Medel hearLIFE AudioStream Ma070401 User manual

Cochlear Implants
User Manual
AudioStream
AW_. (English US)


Table of Contents
. Introduction .............................................................................................................. 
. Intended use – Indications – Contraindications ........................................................ 
Intended use ......................................................................................................................
Indications..........................................................................................................................
Contraindications...............................................................................................................
. AudioStream.............................................................................................................. 
Using AudioStream for the rst time.................................................................................
How to use AudioStream ...................................................................................................
. General precautions and warnings............................................................................ 
. Care and maintenance .............................................................................................. 
Maintenance ......................................................................................................................
Disposal..............................................................................................................................
. Troubleshooting ........................................................................................................ 
. Technical data ..........................................................................................................
Regulatory statements...................................................................................................... 
Symbols............................................................................................................................. 
Guidance and manufacturer’s declaration .......................................................................
. Appendices ..............................................................................................................
Warranty ...........................................................................................................................
Manufacturer address.......................................................................................................
. Contact MED-EL .......................................................................................................

Introduction

. Introduction
This user manual provides information and instructions for the MED-EL AudioStream
(Ma), an optional battery pack cover for the SONNET and SONNET EAS series,
referred as SONNET series in this user manual. It includes descriptions of assembling
instructions and instructions for proper care of the device.
Please contact your healthcare provider or local MED-EL representative with any additional
questions you may have.
NOTE: Please read the user manual of your audio processor carefully before reading
this manual.
Symbols used in this user manual
Information indicating a hazardous situation that, if not avoided, could result in
minor injury or inconvenience for the user and/or property damage.
Information relevant for parents, guardians, or caregivers of children who use the
system.
―
This covers SONNET/SONNET EAS and SONNET /SONNET  EAS audio processors.

Intended use – Indications – Contraindications

. Intended use – Indications –
Contraindications
Intended use
AudioStream is an optional battery pack cover that can be used with the SONNET series
audio processor to stream audio content from mobile devices (e.g. smartphone) to the
SONNET series audio processor.
Indications
AudioStream is intended for users of any age, who have received a SONNET series audio
processor.
AudioStream is intended for use in typical everyday environments (home, ofce, outdoor,
etc.) and suitable for everyday use during a user`s waking hours.
Contraindications
A user must not receive AudioStream if the individual is known to be intolerant of the
materials used in AudioStream.
AudioStream is not intended to be used in environments where radiofrequency (RF)
transmissions are prohibited.

AudioStream

. AudioStream
AudioStream wirelessly connects your audio processor with mobile devices (smartphone,
tablet, etc.) to stream sound like a phone call or music directly to your ears without the
need of intermediate accessories. For compatible Apple®and Android™  devices please
visit our webpage at medel.com.
AudioStream is an optional streaming gadget that is activated by slipping the cover over
your battery pack option.
Please refer to the applicable audio processor user manual for further information about
how to lock the cover into place.
Using AudioStream for the rst time
Assembling AudioStream
To assemble AudioStream, proceed as follows:
unlocked
locked
①Switch off the audio processor by sliding off the battery pack
cover you have been using (make sure that the lock on the
cover is in the unlocked position).
②Assemble a compatible battery pack frame or rechargeable
battery adapter to your audio processor if not already in use.
A compatible battery pack frame or rechargeable battery
adapter is indicated by this symbol .
③Make sure that the lock of the AudioStream cover is in the
unlocked position.
④Slide AudioStream completely over the battery pack frame
or rechargeable battery adapter to switch on the audio
processor.
👪PARENTAL GUIDANCE
When the user is a young child, the battery pack cover lock must always be turned
clockwise into the locked position once the cover has been moved completely over
the frame or rechargeable battery adapter to prevent the child from disassembling
the audio processor. The micro rechargeable battery is NOT suitable for young
children under  years with the SONNET series audio processors as the battery
cannot be locked in place.
―
Android is a trademark of Google LLC

