Respironics BiliTx User Manual
PROFESSIONAL MANUAL
1044672
HM 3/26/08
*+H 9061045220*
REF 1045220
Warranty
© 2007 Respironics, Inc. and its aliates. All rights reserved.
BiliTx™
professional manual
Table of Contents
1. Overview ..................................................................................................................................................... 3
Intended Use ......................................................................................................................................... 3
What is the BiliTx Phototherapy System? .................................................................................... 3
Components of the BiliTx System .................................................................................................. 4
2. Warnings, Cautions, and Symbols ...................................................................................................... 5
Warnings ................................................................................................................................................. 5
Cautions .................................................................................................................................................. 7
Symbols ................................................................................................................................................... 8
3. Setup ........................................................................................................................................................... 9
Checking out the System .................................................................................................................. 9
Setting Up the BiliTx System ............................................................................................................ 9
For Use with a Fiber Optic Panel ............................................................................................ 9
Setup - Wrap-Around Panel .......................................................................................... 10
Setup - Flat Neonatal Panel ........................................................................................... 11
For Use as Overhead Phototherapy ..................................................................................... 13
4. Cleaning and Maintenance .................................................................................................................. 17
Cleaning the Illuminator Device and Fiber Optic Panel......................................................... 17
Maintenance Schedule ...................................................................................................................... 18
Customer Service Information ........................................................................................................ 18
5. Troubleshooting ....................................................................................................................................... 19
6. Specications ............................................................................................................................................ 21
Environmental ...................................................................................................................................... 21
Physical .................................................................................................................................................... 21
Illuminator ..................................................................................................................................... 21
Fiber Optic Panel ......................................................................................................................... 21
Light Source ........................................................................................................................................... 22
Minimum Irradiance Level ................................................................................................................ 22
Wavelength ............................................................................................................................................ 22
BiliTx Professional Manual
2
Overhead Radiometer Certication .............................................................................................. 23
Eective Surface Area (Overhead Phototherapy) ................................................................... 24
Intensity Ratio ....................................................................................................................................... 24
Audible Noise ........................................................................................................................................ 24
Standards Compliance ....................................................................................................................... 25
Electrical Requirements ..................................................................................................................... 25
Disposal ................................................................................................................................................... 25
Appendix A: EMC Information ................................................................................................................. 27
BiliTx Warranty ............................................................................................................................................... 31
BiliTx™
professional manual
1. Overview
This chapter explains how the BiliTx Phototherapy System is used to treat infant jaundice and it lists the
components of the BiliTx system.
Intended Use
The BiliTx is intended to treat hyperbilirubinemia through phototherapy. When used as overhead phototherapy
treatment, the BiliTx is for hospital/institutional use only and when used with the ber optic light panel the BiliTx
is for home or hospital/institutional use.
What is the BiliTx Phototherapy System?
The BiliTx phototherapy system uses blue light emitting diodes (LEDs) to convert bilirubin to waste products
that are mostly excreted through urine and stool, thus reducing the bilirubin level in the baby’s blood.
The BiliTx can be used as a ber optic phototherapy system or as an overhead phototherapy system.
When used as a ber optic phototherapy system, the Illuminator device sends light out of the ber optic cable
to the entire area of the panel. The panel is inserted into a protective cover. This wrap is soft and comfortable
and allows the therapeutic light to be emitted towards the baby. With this use of the BiliTx system, the baby can
be held and fed and enjoy the healing comfort of parents while treatment is administered. Additionally, when
the BiliTx system is properly used with the ber optic panel the baby’s eyes do not need to be protected as with
conventional phototherapy.
When the BiliTx is used as overhead phototherapy, the Illuminator device is connected, using the overhead
therapy kit, to a hospital intravenous (IV) pole and can be positioned over an incubator or radiant warmer.
The unit delivers phototherapy by sending a band of blue light down onto the baby. With this method of
phototherapy, the baby’s eyes must be covered with appropriate eye patches, such as the WeeSpecs® Supreme
phototherapy mask.
BiliTx Professional Manual
4
Components of the BiliTx System
The BiliTx system includes the following components. Some
components are optional accessories that may not be packaged with
your device.
1
2
3
4
1
2
3
4
7
5
6
Fiber Optic Light Panel
Conguration for Home or
Hospital/Institutional Use
1. Illuminator Device with
AC Power Cord
2. Fiber Optic Panel
3. Disposable Cover
4. Illuminator Device
Carrying Case
(optional)
5. System Carrying Case
(optional) (not shown)
6. Tape (not shown)
7. Instruction Manual (not
shown)
Fiber Optic Light Panel
Conguration Contents
Overhead Phototherapy
Conguration for
Hospital/Institutional Use
1. Illuminator Device with
AC Power Cord
2. Mounting Brace
3. Circuit Support Arm
4. Circuit Support Adapter
5. Fiber Optic Panel
6. Disposable Cover
7. Illuminator Device
Carrying Case
(optional)
8. Instruction Manual (not
shown)
Overhead Phototherapy
Conguration Contents
BiliTx™
professional manual
2. Warnings, Cautions, and Symbols
Warnings
Use the Bili • Tx only for its intended use as described in this
manual.
Eye protection is necessary if the Illuminator device will •
be used for overhead phototherapy or if the panel is
illuminated while not attached to the baby. Normal use
of the Illuminator device with the panel in a disposable
cover does not require the use of eye protection.
