GE BiliSoft 2.0 Operation Manual
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GE BiliSoft 2.0 Operation Manual

Phototherapy system
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BiliSoft™ 2.0
Phototherapy System
Lumitex
TM
Lighting by
Operation Manual

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Summary of Contents for GE BiliSoft 2.0

  • Page 1 BiliSoft™ 2.0 Phototherapy System Lumitex Lighting by Operation Manual...
  • Page 2 Warranty This product is sold by GE Healthcare with a GE depot repair warranty that covers labor and parts under the terms and conditions set forth in the GE Healthcare Warranty Statement presented to the customer at the point of sale. The light pad, light box chassis and cooling fan carry a 12-month warranty.

  • Page 3: Table Of Contents

    Appendix A1 - Additional Safety Information ................A1-1 Statements ............................A1-1 Appendix A2 - Home Use ......................A2-1 Homecare Providers ..........................A2-1 Parents or Guardians ........................... A2-1 Before You Begin Treatment ......................A2-1 The BiliSoft 2.0 Phototherapy System Components ................A2-2...
  • Page 4 How it works............................A2-2 Installing Pad Covers ........................... A2-3 Soiled Pad Covers ..........................A2-4 Prepare the Baby – Remove Clothing ....................A2-5 Positioning the Baby ..........................A2-5 Using the Pad Straps to Swaddle the Baby ..................A2-6 Use of Additional Blankets....................... A2-7 Eye Protection for the Baby ........................

  • Page 5: Indications For Use

    The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

  • Page 6: About This Product

    Description BiliSoft 2.0 Phototherapy System consists of a light box and a detachable fiberoptic light pad with a long, flexible fiberoptic cable. The fiberoptic cable delivers light from a high intensity LED module in the light box to the fiberoptic light pad.

  • Page 7: User Responsibility

    Should repair or replacement become necessary, Lumitex recommends that a request for service be made to the nearest GE Healthcare Regional Service Center listed on the back cover. This Product, or any of its parts, should only be repaired by trained GE Healthcare technicians.
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  • Page 9: Important Safety Information

    Important Safety Information WARNINGS: Eye Protection: Long exposure to any phototherapy light may cause eye damage. Never look directly at the light. Infants should wear eye protection during therapy. Take care to protect the eyes of nearby infants. Home Users: Always follow your healthcare professional’s instructions.
  • Page 10 Combustible Gases: Do not use the BiliSoft 2.0 in the presence of flammable anesthetics (e.g. ether) mixtures with air or with oxygen or nitrous oxide. These mixtures can support combustion. A possible explosion hazard exists under these conditions.

  • Page 11: Contraindications

    Trip Hazard: The power cord can be a trip hazard. Do not leave the cord unattended when located in traffic areas. Unit Damage: A damaged or defective unit or accessory should not be used. Electric Shock Hazard : Do not attempt to insert objects into the intake or exhaust vents on the cover. CAUTIONS: Electromagnetic Interference: The user needs to be aware of electromagnetic interference, or EMC.
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  • Page 13: Care Of The Patient's Skin

    Care of the Patient’s Skin Important clinical information – please read carefully before using this device. The skin has a number of roles. It provides a protective barrier against chemical, mechanical, and biological injuries. It helps maintain body temperature. It also serves as a route for water excretion, especially in premature infants.
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  • Page 15: Safety Information

    Safety Information Symbol Definitions Symbol Description Electrical shock hazard possible. WARNING statements are used when the possibility of injury exists. CAUTION statements are used when there is a possibility to damage the equipment. NOTE statements are used to provide additional information, or NOTE: clarify a point.
  • Page 16 Symbol Description Do not spray cleaner directly onto the fiberoptic lens. The fiberoptic lens require special cleaning methods. See cleaning section of this manual for complete details. European Authorized Representative Manufacturer ETL approval symbol US Federal law restricts this device to sale by or on the order of a Only licensed medical practitioner.
  • Page 17 Symbol Description Beginning in September 2016, some medical devices sold in the USA must be labeled with a Unique Device Identifier (UDI). SMALL PAD LARGE PAD The baby outline defines the side of the pad upon which to place the baby. Place the baby on this side of the pad.
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  • Page 19: Chapter 1 Components And User Controls

    Chapter 1 Components and User Controls BiliSoft 2.0 Light Box The Light Box contains the output LED module, a power supply, a cooling fan and temperature protection circuitry. The power supply is universal. The device can be supplied by any standard AC main power source.
  • Page 20 Component/Control Function 1. Standby Switch – Turns the unit ON/OFF. The green light in the switch indicates that the standby switch is turned on and the unit has power. 2. Hour Meter –The non- resettable hour meter shows the number of hours a light pad has been active during the life of the light box.
  • Page 21 7. Air Filter & Air Intake Vents – For proper cooling it is important to keep the air filter clean and clear of obstructions. See the maintenance section of this manual for more details. 8. AC Power Cord Receptacle – Is where the AC power cord plugs 9.

