Intended use – Indications – Contraindications
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2. Intended use – Indications –
Contraindications
Intended use
The FineTuner Echo is an external part of the MED‑EL Cochlear Implant System. The
FineTuner Echo is intended to be used as a remote control for recipients having
received a compatible MED‑EL audio processor. The FineTuner Echo is intended to be
used as an audio processor test device (formerly known as Speech Processor Test
Device) for easy recognition of the working status and the most common functional
problems such as defective coil cables, defective microphones or weak batteries of
MED‑EL audio processors. The FineTuner Echo is intended to be used by a patient all
day long during waking hours, there are no restrictions in the frequency of use. The
FineTuner Echo is intended to be used in typical everyday environments (e.g. home,
ofce, outdoor, etc.) and also in a clinical environment (e.g. audiologist's ofce).
Indications
Any user having received a MED‑EL Cochlear Implant is a potential user of the FineTuner
Echo. Additionally, any person that interacts with a MED‑EL Cochlear Implant user (e.g.
parents of implanted children, audiologists, teachers of implanted children, etc.) might
use the FineTuner Echo.
As the FineTuner Echo is a component of the MED‑EL Cochlear Implant System, all
indications stated for the MED‑EL Cochlear Implant System are applicable.
Contraindications
A patient must not receive a FineTuner Echo if the individual is known to be intolerant
of the materials used in the FineTuner Echo. The FineTuner Echo is not intended to be
used in environments where RF transmissions are prohibited. Patients who are not
able to use the FineTuner Echo are not intended to use the device. Parents/carers shall
operate the FineTuner Echo for them.
As the FineTuner Echo is a component of the MED‑EL Cochlear Implant System, all
contraindications stated for the MED‑EL Cochlear Implant System are applicable.
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