Motif Medical Motif Phototherapy Blanket BiliTouch Quick start guide

Motif
Phototherapy
Blanket BiliTouch™
Operational Manual
Please note: color and patterns may vary.

Meet The Motif
Phototherapy
Blanket, The
2
1. Introduction
The ultraportable, lightweight,
battery-powered, phototherapy device.
Helping promote mom and newborn bonding while
providing the therapy needed.*
*It is suggested to limit the length
of time holding the patient during
treatment to help prevent heat
buildup.
Please note: color and patterns may vary.

Index
1. Introduction 2
2. Intended Use 6
3. Safety Information 7
4. Symbols 9
5. Product Information 12
5.1 Description of Each Part 13
5.2 Button Descriptions 14
5.3 LCD Description 15
6. How to Use 16
6.1 Preparation Before Use 16
6.2 Basic Operation 17
6.3 Operation Mode 18
6.4 How to Operate 19
7. Precautions for Light Pad 21
8. Alerts 22
9. Essential Performance 23
10. Maintenance and Cleaning 24
10.1 Brightness Check 24
10.2 Cleaning 25
11. Troubleshooting 26
12. Manufacturers Declaration on EMC 27
12.1 Electromagnetic Emissions 27
12.2 Recommended Separation Distances between Portable 28
and Mobile RF Communications Equipment and the
Phototherapy Blanket
12.3 Electromagnetic Immunity 29
13. Product Specificaions 31
14. Warranty 33
Proprietary Material
Information and descriptions contained in this manual are the
property of Motif Medical®and may not be copied, reproduced,
disseminated, or distributed without express written permission
from Motif Medical®.
Information furnished by Motif Medical®is believed to be
accurate and reliable. However, no responsibility is assumed by
Motif Medical®for its use, or any infringements of patents or other
rights of third parties that may result from its use. No license is
granted by implication or otherwise under any patent or patent
rights of Motif Medical®.
The information contained herein is subjects to change without
notice.
Prepared By:
Motif Medical®
8 The Green Suite 5601
Dover, DE 19901
Please note: color and patterns may vary.

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Contraindications
It should not be used in cases of congenital porphyria, a family
history of porphyria, and treatment with photosensitive drugs or
medicines.
2. Intended Use
The Phototherapy Blanket is intended to be used for 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 Phototherapy Blanket can be
used in a hospital or at home.
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 life-span.
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 cell is shorter than that
of adult, which makes a lot of bilirubin, the function of 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 issue 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 Phototherapy Blanket light pad consists of LEDs that
emits light of peak wavelength 455 to 465 nm. 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 the Phototherapy Blanket has two types of intensity,
high and low.
Before using the Phototherapy Blanket, read this entire manual and be fully understood
and follow instructions and safety information to prevent injury.
Warning: To avoid health risk and reduce the
risk of injury
• Eye Protection: Do not look directly into the LED.
During the treatment, always use eye protection 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.
3. Safety Information
Warning: Can lead to serious injury or death
• The patient’s body temperature should be measured
periodically so that the temperature does not rise too
much.
• To minimize the heat between the light 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 light pad are wrapped in a material that does
not allow heat to escape, such as a thick blanket or
clothes. When the temperature alert is on, check the
patient’s body temperature.
• Do not use the device while bathing the patient.
• Do not use the device near water.
• Do not use the device device without a disposable
cover.
• Do not use the device with other thermotherapy
devices. (incubators, heaters, mattresses that may
affect the patient’s body temperature, etc.)
• 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.
• The Phototherapy Blanket 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 Phototherapy Blanket
cannot be used adjacent to or with other devices.
• Do not touch or manipulate the Phototherapy Blanket
with wet hands, as it may cause electric shock.
Caution: Can lead to minor injury or product/
property damage
• Do not use the device outdoors, where aerosol
(spray) products are being used, or where oxygen is
administered.
• When disposing of the Phototherapy Blanket, please
follow all laws regarding recycling.
• When disposing of packaging materials, comply with
local waste disposal law 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 Motif Medical®.
• Unpack carefully to avoid damaging the device. Inspect
the packaging before unpacking. In case of damage,
immediately contact Motif Medical®. 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 light pad may damage it.
• Use the cover provided only, otherwise, treatment may
not be effective due to decreased light output.
Wavelength λ (nm)
FIgure 1. Relative light intensity according to the wavelength of the LED
component. This graph is from the datasheet.
Relative Emission Intensity (%)

