Medel SAMBA 2 User manual

Business Unit Vibrant
AW53003_1.0 (English US)
SAMBA 2 Audio Processor
English

1
Table of contents
Instructions for use
1. Contents of the package........................................................................................... 3
2. Introduction .............................................................................................................. 4
3. General information .................................................................................................. 5
Device description..............................................................................................................5
SAMBA 2 Audio Processor overview ..................................................................................6
Intended use – Indications – Contraindications................................................................7
Intolerances .......................................................................................................................7
4. User information ....................................................................................................... 8
Switching SAMBA 2 on/off.................................................................................................8
Placing SAMBA 2 over the implant.....................................................................................9
Changing program and volume........................................................................................ 10
SAMBA 2 Remote app ...................................................................................................... 10
Battery status ................................................................................................................... 11
Changing the battery........................................................................................................ 11
Changing the cover...........................................................................................................14
Using the attachment clips...............................................................................................15
Maintenance .....................................................................................................................15
Cleaning ............................................................................................................................16
Storage, handling and disposal.........................................................................................16
Compatibility with optional user accessories ...................................................................16
5. Troubleshooting .......................................................................................................17
6. Audiologist/healthcare professional information .................................................... 20
Supplementary equipment to program and handle the SAMBA 2 ..................................20
Information and recommended training ..........................................................................21
Programming the SAMBA 2..............................................................................................22
Changing the magnet ......................................................................................................23
Advanced troubleshooting for the audiologist/healthcare professional.........................24

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7. Warnings and precautions....................................................................................... 26
Warnings ..........................................................................................................................26
Precautions ......................................................................................................................27
Possible adverse events associated with Bonebridge surgery........................................28
Interference with other equipment.................................................................................29
Initial activation ................................................................................................................31
8. Clinical summary .................................................................................................... 32
9. Miscellaneous.......................................................................................................... 63
Technical data ..................................................................................................................63
Warranty statement.........................................................................................................65
Symbols............................................................................................................................65
Radio frequency/Telecommunication information...........................................................66

Contents of the package
3
1. Contents of the package
• SAMBA 2 Audio Processor
• Daily case
• Set of batteries
• Set of interchangeable covers
• Attachment clips for hair and clothes
• Accompanying documents

Introduction
4
2. Introduction
These instructions for use cover the use of the SAMBA 2 Audio Processor.
You should read the instructions for use carefully and completely so that you are famil‑
iar with the operation and maintenance of your audio processor. Please do not hesitate
to contact your audiologist/healthcare professional, clinic or MED‑EL representative
with any additional questions you may have.
The following symbols will be used throughout this document:
⚠Information indicating a hazardous situation that, if not avoided, could result in
death or serious injury.
⚠Information indicating a hazardous situation that, if not avoided, could result in
minor injury or inconvenience for the user and/or property damage.
👪Information particularly relevant for parents, guardians or caregivers of children
who use the system.
NOTE:
The SAMBA 2 BB Audio Processor will also be referred to as SAMBA 2 or audio proces‑
sor in these instructions for use.
⚠CAUTION
The SAMBA 2 Audio Processor is only to be used with a Bonebridge Bone Conduc-
tion Implant (BCI 601 or BCI 602).

General information
5
3. General information
Device description
The Bonebridge system consists of two major components: the osseointegrated implant,
called Bonebridge Bone Conduction Implant (BCI), and the externally worn audio processor.
The externally worn audio processor is attached to the user’s head, behind the ear. A
magnet in the audio processor is attracted to an opposing magnet within the implant. The
audio processor includes two microphones to pick up sound from the environment, sound
processing circuitry to modify the output signal to the user’s specic requirements, and a
digital compression processor. The device is powered by a single 675 zinc-air battery. The
Bonebridge system is activated by simply tting the audio processor. The audio processor is
intended for the home use environment.
The implanted part of the Bonebridge system consists of the internal coil and the Bone
Conduction – Floating Mass Transducer (BC-FMT). A signal from the audio processor is
transferred across the skin to the internal coil. The internal coil then relays the signal to
the BC-FMT. The BC-FMT converts the signal into vibrations, which are interpreted by the
user as sound. The implanted portion of the Bonebridge system is not operated directly
and has no specic maintenance requirements. The user does, however, have operation
and maintenance responsibilities for the audio processor and its accessories.

