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Pacifier Activated Lullaby
Instructions for Use
®
IFU English
500055 Rev E
© 2023 by NeoLight, LLC.
All rights reserved.

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Summary of Contents for NeoLight Pacifier Activated Lullaby

  • Page 1 ® Pacifier Activated Lullaby Instructions for Use IFU English 500055 Rev E © 2023 by NeoLight, LLC. All rights reserved.
  • Page 2 This manual may not be reprinted or copied in whole or in part without written consent from NeoLight LLC. The content of this manual may change without notice. NeoLight LLC 1475 N Scottsdale Rd, Suite 110, Scottsdale, AZ 85257 Made In USA...
  • Page 3: Table Of Contents

    9.3 Use of PAL Device for Recording & Using Mother’s Voice ................ 23 Chapter 10: Compliance Declaration .......................... 26 Chapter 11: Warranty ..............................29 Chapter 12: Customer Service: ............................ 29 © 2023 by NeoLight LLC. Page 2 of 30 All rights reserved. 500055 Rev E...
  • Page 4 This page is left intentionally blank. © 2023 by NeoLight LLC. Page 3 of 30 All rights reserved. 500055 Rev E...
  • Page 5: User Responsibility

    Should such repair or replacement become necessary, NeoLight recommends making a service request by contacting Customer Service. This product or any of its parts should not be repaired other than in accordance with written instructions provided by NeoLight and by NeoLight trained personnel.
  • Page 6: Chapter 1: About This Manual

    90 minutes have elapsed. A PAL session may be administered for 15 minutes once or twice daily until the infant is able to suck effectively. © 2023 by NeoLight LLC. Page 5 of 30 All rights reserved.
  • Page 7: Chapter 2: Safety Information

    Type B.F. Applied parts Symbol placed next to CAUTION or WARNING to alert the users to important statements Do not expose to dust or moisture IP0X © 2023 by NeoLight LLC. Page 6 of 30 All rights reserved. 500055 Rev E...
  • Page 8 PAL device Background information provided to clarify a particular step or procedure. NOTE Information in this category is not considered precautionary © 2023 by NeoLight LLC. Page 7 of 30 All rights reserved. 500055 Rev E...
  • Page 9: Warnings And Cautions

    CAUTION: Keep all cords away from heat sources CAUTION: Make sure that all cabling is routed away from the infant as to not impair movement © 2023 by NeoLight LLC. Page 8 of 30 All rights reserved. 500055 Rev E...
  • Page 10 CAUTION: Do not use speakers, power supplies, or any other accessory not supplied by Neolight as this could result in injury as well as void all warranties and regulatory certifications CAUTION: Dispose of batteries according to local regulations CAUTION: The PAL Player should be placed at the patients' midline at approximately 6 inches from...
  • Page 11 This page is left blank intentionally. © 2023 by NeoLight LLC. Page 10 of 30 All rights reserved. 500055 Rev E...
  • Page 12: Chapter 3: Components And Controls

    The PAL Device automatically defaults to the SD port, if both the SD port and USB port are connected. The screen will display “Media Select” - you highlight your choice and press SELECT. If © 2023 by NeoLight LLC. Page 11 of 30 All rights reserved.
  • Page 13 & not show the sensor as “expired” until the session has ended by restarting PAL Device. • The PAL Sensor contains a circuit board. Dispose of expired PAL Sensors in accordance with local regulations or contact manufacturer for advice. © 2023 by NeoLight LLC. Page 12 of 30 All rights reserved. 500055 Rev E...
  • Page 14: Chapter 4: Operation

    MP3’s from a standard USB flash drive. To use the USB port, insert the USB flash drive into the USB port on the side of the unit shown above. © 2023 by NeoLight LLC. Page 13 of 30 All rights reserved.
  • Page 15: Modes Of Operation

    UP/DOWN arrows. When choice is highlighted, press SELECT again. 8. When Setup is complete, user must navigate to EXIT TO BEGIN. Press SELECT and PAL © 2023 by NeoLight LLC. Page 14 of 30 All rights reserved. 500055 Rev E...
  • Page 16 SELECT again. Once Setup is complete, user must navigate to EXIT TO BEGIN. Press SELECT and you will proceed to the music display screen. © 2023 by NeoLight LLC. Page 15 of 30 All rights reserved. 500055 Rev E...
  • Page 17: Chapter 5: Routine Maintenance Procedures

