BiliSoft LED Phototherapy System - Apria

GE HealthcareBiliSoft LEDPhototherapy SystemOperation and Maintenance ManualBiliSoft LED Phototherapy SystemOperation and Maintenance Manual - EnglishM1110147Rev. 5 2007 Datex-Ohmeda. All rights reserved.

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Table of ContentsUser Responsibility.vCare of the Skin.viiChapter 1 Product Description . 1-1Intended Use . 1-1Description . 1-1Chapter 2 Safety Information . 2-1Symbol Definitions. 2-1General Safety Information. 2-3Chapter 3 Home Use . 3-1Homecare provider. 3-1Parents or Guardians . 3-1Recording Daily Activities. 3-2Taking Temperatures . 3-2Urine/Stools . 3-2Feeding . 3-2Treatment Time. 3-2Bathing. 3-2Daily Record Sheet . 3-3Chapter 4 Components and User Controls. 4-1BiliSoft Light Box. 4-1BiliSoft Fiberoptic Light Pad Assembly. 4-3Soft Cover Options (Disposables). 4-4Chapter 5 Operating Instructions . 5-1Checking the Unit. 5-1Positioning the Unit. 5-3Attaching the Mounting Bracket . 5-4Using the Unit . 5-5Chapter 6 Troubleshooting. 6-1Alarm/Troubleshooting Guide. 6-1Chapter 7 Routine Cleaning and Maintenance. 7-1Maintenance Schedule. 7-1Cleaning and Disinfecting. 7-2BiliSoft Light Box . 7-2BiliSoft Fiberoptic Light Pad and Cable. 7-3BiliSoft Cable Connector and Fiberoptic Lenses . 7-4Air Filter . 7-5Chapter 8 Accessories and Replacement Parts. 8-1Chapter 9 Specifications . 9-1Chapter 10 Technical Reference.10-1Warranty. ICB-1M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.iii

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User ResponsibilityThis Product will perform in conformity with the description thereof contained in thisoperating manual and accompanying labels and/or inserts, when assembled,operated, maintained and repaired in accordance with the instructions provided. ThisProduct must be checked periodically. A defective Product should not be used. Partsthat are broken, missing, plainly worn, distorted or contaminated should be replacedimmediately. Should such repair or replacement become necessary, GE Healthcarerecommends that a telephone or written request for service advice be made to thenearest GE Healthcare Regional Service Center. This Product or any of its parts shouldnot be repaired other than in accordance with written instructions provided by GEHealthcare and by GE Healthcare trained personnel. The Product must not be alteredwithout GE Healthcare’s prior written approval. The user of this Product shall have thesole responsibility for any malfunction that results from improper use, faultymaintenance, improper repair, damage or alteration by anyone other than GEHealthcare.CAUTION:US Federal law restricts this device to sale by or on the order of alicensed medical practitioner.GE Healthcare has declared that this product conforms with the European CouncilDirective 93/42/EEC Medical Device Directive when it is used in accordance with theinstructions provided in the Operation and Maintenance Manual.This symbol indicates that the waste of electrical and electronic equipment must notbe disposed as unsorted municipal waste and must be collected separately. Pleasecontact an authorized representative of the manufacturer for information concerningthe decommissioning of your equipment.M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.v

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Care of the SkinImportant clinical information – please read carefully before using this device.The skin serves as a protective barrier against chemical, mechanical, and biological insults.The skin is also important in the regulation of body temperature and serves as a route ofwater excretion, especially in premature infants. The introduction of new intensive-caretechniques has been associated with the increased survival of very small, premature infants.The immaturity of the skin of the very low weight infants, coupled with excessiveinstrumentation and handling, poses previously unrecognized problems for the nursing careof these infants.1Please read, evaluate and implement the following recommendations as appropriate:1. Please refer to the following standard of skin care recommendations as given in theliterature2 when utilizing this device with all infants. Special attention should be givento sanitation and skin integrity. Observe color, rashes, excoriation Clean skin with warm water Clean perineal area after stooling Change infant’s position every 2 hours2. This device is intended only for the treatment of existing hyperbilirubinemia. Use ofthis device for prophylactic treatment, particularly of premature infants, is notrecommended. These infants have extremely fragile skin3 and various clinical studieshave produced inconsistent conclusions concerning the effectiveness of prophylacticphototherapy treatment. 4, 51NAACOG(1992), OGN Nursing Practice Resource, Neonatal Skin Care, NAACOG.2ibid3Rutter, N., The immature skin, British Medical Bulletin, Vol. 44, No. 4, 19884Curtis-Cohen, M., et al, Randomized trial of prophylactic phototherapy in the infant with very low birth weight,The Journal of Pediatrics, July, 19855Brown, A., et al, Efficacy of Phototherapy in Prevention and Management of Neonatal Hyberbilirubinemia,Pediatrics, February , 1988M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.vii

