GE BiliSoft User manual

GE Healthcare
BiliSoft™ LED
Phototherapy System
Operation and Maintenance Manual
BiliSoft™ LED Phototherapy System
Operation and Maintenance Manual - English
M1110147
Rev. 5
© 2007 Datex-Ohmeda. All rights reserved.

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M1110147 Rev. 5© 2007 Datex-Ohmeda. All rights reserved. iii
Table of Contents
User Responsibility............................................................................................................................................v
Care of the Skin................................................................................................................................................vii
Chapter 1 Product Description ...................................................................................................................1-1
Intended Use .............................................................................................................................................................................. 1-1
Description .................................................................................................................................................................................. 1-1
Chapter 2 Safety Information .....................................................................................................................2-1
Symbol Definitions................................................................................................................................................................... 2-1
General Safety Information................................................................................................................................................. 2-3
Chapter 3 Home Use .....................................................................................................................................3-1
Homecare provider................................................................................................................................................................. 3-1
Parents or Guardians............................................................................................................................................................. 3-1
Recording Daily Activities................................................................................................................................................ 3-2
Taking Temperatures........................................................................................................................................................ 3-2
Urine/Stools ........................................................................................................................................................................... 3-2
Feeding .................................................................................................................................................................................... 3-2
Treatment Time.................................................................................................................................................................... 3-2
Bathing..................................................................................................................................................................................... 3-2
Daily Record Sheet .................................................................................................................................................................. 3-3
Chapter 4 Components and User Controls...............................................................................................4-1
BiliSoft Light Box....................................................................................................................................................................... 4-1
BiliSoft Fiberoptic Light Pad Assembly........................................................................................................................... 4-3
Soft Cover Options (Disposables)...................................................................................................................................... 4-4
Chapter 5 Operating Instructions .............................................................................................................5-1
Checking the Unit..................................................................................................................................................................... 5-1
Positioning the Unit................................................................................................................................................................. 5-3
Attaching the Mounting Bracket ...................................................................................................................................... 5-4
Using the Unit ............................................................................................................................................................................ 5-5
Chapter 6 Troubleshooting.......................................................................................................................... 6-1
Alarm/Troubleshooting Guide............................................................................................................................................ 6-1
Chapter 7 Routine Cleaning and Maintenance........................................................................................7-1
Maintenance Schedule.......................................................................................................................................................... 7-1
Cleaning and Disinfecting.................................................................................................................................................... 7-2
BiliSoft Light Box .................................................................................................................................................................. 7-2
BiliSoft Fiberoptic Light Pad and Cable..................................................................................................................... 7-3
BiliSoft Cable Connector and Fiberoptic Lenses .................................................................................................. 7-4
Air Filter .................................................................................................................................................................................... 7-5
Chapter 8 Accessories and Replacement Parts.......................................................................................8-1
Chapter 9 Specifications ..............................................................................................................................9-1
Chapter 10 Technical Reference...............................................................................................................10-1
Warranty..................................................................................................................................................... ICB-1

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User Responsibility
This Product will perform in conformity with the description thereof contained in this
operating manual and accompanying labels and/or inserts, when assembled,
operated, maintained and repaired in accordance with the instructions provided. This
Product must be checked periodically. A defective Product should not be used. Parts
that are broken, missing, plainly worn, distorted or contaminated should be replaced
immediately. Should such repair or replacement become necessary, GE Healthcare
recommends that a telephone or written request for service advice be made to the
nearest GE Healthcare Regional Service Center. This Product or any of its parts should
not be repaired other than in accordance with written instructions provided by GE
Healthcare and by GE Healthcare trained personnel. The Product must not be altered
without GE Healthcare’s prior written approval. The user of this Product shall have the
sole responsibility for any malfunction that results from improper use, faulty
maintenance, improper repair, damage or alteration by anyone other than GE
Healthcare.
CAUTION:
US Federal law restricts this device to sale by or on the order of a
licensed medical practitioner.
GE Healthcare has declared that this product conforms with the European Council
Directive 93/42/EEC Medical Device Directive when it is used in accordance with the
instructions provided in the Operation and Maintenance Manual.
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 decommissioning of your equipment.
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M1110147 Rev. 5© 2007 Datex-Ohmeda. All rights reserved. vii
Care of the Skin
Important clinical information – please read carefully before using this device.
The skin serves as a protective barrier against chemical, mechanical, and biological insults.
The skin is also important in the regulation of body temperature and serves as a route of
water excretion, especially in premature infants. The introduction of new intensive-care
techniques has been associated with the increased survival of very small, premature infants.
The immaturity of the skin of the very low weight infants, coupled with excessive
instrumentation and handling, 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 with all infants. 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 for prophylactic treatment, particularly of premature infants, is not
recommended. These infants have extremely fragile skin3and various clinical studies
have produced inconsistent conclusions concerning the effectiveness of prophylactic
phototherapy 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 Hyberbilirubinemia,
Pediatrics, February , 1988

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M1110147 Rev. 5© 2007 Datex-Ohmeda. All rights reserved 1-1
Chapter 1
Product Description
Intended Use
The BiliSoft LED Phototherapy System provides light therapy for the treatment of indirect
hyperbilirubinemia, commonly known as neonatal jaundice, in a hospital or home setting.
Description
The BiliSoft LED 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 440-460 nanometer).
Units are available with two fiberoptic pad sizes: large (25cm x 30cm) and small (15cm x
30cm). The large pad’s nominal spectral irradiance is 35 µW•cm-2•nm-1 through a typical
BiliSoft Pad Cover or BiliSoft Nest. The small pad’s nominal spectral irradiance is
50 µW•cm-2•nm-1 through a typical BiliSoft Pad Cover or BiliSoft Nest.

