AW9387_10_User Manual SONNET Mini Battery Pack - MED

AW9387_10_User Manual SONNET Mini Battery Pack - MED
Cochlear Implants
SONNET Mini Battery Pack
User Manual
AW9387_1.0 (English)
Table of Contents
1. Table of Contents
2. INTRODUCTION
Product description
3. INTENDED USE – INDICATIONS – CONTRA-INDICATIONS
Intended use
2
3
4
4
Indications4
Contra-indications5
4. SONNET MINI BATTERY PACK
6
System components
6
Wearing options
7
How to connect the SONNET Mini Battery Pack to the SONNET control unit
9
5. EXTERNAL AUDIO CONNECTION
How to connect external audio devices
6. G
ENERAL PRECAUTIONS AND WARNINGS
14
14
17
General precautions for your Mini Battery Pack
17
General precautions for batteries
19
7. C ARE AND MAINTENANCE
20
Battery20
Changing the battery
21
8. TROUBLESHOOTING
23
9. TECHNICAL DATA
24
Materials25
Symbols25
Guidance and manufacturer’s declaration
10. APPENDICES
27
31
Warranty and guarantee
31
Manufacturer address
31
11. CONTACT MED‑EL
32
1
Introductio
2. Introduction
This user manual provides information and instructions regarding the MED‑EL SONNET Mini
Battery Pack. It includes descriptions of available parts and configurations as well as instructions for troubleshooting and proper care of the system and its components.
The SONNET Mini Battery Pack is connected to the SONNET control unit. Please also refer to
the applicable audio processor user manual, which you should have received with your audio
processor.
Please contact your CI centre or MED‑EL with any additional questions you may have.
IMPORTANT
For additional information on the safe use of the MED‑EL Cochlear Implant System please
refer to your audio processor user manual or ask your CI centre or MED‑EL.
This symbol indicates information that is particularly relevant for parents of implanted
children.
2
Introductio
PRODUCT DESCRIPTION
The SONNET Mini Battery Pack is a device enabling external power supply of one SONNET
control unit. It is connected to the control unit with a cable.
NOTE:
Only Mini Battery Pack Revision 2.0 or higher (indicated by /2 or a higher number after
the serial number which can be found on the label in the battery compartment) is able to
fully support the SONNET audio processor.
The SONNET Mini Battery Pack requires one primary or one rechargeable 1.2 to 1.6 Volt size
AAA battery. Alternatively, it may also be powered by the DaCapo PowerPack.
The SONNET Mini Battery Pack features an EA (Euro Audio) socket to connect external audio
devices for use with the SONNET audio processor. Depending on the connection cable, the
signal is either sent directly to the control unit, deactivating the microphone signal, or it is
mixed with the control unit microphone signal.
The CS44 socket is only a legacy socket, it has no function for a SONNET control unit.
IMPORTANT
It is the user’s responsibility to make sure that any connected external audio device is either
battery-powered or meets appropriate safety requirements. Do not connect mains-powered
devices that do not meet appropriate safety requirements directly to the SONNET Mini
Battery Pack.
Make sure to read the safety information in chapter 6, paragraph “TV, Radio, FM Systems,
etc.” before connecting any external equipment to your SONNET Mini Battery Pack.
3
Intended use – Indications – Contra-indications
3. Intended use – Indications –
Contra-indications
INTENDED USE
The SONNET Mini Battery Pack is an external battery pack used to power one MED‑EL SONNET
control unit. It can be worn on the upper body or the hip using different cable lengths to
connect the SONNET Mini Battery Pack to one processor unit.
INDICATIONS
Patients who received a MED‑EL SONNET audio processor unit are indicated to use the
SONNET Mini Battery Pack in typical everyday environments. This includes patients of any
age, any sex and any nationality.
The SONNET Mini Battery Pack is normally worn during the day.
The user of a SONNET Mini Battery Pack does not need any special skills or elevated level of
education, however, the user (or custodian if the user is a small child or handicapped person
not able to perform the actions listed below) shall at a minimum be able to perform the following actions:
•
Switching ON/OFF
•
Changing battery
•
Attaching the SONNET Mini Battery Pack to the patient’s clothes
•
Connecting/disconnecting the SONNET Mini Battery Pack Cable
As the SONNET Mini Battery Pack is a component of the MED‑EL Cochlear Implant System, all
indications stated for the MED‑EL Cochlear Implant System are applicable.
