Medel OPUS 2 User manual
AW 5473 Rev. 1.0 (English US)
MED-EL Worldwide Headquarters AW 5473 Rev. 1.0 (English US)
Table of contents 1
1. Tableofcontents 1
2. Introduction 3
3. Intendeduse–Indications–Contraindications 4
Intended use 4
Indications 4
Contra-indications 5
4. Gettingstarted 6
The parts of the system 6
5. OPUS2speechprocessor 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. Specialconsiderationsforyoungchildren 23
7. Generalprecautionsandwarnings 24
General precautions for your Cochlear Implant System 25
Precautions for medical procedures 30
8. Careandmaintenance 32
Maintenance 32
Batteries 33
Weekly maintenance of your OPUS 2 speech processor 37
Table of contents
2
9. Troubleshooting 38
Speech Processor Test Device 38
FineTuner 39
OPUS 2 red indicator light 40
Private alert 42
FineTuner indicator functions 43
10. Technicaldata 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
4
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
6
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
8
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
OPUS 2 speech processor 9
Your audiologist will program your OPUS 2 speech processor to your needs. The FineTuner is
an accessory device to help you optimally use your speech processor in changing daily listening
situations.
Your OPUS 2 speech processor has only an ON/OFF switch, all other functions are accessed
with a separate device, the FineTuner, which transmits commands to your OPUS 2 speech
processor via a radio frequency (RF) link. Its ergonomic design and larger size keys facilitate
changing the settings of your OPUS 2 speech processor.
Keeping the FineTuner out of the reach of children prevents them from inadvertently changing
the settings of their OPUS 2.
The FineTuner is not necessary for the function of your speech processor. When switched on,
the OPUS 2 speech processor activates the same program, volume and audio sensitivity setting
it had when it was switched off.
The FineTuner is configured for its designated target OPUS 2 speech processor, i.e. only the
target OPUS 2 speech processor will execute the desired command when a certain key is
pressed on the FineTuner. The typical maximum operating distance between the FineTuner and
the OPUS 2 speech processor is approximately 80 cm (2.62 ft.). This range could be decreased
close to electronic and electrical equipment even if this equipment complies with all applicable
electromagnetic emission requirements.
The FineTuner is configured for your speech processor and cannot be used by another cochlear
implant user. Your audiologist or clinical staff will configure the FineTuner to your needs.
Sometimes it may be necessary that you synchronize your FineTuner and speech processor (e.g.
if you purchase a backup FineTuner). Switch off your OPUS 2 speech processor and place the
coil of the OPUS 2 speech processor system on the keyboard of the FineTuner (approximately
over key MT ). Then switch on your OPUS 2 speech processor. The speech processor and the
FineTuner will be synchronized automatically. Successful synchronization is indicated by a short
blinking signal of the two amber indicator lights on your FineTuner.
If you want to use your FineTuner for both speech processor systems, your audiologist or
clinical engineer has received the MAESTRO software manual with detailed programming
information and will assign two speech processors to your dataset. Once your OPUS 2 speech
processors are programmed correctly, the synchronization procedure described above should
be performed with both speech processors.
OPUS 2 speech processor
10
Fig. 5
• Two keys to increase + or decrease – overall loudness. Loudness is
increased or decreased continuously.
• Two keys to increase or decrease the audio sensitivity. Audio
sensitivity is increased or decreased continuously.
• This key sets overall volume and audio sensitivity to predefined values
determined by your audiologist or clinical staff.
• Four keys to access four different programs.
• Three keys to select the microphone M, the telecoil T or the
microphone and the telecoil (mix) MT as the signal source.
• (for bilateral patients only)The Processor Selection keys allow
selecting the left , right or both processors . These buttons are also required in
programming mode, e.g. to activate or deactivate the keyboard lock (see Chapter 5, OPUS 2
speech processor, FineTuner, FineTuner functions - Automatic keyboard lock).
All FineTuner controls can be selectively disabled by your audiologist or clinical staff by disabling
the respective command in the control unit. Your FineTuner will still be able to transmit all
commands, but your control unit will not execute disabled commands.
