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
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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
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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
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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
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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
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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