Related Manuals for ActiGraph LEAP
Summary of Contents for ActiGraph LEAP
- Page 1 Instructions for ActiGraph LEAP ™ ActiGraph LEAP™ E.200.6025 Released: 12/07/2023 Rev: 0...
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Page 2: Table Of Contents
Getting Started .................................. Assignment ..................................Information for Participants ............................. Uploading ..................................Viewing Participant Data ............................Unassignment ................................. Lost or Broken LEAP(s) ............................... Frequently Asked Questions ............................Regulatory Information ............................... ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 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: Study Package
Study Package PC + ActiSync Software CentrePoint Account ActiGraph LEAP™ ActiGraph LEAP™ Charger Wall Plug CentrePoint Data Hub + Power Cable (optional) ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM... -
Page 5: Getting Started
Getting Started Allow firewall access to the following URLs Contact your local IT department prior to assigning LEAP(s) to ensure the following URLs are whitelisted for open and secure web communication and have access to the ActiGraph services. Please contact support@theactigraph.com... - Page 6 The LEAP should be fully charged before assignment and deployment. It takes up to 2-3 hours to fully charge an LEAP. Charging temperature range is 0°C to 40°C. Connect the charging dock to a wall outlet using the supplied wall plug.
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Page 7: Assignment
Assigning an LEAP to a new participant Assigning an LEAP to a new participant will take approximately 3-5 minutes. Make sure the LEAP is fully charged prior to assignment. Verify that ActiSync is running on the PC by checking for small icon in the taskbar. - Page 8 Weight: (kg or lbs) • 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. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM...
- Page 9 Continued Remove the LEAP from the charging dock. 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 10 Upload Complete Please note: If you see a warning sign on the screen of the LEAP, pull it from the charger and place again. Make sure you see a check-mark on the screen before proceeding to the next step. Verify connection and test upload status in Login to the CentrePoint web portal.
- Page 11 Give the LEAP, charger, and all accessories to the participant and provide the following Wear the LEAP securely on your non-dominant wrist for 24 hours a day for the duration of the study. There is no need to remove the LEAP for bathing or other water activities. There is no need to remove the LEAP at night or during sleep periods.
- Page 12 Assigning an LEAP to an existing participant To assign a LEAP to an existing participant (such as in the case of a lost or broken device) or if the visit schedule requires collection and reassignment. Follow these steps to assign a LEAP to an existing participant (such as, in the case of a lost or broken device) or if the visit schedule requires collection and reassignment: •...
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Page 13: Information For Participants
LEAP at night or during sleep periods. • Be sure to bring the LEAP with you to every site visit. Bring the CP Data Hub, charger, and all other accessories to your final site visit. Strap Instructions Pull the strap through the buckle so that it is comfortably taught with no gaps between the strap and your skin but does not compress the skin. - Page 14 Charging the LEAP You will be required to fully charge the LEAP once every 3 weeks, preferably at night time (e.g. before you go to bed). This takes approximately 2-3 hours. Data will be uploaded each time the LEAP is connected to the CP Data Hub.
- Page 15 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 charger. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM...
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Page 16: Uploading
1-2 hours to be processed by CentrePoint. For this study, a day is consider compliant if the LEAP 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.”... -
Page 17: 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. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM... - Page 18 “Subject Detail Views.” The “Wear Details” section displays daily details on subject wear time compliance. For this study, a participant is considered wear compliant for the day if the LEAP was worn for 80% of the time in a 24 hour period.
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Page 19: Unassignment
Verify that ActiSync is running on the PC by checking for small icon in the taskbar. Connect the charger to the computer using the provided USB cable and place the LEAP on the charger. The ActiSync icon will turn yellow and the data will upload automatically to the system. - Page 20 From the “Subject Details” page, select “Stop Collecting Data” to remove the participant assignment from the LEAP. Place the LEAP back onto the charger to perform the final upload and complete the unassignment. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0...
- Page 21 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. Cleaning the LEAP multiple times during its expected service life will not cause a loss of basic safety or essential performance.
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Page 22: Lost Or Broken Leap(S)
Only one LEAP can be assigned to a participant at any given time. Lost or broken To disassociate an LEAP, 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 ACTIGRAPH LEAP™... - Page 23 Continued Select “Remove monitor assignment from this subject” to disassociate the LEAP. To assign a replacement LEAP, follow the instructions on page 11 for assigning a monitor to an existing participant. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0...
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Page 24: Frequently Asked Questions
What if the LEAP is lost or broken? If a LEAP is lost or broken, follow the instructions on page 20 to remove the device association and assign a new LEAP to the participant. Report lost or broken LEAP(s) to your Site Administrator and ActiGraph. - Page 25 If a participant reports a skin reaction from wearing the LEAP or becomes uncomfortable, the participant should be instructed to stop wearing the LEAP immediately and bring it back to the site. The site team should contact ActiGraph Support team for further assistance.
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Page 26: 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 27 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 28 Cet équipement est conforme aux limites d’exposition aux radiations IC CNR-102 établies pour un environnement non contrôlé. Cet émetteur ne doit pas être colocalisé ou fonctionner en conjonction avec une autre antenne ou un autre émetteur. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM...
- Page 29 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 STM2XXXXXXXX be identified. The manufacturing date is included in the serial number. ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM...
- Page 30 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 31 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 32 This product has received the SRRC Type Approval certification in compliance with Chinese standards for radio transmission equipment. The SRRC Certificate is issued by MIIT (Ministry of Industry and Information Technology). ACTIGRAPH LEAP™ | E.200.6025 | RELEASED: 10/09/2023 | REV: 0 THEACTIGRAPH.COM...
- Page 33 +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...