Bistos BT-450 User manual

Infant Phototherapy Equipment
BT-450
Operation Manual
Please keep this user’s guide for future reference.
P/N: 450-ENG-OPM-EXP-R01

BT-450 Operation manual
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Table of Contents
Intended use/Indications for use ------------------------------------------------------------------------------3
Product Description --------------------------------------------------------------------------------------3
Contraindications ---------------------------------------------------------------------------------------3
1. Safety Information ------------------------------------------------------------------------------------4
2. Product Configuration --------------------------------------------------------------------------9
2.1 Description of each part --------------------------------------------------------------------9
2.2 Button descriptions ----------------------------------------------------------------------10
2.3 LCD Description -------------------------------------------------------------------------10
3. How to use --------------------------------------------------------------------------------------------------11
3.1 Preparation before use ---------------------------------------------------------------------11
3.2 Patient placement -----------------------------------------------------------------------12
3.3 Product operation ---------------------------------------------------------------------13
3.3.1 Operation mode -------------------------------------------------------------------13
3.3.2 How to operate -------------------------------------------------------------------------13
4. Alarm ---------------------------------------------------------------------------------------------------------15
4.1 Alarm condition --------------------------------------------------------------------------------------15
4.2 Alarm characteristics ------------------------------------------------------------------------------15
5. Precautions for Pad -------------------------------------------------------------------------------16
6. Essential Performance ----------------------------------------------------------------------------16
7. Cleaning and maintenance ----------------------------------------------------------------------16
7.1 Brightness check -------------------------------------------------------------------------16
7.2 Cleaning --------------------------------------------------------------------------------------17
8. Troubleshooting ------------------------------------------------------------------------------------17
9. Manufacturer’s declaration on EMC ------------------------------------------------------------------17
9.1 Electromagnetic emissions ------------------------------------------------------------18
9.2 Recommended separation distances between portable and mobile RF communications
equipment and the Infant Phototherapy Equipment ---------------------------------------18
9.3 Electromagnetic immunity ---------------------------------------------------------------19
10. Product Specifications ---------------------------------------------------------------------------21
Product Warranty ------------------------------------------------------------------------------------------23

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Intended use/Indications for use
The infant phototherapy equipment, BT-450 is indicated for use to treatment of infants diagnosed with
hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the
skin and the whites of the eyes. The devices can be used in a hospital or at home.
The device is designed to use for patient population described in the infant, who is age up to 3 months and
weight less than 10kg.
Product Description
Jaundice refers to the yellow appearance of the skin that
occurs with the deposition of bilirubin in the dermal and
subcutaneous tissue. Bilirubin is the orange-yellow pigment
of bile, formed principally by the breakdown of hemoglobin
in red blood cells at the end of their normal lifespan.
Normally in the body, bilirubin is processed through the liver,
where it is conjugated to glucuronic acid by the enzyme in
the liver. This conjugated form of bilirubin is then excreted
into the bile and removed from the body via the gut. When
this excretion process is low following birth, does not work
efficiently, or is overwhelmed by the amount of
endogenously produced bilirubin, the amount of bilirubin in the body increases, resulting in
hyperbilirubinemia and jaundice.
In newborns, the lifespan of red blood cells is shorter than that of adults, which makes a lot of bilirubin, the
function of an enzyme to conjugate the bilirubin is poor, and the function to excrete bilirubin out of the
body is also weak.
Phototherapy refers to the use of light to convert unconjugated bilirubin molecules into water-soluble
isomers that can be excreted in bile or urine without the need for conjugation. Bilirubin absorbs light most
strongly in the blue region of the spectrum near 460 nm, a region in which penetration of tissue by light
increases markedly with increasing wavelength. Only wavelengths that penetrate tissue and are absorbed
by bilirubin have a phototherapeutic effect. Lamps with output predominantly in the 460-to-490-nm blue
region of the spectrum are probably the most effective for treating hyperbilirubinemia.
The infant phototherapy equipment, BT-450 pad consists of LEDs that emits light of peak wavelength 455
to 465 nm. The microcontroller generates the PWM, and it is rectified to direct current through a resistor
and a capacitor. When the rectified PWM is output through the LED driver, the LED can be stably turned on.
The intensity of light can be adjusted by changing the duty cycle of PWM, and BT-450 has two types of
intensity, high and low.
WARNING
Eye Protection: Do not look directly into the LED. During the treatment, always use
a patch or equipment to protect a baby’s eyes.
Periodically, check the hospital or treatment protocol and makes sure that the
baby’s eyes are protected from contamination.
Patients near the light should use protective pads or equipment to protect their
eyes.
Contraindications
It should not be used in cases of congenital porphyria, a family history of porphyria, and treatment with
photosensitive drugs or medicines.

