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APPLIED STANDARDS AND
APPROVALS
FDA approved. For home use only.
This product conforms to the provisions of
the EC directive MDD(93/42/EEC).
The following standards apply to design
and/or manufacturing of the products:
• ASTM E 1965-98: Standard Specification
for infrared thermometers for intermittent
determination of patient temperature.
• EN 980:1997: Graphical symbol for
use in the labeling of medical devices.
• EN 60601-1: Medical electrical
equipment – Part 1: General require-
ment for safety.
• EN60601-1-2: Medical electrical
equipment – Part 2: Collateral stan-
dard: Electromagnetic compatibility –
Requirements and tests.
LIMITED PRODUCT WARRANTY
The BébéSounds
®
Ear Thermometer,
distributed by Unisar Inc., has a limited
warranty against defects for a period of
three years from the original purchase date.
Battery life or damage due to misuse or
abuse are excluded from this warranty.
In-Warranty Procedure
In the event service is required due to
defect or malfunction during the warranty
period, Unisar Inc. will replace or repair the
product under warranty. The repair or
replacement of the defective item will be
free of charge. Repair or replacement of
the defective item is subject to verification
of the malfunction or defect when delivered
to:
Unisar
®
Service Center
15 West 36th Street
New York, NY 10018 USA
Please enclose dated proof of purchase with
your return.
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