ERTUNÇ ÖZCAN

BABYNEST H-100 MODEL

TRANSPORT BABY INCUBATOR
USER MANUAL

Release Date : 11.05.2017

Rev. Date /No : 13.02.2019 / 1
Babynest H-100 User, Maintenance and Service Guide

INTRODUCTION

ERTUNÇ ÖZCAN firm was established by Ertunç Özcan in 1968. Since that year it has been in service
as a private association operating in the fields of import, export, production and service with the aim of
selling medical devices and equipment alongside hospital and laboratory supplies in Turkey. Since
2002, Ertunc Ozcan has been manufacturing medical devices in its plant.

For further information on our firm and products you can contact us on the below stated phone number,
address and e-mail.

CENTER, DESIGN AND PRODUCTION

Design and production activities in the scope of IS0 9001:2015, ISO 13485:2012 standards and MDD
93/42/EEC; It covers the design, production, sales, distribution and technical service activities of
phototherapy and incubation devices and accessories.

Address : ASO 2.ve 3. OSB 2036. Cad. No:1 Temelli/Sincan/Ankara/Türkiye

Tel : +9(0312) 641 41 34
Fax : +9(0312) 641 40 06
Web : www.ertuncozcan.com
E-mail : [email protected]

ELEKTRONIC DESIGN AND SOFTWARE

Ertunç Özcan Medikal Cihazlar Ltd. Şti. Our company has been working on electronic software and
hardware in the organization.

Address: İvedik Osb Mah. Teknopark Ankara 2224 Cad. No:1 Zemin kat F-Z21 Yenimahalle Ankara /
Türkiye
Tel :(0312) 354 82 71
Fax :(0312) 354 81 97

STORE

The distribution of the products belonging to the companies that we are the distributor of in Turkey
covers the activities of the company to be stored in the scope of imports.

Address: ASO 2. Ve 3. OSB 2037. Cad. No:16/A Temelli / Sincan / Ankara / Türkiye
Tel :(0312) 502 05 97

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Babynest H-100 User, Maintenance and Service Guide

CONTENTS

INTRODUCTION 2
DEFINITIONS AND ICONS 5
PURPOSE OF USAGE 6
RESPONSIBILITY OF THE MANUFACTURER 6
OPERATING PRECAUTIONS 7
ELECTRICAL PRECAUTIONS 8
EXPLOSION PRECAUTIONS 8
HUMIDITY PRECAUTIONS 8
OXYGEN PRECAUTIONS 9
SAFETY MEASURES 9

PART 1. OVERWIEV
1.1 INTRODUCTION 11
1.2 DESCRIPTION 11
1.3 FEATURES 11
TABLE 1.3 FEATURES 12

PART 2. INSTALLATION AND CONTROL OF THE SYSTEM

2.1 MECHANIC CONTROL 15
2.2 CONTROL OF THE MEASURING MODULE 15
2.3 CONTROL OF THE ACCESSORIES 16

PART 3. FUNCTIONAL DESCRIPTION

3.1 GENERAL 19
3.2 FUNCTION 19
3.2.1 CHECKING THE TEMPERATURE 19
3.2.2 AIR CONTROL MODE 19
3.2.3 SKIN CONTROL MODE 19
3.2.4 SPO2 CONTROL MODE 19
3.2.5 OXYGEN CONTROL MODE 20

PART 4. USAGE THE BABYNEST H-100 CONTROL PANEL

4.1 ELECTRONIC CONTROL MODULE 21
4.2 SENSOR ACCESS / POWER MODULE 21
4.3 CONTROL MODULE KEYPAD 22

PART 5. OPERATION OF THE CONTROL MODULE

5.1 OPERATION 23
5.2 THE CASE OF POWER FAILURE 23

PART 6. MENU
6.1 SYMBOLS USED ON THE SCREEN (FUNCTION KEYPAD) 25
6.2. FUNCTIONAL MENU 27

PART 7. WARNINGS, ALARMS, ERRORS AND OBSTRUCTIONS

7.1 ALARM TABLE 28
7.1.1 MUTE/RESET OF ALARMS 29
7.2 ERRORS 29
PART 8. BABYNEST H-100 TRANSPORT INCUBATOR APPLICATION
8.1 GENERAL USAGE 30
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Babynest H-100 User, Maintenance and Service Guide

8.2 ACCESS TO NEWBORN 21

8.3 LIFTING AND LOWERING OF THE CANOPY 32
8.4 THE USE OF THE MOISTURIZING SPONGE 33
8.5 AIR INLET MICROFILTER 34
8.6 AIR AND OXYGEN 34
8.7 CONTROL COMPLETE 35

PART 9. CLEANING AND MAINTENANCE, REPAIR

9.1 GENERAL 36
9.2 MAINTENANCE 36
9.3 CLEANING 37
9.3.1 CLEANING PROCEDURE OF THE PATIENT PROBE 38
9.3.2 CLEANING AGENTS 39

PART 10. TROUBLE SHOOTING

TABLE 10 TROUBLE SHOOTING 40

PART 11. NOTIFIED BODIES INFORMATION 38

ANNEXE A- ELECTROMAGNETIC COMPLIANCE

ELECTRO MAGNETIC COMPLIANCE GUIDE 39

ANNEXE B- SUITABILITY OF STANDARDS AND DIRECTIVES

INFORMATION OF COMPLIANCE OF STANDARDS AND DIRECTIVES 45

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Babynest H-100 User, Maintenance and Service Guide

DEFINITIONS AND ICONS

NOTE, IMPORTANT, CAUTION AND WARNING

NOTE: Is used under the circumstances where clarification is need for conflictive or confusing
situations or where the processes/conditions may be misinterpreted or neglected.

IMPORTANT: Is used to highlight a situation that is more important than the NOTEs.

CAUTION: The term CAUTION is used in situations where there is a possibility of damaging the
equipment.
WARNING: The term WARNING is used in situations where there is a possibility of injuring the
patient or the user

ICONS

Caution: See the Relevant Caution : Danger of Electrical

Annexes Shock

See the User Manual Type BF Implementation Part

Power On (connect to a wall

Caution: Hot Surface
power switch)

Power Off (disconnect from the

Manufacturer
wall power switch)

Alternative Flow Do not throw out

WARNING information European Conformity

MAX. Maximum Serial Number

Weight Limit Keep Dry

Fragile

5
Babynest H-100 User, Maintenance and Service Guide

This manual shall explain all the functions and their usage instructions of the Ertunç Özcan brand
Babynest H-100 model transport incubator.

NOTE !

The explanations about the device which is stated in the user guide will be shown on Babynest H-100
model.

PURPOSE OF USAGE

The BabyNest H-100 model transport infant incubator is a baby transport incubator, which is designed
to provide a thermal environment suitable for newborns and premature babies.
It has been designed for the transport of infants with serious diseases in neonatal and high risk groups
with low weight.

The temperature of the baby's incubator and the baby's skin temperature can be monitored continuously
from the incubator screen.

RESPONSIBILITY OF THE MANUFACTURER

The assembly, modification, repair/maintenance and calibration activities of all the transport incubator
devices that has been manufactured and sold by Ertunc Ozcan, is done by qualified technical personnel
with the tools which are in accordance with the standards. Ertunc Ozcan is responsible for the
reliability, safety and performance.

Ertunc Ozcan is not responsible for the use of the transport incubator without following the instructions
and maintenance guidelines. The device can only be repaired and calibrated by an authorized service
staff.

All the users who operates the device must read and understand this user guide. When the transport
incubator is not in use it must be stored with this user guide.

For further or detailed information contact the manufacturer.

CAUTION: During the warranty period if the transport incubator is interfered by unauthorized people,
the warranty will be invalid.

The usage life of the unit you purchased is 10 years. This is the period for keeping the spare
parts required for the unit to operate as described.

