Medtronic 9767 User Manual 33572
Medtronic, Inc. 33572
8
| Download: |  |
| Mirror Download [FCC.gov] | |
| Document ID | 33572 |
| Application ID | hI3B36PCpuWwUJIT9zKXNQ== |
| Document Description | 8 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 22.62kB (282690 bits) |
| Date Submitted | 1999-04-21 00:00:00 |
| Date Available | 1999-07-02 00:00:00 |
| Creation Date | 2001-06-28 10:33:05 |
| Producing Software | Acrobat Distiller 4.0 for Windows |
| Document Lastmod | 2001-06-28 10:33:08 |
| Document Title | 33572.pdf |
| Document Author: | jsoscia |
9767inst.frm Pagel Tuesday, FMWNQ§M§WTIAL {a
G}
' Th | in!“ a
Medtromcltzzl mm”
Medlronic represenlntlve.
7 Installation
1‘Vlorlcl 97 67/976 7L Instructions
$‘ $ “9
Pam? 197759—001 Rev A
9767inst.frm Page 2 Tuesday, FMEQWNB§WER§FML
About These Instructions
About These Instructions
These instructions explain how to install The Medtronic® Model
9767/9767L for a Medlronic® Model 9790 series programmer
("programmer”).
Note: Please return the Model 9766AID766AL programming
head to Medtronic Instrument Service in the pre-labeled box
provided in the Model 9767197671. package.
Contents of Package
I Model 9767/9767L programming head and TEM (Telemetry
Electronics Module)
I Screwdriver (packaged with the Model 9767/9767”
- Packaging materials for return of Model 9766A/9766AL
programming head (included with 9767 packaging)
- Product literature
Installation Instructions
If your programmer does not have an Analyzer module installed,
follow the instructions in the ”Installing Programming Head
Without Analyzer" section.
If your programmer does have an Analyzer module installed,
follow the instructions in the "Installing Programming Head With
Analyzer" section.
{It
Pam! 197759-001 Rev A
{B 9767inst.frm Page 3 Tuesday, FMW9H55§WWT'AL
Installing Programming Head Without Analyzer
Installing Programming Head Without
Analyzer
The following instructions describe the sieps involved to install
the Model 9767/9767L to a Model 9790 / 9790C programmer with
no Analyzer module installed.
Preparing the programmer:
1. Turn off the programmer, Do not install the programming
head while the programmer is turned on.
2. Remove any cables or accessories from the storage
compartment under the lid of the programmer. Place the
touch pen outside of the compartment as shown in Figure 1.
Note: Do not disconnect the touch pen from the programmer.
3. Remove the lid of the programmer by:
{B a. Squeezing together the tips of the prongs on the right
underside of the lid and push them up, out of the slots
they are in, as shown in Figure 1.
b. Sliding the lid off, disengaging the pin on the left side of
the lid from the socket on the programmer.
4. Remove the partition from the compartment by lifting up on
the front edge of the partition and rocking it back and forth
until it loosens. Discard the partition once it is removed.
5. Disconnect the Model 9766A/9766AL programming head
from the telemetry port in the compartment as shown in
Figure 1.
$ 6}
Pam? 197759-001 Rev A
$ 9767inst4frm Page4 Tuesday, FMEQHQNB§W§JRWTML
Installing ngmmming Head Without Analyzer
Figure 1. Preparing a programmer wlrn no Analyzer.
Installing the TEM:
Q 1. Remove the small screw next to the partition slot located on
the back wall,
2. Place the TEM in the programmer compartment by:
a. Holding the TEM such that the connectorjack is facing to
the right in the compartment.
b. Inserting the TEM so that the raised fin on the top slides
under the programming head’s storage space.
3. Insert the small screw, and secure the TEM in place
4. Connect the TEM to the programmer‘s telemetry port
Connecting the Model 9767/9757L programming head:
1. Connect the Model 9767/9767L programming head to the
telemetry port on the TEMA
2. RE-install the programmer lid.
{E $
PaI1# 197759—001 Rev A
{l} 9767inst.frm Page 5 Tuesday, FNWQ,N5§§WJQEW'AL
Installing Programming Head With an Analyzer
Installing Programming Head With an
Analyzer
The following instructions describe the steps involved to install
the Model 9767/9767L to a Model 9790/9790C programmer with
a Medtronic Model 8090 Analyzer.
