MED EL Elektro Ger te ME1300 SONNET Me1310 / Me1320 User Manual part 2

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Care and maintenance
WEEKLY MAINTENANCE OF YOUR AUDIO PROCESSOR
Thoroughly wipe the external parts of your audio processor with a tissue and let them dry
completely.
Drying your audio processor
The audio processor system includes a drying kit (electrical drying kit or drying box with
drying capsules). For detailed information, please read the respective drying kit user manual.
The audio processor need not be completely disassembled. The batteries may remain in the
battery pack frame but the battery pack cover should be removed from your audio processor.
We recommend that you dry your audio processor once a day (preferably overnight);
although how often you will need to dry your equipment depends on the humidity in your
environment. Excessive perspiration or high humidity in the air will require more frequent
use of the drying kit.
Never swallow any drying capsules which may be included in the drying kit!
BATTERIES
The SONNET audio processor requires two 675 zinc air batteries. These batteries supply the
external and internal components of the MED‑EL Cochlear Implant System with energy. If you
want to get more information on batteries, please contact your local MED‑EL representative
or CI center.
The battery pack cover has air inlets on its outer side. Do not cover these inlets as this may
shorten battery life. If the inlets are contaminated, carefully clean them with the enclosed
cleaning brush. If the contamination cannot be removed with the cleaning brush, replace the
entire battery pack cover with a new one.
NOTE:
It is recommended to only use high power zinc air batteries to power the SONNET.
48
Care and maintenance
IMPORTANT
•
Wash your hands after handling disposable batteries.
•
Do not try to recharge disposable batteries.
•
Do not disassemble, deform, immerse in water or incinerate batteries.
•
Avoid mix-up of old and new batteries or batteries of different types of brands.
•
Do not short-circuit batteries, e.g. by allowing the terminals of batteries to touch,
carrying batteries loose in your pockets, wallet or purse or touching the battery terminals
with metals (coins, wires, keys, etc.).
•
•
Store unused batteries in their original packaging, in a cool and dry place.
Do not expose batteries to heat (e.g. never leave batteries in direct sunlight, behind a
window or in a car).
•
Do not use damaged, deformed batteries or leaking batteries. If any kind of substance
leaks out of a battery, avoid direct skin contact with that substance. Such a substance
could cause a chemical burn. In case of eye contact, rinse with copious amounts of water
and seek medical attention immediately.
•
If you are not going to use your audio processor for an extended period of time, you
should remove the batteries and store them separately. Cover the air openings on the
top with adhesive tape when storing the batteries to avoid discharge.
•
Always remove used batteries immediately to avoid leakage and possible damage to the
device.
•
Used batteries should be disposed of according to local regulations. Generally, batteries
are collected separately and not disposed of with the household garbage.
To prevent children from swallowing or choking on batteries, always keep new and
used batteries out of the reach of children. Children shall be instructed not to swallow
or put any components of their MED‑EL Cochlear Implant System into their mouths or to play
with any components. In young children, the battery pack cover lock must always be turned
clockwise into the locked position (see Fig. 7-2), once the cover has been moved completely
over the frame, to prevent the child from disassembling the audio processor.
Do not allow children to replace batteries without adult supervision.
49
Care and maintenance
Changing the batteries of your SONNET audio processor
When the indicator light on the control unit blinks red continuously (
), the
battery set must be replaced (see also chapter 8, Troubleshooting).
To change the batteries, proceed as follows:
1. Remove the SONNET and the coil from your head.
2. Make sure that the battery pack cover lock is in the unlocked position, as shown in Fig.
7-1. When it is not in the unlocked position, use the screwdriver provided with your
SONNET kit to turn it counter-clockwise into the unlocked position.
3. Pull back and completely remove the battery pack cover.
4. Replace the used battery set by removing the two batteries with the coil magnet. To do
so, move the center of the bottom part of the coil over each battery separately. Try not
to touch the battery contacts (see Fig. 22).
IMPORTANT
Be careful not to place the coil on the SONNET control unit.
5. Before inserting the new battery set, make sure that the battery contacts are clean and
dry. Remove the foil stickers covering the zinc air batteries before use. Check for correct
polarity when inserting the new batteries. The positive pole
the
must face outward, i.e.
sign is still visible after the batteries have been inserted.
6. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig.
7-1. When it is not in the unlocked position, use the screwdriver provided with your
SONNET kit to turn it counter-clockwise into the unlocked position.
