Service Manual - Frank`s Hospital Workshop
Contents
1. 5 4 3 2 1 REV CN DESCRIPTION DATE DRAWN BY CHECKED BY APPROVED BY SEE SHEET 1 5V R21 100K 05 R10 1 IRLML5103 LM317 6 8 D2 POGO PINS V a Hyn 2 1 77016 R8 RS MRA4003 11 R11B RUC RUD 2 R13 R48 YOK 62 gt 62 gt 62 gt 62 gt 124K 6 19K 1 iw iw 1 4 ARA 5 d 9 D5 06 R14 R47 Z N P6SMB6 8AT3 D6 V e 6 IRLML2402 3 01K Z N P6SMB15AT3 R59 E ou 1 IRLML2402 R12 10K 1K 7 d V ra 2 4 TI R20 R29 R30 5vo 16K 10K 1M 3v R31 10K dert C13 Ss met d Kav 7 1uF A5 D11 ICS1702 LM393A SO J9 11 8 cue H 1 7 2 10 SELO MMBD914LT1 R33 J5 1 44 SEU MIN Co R61 R62 AUXO THERM H KA 15 PF2 dS 1 LA 8 DTSEL w MM2 d R32 2 2 4 Rc 9 om CN2 O 5V lt AKA 2 lt or2 m MOLEX 3 R60 10K AAA 2 05v lt lt UT LwaesA so RESPIRONICS Title Bize Document Number Rev 1014726 0 Date Wednesday October 30 2002 Sheet 3 of 3 2 BiliChek Service Manual 26 RESPIRONICS 11 3 4 1014988 Charger Base PCB Component Layout te B E2. 5 4 3 2 1 REV CN DESCRIPTION DATE DRAWN BY CHECKED BY APPROVED BY SEE SHEET 1 5V o R19 100K 5 2 R3 1 a LM317 6 8 D1 POGO PINS IRLML5103 3 2 D V O VIN VOUT 1 27015 Cl ADU 18 MRA4003 R4A 8482 R4C2 2402 R6 R46 62 gt 62 gt 62 gt 62 gt 121K 6 19K 1 4 D A 55 5 Q3 R7 R45 P6SMB6 8AT3 tur IRLML2402 3 01K D4 ZN R55 Q1 1 P6SMB15AT3 DI IRLML2402 R5 NA 10K 1K WZ Ww x J6 EA 2 1 VO R15 R23 R24 devo 16K 10K 1M P 3v my R25 1 Gib 10K ze 45V C7 9 45V 100pF KAN R22 tur V 10K M 6 D10 ICS1702 LM393A SO AT B OPRF x L 9 2 SEL MMBD914LT1 R27 2 14 AUXO A Ror AKA ma 1 15 Axi 1 10K 1M 3 18 4 prsEL MM1 4 R26 2 12 RC 1 SV RED1 lt lt AKA 4 MRN OT1 MOLEX 3 R56 WZ 10K AAA 2 05 lt lt LM393A SO WA 5V o E 3 A RESPIRONICS Title v BILICHEK CHARGER PCA Size Document Number Rev S1014726 0 Date Wednesday October 30 2002 Sheet 2 of 3 5 4 3 2 1 1014988 BiliChek Service Manual RESPIRONICS Charger Base PCB Schematic continued 1014988
3. Z N MMSZ5237BT1 Tx 10uFZT 1uF Ee lte ele V 8 2v 5 K 5V B P R50 10 EH Per d R34 4K 3 1 Pra C P 100 2 R36 10K 5 4 lt 2 R37 wow 1 AAP R38 10K 10 NA R39 10k 4 ui R40 10K c9 PAT R41 10K Osci H2 MR1 A pl KRD2 R42 10K PA4 1 2 S 4Mh Ge 0862 HZ u2 18 Hi PAO 0 fr RESET 3 CZ GREEN IRQ 2 SOT A4 Y4 al PB2 4 cH 5 YE 18 f 5 0 9 Vad PB1 2 amp MM1 A6 Y6 Vss PBO PFI ce AT YE 68HC05J1 m y 5 2 avla Y Ka mig 2 MM74HC541 GNI 4 6 8 5Vo 2 10 R53 9 53K NOTES 1 INDICATES ITEMS NOT INSTALLED 9 0 5 RESPIRONICS R54 THIS SCHEMATIC WAS CREATED 1 05K USING ORCAD TO REPLACE THE We is SCHEMATIC DEVELOPED USING BILICHEK CHARGER PCA SCHEMA THIS SCHEMATIC WAS us T Document Number NOT USED FOR BOARD LAYOUT 1014726 1 ot 3 Wednesday October 30 2002 Sheet 1 1014988 BiliChek Service Manual RESPIRONICS Charger Base PCB Schematic continued
4. TN A BiliChek bes Non Invasive Bilirubin Analyzer BiliChek Service Manual RESPIRONICS This BiliChek system is the subject of U S Patent US patent 5 353 790 5 792 049 5 860 421 5 924 981 6 002 482 6 045 502 6 192 734 and patents pending BiliChek is a trademark of Respironics Inc 1014988 BiliChek Service Manual RESPIRONICS Limited Warranty Respironics warrants that the BiliChek device shall be free from defects of workmanship and materials and will perform in accordance with the product specifications for a period of one year from the date of sale by Respironics If the product fails to perform in accordance with the product specifications Respironics will repair or replace at its option the defective material or part Respironics will pay customary freight charges from Respironics to the dealer location only This warranty does not cover damage caused by accident misuse abuse alteration and other defects not related to materials or workmanship Respironics disclaims all liability for economic loss loss of profits overhead or consequential damages which may be claimed to arise from any sale or use of this product Some states do not allow the exclusion or limitation of incidental or consequential dames so the above limitation or exclusion may not apply to you This warranty is given in lieu of all other express warranties In addition any implied warranty including any warranty of merchantability
5. 13 5 Battery Pack Repair Replacement The BiliChek battery pack contains 5 Ni Cd batteries and is a sealed unit Any attempt to open will destroy the pack It is not repairable and will be exchanged at no charge during warranty Out of warranty replacements may be purchased from Respironics or your local distributor 1014988 NOTE For diagnosis of suspected battery pack failure see section 11 1 and section 11 3 1 NOTE Batteries must be disposed of properly and in accor dance with local ordinance Do not incinerate or throw in trash or land fills 14 0 Software Upgrades As software upgrades are required for system options or enhancements instructions software and any required tools or equipment needed for the upgrade will be sent if requested NOTE There may be a charge for software upgrades that are not required for product safety or effectiveness Check with your local distributor for information regarding upgrades BiliChek Service Manual 34 RESPIRONICS 15 0 Respironics Customer Service and Product Support Contact Information Respironics is committed to customer satisfaction and may be contacted with any questions or for technical support For technical assistance contact Respironics Customer Satisfaction US and Canada Phone 1 800 345 6443 Fax 1 800 886 0245 International Phone 1 724 387 4000 Fax 1 724 387 5012 Visit respironics Home Page on the World Wide Web at www respironics com or e
