ActiGraph 01 Users Manual

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User’s Manual for the wGT3X+ and
wActiSleep+

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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. This table shall be maintained as long as this document is
active.

Revision

Brief Description of Change

Date of

Approval

A

Initial version

5/30/2012

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Change Page

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Table of Contents

Important Information and Symbols ............................................................................................................ 4

Introduction .................................................................................................................................................. 7

Specifications and Functionality of the wGT3X+ and wActiSleep+ ............................................................... 7

Data ........................................................................................................................................................... 7

Acceleration .......................................................................................................................................... 7

Ambient Light ........................................................................................................................................ 7

Steps ...................................................................................................................................................... 8

Inclinometer .......................................................................................................................................... 8

Low Frequency Extension ..................................................................................................................... 9

Data Collection ...................................................................................................................................... 9

Water Resistance ................................................................................................................................ 10

Wireless ................................................................................................................................................... 10

Sensor Connectivity ............................................................................................................................ 10

Wireless Reporting and Control .......................................................................................................... 10

Battery..................................................................................................................................................... 11

Low Voltage Mode (HALT) .................................................................................................................. 13

Recharging and LED Decoding ............................................................................................................ 13

Wearing the Device ..................................................................................................................................... 15

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49 E. Chase St. Pensacola, FL 32502 tel [phone] fax [phone]

The devices are compliant with IEC (International Electrotechnical Commission) standards
for "Type BF Applied Part" - meaning they comply with requirements for protection
against electrical shock.

CAUTION: Do not simultaneously charge and wear 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.
Class II medical device

 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

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.

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Important Information and Symbols

The wGT3X+ and wActiSleep+ devices abide by the following regulations listed below and give
explanation into the symbols that are found on each device. These symbols and statements apply to
both the wGT3X+ device and the wActiSleep+.

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.

49 E. Chase St. Pensacola, FL 32502 tel [phone] fax [phone]

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These 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: 1988 + A1: 1991 + A2: 1995 – 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 55011:2009, inc. A1:2010 – Limits and methods of measurement of radio

disturbance, characteristics of industrial, scientific and medical radio frequency
equipment

 EN 300 440-2 V1.4.1 – Electromagnetic compatibility and Radio spectrum Matters

(ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz
frequency range; Part 2: Harmonized EN covering the essential requirements of
article 3.2 of the R&TTE Directive (wGT3X+ device only)

 EN 301 489-3 V1.4.1 – Electromagnetic compatibility and Radio spectrum Matters

(ERM); Electromagnetic Compatibility (EMC) standard for radio equipment; Part
3: Specific conditions for Short-Range Devices (SRD) operating on frequencies
between 9kHz and 40GHz

These devices comply with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.

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