General information
6
SAMBA 2 Audio Processor overview
①Microphone openings
②Indicator relevant for users with two implants
(= right side, = left side)
③Magnet
④Interchangeable cover
⑤Battery compartment
⑥Air vents
⑦Bracket groove (recess for attachment clip xation)
Top view
Side view
Bottom view
Front view
①②
④
③
⑤
⑥
⑦

General information
7
Intended use – Indications – Contraindications
Intended use
The SAMBA 2 Audio Processor is an external part of the Bonebridge system. The
Bonebridge is intended to improve hearing for patients with conductive or mixed hearing
losses, bilateral tting or single-sided deafness.
The Bonebridge augments hearing by providing acoustic information to the inner ear via
bone conduction. This is achieved by actuating a vibratory transducer, which is implanted
in the temporal bone.
Indications and contraindications
Patients implanted with a Bonebridge are indicated to use the SAMBA 2 Audio Processor.
As the SAMBA 2 is a component of the Bonebridge system, all indications and contraindi-
cations for the Bonebridge are applicable.
NOTE:
Important information related to indications,contraindications, warnings and risks
for your implant are shipped in a separate document to your clinic together with the
implant (instructions for use of the implant). If you want to review this information,
please contact your clinic or MED‑EL.
⚠CAUTION
It is recommended that BCI recipients receive age-appropriate vaccinations includ-
ing a pneumococcal meningitis vaccination prior to implantation.
Intolerances
Persons known to be intolerant of the materials used in the implant or the audio processor
should not receive the Bonebridge system. Refer to section Miscellaneous for information
on the materials used in the SAMBA 2 which are in contact with tissue.

User information
8
4. User information
Switching SAMBA 2 on/off
Open the battery compartment about 5mm (3/16 in) to switch the SAMBA 2 off.
Always open the battery compartment whenever the audio processor is not in use to
extend the life of your device’s battery.
👪PARENTAL GUIDANCE
If the child/user refuses to wear the audio processor or indicates uncomfortable
hearing sensations, remove and turn off the audio processor and have the system
checked at the clinic.
ON OFF

User information
9
Placing SAMBA 2 over the implant
The audio processor is kept in position over the implant by magnetic force. Your audi-
ologist/healthcare professional can exchange the magnet of the audio processor to a
different strength for your best benet.
NOTE:
Bilateral users must check the indicator symbols on the bottom of each SAMBA 2 Audio
Processor before placing the devices over the implants ( = right side application,
= left side application).
⚠CAUTION
Take care not to drop the audio processor during handling. Keep good hold of the
audio processor
• when you place it over the implant.
• when you remove it from the implant.
• during dressing/undressing.
⚠CAUTION
Return to your audiologist/healthcare professional
• if wearing the audio processor causes redness or discomfort to your skin.
• if the audio processor seems to fall off frequently.
Implant system activatedThis side up

User information
10
Changing program and volume
The audio processor offers up to six programs (one on default). These programs are freely
adaptable by the audiologist/healthcare professional.
The audiologist/healthcare professional can adjust the signal processing for different hear-
ing environments (e.g. Program 1 for standard conditions (default), Program 2 for ambient
noise, Program 3 optimized for music etc.).
NOTE:
After turning on the audio processor, the rst program is always active.
The universal Program 1 automatically adapts to listening situations and has been set and
customized by your audiologist/healthcare professional. If you have questions regarding
changing the volume and switching between programs, contact your audiologist/health-
care professional.
SAMBA 2 Remote app
The SAMBA 2 Remote app allows you to adjust your SAMBA 2 from your Android or iOS
smartphone without the need for any additional hardware. The app is free to download
from the Google Play Store or Apple App Store¹.
The SAMBA 2 Remote app generates short control signals which may be audible. While
using the app do not hold the loudspeaker of this device to your ears or the ears of
others. Do not use the device with headphones, headsets or other audio playback devices.
Installation
1. Install the SAMBA 2 Remote app.
2. Launch the app on your mobile device and follow the instructions given.
3. Setup with QR code: Use this option if you have received a Setup QR code from your
audiologist/healthcare professional. Simply scan the QR code.
Manual setup: Use this option, if you don’t have a Setup QR code. Follow the prompts on
the screen of your device.
Features
• Select hearing programs
• Adjust volume and sound balance
• Adjust of volume of masking signal
• Check battery status of the audio processor
• Mute
―
1 The SAMBA 2 Remote app may not be available in some countries. Contact your audiologist/healthcare
professional or your local MED-EL representative for specic information.