6. No Yes charged and is ready NOTE Allow about 3 seconds for the BSI light s to illuminate Check to ensure that the battery pack is seated in the well and power is applied to the charger base Try another battery pack If the BSI illuminates with the second battery pack first battery pack is defective Order a replacement battery pack from your distributor The battery pack is fully for use in an HHU The battery pack is charging Leave it in the charger base untill the BSI light glows green See note 1 below Test the power supply in the following manner Check the incoming line voltage from the mains circuit It will be either 115 VAC or 220 VAC depending on your locale If the incoming power is OK plug in the power supply and check it s output voltage at the connector that plugs into the charger base It should be approx 12 VDC If the output is incorrect the power supply is defective and must be replaced Contact your distributor for a replacement If the power supply is operating correctly connect the power supply to the charger base If the BSI lights do not illuminate the charger base is defective and must be repaired or replaced For repair see section 11 3 of this manual schematics and drawings and for replacement contact your distributor Is the BSI blinking Red Try another battery pack If the second
7. apply a new SE BiliCal may be used to protect the fiberoptic BiliCal Individual Calibration Tip immediately prior to per e Ih anit im a automaticall forming a test Inaccurate test results will occur if this is not done Removal of the tip after calibration and prior to a patient measurement will result in loss of calibration The entire calibration sequence must be repeated with a new calibration tip 1014988 BiliChek Service Manual 17 RESPIRONICS 11 0 Troubleshooting Guide 11 1 Troubleshooting Guide Indication Solution No user set up information identified Install a charged battery pack into the HHU Press 1 and F2 at the same time hold for one second and then release This places the HHU in the Set up mode Enter settings specific to your institution See section 10 0 of this manual for Set up Mode instructions Calibration measurement is unacceptable Press and release F1 and F2 at the same time Ensure tip is in place and retry the calibration If the error continues 1 Place a fully charged Battery Pack in the HHU install a new BiliCal Tip and try again to calibrate several times 2 Remove and rotate the BiliCa tip and retry 3 Replace the measurement light bulb see Section 14 1 for instructions and retry Ifthe error is still present the HHU has malfunctioned and requires service Call Respironics or your distributor Patient measurement is unacceptable Press
8. mail service respironics com or clinical respironics com 1014988 BiliChek Service Manual 35 Reorder B800 25 RESPIRONICS Www respironics com RESPIRONICS 1001 Murry Ridge Lane Murrysville Pennsylvania 15668 8550 USA RESPIRONICS Deutschland Gewerbestrasse 17 82211 Herrsching Germany Revision 1014988 DS 07 14 03
9. or fitness for the particular purpose is limited to years Some states do not allow limitations on how long an implied warranty lasts so the above limitation may not apply to you This warranty gives you specific legal rights and you may also have other rights which vary from state to state The warranty for repairs is ninety days for labor and one year on the part s that was replaced To exercise your rights under this warranty contact Respironics Inc at 1 800 345 6443 US and Canada only or 1 724 387 4000 Visit Respironics Home Page on the World Wide Web www respironics com e RESPIRONICS RESPIRONICS 1001 Murry Ridge Lane Deutschland Murrysville Pennsylvania Gewetbestrasse 17 15668 8550 USA 82211 Herrsching Germany RESPIRONICS Table of Contents 11 1 Troubleshooting Guide 18 11 2 Troubleshooting Flow Chart 20 11 3 Drawings and Schematics 22 1 0 Symbols 5 11 3 1 Battery Pack Electrical Schematic 22 11 3 2 Charger Base Exploded View Drawing 23 2 0 Purpose of the 1 6 11 3 3 Charger Base PCB Schematic 24 11 3 4 Charger Base PCB Component Layout 28 3 0 Theory of Operation 0000000000000000000000000000000000009 6 11 4 HH
10. read SET and either mg dL or mol L will be displayed NOTE The default value is mg dL 1014988 BiliChek Service Manual Press F2 to toggle between values F1 to accept your choice and advance to the next function Ce JC Automatic power off time interval To conserve battery power the unit has an automatic time out feature which turns the unit off if it is idle for a specified time period L d NOTE The default time is set at 120 seconds Press F2 to toggle between the 60 or 120 second choices and F1 to accept your choice and advance to the next function IIn IL LJ Selecting the time format The system will display time in either the 12 hour or 24 hour format NOTE The 12 hour format is the default setting 15 RESPIRONICS Press F2 to toggle between the formats and F1 to Press F2 to toggle between the formats and F1 to accept your choice and advance to setting the time accept and to advance to setting the date gH sane Lass Setting the date Setting the time Depending on the format selected the current month or day After choosing the time format SET appears on the display digit will flash and the current clock time will be shown Press F2 to scroll through the choices The hour digits will be flashing Press F1 to accept and the next digit will begin Press F2 to scroll through the hours flashing Press F1 to accept the hour and the minute digit
11. the hand held unit into the charger base well as shown on page 12 of this manual The indicator light will glow amber to indicate that the battery pack is being charged consult section 11 2 Troubleshooting Flow Chart of this manual if the indicator is blinking red or not illuminated Now insert the auxiliary battery pack into well as shown on page 12 of this manual The BSI will glow amber to indicate that it is charging Charge both battery packs fully until green lights are displayed on both BISs page 12 BiliChek Service Manual 13 RESPIRONICS 9 0 Set Up Mode To initially set up the BiliChek or to customize it for a spe cific institution the following list of features can be changed from the initial factory settings Select audio On Off Select the measurement units mg dl or Umol L Set the automatic power off time interval 60 or 120 seconds Select the time format 12H or 24H Set the current time Select the date format MO DA or DA MO Set the current date em Audio Measurement 1 Reading _ 4 Measurement Units L BB 88 Time Format Dead Battery Icon gt Ix 88 88 88 22 25 Date Format Low Battery Icon 1014988 To Turn The Unit On Install a fully charged battery pack Ensure that the battery pack is fully in place and latched If EOO is displayed see Section 11 0 of this manual Press an
