GE BiliSoft 2.0 User manual

BiliSoft™ 2.0
Phototherapy System
Lighting by LumitexTM
Operation Manual

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© 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.

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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

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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

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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.

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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.

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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.

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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.

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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.