25 TUNNEL DE PHOTOTHERAPIE Babyblue 360 LED User and Maintenance Manual

TENDE Babyblue 360
Tunnel Type Intensive LED Phototherapy Device

User Manual
Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy

User and Maintenance Manual
© 2017 Tende Elektronik Yaz. Müh. İle. Mak. San. ve Tic. Ltd. Şti
All Rights Reserved.
TENDE ELEKTRONİK YAZILIM MÜHENDİSLİK İLETİŞİM MAKİNA SAN. VE TİC. LTD. ŞTİ.
Ankara Teknopark TGB Yerleşkesi 2224. Cadde No: 1 E Blok Zemin Kat
Kapı No: EÜZ-12 Yenimahalle, 06378 ANKARA/ TÜRKİYE
Phone: +90 312 397 07 33, 90 312 397 37 07 Fax: +90 312 397 17 87
www.tende.com.tr info@tende.com.tr
User Notice
The information in this document aims to present an adequate information source to the user about the
spare part order, maintenance, use and installation of the given device. For the safety of user and
patient, it is required to follow the instructions in the guide and the device is required to be operated by
appropriately educated skilled medical personnel. The information in this manual has been confirmed
during the editor publication date.
Limited Warranty
Tende equipment is warranted from the date of delivery under normal operating and service conditions.
This warranty doesn’t include consumable materials (like sensors, joints, batteries, hinges, LEDs,
hammock, etc…) or the broken parts resulted from misuses.
This warranty includes the maintenance or change of malfunctioning or failure parts with in the
warranty period. The warranty doesn’t include the devices which some changes made on without any
written permit by Tende. Seller isn’t responsible for any direct or indirect damages or crushes. This
warranty is not assignable.
Technical Support
The repair of the warranted Tende equipment should be done in authorized Service points. In case of
maintenance, contact to Tende Service Centers. Note the model and serial number of failed or defective
unite before contacting to Tende Technical Service Centers and make sure that you inform Tende
Technical Service for this number.
In the case that you are required to send the equipment, pack it carefully with all accessories to prevent
damages resulted from delivery. Place all equipment parts into the pack. Tende Elektronik Yazılım
Mühendislik İletişim Makine San. ve Tic. Ltd. Şti is not responsible for damages during the delivery or
inappropriate delivery of the equipment.
Contact Information for Customers

Please contact to us via the contact information given below in case of suspecting the safety and
operation of the device or get more information about it.
Tende Elektronik Yazılım Mühendislik İletişim Makine San. ve Tic. Ltd. Şti.
Address: Ankara Teknopark TGB Yerleşkesi 2224. Cadde No: 1 E Blok Zemin Kat Kapı No: EÜZ-12
Yenimahalle, 06378 ANKARA / TÜRKİYE
Phone: +90 312 397 07 33, Fax: +90 312 397 17 87,
e-mail: info@tende.com.tr, web: www.tende.com.tr
Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy User Manual Page 2
Publication Date: 05.01.2018 Rev. Date:
Rev. No: 00
Warning, Caution and Note
WARNING
CAUTION
NOTE
Except the started in this guide maintenance, the other maintenance/repairs are started in service
guides for use of service representatives trained by Tende Elektronik Yazılım Mühendislik İletişim
Makine San. ve Tic. Ltd. Şti.
WARNING: The “WARNING” statement is used in the cases of incidence of patient and user injuries.
CAUTION: The “CAUTION” Statement is used in the cases the equipment may be damaged.
NOTE: The “NOTE” statement provides extra information to explain the any issues stated in the text.
Rev. No: 00
CONTENTS
1. GENERAL INFORMATION ................................................................................................................ 5

2. DEVICE DESCRIPTION AND INTENDED USE .................................................................................... 6
3. SAFETY INFORMATION ................................................................................................................... 7
4. FEATURES OF EQUIPMENT ........................................................................................................... 12
5. ENVIRONMENTAL CONDITIONS ................................................................................................... 13
6. LIGHT SOURCE FEATURES ............................................................................................................. 13
7. PARAMETERS ................................................................................................................................ 13
8. PARTS OF EQUIPMENT.................................................................................................................. 14
9. PRE-USE CHECKS............................................................................................................................ 20
10. INSTALLATION ............................................................................................................................... 21
11. DEVICE USAGE ............................................................................................................................... 22
12. TROUBLESHOOTING, ALARMS AND WARNINGS ......................................................................... 30
13. CLEANING ...................................................................................................................................... 34
14. MAINTENANCE .............................................................................................................................. 36
APPENDIX A – ELECTROMAGNETIC CONFORMITY .............................................................................. 37
APPENDIX B – CONFORMITY FOR STANDARDS AND INSTRUCTIONS ................................................. 38
Rev. No: 00
1. GENERAL INFORMATION
Tende located in Ankara Teknopark building, has been operating in medical sector since 1997.
Tende aims to follow, develop and apply technological developments and has been involved in designing
and manufacturing of medical equipment electronic parts. Today, hundreds of hospitals in many
countries have been equipped with sensitivity and safety requiring electronic control units of various
infant incubators, sterilization and phototherapy equipment, designed and manufactured by Tende.
For more information about our company and products, please contact to us by using below address
phone or email.
MANUFACTURER AND AUTHORIZED SERVICE
Tende Elektronik Yazılım Mühendislik İletişim Makine San. ve Tic. Ltd. Şti.
Yenimahalle, 06378 ANKARA / TÜRKİYE
Phone: +90 312 397 07 33, +90 312 397 37 07

