Medel OPUS 2 Manual de usuario



AW 5473 Rev. 1.0 (English US)

MED-EL Worldwide Headquarters AW 5473 Rev. 1.0 (English US)

Table of contents 1

1. Tableofcontents 1

2. Introduction 3

3. Intendeduse–Indications–Contraindications 4

Intended use 4

Indications 4

Contra-indications 5

4. Gettingstarted 6

The parts of the system 6

5. OPUS2speechprocessor 8

Control unit 8

FineTuner 9

Battery pack 12

Coil 14

Coil cable 14

Connecting Assistive Listening Devices 16

Additional wearing options 18

Earhook/Microphone cover 22

Safety lock 23

6. Specialconsiderationsforyoungchildren 23

7. Generalprecautionsandwarnings 24

General precautions for your Cochlear Implant System 25

Precautions for medical procedures 30

8. Careandmaintenance 32

Maintenance 32

Batteries 33

Weekly maintenance of your OPUS 2 speech processor 37

 

Table of contents

9. Troubleshooting 38

Speech Processor Test Device 38

FineTuner 39

OPUS 2 red indicator light 40

Private alert 42

FineTuner indicator functions 43

10. Technicaldata 44

Speech processor 44

FineTuner 46

Speech Processor Test Device 47

Symbols 48

Guidance and manufacturer’s declaration 49

11. Appendices 53

Warranty, guarantee and registration card 53

Manufacturer address 53

Introduction 3

This user manual provides information and instructions regarding the MED-EL Cochlear

Implant System with the OPUS 2 speech processor. It includes descriptions of available

parts, wearing configurations, and accessories for the OPUS 2, as well as instructions for

troubleshooting and proper care of the external cochlear implant equipment.

Your MED-EL Cochlear Implant System consists of the PULSARCI100 or SONATATI100 Implants,

the external OPUS 2 speech processor (including FineTuner), the COMT+ P Coil, the external

components and accessories, and the related external hardware and software used by your

audiologist.

We recommend that you read this manual in its entirety.

Information particularly relevant for parents of implanted children is added, wherever

necessary, in this font and with this symbol.

The adjustment to a cochlear implant and adequate fitting of the device are gradual processes

that occur over time. It is important to remember that your ability to hear with your new

MED-EL system may take a little time while you become accustomed to this new method of

hearing.

After your initial fitting, you will need to return to your CI center on a regular basis for

reprogramming. Frequent reprogramming may be required during the first year of implant use.

This is normal and necessary, and it reflects a learning process that occurs as you become more

and more accustomed to stimulation through the implant. As more time passes, you will likely

find that you may require fewer and fewer sessions. Most patients continue to need occasional

adjustments for as long as they use their implant.

Please contact your CI center or MED-EL with any additional questions you may have.

 

Intended use – Indications – Contraindications



The OPUS 2 speech processor is part of the MED-EL Cochlear Implant System. The MED-EL

Cochlear Implant System is intended to evoke auditory sensation via electrical stimulation of

the auditory pathways for severely to profoundly hearing impaired individuals who obtain little

or no benefit from acoustic amplification in the best aided condition.



The OPUS 2 speech processor is an external component of the MED-EL Cochlear Implant

System and is indicated for use on patients who have been implanted with PULSARCI100 and/or

SONATATI100 cochlear implants. The MED-EL Cochlear Implant System is indicated for:

 Adults eighteen (18) years of age or older who have bilateral, sensorineural hearing

impairment and obtain limited benefit from appropriately fitted binaural hearing aids.

These individuals typically demonstrate bilateral severe to profound sensorineural hearing

loss determined by a pure tone average of 70 dB or greater at 500 Hz, 1000 Hz, and 2000

Hz. Limited benefit from amplification is defined by test scores of 40% correct or less in

best aided listening condition on CD recorded tests of open-set sentence recognition

(Hearing In Noise Test [HINT] sentences).

 Children aged twelve (12) months to seventeen (17) years eleven (11) months must

demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or

greater at 1000 Hz. In younger children, little or no benefit is defined by lack of progress

in the development of simple auditory skills in conjunction with appropriate amplification

and participation in intensive aural habilitation over a three (3) to six (6) month period. In

older children, lack of aid benefit is defined as < 20% correct on the Multi-syllabic Lexical

Neighbourhood Test (MLNT) or Lexical Neighbourhood Test (LNT), depending upon the

child‘s cognitive ability and linguistic skills. A three (3) to six (6) month hearing aid trial is

required for children without previous experience with hearing aids. Radiological evidence

of cochlear ossification may justify a shorter trial with amplification.

As the OPUS 2 is a component of the MED-EL Cochlear Implant System, all indications stated

for the Cochlear Implant System are applicable.

To obtain optimal benefit from the cochle ar implant, candidates shall be sufficiently motivated

and shall understand the importance of returning to the CI center for regular speech processor

programming, assessment sessions and training.

 

 

Intended use – Indications – Contraindications 5



A patient must not receive an OPUS 2 speech processor if the individual is known to be

intolerant of the materials used in the OPUS 2 control unit, battery pack, earhook, FM Battery

Pack Cover or FineTuner. For details please refer to Chapter 10, Technical data.

As the OPUS 2 is a component of the MED-EL Cochlear Implant System, all contra-indications

stated for the Cochlear Implant System are applicable.

The FineTuner is not intended to be used in environments where RF transmissions are

prohibited.



      



Getting started



The MED-EL Cochlear Implant System is an active medical device that has internal (implanted)

and external parts. The internal part of the device is surgically implanted behind the ear in the

skull, while the external components are worn behind the ear or on the body.

 

Fig. 1 PULSARCI100 and SONATATI100 cochlear implant

Getting started 7

The external parts include the OPUS 2 speech processor and the speech processor accessories.

In its basic configuration, the OPUS 2 speech processor consists of the control unit with the

earhook attached, the battery pack frame and cover, the connecting piece, the coil and the coil

cable. A device called a FineTuner facilitates access to various speech processor functions.

The coil is held in place by magnetic attraction to the implant.

The speech processor uses batteries that provide sufficient power for both the external and

the implanted electronics. The implanted part does not contain batteries.

Fig. 2 Your OPUS 2 speech processor

OPUS 2 speech processor





The battery pack lock functions as an ON/OFF switch.

You may select the following positions:

Battery pack lock open: 

Battery pack lock closed: 

After switching on the OPUS 2 speech processor, the red indicator light in the earhook will blink

up to four times indicating the activated program (i.e. number of blink signals corresponds to

the number of activated program). During this time the speech processor is already working.

In position OFF, the speech processor is turned off. No current is drawn in this position. Make

sure to open the battery pack lock of your speech processor when not in use, as this prolongs

the lifetime of the batteries (see also Chapter 8, Care and maintenance).

The OPUS 2 speech processor has an integrated telephone coil (telecoil). The telecoil picks up

magnetic sound signals coming from telephone receivers or loop systems, which are installed

in some public buildings, and converts them into electrical signals. When you switch on the

speech processor, the microphone is active even if you had the telecoil selected before you

switched off the speech processor. When the telecoil is active, you may hear buzzing sounds

when operating a FineTuner key. The buzzing is normal and indicates that a command is being

sent. To reduce interference with various electronic and electrical equipment when the telecoil

is active, we recommend you reduce audio sensitivity (see Chapter 5, OPUS 2 speech processor,

FineTuner, FineTuner controls).

 

Fig. 3 The OPUS 2 speech processor in position OFF Fig. 4 The OPUS 2 speech processor in position ON

 

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