During overhead therapy, check the eye protection to •
ensure that they remain properly tted.
Ensure that other patients near the phototherapy •
equipment are not exposed to the phototherapy. Patients
adjacent to overhead phototherapy treatment may need
to be protected with eye protection.
Some operators may experience mild eects (e.g., •
headache, nausea) if in the irradiated area for a long
period of time. To minimize the eects, use the system
in an area with a lot of light or use glasses with yellow
lenses.
Bilirubin photoisomers may cause toxic eects. •
Do not leave the Illuminator device on when the ber •
optic panel is not around the baby.
Always turn o and unplug the Illuminator device during •
cleaning or servicing.
WARNING
A warning indicates the
possibility of injury to the user or
operator.
Caution! US federal law restricts this device to sale by or on the order of a
physician.
BiliTx Professional Manual
6
Do not use the Bili
• Tx system in the presence of ammable
substances such as anesthetics, cleaning agents, or gases
that support combustion (e.g. oxygen, nitrous oxide).
Do not use while bathing the baby. •
Do not place or store the Bili • Tx system where it can fall or
be pulled into a tub or sink.
If the Illuminator device falls into water or if uid is spilled •
on the device do not reach for it without rst unplugging
the cord. Discontinue use of the device and contact an
authorized Respironics service center.
Never operate the Illuminator device if it has a damaged •
plug or damaged or frayed power cord or wires. Do not
insert anything into the end of the plug.
Do not use an extension cord. •
Always connect the device to a properly grounded outlet. •
If therapy is interrupted for any reason, resume therapy •
as soon as possible.
Carefully place the panel cable to avoid entanglement. •
Position the Illuminator device on a stable surface, •
preferably lower than the infant. When the BiliTx system
is used with the ber optic panel conguration and
carrying case, the device can hang on the outside of a
crib or treatment area.
Do not place the Illuminator device, power supply, or •
carrying case in an incubator or infant warmer.
Do not place a temperature sensor for the infant warmer •
or incubator under the ber optic panel or in the surface
area of the overhead phototherapy light.
Do not place the Illuminator device, power supply, or •
carrying case in a crib or other treatment area next to the
baby.
Never block the air vents of the unit or place it on a soft •
surface such as a bed, crib, carpeted oor, or couch where
the air vents may be blocked.
Chapter 2 Warnings, Cautions, and Symbols
7
During phototherapy, the the baby’s water balance may •
become disturbed. Before and during phototherapy,
make sure the baby is properly hydrated and that his or
her body temperature is maintained.
After treatment has begun, the baby’s bilirubin level •
should be measured to make sure therapy is eective.
Adjust therapy location and time as necessary to avoid •
degradation of photosensitive drugs and infusion liquids.
Do not store any drugs in the illuminated area.
The ber optic panel must not be covered by anything •
except with the cover provided. Any other type of cover
will cause a reduction in light intensity. The setup
instructions must be followed exactly.
Varying ambient conditions, such as the ambient •
temperature and/or dierent radiation sources, may
adversely aect the patient. Please refer to your
hospital phototherapy policy and procedure regarding
appropriate ambient conditions.
Cautions
Keep the unit away from any heated surface. •
Do not scratch, damage, or soil the ferrule end of the •
panel. Also, do not place sharp or heavy items on the
panel, this can damage the panel and aect its light
output.
Do not dry the ber optic panel with articial heat. •
If the device is dropped, contact your an authorized •
service representative to inspect for proper operation.
CAUTION
A caution indicates the
possibility of damage to the
device.
BiliTx Professional Manual
8
Symbols
The following symbols appear on the BiliTx system.
Symbol Explanation
Therapy On/O
Consult accompanying instructions for use
Type BF applied part
AC Power
European Declaration of Conformity
3141786
Canadian/US Safety Certication. Conforms to ANSI/UL STD. 2601.
Certied to CAN/CSA C22.2 STD. NO. 601.1.
Eye shields required
BiliTx™
professional manual
3. Setup
Checking out the System
Prior to each patient setup, the hospital should check the light
intensity of the unit. The Joey Dosimeter should be used to measure
the light intensity. See the Cleaning and Maintenance section later in
this manual for more information.
Setting Up the BiliTx System
For Use with a Fiber Optic Panel
1. Place the appropriate cover on the panel and position the baby
and panel as described later in this chapter. (See Setup-Wrap
Around Panel or Flat Neonatal Panel.)
2. Place the Illuminator device on a hard, at surface or using
the carrying case, hang the unit on the outside of a crib or the
treatment area, away from any heat source. Make sure it is no
more than four feet from where the baby will be positioned.
3. Insert the metal end of the light panel cable, called the
ferrule, with the metal post facing up, into the opening on the
Illuminator unit. Rotate the ferrule a ¼ turn counter-clockwise
to lock into place. The light will not come on if the panel is not
inserted in the Illuminator device.
4. Plug the Illuminator device into an electrical outlet. The Therapy
On/O button will ash green.
WARNING
After treatment has begun, the
baby’s bilirubin level should be
measured to make sure therapy
is eective.
CAUTION
Do not block any of the air vents
on the Illuminator device.
Connecting the light panel
cable to the illuminator
device
CAUTION
If the power cord or wires need
repair or replacement, do not
connect the unit.
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