Advanced Bionics Slim HP Manual de usuario

Slim HP, Slim HP Mic, Slim HP AquaMic™,

Slim HP Color Caps

CI-5320, CI-5322, CI-5321, CI-7131, CI-7132

instructions for use

English, Français, Español

SYMBOLS TABLE

Labeling symbols and their meanings

Date of Manufacture

Manufacturer

Model number

LOT number

Unique Device Identiﬁer

Type of Protection: BF

Suitable temperature range for transport

and storage

See Instructions for Use

Fragile

Do not get wet

Suitable relative humidity range for transport

and storage

XXXX-XX-XX

Caution (refer to “Cautions & Warnings”

section for further information)

Dispose of in accordance with applicable

national and local regulations

MR Unsafe

IPxx Ingress Protection Rating

Limitations and Contraindications

There are no known limitations or contraindications for

theSlim HPs.

Precautions, Cautions, and Warnings

• This device should be used only by the individual for

whom it is prescribed.

• Do not remove or replace the Slim HP cable from the

sound processor or waterproof wearing solution while

underwater. If the cable becomes accidently detached

during water use, remove the headpiece and sound

processor from the water and dry both devices prior to

re-connecting the cable to the sound processor.

• CHOKING HAZARD: Contains small parts that pose

a hazard of inhalation, choking, or ingestion. If any

parts are swallowed or inhaled, consult a physician or

hospital immediately.

• Do not leave children unattended with or allow children

to play with the Slim HPs or Slim HP Magnets.

• Do not allow children to place the Slim HPs or Slim HP

Magnets in the mouth.

• The large Slim HP Color Cap is for use by recipients

older than 3 years of age, as this color cap and

the Slim HP magnet may become displaced upon

dropping.

• Due to increased risk of strangulation, do not use

cables longer than 81cm (32”) with young children.

• Remove your sound processor and consult your coch-

lear implant professional if uncomfortable sounds are

heard or in case of discomfort, pain or skin irritation.

• Be sure to choose a cable length that does not require

looping or bundling of the cable due to excess length.

• The headpiece must only be used by the intended

person and not by others.

• Do not use a headpiece, magnet, or any associated

part, that is broken, damaged, or cracked.

• The color cap must be attached when the headpiece

is in use.

• Store spare magnets safely and away from cards that

may have a magnetic strip (e.g. credit cards) and from

other spare magnets or headpieces.

• High levels of static electricity may damage electronic

components of your sound processor or implant. Care

should be taken to avoid exposure of the system to

static electricity.

• Use the lowest strength magnet required to ensure

sucient magnetic attraction of the headpiece.

• Contact your cochlear implant professional to adjust

the magnet strength if the magnetic attraction of the

headpiece is insucient.

• If the headpiece magnet is too strong, pressure sores

may develop at the headpiece site. If this happens, or

if you experience any discomfort, irritation, pressure,

or redness in this area, contact your cochlear implant

professional.

• Although electromagnetic emissions of the Slim HPs

have been conﬁrmed within safe limits, some other

devices could be sensitive to such emissions. If you

notice other devices do not behave as expected when

your Slim HPs are nearby, separate the devices.

• The magnetic ﬁeld created by the headpiece magnet

may alter the programming of magnetic shunts. Users

of magnetic shunts should consider o-the-shelf

retention methods.

• In the event that you experience any issues with your

product, please contact your cochlear implant profes-

sional or the manufacturer. Do not attempt to service

or modify the Slim HPs. Doing so may compromise

system performance and will void the manufactur-

er’s warranty. Products should be serviced only at

Advanced Bionics and damaged products should be

returned to Advanced Bionics.

Undesireable Side Effects

Undesirable side eects of your Slim HPs may include skin

irritation and discomfort from pressure on the ear or head,

device overheating, or overly loud sounds.

Product Description

The Slim HP is a headpiece with an integrated cable

designed for use with a sound processor worn on the

ear. The Slim HP is available with cable lengths of

3.5inches/9cm, 4.25 inches/11cm, and 5.5 inches/14cm.

