SKIN TEMPERATURE SENSOR ALARM

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FLOW CHART 5.6 OVER-TEMP FAILURE

FLOW CHART 5.7 LOW-VOLTAGE ALARM (SHEET 1 OF 6)

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FLOW CHART 5.7 LOW-VOLTAGE ALARM (SHEET 2 OF 6)

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FLOW CHART 5.7 LOW-VOLTAGE ALARM (SHEET 3 OF 6)

FLOW CHART 5.7 LOW-VOLTAGE ALARM (SHEET 4 OF 6)

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FLOW CHART 5.7 LOW-VOLTAGE ALARM (SHEET 6 OF 6)

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FLOW CHART 5.8 POWER FAILURE ALARM (SHEET 1 OF 3)

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FLOW CHART 5.8 POWER FAILURE ALARM (SHEET 2 OF 3)

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FLOW CHART 5.8 POWER FAILURE ALARM (SHEET 3 OF 3)

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8.7. Troubleshooting
WARNING: The main part of the incubator is the temperature controller. The sensor, motor fan and
heater provide air heating and air circulation. In this case, when any of the parts fail, the ambient
temperature of the infant will be affected. For example, the aging and deterioration of heating will
affect the heating rate and result in the temperature not rising; Fan aging and deterioration will affect
the integrity of the temperature and change the air circulation. Sensor aging and deterioration will
affect temperature reading. The self-test process of the control unit, the fan motor, the sensor, the
alarms for overheating and isolated overtemperature are aimed at ensuring the perfect care of the
infant. Moreover, doctors should check the functions before use. There may be many errors during
the service life of the incubator, as in Table 7.1. When the alarm sounds, the cause of the error is
found and the error is completely eliminated before the unit is used.

TABLE 7.1. Some malfunctions and solutions

SIGNS POSSIBLE WHY WHAT TO DO

Screen does not work, power Power button off Press the power button
failure alarm does not work
Power supply is off Turn on the power

Fuse blown Take it to the technical service


Audible and illuminated
power failure alarm
Power cord not connected Plug the cable

No battery installed Push the battery tray again

Voltage is too low battery Connect to AC power supply


urgently

Low voltage alarm E10 Low voltage DC power supply Connect to another power source
or turn off from the main button

Faulty power supply board Take it to the technical service


1. No air temperature sensor Take it to the technical service
Weather connection
sensor alarm
2. Air temperature sensor Take it to the technical service
E01 defective
1. Skin temperature sensor Plug in
unplugged
Sensor Skin sensor alarm
2. Skin temperature sensor not Take it to the technical service
failure E02
connected
alarm
3. Skin temperature sensor is Take it to the technical service
defective
1. Isolated sensor not connected Take it to the technical service
Isolated
sensor alarm 2. Isolated sensor is defective Take it to the technical service

Skin sensor not in Skin sensor is not in the Check the skin sensor
place alarm correct position location

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TABLE 7.1. Some malfunctions and solutions - Continue

SIGNS POSSIBLE WHY WHAT TO DO

Fan motor failure Engine Damage Take it to the technical service


E05
Fan motor
failure
Fan motor speed Fan motor speed is Take it to the technical service
alarm
is low or does not less than 1000 rpm
spin E06
Fan motor does not rotate Take it to the technical service
A heat source nearby Move away from heat source

Over temperature alarm E07 Temperature control system Take it to the technical service
out of control
Isolated overheating sensor Take it to the technical service
damaged
Front panel or access windows Close all access windows and
and iris entry section remain partitions
open
Deviation alarm E08 or E09
Big change in ambient Check the ambient temperature
temperature
A heat source nearby Move away from heat source

IC X5045 damaged Take it to the technical service


All alarm indicators are flashing
System alarm E11 System data reading is corrupt Restart the temperature control
unit

No screen Take it to the technical service

No warm-up Take it to the technical service

The height of the carrying table The roller of the transport table Take it to the technical service
cannot be adjusted is defective

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9. MAIN PARTS LIST AND PARTS NUMBER
9.1 GENERAL
This section provides parts lists for infant incubator. Part numbers of
accessories are provided below:

5
3

6 2

FIGURE 6.1 PARTS LOCATION DIAGRAM, WHOLE UNIT

TABLE 6.1 PARTS AND ACCESSORIES LIST, WHOLE UNIT

No. Name Parts No.

1 Trolley 36.08.001.01

2 Controller 36.38.021.01

3 Hood 36.02.001.00S

4 Base 36.04.047.00S

5 I. V. Pole Groupware 36.11.001.00S

6 Oxygen feeding valve 86.61.110.00

7 Oxygen cylinder 86.61.063.00

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FLOW CHART 6.2 REPLACING PARTS FOR HOOD SHEET 1 OF 2

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FLOW CHART 6.2 REPLACING PARTS FOR HOOD SHEET 2 OF 2

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TABLE 6.2 LIST OF REPLACING PARTS FOR HOOD

No. Name Parts No.


