USER INSTRUCTION MANUAL

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Manufactured by: Respironics • 1001 Murry Ridge Lane • Murrysville, PA 15668

USA 1-800-345-6443 • Outside USA +1-724-387-4000
Respironics Deutschland +49 8152 93060
www.respironics.com

Copyright: © 2003 Respironics, Inc. All Rights Reserved.

KleenaSeptic and Cavicide are registered trademarks of Metrex Research Corporation.
Vitros BuBc Slides is a registered trademark of Johnson and Johnson.
NOTE: Due to continual product innovation, specifications in this manual are subject to change.
For questions, please contact Respironics or your local dealer.

Printed in USA US Patents 5,353,790 5,792,049 5,860,421 5,924,981, 6,002,482, 6,226,541, 6,192,734, 6,045,502 and Patents Pending
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 PREFACE

About This Manual

This User Instruction Manual has been prepared by Respironics, Inc. for both first-time and experienced users of the

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BiliChek® System. This manual provides basic instructions for use and troubleshooting procedures. To ensure safe
operation of this product the user should read the entire instruction manual before operating the device. Save this manual
for future reference.

CE NOTICE
Marking by the indicates compliance of this BiliChek System, manufactured by Respironics, Inc. to the Medical
Device Directive 93/42/EEC of 14 June 1993.

TABLE OF CONTENTS

1.0 Warranty, and Return Policy Information .................................................................................................................... 2

2.0 Notational Descriptions ................................................................................................................................................ 2
2.1 Symbols ................................................................................................................................................................. 3
3.0 Introduction .................................................................................................................................................................. 4
4.0 Purpose of the Device .................................................................................................................................................. 4
5.0 Theory of Operation .................................................................................................................................................. 4-6
6.0 Warnings and Cautions ................................................................................................................................................ 7
7.0 Description of the BiliChek® System ......................................................................................................................... 8
8.0 Specifications ............................................................................................................................................................... 9
9.0 Functional Components ............................................................................................................................................. 10
9.1 BiliChek Hand-Held Unit (HHU) ....................................................................................................................... 10
9.2 Charger Base ....................................................................................................................................................... 11
10.0 Initial Set-up ............................................................................................................................................................... 12
11.0 Set-up Mode ............................................................................................................................................................... 13
12.0 Instructions for Use .................................................................................................................................................... 17
12.1 Completing a Patient Test -- Performing the Calibration ................................................................................. 17
12.2 Completing a Patient Test -- Performing the Patient Test ................................................................................ 18
12.3 User Recommendations for Use During and After Phototherapy ..................................................................... 19
13.0 Troubleshooting Guide .............................................................................................................................................. 21
14.0 Cleaning and Maintenance ......................................................................................................................................... 22
15.0 Attaching the Charger Base to a Wall ........................................................................................................................ 23

1
 1.0 WARRANTY AND RETURN POLICY INFORMATION

Respironics, Inc. warrants the BiliChek® (“unit”) to be free from defects in materials and workmanship for a period of one
(1) year from the date of shipment to the user or 18 months from the date of shipment by Respironics, Inc., whichever comes
first. If the product fails to perform in accordance with the product specifications, Respironics, Inc. will repair or replace, at
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its option, the defective material or part. Respironics, Inc. will pay customary freight charges from Respironics, Inc. to the
dealer location only. This warranty does not cover damage caused by accident, misuse, abuse, alteration and other defects
not related to material or workmanship. To exercise your rights under this warranty, contact your local, authorized
Respironics, Inc. dealer or Respironics.

2.0 NOTATIONAL DESCRIPTIONS

Throughout this manual, there are blocks of text in bold or italic type. These blocks are warnings, cautions, notes, and
technique tips and they are used as follows:

WARNING: A WARNING indicates the possibility for injury to the user or operator.

CAUTION: A CAUTION indicates the possibility of damage to the device.

NOTE: A NOTE provides important general information that will help you make better use of your
product.

TECHNIQUE TIP: A Technique Tip indicates important specific information that will help you make
better use of your product.

2
 2.1 SYMBOLS

• Symbol for “Attention, • Symbol for “Battery Deep Discharge

See Instructions For Use” and Recharge”

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•• Symbol
Symbol for
for “Use
“UsedWith”
With” • Symbol for “Battery Charging”

• Symbol for “Do Not Reuse” • Symbol for “Rechargeable Battery

Recycle Corporation”

• Symbol for “Use By”

• Symbol for “Do Not Throw in Trash”

• Symbol for “Batch Code”

• Symbol for “Nickel Cadmium Battery”

• Symbol for “Recycle”

• Symbol for “Storage Conditions”

• Symbol for “Serial Number”

• Symbol for “Date of Manufacture”

• Symbol for “Catalog Number”

•• Symbol
Symbol for
for “Indoor
“Indoor Use”
Use”

• Denotes this system is ETL Listed mbol for “Class B”

and conforms to ANSI/UL STD.
2601. Certified to CAN/CSA C22.2 • Symbol for “Class B”
STD. NO. 601.1.

