ActiGraph LEAP Wearable Device Smartwatch Instruction Manual

ActiGraph LEAP Wearable Device Smartwatch Instruction Manual

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 Centre Point software system. This manual provides instructions on how to setup, deploy, and upload data from the LEAP to the Centre Point 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 – 256 Hertz| Water Resistance                      IPX7 (1 meter, 30 minutes)
Battery Life| 32 Days| Wear Location Multiple
Data Storage| 79 Days / 1 GB| Warranty 1 year

*32 days at default 32 Hz sample rate and display on 48 times/day

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. ACTi Graph’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.

ActiGraph LEAP Accessories

• ActiGraph LEAP™

• ActiGraph LEAP Charger

• Wall Plug

Information for Site Administrators

Charge the LEAP

The LEAP should be fully charged before assignment and deployment. It takes up to 2-3 hours to fully charge a LEAP. 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 grooves on the charger. The LEAP will snap into place magnetically

3. 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.

4. 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).

Assigning a LEAP to a new participant

To assign a LEAP to a new participant, refer to the Centre Point Instructions For Use.

1. 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.

Halt Mode
Stop icon will be displayed if the LEAP is not collecting data.

Active Mode
A running person icon will be displayed if the LEAP is collecting data.

Information for Participants

Wearing the Activity Monitor
Wear the activity monitor on your non-dominant wrist like a wristwatch. The non-dominant wrist is the one that is not used to write. The activity monitor should only be worn by the study participant.
Strap Instructions
Pull the strap through the buckle so that it is comfortably snug and there is no slack or gaps between the strap and your skin. Insert the tongue of the buckle into the nearest hole. For the best data quality, tighten the strap one hole further during exercise.

Confirming the Fit

• The strap should feel secure but comfortable on the wrist. Participants can rotate their wrist back and forth quickly and check if the device stays in position on their wrist.
• The device should not be affixed too far up the arm, such that it might slide down toward the hand and loosen.
• The device should not be affixed too far toward the hand; if the wrist is bent upwards, the back of the hand should not touch the body of the device.

Preventing a skin reaction while wearing the LEAP device
Avoid using perfume, lotion, suntan/sunscreen or insect repellent on the area where the activity monitor is worn. If the activity monitor comes in contact with these or any other chemicals, clean the device and silicone strap with 70% IPA and the skin with soapy water, making sure to completely rinse and dry the skin, device, and strap before putting back on. As a preventative measure, the activity monitor and strap can be cleaned on a regular basis.

Please note:

• You may wear the activity monitor while bathing or showering. However, remove the activity monitor 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
The LEAP should be fully charged periodically according to your study protocol. It takes up to 2-3 hours to fully charge a LEAP.

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 grooves on the charger. The LEAP will snap into place magnetically. Please note: An internet connection is not required to charge the LEAP(s).
3. 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.

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

Turning on the Activity Monitor Screen

To activate the activity monitor screen, simply press and release the button located on the right side within 2 seconds. The screen will stay illuminated for five seconds before automatically shutting off.

Marking an Event on the Activity Monitor

1. Press and hold the button located on the right side of the activity monitor for at least 2.5 seconds. After one second, you will see the icon displayed below.

2. As you continue to press and hold the button, the circle will gradually fill up until the final event marker icon is displayed below.

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.

What if the LEAP battery dies in the field?
If the participant is using the Centre Point Data Hub or Centre Point Connect during the study, charge the LEAP using either the Centre Point Data Hub or the Wall Plug. If they are not using either the Centre Point Data Hub or Centre Point Connect, the participant will need to bring the LEAP back to the site to recharge and reinitialize since depleting the battery will cause the LEAP to lose its time.

Halt Mode
Stop icon will be displayed if the LEAP is not collecting data.

Active Mode
A running person icon will be displayed if the LEAP is collecting data.

What if the LEAP is lost or broken?
If a LEAP is lost or broken, report lost or broken LEAP(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 LEAP.

What if a participant reports a skin reaction?

Although the LEAP device and LEAP silicone strap are tested to the ISO 10993 standard for biological safety, we do receive occasional reports of skin irritation as it’s not something that can be 100% guarded against. This can be due to allergies, environmental factors, or extended exposure to irritants like soap, sweat or other chemicals. For components which contact the skin, ActiGraph does not use materials which are known to be irritants such as Nickel and Latex. If the reaction is mild, the recommendation is to remove the activity monitor  and clean the device and silicone strap with 70% IPA and the skin with soapy water, making sure to completely rinse and dry the skin, device, and strap before putting back on. If there are any open wounds or severely irritated skin, discontinue wearing the activity monitor to prevent further irritation and have it returned to the site. Then contact ActiGraph Support team for further assistance. We do offer alternative wristband options that might be more suitable for the participant.