1 Side door 36.02.002.01
2 Hood 36.02.006.00

3 Front door 36.02.011.01


4 Window touch head 05.02.013.00
5 I. V. soft port 36.02.015.01

6 Spanner 41.17.060.00

7 Spanner bolt 41.17.061.01

8 Column compressed spring 41.17.062.00

9 Hexagon nut M5 86.44.338.00

10 Lock of box gemel seat 36.02.016.01S

11 86.44.218.00

12 Spring washer 4 86.44.414.00

13 Hexagon nut M4 86.44.336.00

14 Seal nail 36.02.020.02

15 Perforative peg 36.02.021.01

16 Lock of box 36.02.022.03

17 Side door gemel seat 36.02.023.00

18 Place-bolt 36.02.035.01

19 Front door gemel seat 36.02.024.00

20 Latch seat 05.02.015.01

21 Access door 05.02.014.02

22 Seal 36.02.025.01

23 Front door heat insulation 36.02.026.00

24 86.44.152.00

25 86.44.149.00

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TABLE 6.2 LIST OF REPLACING PARTS FOR HOOD (CONTINUE)

No. Name Parts No.

26 05.02.026.00

27 Door spring 36.02.033.00

28 05.02.028.02

29 05.02.029.00

30 86.44.510.00

31 86.44.472.00

32 Latch stopper 05.02.032.00

33 Spring (1) 05.02.034.00

34 Access door latch 05.02.035.03

35 Ring assembly 05.02.024.00

36 86.44.256.00

37 M3 bolt cover 05.02.046.01

38 Terminal door heat insulation 36.02.030.00

39 Fixing circle 05.02.023.00

40 Iris port 05.02.022.00

41 The groupware of rotating port sleeve 05.02.025.00

42 86.44.226.00

43 The seal for terminal door 36.02.034.01

44 Fflat washer 4 86.44.442.00

45 Fflat washer 3 86.44.440.00

46 Spring washer 3 86.44.412.00.

47 Wench plug 41.52.040.00

48 Spring( ) 05.02.034.00
49 Transition plate 13.02.044.01

50 B type cylindrical pin 86.44.471.00

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TABLE 6.2 LIST OF REPLACING PARTS FOR HOOD (CONTINUE)

No. Name Parts No.

51 Cross groove head bolt M3 14 86.44.150.00

52 O type seal circle 6.3 1.8 86.44.509.00

53 Cross groove countersunk head bolt M3 8 86.44.216.00

54 Lock fastening 05.02.040.04

55 Lifting pin 05.02.032.00

56 Locking seat 05.02.042.01

57 Locking seat C 36.50.082.00

58 Doors and windows note label 12.50.048.00

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FLOW CHART 6.3 REPLACING PARTS FOR BOX BODY ABOUT INCUBATOR

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TABLE 6.3LIST OF REPLACING PARTS FOR INCUBATOR

No. Name Parts No.

1 Incubator body 36.04.048.01

2 Spring board 36.04.049.00

3 Cross groove head 86.44.164.00

4 Fflat washer 4 86.44.442.00

5 Spring washer 4 86.44.414.00

6 Hexagon nut M4 86.44.336.00

7 Seal washer 36.04.050.01

8 86.44.161.00

9 Bed handle 36.04.051.00

10 Underlying board for clambering base 36.04.052.00

11 clambering base 36.04.053.00

12 86.44.207.00

13 Spring slice bolt 36.04.054.00

14 Reservoir bar 36.04.055.00

15 Label for humidity sponge 36.04.056.02

16 The right pressure bar for bed 36.04.058.00

17 The left pressure bar for bed 36.04.059.00

18 The seal washer for hood 36.04.060.01

19 86.44.268.00

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FLOW CHART 6.4 REPLACING PARTS FOR I.V. POLE GROUPWARE

TABLE 6.4 LIST OF REPLACING PARTS FOR I.V. POLE GROUPWARE


No. Name Parts No.

1 Hook groupware 13.11.009.00

2 Hexagon nut M6 86.44.340.00

3 Hoop circle 36.11.002.00

4 Hoop nut 36.11.003.00

5 I.V. column 36.11.004.00

6 I.V. pillar 36.11.005.00

7 I.V. seat 36.11.006.00

8 86.44.099.00

9 Place limit head 36.11.007.00

10 86.44.136.00

11 Label for weight of I.V.Pole 36.11.010.03

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FLOW CHART 6.5 REPLACING PARTS FOR STANDARD TROLLY (SHEET 1 OF 2)

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FLOW CHART 6.5 REPLACING PARTS FOR STANDARD TROLLY (SHEET 2 OF 2)

TABLE 6.5 LIST OF REPLACING PARTS FOR STAND

No. Name Parts No.