3
 3.0 INTRODUCTION

Jaundice is a condition characterized by yellowing of the skin and eyes that is caused by an excess of bilirubin in the
blood. Bilirubin is a normal waste product resulting from the breakdown of red blood cells and is removed from the
body by the liver. Prior to birth, bilirubin in an infant is processed by the mother’s liver and excreted. After birth, an
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infant must eliminate bilirubin without the mother’s help. It may take the infant’s system several days to begin
eliminating bilirubin from the blood faster than it is produced. Infants who are born prematurely, who are underfed, or
who belong to certain ethnic groups are at increased risk of developing jaundice. The initial screening of jaundice is
the observation of yellow skin. This is a subjective determination prone to errors due to differing skin colors and
gestational ages. Bilirubin levels normally peak in full-term infants 4 to 5 days after birth and may peak later in
premature infants. If the infant’s serum bilirubin levels continue to rise the infant is at risk for kernicterus (the deposit
of bilirubin in the brain at toxic levels which can cause permanent neurologic impairment).

4.0 PURPOSE OF THE DEVICE

The BiliChek® Non-Invasive Bilirubin Analyzer is a non-invasive transcutaneous bilirubinometer, which predicts total
serum bilirubin levels before, during, and post phototherapy in neonates without regard to gender, gestational age, race,
or bodyweight. Neonates whose BiliChek test results are indicative of hyperbilirubinemia must be evaluated by their
physician(s) for appropriate patient management. The BiliChek provides a numerical measurement of predicted
bilirubin count in mg/dL or µmol/L within a clinically beneficial range that has been correlated with total serum
bilirubin concentration measured by High Pressure Liquid Chromotography (HPLC). The device is used by Health
Care Professionals to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia.

5.0 THEORY OF OPERATION

The BiliChek works by directing white light into the skin of the newborn and measuring the intensity of the specific
wavelengths that are returned. By knowing the spectral properties of the components within the skin, one can subtract
out the interfering components and determine the concentration of bilirubin.

Each photon has a characteristic wavelength. As light enters skin tissue it can collide with the structural components
such as collagen fibers. When a collision occurs, the photon loses energy and the direction of travel is changed. This
is called a scattering event. If enough of these scattering events occur, the photon completely loses its energy and is
absorbed. If a photon is scattered such that it is re-emitted from the skin, it is reflected.

Photons with longer wavelengths (in the red region of the spectrum) are scattered less than photons with shorter
wavelengths (in the blue region of the spectrum). This phenomenon is called wavelength-dependent scattering and
explains why the skin appears red when you shine a bright light through it. It is also one of the reasons why the
optical properties of the newborn’s skin changes with advancing gestational and post-natal age. As the skin matures,
it becomes thicker and there is greater keratinization of the cell membranes which increases the scattering of
incident light.

Photons of specific wavelengths are also preferentially absorbed by certain molecules. By plotting the absorption
against the wavelength one can visualize characteristic absorption spectra of the particular molecules. For example,
melanin has a near-linear absorption spectrum in the visible spectrum and, like the scattering phenomenon, there is
greater absorption of photons with shorter wavelengths than in the red region of the spectrum. Conversely,
hemoglobin is a much more complicated absorber which is compounded by the fact that oxyhemoglobin and
deoxyhemoglobin have different profiles. The peak absorption of photons by bilirubin occurs at a wavelength of
460nm. This is in the blue portion of the spectrum and is the reason why blue lights are sometimes preferred for
phototherapy. It is also in a region of the spectrum at which hemoglobin absorption is relatively low.

4
The light reflected from the skin of neonates and collected by the BiliChek is analyzed with a highly sophisticated,
proprietary algorithm to generate a serum bilirubin measurement. The major skin components (figure 1) which impact
the spectral reflectance in newborns are (1) dermal maturity, (2) melanin, (3) hemoglobin, and (4) bilirubin. The
intensity of the reflected light is converted to absorbance units, Optical Density (OD), for analysis. The total OD at
each measured wavelength is equal to the sum of the component ODs. This is represented mathematically as:

OD = OD + OD + OD + OD

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total derm mel heme bili

By utilizing known spectral characteristics of each component, the contribution to the total OD can be sequentially
subtracted until bilirubin is all that is remaining.

1
Non-Invasive Skin Spectral Components

FIGURE 1
1
Non-Invasive Skin Spectral Components
1
Jacques, S., Saidi, I., Ladner, A., and D. Oelberg. Developing an optical fiber reflectance spectrometer to monitor bilirubinemia in neonates.

Each of these components have also been considered in the development of the algorithm by which the BiliChek
computes the bilirubin measurement. By measuring the intensity of the reflected light at more than 100 individual
wavelength bands across the visible spectrum, a spectral analysis can be performed. By normalizing against a
reference standard, the BiliCal™, the variations over time of the bulb and the photo-detectors are eliminated. The peak
absorption of the bilirubin at approximately 460nm is measured by subtracting the absorption of the other components
from the total skin absorption. This is represented by the equation below.

OD = OD - OD - OD - OD
bili total mel heme derm

The absorption of light by a molecule is proportional to its concentration. Therefore, the absorption of bilirubin, as
calculated above, is proportional to the concentration of bilirubin in the subcutaneous capillary beds and subcutaneous
tissue. By subtracting the contribution of the aforementioned components, the bilirubin absorbance can be quantified and
is correlated to the laboratory total serum bilirubin levels.
1
SPIE Proceedings 2975, Laser-Tissue Interactions, San Jose, CA Feb. 1997. 1-7.

5
 Protecting a Measurement Site
Exposure of a neonate to phototherapy creates changes in the skin due to the therapuetic affects of phototherapy lights.
If a small portion of the newborn skin is protected from the therapeutic affects of phototherapy lights, the relationship
between the skin bilirubin in the protected skin site and blood bilirubin is likely to be maintained. The accuracy of the
BiliChek® transcutaneous bilirubin measurement taken from a protected site during and after phototherapy has been
determined in a controlled clinical study. The recommendations in the User Instructions are based on the results of this
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study.