4
Intended use – Indications – Contra-indications
CONTRA-INDICATIONS
A patient must not receive the SONNET Mini Battery Pack if the individual is known to be
intolerant of the materials used in the SONNET audio processor or the SONNET Mini Battery
Pack. For details, refer to chapter Technical data in the audio processor user manual and in
this user manual.
For more information on intended use, indications and contra-indications of your audio processor, refer to the applicable audio processor user manual.
5
SONNET Mini Battery Pack
4. SONNET Mini Battery Pack
SYSTEM COMPONENTS
The SONNET Mini Battery Pack consists of the following components:
Fig. 1 Mini Battery Pack
Fig. 2a SONNET Mini Battery Pack Cable
Fig. 2b SONNET Mini Battery Pack Adapter
6
SONNET Mini Battery Pack
The SONNET Mini Battery Pack Cable features a lock. When attaching/removing the SONNET
Mini Battery Pack Cable, always make sure that the lock is in the unlocked position (see
Fig. 3).
unlocked
locked
Fig. 3 SONNET Mini Battery Pack Cable lock
WEARING OPTIONS
The SONNET Mini Battery Pack comes with a pouch, a small clip to connect to the pouch and
a lanyard.
Fig. 4 Pouch with clip and lanyard
7
SONNET Mini Battery Pack
To connect the clip to the pouch, proceed as shown in Fig. 5.
1
2
Fig. 5 Connecting clip to pouch
To remove the clip from the pouch, insert the tip of a ballpoint pen into the opening on the
clip and press down the small knob to disengage the connection. At the same time push the
clip down to remove it from the pouch.
You can wear the SONNET Mini Battery Pack on the upper body or on the hip. The SONNET
Mini Battery Pack comes in two kits containing different cable lengths to connect the
SONNET Mini Battery Pack to the control unit.
Fig. 6 Wearing options
Do not use the lanyard with children under 3 years to avoid the risk of strangulation.
Keep the lanyard out of the reach of children under 3 years.
8
SONNET Mini Battery Pack
HOW TO CONNECT THE SONNET MINI BATTERY PACK
TO THE SONNET CONTROL UNIT
Coil
Coil cable
SONNET
Control Unit
SONNET Mini Battery Pack
Adapter
SONNET Mini Battery Pack
Cable
Fig. 7 SONNET components and SONNET Mini Battery Pack Adapter and Cable
9
SONNET Mini Battery Pack
1) Connect the coil cable to the control unit. Make sure that the cable plug is positioned
correctly. The slanting edge must face down.
2) Connect the SONNET Mini Battery Pack Adapter to the SONNET control unit. Insert the rib
on the control unit into the matching groove of the SONNET Mini Battery Pack Adapter.
Push the opposite end of the SONNET Mini Battery Pack Adapter onto the control unit
until the release lever engages (see Fig. 8).
1
2
Fig. 8 Connecting the SONNET Mini Battery Pack Adapter to the SONNET control unit
3) Make sure that the lock on the SONNET Mini Battery Pack Cable is in the unlocked position. When it is not in the unlocked position, use the screwdriver pw rovided with your
SONNET kit to turn it counter-clockwise into the unlocked position (see Fig 3).
4) Slide the SONNET Mini Battery Pack Cable over the SONNET Mini Battery Pack Adapter.
The SONNET Mini Battery Pack Cable is oriented correctly when the lock faces towards
the earhook of the SONNET control unit.
For young children, the safety lock must be turned clockwise into the locked
position (see Fig. 3) once the SONNET Mini Battery Pack Cable has been moved
completely over the SONNET Mini Battery Pack Adapter to prevent the child from disassembling the audio processor. See your SONNET user manual for details.
5) Place the control unit with the connected SONNET Mini Battery Pack Cable on your ear
and connect the other end of the SONNET Mini Battery Pack Cable to the Mini Battery
Pack. Mind correct orientation of the plug and do not use excessive force when connecting the cable (see Fig. 9).
10
SONNET Mini Battery Pack
Fig. 9 Connecting the SONNET Mini Battery Pack Cable to the Mini Battery Pack
IMPORTANT
To prolong your cable’s life, we recommend the following:
•
Do not bend the cable.
