User's Manual

Appendix B
Compliance Information
B1 FCC Statement
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.
Modifications not expressly approved by Tobii Dynavox could void the user’s authority to operate the equipment
under FCC rules.
B1.1 For P15B Equipment
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 installa-
tion. 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.
B1.2 For Portable Devices
FCC RF Radiation Exposure Statement:
1. This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
2. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This de-
vice was tested for typical hand held operations with the device contacted directly to the human body to the sides of
the device. To maintain compliance with FCC RF exposure compliance requirements, avoid direct contact to the
transmitting antenna during transmitting.
B2 Radio Wave Exposure and Specific Absorption Rate (SAR)
Information
The Tobii Dynavox I-Series device has been tested as a Class 1 Medical Device. Medical electrical equipment such as this
requires special caution regarding Electro-magnetic Compatibility (EMC) and thus needs to be installed and placed into
service according to the information provided in this manual.
Using other cables and accessories other than those provided or that are integrated in the device may affect
EMC performance.
The SAR (Specific Absorbtion Rate) limit as dictated by the FCC (in the USA) and by the IC (in Canada) is 1.6W/kg aver-
aged over 1 gram of tissue. In Europe/EU (CE regulations) it is 2.0 W/kg averaged over 10 grams of tissue. The Devices,
I–13 (FCC ID: 2AAOV-GGI13), (IC ID 5534A-GGI13) and I–16 (FCC ID: 2AAOV-GGI16), (IC ID 5534A-GGI16) have been
tested against these SAR limits to maintain compliance with FCC/IC/CE RF exposure requirements.
This equipment complies with FCC/IC/EU RF radiation exposure limits set forth for an uncontrolled environment.
The highest SAR value for the I–13 device is 1.168 W/kg and for the I–16 device is 0.656 W/kg.
In order to maintain compliance as a Class 1 Medical device, the switches that are used in combination with the Tobii Dyna-
vox I-Series device must fulfill the isolation requirements of IEC/EN 60601-1 based on 15 V DC. They must be electrically
floating switches (switches that are not grounded).
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Appendix B Compliance Information
Tobii Dynavox I-Series User’s manual v. - en-US