BiliTx - 67.20.66.239
BiliTxProfessional ManualREF 1045220* H906104522001*Manufactured forChildren’s Medical Ventures, LLC191 Wyngate DriveMonroeville, PA 15146Respironics DeutschlandGewerbestrasse 1782211 Herrsching, Germany10753090086HM 5/18/10
Warranty 2010 Koninklijke Philips Electronics N.V. All rights reserved.
BiliTxprofessional manualTable of Contents1. Overview. 3Intended Use. 3What is the BiliTx Phototherapy System?. 3Components of the BiliTx System. 42. Warnings, Cautions, and Symbols. 5Warnings. 5Cautions. 7Symbols. 83. Setup . 9Checking out the System. 9Setting Up the BiliTx System. 9For Use with a Fiber Optic Panel. 9Setup - Wrap-Around Panel. 10Setup - Flat Neonatal Panel. 11For Use as Overhead Phototherapy. 134. Cleaning, Maintenance, and Service. 17Cleaning the Illuminator Device and Fiber Optic Panel. 17Maintenance Schedule. 18Service. 18BiliTx Internal Components. 19Customer Service Information. 205. Troubleshooting. 216. Specifications. 23Environmental. 23Physical. 23Illuminator. 23Fiber Optic Panel. 23Light Source. 24
2Minimum Irradiance Level. 24Wavelength. 24Overhead Spectral Irradiance. 25Overhead Radiometer Certification. 25Effective Surface Area (Overhead Phototherapy) . 26Intensity Ratio. 26Audible Noise. 26Standards Compliance. 27Electrical Requirements. 27Disposal. 27Appendix A: EMC Information. 29BiliTx Warranty. 33BiliTx Professional Manual
BiliTxprofessional manual1. OverviewThis chapter explains how the BiliTx Phototherapy System is used to treat infant jaundice and it lists thecomponents of the BiliTx system.Intended UseThe BiliTx is intended to treat hyperbilirubinemia through phototherapy. When used as overhead phototherapytreatment, the BiliTx is for hospital/institutional use only and when used with the fiber optic light panel the BiliTxis for home or hospital/institutional use.What is the BiliTx Phototherapy System?The BiliTx phototherapy system uses blue light emitting diodes (LEDs) to convert bilirubin to waste productsthat are mostly excreted through urine and stool, thus reducing the bilirubin level in the baby’s blood.The BiliTx can be used as a fiber optic phototherapy system or as an overhead phototherapy system.When used as a fiber optic phototherapy system, the Illuminator device sends light out of the fiber optic cableto the entire area of the panel. The panel is inserted into a protective cover. This wrap is soft and comfortableand allows the therapeutic light to be emitted towards the baby. With this use of the BiliTx system, the baby canbe held and fed and enjoy the healing comfort of parents while treatment is administered. Additionally, whenthe BiliTx system is properly used with the fiber optic panel the baby’s eyes do not need to be protected as withconventional phototherapy.When the BiliTx is used as overhead phototherapy, the Illuminator device is connected, using the overheadtherapy kit, to a hospital intravenous (IV) pole and can be positioned over an incubator or radiant warmer.The unit delivers phototherapy by sending a band of blue light down onto the baby. With this method ofphototherapy, the baby’s eyes must be covered with appropriate eye patches, such as the WeeSpecs Supremephototherapy mask.
