Respironics BiliTx Manual
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Respironics BiliTx Manual

Phototherapy system
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P RO FES SI ON AL MAN UAL
REF 1045220
* + H 9 0 6 1 0 4 5 2 2 0 *
1044672
HM 3/26/08

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Summary of Contents for Respironics BiliTx

  • Page 1 P RO FES SI ON AL MAN UAL REF 1045220 * + H 9 0 6 1 0 4 5 2 2 0 * 1044672 HM 3/26/08...
  • Page 2 Warranty © 2007 Respironics, Inc. and its affiliates. All rights reserved.

  • Page 3: Table Of Contents

    Table of Contents 1. Overview ..............................3 Intended Use ............................3 What is the BiliTx Phototherapy System? ..................3 Components of the BiliTx System ....................4 2. Warnings, Cautions, and Symbols ...................... 5 Warnings ..............................5 Cautions ..............................7 Symbols ..............................
  • Page 4 Overhead Radiometer Certification ....................23 Effective Surface Area (Overhead Phototherapy) ..............24 Intensity Ratio ............................24 Audible Noise ............................24 Standards Compliance ........................25 Electrical Requirements ........................25 Disposal ..............................25 Appendix A: EMC Information ......................... 27 BiliTx Warranty ............................... 31 BiliTx Professional Manual...

  • Page 5: Overview

    Additionally, when the BiliTx system is properly used with the fiber optic panel the baby’s eyes do not need to be protected as with conventional phototherapy.

  • Page 6: Components Of The Bilitx System

    Components of the BiliTx System Fiber Optic Light Panel Configuration for Home or Hospital/Institutional Use The BiliTx system includes the following components. Some components are optional accessories that may not be packaged with Illuminator Device with your device. AC Power Cord 2.

  • Page 7: Warnings, Cautions, And Symbols

    BiliTx™ professional manual 2. Warnings, Cautions, and Symbols WARNING Caution! US federal law restricts this device to sale by or on the order of a physician. A warning indicates the possibility of injury to the user or Warnings operator. •...
  • Page 8 Carefully place the panel cable to avoid entanglement. • Position the Illuminator device on a stable surface, preferably lower than the infant. When the BiliTx system is used with the fiber optic panel configuration and carrying case, the device can hang on the outside of a crib or treatment area.

  • Page 9: Cautions

    • During phototherapy, the the baby’s water balance may become disturbed. Before and during phototherapy, make sure the baby is properly hydrated and that his or her body temperature is maintained. • After treatment has begun, the baby’s bilirubin level should be measured to make sure therapy is effective.

  • Page 10: Symbols

    Symbols The following symbols appear on the BiliTx system. Symbol Explanation Therapy On/Off Consult accompanying instructions for use Type BF applied part AC Power European Declaration of Conformity Canadian/US Safety Certification. Conforms to ANSI/UL STD. 2601. Certified to CAN/CSA C22.2 STD. NO. 601.1.

  • Page 11: Setup

    See the Cleaning and Maintenance section later in this manual for more information. Setting Up the BiliTx System For Use with a Fiber Optic Panel CAUTION Do not block any of the air vents 1.

  • Page 12: Setup - Wrap-Around Panel

    2. Place the covered panel under the baby’s torso, positioning it so it is under the baby’s armpits. 3. Wrap the panel around the baby. Use the tape or hook and loop tabs to secure the panel around the baby. Positioning the fiber optic panel BiliTx Professional Manual...

  • Page 13: Setup - Flat Neonatal Panel

    4. If the disposable cover becomes soiled, discard it and replace with a clean one. The cloth cover may be washed with mild soap and water. NOTES For a larger or more active baby, you may want to tape the panel to the baby’s diaper.
  • Page 14 You may wrap the baby in a blanket or put the baby in a sleeper. WARNING If using tape to secure the panel, do not adhere the tape to the baby’s skin. Wrapping and securing the T-vest BiliTx Professional Manual...