•
When unplugging the cable, pull on the plug and not on the cable itself.
•
Do not lift the Mini Battery Pack or audio processor by the cable.
•
Do not use excessive force when unplugging the cable.
6) Attach the Mini Battery Pack to your clothes. For a more detailed description of the available options, see sections System components and Wearing options in this chapter.
7) Switch on the Mini Battery Pack. After switching it on, the indicator light of the SONNET
control unit will blink green up to four times indicating the activated programme. You can
check this by looking into a mirror or by connecting the control unit to the Mini Battery
Pack before placing it on your ear. (See your audio processor user manual for details on
blinking signals of the indicator light.)
11
SONNET Mini Battery Pack
Fig. 10 SONNET Mini Battery Pack connected to the SONNET control unit
12
SONNET Mini Battery Pack
ON/OFF switch
You may select the following positions:
– OFF: push down
 – ON: push up
In the OFF position, the SONNET Mini Battery Pack is turned off. No current is drawn in this
position. Make sure to turn OFF your SONNET Mini Battery Pack when it is not in use, as
this prolongs the lifetime of the battery. In the ON position, the SONNET Mini Battery Pack
is turned on (see Fig. 11).
ON
OFF
Fig. 11 ON/OFF switch (battery compartment lock)
Battery compartment lock
The ON/OFF switch also functions as a battery compartment lock. In the ON position, the
battery compartment cover is locked and cannot be removed. In the OFF position, the battery
compartment cover is open and can be removed. To prevent the cover from falling off too
easily when the lock is open, the battery pack has two small knobs which engage in the two
recesses on the inside of the cover. Be careful not to lose the battery compartment cover.
13
External audio connection
5. External audio connection
Safety advice
Make sure to read the safety information in chapter 6, paragraph “TV, Radio, FM Systems,
etc.” before connecting any external equipment to your SONNET Mini Battery Pack.
HOW TO CONNECT EXTERNAL AUDIO DEVICES
Your SONNET Mini Battery Pack is equipped with an EA (Euro Audio) socket to allow connection of external audio devices (e.g. assistive listening devices).
The EA (Euro Audio) socket is located opposite the ON/OFF switch under the elastic flap
above the socket for the SONNET Mini Battery Pack Cable. Open the flap and insert the
three-pin connector of the adapter cable. Mind the orientation of the three pins and do not
use excessive force when connecting the cable (see Fig. 12).
Direct link FM systems (e.g. Oticon Amigo, Phonak MLxi) may be connected to the Mini Battery Pack without an adapter cable (see Fig. 13).
Fig. 12 Connecting external audio sources to the
EA socket of the Mini Battery Pack
Fig. 13 Connecting direct link FM-systems to the
EA socket of the Mini Battery Pack
Connect the other end of the audio cable to the audio output of the audio device.
14
External audio connection
Mix mode:
When connected to an external device, the audio processor microphone remains active. This
allows you to hear input from the external device and the audio processor. Use this mode
when you want to continue hearing both the external device and the sounds around you (for
example, both music and someone talking to you).
Mix cables are indicated by a yellow 3.5 mm plug.
Ext mode:
When connected to an external device, the audio processor microphone is deactivated. You
will hear input from the external device only.
Ext cables are indicated by a red 3.5 mm plug.
WARNING
Do not use cables longer than 1 m as these cables may result in increased electromagnetic
emissions or decreased electromagnetic immunity of your audio processor system.
Cables from MED‑EL are available for Mix and Ext mode. For more information, please contact
your local MED‑EL office.
15
External audio connection
Assistive listening devices and other audio devices
Assistive listening devices are external audio devices that may be used together with the
SONNET Mini Battery Pack. They usually work by transmitting a signal “wirelessly”, generally
by using radio or infrared transmission. The speaker wears a small microphone and
transmitter, while the listener carries a receiver that picks up the transmitted signal. Before
you connect an assistive listening device directly to the external audio connection of your
SONNET Mini Battery Pack, consult with MED‑EL to verify compatibility. This also applies to
assistive listening devices which can be used to transmit the sound from a television or radio,
and those for use in educational settings for hearing-impaired students.
