ActiGraph LEAP Small Worn Activity Monitor Instructions

ActiGraph LEAP Small Worn Activity Monitor

Product Information

ActiGraph LEAPTM
The ActiGraph LEAP (LEAP) from ActiGraph captures and records continuous, high-resolution acceleration data, which are converted into a 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 LEAP to the CentrePoint software system. The intended user(s) of this LEAP is the participant or end-user.

Technical Specifications

days / 1 GB

*At 32 Hz (default) sample rate.

Intended Use/Indications for Use
The ActiGraph LEAP is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. 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.

About ActiGraph
ActiGraph is pioneering the digital transformation of clinical research. ActiGraph’s medical-grade wearable technology platform has been used to capture real-world, continuous digital measures for nearly 200 industry- sponsored clinical trials and thousands of academic research studies. Appearing in over 22,000 published scientific papers to date, ActiGraph is the most experienced and trusted wearable technology partner in the industry.

Study Package

• PC + ActiSync Software
• CentrePoint Account
• ActiGraph LEAPTM
• ActiGraph LEAPTM Charger
• Wall Plug
• CentrePoint Data Hub + Power Cable (optional)

Product Usage Instructions

Getting Started

1. Allow firewall access to the following URLs:
   • ActiSync Service
   • Main Web Portal
   • Blob Azure Storage

Contact your local IT department prior to assigning LEAP(s) to ensure the above URLs are whitelisted for open and secure web communication and have access to the ActiGraph services. Please contact support@theactigraph.com for any additional questions or further assistance.

Please note:
Clicking on the links above does not confirm open access. URLs must be added to the IT whitelist. If you are having trouble assigning a LEAP and have not contacted your IT department yet, please do so.

Frequently Asked Questions (FAQ)

1. Q: What is the battery life of the ActiGraph LEAP?
   A: The ActiGraph LEAP has a battery life of 30 days*

2. Q: What is the sample rate of the ActiGraph LEAP?
   A: The ActiGraph LEAP has a sample rate of 32 Hertz (default) – 256 Hertz*

3. Q: What is the warranty period for the ActiGraph LEAP?
   A: The ActiGraph LEAP comes with a 1-year warranty.

Overview

ActiGraph LEAP™
The ActiGraph LEAP (LEAP) 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 LEAP to the CentrePoint software system. The intended user(s) of this LEAP is the participant or end-user.

Technical Specifications

Dimensions| 3.85 x 3.9 x 1.225 cm| Dynamic Range +/- 8G
---|---|---
Weight| 24 grams| Communication                                          USB, Bluetooth® LE 5.3
Sample Rate| 32 Hertz (default) – 256 Hertz| Water Resistance 1 meter, 30 minutes
Battery Life| 30 days*| Wear Location Multiple
Data Storage| 30 days / 1 GB| Warranty 1 year

*At 32 Hz (default) sample rate.

Intended Use / Indications for Use
The ActiGraph LEAP is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. 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.

About ActiGraph
ActiGraph is pioneering the digital transformation of clinical research. ActiGraph’s medical-grade wearable technology platform has been used to capture real-world, continuous digital measures for nearly 200 industry- sponsored clinical trials and thousands of academic research studies. Appearing in over 22,000 published scientific papers to date, ActiGraph is the most experienced and trusted wearable technology partner in the industry.

Study Package

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 for any additional questions or further assistance.

ActiSync Service

• https://studyadmin-actisync-service.actigraphcorp.com
• Connection point for the ActiSync client software order to determine the current assignment status of a device and instruct ActiSync how to proceed

Blob Azure Storage

• https://acticlouduploadsprod.blob.core.windows.net
• Allows ActiSync to extract the data from the LEAP and store it on our cloud storage server

Main Web Portal

• https://studyadmin.actigraphcorp.com
• Site personnel directly accesses this URL to create and monitor participants during the study

Please note:
Clicking on the links above does not confirm open access. URLs must be added to the IT whitelist. If you are having trouble assigning an LEAP and have not contacted your IT department yet, please do so.

CENTREPOINT® System Requirements
The CentrePoint system is only compatible with TLS 1.2 or higher security protocols. Contact your local IT department to ensure your systems meet the latest security protocols and have access to the ActiGraph services.