4Components of the BiliTx SystemThe BiliTx system includes the following components. Somecomponents are optional accessories that may not be packaged withyour device.3Fiber Optic Light PanelConfiguration for Home orHospital/Institutional Use1.Illuminator Device withAC Power Cord2. Fiber Optic Panel3. Illuminator DeviceCarrying Case(optional)14. System Carrying Case(optional) (not shown)5. Instruction Manual (notshown)2Fiber Optic Light PanelConfiguration Contents23Overhead PhototherapyConfiguration forHospital/Institutional Use1. Illuminator Device withAC Power Cord2. Mounting Brace413. Circuit Support Arm4. Circuit Support Adapter5. Fiber Optic Panel6. Illuminator DeviceCarrying Case(optional)657. Instruction Manual (notshown)Overhead PhototherapyConfiguration ContentsBiliTx Professional Manual
BiliTxprofessional manual2. Warnings, Cautions, and SymbolsCaution! US federal law restricts this device to sale by or on the order of aphysician.Warnings Use the BiliTx only for its intended use as described in thismanual. Eye protection is necessary if the Illuminator device willbe used for overhead phototherapy or if the panel isilluminated while not attached to the baby. Normal useof the Illuminator device with the panel in a disposablecover does not require the use of eye protection. During overhead therapy, check the eye protection toensure that they remain properly fitted. Ensure that other patients near the phototherapyequipment are not exposed to the phototherapy. Patientsadjacent to overhead phototherapy treatment may needto be protected with eye protection. Some operators may experience mild effects (e.g.,headache, nausea) if in the irradiated area for a longperiod of time. To minimize the effects, use the systemin an area with a lot of light or use glasses with yellowlenses. Bilirubin photoisomers may cause toxic effects. Do not leave the Illuminator device on when the fiberoptic panel is not around the baby. Always turn off and unplug the Illuminator device duringcleaning or servicing.WARNINGA warning indicates thepossibility of injury to the user oroperator.
6 Do not use the BiliTx system in the presence of flammablesubstances such as anesthetics, cleaning agents, or gasesthat support combustion (e.g. oxygen, nitrous oxide). Do not use while bathing the baby. Do not place or store the BiliTx system where it can fall orbe pulled into a tub or sink. If the Illuminator device falls into water or if fluid is spilledon the device do not reach for it without first unpluggingthe cord. Discontinue use of the device and contact anauthorized Philips Children’s Medical Ventures servicecenter. Never operate the Illuminator device if it has a damagedplug or damaged or frayed power cord or wires. Do notinsert anything into the end of the plug. Do not use an extension cord. Always connect the device to a properly grounded outlet. If therapy is interrupted for any reason, resume therapyas soon as possible. Carefully place the panel cable to avoid entanglement. Position the Illuminator device on a stable surface,preferably lower than the infant. When the BiliTx systemis used with the fiber optic panel configuration andcarrying case, the device can hang on the outside of acrib or treatment area. Do not place the Illuminator device, power supply, orcarrying case in an incubator or infant warmer. Do not place a temperature sensor for the infant warmeror incubator under the fiber optic panel or in the surfacearea of the overhead phototherapy light. Do not place the Illuminator device, power supply, orcarrying case in a crib or other treatment area next to thebaby. Never block the air vents of the unit or place it on a softsurface such as a bed, crib, carpeted floor, or couch wherethe air vents may be blocked.BiliTx Professional Manual
7 During phototherapy, the the baby’s water balance maybecome disturbed. Before and during phototherapy,make sure the baby is properly hydrated and that his orher body temperature is maintained. After treatment has begun, the baby’s bilirubin levelshould be measured to make sure therapy is effective. Adjust therapy location and time as necessary to avoiddegradation of photosensitive drugs and infusion liquids.Do not store any drugs in the illuminated area. The fiber optic panel must not be covered by anythingexcept with the cover provided. Any other type of coverwill cause a reduction in light intensity. The setupinstructions must be followed exactly. Varying ambient conditions, such as the ambienttemperature and/or different radiation sources, mayadversely affect the patient. Please refer to yourhospital phototherapy policy and procedure regardingappropriate ambient conditions.Cautions Keep the unit away from any heated surface. Do not scratch, damage, or soil the ferrule end of thepanel. Also, do not place sharp or heavy items on thepanel, this can damage the panel and affect its lightoutput.CAUTIONA caution indicates thepossibility of damage to thedevice. Do not dry the fiber optic panel with artificial heat. If the device is dropped, contact your an authorizedservice representative to inspect for proper operation.Chapter 2 Warnings, Cautions, and Symbols