As many external audio devices have separate left and right stereo channels and separate
input levels, you will need a special cable for connection to your SONNET Mini Battery Pack.
Please contact MED‑EL for information on how to obtain a connection cable.
When connecting an external device to the external audio input, make sure that the device
and the audio processor are both turned off. Activate the audio processor before turning on
the external device.
If you are uncertain about whether a particular device is safe to use with the external audio
connection, ask your clinic or MED‑EL office before experimenting with it.
16
General precautions and warnings
6. G
eneral precautions and warnings
IMPORTANT
For additional information on the safe use of the MED‑EL Cochlear Implant System, please
refer to your audio processor user manual or ask your CI centre or MED‑EL.
GENERAL PRECAUTIONS FOR YOUR MINI BATTERY PACK
The SONNET Mini Battery Pack contains sophisticated electronic components which require
special precautions regarding electromagnetic compatibility (EMC). When activating the
SONNET Mini Battery Pack always follow the guidelines outlined in this section and in chapter
9, Technical data, Guidance and manufacturer’s declaration.
•
Always handle all components of the SONNET Mini Battery Pack with care to achieve
•
The electronics are durable but must be treated with care.
•
Never open the housing of your SONNET Mini Battery Pack. Unauthorised opening in-
maximum lifetime and to avoid any risks (e.g. injury).
validates the warranty. To change the battery or clean the battery contacts, remove the
battery compartment cover as described in chapter 7, Care and maintenance.
•
Your SONNET Mini Battery Pack and its components do not require regular maintenance
•
The defined operating temperature range for the SONNET Mini Battery Pack is between
by clinic personnel or other experts.
+0 °C (32 °F) and +50 °C (122 °F).
•
Do not leave the SONNET Mini Battery Pack in direct sunlight (especially inside a car).
Long exposure to direct sunlight might damage the SONNET Mini Battery Pack or any
other system component.
•
Avoid getting your SONNET Mini Battery Pack wet as this may impair its function. Always
remove and switch off the external parts of your MED-EL Cochlear Implant System and
keep them in a dry place before bathing, showering or engaging in other water-related
activities.
•
If the external parts become wet, switch off the SONNET Mini Battery Pack as quickly
as possible, remove the battery, unplug the SONNET Mini Battery Pack from the control
unit and gently wipe all external parts dry, using a soft, absorbent cloth. Then put the
SONNET Mini Battery Pack in the drying kit, supplied with your audio processor, to allow
the SONNET Mini Battery Pack to dry out (preferably overnight). If in doubt, repeat the
drying process.
17
General precautions and warnings
•
You also have to take care of the external components of your/your child’s MED‑EL
Cochlear Implant System. They should not be dropped or subjected to dangerous areas
(e.g. machines or high voltage) which could result in damage to the components.
•
If possible, wear your Mini Battery Pack and the SONNET Mini Battery Pack Cable underneath your clothing to avoid rubbing against charged items to reduce the risk of electrostatic discharge.
•
TV, Radio, FM Systems, etc.: When intending to connect an external audio device to the
SONNET Mini Battery Pack that is powered by mains power, i.e. plugged into the wall
or a power strip, always make sure first that this mains-powered external audio device
meets the safety requirements stated in the standards EN/IEC 60065, EN/IEC 60601-1
and/or appropriate national standards. If the mains-powered device does not bear a CE
mark (
), which is usually found on the device’s type label, you cannot presume that
the mains-powered device meets the above safety requirements and must therefore not
be connected to your SONNET Mini Battery Pack. Connecting a mains-powered device to
your SONNET Mini Battery Pack that does not meet the above safety requirements could
cause an electric shock. You can safely connect battery-powered external audio devices
to your SONNET Mini Battery Pack. Special cables may be needed (e.g. for connection to
FM systems). For more information please contact MED‑EL.
•
Mobile phones and other portable and mobile RF communications equipment may interfere with the external parts of your MED‑EL Cochlear Implant System. As the experiences
of other MED‑EL users have shown, the system is compatible with most mobile phones.
Results with a certain mobile phone may vary depending on the provider or type of
phone. If you are considering purchasing a mobile telephone, you should test it beforehand for possible interference.
•
Do not use your SONNET Mini Battery Pack adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, your SONNET Mini Battery Pack should be observed to verify normal operation in the configuration in which it is used.
