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
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