8SymbolsThe following symbols appear on the BiliTx system.SymbolExplanationTherapy On/OffConsult accompanying instructions for useType BF applied partAC PowerEuropean Declaration of Conformity0086Canadian/US Safety Certification. Conforms to ANSI/UL STD. 2601.Certified to CAN/CSA C22.2 STD. NO. 601.1.3158805Eye shields requiredLock and UnlockBiliTx Professional Manual
BiliTxprofessional manual3. SetupChecking out the SystemPrior to each patient setup, the hospital should check the lightintensity of the unit. The Joey Dosimeter should be used to measurethe light intensity. See the Cleaning and Maintenance section later inthis manual for more information.WARNINGAfter treatment has begun, thebaby’s bilirubin level should bemeasured to make sure therapyis effective.Setting Up the BiliTx SystemFor Use with a Fiber Optic Panel1. Place the appropriate cover on the panel and position the babyand panel as described later in this chapter. (See Setup-WrapAround Panel or Flat Neonatal Panel.)CAUTIONDo not block any of the air ventson the Illuminator device.2. Place the Illuminator device on a hard, flat surface or usingthe carrying case, hang the unit on the outside of a crib or thetreatment area, away from any heat source. Make sure it is nomore than four feet from where the baby will be positioned.3. Insert the metal end of the light panel cable, called theferrule, with the metal post facing up, into the opening onthe Illuminator unit. Push the ferrule in and rotate it counterclockwise to lock into place. The light will not come on if thepanel is not inserted in the Illuminator device.4. Plug the Illuminator device into an electrical outlet. The TherapyOn/Off button will flash green.Connecting the light panelcable to the illuminatordeviceCAUTIONIf the power cord or wires needrepair or replacement, do notconnect the unit.
105. Press the Therapy On/Off button to turn the Illuminator deviceon and begin phototherapy. The Therapy button will illuminategreen.Turning on the illuminatordevice6. To turn off the device when therapy is complete, press and holdthe Therapy On/Off button for 3 seconds.Setup - Wrap-Around PanelThis section explains how to prepare a baby for a phototherapytreatment using the wrap-around fiber optic light panel.The fiber optic panel must NOT be covered by anything except withthe cover provided. Any other type of cover could cause a reductionin light intensity. The setup instructions must be followed exactly.This panel provides full coverage around the baby’s torso. It is mostcommonly used on patients at home.1. Place a disposable or reusable cover onto the panel with thelight emitting side of the panel facing the sheer side of the cover.Wrap-around panel withdisposable coverhook and loop tabs2. Place the covered panel under the baby’s torso, positioning it soit is under the baby’s armpits.Positioning the fiber opticpanelBiliTx Professional Manual
113. Wrap the panel around the baby. Use the tape or hook and looptabs to secure the panel around the baby.4. If the disposable cover becomes soiled, discard it and replacewith a clean one. The cloth cover may be washed with mild soapand water.NOTESFor a larger or more active baby, you may want to tape the panel to the baby’sdiaper.To be sure the panel is not wrapped too tightly, insert your finger between thepanel and the baby’s body. Your finger should fit easily.Wrapping and securing thepanelYou may wrap the baby in a blanket or put the baby in a sleeper.WARNINGIf using tape to secure the panel, do not adhere the tape to the baby’s skin.Setup - Flat Neonatal PanelThis section explains how to prepare a baby for a phototherapytreatment using the flat neonatal fiber optic light panel.The fiber optic panel must NOT be covered by anything except withthe disposable cover provided. Any other type of cover could cause areduction in light intensity. The setup instructions must be followedexactly.This panel is ideal for preemie or underweight infants; it may also beused on full-term infants.1. The protective cover for the neonatal panel is a T-vest. Slide thevertical section of the T, with the light facing the sheer side of thecover, onto the panel.hook and loop tabsNeonatal panel with t-vestChapter 3 Setup