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1. Safety information
Before using the infant phototherapy equipment, read this entire manual and be fully understood, and
follow instructions and safety information to prevent injury.
Symbols and safety sign used:
The following symbols and safety signs identify all instructions that are important to safety. Failure to
follow these instructions can lead to injury or damage to the infant phototherapy equipment. When used
in conjunction with the following words, the symbols indicate:
WARNING
Can incur serious injury or death.
CAUTION
Can incur minor injury or product/property damage
The following symbols and safety signs are placed on the product, label, packing, and this manual to stand
for the information about:
Symbol
Standard/Symbol Reference no.
Description
ISO 7010 —Graphical symbols —Safety
colours and safety signs —Registered
safety signs / W001
Used to display safety information for
warnings.
Before using the BT-450, please be fully
understand the information provided with
the device.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.4.4
Used to display safety information for
caution.
Before using the BT-450, please be fully
understand the information provided with
the device.
IP21
IP22
IP23
IEC 60529 Degrees of protection
provided by enclosures
These indicate the protection level against
the ingress of solid objects and liquid.
IPX1 is protection against falling water
drops vertically.
IPX2 is protection against some falling
water drops vertically when the enclosure
tilted up to 15°.
IPX3 is protection against spraying water
at any angle up to 60° from the vertical
shall.
IP2X is protection against solid foreign
objects like a finger.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.4.3
Refer to the operation manual. Read the
manual before placing the device.
ISO 7010 —Graphical symbols —Safety
colours and safety signs —Registered
safety signs / M002
Refer to the operation manual. Read the
manual before placing the device.
IEC 60417 —Graphical Symbols for Use
on Equipment / 5032
This symbol means alternating current.
IEC 60417 —Graphical Symbols for Use
on Equipment / 5031
This symbol means a DC power adapter.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
This symbol indicates the manufacturer.

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Part 1: General requirements / 5.1.1
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.1.3
This symbol indicates the date of
manufacture.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.1.7
This symbol indicates the serial number of
the device.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.1.6
This symbol indicates a reference number.
IEC 60417 —Graphical Symbols for Use
on Equipment / 5172
This symbol means the power adapter is a
Class II device.
IEC 60417 —Graphical Symbols for Use
on Equipment / 5333
This symbol indicates the BF applied part.
This applies to the Pad.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.4
This symbol indicates to keep the device
dry.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.1
This symbol indicates the medical device
that can be broken or damaged if not
handled carefully.
ISO 7000 —Graphical symbols for use on
equipment -- Registered symbols / 0623
This symbol indicates to keep upright
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.2
This symbol indicates to keep the device
away from sunlight.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.7
This symbol indicates the temperature
limitation for transport and storage.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.8
This symbol indicates the humidity
limitation for transport and storage.
ISO 15223-1, Medical Devices—Symbols
to be used with medical device labels,
labeling and information to be supplied –
Part 1: General requirements / 5.3.9
This symbol indicates the range of
atmospheric pressure to which the medical
device can be safely exposed for transport
and storage.
Universal Recycling symbol
This symbol indicates the packing material
is recyclable.
IEC TR 60878, Graphical symbols for
electrical equipment in medical practice
This symbol indicates that always protect
the infant’s eyes with eye patches or
equivalent.