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The following symbols and safety signs are placed on product, label, packing and this
manual in order to stand for the information about:
4. Symbols
Symbol Standard/Symbol Reference No. Description
ISO 7010 — Graphical symbols — Safety colors
and safety signs — Registered safety signs /
W001
Used to display safety information for warnings.
Before using the Phototherapy Blanket, 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 Phototherapy Blanket, please be fully understand the
information provided with the device.
IP21
IP22
IP23
IEC 60529 Degrees of protection provided by
enclosures
Indicates the protection level against the ingress of solid object and
liquid.
IPX1 is protection against some falling water drops vertically.
IPX3 is protection against spraying water at any angle up to 60° from the
vertical shall.
IPX2 is protection against some falling water drops vertically when
enclosure tilted up to 15°.
IP2X is protection against solid foreign object 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 operation manual. Read manual before placing the device.
IEC 60417 — Graphical Symbols for Use on
Equipment / 5032 IEC 60417 — Graphical Symbols for Use on Equipment / 5032
IEC 60417 — Graphical Symbols for Use on
Equipment / 5031 IEC 60417 — Graphical Symbols for Use on Equipment / 5031
SN
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
Indicates the serial number of the device.
REF
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
Indicates a reference number.
Warning: Can lead to serious injury or death
• If the device falls into water, do not touch any electrical
appliances and immediately disconnect the power
from the power outlet.
• Use the Phototherapy Blanket for neonatal jaundice
treatment only as the intended use described in this
manual.
• Keep the device out of direct sunlight.
• The Phototherapy Blanket 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.
• 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.
• Flamable gas: Do not use the light 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 chapter 10 of this manual.
• Use of the wrong LED or accessories not provided by
Motif Medical®may damage the LED and cause injury
to the user or patient.
• Using a reflective film can cause an increase in
body temperature when the film affects a type of
phototherapy radiation.
Caution: Can lead to minor injury or product/
property damage
• There should be no material (ex. Blanket, clothes,
etc.) between the covered light pad and the patient.
Covered light 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 should 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.
• The Phototherapy Blanket is a 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.
• During phototherapy, the patient’s body temperature
should be monitored.
• Do not place drugs or fluids in the irradiated area.
• While the Phototherapy Blanket 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.
• The Phototherapy Blanket can only be repaired or
replaced by qualified personnel.
3. SAFTEY INFORMATION

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4. SYMBOLS
Symbol Standard/Symbol Reference No. Description
IEC 60417 — Graphical Symbols for Use on
Equipment / 5333
Indicates the BF applied part.
This applies to the pad. (PAD)
ISO 7010 — Graphical symbols — Safety
colours and safety signs — Registered
safety signs / M002
Refer to operation manual. Read manual before placing the device.
Rx ONLY 81 FR 38911, June 15, 2016 Prescription only (USA)
ASTM F2503 — Standard practice for marking
medical devices and other items for safety in the
magnetic resonance environment
Indicates an item is known to pose hazards in all MRI environments.
IEC 60417 — Graphical Symbols for Use on
Equipment / 5172 This symbol means the power adapter is a Class II device.
ISO 15223-1, Medical Devices — Symbols to be
used with medical device labels, labeling and
information to be supplied – Part 1: General
requirements / 5.3.4
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
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 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
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 / 5.3.7
Indicates the temperature limitation for transport and storage.
Symbol Standard/Symbol Reference No. Description
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)
Symbols on the Adaptor:
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
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
Indicates the range of atmospheric pressure to which the medical device
can be safely exposed for transport and storage.
Universal Recycling symbol Indicates the packing material is recyclable.
IEC TR 60878, Graphical symbols for electrical
equipment in medical practice Indicated that always protect the infant’s eyes with eye protection.