122. Lay the covered panel on a flat surface. Be sure the lightemitting side is facing up.3. Position the baby’s chest or back directly on the panel. The cableconnected to the panel should be between the baby’s legs.4. Secure the T-vest to the baby by first wrapping the side withoutthe tape or hook and loop tab around the baby’s midsection.Then, wrap the side with the tape or hook and loop tab over theinfant. If using tape, peel off the protective cover on the tab, andsecure it. Be sure the vest is snug.5. If your cover has the hook and loop tabs, you can secure thecover by pulling the hook and loop tab on the bottom corner ofthe cover up and accross the cover, tightening the cover aroundthe cable between the baby’s legs.Positioning the baby on thepanel6. If the T-vest becomes soiled, discard it and replace it with a newone.NOTESFor a larger or more active baby, you may want to tape the panel to the baby’sdiaper.To be sure the panel is not wrapped too tightly, insert your finger between thepanel and the baby’s body. Your finger should fit easily.You may wrap the baby in a blanket or put the baby in a sleeper.WARNINGIf using tape to secure the panel, do not adhere the tape to the baby’s skin.Wrapping and securing theT-vestBiliTx Professional Manual
13For Use as Overhead PhototherapyNOTE: Overhead phototherapy is for hospital/institutional use only.The following section explains how to prepare the unit for overheadphototherapy treatment. Overhead phototherapy can be used whilethe baby is in an incubator or radiant warmer. You will need themounting brace accessory kit to set up and position the device.CAUTIONDo not block any of the air ventson the Illuminator unit.1. Attach the mounting brace to a standard hospital intravenous(IV) pole. To attach, place the clamp around the IV pole thentighten using the screw provided.Attaching the brace to an IVpole2. Connect the circuit support arm to the mounting brace. Tosecurely attach, turn and lock the circuit support arm into place.Attaching the circuit supportarm to the mounting brace3. Insert the circuit support adapter into the opening on theIlluminator device with the metal post facing up. Push theadapter in and turn it counter-clockwise to securely lock in place.Attaching the circuit supportadapter to the IlluminatordeviceChapter 3 Setup
144. Connect the circuit support adapter to the clamp on the circuitsupport arm. Tighten in place by turning the handle on theclamp.Connecting the circuitsupport adapter to thecircuit support armWARNING5. Attach the device power cord to the circuit support arm.6. Position the device over the baby ensuring that it is no closerthan 6 inches from the baby. The intensity of light can beadjusted by positioning the light source closer or farther awayfrom the baby. See the light intensity chart in the Specificationschapter of this manual for the approximate light intensity atspecific distances from the device.7. Cover the baby’s eyes with the appropriate eye protection. Referto the instructions included with your eye protection.8. Plug the Illuminator device into an electrical outlet. The powerbutton will flash green.9. Press the Therapy On/Off button to turn the Illuminator deviceon. The Therapy button will illuminate green.The power cord must beattached to the circuit supportarm to avoid entanglement.WARNINGDo NOT position the devicecloser than 6 inches from thebaby.WARNINGVerify that the Illuminator unit issecurely attached to the circuitsupport arm and the mountingbrace is securely attached to theIV pole before placing the babyunder the device.WARNING10. To turn off the device when therapy is complete, press and holdthe Therapy On/Off button for 3 seconds.Place the IV pole supportingthe unit so that it will not beaccidentally disturbed duringoverhead therapy.CAUTIONIf the power cord or wires needrepair or replacement, do notconnect the device.BiliTx Professional Manual
15The graphic below shows the complete overhead phototherapysetup.Overhead phototherapycomplete assemblyUsing the In-Use Carrying CaseAn optional, in-use carrying case is available for use with theIlluminator device. The carrying case allows for easy mobilityduring phototherapy treatment. To place the carrying case on theIlluminator device, simply slide it over the device and adjust theposition so that the Start/Stop button is visible. The shoulder strapshould be located at the same end as the power cord. You can adjustthe shoulder strap as necessary using the hook and loop tabs.Therapy On/OffButtonShoulder StrapChapter 3 Setup