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BABYNEST H-100 MODEL TRANSPORT INCUBATOR

OPERATION PRECAUTIONS

WARNINGS

 Misuse of the transport incubator can injure the infant. The transport incubators must be used only
by the appropriately trained personnel under the supervision of a qualified medical personnel.

 The transport incubator shall not be used if it is not operating properly. Technical service must be
given by an authorized and qualified staff.

 When the entry doors are open, there will be warm air flow between the entry door and the
mattress. This air flow temperature is usually higher than the air temperature inside of the
transport incubator hood. The infant must be kept away from this warm air flow, so as to prevent
possible injuries.

 For the safety of the infant, do not leave the infant unattended when the access ports and doors are
remained open.

 The set temperature cannot be achieved if the doors are remained open due to the effect of
environment temperature. For that reason, do not leave the access doors remained open more than
needed. When the access doors are remained open the temperature values may not be reliable.

 To prevent the infant from overheating the skin temperature must be monitored and checked in
skin or air mode. The skin temperature must not be checked through rectal.

 Direct sunlight or phototherapy devices and devices which produce similar heat may affect the
temperature inside the transport incubator in accordance with effecting the canopy temperature of
the transport incubators unit as well as the new-born’s skin temperature. Be careful about this
situation.

 Auxiliary equipment which sparks shall not be placed in or beside of the infant transport
incubator.

 Make sure that the attached parts of the transport incubator shall not exceed the maximum weight
capacity of the transport incubator.

 The skin temperature sensor shall not be used as a rectal temperature sensor.

 The canopy shall never be lifted when the infant is inside the transport incubator. The infant must
always be accessed by the front door.

 Accessories, which may affect or even change the air flow shall not be used inside of the transport
incubator. Otherwise the inside temperature of the transport incubator is going to change and the
homogenization shall fail and this effect the skin temperature of the new born.

 When moving the transport incubator, two or more people are needed in order to have sufficient
control of the transport incubator. Avoid moving the transport incubator while the new-born is
inside.

 Make sure the bed is covered with cotton flannel type textile before laying the new-born inside.

 When the device is not in use, turn it off from the on/off button.

 When the treatment is completed turn the device off by using the on/off button and for safety,
unplugs the power cable of the device from the switch until using it again.
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

 When connecting the device to the mains and external power supply, always follow the voltage
values in the user manual.

ELECTRICAL PRECAUTIONS

WARNINGS
 For the safety of grounding, plug in the power cable only to electric switches meet with hospital
class type switches which are grounded in the required way. In case of any doubt on the
grounding connection, do not turn on the device.

 The service of the device shall be done by a qualified and sufficient technical personnel due to the
danger of being electric shocked.

 Make sure the electrical features stated in the product features are fulfilled. Otherwise personal
injury or equipment damages may occur.

 Some chemical cleaning substances might be conductive. Do not allow these cleaning substances
to contact the electrical parts and do not spray these cleaning substances on surfaces. Personal
injury or equipment damage may occur.

 The cleaning of the control module of the device shall not be conducted by means of spraying or
with a similar way. Cleaning substances which may be constituent may cause personal injury or
equipment damage.

 Electrical equipment has a potential risk of electro shock. In this regard, please do train your
employee concerning with the risk of using electrical equipment.

 When connecting the device to the mains and external power supply, always follow the voltage
values in the user manual.

EXPLOSION PRECAUTIONS

WARNINGS

 Do not use the transport incubator in environments consist of easily flammable substances and
gasses (such as anaesthetic gasses) environments. It can lead to personal injury or equipment
damage.

 Do not clean the transport incubator with flammable substances, as even a small amount of
flammable gas, such as ether and alcohol, remained inside of the infant transport incubator might
cause fire when it meets with oxygen.

 During the cleaning and maintenance, turn off the oxygen supply of the transport incubator.
When cleaning and/or maintaining is completed in an environment enriched with oxygen, the risk
of fire and explosion might occur.

 Keep away all the ignition sources such as matches, lighter, electric stoves etc. from the location
of the transport incubator. Textile, oil and other flammable substances catch fire easily and burn
intensively in air which is enriched with oxygen.

HUMIDITY PRECAUTIONS

WARNINGS
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

 Soak the moisturizing sponge with water and place in the sponge section.

 Make sure all the access doors are closed and the hose connection ports are connected as required.
Access doors remained open decrease the humidity level inside of the transport incubator.
Personal injury or equipment damage may occur.

OXYGEN PRECAUTIONS

WARNINGS

 The misuse of additional oxygen can lead to severe side effects including blindness, cerebral
damage and death. The dangers may vary according to the infant. The method of oxygen
treatment, concentration and practice time shall be decided by the doctor who is carrying out the
treatment.

 Doctor shall be contacted immediately in case of an emergency where an oxygen treatment is

needed.

 The oxygen concentration which the infant breathes does not designate the partial pressure of the
oxygen in blood (SPO2). The SPO2 blood value shall be measured with the appropriate clinic
techniques if it is approved by the doctor.

 The oxygen flow rates cannot be used as a right scale of the oxygen concentration in the transport
incubator. The oxygen concentrations shall be measured with a calibrated oxygen analyser
regularly as stated by the doctor.

 Expired air filter, may increase the oxygen concentration and cause carbon dioxide. The air filters
shall be changed regularly.

 The oxygen treatment may increase the noise level of the hood.

SAFETY PRECAUTIONS

WARNINGS
 Before using the transport incubator this users guide must be read throughout and understood.
Otherwise injuries may occur.

 The misuse of the transport incubator may injure the new-born.

 The transport incubator shall be used only by an educated staff member who is in guidance of a
doctor who has the appropriate qualifications and who knows the risks and benefits of the
transport incubator that are known so far.

 Do not open the canopy by lifting it while the new-born is inside the transport incubator. Access to
the new-born by the entry doors. Otherwise it can lead to personal injury or equipment damage.

 For the safety of the new-born, do not leave the new-born unattended when the entry doors are
remained open. Personal injury may occur.

 During the use of airflow passages, the input panels must be kept open in order to prevent patient
safety and transport incubative performance.

 To prevent the new-born from having high temperature. Do not place the transport incubator in
direct sun light or under radiant heaters

 Do not place a surgical cover or a blanket on the new-born. The heat source may lead to injuries
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

and burns.

 Only the authorized staff member can access the battery (cell battery) part, in case of a chemical
leakage.

 To place the new-born into the transport incubator use the entry doors. The canopy shall not be
opened for the placement of the new-born.

 Always activate the wheel breaks before placing the infant into the incubator.

 Electro surgical units or other devices that can spread electromagnetic waves may cause the skin
temperature probe to detect a different value of temperature because of the absorbed electrical
energy.

 When opening or closing the entry panels or intervention windows, in order to prevent the new-
born from getting injured, the infant’s clothes, hoses, cables etc. must be kept in the boundaries of
the bed.

 Before moving the bed, taking it out, heightening it or lowering it make sure to check all the hoses
and cables of the patient to prevent the new-born from getting injured.

 When connecting the device to the mains and external power supply, always follow the voltage
values in the user manual.

PART 1
OVERVIEW
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

1.1. INTRODUCTION
This manual provides instructions for operation, cleaning, maintenance and troubleshooting of the
Ertunc Özcan Babynest Model H-100 Baby Transport incubators. The manufacturer shall not be liable
for the improper performance of the transport incubator if the user does not operate the unit in
accordance with the instructions, does not conform to the maintenance recommendations in Section 9
of this manual and it is repaired with parts that are not allowed to be used. Calibration and repair shall
only be carried out by qualified service personnel.
This manual should be read and understood thoroughly by all persons who will operate the transport
incubator.
This manual should be kept in a place that is easily accessible by the people who will use it.
If you do not understand something, please contact ERTUNC ÖZCAN Company for more
information.
1.2. DESCRIPTION
The air circulation system of the transport incubator ensures stable temperature control, uniform
temperature distribution, humidification, effective isolation of baby from airborne contaminants and
control of oxygen concentrations.
Access to baby is provided by access panels. Hot air flow is provided from the bottom of the front
edge of the pad to the top of the inlet panel outlet when the inlet panel is open; this mostly reduces the
temperature drop in the air canopy.
The Transport incubator is designed for use at ambient operating temperatures of 20°C to 30°C under
normal conditions.
In Babynest Model H-100 Baby Transport Incubators, skin or air temperature control is selected with
the control module.
1.3. FEATURES
Specifications of the transport incubator are provided in Table 1.3. All specifications are subject to
change without notice.
The use of inlet panels that can change the air flow pattern or other equipment and devices in the
transport incubator can affect temperature regulation, temperature variability, transport incubator’s
temperature relation and baby’s skin temperature depending on central pad temperature.