Fax: +90 312 397 17 87
Web: www.tende.com.tr
e-mail: info@tende.com.tr
Rev. No: 00
2. DEVICE DESCRIPTION AND INTENDED USE
Tunnel type intensive LED phototherapy device; for use in newborn jaundice treatment and it is a
wheeled device designed in a tunnel type.
Do not look directly to the LEDs because of damaging eyes. During treatment, always
protect patient’s eyes. Periodically check the patient’s eyes are protected to light of
phototherapy. Sensitive individuals may experience headache, nausea or mild vertigo if
he/she stays too long in the irradiated area. Using the device in a well-lighted area or wearing
glasses with orange lenses can alleviate potential effects.
Situated in the User's Guide pictures can vary.
Rev. No: 00
3. SAFETY INFORMATION
User manual; contains important information to ensure the security of patients, users and
devices. Before using the device, read the user manual carefully.
Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy Device belongs to TENDE
ELEKTRONİK YAZILIM MÜHENDİSLİK İLETİŞİM MAKİNA SANAYİ VE TİCARET LİMİTED
ŞİRKETİ. Whole or part of user manual cannot be copied or reprinted.
3.1. To Be Taken into Account by The User

Operating the device without adequate knowledge and equipment may damage the
patient, the user, and the device. Before using the device, read the user manual carefully.
Intervention to the equipment should only be carried out by trained technical personnel.
Other than technical personnel interventions may harm the patient or the device.
The device should not be used in any way except for the intended use.
The wheels must be locked to prevent the device from moving on the wheels.
The warnings on the labels placed on the device and the warnings in the operating
instructions must be observed.
If the device is moved, the device must be switched off and upper cabin heights should be
at minimum level.
Look at the electrical values on the phototherapy to make sure that the used electrical
system of the building is compatible with phototherapy. For safe, plug the device directly
into the building's grounded electrical wall socket, do not use extension cables.
Device should not be used with damaged power cable.
The device must be sure it's safe and clean working environment before use.
The light intensity of the device should be measured with a calibrated device at periodic
time.
Rev. No: 00
Electrical and electronic control circuit components are located on the colon and screen.
This section must not be turn on except for technical service personnel. The opening of
these parts, electrical shock and/or cause damage to the device.
The use of the device with other device may increase the patient’s body temperature.
Should not be used with the product that may cause glare and an explosion hazard.
Patient's body temperature should be controlled during treatment.
The light generated can degrade photosensitive medications. Do not place or store any
drugs near or in the illuminated area.
Do not use the device out in the presence of flammable gas.( oxygen, nitrous oxide or other
anesthetic agents)
During treatment, always protect patient’s eyes. Periodically check the patient’s eyes are
protected to light of phototherapy.
Sensitive individuals may experience headache, nausea or mild vertigo if patient stays too
long in the area. Using the Tunnel Phototherapy in a well-lighted area or wearing glasses
with yellow lenses can alleviate potential effects.
When it is understood that the device is not functioning, the device should not be used and
contact with the technical service unit. Manufacturer and technical service are not
responsible if the parts and appliances of device are used in malfunction. Inaccurate using
of device can damage the users, patients or equipment.
Only LEDs which are suggested by manufacturer should be used. When using different LEDs,
it can affect the performance and reliability. The manufacturer is not responsible of the
using not recommending LEDs.
Do not use the device, if the device is damaged, broken, or exceeder of LED life. Please
contact with technical service.
Only accessories which are suggested by manufacturer should be used. Use of different
accessories, it can affect the performance and reliability.
Use the manufacturer’s spare parts for the device. Spare parts not approved by the
manufacturer may cause damage to the patient and device.
Do not use different skin probe that is not provided by manufacturer. Be especially careful
to verify the contact between the skin temperature sensor and the skin and make sure that
the sensor cannot become dislodged or partially separated from the skin, and also control
periodically.
Rev. No: 00
Do not touch the LCD screen with sharp objects and fingernail. It may damage the screen
surface.
Ensure that the hammock unit in the place. Ensure that to the place the transparent
protective plate fitted in properly. Do not start treatment when hammocks and hammock
frame not in place.
Tunnel Phototherapy hammocks have a maximum capacity of 10 kg.
The device does not include any medical waste. Parts that are out of use must be disposed
of in accordance with waste regulations.
Always turn off the device and disconnect the power cable when cleaning the device.
When patient is changed, sterilize skin temperature probe according to probe user manual.
Do not use aluminum foil to improve the device efficiency. It may cause the patient's body
temperature will rise.
3.2. Warnings About Situations That Might Occur During Treatment

Some side effects may occur during treatment. (The increase in blood flow by expansion of
blood vessels surface, a red rash on the skin, The increase in body loss of water, eye
damage, changes in intestinal absorption.) The patient's condition should be checked
periodically.
Should be protect the operator eyes which are near to the phototherapy light.
During treatment, measure the patient’s bilirubin level periodically.
During treatment in infants eye protection tape should be checked at periodic time, and
make sure that eye protection tape cannot become dislodged and also control periodically.
Be especially careful to verify the contact between the skin temperature sensor and make
sure that the sensor cannot become dislodged or partially separated from the skin, and also
control periodically.
During the treatment, the patient's water needs should be checked because it causes water
loss during treatment.
Rev. No: 00
Treatment should be discontinued in any negative situation and the patient should be
removed from the device.
3.3. Warnings Related with Environmental Conditions

These environmental factors such as air flow in patients treated with phototherapy can be
the effect on body temperature.
Unsuitable environmental temperature can cause adverse effect on the patient’s body
temperature.
Environmental conditions for the operation of the device is specified in the user's
manual.When Using the device unsuitable conditions will damage the device.
3.4. Limited Warranty
• Warranty period; begins when the device is shipped.

