natus neoBLUE compact User Manual
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natus neoBLUE compact User Manual

natus neoBLUE compact User Manual

Led phototherapy system
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neoBLUE
compact
®
User Manual
P/N 061083 Rev A
Revision Date 02/12/2021

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Summary of Contents for natus neoBLUE compact

  • Page 1 neoBLUE compact ® User Manual P/N 061083 Rev A Revision Date 02/12/2021...
  • 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

    Contents 1 Product Description ................1 2 Safety Information ..................4 2.1 Explanation of Terminology ..................... 4 2.2 General Safety Information ....................4 2.3 Safety Symbols ......................... 8 3 Components and User Controls ............11 3.1 Light Enclosure ....................... 11 3.2 Arm (optional) ........................11 3.3 Rollstand (optional) ......................

  • Page 4: Product Description

    ® The neoBLUE compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact Arm, and with the neoBLUE compact Rollstand. Intended Use The neoBLUE compact LED Phototherapy System is intended for the treatment of neonatal hyperbilirubinemia.
  • Page 5 As with all phototherapy lights, protective eyeshades must be used to protect the infant’s eyes from excessive light exposure. The neoBLUE compact light is also equipped with a white exam light feature that provides approximately 10,000 lux of neutral white light for general examinations.
  • Page 6 The following accessories are included with each light: a USB Flash Drive containing the User Manual and Service Manual and a power cord. Arm (optional) The neoBLUE compact Arm is designed to attach to poles with 0.75 to 1.5 inch (1.91 to 3.81 cm) diameters. Rollstand (optional)

  • Page 7: Safety Information

    Note: Background information provided to clarify a particular step or procedure. 2.2 General Safety Information The neoBLUE compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact Arm, and with the neoBLUE compact Rollstand. All configurations were tested for safety and stability and no differences were noted between various configurations.
  • Page 8 Warning! Attachment of Arm with Pole Mount: When attaching the light to any floor stand other than the neoBLUE compact Rollstand, the user must validate that it conforms to Regulatory/Safety Standards noted in Specifications (Section 8).
  • Page 9 Warning! Placement directly on incubator: The use of skin- controlled mode (patient servo) of the incubator or radiant warmer is recommended unless manual mode (air servo) specifically prescribed. While both modes require patient monitoring, manual mode requires constant attention. In manual mode, care must be taken to observe any changes in ambient conditions (drafts, sunlight, phototherapy light usage, etc.) as small changes can have an effect on patient temperature.
  • 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 compact system, or place anything on top of the light. The Rollstand, Arm hardware and light are not designed to support additional equipment.

  • Page 11: Safety Symbols

    Caution: This device is rated IPX0 indicating that no water ingress protection is provided. Important! Use of nonstandard components: The unit uses a specific type of LED. Consult the manufacturer for repair and replacement of LEDs. Use of incorrect LEDs can adversely affect performance and/or damage the light.
  • Page 12 Symbol Meaning Warning Caution Consult Instructions for Use Authorized European Representative Date of Manufacturing Legal Manufacturer Disposal at end of operating life instructions Catalog Number Serial Number Lot Number Atmospheric Pressure Limitation Humidity Limitation Temperature Limit Device is cleared for the US market as requiring a prescription Medical Device Medical Device...
  • Page 13 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 14: Components And User Controls

    Components and User Controls 3.1 Light Enclosure The neoBLUE compact LED Phototherapy System can be placed on top of an incubator. Components include the light enclosure and power cord. Vents: There is one fan outlet vent at the back of the light enclosure. The ventilation fan prevents the unit from overheating.

  • Page 15: Rollstand (Optional)

    3.3 Rollstand (optional) The neoBLUE compact LED Phototherapy System and Arm can be mounted to the optional neoBLUE compact Rollstand for use with incubators, infant warmers, bassinets, or open beds. Height Adjustment: Adjust the height of the light enclosure by adjusting the gooseneck portion of the Arm and/or by moving the location of the Arm clamp up or down the Rollstand.