TABLE 1.3 FEATURES

CLASSIFICATIONS Class IIb
ELECTRICAL CLASS I
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

TYPE BF

STANDARDS:
Designed in accordance with the requirements below stated standards
(93/42/EEC) Medical Device Directive council decision
TS EN60601-1: 2009
TS EN60601-2: 2016
TS EN60601-2-19: 2011
TS EN60601-2-19-A11: 2012

ELECTRICAL FEATURES:
Power Requirements 110 / 220-240 VAC (±%10) VAC
Frequency 50-60 Hz
Power Consumption 75 W
Extrernal DC Battery 12 VDC Nominal, 11 V DC to 13 V DC
Battery 12 VDC 26AH lead acid dry type

WARNİNG: When connecting the device to the mains and external power supplies, always
follow the voltage values in the user manual.

INCUBATOR FEATURES:
Incubator Outside Dimensions 50.6 (Y) x 53.0 (G) x 102.0 (D) cm
Incubator Weight 40.0 Kg
New-born Bed Tray Size 63 (G) x 31.5 (Y) cm (±1cm)
Bed capacity 10 Kg
The pulling out level of the bed 20 cm
Noise level of the canopy environment
≤ 49 dB
Cable and Hose Entrances (Grommets) 5 pcs.
Intervention Doors 5 pcs.
Air Filter <0,5 µ

CONTROL OF AIR TEMPERATURE AND SKIN TEMPERATURE

Air Mode Control Range 17°C – 38.9°C
Skin Mode Control Range 34°C – 38.9°C
Measurement Sensitivity 0,1°C
Warm-up Time 22 minutes

OXYGEN MEASUREMENT RANGE

Oxygen Indication Sensitivity 1%
Accuracy of Oxygen Control ± 5%, 21% Cal
Oxygen Measure Range 15% – 99%
Inlet Pressure Range Up to 70 psi – 4,8 bar
O2 Sensor Operational Temperature Range 20°C – 41°C

PROTECTION CLASSES AGAINST WATER AND FOREIGN PARTICLES:

IPX0 and IP0X
Temperature:
Operating Temperature Environment between -15˚C and +40˚C
Storing Temperature Environment between -25˚C and +60˚C

Humidity:
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Between 5% and 85% Relative Humidity

Operating Humidity
Non-condensable
Between 0% and 99% Relative Humidity
Storing Humidity
Noncondensable
SOFTWARE FEATURES
Languages Turkish and English

Control Panel Screen:

Parameters monitored on LCD screen indicators:
• Temperature value of the set operating mode
• Set air tempature
• Measured air tempature
• Measured skin tempature
• Measured oxygen rate
• Set SPO2 rate
• Measured SPO2 rate
• Battery Level
• Menu settings
• Alarm

Standard Features:
• Reusable skin probe
• Air filter
• Moisturizing sponge
• Disposable skin probe
• Monitor shelf
• Serum holder
• Iris port
• Power cable
• Oxygen Tank
• Examination Lamp
• Flowmeter

Optional Features:
• Masimo SPO2 probe
• Transport Trolley
• Strecher platforms
• Oxygen sensor
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Figure1: Babynest H-100 Model Transport Incubator

BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

PART 2
INSTALLATION AND CONTROL OF THE SYSTEM

CAUTION: Read this entire manual before using the transport incubator. This transport
incubator may cause injury to the patient or the user if used without understanding its entire operation.
Be careful not to damage the equipment and unprotected sensitive surfaces when unpacking.
Otherwise, personal injury or equipment damage may occur.
2.1 MECHANICAL CONTROL
Perform the following procedure for checking.
• Unplug the power cable.
• Check for any damage to the power cable. Replace the cable if damaged.
• Check all the parts before installation. Make sure that there are no missing or damaged parts.
• Check the movement of the stretcher wheels. Make sure that the incubator is stable on the
stretcher. Make sure that the incubator stand is stable when the wheels are locked and the wheels
move smoothly when the wheel are not locked.
• Manually check whether each stretcher wheel is loose or not by lifting each corner of the transport
incubator. This check must be done by two people. During use with a loose wheel, there is a risk
of tipping. The transport incubator must not be placed on the stretcher until the loose wheels have
been replaced.
• Make sure that the access panels (front, back and side) open and close properly. Make sure the
access panels are closed.
• Check the access windows. Open the access windows by pressing the latch. The lid must open
automatically. Close the access windows and make sure the latches hold the lid.
2.2 CHECKING THE MEASUREMENT MODULE
Perform the following procedure for checking.
• Make sure the power cable is connected to the plug and the device.
• Check for the connections of the measurement module.
• Switch on the device with the On/Off buttons. The device performs self-test system check at
power-on. Wait for this test to be completed.
• Make sure that the skin probe and SPO2 probe are functional. To do this, follow the variation of
the skin temperature on the screen by heating the skin probe with your hand.

CAUTION: Using alternative methods, you can test to see if the SPO2 probe works
correctly. If you observe that it is not working properly depending on the test result, contact the
technical service.
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

2.3 CHECKING THE ACCESSORIES

The accessories for the device are listed in Table 2.3.
TABLE 2.3 ACCESSORIES
SPO2 Probe: It measures the amount of oxygen
molecules in the patient's blood by the hemoglobin
molecules (SpO2) and thus calculates the pulse.

Reusable skin probe: Measures the patient's skin

temperature.

Power Cable : It allows the device to be supplied

from the mains voltage.

Monitor shelf: It is used with a capacity of 5 kg

and it is used to place the system / device on the
device on a maximum of 5 kg.

Disposable skin probe: Measures the patient's

skin temperature.

Serum Holder: Allows the serum fluid to be

transported.

Iris Port: It is used to keep stable ambient

conditions within the device balanced during
intervention from the lid.
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Oxygen sensor: Measures the amount of oxygen

given to the patient.

Air filter: Used to filter intake air.

Transport trolley: Used to transport and change

the height of the incubator.

Stretcher locking mechanism: With four wheels

and brake mechanism; The adjustable system at
two or three different height levels is mounted on
the carriage.

Oxygen tube: Used to provide oxygen to the baby.

(White tube)
Dry air tube: Used to provide air to the baby.
(Yellow tube)

Examination Lamp: The lighting system provides

to baby comfortable conditions.
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Flowmeter: Used to measure of oxygen ratio.

Ambulance Cable: Allows the external power

supply to be connected to the device.

• Check all the accessories. Make sure that they are not missing or damaged.
• Make sure all accessories are securely mounted.

CAUTION: DISINFECT THE INCUBATOR BEFORE USE.

PART 3
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

FUNCTIONAL EXPLANATION
3.1. GENERAL
This section includes a general description on the functions of the Babynest Model H-100 incubator.