User information
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NOTE:
The app only works in one direction and does not receive any information from the
audio processor. When switching on, the audio processor automatically starts in the
Universal‑program (Program 1) and with default volume, whereas the app shows the
last chosen program and volume slider position. To switch programs, click on the
desired one. To change volume, click on the desired location on the slider bar.
NOTE:
The volume slider is absolute. A particular position of the slider indicates a designated
increase or decrease in volume.
NOTE:
If the settings of your audio processor were changed by your healthcare professional,
the app needs to be set up again.
Battery status
The audio processor is designed to be very energy-efcient and has a battery lifetime of
approximately 8 to 10 days. This is based on an average daily use of 12.6 to 16 hours at an
average volume level.
The battery life of the audio processor may vary depending on the selected program,
environment and duration of use.
Changing the battery
If the battery is low and you hear a series of beeps, it must be replaced. The loudness and
pitch of the beeps can be preset by your audiologist/healthcare professional.
⚠CAUTION
Only use size 675 zinc-air batteries (also called PR44 batteries). Using batteries of
other sizes, voltages, or power levels may cause irreparable damage to the audio
processor. Never try to recharge 675 zinc-air batteries.
If you notice a change in sound quality, it is recommended that you replace the battery
rst.
NOTE:
If your device does not work properly, check the section Troubleshooting. If the prob‑
lem persists, contact your audiologist/healthcare professional.

User information
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To change the battery, follow these steps:
Remove used battery
Insert new battery
NOTE:
It is recommended to peel the protective lm off the battery one to two minutes
before battery insertion. This time is needed for the zinc‑air battery to charge up
completely.
①
②
④
③
⑥
⑤

User information
13
Spare battery
It is recommended that you always carry a spare battery in its original packaging with you.
Disposal of battery
Always remove the used battery immediately to avoid battery leakage and possible dam-
age to the audio processor. To avoid environmental pollution, do not throw batteries into
household trash. Recycle or dispose of used batteries according to local regulations.
👪PARENTAL GUIDANCE
Parents, guardians or caregivers are advised to regularly change the battery as
necessary and, if in doubt, check the status of the battery.
⚠WARNING
To prevent children and those who, for a variety of reasons, lack the ability to
appropriately handle and manipulate small parts from swallowing or choking on
batteries, always keep new and used batteries out of their reach.
If you suspect your child has swallowed or inserted a button battery, immediately
seek for expert advice at your nearest emergency ward.

User information
14
Changing the cover
Different covers can be used to change and customize the appearance of your SAMBA 2.
NOTE:
If the cover is broken or the membranes underneath the microphone openings are
damaged or clogged, the cover must be exchanged.
⚠CAUTION
Take care not to stress the battery compartment when changing the cover.
To change the cover, follow these steps:
NOTE:
If applied correctly, the cover snaps into place easily. Do not apply undue force.
NOTE:
The battery does not have to be removed to change the cover.
①
Close the battery compartment.
Insert your ngertips into the nger grooves between
the cover and the audio processor. Carefully lift and
remove the cover.
②
Take a look at your new cover and the snap-on
connection (marked). The cover should be afxed in
two steps.
It is important to snap the cover in place in two steps
as shown. First press together on the side far away
from the battery compartment, and then on the
battery compartment side.
④
③

User information
15
Using the attachment clips
Attachment clips are provided for additional xation of the audio processor to your hair
or clothes. Secured xation may be desirable for example during sports activities or for
children.
👪PARENTAL GUIDANCE
Especially for children it is recommended to use the attachment clip in situations
with a risk of the device falling off.
Additional xation of the SAMBA 2 with the attachment clip for clothes (①) or the hair
(②).
NOTE:
Close the battery compartment and hold the battery compartment closed before you
remove the attachment clip from the audio processor.
Maintenance
Your audio processor is designed for durability and reliability. When handled with sufcient
care, it will function for a long time.
Other than replacing the battery there are no serviceable features on the audio processor.
If your device does not work properly, check the section Troubleshooting. If you cannot
solve the problem following the recommended actions in the troubleshooting section,
please return to your audiologist/healthcare professional for advice.
Please have your audio processor checked by your audiologist/healthcare professional at
least every two years.
①
②

User information
16
Cleaning
It is recommended to clean the audio processor weekly or when necessary. The housing
of the audio processor features moisture and dust protection and may be cleaned on
the outside with a damp cloth and mild soap or soft baby wipes. Do not clean the audio
processor in or under water to prevent water from entering.
⚠CAUTION
The audio processor is not waterproof.
Storage, handling and disposal
Store the audio processor in a dry place and protect it from direct sunlight, e.g. by using
the daily case provided. Always remove the battery if you do not use the audio processor
for a long period of time to avoid battery leakage and possible damage to the audio
processor.
If you live in a humid climate or perspire heavily, it is recommended to use a drying kit for
storage (sold separately).
The audio processor must not be disposed of with household waste. You are responsible
for disposing the audio processor by returning it to MED-EL or your local MED-EL represen-
tative.
Compatibility with optional user accessories
• The SAMBA 2 Remote is an optional mobile application (app) which can assist with
switching between simple audio processor settings, as predened by your audiologist/
healthcare professional. The SAMBA 2 Remote app can be downloaded separately.
• SAMBA 2 GO is an optional assistive streaming device which can be used to stream
sound from your mobile device or TV. Additionally, it can assist with switching between
simple audio processor settings, as predened by your audiologist/healthcare profes-
sional. SAMBA 2 GO is available separately.