Without Phototherapy With Phototherapy

Skin Skin
Bilirubin Bilirubin Bilirubin
Photo-Products

Blood Blood
Bilirubin Bilirubin Photo-Products Bilirubin

6
 6.0 WARNINGS AND CAUTIONS

CAUTION: US federal law restricts this device to sale by or on the order of a physician.

WARNINGS

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• The BiliChek® Hand-Held Unit is to be operated only in conjunction with Respironics approved charger base, battery
packs, power supply, and BiliCalTM Individual Calibration Tips.
• Do not point at eyes while taking a measurement.
• Do not use on areas of the skin with visible bruising.
• If you suspect BiliChek is interfering with other electronic devices or vice versa, try the following measures to
correct it:
• Relocate the device until the interference stops.
• Move the BiliChek farther away from the device.
• Plug the BiliChek Power Supply into a different power outlet so that the BiliChek Power Supply and the
device are on different breaker or fuse circuits.
• Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Do not puncture or incinerate the battery pack or dispose of in a landfill. Batteries should be disposed of properly
according to local guidelines.
• Do not use outdoors or place in direct sunlight.
• The charger base unit (battery charger) should be plugged into a properly grounded outlet. Do not operate with
damaged plug or cord.

CAUTIONS

• The BiliCal Individual Calibration Tip should not be exposed to light for extended periods of time. Keep the
BiliCal in its package prior to use.
• If the product is dropped and frequent error messages occur, it should be inspected for proper operation by an
authorized service representative.
• Do not immerse in water or other liquid.
• Do not let power cord hang over edge of counter or table as this may pose a tripping hazard.

CONTRAINDICATIONS

• The BiliChek should not be used on patients who have undergone an exchange transfusion.
• Avoid using measurement sites with the following conditions since they can produce erroneous results:
• Brusing
• Birthmarks
• Hematomas
• Excessive Hairiness

NOTES
Certain medical conditions and medications are known to disrupt bilirubin-albumin carrying capacity and binding.
These factors may alter the transcutaneous bilirubin measurement by increasing or decreasing the bilirubin deposition
in the skin especially at high total serum bilirubin concentrations (>15 mg/dL or 255 µmol/L). Therefore, additional
caution should be used in interpreting the BiliChek measurement in patients with serious illnesses or complications
such as septicemia, PDA, IVH, and RDS. In these patients, a separate serum bilirubin measurement should be
considered if the BiliChek indicates elevated bilirubin levels.

There is limited data on use of the BiliChek on patients under intensive phototherapy (>30 µW/cm2/nm or 1.5 m
Wcm2), double-sided phototherapy, or after exchange transfusions. Caution should be used in interpreting BiliChek
results under these conditions.

7
 7.0 DESCRIPTION OF THE BiliChek® System

The BiliChek System consists of a hand-held unit called the BiliChek (REF B800-13 ). The BiliChek System
(Part # B800/B801) also includes the following items:
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Quantity Description REF Number

2 Battery Packs B800-20
1 Charger Base B800-21
1 BiliChek Power Supply - North America B800-16
or
1 BiliChek Power Supply - International B800-17
1 Bag of 10 BilEclipse™ Phototherapy Protective Patches B800-12
1 Bag of 10 BiliCal™ Disposable Calibration Tips B800-10
1 User Instruction Manual - North America B800-19
or
1 User Instruction Manual - International B800-23/B800-24
Optional Table Top Power Supply (100V/250V) 47/63 Hz B800-18

WARNING: The BiliChek Hand-Held Unit is to be used only with these and approved
replacement parts and accessories.

The BiliChek System - North America

Bag of 10
10
BiliCal Disposable Calibration Tips
BiliCal ™
BiliChek Disposable Calibration Tip
Reorder Number: B800-10

Patent No. 5,792,049 5,860,421

5,924,981 6,002,482 6,226,541
and Patents Pending

2 60°C

-40°C

Bag of 10

The BiliChek System - International

Bag of 10

10

BiliCal ™
BiliChek Disposable Calibration Tip
Reorder Number: B800-10

Patent No. 5,792,049 5,860,421

5,924,981 6,002,482 6,226,541

Bag of 10
and Patents Pending

2 60°C

-40°C

BiliCal Disposable Calibration Tips

8
 8.0 SPECIFICATIONS

BiliChek® System

• Total weight ............................................................................................................................................................... 974 g

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BiliChek Hand-Held Unit

• Weight (with battery pack) ......................................................................................................................................... 346 g

• Dimensions ........................................................................................................................................ Refer to figure below

Battery Packs

• Type ........................................................................................................................................................................... Ni-Cd

• Dimensions
• Height ............................................................................................................................................................. 6.5 cm
• Depth .............................................................................................................................................................. 4.8 cm
• Width .............................................................................................................................................................. 3.5 cm
• Weight .............................................................................................................................................................. 147 g
• Voltage ............................................................................................................................................................................. 6V
• Capacity ............................................................................................................................................................ 700 mA Hrs
• Measurements per full charge ................................................................. Minimum 100 measurements on a single charge
• Life span .................................................................................................................................................... Minimum 1 year
• Recharge cycle ..................................................................................................................................... 4.6 hours maximum
• Discharge and recharge cycle .............................................................................................................. 9.2 hours maximum