3.2. FUNCTION EXPLANATION

The temperature, humidity and oxygen concentration are controlled by the force-air circulation
system. The ambient air is passed through the air suction filter by an engine-driven fan in a controlled
manner and taken into the system. Part of this air which is directed into the canopy at the same time is
again sucked by the fan and passed through the heater. The air enters the canopy through the guiding
devices on the main body. The air then passes through the front, rear and side inner walls.
When the front and/or rear and/or side inlet panels are open, a hot air curtain is created and the air
continues to flow upward through the open panel. This curtain minimizes reduction of air temperature
in the incubator when the front and/or rear and/or side entrance curtain is open.
Temperature of the transport incubator is regulated using the air or skin temperature. The user sets the
air or skin mode.
The location of the incubator can be easily replaced by the trolley. Our system is mounted on a four-
wheeled, three-stage folding trolley with at least two brakes. Transport trolley used in Emergency
Assistance Ambulances in Ministry of Health inventory, Spencer, EMS etc. it can be fixed to the floor
of the stretcher platforms, it is compatible with all of them and it can be placed easily without any
tools and ambulance changes.
External lamp, lighthing insufficiently inside the incubator ambiance.
3.2.1. CHECKING THE TEMPERATURE
Temperature of the Babynest Model H-100 transport incubator is controlled by using the internal
temperature of the transport incubator or baby’s skin temperature. The desired mode can be selected
with a control module key and the operating mode can be monitored from the screen. The actual
temperature values can be monitored at the same time on two independent displays of the control
module.
3.2.2 AIR CONTROL MODE
The transport incubator’s air temperature is monitored through the control module. Air is supplied to
the heater control circuit, which controls the heater output, in order to keep the transport incubator’s
temperature at the set value.
3.2.3 SKIN CONTROL MODE
The baby's skin is directly connected to a temperature sensor. After the skin temperature is set to the
desired value on the control module, the skin temperature read from the baby sensor is monitored on
the control module display.
During skin mode control, the baby skin temperature indicator does not show any value if the sensor is
removed from its slot.
3.2.4 SPO2 CONTROL MODE
A SPO2 sensor is attached directly to the baby's finger. After the SPO2 is set to the desired value on the
control module, the SPO2 value read from the baby sensor is monitored on the control module display.
During SPO2 mode control, the SPO2 indicator of the baby does not show any value if the sensor is
separated from the part touching the baby.

In this mode, the BPM value is kept between 25 BPM and 240 BPM and SpO2 value is kept between
2% and 100%.

3.2.5 OXYGEN MEASUREMENT RANGE

BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

The internal atmosphere of the incubator can be enriched with oxygen. Oxygen can be delivered to the
baby through a pressurized oxygen tube with pressure relief valve and flowmeter, or through the
hospital central system with a flowmeter.

CAUTION: Knowing that an oxygen concentration of more than 40% is harmful to the
baby, the use of oxygen in the incubator should only be recommended and supervised by
experienced medical personnel.

CAUTION: When oxygen is supplied to the incubator, the oxygen concentration must
always be measured with an oxygen analyzer.

PART 4
USAGE THE BABYNEST H-100 CONTROL PANEL

4.1 ELECTRONIC CONTROL MODULE

BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Figure 4.1.1 - Front View of Electronic Control Panel

The control module keypad allows all settings of the transport incubator to be made and monitored.
Keypad functions are described in detail in Section 4.3.

Figure 4.1.2 Control module On/Off key

4.2 SENSOR ACCESS / POWER MODULE

Examination On/Off Switch
lamp

Skin Probe External

Conector DC inlet Power Input

Figure 4.2 – Sensor Access / Power Group

1 Skin Temperature Probe Connector, 1 External DC-Inlet, 1 ON/OFF Switch, 1 Examination Lamp, 1
Power Input of the transport incubator are as follows.

4.3 CONTROL MODULE KEYPAD

Set temperature Display Skin temperature Display
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Air temperature display Oxygen Value Display

Temperature control Screen Oxygen control Switches

Device mains power/battery

indicator
Masimo SpO2 Display
Information display
Masimo SpO2 Control
Switches

On/Off Switch

Alarm Mute Key-Lock

button

Figure 4.3: Membrane keypad

1. Device Mains Power/Battery Indicator: The mains power is activated if the device is powered
from the mains. If the power is interrupted or the plug is pulled out internal battery indicator is
automatically activated. While an external battery is in use, and the current status of the battery
can be monitored in % on the control module. When power is restored or plugged in, the system
shall automatically start from the mains / DC voltage and the internal battery can be charged while
the device is operating from mains voltage.

2. Baby Skin Temperature Indicator: It indicates the skin temperature of the baby. It tries to keep
the baby’s skin temperature at the value set by the user.

3. Air Skin Temperature Indicator: It indicates the internal temperature of the canopy. It tries to
keep the internal air temperature at the value set by the user.

4. Device Lock Key: If no key is pressed on the control module, the device locks itself up within 20
seconds.

5. Alarm Key: If an alarm condition has occurred, the indicator flashes, it activates by giving a
visual and audible alarm with yellow light. If the reported alarm is an alarm that can be silenced, it
will be deactivated by pressing it when a new alarm condition is not generated. The alarm is
canceled by the system as soon as the silenced alarm condition is over.

6. Oxygen Indicator: It indicates the oxygen concentration.

7. SPO2 Indicator: It indicates the SPO2 value.

8. On/Off Key: It allows the device to be turned on and function, and when the device is running, it
is completely turned off when the same key is pressed again.
PART 5
OPERATING THE CONTROL MODULE

5.1 OPERATION
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To operate the device, first connect the power cable to the power socket in the power group and to the
mains plug.

CAUTION: Ensure that the electrical specifications specified in the product specifications are
met.

CAUTION: When connecting the device to the mains and external power supply, always follow
the voltage values in the user manual.

Make sure you attach the accessories supplied with the device to the places shown in Figure 4.2.
Operate the device by pressing the On/Off switch on the control module (Figure 4.1) and on the power
supply (Figure 4.2).

Figure 5.1: View of the screen after turning on the device

The device is designed so that all data can be displayed on one screen.

If the set values appear as “---”, then that parameter is not used in the cabinet and it means that it is
turned off by the user. When the parameter is turned off, if there are alarm conditions related to the
parameter, the alarm conditions that depend on that parameter will also be canceled.

5.2. THE CASE OF POWER FAILURE

The priority sequence of the device's feed source is as follows.

1-Mains,
2-Ambulance supply,
3-Battery.
In case of interruption of the energy from the device, the 220 V AC mains sockets in the ambulance
and/or 12 V DC cigarette lighter input (charging) with the necessary equipment can be provided to
continue the operation of the device. In addition, the device has a rechargeable battery. In case of
cutting the energy from the device, the rechargeable battery will be activated automatically. An
audible warning will occur. The audible alarm can be silencated with the alarm mute key if desired.
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Your recorded measurements before the power outage will not be lost with a power outage, and these
values will continue to be recorded. Once the power of the device is restored, the power failure failure
will be eliminated and your device returns to normal operation functions.

PART 6
MENUS

6.1 SYMBOLS USED ON THE SCREEN (FUNCTION KEYPADS)

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On/Off key: The switch to turn the device on

and off the control panel.
Device lock key: Locks or makes use of all
keys. If no key is pressed for 15-20 seconds,
the system detects it and enters automatic key
lock mode.
Alarm mute buton: If an alarm condition has
occurred, the indicator flashes with a red light
and activates with a visual and audible alarm.
If the alarm reported is a silent alarm, it will
deactivate the alarm for 15 minutes if no new
alarm condition occurs when pressed.
However, the alarm status can be detected
from the alarm indicator on the display by the
alarm status light indicator on the membrane
keypad. As soon as the silenced alarm
condition disappears, the alarm is canceled by
the system.

Weather mode indicator: Indicates that the

device is operating in air mode.

High temperature display: High air

temperature for air mode is the illuminated
indicator that is activated when a high skin
temperature alarm occurs for the skin mode.
Low temperature display: The low air
temperature for the air mode is the illuminated
indicator that is activated when a low skin
temperature alarm occurs for the skin mode.
Fault indication: Air mode is the light
indicator that is activated during use, when the
skin mode is in use, during failure during
oxygenation.