  • Page 16: Panel Controls

    Service Indicator: This indicator light will glow red if the device requires service (refer to the Service Manual). Device Timer: The neoBLUE compact light is equipped with a device timer, located on the bottom of the light to track the total number of hours the blue light is switched on.

  • Page 17: Assembly And Operating Instructions

    Assembly and Operating Instructions 4.1 Assembly The neoBLUE compact light, Arm, and Rollstand are shipped in separate boxes whether ordered separately or as a set. Unpack the shipping boxes. Check contents against the packing lists. Attach the suction cups to the light. Install the four suction cups supplied with the light into the four threaded inserts on the underside of the light enclosure before using the product.
  • Page 18 Arm next to the Arm clamp, and plug into an AC outlet. Warning! Attachment of Arm with Pole Mount: When attaching the light to any floor stand other than the neoBLUE compact Rollstand, the user must validate that it conforms to Regulatory/Safety Standards noted in Specifications (Section 8).

  • Page 19: Operating The Device

    Warning! Use with Radiant Warmer: Do not place the neoBLUE compact light directly under radiant heat source. The light should be placed in line with the side of the heat element and angled toward the infant. To assemble the light and Arm hardware to the Rollstand, follow these steps: Attach the Arm to the Rollstand.
  • Page 20 Shield infant’s eyes with protective eye shields designed for use during phototherapy. ® Biliband Eye Protectors Sizes: Micro (P/N 900644) Premature (P/N 900643) Regular (P/N 900642) Warning! Eye Protection: Do not look directly into the LEDs. During treatment or use of the white exam light, always protect the baby’s eyes with eye patches or equivalent.
  • Page 21 Turn on white exam light as needed. Press exam light button on. Turn off white exam light when finished. Press exam light button off, or press the On/Standby button to resume blue treatment light. 10 Turn off blue treatment light when finished. Press On/Standby button.

  • Page 22: Troubleshooting Guide

    Troubleshooting Guide Note: The neoBLUE compact Service Manual is available separately. Warning! Disconnect electrical power: Always switch off the power and disconnect the power cord when repairing or cleaning the light. Problem Probable Cause Action  Verify that unit is plugged in.

  • Page 23: Routine Cleaning And Maintenance

    If the intensity of light falls below hospital-defined minimums due to degradation or increased distance from the light enclosure to the infant, then the light should be readjusted. Please refer to the neoBLUE compact Service Manual for more information. Note: The light will continue to operate with minimal degradation over time.
  • Page 24  Do not clean with alcohol, acetone, or other solvents.  Never immerse the light or its component parts. Note: The following hospital disinfectants are safe to use on this product (Cavicide/CaviWipes, PDI Sani-Cloth wipes, Clorox Germicidal wipes, Sporicidin, 5% bleach). Note: To ensure correct operating temperature, the vent filter on the underside of the light should be kept clear and free of dust.

  • Page 25: Technical Reference

    Technical Reference The following graph shows the normalized spectra of the blue LEDs and the spectral sensitivity of the radiometer. Radiometer Spectral Response neoBLUE compact LED Normalized Spectral Distribution Wavelength [nm] Measurements for this light were made using a standard radiometer.

  • Page 26: Specifications

    Specifications Light Source Blue and White LEDs Wavelength Blue: Peak between 450 and 470 nm Intensity Peak intensity at 35 cm (13.75 in) Factory setting 15 ±2 µW/cm /nm (total irradiance 1200 µW/cm High 35 ±2 µW/cm /nm (total irradiance 2800 µW/cm Adjustable setting Approx.
  • Page 27 Environmental Operating Temperature/Humidity 41° F to 95° F (5 to 35 C) / 10% to 90% non-condensing Storage Temperature/Humidity -22° F to 122° F (-30 to 50 C) / 5% to 95% non-condensing Altitude / atmospheric pressure -1000 feet to +20,000 feet (50 kPa to 106 kPa) Regulatory Standards IEC 60601-1: Edition 3.1 IEC 60601-2-50: Edition 2...

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