Respironics BiliChek User manual

Purpose

To outline and define the use of the BiliChek Noninvasive
Bilirubin Analyzer in the clinical setting, which may include
the Newborn Nursery, Neonatal Intensive Care Unit,
Outpatient Clinic, Laboratory, Home Nursing Agency,
Emergency Department and Physician Office.

Scope

The BiliChek Noninvasive Bilirubin Analyzer is approved for
use as an accurate predictor of total serum bilirubin (TSB)
in infants and neonates. Intended use:

• Pre, during and post phototherapy

• Gestational age: 27 to 42 weeks

• Postnatal age: 0 to 20 days

• Weight range: 950 to 4995 grams

Classifications and Definitions

The BiliChek Noninvasive Bilirubin Analyzer device is an
alternative to subcutaneous (traditional heel stick TSB)
bilirubin testing as correlated to High Performance Liquid
Chromatography (the gold standard in serum bilirubin analy­sis). Because BiliChek is noninvasive, there is no pain,
trauma or risk of infection to the patient.

BiliChek performance has been clinically proven in patients
within the following parameters:

• Gestational age: 27 to 42 weeks

• Postnatal age: 0 to 20 days

• Weight: 950 to 4995 grams

BiliChek should not be used in the following situations:

• Following exchange transfusion.

• The measurement site on the forehead contains exces­sive bruising, birthmarks, hematomas or excessive hairi­ness as this can produce erroneous results.

Note: If unable to use the forehead, we recommend using the
sternum as an alternative measurement site.

Only properly trained personnel should perform BiliChek
testing. Such personnel may include:

• Nursing staff

• Laboratory personnel

• Physician

• Home health provider

Staff Competency Validation

All clinical personnel responsible for performing BiliChek
testing must be properly trained prior to use of the device in
a clinical setting to ensure accurate test results. Training will
be documented as follows:

1

Clinical personnel will receive a demonstration of the
equipment by an experienced BiliChek operator and will
be responsible for reading the information provided in
the "User Instruction Manual" and any other training
materials provided by the manufacturer.

2

Clinical personnel will perform a return demonstration on
three infants in the presence of an experienced BiliChek
operator.

3

Successful completion of training will be documented in
the employee's education record.

T

esting Procedure

Initialize the Unit

1

Install a fully charged battery pack into the battery com­partment of the unit.

2

Press and release either the F1 (blue) or F2 (gray) but­ton on the front of the BiliChek unit to turn the device
on.

3

The device will perform a self-test, momentarily display­ing all LCD indicators. When the self-test is complete,
the home screen will be visible displaying the last mea­surement, time and date or an error code message (if
applicable).

BiliChek®Noninvasive Bilirubin Analyzer

Suggested Usage Protocol

4

If this is the first time the BiliChek device is used,
it will be necessary to enter the set-up mode and
program the display settings before proceeding.
Please refer to the "User Instruction Manual" for
complete set-up instructions.

5

BiliChek does not have an off switch and will
automatically turn off if it is idle for a user-specified
period of time (60 or 120 seconds).

Perform Calibration

1

Remove a new BiliCal™ disposable tip from its foil
pouch and apply it to the optical sensor on the
BiliChek handheld device before each use.

2

Firmly press the BiliCal on the BiliChek handheld
device to ensure proper seating of the tip.

3

With the home screen displayed, press and release
the trigger button (blue button located on the hand
grip) to start calibration.

4

Three dashes (---) will flash in the display window
and the Measurement Status Indicator (MSI) will
be amber if the BiliCal is properly seated, indicating
the device is ready to calibrate. (If the BiliCal is not
properly seated, the MSI will be red and an E01
error message will be displayed.)

5

Press and release the trigger button again. The
dashed lines will stop flashing indicating that
BiliChek is calibrating.

6

The MSI will be amber colored and a beep will be
heard (if audible alarm is enabled). The display win­dow will read (005) to indicate that the calibration
was completed successfully. If there is a failure in
calibration an error message will be displayed and
you will be unable to proceed with testing. Refer to
the troubleshooting section of the "User Instruction
Manual."

Perform Patient Test

1

After performing the calibration, pull on the BiliCal tab
and peel away the protective covering (calibration
material) from the disposable tip and discard.

2

Press and release the trigger button. The device is
now activated and ready to take a measurement.
("005" will be displayed and blinking.)

