Respironics bilichek User manual

USER MANUAL MANUEL DE L’UTILISATEUR MANUALE DELL’UTENTE
BENUTzERhANDBUch MANUAL DEL USUARIo MANUAL Do UTILIzADoR
BiliChek
1005175
HM 9/7/09
Manufactured for
Children’s Medical Ventures, LLC
1001 Murry Ridge Lane
Murrysville, PA 15668 USA
Respironics Deutschland
Gewerbestrasse 17
82211 Herrsching, Germany
1062275
*+H90610622750A*

BiliChek, BiliCal and BilEclipse are trademarks of Respironics, Inc. and its afliates.
© 2009 Respironics, Inc. and its afliates.
BiliChek
user manual
English

1. Introduction ........................................................................................................................................1
About This Manual.........................................................................................................................1
BiliChek Description......................................................................................................................1
Intended Use...................................................................................................................................1
Jaundice ...........................................................................................................................................2
Theory of Operation ....................................................................................................................2
Protecting a Measurement Site...................................................................................................4
Components of the BiliChek system..........................................................................................5
2.Warnings, Cautions, Contraindications, and Symbols.................................................................6
Warnings..........................................................................................................................................6
Cautions...........................................................................................................................................7
Contraindications ..........................................................................................................................7
Notes ...........................................................................................................................................8
Symbols ...........................................................................................................................................8
3. Set Up...................................................................................................................................................10
Initial Set Up....................................................................................................................................10
Attaching the Hand-Held Unit Battery.....................................................................................10
Connecting the Charger Base Power Cord ............................................................................11
Connecting the Charger Base Ethernet Cable .......................................................................12
Charging the Hand-Held Unit Battery......................................................................................12
4.Viewing and Changing Settings........................................................................................................13
BiliChek Hand-Held Unit (HHU) ................................................................................................13
BiliChek Keypad ......................................................................................................................13
Turning the Unit On......................................................................................................................14
Navigating the Menu Screens......................................................................................................14
Accessing On-Screen Help..........................................................................................................15
Returning to the Home Screen..................................................................................................15
BiliChek
user manual
Table of Contents
English

BiliChek user manual
4
Changing the Settings....................................................................................................................15
Customizing the Settings..............................................................................................................16
Selecting a Language..............................................................................................................16
Selecting a Time and Date Format.....................................................................................17
Entering the Current Time and Date................................................................................19
Additional Settings ...............................................................................................................20
Calibrating and Taking a Reading ................................................................................................22
Using Other Features ...................................................................................................................24
History.....................................................................................................................................24
Stand-by ...................................................................................................................................25
Recommendations for Use During and After Phototherapy ...............................................25
During Phototherapy ............................................................................................................25
BilEclipse .................................................................................................................................26
After Phototherapy ...............................................................................................................27
5. Cleaning, Maintenance, and Service ...............................................................................................28
Cleaning ...........................................................................................................................................28
Maintenance ....................................................................................................................................29
Changing the Measurement Light Bulb ............................................................................28
Changing the Battery............................................................................................................31
Service ...........................................................................................................................................31
Customer Service Information...................................................................................................31
6. Specications.......................................................................................................................................32
Environmental.................................................................................................................................32
Physical ...........................................................................................................................................32
BiliChek System.....................................................................................................................32
BiliChek Hand-Held Unit.....................................................................................................32
Charger Base ..........................................................................................................................32
Light Bulb.................................................................................................................................32
Standards Compliance ..................................................................................................................33
Electrical Requirements................................................................................................................33
WEEE/RoHS Recycling Directives .............................................................................................33
Disposal ...........................................................................................................................................33
Appendix A. EMC Information ............................................................................................................34
Appendix B.Warranty...........................................................................................................................38

English
About This Manual
This User manual has been prepared for both rst-time and experienced users of the 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 unit. Save this manual for future reference.
BiliChek Description
The BiliChek provides a numerical measurement of predicted bilirubin count in mg/dL or µmol/L
within a clinically benecial range that has been correlated with total serum bilirubin concentration
measured by High Pressure Liquid Chromatography (HPLC).The device is intended for use in the
hospital or institutional environment, including clinics, physician’s ofces, and home nursing agencies, to
assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia.
Intended Use
The BiliChek Non-Invasive Bilirubin Analyzer is a non-invasive transcutaneous bilirubinometer, which
is intended as an index to predict serum bilirubin levels prior to phototherapy (pre-phototherapy),
during, and post phototherapy in neonates, without regard to gender, gestational age, or body weight.
Neonates whose BiliChek test results are indicative of hyperbilirubinemia are evaluated by their
physician(s) for appropriate patient management.
BiliChek
user manual
1. Introduction