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Caution
• Use only Motif Medical® accessories.
• Check the eye protection and cover for wear or
damage before use and replace them if necessary. Do
not use them if there signs of damage or defects.
• The eye protection and cover are disposable, multiple
uses are prohibited.
• To maintain optimum performance, it is recommended
to replace consumables periodically.
5. Product Configuration
5.1 Description of Each Part
6Light Pad
Has a built in LED module and temperature sensor.
7Temperature Sensor
Measures temperature in the light pad to protect the
patient from the heat of the LED.
8Illuminated Area
Lighting area from the built in LED.
Light Pad
1LCD Display
Shows the current operation status. (Adapter and
Battery status, running and remaining time, light
intensity, etc.)
2Operating Buttons
Power ON/OFF, Light Intensity, and Operating Time
can be set.
3Control Box
Has buttons to control the device and an LCD display
shows the current operation status.
4Power Adapter Terminal
Terminal to plug in the power adapter for charging.
5Pad Connection Terminal
Terminal to connect the light pad.
Control Box
6
7
8
3
4
5
2
1
2
1
When unpacking, make sure you have all the following items.
The eye protection and cover are single-patient. The standard
components are as follows:
1Control Box
2Light Pad
3Cover (disposable)
Please note: color and patterns may vary.
4Eye Protection (disposable)
5Power Adapter
6Quick Guide
7User Manual
3
5
6 7
4

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5. PRODUCT CONFIGURATION
5.2 Button Description
1Power Button
For power ON/OFF.
2Light Intensity Control Button
Sets the Light Intensity to High, Low, or OFF.
330-Minute Increase Button
Decrease the scheduled Operating Time by 30
minutes in timer mode.
430-Minute Decrease Button
Increase the scheduled Operating Time by 30
minutes in timer mode.
1Temperature Alert
The light pad will automatically turn off and an alarm
will sound to alert when the temperature becomes
too close to 104°F.
2Light Pad Alert
Will appear on the screen if there is an issue with the
lightpad functioning properly.
3Charging Indicator
Appears when the power adaptor is attached and
device is charging.
4Battery Status and Low Battery Alert
Displays the current battery level.
When the battery is low, the battery icon flashes
and it sounds an information signal. The low battery
information signal turns off after 10 seconds.
5Operating Time
Shows the total elapsed time light pad was on for
current session.
6Remaining Time
Shows the remaining time on the timer mode.
7Light Intensity
Show the current set light intensity (High, Low, OFF)
5.3 LCD Description
Warning
• If the temperature alert is on, check the patient’s body
temperature.
• If the patient’s body temperature is too high, the light
pads should be separated from the patient.
• If the low battery alert is on, connect the adapter to
the device.
1 2 3 4
1
3
4
5
6
7
2

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6. How to Use
6.2 Basic Operation
Patient Placement
6.1 Preparation Before Use
Before Use
1. Ensure the arrow symbols on the pad connector and
the control box are aligned, then connect them. When
disconnecting, pull the metal collar toward the light pad to
disengage it.
2. Put the light pad in the disposable cover. The end of the cover
that does not contain the velcro straps and the LED side of
the light pad should be touching. If you fold the light pad and
insert it, it would be easier. If the cover gets dirty during use,
discard the cover and use a new one. If there is any foreign
substance on the light pad, it must be washed according to
“Chapter 10: Maintenance and Cleaning” before use.
3. Install the eye protection on the patient’s eyes.
1. As shown in the picture, place the patient on the light pad
wrapped with a cover light emitting area of the light pad
should face up or underneath the patient. When placing the
patience on light pad, be sure patient’s back and temperature
sensor location are aligned.
2. After wrapping the light pad around the patient, fix it with
velcro. The power cord should be facing the floor.
1.
2.
3.
1.
2.
Please note: color and patterns of the
disposable cover may vary.
Please note: color and patterns of the
disposable cover may vary.

