Inventis TRIANGLE, Manual, Page: 12 / 368

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1.5.3 Hygiene
Disinfect the headphone cushions between one patient and the next,
following the procedure described in Chapter 7.
Earpieces of the insert earphones are disposable. Do not use the
same earpiece for different patients. Dispose of them after use.
1.5.4 Use
The device can 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 any service or maintenance while the device is being
used on a patient.
1.6 D
ISPOSAL
Like any other electronic device, your audiometer contains extremely small
quantities of certain hazardous substances. If such substances enter the normal
waste disposal cycle without suitable preliminary treatment, they can cause
damage to the environment and to health. Accordingly, at the end of its service
life, each component of the device 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 return them to the
reseller when purchasing a new device 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.
1.7 C
ONFORMITY
The Triangle audiometer is a class IIa device, in accordance with Annex IX of
the medical devices directive 93/42/EEC as amended and supplemented by
directive 2007/47/EC. Inventis srl is a company ISO 13485 certified.
1.8 S
YMBOLS
Warning: the use of this device requires certain precautions. To
ensure safe use, consult the accompanying documentation.