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ENGLISH

6

Skin

Bilirubin

Blood

Bilirubin

Without Phototherapy

With Phototherapy

Skin

Bilirubin

Blood

Bilirubin

Bilirubin

Bilirubin Photo-Products

Photo-Products

Protecting a Measurement Site

Exposure of a neonate to phototherapy creates changes in the skin due to the therapuetic affects of phototherapy lights.
If a small portion of the newborn skin is protected from the therapeutic affects 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
Bili

Chek®

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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Содержание bilichek

Страница 1: ...ghts 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 22...

Страница 2: ...ENGLISH ...

Страница 3: ...C of 14 June 1993 1 TABLE OF CONTENTS 1 0 Warranty and Return Policy Information 2 2 0 Notational Descriptions 2 2 1 Symbols 3 3 0 Introduction 4 4 0 Purpose of the Device 4 5 0 Theory of Operation 4 6 6 0 Warnings and Cautions 7 7 0 Description of the BiliChek System 8 8 0 Specifications 9 9 0 Functional Components 10 9 1 BiliChek Hand Held Unit HHU 10 9 2 Charger Base 11 10 0 Initial Set up 12 1...

Страница 4: ...r damage caused by accident misuse abuse alteration and other defects not related to material or workmanship To exercise your rights under this warranty contact your local authorized Respironics Inc dealer or Respironics 2 0 NOTATIONAL DESCRIPTIONS Throughout this manual there are blocks of text in bold or italic type These blocks are warnings cautions notes and technique tips and they are used as...

Страница 5: ...for Nickel Cadmium Battery Symbol for Storage Conditions Symbol for Indoor Use mbol for Class B 3 Symbol for Used With Symbol for Do Not Reuse Symbol for Use By Symbol for Batch Code Symbol for Recycle Symbol for Serial Number Symbol for Catalog Number Denotes this system is ETL Listed and conforms to ANSI UL STD 2601 Certified to CAN CSA C22 2 STD NO 601 1 Symbol for Date of Manufacture Symbol fo...

Страница 6: ...PERATION 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 Each photon has a characteristic wavelength As light enters skin tissue it can col...

Страница 7: ...also been considered in the development of the algorithm by which the BiliChek computes the bilirubin measurement By measuring the intensity of the reflected 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 elimi...

Страница 8: ...otherapy lights If a small portion of the newborn skin is protected from the therapeutic affects 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 cl...

Страница 9: ...ight 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 inspected for proper operation by an authorized service representative Do not immerse in water or other liquid Do not let power cord hang over edge of counter or table as this may pose a tripping hazard CONTRAINDICATIONS The BiliChek should not be ...

Страница 10: ...uction Manual International B800 23 B800 24 Optional Table Top Power Supply 100V 250V 47 63 Hz B800 18 WARNING The BiliChek Hand Held Unit is to be used only with these and approved replacement parts and accessories 10 BiliCal BiliChek Disposable Calibration Tip Reorder Number B800 10 2 40 C 40 C 40 C 60 C 60 C 60 C Patent No 5 792 049 5 860 421 5 924 981 6 002 482 6 226 541 and Patents Pending Ba...

Страница 11: ...5 cm Depth 4 8 cm Width 3 5 cm Weight 147 g Voltage 6V Capacity 700 mA Hrs Measurements per full charge Minimum 100 measurements on a single charge Life span Minimum 1 year Recharge cycle 4 6 hours maximum Discharge and recharge cycle 9 2 hours maximum Charger Base Dimensions Height 7 6 cm Depth 12 1 cm Width 12 4 cm Weight 264 g Light Bulb Type Tungsten Bulb life Minimum 30 000 measurements 9 ...

Страница 12: ...ient measurement 2 FUNCTION buttons The two buttons on the top side are FUNCTION buttons The teal button on the left is referred to as F1 and the gray button on the right as F2 These are used to initiate non routine functions such as set up changing time and date etc 3 BiliCal Individual Calibration Tip This tip serves five purposes a device calibration before each patient measurement b protection...

Страница 13: ... switch located on the bottom of the charger base It is recommended by the manufacturer to discharge each battery pack every month To drain a battery pack of power place the Deep Discharge switch in the right position and place the BiliChek battery pack in well B of the charger base The discharge recharge cycle will take approximately 4 6 to 9 2 hours depending on the amount of charge in the batte...