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Symbols on the adapter
Symbol
Standard/ Symbol Reference no.
Description of symbol
IEC 60417 —Graphical Symbols
for Use on Equipment / 5172
This symbol indicates that the power adapter is a
class II device.
IEC 60417 —Graphical Symbols
for Use on Equipment / 5957
This symbol indicates that the power adapter is for
indoor use only.
UL Mark
(200-195S 10M/8/98)
This symbol indicates compliance with both
Canadian and U.S. component requirements.
(Recognized Component Mark for Canada and the
United States)
WARNING
Check every 2–4 hours the patient’s condition including body temperature and skin against
hyperthermia, pressure ulcers, water loss, hygiene, etc.
To minimize the heat between the pad and the patient, the patient should not be wrapped in a
thick blanket or wrapped too tightly.
The patient’s body temperature may rise if the patient and pads are wrapped in a material that
does not allow heat to escape, such as a thick blanket or clothes. When the temperature warning
is on, check the patient’s body temperature.
Not for use with patients greater than 10 kg.
Do not use the device while bathing the patient.
Do not use the device near water.
Do not use the device without a disposable cover.
Do not use the device with other thermotherapy devices that may affect the patient’s body
temperature such as incubators, heaters, mattresses, heating blankets, etc.
During phototherapy, the patient’s skin and core body temperature should be monitored.
Do not use the device with ECG (EKG) device.
Do not use the device in the presence of flammable materials.
Class I equipment: There is a risk of electric shock, so this equipment should be connected to a
power supply with protective earth.
If the power rating is inappropriate or the device is connected to an outlet that is not grounded,
there is a risk of electric shock or fire. If in doubt about the grounding condition, have an
electrician inspect it.
BT-450 should be used under the direction of appropriately trained personnel and qualified
medical personnel who are familiar with the currently known risks and benefits of neonatal
jaundice therapy.
If the normal operation of this device with other devices nearby is not confirmed, the BT-450
cannot be used adjacent to or with other devices.
Do not touch or manipulate BT-450 with wet hands, as it may cause electric shock.
If the device falls into water, do not touch any electrical appliances and immediately disconnect
the power from the power outlet.
Do not place the power cable in a place where people or objects frequently move. There is a risk
of electric shock.
Use the BT-450 for neonatal jaundice treatment only as the intended use described in this
manual.
Keep the device out of direct sunlight.
BT-450 and accessories are not heat resistant. Avoid contact with radiators, open flames, or
heated surfaces.
Supervision is required when using the device near children or pets. Keep all parts out of reach
when not in use.

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Eye protection: Do not look directly into the LED. During treatment, always protect your baby’s
eyes with an eye patch or protective equipment. Periodically, check the hospital or treatment
protocol and makes sure that the baby’s eyes are protected from contamination. Patients near
the light should use protective pads or equipment to protect their eyes.
Sensitive people may develop headaches, nausea, or mild dizziness if left in the irradiated area
for too long. Wearing yellow lens glasses can reduce the potential impact.
Bilirubin Photo isomers may have toxic effects.
Water balance: Water balance may be disturbed for some patients.
Photosensitive Drugs: Irradiation may reduce the effectiveness of light-sensitive drugs. Do not
store the medication near light irradiation.
Flammable gas: Do not use the device near combustible gases. (eg oxygen, nitrogen dioxide, or
other anesthetics)
Power off: When cleaning the light source, always turn off the power and remove the power
cable.
Even an adult may be affected by staying in the light for a long time.
Do not use flammable solution directly on the LED lamp. The LED lamp may be damaged or its
function may deteriorate. For cleaning or maintenance, follow the instructions described in
section 7 of this manual.
Use of other accessories not provided by Bistos Co., Ltd. may degrade the safety and
performance of the device, so be sure to use the designated accessories.
Using a reflective film can cause an increase in body temperature when the film affects a type of
phototherapy radiation.
Blue light might interfere with the clinical management of a patient with cyanosis.
Infants with increased direct reactions or cholestatic jaundice after receiving phototherapy may
develop the bronze-baby syndrome.
Do not use any damaged parts including the power adapter.
Before using the device, visually check each part for cracks, folds, tears, discoloration, or
deterioration. If damage to the device is observed, discontinue until the part is replaced.
Do not use the BT-450 for neonatal jaundice treatment near or in combination with other
equipment. If you want to use adjacent to or overlapping with devices, you must confirm the
normal operation or BT-450.
Portable RF communication equipment (including peripheral devices such as antenna cables and
external antennas) should not be used closer than 30cm (12 inches) to any part of the BT-450,
including cables specified by the manufacturer. Otherwise, the performance of this device may
be degraded. Wireless home network devices, mobile phones, wireless phones, and wireless
communications equipment such as base stations and radios can affect the device and should be
used at a distance of 1 m or more.
This device requires special precautions regarding EMC and must be serviced according to the
EMC information provided in this manual.
Excessive electromagnetic interference may cause the device to generate excessively high or low
light levels temporarily. Use the device in an appropriate environment stated in this manual.
Components other than those approved for use with this device may increase or decrease
immunity.
Do not open the pad cable where there the power is connected. There is a risk of electric shock.
Do not disassemble the device. The battery can be replaced by disassembling the device by an
authorized service person and must be replaced with a battery of the same model and
specification.
Incorrect battery replacement may cause high temperature, fire, or explosion.
If the device is not used for a long time, the battery must be removed and stored. Charge the
battery and store it at room temperature with low humidity.
Use only the AC/DC power adapter supplied or designated by Bistos. Use of adapters other than
those provided or specified by the manufacturer may increase electromagnetic emissions or
reduce the electromagnetic immunity of the device, resulting in improper operation.