•
Do not use your SONNET Mini Battery Pack in the vicinity of strong ionising radiation
(x-ray machines) or electromagnetic fields (MRI). Such radiation or fields may stop your
MED-EL Cochlear Implant System from working.
•
Do not use the system components under environmental conditions other than those
described in chapter 9, Technical data. Take particular care to avoid excessive heat. Excessive heat might damage the SONNET Mini Battery Pack and make it unusable.
•
Do not use your SONNET Mini Battery Pack with accessories other than those listed in
the audio processor user manual or approved by MED‑EL for use. Using other accessories
may stop your MED-EL Cochlear Implant System from working.
•
Ensure that the SONNET Mini Battery Pack Cable is never put around your/your child’s
neck in order to avoid the risk of strangulation.
18
General precautions and warnings
GENERAL PRECAUTIONS FOR BATTERIES
•
Do not try to charge any (rechargeable) batteries in the SONNET Mini Battery Pack. The
SONNET Mini Battery Pack has no charging function.
•
Do not touch leaking batteries. The electrolytes contained in the batteries are hazardous
to your health. If the electrolyte gets into your eyes, rinse them immediately with water.
Do not rub. Seek medical care immediately.
•
Do not use or leave the batteries in the vicinity of excessive heat (open fire, stove, oven,
•
Do not incinerate the batteries.
•
Do not puncture, crack, or otherwise breach the case of the batteries, e.g. do not drive
•
Do not open or modify the batteries.
•
Do not place the batteries in microwave ovens, high-pressure containers or on induction
•
Immediately discontinue using the batteries if during use, charging or storing, the batter-
etc.).
nails through the batteries, hit them with a hammer or step on them.
stovetops.
ies emit an unusual smell, feel hot, change colour and/or shape or appear abnormal in
any way.
•
Keep the batteries out of the reach of children. If a battery is swallowed, contact your
•
Do not short-circuit the batteries, e.g., by connecting metals (such as wires) to the
physician or local poison control centre immediately.
negative and positive terminals. When carrying any battery in the pocket of your trousers
or in your wallet or purse, ensure that it does not rub against other metals, e.g. keys,
coins.
•
You should always handle your batteries with care. Misuse may result in the batteries
causing heat, smoke, rupture, flame or leakage.
19
Care and maintenance
7. Care and maintenance
For maintenance of your audio processor, please refer to the SONNET audio processor user
manual.
Do not clean the SONNET Mini Battery Pack in or under water. Use a damp cloth to gently
clean the components. Do not use aggressive cleaning agents. Prevent water from running
into the Mini Battery Pack via the connectors or controls.
Do not try to repair the electronic parts of the system, and do not try to open any component
of the system, as this invalidates the manufacturer warranty.
Do not touch the battery contacts. If the contacts need to be cleaned, use a cotton swab
and a small amount of cleaning alcohol. Gently wipe dry after cleaning.
BATTERY
The SONNET Mini Battery Pack requires one primary or rechargeable AAA battery (1.2 to 1.6
Volt). Alternatively, it may also be powered by a DaCapo PowerPack.
IMPORTANT
Always use only one type of battery. The SONNET Mini Battery Pack has no charging function
for any battery type! For rechargeable batteries always use the specified charger to recharge
the battery.
AAA batteries of low quality may adversely affect the hours of operation. Please note
that rechargeable AAA batteries reach their full capacity only after the first 3–4 charging/
discharging cycles. It is recommended to use rechargeable AAA batteries.
Do not touch the battery contacts on any battery type and in the SONNET Mini Battery Pack.
If the contacts in the SONNET Mini Battery Pack need to be cleaned, use a cotton swab and
a small amount of cleaning alcohol. Gently wipe dry after cleaning.
If you do not use the SONNET Mini Battery Pack for an extended period of time, you should
remove any type of battery and store it separately.
20
Care and maintenance
CHANGING THE BATTERY
1) When the indicator light on the control unit blinks red continuously, the battery must be
replaced.
2) Before exchanging the battery, turn off the SONNET Mini Battery Pack.
3) When the SONNET Mini Battery Pack is deactivated, the battery compartment is automatically unlocked. You can now remove the battery compartment cover (see Fig. 14).
Fig. 14 Open the battery compartment
Fig. 15 Insert the AAA battery
4) Remove the empty battery.
