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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