Infant Incubator

Model:111

Service Manual
August2019 Cr-Wi-09 Rev:01
Contents
1-Preface ......................................................................................................................................... 1
2-Purpose........................................................................................................................................ 2
3-Audience ..................................................................................................................................... 2
4-Definition .................................................................................................................................... 2
4-1-Symbol definition ............................................................................................................ 2
4-2-Thechnical definition..................................................................................................... 2
5-Disclimer ..................................................................................................................................... 4
6-Introduction .............................................................................................................................. 5
6-1-Incubator ............................................................................................................................ 5
6-2-Different parts identification ..................................................................................... 6
6-3-Control panel ................................................................................................................. 10
7-Spesification ........................................................................................................................... 11
8-Installation .............................................................................................................................. 13
8-1-Installation ambient conditions ............................................................................. 13
8-2-Power outlet and grounding ................................................................................... 15
8-3-Unpackaging................................................................................................................... 17
8-4-Start-Up ............................................................................................................................ 19
9-Calibration............................................................................................................................... 23
9-1-Calibration ambiance conditions .......................................................................... 23
9-2-Calibration instrument .............................................................................................. 23
9-3-Calibratin method ........................................................................................................ 23
Air temperature sensor calibration .......................................................................... 23
Skin temperature sensor calibration........................................................................ 25
10-Cleaning and Disinfection .............................................................................................. 26
10-1-Enclosure ...................................................................................................................... 27
I i Acce Po Cuff ...................................................................................................... 27
A
 Acce Panel R bber Packing ................................................................................... 27
Rubber grommets ............................................................................................................. 28
Inner wall panel................................................................................................................. 28
Enclosure.............................................................................................................................. 28
10-2-Mattress Platform and Parts Beneath .............................................................. 29
Mattress Tray ..................................................................................................................... 29
Slider Tray ........................................................................................................................... 29
Main Deck............................................................................................................................. 30
Fan impeller ........................................................................................................................ 30
Heater radiator .................................................................................................................. 31
10-3-Humidity Reservoir .................................................................................................. 31
10-4-Skin Sensor................................................................................................................... 32
10-5-Mattress ......................................................................................................................... 32
11-Trouble shooting Guide .................................................................................................. 33
11-1-De ice Alarm .......................................................................................................... 33
11-2-Symptom, Cause and Remedy .............................................................................. 37
12-Replacement ........................................................................................................................ 41
12-1-Replacement part list............................................................................................... 41
Enclosure.............................................................................................................................. 41
Mattress platform ............................................................................................................. 42
Cabinet contents................................................................................................................ 42
Contents on cabinet body .............................................................................................. 43
Control unit ......................................................................................................................... 44
Beneath the cabinet separator plate ........................................................................ 45
VHA stand............................................................................................................................. 46
Caster base........................................................................................................................... 46
IV Stand ................................................................................................................................. 47
12-2-Replacement methods............................................................................................. 48
B
 Enclosure.............................................................................................................................. 48
Drawer................................................................................................................................... 52
Elevating foot pedals ....................................................................................................... 53
Cabinet separator plate .................................................................................................. 54
Jack .......................................................................................................................................... 56
Sensors .................................................................................................................................. 57
Fuses....................................................................................................................................... 58
Inline fuses replacement ............................................................................................... 58
Panel mounts fuse replacement ................................................................................. 59
Battery ................................................................................................................................... 60
Electrical boards ............................................................................................................... 60
13-Block diagrams ................................................................................................................... 61
13-1- Hardware Architecture .......................................................................................... 61
13-2- Circuit Boards ............................................................................................................ 62
13-3-Insulutiuon Diagrams .............................................................................................. 63
13-4-Software Architecture ............................................................................................. 64
14-Service .................................................................................................................................... 65
15- Authorized Representatives ........................................................................................ 66
15-1-European Authorized Representatives ............................................................ 66
15-2- Sale and Service Agents ......................................................................................... 67
In Iran .................................................................................................................................... 67
Outside of Iran.................................................................................................................... 68
Annex1. Inspection .................................................................................................................. 69
Annex2. Inspection documentation form ..................................................................... 75

C
1-Preface

TOSAN Company, Pioneer of neonatal resuscitation systems production in Iran, was founded in
1983. Since then TOSAN s primar goal as al a s to introduce inno ati e and cost effecti e
solutions in order to impro e the ne born s li es.

Being a pioneer in Iran, TOSAN succeeded to manufacture the first infant incubator in its early
days of establishment, named Mozhdeh. Infant incubator has been the main product of this
company up until now, though TOSAN has developed new products that serves its goal through
these years such as transport incubator, infant radiant warmer, and phototherapy appliance to
name few.

Infant Incubator Model 111

Infant Transport Incubator Model 320
Infant Radiant warmer Model 083
8 Lamps intensive Phototherapy Model 222
12 Lamps intensive Phototherapy Model 224
16 Lamps intensive Phototherapy Model 225
Infant Stand Phototherapy Model 023
Home Phototherapy Model 027
Infant Servo Warmer Model 053
Infant Simple Warmer Model 052
Infant Cot Model 033
Infant Simple Cot Model 031
Infant Cot with tilting system Model 032
Simple Cot-Warmer Model 140
Servo Cot-Warmer Model 130
Head Holder Model 048
Adult Oxygen Hood Model 047
Infant Oxygen Hood Model 041, 042, 044
Infant Height Measurement Model 072
Infant Blindfold Model 150

Quality assurance of all activities that take place in this company coincides with strict rules of
ISO9001 and ISO13485. Due to the fact that all products of the company are designed and
manufactured based on international standards, TOSAN not onl pro ides Iran s market ith its
medical appliances but also has find its way through international market like Russia, Iraq,
Saudi Arabia, UAE, Turkey, and etc.

1
2-Purpose
This manual describes maintenance and service methods for Infant Incubator Model 111. It also
includes calibration, cleaning and disinfection, troubleshooting and a list of replacement parts.
Furthermore various kinds of inspection are described in detail in this manual.

3-Audience
This document is only provided for trained and authorized service personnel of TOSAN
Company. Failure to do so could result in personal injury or equipment damage.

4-Definition
4-1-Symbol definition
This symbol highlights a WARNING or CAUTION.

This symbol highlights an ELECTRICAL SHOCK HAZARD WARNING

This symbol highlights an important POINT or REMINDER

Thi mbol ho TOSAN Compan AUTHORIZED REPRESENTATIVE in

EUROPE.

4-2-Thechnical definition

Skin temperature sensor: Sen or hich i probe i in alled on infan bod and read
infan kin empera re.

Air temperature sensor: Sensor which its probe is placed inside the enclosure and reads air
temperature of the enclosure.

Thermostat sensor: An independent temperature sensor which its probe is placed inside the
enclosure and reads air temperature of the enclosure.

Humidity sensor: Sensor which its probe is placed inside the enclosure and reads relative
humidity within the enclosure.

Skin temperature: Infan kin empera re hich i en ed b kin empera re en or.

2
Air temperature: Air temperature within the enclosure which is sensed by air temperature
sensor.

Relative humidity: Amount of water vapor present inside the enclosure expressed as
percentage of the amount needed for saturation at the same temperature. This value is sensed by
humidity sensor.

Set skin temperature: Desired infant s skin temperature which is set by the user. Control
system adjusts the skin temperature of the infant based on this value.

Set air temperature: Desired air temperature which is set by the user. Control system adjusts
the air temperature of the enclosure based on this value.

Set relative humidity: Desired relative humidity which is set by the user. Control system
adjusts the humidity of the enclosure based on this value.

Control temperature: The set temperature that temperature control system operates based on
it. This value, in Air temperature control mode is set air temperature and in skin temperature
control mode is set skin temperature .

Control relative humidity: The set relative humidity that humidity control system operates
based on it.

Air Mode: In this control mode, the incubator controls air temperature within the enclosure by
getting feedbacks from air temperature within the enclosure.

Skin Mode: In this control mode, the incubator controls air temperature within the enclosure by
getting feedbacks from infant s skin temperature.

Normal Operation mode: The default operation mode that user can set air temperature within
the incubator between 20ºC and 37ºC. This operation can be activated in both Skin Mode and
Air Mode.

Special Operation mode: Operation mode of the device which is also described as 39 C
Mode . In this operating mode user can set air temperature within the enclosure up to 39 C.
This operation can be activated only in Air Mode.

