GE BiliSoft 2.0 User manual

BiliSoft™ 2.0
Phototherapy System
Lighting by LumitexTM
Operation Manual

ii
© 2017 by Lumitex Inc.
All rights reserved. Lumitex Inc. and General Electric Company reserve the right to make changes in
specifications and features shown herein, or discontinue the product described at any time without
notice or obligation. Contact your GE Representative for the most current information. Lumitex is a
registered trademark of Lumitex, Inc. Copyright 2000 Lumitex, Inc. BiliSoft is a registered trademark
owned by Datex-Ohmeda, Inc. GE and GE Monogram are trademarks of General Electric Company.
All other company and product names mentioned may be trademarks of the companies with which
they are associated.
Warranty
This product is sold by GE Healthcare with a GE depot repair warranty that covers labor and parts
under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the
customer at the point of sale. The light pad, light box chassis and cooling fan carry a 12-month
warranty. The electronics carry a 24-month warranty. The phototherapy LED carries a 36-month
warranty.
The product warranty is only offered through GE service depot. Field service is not covered
under warranty for this product.

iii
Table of Contents
Indications for Use .............................................................................................................................v
About this Manual .............................................................................................................................v
About this Product............................................................................................................................vi
User Responsibility .......................................................................................................................... vii
Important Safety Information ........................................................................................................... ix
Contraindications .....................................................................................................................................xi
Care of the Patient’s Skin ................................................................................................................ xiii
Safety Information........................................................................................................................... xv
Symbol Definitions .................................................................................................................................. xv
Chapter 1 Components and User Controls .......................................................................................1-1
BiliSoft 2.0 Light Box.............................................................................................................................. 1-1
BiliSoft 2.0 Light Pad Assembly ............................................................................................................. 1-4
Soft Cover Options (Disposables).......................................................................................................... 1-5
Chapter 2 Operating Instructions.....................................................................................................2-1
Pre-use Checkout Procedure................................................................................................................. 2-1
Light Pad Output ................................................................................................................................... 2-2
Positioning the Unit............................................................................................................................... 2-3
Attaching the Mounting Bracket........................................................................................................... 2-4
Using the Unit........................................................................................................................................ 2-5
Installing Pad Covers ............................................................................................................................. 2-6
Chapter 3 Troubleshooting..............................................................................................................3-1
Indicator Lights/Troubleshooting Guide ............................................................................................... 3-1
Chapter 4 Routine Cleaning and Maintenance .................................................................................4-1
Cleaning and Disinfecting...................................................................................................................... 4-1
Approved Cleaning Solutions............................................................................................................. 4-1
Point of Use Cleaning......................................................................................................................... 4-2
Cleaning the Light Box between Patients.......................................................................................... 4-2
Cleaning the Light Pad and Cable between Patients......................................................................... 4-3
Cleaning the Light Pad Connector, Fiberoptic Lens and Connector Port Between Patients............. 4-4
Air Filter Cleaning/Replacement........................................................................................................ 4-5
Factors that affect product life.......................................................................................................... 4-5
Product storage ................................................................................................................................. 4-6
Chapter 5........................................................................................................................................5-1
Chapter 6 Optional Equipment and Replacement Parts ....................................................................6-1
Chapter 7 Specifications..................................................................................................................7-1
Chapter 8 Technical Reference ........................................................................................................8-1
Spectral Irradiance Light Output ........................................................................................................... 8-1
Effective Pad Area for Irradiance Output.............................................................................................. 8-2
Pad Output Measurement Points ......................................................................................................... 8-2
Chapter 9 EMC Guidance.................................................................................................................9-1
Degraded Performance Characteristics ................................................................................................ 9-1
EMC Service Life .................................................................................................................................... 9-5
Appendix A1 - Additional Safety Information ................................................................................ A1-1
Statements .......................................................................................................................................... A1-1
Appendix A2 - Home Use.............................................................................................................. A2-1
Homecare Providers............................................................................................................................A2-1
Parents or Guardians...........................................................................................................................A2-1
Before You Begin Treatment ...........................................................................................................A2-1
The BiliSoft 2.0 Phototherapy System Components ........................................................................... A2-2