7. Slide the battery pack cover completely over the battery pack frame to switch on the
SONNET (see Fig. 4). Mind the correct orientation of the battery pack cover when sliding
it over the frame and do not use excessive force. The orientation is correct when the
air inlets on the battery pack cover are on the same side as the coil cable socket in the
control unit.
50
Care and maintenance
In young children, the battery pack cover lock must always be turned clockwise into
the locked position (see Fig. 7-2), once the cover has been moved completely over the
frame, to prevent the child from disassembling the audio processor.
Fig. 22 Changing the batteries of your audio processor
51
Care and maintenance
Changing the battery of your FineTuner
When your FineTuner generates an optical low battery warning signal (see also chapter 4,
SONNET audio processor, FineTuner, FineTuner functions), replacing the battery of your
FineTuner is recommended.
To change the battery, proceed as follows:
1. Open the lid on the back of the FineTuner with a small screwdriver.
2. Replace the used button battery (type CR2025) by removing it with the coil magnet or by
gently shaking it into your hand. Try not to touch the battery contacts.
3. Insert the new battery with the
sign facing up.
4. Close the lid by carefully inserting it on the right side, then sliding it into place and
tightening the screw.
Fig. 23 Changing the battery of your FineTuner
52
Troubleshooting
8. Troubleshooting
Once you are familiar with your MED‑EL Cochlear Implant System, you will not find it difficult to
handle minor technical problems, which are similar to those encountered in other electronic
devices. Problems with functioning are most frequently related to batteries or cables.
Using cables or plugs not recommended or supplied by MED‑EL may damage your MED‑EL
Cochlear Implant System or cause uncomfortable stimulation and the warranty may become
void. If you have any questions or problems, please get in touch with your CI center or
nearest MED‑EL office.
Switching the audio processor on or off can cause a soft sound. You can remove the coil from
the implant site before operating the switch if this sound bothers you.
IMPORTANT
If troubleshooting does not eliminate the problem and you do not hear sound with your
MED‑EL Cochlear Implant System, please contact your clinic or CI center immediately.
53
Troubleshooting
SPEECH PROCESSOR TEST DEVICE
Red indicator light
Fig. 24 Speech Processor Test Device
For your convenience you have been provided with a small grey Speech Processor Test Device.
The Speech Processor Test Device is a simple, optional troubleshooting tool for MED‑EL audio
processors and is intended for use by cochlear implant users or other persons interacting
with cochlear implant patients (parents, audiologists, teachers, etc.).
The Speech Processor Test Device is not necessary for the function of your audio processor.
It is simply intended to help detect most common audio processor problems like defective
coil cables, defective audio processor microphones, weak batteries or other minor defects
that might cause improper functioning of the audio processor.
If you suspect a malfunction of your audio processor, contact your CI center or MED‑EL or
try the following procedure:
Switch on the audio processor and make sure that it is supplied with functioning batteries.
Place the coil underneath the Speech Processor Test Device (see Fig. 24). The coil will position
itself correctly due to magnetic attraction.
When speaking into the microphone, the red light on the Speech Processor Test Device
should flicker in the rhythm of your voice. If the red light does not light up or stays on
constantly, try the following:
•
Adjust the volume setting. By using the appropriate loudness setting, you should be able
to recognize the flickering of the red light in the rhythm of your voice.
•
Change the batteries.
•
Replace the existing coil cable with a substitute cable.
We recommend you try these steps, even if you are not using your Speech Processor Test
Device. If these measures are not successful, immediately contact your CI center or MED‑EL.
Do not try to open the audio processor or to disassemble the coil, as this will cause damage
to the device and immediately void any warranty.
54
Troubleshooting
The Speech Processor Test Device should be handled with care to achieve maximum lifetime
and to ensure proper function. Do not expose your Speech Processor Test Device to
conditions other than those suitable for your audio processor (see also chapter 6, General
precautions and warnings).
FINETUNER
The FineTuner transmits commands to the audio processor via a radio frequency (RF) link.
If the audio processor does not respond to FineTuner commands, the following may be
potential reasons and solutions for this:
•
The audio processor is out of the FineTuner’s operational range. To overcome this, you
should move the FineTuner closer to the audio processor.
•
The FineTuner keyboard lock is active. In this case, follow the instructions for the
unlocking function as described in chapter 4, SONNET audio processor, FineTuner,
FineTuner functions.
•
Interference from other electronic or electrical equipment is present that blocks the
transmission. To eliminate this interference, you need to move the FineTuner closer to
the audio processor and/or go to a different location.