A.S.D: abbreviated of Air Set Deviation.

3
5-Disclimer
Replacement parts will only be supplied by TOSAN Company during the useful life of the
device. TOSAN Company shall not be responsible for any fault or broken part if this period is
passed. After expiration of useful life time all obligations for warranty shall be terminated and
TOSAN Company shall no longer accept any warranty claims.

Only trained personnel are authorized to service, calibrate, and repair the device. Failure to
do so could result in personal injury or equipment damage. In this case TOSAN Company shall
not be responsible for any injury, and device s guarantee and warrantee will be terminated.

Only use spare parts which are specified in replacement parts and supplied by TOSAN
Company for service and maintenance purposes. Failure to do so could result in personal injury
or equipment damage. In this case TOSAN Company shall not be responsible for any injury,
and device s guarantee and warrantee will be terminated.

TOSAN s authori ed representatives are not allowed to sell a device unless TOSAN
Company is informed. Failure to do so could result in personal injury or equipment damage. In
this case TOSAN Company shall not be responsible for any injury, and device s guarantee and
warrantee will be terminated.
Consumable parts are excluded from warranty obligations.
To service, calibrate and repair the device user should follow procedures which are
specified in this manual. Failure to do so could result in personal injury or equipment damage.
In this case TOSAN Company shall not be responsible for any injury, and device s guarantee
and warrantee will be terminated.

In case of product recall or major modifications and repairs, all TOSAN representatives are
obligated to collect all devices. Failure to do so could result in personal injury or equipment
damage. In this case TOSAN Company shall not be responsible for any injury, and device s
guarantee and warrantee will be terminated.

TOSAN s authori ed representatives are obligated to service and calibrate sold and
installed devices at regular intervals. Failure to do so could result in personal injury or
equipment damage. In this case TOSAN Company shall not be responsible for any injury, and
device s guarantee and warrantee will be terminated.

TOSAN s authorized representatives should be present in installation site for any new
devices. Failure to do so could result in personal injury or equipment damage. In this case
TOSAN Company shall not be responsible for any injury, and device s guarantee and warrantee
will be terminated.

4
6-Introduction

6-1-Incubator
Infant Incubator, Model 111 is a Medical Electrical Equipment, which enables simultaneous
c n l f em e a e, gen and h midi a ame e affec ing he infan . The inc ba
enclosure is mounted on a stand with adjustable height. Incubator features various audible and
visible alarms to prevent from any kind of hazard for patient or the equipment. It worth
mentioning that according to new researches doctors believe that if neonates spend the first 4
days of their life after birth in an incubator, it would help their growth ince he inc ba
en i nmen i a im la i n f hei m he mb.

Infant incubator is widely used in birthing center and neonatal intensive care unit (NICU) of
hospitals only by doctors and nurses who have received the necessary training to use the device.
It provides a safe and stable environment in terms of temperature, humidity and oxygen for
infant, often those who are premature or were born with an illness or disability. This safe and
stable environment is prepared by a proper air circulation system in the incubator enclosure.
This circulation system consists of heating elements, boiler, fans, air and skin temperature
sensors, humidity sensor, main control board, and mechanical mechanisms of the enclosure. As
a fully enclosed and controlled environment, the incubator could protect infants from a wide
range of dangers and help premature infants to save their energy to grow.

5
6-2-Different parts identification

Figure 6-1: Inc ba o different sections- Part A

NO Name NO Name
① Enclosure Caster base
② Ad i a ce a e a ch VHA Stand
③ Acce a e a ch Control panel
④ Access panel Humidity reservoir cover
⑤ Mattress platform tilting knob I.V stand holder
⑥ Handel Ad i a ce a e ha d e
⑦ Drawer Mattress platform
⑧ Caster with break Iris access port
Elevating foot pedal I.V stand
Caster Sensor placement location

Table 6-1: Inc ba o different sections- Part A

6
 NO Name
① Enclosure l ck
② Oxygen inlet nozzle
③ Rubber grommet

Figure 6-2: Inc ba o different sections- Part B Table 6-2: Inc ba o different sections- Part B

Figure 6-3: Inc ba o different sections- Part C

NO Name
① Thermostat sensor connector
② Skin Temperature sensor connector
③ Relative humidity sensor connector
④ Skin Temperature sensor connector
Humidity reservoir tray

Table 6-3: Inc ba o different sections- Part C

7
 NO Name
① Boiler cover
② Power cord holder
③ Air intake micro filter cover
④ Enclos re s hinge placemen
Rear access panel
Rear access panel s la ch

Table 6-4: Inc ba o different sections- Part D

Figure 6-4: Inc ba o different sections- Part D

NO Name
① Sliding arm
② Tilting arm
③ Main deck
④ Slider tray
Mattress tray
Mattress

Table 6-5: Inc ba o different sections- Part E

Figure 6-5: Inc ba o different sections- Part E

8
 NO Name
① Airflow passages
② Heater radiator
Circulation fan impeller

Table 6-6: Inc ba o different sections- Part F

Figure 6-6: Inc ba o different sections- Part F

9
6-3-Control panel

Figure 6-7: I c ba c l a el

NO Name NO Name
① Cut out alarm indicator Air temperature setting switches
② Heater operation indicator Set air temperature display
Oxygen expellant fan failure alarm Incubator air temperature display
③
indicator
Over heat (in skin mode) alarm indicator
④ Low battery alarm indicator
Skin sensor failure alarm indicator
⑤ Line interruption alarm indicator
Air mode or skin mode selector switch
⑥ ON/OFF switch
Skin temperature setting switches
⑦ Circulation Fan failure alarm indicator
Over heat (in air mode) alarm 21 Set skin temperature display
⑧
indicator
22 Skin temperature display
Air sensor failure alarm indicator
23 Relative humidity display
39 C indica o
24 Low water level alarm indicator
Override switch(39°C)
25 Relative humidity selector switch
A.S.D ala m silent switch
26 Relative humidity setting switches
A.S.D (Air Set Deviation) alarm
indicator 27 Set relative humidity display

Table 6-7: I c ba c l a el

10
7-Spesification

Power requirements 220V-240V AC, 50 Hz, 500W(Maximum)

Type of protection: Class I
Degree of protection: Type BF
Classification Mode of operation: Continuous operation.
VHA (Variable height adjustment) stand is for intermittent
operation (1 minute on - 4 minutes off).
Temperature: 20-30ºC
Installation ambient
Relative humidity: 30-75%
condition
Allowed altitude: up to 2600m
Temperature: 0-50ºC
Storing condition Relative humidity: 30-75%
Allowed altitude: up to 3200m
Height:120-140cm
Dimension Length: 93cm
Width: 60cm
Weight 87Kg
IV Stand: 3Kg
Maximum allowed
Each drawer: 5Kg
load
Mattress: 10Kg
Earth leakage current <500µA
Patient leakage current <10µA
Touch current <100µA
Protective measures
Insulation level: Primary-Secondary 2×MOPP
Primary-Earth 1×MOPP
Secondary-Earth 1×MOPP
Temperature control
Skin mode(Servo)/Air mode(Manual)
mode
Skin mode: 28-37.5ºC
Temperature setting Air mode: (Normal operation) 20-37ºC
range (special operation(39ºC)):up to 39ºC
In 0.1ºC increments
Skin temperature: 0-50ºC
Temperature display Precision: ±0.3ºC
range Incubator air temperature: 0-50ºC
Precision: ±0.8ºC

11
 Warming time Less than 30 minuets
Humidity setting
30-90% RH (In 1% increments)
range
Humidity display
15-99% RH (Precision: ±5%)
range
Oxygen Oxygen maximum pressure: 1.5 bar
CO2concentration
Less than 0.5%
within the enclosure

Table 7-1: Specifications

12
8-Installation
Thoroughly read and understand the manual prior to use of the incubator. Failure to do so
could result in personal injury or equipment damage.

Installation process should be done only by trained personnel of TOSAN’s service

representatives. Failure to do so could lead to its degraded performance of the device. In this
case TOSAN Company will not be responsible.

Make sure skin and air sensors are not damaged while moving the trays.

Incubator misuse may result in harm to the infant. Make sure only properly trained
personnel are using the incubator as directed by an appropriately qualified attending physician
aware of currently known risks and benefits.

8-1-Installation ambient conditions

Be sure to bear in mind when you are raising enclosure, I.V stand may block the way.
Install the unit out of reach of small children.

