ActiGraph 02 Users Manual

www.theactigraph.com

wGT3X-BT User’s Manual

Document No. MOS13DOC09

Revision: D

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About the
change page
table

The following table describes the changes that have been made to this document
since its original baseline. Documents affected by the changes made need to be
listed and updated to keep procedures up to date. This table shall be maintained as
long as this document is active.

Revision

Description of Change/Documents Affected

Effective Date

A

- Initial Release

5/31/13

B

- Made numerous changes to obtain regulatory approval

8/20/13

C

- On page 6 the Class II medical device symbol was changed

from FDA to square within a square symbol. Updated the
Appendix. Updated the battery life tables.

10/31/13

D

- Updated FCC 15.105 digital devices statement

1/17/14

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Change Page

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Document Approval

Printed Name of Document Creator or Editor: ______________________________

Printed Name of Reviewing Manager: ______________________________ ☐ Approved
Signature: ________________________ Date and Time: ________________________

Printed Name of Reviewing Quality Department Representative: ________________________________
Signature: ________________________ Effective Date: _________________________

*Hard copies are to be printed, signed, and kept on file with the Quality Department.

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Table of Contents

Important Information and Symbols ............................................................................................................ 6

Introduction ................................................................................................................................................ 10

Specifications and Functionality of the wGT3X-BT ..................................................................................... 10

Data ......................................................................................................................................................... 10

Acceleration ........................................................................................................................................ 10

Ambient Light ...................................................................................................................................... 10

Steps .................................................................................................................................................... 11

Inclinometer ........................................................................................................................................ 11

Low Frequency Extension ................................................................................................................... 12

Data Collection .................................................................................................................................... 12

Water Resistance ................................................................................................................................ 13

Wireless ................................................................................................................................................... 13

Heart Rate ........................................................................................................................................... 13

Wireless Reporting and Control .......................................................................................................... 13

Battery..................................................................................................................................................... 14

Low Voltage Mode (HALT) .................................................................................................................. 17

Recharging and LED Decoding ............................................................................................................ 17

Wearing the Device ................................................................................................................................. 19

Miscellaneous Device Information ............................................................................................................. 19

Degradable Components ........................................................................................................................ 19

Other Possible Negative Effects .............................................................................................................. 19

Wear Locations ....................................................................................................................................... 19

Device Serial Number Label .................................................................................................................... 20

Cleaning the Device ................................................................................................................................ 20

Device Storage and Life Expectancy ....................................................................................................... 20

Device Maintenance ............................................................................................................................... 20

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Accessories .............................................................................................................................................. 20

Replacement of Parts Subject to Deterioration .................................................................................. 21

Connection and disconnect of detachable accessories ...................................................................... 21

Appendix ..................................................................................................................................................... 23

Risk Management Documentation ......................................................................................................... 23

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CAUTION: The battery is to only be changed by trained ActiGraph personnel. The battery
is only allowed to be connected in a certain manner and any incorrect replacement can
result in a hazard.

The devices are compliant with IEC (International Electrotechnical Commission) standards
for "Type BF Applied Part" - meaning they comply 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 Polycarbonate and/or Polyvinyl Chloride
materials. If you have any allergic reactions to Polycarbonate and/or Polyvinyl Chloride
materials, please consult your doctor before using an ActiGraph device.

CAUTION: Do not simultaneously wear and charge, service, or provide any maintenance
on the device. The end user should not be in the patient vicinity when being charged1

CAUTION: Transporting or operating these devices outside of the temperature range of

-20oC to +60oC could lead to dangerous conditions and/or incorrect data collection.

CAUTION: Modification to ActiGraph devices is not permitted and will void all warranties
if tampered and/or modified. Do not modify the device in any way.

CAUTION: Do not swallow any part of this device. If a piece has been swallowed, contact
your local poison control hotline or seek medical attention as soon as possible.

NOTICE: Device does not have any contraindication(s)

NOTICE: Only use a USB 2.0 cable to connect to the device. Only use ActiGraph approved
USB hubs to charge the device. Do not connect the device via the USB 2.0 port to
anything else but a computer and ActiGraph approved USB hub.

NOTICE: No precautions need to be taken in the event of changes in the performance of
the device.

Class II medical device

1

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Important Information and Symbols

The wGT3X-BT device abides by the following regulations listed below and gives explanation into the
symbols that are found on each device.

A patient vicinity is areas in which PATIENTS are normally cared for and the space with surfaces likely to be contacted by the

PATIENT or an attendant who can touch the PATIENT. This encloses a space within the room 1,83 m (6 feet) beyond the perimeter
of the bed (examination table, dental chair, treatment booth, and the like) in its intended location, and extending vertically 2,29 m (7­1/2 feet) above the floor.

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These devices comply 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
 FCC Part 15.207 – Modular Transmitter AC Line Conducted Emissions
 FCC Part 15.249 – Radiated Emission Limits of Intentional Radiators

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 of 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.

The devices are classified as Class I medical devices within the European Union and have
been approved to be sold as medical devices according to the European Union's
regulatory requirements listed below:

 EN 60601-1 (3

rd

Edition) – Medical Electrical Equipment Part 1: General

Requirements for Safety

 EN 60601-1-2:2007, inc. C:2010 – Medical Electrical Equipment Part 1-2: General

Requirements for Basic Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility – Requirements and tests IEC 60601-1-2 (Modified)

 EN 61000-4-2:2009 – Electromagnetic Compatibility – Part 4: Testing and

measurement techniques – Section 2: Electrostatic discharge immunity test

 EN 61000-4-3:2006, inc. A2:2010 – Electromagnetic Compatibility – Part 4: Testing

and measurement techniques – Section 3: Radiated, radio-frequency,
electromagnetic field immunity test

 EN 61000-4-8:2010 – Electromagnetic Compatibility – Part 4: Testing and

measurement techniques – Section 8: Power frequency magnetic field immunity
test

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