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M1110150 006

Appendix D: Additional Safety Information

Symbols

The following symbol appears on the unit:

Symbol

Description

Consult accompanying documents.

Do not place items in radiant heat path.

Cover the patient’s eyes during phototherapy.

Checkout Procedures

Examine the unit for any missing or damaged labels.

Specifications

The product is designed to meet a life span of 7 years. However, with proper maintenance and repairs, the

service life can be extended as long as service parts are available.

Содержание BiliSoft

Страница 3: ...iSoft Light Box 5 BiliSoft Fiberoptic Light Pad Assembly 6 Soft Cover Options Disposables 7 Chapter 4 Troubleshooting 9 Troubleshooting Guide 9 Chapter 5 Replacement Checkout Procedures 13 Fuse Replacement 13 LED Module Replacement 14 Air Filter Cleaning Replacement 15 Accessing Replacing Other Internal Components 16 Checkout Procedures 16 Electrical Safety Checkout Procedure 17 Light Intensity Ch...

Страница 4: ...9 Electrical Specifications 29 Environmental Operating Conditions 29 Storage Requirements 29 Performance Specifications 30 Physical Specifications 30 Regulatory Standards 31 Chapter 9 Technical Reference 33 EMC Guidance 34 Appendix Additional Safety Information 39 Statements 39 Symbols 40 Checkout Procedures 40 Specifications 40 Warranty ...

Страница 5: ...in the text Repair Policy CAUTION The procedures described in this service manual should be performed by trained and authorized personnel only Maintenance should only be undertaken by competent individuals who have a general knowledge of and experience with devices of this nature No repairs should ever be undertaken or attempted by anyone not having such qualifications Genuine replacement parts ma...

Страница 6: ...ента е да осигури превод Не използвайте оборудването преди да сте се консултирали и разбрали упътването за работа Неспазването на това предупреждение може да доведе до нараняване на доставчика на услугата оператора или пациентa в резултат на токов удар механична или друга опасност ZH CN 警告本维修手册仅提供英文版本如果客户的维修服务人员需要非英文版本则客户需自行提供翻译服务未详细阅读和完全理解本维修手册之前不得进行维修忽略本警告可能对维修服务人员操作人员或患者造成电击机械伤害或其他形式的伤 ...

Страница 7: ... dojít k poranění pracovníka prodejního servisu obslužného personálu nebo pacientů vlivem elektrického proudu respektive vlivem mechanických či jiných rizik DA ADVARSEL Denne servicemanual findes kun på engelsk Hvis en kundes tekniker har brug for et andet sprog end engelsk er det kundens ansvar at sørge for oversættelse Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual ...

Страница 8: ...useosutaja operaatori või patsiendi vigastamist elektrilöögi mehaanilise või muu ohu tagajärjel FI VAROITUS Tämä huolto ohje on saatavilla vain englanniksi Jos asiakkaan huoltohenkilöstö vaatii muuta kuin englanninkielistä materiaalia tarvittavan käännöksen hankkiminen on asiakkaan vastuulla Älä yritä korjata laitteistoa ennen kuin olet varmasti lukenut ja ymmärtänyt tämän huolto ohjeen Mikäli tät...

Страница 9: ...εί και κατανοήσει το παρόν εγχειρίδιο σέρβις Αν δεν προσέξετε την προειδοποίηση αυτή ενδέχεται να προκληθεί τραυματισμός στον τεχνικό σέρβις στο χειριστή ή στον ασθενή από ηλεκτροπληξία μηχανικούς ή άλλους κινδύνους HU FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt akkor a vevő felelőssége a fordítás elkészí...