Fig. 5 FineTuner
OPUS 2 speech processor 11
To avoid unintentional operation of a key, the FineTuner features an
optional automatic keyboard lock. This function electronically locks the keyboard if no key is
pressed for more than 10 seconds.
To activate the keyboard lock feature of your FineTuner, press the key for more than 5
seconds to enter the program mode (the red and both amber indicator lights on your FineTuner
will both start blinking alternately indicating that you have successfully entered the FineTuner’s
program mode) and then the key to activate the automatic keyboard lock (the FineTuner
will confirm successful activation of the automatic keyboard lock by a short blinking signal of
the two amber indicator lights).
To deactivate the automatic keyboard lock enter the program mode just as described above
and press the key. As above the FineTuner will confirm successful deactivation of the
automatic keyboard lock by a short blinking signal of the two amber indicator lights.
To activate a certain function while the keyboard lock is active, press the desired function key
twice. The first click temporarily unlocks the keyboard, the second click executes the command.
After 10 seconds without pressing another key, the keyboard lock is active again.
The processor features an optical warning signal, which appears as a red
indicator light flashing 3 times on the FineTuner. The signal is generated after pressing a key if
the voltage level of the FineTuner reaches a critical lower limit (see also Chapter 8, Care and
Maintenance, Batteries, Changing the battery of your FineTuner).
The FineTuner stops transmitting after 3 seconds to save energy, even
if the key is still pressed.
Your FineTuner does not have an ON/OFF switch.
Three indicator lights with different colors (2 amber, 1 red) indicate various conditions of
the FineTuner. For a detailed description of their function see Chapter 9, Troubleshooting.
The FineTuner does not affect connected Assistive Listening Devices (ALD’s).
OPUS 2 speech processor
12
The OPUS 2 battery pack consists of the battery pack frame holding 3 hearing aid batteries,
and the battery pack cover. The battery pack cover slides over the battery pack frame and is
held in place by the battery pack lock which also functions as the ON/OFF switch of the control
unit (see Fig. 3+4). This configuration allows the entire speech processor to be worn at the ear
and is the most common configuration for older children and adults.
Fig. 6 How to assemble the control unit and battery pack
Coil cable
Control unit
Coil
Battery pack
Earhook
Connecting piece
OPUS 2 speech processor 13
Connect the 9.5 cm cable to the coil. There is a guide pin on the coil end of the cable. This
guide pin is thicker than the two remaining pins, so there is only one correct way to insert
the cable into the coil (see Fig. 6).
Connect the opposite end of the cable into the control unit (see Fig. 7).
Add the battery pack frame with the cutout area positioned to accommodate the coil cable
plug.
Insert the pins of the connecting piece into the small holes at the bottom of the control unit.
If this configuration is used with children:
For young children, it is mandatory to use the safety lock to prevent them from disassembling
the speech processor (see Chapter 5, OPUS 2 speech processor, Safety lock).
Add fresh batteries.
Add the battery pack cover and close the battery pack lock to switch the processor on.
The red indicator light in the earhook will blink up to four times indicating the activated
program.
Position the speech processor on the ear and the coil over the implant.
Choose the desired program, volume and sensitivity settings with the FineTuner.
Only parents/adults are allowed to disassemble the device to change defective parts. Parents/
adults must check the device frequently for damage or missing parts.
For more wearing options see Chapter 5, OPUS 2 speech processor, Additional wearing options.
An ear-mold may help keep the processor in position on the ear. Contact your CI center or
audiologist for assistance.
OPUS 2 speech processor
14
The coil connects the OPUS 2 speech processor with the implant. It sends both energy and the
coded acoustic signal through the skin to the implant.
A small magnet is located in the center of the coil to hold it in place on the head over the
implant package. The magnet strength can be adjusted by your audiologist or clinical staff to
meet your individual needs.
If you notice any signs of skin irritation around the coil, contact your clinic or CI center.
It is easiest to observe children when playing or in everyday situations to determine whether
the coil is properly attracted to the implant. If the coil falls off too easily, your child may
develop an aversion to wearing the coil. During the first months after surgery, you should regularly
check the skin under the coil for irritation. As the child grows, skin thickness will increase and the
magnetic attraction force will need to be adjusted by increasing the number of magnets. Your
audiologist can adjust the magnet strength of the coil.