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Do not place the device where it is difficult to disconnect the adapter.
Be careful not to let dust or especially metallic objects get into the device.
Keep away from electric heaters.
Do not place in a humid or hot place.
Do not use the device where humidity, temperature, and atmospheric pressure are beyond those
specified in this manual.
Do not place in a hazardous location that leaks chemicals or explosive gases.
CAUTION
BT-450 is non-transit-operable equipment that can be used at home.
Lay operators (non-experts, people who are not good at operating the machine) can also
operate.
The patient’s condition should be monitored during phototherapy.
Do not place drugs or liquids around the light source that may be deteriorated by the light
source.
While BT-450 is in operation, wear protective equipment to protect the patient’s eyes, and
frequently check whether it is properly worn.
Keep all components dry after cleaning and disinfecting.
When charging is complete, immediately disconnect the power adapter from the device.
The battery charging stage displayed on the LCD may differ from the actual battery capacity. Use
a fully charged device whenever possible.
If a low battery status is displayed, charge the battery immediately.
If you are not using the device for a long time, make sure the battery is fully charged before
keeping the device.
If you use a device that has not been used for a long time, check whether it operates safely
before use.
BT-450 can only be repaired or replaced by qualified personnel.
Do not use the device outdoors, where aerosol (spray) products are being used, or where oxygen
is administered.
When disposing of BT-450, please follow all laws regarding recycling.
When disposing of packaging materials, comply with local waste disposal laws and regulations.
Keep the packaging material out of reach of children.
Dispose of or recycle replaced batteries properly according to local regulations.
Always use accessories provided by Bistos.
Unpack carefully to avoid damaging the device. Inspect the packaging before unpacking. In case
of damage, immediately contact Bistos. Unpack correctly, carefully remove the unit and
components from the box and check the list. Make sure there is no damage to the device, and do
not use it if it is damaged.
Excessive pressure on the pad may damage it.
Use the cover provided only, otherwise, treatment may not be effective due to decreased light
output.
There should be no material (ex. Blanket, clothes, etc.) between the covered pad and the
patient. Covered pads should always be on bare skin.
Patients should always wear diapers. This is especially important for male patients because
prolonged exposure to light on the male genitals can be harmful.
Treatment using the device shall be as directed by the doctor.
Do not let the device come into contact with liquids.
Do not throw or shake the device.
If the device is crushed or damaged, such as a hole, stop using it.
When charging the device, connect the AC adapter to the control box and charge it until the
battery charging stage indicator shows full.