Страница 10: ...ビスマニュアルには英語版しかありませんサービスを担当される業者が英語以外の言語を要求される場合翻訳作業はその業者の責任で行うものとさせていただきますこのサービスマニュアルを熟読し理解せずに装置のサービスを行わないでくださいこの警告に従わない場合サービスを担当される方操作員あるいは患者さんが感電や機械的又はその他の危険により負傷する可能性があります KO 경고 본 서비스 매뉴얼은 영어로만 이용하실 수 있습니다 고객의 서비스 제공자가 영어 이외의 언어를 요구할 경우 번역 서비스를 제공하는 것은 고객의 책임입니다 본 서비스 매뉴얼을 참조하여 숙지하지 않은 이상 해당 장비를 수리하려고 시도하지 마십시오 본 경고 사항에 유의하지 않으면 전기 쇼크 기계적 위험 또는 기타 위험으로 인해 서비스 제공자 사용자 또는 환자에게 부상을 입힐 수...

Страница 11: ...ren eller pasienten skades på grunn av elektrisk støt mekaniske eller andre farer PL OSTRZEŻENIE Niniejszy podręcznik serwisowy dostępny jest jedynie w języku angielskim Jeśli serwisant klienta wymaga języka innego niż angielski zapewnienie usługi tłumaczenia jest obowiązkiem klienta Nie próbować serwisować urządzenia bez zapoznania się z niniejszym podręcznikiem serwisowym i zrozumienia go Niezas...

Страница 12: ...ent ar putea duce la rănirea depanatorului operatorului sau pacientului în urma pericolelor de electrocutare mecanice sau de altă natură RU ОСТОРОЖНО Данное руководство по техническому обслуживанию представлено только на английском языке Если сервисному персоналу клиента необходимо руководство не на английском а на каком то другом языке клиенту следует самостоятельно обеспечить перевод Перед техни...

Страница 13: ...cia del presente aviso puede dar lugar a que el proveedor de servicios el operador o el paciente sufran lesiones provocadas por causas eléctricas mecánicas o de otra naturaleza SV VARNING Den här servicehandboken finns bara tillgänglig på engelska Om en kunds servicetekniker har behov av ett annat språk än engelska ansvarar kunden för att tillhandahålla översättningstjänster Försök inte utföra ser...

Страница 14: ...cesi mevcuttur Eğer müşteri teknisyeni bu kılavuzu ingilizce dışında bir başka lisandan talep ederse bunu tercüme ettirmek müşteriye düşer Servis kılavuzunu okuyup anlamadan ekipmanlara müdahale etmeyiniz Bu uyarıya uyulmaması elektrik mekanik veya diğer tehlikelerden dolayı teknisyen operatör veya hastanın yaralanmasına yol açabilir ...

Страница 15: ...uipment T This letter appearing before a fuselink value indicates a time delay fuselink Cover patient s eyes during phototherapy On Off Standby Switch Unit overheated indicator Hour meter LED failure indicator Do not spray cleaner directly onto the fiberoptic lenses The fiberoptic lenses require special cleaning methods See cleaning section of this manual for complete details See the Operation Man...

Страница 16: ... clean the BiliSoft LED Phototherapy System or any of its parts CAUTION Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the service manual Portable and mobile RF communications equipment can affect Medical Electrical Equipment The BiliSoft LED Phototherapy System should not be used adja...

Страница 17: ...ipped When the solid state thermostat on the LED PCB is tripped the fan still gets 12V to help cool the box The Control PCB also delivers 12V to the Standby Switch lamp When the LED current sensor on the Control PCB detects that at least one pair of LED s is not working properly the LED module failure indicator on the Front PCB blinks When the thermostat on the LED PCB is tripped the unit overheat...

Страница 19: ...Switch Turns the unit on off The green light on the switch indicates that the standby switch is turned on and the unit is powered 2 Hour Meter The non resettable hour meter runs whenever the fiberoptic light pad is illuminated If the fiberoptic cable is not fully inserted into the light box the LEDs are automatically shut off and the hour meter does not run 3 Unit Overheated Indicator When the red...

Страница 20: ... right side of the light box BiliSoft Fiberoptic Light Pad Assembly The fiberoptic light pad comes in two sizes large and small The LED light source in the BiliSoft light box is focused on the fiberoptic lenses at the end of the fiberoptic cable connector The fiberoptic cable contains plastic fibers that transmit light from the light box to the light pad The light pad is constructed of these plast...