Preparing the programmer:
1. Turn off the programmer. Do not install the programing
head while the programmer is turned on.
2. Remove any cables or accessories from the storage
compartment under the lid of the programmer. Place the
touch pen outside of the compartment as shown in Figure 2.
Note: Do not disconnect the touch pen from the programmer
3. Disconnect the Model 9766A/9766AL programming head
from the telemetry port on the underside of the Analyzer
$ module (see Figure 2).
4. Remove the lid of the programmer by:
a. Disconneco'ng the Analyzer module from the
programmer.
b. Releasing the locking bar.
0. Squeezing together the tips of the prongs on the right
underside of the lid and push them up, out of the slots
they are in.
do Sliding the lid off, disengaging the pin on the left side of
the lid from the socket on the programmer.
{l} $~
Pam! 197759-001 Rev A
Q} 9767inst.frm Page6 Tuesday.FMle5§&w5RW1-IAL ‘
Installing Programming Head With an Analyzer
Figure 2. Preparing a programmer wilh an
Analyzer.
Installing the TEM and connecting the 9767/9767L
6} Programming Head:
1. Remove the small screw next to the partition 5101 located on
the back wall.
2. Place the TEM in the programmer compartment by:
a. Holding the TEM such that the connector jack is facing to
the right in the compartment
b. Inserting the TEM so that the raised fin on the top slides
under the programing head's storage space.
3. Insert the small screw, and secure the TEM in place.
4. Connect the Model 9767/97671. programming head to the
telemetry port on the TEM.
5. Reconnect the Analyzer module to the programmer.
6. Replace the Analyzer lid.
7. Connect the TEM to the telemetry port on the underside of
the Analyzer module.
{1} 69-
Part# 197759001 Rev A
Q} 9767instfrm Page7 Tuesday, FMEQWN5§§WERWT'AL
Installing Programming Hmd With an Analyzer
This completes the Model 9767/9767L programming head and
TEM installation procedure. The programming head and TEM are
now prepared for use as described in the Model 9767/9767L
Technical Manual.
$ 6}
Part# 197759-001 Rev A
l'fCC/MlLON “mg mg
MEDTRONIC CONFIDENTIAL ACCHEMLfRS
Q} 9767ee.bk : 9767eeAfcv Page 1 Tu+d®February 23, 1999 10:02 AM
9767 Technical
976 7L manual
Programmlng head
$ 03mm. Fedsmuaw (USA) msmcrs this device to $
sale by man the amino/a physician
Invanigwmal device
69 @
Pam: 197372-001 Rev A
MEDTRONIC CONFIDENTIAL AccRGMLFRs
Q} 9767ec.bk : 9767ee,fcv Page 2 Tu+dێfebruary 23, [999 10:02 AM
Cut/Non: Investigations! device. Limited by
Fads/e! Ls w (u A) la invesrr'gnlinnel use,
This produc'is mar shipped in 1 mm stale,
Exclusively for Elm/cal lnvasflgm'ms
$—
Pam! 187372-001 Rev A
MEDTRONIC CONFIDENTIAL ACCHSMLFRS
G} 9767ee.bk : 97673easym Page iii T e$ ,February 23, 1999 10:02 AM
EXPLANATION OF SYMBOLS ON
PACKAGE LABELING
& Road Inswaion manual
prinrln usa
E Yype a; Equipmam.
m“ m: symbol maamlhalme
"-® davica m Iisiad m npplimbla
us and Canadian eatery
summit by Underwriters
[summaries Inc.
fl Manufacturing Dela
5“ serial Number
Q fax $
A Q1» CAUTION: n—us CONTAINS
"' A STRONG MAGN Er.
PHOXIMITV TO MAGNETIC
asconnwe TAPE AND
DISKS SHOULD as
AVOIDED.
CAUTION: DO NOT
9 UNPLUG DEVICE WHILE
THE POWER IS ON.