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2. Product configuration
When unpacking, make sure you have all the following items. The eyeshield patch and cover are disposable
and the pad is consumable. The standard components are as follows.
Name
User Manual
Power Adapter
Control Box
Shape

Quantity
1
1
1
Name
Pad
Cover
Eyeshield Patch
Shape
Quantity
1
1(disposable)
1(disposable)
CAUTION
Use only Bistos accessories.
Check the consumables for wear or damage before use and replace them if necessary. Do not
use them if there are signs of damage or defects.
The eyeshield patch and cover are disposable, multiple uses are prohibited.
To maintain optimum performance, it is recommended to replace consumables periodically.
2.1 Description of each part

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No.
Name
Description
①
Control Box
Has a button to control the device and an LCD display shows the current
operation status.
②
LCD display
Shows the current operation status. (Adapter and Battery status,
running and remaining time, light intensity, etc.)
③
Operating Button
Power ON/OFF, Light intensity, and operating time can be set.
④
Pad connection
terminal
Terminal to connect the pad.
⑤
Power adapter
terminal
Terminal to plug in the power adapter for charging.
⑥
Pad
Has a built-in LED module and temperature sensor.
⑦
Light emitting
area
Light emitting area from the built-in LED.
⑧
Pad connection
part
Part to connect with control box
⑨
Temperature
Sensor
Measures temperature in the pad to protect the patient from the heat
of the LED.
2.2 Button Description
No
Name
Description
①
Power Button
For power ON/OFF
②
Light Intensity control
Button
Sets the light intensity to one of High, Low, and OFF.
③
30-minute increase
Button
Increase the scheduled operating time by 30-minutes in timer
mode.
④
30-minute decrease
Button
Decrease the scheduled operating time by 30-minutes in timer
mode.
2.3 LCD Description

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WARNING
•If the high temperature icon appears, turn off the control box and check
the patient’s body temperature.
•If the low battery information signal is on, connect the adapter to the
device.
3. How to use
3.1 Preparation before use
①Check the arrow symbols on the pad connector and the control box and then combine them.
NOTE
When disconnecting
: Pull the metal part toward the pad to disengage it.
No
Name
Description
①
High temperature icon
If the contact part temperature of the pad is high, the pad is
automatically turned off before the temperature exceeds 40 °C.
The high temperature icon appears on the display.
②
Pad connection icon
If the communication between the control box and the pad is
not normal, the pad connection icon appears on the display.
③
Light intensity
Display the current set light intensity (High, Low, OFF).
④
Battery icon
Display the current battery level.
⑤
Charging icon
The charging icon appears when the adaptor charges the device.
⑥
Operating Time
Display the elapsed time from the pad was on.
⑦
Remaining Time
Display the remaining time set in the timer mode.
⑧
Total Usage Time
Display the total usage time from the pad was on for the first
time.
⑨
Firmware version
Display the currently downloaded firmware version.

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②Put the pad in the disposable cover. Put the without Velcro side of the cover and the LED side of
the pad facing the same side.
NOTE
If the cover gets dirty during use, discard the cover and use a new one. If there is any foreign
substance on the pad, it must be cleaned according to “Section 7 Cleaning and maintenance.”
before use.
③Before starting the phototherapy treatment, always
shield the baby’s eyes.
Use the certified product (e.g. eye mask/shield) for blue
light protection from phototherapy.
WARNING
Eye protection: Do not look directly at the LED. During treatment, the baby’s
eyes should always be protected with an eye shield or other eye protection
device.
Make sure that the baby’s eyes are protected from contamination regularly.
Patients near the light should use protective pads or equipment to protect
their eyes.
3.2 Patient placement
① Ensure the pad is already wrapped with the disposable cover. As
shown in the picture on the left, place the patient into the light emitting
area of the pad. When placing the patient on Light pad, be sure the
patient’s back and temperature sensor location are aligned.
②Wrap the patient with a pad, fix it with Velcro.