•
The audio processor and the FineTuner are not synchronized. In this case, you need to
refer to the section described in chapter 4, SONNET audio processor, FineTuner, How to
configure your FineTuner.
•
In the case of a suspected malfunction of the FineTuner, you need to remove the battery
and re-insert it after a few minutes, as described in chapter 7, Care and maintenance,
Batteries, Changing the battery of your FineTuner.
•
The FineTuner battery is low. In this case you need to replace the battery as described in
chapter 7, Care and maintenance, Batteries, Changing the battery of your FineTuner.
•
The desired command in the audio processor has been disabled by your audiologist
during fitting. To enable this command, you will need to contact your clinic, CI center or
MED‑EL.
•
The indicator light in the audio processor has been disabled by your audiologist during
fitting. To enable the indicator light, you will need to contact your clinic, CI center or
MED‑EL.
55
Troubleshooting
Additional troubleshooting information:
•
If you or your child have used the T (telecoil) or MT (microphone and telecoil) settings
and are unable to return to the M (microphone) signal source input with the FineTuner,
you need to switch the audio processor off and on again. When the audio processor is
switched on again, it will automatically start with the M (microphone) setting activated.
•
If you or your child have lost the FineTuner, please contact your clinic, CI center or
MED‑EL immediately and ask for a replacement.
SONNET INDICATOR LIGHT
The multi-color indicator light on top of the audio processor flashes with different patterns
and colors to indicate different conditions. If the indicator light begins flashing, use the
following tables to determine the cause. Your audiologist can deactivate the blinking signals
(except error patterns) if you prefer this.
Error patterns (RED)
Blinking pattern
Meaning
Required action
Remarks
approx. 2 sec
Electronic problem
or temporary
processor
disturbance
Switch processor off.
Switch processor
back on.
If the blinking persists,
the audio processor must
be replaced.
approx. 2 sec
Selected position
is not programmed,
or there has been a
programming failure
Select another
position.
If the blinking persists,
the processor should be
reprogrammed by the
clinic.
approx. 0.25 sec
Electronic problem
or temporary
processor
disturbance
Switch processor off.
Switch processor
back on.
If the blinking persists,
the processor should
be reprogrammed by
the clinic; if the blinking
still persists, the audio
processor must be
replaced.
approx. 2 sec
Electronic problem
or programming
failure
Switch processor off.
Switch processor
back on.
If the blinking persists,
the processor must be
reprogrammed.
approx. 2 sec
Electronic problem
or temporary
processor
disturbance
Switch processor off.
Switch processor
back on.
56
Troubleshooting
Warning patterns (RED)
Blinking pattern
Meaning
Required action
Remarks
Batteries empty
Switch processor
off. Change the
batteries.
Switch processor
back on.
If the processor is not switched
off, the indicator light will
continue to blink.
Maximum or
minimum value
of volume or
audio sensitivity
range reached
Stop pushing
button(s) on
FineTuner.
approx. 1 sec
Confirmation pattern (GREEN)
Blinking pattern
Meaning
Required action
Remarks
Brief flash of indicator light
FineTuner
command
received and
accepted
None
IMPORTANT:
Pressing the Default key
on
your FineTuner only affects
volume and audio sensitivity.
The program position does not
change.
Program change pattern (GREEN)
Blinking pattern
Meaning
Required action
Remarks
None
approx. 1 sec
Program 1 to 4
selected
The indicator light will blink
depending on the selected
program position.
Meaning
Required action
Remarks
The processor
is initialized and
working
None
approx. 1 sec
approx. 1 sec
approx. 1 sec
Status pattern (GREEN)
Blinking pattern
approx. 3.5 sec
57
Troubleshooting
PRIVATE ALERT
The private alert feature allows adding an acoustic warning signal to the audio signal. This
added signal is audible only to the user of the audio processor and can be adjusted in 8
loudness steps. Your audiologist will set the loudness accordingly.
Battery low warning signal
If the battery voltage falls below a certain level, four short warning beeps will be generated
approximately every 14 seconds. You are still able to hear, but you should change the
batteries of the audio processor as soon as possible.
End of range reached warning signal
If a maximum or minimum value of volume or audio sensitivity has been reached, a continuous
beeping signal is audible for the user as long as the key of the FineTuner is pressed.
Confirmation signal
If a command from the FineTuner has been executed successfully by the audio processor, a
confirmation beep is audible for the user of the audio processor.
These 3 signals may be deactivated by your audiologist if this is your preference.
