natus neoBLUE User Manual

natus neoBLUE User Manual

Led phototherapy system
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neoBLUE
LED Phototherapy System
User Manual
P/N 027159 Rev C
Revision Date 2021-07

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Table of Contents
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Summary of Contents for natus neoBLUE

  • Page 1 ® neoBLUE LED Phototherapy System User Manual P/N 027159 Rev C Revision Date 2021-07...
  • Page 2 International Support - Please contact your local Distributor. Distributor locations can be found at www.natus.com This manual may not be reprinted or copied in whole or in part without written consent from Natus Medical Incorporated. The content of this manual may change without notice.
  • Page 3: Table Of Contents

    Table of Contents 1. PRODUCT DESCRIPTION ............................3 2. SAFETY INFORMATION ............................5 ............................ 5 XPLANATION OF ERMINOLOGY ............................. 6 ENERAL AFETY NFORMATION ............................... 10 AFETY YMBOLS 3. SAFETY INFORMATION ............................12 ..........................12 IGHT NCLOSURE AND TAND ............................13 RONT ANEL ONTROLS...
  • Page 4: Product Description

    Light Source The light consists of a lightweight plastic light enclosure. When used with the neoBLUE roll stand, the light can be tilted and adjusted both horizontally and vertically on the roll stand assembly. The light enclosure can be tilted to approximately 40° up from horizontal (the resting position).
  • Page 5 Timer The neoBLUE light is equipped with a timer to track the total number of hours it is switched on. The timer will count up to a maximum of 9999999.9 hours. The decimal point will be flashing at a steady rate when the timer is counting. When the timer is not counting, the decimal point will not flash.
  • Page 6: Safety Information

    Other explanatory information is highlighted with the word NOTE. Information in this category is not considered precautionary. NOTE: Background information provided to clarify a particular step or procedure. neoBLUE LED Phototherapy System User Manual Page 5 of 22 ®...
  • Page 7: General Safety Information

    Health and Clinical Excellence – Neonatal Jaundice). NOTE: Any serious incident that has occurred in relation to the device should be reported to Natus Medical Incorporated and the competent authority of the Member State in which the user and/or patient is established.
  • Page 8 Warning! Attachment of Light Enclosure: When attaching the light to any floor stand other than the neoBLUE roll stand, confirm weight capacity and stability of the stand. (Section 8). Warning! Monitor infants regularly during treatment per your institution’s protocols. Use the following guidelines: Measure the patient’s bilirubin level periodically.
  • Page 9 Warning! Operator Safety: Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the irradiated area. Using the neoBLUE system in a well- lighted area or wearing glasses with yellow lenses can alleviate potential effects. The neoBLUE light drapes may be used and are available through Natus Medical Incorporated (P/N 001241).
  • Page 10 Caution: Other equipment: Do not attach other equipment not supplied by Natus Medical Incorporated and indicated for use with the light to the neoBLUE system, or place anything on top of the light. The roll stand and light are not designed to support additional equipment.
  • Page 11: Safety Symbols

    Authorized European Representative Date of Manufacturing Legal Manufacturer Fuse Device is cleared for the US market as requiring a prescription Disposal at end of operating life instructions Fragile This Side Up neoBLUE LED Phototherapy System User Manual Page 10 of 22 ®...
  • Page 12 WEEE is reused or recycled safely. In line with that commitment Natus Medical Incorporated may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made.
  • Page 13: Safety Information

    Roll stand base: the low profile circular base is designed to prevent tipping when the light is at any angle or distance from roll stand. Base fits under standard incubators to allow easy placement. neoBLUE LED Phototherapy System User Manual Page 12 of 22 ®...
  • Page 14: Front Panel Controls

    Passive air conduction vents (along bottom sides, front, and back edges) Timer: The neoBLUE light is equipped with a timer to track the total number of hours it is switched on. The timer will count up to a maximum of 9999999.9 hours. The decimal point will be flashing at a steady rate when the timer is counting.
  • Page 15: Assembly And Operating Instructions

    “Cleaning” for more information on vents) ASSEMBLY AND OPERATING INSTRUCTIONS Assembly The neoBLUE system consists of two products shipped in two separate boxes. One box contains the light enclosure and the other box contains the roll stand (post/attachment arm and base).
  • Page 16 Warning! Operator Safety: Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the irradiated area. Using the neoBLUE system in a well-lighted area or wearing glasses with yellow lenses can alleviate potential effects. The neoBLUE light drapes may be used and are available through Natus Medical Incorporated (P/N 001241).
  • Page 17 • Monitor patient temperature and fluid status, especially when used with thermotherapy. • Periodically verify that the baby’s eyes are protected and free of infection. 9. When finished, switch power to stand-by and remove light from the therapy area. neoBLUE LED Phototherapy System User Manual Page 16 of 22...
  • Page 18: Troubleshooting Guide

    TROUBLESHOOTING GUIDE NOTE: neoBLUE device Service Manual available separately. In the USA, contact Natus Technical Service at +1-888-496-2887 or E-mail: technical_service@natus.com International Support - Please contact your local Distributor. Distributor locations can be found at www.natus.com. Warning! Disconnect power cord before opening the light for repair.
  • Page 19: Routine Cleaning And Maintenance

    Natus Medical Incorporated recommends using a properly calibrated neoBLUE Radiometer for measuring the intensity of the neoBLUE light. If this meter is not available, it is important to measure the intensity with a radiometer specifically designed to measure the narrow wavelength spectrum of blue LEDs.
  • Page 20: Adjusting The Light Intensity

    The desired setting is selected using the left rocker switch on the front panel of the light. The light output was factory calibrated with the neoBLUE Radiometer to provide an initial intensity of 35 μW/cm /nm at the high setting and 15 μW/cm...
  • Page 21: Technical Reference

    Natus Medical Incorporated recommends using the neoBLUE Radiometer for measuring the intensity of the neoBLUE device. If this meter is not available, it is important to measure the intensity with a radiometer specifically designed to measure the narrow wavelength spectrum of blue LEDs.
  • Page 22: Specifications

    < 9 to 13 ± 1 inches A1; 2012, AAMI 60601-2-50 AMD 1 (23 cm to 33 cm ± 2.5 cm) CAN/CSA-C22.2 NO. 60601-1-14, CAN/CSA-C22.2 NO. 60601-2-50-10 neoBLUE LED Phototherapy System User Manual Page 21 of 22 ®...
  • Page 23 LED Phototherapy System User Manual Page 22 of 22 ®...

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