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BiliTxprofessional manual4. Cleaning, Maintenance, andServiceThis section explains how to clean, check, and maintain the BiliTxsystem.Cleaning the Illuminator Device and FiberOptic PanelFollow the instructions in this section any time the Illuminator deviceor fiber optic panel is dirty.1. Use soapy water, a 10% bleach solution or full strength ammonia.2. Use a soft sponge or cloth to apply the cleaner.3. Apply the cleaning solution to the sponge or cloth and wipedown the fiber optic panel and Illuminator.4. Allow the equipment to air dry. DO NOT DRY WITH ANY MEANSOF ARTIFICIAL HEAT.5. Wipe the Illuminator device and panel with a dry cloth.If the in-use carrying case becomes soiled, it can be wiped with adamp cloth.CAUTIONBe sure the Illuminator deviceis turned off and is unpluggedbefore cleaning. Do not immerseany part of the equipment inany liquid.CAUTIONKeep the fiber optic panel awayfrom sharp objects that couldscratch or puncture the cover.WARNINGWhen cleaning, DO NOT USE: Phenolic compound basedgermicide cleaner/disinfectant Gluteraldhyde disinfectant/sterilants Regular commercial cleaners orlaundry detergents Iodine solutions, strong acids orstrong alkali solutionsThese solutions could leaveresidue on the surfaces, and /or be abrasive or harmful to theinfant.
18Maintenance ScheduleFollow the schedule and instructions below to keep the BiliTx systemproperly maintained. The light has a minimum lifetime of 30,000hours. The number of hours your device has been used can be foundin the window on the bottom of the device.Before Each Patient UseAs NeededCheck the light intensity using the Joey Dosimeter. Clean the Illuminator device andTo measure the light intensity, take a measurement fiber optic panel.from three different areas on the panel, and thencalculate the average. If the intensity falls belowthe minimum standard, contact Philips Children’sMedical Ventures Customer Service.Replace the disposable light panel cover or vest.Inspect the power cord and plug for damage orfraying.Verify light does not illuminate when panel is notinserted or connected to the IV pole.ServiceThere are no field servicable parts in the BiliTx system. Do notattempt to open the device. Doing so will reduce the life of thedevice and invalidate the manufacturer’s warranty. Only qualifiedfactory service personnel can service the device.After patient use cleaning is the only preventative manintenace thatshould be performed by the user.BiliTx Professional Manual
19BiliTx Internal ComponentsThe following graphics show the internal components of the BiliTx.*hour metercircuit arm adapter(hospital use only)optical lightenginelensewire dthermalcutoutcoolingfanrearenclosure*power button not shownChapter 4 Cleaning and Maintenance
20Customer Service InformationTo contact Philips Children’s Medical Ventures directly, call the PhilipsChildren’s Medical Ventures Customer Service department at1-800-345-6443 or 1-724-387-4000.You can also use the following address:Children’s Medical Ventures, LLC191 Wyngate DriveMonroeville, Pennsylvania15146 USABiliTx Professional ManualHELPFUL TIPVisit Philips Children’s MedicalVentures web site atwww.philips.com/childmed.
BiliTxprofessional manual5. TroubleshootingThe following is a list of problems that may occur while using the BiliTx system. For additionalinformation, contact Philips Children’s Medical Ventures Customer Service at 1-800-345-6443 or1-724-387-4000.WARNINGIf therapy is interrupted for one hour or longer, resume therapy as soon as possible.ProblemTherapy On/Off button is notgreenReason/ActionCheck to make sure power cord is properly attached andplugged into an active electrical outlet.Ensure the device is turned on.Therapy On/Off button is notflashing greenIf the power cord is properly attached and plugged into anactive electric outlet and the Therapy On/Off button is notflashing green, but the device will turn on, continue to use thedevice for therapy.Light is not being emitted fromfiber optic panelCheck to make sure panel is securely locked into Illuminatordevice.Yellow LED is flashingEnsure the panel or circuit support adapter is securely lockedinto place. If light continues to flash, contact Philips Children’sMedical VenturesLoss of power or light sourcefailureContact Philips Children’s Medical VenturesLight is not being emitted from Check to make sure the Illuminator device is securely attachedthe illuminator device whento the circuit support adapter accessory.connected to the circuit supportadapter and the yellow LED isflashingDevice will not turn off whenthe Therapy On/Off button ispressedPress and hold the Therapy On/Off button for 3 seconds.