Slim HP with Color Cap

Sound Processor

Connector

Integrated

Cable

The Slim HP Mic is a headpiece with an integrated

12inch/30cm cable and a microphone designed for use with

a sound processor worn o the ear (for example, in a clip).

Sound Processor

Connector

Integrated Cable

Microphone

Slim HP Mic with

Color Cap

The Slim HP AquaMic™ headpiece is a waterproof head-

piece with an integrated cable and a microphone designed

for use with waterproof solutions (e.g., Neptune, AquaCase,

or M Waterproof Battery). The Slim HP AquaMic is available

with cable lengths of 12 inches/30cm, 18 inches/46cm,

24inches/61cm, and 42 inches/107cm.

Sound Processor

Connector

Integrated Cable

Microphone

Slim HP AquaMic

with Color Cap

Cable Clip

The Slim HPs are compatible with the following accessory

products: Slim HP Magnets, Slim HP Color Caps, and the

Slim HP Color Cap Removal Tool.

The Slim HPs contain a magnet well designed to accom-

modate the appropriate Slim HP magnet with appropriate

strength to ensure retention between the cochlear implant

and the headpiece. The Standard Magnets are for use

by recipients of CII, HiRes 90k, HiRes 90k Advantage,

and HiRes Ultra implants. The 3D Magnets are for use by

recipients of HiRes Ultra 3D implants.

The Slim HP Color Cap snaps in place on top of the

headpiece securely covering the magnet well and the

microphone. There are two sizes of Slim HP Color Caps:

Standard and Large. The Standard Color Cap is for use

with the smallest Slim HP Magnets: Standard Magnet sizes

1 through 5 and 3D Magnet sizes 1 through 4. The Large

Color Cap is for use with the largest Slim HP Magnets:

Standard Magnet sizes 6 and 7 and 3D Magnet sizes 5,

6, and 7.

Intended Use

The Slim HPs are intended to transfer sound signals and

power between your Advanced Bionics’ cochlear implant

and sound processor. A microphone embedded in the

Slim HP Mic and Slim HP AquaMic, if enabled, allows the

headpiece to also function as a sound input source.

The intended users of the Slim HPs are users of the

Neptune, Naída™ CI Q, Naída™ CI M, or Sky CI™ M

sound processors. The intended use environments of the

Slim HPs are healthcare and daily living environments.

Compatibility

The Slim HPs are compatible with Neptune, Naída CI Q,

Naída CI M, or Sky CI M sound processors from

Advanced Bionics.

Operating Instructions

Assembly Instructions

To operate your headpiece with your cochlear implant

system you will need to install a Slim HP Magnet and

attach a Slim HP Color Cap, as follows:

1. Insert the Slim HP Magnet into the magnet well of the

headpiece.

a. For recipients using the Standard Magnet, no speciﬁc

magnet orientation is required.

b.For recipients using the 3D Magnet, the magnet

should be inserted so that the arrow on the magnet

points up when the headpiece is on the head.

2. Attach a color cap (See “Color Caps” section).

3. Attach the headpiece and cable to your sound

processor (See “Cables” section).

4. Then place the bottom side of the headpiece over the

internal magnet of your cochlear implant.

NOTE: For recipients of HiRes Ultra 3D implants, if the

headpiece repels or pushes away when brought over

the internal device, rotate the headpiece back and forth

as you move the headpiece closer towards the implant.

Once attraction is felt, adjust the headpiece to the

original orientation and place on head.

NOTE: For recipients of HiRes Ultra 3D implants, when

in a magnetic ﬁeld or when the headpiece is removed,

you may feel the internal components of the magnet

vibrate and/or rotate. This movement is expected as

the magnets are designed to rotate in the presence

of strong magnetic ﬁelds.This movement may be

noticeable and is not expected to be uncomfortable.

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Este manual sirve para los siguientes modelos

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