12. 4988 BiliChek Service Manual 30 RESPIRONICS NOTE The following sub errors are displayed in the date field Firmware version 2 3 3 6 and below 0256 External reference voltage outside of limits 0512 5V analog supply below limit 1024 Programming voltage below limit 2048 Clinical Error 4096 Internal system error detected during clinical testing 8192 Microspectrometer SN 000000 Firmware version 2 4 3 8 and above 0128 Programming voltage below limit 0256 0512 Internal system error detected during clinical testing 1024 Microspectrometer SN 000000 1014988 BiliChek Service Manual 51 RESPIRONICS 12 0 Routine Operator Cleaning The BiliChek System is made of an easy to clean material with a smooth textured surface One of the following clean ing agents is recommended for cleaning the exterior of the HHU Battery Charger Base and Battery Packs KleenaSeptic Cavicide 70 to 9096 Isopropyl Alcohol solution 1 Bleach solution Spray the cleaning agent on a soft damp cloth and wipe clean the BiliChek system The same procedure can be used to clean the display window Caution Clean the measurement tip with 90 or higher Isopropyl Alcohol using a soft optical surface cleaning wipe WARNING Do not immerse any part of the system in water or other liquid If liquids spill onto the unit wipe with a damp cloth and allow to dry prior to using the system WARNING Do not attempt to clean and
13. EM 7 6cm 9745 V De s 12 1cm BiliChek Hand Held Unit NL 12 4cm Weight with battery pack mmm 346g PF E al 264g DIMENSIONS ae NT M See figure below Light Bulb pe lem gt 21 65cm YPE eanas Tungsten loris cil mue eod Minimum measurements FRONT 4 SIDE Power Supply VIEW S46cm 781M VIEW j D Domestic m ON ia 120V 60Hz ce AA 12 VDC 0 75 Amp Battery Packs e Type dl ln a ane Ni Cd nternational Dimensions Sapite a R 100 240 VAC 10 STEE 6 5 47 63 Hz de A 4 8cm 2 E 3 5cm aedes o n engan eon 12 VDC 2 75 Amp Weight rcseo mairei 147g WEITEN 6V Environmental Conditions for Use 700mA Hrs BiliChek System and Individual Calibration Tip may Measurements per full charge Minimum 100 be stored at 40 C to 60 C 40 F to 140 F with on a single noncondensing relative humidity of 95 for a duration of at charge least 24 hours Minimum 1 year Recharge 4 6 hours BiliChek System and BiliCal Individual Calibration Tip are maximum intended to operate between temperatures of 5 C to 40 C e Discharge and Recharge Cycle 9 2 hours 41 F to 104 F with 0 to 85 relative humidity without maximum condensation 1014988 BiliChek Service Manual 10 RESPIRONICS 7 0 Functional Description BiliChek Hand Held Unit HHU The BiliC
14. U Error Code List 29 40 Warnings and Precautions eee 8 12 0 Routine Operator Cleaning 33 5 0 Description of the BiliChek System 9 13 0 Maintenance and Repair Replacement 33 13 1 HHU Measurement Bulb Replacement 33 6 0 System Specifications 000000000000000000000000000000090009 10 13 2 Charger Base Repair ENEE 34 13 3 Hand Held Unit HHU Repair 35 7 0 Functional Description m M 11 13 4 Power Supply Repair Replacement eet 35 13 5 Battery Pack Repair Replacement 35 8 0 Initial Set UpP ssssssssssssvssessssssssssssresessssrssssssssssosss 13 14 0 Software Upgrades sccssccsssecssssssessssssessoesees 35 9 0 Set up 14 14 1 Upgrade Instructions ccccccccccccecccseseseeeeee 35 10 0 Operation of the Device 17 15 0 Customer Service and Product Support 10 1Performing a Calibration 17 Contact Information aeo oria sensen han sens 36 10 2Performing a Measurement 17 11 0 Troubleshooting aorta totae onn noob adorno 18 Table of Contents RESPIRONICS 1 0 Symbols Symbol for Attention e Symbol for Battery Deep Discharge T See Instructions For Use and Recharge Symbol for Use With e Symbol for battery Charging Di e Symbol for Rechargeable Batter
15. ack in the charger base 12 RESPIRONICS NOTE When Deep Discharging the battery pack the BSI will blink amber during the discharge cycle become constant amber when recharging and then green when fully charge NOTE IF the BSI is flashing red when the battery pack is in place try resetting the battery pack in the charging well If the problem persists try another battery pack If the problem continues the charger base has malfunctioned and needs service 8 0 Initial Set Up Visually inspect that all components are without physical damage Plug the power cord into the power supply and then into a grounded outlet Connect the power supply to the charger base by inserting the plug into the socket on the rear of the charger base The Battery Status Indicator BST lights will flash red green amber and then off approxi mately 1 second each to indicate proper operation Connect Power Supply to Charoer Socket 1014988 To install the battery pack insert the bottom of the battery pack into the bottom of the BiliChek hand held unit and then rotate battery and snap it into place To remove the battery pack press the release latch at the top of the battery pack and rotate it out of the BiliChek hand held unit Install and Remove Battery Pack Before the initial use both battery packs should be fully charged After installing one of the battery packs into the BiliChek hand held unit insert