• Warranty does not include consumables materials (LEDs, hammock).
• Repairing period is the time between the broken device arrives to Tende Ltd. and the shipment to
customer. Repairing period time does not exceed 15 working days.
• Tende Ltd. is responsible to fix the devices in the warranty coverage.
• The following items describe the out of warranty conditions.
- Incorrect use of the device.
- Failure to follow the warnings contained in the manual
- Any physical damage on the device
- Causes of any defectives occurred by Natural disasters,
• The invoice stands for warranty certificate. Invoices must be kept for warranty.
• The customer is responsible to send the device to the sales agent or manufacturer.
If your device requires repair or maintenance, contact local seller or Tende Elektronik
Yazılım Mühendislik İletişim Makine San. ve Tic. Ltd. Şti. Before contact, notice at model
number and serial number of the device.
In the case that you are required to send the equipment, pack it carefully with all
accessories to prevent damages resulted from delivery. Place all equipment parts into the
pack. Tende Elektronik Yazılım Mühendislik İletişim Makine San. ve Tic. Ltd. Şti is not
responsible for damages during the deliver in appropriate delivery of the equipment.
3.5. Manufacturer Responsibility
The repair of the warranted Tende equipment should be done in authorized service points. In case of
maintenance, contact to Tende Technical Service Centers and make sure to inform serial number.
Tende warranty that all of its new equipment are excluded of any material or poor workmanship
deficiencies under the normal operation and service conditions a long 2 years starting from the delivery
date. This warranty doesn’t include consumable materials (LED, hammock) or the broken parts resulted
from misuses.
Rev. No: 00
This warranty includes the maintenance or change of malfunctioning or failure parts within the warranty
period. The warranty doesn’t include the devices which some changes made on without any written
permit by Tende. Seller isn’t responsible for any directed or indirect damages or crushes. This warranty is
not assignable.
Tende as a manufacturer; with all the equipment and equipment’s that it produces, with its trained
technical staff authorized for renewal, modification, repair-maintenance and calibration activities.
Rev. No: 00
4. FEATURES OF EQUIPMENT
4.1. Electric Power and Voltage
Voltage (VAC) Frequency (Hz) Power (W)

100 - 240 50 - 60 Max. 135
4.2. Dimensions and Weight
Width (cm) Depth (cm) Height (cm) Weight (Kg)

Min. 140
60 94 86
Max. 170
4.3. LED Wavelength Feature
The following graph shows the spectrophotometer analysis of blue LEDs.
Figure 4.3.1: Blue LED Spectra
NOTE: Measurements done by using a standard spectrophotometer.
Rev. No: 00
5. ENVIRONMENTAL CONDITIONS
Temperature Relative Humidity

Operating 15 - 40°C < 90% (non-condensing)
Storage -20 - +50°C < 90% (non-condensing)
6. LIGHT SOURCE FEATURES
Light Source Wavelength Light Intensity LED Lifetime

Blue LED 460nm ± 2% 25-120 µW/ /nm >20.000 hours
7. PARAMETERS
Measurement Range Display Resolution Temp. Alarm Limit

AIR TEMPERATURE 15-45°C 0.1°C User specified
SKIN TEMPERATURE 15-45°C 0.1°C User specified
Set Range Measurement Range Display Resolution