  • Page 22: Bilisoft 2.0 Light Pad Assembly

    The large pad surface is 10x12 inches. The LED light source in the BiliSoft 2.0 light box is focused on the fiberoptic lens at the end of the Light Pad connector. The fiberoptic cable contains plastic fibers that transmit light from the light box to the light pad.

  • Page 23: Soft Cover Options (Disposables)

    Soft Cover Options (Disposables) The BiliSoft Pad Covers and Nest are designed for use with both premature and full-term infants. They are available in small and large sizes to match the size of the Light Pad. Warning: The soft covers are single-use products. They are not to be reused on a different patient.
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  • Page 25: Chapter 2 Operating Instructions

    4. Connect the power cord to the back of the unit, then to an appropriate power source. 5. Turn the BiliSoft 2.0 Phototherapy System on using the Standby Switch on the front of the unit, the Over-Temperature and LED Failure Indicators will briefly illuminate.

  • Page 26: Light Pad Output

    Light Pad Output New BiliSoft 2.0 devices are shipped with light outputs that fall within a range. This range is the rated output. The rated output is different between the small and large pads. With proper care, the Light Pad output will match the Light Box output for the life of the product.

  • Page 27: Positioning The Unit

    Positioning the Unit WARNINGS: Never position the unit where it could fall and injure a patient or caregiver. Never place the light box inside of an incubator, warmer or bassinet with the patient. This could cause possible injury to the patient. Never position the unit in the path of, or next to, sources of heat.

  • Page 28: Attaching The Mounting Bracket

    The BiliSoft 2.0 Phototherapy system Light Pad is placed under the patient. The pad can be placed on top of a crib, bed or basinet, mattress and the patient is then placed on top of the light pad. Alternatively, the Light Pad and the patient can be wrapped together using a blanket.

  • Page 29: Using The Unit

    Using the Unit WARNINGS: Handle the Light Pad Connector with caution. Patients and caregivers can be injured if struck by the pad connector. Use the BiliSoft Cover and Nest with caution. The cloth tie straps should be tied together when they are not being used. Loose straps can cause strangulation or a choking hazard.

  • Page 30: Installing Pad Covers

    Installing Pad Covers Installing Flat Pad Covers Onto Pad 1. After the Pre-Use Checkout, gently insert the fiberoptic pad into a flat pad cover (shown below). The back of pad should face the strap side of the cover as shown. For patient comfort and hygiene, never place a baby directly on the bare fiberoptic light pad.
  • Page 31 3. Place the baby on the padded side of the flat cover or Nest. Adjust the straps as needed to help swaddle the patient. IMPORTANT: Be sure to position the patient to expose the most amount of their skin to the pad light.
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  • Page 33: Chapter 3 Troubleshooting

    Chapter 3 Troubleshooting Indicator Lights/Troubleshooting Guide Symptom Likely causes Troubleshooting steps Unit Overheated Clogged air filter, 1. Turn off the standby switch and disconnect Indicator light is on. blocked vents, the power cord from the outlet. fan or hardware 2. Make sure that the air filter in the back of failure.
  • Page 34 Symptom Likely causes Troubleshooting steps Light output Fiberoptic pad 1. Make sure that the fiberoptic cable measurement is connector is not connector is fully inserted into the light box. 25% below fully inserted into 2. Make sure that the surface of the fiberoptic minimum rated the light box.
  • Page 35 Symptom Likely causes Troubleshooting steps No light output. Fiberoptic pad 1. Confirm that the fiberoptic cable connector connector is not is fully inserted in the light box. If the fully inserted into fiberoptic cable connector is not fully the light box. inserted in the light box, the LED module is automatically shut off.
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  • Page 37: Chapter 4 Routine Cleaning And Maintenance

    Do not use a phenolic compound based cleaner. Phenolic compounds can increase bilirubin levels in infants. CAUTIONS: Do not autoclave or gas sterilize the any part of the BiliSoft 2.0 DO NOT use any of the following cleaners. They will damage the device. ...

  • Page 38: Point Of Use Cleaning

    While the BiliSoft 2.0 is in use, the pad, in particular, may be exposed to bodily fluids and matter. The cloth pad covers will help contain such materials, but if during the course of changing the pad cover it is noticed that these materials leeched onto the pad, the user should wipe the surface to remove the debris before applying a new cover.