To avoid overheating the infant due to direct radiation, do not position the incubator in
direct sunlight or under other sources of radiant heat.

Do not jolt the unit or bump it against anything. The screws or fixed parts may become
loose.

Do not position the incubator near warmers and cooling equipment.

Existence of any barrier in front of air intake micro filter could prevent air circulation
properly. Do not install the device where there is a wall or any other barrier closer than 30
centimeters from air intake filter. Failure to do so could result in personal injury.

To avoid possible tip-over or damage to adjacent carts, IV stands, drawers, etc., keep at
least a 30 cm perimeter area clear around the vertical height adjustable stand.

13
 Phototherapy units located too close to the incubator may affect enclosure wall
temperature, incubator enclosure temperature, and infant skin temperature. Personal injury or
equipment damage could occur.

Locating phototherapy units too close to the incubator may affect incubator enclosure
temperature and infant’s skin temperature. Personal injury or equipment damage could occur.

Never place objects taller than the top of the wheel casters beneath the incubator stand.
Placement of objects there could interfere with the stability of the vertical height adjustable
stand. Personal injury or equipment damage could occur.

Place the unit on a stable surface. Placing the unit on an unstable platform or a tilted
surface will cause it to fall or drop and may hurt someone. Check the strength of the place
where the unit is to be placed or installed.

Infant Incubator Model 111 comply with the requirements 60601-1 and 60601-2- when
operating within the following conditions:

An ambient temperature between +20 °C and +30 °C

An ambient relative humidity between 30% and 75%
An ambient air velocity less than 0.3 m/s
An ambient altitude less than 2600m

Ambien temperature above +30 °C or

below +20 °C could affect temperature
setting.

Figure 8-1: I c ba a be e ea e

Distance between incubator and warmers or

cooling equipment should not be less than
60cm.

Figure 8-1: I c ba a be e ea e

14
Do not place Infant Incubator
Model 111 in direct sunlight or
under other sources of radiant heat.

Figure 8-3: Not placing the device in direct sunlight

8-2-Power outlet and grounding

The potential for electrical shock exists with electrical equipment. Establish policies and
procedures to educate your staff on the risks associated with electrical equipment.

To ensure grounding reliability, plug the AC power cord only into a properly grounded 3-
wire hospital-grade or hospital-use outlet. Do not use extension cords. If any doubt exists as to
the grounding connection, do not operate the equipment. Personal injury or equipment damage
could occur.

To prevent equipment damage or accidental power disconnections, do not plug an

incubator power cord directly to an AC wall socket when the incubator is mounted on a
pedestal/stand. Always provide power to the incubator by using the power cord coming directly
from the pedestal/stand.

Avoid damaging the power cord.

A damaged power cord may cause a fire or an electric shock.

Do not pinch the power cord between the unit and the wall, a shelf or the floor.
Do not place the power cord near a heating apparatus or heat it.
Do not put anything heavy on the power cord.
Always grasp the power plug with your hand to remove the power cord from the power
outlet.
A damaged power cord should be replaced immediately with a new one.
15
 Use only the power cord supplied with the unit. Otherwise, a fire or an electric shock may
result. Personal injury or equipment damage could occur.

A damaged power cord only should be replaced by service unit of TOSAN Company.

Do not touch the power plug with a wet hand. Touching the power plug with a wet hand may
cause an electric shock.

The power outlet should be located near the unit to prevent accidental contact with a
trailing power cord. Use a separate power outlet for each unit.

Do not connect other devices on the power outlet which the unit is plugged in.

Do not twist or pull the cords by force. If any defects are found, ask an expert for repair
without attempting to repair it yourself.

Remove the power plug from the power outlet before moving the unit to another place or
when the unit is not going to be used for a long time. Moving the unit to another place with the
power plug connected to the power outlet will damage the power cord and may cause a fire or
an electric shock. Personal injury or equipment damage could occur.

Due to the risk of electrical shock hazard, only qualified personnel with appropriate
service documentation should service the unit.

Make sure the building power source is compatible with the electrical specifications
shown on the incubator. Failure to do so could result in personal injury or equipment damage.

Batteries can present a risk of electric shock. The following precautions should be taken
when working on batteries: remove watches, rings or other metal objects; use tools with
insulated handles.

Some chemical cleaning agents may be conductive and leave a residue that may permit a
build-up of conductive dust or dirt. Do not allow cleaning agents to contact electrical
components, and do not spray cleaning solutions onto any of these surfaces. Personal injury or
equipment damage could occur.

Unplug the unit from its power source prior to cleaning or maintenance. Failure to do so
could result in personal injury or equipment damage.

16
 Do not expose the unit to excessive moisture that would allow for liquid pooling. Personal
injury or equipment damage could occur.

Smoking is prohibited in the room where the unit is installed. Do not place any possible
ignition sources in the room.

Do not disassemble or modify the unit. Disassembling or modifying the unit may cause a
fire, an electric shock or injury.

Only TOSAN’s service unit is allowed to replace unit’s battery.

If any defect or disorder, when the battery was getting charged, was found, call TOSAN’s
service representatives immediately.

Do not connect the Infant Incubator Model 111 to a surge suppressor.

Device’s power source shall be a 220V Ac, 50Hz properly grounded 3-wire outlet.

8-3-Unpackaging
When removing the equipment from the packing box, take care not to scratch or otherwise
damage unprotected surfaces.

1-Prior to removing incubator from the packing box, cut 3 plastic packing straps and lift the box
with the help of two men.

Figure 8-4: I c ba b ac g

17
2- Carefully remove incubator and IV
stand which is connected to front handle
of device by cable tie. Then remove their
plastic packing.

Figure 8-5: Removing incubator from its packing

3- Cut the cable tie and separate IV stand. Then

remove its plastic package.

Figure 8-6: Removing IV stand from its packing

18
4-Assemble IV stand on its right place
and fix it by mounting screws. Also
assemble its antenna on the top of the
IV stand.

Figure 8-7: Assembling the IV stand

5-Cut the plastic packing strap which has

fixed mattress and mattress tray to slider tray.

Figure 8-8: Infant mattress unpacking

8-4-Start-Up
Be sure to perform start-up inspection. Using the unit without performing start-up
inspection may let a defect pass unnoticed and cause a serious accident.

After turning the device on, allow at least 30 minutes to incubator temperature gets stable.

After unpacking the device, first you should place main deck on its right position in such a way
that air circulation and heater parts be completely covered by it.

Place lide a ail n hei igh i i n. The h ld be able m e he igh and lef .

19
Place slider tray through its bars on its
right position, in such a way that when it
is moving to forward, gets lock on slider
tra s rails.

Figure 8-9: Slider tray placement

Place mattress tray on slider tray.

Figure 8-10: Mattress tray placement

Connect skin temperature sensor to its connector at left side of the device and then put its probe
on enclosure. Also connect air temperature sensor, thermostat sensor and humidity sensor to
their connectors. Figure 6-3 shows these connectors.

All these sensors are joined to the device by cable tie in their right place to prevent
improper connection.

20
Place probe of air temperature sensor,
humidity sensor and thermostat sensor
on their right position that are shown in
figure below.

Figure 8-11: Air temperature sensor placement

Plug the device power cord into an

appropriate AC power source.

Figure 8-12: Plugging the device in

Press ON/OFF button which is placed

on de ice s panel to turn on the de ice.

Figure 8-15: Turning the device on

21
Heater operation indicator ho de ice hea e o e a ing a e. If he co e onding LED
blinks it indicates that the heater is working. There is a direct connection between the blinking
speed and the power delivered to the heater. If the corresponding LED is continuously on, it
indicates that the heater is working with maximum power whereas turned off LED means that
no power is delivered to the heater. (See figure 6-7(2))

22
9-Calibration
To increase the life time of the incubator, calibrate the device (air and skin sensors) every
6 months. The calibration should be done only by trained personnel of TOSAN e ice
representatives. Failure to do so could lead to its degraded performance of the device. In this
case TOSAN Company will not be responsible.

9-1-Calibration ambiance conditions

Calibration of the device should be done within the following conditions.

An ambient temperature between +20 °C and +30 °C

An ambient relative humidity between 30% and 75%
An ambient air velocity less than 0.3 m/s
An ambient altitude less than 2600m

Ambien temperature above +30 °C or below +20 °C could affect temperature setting.