AudioStream

Pairing and conguring AudioStream
To stream sound via AudioStream directly to your processor, you rst have to pair
AudioStream.
To pair your mobile device with AudioStream and congure AudioStream,proceed as
follows:
①Download the latest AudioKey app from your app store.
②Start the AudioKey app on your mobile device and enter the connectivity options menu.
③Select AudioStream/Conguration and follow the instructions in the app.
Once successfully congured, you can use AudioStream to enjoy sound from any paired
compatible mobile device. You need not congure AudioStream again.
How to use AudioStream
Making phone calls
To use AudioStream for phone calls, proceed as follows:
①Switch on the audio processor.
②Ensure that your AudioStream is paired with your phone and a Bluetooth® wireless
technology connection is established.
③To start a phone call, proceed as you usually would on your mobile phone by speaking
into your phone. You will automatically hear the conversation streamed to your implant.
④To receive a phone call, simply pick it up on your phone and enjoy your conversation.
Streaming audio
To stream music or other audio signals (e.g. an audio book) from a mobile device,
proceed as follows:
①Switch on the audio processor.
②Ensure that your AudioStream is paired with your phone and a Bluetooth connection is
established.
③Switch on your sound source and sound from your mobile device is now streamed
directly to AudioStream.
The Bluetooth®word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any
use of such marks by MED-EL is under license.

General precautions and warnings

. General precautions and warnings
This section contains information on the safe use of your AudioStream. Please read this
information carefully. Your healthcare provider or local MED-EL representative will assist
you with any additional questions you may have.
AudioStream contains electronic components which require special precautions regarding
electromagnetic compatibility (EMC).
Always follow the guidelines outlined in this section and chapter Technical data, Guidance
and manufacturer’s declaration.
• Always use AudioStream with the compatible battery pack frame or rechargeable
battery adapter.
• Always handle AudioStream with care to achieve maximum lifetime and to avoid any
risks.
• The electronics are durable but must be treated with care.
• Do not use AudioStream under environmental conditions other than those described in
chapter Technical data.
• The dened operating temperature range for AudioStream is between °C and + °C
(+°F and + °F). Avoid excessive heat. Excessive heat might damage AudioStream
and make it unusable.
• Do not leave AudioStream in direct sunlight (especially inside a car). Long exposure to
direct sunlight could damage AudioStream.
• Avoid getting AudioStream wet as this may impair its function. If AudioStream gets
wet, make sure to disassemble it from your audio processor, wipe it dry and place it
in your drying kit. 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.
• Do not use AudioStream in the vicinity of strong ionizing radiation (x-ray machines) or
electromagnetic elds (MRI). Such radiation or elds may stop your MED-EL Cochlear
Implant System from working.
• Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than cm ( in.) to any part of
AudioStream, including cables specied by MED-EL. Otherwise, degradation of the
performance of AudioStream could result.
• Do not use AudioStream in environments where radio frequency (RF) transmissions are
prohibited.
• Use of audio processors other than those specied or provided by MED-EL could result
in increased electromagnetic emissions or decreased electromagnetic immunity of
AudioStream and result in improper operation.

General precautions and warnings

• Do not modify the housing, the electronics or any part of AudioStream.
• Do not use AudioStream with any device other than those listed in this manual or
approved by MED-EL to ensure proper operation of AudioStream.
⚠CAUTION
Use of Bluetooth wireless technology or any changes to the Bluetooth wireless
technology (e.g. rmware updates, hardware changes, connection/disconnection
of additional devices, etc.) could introduce previously unidentied risks. If such
risks are identied, they shall be analyzed, evaluated and controlled.
👪PARENTAL GUIDANCE
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.
Swallowing of system components could cause suffocation or internal injury.
When the user is a young child, the battery pack cover lock must always be turned
clockwise into the locked position once the cover has been moved completely over
the frame or rechargeable battery adapter to prevent the child from disassembling
the audio processor. The micro rechargeable battery is therefore not suitable for
young children.
Air travel
In addition to EASA (European Aviation Safety Agency) and FAA (Federal Aviation Admin-
istration) requirements, airline regulations require suspending wireless operations before
boarding an airplane. AudioStream should not be used on aircrafts unless specically
permitted by the ight personnel. Please replace your AudioStream with another battery
pack cover.

Care and maintenance

. Care and maintenance
Maintenance
AudioStream is designed for durability and reliability. Handle your AudioStream with care.
• Do not drop the device.
• Do not try to repair electronic parts of your AudioStream and do not try to open the
device as this invalidates the warranty.
• Protect AudioStream from liquids, dust and excessive temperatures.
• Do not clean AudioStream in or under water. Use a damp cloth to gently clean
AudioStream. Never use household cleaning products.
• Dry AudioStream overnight in the drying kit shipped with your audio processor to pre-
vent corrosion of the contacts. Do not use a microwave or any other heating devices
to dry AudioStream.
• Your AudioStream does not require regular maintenance by clinic personnel or
other experts.
If the device does not work properly, see chapter Troubleshooting for possible solutions.
If you still cannot solve the problem, please contact your healthcare provider or local
MED-EL representative for advice.
Disposal
We advise to dispose 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 elec-
tronic and electrical waste equipment will ensure safety of human health and environment.

