Medel Mi1250 SYNCHRONY 2 Bedienungsanleitung

Cochlear Implants

English

Kochleárny implantát

Mi1250 SYNCHRONY 2

Standard | Medium | Compressed | FLEXSOFT | FLEX28

FLEX26 | FLEX24 | FLEX20 | FORM24 | FORM19

Slovenčina

AW38654_1.0 (Slovak)

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

111.2

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 Standard

SYNCHRONY 2 Medium

SYNCHRONY 2 Compressed

18.8

47.3

Standard Electrode array

2.4

26.4

31.5**

Ø 1.3*

Ø 0.5

Standard Electrode Array

111.2

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

18.8

47.3

111.2

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

18.8

47.3

Compressed Electrode Array

Medium Electrode Array

Medium Electrode array

24**

Ø 0.8*

Ø 0.5 20.9

1.9

Compressed Electrode array

15**

1.1

Ø 0.5 12.1 Ø 0.8*

Opening instruction

Inštrukcie na otváranie

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

111.2

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 Standard

SYNCHRONY 2 Medium

SYNCHRONY 2 Compressed

18.8

47.3

Standard Electrode array

2.4

26.4

31.5**

Ø 1.3*

Ø 0.5

Standard Electrode Array

111.2

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

18.8

47.3

111.2

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

18.8

47.3

Compressed Electrode Array

Medium Electrode Array

Medium Electrode array

24**

Ø 0.8*

Ø 0.5 20.9

1.9

Compressed Electrode array

15**

1.1

Ø 0.5 12.1 Ø 0.8*

Typické rozmery v mm

* Odporúčaný priemer kochleostómie a okrúhleho okienka

** Odporúčaná hĺbka zavedenia elektródového poľa

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

104.2

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 FLEX24

SYNCHRONY 2 FLEX20

SYNCHRONY 2 FORM24

18.8

47.3

FLEX24 Electrode Array

99.7

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

18.8

47.3

102.7

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

18.8

47.3

FORM24 Electrode Array

FLEX20 Electrode Array

24**

1.9

20.9Ø 0.3

Ø 0.5

Ø 0.8*

FLEX24 Electrode array

FLEX20 Electrode array

1.4

15.4Ø 0.3

Ø 0.5

Ø 0.8*

20**

FORM24 Electrode array

1.7 2.4

18.7Ø 0.5 Ø 0.8*

Ø 1.9*

24**

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

110.9

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 FLEXSOFT

SYNCHRONY 2 FLEX28

SYNCHRONY 2 FLEX26

18.8

47.3

FLEXSOFT Electrode Array

108.2

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

18.8

47.3

105.2

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

18.8

47.3

FLEX26 Electrode Array

FLEX28 Electrode Array

FLEXSOFT Electrode array

31.5**

2.4

26.4Ø 0.4

Ø 0.5

Ø 1.3*

FLEX28 Electrode array

28**

2.1

23.1Ø 0.4

Ø 0.5

Ø 0.8*

FLEX26 Electrode array

26**

1.9

20.9Ø 0.3

Ø 0.5

Ø 0.8*

Typické rozmery v mm

* Odporúčaný priemer kochleostómie a okrúhleho okienka

** Odporúčaná hĺbka zavedenia elektródového poľa

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

104.2

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 FLEX24

SYNCHRONY 2 FLEX20

SYNCHRONY 2 FORM24

18.8

47.3

FLEX24 Electrode Array

99.7

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

18.8

47.3

102.7

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

18.8

47.3

FORM24 Electrode Array

FLEX20 Electrode Array

24**

1.9

20.9Ø 0.3

Ø 0.5

Ø 0.8*

FLEX24 Electrode array

FLEX20 Electrode array

1.4

15.4Ø 0.3

Ø 0.5

Ø 0.8*

20**

FORM24 Electrode array

1.7 2.4

18.7

Ø 0.5 Ø 0.8*

Ø 1.9*

24**

Typical dimensions in mm

* Recommended diameter of cochleostomy & RW opening

** Recommended insertion depth of electrode array

110.9

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 FLEXSOFT

SYNCHRONY 2 FLEX28

SYNCHRONY 2 FLEX26

18.8

47.3