  • Page 39: Cleaning The Light Pad And Cable Between Patients

    CAUTION: Use approved cleaning solution sparingly on a cloth when cleaning the exterior of the light box. Do not saturate the cloth - excessive solution may flow into the light box causing damage to internal components. 1. Unplug the power cord. 2.

  • Page 40: Cleaning The Light Pad Connector, Fiberoptic Lens And Connector Port Between Patients

    1. Thoroughly pre-clean heavily soiled areas using an approved cleaning solution (except for bleach solution), applied to a clean cloth, or sponge, after wringing out the excess. Clean the outside of the light pad and cable with the moistened cloth or sponge until visible debris and blood are removed.

  • Page 41: Air Filter Cleaning/Replacement

    Air Filter Cleaning/Replacement The air filter on the rear of the light box should be kept clean and free of lint to prevent overheating. The filter can be removed for cleaning without needing a tool. Figure Procedure Disconnect power to the unit. To remove the Air Filter, flex the Filter Cover and remove the tabs from the lower and upper slots that secure the Filter Cover.

  • Page 42: Product Storage

    Product storage CAUTION: Never store the lightbox on top of the light pad. The light box feet will discolor the pad. Exposing the light pad’s plastic cover ultraviolet light can cause premature breakdown of the plastic material. Do not leave the light pad in direct sunlight. It is recommended to disconnect the Light Pad and hang straight, or lay flat during storage between uses.

  • Page 43: Chapter 5

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  • Page 45: Chapter 6 Optional Equipment And Replacement Parts

    Bracket, Dovetail Rail, female (for mounting to an Ohmeda dovetail rail or 6600-0031-900 Giraffe Spot PT Lite roll stand – order male bracket separately) BiliSoft Mounting Bracket, male (mounts the BiliSoft 2.0 to Ohmeda mobile M1097110 stand, Giraffe Spot PT Lite roll stand, or Ohmeda dovetail rail – order the...
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  • Page 47: Chapter 7 Specifications

    Chapter 7 Specifications Note: All specifications are nominal and are subject to change without notice. Electrical Specifications Device Insulation Class Class II Double Insulated Applied Parts (Light Pad) Type BF Input Voltage 100 – 240 V , 50/60 Hz Input Current 0.25A –...
  • Page 48 Small Pad – 70 µW•cm •nm (+/- 25%) 6-point check Note: When the BiliSoft 2.0 fiberoptic light pad is inserted Using an Ohmeda Medical into a BiliSoft Pad Cover or BiliSoft Nest, the average BiliBlanket Meter II spectral irradiance is 35 µW•cm •nm...

  • Page 49: Chapter 8 Technical Reference

    Chapter 8 Technical Reference Spectral Irradiance Light Output BiliSoft 8.9 mW/cm (bare fiberoptic pad, small) Average Total Irradiance for Bilirubin* 6.1 mW/cm (bare fiberoptic pad, large) Note: (measured with a spectroradiometer between 400-550 nm)

  • Page 50: Effective Pad Area For Irradiance Output

    Effective Pad Area for Irradiance Output Pad Output Measurement Points Small Pad Measurement Grid Large Pad Measurement Grid...

  • Page 51: Chapter 9 Emc Guidance

    Do not use extension cords. The BiliSoft 2.0 is intended to be used in a hospital and home setting. Use of the BiliSoft 2.0 in other settings may result in disruption of nearby devices, or the BiliSoft 2.0 itself.
  • Page 52 Manufacturer’s Guidance and Declaration Regarding Electromagnetic Emissions The BiliSoft 2.0 is intended for use in the electromagnetic environment specified below. The customer or the user of the BiliSoft 2.0 should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance The BiliSoft 2.0 uses RF energy only for its internal function.
  • Page 53 NOTE 1: Ut stands for the AC main voltage prior to application of the test level. NOTE 2: The BiliSoft 2.0 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BiliSoft 2.0.
  • Page 54 Electromagnetic Immunity to RF Wireless Communication Devices The BiliSoft 2.0 is intended for use in the RF Wireless environment specified below. The customer or the user of the BiliSoft 2.0 should assure that it is used in such an environment.