3

Gently press the BiliCal against the infant's forehead
or sternum. The MSI on the display will change from
amber to green and "005" will stop blinking when
proper pressure is applied.

4

Hold the BiliChek handheld device steady until the
measurement is complete (1 to 3 seconds). The
device will beep if the audible alarm is enabled.

5

Perform a series of five measurements by lifting and
replacing the BiliCal on the center of the infant's
forehead or sternum. Press and release the trigger
button before each measurement. The current
measurement will be indicated on the display
(005…003…001).

6

Upon completion of the five measurements, a final
beep will sound and the test result will be displayed
along with the current time and date. Remove and
discard the disposable tip.

7

Place the blue protective tip cover onto the BiliChek
handheld device (an un-used BiliCal can be used if
the protective cover becomes lost or damaged).

8

The BiliChek unit will turn off automatically.

Document Result

1

Document the patient test result, date and time in the
appropriate area on the patient's chart.

2

Notify the attending physician as appropriate.

3

Obtain follow-up measurements in accordance with
physician orders.

QA Documentation Procedure

The BiliChek device performs internal calibration con-
trols prior to each patient test. The device will not permit
testing to occur if the calibration does not meet the con­trol specifications. In order to document completion of
the calibration prior to each test to meet JCAHO require­ments you should complete a "Quality Documentation
Record" similar to the sample on the next page. An indi­vidual record should be maintained for each BiliChek
device and tracked by serial number.

BiliChek®Noninvasive Bilirubin Analyzer - Suggested Usage Protocol, Continued

Cleaning and Maintenance

The following is a list of recommended cleaning agens
for the BiliChek:

• KleenAseptic

®

• Cavicide

®

• 70% - 90% Isopropyl alcohol

• 1% Bleach

To clean, spray the cleaning agent of choice onto a
damp cloth and wipe the BiliChek system and display
window clean.

Warning: Do not immerse the BiliChek in water or
other liquid. If liquids spill onto the unit, wipe with a
cloth and let unit dry before use.

Warning: Do not attempt to clean and/or reuse the
BiliCal disposable tip.

Patient Test Implementation Guidelines

I

nfants with one or more of the following risk factors for

hyperbilirubinemia will be screened for elevated bilirubin
levels with the BiliChek Noninvasive Bilirubin Analyzer.

• 10% loss of birth weight

• Poor feeder

• Excessive bruising

• Blood group incompatibility

• < 37 weeks gestation and/or 2500 grams

• Visible jaundice

A total serum bilirubin (TSB) (blood draw) will be
obtained prior to the initiation of phototherapy treatment
ordered by the attending physician, based on the follow­ing criteria:

• Infants < 24 hours of age with BiliChek TcB
of >

10 mg/dL

• Infants > 24 hours of age with BiliChek TcB
of > 12 mg/dL

• Infants >

48 hours of age with BiliChek TcB

of >

15 mg/dL

• Infants > 72 hours of age with BiliChek TcB
of > 17 mg/dL

Note: These guidelines are intended to serve only as a
reference. They shall be used only in conjunction with
the instructions and/or protocol set forth by the physician
and institution in which the device is being used. The
guidelines are not intended to supercede established
medical protocols.

Use During Phototherapy

Prior to the initiation of phototherapy, the measurement
site on the infant's forehead or sternum must be covered
with a photo-opaque material such as the BilEclipse™
Phototherapy Protective Patch. The patch must remain in
place throughout phototherapy. To take a measurement:

1

Turn off the phototherapy light(s) (fiberoptic or over­head).

2

Open the BilEclipse flap or remove other photo­opaque patch.

3

Perform the BiliChek measurement according to
manufacturer's instructions.

4

Replace the BilEclipse flap or other photo-opaque
patch.

5

Resume phototherapy as ordered.

Note: Clinical studies indicate that up to 48 hours may
be required before the skin treated by phototherapy
returns to the bilirubin level of an unexposed site.
Therefore measurements from an unprotected site are
not reliable.

Note: Newborns that are placed near a window with high
exposure to sunlight may experience "natural photothera­py" which may alter the BiliChek results.