Heater power indicator: Indicates the

operating power of the heater.

Hale> 37 Indicator: This display is activated

when the temperature setpoint (in air mode
and skin mode) is desired to be set above 37 °
C. In order to adjust the temperature to
temperatures higher than 37 ° C, the function
key must be pressed.
Mode Switch Key: Switches from Air mode
to Skin mode, skin mode to air mode.

Increase / decrease key: To decrease the “+”

value to be set, tuş - acak is used to decrease.

Skin mode indicator: Indicates that the

device is operating in skin mode.
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High oxygen value indicator: If the oxygen

value read from the module is 5% higher than
the set oxygen value, a high oxygen value
alarm occurs. This is the illuminated indicator
that is activated when an alarm occurs.
Low oxygen value indicator: If the oxygen
value read from the module is 5% lower than
the set oxygen value, a low oxygen value
alarm occurs. This is the illuminated indicator
that is activated when an alarm occurs.
Oxygen calibration key: It is the key that
should be used when oxygen calibration is
desired.

Confirmation key: The key to confirm the set

oxygen or SPO2 value.

Mains power indicator: Indicates that the

unit is operating on mains voltage.

Ambulance mode: Indicates that the device is

supplied from the battery in the ambulance or
by the network in the current facilities.

DC power mode: Indicates that the device is

operating with 12 VDC power.

Low battery indicator: When the device is

running on battery and the battery capacity is
low, it is activated with LED indicator.

Battery power indicator: Indicates the power

at which the device is running while operating
the battery.

Low SpO2 Value: This is the display with

LED, which is activated when the SpO2 value
is lower than the set high SpO2 limit.

High SpO2 Value: This is the LED display

that is activated when the SpO2 value is higher
than the high SpO2 limit set.

Low PR Value: This is the LED display

which is activated when the PR value is lower
than the set high PR limit.
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High PR Value: LED display which is

activated when PR value is higher than high
PR limit set by operator.

Function change key: Used to switch

between SPO2 and PR modes.

System fault indicator: This is the LED

display which is activated when there is a
fault in the control module.

Indication of air recirculation fault: If there

is any problem in air circulation, ’’ air flow
failure ’‘ is the indicator with LED activated.

6.2. FUNCTION MENUS

Function menus are menus where parameter settings, changes and records are made. Transitions
between these menus are made with the function changing key. The functions linked to function keys
of menus are given under the title "6.1 Symbols Used on the Screen".

PART 7
WARNINGS, ALARMS, ERRORS AND OBSTRUCTIONS

7.1. ALARM TABLE

BabyNest H-100 Alarm Table

Alarm Info
Alarm Symbol Cause of Alarm
Type Screen
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The air temperature in air mode

is 1.5°C below the set
Low Air Standard LO temperature after the temperature
Temperature Alarm AIR has been attained or if no
operation is carried out for 1
hour.
The air temperature in air mode
is 1.5°C above the set
High Air Standard temperature after the temperature
HI AIR
Temperature Alarm has been attained or if no
operation is carried out for 1
hour.
Alarm If the air temperature >40°C, the
High Air
cannot be HI AIR heater shall be disabled and
Temperature
muted system shut down.
Alarm
Faulty Air DFC If the Air Temperature Sensor is
cannot be
Sensor AIR faulty
muted
The skin temperature in skin
mode is 1.0°C below the set
Low Skin Standard LO temperature after the temperature
Temperature Alarm SKIN has been attained or if no
operation is carried out for 1
hour.
The skin temperature in skin
mode is 1.0°C above the set
High Skin Standard HI temperature after the temperature
Temperature Alarm SKIN has been attained or if no
operation is carried out for 1
hour.
Alarm If the skin temperature >40°C,
High Skin HI
cannot be the heater shall be disabled and
Temperature SKIN
muted system shut down.
Alarm
Faulty Skin DFC If the Skin Temperature Sensor is
cannot be
Sensor SKIN defective
muted
Removed Warning NO The skin sensor is removed
Skin Sensor Alarm SKIN during skin mode operation.
The measured oxygen level is 5
Low units below the set oxygen value
Standard
Oxygen LO O2 after reaching the oxygen steady
Alarm
Value state or after 30 minutes of
inactivity.
The measured oxygen level is 5
High units above the set oxygen value
Standard
Oxygen HI O2 after reaching the oxygen steady
Alarm
Value state or after 30 minutes of
inactivity.
No Oxygen Warning No oxygen sensor connected to
NO O2
Sensor Alarm the incubator
Faulty
Warning DFC
Oxygen If the oxygen sensor is defective
Alarm O2
Sensor
Low SPO2 SpO2
Warning LO If the SPO2 value is higher than
Value Alarm SPO2 SPO2 highest limit set by the
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operator
If the SPO2 value is higher than
High SPO2 Warning HI
SpO2 SPO2 highest limit set by the
Value Alarm SPO2
operator
If the PR value is lower than
Low PR Warning
LO PR highest PR limit set by the
Value Alarm
operator
If the PR value is higher than
High PR Warning
HI PR highest PR limit set by the
Value Alarm
operator
Warning LO
Low Battery If the battery level is low
Alarm BAT
Alarm
System SYS The error is associated with
SYS cannot be
Error ERR Software or Hardware parts.
muted

7.1.1 MUTE/RESET OF ALARMS

Mute: The alarm can be muted by pressing the mute button in the event of an alarm. As long as the
audible alarm system is disabled, the alarm can be continuously monitored from the illuminated
display on the control module. It is muted by this key. If another alarm occurs during this time, the
alarm muting feature is automatically disabled.
Reset: It cancels the alarm if the alarm condition is disappeared.

7.2. ERRORS
If the mains power is interrupted, it will sound an alarm and the device
Power Interruption
will start feeding by the internal battery.
It is activated when there is any malfunction in the electronic part inside
System Error
the device.
Air circulation failure It is activated when there is a problem in air circulation.
When the fan motor is not running or the air flow balance in the cabin is
Fan Failure disturbed, it will sound in written and audible. Contact a technical
service department.
If the external power is interrupted, the alarm is written and audible, and
the device starts to work with the battery. In battery mode, the device
Power Failure operates for 4 hours *.
* Battery working time; may vary depending on environmental
conditions, battery capacity, battery usage time, etc.

PART 8
BABYNEST H-100 THE TRANSPORT INCUBATOR APPLICATION
8.1 GENERAL USE
The following procedures must be carried out for the use of the transport incubator.
• Make sure the wheels are locked.

CAUTION: Make sure to lock the wheel brakes before laying baby down in the transport
incubator.
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1. Connect the power cable of the transport incubator in accordance with the electrical requirements
specified in the technical specifications.
2. If an extension cable is used, attach the power cable of the incubator to the extension cable and
extension cable to the plug.
3. Operate the transport incubator through the On/Off buttons on the power unit and on the control
panel.

4. When the device is first turned on, the control circuit performs a self-test. Selft-test phases are as
follows.

CAUTION: Heat the incubator before laying baby down into the transport incubator.
5. Select air or skin temperature mode control.
IMPORTANT: The temperature control mode and temperature settings must be set by the doctor.
Baby's rectal and/or axillary temperature must be monitored regularly according to the instructions of
the doctor or nurse concerned.

6. Lay the baby down on the pad.

7. Attach the SpO2 probe to the baby’s finger. Make sure that the sensors in the probe are attached
correctly to the finger of the baby, it is not possible making measurement for the sensors in failure
to detect.

8. Place the skin probe on the baby’s skin. Place the probe according to the baby's lying position.
Before placing the probe, make sure that the baby's skin is dry and clean. Below are the possible
conditions that can occur with the skin probe. If these conditions occur, it may cause the baby to
be heated too much or too little.