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6.4 How to Operate
Modes Power On/Off
Mode Setting
1. Press and hold the power button for about 1 second to turn
the Power ON or OFF.
2. When booting, the Total Run Time is displayed at the bottom
of the LCD display.
6. HOW TO USE
6.3 Operation Mode
Normal Mode
The light pad is on and operates continuously.
Normal Mode
Use the button to set the intensity level and it will run
continuously.
Timer Mode
Use the button to set the desired Timer time in
increments of 30 minutes.
Timer can be set a maximum 24 hours.
Set the light intensity to High or Low by using the button.
Timer Mode
The light pad is on, after intensity level is selected and, when the
timer indicates the time mode higher than 0 minute; the device
operates in Timer Mode. In Timer Mode, the light pad operates
as long as the set time. When the set time reaches 0 minutes, the
light pad turns off.
And the maximum setting time is 24 hours.
The light pad automatically turns off after 24 hours.
Boot Screen
Basic Screen

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Light Pad Output Setting
LCD Auto-Off
1. When the power is ON, the status of the light pad is OFF.
2. Press the light intensity control button to determine the light
pad output.
3. Light pad intensity 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 light pad
output is set to High or Low, this light pad output set status is
recorded. So when the power is turned on again and preset
the intensity control button, the light pad output indicates the
previous set status.
5. However, when the device power is turned OFF with the
light pad output is set to OFF, the light pad output status will
indicate the High when the light intensity control button is
pressed after the device is turned ON again.
Contact customer service if light output is out of SPEC
1. When there is no button input for 10 minutes, the LCD
automatically turns off, but the device will continue to operate
normally. The LCD can be turned ON by briefly pressing any
of the four buttons.
Charge the battery immediately when the Low Battery alert
flashes.
If the device has not been used for a long time, make sure the
battery is fully charged before use.
Light Pad — High
Light Pad — Low
Light Pad — O
LCD — O
Notice
• The battery level indication displayed on the LCD may
differ from the actual battery capacity. Make sure that
the device is fully charged before use.
• Measure the patient’s bilirubin level regularly.
Warning: To protect eyes
• Do not look directly at the LED. During treatment, the
baby’s eyes should always be protected with 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.
Caution
• There should be no other material (blanket, clothing,
etc.) between the covered light pad and the patient.
Covered light pads should always be on patient’s bare
skin.
6. HOW TO USE
7. Precautions for Light Pad
1. Light Intensity check: Before use, measure the output power
of the LED using a measuring device. LED output is 60±10 μW/
cm²/nm when it is High, and 30±10 μW/cm²/nm when it is Low.
2. Protect the infant with eye protection designed for use for
phototherapy.
3. Make sure the patient does not get off the light pad during
treatment. The light intensity decreases when the patient is
away from the light source.
4. If the Light Pad Alert appears on the screen, please check
the connection of light pad and control box (see Chapter 11.
Troubleshooting). Try disconnecting and then reconnecting
the light pad to the control box. If the issue remains, turn off
the device and contact Motif Medical® Customer Service.

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8. Alerts
Warning
• If the high temperature alert 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 information alarm signal
sounds, turn off the control box. And use it by setting
the intensity to LOW.
• When the temperature information alarm signal sounds,
remove the thick blanket or clothes surrounding the
pad.
• When using the phototherapy equipment, periodically
measure and check the patient’s temperature.
Alert Condition
1. Alert Name: High Temperature
Alert Description: 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, and beep alarm sounds until the user
turns off the control box.
Alert Characteristics
1. Alert Name: High Temperature
Alert Priority: Low priority
Audible Alarm: Beep-beep
Alert Icon: The temperature icon is displayed and blinked
until the user turns off the control box.
2. Alert Name: Low Battery
Alert Priority: Information signal
Audible Alarm: Beep
Alert Icon: The battery icon is displayed and blinked.
High Intensity: 60±10 μW/cm²/nm
Low Intensity: 30±10 μW/cm²/nm
9. Essential Performance
The essential performance of the Motif Phototherapy Blanket is the amount of light in the
specific wavelength band performing the treatment.
The basis for this determination is that the recommended
minimum amount of light for decomposition of bilirubin is 30 μW/
cm²/nm and the maximum amount of light is 60 μW/cm²/nm..
Alert symbols for different conditions of the Motif Phototherapy Blanket will appear
on the LCD screen.
3. Alert Name: Light Pad
Alert Priority: Information signal
Audible Alarm: Beep
Alert Icon: The light pad alert icon is displayed.