TREATMENT TIME (hour: minute) (hour: minute: second) (second)
999:59 999:59:59 1
Rev. No: 00
8. PARTS OF EQUIPMENT
8.1. Parts of Main Equipment
8.1.1. Front View On Device
1. Monitor Tray
2. Observation Window
3. Upper Cabin
4. LCD Screen
5. LED Kit
6. Lower Cabin
7. Height Adjustment Unit
8. Lockable Wheels
Figure 8.1.1: Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy Device Front View
Rev. No: 00
1. Monitor Tray: It is the part reserved for the monitor used externally from the device. It is also
used as a serum hanger.
2. Observation Window: It is the part where the baby’s condition is observed during treatment.
There are 4 observation Windows on the device.
3. Upper Cabin: It is the moving part of device. The color touch screen, monitor tray, air probe and
skin probe are located in the upper cabin. Upper cabin height can be adjusted to desired level.
4. LCD Screen: It is the user interface. Thanks to the LCD screen; the light intensity, the height at the
upper cabin etc. the duration of the treatment can be controlled.
5. LED Kit: Each LED kit has 8 blue LEDs. There are 10 LED kits on the device.
6. Lower Cabin: It is the stable part of device. The hammock unit, bottom LED kit etc. are located in
the lower cabin.
7. Height Adjustment Unit: It is the mechanism that provides upper cabin movement which is
controlled from LCD screen.
8. Lockable Wheels: It is a mechanism that allows the device to be easily moved and fixed. There are
4 lockable wheels on the device. Wheels should be locked when the device in use.
8.1.2. Hammock Unit
Figure 8.1.2: Hammock Unit
Hammock Unit: Hammock frame, bottom protection tray, are Located in the hammock unit.
1. Hammock Frame: It is attached to the hammock unit. Start treatment ensure that the hammocks
and hammock frame in place
2. Locked Rail: Locked rail prevents the hammock unit from leaving the device.
Rev. No: 00
3. Bottom Protection Tray: It is placed in the hammock unit. It is the part that prevents the baby from
falling.
4. Hammock: It should be made of bio compatible. Nylon thread should not be used in its composition.
It must pass the light. The hammock is cleaned as suggested by the manufacturer. Hammock must be
replaced with a product made from the material recommended by the manufacturer.
8.1.3. Device Power Connection
1. On / Off Switch
2. AC Power Input Fuses
3. AC Power Cable Input
Figure 8.1.3: Device Connections
Rev. No: 00
8.2. Labels and Symbols
Trademark Label
Follow operating instructions
Device Off
Device On
Fuse
Manufacturer
Production Date
Alternative Current
CE Symbol
BF Type Applied Part
Max. Weigh for Monitor Tray
Protective Grounding Terminal
Warning High Voltage
Warning Protect The Baby’s Eyes with an Eye Pad While You Are in
Treatment
Warning Hand Squeeze
Serial Number
Warranty Label
Device Product Label
Table 1: Label and Symbol
Rev. No: 00
8.3. Control Systems
8.3.1. Main
Menu
Figure 8.3.1.1: Main Menu Functions
1. Skin Temperature Icon: This symbol represents skin temperature. If the skin temperature is higher
than the set upper limit alarm value, the icon turns red and an audible warning is given. If the skin
temperature is lower than the set lower limit alarm value, the icon turn blue and an audible warning is
given.
2. Skin Temperature Alarm Set Indication: "The value is shown as °C. The upper limit set value is at the
top and the lower limit set value is at the bottom.
3. Skin Temperature Indicator: The temperature reading from the skin probe as "ᵒC" on display. If the
skin probe is not attached and / or is defective, the temperature indicator is shown as "** _ *".
4. Air Temperature Icon: This symbol represents the temperature inside the cabin. If the air temperature
is higher than the set upper limit alarm value, the icon turn red and audible warning is given. If the air
temperature is lower than the set lower limit alarm value, the icon turns blue and audible warning
given.
5. Air Temperature Alarm Set Indication: "The value is shown as °C. The upper limit set value is at the
top and the lower limit set value is at the bottom.
6. Air Temperature Indicator: Displays the temperature reading from the air probe as “°C”. If the air
probe is not attached and/or is defective, the temperature display part is shown as “ **_* ”.
Rev. No: 00
7. Alarm Notification and Mute Icon: Alarm Symbol is turns red and audible warning given when an
alarm occurs in the device. Touch this icon to silence the alarm. In this case an "x" symbol will appear
in front of the icon.
8. Activation Symbol for LEDs Kit in The Upper Cabin: This icon is used to activate the LED units located
in the upper cabin. This icon turns blue when the LED kits are active. When this icon is clicked twice,
the led units, in the upper cabin, stop working. (The operation of the LED units in the upper cabinet
cannot be stopped when the led units in the lower cabinet do not work.)
9. Activation Symbol for LEDs Kit in The Lower Cabin: This icon is used to activate the LED units located
in the lower cabin. This icon turns blue when the LED kits are active. When this icon is clicked twice,
the led units, in the lower cabin, stop working. (The operation of the LED units in the lower cabinet
cannot be stopped when the led units in the upper cabinet do not work.)
10. Clock Indicator: Real time information is shown in this section. The time setting is done on the settings
menu.
11. Settings Menu: You can access the settings menu by click this icon. Language, clock, LED time
information and service screens can be accessed with this menu.
12. Maximum Light Intensity Symbol: This symbol is used to achieve maximum light intensity.
13. Treatment Start-Pause Symbol: This icon is clicked to start the treatment or pause the current
treatment.
14. Date Indicator: Real date information is shown in this section. The date setting is done on the settings
menu.
15. Upper Cabin Height Decrease Symbol: This symbol is used to move downwards the upper cabinet.
The user is warned when there is a distance of 5cm between the upper and lower cabin.
16. Upper Cabin Height Increase Symbol: This symbol is used to move upwards the upper cabinet.
17. Treatment Time Reset Symbol: This symbol is used to reset treatment time.
18. Treatment Time Setting Symbol: This symbol is used to set the treatment period. Treatment time can
be set in hours and minutes.
19. Treatment Time Indicator: If a treatment period is not set, it shows how long the treatment has
continued. If a treatment time is set, indicates the remaining time to complete treatment.
20. Light Intensity Level Indicator: This is the part where the light intensity level set by the user can be
observed.
21. Light Intensity Decrease Symbol: This symbol is used to reduce the light intensity. Each time the icon is
clicked, the light intensity level decreases.
22. Light Intensity Increase Symbol: This symbol is used to increase the light intensity. Each time the icon
is clicked, the light intensity level increases.
Rev. No: 00
9. PRE-USE CHECKS
Conditions to be checked before use on the device;
Check the electricity is suitable for use. For safe grounding, plug the device directly into the
building's electrical wall socket, do not use extension cables.
Make sure that the hammock is not torn and threadbare.
Make sure the protection tray under the hammock module is in place.
Make sure that the wheels are locked so that the device cannot move during use.
Make sure that the air and skin probes are in place and correctly fitted. Do not use the
device when the air probe is not installed.
Make sure that the LED units on your device are solid and complete. Do not use the device
when have faulty LEDs.
You should always protect the baby's eyes with an eye protection bandage while you are in
treatment.
Do not use the device if the device functioning is not as described. Please contact a trained
technical person to get information about the device.
Rev. No: 00
10. INSTALLATION
10.1. Installation and Preliminary Information

Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy Device is delivered as assembled. No
external equipment is needed for device installation.
10.2. Box Contents
- Power Cable
Figure 10.2.1: Power Cable
- Skin Probe
Figure 10.2.2: Skin Probe
- Instructions for use
Figure 10.2.3: Instruction Manual or CD
Rev. No: 00
11. DEVICE USAGE
After the installation of the device is completed, the device is operated in accordance with the following
instructions.
11.1. Pre-use Check

Before using the device, read the 9th main title of this document, "Pre-use check of the device", and the
operating conditions should be made fit to this title.
11.2. Operation of Device
- Make sure the environment is clean and suitable before operating the device.
- Check the electrical source which the device will be connected (100-240 VAC 50-60 Hz, grounded).
Check the electricity is suitable for use. For safe grounding, plug the device directly into the
building's electrical wall socket, do not use extension cables.
- For baby skin temperature measurement, the probes should also be contact completely and
smoothly on the patient skin.
Do not use different skin probe that is not provided by manufacturer. Be especially careful
to verify the contact between the skin temperature sensor and the skin and make sure that
the sensor cannot become dislodged or partially separated from the skin, and also control
periodically. When the patient is changed, the skin temperature probe should be sterilized
according to the described in the skin probe manual.
- To operate the device, push the on off button in the column.