  • Page 55: Emc Service Life

    EMC Service Life The EMC Service Life will match the Expected Service Life of the product defined in Chapter 7 by:  Following the recommended service and maintenance schedule found in the Service and Maintenance manual.  Using only recommended service parts as found in Chapter 8 or within the Service manual.
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  • Page 57: Appendix A1 - Additional Safety Information

    Improper disposal could result in personal injury or harm the environment.  This device is only to be used by those trained in the use of the BiliSoft 2.0.  The BiliSoft 2.0 should be used by direction of qualified medical personnel. Medical personnel should be familiar with currently known risks and benefits of infant phototherapy.
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  • Page 59: Appendix A2 - Home Use

    Appendix A2 - Home Use Homecare Providers When delivering the BiliSoft 2.0 System for use in the home, make sure to provide adequate training for the caregivers. Make sure to thoroughly explain this manual. Leave this manual with the caregivers. Provide eye covers.

  • Page 60: The Bilisoft 2.0 Phototherapy System Components

    The BiliSoft 2.0 Phototherapy System Components POWER CORD LIGHT BOX FIBEROPTIC PAD (large pad shown) FLAT PAD COVER PAD COVER NEST This Product must be periodically checked. A defective Product should not be used. Broken, missing, plainly worn, distorted or contaminated parts should be replaced immediately. No modification or alteration of this device is allowed.

  • Page 61: Installing Pad Covers

    It is important to have the blue light side with baby symbol directed toward the baby. Installing Flat Pad Covers Onto Pad 1. Gently insert the BiliSoft 2.0 fiberoptic pad into a BiliSoft flat pad cover (shown below). The back of pad should face the strap side of the cover as shown.

  • Page 62: Soiled Pad Covers

    Installing Pad Nest Covers Onto Pad 1. Gently insert the BiliSoft 2.0 fiberoptic pad into a BiliSoft 2.0 Nest cover (shown below). The back of pad should face away from the foot roll as shown. For baby’s comfort and hygiene, never place a baby directly on the bare fiberoptic light pad.

  • Page 63: Prepare The Baby - Remove Clothing

    Prepare the Baby – Remove Clothing Prior to positioning the baby on the pad it is important to remove all clothing but your baby’s diaper. The therapy is only effective if the baby’s skin is exposed to the blue light. Clothing such as sleepers will prevent the light from reaching the baby skin Positioning the Baby Regularly check that the patient is in the treatment area of the device.

  • Page 64: Using The Pad Straps To Swaddle The Baby

    PLACING BABY ON NEST 1. Place the baby on the padded side of the Nest. (The straps are on the sides.) Fiberoptic cable is at the baby’s feet. The foot roll is for the baby’s feet, not the head. IMPORTANT: Be sure to position the baby to expose the most amount of their skin to the pad light.

  • Page 65: Use Of Additional Blankets

    Use of Additional Blankets USE of ADDITIONAL BLANKET 1. The baby on the light pad may be covered or wrapped in an additional thin blanket to help swaddle. The baby can be held and fed during the treatment. The baby will continue to receive effective treatment as long as their skin remains exposed the pad light.

  • Page 66: Ready The Unit For Operation

    Protect the baby’s eyes with eye patches or an equivalent appropriate eye protection product. Without Blanket With Blanket Ready the Unit for Operation Placement of Light Box Place the light box on a smooth flat surface such as a table top so that it is out of the reach of other children or pets.
  • Page 67 Ready the Unit and Begin Treatment 1. Attach power cord by firmly inserting connector into Light Box receptacle. 2. Plug power cord into wall socket. 3. Route power cord to prevent tripping over it. 4. Insert the fiberoptic cable connector in the box.

  • Page 68: Frequently Asked Questions

    Frequently Asked Questions Feeding Time You can feed your baby while continuing to provide treatment. Follow your baby’s regular feeding schedule. Your healthcare provider can help you determine the proper schedule. Note the feeding times and amount of breast milk or formula taken, or length of time fed, on the record form. Make sure to give your baby plenty of fluids during treatment periods.

  • Page 69: Recording Daily Treatment

    Recording Daily Treatment Keep a daily record of your baby’s activities and condition. Use the example template of a simple record form shown here. This will provide your doctor with an accurate account of your baby's activities, and allow them to better assess the progress being made. A2-11...

  • Page 70: Homecare Use - Quick Reference

    Homecare Use - Quick Reference Cover Pad Undress Baby Position Baby Swaddle With Straps Optional Blanket Cover Baby’s Eyes Plug in Cord Plug in Pad Turn on Unit A2-12...
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  • Page 72 Authorized Lumitex service is provided by GE Healthcare. See list of service centers below. World Headquarters Europe, Middle East, Africa GE Healthcare GE Healthcare 9900 West Innovation Drive P.O. Box 900 Wauwatosa, WI 53226-4856 FIN-00031 GE Finland Tel 1 800 345 2700...

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