Страница 21: ...r or BiliSoft Nest when used with the patient Soft Cover Options Disposables The BiliSoft Pad Cover and BiliSoft Nest are designed for use with both premature and full term infants The BiliSoft Pad Cover and BiliSoft Nest are available in small and large sizes to accommodate whichever fiberoptic light pad is used BiliSoft Pad Cover BiliSoft Nest A flat cushioned cover with straps A cushioned cover...

Страница 23: ...ck that the air filter in the back of the unit and the air vents on either side of the unit are unobstructed 2 Inspect the air filter Clean or replace if clogged 3 Check that the environment that the unit is being operated in does not have ambient temperature above 35 C 95 F 4 Turn off the power and allow the unit to cool NOTE It can take up to 10 minutes for the thermostat to reset 5 Check that t...

Страница 24: ... fiberoptic pad connector switch C Standby switch is on but green indicator does not light green off 1 Check that the power cord is in good condition and properly connected at both the light source and the line power source 2 Check the fuses Replace if necessary 3 Remove the cover and check the AC input to the Power Supply at connector J1 If there is no AC voltage present replace the EMI filter or...

Страница 25: ...is fully inserted and that nothing is obstructing the port 3 Check the LED lenses inside the fiberoptic pad connector port for discoloration or damage NOTE See Operation and Maintenance Manual for approved cleaning procedure 4 Check the fiberoptic light pad and fiberoptic lenses on the connector for discoloration or damage NOTE See Operation and Maintenance Manual for approved cleaning procedure 5...

Страница 26: ... PCB and fiberoptic pad connector switch connections 3 Check the continuity through the switch If the switch is working replace the Control PCB If the switch is not working replace the switch K Hour meter is not working 1 If there is no light output see B 2 Check the connections on the Display PCB and the Control PCB 3 Check pin 3 on the Display PCB ribbon cable for voltage if voltage is present r...

Страница 27: ... Anytime the unit is disassembled back cover is removed the electrical safety tests and light intensity measurement procedure must be performed to assure that the unit is functioning properly Fuse Replacement Figure Procedure Fuses Fuse holder Power cord connector 1 Use a flat head screwdriver to pry open the fuse holder on the power cord connector EMI filter 2 Replace both fuses 3 Snap fuse holde...

Страница 28: ...iver to remove the four screws and lockwashers that secure the rear access cover 2 Remove the four LED module mounting screws 3 Disconnect the ribbon cable J2 4 Connect the ribbon cable to the new LED module and secure the LED module with the mounting hardware removed in step 2 5 Reinstall the rear access cover 6 Record the time from the hour meter in order to accurately track the LED module life ...

Страница 29: ... it 2 To remove the air filter use a Phillips screwdriver to remove the four screws and lockwashers that secure the rear access cover 3 Use a Phillips screwdriver and adjustable wrench or nut driver to remove the 4 screws lockwashers and nuts retaining the air filter 4 Clean or replace the air filter as needed 5 Attach the air filter using the hardware removed above in step 2 6 Reinstall the rear ...

Страница 30: ...ewdriver to remove the two screws on the back of the unit at the very top of the sheet metal plate 4 Carefully slide the inside chassis out from within the cover 5 Use the exploded views in the Spare Parts section of this manual for replacement of individual components 6 When completed slide the inside chassis back into the cover being careful not to pinch any wires 7 Reverse the steps above to cl...

Страница 31: ...Cover or BiliSoft Nest at this time 5 Use a properly calibrated Ohmeda Medical BiliBlanket Meter II to check the irradiance level of the unit using the template printed on the fiberoptic light pad There are two ways to check the irradiance level a center row quick check which provides approximate irradiance values and the more comprehensive 6 point for small fiberoptic light pad or 9 point for lar...

Страница 32: ...0 A B C D E F 6 70 Using an Ohmeda Medical BiliBlanket Meter II NOTE When the BiliSoft fiberoptic light pad is inserted into a BiliSoft Pad Cover or BiliSoft Nest the nominal spectral irradiance is 35 µW cm 2 nm 1 large pad 50 µW cm 2 nm 1 small pad Once the check is complete turn the unit off The unit is ready for use It is recommended that the BiliSoft LED Phototherapy System be checked with the...

