Professional Documents
Culture Documents
Video Gamera
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English
stryker' PROIOTYFE
Stryker E[doscop,r'
5.li[) Opticd Court
Sulose, CA e51-18LISA
I {08 :5.1 2L(r0,I 80il 624 {{:2
ww-slryker:com
It Warningsand Gautions
SymbolDefinitions
................EN-3
n
.............
EN-s
il CameraHead .........
C-MountCoupler
............
EN-g
EN-10
Operation Instructions
....EN-16
EN-18
I; Usingthe ConfigurationMenu
ControllingRemoteVideoAccessories
EN-21
EN-21
n
Usingthe SFB Seriallnterface EN-22
Usingthe DVI FiberOutputs EN-22
the
Operating Camerawith a LightSource EN-23
il Troubleshooting EN-24
; EN-T
Gleaningand Sterilization ........FN
')l il
Console
theCamera
Cleaning ..."..'....'
FN Warnings and Gautions
Cleaningthe CameraHead
Disinfectingthe Camera Head I N ;,ll
T Pleaseread this manual and fclllowits instructionscarefully.The words warning,
caution, and note carry specialmeaningsand shouldbe carefullyreviewed:
theCameraHead
Sterilizing I l.l ;'1l
UserMaintenance lN,ll
il Warning The personal safety of the patient or physician rnay be
involved. Disregarding this information could result in injury
Technical Specifications lN :t: to the patient or user.
ElectromagneticCompatibility lN il'l
llll
il Caution Specialserviceproceduresor precautionsmust be followed to
avoid damaging the instrurnent.
Warranty '..'-...EN easieror impottant
to makemaintenauce
S e rv i c e a nd Gla im s .............. il
. . . . . . . . . E N-3 9
Note Specialinformatiot-t
informatiot-tmoLeclear.
An exclamationmark within a triar.rgleis intendedto alertthe
userto thc prlesence of irnportantopelatingand rlaiutenatrce
instructionsin the literatureaccolnpallyingthe product'
;
A lightning bolt rvithin a triangleis ir-rterldedto warn of the
F
prcsenceofhazardousvoltage.Re1'er all service1oauthorized
oersonnel.
F
il
Warning IMPORTANT SAFETY NOTICE: Before operating this device,
pleaseread this operating rnanual thoroughly and carefully'
When using this device with a light source' fire and/or severe
injury rnay result to the patient, user or inanimate objectsif
the instructions in this rnanual are not followed. All light
sourcescan generatesignificant amounts ofheat at the scope
tip, the scopelight post, the light cable tip, and/or near the
1il light cable adapter. Higher levels of brightness frorn the light
source result in higher levels of heat. Always adjust the
brip;htnesslevel of the calnera and the rnonitor before
acljusting the brightness level of the light source. Adjust the
til trrightness level of the light source to the minirnurn brightness
necessaryto adequately illurninate the surp;icalsite' In
trr
and therefore rnay still result in fire or burns to the patient,
user, or inanirnate objects. alreadylisted,other symbolsfounclon the
In additirxt to the cautionarysyrnt:rols
l188HD Carneraand in this manual have specificmeaningsthat clarifythe
Warning To avoid potential seriousinjury to the user and patient, and/
or darnageto this device, the user rnust: properuseand storageof the 1l88IID Camera.'l'hefollowinglist definesthe
t
shipr-ucnt.If danrageis detecfed,rcl'crto thc "Serviceand Claims"
sectiorlof this rnanual. humidig ratir-rgs
Operatir-rg
{
2. Readthis operatingmanualthoroughly,es1; -i,rllythc warnings,and be
3.
familiarwith its contentsbelbreconuectingand usingthis cqr.riprucnt.
knowledgeof thc uscof tlris
Be a qualifiedphysician,havingccurrplete
f ()peralri'
i pr essurreat ir r gs
equlpment. tl
a
4. l'est this equipmcntprior to a surgicalprocedure.This unit was fully
tI ratings
0peratingtemprcrature
t
- /a
testedat the factorybefbreshipment.
5. Avcliddissenbling arrypart of the camerahead,as doing so may break
I i)enotescomplianceto (IAN/CSA C22.2No 601.1-M90ar"rd
6.
the seals,causingleakageand/orelcctricshock.
Avoid rerloving coverson the control unit, as doing so may cause
I
I
b
'."X';' tJL60601, 1.
lr
7. n<ltspeci[ically
Attemptno internalrepairsor adjustments in
clctirilcel
this operatingntanual.
tt.
9. catt
Neversterilizethe cameraconsolc,lrccauscthc delicateelectronies
i rt l l ti s rni tttui tl .
P ayc los eat t e n ti o nIo th ec a rca n d c l c i rrri nign sl rucl i orrs
Ar-rydeviationlray causc.litrnagc.
r-:7
t Equipotentiality
not withstandthisprocedure.