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BiliTxprofessional manual6. ive HumidityOperating-4 to 122 F (-20 to 50 C)59 to 95 F (15 to 35 C)15-95% Non-condensing15-95% Non-condensingPhysicalIlluminatorSize: 6.34 in. x 2.92 in. (16.10 cm x 7.40 cm)Weight: 2.50 lb. (1.13 kg)Fiber Optic PanelModel:EG-2000 (Wrap Around Panel)Overall Pad Size-Standard:4.00” x 15.00” (10.16 cm x 38.10 cm)Illuminated Area-Standard:3.00” x 14.00” (7.62 cm x 35.56 cm)Model:EG-2000N (Flat Neonatal Panel)Overall Pad Size-Neonatal:5.00” x 7.00” (12.70 cm x 17.78 cm)Illuminated Area-Neonatal:4.00” x 6.00” (10.16 cm x 15.24 cm)
24Light SourceMinimum Irradiance LevelStandard Panel-Light:30µW/cm2/nmNeonatal Panel-Light:55µW/cm2/nmOverhead Therapy:When the illuminator is positioned 30 cm (12 inches)above the neonate: 30 µW/cm2/nmWavelengthBlue LEDs:Peak between 460 nm and 480 nmThe graph below shows the total spectral irrandiance of the Illuminator device averaged over awavelength range. Also included is a calibration curve of the Joey Dosimeter, which was used totake the measurements of the light.1009080% 40350360370380390400410420430440450460Wavelength (nm)BiliTx Professional Manual470480490500510520530540550
25Overhead Spectral IrradianceTotal Irradiance of 94 mW/cm².Spectral IrradianceSpectral Irradiance (mW/cm2 avelength (nm)Overhead Radiometer CertificationChapter 6 Specifications
26Light Intensity (Overhead Phototherapy)DistanceIrradiance (µW/cm2/nm)15 cm (6 in)11230 cm (12 in)3045 cm (18 in)1660 cm (24 in)9Effective Surface Area (Overhead Phototherapy)14 cm diameter at a height of 30 cm (12 inches)30 cm14 cm diameterIntensity RatioStandard Panel, Neonatal Panel, and Overhead Phototherapy : .4 (minimum to maximum)Audible Noise 60 dB(A). Measured in accordance with IEC 60601-2-50.BiliTx Professional Manual
27Standards ComplianceThis device is designed to conform to the following standards: IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment IEC 60601-2-50 Requirements for the Safety of Infant Phototherapy Equipment Electromagnetic Compatibility: EN 60601-1-2, 2nd edition.Electrical RequirementsAC Power100-240 VAC, 50/60 Hz, 1.0 AType of Protection Against Electrical ShockClass I EquipmentDegree of Protection Against ElectricalShockType BF Applied PartDegree of Protection Against Ingress ofWaterOrdinary Protection, IPX0Mode of OperationContinuousDisposalDispose of this device in accordance with local regulations.Chapter 6 Specifications
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BiliTxprofessional manualAppendix A: EMC InformationGuidance and Manufacturer’s Declaration - ElectromagneticEmissionsThis device is intended for use in the electromagnetic environment specified below. The user of thisdevice should make sure it is used in such an environment.Emissions TestRF emissionsComplianceGroup 1CISPR 11Electromagnetic Environment - GuidanceThe device uses RF energy only for its internal function.Therefore, its RF emissions are very
The BiliTx phototherapy system uses blue light emitting diodes (LEDs) to convert bilirubin to waste products that are mostly excreted through urine and stool, thus reducing the bilirubin level in the baby’s blood. The BiliTx can be used as a fiber optic phototherapy system or as an overhead phototherapy system.
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