Internet Browsers

• Microsoft Internet Explorer 11 or newer
• Microsoft Edge
• Mozilla Firefox
• Google Chrome

API Integrations

• Java 8(1.8) or higher
• .NET 4.6.2 or newer
• Python 2.7.9 or higher
• Ruby 2.0 or higher
• OpenSSL 1.0.1 or higher
• Mozilla NSS 3.15.1 or higher

Operating Systems

• Windows 10 or newer*

Sites using operating systems older than Windows 10 (e.g. Windows 7), should contact ActiGraph support for further instructions.

Install ActiSync software

1. Download the ActiSync software from https://actigraphcorp.com/actisync.
2. Double-click the file to open and follow the prompts to complete the installation.

ActiSync System Requirements
OS Windows 10 or later (ActiSync is not compatible with MacOS) CPU Dual-core processor | HDD 20MB, USB 2.0

Charge the LEAP
The LEAP should be fully charged before assignment and deployment. It takes up to 2-3 hours to fully charge an LEAP. The charging temperature range is 0°C to 40°C.

1. Connect the charging dock to a wall outlet using the supplied wall plug.
2. Connect the LEAP to the ActiGraph LEAP™ Charger by placing the LEAP on top of the charger making sure the charging pins are aligned to the correct groves on the charger. The LEAP will snap into place magnetically.
3. The LEAP is fully charged once a solid battery icon appears on the screen.

Please note: An Internet connection is not required to charge the LEAP(s).

Assignment

LEAP(s) will be assigned to participants at Visit 1. Participants are instructed to bring the LEAP, charging dock, and all accessories back to the Final Visit, during which the LEAP will be unassigned and returned to inventory.

Assigning an LEAP to a new participant
Assigning a LEAP to a new participant will take approximately 3-5 minutes. Make sure the LEAP is fully charged prior to assignment.

1. Verify that ActiSync is running on the PC by checking for the small icon in the taskbar.

2. Connect the charging dock to the computer using the provided USB cable and insert the LEAP into the charging dock.

3. Once connected, the ActiSync icon will turn yellow and a dialog box will open.

4. Select “Assign the subject now.”

5. The CentrePoint web portal will open in your web browser.

6. Enter your CentrePoint login information.

7. Complete Device Assignment by entering the following information:

   • Site: Select the appropriate site from the dropdown menu. Site coordinators will only have one option available (their site). If you have access to more than one study, select the correct study before you continue with Device Assignment.
   • Subject Identifier: This will be six characters long (XXX-XXX), where the first three characters will be prefilled with your site ID and the last three numeric digits are the participant number.
   • Date of Birth: (DD-MM-YYYY)
   • Weight: (kg or lbs)
   • Wear position: Left Non-Dominant Wrist or Right Non-Dominant Wrist.

8. Select “Assign Device to a New Subject.” Wait for progress bar to indicate that assignment is complete.

9. 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.

10. Pair the CP Data Hub with the LEAP
    (If you’re not using a CentrePoint Data Hub, skip ahead to Information for Participants)

    • Connect the adapter end of the power cable into the back of the CP Data Hub and plug the other end into a wall outlet.
    • The blue LED status light on the back of the CP Data Hub will flash during startup. It may take up to 20 seconds for the light to begin to flash. Once the CP Data Hub connects to the cellular network, the blue LED light will stay on solid.
    • Connect the charger to the USB port on the CP Data Hub using the USB cable.
    • Place the LEAP on the charger. Once connected, a progress wheel will appear on the screen indicating that an upload has begun. When the upload is complete, a checkmark will appear on the screen.
      Please note: If you see a warning sign on the screen of the LEAP, pull it from the charger and place it again. Make sure you see a checkmark on the screen before proceeding to the next step.

11. Verify connection and test upload status in

    • Login to the CentrePoint web portal. Select the “Subjects” tab from the left-hand menu, and select the desired subject from the list.
    • You will be directed to the “Subject Details” page. Select the “Subject Timeline” tab, and verify that an upload has occurred via Data Hub USB. The LEAP and the CP Data Hub are now paired.

