Page 1
PROFESSIONAL MANUAL
1044672
HM 3/26/08
*+H 9061045220*
REF 1045220
Page 2
Warranty
© 2007 Respironics, Inc. and its aliates. All rights reserved.
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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
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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
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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.
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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
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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.
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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.
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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.
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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
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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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BiliTx Professional Manual
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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
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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
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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
Page 15
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.
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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 Specications
chapter of this manual for the approximate light intensity at
specic 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.
Page 17
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
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BiliTx Professional Manual
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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.
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BiliTx Professional Manual
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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.
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BiliTx™
professional manual
5. Troubleshooting
The following is a list of problems that may occur while using the BiliTx system. For additional
information, refer to the BiliTx Service Manual or contact Respironics Customer Service at 1-800-345-
6443 or 1-724-387-4000.
WARNING
If therapy is interrupted for one hour or longer, resume therapy as soon as possible.
Problem Reason/Action
Therapy On/O button is not
green
Check to make sure power cord is properly attached and
plugged into an active electrical outlet.
Ensure the device is turned on.
Therapy On/O button is not
ashing green
If the power cord is properly attached and plugged into an
active electric outlet and the Therapy On/O button is not
ashing green, but the device will turn on, continue to use the
device for therapy.
Light is not being emitted from
ber optic panel
Check to make sure panel is securely locked into Illuminator
device.
Yellow LED is ashing Ensure the panel or circuit support adapter is securely locked
into place. If light continues to ash, contact Respironics.
Loss of power or light source
failure
Contact Respironics.
Light is not being emitted from
the illuminator device when
connected to the circuit support
adapter and the yellow LED is
ashing
Check to make sure the Illuminator device is securely attached
to the circuit support adapter accessory.
Device will not turn o when
the Therapy On/O button is
pressed
Press and hold the Therapy On/O button for 3 seconds.
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BiliTx Professional Manual
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BiliTx™
professional manual
6. Specications
Environmental
Storage Operating
Temperature -20 to +50° C 15 to 35° C
Relative Humidity 15-95% Non-condensing 15-95% Non-condensing
Physical
Illuminator
Size: 6.34 in. x 2.92 in. (16.10 cm x 7.40 cm)
Weight: <2.50 lb. (1.13 kg)
Fiber Optic Panel
Model: EG-2000 (Wrap Around Panel)
Overall Pad Size-Standard: 4.00” x 15.00” (10.16 cm x 38.10 cm)
Illuminated Area-Standard: 3.00” x 14.00” (7.62 cm x 35.56 cm)
Model: EG-2000N (Flat Neonatal Panel)
Overall Pad Size-Neonatal: 5.00” x 7.00” (12.70 cm x 17.78 cm)
Illuminated Area-Neonatal: 4.00” x 6.00” (10.16 cm x 15.24 cm)
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Light Source
Minimum Irradiance Level
Standard Panel-Light: 30µW/cm2/nm
Neonatal Panel-Light: 55µW/cm2/nm
Overhead Therapy: When the illuminator is positioned 30 cm (12 inches)
above the neonate: 30 µW/cm2/nm
Wavelength
Blue LEDs: Peak between 460 nm and 480 nm
The graph below shows the total spectral irrandiance of the Illuminator device averaged over a
wavelength range. Also included is a calibration curve of the Joey Dosimeter, which was used to
take the measurements of the light.
0
10
20
30
40
50
60
70
80
90
100
320 330 340 350 360 370 380 390 400 410 420 430 440 450 460 470 480 490 500 510 520 530 540 550
Wavelength (nm)
% Normalized
Response/Intensity
Page 25
Chapter 6 Specications
23
Overhead Spectral Irradiance
Total Irradiance of 94 mW/cm².
Spectral Irradiance
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
320
330
340
350
360
370
380
390
400
410
420
430
440
450
460
470
480
490
500
510
520
530
540
550
Wavelength (nm)
Spectral Irradiance (mW/cm2 nm)
Overhead Radiometer Certication
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BiliTx Professional Manual
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Light Intensity (Overhead Phototherapy)
Distance Irradiance (µW/cm2/nm)
15 cm (6 in) 112
30 cm (12 in) 30
45 cm (18 in) 16
60 cm (24 in) 9
Eective Surface Area (Overhead Phototherapy)
14 cm diameter at a height of 30 cm (12 inches)
14 cm diameter
30 cm
Intensity Ratio
Standard Panel, Neonatal Panel, and Overhead Phototherapy : > .4 (minimum to maximum)
Audible Noise
< 60 dB(A). Measured in accordance with IEC 60601-2-50.