Troubleshooting

. Troubleshooting
For assistance and reporting of issues associated with this MED-EL product or to report
unexpected operation or events, contact your local MED-EL representative.
Please also refer to the applicable audio processor user manual for troubleshooting
guidelines.
Problem Possible cause Recommended action
Pairing process failed Disruptions in pairing
process
• Switch on the Bluetooth functionality on the mobile
device.
• Switch the processor off and on to put AudioStream
in pairing mode.
• Your smartphone must be compatible with AudioStream.
Visit our website at medel.com for a list of compatible
smartphones.
• Make sure your smartphone uses the correct operating
system: Android  or higher for Android devices; iOS  or
higher for Apple devices.
• Closely follow the pairing procedure as described in the
AudioKey app. Make sure you have the correct version of
the AudioKey app installed.
• Make sure AudioStream is not paired to another mobile
device when you want to pair it to a new device.
• Move AudioStream device(s) closer to the mobile device
you intend to pair to.
Audio streaming
does not start
AudioStream is not yet
paired
• Pair AudioStream to the mobile device (see chapter ,
AudioStream, Pairing and conguring AudioStream).
No sound perceptible
during an active stream
AudioStream is out of
range
• Ensure that your audio processor is turned on.
• Replace audio processor battery if empty.
• Ensure that the audio processor is within range.
Distortions during
audio streaming
(interruptions, noise)
Device is not within
range or interference
from other devices
• Clean the FM contacts on the side of the audio processor.
• Reduce distance between device and audio processor.
• If possible, remove interfering device (especially in the
.GHz band, e.g. a Wi-Fi router or computer).
• If possible, change location of Wi-Fi router and/or PC.
• If possible, use the GHz band of your Wi-Fi system.
• In case of a phone call, do not place the phone too close
to AudioStream.
No sound perceptible
or sound too low
Volume too low • Clean the FM contacts on the side of the audio processor.
• Increase volume on mobile device (e.g. smartphone).
• If volume remains too low, increase volume on audio
processor.
Sound too loud
or cracking
Volume too high • Clean the FM contacts on the side of the audio processor.
• Decrease volume on mobile device (e.g. smartphone).
• If volume remains too high, decrease volume on audio
processor.

Technical data

. Technical data
Model AudioStream (Ma)
Dimensions
. mm
(.in.)
. mm
(.in.)
.mm
(.in.)
.mm
(.in.)
Weight• SONNET series for CI with AudioStream (including batteries): . g (.oz.)
• SONNET series for EAS with AudioStream (including batteries): .g (.oz.)
Materials Mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS)
Temperature and
humidity range
• Operating temperature range: °C to +°C (+ °F to + °F)
• Storage temperature range: – °C to + °C (–. °F to + °F)
• Relative humidity range: % to %
• Atmospheric pressure range: hPa (mbar) to hPa (mbar)
Essential performance None of the performance characteristics of AudioStream are essential performance
as dened in IEC -.
Expected service life The expected service life of AudioStream as dened in IEC - is  years.
There are no actions needed to maintain basic safety with regard to electromag-
netic disturbances for the expected service life.
Radio frequency link • Frequency band of reception/transmission:  MHz – . MHz
• Short Range Device (SRD) according to ERC/REC - Annex  (band B)
• Type of modulation: Gaussian frequency shift keying (GFSK)
• Maximum effective radiated power (ERP): W (–.dBm)
• Channel band width:  MHz
typical values

Technical data

Regulatory statements
Applicable in Canada only:
Model: AudioStream (Ma) – IC: A-AS
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic
Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions:
() this device may not cause interference, and () this device must accept any interference, including
interference that may cause undesired operation of the device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation,
Sciences et Développement économique Canada applicables aux appareils radio exempts de licence.
L’exploitation est autorisée aux deux conditions suivantes : () l’appareil ne doit pas produire de brouillage,
et () 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: AudioStream (Ma) – FCC ID: VNP-AS
This device complies with part  of the FCC Rules. Operation is subject to the following two conditions:
() This device may not cause harmful interference, and () this device must accept any interference received,
including interference that may cause undesired operation.
Warning: Changes or modications 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  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.
Symbols
AudioStream is in compliance with directive //EEC (Active Implantable Medical Devices/AIMD).
CE marking, rst applied in 
Hereby MED-EL Elektromedizinische Geräte GmbH declares that the radio equipment type AudioStream
is in compliance with directive //EU. The full text of the EU declaration of conformity is available at
the following internet address: www.medel.com/compliance
Caution, consult the instructions for use (manual) for important cautionary information
Refer to instructions for use
Manufacturer
Catalog number