Charger Base

• Dimensions
• Height ............................................................................................................................................................. 7.6 cm
• Depth ............................................................................................................................................................ 12.1 cm
• Width ............................................................................................................................................................ 12.4 cm
• Weight ......................................................................................................................................................................... 264 g

Light Bulb

• Type ....................................................................................................................................................................... Tungsten

• Bulb life ............................................................................................................................ Minimum 30,000 measurements

9
 Power Supply

• Input .................................................................................................................................................... 100-250 V, 47-63 Hz

• Output ................................................................................................................................................... 12 VDC, 2.75 Amp
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Environmental Conditions for Use

BiliChek System and BiliCal™ Individual Calibration Tip may be stored at -40°C to 60°C (-40°F to 140°F) with
noncondensing relative humidity of 95% for a duration of at least 24 hours.

BiliChek System and BiliCal Individual Calibration Tip are intended to operate between temperatures of 5°C to 40°C
(41°F to 104°F) with 0% to 85% relative humidity without condensation.

9.0 FUNCTIONAL COMPONENTS

9.1 BiliChek® Hand-Held Unit (HHU)

The BiliChek Hand-Held Unit consists of the following functional components:

1. TRIGGER button -- The single button on the bottom of the unit is called the TRIGGER. It is used to initiate
calibration and patient measurement.

2. FUNCTION buttons -- The two buttons on the top side are FUNCTION buttons. The teal button on
the left is referred to as F1, and the gray button on the right as F2. These are used to initiate
non-routine functions such as set-up, changing time and date etc.

3. BiliCal Individual Calibration Tip -- This tip serves five purposes:

a) device calibration before each patient measurement,
b) protection of the fiber-optic probe,
c) protection of the surface of the calibration material,
d) positioning aid to ensure proper placement of the probe,
e) a clean surface for each patient measurement.

4 Display window -- The display window shows the bilirubin measurement, time and date, audio and
battery icons, Measurement Status Indicator (MSI) as well as other system and error messages.

5. Battery pack -- Located in the bottom portion of the handle, it provides the electrical energy to
operate the various components.

BiliChek Hand-Held Unit

(teal)

10
 9.2 Charger Base

The charger base contains two wells, A and B, which recharge the battery pack in the BiliChek® and a spare battery pack,
respectively. The two small lights on the front of the charger base (Battery Status Indicators or BSI) indicate the operation
of the battery charger and battery charge status.

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THE CHARGER BASE
• The BiliChek is placed in the left hand well “A” with the display window facing the operator.

• The spare battery pack is placed in the right hand well “B” with the latch up and facing the operator.

CAUTION: The BiliChek unit will not fit in well “B” of the charger base. The battery pack
can fit into well “A”, but may not make correct connection to the charger base.

• In order to maintain optimal battery performance and battery life, the battery packs should periodically be fully
drained of power. The charger base has the ability to manually drain the battery by using the “Charge/Deep
Discharge” switch located on the bottom of the charger base. It is recommended by the manufacturer to discharge
each battery pack every month. To drain a battery pack of power, place the Deep Discharge switch in the
“right” ( ) position and place the BiliChek battery pack in well B of the charger base. The discharge/recharge
cycle will take approximately 4.6 to 9.2 hours depending on the amount of charge in the battery pack. The green
light will illuminate when the battery pack has completely discharged and recharged. After both battery packs have
been discharged and recharged, place the Deep Discharge switch in the “left” position ( ).

NOTE: Only the battery pack in Well B will be deep discharged and recharged.

CAUTION: Leaving the Deep Discharge switch in the “right” position at all times will drain
the battery pack before every recharge. This will increase the duration of the
recharging cycle and may reduce the overall life of the battery packs.

NOTE: If a battery pack is moved or bumped during the deep discharge cycle this may cause the deep
discharge cycle to begin again.

The BiliChek System BiliCal

Individual
Calibration Tip

11
 THE BATTERY STATUS INDICATOR (BSI)

BSI Color Battery Charger Mode Solution

Off Battery pack not sensed in well or Place battery pack in well and/or check all power
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charger base not connected to connections.

power supply.

Green Battery pack fully charged. Battery pack ready for use.

Amber Battery pack in well is charging, Continue charging until green light appears.
but not ready.

Amber flashing Battery pack in well B is deep Continue charging until green light appears.
discharging.

Red flashing Bad battery pack or charger base. Replace battery pack in charger base. If problem
persists with new battery pack, charger base has
malfunctioned. Call for service.

NOTE: When Deep Discharging the battery pack, the BSI will blink amber then become a constant
amber color when charging.

NOTE: If the BSI is flashing red when battery pack is in place, try resetting the battery pack in the
charging well. If problem persists, set a new battery pack in charger base. If problem
continues with a new battery pack, the charger base has malfunctioned.

10.0 INITIAL SET-UP

• Visually inspect that all components are without physical damage. If damage is noted, please contact your local
dealer/distributor or Respironics.

• Plug the power cord into the power supply and then into a grounded outlet.

• Connect the power supply to the charger base by inserting the plug into the socket on the rear of the charger base. The
Battery Status Indicator (BSI) lights will flash red, green, amber, and then off (approximately 1 second each) to
indicate proper operation.

Charger Base

12
INSERTION AND REMOVAL OF BATTERY PACKS

• To install the battery pack, insert the bottom of the battery pack into the bottom of the BiliChek® then rotate
battery and snap into place.