12. Remove the LEAP from the charger by pulling the LEAP away from the charger.

Assignment Completed
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.
• Use the charging dock to fully charge the LEAP once every 3 weeks. Be sure to bring the LEAP, charger, and all accessories back to the Final Visit for a final upload and completion of the assessment.

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:

• Complete steps 1- 6 above on page 8.
• Scroll to the bottom of the page and select the corresponding subject identifier from the list.
• Select “Assi gn Device to an Existing Subject.” Wait for the progress bar to indicate that the assignment is

Please note:
We encourage the reuse of the previously assigned LEAP that the participant used during the first monitoring period. Otherwise, a new LEAP and watch band should be used.

Information for Participants

How do I wear the LEAP?
Fasten the LEAP to your non-dominant wrist, so the numbers on the screen are not upside down when viewed like a wristwatch. The non-dominant wrist is the one that is not used to write. The LEAP should only be worn by the study participant.

• Wear the LEAP device on your wrist, at least one finger width from the wrist bone.
• Tighten the strap around your wrist.
• Put the strap into the buckle, tighten until it’s applied, without force on the wrist (no move, no space between wrist/strap/device)
• Tighten one more hole in bracelet
• When you push the wristband upwards, you shouldn’t be able to see the sensor’s LED
• For the most accurate heart rate measurement
• We recommend that you put on your device a few minutes before starting the heart rate measurement.
• It’s also advisable to warm up your skin if your hand and wrist get cold easily. Activate your blood circulation before starting your session.

When do I wear the LEAP?

• The LEAP should be worn 24 hours a day according to the schedule below. There’s no need to remove the 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. Then pull strap to tighten to one more hole past that and insert buckle tongue to secure. The strap should feel secure but comfortable on your wrist.

Please note:

• You may wear the LEAP while bathing or showering. However, remove the LEAP for any water activity that exceeds 1 meter of depth for more than 30 minutes.
• Data will not be negatively affected by lint, dust, or direct sunlight.
• 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.

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.

1. Place the LEAP on the charger by placing the LEAP on top of the charger. The LEAP will snap into place magnetically. 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.
2. While the LEAP is connected to the charger, an animated battery icon will appear on the screen to indicate charging. The LEAP is fully charged once a solid battery icon appears on the screen.
3. Remove the LEAP from the charger by pulling the LEAP away from the charger. Continue wearing the LEAP according to instructions.

Setting up the CentrePoint Data Hub

1. The CP Data Hub should be placed at home in a location where you spend most of your time.
2. Connect the adapter end of the power cable to the back of the CP Data Hub, and plug the other end into a wall outlet.
3. The blue LED on the back of the CP Data Hub will begin to flash during startup. Once the CP Data Hub connects to the cellular network, the blue LED will stay on solid.
4. 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.

Uploading

Upload LEAP(s)
Participants are instructed to bring the LEAP with them to every site visit, during which sites can upload activity data and review wear compliance.

1. Verify that ActiSync is running on the PC by checking for small icon in the taskbar.

2. 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 begin to upload automatically to the system.

3. Once the upload is complete, a browser window will open to display the “Subject Upload Compliance” page.

4. Enter your CentrePoint login information.

5. Subject Wear Compliance
   Following an ActiSync upload, you will be prompted to acknowledge wear compliance. Please note wear compliance results may take up to 1-2 hours to be processed by CentrePoint. For this study, a day is considered 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.”

6. Remove the LEAP from the charger, and return it to the participant for continued monitoring.

Viewing Participant Data

Go to the CentrePoint Main Portal at https://centrepoint.actigraphcorp.com and log in using your username and password.

Once logged in, you will be directed to the “Study Home Dashboard” page. All uploads are instantly logged in the “Activity 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.

Go to the “Subject Details” page and select “Subject Timeline.” Each timestamped data upload is logged and the amount of new data, LEAP battery level, and upload source are provided.

Reviewing wear compliance
To review a participant’s wear compliance, go to the “Subject Details” page and select “Wear Details” from the drop-down menu labeled “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 24 hours. You should review “Wear Details” regularly to verify that participants’ wear compliance meets minimum requirements

Unassignment

At the Final Visit, the LEAP will be uploaded and unassigned from the participant. Sites will then collect the LEAP(s), charging docks, and all accessories and return them to inventory.

