MED-EL Me151 Series, Руководство пользователя

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Intended use – Indications – Contraindications
9
Indications
The SONNET 2 audio processor is an external component of the MED‑EL Cochlear
Implant System and is indicated for use in patients who have been implanted with
Mi1200 SYNCHRONY or Mi1210 SYNCHRONY ST (hereafter referred to as SYNCHRONY),
Mi1000 CONCERTO (hereafter referred to as CONCERTO), SONATAti
100
(hereafter referred
to as SONATA), PULSARci
100
(hereafter referred to as PULSAR), C40+ or C40 cochlear
implants
(3)
.
The SONNET 2 is indicated to be used in typical everyday environments (home, office,
outdoor etc.) and is appropriate for patients of any age.
The hearing aid functionality of the SONNET 2 is intended to be used by patients with
functional low frequency hearing. Post‑operative acoustic amplification (i.e. use of com‑
bined electric‑acoustic stimulation) is indicated for hearing losses between 30 dBHL and
80 dBHL (when using the half gain fitting rule) in the frequency range between 125 Hz
and 1700 Hz.
The SONNET 2 is intended to be used every day during a patient’s waking hours.
The user of a SONNET 2 does not need any special skills or elevated level of education,
however, the user (or custodian if the user is a child or a handicapped person not able
to perform the actions listed below) shall at minimum be able to perform the following
actions:
• Switching ON/OFF
• Changing batteries
• Placing/removing SONNET 2 on/from the ear
• Placing/removing coil over/from the implant site
As the SONNET 2 is a component of the MED‑EL Cochlear Implant System, all indica‑
tions stated for the MED‑EL Cochlear Implant System are applicable.
3 Not all products in this document are currently approved or available in all countries. Please contact your
local MED‑EL representative for information on current product availability in your country.