• To remove the battery pack press the release latch at the top of the battery pack and rotate out of the

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BiliChek.

BiliChek Hand-Held Unit

Install and Remove
Battery Pack

Before initial use, both battery packs should be fully charged. After installing one of the battery packs into the
BiliChek, insert the BiliChek into the charger base well “A” as shown in section 10.2 of this manual. The indicator
light will glow amber to indicate that the battery pack is being charged (consult the troubleshooting section of this
manual if the indicator light is flashing red or is not illuminated). Now insert the auxiliary battery pack into well “B” as
shown in section 10.2 of this manual. The BSI will glow amber to indicate that it is charging. Charge battery packs
fully until green light is displayed on the BSI (refer to section 10.2 of this manual).

WARNING: The battery pack is designed to work only with the BiliChek. Do not attempt to
use the battery pack with other products.

WARNING: Do not puncture or incinerate the battery or dispose of in a landfill. The battery
pack should be disposed of properly according to local guidelines.

11.0 SET-UP MODE

Before you use the BiliChek® for the first time, you must review or change certain factory settings. You can also use
these procedures to change any of the settings at a later time. The following is a list of features that can be customized to
your specific institution:

• Audio On/Off
• Measurement Units (mg/dL or µmol/L)
• Automatic Power Off Time Interval (60 or 120 seconds)
• Time Format (12H or 24H)
• Time
• Date format (MO/DA or DA/MO)
• Date

13
 BiliChek Display Window
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TO TURN THE UNIT ON

• Install a charged battery pack into the battery compartment. Ensure the battery pack is all the way in and securely
latched.
• Press and release either F1 or F2.
• The unit will perform a self test, momentarily displaying all LCD indicators, Measurement Status Indicator, software
revision, current configuration screen and end at the home screen displaying the last measurement, time and date, or
error code message (consult troubleshooting section of this manual if error code E00 is displayed).

NOTE: The BiliChek Hand-Held Unit does not have an off switch. The BiliChek will automatically
turn off if it is idle for a specified period of time.

BiliChek Hand-Held Unit

F2 Button (gray)

Display Window Battery Pack

MSI F1 Button (teal)

TO ACCESS THE USER SET-UP FUNCTION

• Press F1 and F2 at the same time, hold for one second, and then release. This places the unit in the Set-up Mode.
• While in this mode, the F1 button (teal) advances to the next item. The F2 key (gray) changes the value of the .........
current item.

NOTE: To exit this mode at any time press and release F1 and F2 at the same time. All information
that you have entered up to that point will be saved and displayed.

AUDIO ON/OFF
The audio Set-up, indicated by the speaker icon on the display, allows you to determine whether you want the system to
provide sound (beeps) during operation.

NOTE: ON is the default setting.

• Press and release F2 to toggle the speaker on and off.

• Press and release F1 to accept your choice and advance to the next Set-up function.

14
SETTING THE MEASUREMENT UNITS
The system allows you to select the units in which the measurement will be displayed. The display will say SET and
either mg/dL or µmol/L will be displayed.

NOTE: The default value is mg/dL.

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• Press and release F2 to toggle between mg/dL and µmol/L.
• Press and release F1 to accept your choice and advance to the next Set-up function.

AUTOMATIC POWER-OFF TIME INTERVAL

To conserve battery power, the unit has an automatic time-out feature. This means that the system will automatically turn
off if it is idle for a specified period of time. Pressing F1 or F2 will restart the unit after it has powered off.

NOTE: The default is 120 seconds.

• Press and release F2 to toggle between the options 60 and 120 seconds.
• Press and release F1 to accept your choice and advance to the next Set-up
function.

NOTE: This unit is equipped with a Critical Power-Off feature. After completing the calibration, the
unit will sound an alarm if no measurement is performed within a set period of time. The unit
will power-off 20 seconds later if F1 or F2 is not pressed. If the unit automatically shuts off, it is
necessary to perform another calibration after restarting.

SELECTING THE TIME FORMAT

You can specify the time display format -- in the 12 hour clock format or the 24 hour clock format.

NOTE: The 12 hour format is the default setting.

• Press and release F2 to toggle between 12H and 24H format.

• Press and release F1 to accept your choice and advance to setting the time.

15
 SETTING THE TIME
After choosing the time format, SET appears on the display and the current clock time will be shown.
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• The hour digit will flash.

• Press and release F2 to scroll through the hours.
• Press and release F1 when the hour you want is displayed. The minute digits will now flash.
• Press and release F1 to select what is displayed, or
• Press and release F2 to scroll through the minutes.
• Press and release F1 to accept your choice and advance to setting the date format.

SELECTING THE DATE FORMAT

You can choose to display the date in the month/day format or in day/month format.

NOTE: The month/day format is the default setting.

• Press and release F2 to toggle between MO/DA and DA/MO format.

• Press and release F1 to accept your choice and advance to setting the date.

SETTING THE DATE

Depending on the date format you selected, the current month or day will flash first.

• The month (day) will flash.

• Press and release F2 to scroll through the months (days).
• Press and release F1 when the correct month (day) is displayed. The day (month) digit will now flash.
• Press and release F1 to select the displayed value, or
• Press and release F2 to scroll through the days (months).
• Press and release F1 to accept your choice.
• Press and release F1 to select the displayed year.
• Press and release F2 scroll through the year.
• Press and release F1 to accept your choice. The next digit will flash.
• Press and release F1 to accept your choice.
• Continue this sequence until all digits have been entered.
• Press and release F1 to accept your choice.
• Continue this sequence until all digits have been entered.

