ClearSounds CS10 Guia do Utilizador descarregar pdf (Página 24)

APPENDIX

IMPORTANT INFORMATION

Industry Canada Regulatory Information

Operation of this device 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. See RSS-GEN 7.1.5.

FDA Note on Personal Sound Amplifiers (PSAPs)

PSAPs are intended to amplify environmental sound for non-hearing impaired

consumers. They are not intended to compensate for hearing impairment.

Examples of situations in which PSAPs typically are used include hunting

(listening for prey), bird watching, listening to lectures with a distant speaker,

and listening to soft sounds that would be difficult to hear (e.g., distant

conversations, performances). Because PSAPs are not intended to diagnose,

treat, cure or mitigate disease and do not alter the structure or function of

the body, they are not devices as defined in the Food, Drug and Cosmetic Act.

As such, there is no regulatory classification, product code, or definition for

these products. Furthermore, there are not requirements for registration of man-

ufacturers and listing of these products with FDA.

However, PSAPs are subject to applicable provisions of the Radiation Control

for Health and Safety Act of 1968, under which FDA regulates electronic

products that emit sonic vibrations, such as sound amplification equipment.

(See also 21 CFR 1000.15.) Manufacturers of PSAPs must report defects and

adverse events and take other measures described in 21 CFR Part 1003.

Manufacturers of PSAPs must also comply with requirements to repurchase,

repair, or replace electronic products required under 21 CFR Part 1004.

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ClearSounds CS10 Guia do Utilizador Página 24