General Warnings - Soundworld Bluetooth Serie Manual De Uso

APPENDIX
IMPORTANT INFORMATION
Bluetooth
The Bluetooth ® word mark and logos are owned by the Bluetooth SIG, Inc.
and any use of such marks by Sound World Solutions is under license.
Other trademarks and trade names are those of their respective owners.

General Warnings

If you have or think you may have any one of the following symptoms,
do not use this product until you have consulted a physician:
• History of excessive wax build-up
• Pain or discomfort in the ear
• Fluid or drainage from the ear within the past 90 days
• Ear canal blockage, a lasting ear infection, or a plugged up
fullness feeling
• Visible deformity of the ear
• Sudden, rapid progressing, or fluctuating hearing loss within
the past 90 days
• Chronic difficulty hearing
• Ringing in only one ear
• Hearing loss only in one ear that worsened in the past 90 days
• Spells of acute or chronic dizziness
Pacemakers and defibrillators can be sensitive to magnetic fields.
Do not place CS50 earpiece or batteries in a shirt pocket or near your
pacemaker or defibrillator.
Keep all parts of the CS50 earpiece and charger kit away from children
under the age of 3. These components contain small parts that may
present a choking hazard.
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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
manufacturers 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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