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WARNING
•To minimize the heat between the pad and the patient, the patient
should not be wrapped in a thick blanket or wrapped too tightly.
•The patient’s body temperature may rise if the patient and pads are
wrapped in a material that does not allow heat to escape, such as a thick
blanket or clothes.
•Do not use the device without a disposable cover.
•Do not use the device with other thermotherapy devices that may affect
the patient’s body temperature such as incubators, heaters, mattresses,
heating blankets, etc.
3.3 Product Operation
3.3.1 Operation mode
Mode
Description
Normal
Mode
The pad is on when the timer indicates 0 then the device operates in the normal
mode.
Timer
Mode
The pad is on when the timer indicates higher than 0minutes; the device operates in
Timer Mode. In timer mode, the pad operates as long as the set time. When the set
time reaches 0 minutes, the pad turns off.
And the maximum setting time is 24hours.
The pad automatically turns off after 24hours.
3.3.2 How to operate
(1) Power ON/OFF
1) Press the power button ( ) for more than 1 second to turn the power ON or OFF.
2) When booting, the total usage time and F/W version are displayed at the bottom of the LCD display.
< Boot screen >
< Basic screen >
(2) Mode setting
1) Normal mode
①Use the 30 minutes decrease
button( ) to set the Timer 0
minutes.
②Set the light intensity to High or Low by
using the light intensity control
button( ).
③In the normal mode, the power is not
automatically turned off, so the user must
manually turn off the power.

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2) Timer mode
①Use the 30 minutes increase or decrease
button( ) to set the desired Timer
time.
②The timer can be set at a maximum of 24
hours.
③Set the light intensity to High or Low by
using the light intensity control
button( ).
(3) Pad output setting
1) When the power is turned on, the status of the pad is OFF.
2) Press the light intensity control button to determine the pad output.
3) Pad output can be set as one of OFF, High, and Low.
(High : 60±10 μW/cm²/nm, Low : 30±10 μW/cm²/nm)
4) When the device power is turned off while the pad output is set to High or Low, this pad output set
status is recorded. So when the power is turned on again and presses the intensity control button,
the pad output indicates the previous set status.
5) However, when the device power is turned off with the pad output is set to off, the pad output status
will indicate High when the light intensity control button is pressed after the device is turned on
again.
< Off >
< High >
< Low >
(4) LCD Auto-Off
When there is no button input for 10minutes during use, the LCD turns off but the device is working
normally. The LCD is turned on by briefly pressing one of the four buttons.
NOTE
•The charging level indication displayed on the LCD may differ from the actual battery capacity.
Make sure that the device is fully charged before use.
•Charge the battery immediately when the low battery warning flashes.
•If the device has not been used for a long time, make sure the battery is fully charged before use.
•Measure the patient’s bilirubin level regularly.

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4. Alarm
4.1 Alarm condition
(1) High temperature
If the contact part temperature of the pad is high, the pad is automatically turned off before the
temperature exceeds 40 °C. The high temperature icon ( ) appears on the LCD display, and the beep
alarm sounds until the user turns off the control box.
(2) Low battery
When the battery becomes low, the low battery icon ( ) appears on the display, the beep alarm will
sound for 10 seconds, and the control box and the pad will automatically turn off.
(3) Pad connection
If the communication between the control box and the pad is irregular, the pad connection icon ( )
appears on the LCD display. The beep alarm will sound once and the pad turns off automatically. The icon
disappears when the control box and the pad are properly reconnected.
4.2 Alarm characteristics
(1) High temperature
•Alarm priority: Low priority
•Audible alarm: Beep-beep
•Alarm icon: The high temperature icon( ) is displayed and blinked until the user turns off
the control box.
(2) Low battery
•Alarm priority: Information signal
•Audible alarm: Beep
•Alarm icon: The battery icon( ) is displayed and blinked.
(3) Pad connection
•Alarm priority: Information signal
•Audible alarm: Beep
•Alarm icon: The pad connection icon( ) is displayed.
WARNING
•If the high temperature alarm is on, check the patient’s body temperature.
•If the patient’s body temperature is too high, the pad should be separated
from the patient.
•When the high temperature alarm sounds, turn off the control box. Use it
again after the pad has cooled down sufficiently.
•When the temperature information signal sounds, remove the thick
blanket or clothes surrounding the pad.
•When using the phototherapy equipment, periodically measure the
patient’s temperature and check it.