9-2-Calibration instrument
To calibrate de ice kin and ai em e a e en , e defined a calib a e m de in de ice.
You need only a calibrated thermometer which is accepted by TOSAN Company.

9-3-Calibratin method
Air temperature sensor calibration

Place he m me e be in cen e
and at a distance of 10 cm from the
mattress.

Figure 9-1: The ee be ace e ca i

23
Set the set air temperature on 30ºC and wait to achieve that. After that the heater gets off you
should compare air temperature which is read by thermometer and air temperature sensor. If
difference is more than admissible error (±0.2ºC) you should calibrate the sensor.

To remove this error you should

activate calibration mode in
device. Hold skin temperature
setting switch (up) for almost 20
seconds to activate calibration
mode. “CA.L” will be written on
set air temperature display in this
mode.

Figure 9-2: Air sensor calibration mode

Then by using air temperature

setting switches, set display air
temperature on the temperature
which has been sensed by
thermometer.

Figure 9-3: Error removing

After that again, by holding

skin temperature setting switch
(up) for almost 20 seconds,
save these changes and go out
from calibration mode.

Figure 9-4: Saving changes

Do all these processes for 3 other temperatures: 32ºC, 34ºC and 36ºC.

24
Skin temperature sensor calibration
P ace he ee be i ce e a d a a di a ce f 10 c f he a e .A di a
skin temperature on it. (See figure 9-1)

Set the set skin temperature on 30ºC and wait to achieve that. After that the heater gets off you
should compare skin temperature which is read by thermometer and skin temperature sensor. If
difference is more than admissible error (±0.2ºC) you should calibrate the sensor.

To remove this error you

should activate calibration
mode in device. Hold air
temperature setting switch (up)
for almost 20 seconds to
activate calibration mode.
CA.L i be i e set
skin temperature display in
this mode. Figure 9-5: Skin sensor calibration mode

Then by using skin temperature

setting switches, set display skin
temperature on the temperature
which has been sensed by
thermometer.

Figure 9-6: Error removing

After that again, by holding

air temperature setting switch
(up) for almost 20 seconds,
save these changes and go out
from calibration mode.

Figure 9-7: Saving changes

Do all these processes for 3 other temperatures: 32ºC, 34ºC and 36ºC.
25
10-Cleaning and Disinfection
A dirty air intake micro filter could affect performance or cause carbon dioxide (CO2)
build-up. Ensure that the filter is checked on a routine basis commensurate with local
conditions. Particularly, if the unit is used in an unusually dusty environment, more frequent
replacements may be necessary. Failure to do so could result in infant injury or equipment
damage.

A fire and explosion hazard exists when performing cleaning or maintenance procedures
in an oxygen-enriched environment. Make sure that the oxygen supply is turned off and the
oxygen hose to the incubator is disconnected when performing cleaning and maintenance
procedures. Turn off or disconnect oxygen supplies during periods of non-use. Failure to do so
could result in personal injury or equipment damage.

Do not use Alcohol, Ether, Dettol, Chlorhexidine and other flammable materials for
cleaning the device. Also do not clean the enclosure with alcohol and any material that contains
alcohol.

F ll all d c ma fac e clea i g i ci . Fail e d c ld e l i

personal injury or equipment damage.

Be sure to clean and disinfect the unit before using it for the first time after purchase. The
unit is shipped without being disinfected.

To avoid contamination spread, use separate and clean cloth for each device.

Do not push any ac mi a e hi g i c ba a el a id damaging panel.

Be e bea i mi d ll d he e cl e bef e elea i g e cl e l ck.

Failure to do so could result in equipment damage.

Some chemical cleaning agents may be conductive and leave a residue that may permit a
build-up of conductive dust or dirt. Do not allow cleaning agents to contact electrical
components, and do not spray cleaning solutions onto any of these surfaces. Personal injury or
equipment damage could occur.

Unplug the unit from its power source prior to cleaning or maintenance. Failure to do so
could result in personal injury or equipment damage.

26
 For disinfecting different parts it is highly recommended to use Descosept Spezial 0%
wipe.

To place a new infant in the incubator, enclosure should be cleaned and disinfected.

Make sure that during each part of the cleaning, the device is unplugged.

10-1-Enclosure

Do not use Alcohol, Ether, Dettol, Chlorhexidine and other flammable materials for
cleaning the device. Also do not clean the enclosure with alcohol and any material that contains
alcohol.

Be sure to bear in mind not to pull down the enclosure before releasing enclosure latch.
Failure to do so could result in equipment damage.

Iris Acc P C

Remove all the Iris access por s c ffs.

Immerse and disinfect them, by using
recommended disinfection wipe.

Figure 10-1: Acce c ff c ea

Acc Pa R bb Pac

Remove the rubber packing from all the access

panels. Immerse and disinfect them, by using
recommended disinfection wipe.

Figure 10-2: Rubber packing cleaning

27
Rubber grommets

Remove the rubber grommet from the

enclosure. Immerse and disinfect them, by
using recommended disinfection wipe.

Figure 10-3: Rubber grommets cleaning

Inner wall panel

Open admittance panel and remove all inner wall panels from the device. To remove them, open
the screw placed on admittance panel, then separate inner walls from outer ones. Clean and
disinfect them, by using a soft cloth demanded with recommended disinfection wipe.

Figure 10-4: Inner wall panels cleaning

Enclosure

After all the parts are removed from the

enclosure, wipe the inside and the outside
of the enclosure clean by using a soft cloth
demanded with recommended disinfection
wipe.

Figure 10-5: Enclosure cleaning

28
10-2-Mattress Platform and Parts Beneath
Failure to clean the heater radiator and fan impeller could result in sufficient lint build-up
to reduce airflow, which could affect the temperature control and cause high oxygen
concentrations. Personal injury or equipment damage could occur.

During cleaning or transferring, make sure that the mattress is safe. If mattress gets torn, it
becomes a contamination supply.

Be sure to bear in mind when you are raising enclosure, I.V stand may block the way.

Be sure to bear in mind when you are raising or pulling down the enclosure, skin sensor
cable does not remain under the enclosure.

Mattress Tray

Raise the enclosure by both edges and let it to

gets lock. Remove the mattress tray and wipe
clean and disinfect them, by using a soft cloth
demanded with recommended disinfection
wipe.

Figure 10-6: Mattress tray cleaning

Slider Tray

Push slider tray fully backward. When it

is removed from the rails, lift it up and
take it out. Then wipe clean and disinfect
them, by using a soft cloth demanded
with recommended disinfection wipe.

Figure 10-7: Slider tray cleaning

29
Main Deck

To remove main deck for cleaning, first

you should remove these bars which
are placed on top of that.

Figure 10-8: Bars removing

Lift up the main deck and take it out.

Then wipe clean and disinfect them, by
using a soft cloth demanded with
recommended disinfection wipe.

Figure 10-9: Main deck cleaning

Fan impeller

Pull up and remove the fan impeller. Then

wipe clean and disinfect them, by using a
soft cloth demanded with recommended
disinfection wipe.

Figure 10-10: Fan impeller cleaning

30
Heater radiator

The heater can be sufficiently hot to cause burns; avoid removing or touching for cleaning
the heater, until the unit has been switched off for at least 1hour.

Heater radiator is placed next to the fan.

By using a soft cloth demanded with
recommended disinfection wipe, clean and
disinfects heater radiator completely.

Figure 10-11: Heater radiator cleaning

10-3-Humidity Reservoir
To prevent micro-organisms multiplication, deplete the reservoir completely from water, when
o re no ing he humidity system. In order to deplete reservoir, pull humidity reservoir tray
out and bring humidity reservoir out carefully. Open reservoir door and deplete it from water.

After that wash and disinfect

reservoir and its door with
recommended disinfection wipe.

Figure 10-12: Humidity reservoir cleaning

31
Then wipe clean and disinfect reservoir tray, by using a soft cloth demanded with recommended
disinfection wipe.

10-4-Skin Sensor

Wipe a used probe lightly with a soft cloth demanded with recommended disinfection wipe.

10-5-Mattress
During cleaning or transferring, make sure that the mattress is safe. If mattress gets torn, it
becomes a contamination supply.

Do not wash mattress in washing machine or do not use autoclave.

Remove the mattress before placing

a new infant in the device. Remove
its disposable mattress cover, then
wipe it clean and disinfect it by
using a soft cloth demanded with
recommended disinfection wipe.
Figure 10-13: Mattress cleaning

Next cover the mattress again by using a new disposable mattress cover.