FLEXSOFT Electrode Array

108.2

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

18.8

47.3

105.2

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

18.8

47.3

FLEX26 Electrode Array

FLEX28 Electrode Array

FLEXSOFT Electrode array

31.5**

2.4

26.4Ø 0.4

Ø 0.5

Ø 1.3*

FLEX28 Electrode array

28**

2.1

23.1Ø 0.4

Ø 0.5

Ø 0.8*

FLEX26 Electrode array

26**

1.9

20.9Ø 0.3

Ø 0.5

Ø 0.8*

Typické rozmery v mm

* Odporúčaný priemer kochleostómie a okrúhleho okienka

** Odporúčaná hĺbka zavedenia elektródového poľa

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 FORM19

18.8

47.3

FORM19 Electrode Array

FORM19 Electrode array

19**

2.4

1.3

14.3Ø 0.5 Ø 0.8*

Ø 1.9*

Typické rozmery v mm

* Odporúčaný priemer kochleostómie a okrúhleho okienka

** Odporúčaná hĺbka zavedenia elektródového poľa

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 FORM19

18.8

47.3

FORM19 Electrode Array

FORM19 Electrode array

19**

2.4

1.3

14.3Ø 0.5 Ø 0.8*

Ø 1.9*

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 = 500µA

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 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 FORM19

18.8

47.3

FORM19 Electrode Array

FORM19 Electrode array

19**

2.4

1.3

14.3Ø 0.5 Ø 0.8*

Ø 1.9*

English

Specication and characteristics for each lead and electrode array

• The implant has 24 independent current sources stimulating 12 independent elec‑

trode channels in monopolar mode.

• The electrode is made of medical grade silicone, platinum (electrode contacts) and

platinum/iridium (90/10) wires and PEEK.

• All electrode variants have a straight design. The electrode does not deliver any

medicinal substances.

• Geometric surface area of the stimulation reference electrode = 50mm².

• Physical dimensions of the electrodes:

Electrode type Length

of the

electrode

lead *

Cross-sectional dimen-

sions of the electrode

array

Geometric surface

area per channel

Distance

at proximal

end of array *

at distal end

of array *

of smallest

stimulating

electrode

contact **

of largest

stimulating

electrode

contact **

between

contacts *

between

most proxi‑

mal and

most distal

contact *

Standard 111.2 1.3 × 1.3 0.5 × 0.5 0.14 0.14 2.4 26.4

Medium 111.2 0.8 × 0.8 0.5 × 0.5 0.14 0.14 1.9 20.9

Compressed 111.2 0.7 × 0.7 0.5 × 0.5 0.14 0.14 1.1 12.1

FLEXSOFT 110.9 1.3 × 1.3 0.5 × 0.4 0.13 0.14 2.4 26.4

FLEX28 108.2 0.8 × 0.8 0.5 × 0.4 0.13 0.14 2.1 23.1

FLEX26 105.2 0.8 × 0.8 0.5 × 0.3 0.13 0.14 1.9 20.9

FLEX24 104.2 0.8 × 0.8 0.5 × 0.3 0.13 0.14 1.9 20.9

FLEX20 99.7 0.8 × 0.8 0.5 × 0.3 0.13 0.14 1.4 15.4

FORM24 102.7 0.8 × 0.8 0.5 × 0.5 0.14 0.14 1.7 18.7

FORM19 97.7 0.8 × 0.8 0.5 × 0.5 0.14 0.14 1.3 14.3

* typical value, mm ** typical value, mm²

The implant does not have any connector.

Some implant electrode types mentioned in these Instructions for Use may not be

released for distribution in all markets. Please contact your local MED‑EL representative

for information on current product availability in your country.

Intended use

The MED‑EL Cochlear Implant System is intended to evoke auditory sensations via elec‑

trical stimulation of the auditory pathways for severely to profoundly hearing impaired

individuals who obtain little or no benet from acoustic amplication in the best aided

condition.

English

Additionally the MED‑EL Cochlear Implant System used in combination with the implant

variant SYNCHRONY 2 FLEX24 is intended to evoke auditory sensations via electrical

stimulation or via combined electric‑acoustic stimulation (EAS) of the auditory path‑

ways for partially deaf individuals, who obtain benet from acoustic amplication in the

lower frequencies only.