When you have accepted the desired date, your changes will automatically be saved and the unit will return to the
home screen.

16
12.0 INSTRUCTIONS FOR USE

12.1 Completing a Patient Test -- Performing the Calibration

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TO TURN THE UNIT ON
Individual Tip Placement
• If there is no battery pack, insert a charged battery pack into the
battery compartment.
• Apply a new BiliCal™ Individual Calibration Tip to the unit.
• Firmly press the BiliCal Tip on to the BiliChek® Hand-Held Unit to ensure
proper seating of the Tip.
• Press and release either F1 or F2.
• The unit will perform a self-test, momentarily displaying all LCD indicators,
Measurement Status Indicator, software revision, configuration screen and end at
the home screen.

NOTE: Press and hold F1 to illuminate the back light of the display window. This option is not
available in the Set-up Mode.

NOTE: The home screen will remain until the TRIGGER button is pressed or the user Set-up Mode is
entered.

CALIBRATION
• Press and release the TRIGGER button to start calibration.
• Three dashes (---) will flash in the display window and the MSI will be amber if
a BiliCal Tip is in place, indicating the system is ready to calibrate. If a
BiliCal Tip is not in place the MSI will be red. Attach a BiliCal Tip before
continuing.
• Press and release the TRIGGER button. The dashed lines will stop
flashing indicating that the system is calibrating.
• When calibration is complete the MSI will be amber, you will hear a beep (if the
audio is on), and the display window will read “005”.

NOTE: If a problem occurs during calibration an error message will be displayed. Refer to the
Troubleshooting Section of the manual for instruction.

NOTE: To exit during calibration or measurement, press F1 and F2 to return to the home screen.
The user will then need to repeat the procedure.

NOTE: This unit is equipped with a Critical Power-Off feature. After completing the calibration, the
unit will sound an alarm if no measurement is performed within a preset period of time. The
unit will power-off 20 seconds later if F1 or F2 is not pressed. If the unit automatically shuts
off, it is necessary to perform another calibration after restarting.

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 12.2 Completing a Patient Test -- Performing the Patient Test

TAKING A MEASUREMENT
• After performing the calibration, pull on the BiliCal™ tab and peel away the protective
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covering and calibration material from the BiliCal Individual Calibration Tip and
dispose. The display should be blinking “005” indicating that 5 measurements need to be
made.
• Press and release the TRIGGER button. The unit is now activated and ready to
take a measurement. Gently press the BiliCal Tip against the infant’s forehead. The
Measurement Status Indicator (MSI) on the display will change from amber to green
when proper pressure is applied. Do not continue to increase pressure, this will result in
YES NO an E04 error message.
Skin • The display will read “005” and will stop blinking when proper pressure has been
applied. The measurement should take less than 2 seconds. At the end of the
measurement, a beep will sound (if audio is on) and the display will change to “004”.
Place Disposable Tip
flat on forehead • Lift the BiliCal Tip off the center of the infant’s forehead between each
measurement. Press and release the trigger button before reapplying the BiliCal Tip on
the infant’s forehead for each measurement. The current measurement being taken will
be indicated on the display (005...003...001) and the unit will beep one time (if the audio
is on) for each measurement successfully completed.
• Upon completion of the five measurements, a beep sounds (if the audio is on) and the
test results are displayed with the current time and date.
• Remove and dispose of the BiliCal Individual Calibration Tip.
• Place the Protective Cover onto the BiliChek per manufacturer’s recommendation. (If
the protective cap is lost a BiliCal may be used to protect the fiberoptic probe.)
• The Hand-Held Unit will turn off automatically.

TECHNIQUE TIP:
To assist the user with applying proper pressure while performing a patient measurement, a Measurement Status Indicator
(MSI) has been included in the display. The following are the MSI color coding indicators:
• The MSI will be red until the user applies a BiliCal Individual Calibration Tip or during an error message.
• The MSI is amber when the user performs a calibration.
• The MSI is amber when the user begins a measurement.
• The MSI turns green when proper pressure is applied during a patient measurement.
• The MSI will return to amber if excessive pressure is applied.
• If during a measurement the user moves out of the “pressure zone” the MSI turns red and an E04 error is
displayed. Press and release F1 and F2 at the same time to retake the measurement. All previous successful
measurements are saved.

TECHNIQUE TIP:
Be sure to hold the BiliCal Individual Calibration Tip flat against the patient’s forehead and in place until the test is complete.
By visualizing the skin pressed flat all around the clear ring, the user can ensure the Disposable Tip is flat against the skin
surface. Once proper pressure is applied, the display will stop blinking and the MSI will turn green. If the BiliChek is moving
during a measurement, the error code E04 is displayed.

NOTE: A single tone indicates a successful reading (if the audio is on). A double tone indicates that the
reading was not successful, and an error code is displayed.

NOTE: If an error code is displayed, you do not need to calibrate the unit again. After an error is
displayed, press and release F1 and F2 at the same time to return to the previous measurement
screen. Reapply the tip to the baby’s forehead and take another measurement.

WARNING: It is critical to calibrate the unit and apply a new BiliCal Individual Calibration Tip immediately
prior to performing a test. Inaccurate test results will occur if this is not done. Removal of the tip after calibration
and prior to a patient measurement will result in loss of calibration. The entire calibration sequence must be
repeated with a new BiliCal Tip.