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5. Precautions for Pad
(1) Before use, measure the output power of the LED using a measuring device according to section 7.1
Brightness check.
(2) Protect the infant’s eyes with a protective eye shield designed for use of phototherapy.
(3) The cover is disposable, and multiple uses are prohibited. Replace the cover every 24 hours, between
patients, or if soiled, whichever occurs first.
WARNING
Eye protection: Do not look directly at the LED. During treatment, the baby’s
eyes should always be protected with an eye shield or other eye protection
device.
Make sure that the baby’s eyes are protected from contamination regularly.
Patients near the light should use protective pads or equipment to protect
their eyes.
(4) Make sure the patient does not get off the pad during treatment. The light intensity decreases when the
patient is away from the light source.
CAUTION
There should be no other material (blanket, clothing, etc.) between the covered
pad and the patient. Covered pads should always be on a patient’s bare skin.
6. Essential Performance(EP)
The infant phototherapy equipment, BT-450 irradiates the blue lights of the following conditions to treat
jaundice.
-low Intensity: 30 ± 10 μW/cm2/nm
-high intensity: 60 ± 10 μW/cm2/nm
7. Cleaning and maintenance
7.1 Brightness check
Before use, it is recommended to measure the light intensity of the pad using a calibrated measuring device.
The light intensity of the pad must be measured with the pad disposable cover on, and the receptor part of
the measuring device is directed toward the light emitting area of the pad.
If the intensity is not verified to 60±10 μW/cm²/nm when it is high, and 30±10 μW/cm²/nm when it is low,
Pad might need a replacement. Otherwise, it is normally recommended to replace the pad after 3 years of
use, based on operating the pad 24 hours a day.
WARNING
Do not open the pad arbitrarily or attempt to change the LEDs. Only qualified
personnel should perform service.
LEDs that are changed without the manufacturer’s permission can influence the
safety and effectiveness of phototherapy.
NOTE
The LEDs of the pad are not subject to repair, and if necessary, the entire pad including the LEDS should
be replaced. Contact Bistos Service Center.

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7.2 Cleaning
(1) Wash
-Before cleaning, turn off the device and disconnect the pad connector.
-Remove residues on the surface of the control box and pad with a soft brush or soft clean-
cloth wet with a proper amount of clear water.
(2) Disinfection
-Before disinfection, turn off the device and disconnect the pad connector.
-Clean the surface of the control box and pad with a soft brush or soft clean-cloth wet with a
proper amount of 70 ~ 90 % alcohol (Ethanol alcohol or isopropyl alcohol).
-Always follow the hospital’s hygiene regulations when handling devices contaminated with
bodily fluids or other substances.
WARNING
Disconnect the AC power cable before cleaning.
Turn off the device and disconnect the pad connector before cleaning.
CAUTION
Clean the pads before use on a new patient.
8. Troubleshooting
Problem
Solution
The battery cannot be
charged.
•Check if the power adapter is properly connected.
•If the charging problem persists, replace the power adapter with
a new one.
•If the charging problem persists, the battery needs to be
replaced. Contact Bistos Service Center.
The power does not turn
on.
•Check the battery charging status.
•Inspect the power button and the outside of the control box for
foreign substances.
The control box gets wet.
•Remove the plug of the power adapter from the socket.
•Turn off the power of the control box.
•Wipe the body with a dry cloth and store it in a warm dry place
for at least 12 hours.
LED does not light up.
•Check if the pad is properly connected to the control box.
•If parts of the LED module do not light on, the pad needs to be
replaced.
The pad connection icon
still appears.
•Unplug the pad connector and reconnect it to the control box.
•If the pad connection icon still appears, the pad needs to be
replaced. Contact Bistos Service Center.
※If the problem is not solved or have additional questions, contact Bistos Service Center.
9. Manufacturer’s declaration on EMC
The Infant Phototherapy Equipment needs special precautions regarding EMC (Electromagnetic
compatibility) and needs to be used according to the EMC information provided in this user manual.
Wireless communications equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can affect the Infant Phototherapy Equipment and should
be kept at least 1 m away from the equipment. And it does not suitable for use in an MRI environment.

