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1.7.4
Use
The instrument is able to generate tones at an intensity potentially
damaging to the patient. Take particular care to set the intensity of
the tone correctly before it is presented.
Do not perform service or maintenance while using the device on a
patient.
1.8
D
ISPOSAL
Like any other electronic device, the Timpani tympanometer contains certain
extremely hazardous substances, albeit in extremely small proportions. If
released into the normal refuse collection system without suitable preliminary
treatment, these substances cause serious damage to the environment and to
health. At the end of its service life, accordingly, each component of the
appliance must go through a sorted collection process: this means that the user
should deliver (or dispatch) waste items to the sorted collection centers set up by
local authorities, or alternatively, hand them back to the dealer when purchasing
a new appliance of the same or similar type.
Thanks to the sorted collection of waste items and the subsequent processing,
recovery and disposal operations they undergo, appliances can be made from
recycled materials, and any negative impact of improper waste management on
the environment and on health can be suitably limited.
1.9
C
ONFORMITY
The Timpani tympanometer is a class II device, in accordance with Annex IX of
the medical devices directive 93/42/EEC as amended and supplemented by
directive 2007/47/EC. Inventis is a company certified to ISO 13485.
1.10 S
YMBOLS ON LABELS
Warning: the use of this instrument calls for certain
precautions; to ensure safe use, consult the accompanying
documentation.
Refer to the instructions for use.
Follow the instructions for use.
Device serial number:
-
characters 1-5: Inventis product code
EN
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