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ActiGraph wGT3X+ - Regulatory Compliance and Safety; Device Certifications and Symbols; Operational Safety Warnings

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www.theactigraph.com
P a g e | 4
49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904
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+.
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 charged
1
CAUTION: Transporting or operating these devices outside of the temperature range of
-20
o
C to +60
o
C 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.
1
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 (7-
1/2 feet) above the floor.

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