- The device screen will be turned on after device checks have been performed. The treatment can be
started or stopped with the corresponding symbols on the screen.
The wheels must be locked when the device is working.
Rev. No: 00
11.3. Main Menu and Submenus
11.3.1 Main Menu
The menu that appears on the screen when the device is turned on.
Figure 11.3.1: Main Menu
On the main menu;
- Skin and air temperature alarm set values, treatment duration, active LED section, current date
and time information can be observed.
- Light intensity, one-button intensive phototherapy, active LED section and upper cabin height
can be adjusted.
- Settings, skin and air temperature alarm set values, treatment time setting menu are accessed.
- Therapy period can be reset or silenced alarms can be silenced, treatment can be started and
stopped.
11.3.2. Settings Menu
When the MENU icon is clicked in the main menu, the settings submenu screen is displayed (Figure
11.3.2). The submenus of the device can be accessed even when the treatment is continued.
Language Settings: Language selection is made in this section. Click the "Language" tab on the Settings
menu to access the language settings.
There are three options for language: Turkish, English, German. The language become active when you
click on the preferred language option. If you click the back symbol, it returns to the main menu.
Rev. No: 00
Figure 11.3.2: Settings Menu
Date and Time Settings: The date and time can be set in this menu. Click the "Time" tab on the Settings
menu to access the time and date setting.
To set the date and time; the preferred section (Day, Month, Year, Hour, Minute) is selected. Date and
time are adjusted using the up and down icon.
After the date and time values are set, click the check icon to save. In the window that opens after click
the confirmation icon, the text "Date and time setting has been changed" and a confirmation icon are
displayed. When the confirmation icon is clicked, the date and time setting is changed.
If you do not want to change the date and time setting, you can return to the main menu by click the
back icon while on the setting menu.
LED Time: The operating time of the LEDs is shown on this menu. Click the "LED Time" tab on the
Settings menu to access the LED time menu.
The LED time used can be monitored on this menu. LED times can be observed separately as upper cabin
and lower cabin. The LED times are shown separately for each light intensity level and the total LED time
is shown at the bottom row.
All LED array must be changed when are expired.
LED time should be reset when LED array are changed. Resetting of the LED time can only
be performed by authorized technical service.
Info: This menu contains information about the device. The info menu is accessed by click the "Info" tab
on the settings menu. In this menu, Product Name, DRV and LCD software version information can be
observed.
Service: The service menu is only a menu to be used by the authorized technical service and is described
in the service manual of the device.
Rev. No: 00
11.3.3. Skin Temperature Alarm Setting Menu
The skin probe must be attached to the device in order to enter the skin temperature set menu. While
the skin probe is attached and constant, when the skin icon on the main menu is click, can entered to
the skin alarm menu. Upper and lower limit alarm values for skin temperature alarm can be set from this
tab.
Note: The skin icon becomes red when the skin temperature is high and the device gives audible alarm.
If the skin temperature is low, the skin icon becomes blue and the device gives audible alarm.
Figure 11.3.3: Main Menu and Skin Temperature Alarm Setting Menu
1- Skin temperature alarm upper limit setting icon

2- Skin temperature alarm upper limit value
3- Skin temperature alarm value increase button
4- Skin temperature alarm lower limit setting icon
5- Skin temperature alarm lower limit value
6- Skin temperature alarm value decrease button
7-Confirm
8-Back
It is possible to set the upper limit alarm value between 34.0°C - 39.0°C and the lower limit alarm value
is between 33.0°C - 38.0°C.
The alarm upper limit value must be at least 1°C higher than the alarm lower limit value.
When you want to save the entered alarm limit values, click to the confirm icon.
The values entered are not saved when the back icon is click, the last alarm value is activated.
11.3.4. Air Temperature Alarm Setting Menu
The air probe must be attached to the device in order to enter the skin temperature set menu. While
the air probe is attached and constant, when the air icon on the main menu is click, can entered to the
air alarm menu. Upper and lower limit alarm values for air temperature alarm can be set from this tab.
Note: The air icon becomes red when the air temperature is high and the device gives audible alarm. If
the air temperature is low, the air icon becomes blue and the device gives audible alarm.
Rev. No: 00
Figure 11.3.4: Main Menu and Air Temperature Alarm Setting Menu
1- Air temperature alarm upper limit setting icon

2- Air temperature alarm upper limit value
3- Air temperature alarm value increase button
4- Air temperature alarm lower limit setting icon
5- Air temperature alarm lower limit value
6- Air temperature alarm value decrease button
7-Confirm
8-Back
It is possible to set the upper limit alarm value between 16.0°C - 42.0°C and the lower limit alarm value
is between 15.0°C - 41.0°C.
The alarm upper limit value must be at least 1°C higher than the alarm lower limit value.
When you want to save the entered alarm limit values, click to the confirm icon.
The values entered are not saved when the back icon is click, the last alarm value is activated.
11.3.5. Therapy Period Setting Menu
Therapy period is set on this tab. When the clock icon is click, the therapy period setting menu is
entered. The therapy period can be set in hours and minutes.
Note: Therapy period is reset when the icon that to the right of the therapy period indicator is click
without treatment.
Rev. No: 00
Figure 11.3.5: Main Menu and Skin Therapy Period Setting Menu
1- Therapy period increase button

2- Therapy period decrease button
3-Hours
4-Minutes
5-Confirm
6-Back
Therapy period values is possible to set the hour value in the range of "0-999" and the minute value in
the range of "0-59"
When you want to save the entered therapy period, click to the confirm icon.
The values entered are not saved when the back icon is click.
Rev. No: 00
11.4. Preparation and Baby Placement
The wheels must be locked before the therapy.
The phototherapy hammock unit is take out by operator and the baby's body is placed on the center of
the hammock (Figure 11.4.1).
The eye patch must be worn to prevent from damage that may occur in the baby's eyes. Once the
preparations have been completed for the baby, the hammock unit be incorporated into the device via
the rail system.
Figure 11.4.1: Baby Placement
Operator should always be sure that the baby phototherapy hammock unit is in place and
durable.
Rev. No: 00
11.5. Therapy Procedures
11.5.1. Start Therapy

When the green therapy start icon on the LCD screen is click, the warning "Please wear eye patch"
become visible and when the pop-up confirmation button is click, the therapy begins. The LED light
intensity can be adjusted during therapy. When the therapy starts, the indicator becomes active. if the
therapy period has been set, operator can observe on main menu how long to ending therapy. If the
therapy period has not been set, the operator can observe how long the therapy has started.
Note: The Babyblue 360 tunnel type intensive LED phototherapy device take effect in a shorter time
than other conventional phototherapy devices because of 360-degree therapy.
11.5.2. Pause of Therapy