58
Troubleshooting
FINETUNER INDICATOR FUNCTIONS
Three indicator lights with different colors (left and right: amber; center: red [warnings])
indicate various conditions of the FineTuner.
Keyboard locked
If you press a key while the keyboard is locked, the red indicator light comes on. For power
saving reasons the red indicator light goes off after 5 seconds even if the key is still pressed.
Transmitting
If a key is accepted and the FineTuner transmits commands to the audio processor, the left
or right or both indicator lights (depending on the current side mode of the FineTuner) blink
synchronously to the transmitted signals. To save energy, the FineTuner stops transmitting
(and the indicator light stops blinking) after 3 seconds, even if the key is still pressed.
Switch to side
If the FineTuner is programmed for two different audio processors (for bilateral users), the
left indicator light illuminates when pressing ; the right indicator light illuminates when
pressing  and both indicator lights illuminate when pressing . To save energy, any
indicator light goes off after 5 seconds even if the key is still pressed (if  is pressed for
more than 5 seconds, the FineTuner enters the program mode, see below).
Low battery
The FineTuner checks the battery status after each transmission to the audio processor. If
a low battery status is detected, the red indicator light (center) blinks in a regular pattern
- red indicator light on your FineTuner goes on 3 times).
Configuration successful
If configuration of your FineTuner (see chapter 4, SONNET audio processor, FineTuner, How
to configure your FineTuner) was successful, or if the automatic keyboard lock feature
was successfully activated/deactivated, both amber indicator lights will illuminate for
approximately one second.
Program mode
If  is pressed for more than 5 seconds (must be unlocked; see chapter 4, SONNET audio
processor, FineTuner, FineTuner functions for locking/unlocking instructions), the FineTuner
enters the program mode. The three indicator lights start flashing. When the red indicator
light is on, the two amber indicator lights are off and vice versa. Flashing stops and the
program mode is left after 5 seconds or earlier when a correct key is pressed.
59
Technical data
9. Technical data
AUDIO PROCESSOR
Dimensions of SONNET audio processor (mm/in.)1
5.9 mm (0.232 in.)
56.7 mm (2.232 in.)
37.4 mm (1.472 in.)
Weight1
9.3 mm (0.366 in.)
10.6 g (0.374 oz.) (including batteries)
Power supply
2 hearing aid batteries type 675 zinc air (1.4 V), high power batteries recommended
Hardware
•
Fully digital signal processing
•
Various parameters programmable
•
4 programs selectable
•
Up to 12 band pass filters; filter characteristics programmable
•
Non-linear amplification programmable
•
2 omnidirectional microphones
•
Integrated telecoil
•
Audio processor self-test: checksum on programs, continuous parity check
•
Automatic Gain Control (AGC) configurable
•
FineTuner commands can selectively be disabled
1 typical values
60
Technical data
Audio input
•
Via FM Battery Pack Cover
•
Hearing aid type three pin connection (Euro Audio) acc. to IEC 60118–12
•
Sensitivity: –57.5 dBV1 (corresponds to 70 dB SPL at 1 kHz)
•
Impedance: 4.5 kΩ1
Controls/Indicators
•
ON/OFF switch
•
Indicator light: 1 multi-color LED
Materials
•
Mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS): audio
processor, all colors
•
Polyamide (PA): earhook
Temperature and humidity range
Operating temperature range: 0 °C to 50 °C (32 °F to 122 °F)
Storage temperature range: –20 °C to 60 °C (–4 °F to 140 °F)
Relative humidity range: 10 % to 93 %
Essential performance
None of the performance characteristics of the SONNET (incl. all accessories) are essential
performance, as defined in IEC 60601-1
Radio frequency (RF) link (FineTuner)
Frequency band of reception: 9.07 kHz (±3 %)
Radio frequency link (wireless network)
Frequency band of reception / transmission: 2400 MHz - 2483.5 MHz
Short Range Device (SRD) according to ERC/REC 70-03 Annex 1 (band H)
Receiver category 3
Type of modulation: Gaussian frequency shift keying (GFSK)
Maximum effective radiated power (ERP): 106µW (–9.75 dBm)
1 typical values
61
Technical data
FINETUNER
Dimensions1
Length: 85.5 mm (3.366 in.)
Width: 54.0 mm (2.126 in.)
Height: 6.3 mm (0.248 in.)