After cleaning the device, reassemble all part of the device.

32
11-Trouble shooting Guide
Check the operation of the peripheral devices. If a device transmitting or receiving weak
signals is installed near the unit, it may be affected by the electromagnetic waves generated by
the latter. Check the operation of peripheral devices for any effect after any repair.

Only facility-authorized personnel should perform preventive maintenance or

troubleshooting on the Infant Incubator, Model 111. Preventive maintenance performed by
unauthorized personnel could result in personal injury or equipment damage.

Be sure to bear in mind all alarm check outs after any repair. (See Annex I)

11-1-De ice Ala

The device will activate audible and visible alarms in following situation and when it was
necessary, it would cut off the heater.

Figure 11-1: Alarms

33
 Alarm Audible or Visible* Priority
Alarm Message Description
number Indicator Level
Circulation
This alarm occurs if a failure is
1 Fan Failure A/V High
detected in the circulation fan
(C.F.F)
This alarm occurs if a failure is
Oxygen Fan
2 A/V High detected in the oxygen expellant
Failure (O.F.F)
fan
In air mode: This alarm occurs if a
failure is detected in air
Sensor Failure temperature sensor
3 A/V High
(SEN.F) In skin mode: This alarm occurs if
a failure is detected in skin
temperature sensor
In air mode: This alarm is
activated if the displayed air
temperature exceeds 38°C in
normal operation and 40ºC in
4 Over Heat A/V High special operation(39ºC)

In skin mode: This alarm is

ac i a ed if he i fa i
temperature exceeds 38.5°C
1-This alarm occurs when a failure
is detected in heater control system

2- This alarm occurs when a

failure detected in thermostat
temperature sensor
4 Cut-Out(s) A/V High
In both situations when enclosure
temperature exceeds 38ºC in
normal operation and 40ºC in
special operation(39ºC), thermostat
operates and cuts off the heater

34
 Alarm Audible or Visible* Priority
Alarm Message Description
number Indicator Level
In air mode: This alarm occurs
when the indicated displayed air
temperature differs from the
control temperature by
>±3ºC
In air mode, Air.S.D alarm
on t be activated unless air
control temperature is set by
operator at least once.

Mediu In skin mode: This alarm occurs

6 Air.S.D A/V
m when the indicated displayed air
temperature differs from the
control temperature by
>±1°C
In skin mode for assurance of
infant s skin sensor connection,
Air.S.D alarm on t be activated
unless skin control temperature is
set b operator and infant s bod
temperature achieve to control
temperature at least once.
Low Water This alarm occurs when humidity
7 A/V Low
(L.W) reservoir is empty.
Line
This alarm occurs during line
8 Interruption A/V Low
interruption for 10 minutes
(L.I)
This alarm occurs when a failure is
Low Battery Mediu
9 A/V detected in back up battery or in its
(L.B) m
charging circuit
Humidity
Sensor Failure This alarm occurs when a failure
10 A/V Low
(displayed detected in humidity sensor
humidity is 02)
*As shown in figure 11-1 visible indicator for all alarms e cept Humidit Sensor Failure is a
blinking LED, and for Humidit Sensor Failure visible alarm relative humidit displa sho s
02 .

Table 11-1: Alarms

35
 Priority Description
Alarm tone sequence(10 beeps), Red LED flashes
High

Alarm tone sequence(3 beeps), Red LED flashes

Medium

Alarm tone sequence(2 beeps), Red LED flashes

Low

Table 11-2: Alarm frequency

Necessary procedure after cut-out alarm activation:

Immediately turn off the device.

Wait 30 minutes for the device to get cold.
Turn on the device again and check if cut-out alarm is still remained active, respectively
check the operation of thermostat circuit, power management board and finally
controller board. Replace them, if there is a fault in each path.

Cut-Out alarm is more vital than other alarms. If this alarm gets activated, other alarms will
be considered as less important alarms and you should do necessary procedure without
considering other alarms. Cut-Out alarm also will be activated if air temperature sensor is
disconnected.

36
11-2-Symptom, Cause and Remedy
Symptom Possible causes
The device does not -The device is not plugged in
turn on
-The ON/OFF button is not pushed
-Power interruption has occurred
-There is a torn or damage in
o e co d a h
-Fuses reset circuit.
Incubators air -Ambient temperature is too low
temperature does not
rise or Air S.D alarm
occurs -The air temperature sensor
connector is not connected
correctly in its position.
-Air temperature sensor is damaged -Replace air temperature
-In skin mode the skin temperature -Check skin temperature sensor
sensor connector is not connected connection in skin mode.
correctly in its position.
-In skin mode skin temperature
en o obe i no in alled
o e l on infan bod .
-Skin temperature sensor is
damaged.
-Admittance or access panel or
access ports are open.
-Admi ance o acce anel
latches are damaged.
-Rubber grommets are not properly -Check rubber grommet
installed
-Thermostat cuts-off the circuit
-Heater does not work properly
-Circulation fan impeller is
damaged
-Circulation fan motor does not
work properly.
37
Remedy
-Check if the power cord is
plugged in properly
-Press ON/OFF button to turn
on the device
-Check if power interruption
has occurred
-Check torn or damage
e i ence in o e co d a h,
if there is, replace that.
-Replace fuses.
-Check if ambient temperature
is in the allowed range
-Check air temperature sensor
connection.
sensor.
-Check skin temperature sensor
in alla ion on infan bod in
skin mode.
-Replace skin temperature
sensor
-Check if admittance or access
panels or access ports are
closed.
-Check if admittance or access
anel la che work properly
or they are broken. If there is
replace that.
installation
-Check if thermostat cuts the
circuit off
-Check if heater works
properly, if dose not replace it.
-Check if fan impeller is
broken, replace it.
-Check if circulation fan works
properly, if not, replace it.
 Symptom Possible causes Remedy
I c ba ai -The device is placed near a -Check if there is a warmer near
temperature is more warmer the device
than control -Ambient temperature is too high -Check if ambient temperature is
temperature or in the allowed range
Over Heat alarm occurs -The incubator is placed in direct -Check if the device is placed in
sunlight direct sunlight
-The air temperature sensor -Check air temperature sensor
connector is not connected connection
correctly in its position.
-Air temperature sensor is damaged -Replace air temperature sensor.

-In skin mode the skin temperature -Check skin temperature sensor
sensor connector is not connected connection in skin mode.
correctly in its position.
-In skin mode skin temperature -Check skin temperature sensor
e be i i alled i alla i i fa b d i
el i fa b d . skin mode.
-Skin temperature sensor is -Replace skin temperature
damaged. sensor.
-Air intake micro filter is damaged -Check air intake micro filter is
or dirty. not damaged or dirty and replace
it.
-Controller board does not work -Check if controller board works
properly properly, if not, replace it.
-Opt coupler board does not work -Check if opt coupler board
properly works properly, if not, replace it.
Relative humidity of -Humidity reservoir is empty. -Check water level in the
the incubator does not humidity reservoir
reach to the set value -Admittance or access panel or -Check if admittance or access
access ports are open. panels or access ports are
closed.
-Admi a ce acce a el -Check if admittance or access
latches are damaged. a el la che k el .
-Rubber grommets are not properly -Check rubber grommet
installed installation
-There is a sediment in humidity -Check if there is sediment in
em be if d e h midi em be, if he e
distill water is replace it.
-There is a barrier or kink in -Check barrier or kink existence
h midi em be a h. i h midi em be a h
-Controller board does not work -Check if controller board works
properly properly, if not, replace it
-Opt coupler board does not work -Check if opt coupler board
properly works properly, if not, replace it