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 12.3 User Recommendations for Use During and After Phototherapy

During Phototherapy
• Select the site at which the BiliChek® measurement will be taken. The preferred site is the flat area of the
forehead between the infant’s eyebrows.

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1
• A photo-opaque material (such as BilEclipse™ Phototherapy Protective Patch or adhesive skin patches) must be
positioned over the measurement site on the forehead prior to the start of phototherapy. Any necessary
precautions should be taken to ensure that the material does not move in such a way as to expose the measurement
site to the phototherapy lights.
• All phototherapy lights should be turned off while a BiliChek measurement is taken. Ensure that the preferred
measurement site is still covered. Open the BilEclipse protective patch light blocking material and take the
BiliChek measurement from the preferred site. Close the BilEclipse flap and continue the phototherapy or remove
the BilEclipse and discontinue the phototherapy as indicated. (You may choose to leave the BilEclipse in place
after phototherapy is discontinued to identify the correct measurement site for future measurements.)

NOTE: Studies on the repeatability of the BiliChek measurement have established precision specifications (see
the Clinical Indications For Use for details). The source of variation in the measurement is the
heterogeneous nature of skin and the bilirubin deposition. Small changes in successive transcutaneous
bilirubin measurement of less than 2.0 mg/dL or 34 µmol/L (increases or decreases) should not be
interpreted as definite trends.

Respironics recommends the use of the BilEclipse Phototherapy Protective Patch for all forms of phototherapy use.
Some degree of light blocking can be provided with the other methods listed below.

BilEclipse
1. Always clean the skin site before you place the BilEclipse on the infant.
Respironics makes no recommendations on the type of cleaning agent that is used.
Any liquids, lotions, or creams will reduce the adhesiveness of the patch and
increase the likelihood that it will fall off during phototherapy.
2. When you lift the LID of the patch to take a measurement, it may be helpful to place
your finger on the edge of the BASE in order to make sure that the entire patch is
not pulled off of the infant’s skin.
3. When you close the LID, make sure that it is in good contact with the BASE around
the entire patch. Although it is unlikely that light will penetrate the sides, any light
that does reach the skin could affect the BiliChek measurement.
4. After phototherapy has been completed, it is recommended that the BilEclipse be left on the skin until no
future BiliChek measurements are likely to be made. Although no further changes in the skin will occur after
the phototherapy lights are turned off, leaving the patch in place will ensure that future measurements are
made from the same, protected location.

Eye Patches:
Take precautions to ensure that the eye patches cover a large portion of the forehead, especially the site at which the
BiliChek measurement will be taken. Secure the eye patches to prevent them from moving and exposing the measure-
ment site to the phototherapy lights.

Adhesive Skin Patches:

Place the adhesive skin patch on the forehead at an anatomic site, such as between the infant’s eyebrows, which can be
identified even after the patch has been removed after phototherapy has been discontinued. Commonly available patches
for skin temperature probes and monitor leads can be used for this purpose provided they are opaque to light. As an extra
precaution, the patches can be left in place even after the phototherapy has been discontinued in order to identify the
correct measurement site.

1
Chin KC, MJ Moseley and SC Bayless “Light Transmission of Phototherapy Eyeshields,” Arch of Dis in Childhood, 1987, 62(9), pp 970-1

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 Bonnets:
Although bonnets may cover the forehead during phototherapy it should be verified that they are opaque to light and
extra precautions must be taken to prevent them from moving and thereby exposing the forehead to the phototherapy
lights. Since many materials used for bonnets are not completely opaque, it is recommended that an adhesive patch be
placed on the forehead under the bonnet.
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Amber Shields and Hoods:

Amber phototherapy shields or hoods which are used to protect the newborn’s eyes during phototherapy still allow some
light to penetrate. Some manufacturer’s test data indicates the light blocking cut-off is ~520 nm. Some clinical studies
have indicated that green lights (with wavelengths greater than 520 nm) may have phototherapeutic effects. The
BiliChek transcutaneous bilirubin measurement has not been verified with the use of these products, therefore, it is
recommended that an adhesive patch or other light blocking method should be used in conjunction with these products
at this time.

Eye Patches Adhesive Bonnet Amber Shield

Skin Patch or Hood

Recommended Measurement Site

After Phototherapy:
Appropriate measures should be taken to ensure that any measurements taken from newborns after they have received
phototherapy are taken from a site on the forehead that was not exposed to the phototherapy lights. The exact procedures
that should be used will depend on the type of phototherapy protection used as described above. Although leaving a
BilEclipse Phototherapy Protective Patch in place is not necessary once the phototherapy lights are removed, it will
ensure that the same site is used for subsequent BiliChek measurements.

NOTE: Clinical studies indicate that as many as 48 hours may be required before the skin treated by photo-
therapy returns to the bilirubin level of an unexposed site.

NOTE: Newborns that are placed near windows with high exposure to sunlight may experience “natural
phototherapy”. This may be particularly true when the newborn has already been discharged home and
is returning to a hospital, clinic, or office facility for testing.

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 13.0 TROUBLESHOOTING GUIDE

At times, you may receive an error code (E01, E02, etc.) or warning symbol in the display window. The following is a
guide to help you correct a system problem.