Weight: 33.0 g (1.164 oz.) (incl. battery)
Controls/Indicators
•
Default key
•
Volume keys
•
Sensitivity keys
•
Program selection keys
•
Input selection keys
•
Processor selection keys
•
Indicator lights: 1 red LED, 2 amber LEDs
Power supply
•
1 lithium/manganese dioxide battery type CR2025 (3 V)
•
Battery life expectancy is typically more than 6 months
Classification
•
Short Range Device (SRD) according to ERC/REC 70–03 Annex 9 (band A1) and Annex 12
(band A)
•
Equipment class 3
•
47 CFR Part 15 Low Power Transmitter below 1705 kHz-US
Materials
Mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS)
Temperature and humidity range
Operating temperature range: 0 °C to 50 °C (32 °F to 122 °F)
Storage temperature range: –20 °C to 60 °C (–4 °F to 140 °F)
Relative humidity range: 10 % to 93 %
Radio frequency (RF) link
Carrier frequency: 9.07 kHz (±0.7 %)
Type of modulation: phase shift keying (PSK)
Maximum RF output power: 11.7 dBµA/m @ 10 m
Maximum operating distance: ~ 1.15 m (3.77 ft.)
1 typical values
62
Technical data
REGULATORY STATEMENTS
Applicable in Canada only:
Model: SONNET (Me1310), SONNET EAS (Me1320)
Model: FineTuner
IC: 11986 A-ME1300
Canada 310
The above devices comply with Industry Canada licence-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.
Les appareils mentionnés ci-dessus sont conformes aux CNR d’Industrie Canada applicables
aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions
suivantes : (1) l’appareil ne doit pas produire de brouillage, et (2) l’appareil doit accepter tout
brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le
fonctionnement.
Applicable in the USA only:
Model: FineTuner
Model: SONNET (Me1310), SONNET EAS (Me1320)
FCC ID: VNP-FT
FCC ID: VNP-ME1300
The above devices comply with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device must
accept any interference received, including interference that may cause undesired operation.
Warning: Changes or modifications made to this equipment not expressly approved by
MED‑EL may void the FCC authorization to operate this equipment. NOTE: This equipment
has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses
and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular installation. lf this equipment
does cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
•
Reorient or relocate the receiving antenna.
•
lncrease the separation between the equipment and receiver.
•
Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
•
Consult the dealer or an experienced radio/TV technician for help.
63
Technical data
SYMBOLS
The SONNET audio processor and the FineTuner are in compliance with directive
90/385/EEC (Active Implantable Medical Devices/AIMD).
CE mark applied in 2014
Hereby MED‑EL declares that the SONNET audio processor and the FineTuner are in
compliance with the essential requirements and other relevant provisions of directive 1999/5/
EC (Radio Equipment and Telecommunications Terminal Equipment/R&TTE). The Declaration
of Conformity can be obtained directly from MED‑EL Worldwide Headquarters (for address
see chapter 10, Appendices).
MR unsafe
MR Conditional
Caution, consult the instructions for use (manual) for important cautionary
information
Type BF
(IEC 60601–1)
Non-ionizing radiation
Fragile; handle with care
Relative humidity
Temperature limit
64
Technical data
IP54
IP54
Moisture and dust protection acc. to IEC 60529
This classification means that your audio processor is protected against failure
from ingress of dust and splashing water when fully assembled and in the ON
position, i.e. when
•
the microphone cover and the earhook are snapped onto the control unit,
•
an ear mold is connected to the earhook (only relevant for SONNETeas variant),
•
the coil cable and coil is connected to the control unit,
•
the battery pack frame is connected to the control unit,
•
the standard battery pack cover is completely moved over the battery pack
frame (ON position).
The FineTuner and the Speech Processor Test Device are in compliance with
directive 2002/96/EC (Waste Electrical and Electronic Equipment/WEEE).
The WEEE logo (
) on the product or in this user manual indicates that this
product must not be disposed of or dumped with your other household waste. You
are liable to dispose of all external components of your MED‑EL Cochlear Implant
System by returning them to your local MED‑EL subsidiary or distributor. Isolated
collection and proper recovery of your electronic and electrical waste equipment
at the time of disposal will allow us to help conserve natural resources. Moreover,
proper recycling of the electronic and electrical waste equipment will ensure safety
of human health and environment.
SPEECH PROCESSOR TEST DEVICE
The Speech Processor Test Device is in compliance with directive 2004/108/EC
(Electromagnetic Compatibility/EMC).