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Chapter 1Product DescriptionIntended UseThe BiliSoft LED Phototherapy System provides light therapy for the treatment of indirecthyperbilirubinemia, commonly known as neonatal jaundice, in a hospital or home setting.DescriptionThe BiliSoft LED Phototherapy System consists of a light box and a detachable fiberoptic lightpad with a long, flexible fiberoptic cable. The fiberoptic cable delivers light from a highintensity LED module in the light box to the fiberoptic light pad. The flexible fiberoptic lightpad is placed in a soft BiliSoft Pad Cover or BiliSoft Nest that is then brought into contact withthe patient’s skin. The patient is exposed to light in the wavelength of 430-490 nanometerrange (peak 440-460 nanometer).Units are available with two fiberoptic pad sizes: large (25cm x 30cm) and small (15cm x30cm). The large pad’s nominal spectral irradiance is 35 µW cm-2 nm-1 through a typicalBiliSoft Pad Cover or BiliSoft Nest. The small pad’s nominal spectral irradiance is50 µW cm-2 nm-1 through a typical BiliSoft Pad Cover or BiliSoft Nest.M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved1-1

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Chapter 2Safety InformationSymbol DefinitionsSymbolDescriptionNext to each WARNING or CAUTION, we have placed an“attention, read accompanying documents” symbol to alertyou to the presence of these important statements. When theattention symbol appears in front of text that is printed on thesystem itself, it means that the text is elaborated upon in theoperation manual.WARNING:A WARNING statement is used when the possibility of injuryexists.CAUTION:A CAUTION statement is used when the possibility of damageto the equipment exists.NOTE: A NOTE provides additional information to clarify a point inthe text.Indicates alternating current.Indicates IEC Type B equipment.TThis letter appearing before a fuselink value indicates a timedelay fuselink.Cover patient’s eyes during phototherapy.On/Off Standby SwitchUnit overheated indicatorM1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.2-1

Hour meterLED failure indicatorDo not spray cleaner directly onto the fiberoptic lenses. Thefiberoptic lenses require special cleaning methods. Seecleaning section of this manual for complete details.See the Operation Manual for more information.European Union RepresentativeManufacturerETL symbolCE markWEEE symbolGround/Earthing2-2M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.

General Safety InformationWARNING:Eye Protection: Direct exposure of the eyes to any phototherapy lightmay cause eye damage. Always protect the baby’s eyes with eyepatches or an equivalent appropriate eye protection product.Periodically and/or per your hospital protocol or healthcare provider’sinstructions, verify that the patient’s eyes are protected and free ofinfection. Care should also be taken to protect the eyes of patientsadjacent to the treatment area, when necessary.WARNING:Home Users: During phototherapy treatment always follow yourhealthcare professional’s care instructions.WARNING:Caregiver Side Effects: Looking at light emitted by any phototherapydevice for prolonged periods may cause side effects, such as headache,nausea, or mild vertigo, in some caregivers or visitors.WARNING:Bilirubin Levels: The bilirubin levels of patients receiving phototherapyshould be regularly measured.WARNING:Possible Risks: All phototherapy methods have possible risks including,but not limited to apnea, bronze baby syndrome, diarrhea,hyperpigmentation-reddening, patent ductus arteriosus, riboflavincalcium and other deficiencies, skin blistering, skin irritation andthrombocytopenia. Monitor the patient closely for signs of theseconditions during phototherapy.WARNING:Porphyrins/Photoisomers: Bilirubin photoisomers may cause toxiceffects. Porphyrins are the by-products of the photochemical breakdown of the bilirubin molecule. In some cases, exposure of porphyrinsto phototherapy may result in a localized reddening of the patient’s skin.Therefore, skin assessment is recommended with all types ofphototherapy.WARNING:Photosensitive Drugs: The light generated by phototherapy devices candegrade photosensitive medications. Do not place or store any drugsnear or in the illuminated area.M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.2-3

WARNING:Water Loss: The radiant energy from phototherapy lights can increase apatient’s insensible water loss. Take appropriate measures to maintainthe patient’s fluid balance while administering phototherapy.WARNING:Skin Temperature: Phototherapy light can affect the temperature inthermoregulation devices (incubator, radiant warmers or heatedmattresses) and may raise the patient’s body temperature. It isrecommended to use the incubator or warmer in skin controlled (servo)mode. Always monitor the patient’s temperature to avoid temperaturefluctuations during phototherapy.WARNING:Reflective Foils: Using reflective foils to increase the efficacy ofphototherapy may cause hazardous patient body temperatures.WARNING:Combustible Gases: Do not use the BiliSoft LED Phototherapy System inthe presence of gases that support combustion like oxygen, nitrousoxide or other flammable or combustible anesthetics.WARNING:Flammable Solutions: Never use flammable solutions to clean the BiliSoft LEDPhototherapy System or any of its parts.CAUTION:Medical Electrical Equipment needs special precautions regarding EMC andneeds to be installed and put into service according to the EMC informationprovided in the service manual.Portable and mobile RF communications equipment can affect MedicalElectrical Equipment.The BiliSoft LED Phototherapy System should not be used adjacent to or bestacked on other equipment. If adjacent or stacked use is necessary, theBiliSoft LED Phototherapy System should be observed to verify normaloperation in the configuration in which it will be used.2-4M1110147 Rev. 5 2007 Datex-Ohmeda. All rights reserved.