Display

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Window Indication Solution
E00 No user set-up information identified. Install a charged battery pack into the battery compartment.
Press F1 and F2 at the same time, hold for one second and
then release. This places the unit in the Set-up mode. Enter
settings specific to your institution, see section 12.0 for
Set-up mode instructions.
E01 Calibration measurement is unacceptable. Press and release F1 and F2 at the same time. Ensure the
BiliCal™ Tip is in place. Press the TRIGGER button to
restart calibration (---). If error continues try another
BiliCal Tip. If error persists, remove the BiliCal and clean
the optical measurement tip (under disposable tip) with
approved cleaning agent, repeat calibration. If error
continues replace measurement light bulb (see section 15.0
for replacement instructions) and repeat calibration. If error
E01 persists, call for service.
E02 Patient measurement is unacceptable. Press and release F1 and F2 at the same time. Retest the
patient. If E02 occurs again, replace BiliCal, repeat
calibration and retest patient. If E02 continues, call for service.
E03 Disposable Tip removed between the calibration and Press and release F1 and F2 at the same time. Remove the
measurement scan or the BiliChek is being used BiliCal. Replace with a new tip and recalibrate. If E03
in an environment with too much ambient light. error is indicated even though the Disposable Tip has not
been removed, the ambient light level is too high. The
BiliChek should not be used outdoors, too close to infra-red
radiant warmers, or in areas with high levels of sunlight.
Move to an area of lower light levels and press the F1 and
F2 buttons at the same time.
E04 Too much movement during the measurement. Press and release F1 and F2 and retest the patient.
E05 Measurement is out of clinically proven range. Obtain a Total Serum Bilirubin level (TSB).
HIGH

E10 Light bulb is burned out. Replace measurement light bulb, see section 15.0 for
replacement instructions. If error continues, call for service.
E99 System error is detected. Call for service.
Low battery pack, there are approximately 10 Replace current battery pack with a fully charged battery
measurements left when the icon first appears. from the charger base and place discharged battery pack into
well “B”for charging.
Discharged battery pack, no measurements Replace current battery with a fully charged battery pack
can be taken. from the charger base and place discharged battery pack into
well “B” for charging.

THE BATTERY STATUS INDICATOR (BSI)

BSI Color Battery Charger Mode Solution
Off Battery pack not sensed in well or charger Place battery pack in well and/or check all power
base not connected to power supply. connections.
Green Battery pack fully charged. Battery pack is ready for use.
Amber Battery pack in well charging, but not Continue charging until green light appears.
ready.
Amber flashing Battery pack in well deep discharging. Continue charging until green light appears.
Red flashing Bad battery pack or charger base. Replace battery pack. If problem persists with new
(battery pack in well) battery pack, charger base has malfunctioned. Call
for service.

Contact your local dealer or Respironics if frequent errors occur.

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 14.0 CLEANING AND MAINTENANCE

The BiliChek® System is made of an easy to clean smooth surface. The following cleaning agents are recommended
for use:
• KleenaSeptic®
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• Cavicide®
• 70% - 90% Isopropyl Alcohol
• 1% Bleach
Spray cleaning agent of choice onto a damp cloth to wipe clean the BiliChek System. This same procedure may also be
used for the display window.

WARNING: Do not immerse in water or other liquid. If liquids spill onto unit, wipe with a
damp cloth and let unit dry before using.

WARNING: Do not attempt to clean and/or reuse BiliCal™ Individual Caibration Tip.

CAUTION: Clean the optical measurement tip (only) with 90% or higher Isopropyl Alcohol
using a soft optical surface cleaning wipe.

CHANGING THE MEASUREMENT LIGHT BULB

If the light bulb is not operating and error code E01 or E10 (refer to troubleshooting section of this manual) is displayed,
it is necessary to replace the light bulb using a manufactured approved Replacement Bulb Kit (REF B800-22).

• Remove the battery pack from the bottom of the BiliChek unit.
• Remove the protective label.
• Remove the lamp cap using a flat tip or Phillips head screw driver.
• Grab the loop of the light bulb with forceps or similar tool/instrument.
• Gently pull to remove lamp assembly.
• Insert factory specified replacement lamp assembly.
• Install the replacement lamp cap supplied with the bulb, do not over tighten.
• Apply new protective label.
• Securely attach battery pack.
• Apply new BiliCal Tip, supplied with replacement kit.
• Turn power on.
• Perform multiple calibrations until unit accepts calibration.

WARNING: The BiliChek is to be used only with an approved Replacement Bulb Kit from the
manufacturer. Do not over tighten lamp cap.

WARNING: There are no field serviceable components which can be accessed from the
battery pack opening. Do not attempt to separate the upper and lower bodies or
remove the junction screw. Doing so could damage the fiber-optics and will
invalidate the manufacturers warranty.

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 15.0 ATTACHING THE CHARGER BASE TO A WALL

A charger base template has been provided below, to assist with mounting the charger base to the wall. The charger base,
with the BiliChek® unit, and additional battery pack weight is approximately 974 g.

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For wall mounting of the charger base the user should purchase the appropriate anchor for the type of wall. For example,
if the user is mounting to a sheetrock wall, hollow wall fasteners should be used. If the user is mounting to a wood wall,
wood screws should be used.

Insert the screw into the wall leaving a gap of approximately .25 cm of the screw exposed between the wall and the head
of the screw. Place the unit on the screw to check the fit and adjust as required.

WARNING: Do not mount charger base over or near any heating device, sink or basin. Do not
hang anything or place any objects other than the BiliChek Hand-Held Unit and/
or battery packs in the charger base. Maximum downward force on charger base
should not exceed 2500 g.

Full Size Charger Base Template

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