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Chapter 2
Safety Information
Symbol Definitions
Symbol Description
Next to each WARNING or CAUTION, we have placed an
“attention, read accompanying documents” symbol to alert
you to the presence of these important statements. When the
attention symbol appears in front of text that is printed on the
system itself, it means that the text is elaborated upon in the
operation manual.
WARNING: A WARNING statement is used when the possibility of injury
exists.
CAUTION: A CAUTION statement is used when the possibility of damage
to the equipment exists.
NOTE: A NOTE provides additional information to clarify a point in
the text.
~Indicates alternating current.
Indicates IEC Type B equipment.
TThis letter appearing before a fuselink value indicates a time
delay fuselink.
Cover patient’s eyes during phototherapy.
On/Off Standby Switch
Unit overheated indicator
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Hour meter
LED failure indicator
Do not spray cleaner directly onto the fiberoptic lenses. The
fiberoptic lenses require special cleaning methods. See
cleaning section of this manual for complete details.
See the Operation Manual for more information.
European Union Representative
Manufacturer
ETL symbol
CE mark
WEEE symbol
Ground/Earthing
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General Safety Information
WARNING:
Eye Protection: Direct exposure of the eyes to any phototherapy light
may cause eye damage. Always protect the baby’s eyes with eye
patches or an equivalent appropriate eye protection product.
Periodically and/or per your hospital protocol or healthcare provider’s
instructions, verify that the patient’s eyes are protected and free of
infection. Care should also be taken to protect the eyes of patients
adjacent to the treatment area, when necessary.
WARNING:
Home Users: During phototherapy treatment always follow your
healthcare professional’s care instructions.
WARNING:
Caregiver Side Effects: Looking at light emitted by any phototherapy
device for prolonged periods may cause side effects, such as headache,
nausea, or mild vertigo, in some caregivers or visitors.
WARNING:
Bilirubin Levels: The bilirubin levels of patients receiving phototherapy
should be regularly measured.
WARNING:
Possible Risks: All phototherapy methods have 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. Monitor the patient closely for signs of these
conditions during phototherapy.
WARNING:
Porphyrins/Photoisomers: Bilirubin photoisomers may cause toxic
effects. Porphyrins are the by-products of the photochemical break
down of the bilirubin molecule. In some cases, exposure of porphyrins
to phototherapy may result in a localized reddening of the patient’s skin.
Therefore, skin assessment is recommended with all types of
phototherapy.
WARNING:
Photosensitive Drugs: The light generated by phototherapy devices can
degrade photosensitive medications. Do not place or store any drugs
near or in the illuminated area.
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WARNING:
Water Loss: The radiant energy from phototherapy lights can increase a
patient’s insensible water loss. Take appropriate measures to maintain
the patient’s fluid balance while administering phototherapy.
WARNING:
Skin Temperature: Phototherapy light can affect the temperature in
thermoregulation devices (incubator, radiant warmers or heated
mattresses) and may raise the patient’s body temperature. It is
recommended to use the incubator or warmer in skin controlled (servo)
mode. Always monitor the patient’s temperature to avoid temperature
fluctuations during phototherapy.
WARNING:
Reflective Foils: Using reflective foils to increase the efficacy of
phototherapy may cause hazardous patient body temperatures.
WARNING:
Combustible Gases: Do not use the BiliSoft LED Phototherapy System in
the presence of gases that support combustion like oxygen, nitrous
oxide or other flammable or combustible anesthetics.
WARNING:
Flammable Solutions: Never use flammable solutions to clean the BiliSoft LED
Phototherapy System or any of its parts.
CAUTION:
Medical Electrical Equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in the service manual.
Portable and mobile RF communications equipment can affect Medical
Electrical Equipment.
The BiliSoft LED Phototherapy System should not be used adjacent to or be
stacked on other equipment. If adjacent or stacked use is necessary, the
BiliSoft LED Phototherapy System should be observed to verify normal
operation in the configuration in which it will be used.
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Chapter 3
Home Use
Homecare provider
Ensure when you deliver BiliSoft LED Phototherapy System for use in the home that you
provide adequate in-service training for parents or guardians. Be sure to provide this
Operation Manual and eye covers.
Parents or Guardians
Ask your healthcare provider for information about monitoring your baby during the
phototherapy treatment. Follow your doctor’s recommendation for treatment duration.
Before you begin treatment, place the following items close to the treatment area:
• Phone numbers of doctor, hospital and home healthcare provider
• Thermometer
• Extra BiliSoft Covers or BiliSoft Nests
To properly operate the unit, follow the steps described in "Using the Unit" in Chapter 5 of this
manual.
Position your baby according to your doctor’s recommendations.
Ensure that as much of the baby’s skin as possible is in direct contact with the illuminated
section of the covered light pad. The baby, along with the light pad, may be covered or
wrapped in a thin blanket. It is possible to hold and feed the baby while continuing treatment.
The baby will continue to receive effective phototherapy treatment as long as the covered,
light emitting section of the pad remains in direct contact with the skin. You may swaddle
the baby.
Cover the baby’s eyes when using the BiliSoft LED Phototherapy System to shield them from
light emitted by the BiliSoft fiberoptic light pad.
WARNING:
Direct exposure of the eyes to any phototherapy light may cause eye
damage. Always protect the baby’s eyes with eye patches or an
equivalent appropriate eye protection product. Periodically and/or per
your hospital protocol or healthcare provider’s instructions, verify that
the patient’s eyes are protected and free of infection. Care should also
be taken to protect the eyes of patients adjacent to the treatment area,
when necessary.
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Recording Daily Activities
You should keep a daily record of your baby’s activities and condition. A sample of an easy-
to-use chart is provided on the following page. These records will provide your healthcare
provider or physician with an accurate account of your baby's activities, enabling them to
better assess the progress being made.
Taking Temperatures
It is important to monitor your baby’s temperature during phototherapy sessions. Your doctor
will tell you the range of acceptable temperatures for your infant and may suggest a method
for taking temperatures. For charting purposes, it is important that you use the same method
each time you take your baby's temperature.
Urine/Stools
It is essential that you count and record the number of stools and wet diapers. You will also
be asked to describe stools. Loose stools, black or dark green sticky stools are common
during phototherapy. These observations will help your healthcare provider determine if your
baby is getting enough fluids and will signify any significant changes in their condition. On
your record sheet, note occurrences under the appropriate column and describe the stools.
Feeding
Follow your baby’s regular feeding schedule. Your healthcare provider can help you
determine this. Note feeding times and amount of formula taken, or length of time fed, on
the record sheet.
Treatment Time
Your healthcare provider or physician will tell you how long your baby needs to undergo
treatment. Record the actual times at which your baby is put on and taken off the BiliSoft
LED Phototherapy System during each 24-hour period. Apply phototherapy for as long as
possible during each 24-hour period.
Bathing
You may continue your baby's normal bathing routine. Discontinue phototherapy during
bathing.
WARNING:
If you have questions or concerns contact your healthcare provider
immediately.
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Note:
This form is provided as a reference only. To preserve the integrity of this manual, please do not
write directly on this page or remove this page from the manual. Reproduce this form, if desired.
Daily Record Sheet
Name: Date:
Birth Date: Bilirubin Level:
Method of Temperature Taking:
M1110147 Rev.5© 2007 Datex-Ohmeda. All rights reserved. 3-3
Time Temperature Number of Diapers
(indicate wet and/or stool with description)
Amount Fed
Times when baby is put on and taken off phototherapy treatment:
On Off On Off On Off
Comments:

