Warnings and Precautions Warnings

Warnings and Precautions This document describes the warnings and precautions that apply to your
cochlear imp lant system. Read this document carefully to ensure that you
understand the care of your system.
DIscuss these warnings and precautions with your physician before undergoing
any major medical procedure.
Warnings
Medical treatments generating induced currents
Some medical treatments generate induced currents that may cause tissue
damage or permanent damage to the cochlear implant Warnings for specifiC
treatments are given below.
Electrosurgery: Electrosurgical instruments are capable of inducing radio
frequency currents that could flow through the electrode array. Monopolar
electrosurgical instruments must not be used on the head or neck of a
cochlear Imp lant patient as induced currents could cause damage to cochlear
tissues or permanent damage to the implant Bipolar electrosurgical
instruments may be used on the head and neck of patients, however. the
cautery e lectrodes must not contact the implant and should be kept more
than I cm or Y:2 in. from the extracochlear e lectrodes.
Diathermy: Do not use therapeutic or medical diathermy
(thermopenetration) using electromagnetic radiation (magnetic induction coils
or microwave) . High currents induced into the electrode lead can cause tissue
damage to the cochlea or permanent damage to the implant
Medical diathermy using ultrasound may be used below the head and neck.
Neurostimulation: Do not use neurostimulation directly over the cochlear
implant High currents induced into the electrode lead can cause tissue
damage to the cochlea or permanent damage to the implant
Cochlear
Electroconvulsive Therapy: Do not use electroconvulsive therapy on a
cochlear implant patient under any Circumstances,
Electroconvulsive therapy may cause tissue damage to the cochlea or
damage to the cochlear implant
Ionizing Radiation Therapy: Do not use this therapy directly over the
cochlear implant because it may cause damage to the implant
Magnetic Resonance Imaging (MRI): Magnetic Resonance Imaging (MRI) is
contraindicated except under the circumstances described be low. Do not
all ow a patient with a cochlear implant to be in a room where an MRI
scanner is located except under the following special circumstances,
The N ucleus® 24 cochlear implant and some N ucleus® 22 cochlear implants
have a removable magnet and specific design characteristics to enable it to
withstand MRI up to 1.5 tesla, but not higher.
For patients w it h a Nucleus 22 cochlear implant without a removable
magnet. MRI is contraindicated.
If uncertain, to verify that the patient has a Nucleus® cochlear implant with a
removable magnet, the physician should use an X-ray to check the
radiopaque lettering on the implantThere are three platinum characters
printed on each implant If the middle character is a 'C', 'H', 'j', 'L', 'P', T, '2', '5'
or '7' the implant has a removable magnet
The magnet must be surgically removed prior to undertaking M RI as tissue
damage may occur if the recipient is exposed to MRI with the magnet in
place.
The patient must take off the speech processor and headset before entering
a room where an MRI scanner is located,
The quality of MRI w ill be affected by the metal in the cochlear implant
Image shadowing may extend as far as 6 cm or - 2 y" in. from the implant.
thereby resulting in loss of diagnostic information in the vicinity of the
implant
If you require addrtional information about removal of the magnet. please
contact Cochlear.
Meningitis
Prior to implantation, candidates should consult their primary care physician and
implanting surgeon regarding vaccination status against organisms that cause
meningitis. Meningitis is a known risk of inner ear surgery and candidates should
be appropriately counsel led of this risk. In addition, certain preoperative condI­
tions may increase the risk of meningitis w ith or w ithout a cochlear implant.
T hese conditions incl ude Mondini's syndrome and other congenital cochlear
malformations, concurrent CSF shunts or drains, recurrent episodes of bacterial
meningitis prior to implantation, perilymph fistulas and skull fracture/defect with
CSF communication.
Loss of residual hearing
Insertion of the electrode into the cochlea will result in complete loss of residual
hearing in the implanted ear
Long-term effects of electrical stimulation by the
cochlear implant
Most patients can benefit from electrical stimulation levels that are considered
safe, based on animal experimental data. For some patients, the levels needed to
produce the loudest sounds exceed these levels. The long-term effects of such
stimulation in humans are unknown.
Small parts hazard
Parents and caregivers should be counselled that the external implant system
contains small parts that may be hazardous if swallowed or may cause choking if
inhaled.
Battery ingestion
Batteries can be harmful if swallowed. Ensure that batteries are kept out of reach
of young children. If swallowed, seek prompt medical attention at the nearest
emergency centre.
Head trauma
A blow to the head in the area of the cochlear implant may damage t he implant
and result in its failure. Young children who are developing their motor skills are
at greater rISk to receive an impact to t he head from a hard object (e .g. a t able or
chair).
Warnings and PrecCl
Precautions If you experience a significant change in performance or the sound
becomes uncomfortable, turn off your speech processor and contact your
implant centre.