Patient ID Date

New Tip
Applied

Calibration

Tcb Measurement

Mg/dL/mmol/L

BiliChek® Noninvasive Bilirubin Analyzer

QUALITY DOCUMENTATION RECORD

Device Serial #: ____________________________

Xxxxxx

Yyyyyy

Zzzzzz

4/10/06

4/11/06

4/11/06

Y

Y

Y

Y

Y

Y

005

005

005

5.6

7. 8

12.6

Passed Display

References

American Academy of Pediatrics, Subcommittee of
Neonatal Hyperbilirubinemia. (2004). Management of
hyperbilirubinemia in the newborn infant 35 or more
weeks of gestation. Pediatrics, 114(1), 297-316.

Bhutani, V.K., Johnson, L., Sivieri, E.M. (1999).
Predictive ability of a predischarge hour-specific serum
bilirubin for subsequent significant bilirubinemia in
healthy term and near-term newborns. Pediatrics, 103,
6-14.

Bhutani, V.K., Crossley, G.R., Adler, S., et al. (2000).
Noninvasive measurement of total serum bilirubin in a
multiracial predischarge newborn to assess the risk of
severe hyperbilirubinemia. Pediatrics, 106(2).

Cabra, M., Whitfield, J. (2005). The challenge of prevent­ing neonatal bilirubin encephalopathy: a new nursing pro­tocol in the well newborn nursery. BUMC Proceedings,
18, 217-219.

Jangaard, K.A., Curtis, H., Goldbloom, R.B. (2006).
Estimation of bilirubin using bilichek, a transcutaneous
bilirubin measurement devise: effects of gestation age
and use of phototherapy. Journal of Paediatrics and
Child Health, 11(2), 79-83.

Janjindamai, W., Tansantiwong, T. (2005). Accuracy of
transcutaneous bilirubinometer estimates using bilicheck
in thai neonates. Journal of the Medical Association of
Thailand, 88(2), 187-90.

Kazmierczak, S., Robertson, A., Briley, K., Kreamer, B.,
Gourley, G. (2004). Transcutaneous measurement of
bilirubin in newborn: comparison with an automated jen­drassik-grof procedure and HPLC. Clinical Chemistry,
50, 433-435.

Petersen, J., Okorodudu, A., Mohammad, A., Fernando,
A., Shattuck, K. (2005). Association of transcutaneous
bilirubin testing in hospital with decreased readmission
rate for hyperbilirubinemia. Clinical Chemistry, 51(3),
540-544.

Poland, R., Hartenberger, C., McHenry, H., His, A.
(2004). Comparison of skin sites for estimating serum
total bilirubin in in-patients and out-patients: chest is
superior to brow. Journal of Perinatology, 24, 541-543.

Robertson, A., Kazmierczak, S., Vos, P. (2002). Improved
transcutaneous bilirubinometry: comparison of spectrx
bilicheck and minolta jaundice meter jm-102 for estimat­ing total serum bilirubin in a normal newborn population.
Journal of Perinatology, 22,12-14.

Rubaltelli, F.F., Gourley GR, Loskamp N, Modi N, Roth­Kleiner M., Sender A., Vert P. (2001) Transcutaneous
bilirubin measurement: a multicenter evaluation of a new
device. Pediatrics, 107,1264-1271.

Slusher, T., Angyo, I., Bode-Thomas, F., Akor, F., Pam, S.,
Adetunji, A., et al. (2004). Transcutaneous bilirubin mea­surements and serum total bilirubin levels in indigenous
African infants. Pediatrics, 113(6), 1636-1641.

Willems, W.A., van den Berg, L.M., de Wit, H., Molendijk,
A. (2004). Transcutaneous bilirubinometry with the
bilicheck in very premature newborns. The Journal of
Maternal-Fetal and Neonatal Medicine, 16, 209-214.

Customer Service: 1-800-345-6443 or 724-387-4000
Respironics Europe: [phone]
Respironics Asia Pacific: [phone]

Geyer WMB 05/08/06 MCI 4100576 PN 1035436

Respironics, the Children’s Medical Ventures heart design logo, BiliChek and
BiliCal are registered trademarks of Respironics, Inc. and its affiliates. BilEclipse
is a trademark of Respironics, Inc. and its affiliates. © 2006 Respironics, Inc. and
its affiliates. All rights reserved. KleenAseptic and Cavacide are registered
trademarks of Sybron Dental Specialties, Inc.

BiliChek® Noninvasive Bilirubin Analyzer

QUALITY DOCUMENTATION RECORD

Patient ID # Date

New Tip
Applied

TcB Measurement

Mg/dL/mmol/L

Device Serial #: ____________________________

Calibration

Passed Display