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USER INSTRUCTION MANUAL
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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Summary of Contents for Respironics BiliChek
- Page 1 USER INSTRUCTION MANUAL 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.
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Page 3: Table Of Contents
PREFACE About This Manual This User Instruction Manual has been prepared by Respironics, Inc. for both first-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 device. Save this manual for future reference. -
Page 4: 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. -
Page 5: Symbols
2.1 SYMBOLS • Symbol for “Attention, • Symbol for “Battery Deep Discharge See Instructions For Use” and Recharge” • Symbol for “Used With” • Symbol for “Use With” • Symbol for “Battery Charging” • Symbol for “Do Not Reuse” • Symbol for “Rechargeable Battery Recycle Corporation”... -
Page 6: Introduction
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. - Page 7 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.
- Page 8 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.
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Page 9: Warnings And Cautions
• 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: •... -
Page 10: Description Of The Bilichek® System
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: Quantity Description REF Number Battery Packs B800-20 Charger Base... -
Page 11: Specifications
8.0 SPECIFICATIONS BiliChek® System • Total weight ................................974 g 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 •... -
Page 12: Functional Components
Output ..............................12 VDC, 2.75 Amp 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. -
Page 13: Charger Base
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. -
Page 14: Initial Set-Up
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. •... -
Page 15: Set-Up Mode
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: •... - Page 16 (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.
- Page 17 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. • Press and release F2 to toggle between mg/dL and µmol/L. •...
- Page 18 SETTING THE TIME After choosing the time format, SET appears on the display and the current clock time will be shown. • 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. •...
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Page 19: Instructions For Use
• 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. -
Page 20: Completing A Patient Test -- Performing The Patient Test
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. -
Page 21: User Recommendations For Use During And After Phototherapy
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. • A photo-opaque material (such as BilEclipse™... - Page 22 (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.
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Page 23: Troubleshooting Guide
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. -
Page 24: Cleaning And Maintenance
• 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. -
Page 25: 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. 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.
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