Additionally, the MED‑EL Cochlear Implant System used in combination with the implant

variants SYNCHRONY 2 FLEX20 is intended to evoke auditory sensations via electrical

stimulation or via combined electric‑acoustic stimulation (EAS) of the auditory path‑

ways for partially deaf individuals, who obtain benet from acoustic amplication in the

lower frequencies only.

The MED‑EL Cochlear Implant System is also intended to evoke auditory sensations via

electrical stimulation of the auditory pathways for individuals with single–sided deaf‑

ness, which is dened as severe to profound hearing impairment in one ear and normal

hearing or mild to moderate hearing impairment in the other ear.

Indications

• The cochlear implant evokes acoustic perception via electrical stimulation of the

auditory nerve. A functional auditory nerve is thus a prerequisite for successful

cochlear implantation.

• MED‑EL strongly recommends using optimally tted hearing aids for a minimum of

three months before deciding that a cochlear implant is the preferential option.

However, if an individual was deafened by an infectious disease, which can lead to

ossication and if there are signs of cochlear ossication there may be no need to

try a hearing aid. In these cases, implantation should not usually be delayed.

• To obtain the optimal benet from the implant, the prospective implant users and

their families shall be highly motivated and have realistic expectations about the

expected benet of the implant and shall understand the importance of returning

to the implant centre for regular audio processor programming, assessment ses‑

sions and training.

• A preoperative assessment according to the local professional standards must be

conducted.

• Cochlear implants SYNCHRONY 2 Standard are intended to be used in open

cochleae (no obliteration or ossication) for an electrode insertion depth of about

31mm.

• Cochlear implants SYNCHRONY 2 Medium are intended to be used in open cochleae

(no obliteration or ossication) with mild malformation for an electrode insertion

depth of about 24mm as per request of the surgeon.

English

• Cochlear implants SYNCHRONY 2 Compressed are intended to be used in cochleae

with moderate obliteration, ossication, or malformation for an electrode insertion

depth of about 15mm as per request of the surgeon.

• Cochlear implants SYNCHRONY 2 FLEXSOFT are intended to be used in open cochleae

(no obliteration or ossication) for an electrode insertion depth of about 31mm.

• Cochlear implants SYNCHRONY 2 FLEX28 are intended to be used in open cochleae

(no obliteration or ossication) for an electrode insertion depth of about 28mm.

• Cochlear implants SYNCHRONY 2 FLEX26 are intended to be used in open cochleae

(no obliteration or ossication) for an electrode insertion depth of about 26mm.

• Cochlear implants SYNCHRONY 2 FLEX24 for non‑EAS indication are intended to be

used in open cochleae (no obliteration or ossication) for an electrode insertion

depth of about 24mm as per request of the surgeon.

• Cochlear implants SYNCHRONY 2 FLEX24 used for EAS are indicated for partially deaf

individuals with mild to moderate sensorineural hearing loss in the low frequencies,

sloping to a profound sensorineural hearing loss in the high frequencies.

• Cochlear implants SYNCHRONY 2 FLEX20 for non‑EAS indication are intended to be

used in open cochleae (no obliteration or ossication) for an electrode insertion

depth of about 20mm as per request of the surgeon.

• Cochlear implants SYNCHRONY 2 FLEX20 used for EAS are indicated for partially deaf

individuals with mild to moderate sensorineural hearing loss in the low frequencies,

sloping to a profound sensorineural hearing loss in high frequencies.

• Cochlear implants SYNCHRONY 2 FORM24 are intended to be used in open cochleae

(no obliteration or ossication) or in cochleae with malformation for an electrode

insertion depth of about 24mm and/or when cerebrospinal uid (CSF) leakage is

expected.

• Cochlear implants SYNCHRONY 2 FORM19 are intended to be used in cochleae with

malformation, obliteration or ossication for an electrode insertion depth of about

19mm and/or when cerebrospinal uid (CSF) leakage is expected.

Contraindications

An individual must not be implanted,

• if the individual is known to be intolerant of the materials used in the implant

(including medical grade silicone, platinum, iridium and parylene c);

• if there is an absence of cochlear development;

• if the cause of deafness is non‑functionality of the auditory nerve and/or the upper

auditory pathway;

• if external or middle ear infections are present or if the tympanic membrane is

perforated in the ear to be implanted;

• if there are medical contraindications to surgery of the middle and inner ear and

anaesthesia as required;

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