This document describes the warnings and
cochlear implant system. Read this docume
understand the care of your system.
Use the cochlear implant system only with the approved devices and
accessories listed in the manual.
DIscuss these warnings and precautions wi1
any major medical procedure.
The speech processor and other parts of the system contain complex
electronic parts. These parts are durable but must be treated with care. The
speech processor must not be opened by anyone other than Cochlear's
qualified service personnel or the warranty will be invalidated.
Each speech processor is programmed specifically for each individual. Never
wear another person's speech processor or lend yours to another user
Using another person's speech processor may result in uncomfortably loud
or distorted sounds.
Do not operate the speech processor at temperatures above +40° C or
+ 104° F or less than +5° C or +41 ° F.
Do not store the speech processor at temperatures above +50° C or
+ 122° F or less than -20° C or _4° F.
The speech processor sound quality may be intermittently distorted when
you are within approximately 1.6 km or I mile of a radio or television
transmission tower The effect is temporary and will not damage the speech
processor
Theft and metal detection systems
Devices such as airport metal detectors and commercial theft detection
systems produce strong electromagnetic ~elds. Some cochlear implant
recipients may experience a distorted sound sensation when passing
through or near one of these devices. To avoid this, turn off the speech
processor when in the vicinrty of one of these devices.
The materials used in the cochlear implant may activate metal detection
systems. For this reason, recipients should carry the Cochlear Implant
Patient Identi~cation Card wrth them at all times.
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Warnings
Medical treatments gener
Some medical treatments generate inducec
damage or permanent damage to the coch
treatments are given below.
Electrosurgery: Electrosurgical instrume
frequency currents that could fiow throu
electrosurgical instruments must not be
cochlear implant patient as induced cum
tissues or permanent damage to the imp
instruments may be used on the head ar
cautery electrodes must not contact the
than I cm or Y2 in. from the extracochle,
Diathermy: Do not use therapeutic or n
(thermo penetration) using electromagne
or microwave). High currents induced in1
damage to the cochlea or permanent da
Medical diathermy using ultrasound may
Neurostimulation: Do not use neurostir
implant High currents induced into the e
damage to the cochlea or permanent daJ
Electrostatic discharge
A discharge or static electricity can damage the electrical components or
the cochlear implant system or corrupt the program in the speech
processor
If static electricity is present (e.g. when putting on or removing clothes
over the head or getting out of a vehicle), coch lear implant recipients
should touch something conductive (e.g. a metal door handle) before the
cochlear implant system contacts any object or person .
Prior to engaging in activities that create extreme electrostatic discharge,
such as playing on plastic slides, the speech processor and headset should
be removed . Clinicians should use an anti-static shield on the computer
monitor when programm ing a cochlear implant recipient.
Mobile telephones
Some t ypes of digital mobile telephones (eg GSM as used In some
countries) may interfere w it h the operation of the external equipment. As
a result, cochlear implant recipients may perceive a distorted sound
sensation when in close proximity, 1-4m or 3-12 ft, to a digital mobile
telephone in use .
Air travel
Some airlines request that passengers turn off electrical equipment, such as
laptop computers, during take-off and landing or whenever the seat belt
sign is iliuminated.Your speech processor is a computer and thererore it
should be turned off when such a request is made You should notify airline
personnel of your hearing impairment so they can alert you to safety
measures.
Co chi... Ltd (ABN 96 002 618 073) 14 Mars Road. Lane Cove N5W 2066. Australia Te l: 6129428 6555 Fax: 61 294286152
Cochlea,. Ame,.icaJi 400 Inverness Parkway. Suite 400, Englewood CO SO 112. USA Tel : I 3D] 790 9010 Fax: I 3037929025
Cochlea,. EUI'"ope Ltd 22-24 Worple Road, Wimbledon, London SWI9 4DD. United Kingdom Tel: 44 20 8879 4900 Fax: 44 20 8946 9066
Cochlea,. AG Margarethenstra.5se 47. CH - 4053 Basel, Switzerland Tel: 41 61 2050404 Fax: 41 61 2050405
Cochlear GmbH Karl-Wiechert-All ee 76A. D-30625 Hannover, Germany Tel: 49 511 542 770 Fax: 49 5 II 542 7770
Niho" Cochlear Co Ltd Ochanomlzu-Molomachi 8ldg, 2-1-7 Hongo. Bunkyo·Ku. Tokyo II 1-0011. Japan Tel: 81 ] ]8170241 Fax: 81 ]]8170245
Cochlear (HK) Ltd 2 J F Shun He Tower. 24-30 Ice House Street. Central. Hong Kong Tel: 852 2530 577) Fax: 852 2530 5183
www.cDchlear.com
Printed in Australia
Nucleus is a registered trademark of Cochlear Limited.
N95408F 1552
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