Therabody SmartGoogles Bedienungsanleitung Seite 21

device should have no visible signs of debris or moisture. Only clean with a damp
cloth or alcohol-free cleansing wipe by wiping the device. Do not submerge the
device in water or clean it under running water. Do not allow the device to come
into contact with corrosive solutions, which can damage the device's appearance
and function.
11.STORING THE DEVICE AND ACCESSORIES. Store in a cool, dry place. Only
charge the device when the ambient temperature is between 40°C/104°F and
0°C/32°F. Do not store the device or charging cable where temperatures may
exceed 70°C/158°F, such as in direct sunlight, in a vehicle, or in a metal building
during the summer.
12.DEVICE DISPOSAL. This device contains a lithium-ion battery, and care must
be taken upon disposal of the device. Before disposal of this device, please review
your local laws and requirements surrounding Lithium-Ion Battery disposal. The
preferred method of disposal is recycling the whole device.
Reporting adverse events to FDA
MedWatch is the Food and Drug Administration's (FDA) program for reporting
serious reactions, product quality problems, therapeutic inequivalence/failure,
and product use errors with human medical products, including drugs, biologic
products, medical devices, dietary supplements, infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to
a medical product, you are encouraged to take the reporting form to your doctor.
Your health care provider can provide clinical information based on your medical
record that can help the FDA evaluate your report. However, we understand that
for a variety of reasons, you may not wish to have the form filled out by your health-
care provider, or your health care provider may choose not to complete the form.
Your health care provider is not required to report to the FDA. In these situations,
you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from the FDA when your report is received.
Reports are reviewed by FDA staff. You will be personally contacted only if we need
additional information.
Submitting adverse event reports to FDA
Use one of the methods below to submit voluntary adverse event reports to
the FDA:
1.Report Online at: www.accessdata.fda.gov/scripts/medwatch/index.cfm?ac-
tion=reporting.home
2.Consumer Reporting Form FDA 3500B. Follow the instructions on the form to
either fax or mail it in for submission. For help filling out the form, see MedWatch-
Learn. The form is available at: www.fda.gov/ downloads/aboutFDA/reportsman-
ualsforms/forms/ucm349464.pdf
3.Call FDA at 1-800-FDA-1088 to report by telephone.
4.Reporting Form FDA 3500 commonly used by health professionals. The form
is available at: www.fda.gov/ downloads/aboutFDA/reportmanualsforms/forms/
ucm163919.pdf
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