• Do not place the probe between the baby and the pad. Otherwise it may cause incorrect
measurement.
• Do not pull the probe wires. Separate the probe from the skin by carefully pulling off the
adhesive part. Remove the probe from the measuring module by holding the module.
• Check at regular intervals that the probe is connected. If the probe is not in contact with the
skin, it may cause incorrect measurements.
• When phototherapy lamps are used, the probe must not be located directly on the temperature
path the lamp is emitting. Place the probe somewhere protected from the light of the lamp.
The phototherapy lamp can increase the temperature of the baby's skin.
• Do not open the bag of the probe unless necessary for use. Replace the damaged probe.

9. There are a total of 5 hose entries on the incubator panel (Figure 8.1). The cables and hoses to be
used for baby's treatment and control are passed through these entrances to prevent heat loss.
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Figure 8.1 Hose entries

8.2 ACCESS TO NEWBORN

There are two entrance panels on the front and rear of the canopy, which open to allow easy access to
the inside. The lid can be opened and locked by rotating the latches on the right and left upper corners
of these access panels. After opening the lid, taking out the pad by sliding the pad forward allows
easier intervention to the baby.

Rotate the latches of the access panels.

Incubator’s oval panels are easily opened

with one hand and the baby is placed
inside.

Open the side window to take out the pad

from the canopy.

To take out the pad from the locked part,

open the locks on the corners.
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Hold the pad from the handle on the side

of the pad and pull it towards yourself.

Emergency windows are also used to intervene in the baby. There are 5 emergency windows on the
canopy. The emergency window can be opened easily by pushing the latch on the top with the elbow
to prevent microbial contamination.

CAUTION: Keep the emergency windows closed for baby's safety when using the transport
incubator.

CAUTION: Heat the incubator before putting baby into the transport incubator.

CAUTION: Do not leave the baby alone in the transport incubator while access panels or
emergency windows are open.

8.3 LIFTING AND LOWERING OF THE CANOPY

CAUTION: When there is a baby in the transport incubator, do not upraise the canopy. Upraise
the canopy only for cleaning and disassembly.

CAUTION: Turn off the control panel before upraising the canopy.
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While opening the canopy window, turn it from

the hatches towards yourself.
3

You can intervene to the baby through the window

entrances by pressing the opening part on the
canopy window.

8.4 THE USE OF THE MOISTURIZING SPONGE

To moisten the air circulation in the transport incubator, first moisten the sponge under the pad holder.
If attention is paid to the amount of water drawn into the pad, it is seen that the humidity is high.
The moisturizing sponge is shown in Figure 8.4.
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Figure 8.4 The Moisturizing Sponge

CAUTION: Use distilled sterilized water to avoid bacterial contamination. Replace the sponge
whenever incubator is cleaned.

CAUTION: Moisten the sponge out of the incubator. It is not advisable to pour water directly
into the incubator, because the water may pass through the air conduction section and affect the
control system.

8.5 AIR INLET MICROFILTER

Stone filter is used at the inlet of oxygen. It should be replaced if it appears dirty.

CAUTION: Dirty air inlet microfilter can affect oxygen concentrations and/or lead to the
formation of carbon dioxide. The filter should be checked regularly and replaced at least every three
months.

8.6 AIR AND OXYGEN

The filter cartridge for the inlet valve should be checked every four months and should be replaced if
the edges are greyed or darkened. Contact a qualified service personnel for this.

Figure 8.6 Air and Oxygen inlet

Oxygen can be supplied through a wall source, through an oxygen cylinder, or through a flowmeter.
Oxygen Concentration Guide is shown in Table 8.6.
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Table 8.6 Oxygen Concentration Guide

Oxygen Input Normal Range
2 Lpm 25-30
4 Lpm 29-35
6 Lpm 33-41
8 Lpm 38-52
10 Lpm 45-75
12 Lpm 65-95

CAUTION:

- In order to confirm that the predicted oxygen concentration is given, the oxygen concentrations
must always be measured separately.
- Unconscious use of supplemental oxygen can lead to serious side complications including
blindness, brain injury and death. Hazards may vary by baby. The method, concentration and
duration of treatment should be determined by the relevant physician.
- Oxygen therapy can increase the level of noise in the incubator.
- If oxygen is needed in an emergency, the doctor should be notified immediately.
- The oxygen concentration inhaled by the infant does not determine the oxygen partial pressure
(SPO2) of the blood. When appropriate by the relevant physician, the blood SPO2 value should be
measured by accepted clinical techniques.
After each change of the oxygen flow setting, allow 30 minutes for the concentrations.
8.7 CONTROL COMPLETE
If the transport incubator is to be used, take it in the air mode control and keep the incubator running
until ready for use. If the transport incubator is not to be used, turn it off and remove the power cable
from the plug.
OPERATION DURING THE USAGE

IMPORTANT: The incubator should not be put in service without general operation and function
check procedures (Section 8).
The transport incubator must be ventilated and in the air mode, it must be subjected to pre-heating
process up to the temperature prescribed by the relevant physician, or up to the temperature specified
by the department.
NOTE: When connecting the device to the mains and external power supplies, always follow the
voltage values in the user manual.
During preheating of the incubator, it must be operated without wetting the moisturizing
sponge.
NOTE: The air vents that are functioning when the access panel of the transport incubator is open
may be adversely affected by air flow, fan or ventilation. Take precautions to keep the incubator away
from such air currents.
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PART 9
CLEANING, MAINTENANCE & REPAIR

CAUTION: Do not displace the incubator without removing all auxiliary devices from the
incubator. Before cleaning or maintaining, ensure that all oxygen supply units connected to the
incubator are closed and dismantled. There is a risk of fire hazard in environments enriched with
oxygen.
Unplug the power cable to disconnect electricity before service or maintenance procedures are applied.
Deposits that remain from ether, alcohol, or similar cleaning solutions may cause fire.
The air microfilter cannot be sterilized or cleaned by a process such as washing. Replace the air
microfilter every 3 months.

9.1 GENERAL
This part includes cleaning and maintenance instructions. Dismantling instructions are also included
where necessary. Except as described in this section, maintenance must only be performed by
qualified service personnel. Cleaning must be carried out by qualified personnel after every use and in
any case necessary. Control module isn’t affected from dust proof and liquids.
Calibration procedures should be done at intervals of 12 months.
Repairs must only be performed by the Ertunc Ozcan Technical Service under warranty. Do not use
the device that you think is faulty.
Cleaning should be done with the non-scratch cleaning cloth produced for delicate surfaces. Do not
spray, spill, disinfectance etc. to the surface to be cleaned. Use the cleaning cloths with disinfectant.
9.2 MAINTENANCE
The recommended maintenance periods are shown below. Always follow hospital and local
regulations for the required intervals.
Weekly or after each patient
If used, disinfect the humidifier. Clean the incubator and check the air filter. Disinfect the incubator if
necessary, or after use in patients with contagious disease.
Once every three months
Replace the air microfilter.
Note: This is the minimum replacement interval of the filter. The filter must be replaced when it
appears dirty.
Once a year
It is recommended to replace the internal battery of the control panel, which monitors the data present
at power failure. Internal battery shown in figüre 9.2.
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Figure 9.2 Internal Battery

9.3 CLEANING
When the baby is discharged or at least once a week, the incubator should be completely cleaned and
disinfected. Cleaning by disassembling the parts is the most effective way.
Wipe the surface of the heater with a soft cloth soaked with disinfectant etc. Always follow the
instructions of the cleaning solution manufacturer for use.

CAUTION: Remove the power cable before cleaning the transport incubator.
1. Prior to dismantling, locking mechanisms of the four wheels of the incubator must be engaged to
ensure safety. To lock the wheels, the latch must be in the lock position by pressing the latch on
the wheel.

2. Make sure the power cable of the incubator is removed from the socket.

3. Turn off the control panel using the On/Off button.

4. Wipe the surface of the heater with a soft cloth soaked with disinfectant etc. Always follow the
instructions of the cleaning solution manufacturer for use.
5. Using the canopy lifting arms, tilt the canopy slowly backwards until the latch snap. Upraise the
canopy and, when performing the following operations, wipe the surface of the heater with a soft
cloth soaked with disinfectant etc. for each step. Always follow the instructions of the cleaning
solution manufacturer for use.

