ActiGraph CENTREPOINT Insight Watch User Manual

ActiGraph CENTREPOINT Insight Watch User Manual

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User Guide
Insight Watch
CENTREPOINT
CentrePoint Insight Watch
|
E.200.6002
|
Released: 01/09/2023
|
Rev: 7

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Summary of Contents for ActiGraph CENTREPOINT Insight Watch

  • Page 1 User Guide Insight Watch CENTREPOINT CentrePoint Insight Watch E.200.6002 Released: 01/09/2023 Rev: 7...
  • Page 2: Table Of Contents

    CENTREPOINT Insight Watch The CentrePoint Insight Watch (CPW01) from ActiGraph captures and records continuous, high resolution acceleration data, which are converted into variety of objective physical activity and sleep measures within the cloud-based CentrePoint software system. This manual provides instructions on how to setup, deploy, and upload data from the CPW01 to the CentrePoint software system.
  • Page 3: Study Package

    Study Package PC + ActiSync Software CentrePoint Account CP Insight Watch (CPIW01) Charging Dock USB Cable Wall Plug CentrePoint Data Hub + Power Cable (optional) CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 4: Getting Started

    OpenSSL 1.0.1 or higher • • Mozilla NSS 3.15.1 or higher • * Sites using operating systems older than Windows 10 (e.g. Windows 7), should contact ActiGraph support for further instructions. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 5 The CPW01 is fully charged once a solid battery icon appears on the screen. Please note: An Internet connection is not required to charge the CPW01(s). CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 6: Assignment

    Once connected, the ActiSync icon will turn yellow and a dialog box will open. Select “Assign the subject now.” The CentrePoint web portal will open in your web browser. Enter your CentrePoint login information. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 7 • Wear position: Left Non-Dominant Wrist or Right Non-Dominant Wrist. • Select “Assign Device to a New Subject.” Wait for progress bar to indicate that assignment is complete. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 8 Once the CP Data Hub connects to the cellular network, the blue LED light will stay on solid. USB Port Power Status Light • Connect the charging dock to the USB port on the CP Data Hub using the USB cable. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 9 Verify connection and test upload status in CentrePoint • Login to the CentrePoint web portal. Select the “Subjects” tab from the left hand menu, and select the desired subject from the list. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 10 Use the charging dock to fully charge the CPW01 once every 3 weeks. Be sure to bring the CPW01, charging dock, and all accessories back to the Final Visit for a final upload and completion of the assessment. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 11 Please note: We encourage the reuse of the previously assigned CPW01 that the participant used during the first monitoring period. Otherwise, a new CPW01 and watch band should be used. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 12: Information For Participants

    CPW01 until the button on the right side fits in the side opening of the plastic tab. A progress wheel will appear on the screen indicating that an upload has begun. When the upload is complete, a check-mark will appear on the screen. Uploading Upload Complete CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 13 Once the CP Data Hub is successfully connected, plug the USB cable into the USB port on the side of the Hub, and plug the other end into the charging dock. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 14: Uploading

    CPW01 was worn for at least 80% of the time in a 24 hour period. If the wear compliance summary does not appear, we ask that you still select “I Acknowledge Wear Compliance.” Remove the CPW01 from the charging dock, and return it to the participant for continued monitoring. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 15: Viewing Participant Data

    Feed” on the “Study Home Dashboard.” To view detailed upload information for a participant, select the “Subjects” tab from the left hand menu, and select the desired subject ID from the list. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 16 CPW01 was worn for 80% of the time in a 24 hour period. You should review “Wear Details” regularly to verify that participants’ wear compliance meets minimum requirements for this study. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 17: Unassignment

    Once the upload is complete, a browser window will open to display the “Subject Upload Compliance” page. Mark the corresponding milestone and select “I Acknowledge Subject’s Wear Compliance.” CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 18 From the “Subject Details” page, select “Stop Collecting Data” to remove the participant assignment from the CPW01. Insert the CPW01 back into the charging dock to perform the final upload and complete the unassignment. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 19 The ActiGraph CPW01 devices are not to be sterilized because damage may occur. Although the CPW01 devices from ActiGraph are not required to be cleaned on any predetermined schedule, it is advised that the devices be cleaned after each use by a user.
  • Page 20: Lost Or Broken Cpw01(S)

    To disassociate an CPW01, select the “Subjects” tab from the left hand menu, and select the desired subject from the list. From the “Subject Details” page, select either “Lost monitor” or “Broken/Damaged monitor.” CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 21 Select “Remove monitor assignment from this subject” to disassociate the CPW01. To assign a replacement CPW01, follow the instructions on page 11 for assigning a monitor to an existing participant. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 22: Frequently Asked Questions

    If a CPW01 is lost or broken, follow the instructions on page 20 to remove the device association and assign a new CPW01 to the participant. Report lost or broken CPW01(s) to your Site Administrator and ActiGraph. What should a participant do when traveling? If a participant is traveling, the participant should be instructed to bring the charging dock and USB cable with them to charge the CPW01.
  • Page 23 ½” thick and also we use a 3/16” thick wrap. What to do at the end of the study? At the end of the study and after collecting all CPW01(s), charging docks, and cables, contact our ActiGraph Support team at support@theactigraph.com...
  • Page 24: 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 25 NOTICE: No precautions need to be taken in the event of changes in the performance of the product. NOTICE: Product does not have any contraindication(s) NOTICE: Only use ActiGraph’s approved charging dock to charge the device. Do not connect the device to anything else but a computer and an ActiGraph approved charging dock.
  • Page 26 Indicates the need for the user to consult the instructions for use. 10 ISO 3864-1 Serial Number Indicates the manufacturer’s serial number so that a specific medical device can be identified. CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 27 Regulatory Information Continued Manufacturer ActiGraph is the medical device manufacturer and is located at 49 E. Chase Street, Pensacola, Florida 32502. Operating Temperature Range ° Indicates the operating temperature range to which the medical device can be safely exposed. °...
  • Page 28 Giteki GITEKI CERTIFICATION (TECHNICAL STANDARDs CONFORMITY CERTIFICATION AND CONSTRUCTION DESIGN CERTIFICATION) CENTREPOINT INSIGHT WATCH | E.200.6002 | RELEASED: 01/09/2023 | REV: 7 THEACTIGRAPH.COM...
  • Page 29 U.S. federal law restricts this device for sale by or on the order of a physician. 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 the...

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