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2.0 in 2.0 in3.9 in 3.9 in 3.9 in
16.1 in
4.7 in
10. MaintenanceandCleaning
10.1 BrightnessCheck
Notice
• It is recommended to change the light pad after 3
years of use, based on operating the light pad 24
hours a day, or 20,000 hours.
A qualified technician can test the light pad intensity and, if
necessary, adjust the brightness to get the desired output
intensity. If measured light pad intensity is outside of the
essential performance specification range, please contact
Motif Medical® customer service.
Warning: To protect eyes
• Only qualified personnel should perform service and
repairs and adjust light source.
10.2 Cleaning
Wash
Disinfection
• Before cleaning, turn off the device and disconnect the pad
connector.
• Moisten a soft sponge or soft cloth with water to remove dust
on the light pad.
• Before cleaning, turn off the device and disconnect the power
cable.
• 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.
• Before disinfecting, turn off the device and disconnect the
pad connector.
• Always follow the hospital’s hygiene regulations when
handling devices contaminated with bodily fluids or other
substances.
• 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).
Caution
• Clean the light pads before use on a new patient.

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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 the Motif Medical® Customer
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.
• Replace the parts as necessary.
The Control Box gets wet • Remove the plug of the power adapter from the socket.
• Turn o the power of the control box.
• Wipe the body with a dry cloth and store it in a warm dry place for least 12 hours.
LED does not light up • Check if the light pad is properly connected to the control box.
• Replace the parts as necessary.
• If parts of the LED module do not light on, the light pad needs to be replaced.
Heat over 104°F • Turn OFF device, wait 30 minutes, then turn it back ON.
11. Troubleshooting
Notice
• If the problem is not solved or have additional
questions, contact Motif Medical® by calling (844) 272-
8390 or emailing [email protected].
Emissions Test Compliance Electromagnetic Environmental-Guidance
RF Emissions CISPR 11 Group 1
The Phototherapy Blanket 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 Phototherapy Blanket 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 Fluctuations/Flicker
Emissions IEC61000-3-3 Complies
12. Manufacturer’s Declarations on EMC
The Phototherapy Blanket 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 Phototherapy Blanket
and should be kept at least 1 m away from the equipment. And it
is not suitable for use in an MRI environment.
12.1 Electromagnetic Emissions
The Phototherapy Blanket is intended for use in the
electromagnetic environment specified below. The customer or
the user of the Phototherapy Blanket should assure that it is used
in such an environment.
Warning
• The Phototherapy Blanket should not be used adjacent
to or stacked with other equipment. If adjacent or
stacked use is necessary, the Phototherapy Blanket
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 pump, 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 results in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result
in improper operation.

29Motif Medical® | BiliTouch Phototherapy Blanket | Operational Manual
28
Rated Maximum Output
Power of Transmitter [W]
Separation Distance According to 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
12.2 Recommended Separation
Distances between Portable
and Mobile RF Communications
Equipment and the Phototherapy
Blanket
The Phototherapy Blanket is intended for use in the
electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Phototherapy
Blanket can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile
RF communications equipment and the Phototherapy Blanket as
recommended below, according to the maximum output power
of the communications equipment.
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 p is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
*At80 MHzand800MHz,the separationdistancefor thehigherfrequencyrangeapplies.
*These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reflection from structures, objects and people.
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, a
relative humidity of at least 30% is
recommended.
Electrical fast
ransient/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
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
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 0.5 sec)
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 0.5 sec)
0 % UT
(100% dip in UT)
for 250/300 cyclesa
(for 5 sec)
Mains power quality should be
that of a typical commercial or
hospital environment.
If the user of the Phototherapy
Blanket requires continued
operation during power mains
interruptions, it is recommended
that the Phototherapy Blanket is
powered from an uninterruptible
power supply or a battery.
Power frequency (50/60 Hz)
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.
12. MANUFACTURER’S DECLARATIONS ON EMC
12.3 ElectromagneticImmunity
The Phototherapy Blanket is intended for use in the
electromagnetic environment specified below. The customer
or the user of the Phototherapy Blanket should assure that it is
used in such an environment.
*UT is 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.