CE mark applied in 2005
65
Technical data
GUIDANCE AND MANUFACTURER’S DECLARATION
Tables according to IEC 60601-1-2 for SONNET
Electromagnetic emissions – for all equipment and systems
The SONNET is intended for use in the electromagnetic environment specified below. The
customer or the user of the SONNET should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The SONNET uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
The SONNET is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
66
Technical data
Electromagnetic immunity – for all equipment and systems
The SONNET is intended for use in the electromagnetic environment specified below. The
customer or the user of the SONNET should assure that it is used in such an environment.
Electromagnetic environment
– guidance
Immunity test
IEC 60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power supply
lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Not applicable
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the SONNET requires
continued operation during
power mains interruptions,
it is recommended that the
SONNET be powered from an
uninterrupted power supply or
a battery.
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or hospital
environment.
Electrical fast transient/burst
IEC 61000-4-4
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30 %.
±1 kV for input/output
lines
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Voltage dips, short
interruptions and voltage
variations on power supply
lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE
3 A/m
UT is the a.c. mains voltage prior to application of the test level.
67
Technical data
Electromagnetic immunity – for equipment and systems that are not lifesupporting
The SONNET is intended for use in the electromagnetic environment specified below. The
customer or the user of the SONNET should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the SONNET, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
d = 1.17 *
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
d = 1.17 * P
80 MHz to 800 MHz
d = 2.33 * P
800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the SONNET is used
exceeds the applicable RF compliance level above, the SONNET should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the SONNET.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
68
Technical data
Recommended separation distances between portable and mobile RF
communications equipment and the SONNET – for equipment and systems that
are not life-supporting
The SONNET is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the SONNET can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the SONNET as recommended
below according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = 1.17 * P
80 MHz to 800 MHz
d = 1.17 * P
800 MHz to 2.5 GHz
d = 2.33 * P
0.01
0.12 (0.39 ft.)
0.12 (0.39 ft.)
0.23 (0.75 ft.)
0.1
0.37 (1.21 ft.)
0.37 (1.21 ft.)
0.74 (2.43 ft.)
1.17 (3.84 ft.)
1.17 (3.84 ft.)
2.33 (7.64 ft.)
10
3.70 (12.14 ft.)
3.70 (12.14 ft.)
7.39 (24.25 ft.)
100
11.70 (38.39 ft.)
11.70 (38.39 ft.)
23.30 (76.44 ft.)
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
69
Appendices
10. Appendices
WARRANTY, GUARANTEE AND REGISTRATION CARD
Our warranty is in agreement with statutory warranty claims. In addition, we grant a five- year
guarantee for the SONNET audio processor and coil. This warranty exclusively covers product
failures; it shall not apply to any MED‑EL product subjected to physical or electrical abuse
or misuse, or operated in any manner inconsistent with the applicable MED‑EL instructions.
Statutory warranty claims shall not be granted unless the registration card is completed
and returned to MED‑EL within three weeks of the initial fitting. The warranty period for the
SONNET audio processor and coil begins with the date of first audio processor fitting. The
implant itself is covered by a 10-year warranty. MED‑EL shall provide a new implant, free of
charge, if the implant fails due to a mechanical or electrical defect caused by MED‑EL. The
warranty period for the implant begins with the date of implant surgery and depends on the
completion and return of the registration form (CI patient card) that is delivered to the clinic
with the implant. Guarantees exceeding statutory warranty periods shall not be granted
unless the registration form is completed and sent to MED‑EL. Please ensure that you and
your clinic complete both the registration card and registration form (CI patient card), and
return them to MED‑EL via registered mail.
MANUFACTURER ADDRESS
MED‑EL Elektromedizinische Geräte GmbH
Worldwide Headquarters
Fürstenweg 77a
6020 Innsbruck, Austria
Tel: +43 (0) 5 77 88
E-Mail: office@medel.com
MED‑EL distributor in the U.S.:
MED‑EL Corporation, USA
2511 Old Cornwallis Road, Suite 100
Durham, NC 27713, USA
Tel.: (919) 572–2222
Fax: (919) 484–9229
Toll free: (888) MED‑EL-CI (633-3524)
E-Mail: implants-usa@medel.com
70
Contact MED‑EL
11. Contact MED‑EL
Please refer to the accompanying Contact Sheet for your local office.
71
MED-EL Elektromedizinische Geräte GmbH
Worldwide Headquarters
Fürstenweg 77a
6020 Innsbruck, Austria
office@medel.com
93%
10%
+60°C
(+140°F)
-20°C
(-4°F)
medel.com

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