Disclaimer Of Warranties - Cochlear INERAID Owner's Handbook Manual

that it cou ld lead to meningitis. This is why it is
important that you visit your physician if you suspect
an infection.
Electrical Stimulation
Animal studies have revealed some bone growth
around stimulated electrodes implanted in the
cochlea. However, patients with cochlear implants
have not complained of decreased heanng ability
which could be attributed to bone formation .
Theoretically, electrical stimulation may result
in nerve degeneration; however, this has not been
measured or observed in any patients.
Less than 1 o/o of the single-channel cochlear
implant patients have reported dizziness or failure of
muscular coordination when the implanted elec-
trod es were stimulated. None of the patients using
the INERAID artifi c ial ear have reported th is
condition.
Tinnitus
Electrode insertion and stimulation may cause
inner ear trauma which cou ld result in tinni. t us
( ring ing in the ears).
Electrical Discharge
Risk of electrical discharge has been minimizep
by circuit design. Many electrical components wou ld
have to fail simultaneously. If this occurs, you would
hear a loud sound and should quickly pull the break-
away connector to disconnect the sound processor.
Damage to Percutaneous Pedestal
There is the possibility that a sharp blow to your
head may break the pedestal. A broken pedestal
may need to be surgically removed .
WARNINGS
Except for c hanging batteries, you should not
open the sound processor or attempt to alter any of
the internal control settings or components. There
are no user servicab le parts inside and all servici ng
should be referred to Symbion, Inc.
Do not continue to wear the artificial ear if it is
not working properly. This cou ld result in further
damage. ·
No attachments or cables other than those pro-
vided by Symbion , Inc. should be used with the
. I
(
t
artific Ia I ear.
The sound processor shou ld not be used if there
is obvious damage. It should not be used for any-
thing other than its intended purpose.
DISCLAIMER OF WARRANTIES
The INERAID artificial ear is a medical device
wh ich has been granted an exemption, as an investi-
gational device, by the Food and Drug Ad ministra-
tion. Although Symbion, Inc., the manufacturer of
the INERAID artificial ear, has utilized great care in
developing and manufacturing the INERAID arti-
ficial ear, it can not make any warranties of any kind
concern ing the performance of the artificial ear
because of the technically complex nature of the
device. and because the performance of the device
will be dependent upon the med ica l condition of
each individual user.
SYMBION WARRANTY POLICY ARTIFICIAL HEARING PROD UCTS
Symbion Inc. has exercised reasonable care In the choice o l materia ls and ma nu-
facture o f th ese produ cts Symbion excludes all warr
anues except those specifically
trsted , whether expressed or imp lied by operat10n ot taw or Otherwise. 1nctud1ng, but
not hm+ ted to , any IIll plied warrant1es or merchantabili1y or l 1 1 ness Symbion, Inc
shall not b e liable tor a ny inetdental or consequential toss, d amage or expense.
directly or Indirectly. arising
f rom
the use of these products Symbio n. Inc l'letther
assumes nof a uthonzes any o ther p erson to assume for II, any other or add1tiona l
liabili ty o r r esponsibility In connection w1th lh1s d evi ce
Th
l$ policy is ett eclive
beg•nn.ng
December 1. t
985-
SPECIFIC WARRANTIES
$ymb10n, Inc . wa rra'lls the following products to be free from defects In matenals
and workma nshjp lor th e peuod spec+fi ed
500504 Ea r hook Assembty
Nt A
All
System
Cabl ~
500534 Sound Processor
500703 Electrode Analyzer
500702
Ph on ix Interface
500704 lEA Test Lo ad
6 Mor11hs
6 Months
12 Months
12 Months
12 Months
12 Months
All warrant y periods are from the date of purcha se ln U1e e11ent o r a d efect In
maten als o r workmansh•P, Symbio n, Inc. Wtll. at ils opbon , 81ther reptac;:e or rep a•r at
no charge any defect no t resul ting from misuse or s.buse. No warranty considef'ation
will be given on parts showing
e>-~ idence
of ta.mpenng or d isassembly Fo r p rompt
serv•ce return produc:1s to: Symbion. Inc., 82 5 Nort h 300 West, Salt Lake
Clty.
Utah 84103. (800) 654·7400
Products must be securely wrapp ed, sent p repal a and ln eu red . Ple ase enclose a
note descnbtng the problem
RETURNED GOODS POLICY
Authorlzatlon mus t be rece1ved from Symbion, Inc., or one of + 1 8 dealers p rior to the
return of merchandise. Me rchand1se r et urned must haYe all man ufac turer 's seal s
Intact and be received within 60 days of date of ll'lVOice to
be
eligib le for credit o r
replacement. Retu rned p roducts may be subrect to a res tockln g ch arge
E xpuat.ton Da te 10·31-87
r.
symbion,inc
825 North 300 West· Salt Lake City, Utah
841
03
(801) 531 -7022
·Telex:
453 230
· Fax:
801 531 6296
TDD/ TlY (801) 359-1656
Part Number 940001
SY'v1 2·86 ' 250