Respironics BiliChek User manual

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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
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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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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
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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: +33-1-47-52-30-00 Respironics Asia Pacific: +81-3-5280-9611
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.
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BiliChek® Noninvasive Bilirubin Analyzer
QUALITY DOCUMENTATION RECORD
Patient ID # Date
New Tip Applied
TcB Measurement
Mg/dL/mmol/L
Device Serial #: ____________________________
Calibration
Passed Display
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