GE BiliSoft Operation And Maintenance Manual
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GE BiliSoft Operation And Maintenance Manual

Phototherapy system
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GE Healthcare
BiliSoft™ LED
Phototherapy System
Operation and Maintenance Manual
BiliSoft™ LED Phototherapy System
Operation and Maintenance Manual - English
M1110147
Rev.
5
© 2007 Datex-Ohmeda. All rights reserved.

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  • Page 1 GE Healthcare BiliSoft™ LED Phototherapy System Operation and Maintenance Manual BiliSoft™ LED Phototherapy System Operation and Maintenance Manual - English M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.
  • Page 2 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 3: Table Of Contents

    Cleaning and Disinfecting..............................7-2 BiliSoft Light Box .................................. 7-2 BiliSoft Fiberoptic Light Pad and Cable........................7-3 BiliSoft Cable Connector and Fiberoptic Lenses ....................7-4 Air Filter ....................................7-5 Chapter 8 Accessories and Replacement Parts..................8-1 Chapter 9 Specifications ..........................9-1 Chapter 10 Technical Reference.......................10-1...
  • Page 4 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 5: User Responsibility

    GE Healthcare Regional Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by GE Healthcare and by GE Healthcare trained personnel.
  • Page 6 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 7: Care Of The Skin

    Care of the Skin Important 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 of water excretion, especially in premature infants.
  • Page 8 This page intentionally left blank. viii M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 9: Chapter 1 Product Description

    LED module in the light box to the fiberoptic light pad. The flexible fiberoptic light pad is placed in a soft BiliSoft Pad Cover or BiliSoft Nest that is then brought into contact with the patient’s skin. The patient is exposed to light in the wavelength of 430-490 nanometer range (peak 440-460 nanometer).
  • Page 10 This page intentionally left blank. M1110147 Rev.5 © 2007 Datex-Ohmeda. All rights reserved.

  • Page 11: Chapter 2 Safety Information

    Chapter 2 Safety Information Symbol Definitions Symbol Description Next to each WARNING or CAUTION, we have placed an “attention, read accompanying documents” symbol to alert you to the presence of these important statements. When the attention symbol appears in front of text that is printed on the system itself, it means that the text is elaborated upon in the operation manual.
  • Page 12 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 Manual for more information. European Union Representative Manufacturer ETL symbol CE mark...

  • Page 13: General Safety Information

    General Safety Information WARNING: Eye Protection: Direct exposure of the eyes to any phototherapy light may cause eye damage. Always protect the baby’s eyes with eye patches or an equivalent appropriate eye protection product. Periodically and/or per your hospital protocol or healthcare provider’s instructions, verify that the patient’s eyes are protected and free of infection.
  • Page 14 Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The BiliSoft LED Phototherapy System should not be used adjacent to or be stacked on other equipment. If adjacent or stacked use is necessary, the BiliSoft LED Phototherapy System should be observed to verify normal operation in the configuration in which it will be used.

  • Page 15: Chapter 3 Home Use

    Chapter 3 Home Use Homecare provider Ensure when you deliver BiliSoft LED Phototherapy System for use in the home that you provide adequate in-service training for parents or guardians. Be sure to provide this Operation Manual and eye covers. Parents or Guardians Ask your healthcare provider for information about monitoring your baby during the phototherapy treatment.

  • Page 16: Recording Daily Activities

    Your healthcare provider or physician will tell you how long your baby needs to undergo treatment. Record the actual times at which your baby is put on and taken off the BiliSoft LED Phototherapy System during each 24-hour period. Apply phototherapy for as long as possible during each 24-hour period.

  • Page 17: Daily Record Sheet

    Note: This form is provided as a reference only. To preserve the integrity of this manual, please do not write directly on this page or remove this page from the manual. Reproduce this form, if desired. Daily Record Sheet Name: Date: Birth Date: Bilirubin Level:...
  • Page 18 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 19: Chapter 4 Components And User Controls

    Chapter 4 Components and User Controls BiliSoft Light Box The light box contains the LED module, a power supply, a cooling system, and an overheating protection. The universal power supply allows the unit to be supplied via any standard AC main power source at either 50 or 60 Hertz that has voltages in the range of 90 to 264 V~.
  • Page 20 Component/Control Function 5. Fiberoptic Light Pad Assembly Port - Where the fiberoptic light pad assembly connects to the main unit. An LED shutoff switch inside the port automatically shuts off the LED module whenever the fiberoptic light pad assembly is disconnected.

  • Page 21: 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.

  • Page 22: 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.

  • Page 23: Chapter 5 Operating Instructions

    4. Connect the power cord to the back of the unit, then to an appropriately grounded power source. 5. Turn the BiliSoft LED Phototherapy System on using the standby switch on the front of the unit and allow it to run for five (5) minutes.
  • Page 24 (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 •nm...

  • Page 25: Positioning The Unit

    Note: To avoid damage to the BiliSoft unit, use care when the BiliSoft is attached to other equipment that is being transported to ensure that the unit is protected from impacting door jambs or any other obstacles.