6. After opening the canopy, pull the baby pad tray toward you. Take out the baby pad and the tray
by upraising them.
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7. Once you have taken out the baby pad and the tray, bring the bottom tray back to its original
position. While in this position, hold it from both sides and lift it up.

8. Take out the base tray by opening the lock mechanism on the right and left side of the incubator.

9. Pull out the fan and heater top plate.

CAUTION: Do not dismantle the heater without cooling the heater. That is, at least 45
minutes must be waited for a turned off incubator to cool.
A non-cooled heater can cause burns.
10. Pull out the fan and heater.
11. After removing the fan and heater, clean all surfaces.
12. Place the heater and fan in place, paying attention to what you install correctly.

13. Place the top plate in its place.

14. Pull out the emergency window ports.

Figure 9.3 Removal of iris ports

15. Remove the screws by opening the two sides of the air inlet microfilter.
16. Reinstall the incubator and make sure that it is completely dry, and finally install the control panel.

9.3.1 CLEANING THE PATIENT PROBE

Check that the patient probe are single-use or multi-use.
Disposable skin temperature probes must not be cleaned or used.

CAUTION: Disposable skin probes are not designed and approved for reuse. Reuse can affect
measurement accuracy and system performance or cause malfunction due to product cleaning,
disinfection, resterilization or physical damage from re-use.
The should user ensure that this product is not damaged or contaminated by the product between
uses of the same patient.

Reusable skin probes and the SpO2 probe should be carefully wiped clean with a soft, damp cloth
applied with disinfection material that can be used safely in probe materials. Make sure all cleaning
materials are cleaned and dried.

9.3.2. CLEANING AGENTS

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Iodophor or quaternary disinfecting detergent should be used, but only after the incubator has been
emptied and dismantled as described in paragraph 9.2.1. Follow the manufacturer's instructions for use
while using any antiseptic agent.

CAUTION: Do not clean the incubator with organic solvents, stripping compounds, strong
acids or strong bases. These compounds can damage the parts.

Do not immerse the parts in the cleaning solution. Cleaning should be done with the non-scratch
cleaning cloth produced for delicate surfaces. Do not spray, spill, disinfectance etc. to the surface to be
cleaned. Use the cleaning cloths with disinfectant. Wipe the cleaning solutions on the parts and dry
them.
Do not allow cleaning solutions to leak between plastic parts in any way and without drying.
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PART 10 TROUBLESHOOTING
Troubleshooting for the transport incubator is shown in Table 10. If the fault cannot be determined
from the tables, the unit must be taken from service and serviced by a qualified service technician
trained by manufacturer. If the incubator cannot be operated, contact the technical service.
TABLE 10 TROUBLESHOOTING
Indication Possible cause Solution
The system has no power
The main power switch of the
and the Power Fail Alarm Turn on the Power Switch.
incubator is off.
is not running.
The power cable is not connected Make sure the power cable of the
to the plug (there is no UPS) incubator is connected to the plug.
Power Fail Alarm is The power cable is not connected Make sure the power cable of the
active to the incubator (there is no UPS) incubator is connected.
Batteries are not charging. (there
is a UPS)
Access lids or iris ports are open Close all the lids and ports.
Low temperature alarm is
active The skin prove is not fixed well Check the connection of the skin
(only in SKIN operating mode) probe.
Low skin temperature is The skin prove is not fixed well Check the connection of the skin
active (only in SKIN operating mode) probe.
Access lids or iris ports are open Close all the lids and ports.
Iris entry ports glands are open or Check the connection of the port
not connected properly glands.
Hose inlet holes are not properly Check the connection of hose inlet
connected. holes.
Main Platform is not properly Make sure that the platform is
Low Oxygen
installed. properly installed.
Concentrations
Air inlet microfilter cover is not Check and fix the air inlet
properly fixed. microfilter cover.
Air inlet microfilter is not Check the air inlet microfilter and
installed. install it when necessary.
Turn off the incubator and remove
The internal pipe is not installed.
from service.
Check it and install when
Filter is not installed
necessary.
Air inlet microfilter is dirty. Replace the filter
Air inlet pipe is not installed Install the air inlet pipe
High Oxygen
Dirty fan does not function
Concentrations Check the fan
properly
Make sure fan is installed. If it is
Air circulation inside the
installed, turn off the incubator and
incubator is insufficient
remove from service.
High Temperature and/or
The main platform or canopy Check the sealing and install it
High Set Temperature
sealing is not installed properly properly.
Alarm
Remove the materials that prevent
Prevention of air circulation
Incorrect temperature regular air circulation.
reading Pad or pad tray is in incorrect Check the position of the pad or
position pad tray
Non-working device from External power supply supply is Check external power supply
external power sources not in voltage intervals source voltages
PART 11
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INFORMATION OF NOTIFIED BODY

ACCORDING TO MDD (93/42/EEC) MEDICAL DEVICE DIRECTIVE;

When the device features or performances are noticed to have tensions or functioning failures which
may cause deaths or cause health injuries to the patient or the end-user. When there is a deficiency
instruction that may cause these dangers, deactivate the device and contact with our authorized
representatives if you are stated in the European community or our head office. Depending on the
problem of the device, repairing shall be conducted at the location of the device or at our head office.

MDD (93/42/EEC)

APPROVED ORGANIZATION INFORMATION

Organization
KIWA BELGELENDİRME HİZMETLERİ A.Ş.
Name
ADDRESS ITOSB 9.CAD. NO:15 TEPEÖREN, TUZLA/İST.
Organization NO. 1984
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ANNEX A - Electromagnetic Compatibility

ELECTROMAGNETIC COMPATIBILITY (EMC) GUIDE

Safety standards: IEC 60601-1, IEC 60601-2-20

EMC Standards: IEC 60601-1-2

WARNING
Electrical medical devices require special precautions regarding the EMC and they need to be built
and used appropriately to the stated EMC information.

WARNING
Portable and mobile RF communication devices may affect the electrical medical devices. Be careful
when using these devices around electrical medical devices.

WARNING
This device/system is designed to be used only by a professional health officer. This device/system
may cause radio interferences and may cause disorder to the working order of the devices closed by.
Precautions to reduce negative effects may include; the air can be secured or the place of the
device/system can be changed orientation can be carried out again.

Electromagnetic Compatibility and Tests

BabyNest H-100 transport incubator has been tested and has fulfilled the conditions of the TS EN
60601-1-2:2016 Electromagnetic campatibility.

Guide and Manufacturers Declaration on Electromagnetic Emissions

Babynest H-100 transport incubator is aimed to be used in the below stated electromagnetic
environment.
The customer or user of the Babynest H-100 transport incubator, must guaranty to use this device in
these environments.
Electromagnetic
Emission Tests Compatibility environment-Guide
Information
The babynest H100 baby
Connection End Distortion Incubaer emits electromagnetic
Voltage Follow the terms energy to fulfill its intended
TS EN 55011/A1 function. The electronic devices
that are nearby may be affected.
Propagation degradation Babynest H100 Baby Incubage
Follow the terms
TS EN 55011/A1 is suitable for use in all
Harmonic emissions TS EN structures other than the
Class A
61000-3-2 structures directly connected to
the public low voltage power
grid, which provides energy to
Voltage fluctuations/clipping
Follow the terms the buildings used for this
TS EN 61000-3-3
purpose with the home and so
on.