38
 Symptom Possible causes Remedy
Low oxygen -Admittance or access panel or -Check if admittance or access
concentrations access ports are open. panels or access ports are
closed.
-Admittance or access panel -Check if admittance or access
latches are damaged. panel la che o k p ope l .
-Rubber grommets are not properly -Check rubber grommet
installed installation
-There is a barrier or kink in -Check barrier or kink existence
oxygen tube path or oxygen inlet. in oxygen tube path and oxygen
inlet.
-Air circulation fan impeller is -Check if air circulation fan
broken or damaged impeller is broken or damaged.
If it is, replace it.
-Air intake micro filter is not -Check ai in ake mic o fil e
existed or is damaged. existence or if it is damaged.
-Oxygen flow meter or oxygen -Check if flow meter or oxygen
monitor does not work properly. monitor works properly.
High oxygen -Air intake micro filter is damaged -Check air intake micro filter is
concentrations or dirty. not damaged or dirty and replace
it.
-Air circulation fan impeller is -Check if air circulation fan
broken or damaged impeller is broken or damaged.
If it is, replace it.
-There is a lack of air circulation -Verify that the impeller is
within the incubator installed. If installed, turn off the
incubator and remove it from
service.
C.F.F alarm occurs -Circulation fan impeller is not -Check if fan impeller is placed
placed properly in its right position correctly
-Air intake micro filter is not -Check air intake micro filter
existed or is damaged. existence or if it is damaged.
-Circulation fan is blocked -Check if there is any barrier has
blocked the circulation fan
-Ci c la ion fan mo o doe no -Check if circulation fan motor
work properly. works properly, if not, replace it.
O.F.F alarm occurs -Oxygen expeller fan is not placed -Check if fan is placed correctly
properly in its right position
-Oxygen expeller fan is blocked -Check if there is any barrier has
blocked the oxygen expeller fan
-Oxygen expeller fan is damaged -Check if oxygen expeller fan is
damaged, and replace it.

39
 Symptom Possible causes
SEN.F alarm occurs -The air temperature sensor
(in air mode) connector is not connected
correctly in its position.
-Air temperature sensor or its cable
is damaged
SEN.F alarm occurs -The skin temperature sensor
(in skin mode) connector is not connected
correctly in its position.
-Skin temperature sensor or its
cable is damaged.
Cut-Out alarm occurs -There is fault in controller board -Check if controller board works
L.W alarm occurs -Humidity reservoir is not placed in -Place humidity reservoir
its right position
-Humidity reservoir is empty
-Re er oir micro i ch i
damaged.
Water sensor is damaged
-There is a barrier or kink in
h midi em be pa h or i i in h midi
damaged.
Line interruption alarm -Power cord is disconnected
while device is turned
-There is a torn or damage in
on occurs and power
po er cord pa h
outage has not
occurred.
L.B alarm occurs -Back up battery is empty
-Charging circuit is damaged.
-Back up battery is damaged.
Humidity sensor failure -The humidity sensor connector is
alarm occurs not connected properly.
-Humidity sensor is damaged
VHA does not work -Jack is damaged.
properly. -Jack motor is damaged.
Table 11-3: Symptom, cause and remedy
40
Remedy
-Check air temperature sensor
connection
-Replace air temperature sensor.
-Check skin temperature sensor
connection.
-Replace skin temperature
sensor.
properly. If not, replace it.
correctly in its position
-Refill humidity reservoir
-Replace re er oir micro
switch.
-Replace water sensor
-Check barrier or kink existence
em be pa h,
if it is damaged replace it.
-Check power cord connection
-Check for tears or damaged
parts in power cord cable.
Replace it if new power cord is
needed.
-Keep device turned on to
charge the battery at least 1
hour. If it does not get charged,
check other items specified
below.
-Replace charging circuit.
-If the problem has not solved,
replace the battery package.
Before replacing the battery
send it to TOSAN Co to ensure
that it is damaged.
-Check humidity sensor
connection.
-Replace humidity sensor.
-Replace jack.
-Replace jack motor.
 12-Replacement

12-1-Replacement part list

Enclosure

Figure 12-1: Encl e c n en

NO Replacement part Part number NO Replacement part Part number

① Enclosure main wall assembly 1116100000 ⑧ Access panel rubber packing 0950000027
Admittance panel operating Access panel hinge (with
② 1116000013 0950000026
knob catches assembly spring) assembly
③ Iris access port hole packing 1116600002 Access panel door 0950000024

④ Iris access port packing 1116600001 Front inner wall 1114000004

⑤ Iris access port cuff 1116600003 Acce a e a ch 0958000000

⑥ Rubber grommet 0950000010 Admittance panel door 1116400001

⑦ Rear inner wall 1116000010 Ad i a ce a e a ch 1116410000

Table 12-1: Encl e contents

41
 Mattress platform

NO Replacement part Part number

① Mattress 1114920000
② Mattress tray 1114900004
③ Slider tray 1114900001
Sliding rails with their
④ 1114900002
screws
⑤ Sliding arm 1114910001
⑥ Tilting arm 1114210005
⑦ Main deck 1114000006
⑧ Slider tray handle 1114900003

Figure 12-2: Mattress platform c n en Table 12-2: Mattress platform c n en

Cabinet contents

NO Replacement part Part number

① Circulation fan impeller 1114700006
② Circulation fan impeller s shaft 1114700004
Circulation fan impeller s
③ 1114700007
washer
④ Enclosure lock cover 1114300003
⑤ Oxygen inlet nozzle 0950000003
⑥ Drawer 1114140000
⑦ Unit assembly 1115000000
⑧ Tilting knob cover 11142 0011
Heater element 3131063400

Table 12-3: Cabinet contents Figure 12-3: Cabinet contents

42
 Contents on cabinet body

NO Replacement part Part number

① Connec o boa d 1117070000
② Boiler cover 1114510002
③ Air intake micro filter cover 1114700002
④ Air intake micro filter 9100000700
Ai in ake mic o fil e holde 1114800001

Table 12-4: Contents on cabinet body- Part A

Figure 12-4: Contents on cabinet body- Part A

NO Replacement part Part number

① Skin temperature sensor 3123010007
② Thermostat sensor 3123020001
③ Humidity sensor 3123020001
④ Air temperature sensor 3123010001
Power cord 3211100001

Table 12-5: Contents on cabinet body- Part B

Figure 12-5: Contents on cabinet body- Part B

43
Control unit

Figure 12-6: Con ol ni contents

NO Replacement part Part number

① Dome switch 8201110000
② Segment board 1117080100
③ Battery pack 3115142000
④ Thermostat board 1117050000
⑤ Switching board 3822000001
⑥ Opt coupler board 1117020000
⑦ Base board 1117060000
⑧ Controller board 1117030000
On/Off switch 3131121102
Power board 1117010000
Charging circuit board 3707070000

Table 12-6: Con ol ni con en

44
 Beneath the cabinet separator plate

Figure 12-7: Contents beneath the cabinet separator plate

NO Replacement part Part number NO Replacement part Part number

① Flexible plastic pipe 9100000564 Oxygen expellant fan 3121024002

② Circ la ion fan be 9100000559 Water level sensor 1114520000

Mattress platform tilting arm Boiler em be 9100000559
③ 1114220000
assembly(left)
Boiler 1114510000
④ H midi re er oir ra be 9100000559
H midi re er oir micro Boiler inlet nozzle 1114500002
⑤ 3110310312
switch Boiler outlet nozzle 1114500001
⑥ Humidity reservoir tray 1114610001
Boiler element 125W 3131063125
Mattress platform tilting arm
⑦ 1114220000
assembly(right) Edge board 1117080000
⑧ Humidity reservoir O-ring 1114621000 Boiler em be 9100000559
Humidity reservoir 1116420000 Circulation fan motor 1114700003

Table 12-7: Contents beneath the cabinet separator plate

45
 VHA stand

NO Replacement part Part number

① Stand s jack 3127150002
② Relay board 0971000000

Table 12-8: VHA a c

Figure 12-8: VHA a c

Caster base

NO Replacement part Part number

① Caster with break 0952000000
② Elevating pedals 1111200000
③ Caster 0953000000
④ Caster base s cover 0950000002

Table 12-9: Ca ba c

Figure 12-9: Ca ba c

46
 IV Stand

NO Replacement part Part number

① IV a d h ba e 1114160005
② IV a d h 1114160006
IV pole 1114160004

Table 12-10: IV stand c n en

Figure 12-10: IV stand c n en

47
12-2-Replacement methods

To replace parts below, first disassemble them by following their procedure specified in each
part, and then assemble them by the reverse order of the procedure.

Enclosure

1- Unscrew the front inner wall.

Figure 12-11: Unscrew the front inner wall

2- Open the admittance panel.

Figure 12-12: Opening the admittance panel

48
3- Remove front and rear inner walls.

Figure 12-13: Removing inner walls

4- L e ad i a ce a el all
screws and detach it from
enclosure.