16. alibra tions as outlined in Section 10 1 of this manual until a successful calibration is achieved WARNING There are no serviceable components in the HHU Removal of the junction screw and attempting to separate the upper and lower housings of the HHU can cause irreversible damage to the internal fiber optics and will invalidate the manufacturers warranty 13 2 Charger Base Repair and Replacement The BiliChek charger base is a micro processor controlled smart charger with Deep Discharge and Recharge capabili ties It requires a 12VDC 0 75 Amp Domestic input from the power supply NOTE Use only the power supply specified by Respironics 1014988 BiliChek Service Manual Defective charger bases will be replaced at no charge during the warranty period After the warranty period if desired the charger base may be repairable however attempts to remove the main PCB can cause permanent damage to the charger To open and inspect repair the charger base the following procedure must be followed To reassemble reverse the procedure Gently remove the 4 clear plastic feet to expose the 4 assembly screws Using small tipped Philips screwdriver remove the 4 screws Gently separate the upper and lower case Inspect the LED connections to ensure that they are securely connected Connect the charger base to the power supply being careful not to short the PCB to tools etc Note Anti Static pro
17. ance can be quantified and is correlated to the laboratory total serum bilirubin levels BiliChek Service Manual 7 RESPIRONICS 4 0 Warnings and Cautions Caution US Federal Law restricts this device to sale by or on the order of a physician Warnings 1014988 The BiliChek Hand Held Unit is to be operated only in conjunction with Respironics approved charger base battery packs power supply and BiliCa Individual Calibration Tips Do not point at eyes while taking a measurement Not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrous oxide Do not use in areas of the skin with visible brusing If you suspect BiliChek is interfering with other electronic devices or vice versa try the following measures to correct it e Relocate the device until the interference stops Move the BiliChek further away from the device e Plug the BiliChek power supply into a different power outlet so that the BiliChek power supply and the device are on different breaker or fuse circuits Do not puncture or incinerate the battery pack or dispose ofin a landfill Batteries should be disposed of properly according to local guidelines Do not use outdoors or place in direct sunlight The charger base unit battery charger should be plugged into a properly grounded outlet Do not operate with damaged plug or cord Cautions The BiliCal Individual Calibration Tip should not be exp
18. and release F1 and F2 at the same time Take another measurement If E02 occurs again replace the BiliCa tip repeat calibration and retry the measurement If the error is still present the HHU has malfunctioned and requires service Call Respironics or your distributor BiliCa Individual Calibration Tip removed between calibration and measurement scan Press and release F1 and F2 at the same time Remove the Individual Calibration Tip Replace with a new tip and recalibrate Too much movement during measurement High Measurement is out of clinically proven range Press and release F1 and F2 at the same time Perform another measurement Obtain a Total Serum Bilirubin level TSB Light bulb is burned out System error is detected Replace measurement light bulb see section 14 1 for instructions If error continues the HHU has malfunctioned and requires service Call Respironics or your distributor Call for Service Low battery pack Maximum of 10 measurements left Replace current battery pack with a fully charged battery pack from the charger base and place the discharged battery in well B for charging Discharged Battery pack No measurements can be taken Replace current battery pack with a fully charged one from the charger base Place the discharged battery pack into well B for charging RESPIRONICS 11 2 Troubleshooting e Flow Chart Hand Held Un
19. battery pack gives the proper indication the first battery pack is defective Order a replacement battery pack from your distributor If the BSI continues blinking red with the second battery pack the charger base is defective and must be repaired or replaced NOTES 1 Ensure that the black switch located on the bottom of the charger base is in the left position charge only If the BSI is blinking amber the charger is in the deep discharge recharge mode and the battery pack is discharging The BSI will glow steady amber when the battery pack is charging and green when the battery pack is fully charged 2 Ensure that all contacts on both the battery pack and the charger base are clean not bent over or broken off and free of any obstructions BiliChek Service Manual 20 RESPIRONICS 11 3 Drawings and Schematics 11 3 1 Battery Pack Electrical Schematic THERMIST P pom ITCH Votage Readings Using a standard Digital Voltmeter the following voltage readings will be obtained from a fully charged battery Pin 1 to Pin 4 7 0 VDC x depending on polarity of leads Pin 5 to Pin 7 7 0 VDC x depending on polarity of leads Pin 5 to Pin 6 7 0 VDC x depending on polarity of leads Pin 6 to Pin 7 0 0 VDC NOTE The battery packs have three 3 contacts on one end and four 4 contacts on the other end Holding the battery pack with the contacts towards you the contacts are n
20. d release either F1 or F2 The unit will turn on and boot up the system During this boot up the software checks the main software activates the measurement light bulb Measurement Status Indicator and all LCD indicators The current software revision and current configuration are dis played The boot up will end at the home screen dis playing the last measurement time and date or display an error code message NOTE The BiliChek hand held unit does not have an OFF switch The power will automatically shut off if it is left idle for a specified period of time 60 or 120 Seconds F2 Button gray Display ve F MSI FI Button teal 4 Battery Pack 4 Trigger Button Disposable Tip BiliChek Service Manual 14 RESPIRONICS To Access the User Set Up Function Press F1 and F2 at the same time hold for one second until the display changes and then release to access the set up mode Use the F1 button to advance to the next item and the F2 button to change the value of the current item To exit the set up mode press F1 and F2 at the same time All changes that were made will be saved and displayed Audio On Off This function allows the user to turn the internal beeper on or off Press F2 to toggle the speaker beeper on and off and F1 to accept your choice and advance to the next function nr M Setting the measurement units The display will