31Motif Medical® | BiliTouch Phototherapy Blanket | Operational Manual
30
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 ISMc and amateur radio bands
80% AM at 1kHz
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Phototherapy
Blanket, 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
surveya, should be less than
the compliance level in each
frequency rangeb.
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
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.
*At 80 MHz and 800 MHz, the higher frequency range applies.
*These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reflection from structures, objects and people.
aField 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 Phototherapy Blanket is used exceeds the applicable
RF compliance level above, the Phototherapy Blanket should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Phototherapy Blanket.
bOver 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
Function
Category Phototherapy Blanket for Neonatal Jaundice Treatment
Light Source
Light intensity (surface of
disposable cover)
High : 60±10 μW/cm²/nm
Low : 30±10 μW/cm²/nm
Eective illuminated area 16.22 in x 4.04 in
Display
Format 2.4” TFT Color LCD
Light Intensity Level Picture
Operating Time Hours display (hour: minute
display)
Battery Charging 3 steps
Function
Mode Normal Mode
Timer Mode
Light pad temperature measurement
13. Product Specifications
Power
Power Adapter
For electrical safety, use only Motif Medical® supplied power adaptor.
Input : (100 to 240) V~, 50/60 Hz, 500 mA
Output : 15 Vdc, 1.2 A
Rechargable Battery
11.1 V Li-ion Polymer 4000 mAh Do not attempt to replace the battery.
Operation time: 10 hours Charging time: 4 hours
12. MANUFACTURER’S DECLARATIONS ON EMC

33Motif Medical® | BiliTouch Phototherapy Blanket | Operational Manual
32
Standard Configuration
User Manual 1 Ea
Control Box 1 Ea
Light Pad 1 Ea
Operation
Operating Temperature 15 °C to 30 °C (59 °F to 86 °F)
Operating Humidity (R.H.) 5% to 85% non-condensing
Atmospheric Pressure 70 kPa to 106 kPa
Component Size Weight
Control Box 3.35 in x 7.28 in x 0.98 in 0.82 lbs
Light Pad 4.72 in x 18.31 in x 0.39 in 0.66 lbs
Storage and Transport
Operating Temperature -20 °C to 60 °C (-4 °F to 140 °F)
Operating Humidity (R.H.) 0% to 95% non-condensing
Atmospheric Pressure 70 kPa to 106 kPa
Option Configuration
Power Adapter 1 Ea
Disposable Cover 1 Ea
Eye Protection 1 Ea
Environmental Condition
Dimension and Weight
14. Product Warranty
Product Name BiliTouch™
Model Motif Phototherapy Blanket
Serial Number
Date of Manufacture
Packing Unit 1 pc
Warranty Period 1 Year from date of purchase
Purchase Date
Customer Information
Name :
Address :
Contact
Seller
Headquarters 1053 E Whitaker Mill RD STE 115
Raleigh, NC 27064
Phone [phone]
Email [email protected]
Homepage www.motifmedical.com
Service Contact
13. PRODUCT SPECIFICATIONS

34
Phone: [phone]
Email: [email protected]
Web: www.motifmedical.com
Manufactured for:
Motif Medical®, LLC
8 The Green, Suite 5601
Dover, DE 19901

Thank you for choosing the
Motif Phototherapy Blanket,
BiliTouch™.
Manufactured for:
Motif Medical®, LLC
8 The Green, Suite 5601
Dover, DE 19901
Phone: [phone]
[email protected]
www.motifmedical.com
P/N: MPB-ENG-OPM-USA-R00