1 Front bar 36.04.002.00

2 Crosspiece 36.04.003.00

3 Back bar 36.04.004.00

4 86.44.233.00

5 Main frame 36.04.005.00

6 Support board 36.04.006.00

7 86.44.247.00

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8 86.44.231.00

9 Spring washer 5 86.44.418.00

10 Flat washer 5 86.44.444.00

11 Cap nut M5 86.44.382.00

12 Outer sawtooth clamping washer 5 86.44.397.00

13 86.44.232.00

14 Hexagon nut M5 86.44.338.00

15 Oxygen cylinder capper 36.04.007.02S

16 86.44.290.00

17 Cross groove 86.44.217.00

18 Spring washer 8 86.44.423.00

19 The left earthed connecting board 36.04.014.00

20 The right earthed connecting board 36.04.066.00

21 Trolley 36.50.038.01S

22 Fixed seat 36.04.011.00

23 Hinge 05.09.036.00S

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FLOW CHART 6.6 REPLACING PARTS FOR TEMPERATURE CONTROL 1

TABLE 6.6 LIST OF REPLACING PARTS FOR TEMPERATURE CONTROL 1

No. Name Parts No.

1 Switch group ware for control 36.07.033.01S

2 86.44.212.00

3 Hexagonal spacer support HTP-315 86.45.010.00

4 Spring washer 3 86.44.412.00

5 Hexagon nut M3 86.44.334.00

6 Frame 36.07.034.00S

7 Panel 37 36.07.005.04

8 86.44.159.00

9 Flat washer 3 86.44.440.00

10 Electrical device name plate 36.07.010.01

11 Shield cover groupware 36.07.035.00S

12 Cross 86.44.215.00

13 Main board 36.40.051.00

14 Hexagonal spacer support HTS-308 86.45.013.00

15 Plastic washer 13.07.008.00

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16 Battery box 12.07.089.00S

17 86.44.215.00

18 Alarm components 12.40.049.03S

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FLOW CHART 6.7 REPLACING PARTS FOR TEMPERATURE CONTROL 2

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TABLE 6.7 LIST OF REPLACING PARTS FOR TEMPERATURE CONTROL 2

No. Name Parts No.

1 86.44.216.00

2 86.44.215.00

3 86.44.165.00

4 Flat washer 4 86.44.442.00

5 Spring washer 4 86.44.414.00

6 Hexagon nut M4 86.44.336.00

7 Connecting group ware of storage battery A 36.07.043.00S

8 Hexagon nut M3 86.44.334.00

9 Spring washer 3 86.44.412.00

10 Flat washer 3 86.44.440.00

11 Hexagonal spacer support HTS-306 86.45.012.00

12 Plastic washer 13.07.008.00

13 Power board 36.07.037.06

14 86.44.159.00

15 Electrical box 36.07.018.01

16 Wiring fastening clip TS-0607 86.45.018.00

17 Vehicular power cord 36.07.045.00S

18 Skin temperature sensor 88.00.003.00

19 86.44.287.00

20 Top baffle 36.07.019.01

21 Bottom baffle groupware 36.07.040.00S

22 Cross groove head bolt 86.44.176.00

23 Grounded poster 12.07.047.00

24 Power switch MMK320S-15 86.60.117.00

25 Power Cord 86.46.012.00

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FLOW CHART 6.8 REPLACING PARTS FOR TEMPERATURE CONTROL 3

TABLE 6.8 LIST OF REPLACING PARTS FOR TEMPERATURE CONTROL 3

No. Name Parts No.

1 Lower poster for elctrical device 36.07.021.03

2 Lower cover baffle 36.07.023.01

3 Sensor socket 36.07.041.01S

4 Cross groove countersunk head 86.44.207.00

5 Hexagon nut M3 86.44.334.00

6 Spring washer 3 86.44.412.00

7 Power socket 3GTJE1 86.55.001.00

8 Power switch C1353ALG-H 86.57.027.00

9 Flat washer 3 86.44.440.00

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10 86.44.148.00

11 Fuse F3.15AH/250V 86.59.008.00

12 Fuse seat R3-11 86.59.017.00

13 The groupware of vehicular power cord 36.07.042.00S

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FIGURE 6.9 REPLACEMENT SPARE PARTS FIGURE OF JACKLIGHT

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TABLE 6.9 REPLACEMENT SPARE PARTS TABLE OF JACKLIGHT

No. Name Parts No.

1 Shell 36.01.002.01

2 Absorbing feet 43.21.001.01

3 86.44.165.00

4 Light frame board 36.01.003.00S

5 Cover board 36.01.005.00

6 Lamp group 36.01.006.01

7 Protection slice 36.01.008.00

8 Socket 86.55.109.00

9 86.44.159.00

10 Flat washer 3 86.44.440.00

11 Spring washer 3 86.44.412.00

12 Power switch 86.57.017.00

13 Flat washer 10 86.44.430.00

14 86.44.348.00

15 86.61.043.00

16 Light feet 36.01.009.03

17 White heat shrinking cannula RSTG- 86.60.034.00

18 The lable of switch 36.01.010.01

19 Plug MC100-50802 86.55.059.00

20 Rectangular faucet JXCK-6.3 86.55.136.00

21 Rectangular faucet SLHT-6.3 86.55.138.00

22 Ring type ferrite ZCA1730-0730 86.60.081.00

23 86.44.158.00

24 86.61.035.00

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