When the "Pause" icon on the LCD screen is click, the therapy is stopped. The "Start" button is click to
start or continues the treatment.
In some cases, the treatment is stopped when the pause button is not click. These situations are:
- If the device is shut down for any reason during Therapy, keeps the latest information in
memory and after the device is turned on, continue last therapy when click "start" icon. (Power
cut etc.)
- When the main on / off button is used when the device needs to be switched off during therapy,
the device keeps the last patient data.
- If the hammock is take out by the operator, the treatment is stopped. The hammock unit should
be incorporated into the device via the rail system for continue to the therapy.
11.5.3. End of Therapy

Treatment finishes because of the following situations;
- The therapy is finished when the set period of therapy is complete. The device turns off the
LEDs. The baby should be taken off from the device. With the "Therapy is Finished" warning on
the screen, the user alerts the user visually and audible.
- When the "Start / Pause" icon on the screen is click, the therapy finishes.
11.5.4. Turn off the Device

The following steps apply;
- Press the on / off button to turn off the device.

-
- The device will also be turned off when the power input cable is unplugged from the wall outlet.
This is not recommended.
Rev. No: 00
12. TROUBLESHOOTING, ALARMS AND WARNINGS
Babyblue 360 LED phototherapy device has been equipped with alarm and safety systems and for
problems that may occur during treatment.
12.1. Troubleshooting
The phototherapy device informs the user with alarms and warnings during operation.
FAULT POSSIBLE REASONS SOLUTIONS

Screen does not display. 1. The power cable is 1. Check the power cables connection.
faulty or not 2. Connect power cord an electric outlet
connected. which has electricity (100-240 VAC 50-
2. There is no AC power 60 Hz)
in the outlet where 3. Check the power fuses, replace if the
the power cord is fuse has blown (fuse ratings are
plugged. shown on the fuse label).
3. The power fuse is 4. Power switch must be checked by
faulty. authorized technical service
4. The power switch is personnel.
faulty. 5. The AC power socket must be checked
5. AC power socket is by an authorized technical service
faulty. personnel.
6. The cable connection 6. Please contact TENDE authorized
is faulty or not correct, technical service.
between the LCD and
DRV.
Touch feature of the 1. The cable connection is 1. Please contact TENDE authorized
screen is not working. faulty or not correct, technical service.
between the DRV and 2. Please contact TENDE authorized
LCD. technical service.
2. LCD is faulty.
One or two LED arrays 1. Hammock unit of 1. The phototherapy hammock unit
not light up phototherapy may not should be placed.
be in place. 2. Please contact TENDE authorized
2. The cable connection technical service.
is faulty or not correct, 3. The LED life is checked by TENDE
between the DRV and authorized technical service
LED arrays. personnel. If necessary, LED arrays
3. The upper or lower should be changed.
cabin LED life is over
20,000 hours.
Image is displayed on 1. The display backlight 1. Please contact TENDE authorized
screen but backlight is (B / L) connection technical service.
off. cable or socket may be
defective.
All functions of the 1. The cable connection 1. Please contact TENDE authorized
device are active but the is faulty or not correct, technical service.
device sound is not between the DRV and 2. Please contact TENDE authorized
audible. LCD Controller. technical service.
Rev. No: 00
2. The LCD controller
printed-circuit card
may be faulty.
LED kit is on but light 1. The upper or lower 1. Please contact TENDE authorized
intensity is low. cabin LED life is over technical service.
20,000 hours. 2. Please contact TENDE authorized
2. Check the lenses and technical service.
replace them if there is
a broken, damaged, or
dirty lens.
Skin temperature 1. The skin probe is not 1. Check skin temperature probe
information is not connected with the connection.
displayed. device. 2. Provide the environment that the
2. Ambient temperature given operating conditions on
is not suitable for brochure.
probe operating 3. If the problem persists despite
conditions. probe replacement, please contact
3. Skin temperature TENDE authorized technical
probe may be service.
defective.
Air temperature 1. The cable of air probe is 1. Please contact TENDE authorized
information is not faulty or not connected. technical service.
displayed. 2. Ambient temperature is 2. Provide the environment that the
not suitable for device given operating conditions on
operating conditions. brochure.
3. The air probe is not 3. Please contact TENDE authorized
connect with device or technical service
the DRV printed-circuit
card is defective.
Height adjustment 1. The cable connection 1. Please contact TENDE authorized
system does not work is faulty or not correct, technical service.
properly. between the DRV and 2. Please contact TENDE authorized
LCD. technical service.
2. LCD is faulty. 3. Please contact TENDE authorized
3. The cable connection technical service.
is faulty or not correct, 4. Please contact TENDE authorized
between the LCD and technical service.
DRV. 5. Please contact TENDE authorized
4. Motor is faulty. technical service.
5. The cable connection 6. Please contact TENDE authorized
is faulty or not correct, technical service
between the motor
and DRV.
6. DRV is faulty.
Table 2: Faults, Reasons and Solutions
The table contains the alarm name, the cause of the alarm and the solution to the problem.
Rev. No: 00
12.2. Alarms
ALARM REASON SOLUTIONS
The skin temperature 1. The measured skin 1. The alarm can be temporarily
icon in the main menu is temperature is above the silenced.
red and audible alarm is upper limit set value. 2. The set upper limit temperature value
available. should be increased.
The skin temperature 1. The measured skin 1. The alarm can be temporarily
icon in the main menu is temperature is below the silenced.
blue and audible alarm is lower limit set value. 2. The set lower limit temperature
available. value should be decreased.
The air temperature icon 1. The measured air 1. The alarm can be temporarily
in the main menu is red temperature is above the silenced.
and audible alarm is upper limit set value. 2. The set upper limit temperature
available. value should be increased.
The air temperature icon 1. The measured air 1. The alarm can be temporarily
in the main menu is blue temperature is below the silenced.
and audible alarm is lower limit set value. 2. The set lower limit temperature
available. value should be decreased.
Table 3: Alarms
Silent alarms; The alarm can be silenced for a period of time determined by the type of alarm when the
mute icon is click (Table 4). At the same time If different alarm conditions occur, all alarm conditions can
be observed on the screen.
ALARM SITUATION TIME