The coil and speech processor are connected by the coil cable. You have to unplug the cable
for maintenance purposes or if you want to replace the cable. It is not necessary to disconnect
the cable when changing the batteries.
Although the cable is designed for maximum durability and flexibility, this part of the MED-EL
Cochlear Implant System is most likely to wear out.
If a cable fails, order a new one immediately.
Do not use the cable with devices other than the OPUS 2 speech processor.
OPUS 2 speech processor 15
Open the battery pack lock and remove the battery pack cover.
Pull the connecting piece straight down until you feel a slight mechanical click. The connecting
piece need not be removed completely but you may do so if you wish.
Disassemble the battery pack frame from the control unit.
Disconnect the coil cable from the control unit and the coil.
Connect the new coil cable to the coil.
Connect the opposite end of the new coil cable into the control unit. Make sure that the
cable plug is correctly positioned. The slanting edge should face up. The cable should face
diagonally upwards.
Reassemble the battery pack frame and the control unit. The coil cable plug rests in the
small cutout section of the angled section of the battery pack.
Push the connecting piece back in place.
Slide the battery pack cover back on and close the battery pack lock. The speech processor
is now active.
Fig. 7 Connecting the coil cable
1 long pin
3 short pins
Coil cable
Control unit
OPUS 2 speech processor
16
The additional components required for the connection of Assistive Listening Devices
(FM Battery Pack Cover and Adapter Cable) are included in the which may
be purchased separately.
A special battery pack cover is provided to connect your OPUS 2 speech processor to external,
battery-powered audio devices, such as portable CD players, MP3 players, AM-FM radios, etc.
The FM Battery Pack Cover is slightly longer than the standard cover to accommodate the
integrated FM connector.
• Open the battery pack lock.
• Remove the battery pack cover.
• Slide on the FM Battery Pack Cover.
• Close the battery pack lock.
Connect the three-pin connector of the Adapter Ca ble (grey end) to the openings at the
bottom of the FM Battery Pack Cover. Mind the orientation of the three pins and do not use
excessive force when connecting the cable.
Connect the audio phone plug (yellow or red end) to the audio output of the battery-powered
device.
Fig. 8 Connecting the FM cable and FM receiver
OPUS 2 speech processor 17
Direct-link FM systems (e.g. Phonic Ear/Oticon Lexis) may be connected to the FM Battery
Pack Cover without an Adapter Cable. Connecting direct-link FM systems will decrease battery
life of your OPUS 2 speech processor.
When connected to an external device, the OPUS 2 microphone remains active.
You will hear inputs from the external device and the speech processor.
Mix cables are indicated by a yellow 3.5 mm plug.
When connected to an external device, the OPUS 2 microphone is deactivated. You will hear
input from the external device only.
Ext cables are indicated by a red 3.5 mm plug.
OPUS 2 speech processor
18
MED-EL’s signature wearing option for infants and young children is the BabyBTETM. The
BabyBTETM has the advantage of allowing a young child to begin using the same ear-level speech
processor that he or she will use for the long term, while still accommodating a baby’s small ear
and activity level. For this wearing option, the entire BTE processor is placed on the clothing,
and only the coil is placed over the implant on the head. This configuration is also referred
to as ActiveWear for users who participate in sports or other activities where a very secure
placement is desired.
For activities that require wearing a helmet, using this configuration allows the microphone of
the speech processor to be positioned outside the helmet, with only the coil and cable fitting
underneath.
When using the BabyBTETM or the ActiveWear configuration, it is important to be aware of
the position of the microphone; it should be positioned in such a way that the majority of
sound will be directed at the microphone port (i.e. facing forward). The microphone should
not be covered or positioned where jewellery and/or clothing could obstruct input to the
microphone.
The additional components required for the BabyBTETM assembly and the ActiveWear
configuration (Straight Battery Pack, 28 cm coil cable, microphone cover, connecting piece,
safety bar, screw-on fixation bar and fixation clip) are included in the
which may be purchased separately.
Fig. 9 How to assemble the BabyBTETM/ActiveWear
Coil cable
Control unit
Coil
Straight Battery Pack
Microphone cover
Connecting piece
Fixation bar
Safety lock
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5
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