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9.1 Electromagnetic emissions
BT-450 is intended for use in the electromagnetic environment specified below. The user should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The Infant Phototherapy Equipment uses RF
energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to
cause interference in nearby electronic
equipment.
RF emissions CISPR 11
Class B
The Infant Phototherapy Equipment is suitable for
use in all establishments, including domestic and
those directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonic emission
IEC61000-3-2
Class A
Voltage fulctuations /flicker
emissionsIEC61000-3-3
Complies
WARNING
The Infant Phototherapy Equipment should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Infant Phototherapy Equipment
should be observed to verify normal operation in the configuration in which it will be used.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the device,
including cables specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
Use of adapter other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
9.2 Recommended separation distances between portable and mobile RF communications
equipment and the Infant Phototherapy Equipment
The Infant Phototherapy Equipment is intended for use in the electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the Infant
Phototherapy Equipment can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment and the Infant
Phototherapy Equipment as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum output
power of transmitter [W]
Separation distance according to the frequency of transmitter [m]
150 kHz ~ 80 MHz
d = 1.2
P
80 MHz ~ 2.7 GHz
d = 2.0
P
0.01
0.12
0.20
0.1
0.38
0.63
1
1.2
2.0
10
3.8
6.3
100
12
20
For transmitters at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where pis the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2) These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.

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9.3 Electromagnetic immunity
The Infant Phototherapy Equipment is intended for use in the electromagnetic environment
specified below. The customer or the user of the Infant Phototherapy Equipment should assure
that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic
environment-guidance
Electrostatic
discharge
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV,
±15kV air
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, relative
humidity of at least 30% is
recommended.
Electrical fast
transient/burst
IEC61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
The mains power quality should
be that of a typical commercial
or hospital environment.
Surge
IEC61000-4-5
±1 kV
line(s) to line(s)
±2 kV
line(s) to earth
±1 kV differential
mode
±2 kV common mode
The mains power quality should
be that of a typical commercial
or hospital environment.
Voltage dips,
short
interruptions,
and voltage
variations on
power supply
input lines
IEC61000-4-11
0% UT
(100% dip in UT)
for 0.5/1 cyclesa)
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 23/30 cyclesa)
(for 0.5sec)
0 % UT
(100% dip in UT)
for 250/300 cycles
(for 5 sec)
0% UT
(100% dip in UT)
for 0.5/1 cyclesa
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 23/30 cyclesa
(for 0.5sec)
0 % UT
(100% dip in UT)
for 250/300 cyclesa
(for 5 sec)
The mains power quality should
be that of a typical commercial
or hospital environment.
If the user of the Infant
Phototherapy Equipment
requires continued operation
during power mains
interruptions, it is
recommended that the Infant
Phototherapy Equipment is
powered from an
uninterruptible power supply or
a battery.
Power
frequency
(50/60 ㎐)
magnetic field
IEC61000-4-8
30 A/m, 50 or 60 Hz
30 A/m, 50 or 60 Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.
aFor example 10/12 means 10 cycles at 50Hz or 12 cycles at 60Hz

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Immunity test
Test level
Compliance level
Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
Outside ISM
bandsa)
6 Vrms
150 kHz to
80 MHz
in ISM and
amateur radio
bands
80% AM at 1kHz
3 Vrms
150 kHz to
80 MHz
Outside ISM
bandsc
6 Vrms
150 kHz to
80 MHz
in ISM c and
amateur radio
bands
80% AM at 1kHz
Portable and mobile RF communications
equipment should be used no closer to
any part of the Infant Phototherapy
Equipment, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
d = 1.2
P
IEC 60601-1-2 : 2007
d = 1.2
P
80 MHz ~ 800 MHz
d = 2.3
P
800 MHz ~ 2.7 MHz
IEC 60601-1-2:2014
d = 2.0
P
800 MHz ~ 2.7 MHz
where P is the maximum output power
rating of the transmitter (W) according
to the transmitter manufacturer and d is
the recommended separation distance
in meters(m)
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a, should be
less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.7 GHz
80%, 1 kHz AM
10 V/m
80 MHz to
2.7 GHz
80%, 1 kHz AM
NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM, and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Infant Phototherapy Equipment is used exceeds the
applicable RF compliance level above, the Infant Phototherapy Equipment should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Infant Phototherapy Equipment.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
cThe ISM(industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765MHz to
6.795 MHz; 13.553MHz to 13.567MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
WARNING
Excessive ambient EM (Electromagnetic) DISTURBANCES can cause the pressure of the unit to
be temporarily excessively high or low. Please use in environments below the above test
standards.