21. e is applied Press and release the TRIGGER to start the Do not continue to increase pressure this will result in calibration cycle an E04 error NR uu Three dashes will flash in the display window The display will read 005 and will stop blinking and the MSI will be amber if a BiliCa Tip is in when proper pressure has been applied The measure place indicating the system is ready to calibrate If ment should take less than 2 seconds At the end of the a BiliCal Tip is not in place the MS will be red measurement a beep will sound if audio is on and indicating that a new tip should be applied the display will change to 004 Press and release the TRIGGER button The dashed Take 005 readings by lifting and replacing the tip on lines will stop flashing indicating that the unit is the forehead and pressing the TRIGGER button for calibrating each measurement The current measurement will be e When calibration is complete the MSI will be indicated on the display 005 004 003 002 001 amber you will hear a beep if the audio 1s on and When the 5 measurements are complete a beep will the display window will read 005 sound if the audio is on and the results will be dis NOTE If an error message is displayed during calibration per refer to section 11 0 of this manual for troubleshooting manufacturer s recommendation If the protective cap WARNING It is critical to calibrate the unit and
22. ee CH EH Hie HCH B DH Ph c LIC EM Ep RK Te elt di o n pe H d d o Wep 9 e o a o mp BOTTOM SEE NOTE 8 mane CONFIDENTIAL AND peor A PROPRIETARY INFORMATION BILICHEK RESPIRONICS INC SE TAS DOCUMENT S CONSIDERED BE CONFIDENTIAL AND PROPRIETARY BY RESPIRONICS PCA CHARGER BASE ALL DESIGN MANUFACTURING USE AND REPRO ASSEMBLY DUCTION RIGHTS RELATED TO THIS INFORMATION AND ALL SALES RIGHTS ASSOCIATED THEREWITH USE REPRODICTION DISTRIGUTION GF mds D 9 18 01 mmm W bata Ek Ee 0 PRIOR WRITTEN CONSENT OF RESPIRONICS arr s KELLOGG 2 23 98 E 21 umos Beri Wi 4 3 1 1014988 BiliChek Service Manual 23 RESPIRONICS Charger Base PCB Schematic continued XEV OW DESCRIPTION DATE DRAWN EY CHECKED BY RPPROVED BY EDE INITIAL WAS SPECTEX 1001067 672 03 p EALINIETH EDMS EDMS COAX POWER M TPS7350 45V 5V J1 9 4 mi SENSE R49 9 Ms 2 Som KK 5V wratoos_ _ or 012 1 c2 J 03 cis ZS 15
23. gain to calibrate If the error is still present change the measurement light bulb and try to calibrate NOTE It will take several If the HHU will not take skin measurements contact your distributor and request instructions for returning the defective HHU to Respironics for repair m Charger Base Place a battery pack in the charger base in the right hand well Well B Does the right hand BSI light glow Does the left hand BSI light glow No gt NOTE The indicator light will take about 3 seconds to illuminate Yes Observe the color of indicator Amber charging Green Fully charged Red Defective Battery pack See page 12 for amplification Yes Remove all battery packs and unplug the charger base Reconnect the charger base to power while observing the BSI lights CN es ha The BSI light seguence should be BOTH LIGHTS Red Green Amber Off Yes ha Insert a battery pack into the charger base right hand well Well v ce The charger base or the power supply is defective QN CD 1014988 BiliChek Service Manual 19 RESPIRONICS Troubleshooting Flow Chart continued 1014988 Is the BSI illuminated Yes Is the BSI Green Is the BSI Amber
24. has a near linear absorption spectrum in the visible spectrum and like the scattering phenomenon there is greater absorption of photons with shorter wavelengths than in the red region of the spectrum Conversely hemoglobin is a much more complicated absorber which is compounded by the fact that oxyhemoglobin and deoxyhemoglobin have different profiles The peak absorption of photons by bilirubin occurs at a wavelength of 460nm This is in the blue portion of the spectrum and is the reason why blue lights are sometimes preferred for phototherapy It is also in the region of the spectrum at which hemoglobin absorption is relatively low RESPIRONICS Theory of Operation continued The light reflected from the skin of neonates and collected by the BiliChek Non Invasive Bilirubin Analyzer is analyzed with a highly sophisticated proprietary algorithm to generate a serum bilirubin measurement The major skin components 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 The total OD at each measured wavelength is equal to the sum ofthe component ODs This is represented mathematically as OD sora OD perm OD 00 OD By utilizing known spectral characteristics of each component the contribution to the total OD can be sequentially subtracted until bilirubi