iv
How it works........................................................................................................................................A2-2
Installing Pad Covers ........................................................................................................................... A2-3
Soiled Pad Covers ............................................................................................................................ A2-4
Prepare the Baby –Remove Clothing .................................................................................................A2-5
Positioning the Baby............................................................................................................................A2-5
Using the Pad Straps to Swaddle the Baby .........................................................................................A2-6
Use of Additional Blankets...............................................................................................................A2-7
Eye Protection for the Baby ................................................................................................................ A2-7
Ready the Unit for Operation.............................................................................................................. A2-8
Placement of Light Box ....................................................................................................................A2-8
Frequently Asked Questions .............................................................................................................A2-10
Feeding Time .................................................................................................................................A2-10
Bathing...........................................................................................................................................A2-10
Taking Temperatures..................................................................................................................... A2-10
Urine/Stools................................................................................................................................... A2-10
Treatment Time .............................................................................................................................A2-10
Recording Daily Treatment............................................................................................................ A2-11
Homecare Use - Quick Reference .....................................................................................................A2-12

v
Indications for Use
The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of
hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the
hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light
considered to be the most effective in the treatment of hyperbilirubinemia.
About this Manual
Conventions
Various types of pictures or icons are used in this manual or on the product. They reinforce the
printed message to alert you to potential safety hazards in one of the following ways:
WARNING:
A WARNING statement is used when the possibility of injury to the patient or
the operator exists.
CAUTION:
A CAUTION statement is used when the possibility of damage to the equipment
exists.

vi
About this Product
Scope and Intended Users
This manual describes how to use and maintain the BiliSoft 2.0 Phototherapy System (also referred
to as BiliSoft 2.0).
The device is intended to be used in hospital and home settings. Intended user groups are trained
caregivers/ parents, hospital staff, and biomedical technicians/ biomed service personnel.
BiliSoft 2.0 should be used by direction of qualified medical personnel. Medical personnel should be
familiar with currently known risks and benefits of infant phototherapy.
Description
BiliSoft 2.0 Phototherapy System consists of a light box and a detachable fiberoptic light pad with a
long, flexible fiberoptic cable. The fiberoptic cable delivers light from a high intensity LED module in
the light box to the fiberoptic light pad. The flexible fiberoptic light pad is placed in a soft BiliSoft Pad
Cover or BiliSoft Nest that is then brought into contact with the patient’s skin. The patient is exposed
to light in the wavelength of 430-490 nanometer range (peak 445-470 nanometer).
Units are available with two fiberoptic pad sizes: small (20cm x 25cm) and large (25cm x 30cm).
Carton Contents
The BiliSoft 2.0 Phototherapy System is shipped with the following contents:
1
Light Source Box with language specific warning labels
1
Light Pad (Small 8x10 inch or Large 10x12 inch)
1
Country / Region specific AC Power cord
1
Operation Manual (Language specific)
1
Service Manual (English Language Only)
2
Disposable Pad Cover, Flat
1
Disposable Pad Cover, Nest
Note: A Home Healthcare model sold to equipment providers will substitute (15) flat pad covers for
the standard disposables.
Note: Replacement disposable pad covers (Flat and Nest) can be purchased from GE Healthcare, see
Chapter 6 for part numbers.

vii
User Responsibility
This product will perform properly, when used and cared for as described in the instructions
provided.
This product must be periodically checked. A defective product should not be used. Broken, missing,
plainly worn, distorted or contaminated parts should be replaced immediately.
Should repair or replacement become necessary, Lumitex recommends that a request for service be
made to the nearest GE Healthcare Regional Service Center listed on the back cover. This Product, or
any of its parts, should only be repaired by trained GE Healthcare technicians.
WARNING:
No modification or alteration of this device is allowed.
WARNING:
US Federal law restricts this device to sale by or on the order of a licensed
medical practitioner.
If repairs are made by anyone other than GE Healthcare trained personnel, the user shall be solely
responsible for any malfunction due to:
Improper use
Inadequate maintenance
Improper repair, damage or alteration
To ensure that the BiliSoft 2.0 Phototherapy System provides effective phototherapy treatment:
Read this manual
Pay special attention to WARNINGs and CAUTIONs that appear in this manual
Use the product according to your healthcare provider’s instructions
This symbol indicates that the waste of electrical and electronic equipment must not be disposed as
unsorted municipal waste and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning the proper disposal of your
equipment.

viii
This page intentionally left blank.

