Respironics BiliTx User manual

PROFESSIONAL MANUAL
1044672
HM 3/26/08
*+H9061045220*
REF 1045220

Warranty
© 2007 Respironics, Inc. and its aliates. 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. Specications ............................................................................................................................................ 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 Certication.............................................................................................. 23
Eective 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
Conguration 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
Conguration Contents
Overhead Phototherapy
Conguration 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
Conguration 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 eects (e.g.,•
headache, nausea) if in the irradiated area for a long
period of time. To minimize the eects, use the system
in an area with a lot of light or use glasses with yellow
lenses.
Bilirubin photoisomers may cause toxic eects.•
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 conguration 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 eective.
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 dierent radiation sources, may
adversely aect 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 aect its light
output.
Do not dry the ber optic panel with articial 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 Certication. Conforms to ANSI/UL STD. 2601.
Certied 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 eective.
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.

BiliTx Professional Manual
10
5. Press the Therapy On/O button to turn the Illuminator device
on and begin phototherapy. The Therapy button will illuminate
green.
6. To turn o the device when therapy is complete, press and hold
the Therapy On/O button for 3 seconds.
Setup - Wrap-Around Panel
This section explains how to prepare a baby for a phototherapy
treatment using the wrap-around ber optic light panel.
The ber optic panel must NOT be covered by anything except with
the cover provided. Any other type of cover could cause a reduction
in light intensity. The setup instructions must be followed exactly.
This panel provides full coverage around the baby’s torso. It is most
commonly used on patients at home.
1. Place a disposable or reusable cover onto the panel with the
light emitting side of the panel facing the sheer side of the cover.
2. Place the covered panel under the baby’s torso, positioning it so
it is under the baby’s armpits.
3. Wrap the panel around the baby. Use the tape or hook and loop
tabs to secure the panel around the baby.
Turning on the illuminator
device
Wrap-around panel with
disposable cover
Positioning the ber optic
panel

Chapter 3 Setup
11
4. If the disposable cover becomes soiled, discard it and replace
with a clean one. The cloth cover may be washed with mild soap
and water.
NOTES
For a larger or more active baby, you may want to tape the panel to the baby’s
diaper.
To be sure the panel is not wrapped too tightly, insert your nger between the
panel and the baby’s body. Your nger should t easily.
You may wrap the baby in a blanket or put the baby in a sleeper.
WARNING
If using tape to secure the panel, do not adhere the tape to the baby’s skin.
Setup - Flat Neonatal Panel
This section explains how to prepare a baby for a phototherapy
treatment using the at neonatal ber optic light panel.
The ber optic panel must NOT be covered by anything except with
the disposable cover provided. Any other type of cover could cause a
reduction in light intensity. The setup instructions must be followed
exactly.
This panel is ideal for preemie or underweight infants; it may also be
used on full-term infants.
1. The protective cover for the neonatal panel is a T-vest. Slide the
vertical section of the T, with the light facing the sheer side of the
cover, onto the panel.
Wrapping and securing the
panel
Neonatal panel with t-vest

BiliTx Professional Manual
12
2. Lay the covered panel on a at surface. Be sure the light
emitting side is facing up.
3. Position the baby’s chest or back directly on the panel. The cable
connected to the panel should be between the baby’s legs.
4. Secure the T-vest to the baby by rst wrapping the side without
the tape around the baby’s midsection. Then, wrap the side with
the tape tab over the infant, peel o the protective cover on the
tab, and secure it. Be sure the vest is snug.
5. If the T-vest becomes soiled, discard it and replace it with a new
one.
NOTES
For a larger or more active baby, you may want to tape the panel to the baby’s
diaper.
To be sure the panel is not wrapped too tightly, insert your nger between the
panel and the baby’s body. Your nger should t easily.
You may wrap the baby in a blanket or put the baby in a sleeper.
WARNING
If using tape to secure the panel, do not adhere the tape to the baby’s skin.
Positioning the baby on the
panel
Wrapping and securing the
T-vest

Chapter 3 Setup
13
CAUTION
Do not block any of the air vents
on the Illuminator unit.
Attaching the brace to an IV
pole
Attaching the circuit support
arm to the mounting brace
Attaching the circuit support
adapter to the Illuminator
device
For Use as Overhead Phototherapy
NOTE: Overhead phototherapy is for hospital/institutional use only.
The following section explains how to prepare the unit for overhead
phototherapy treatment. Overhead phototherapy can be used while
the baby is in an incubator or radiant warmer. You will need the
mounting brace accessory kit to set up and position the device.
1. Attach the mounting brace to a standard hospital intravenous
(IV) pole. To attach, place the clamp around the IV pole then
tighten using the screw provided.
2. Connect the circuit support arm to the mounting brace. To
securely attach, turn and lock the circuit support arm into place.
3. Insert the circuit support adapter into the opening on the
Illuminator device with the metal post facing up. Turn the
adapter counter-clockwise to securely lock in place.