    PDI Super Sani-Cloth AF3 • • Acetones Aromatic hydrocarbons • Ketones • Low molecular weight aliphatic solvents • Ethers • Chlorinated and brominated solvents • Toluene • Ozone © 2023 by NeoLight LLC. Page 16 of 30 All rights reserved. 500055 Rev E...
  • Page 18 Unplug the device. Always turn off and disconnect the device (or remove the batteries) from the power outlet before cleaning NOTE: Please follow your institution's protocol for infection control when cleaning the device © 2023 by NeoLight LLC. Page 17 of 30 All rights reserved. 500055 Rev E...
  • Page 19: Replacing Pal Sensors

    Tools and Materials Required 1. None CAUTION: Only use the NeoLight issued PAL Sensors replacements for the device as any other part may result in the device being ineffective or dangerous to the user CAUTION: Ensure that the device is turned off and unplugged before proceeding 1.
  • Page 20 It could be that your USB flash drive isn’t formatted correctly. If you work for a the option for an MP3 on the hospital system and IT ordered the flash drive, they could have formatted the main menu flash drive © 2023 by NeoLight LLC. Page 19 of 30 All rights reserved. 500055 Rev E...
  • Page 21: Chapter 7: Accessories And Replacement Parts

    Chapter 7: Accessories and Replacement Parts Please contact NeoLight Customer Service for any replacements and parts needed. The following parts are critical components to the efficacy and safety of our products and must be replaced as directed. Part Name Catalog Number...
  • Page 22: Chapter 8: Product Specification

    The PAL Device should be operated in temperatures between 32°F and 104°F (0°C and 40°C), atmospheric pressures between 50 and 106 kPa (7.25psi to 15.3psi), and relative humidity between 15% and 90% R.H non-condensing © 2023 by NeoLight LLC. Page 21 of 30 All rights reserved.
  • Page 23: Chapter 9: Technical Reference

    Experience early fatigue during PO feeds Demonstrate frantic, short sucking bursts followed by fatigue during PO feeds Are not having success with PO feeds for any other reason Protocol: © 2023 by NeoLight LLC. Page 22 of 30 All rights reserved. 500055 Rev E...
  • Page 24: Use Of Pal Device For Recording & Using Mother's Voice

    • Provide parent education • Empower mother • Increase parental involvement in the infant’s care • Increase the infant’s exposure to appropriate auditory stimulation Participation: © 2023 by NeoLight LLC. Page 23 of 30 All rights reserved. 500055 Rev E...
  • Page 25 1. Have a song list (with lyrics) for mom to help her pick out songs to sing. 2. Let mom pick 4 to 5 songs to sing. 3. Record the songs in order from simplest to the most complex. © 2023 by NeoLight LLC. Page 24 of 30 All rights reserved.
  • Page 26 The above is the easiest way to ensure that recording will play on the PAL. If you attempt mother’s voice and are having issues please look at the below troubleshooting section. © 2023 by NeoLight LLC. Page 25 of 30 All rights reserved.
  • Page 27: Chapter 10: Compliance Declaration

    Modifications or use of accessories not expressly approved by the manufacturer are prohibited and may void the user’s authority to operate the equipment © 2023 by NeoLight LLC. Page 26 of 30 All rights reserved.
  • Page 28 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Pacifier Activated Lullaby (P.A.L) Model PAL-HOS is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment. Emission Tests Compliance Electromagnetic Environment – Guidance The Pacifier Activated Lullaby (P.A.L) Model #PAL-HOS uses RF energy...
  • Page 29 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pacifier Activated Lullaby (P.A.L) Model #PAL-HOS is used exceeds the applicable RF compliance level above, the Model should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Pacifier Activated Lullaby (P.A.L) Model...
  • Page 30: Chapter 11: Warranty

    Such warranties are extended only with respect to the first purchase of the PAL Device directly from NeoLight or NeoLight's authorized dealers as new merchandise and are extended to the Purchaser thereof; such warranties do not apply to any resale of the Product.
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Pal-hos

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