Figure 12-14: Unscrewing admittance panel

49
5-Next loosen all screws inside the
enclosure. The ABS caps will be
detached from the structure.

Figure 12-15: Unscrewing the ABS caps

6-To remove the hinge pin from its

holder in left side of the device, which
it connects enclosure to the cabinet,
release the existing retaining ring and
remove the hinge pin. Left hinge
s stem s holder will be detached.

Figure 12-16: Removing the left side hinge pin

50
7- Prior to removing the right side
hinge pin, first hold the encl e
lock in shown position in figure 12-
17 and then remove the right side
hinge pin after realizing the right side
retaining ring. Righ hinge em
holder will not be detached unless the
enclosure is completely detached
from the cabinet.

Figure 12-17: Removing the right side hinge pin

8-To detach enclosure from the

cabine , ill h ld he encl e l ck
in shown position and pull up the
enclosure slowly and carefully.
Encl e and igh hinge em
holder will be detached.

Figure 12-18: Detaching the enclosure from the cabinet

51
Drawer

1- Pull the drawer out of the drawer case until it stops.

2- Place both hands on both sides of the drawer at the back where sides of the drawer runners
connect to the sides of the drawer case. Look for a small horizontal lever on both sides where
the two runners connect with each other.

3- Each lever should have an oval

shaped tab on the end of it. Push
down one of them and push up
another one.

Figure 12-19: Holding the oval shaped tabs

4- Hold the tabs with your fingers. Pull the drawer toward your body. You should hear a small
click as the drawer runners disengage from the cabinet runners on both sides.

5-Unscrew the drawer case from

the cabinet

Figure 12-20: Unscrew the drawer case

52
6- To detach the drawer case
from the cabinet pull it down
and then pull it toward your
body.

Figure 12-21: Detaching the drawer case from the cabinet

Elevating foot pedals

1- Prior to disassemble the elevating foot pedals, first detach drawer, because it covers the VHA
and c e screws.

2- Open all screws of the VHA

and c e and de ach he c e .

Figure 12-22: Unscrewing the VHA and co er

53
2- Disconnect elevating foot
pedals power connector from the
relay board.

Figure 12-23: Di connec ing he ele a ing foo pedal po er connec or

3- Unscrew the elevating foot pedals and detach them from the VHA stand.

Figure 12-24: Detaching the elevating foot pedals

Cabinet separator plate

1- Prior to detach this part, first detach the enclosure and remove mattress platform completely.

54
 2- Then detach unit control, fan
impeller, fan impeller’s washer and
heater.

Figure 12-25: Removing parts on the cabinet separator plate

3- Unscrew two nuts placed on the plate

and they are placement position of tilting
arms, by a wrench.

Figure 12-26: Unscrewing the laceme il i g a m nuts

4-Use two thin crowbars or something else,

in two sides of the plate, to lifting it up.
Therefore perfectly apply enough pressure.
Do this process very carefully, and make
sure do not torn the plate packing rubber.
Be careful do not hurt your hands or the
plate in the event of high force is used

Figure 12-27: Detaching the cabinet separator plate

55
Jack

1- P i de ach de ice jac , di a e b e the cabinet separator plate.

2- Then detach drawers beca e i c e he VHA a d c e ce .

3- O e a ce f he VHA a d c e a d de ach he c e .

Figure 12-28: Un cre ing he VHA and co er

4- Unscrew the VHA a d

nut placed in the center of
cabinet, by a wrench.

Figure 12-29: Unscrewing the VHA stand from the cabinet

56
 5- Di connec he jack po e
connector from the relay board and
remove the jack

Figure 12-30: Di c ec i g de ice jack e c ec

6-Open jack c e placed benea h

the caster base and next to the foot
elevating pedals.

Figure 12-31: U c e i g de ice jack f ca e ba e

Sensors

7-To replace air and thermostat sensor,

disconnect them from their connectors and then
remove their cable carefully which are passed
from plastic clamps on enclosure in shown
direction.

Figure 12-32: Re i g e cable

57
 Fuses
Fuses specifications are determined in below table:

Fuse No. Electrical characteristics

(label on Fuse type Fuse position Operating Breaking capacity
Voltage Current
fuse holder) speed (Interruption)
Glass tube Main power
F1.1 220 v 3A 0.1s 100 A
6.3 x 32mm line
Glass tube Main power
F1.2 220 v 3A 0.1 s 100 A
6.3 x 32mm line
Height
Glass tube
F2.1 adjustment 24 v 3A 0.06 s 100 A
6.3 x 32mm
circuit
Height
Glass tube
F2.2 adjustment 24 v 3A 0.06 s 100 A
6.3 x 32mm
circuit
Controller
Glass tube
F3.1 board power 24 v 0.5 A 2. s 35 A
6.3 x 32mm
supply
Controller
Glass tube
F3.2 board power 24 v 0.5 A 0.2 s 35 A
6.3 x 32mm
supply

Table 12-11: F e ecifica i

There are two kinds of fuses in Infant Incubator Model 111. Inline fuses and panel mount fuses.
F 1.1 and F1.2, which are explained in table 12-10, are mount fuses and F2.1, F2.2, F 3.1 and
F3.2 are Inline fuses.

Inline fuses replacement

1-To replace inline fuses, remove power cord

from the outlet and then push its two sides
toward each other.

Figure 12-33: Replacing inline fuse- Part A

58
 2-Rotate two sides of the inline fuse holder in
opposite directions and anti-clockwise.
Figure 12-34: Replacing inline fuse- Part B

3- Open inline fuse panel.

Figure 12-35: Replacing inline fuse- Part C

4-Change glass tube fuse and close inline fuse holder by pushing two sides of it toward each
other. Next rotate them in clock-wise direction.

Panel mounts fuse replacement

1-To replace panel mount fuse, remove power cord from the outlet.

2- Rotate panel mount fuse holder to its specified

direction and remove it from the device.

Figure 12-36: Replacing panel mount fuse- Part A

3-Take out the glass tube fuse and change it.

Close panel mount fuse holder by turning it
in opposite direction compared to previous
step.
Figure 12-28: Replacing panel mount fuse - Part B

59
Battery
To detach the battery pack fixed on unit control body by a cable tie, carefully cut the cable tie
and disconnect its connector from charging circuit board. While cutting the cable tie make sure
that do not hurt the battery pack by pushing any acuminate things on it.

Electrical boards
Prior to replace electrical boards, make sure that the device is turned off and unplugged. If it is
fixed by screws, first unscrew it and then easily detach it from other boards. Before detaching
the board, make sure there is no installation between this board and other board by wires or
connectors. If was, first disconnect the connections.

60
13-Block diagrams

13-1- Hardware Architecture

Figure 13-1: Hardware architecture of Infant Incubator Model 111

61
62
13-2- Circuit Boards

Figure 13-2: Controller circuit board of Infant Incubator Model 111

63
13-3-Insulutiuon Diagrams

Figure 13-3: Insulation diagram of Infant Incubator Model 111

64
13-4-Software Architecture

Figure 13-4: Software architecture of Infant Incubator Model 111

14-Service
To make sure that Infant incubator Model 111, is working properly in its useful life time and to
prevent any probable hazard happening, the device should be serviced routinely every 6 months.

To service the device you should do some inspections on the device by using inspection list
specified in Annex.1 and then document the inspec ions result in RD-FO-41 form presented in
Annex.2 and deliver a copy of that to TOSAN Company.