BiliChek user manual
2
Jaundice
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 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).
Theory of Operation
The BiliChek works by directing white light into the skin of the newborn and measuring the intensity
of the specic 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.This is called a transcutaneous bilirubin measurement.
Photons of specic wavelengths are 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 proles.
The peak absorption of photons by bilirubin occurs at a wavelength of 460 nm.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.
The light reected 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 (see gure) which impact the spectral reectance in newborns are (1) dermal maturity,
(2) melanin, (3) hemoglobin, and (4) bilirubin. The intensity of the reected 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:
ODtotal = ODderm + ODmel + ODheme + ODbili

Chapter 1. Introduction
3
English
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.
1Jacques, S., Saidi, Il, Ladner, Al, and D. Oelberg. Developing an optical ber reectance
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 reected
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 460 nm is measured by subtracting the
absorption of the other components from the total skin absorption.
This is represented by the equation below.
ODbili = ODtotal - ODmel - ODheme - ODderm
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 quantied and is correlated to the laboratory total
serum bilirubin levels.
1SPIE Proceedings 2975, Laser-Tissue Interactions, San Jose, CA Feb. 1997. 1-7.
Non-Invasive Skin Spectral
Components1

BiliChek user manual
4
Protecting a Measurement Site
Exposure of a neonate to phototherapy creates changes in the skin
due to the therapeutic effects of phototherapy lights. If a small
portion of the newborn skin is protected from the therapeutic effects
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 study.

Chapter 1. Introduction
5
English
Components of the BiliChek System
The BiliChek system includes the following components. Some
components and accessories will be packaged in separate boxes.
12
357
6
4
To reorder parts and accessories, visit the Respironics web site at
www.respironics.com or contact Respironics Customer Service at
1-724-387-4000 or [phone]. WARNING:
The BiliChek Hand-Held Unit is
to be used only with these and
approved Respironics replacement
parts and accessories.
1. BiliChek Hand-Held Unit
2. Battery Door Cover
3. Battery
4. Protective Tip
5. Power Supply
6. BilEclipse Phototherapy
Protective Patches (Bag
of 10)
7. Charger Base
8. User Manual (not shown)
9. Quick Start Guide (not
shown)

Caution! US federal law restricts this device to sale by or on the order of a
physician.
Warnings
The Bili•Chek Hand-Held Unit is to be operated only in
conjunction with Respironics approved charger base, battery
packs, power supply, and BiliCal 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 Bili•Chek 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 Bili–Chek farther away from the device.
Plug the Bili–Chek Power Supply into a different power outlet so
that the BiliChek Power Supply and the device are on different
breaker or fuse circuits.
Do not use in the presence of ammable substances •
such as anesthetics, cleaning agents, or gases that support
combustion (e.g. oxygen, nitrous oxide).
Do not puncture or incinerate the battery pack or dispose•
of in a landll. Batteries should be disposed of properly
according to local regulations.
Do not use outdoors or place in direct sunlight.•
WARNING
A warning indicates the possibility
for injury to the user or operator.
BiliChek
user manual
2.Warnings, Cautions,
Contraindications, and Symbols

Chapter 2. Warnings, Cautions, Contraindications, and Symbols
7
English
CAUTION
A caution indicates the
possibility for damage to the
device.
The charger base unit (battery charger) should be plugged into•
a properly grounded outlet. Do not operate with damaged
plug or cord.
Cautions
The Bili•Cal 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 returned to Respironics.
Do not immerse in water or other liquid.
•
Do not let the power cord hang over the edge of counter or•
table as this may pose a tripping hazard.
Pins of connectors identied with the ESD warning symbol
•
should not be touched. Connections should not be made to
these connectors unless ESD precautionary procedures are
used. Precautionary procedures include methods to prevent
build-up of electrostatic discharge (e.g., air conditioning,
humidications, conductive oor coverings, and non-synthetic
clothing), discharging one’s body to the frames of the
equipment or system or to earth or a large metal object, and
bonding oneself by means of a wrist strap to the equipment or
system or to earth.
Contraindications
The Bili•Chek should not be used in patients who have
undergone an exchange transfusion.
Avoid using measurement sites with the following conditions
•
since they can produce erroneous results:
Bruising
–
Birthmarks–
Hematomas–
Excessive Hairiness–

BiliChek user manual
8
Note: A note places emphasis on
an operating characteristic.
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, Patent Ductus Arteriosus (PDA),
Intravetricular Hemorrhage (IVH), and Respiratory Distress
Syndrome (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.
Symbols
The following symbols appear on the BiliChek unit or accessories.
Symbol Description Symbol Description
Attention, consult
instructions for use
Indoor Use
Use With Type BF Applied Part
Do Not Reuse Enter Key