What is the typical service life of the LEAP?
The expected service life is three (3) years based on the life expectancy of the battery during normal usage.

What is the shelf life of the LEAP?
The battery has a life expectancy of two (2) years during storage, without battery conditioning.

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.

What to do at the end of the study?
At the end of the study and after collecting all LEAP(s), wall plugs, and charging docks, 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, pursuant to 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 in accordance with 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 receiver
• Connect the equipment into 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. WARNING: This product can expose you to chemicals including Bisphenol A which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to
www.P65Warnings.ca.gov

CAUTION: Do not simultaneously wear and charge. Do not 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: Modification to ActiGraph products are not permitted and will void all warranties if tampered 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.
CAUTION: Do not allow small children or pets to play with, bite, or chew on the product or supplied cords to avoid injury or choking. Keep the cord out of reach of children to avoid strangulation.

CAUTION:

• Do not replace the battery. 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 that may result in an explosion or the leakage of flammable liquid or gas.

NOTICE: Product does not have any contraindication(s)
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).
NOTICE: ME Equipment charged via certified external power supply (e.g., IEC 62368 safety standards for information technology equipment or IEC 60601-1 safety standards for medical electrical equipment) with input rated 100-240 VAC, output rated 5V DC, 1 A. The power supply adaptor should be Class II.
FCC 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.

Emergo Europe Westervoortsedijk 60 6827 AT Arnhem The Netherlands
Authorized Representative in European Community
Indicates the authorized representative in the European Community

AUSTRALIAN SPONSOR
Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia
ActiGraph’s Australia Sponsor
Indicates ActiGraph’s authorized Australian Sponsor.

Emergo Consulting (UK) Limited
c/o Cr360 – UL
International
Compass House, Vision
Park Hitson
Cambridge CB24 9BZ
United Kingdom
ActiGraph’s United Kingdom Sponsor
Indicates ActiGraph’s authorized United Kingdom Sponsor

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.

Brazil National Telecommunications Agency (ANATEL) Homological 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.

Manufacturer
ActiGraph is the medical device manufacturer and is located at 70 North Baylean Street, Suite 400. Pensacola, Florida 32502.

Operating Temperature Range
Indicates the operating temperature range to which the medical device can be safely exposed.

Storage Temperature Range
Indicates the operating temperature range to which the medical device can be safely stored.

Recycle: Electronic Equipment
Indicates the medical device should not be disposed of in the trash. Contact ActiGraph Customer Service regarding the disposal of these products.

Lithium Ion (EU)
Indicates the lithium ion battery within the device should not be disposed of in the trash. Contact ActiGraph  Customer Service regarding the disposal of these batteries.

Humidity Range
Indicates the operating humidity range to which the medical device can be safely exposed.

Atmospheric Pressure
Indicates the operating atmospheric pressure to which the medical device can be safely  exposed.

Type BF Applied Part
The LEAP is compliant with IEC (International Electrotechnical Commission) standards for “Type BF Applied Part” – meaning it complies with requirements for user protection against electrical shock. The housing of the device is the only part that is to come into contact with the end user and is made out of copolymer. If you have any allergic reactions to copolymer materials, please consult your doctor before using an ActiGraph device.

IP67:IP67 Rating
The devices are water resistant in accordance with IEC 60529 and have the Ingress Protection Rating: IP67 or immersion in one (1) meter of water for up to 30 minutes.

IP21 :IP21 Rating
The charging docks are protected against solid foreign objects of 12.5 mm and greater and vertically falling water drops in accordance with IEC 60529 and have the International Protection Rating: IP21.

Part 15 FCC Rules
FCC Part 15 is a federal regulation that sets limitations on the amount of electromagnetic interference allowed from digital and electronic devices such as wristwatches, musical instruments, computers, telephones, and low power transmitters.

Giteki
GITEKI CERTIFICATION (TECHNICAL STANDARDs CONFORMITY CERTIFICATION AND CONSTRUCTION DESIGN CERTIFICATION)

UKCA
By affixing the UKCA marking to a product, a manufacturer declares that the product meets all the legal requirements for UKCA marking and can be sold throughout the UK.

CSEM
Centre Suisse d’Electronique et de Micro technique (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
Caution: U.S. Federal law restricts this device to sale by or on the order of physician or other a practitioner for use in the course of their professional practice.

RCM
An RCM compliance label indicates a device has been certified by the supplier as meeting
any applicable, and the standards that apply to that device.

IC: 10333A-05: ISED COMPLIANCE
This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s license-exempt RSS(s). Operation is subject to the following two conditions:

1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired operation of the device.

CMIIT ID: 2023DJ19409 :CMIIT-ID
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).

BC
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

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 8am-5pm CST. Please provide Study Protocol and Site Number.

©2024 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

• Support
• Anatel — Agência Nacional de Telecomunicações

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