6} 6} <9—
Ffirw 197372-001 Rev A
MEDTRONIC CONFIDENTIAL ACCRGMLFRS
G} 9767ee,ch Page 1 Tuesday.Febru @_ 1999 10:19 AM
Description/Intended Use
The Madironico/Wlairun” Model 9757/
9767L consists oi two components: the
programming head and the Talemeiry
Electronics Module (TEM).
The use oi me Model 9767/9767L Is
necessary for all programmer iuncrions
ihai require programmlng or iniarrogafing
operations. The Model 9767/9767l.
provides the communication [Ink between
the Msdironlclvliatron Model 9790/
97900m programmer and a Medironic or
Vliaimn implanmbls device.
The Model B787/9767L programming head
and TEM are under clinical inves1igailon,
The procedures for using the lead as well
as It‘s salary and eificaby. will be evaluated
during ihis Invesilgetlcnal study according
to the clinical Invssflgaflonal pmiecol.
Therefore. ihe ‘lnstrueiions lor Use”
seclian is based on Medlmnic's
experience with similar devices. No claims
lor salary and elieciiveness can be made
ior the Model 9767/9767L programming
head and TEM during clinical evaluation.
Pailenis should be advised by lheir
physician that the Modal e7s7/97s7L
programming head and TEM are under
clinical investigation,
69 {l} {l}
Pam! 197372-001 Rev A
MEDTRDNIC CONFIDENTIAL ACCRsML.FR5
Q} 9767ee.ch Pagez Tuesday, Febru $ 1999 10:19AM
The programmlng head and TEM (see
Flgura 1] m Inslde the Model 9790/9790:
hum garage comparrmam.
9767/97G7L
7 programming
bead $
Figure 1, Mortal 9767/9767L programming
head and TEM
None: The 9757/9767L programming
head can be USN-1 only with me TEM.
The programmrng head contains a
permanent magnsl, a radio frequency (RF)
(mnsmlnsv and rscewer, and a light array.
The pmgmmmmg head mus\ be held over
(he implantable dsvlcs during a
programming crlmarrogaflng opsraflon,
T} a a?
Part“ 197372-001 Rev A
MEDTHONIC CONFIDENTlAL ACCRBML.FH5
Q} 9767ce.ch Page 3 Tuesday, Febru @ 1999 10:19 AM
The TEM is connedsd in the programmer
by a table and resides Inside the
programmer‘s rronr companment.
The Model 9767/9767L Is oompaiible will‘l
all versions Ol (ha Model 979057901:
programmer.
Package Content:
Model 9757 (slandard cable laugh) and
Model 97s7L (long cable length):
One Model 9767 programming head
one Teiemelry Electronics Module
Ons Phillips screwdriver
Documsnieiion
$ Precautlons $—
Check the package prior re use. Damaged
devices should be rammed to Mediwnic.
I Do not expose the programming head
or the TEM to storage temperatures
abuvs 70 ”C (158 “F) or below 40 “C
(40 ”FL
- Do nor posrrian the programming head
over an impianied device during
elscirocautery or enamel dsiibrillfllion
procedures,
- Do nol auloclave [he pmgrammlng
head or lha TEMA
69 G} $
Pam? 197372-001 Flev A
MEDTRONIC CONFIDENTIAL ACCRfiMLfRE
6} 9767e,e.ch Page 4 Tuesday, Febm éég 1999 10:19 AM
I Keep me pmgnamming head away
from any device or material Ihal wlil be
damaged by their magnetic fields.
I The TEM cannot be s|sri|ized.
- The programming head contains a
magnet. Proximity to magnetlc
ramming laps and disks should be
avoldsd.
I This device has been tested lor
compliance lo FCC regulations.
Changes or modifications oi any kind
not expressly approved by Mechanic.
Inc. or Walton Inc. could void Ins
ussl‘s aulhorilyto operate lhis device.
6} Sterilization Q}
Clullon: To sterilixe the programming
head. diswnnect H from me TEM by pulling
its oennecling cable out at the lack on (ha
rlghl side cl tlre TEM unil.