25. he 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 The BiliChek HHU is placed in the left hand well A with the display window facing the operator The spare battery pack is placed in the right hand well B with the latch up and facing the operator Caution The BiliChek Hand Held unit will not fit in well B of the charger base The battery pack can fit into well A but may not make correct connection to the charger base BiliChek Service Manual 11 RESPIRONICS In order to maintain optimal battery performance and battery life the battery packs should periodically be fully drained of power The charger base has the ability to manually drain the battery by using the Charge Deep Discharge 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 H position and place the battery pack in the charger base The discharge recharge cycle will take approxi mately 4 6 to 9 2 hours depending on the amount of the charge in the battery pack The green light will illuminate when the battery pack has completely discharged and recharged After both battery packs have been discharged place the Deep Discharge switch in the left D I position Caut
26. hek Hand Held Unit consists of the following func tional components 1 TRIGGER button The single button the bottom of the unit is called TRIGGER It is used to initiate calibration and patient 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 device calibration before each patient measurement protection of the fiber optic probe protection of the surface of the calibration material positioning aid to ensure proper placement of the probe a clean surface for each patient measurement Bore 4 Display window The display window shows the bilirubin measurement time and date audio and battery icons Measurement Status Indicator MSI as well as other system and error messages 1014988 9 Battery Pack Located in the bottom portion of the handle it provides the electrical energy to operate the iouscomponents F2 Button gray Display fe zz ee NI CH MSI Button teal a Battery Trigger Button Disposable Tip Charger Base The charge base contains two wells A and B which recharge the battery pack in the BiliChek HHU and a spare battery pack respectively T
27. ion Leaving the Deep Discharge switch in the right Hi position at all times will drain the battery pack before every recharge This will increase the duration of the recharg ing cycle and may reduce the overall life of the battery packs NOTE If the battery pack is moved or bumped during the recharge phase of the deep discharge cycle the deep discharge cycle may begin again pn 4 NN Detail Bottom View gt Charge Deep Discharge Switch Charge Deep Discharge Switch 1014988 BiliChek Service Manual The Battery Status Indicator BST Battery pack not sensed in Ensure battery pack is well or charger base not properly seated in properly connected to power well check power supply connections Try another battery if BSI is still off If BSI is still off with second battery the Charger base itself has malfunctioned and requires service Battery pack is fully charged pack is ready or use Battery pack in the well is Continue charging charging but not ready for use until BSI color is green Continue discharging and recharging until BSI color is green NOTE BSI will become steady amber when deep discharge phase of cycle is ended and charging is in progress Battery pack in the well is deep discharging Replace the battery pack If the problem 1s still present with a new battery pack the charger base itself has malfunctioned and requires service Bad battery p
28. it HHU Y Make sure there is a fully charged battery pack in the NOTE battery pack try check the battery pack output with a HHU Press and release either button on top of the HHU F1 or F2 A Does MSI light glow se section 10 0 of this menus Yes Does the display come on Yes Record the display information Refer t o Troubleshooting guide Section 11 1 Will the HHU calibrate No trys to calibrate after a light bulb change If the error is still present record the error sub error code Yes information found in section 11 0 and ha contact your distributor to request Take 5 skin instructions for returning the defective HHU to Respironics for repair measurements No Yes gt The HHU is operating correctly and can be returned to use multimeter It should be between 7 and 7 5 Volts DC Try another Battery pack Place a battery pack in the HHU and place the HHU After the second in the charger base left hand weli Well No a Ce NOTE If the display is fragmented segments missing the HHU is defective Contact your distributor for instructions on the return of defective HHU to Respironics for repair Try several times If still no calibration remove and rotate the Bili Ca tip and try a
29. k and a new BiliCa tip If error persists HHU requires service Peak pixel not found Install a fully charged battery pack and try several calibrations with new BiliCal tips If error persists HHU requires service Stray Light Slope Error Install a fully charged battery pack and try several calibrations with new tips If error persists HHU requires service Mean of dark scan data above threshold Install a fully charged battery pack and try several calibrations with new BiliCal tips If error persists HHU requires service BiliChek Service Manual 28 RESPIRONICS Error E02 Measurement Sub Errors Description 000001 Light intensity below lower threshold specified in data configuration parameters Try several calibrations and measurements If error persists try on another patient If error persists on several patients HHU requires service 000002 Light intensity above upper threshold specified in data configuration parameters Same as in 000001 000008 BiliChek bilirubin measurement below lower limit Same as in 000001 008192 Stray Light Slope Error Try several calibrations and several tips If error persists HHU requires NOTE Firware service Version 2 2 4 3 8 Only 016384 Mean of dark scan data above threshold Try several calibrations and measurements If error persists HHU requires service Error E03 Disposable Disposable tip removed after calibration and before measurements completed E