Guide and Manufacturers Declaration on Electromagnetic Immunity

Babynest H-100 transport incubator is aimed to be used in the below stated electromagnetic
environment. The customer or user of the Babynest H-100 transport incubator, must guaranty to use
this device in these environments.
IEC 60601-1-2 Compatibility Level Electromagnetic
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Immunity Tests Test Level environment-Guide

Information
The site where the
Babynest H-100 transport
± 8 kv Contact incubator is located must
Electrostatic discharge discharge voltage be, wooden, concrete or
(ESD) ± 2 kv, ± 4 kv, ± 8 Follow the terms ceramic tiled. If these sites
IEC 61000-4-2 kv, ± 15 kv air are covered with a
discharge voltage synthetic material, the
relative humidity rate must
at least be 30%.
For ± 2 kV power The capacity of the power
Electrical fast transient supply feeding line network must be at the
burst/explosion Follow the terms capacity of the ones used
IEC 61000-4-4 For ± 1 kV in typical commercial
input/output line environment or a hospital.
The capacity of the power
network must be at the
Sudden impact ± 1 kV differential
Follow the terms capacity of the ones used
IEC 61000-4-5 mode
in typical commercial
environment or a hospital.
< 5% Ut
The capacity of the power
(0.5 to turn, Ut)
network must be at the
dip > 95%)
capacity of the ones used
12V , 0,5 cycle in typical commercial
40% Ut
Voltage dips of the environment or a hospital.
(5 to turn, Ut dip
power source input 96V , 5 cycle If the user of the Babynest
60%)
lines, short interruptions H-100 transport incubator
and voltage variations 168V, 25 cycle needs to keep working in a
70% Ut
IEC 61000-4-11 main supply shortage
(25 to turn,
12V, 5 second situation it is suggested
Ut dip 30%)
that the device is feed by
<5% Ut (5 for
continual power supply or
second, Ut dip
a battery.
>95%)
Note- Ut, is the main voltage before the test levels are applied.

Guide and Manufacturers Declaration on Electromagnetic Protection

Babynest H-100 transport incubator is aimed to be used in the below stated electromagnetic environment.
The customer or user of the Babynest H-100 transport incubator, must guaranty to use this device in these
environments.
IEC 60601-1-2 Suitability Electromagnetic environment-Guide
Immunity Test
Test Level Level Information
Portable and movable RF communication
devices including their cables must not be
any closer to any part of the Babynest H-100
transport incubator than the suggested and
measured suitability of the equality of
transmitter’s frequency.
Suggested stand apart distance

80 MHz with 800 MHz

3 V and 6V 3 V and 6 V
Transmitted RF 150 kHz with
IEC 61000-4-6 80MHz
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800 MHz with 2,5 GHz

exuded RF 3V/m 3 V/m Here, according to the manufacturer of the P

IEC 61000-4-3 80 MHz with transmitter; W kind transmitter is the biggest
2,7 GHz output power and d meter kind is the
suggested stay apart distance. A carried out
electromagnetic field research states that the
field strength spread form stable RF
IEC 60601-2-20 transmitters must be smaller than the
3 V/m 26 MHZ 3V/m Work suitability level of each frequency gap. The
with 1 GHz regularly interference can be seen on the device with
10 V/m 26 the icon shown below.
MHz with 1 GHz

10V/m
No Danger
Note 1- On 80MHz and 800MHz, a higher frequency gap is applied.
Note 2- These guide information can be applied in every situation. Buildings, objects and people can affect
the electromagnetic radiation to be reflected or absorbed.
• ISM (industrial, scientific and medical) bands between 150kHz and 80MHz; 6.765 MHz and 6.795
MHz; 13.553 MHZ and 13.567 MHz, 26.957 MHz and 27.283 MHz and 40.66 MHz and 40.70 MHz
• The suitability levels of ISM frequencies between 150kHz and 80 MHz and 80 MHz and 2.5 GHz, are
aimed to reduce the risk of causing interference if movable/portable communication devices are
accidently taken into the patient fields. For this reason a 10/3 additional factor, is calculated in the
suggested stand apart distance of the frequency gaps located on the feeder.
• The field strength spread from the stable feeder cell towers for the radio telephones (cellular/wireless)
and land radios, amateur radio AM and FM radio broadcast and TV broadcast may not be theory
accurately estimated. To evaluate the electromagnetic fields caused by RF feeders, an electromagnetic
field research must be considered. If the measured field strength of the environment where the Babynest
H-100 transport incubator is used goes over the, above stated. Applicable RF suitability level the
Babynest H-100 transport incubator must be investigated to make sure it is operating properly.

If an abnormal situation is seen in the performance, additional measure may be needed for the
Babynest H-100 transport incubator device such as re-guiding or relocating.
• Between the 150 kHz and 80 MHz frequency gap, the field strengths must be lower than [V1] 3 V/m.

The suggested stay apart distance between portable and movable RF communication devices
and Babynest H-100 transport incubator

Frequency Feeder 150 kHz and 80 150 kHz and 800 800 MHz and 2,5
MHz MHz GHz
Equation

Feeders highest declaration

output power (W) Distance (m) Distance (m) Distance (m)
0.01 0.117m 0.117m 2.33m
0.1 0.37m 0.37m 7.37m
1 1.17m 1.17m 23.3m
10 3.7m 3.7m 73.7m
100 11.7m 11.7m 23.3m
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For the feeders which broadcast in a highest output power which is not stated above, the suggested
stay apart distance "d" in meter (m) must be defined by the applicable equivalent according to the
feeder frequency. Here, the P, according to the feeder manufacturer watt (w) kind is the highest
output power declaration of the feeder.
Note- These guide information, can be applied in all situations. Buildings, objects and people can
affect the electromagnetic radiation to be reflected or absorbed.
Electromagnetic Immunity

Babynest H-100 transport incubator is aimed to be used in the below stated electromagnetic
environment.
The customer or user of the Babynest H-100 transport incubator, must guarantie to use this device in
these environments

IEC 60601-1-2 Compatibility Electromagnetic environment-Guide

Immunity Test
Test Level level Information
Babynest H-100 transport incubator must
be used only in environments that have
3 Vrms and 6Vrms the lowest RF isolation. Also for each
150 kHz and cable that enters the isolated
80MHz environment, an isolation location which
3 Vrms ve 6 has the lowest [isolation efficiency/filter
Transmitted RF Vrms attenuation features] RF filter attenuation
IEC 61000-4-6 must be used. When stated by an
electromagnetic field research, the field
strengths, that passes through the isolated
exuded RF 3V/m surface, spread by the stable RF feeders
IEC 61000-4-3 80 MHz and must be lower than V/m value. The
2,7 GHz 3 V/m interference can be seen on the device
with the icon shown below.

The field strength spread from the stable feeder cell towers for the radio telephones
(cellular/wireless) and land radios, amateur radio AM and FM radio broadcast and TV broadcast
may not be theory accurately estimated. To evaluate the electromagnetic fields caused by RF
feeders, an electromagnetic field research must be considered. If the measured field strength of the
environment where the Babynest H-100 transport incubator is used goes over the, above stated.
Applicable RF suitability level the Babynest H-100 transport incubator must be investigated to
make sure it is operating properly.
Note 1- These guide information can be applied in every situation. Buildings, objects and people
can affect the electromagnetic radiation to be reflected or absorbed.
Note 2- For the actual isolation efficiency and the isolated surface filter attenuation to supply the
lowest feature, it must be approved.

Electrostatic Discharge
The equipment are in accordance with the TS EN 60601-1-2 term and Electrostatic Discharge
Connection lightning.
BABYNEST H-100 Kullanım, Bakım ve Servis Kılavuzu

Annex B -INFORMATION OF COMPLIANCE OF STANDARDS AND DIRECTIVES

Ertunç Özcan has approved that; the device, its use, maintenance and service is in accordance with the
European Commission Directive 93/42 EEC Medical Device Directive.

The second icon states that the electric or electronic equipment shall not be thrown away in a
classified municipal waste and that it must be collected separately. Please contact your authorized
representative to gain information on taking your equipment off service.

The labels on The Device, CE label, User Guide and/or Service Guide shall be
translated into the language of the country that the Device is being dispatched to.