Technical data

Serial number
Fragile; handle with care
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Type BF (IEC –/EN -): The surface of AudioStream, which is in contact with the user, is a
Type BF Applied Part
Non-ionizing electromagnetic radiation
Battery pack recommended for use with wireless accessories
Moisture and dust protection acc. to IEC 
This classication means that your audio processor 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 earmold is connected to the earhook (only relevant for SONNET series EAS)
• the coil cable and coil are connected to the control unit,
• the battery pack frame or rechargeable battery adapter is connected to the control unit,
• AudioStream is completely moved over the battery pack frame or rechargeable battery adapter.
Information indicating a hazardous situation that, if not avoided, could result in inconvenience or minor
injury for the user and/or property damage
Information relevant for parents, guardians or carers of children who use the system
Guidance and manufacturer’s declaration
Tables according to IEC -- for AudioStream
There are no deviations from this collateral standard and no allowances are used.
Electromagnetic emissions – for all equipment and systems
AudioStream is intended for use in the home healthcare environment. The customer or the user of AudioStream should assure that it is used
in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 
Group  AudioStream 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 
Class B AudioStream is suitable for use in all establishments, including domestic establish-
ments and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions
IEC --
Not applicable
Voltage uctuations/icker
emissions
IEC --
Not applicable

Technical data

Electromagnetic immunity – for all equipment and systems
AudioStream is intended for use in the home healthcare environment. The customer or the user of AudioStream should assure that it is
used in such an environment.
Immunity test IEC  test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC --
±kV contact ±kV contact Floors should be wood, concrete or ceramic tile.
If oors are covered with synthetic material, the
relative humidity should be at least %.
±kV air ±kV air
Electrical fast transient/burst
IEC --
±kV for power supply lines Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
±kV for input/output lines
Surge
IEC --
±kV line(s) to line(s) Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
±kV line(s) to earth
Voltage dips, short
interruptions and
voltage variations on
power supply lines
IEC --
% UT for . cycle ( phase) Not applicable Mains power quality should be that of a typical
commercial or hospital environment.
% UT for  cycle
% UTfor / cycles
(/Hz)
% UTfor / cycles
(/Hz)
Power frequency (/Hz)
magnetic eld
IEC --
A/m A/m Power frequency magnetic elds should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
NOTE: UTis the a.c. mains voltage prior to application of the test level.
Electromagnetic immunity – for equipment and systems that are not life-supporting
AudioStream is intended for use in the home healthcare environment. The customer or the user of AudioStream should assure that it is used
in such an environment.
Immunity test IEC  test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC --
 Vrms,  kHz to  MHz Not applicable Portable and mobile RF communications
equipment should be used no closer than  cm to
any part of the audio processor, including cables,
specied by MED-EL. Otherwise degradation of the
performance of the audio processor could result.
 Vrms in ISM and amateur radio bands
between  kHz and  MHz
Radiated RF
IEC --
 V/m,  MHz to . GHz  V/m
 V/m, . GHz to GHz
Proximity elds
from RF wireless
communications
equipment
IEC --
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m
 V/m,  MHz to  MHz  V/m

Appendices

. Appendices
Warranty
Please refer to the accompanying Warranty Statement for information on our warranty
provisions.
Manufacturer address
MED-EL Elektromedizinische Geräte GmbH
Worldwide Headquarters
Fürstenweg a
 Innsbruck, Austria
Tel: + ()   
E-Mail: of[email protected]
MED-EL distributor in the U.S.:
MED-EL Corporation
 Meridian Parkway, Suite 
Durham, NC , USA
Tel.: () -
Fax: () -
Toll free: () MED-EL-CI (-)
E-Mail: implant[email protected]

Contact MED-EL

. Contact MED-EL
Please refer to the accompanying Contact Sheet for your local ofce.
©  MED-EL Elektromedizinische Geräte GmbH.
Document revision . (issued /). All rights reserved.



MED-EL Elektromedizinische Geräte GmbH
Fürstenweg a,  Innsbruck, Austria
of[email protected]om medel.com