Air temperature is high Muting 15 minutes
15 minutes
Air temperature is low Muting
15 minutes
Skin temperature is high Muting
15 minutes
Skin temperature is low Muting
Table 4: Silent Alarms
Rev. No: 00
12.3. Warnings
INDICATION REASONS SOLUTIONS
When the treatment start 1. To protect the patient to 1. The warning pop-up is
icon is clicked to start the adverse effects that blue LED confirmed by place the eye
treatment, the warning lights can cause on the patch to the baby before
"Please place the eye patch patient eye. the treatment. Thus, the
!!!" is displayed on screen. treatment starts.
If the hammock unit is not in 1. It is a precaution for patient 1. When the patient bed is
place when click the start safety. The device does not placed, the warning "Please
treatment icon , the warning start treatment when the place the eye patch !!!"
"The Bed is not in place" is baby bed is not in place. displayed on the screen.
displayed on the screen.
The warning “Skin probe is 1. Skin probe not connected with 1. The skin probe is connected to
not connected or failed!” is device. the device.
displayed on the screen. 2. The skin probe may be 2. The new skin probe should be
defective. requested from technical
3. Skin temperature value is other service.
than the working range. 3. Appropriate conditions must
be established.
The warning “Air probe is 1. Air probe not connected with 1. Please contact the authorized
not connected or failed!” is device. technical service.
displayed on the screen. 2. The air probe may be 2. The new skin probe should be
defective. requested from technical
3. Air temperature value is other service.
than the working range. 3. Appropriate conditions must
be established.
The warning "Lower Cabin 1. It happen when the lower 1. Lower cabin LEDs must be
LED Life Exceed the Time cabin LED life is over 20,000 replaced
Limit is 20,000 Hours" is hours.
The warning "Upper Cabin 1. It happen when the upper cabin 1. Upper cabin LEDs must be
LED Life Exceed the Time LED life is over 20,000 hours. replaced
Limit is 20,000 Hours" is
The warning "Incorrect 1. This warning is displayed, 1. The correct password must
Password” is displayed on when the enter password is be entered.
the screen. incorrectly on the service
menu.
The warning "Treatment 1. Indicates that the user- 2. The therapy is completed.
Finished” is displayed on the specified treatment period is
screen. over.
The warning "Check The 1. When the upper cabin is lifted 1. Lifting down will continue
Inter-Cabins” is displayed on down, it should be checked when click the confirm icon.
the screen. that there is nothing between
the two cabins.
The warning "Reset 1. This warning is displayed when 1. Timer is reset when click the
Treatment Timer” is the treatment timer reset icon confirm icon.
displayed on the screen. on the screen is clicked.
Table 5: Warnings, Reasons and Solutions
Rev. No: 00
13. CLEANING
Cleaning should be done no less than once a week, taking into account the hospital conditions in which
the device is located, and should be cleaned for each new patient if used.
The upper cabin of the device must be lifted before cleaning. The electrical connection must be
removed when the device is in this position.
For cleaning;
- The upper cabin is lifted up.
- Disconnect power cable.
- All the outer case (except lenses and screen) of the unit can be cleaned by proper medical
device disinfection solution. Cleaning must be carried on all surfaces by using the cleaning
solution.
Be aware to not influence solutions the electric socket inputs.
- Lenses and screen are cleaned by using a soft and mild water cloth.
Do not clean the LED’s, lenses and screen by using the cleaning solvents or alcohol. Not
listed above, such as alcohol, acetone, etc. The use of cleaning / disinfecting solutions
may damage this materials .It is not under warranty.
- Never immerse LED units or parts of the device in liquid.

- Cleaning of the hammock;
• Hammock should be taken off from hammock frame.

• The hammock can be washable.
Check that the hammock is worn or torn. When significant deformations are detected, the
hammock must be replaced with a new one.
For sterilization and cleaning information of the skin temperature probe, view the skin
temperature probe manual.
Rev. No: 00
Cleaning solutions that can be safely used:
Active Substance Maksimum Density
Sodium Hypochlorite 0.5% Aqueous Solution
Glutaraldehit 2%
Hydrogen peroxide 6%
Lodophor Solutions 0.27%
Cavicide® 100% Sprey
Table 6: Solutions Information
• Cleaners that are dangerous to use will damage parts of device when you are cleaning;
Isopropyl Alcohol (Its density is more than 15%)

Quaternary Ammonium (Like Virex)
Solvents
Not listed above, such as alcohol, acetone, etc. The use of cleaning / disinfecting solutions
or the use of more concentrated chemicals than those listed above may damage the
device.
Rev. No: 00
14. MAINTENANCE
Maintenance and inspections of this device should be made by the authorized technical service
annually. Please contact Tende technical service department for maintenance and repair of the device.
The motor located in the device may cause vibration. For this reason, the authorized
technical service personnel should be checked at certain intervals and replaced with new
ones if necessary
14.1. LEDs and Light Intensity Checking

The light intensity measurement device that has calibration and can measure between 400 and 500 nm
is necessary to control the phototherapy light intensity.
It is recommended that the intensity of the light be checked before each use. Also, the intensity of light
is checked at every six months.
If one LED on a LED Array is burned out, causing eight LEDs to go off. When one LED Array
is defective, change all of LED Arrays.
14.2. Replacement LED Array

Do not use LEDs which lifetime is end. All LEDs should be changed after LEDs life time is end. Please
contact with the TENDE technical service personnel for changing LED.
Only LEDs which are suggested by manufacturer should be used. When using different
LEDs, it can affect the performance and reliability. The manufacturer is not responsible of
the using incorrect LEDs.
14.3. Replacement Hammock