  • Page 26: Attaching The Mounting Bracket

    Attaching the Mounting Bracket Mounting bracket, male (for Mounting bracket, Mounting bracket, female (for dovetail rail and mobile stand). female (for dovetail Ohmeda mobile stand). rail and Giraffe Spot PT Lite roll stand). M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 27: Using The Unit

    Graphic Description 1. Gently insert the BiliSoft fiberoptic pad into a BiliSoft Pad Cover or BiliSoft Nest. The illuminated side should face up and should be against the padded side of the cover.
  • Page 28 2. Place the baby on the padded side of the BiliSoft cover or BiliSoft Nest. Adjust the straps as needed. IMPORTANT: Be sure the maximum area of illumination is in contact with the patient’s skin. WARNING: Improper use of the BiliSoft Pad Cover straps, BiliSoft Nest straps or fiberoptic cable may cause a strangulation or choking hazard.
  • Page 29 IMPORTANT: For hygienic purposes, never place a baby directly on the bare fiberoptic light pad. The light pad must be covered with the BiliSoft Pad Cover or BiliSoft Nest as described above. BiliSoft Pad Covers and BiliSoft Nests are for single-patient use only. The BiliSoft Pad Cover or BiliSoft Nest must be changed between patients and whenever it is soiled.

  • Page 31: Chapter 6 Troubleshooting

    Chapter 6 Troubleshooting Alarm/Troubleshooting Guide Symptom Likely causes Troubleshooting steps Unit Overheated Clogged air filter, 1. Turn off the standby switch and Indicator light is blocked vents, disconnect the power cord from the fan failure. outlet. Note: It can take up to 10 minutes for the thermal cutout switch to reset and allow the unit to be used again.
  • Page 32 3. Make sure that the irradiance damaged. measurement is taken with the fiberoptic light pad on a flat surface and that the Improper pad is not covered with a BiliSoft Pad measurement Cover or BiliSoft Nest when taking the setup. measurement.
  • Page 33 Symptom Likely causes Troubleshooting steps Hour meter is not Fiberoptic cable is 1. The hour meter only runs when the working. not fully inserted fiberoptic light pad is illuminated. If the into the light box. fiberoptic cable is not fully inserted in the light box, the LEDs are automatically shut Hour meter off and the hour meter does not run.
  • Page 34 This page intentionally left blank M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 35: Chapter 7 Routine Cleaning And Maintenance

    IMPORTANT: For hygienic purposes, never place a baby directly on the bare fiberoptic light pad. The light pad must be covered with the BiliSoft Pad Cover or BiliSoft Nest as described in the Operating Instructions. BiliSoft Pad Covers and BiliSoft Nests are for single-patient use only.

  • Page 36: Cleaning And Disinfecting

    Cleaning and Disinfecting BiliSoft Light Box WARNING: Make sure the light box power cord is disconnected from the power source before cleaning and that the unit is completely dry before using it. WARNING: Never immerse the light box in liquid. Water will short circuit electronic circuitry, causing permanent damage.

  • Page 37: Bilisoft Fiberoptic Light Pad And Cable

    BiliSoft Fiberoptic Light Pad and Cable CAUTION: Never immerse the fiberoptic light pad or fiberoptic cable in liquid. CAUTION: Do not autoclave or gas sterilize the fiberoptic light pad or fiberoptic cable. CAUTION: The fiberoptic cable connector requires special cleaning methods to avoid damage to the fiberoptic lenses.

  • Page 38: Bilisoft Cable Connector And Fiberoptic Lenses

    See table on this page for a list of approved cleaners. The following table lists approved disinfecting solutions (minimize exposure to fiberoptic lenses): WARNING: Never use flammable solutions to treat the BiliSoft LED Phototherapy System or any of its parts. Generic Maximum concentration level...

  • Page 39: Air Filter

    Air Filter The air filter on the rear of the light box should be visually checked and cleaned if needed to prevent air blockage that may cause overheating. The filter may be cleaned by vacuuming it. The filter can also be removed for cleaning. If the filter needs to be removed, take the unit out of service and seek assistance from service personnel.
  • Page 40 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 41: Chapter 8 Accessories And Replacement Parts

    Giraffe Spot PT Lite roll stand – order male bracket separately) M1097110 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)
  • Page 42 This page intentionally left blank. M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 43: Chapter 9 Specifications

    Chapter 9 Specifications Note: All specifications are nominal and are subject to change without notice. Electrical Specifications Input 1.5 A @ 100 – 240 V~, 50/60 Hz Fuses T3.15A @ 250V~, slo-blo type (qty. 2) Leakage Current < 300 µA @ 264 V~ Ground impedance <...
  • Page 44 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 irradiance of the BiliSoft System and replace the LED module when the system is below specifications.

  • Page 45: Chapter 10 Technical Reference

    Chapter 10 Technical Reference The following information is provided for compliance to IEC 6001-2-50. 100% BiliSoft Output Ohmeda Medical BiliBlanket Light Meter Sensitivity Wavelength (nm) Average Total Irradiance for Bilirubin ( measured with a spectroradiometer between 400-550 nm = 10.5 mW•cm (bare fiberoptic pad, small) = 7.9 mW•cm...
  • Page 46 This page intentionally left blank. 10-2 M1110147 Rev. © 2007 Datex-Ohmeda. All rights reserved.

  • Page 47: Warranty

    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 sole and exclusive remedy under the above warranties is limited to...
  • Page 48 Fax 44 1707 260191 BiliSoft™, BiliBlanket ® and Giraffe ® are registered trademarks of Datex-Ohmeda, Inc. Ohmeda Medical, a division of Datex-Ohmeda Inc., a General Electric Company, going to market as GE Healthcare 8880 Gorman Road Laurel MD 20723 410-888-5200 Fax 410-888-0544 www.gehealthcare.com ©...

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