Страница 33: ...5 foot pads 2 Back Cover Kit M1110057 includes back plate and label NOTE When replacing the back plate the old SN insert must be retained and transferred to the new back plate 3 Air Filter M1098511 E D L 2 1 Mounting Bracket screws 4 included in optional Mounting Bracket Kit M1097110 3 C M 4 C 4 Lettered hardware kits listed at end of parts section ...

Страница 34: ...nclosure Kit M1098512 includes enclosure side label set NOTE Proper language label must be selected from the label set and applied to the product 6 Standby Switch M1110058 7 Display PCB M1120981 8 Bezel Lens Kit M1120982 includes bezel lenses 2 lens retainers 2 4 8 6 5 A B 2 8 8 7 8 Lettered hardware kits listed at end of parts section ...

Страница 35: ... 10 heatsink and LED board 10 Fan Kit M1098497 includes mounting screws 4 11 Fuse Kit 6600 0730 214 includes 2 fuses T3 15A 250V slo blo type 12 EMI Filter M1098505 fuses sold separately 13 Control PCB M1185734 Refer to Note 1 after this table 14 Power Supply M1098503 P 4 13 12 11 I J 14 K O 4 9 G N 10 Lettered hardware kits listed at end of parts section ...

Страница 36: ...Bottom Plate Kit M1120993 NOTE When replacing the bottom plate the old SN should be written on the blank label Old Style Pad Connector units with serial number HFAL50306 or lower The external star washers O are placed under the board as shown above during assembly to provide the proper clearance New Style Pad Connector with raised switch mounting surface units with serial number HFAL50307 or highe...

Страница 37: ...hutoff Switch Kit M1185735 1 Power Supply Harness M1185736 1 Standby Switch Harness M1185737 1 Bilisoft units manufactured with the new connector design can be distinguished from the old design units based on their serial number That is units with serial number equal or greater than HFAN50501 are new design units Old design units have serial numbers less than HFAN50501 If any of the four parts M11...

Страница 38: ...8mm Thread Forming Screws Phillips G M1098519 M4 25mm Phillips Machine Screw H M1098518 M3 8mm Phillips Machine Screw I M1098528 M3 10mm Phillips Machine Screw Flat Head J M1098529 M3 Nut W External Tooth Lock Washer K M1098530 M3 5mm Phillips Machine Screw L M1126473 M4 Internal Tooth Lock Washer M M1098527 M4 External Tooth Lock Washer N M1126472 M4 Split Lock Washer O M1126469 M3 external tooth...

Страница 39: ... bracket separately 6700 0014 800 Bracket Dovetail Rail female for mounting to an Ohmeda dovetail rail or Giraffe Spot PT Lite roll stand order male bracket separately 6600 0031 900 BiliSoft Mounting Bracket male mounts the BiliSoft to Ohmeda mobile stand Giraffe Spot PT Lite roll stand or Ohmeda dovetail rail order the appropriate female bracket separately M1097110 Ohmeda Medical BiliBlanket Mete...

Страница 40: ...e Manual Estonian M1129269 Operation and Maintenance Manual Lithuanian M1129289 User Reference Card English M1097124 User Reference Card French M1097147 User Reference Card Spanish M1097152 User Reference Card Italian M1097156 User Reference Card Japanese M1097161 User Reference Card Dutch M1097182 User Reference Card German M1097244 User Reference Card Swedish M1097246 User Reference Card Portugu...

Страница 41: ...ustralian 6600 0574 614 Power Cord United Kingdom 6600 0744 200 Power Cord CE 6600 0745 200 Power Cord Danish M1093124 Power Cord Indian M1153026 Power Cord Israel M1177962 Power Cord South African M1177960 Power Cord Swiss M1171635 Power Cord Philippine M1194543 WARNING The use of accessories replacement parts or power cords other than those specified by the manufacturer may affect the performanc...