If hammock is damaged or significant deformations are detected, the hammock must be replaced with a
new one. Follow below steps to replace hammock:
- Device turn off.
- The baby hammock unit is pulled out.
- The hammock frame is pulled out from the device hammock unit.
- Hammock should be taken off from hammock frame.
- The hammock is changed with a new one.
- The hammock frame is placed.
14.4. Air Probe Replacement

Please contact with TENDE technical service or authorized personnel for changing probes.
14.5. Skin Probe Replacement

If skin probe is damaged or significant deformations are detected, it must be replaced with a new one.
14.6. Clock Battery Replacement

Please contact with the TENDE technical service or authorized personnel.
The clock battery should be renewed every five years. If the clock battery is not replaced by
a qualified service personnel, device, user or patient may be damaged.
Rev. No: 00
APPENDIX A – ELECTROMAGNETIC CONFORMITY
Electromagnetic Conformity Guide (EMC)
Medical Electronic Equipment requires special precautions concerning EMC.
Portable and mobile RF communication equipment may effect Medical Electronic

Equipment. Be careful while using these devices around the Medical Electronic Equipment.
This equipment/system is designed to use only by professional health care personnel. This
equipment/system may cause atmospheric disturbance or disrupt the operation of device
around. It may require taking some precautions like secure the area, replacement or re-
orientation to reduce its negative effects.
Rev. No: 00
APPENDIX B – CONFORMITY FOR STANDARDS AND INSTRUCTIONS
Tende Elektronik ve Yazılım Ltd. Şti has declared and confirmed the device’s conformity to 93/42 EEC
Medical Devices Directives of Community Europe Directives in the case that device is used in accordance
with the instruction in the “User and Maintenance Guide”.
Second symbol impels that electrical and electronic equipment not to be thrown like uncategorized
state waste and to be collected separately. Please contact to authorized representatives for the
information concerning service take off.
Manufacturer:
TENDE Elektronik Yazılım Mühendislik İletişim Makina San. ve Tic. Ltd. Şti.
Yenimahalle / ANKARA, 06378 TÜRKİYE
Phone: +90.312.397.37.07, +90.312.397.07.33

Fax: +90.312.397.17.87
TENDE Elektronik Yazılım Mühendislik İletişim Makina San. ve Tic. Şti. reserves the right to make design
changes, feature changes and model changes without making a declaration. The only guarantee TENDE
Elektronik Yazılım Mühendislik İletişim Makina San. ve Tic. Ltd. Şti gives is the written guarantee given
during the sale.
Information in this manual may not be copied or reproduced in any form without permission from
TENDE Elektronik Yazılım Mühendislik İletişim Makina San. ve Tic. Ltd. Şti.
© 2017 TENDE Elektronik Yazılım Mühendislik İletişim Makina San. ve Tic. Ltd. Şti. ALL RIGHTS
RESERVED.
Changes made without notification will not be applied during modification.
Rev. No: 00

25 TUNNEL DE PHOTOTHERAPIE Babyblue 360 LED User and Maintenance Manual

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25 TUNNEL DE PHOTOTHERAPIE Babyblue 360 LED User and Maintenance Manual

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TENDE Babyblue 360

Tunnel Type Intensive LED Phototherapy Device

Tende Babyblue 360 Tunnel Type Intensive LED Phototherapy

Contact Information for Customers

e-mail: info@tende.com.tr, web: www.tende.com.tr

1. GENERAL INFORMATION ................................................................................................................ 5

MANUFACTURER AND AUTHORIZED SERVICE

Phone: +90 312 397 07 33, +90 312 397 37 07

Situated in the User's Guide pictures can vary.

3.1. To Be Taken into Account by The User

Device should not be used with damaged power cable.

Tunnel Phototherapy hammocks have a maximum capacity of 10 kg.

3.2. Warnings About Situations That Might Occur During Treatment

During treatment, measure the patient’s bilirubin level periodically.

3.3. Warnings Related with Environmental Conditions

3.4. Limited Warranty

• Warranty period; begins when the device is shipped.

3.5. Manufacturer Responsibility

4.1. Electric Power and Voltage

Voltage (VAC) Frequency (Hz) Power (W)

4.2. Dimensions and Weight

Width (cm) Depth (cm) Height (cm) Weight (Kg)

4.3. LED Wavelength Feature

The following graph shows the spectrophotometer analysis of blue LEDs.

Figure 4.3.1: Blue LED Spectra

NOTE: Measurements done by using a standard spectrophotometer.

Temperature Relative Humidity

6. LIGHT SOURCE FEATURES

Light Source Wavelength Light Intensity LED Lifetime

Measurement Range Display Resolution Temp. Alarm Limit

Set Range Measurement Range Display Resolution

8.1.2. Hammock Unit

Figure 8.1.2: Hammock Unit

8.1.3. Device Power Connection

Figure 8.1.3: Device Connections

Follow operating instructions

BF Type Applied Part

Max. Weigh for Monitor Tray

Protective Grounding Terminal

Warning High Voltage

Warning Hand Squeeze

Device Product Label

Table 1: Label and Symbol

Figure 8.3.1.1: Main Menu Functions

Make sure that the hammock is not torn and threadbare.

10.1. Installation and Preliminary Information

10.2. Box Contents

Figure 10.2.1: Power Cable

Figure 10.2.2: Skin Probe

- Instructions for use

Figure 10.2.3: Instruction Manual or CD

11.1. Pre-use Check

11.2. Operation of Device

- To operate the device, push the on off button in the column.

The wheels must be locked when the device is working.

Figure 11.3.1: Main Menu

On the main menu;

11.3.2. Settings Menu

All LED array must be changed when are expired.

1- Skin temperature alarm upper limit setting icon

11.3.4. Air Temperature Alarm Setting Menu

1- Air temperature alarm upper limit setting icon

11.3.5. Therapy Period Setting Menu