Applied standards and approvals, Technical specifications – Bebe Sounds NASALCLEAR #BR140 User Manual
Page 6
APPLIED STANDARDS AND APPROVALS
This product conforms to the provisions of the EC direc-
tive MDD (93/42/EEC).
The following standards apply to design and/or manu-
facturing of the product:
• IEC / EN 980:2003: Graphical symbol for use in the
labeling of medical devices
• IEC / EN 60601-1: Medical electrical equipment
– Part 1: General requirement for safety
• IEC / EN 60601-1-2: Medical electrical equipment
– Part 2: Collateral standard: Electromagnetic
compatibility – Requirements and tests
• ISO 10993-5:1999: Biological evaluation of medical
devices – Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2002: Biological evaluation of medi-
cal devices – Part 10: Tests for irritation and delayed-
typed hypersensitivity
TECHNICAL SPECIFICATIONS
• For home use only
• Requires two (2) AA batteries (not included)
• Ambient storage environment:
-4º-122ºF (-20º- 50ºC)
• Ambient operating environment:
59º-95ºF (15º- 35ºC)
fi rst. If the aspirator is still not operating properly or if
you are having any other technical problems, please
contact the BébéSounds
®
Help Desk at 1-888-232-6476
Mon–Fri from 9:00AM–5:00PM EST.
Figure 8
8. Be sure all parts fi t tightly into each other
before using.
9. Keep in provided storage bag and store in a cool
dry place.
10.Keep out of the reach of children when not in use.
CAUTION:
Never insert the aspirator too far into the nostril. Never
place the tip fi rmly against the inside wall of the nostril.
Never use on ears, mouth, or eyes.
This aspirator is for clearing congestion in nasal pas-
sages. Do not use this device for anything other than its
intended purpose.
WARNING:
This product is not a toy. Do not allow children to play
with it. Individual parts may present a choking hazard.
If you believe your aspirator is defective or otherwise
not operating properly, please check the batteries
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