5) The battery contacts of the Mini Battery Pack and the contacts of the battery must be
clean and dry.
6) Check for correct polarity before inserting the new battery.
Inserting the AAA battery: Insert the AAA battery at the positive pole (+) first and place
it in the Mini Battery Pack as shown in Fig. 15.
Inserting the DaCapo PowerPack: Hold the straight side of the DaCapo PowerPack
between thumb and forefinger and insert the side with the recessed corners into the
Mini Battery Pack as shown in Fig. 16.
7) To close the battery compartment correctly align the battery compartment cover and
push it forward until it snaps into place as shown in Fig. 17. Do not use excessive force
when opening or closing the battery compartment cover. The cover should glide easily
along the guiding grooves in the Mini Battery Pack.
Fig. 16 Insert the DaCapo PowerPack
Fig. 17 Close the battery compartment
21
Troubleshootin
IMPORTANT
Always remove used batteries immediately to avoid leakage and possible damage to the
device.
Used batteries should be disposed of according to local regulations. If you ignore these regulations you will contribute to pollution of the environment. 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 the MED-EL Cochlear Implant System into their mouths or to play
with any components. Swallowing of system components could cause suffocation or internal
injury. See your audio processor user manual for further information.
22
Technical data
8. Troubleshooting
IMPORTANT
Also refer to your audio processor user manual for troubleshooting guidelines.
If the audio processor does not stimulate, try the following steps shown in Fig. 18. You may
also use the Speech Processor Test Device. For a detailed description, refer to your audio
processor user manual.
No stimulation from the
audio processor
Switch on the
SONNET Mini Battery Pack
Check indicator light of
the audio processor
Check battery
no
Flashing?
On?
yes
yes
Battery
empty?
See user manual
Exchange battery
no
Switch off the
SONNET Mini Battery Pack
Contact MED‑EL or your clinic
Check connection cable
yes
Connected correctly?
Cable okay?
no
Connect cable correctly
alternative
Use spare cable
(if available)
Fig. 18 Block chart for troubleshooting
23
Technical data
9. Technical data
29 mm
66 mm
14 mm
Dimensions of the Mini Battery Pack 1
Length: 66 mm
Width: 29 mm
Height: 14 mm
Weight (without battery): <13 g
Power supply
One primary or rechargeable size AAA battery (1.2 – 1.6 V)
Or, alternatively, one DaCapo PowerPack (3.2 – 4.2 V)
Audio input
EA socket: see SONNET user manual
CS44 socket: legacy socket, it has no function for a SONNET control unit
Temperature range and humidity
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 %
Atmospheric pressure range: 700 mbar (hPa) to 1060 mbar (hPa)
For technical data of the audio processor, refer to the applicable audio processor user manual.
Essential performance
None of the performance characteristics of the SONNET (incl. all accessories) and the
SONNET Mini Battery Pack are essential performance as defined in IEC 60601-1.
1 typical values
24
Technical data
Expected service life
The expected service life of the SONNET (incl. all accessories) and the SONNET Mini Battery
Pack as defined in IEC 60601-1 is 5 years.
MATERIALS
SONNET MBP housing material:Blend of polycarbonate and acrylonitrile-butadiene-styrol
polymer (PC/ABS)
ON/OFF switch and CS44 slide: Polyamide (PA)
Elastic flap:
Silicone
Pouch:
Shell: Leather, Lining: Pigskin
Lanyard:
Nylon/Polyamide (PA)
Clip:
Nylon 6-6/Polyamide (PA)
SYMBOLS
The SONNET Mini Battery Pack is in compliance with directive 90/385/EEC (Active
Implantable Medical Devices / AIMD).
CE mark applied in 2011 (Mini Battery Pack) and 2015 (SONNET Mini Battery Pack
Adapter, SONNET Mini Battery Pack Cable)
Caution, consult the instructions for use (manual) for important cautionary
information
Refer to instruction manual / booklet
Relative humidity
Temperature limit
Type BF
(IEC 60601-1 / EN 60601-1)
25
Technical data
Signal input
Signal output
Fragile; handle with care
Not suitable for children under 3 years
IP classification of the behind-the-ear part (SONNET control unit, coil, SONNET Mini
Battery Pack Adapter, SONNET Mini Battery Pack Cable):
Moisture and dust protection acc. to environmental conditions as defined in IEC 60529 for
class IP54.