Chapter 2. Warnings, Cautions, Contraindications, and Symbols
9
English
Symbol Description Symbol Description
Use By Compliant with the Waste
Electrical and Electronics
Equipment/Restriction of the Use
of Certain Hazardous Substances
in Electrical and Electronics
Equipment (WEEE/RoHS) recycling
directives
Catalog Number
3172518
Canadian/US Safety Certication.
Conforms to UL Std. 60601-1.
Certied to CAN/CSA Std. C22.2
No. 601.1
Batch Code European Representative
Serial Number Temperature Range
European Declaration of
Conformity
Relative Humidity Range
AC Power DC Power
Help Key Navigation Arrow Keys

Initial Set Up
Visually inspect all components for physical damage. If damage is
noted, please contact your local dealer/distributor or Respironics.
Attaching the Hand-Held Unit Battery
1. Clip the battery connector into the connector on the hand-held
unit.
2. Fold the battery wires underneath the light bulb compartment.
Slide the battery inside the hand-held unit.
WARNING
The battery is designed to work
only with the BiliChek. Do not
attempt to use the battery pack
with other products.
Connecting the Battery
Inserting the Battery
BiliChek
user manual
3. Set Up
Light Bulb Compartment

Chapter 3. Set Up
11
English
3. Attach the battery compartment cover by sliding the cover up
until it clicks securely in place.
Connecting the Charger Base Power Cord
1. Attach the appropriate plug style to the power supply, if necessary.
2. Plug the socket end of the power cord into the power inlet on the
bottom of the charger base.
3. Plug the pronged end of the cord into a wall outlet. Ensure all
connections are secure.
Attaching the Cover
WARNING
Periodically inspect the power
cord for damage or signs of
wear. Discontinue use and
replace if damaged.
Attaching the Plug
Connecting the Power
Supply to the Charger
Base
3. Set Up

BiliChek user manual
12
Connecting the Charger Base Ethernet Cable
The BiliChek unit can send data to your laboratory information
system if you have the necessary software.To allow this capability,
you must connect the ethernet cable included with your BiliChek
system.
1. Connect one end of the Ethernet cable into the connector on
the bottom of the charger base.
2. Connect the other end of the cable to your network
connection.
Charging the Hand-Held Unit Battery
Before initial use, the battery should be fully charged.
1. Place the BiliChek onto the charger base. A lightning bolt
icon will appear on the battery icon to indicate the battery is
charging.
2. Charge for eight hours or until the battery status icon on the
screen indicates a full charge.
Battery Status
Connecting the Ethernet
Cable

English
BiliChek Hand-Held Unit -
Components
Keypad
Arrow
keys
Home key
Number keys
Help key
Enter key
BiliChek Hand-Held Unit (HHU)
The BiliChek Hand-Held
Unit consists of the
following components:
Display window
•
Keypad•
Calibration Tip•
Barcode Scanner•
Battery compartment•
Charging Pins•
BiliChek Keypad
Use the keypad to navigate
through the on-screen menus.
4.Viewing and Changing Settings
BiliChek
user manual
Calibration tip
Battery
compartment
Display
window
Keypad
Barcode scanner
Charging pins

BiliChek user manual
14
Turning the Unit On
1. Ensure the battery is connected to the unit and fully charged.
2. If the unit is in sleep mode, press the (Enter) key to begin.
3. The unit will power up and then will display the home screen.
Navigating the Menu
Screens
To navigate through all of the menu screens
and settings:
Use the Up and Down arrow keys to
•
scroll through the menu options and
settings.
Use the Left and Right arrow keys to
•
perform the actions specied on the
screens.
Use the
•(Enter) key to save the setting
on the screen.
Enter key
Arrow keys
Enter and Arrow Keys
Battery Indicator
Sound Level
Current Time
Current Date
Note: The BiliChek Hand-Held
Unit does not have an off switch.
The BiliChek will automatically
turn off if it is idle for 2 minutes.
Note: Dashes will display for the
current date and time until they
are set.
Home Screen

Chapter 4. Viewing and Changing Settings
15
English
Home key Help key
BiliChek Keypad
Accessing On-Screen
Help
From any screen, press the
(Help) key on the BiliChek keypad.
A help message for that action will
appear.
Returning to the Home
Screen
You can return to the home
screen at any point by pressing
the (Home) key. If you return
to the home screen in the middle
of a reading, you must start the
measurement process over.
Changing the Settings
Before you use the BiliChek for the rst time, you may review or change
certain factory settings. You can also change any of the settings at a
later time. Choose Setup on the home screen to change settings.At any
time during the setup process, you can press the (Help) key on the
bottom right of the keypad to access on-screen instructions.
IMPORTANT!
Your institution will determine
which information you are
required to enter.
Note: To exit the Setup mode at
any time, press the (Home)
key on the bottom left of the
keypad. Any unsaved data will
be lost.
Setup Selection