30. 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 collide with the structural components such as collagen fibers When a collision occurs the photon loses energy and direction of travel is changed This is called a scattering event If enough of these scattering events occur the photon completely loses its energy and is absorbed If a photon is scattered such that it is re emitted from the skin it is reflected 1014988 BiliChek Service Manual Photons with longer wavelengths in the red region of the spectrum are scattered less than photons with shorter wavelengths in the blue region of the spectrum This phenomenon is called wavelength dependent scattering and explains why the skin appears red when you shine a bright light through it It is also one of the reasons why the optical properties of the newborn s skin changes with advancing gestational and post natal age As the skin matures it becomes thicker and there is greater keratinization of the cell membranes which increases the scattering of incident light Photons of specific wavelengths are also preferentially absorbed by certain molecules By plotting the absorption against the wavelength one can visualize characteristic absorption spectra of the particular molecules For example melanin
31. mm d i 20250 EI E R35 04 01 06 05 a3 rm YI i mI C13 mn Pu ALI 059 5 s 0 ni EECH po Pez HS 1 PG Fei Oros 1 1 4 D3 1 1 1 t 1 t 2i gengen SE DCH DCH a I Rael nem T n54 n53 al DU EL cy gn too 400 cs R52 R58 ol a cli n AG 15 LU at eu e e m po R56 1 R24 010 KS 08 gt gt gt a 4 e H o EJ a 3 gt vw BiliChek Service Manual 27 RESPIRONICS 11 4 Hand Held Unit HHU Error Code List with Explainations NOTE sub errors are displayed in the date field unless specified otherwise in each section See Illustration at the top of page 32 Error E01 Sub Errors 000001 000002 000004 000008 008192 NOTE Firware Version 2 2 4 3 8 Only 016384 1014988 Calibration Description Reference component out of range Install a fully charged battery pack and try several calibrations with new BiliCal tips If error persists HHU requires service Dynamic integration time out of range Install a fully charged battery pack and try several calibrations with new tips If error persists install a new measurement light bulb and try calibration several times If the error still persists the HHU requires service Shape index above threshold Try a fully charged battery pac
32. n is all that is remaining Non Invasive Skin Spectral Components bilirubin blood melanin Optical Density dog Reflectance i5 900 500 600 700 800 nm 300 400 Jacques S Saidi I Ladner A and D Oelberg Developing and optical fiber reflectance spectrometer to monitor bilirubinemia in meonates 1014988 Each of these components have also been considered in the development of the algorithm by which the BiliChek Non Invasive Bilirubin Analyzer 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 BiliCa Individual Calibration tip the variations over time of the bulb and the photo detectors are eliminated The peak absorption of the bilirubin 1s at approximately 460nm as measured by subtracting the absorption of the other components from the total skin absorption This is represented by the equation below OD TOTAL OD OD OD MEL HEME OD BILI DERM The absorption of light by a molecule is proportional to its concentration Therefore the absorption of bilirubin as calculated above is proportional to the concentration of bilirubin in the subcutaneous capillary beds and subcutaneous tissue By subtracting the contribution of the aforementioned components the bilirubin absorb
33. nsure tip is firmly attached an try another calibration and measurement NOTE This error can also occur if HHU is operated in sunlight or other bright light Cover the IRDA port on the front of the HHU and perform another calibration and another measurement Error E04 Movement Excessive movement detected during measurement Take another measurement ensuring no movement of the BiliChek hand held unit while the MSI is green Error E05 BiliChek Bilirubin Measurement High BiliChek Bilirubin measurement is above the upper threshold The BiliChek Non Invasive Bilirubin Analyzer has an upper threshold of 20 mg dl or 340 mol L set in the software If readings are above this threshold a blood sample must be taken to measure the TSB level 1014988 BiliChek Service Manual 29 RESPIRONICS HHU Error Code list with Explanations continued Error E10 No Lamp Current Measurement lamp burned out Replace measurement lamp and perform several calibrations until HHU calibrates If HHU will not calibrate after numerous tries HHU requires service Error E99 Fatal Fatal software error The HHU must be returned for service Contact your distributer to request instructions to return to Respironics for repair The following tables are for information only If an E99 occurs record the sub error and place a note with the HHU when returning it for service Error E99 Fatal Sub Error Tables 0001 0004 0008 0016 0032 0064 0256 101
34. or reuse the BiliCa Individual Calibration Tip 1014988 BiliChek Service Manual 13 0 Maintenance and Repair and Replacement 13 1 Hand Held Unit HHU Measurement Light Bulb Replacement If the instrument bulb is not working and error code E01 or E10 refer to the troubleshooting section 11 4 is displayed it is necessary to replace the measurement light bulb A Re placement Bulb Kit RI P N B800 22 is available from Respironics or your local distributor WARNING The BiliChek Non Invasive Bilirubin Analyzer is to be used only with the approved Replacement Bulb Kit from Respironics Do not over tighten the lamp Remove the battery pack from the bottom of the HHU Remove the protective label covering the lamp assembly Remove the lamp cap using a flat tip screwdriver Grab the loop of the light bulb with forceps or similar tool instrument and gently pull to remove the lamp assembly Insert the replacement lamp assembly using caution not to touch bulb with fingers Be sure to place bulb into socket firmly DO NOT use the lamp cap to tighten bulb into place Apply the new lamp cap and protective label furnished in the kit Insert a fully charged battery pack into the bottom of the HHU 32 RESPIRONICS 13 1 HHU Measurement Light Bulb Replacement continued Attach a new BiliCa Individual Calibration Tip to the BiliChek hand held unit Turn the instrument on and perform repeated c