Troubleshooting
17
5. Troubleshooting
Problem Possible cause Recommended action
No sound No battery inserted Insert a new battery (see section Changing the battery).
Battery empty
Foil covering the battery still
in place
Remove the foil covering the battery (see section
Changing the battery).
Battery inserted upside
down
Check for correct battery position (check polarity, at
side (+) must be on top) (see section Changing the
battery).
Microphone openings or
membranes clogged
1. Change the cover (see section Changing the cover).
2. Contact your audiologist/healthcare professional if
the problem persists. Your audiologist/healthcare
professional can remove any dirt/obstructions from
the microphone openings or membranes.
Loss of electrical connec-
tion due to soiled battery
contacts
Remove the cover (see section Changing the cover),
check visible battery contacts and carefully clean if
necessary. Use a cotton swab and a small amount of
cleaning alcohol. Gently wipe dry after cleaning.
No air ow to battery 1. Wait one or two minutes between removing the
protective lm of the battery and inserting the battery
into your audio processor (to make sure the zinc-air
battery has been sufciently subjected to air).
2. Check the battery compartment if the air vents are
clogged and remove dirt/obstructions.
3. If you cannot solve the problem yourself, contact your
audiologist/healthcare professional.
Device damaged (e.g. by
moisture/shock)
Contact your audiologist/healthcare professional.
Device turned off unknow-
ingly
Turn on the audio processor (see section Switching
SAMBA 2 on/off).
Sound weak Battery low Insert a new battery (see section Changing the battery).
Microphone openings or
membranes clogged
1. Change the cover (see section Changing the cover).
2. Contact your audiologist/healthcare professional if
the problem persists. Your audiologist/healthcare
professional can remove any dirt/obstructions from
the microphone openings or membranes.
Incorrect position of audio
processor
Adjust the orientation of the audio processor on your
implant (see gures in section Placing SAMBA 2 over the
implant).
Volume is turned too low 1. Open and close the battery compartment to reset the
audio processor to the default program and volume.
2. The optional SAMBA 2 Remote app or the SAMBA 2 GO
streaming device could be used to adjust predened
volume or program settings.
3. If you cannot solve the problem yourself, contact your
audiologist/healthcare professional to have the volume
settings adapted to your needs.

Troubleshooting
18
Problem Possible cause Recommended action
Sound too loud Volume is turned too high 1. Open and close the battery compartment to reset the
audio processor to the default program and volume.
2. The optional SAMBA 2 Remote app or the SAMBA 2 GO
streaming device could be used to adjust predened
volume or program settings.
3. If you cannot turn down the volume, stop using the
audio processor and contact your audiologist/health-
care professional to have the volume settings adapted
to your needs.
Fitting program needs
adjustment
Contact your audiologist/healthcare professional to have
the volume settings adapted to your needs.
Audio processor can‑
not be switched on
Battery compartment
blocked
1. Check for correct battery position (check polarity, at
side (+) must be on top) (see section Changing the
battery).
2. Carefully push down the battery when closing the
battery compartment (see section Changing the
battery).
3. If you cannot solve the problem yourself, contact your
audiologist/healthcare professional.
Battery insertion not
possible
Wrong battery type Only use 675 zinc-air batteries (PR44 batteries).
Battery upside down Check for correct battery position (check polarity, at
side (+) must be on top) (see section Changing the
battery).
Audio processor falls
off frequently
Hair over implant too thick Thin out your hair over the implant or, in rare cases,
shave your hair directly under the audio processor to
about 6mm (¼ in).
Magnet too weak Contact your audiologist/healthcare professional.
Skin irritation over
implant
Attachment force too high Contact your audiologist/healthcare professional.
Allergic reaction Stop wearing your audio processor and contact your
audiologist/healthcare professional. Check for materials
of the implant system in tissue contact (see section
Miscellaneous).
Program selection not
possible
Only one program activated Contact your audiologist/healthcare professional.
Electrical problems If all other program selection options listed in this table
fail, contact your audiologist/healthcare professional.
SAMBA 2 Remote app
not working
SAMBA 2 Remote app does
not start
1. Restart your mobile device.
2. Make sure your SAMBA 2 Remote app is up to date.
3. Delete the SAMBA 2 Remote app.
4. Connect to the internet and perform a reinstallation.
5. Contact your audiologist/healthcare professional if the
problem persists.
Distance between audio
processor and mobile
device exceeds operating
distance
1. Bring the mobile device closer to the audio processor.
2. Check broadcast level and select a higher level.
3. Contact your audiologist/healthcare professional if the
problem persists.
SAMBA 2 Remote app not
available in some countries
Contact your audiologist/healthcare professional.