Страница 14: ...hen Deep Discharging the battery pack the BSI will blink amber then become a constant amber color when charging NOTE If the BSI is flashing red when battery pack is in place try resetting the battery pack in the charging well If problem persists set a new battery pack in charger base If problem continues with a new battery pack the charger base has malfunctioned 10 0 INITIAL SET UP Visually inspec...

Страница 15: ...y pack into well B as shown in section 10 2 of this manual The BSI will glow amber to indicate that it is charging Charge battery packs fully until green light is displayed on the BSI refer to section 10 2 of this manual WARNING The battery pack is designed to work only with the BiliChek Do not attempt to use the battery pack with other products WARNING Do not puncture or incinerate the battery or...

Страница 16: ...CCESS THE USER SET UP FUNCTION Press F1 and F2 at the same time hold for one second and then release This places the unit in the Set up Mode While in this mode the F1 button teal advances to the next item The F2 key gray changes the value of the current item NOTE To exit this mode at any time press and release F1 and F2 at the same time All information that you have entered up to that point will b...

Страница 17: ...E The default is 120 seconds Press and release F2 to toggle between the options 60 and 120 seconds Press and release F1 to accept your choice and advance to the next Set up function NOTE This unit is equipped with a Critical Power Off feature After completing the calibration the unit will sound an alarm if no measurement is performed within a set period of time The unit will power off 20 seconds l...

Страница 18: ...dvance to setting the date SETTING THE DATE Depending on the date format you selected the current month or day will flash first The month day will flash Press and release F2 to scroll through the months days Press and release F1 when the correct month day is displayed The day month digit will now flash Press and release F1 to select the displayed value or Press and release F2 to scroll through the...

Страница 19: ...ow and the MSI will be amber if a BiliCal Tip is in place indicating the system is ready to calibrate If a BiliCal Tip is not in place the MSI will be red Attach a BiliCal Tip before continuing Press and release the TRIGGER button The dashed lines will stop flashing indicating that the system is calibrating When calibration is complete the MSI will be amber you will hear a beep if the audio is on ...

Страница 20: ...asurement a Measurement Status Indicator MSI has been included in the display The following are the MSI color coding indicators The MSI will be red until the user applies a BiliCal Individual Calibration Tip or during an error message The MSI is amber when the user performs a calibration The MSI is amber when the user begins a measurement The MSI turns green when proper pressure is applied during ...

Страница 21: ...ite before you place the BilEclipse on the infant Respironics makes no recommendations on the type of cleaning agent that is used Any liquids lotions or creams will reduce the adhesiveness of the patch and increase the likelihood that it will fall off during phototherapy 2 When you lift the LID of the patch to take a measurement it may be helpful to place your finger on the edge of the BASE in ord...

Страница 22: ...ewborn has already been discharged home and is returning to a hospital clinic or office facility for testing Recommended Measurement Site Bonnets Although bonnets may cover the forehead during phototherapy it should be verified that they are opaque to light and extra precautions must be taken to prevent them from moving and thereby exposing the forehead to the phototherapy lights Since many materi...

Страница 23: ...g agent repeat calibration If error continues replace measurement light bulb see section 15 0 for replacement instructions and repeat calibration If error E01 persists call for service E02 Patient measurement is unacceptable Press and release F1 and F2 at the same time Retest the patient If E02 occurs again replace BiliCal repeat calibration and retest patient If E02 continues call for service E03...

Страница 24: ... replace the light bulb using a manufactured approved Replacement Bulb Kit REF B800 22 Remove the battery pack from the bottom of the BiliChek unit Remove the protective label Remove the lamp cap using a flat tip or Phillips head screw driver Grab the loop of the light bulb with forceps or similar tool instrument Gently pull to remove lamp assembly Insert factory specified replacement lamp assembl...

Страница 25: ...wall hollow wall fasteners should be used If the user is mounting to a wood wall wood screws should be used Insert the screw into the wall leaving a gap of approximately 25 cm of the screw exposed between the wall and the head of the screw Place the unit on the screw to check the fit and adjust as required WARNING Do not mount charger base over or near any heating device sink or basin Do not hang ...

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