Final data upload and LEAP unassignment

1. Verify that ActiSync is running on the PC by checking for small icon in the taskbar.
2. 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.
3. 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.”
4. Remove the LEAP from the charger by pulling the LEAP away from the charger.
5. From the “Subject Details” page, select “Stop Collecting Data” to remove the participant assignment from the LEAP.
6. Place the LEAP back onto the charger to perform the final upload and complete the unassignment.
7. A “Da ta Collection Complete” tag will appear in the general tab under the “Subject Details”
8. Collect the LEAP, charger, and all accessories. Clean the LEAP with an alcohol-based solution (wipes or swabs) and store all equipment until the end of the study.
   • LEAP devices from ActiGraph are approved to be cleaned with a non-abrasive cloth and any alcohol-based solution. For optimal results, apply isopropyl alcohol to the cloth, clean the device for 15-20 seconds, and let air dry. The
   • ActiGraph LEAP devices are not to be sterilized because damage may occur. Although the LEAP 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.
   • Cleaning the LEAP multiple times during its expected service life will not cause a loss of basic safety or essential performance.

Please note:
The ActiGraph LEAP™ (LEAP) and accessories should be cleaned with 70% Isopropyl alcohol between each use. Allow 10 minutes to air dry prior to re- use.

Lost or Broken LEAP(s)

If a LEAP is lost or broken, it must be disassociated from the participant before assigning a replacement. Only one LEAP can be assigned to a participant at any given time.

Lost or b roken

1. To disassociate an LEAP, select the “Subjects” tab from the left hand menu, and select the desired subject from the list.
2. From the “Subject Details” page, select either “Lost monitor” or “Broken/Damaged
3. Select “Remove monitor assignment from this subject” to disassociate the LEAP.
4. To assign a replacement LEAP, follow the instructions on page 11 for assigning a monitor to an existing participant.

Frequently Asked Questions

• Q Does the participant wear the LEAP for 24 hours?
  The participant should be instructed to wear the LEAP 24 hours a day.

• Q 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.

• Q What is the battery life of the LEAP?

• Q When and how often does the LEAP need to be charged?
  The participant should be instructed to fully charge the LEAP once every 3 weeks.

• Q How long does it take to charge the LEAP?

• Q What if the LEAP battery dies in the field?
  If the LEAP battery dies, the participant should be instructed to bring the LEAP, charging dock and USB cable back to the site for recharge and reinitialization of the LEAP using the CentrePoint system. Once the LEAP is recharged and reinitialized, verify it is on “Active Mode,“ and return it to the participant for continued monitoring.

• Q 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.

• Q 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 LEAP.

• Q What to do if a participant reports a skin reaction or issue?
  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.

• Q What do the lights on the back of the CP Data Hub

  • Blinking blue light: The CP Data Hub is attempting to connect to the cellular network. If the blinking blue light lasts more than several minutes or happens intermittently throughout the day, remove it from power and wait for the blue light to stop flashing. Once the blue light is off, connect the CP Data Hub back to power and try again. If the problem persists, the CP Data Hub should be moved to a different area with good cellular connection. If the CP Data Hub is still unable to establish a connection, contact your study team to report the problem.
  • Solid blue light: The CP Data Hub is connected to the cellular network and working properly.
  • Red light: The CP Data Hub is not working. Contact your study team to report the problem.

• Q What is the typical service life of the LEAP and accessories battery?
  The only limiting factor of an ActiGraph device, including accessory devices, when calculating life expectancy is the battery. The battery has a life expectancy of five (5) years. The performances of the components inside the device do not degrade over time so the life expectancy of a device is immeasurable.

• Q What is the shelf life of the LEAP and accessories battery?

• Q What is the time to warm the LEAP to an ambient temperature of 20° C?

• Q What is the time to cool the LEAP to an ambient temperature of 20° C?

• Q What are the packaging materials included in the Participant Package?
  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.

• Q What to do at the end of the study?
  At the end of the study and after collecting all LEAP(s), chargers, charging docks, and cables, contact our ActiGraph Support team at support@theactigraph.com and provide your Study Protocol, Site Number, and Serial Number of the LEAP(s) being returned. The ActiGraph Support team will provide you with the return shipping label and further instructions.

