BiliTx P aren t s ’ M anu al REF 1045219 *+H906104521909* Manufactured for Philips Children’s Medical Ventures 191 Wyngate Drive Monroeville, PA 15146 Respironics Deutschland Gewerbestrasse 17 82211 Herrsching, Germany 1075310 0086 HM 5/18/10
Warranty © 2010 Koninkljike Philips Electronics N.V. All rights reserved.
BiliTx parents’ manual Table of Contents 1. Overview...................................................................................................................................................... 3 Intended Use.......................................................................................................................................... 3 What is the BiliTx Phototherapy System?.....................................................................................
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BiliTx parents’ manual 1. Overview This chapter explains how the BiliTx Phototherapy System is used to treat infant jaundice and it lists the components of the BiliTx system. Intended Use The BiliTx is intended to treat hyperbilirubinemia through phototherapy.
4 Components of the BiliTx System Fiber Optic Light Panel Configuration The BiliTx system may include the following components. Note that some components may vary from those shown below or may be optional accessories that are not packaged with your device . 1. Illuminator Device with AC Power Cord 4 2. Fiber Optic Panel 3. Disposable Cover 4. Illuminator Device Carrying Case 5. System Carrying Case (optional) (not shown) 1 6. Parents’ Manual (not shown) 7.
BiliTx parents’ manual 2. Warnings, Cautions, and Symbols Caution! US federal law restricts this device to sale by or on the order of a physician. Warnings •• Use the BiliTx only for its intended use as described in this manual. •• Bilirubin photoisomers may cause toxic effects. •• Do not leave the Illuminator device on when the fiber optic panel is not around the baby. •• Always turn off and unplug the Illuminator device during cleaning or servicing.
6 •• If therapy is interrupted for any reason, resume therapy as soon as possible and contact your home care provider. •• 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.
7 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 0086 Canadian/US Safety Certification. Conforms to ANSI/UL STD. 2601. Certified to CAN/CSA C22.2 STD. NO. 601.1.
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BiliTx parents’ manual 3. Setup Setting Up the BiliTx System 1. Place the appropriate cover on the panel and position the baby and panel as described later in this chapter. (See Setup-Wrap Around Panel or Flat Neonatal Panel.) 2. Place the Illuminator device on a hard, flat surface or using the carrying case, hang the unit on the outside of a crib or the treatment area, away from any heat source. Make sure it is no more than four feet from where the baby will be positioned. 3.
10 Setup - Wrap-Around Panel This section explains how to prepare your baby for a phototherapy treatment using the wrap-around fiber optic light panel. The fiber optic panel must NOT be covered by anything except with the cover provided. Any other type of cover could cause a reduction in light intensity. The setup instructions must be followed exactly. This panel provides full coverage around the baby’s torso. 1.
11 Setup - Flat Neonatal Panel This section explains how to prepare a baby for a phototherapy treatment using the flat neonatal fiber optic light panel. The fiber optic panel must NOT be covered by anything except with the disposable cover provided. Any other type of cover could cause a reduction in light intensity. The setup instructions must be followed exactly. This panel is ideal for preemie or underweight infants; it may also be used on full-term infants. 1.
12 5. If your cover has the hook and loop tabs, you can secure the cover by pulling the hook and loop tab on the bottom corner of the cover up and accross the cover, tightening the cover around the cable between the baby’s legs. 6. If the T-vest becomes soiled, discard it and replace it with a new one. NOTES For a larger or more active baby, you may want to tape the panel to the baby’s diaper. To be sure the panel is not wrapped too tightly, insert your finger between the panel and the baby’s body.
BiliTx parents’ manual 4. Cleaning This section explains how to clean the BiliTx system. Cleaning the Illuminator Device and Fiber Optic Panel Follow the instructions in this section any time the Illuminator device or fiber optic panel is dirty. CAUTION Be sure the Illuminator device is turned off and is unplugged before cleaning. Do not immerse any part of the equipment in any liquid. CAUTION Keep the fiber optic panel away 1. Use soapy water, a 10% bleach solution or full strength ammonia.
14 Customer Service Information If you need to contact Philips Children’s Medical Ventures directly, call the Philips Children’s Medical Ventures Customer Service department at 1-800-345-6443 or 1-724-387-4000. You can also use the following address: Children’s Medical Ventures, LLC 191 Wyngate Drive Monroeville, Pennsylvania 15146 USA BiliTx Parents’ Manual HELPFUL TIP Visit Philips Children’s Medical Ventures web site at www.philips.com/childmed.
BiliTx parents’ manual 5. Troubleshooting The following is a list of problems that may occur while using the BiliTx system. For additional information, contact your home care provider or contact Philips Children’s Medical Ventures Customer Service at 1-800-345-6443 or 724-387-4000. WARNING If therapy is interrupted for one hour or longer, resume therapy as soon as possible and contact your home care provider.
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BiliTx parents’ manual 6. Specifications Environmental Storage Temperature Relative Humidity Operating -4 to 122° F (-20 to +50° C) 59 to 95° F (15 to 35° C) 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) Fiber Optic Panel Model: 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.
18 Light Source Irradiance Level Standard Panel-Light: 30µW/cm2/nm Neonatal Panel-Light: 55µW/cm2/nm Intensity Ratio Standard Panel and Neonatal Panel : > .4 (minimum to maximum) Audible Noise < 60 dB(A). Measured in accordance with IEC 60601-2-50.
BiliTx parents’ 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. Emissions Test RF emissions Compliance Group 1 CISPR 11 Electromagnetic Environment - Guidance The device uses RF energy only for its internal function.
20 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 Level Level Electromagnetic Environment Guidance Electrostatic Discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete (ESD) ±8 kV air ±8 kV air or ceramic tile.
21 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.
22 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and this Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
23 BiliTx parents’ manual BiliTx Warranty Children’s Medical Ventures, LLC warrants your BiliTx Phototherapy System against defects in material and workmanship of the 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, Philips Children’s Medical Ventures warrants the LED light engine for 20,000 hours.
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