35. osed to light for extended periods of time Keep BiliCal Tip in 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 Avoid using measurement sites when the following conditions since they can produce erroneous results Brusing Birthmarks Hematomas Excessive hairiness The BiliChek should not be used on patients who have undergone an exchange transfusion BiliChek Service Manual 8 RESPIRONICS 5 0 Description of the BiliChek System The BiliChek System REF B809 or B801 consists of a hand held unit REF B800 13 and the following items Quantity Description REF Number Rechargeable Battery Packs B800 20 Charger Base B800 21 1 Power Supply International B800 17 Bag of 10 BilEclipse Phototherapy Protective Patch B800 12 BiliChek Manual International 2 Bag of 10 lt BiliCal Disposable Calibration Tips Protective Cover Disposable Tp gt 4 BiliChek Hand Held Unit Bag of 10 BilEclipse Phototherapy Protective Patches N Rechargeable Battery Packs Charger Base 1014988 BiliChek Service Manual 9 RESPIRONICS 6 0 System Specifications tb ene BiliChek System DUE U
36. s will Press F2 to scroll through the choices begin flashing Press F1 to accept and the first year digit will begin Press F2 to scroll through the minutes flashing Press F1 to accept your choice and advance to the next Press F2 to scroll through the digits function Press F1 to accept and the second year digit will begin flashing Press F2 to scroll the digits J LU Press F1 to accept and the date will be saved and the Ig display will return to the home screen Selecting the date format The unit will display the date in the Month Day format or the L Day Month format 01 NOTE the Month Day format is the default setting RESPIRONICS 10 0 Operation Of The Device 10 2 Performing A Measurement 10 1 Performing A Calibration After performing a calibration peel the protective Apply new BiliCal Individual Calibration Tip cover from the BiliCa Individual Calibration Tip and to the unit dispose of it Nu Firmly press the tip onto the BiliChek hand Press and release the TRIGGER button The unit is held unit to ensure proper seating of the Tip now activated and ready to take a measurement Press and release either F1 or F2 Gently press the tip against the infant s forehead The The unit will perform its self test displaying all Measurement Status Indicator MSI will change LCD indicators and end at the home screen from amber to green when proper pressur
37. tection is required to prevent possible damage to the micro processor Using the Schematic in Section 11 3 3 of this manual a standard Digital Multi meter Oscilloscope and small electronic service hand tools perform problem diagnosis and repair Re apply power to the charger base and place battery in well Monitor BSI for correct indication see section 12 Reassemble the charger base The small spring loaded battery contact pins in the charger base wells can be removed and replaced in the event they become bent or broken 33 RESPIRONICS Gently grasp the pin with a pair of small needle nose pliers or equivalent and pull straight up Once the pin is removed a new pin can be inserted in the same manner New pins RI P N 1014776 can be ordered from Respironics or your local distributor 13 3 Hand Held Unit HHU Repair The Hand Held unit HHU is not field serviceable with the exception of the measurement light bulb The unit must be returned to Respironics for service Ifthe HHU is opened the accuracy of the instrument cannot be guaranteed and any remaining warranty will be voided 13 4 Power Supply Repair Replace ment The power supply has no serviceable components In the event of failure it must be replaced If the failure occurs during the warranty period of the system it will be replaced at no charge by Respironics Out of warranty replacements can be purchased from Respironics or your local distributor
38. umbered from left to right 11 33 Charger Base Exploded Views p BSI LED and cover assembly BSI LED and cover assembly Cutaway view showin g battery contact pin assembly NS 12 0088 sy NT trae CH n Co K i Bottom View of Charger base Exploded view of physical assembly top and bottam of charger hase T BSI LED hamess assembiy RESPIRONICS 11 3 3 Charger Base PCB Schematic 4 3 1 wl REVIN RECORD E m cem wen EDMs INITIAL VAS SPECTRX 1001060 673703 cHALLvIRTH EDMS EDMS D D PLACE SOFTWARE REVISION LABEL o 54 E E Un o D 1 Inr o my o o e mm Dn fe Hor de ve R3 m WI SS D BE Tie l 1 ow Ur e corres 10 T O T N n Um 1 0 1 pcs DE p Orcs ooo i i H LU ci4 d d me tL
39. y Symbol for Do Not Reuse Recycle Corporation T 5 Symbol for Do Not Throw in Trash Symbol for Use By gt Symbol for Batch Code e Symbol for Nickel Cadmium Battery e Symbol for Indoor Use Symbol for Recycle 295 e Symbol for Class Symbol for Serial Number Symbol for Catalog Number REF e Symbol for Date of Manufacture Mfd taal o Symbol for Storage Conditions bern e Denotes this system is ETL Listed ETL ely and conforms to ANSI UL STD Bier e 2601 Certified to CAN CSA C22 2 STD NO 601 1 9800845 1014988 BiliChek Service Manual 5 RESPIRONICS 2 0 Purpose of the Device The BiliChek Non Invasive Bilirubin Analyzer accurately determines bilirubin levels in newborn patients without a blood sample regardless of their skin color gestational age or post natal age This product provides rapid point of care bilirubin measurements as a replacement for traditional clinical chemistry methods These results are achieved with no trauma to the patient no risk of infection and potentially reduced cost of monitoring serum bilirubin by minimizing the use of hospital personnel and supplies 3 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 which are returned By
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