The programming neau may be slallllzed
by a vaiidaled alhylene axids gas
stanlizalion method at tempelalums not to
exceed 55 “C (130 °F), Bunglcal controls
should be used to ensure Ihal proper
s‘tarililalifln standards have been met.
6} $ $
Pan» 1973724101 Rev A
fl}
MEDTRONIC CONFIDENTIAL ACCHEMLJHS
9767ee.ch Page 5 Tuesday, Febru
Due to the valiabillly between slenllzers.
preclse slerlllzmlon Inslmcllons cannot be
providedA Conlacl your sterlllzer
manufacturer for more lnlormalion
regavding slerllizefion procedures
clunlng ma Programmlng Mud
Use a brush and 3 mild detergent,
enzymallc cleaner. or 70%Isopropy1
alcanol to remove all visible mnlamlnanls.
Completely dry me pmgrammlng head
munch: The pmgrammlng heed must not
he autucleved.
Instructions For Use
Verify that me Model 9767/9767L
programming head and TEM have been
connected lo me pmgrammer by pullmg
Ilghlly on Ihs TEM cable's mam!
oonnectlng heed, Tna connscflng head
should not move at all. Once counseled.
the TEM cable canno! be removed without
squeezing in the studs on the two sides 0!
lhe melel connecting head.
Par" 1973727001 Rev A
@ 1999 10:19 AM
~$
MEDTRONIC CONFIDENTIAL ACCHSML.FR5
a} 9767ee.ch Page 6 Tuesday, Febru $1 1999 I0:19 AM
For an Implantable Gel/11:9, the
programming head should be held directly
agains1 the patients skin. The face of lhe
programming need mus! be parallel to and
Iyplcally wllhIn Iwo lnchas (5 mm) of lhe
implanted device. The opilmum position or
the programming need my not be direclly
centered over the implements devlce.
Position the programming need over (he
implanmhls device (see Figure 2) before
Inlllaling a programming transmlsslon, a
dale Irensmlsslcn irom (he implantable
device, or a measurement runclton.
Posmonlng ins programming head is
required for any Interaction between the
Q} pregrammer and me implantable device Q,
The programming head should be held In
iriis position untii lne operation Is
completed,
@ a} $-
ParNI 197372-001 Rev A
MEDTRONIC CONFIDENTIAL ACCREML.FH5
a} 9767eerch Page 7 Tuesday, Febru a; 1999 10:19 AM
a} Figure 2. Positioning [he Model 9767/ Q}
97S7L
The P and I buttons on me programming
head correspond Io commands mat
appear on the dlsplay screen or me 9790/
97901: programmer. ReIer Io (he
approprlats software manual to dalermme
which commands the buttons correspond
to (see Figure 3).
a} a} 3
Panic 197372-001 Rev A
MEDTRONIC CONFIDENTIAL ACCRGMLFH5
Q} 9767ee.ch Pages Tuesday, Febru é; 999 10:19 AM
Figure 3' F and I burruns
Any Iemporavlly pragrammed state or
fundlon wlll remaln ln efleci as long as (he
pragmmmlng head is held in place (warms
{B implanled devlce. Lming Ihe programming ‘Q
head cancels a lemporery program and
lerminales any eontlnuous telemetry (such
as Marker Channel telemetry or EGM
wevelorms). Upon removal of the
pmgrammlng head. ma implanlabla devlce
rel/em lo permanermy programmed
values,
Be aware that me magnet In the
programming head may amact metal
inslmmems 01 attach "59" to metal
surfaces.
6}
Farm 197372-001 Rev A
MEDTRONIC CONFIDENTIAL ACCRGML.FR5
Q} 9767ee.ch Page 9 Tuesday, Febru Q; 1999 10:19 AM
Thu hllwlny lelled Warranty‘
Applln to United Shun Customers
Only:
A. Thls leiled warrenly prources me lollcwrng
assurance to me purcnsser or me Model
9757 or wan. pmglammlng need,
hareaher relerree m as me 'Equiprnanr':
1. Should ma Equlpmem rail rp runmlon
wimin normal lolernnm cue lo s
691331 In makedals er wnrkmanshlp
wirrrin a panpd or one year,
commencing wrm me dellvary cl me
Equlpmsm to ma purchaser.