65
15- Authorized Representatives

15-1-European Authorized Representatives

Representative: ATTA Imex.Handel (Manage by Mr. Atta Motedayen)

Registered address: Kaiserstrasse, 27 A, 44135, Dortmund, Germany.
Phone: +49 15 209054809
Email: atta.motedayen@tosanco.com

66
15-2- Sale and Service Agents
In Iran
Representation
Company Managing Contact
No. Code Province/Area
Name Director Number Sale Service

Arash
① Medical 030127 Khorasan Mr. Soleimani 0513-8416200
Equipment
Isfahan,
Chaharmahal and
Bakhtiari,
Mobina Mr.
Kohgiluyeh and
② Medical 040124
Boyer-Ahmad,
Mohammad 031-45837303
Equipment Poor
Kish, Zanjan,
Sistan and
Baluchestan
Tehran,
Hamadan,
Semnan,
Khuzestan,
Mehr 021-66032307
Kermanshah,
③ Avaran 010342
Qom, Qazvin,
Mr. Mardaani 021-66034134
T e e Teb 021-66034172
Bushehr,
Hormozgan,
Markazi, Alborz,
Lorestan
Pazhohesh
④ Sanat 080152 Fars, Kerman Mr. Jahromi 071-3230605
Tizarys
Tajhiz
Mr. Amin
⑤ Gostar 150106 Kurdistan
Zaad
0873-3566083
Aabidar
Pardis
Mr. & Mrs.
⑥ Medical 090114 Gilan
Namadi
013-33601022
Equipment
Electronic Mazandaran,
⑦ Payam
070602
Golestan
Mr. Alizadeh 011-32223035
Behkar
⑧ Teb Sina
100404 Urmia Mr. Rezaee 044-45267668
Neginsan
250121 Ardabil Mr. Fathi 09143517963
Tajhiz
Farmand 050151 East Azerbaijan Mr. Firuz Nia 09143151659

Table 15-1: Agents in Iran

67
Outside of Iran

Representation
No. Company Name Country/Area Contact Number
Sale Service
Global Systech
① Medika Indonesia +622187785135

② Raicord Co Iraq +9647700834229

③ Jalinus Aria Iraq 9647713345671
Modern Aydin
④ Medical Iraq +9647504454022

⑤ Cardio Med Russia +74959555257

⑥ Asia Goldman Lebanon +9618379140
⑦ Ansmed Turkey + 902165579797
⑧ Access Medical Morocco +212-522982960
PROMED Ltd Azerbaijan +994124081724
Sarl Groupe
Biomedical Algeria +213 21 48 02 43
Algerie
Almana General
Saudi Arabia 96638475310
Hospital
Nidus Trading
Corporation Bangladesh +880-2-9104173
Limited
Medical Alhekma Dubai +971551514151
Yafa Medical Dubai +971 6 56 55 325
Arabian United
Libya +21821-4838544
Co
Meridian Tech
Uganda +256414269977
Systems
Fuad Engineering
Yeman +9671266966
Trading
Labora
International Ethiopia +251114665556
Trading Plc

Table 15-2: Agents outside of the Iran

68
Annex1. Inspection
Test list specified below should be applied after first installation and before start up,
after any repair, for each periodical service and after any calibration.

Test list:

1. Checking accompanying documents:

Infant Incubator, Model 111 user manual
Infant Incubator, Model 111service manual
Infant Incubator, Model 111 labels

2. Checking the general condition:

Pull the power plug of Incubator out of the main socket, and check the following
items for visible damage:
The integrity of mechanical parts
Safety related marking, labels and identification plaque
Power cord
Enclosure
Admittance panel including its hinges and locks
Access panels including hinges and locks
Inner walls
Se cable (ai , ki , h midi , he m a )
Se c ec (ai , ki , h midi , he m a )
Mattress
Mattress tray
Control panel
Air intake micro filter
I.V stand
Drawers
Casters and casters with breaks
Handle
Access port and their c ff
Elevating foot pedals
Mattress platform tilting knob
Humidity reservoir

3. Electrical safety tests

The following steps describe the safety checks according to EN 62353:2014 and
EN 60601-1:2012
69
NOTE: Make sure the Tester/Analyzer does not get out of calibration.

3.1. Measuring the protective earth resistance

1. Turnoff the device by using the ON/OFF switch.
2. Unplug the device.
3. Prepare the test set-up as below:

Explanation: measurement is taken with a test voltage of V < 6 VAC and a

test current of I < 25 A.
The voltage drop between the protective earth terminal (at the power plug)
and a conductive part that protectively earthed (TEST point), is measured and
the resistance determined from the current and voltage drop.
The measurement value shall not exceed 300 .

Protective earth resistance:

3.2. Measuring the device leakage current

70
NOTE: This test can be performed only after the protective earth testing has been
passed.

1. Prepare a test set-up as shown below:

Explanation: A test voltage (242 VAC) is present at the power plug of the
Incubator. The current that flows from the protective earth terminal (at the power
plug) and the building protective earth conductor (with the S3 switch open and
close) is the device leakage current.

2. Turn on the device by using ON/OFF switch.

3. Measure the leakage current with switch S3 open, IA =
4. Set the short-circuit at the skin temperature sensor socket
5. Measure the leakage current with switch S3 close, IB =

The maximum value between IA and IB should be less than 500 µA.

Device leakage current: µA

71
 3.3. Measuring the applied part leakage current

NOTE: This test can be performed only after the protective earth testing has been
passed.

1. Prepare a test set-up as shown below:

2. Turn on the device by using ON/OFF switch.

3. Make a short circuit at the skin temperature sensor socket and connect
the test-probe to jumper.

The measurement value shall not exceed 100 µA

Applied part leakage current: µA

4. Functional tests
4.1. Check readiness for operation of Infant Incubator, Model 111.

72
 Then continue with the following tests:

4.2. Checking the air temperature control

1. Plug the power plug into the main socket.
2. Switch on the device by using ON/OFF switch.
3. Use the air mode or skin mode selector switch (AIR/SKIN) and air
temperature setting switches to set the air-temperature target to 32ºC.
The heater should be off after reach the selected target value.

4.3. Checking the skin temperature control

1. Place the skin sensor into the patient enclosure.
2. Connect the skin sensor into its connector.
3. Use the air mode or skin mode selector switch (AIR/SKIN) and skin
temperature setting switches to set the skin-temperature target to 36ºC.
The heater should be off after reach the selected target value.

4.4. Checking the humidity control

1. Check the humidity reservoir to be full.
2. Switch on the humidity system at Relative humidity selector switch
3. Use the relative humidity setting switches to set the humidity target
value to 50%.
The device should reach the selected target value.
4. Switch off the humidity control.

4.5. Checking the alarms

1. L.W.
Push the empty humidity reservoir into the incubator. The L.W. LED
(low water level alarm indicator) should blink and audible alarm
sounds should be heard.

2. SEN.F.
I. Disconnect the skin temperature sensor from its connector. The
SEN.F LED at SKIN TEMPERATURE unit (skin sensor failure alarm
indicator) should blink and audible alarm sounds should be heard. At
the same time the heater should be turned off.

II. Disconnect the air temperature sensor from its connector. The
SEN.F LED at AIR TEMPERATURE unit (air sensor failure alarm

73
 indicator) should blink and audible alarm sounds should be heard. At
the same time the heater should be turned off.

3. F.F.
1. Use the air mode or skin mode selector switch (AIR/SKIN) and skin
temperature setting switches to set the air temperature target to
32ºC.
2. Hold the fan with your hand and prevent it to spinning
The F.F. LED (circulation fan failure alarm indicator) should blink and
audible alarm sounds should be heard. At the same time the heater
should be turned off.

4. Line Interruption
When device is turned on unplug the from the AC power outlet, an
audible alarm sounds should be heard. Then again plug it into the AC
power outlet, the alarm should be silent, as well as the settings should
be resume.

4.6. Checking other functions

Breaks of casters
Enclosure latches
Variable height adjustment system
Mattress platform tilt adjustment system
Slider tra s movement facilit
Oxygen path include; tubes connections beneath the separator plate

74
Annex2. Inspection documentation form
Test documentation:

Dear teammate; TOSAN is led by your opinion, so please give back the test results in
the format of this form and help us continue to improve.

Testing organization: Test before putting into service

Recurrent test
Name of testing person: Test after repair

Responsible organization:

Equipment: Model number:

Serial number:
Tester: Complies:
(measurement equipment) Yes NO
accompanying documents: user manual service manual
general conditions:

Measurements: measured value allowable value

P o ec i e ea h e i ance .m less than 300
m
de ice leakage c en . µA less than 500 µA
applied pa leakage c en . µA less than 100 µA
Functional tests:

Note:

Overall assessment:
□ No safety or functional deficiencies were detected!
□ Deficiencies detected but no direct risk to continue clinical use. Correction required.
□ Equipment shall be taken out of operation until deficiencies are corrected!
□ Equipment does not comply – Taking out of service is recommended!

Name: ____________________

75 RD-FO-41 Rev 00
Manufacturer: TOSAN CO. (Manufacture & supply of Neonatal system)
Registered address: 1st South Floor, No. 65, Chehelsotoon Building
North Allameh Street, SaadatAbad, Tehran, Iran.
Phone/Fax: +98 21 22097416
Email: info@tosanco.com
Hereinafter “TOSAN Co.”
www.tosanco.com