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Instructions for Use
ActiGraph LEAP
Model: LEAP
|
E.200.6025
|
Released: 07/12/2024
|
Rev: 2

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Summary of Contents for ActiGraph LEAP

  • Page 1 Instructions for Use ActiGraph LEAP ™ Model: LEAP E.200.6025 Released: 07/12/2024 Rev: 2...
  • Page 2: Table Of Contents

    Table of Contents Overview ........................................ActiGraph LEAP Accessories ................................. Information for Site Administrators ............................Information for Participants ................................Frequently Asked Questions ................................Regulatory Information .................................. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 3: Overview

    The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
  • Page 4: Actigraph Leap Accessories

    ActiGraph LEAP Accessories ActiGraph LEAP™ Wall Plug ActiGraph LEAP Charger MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 5: Information For Site Administrators

    To assign a LEAP to a new participant, refer to the CentrePoint Instructions For Use. After assigning the LEAP to a participant, wait for the LEAP to go from halt mode into active mode, as indicated by the running person icon in the upper left corner of the screen. This takes approximately 90 seconds.
  • Page 6: Information For Participants

    Pets have the potential to destroy a device. Keep devices away from pets and other animals that may • chew, bite, urinate on, swallow, and/or destroy a device in any other method imaginable. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 7 Charging Fully Charged The LEAP is fully charged once a solid battery icon appears on the screen. Remove the LEAP from the charger by pulling the LEAP away from the charger. Please note: An internet connection is not required to charge the LEAP(s) if connected to computer.
  • Page 8 As you continue to press and hold the button, the circle will gradually fill up until the final event marker icon is displayed below. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 9: Frequently Asked Questions

    Frequently Asked Questions On which wrist should the LEAP be worn? The LEAP should be worn on the non-dominant wrist. The non-dominant wrist is the one that is not used to write. What is the battery life of the LEAP? Approximately 32 days at default 32 Hz sample rate, accelerometer sensor only, and display on 48 times/day.
  • Page 10 The boxes we ship in are 200 lb test-rated cardboard boxes (double ream). The bubble wrap that we use is 1.8 mil - low density polyethylene, ½” thick and also we use a 3/16” thick wrap. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 11: Regulatory Information

    (2) this device must accept any interference received including interference that may cause undesired operation. Changes or modifications not expressly approved by ActiGraph, LLC will void the user’s authority to operate the equipment under FCC regulations.
  • Page 12 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ActiGraph LEAP™, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 13 NOTICE: Only use ActiGraph’s approved charging dock to charge the device. Charging Dock input: 5Vdc, 1000mA. Only use ActiGraph’s approved USB cables with the charging dock. Do not replace the battery; it cannot be replaced (3.85Vdc 250mAh Li-ion Polymer Battery).
  • Page 14 Indicates the need for the user to consult the instructions for use. Serial Number Indicates the manufacturer’s serial number so that a specific medical device can STM2XXXXXXXXX be identified. The manufacturing date is included in the serial number. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 15 Regulatory Information Continued Manufacturer ActiGraph is the medical device manufacturer and is located at 70 North Baylen Street, Suite 400. Pensacola, Florida 32502. Operating Temperature Range ° Indicates the operating temperature range to which the medical device can be safely °...
  • Page 16 UKCA marking and can be sold throughout the UK. CSEM Centre Suisse d’Electronique et de Microtechnique (swiss center of electronic and microtechnology) CSEM is the PPG experts and ActiGraph’s partners in developing the PPG portion of ActiGraph LEAP™ device. Rx Only Rx Only Caution: U.S.
  • Page 17 The mark applies to the California Energy Commission (CEC) Battery Charger System (BCS) certification. The electrical appliance efficiency regulations promulgated by the CEC impose energy-saving efficiency requirements on almost all BCS (battery charging system) products sold in the California market. MODEL: LEAP | E.200.6025 | RELEASED: 07/12/2024 | REV: 2 THEACTIGRAPH.COM...
  • Page 18 +1 (877) 497-6996 (U.S. toll free) support@theactigraph.com Please note: If an ActiGraph device is broken, malfunctioning, or does not appear to be working as intended, the participant should stop wearing it immediately and return it to the site. The site team should then return...

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