5
Typical dimensions in mm
* Recommended diameter of cochleostomy & RW opening
** Recommended insertion depth of electrode array
97.7
Mi1250 Standard
111.2
Mi1250 Medium
111.2
Mi1250 Compressed
111.2
Mi1250 FLEXSOFT
110.9
Mi1250 FLEX28
108.2
Mi1250 FLEX26
105.2
Mi1250 FLEX24
104.2
Mi1250 FLEX20
99.7
Mi1250 FORM24
102.7
Mi1250 FORM19
97.7
4.5
15°
30°
3.3
0.9
SYNCHRONY 2 FORM
19
24
18.8
47.3
29
FORM
19
Electrode Array
FORM19 Electrode array
19
**
2.4
1.3
14.3
Ø 0.5
Ø 0.8
*
Ø 1.9
*
5
Instructions for use
Mi1250 SYNCHRONY 2 Cochlear Implant
Device description
The Mi1250 SYNCHRONY 2 Cochlear Implant (hereafter referred to as SYNCHRONY 2) is
the implantable part of the MED‑EL Hearing Implant System and can only be used to‑
gether with compatible MED‑EL external components. The device consists of a stimula‑
tor, a coil with a removable magnet within its centre, a reference electrode, an EAP ref‑
erence electrode and an active electrode permanently attached to the stimulator. The
active electrode can be of different types, thus resulting in different implant variants
(implant family SYNCHRONY 2). This device is intended to be implanted by adequately
trained and experienced surgeons only.
The implant offers a stimulation mode and a telemetry mode. Stimulation sequences
of biphasic and triphasic pulses can be delivered sequentially or simultaneously on two
or more channels. In telemetry mode the device allows a functional check about the
technical status of the implant including communication over the transcutaneous link
as well as the assessment of the electrode impedances and recording of the electrically
evoked compound action potential of the hearing nerve.
The implant has a mass of 7.7 g (typical weight).
For principal dimensions of the implant refer to the drawings on the previous pages.
The volume of the implant without electrode is 3.9 cm³.
Following materials are in direct contact with human tissue: medical grade silicone,
platinum, iridium and parylene c.
Purpose of the device
Perception of environmental sound and potential for improvement of communicational
abilities.
Performance characteristics
• Output characteristics of a stimulation signal on a 1 kOhm resistor:
Maximum current amplitude: Median value = 1250 µA, range = 500 µA
Maximum pulse width: Median value = 203.8 µs, range = 8.2 µs
• The impedance measurement accuracy is typically better than 5 %.
• The implant is MR Conditional for scanner fi eld strengths of 0.2 Tesla, 1.0 Tesla, 1.5
Tesla and 3.0 Tesla. For more information please refer to Medical Procedures Manual.
• There are no default factory settings of the implant system.
• Proper functioning of the implantable part of the CI system can be checked by
performing telemetry (refer to MED‑EL application software user manual).
ENGLISH
Typical dimensions in mm
* Recommended diameter of cochleostomy & RW opening
** Recommended insertion depth of electrode array
97.7
Mi1250 Standard
111.2
Mi1250 Medium
111.2
Mi1250 Compressed
111.2
Mi1250 FLEXSOFT
110.9
Mi1250 FLEX28
108.2
Mi1250 FLEX26
105.2
Mi1250 FLEX24
104.2
Mi1250 FLEX20
99.7
Mi1250 FORM24
102.7
Mi1250 FORM19
97.7
4.5
15°
30°
3.3
0.9
SYNCHRONY 2 FORM
19
24
18.8
47.3
29
FORM
19
Electrode Array
FORM19 Electrode array
19
**
2.4
1.3
14.3
Ø 0.5
Ø 0.8
*
Ø 1.9
*