Medlmrric will at us option: (a) repair
or mplace any pan or pans DI lhe
Equipment; (p) issue a creclr lo ma
purchaser equal to ma Purchase
Prlce, as calmed ln Subsection A(2).
agalrm me purchase 0! ma
replacemenl Equrpmem or (c)
provide a luncrlonally comparable
replacement Equlprnenr al no
charge.
' Thls Lxmilnd Warranty Is provided by
Mldlrofllc‘ Inc” 7000 oenlrel Avenue N.E..
Minneapolis MN 55432, It appllea only in ma
Unlled sralas, Areas cmslee mu Unlled Slates
smuld comm melr local Mealrcnic
rapresanlallve rm exad (ems or me Llrnlred
Warramya
6} {9 Q}
Pam! 197372-001 Rev A
MEDTRONIC CONFIDENTlAL ACCRGMLJRS
$ 9767eeich Page 10 Tuesday, Febr 3, 1999 10tl9 AM
2. As used narein, Purwflse Face mu
main me lesser 0! (he nel invflioed
price oi me original. ur curler“
functionally cumparable, or
replacamen! Equipmem
BA To qunmy for me iepaii, mpiacemefll or
man sat mm In swam A the iuiiowing
Condilions mus1 he met“
I. The Equipmeni musi be rammed in
Madman": wimin an flays anei
discovery 01 me detect. (Mammnii:
mayv ll its option. repair m
Equipmsm an siia).
z, The Equipmam musmoxmwe been
rsp-ivsd or anemd uniside oi
Memronic'e 1mm in any my which,
6} in me iuagmani ui Medironic, afisms _$_
its mbiiiiy and isihbiliiy. The
Equipment must rim have been
subjaued io misum anus: ur
socidem.
c. This Limiisd warramy is llmnsd to Its express
terms, In particular
10
79 {9 es»—
Pam‘ 197372—001 Rev A
MEDTRONlc CONFIDENTIAL AccnsMLFns
$ 9767ee.ch Page 11 Tuesday, Feb 3, 1999 10:19 AM
1. Excepl as sxvressly provided by (Ms
Umlxm Warranty, MEDTRDNIC IS
NOT RESPONSIBLE FOR ANY
DIRECT, INCIDENYM. OH
CDNSEWENTIAL DAMAGES
BASEDONANY DEFECT. FAILURE
OR MALFUNCHON OF THE
EQUIPMENT. WHETHER THE
CLAIM IS BASED ON WARRANTV,
CONTRACT, Tom on
CTNEHW‘SE
a. 1m Umlled Wunanly u made only to
(he pumnaw av lhe Equipment. AS
To ALL OTHEHS‘ MEn'momc
MAKES NO WARRANTY
EXPRESS on IMPLIED.
momma, BUT NOT LIMITED
To, ANY IMPLIED WARRANTY OF
MERCHANTABILITY, on FTTNEss
FOR A PARflCULAR PURPOSE
WHEI'HER ARISING FROM
STATUTE, COMMON LAW.
custom on OTHERWISE. ND
EXPRESS on IMPLIED
WARRANW To THE PATIENT
SHALL EXTEND BEYOND THE
PERIOD SPECIFIED 1N Au)
ABOVE THIS LIMITEDWARRANTV
SHALL BE THE EXCLUSIVE
REMEDY AVAILABLE TO ANV
PERSON,
11
{I} ® 6}
Farm 197372001 Rev A
MEDTRONIC CONFIDENTIAL ACCHUMLFRS
$ 9767ce.ch Page 12 Tuesday, Feb 3, 1999 10:19AM
3 The exMusicns and limitations 591 out
above an nolimsndsdlo,am1
should not be construed so is ID
ccnlmvane mandalory pmvlsIons m
appficuble law. u any pan or 02m 01
mm meitsd Warranty is held (0 be
"leg-J. unenforceable m m mnflict
wun awlicams law by a noun or
mmpelanl |unsuicnon Iha many 01
me lemammg Demons oi the Lim‘led
warmmy Shall not be awsmsd. and
all lIghE and obligations sh!“ be
wnstrued Ind enforced as H Ibis
umnm Wanamy in not contain ms
pamcular pan of him held lo ha
Invalid. ThIG Limilad Wammly g‘ves
ma purchaser ammo legal nng,
The purchaser may also have other
<6} nghls which van/1mm sms m slaIe. $
4. No person has any amnenvy (a bind
Madtmnlc Io any repvasenlafiofl,
onndilim 07 Warranty except this
lenw Warramy.