  • Page 15: For Use As Overhead Phototherapy

    For Use as Overhead Phototherapy NOTE: Overhead phototherapy is for hospital/institutional use only. CAUTION The following section explains how to prepare the unit for overhead Do not block any of the air vents phototherapy treatment. Overhead phototherapy can be used while on the Illuminator unit.
  • Page 16 10. To turn off the device when therapy is complete, press and hold overhead therapy. the Therapy On/Off button for 3 seconds. CAUTION If the power cord or wires need repair or replacement, do not connect the device. BiliTx Professional Manual...
  • Page 17 The graphic below shows the complete overhead phototherapy setup. Overhead phototherapy complete assembly Using the In-Use Carrying Case An optional, in-use carrying case is available for use with the Illuminator device. The carrying case allows for easy mobility during phototherapy treatment. To place the carrying case on the Illuminator device, simply slide it over the device and adjust the position so that the Start/Stop button is visible.
  • Page 18 BiliTx Professional Manual...

  • Page 19: Cleaning And Maintenance

    BiliTx™ professional manual 4. Cleaning and Maintenance This section explains how to clean, check, and maintain the BiliTx CAUTION system. Be sure the Illuminator device is turned off and is unplugged before cleaning. Do not immerse Cleaning the Illuminator Device and Fiber...

  • Page 20: Maintenance Schedule

    Maintenance Schedule Follow the schedule and instructions below to keep the BiliTx system properly maintained. The light has a minimum lifetime of 30,000 hours. The number of hours your device has been used can be found in the window on the bottom of the device.

  • Page 21: Troubleshooting

    BiliTx™ professional manual 5. Troubleshooting The following is a list of problems that may occur while using the BiliTx system. For additional information, refer to the BiliTx Service Manual or contact Respironics Customer Service at 1-800-345- 6443 or 1-724-387-4000. WARNING If therapy is interrupted for one hour or longer, resume therapy as soon as possible.
  • Page 22 BiliTx Professional Manual...

  • Page 23: Specifications

    BiliTx™ professional manual 6. Specifications Environmental Storage Operating Temperature -20 to +50° C 15 to 35° C Relative Humidity 15-95% Non-condensing 15-95% Non-condensing Physical Illuminator Size: 6.34 in. x 2.92 in. (16.10 cm x 7.40 cm) Weight: <2.50 lb. (1.13 kg)

  • Page 24: Light Source

    The graph below shows the total spectral irrandiance of the Illuminator device averaged over a wavelength range. Also included is a calibration curve of the Joey Dosimeter, which was used to take the measurements of the light. Wavelength (nm) BiliTx Professional Manual...

  • Page 25: Overhead Radiometer Certification

    Overhead Spectral Irradiance Total Irradiance of 94 mW/cm². Spectral Irradiance Wavelength (nm) Overhead Radiometer Certification Chapter 6 Specifications...

  • Page 26: Effective Surface Area (Overhead Phototherapy)

    14 cm diameter at a height of 30 cm (12 inches) 30 cm 14 cm diameter Intensity Ratio Standard 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...

  • Page 27: Standards Compliance

    Standards Compliance This 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 Requirements AC Power 100-240 VAC, 50/60 Hz, 1.0 A...
  • Page 28 BiliTx Professional Manual...

  • Page 29: Appendix A: Emc Information

    BiliTx™ professional manual Appendix A: EMC Information Guidance and Manufacturer’s Declaration - Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment.
  • Page 30 Power frequency magnetic fields Hz) magnetic field should be at levels characteristic of a IEC 61000-4-8 typical location in a typical hospital or home environment. NOTE: U is the a.c. mains voltage prior to application of the test level. BiliTx Professional Manual...
  • Page 31 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test IEC 60601 Test Compliance Electromagnetic Environment - Guidance Level Level...
  • Page 32 Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. BiliTx Professional Manual...

  • Page 33: Bilitx Warranty

    Illuminator device and the fiber optic panels, EG-2000 and EG-2000N, for a period of one (1) year from the date of purchase. In addition, Respironics warrants the LED light engine for 20,000 hours. This warranty does not cover any damage to the illuminating device or the fiber optic panel caused by accident, misuse, tampering, or negligence such as failure to follow the instructions provided in this guide.

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