Страница 43: ...15A 250V slo blo type qty 2 Leakage Current 300 μA 264 V Ground impedance 0 1 ohm from ground pin of the power inlet module to any exposed metal surface Environmental Operating Conditions Ambient temperature 10 C to 35 C 50 to 95 F Humidity 10 to 90 RH non condensing Atmospheric pressure 70 kPa to 106 kPa Storage Requirements Temperature 40 C to 70 C 40 to 158 F Humidity 0 to 100 RH non condensing...

Страница 44: ...mated life Under continuous use tested at room temperature a typical LED module will run for approximately 8 000 to 10 000 hours before the light intensity drops 25 Sound level 44 dB A at 1 meter X ray X ray compatible The LED module life may vary when used in the actual clinical environment Factors such as duty cycle and ambient temperature may impact the life of the LED module Measure the irradi...

Страница 45: ...32 6 for BiliSoft Pad Covers and BiliSoft Nests GE Healthcare has declared that this product conforms with the European Council Directive 93 42 EEC Medical Device Directive when it is used in accordance with the instructions provided in the Operation and Maintenance Manual This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste a...

Страница 47: ... compliance to IEC 60601 2 50 0 50 100 300 350 400 450 500 550 600 Wavelength nm Relative Spectral Response BiliSoft Output Ohmeda Medical BiliBlanket Light Meter Sensitivity Average Total Irradiance for Bilirubin measured with a spectroradiometer between 400 550 nm 10 5 mW cm 2 bare fiberoptic pad small 7 9 mW cm 2 bare fiberoptic pad large ...

Страница 48: ...below The customer or the user of the BiliSoft Phototherapy System should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8kV air 6kV contact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative hum...

Страница 49: ...les 5 Ut 95 dip in Ut for 5 sec 5 Ut 95 dip in Ut for 0 5 sec 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 sec Mains power quality should be that of a typical commercial or hospital or domestic environment If the user of the BiliSoft Phototherapy System requires continued operation during power mains interruption it is recommended that the BiliSoft Photo...

Страница 50: ...F communications equipment should be used no closer to any part of the BiliSoft Phototherapy Unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 150 kHz to 80 MHZ 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W accordin...

Страница 51: ...ions equipment and the BiliSoft Phototherapy System The BiliSoft Phototherapy System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the BiliSoft Phototherapy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communica tions equipment transmitters a...

Страница 52: ...agnetic environment guidance RF emissions CISPR 11 Group 1 The BiliSoft Phototherapy System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The BiliSoft Phototherapy System is suitable for use in all establishments including domestic establishments and and...

Страница 53: ...aste disposal regulations Improper disposal could result in personal injury and environmental impact No additional tasks are required to power down the device after clinical use other than turning off the unit Isolation of the unit from the supply mains can be achieved by unplugging the device WARNING Electrical shock hazard Before servicing always unplug the unit from wall power Phototherapy ligh...

Страница 54: ...ion Consult accompanying documents Do not place items in radiant heat path Cover the patient s eyes during phototherapy Checkout Procedures Examine the unit for any missing or damaged labels Specifications The product is designed to meet a life span of 7 years However with proper maintenance and repairs the service life can be extended as long as service parts are available ...

Страница 55: ... of thirty 30 days with respect to expendable parts The foregoing warranties shall not apply if the Product has been repaired other than by GE Healthcare or in accordance with written instructions provided by GE Healthcare or altered by anyone other than GE Healthcare or if the Product has been subject to abuse misuse negligence or accident GE Healthcare s sole and exclusive obligation and Buyer s...

Страница 56: ...02 Australia 1300 722 229 China 800 810 8188 India 1 800 425 7255 Korea 02 1544 4564 South Eastern Asia 65 6277 3444 Brazil Only GE Healthcare Clinical Sytems Equipamentos Médicos Ltda Av Paulista 37 13º andar CEP 01311 902 Cerqueira César São Paulo SP Brasil Tel 55 11 3053 2500 Fax 55 11 3053 2573 Ohmeda Medical a Division of Datex Ohmeda Inc a General Electric Company 8880 Gorman Road Laurel MD ...

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