ix
Important Safety Information
WARNINGS:
Eye Protection:
Long exposure to any phototherapy light may cause eye damage. Never look
directly at the light. Infants should wear eye protection during therapy. Take
care to protect the eyes of nearby infants.
Home Users:
Always follow your healthcare professional’s instructions.
Caregiver Side Effects:
Caregivers looking at the blue light for a long time may experience headache,
nausea, or mild vertigo.
Bilirubin Levels:
Measure the bilirubin levels during treatment. Follow hospital policies and
procedures.
Possible Risks:
All phototherapy has possible risks including, but not limited to:
Apnea
Bronze baby syndrome
Diarrhea
Hyperpigmentation-reddening
Patent ductus arteriosus
Riboflavin-calcium and other deficiencies
Skin blistering
Skin irritation and thrombocytopenia
Watch closely for signs of these conditions during treatment.
Porphyrins/Photoisomers:
Bilirubin photoisomers may cause toxic effects. Porphyrins are the result of the
breakdown of the bilirubin molecule. Exposure of porphyrins to phototherapy
may result in a localized reddening of the patient’s skin. Monitoring of the skin is
recommended.
Photosensitive Drugs:
The phototherapy light can harm drugs and other infusion liquids. Shield any IV
tubing with an appropriate material. Do not store drugs or infusion liquids near
the phototherapy light.
Power Cord:
Do not block the power cord plug. It can be disconnected for emergency power
shutoff.

x
Hospital Policy & Procedures:
Follow hospital policies and procedures for assessing
Bilirubin
Temperature
Skin
Eyes
Disposal:
Dispose of all waste as required by federal, state, and local waste regulations.
Improper disposal could result in personal injury or harm the environment.
Skin Color:
The blue light can mask skin color changes such as cyanosis.
Patient Positioning:
Regularly check that the patient is in the treatment area of the device.
Product Mounting and Service:
Do not mount the system to a Dove Rail, or service the unit, while a patient is in
the bed, or is receiving treatment.
Patient Water Loss:
Phototherapy treatment can increase a patient’s insensible water loss. Maintain
the patient’s fluid balance while administering phototherapy.
Patient Skin Temperature:
Phototherapy used with warming devices may raise the patient’s body
temperature. Incubator or warming beds should use skin controlled (servo)
mode for warming during treatment. Always monitor the patient’s temperature
to avoid temperature fluctuations during treatment.
Reflective Foils:
Do not use foils or reflective materials with the treatment. Hazardous patient
body temperatures may result.
Combustible Gases:
Do not use the BiliSoft 2.0 in the presence of flammable anesthetics (e.g. ether)
mixtures with air or with oxygen or nitrous oxide. These mixtures can support
combustion. A possible explosion hazard exists under these conditions.
Flammable Solutions:
Never use flammable solutions to clean the BiliSoft 2.0 Phototherapy System or
any of its parts.
Oxygen:
Oxygen rich air greatly reduces the temperature at which materials burn.
Remove all opaque materials from the immediate light path when using the light
while administering oxygen.

xi
Trip Hazard:
The power cord can be a trip hazard. Do not leave the cord unattended when
located in traffic areas.
Unit Damage:
A damaged or defective unit or accessory should not be used.
Electric Shock Hazard :
Do not attempt to insert objects into the intake or exhaust vents on the cover.
CAUTIONS:
Electromagnetic Interference:
The user needs to be aware of electromagnetic interference, or EMC. This
device is to be installed and put into service according to the EMC information
provided in Chapter 9.
Roll Stand:
If the system is mounted on a portable roll stand, lock the wheels to prevent
movement during the therapy.
Trip Hazard:
The power cord can be a trip hazard. Do not leave the cord unattended when
located in traffic areas.
Unit Damage :
Do not attempt to insert objects into the intake or exhaust vents on the cover.
Contraindications
The following patient symptoms or conditions make phototherapy treatment inadvisable*.
Congenital porphyria or family history of porphyria.
Concomitant use of drugs or agents that are photosensitive.
Concurrent therapy with metalloporphyrin heme oxygenase inhibitors.
Phototherapy effectiveness may be reduced in presence of cholestasis (direct hyperbilirubinemia).
* MacDonald & Ramasethu (2007). Atlas of Procedures in Neonatology, Lippincott Williams & Wilkins, Philadelphia, PA

xii
This page intentionally left blank.