12
$ 6} $
Per“ I97372—DOI Rev A
G}
{B
MEDTRONIC CONFIDENTIAL AccnsML.FR5
9767ee.ch Page 13 Tuesday, Feb:
Th. followlng leltvd W-rumy Applies
m Cunnmerc Oumd- flw Unllzd
Sm“:
A. This LIMITED WARRANW plovldas me
lolluwlng assurance In ms pumhassrolms
Mnflsl 9737 m 9757L progmmmlng head.
hereanal rafelled m as me 'Equipmefl|'.
mar should ma Equlpmem mil to lunmlon
wllnln llama! lolemncss due la a calm in
malerlalsorworkmansnb wmllna pennu cl
nne yeah commenu'rlg wilh the salivary at
me Equipment mule purchaser, Memmnic
or vnalmn will a| Inelr upfiorl: (a) repair or
revues any defective pan or puns nl me
Equlpmenl; (b) issue a msdll squal to me
ollglnal Equbmam purchase pllce (bur mu
to exceed me valus cl ma mplacemefll
Equlpmenr), ngalllsl we purchase 01
mpiacamam Eqmpmem. or (c) erIde
1unc1llmally wmpnmhle replacement
Equipmunl al no chalgo,
5. Yo qualllylor lm; repair, rsplacemem or
cledlL Thu lullnwmg commons musr be
ml:
l. The Equipment must be rammed lo
Medtmnic urV'naImn within mmm)
days anardwcvely cl llle delem.
(Medlrollic nr Vihlmll may, al men
nation, rspaillha Equlpment on slle).
13
Pan” 197372—001 Rev A
3, 1999 10:19AM
{B
MEDTHONIC CONFIDENTIAL ACCREML.FH5
q} 9767ee.ch Page 14 Tuesday, Febr 3, 1999 10:19 AM
2. The Equlpmenl mus! nol have been
repaired or altered by snmeons orner
lhan Memronrcnrwlalron in any way
whluh, ln lne judgmam cl Medmmic
w Wallon, afiecls it slanilrty and
mllahilny
a The Equipment must not have been
summed to misuse, abuse or
amruent.
c. This UMITED WARRANTV is Ilmned lo lrs
express lanrrs ln particular, Mennonlc nr
Warren ll nor rsspnnsihla lorany
rncraenlal ur cansequenllal damages
based on any use, defect at lnilure 0! me
Equlpmant, whether IM claim Is based on
warranty, connacl, ion or umerwlser
{B D. The exclusions and Ilmllaflons sel errl above Q}
are nul Inlendufl lo, and should not be
oonslrued so as an conrravene mandatory
pmvlsims ol applicable law ll any pan or
larm or this LIMITED WARRANT! is held
by any calm cl campslsnl jurisdiction to in
illegal, rrnenlnrccnnle or In conflict wim
nppllcnbla lawr mevalrally tha remainlng
parlion ol lna LIMITED WARRANTV snall
nor be Mensa and all nglrrs and
culgan‘nns snarl be canmad ma
enlolced ls ll (hls LIMITED WARRANTV
am nol conrar'n lne pamcular pan or Ierm
had ll) be invalki
14
Farm 1973724101 Rev A
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.3 Linearized : Yes Create Date : 2001:06:28 10:33:05 Producer : Acrobat Distiller 4.0 for Windows Author : jsoscia Title : 33572.pdf Modify Date : 2001:06:28 10:33:08-04:00 Page Count : 24EXIF Metadata provided by EXIF.tools