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Chapter 4
Components and User Controls
BiliSoft Light Box
The light box contains the LED module, a power supply, a cooling system, and an overheating
protection. The universal power supply allows the unit to be supplied via any standard AC
main power source at either 50 or 60 Hertz that has voltages in the range of 90 to 264 V~.
The LED module produces a very narrow bandwidth of light with no appreciable amount of
ultraviolet or infrared light. The light box is cooled by a fan, and a thermal cutout switch
located on the LED module protects the light box from overheating. The LED module in the
light box is activated only when the fiber optic cable is plugged into the system.
Component/Control Function
1. Standby Switch – Turns the
unit on/off. The green light on
the switch indicates that the
standby switch is turned on
and the unit is powered.
2. Hour Meter –The non-
resettable hour meter runs
whenever the fiberoptic light
pad is illuminated. If the
fiberoptic cable is not fully
inserted into the light box, the
LEDs are 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 the 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, at least one of the
three LED pairs has failed. See
the Troubleshooting Guide for
more details.
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Component/Control Function
5. Fiberoptic Light Pad Assembly
Port - Where the fiberoptic
light pad assembly connects to
the main unit. An LED shutoff
switch inside the port
automatically shuts off the LED
module whenever the
fiberoptic light pad assembly is
disconnected.
6. Air Vents –For proper cooling
it is important to keep the air
vents clear of obstruction.
7. Air Filter – For proper cooling it
is important to keep the air
filter clear of obstruction. See
the maintenance section of
this manual for more details.
8. Power Cord Receptacle
9. Fuse Cover - Houses two
power inlet fuses
10. Mounting Bracket Holes –
Four holes on the bottom of
the main unit are used to
attach the optional mounting
bracket. The mounting bracket
can be positioned on the left or
right side of the light box.