Regulatory Information

Regulatory Statements

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (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.

• FCC Part 15.107 – AC Conducted Emissions
• FCC Part 15.109 – Radiated Emissions

Please note:
This equipment has been tested and found to comply with the limits for a Class B digital device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used by the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and the receiver
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected
• Consult the dealer or an experienced radio/TV technician for help

Regulatory Symbols

• WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• WARNING: Use of accessories, transducers, and cables other than those specified or provided by ActiGraph could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment or decreased electromagnetic immunity of this equipment and result in improper operation.
• 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.
• WARNING: Both the ActiGraph Leap device and charger contain magnets. Under certain conditions, magnets and electromagnetic fields might interfere with medical devices. For example, implanted pacemakers and defibrillators might contain sensors that respond to magnets when in close contact. To avoid any potential interactions with these types of medical devices, keep this device and charger a safe distance away from your medical device (more than 6 inches / 15 cm apart). Consult with your physician and your medical device manufacturer for specific guidelines.
• If you suspect that your ActiGraph Leap device or charger is interfering with your medical device, stop using your ActiGraph Leap device and consult your physician and your medical device manufacturer.
• CAUTION: Do not simultaneously wear and charge, service, or provide any maintenance on the product.
• CAUTION: Transport and storage of this product outside of the temperature range of -20° C to 55° C, 15 – 90%, non-condensing 700 hPa to 1060 hPa could lead to dangerous conditions.
• CAUTION: Operating this product outside of the temperature range of 0° C to 40° C could lead to dangerous conditions.
• CAUTION: Modifications to ActiGraph products are not permitted and will void all warranties if tampered with and/or modified. Do not modify the product in any way as this can be unsafe to the end user.
• CAUTION: Do not swallow any part of this product. If a piece has been swallowed, contact your local poison control hotline or seek medical attention as soon as possible.
• 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 product or accessory.
• NOTICE: Only use ActiGraph’s approved USB cables with the charging dock.
• NOTICE: The ActiGraph LEAP™ may be used in any instance where quantifiable analysis of physical motion is desirable.
• NOTICE: ME Equipment charged via certified external power supply with input rated 90-264 Vac and output of up to 5Vdc.
• CAUTION:
  • Replacement of battery with an incorrect type that can defeat a safeguard (for example, in the case of some lithium battery types);
  • Disposal of a battery into fire or a hot oven, or mechanically crushing or cutting of a battery, that can result in an explosion;
  • Leaving a battery in an extremely high temperature surrounding environment that can result in an explosion or the leakage of flammable liquid of gas;
  • A battery subjected to extremely low air pressure may result in an explosion or the leakage of flammable liquid or gas.

FCC RADIATION EXPOSURE
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

ISED RADIATION EXPOSURE
This equipment complies with IC RSS-102 radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

Catalog Number
Indicates the manufacturer’s catalogue number so that the medical device can be identified for reordering.

CE Symbol
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. ActiGraph’s products abide with the Medical Device Directive 93/42/EEC and Radio Equipment Directive 2014/53/EU.

Brazil National Telecommunications Agency (ANATEL) Homologação Number
This equipment operates on a secondary basis, that is, not entitled to protection from harmful interference, even for stations of the same type, and may not cause interference to systems operating on a primary basis.

Consult Instructions for Use
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 be identified. The manufacturing date is included in the serial number.

Support Information

How do I contact support in case help is needed?
Go to theactigraph.com/support for user manuals, frequently asked questions and a common knowledge database with step- by-step solutions. Contact the ActiGraph Support team via email at support@theactigraph.com, or call the U.S. toll-free number +1 877-497-6996 from Monday to Friday 8 am-5 pm CST. Please provide the Study Protocol and Site Number.

©2023 ActiGraph, LLC. All rights reserved.

70 North Baylen Street, Suite 400. Pensacola, FL 32502 +1 850-332-7900 | +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 the device to ActiGraph.

References

• ActiGraph
• Support
• Anatel — Agência Nacional de Telecomunicações
• ActiSync
• Login - CentrePoint
• Login - CentrePoint

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