Page 27
Chapter 6 Specications
25
Standards Compliance
This device is designed to conform to the following standards:
IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment •
IEC 60601-2-50 Requirements for the Safety of Infant Phototherapy Equipment •
Electromagnetic Compatibility: EN 60601-1-2, 2nd edition. •
Electrical Requirements
AC Power 100-240 VAC, 50/60 Hz, 1.0 A
Type of Protection Against Electrical Shock Class I Equipment
Degree of Protection Against Electrical
Shock
Type BF Applied Part
Degree of Protection Against Ingress of
Water
Ordinary Protection, IPX0
Mode of Operation Continuous
Disposal
Dispose of this device in accordance with local regulations.
Page 28
BiliTx Professional Manual
26
Page 29
Appendix A: EMC Information
BiliTx™
professional manual
Appendix A: EMC Information
Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions
This device is intended for use in the electromagnetic environment specied below. The user of this
device should make sure it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11
Class B The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/Flicker
emissions
IEC 61000-3-3
Complies
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BiliTx Professional Manual
28
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
This device is intended for use in the electromagnetic environment specied below. The user of this
device should make sure it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance Level Electromagnetic Environment -
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical Fast Transient/
Burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input-output
lines
±2 kV for supply mains
±1 kV for input/output
lines
Mains power quality should be
that of a typical home or hospital
environment.
Surge
IEC 61000-4-5
±1 kV dierential mode
±2 kV common mode
±1 kV dierential mode
±2 kV for common mode
Mains power quality should be
that of a typical home or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% U
T
(>95% dip in UT) for 0.5
cycle
40% U
T
(60% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5
sec
<5% U
T
(>95% dip in UT) for 0.5
cycle
40% U
T
(50% dip in UT) for 5
cycles
70% UT
(30% dip in UT) for 25
cycles
<5% UT
(>95% dip in UT) for 5
sec
Mains power quality should be
that of a typical home or hospital
environment.
Power frequency (50/60
Hz) magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds
should be at levels characteristic of a
typical location in a typical hospital
or home environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Page 31
Appendix A: EMC Information
29
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
This device is intended for use in the electromagnetic environment specied below. The user of this
device should make sure it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
d = 1.2 150 kHz to 80 MHz
d = 1.2 80 MHz to 800 MHz
d = 2.3 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey a,
should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from
structures, objects, and people.
a: Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the
location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device.
b: Over the frequency range 150 kHz to 80 MHz, the eld strengths should be less than 3 V/m.
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BiliTx Professional Manual
30
Recommended Separation Distances between Portable and Mobile
RF Communications Equipment and this Device
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and this device as recommended below, according to
the maximum output power of the communications equipment.
Rated Maximum Power
Output of Transmitter
(W)
Separation Distance According to Frequency of Transmitter
(m)
150 kHz to 80 MHz
d = 1.2
80 MHz to 800 MHz
d = 1.2
800 MHz to 2.5 GHz
d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from
structures, objects, and people.
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31
BiliTx Warranty
Respironics, Inc. warrants your BiliTx Phototherapy System against defects in material and
workmanship of the Illuminator device and the ber optic panels, EG-2000 and EG-2000N, for a
period of one (1) year from the date of purchase. In addition, Respironics warrants the LED light
engine for 20,000 hours. This warranty does not cover any damage to the illuminating device
or the ber optic panel caused by accident, misuse, tampering, or negligence such as failure to
follow the instructions provided in this guide. In the event your phototherapy illumination unit
fails to give satisfactory performance within the warranty period and conditions, Respironics,
Inc. will repair or replace your illuminating device at no charge for parts or labor. The foregoing
warranties are in lieu of all other warranties expressed or implied, including without limitation
any implied warranty of merchantability or tness for a particular purpose.
BiliTx™
professional manual
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32
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