Nanit Breathing Motion Monitoring System Instructions For Use Manual

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Breathing Motion Monitoring System
Instructions for Use

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Summary of Contents for Nanit Breathing Motion Monitoring System

  • Page 1 Breathing Motion Monitoring System Instructions for Use...
  • Page 2: Table Of Contents

    (electrical e[ects) ......10 Safe disposal instructions ...................... 13 Instructions when to consult a healthcare professional ............13 Nanit Customer Service and Troubleshooting Contact Information .......... 13 Date of issue/revision ......................13 Symbol Annex ........................14...
  • Page 3: Name Of Device

    Cloud, Nanit Breathing Wear, and Nanit Camera Stands. The Nanit Pro Camera provides live video/audio feed of the baby while it is in the crib, which is accessible to the caregiver via the Nanit App. The Nanit Pro Camera also contains the Breathing Monitoring Algorithm.
  • Page 4: Product Configurations

    Instructions For Use • Nanit Pro Camera to be mounted via a Nanit Camera Stand in order to provide a view of the baby’s crib. • Nanit Breathing Wear to be worn by the baby in the crib. • Active Wi-Fi connection or P2P connection (Nanit Pro Camera) •...
  • Page 5: Product Lifetime

    The Nanit Breathing Motion Monitoring System is intended to track and monitor the respiratory rate of infants (0-24 months) while they are asleep in the crib using video captured by the Nanit Pro Camera, in conjunction with the Nanit Breathing Wear, once activated via the Nanit App.
  • Page 6: Intended User

    Instructions For Use Intended User The Breathing Motion Monitoring System is designed for use by infant caregivers in the home environment. Performance characteristics of the device Power adapter: • Power Input 230V, 50 Hz • Power Output 5V, 2.1A DC Nanit Pro Camera •...
  • Page 7: Specifications User Requires To Use Device Appropriately

    Instructions For Use Specifications user requires to use device appropriately • The Nanit Pro Camera must be paired to the Nanit App via a Bluetooth connection to the user’s mobile device prior to use. • The Nanit Pro Camera requires a local Wi-Fi connection in order to communicate with the Nanit App for the purpose of Breathing Motion Monitoring.
  • Page 8: Preparatory Treatment/Handling Of The Device Before It Is Ready For Use Or During Use

    10. Click ‘Start’ button to initiate breathing monitoring. 11. The Camera detects the pattern on the Breathing Wear. Should motion not be detected, you will be altered on the camera and in your device via a Red Alert in your Nanit App. Red-Alerts When the Nanit Camera is able to detect the baby in the crib but is unable to detect breathing motion for 20 seconds, the Red-Alert will be triggered.
  • Page 9: Information Needed To Verify Whether Device Is Properly Installed

    Instructions For Use Figure 2. Red-Alert Dismissal via the Nanit Application Information needed to verify whether device is properly installed • How to ensure Camera is paired to phone o Turn the camera on. When the camera completes the boot up sequence, an LED will blink twice.
  • Page 10: Methods For Eliminating Risks Encountered By Persons Involved In Installing Devices

    • Ensure the Nanit wall mount is properly installed prior to a[ixing the Nanit Pro Camera. • Place the Nanit floor mount in a location which does not represent a tripping or tipping hazard. • Install the Nanit App’s latest version via the Apple App Store or the Google Play Store.
  • Page 11 68° and 72° F (20° – 22° C) • Do not use the Nanit Breathing Wear Sleeping Bag on a baby who is ill and has a fever, as this can further increase body temperature - Baby should not feel hot to the touch •...
  • Page 12 Do attempt to open the camera enclosure or touch any internal components. • Use of the Nanit Camera adjacent to or stacked with other equipment should be • avoided because it could result in improper operation. If such use is necessary,...
  • Page 13: Safe Disposal Instructions

    Do not use cleaning agents on the camera. • The Nanit Camera uses four (4) 850nm infrared LEDs at an intensity of 60 mW per sensor. Keep the camera at least 3 feet away from the crib and do not look directly into the sensors.
  • Page 14: Symbol Annex

    Instructions For Use Symbol Annex This checklist covers the IEC 60601-1, Edition 3.1 requirements for the labeling and the accompanying documents (IFU) of Medical Electrical Equipment. It also includes information and interpretations for the clause requirements, as applicable. Clause Requirement Comment 7.2.3 Consult Accompanying Documents:...
  • Page 15 Instructions For Use 7.4.1 Power Switches: Switches for “on” & “off” positions to control power to ME Equipment/parts (including mains switches) - Marked with Symbols 12 and 13, for Mains on/off (or) 7.4.2 Control device or switch that brings the ME Equipment into the "stand-by" condition, - Marked with Symbol 29 -Control functionality, but not mains power to the equipment Safety signs:...

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