This classification means that the behind-the-ear part is protected against failure from
ingressing dust and splashing water when fully assembled, i.e. when
•
the microphone cover and the earhook are snapped onto the control unit,
•
an ear mould is connected to the earhook (only relevant for SONNETeas variant),
•
the coil cable and coil is connected to the control unit,
•
the SONNET Mini Battery Pack Adapter is connected to the control unit,
•the SONNET Mini Battery Pack Cable is completely moved over the SONNET Mini Battery
Pack Adapter.
IP classification of the Mini Battery Pack:
Moisture protection and protection from solid foreign objects acc. to environmental conditions as defined in IEC 60529 for class IP22.
This classification means that the Mini Battery Pack remains safe when exposed to dripping
water and no solid objects larger than 12.5 mm can penetrate the housing when fully
assembled, i.e. when
•
the SONNET Mini Battery Pack Cable is plugged into the Mini Battery Pack,
•
the battery compartment cover is fully moved over the battery compartment.
26
Technical data
GUIDANCE AND MANUFACTURER’S DECLARATION
Tables according to IEC 60601-1-2 for the SONNET Mini Battery Pack
Electromagnetic emissions – for all equipment and systems
The SONNET Mini Battery Pack is intended for use in the electromagnetic environment specified below. The customer or the user of the SONNET Mini Battery Pack should assure that it
is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The SONNET Mini Battery Pack 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
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable
The SONNET Mini Battery Pack 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.
27
Technical data
Electromagnetic immunity – for all equipment and systems
The SONNET Mini Battery Pack is intended for use in the electromagnetic environment
specified below. The customer or the user of the SONNET Mini Battery Pack should assure
that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be
at least 30 %.
Electrical fast
transient / burst
IEC 61000-4-4
±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 Mini Battery
Pack requires continued operation
during power mains interruptions, it is
recommended that the SONNET Mini
Battery Pack 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.
±1 kV for input/output
lines
Surge
IEC 61000-4-5
±1 kV line(s) to line(s)
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
±2 kV line(s) to earth
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
3 A/m
NOTE UT is the a.c. mains voltage prior to application of the test level.
28
Technical data
Electromagnetic immunity – for equipment and systems that are not life-supporting
The SONNET Mini Battery Pack is intended for use in the electromagnetic environment specified below. The customer or the user of the SONNET Mini Battery Pack 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 Mini Battery Pack, 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 * P
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 Mini
Battery Pack is used exceeds the applicable RF compliance level above, the SONNET Mini Battery Pack should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the SONNET Mini Battery Pack.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
29
Technical data
Recommended separation distances between portable and mobile RF communications
equipment and the SONNET Mini Battery Pack – for equipment and systems that are not
life-supporting
The SONNET Mini Battery Pack is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the SONNET
Mini Battery Pack can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
SONNET Mini Battery Pack as recommended below according to the maximum output power
of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output power of
transmitter
W
150 kHz to 80 MHz
d = 1.17 * P
80 MHz to 800 MHz
d = 1.17 * P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
800 MHz to 2.5 GHz
d = 2.33 * P
1
1.17
1.17
2.33
10
3.70
3.70
7.39
100
11.70
11.70
23.30
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (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.
Examples for wireless (RF) communications equipment:
Equipment
Recommended separation distance in m
wireless home network device (e.g. WiFi router)
0.74
cordless telephone / base station
1.65
walkie-talkie
2.33
mobile phone
3.30
30
Appendice
10. Appendices
WARRANTY AND GUARANTEE
Our warranty is in agreement with statutory warranty claims.
In addition, we grant a one-year guarantee for the Mini Battery Pack unless local laws provide for longer warranties.
The 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.
The period of warranty and guarantee begins on the day of delivery of the device and/or the
first audio processor fitting. If the Mini Battery Pack is delivered after the audio processor,
the period of warranty and guarantee begins on the day of receipt of the Mini Battery Pack.
Repair of a device under guarantee does not renew or prolong the original guarantee period.
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
31
Contact MED‑EL
11. Contact MED‑EL
Please refer to the accompanying Contact Sheet for your local office.
32
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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