BiliTx Professional Manual
14
4. Connect the circuit support adapter to the clamp on the circuit
support arm. Tighten in place by turning the handle on the
clamp.
5. Attach the device power cord to the circuit support arm.
6. Position the device over the baby ensuring that it is no closer
than 6 inches from the baby. The intensity of light can be
adjusted by positioning the light source closer or farther away
from the baby. See the light intensity chart in the Specications
chapter of this manual for the approximate light intensity at
specic distances from the device.
7. Cover the baby’s eyes with the appropriate eye protection. Refer
to the instructions included with your eye protection.
8. Plug the Illuminator device into an electrical outlet. The power
button will ash green.
9. Press the Therapy On/O button to turn the Illuminator device
on. The Therapy button will illuminate green.
10. To turn o the device when therapy is complete, press and hold
the Therapy On/O button for 3 seconds.
Connecting the circuit
support adapter to the
circuit support arm
WARNING
The power cord must be
attached to the circuit support
arm to avoid entanglement.
WARNING
Do NOT position the device
closer than 6 inches from the
baby.
WARNING
Verify that the Illuminator unit is
securely attached to the circuit
support arm and the mounting
brace is securely attached to the
IV pole before placing the baby
under the device.
WARNING
Place the IV pole supporting
the unit so that it will not be
accidentally disturbed during
overhead therapy.
CAUTION
If the power cord or wires need
repair or replacement, do not
connect the device.

Chapter 3 Setup
15
The graphic below shows the complete overhead phototherapy
setup.
Using the In-Use Carrying Case
An optional, in-use carrying case is available for use with the
Illuminator device. The carrying case allows for easy mobility
during phototherapy treatment. To place the carrying case on the
Illuminator device, simply slide it over the device and adjust the
position so that the Start/Stop button is visible. The shoulder strap
should be located at the same end as the power cord. You can adjust
the shoulder strap as necessary using the hook and loop tabs.
Therapy On/O
Button
Shoulder Strap
Overhead phototherapy
complete assembly

BiliTx Professional Manual
16

BiliTx™
professional manual
4. Cleaning and Maintenance
This section explains how to clean, check, and maintain the BiliTx
system.
Cleaning the Illuminator Device and Fiber
Optic Panel
Follow the instructions in this section any time the Illuminator device
or ber optic panel is dirty.
1. Use soapy water, a 10% bleach solution or full strength ammonia.
2. Use a soft sponge or cloth to apply the cleaner.
3. Apply the cleaning solution to the sponge or cloth and wipe
down the ber optic panel and Illuminator.
4. Allow the equipment to air dry. DO NOT DRY WITH ANY MEANS
OF ARTIFICIAL HEAT.
5. Wipe the Illuminator device and panel with a dry cloth.
If the in-use carrying case becomes soiled, it can be wiped with a
damp cloth.
CAUTION
Be sure the Illuminator device
is turned o and is unplugged
before cleaning. Do not immerse
any part of the equipment in
any liquid.
CAUTION
Keep the ber optic panel away
from sharp objects that could
scratch or puncture the cover.
WARNING
When cleaning, DO NOT USE:
• Phenolic compound based
germicide cleaner/disinfectant
• Gluteraldhyde disinfectant/
sterilants
• Regular commercial cleaners or
laundry detergents
• Iodine solutions, strong acids or
strong alkali solutions
These solutions could leave
residue on the surfaces, and /or
be abrasive or harmful to the
infant.

BiliTx Professional Manual
18
Maintenance Schedule
Follow the schedule and instructions below to keep the BiliTx system
properly maintained. The light has a minimum lifetime of 30,000
hours. The number of hours your device has been used can be found
in the window on the bottom of the device.
Before Each Patient Use As Needed
Check light intensity. The Joey Dosimeter should
be used to measure the light intensity. If the
intensity falls below the minimum standard,
contact Respironics Customer Service.
Clean the Illuminator device and
ber optic panel.
Replace the disposable light panel cover or vest.
Inspect the power cord and plug for damage or
fraying.
Verify light does not illuminate when panel is not
inserted or connected to the IV pole.
Customer Service Information
To contact Respironics directly, call the Respironics Customer Service
department at 1-800-345-6443 or 1-724-387-4000.
You can also use the following address:
Respironics
1001 Murry Ridge Lane
Murrysville, Pennsylvania
15668-8550 USA
HELPFUL TIP
Visit Respironics web site at
www.respironics.com.