xiii
Care of the Patient’s Skin
Important clinical information –please read carefully before using this device.
The skin has a number of roles. It provides a protective barrier against chemical, mechanical, and
biological injuries. It helps maintain body temperature. It also serves as a route for water excretion,
especially in premature infants.
The introduction of new intensive care techniques has increased survival of very small, premature
infants. Very low weight infants do not have fully developed skin. Combined with more
instrumentation and handling, this poses previously unrecognized problems for the nursing care of
these infants.1
Please read, evaluate and implement the following recommendations as appropriate:
1. Please refer to the following standard of skin care recommendations as given in the
literature2when utilizing this device. Special attention should be given to sanitation and
skin integrity.
Observe color, rashes, excoriation.
Clean skin with warm water.
Clean perineal area after stooling.
Change infant’s position every 2 hours.
2. This device is intended only for the treatment of existing hyperbilirubinemia. Use of this
device as preventative treatment is not recommended. Premature infants have
extremely fragile skin3and various clinical studies have produced different conclusions
concerning the effectiveness of preventative treatment. 4, 5
1NAACOG (1992), OGN Nursing Practice Resource, Neonatal Skin Care, NAACOG.
2ibid
3Rutter, N., The immature skin,
British Medical Bulletin , Vol. 44, No. 4, 1988
4Curtis-Cohen, M., et al, Randomized trial of prophylactic phototherapy in the infant with very low birth weight,
The Journal of Pediatrics , July, 1985
5Brown, A., et al, Efficacy of Phototherapy in Prevention and Management of Neonatal Hyperbilirubinemia,
Pediatrics , February, 1988

xiv
This page intentionally left blank.

xv
Safety Information
Symbol Definitions
Symbol
Description
Electrical shock hazard possible.
WARNING statements are used when the possibility of injury exists.
CAUTION statements are used when there is a possibility to damage
the equipment.
NOTE:
NOTE statements are used to provide additional information, or
clarify a point.
~
Indicates alternating current (AC).
Type BF applied part.
Cover the patient’s eyes during phototherapy.
On/Off Standby Switch
Unit overheated indicator
Hour meter
LED failure indicator
Double Insulated
See the Operation Manual for more information.

xvi
Symbol
Description
Do not spray cleaner directly onto the fiberoptic lens. The fiberoptic
lens require special cleaning methods. See cleaning section of this
manual for complete details.
European Authorized Representative
Manufacturer
ETL approval symbol
Rx Only
US Federal law restricts this device to sale by or on the order of a
licensed medical practitioner. (Applicable only in the USA)
Do not place items in path of radiant heater
Waste Electrical and Electronic Equipment Directive symbol
CE mark - Lumitex declares that product displaying the CE mark
conforms to the Regulation (EU) 2017/745.
Do Not Reuse
IP21
Protection levels for solid objects and water ingress (light box):
2 - Fingers or similar objects < 12.5mm diameter
1 - Dripping water (vertically falling drops)
IPX4
Protection levels for water ingress (light pad):
4 - Water splashing against the enclosure from any direction
shall have no harmful effect.
Serial Number
Part Number
UDI
Unique Device Identifier. The UDI is a unique identifier for a medical
device.
SN
REF

xvii
Symbol
Description
Beginning in September 2016, some medical devices
sold in the USA must be labeled with a Unique Device
Identifier (UDI).
SMALL PAD LARGE PAD
The baby outline defines the side of the pad upon
which to place the baby. Place the baby on this side of
the pad.

xviii
This page intentionally left blank.

1-1
Chapter 1
Components and User Controls
BiliSoft 2.0 Light Box
The Light Box contains the output LED module, a power supply, a cooling fan and temperature
protection circuitry.
The power supply is universal. The device can be supplied by any standard AC main power source.
The rated input voltage is 100-240VAC at 50/60 Hz. The rated input current is 0.25-0.75 Amps.
The LED module emits a very narrow band of blue light with no appreciable amount of ultraviolet or
infrared light. The LED module can only be activated when the pad connector is plugged into the
system.
The light box is cooled by a fan. A thermal sensor located on the LED module protects the device
from overheating. It also prevents operation if the temperature is below freezing.

1-2
Component/Control
Function
1. Standby Switch –Turns the
unit ON/OFF. The green light in
the switch indicates that the
standby switch is turned on
and the unit has power.
2. Hour Meter –The non-
resettable hour meter shows
the number of hours a light pad
has been active during the life
of the light box. If the Light Pad
connector is not fully inserted
into the light box, the LED is
automatically shut off and the
hour meter does not run. Note:
The hour meter is provided to
track LED life and is not
intended to be used to measure
therapy durations.
3. Unit Overheated Indicator –
When this red indicator light is
ON, the unit has overheated.
See Troubleshooting Guide for
more details.
4. LED Module Failure Indicator -
When the red indicator light
FLASHES, the LED module has
failed. See the Troubleshooting
Guide for more details.
5. Light Pad Connector Port –
Where the light pad assembly
connects to the main unit. A
shutoff switch inside the port
automatically turns off the LED
module whenever the fiberoptic
light pad assembly is removed.
6. Exhaust Air Vents –For proper
cooling it is important to keep
the air vents clear of
obstructions.
1
2
3
4
5
6
1
2
3
4
5
6