/'T\
10. l)isconnectthe controlunit fron the electricaloutletwhen ir-rspecting t-:-i I)rotectivcearthground
the fuses. \--l
tr A
sensitivepartsthat arepreciselyaligned.
Fuserating
rl /r)l
1 3 ' E ns ur et hat re a d j u s tm e n ts ,mo d i fi c i tti .tts ' i l l l (l rrrl l r' rl t' t' rl l trrl ,tl l
by per s onsau th o ri z e b d y S try k c rIi tttl ,rs t,' 1 ry,
'l'hissynrbolindicatesthat the wasfeof electricaland electronic
\:r
c ont plies
l s ti tl l i tl i o rrr'l llr,' tt l r \' ,tttl" l ' r t,rl tr['t" ' ,rtt
1 4. E ns ur et hat t h e e l e c tri c ai n
wit h (l rcN l i (l i rrrtl( )l i (I l i rrrrl t' l rrrt'.'
I'h e war r ant y is v oidi (' i rn y otll rc s en ' ;tt' rttttl l \,rtr' (l t',try1,rl ,l ,,l
lr t.\ cquiprlcnt must not be disposedas unsortedmunicipalwasteancl
nrustlrc coilectedseparately.Pleasecontactthe manufactureror other
iruthorizcddisposalcolrpany tclclecommission your equipt.uent.
II
EN-4
tr EN.5
Product Description and Intended Use
It
The stryker EndoscopyI l88HD Medicalvideo camerais a high-definition
calrera usedto capturestill and video ir-nages
of endosctlpicsurgicalapplications.
The I 188HD MedicalVideoCanreraconsistsof thrcc rlain components:
IH
. Cameraconsole(p/N 1l{:t8-010-000)
. Cam er ahe a d(P/N 1 1 8 8 -2 1 0i 0- 5 )
. C- m ountc o u p l e r(P/N I1 8 8 -0 2 0 -1 2 2 )
H
The 1188I{Dalsocomeswith variousconnectioncablcswliich,like the other
conponents,can be purchasedtogetheror separately.
{.
Warning Federallaw (United Statesof Arnerica) restricts this device to
I
ttu
use by, or on the order of, a physician.
17 18
Gamera Gonsole
The cameraconsoleor carnera control unit (ccu) is the control centerfor the
l lltlJI{D Medical Video Cameraand processes the video and photographic
imagescapturedduring the surgicalprocedure.The consolefront panel features r#:iSi:*:*
r tt
controlsfor adjustingthe enhancementlevel,Iight level,zoorl, and white balance.
'fhe lront panelallowsselectionof surgicalspecialtysettingsthat optimize
cameraperfornance for specificsurgicalprocedures.f'he front panelalso allows
activationof remoteoutputs.
'I'herearpanelprovidesportsfor connectingthe
rF #-({3d
11{tttllD(lamerato viewingand
recordingequipment,suchasvideomonitors,the SDC HD, or photo prir.rtcrs.
II EnhanceButtons:Increaseor decrease
2. imagesharpness
3. SpecialtyScreen:Displayswhich surgicalpresetsettinghasbeen
selected
rr 4.
5.
SpecialtyButton: Selectsdifferent surgicalr.ttilrg,
P Button: Controls ir-nage(picture) capturevia remotesI and 2
n 6.
7.
tt.
Up and Down Arrow Buttons: Controls imagelight or zoom level
W Button: Controlsrvhitebalanceand inage light or zoom level
CarneraConnector:(lounectsto the I IBBHI) Car.nera
llead
H il.
11
RemoteOut 1: Connectsto a video accessory
remoleswitch
Remote Out 2: Connectsto a video accessoryremote switclt
EN-6
il EN-7
13. Fiber Outputs (optical):DVI outputfor connectionto Lucent
connectorfibers
H Gamera Head
14. S-Video1 Out: Analogvideo output
15. S-Video2 Out: Analogvideo output
t The carnerahead connectsto the cameracousoleand capturesvideo and
photographicimages,which it relaysto the cameraconsole.It featuresseveral
through a lruttot-rkeypadlocatedon the top of the
controlsthat are accessible
16. SFBConnectors:lnables FireWireconnectionwith Strykcr|ircWirc
devices.Providesconnectionfor remote diasnosesand future soltware
upgrades.
il I
camerahead (see the "OperationInstructions"sectionof this manual).
I:| I.
2.
CameraCable
CarneraHead: Capturesphotographicand video ir-nages,
provides
Ir|
cameracontrols,and connectswith a focusingcoupler
3. Soaking Cap: Protectstl.recableconnectorduring cleaningancl
slerilizatior-t
II
FI
ill
EN-8
til EN-9
G-Mount Goupler
The C-Mount coupler threadsonto the faccof thc camcrahead,enabliirga scope
to be attachedto the canera.It providesa filcusingring to adjustimage
sharpness.
+
*
Setup and lnterconnection
Note StrykerEndoscopyconsidersiustructionaltraining,or inservice,
an integralpart of the I 188HDMedicalVideoCamera.Yourlocal
'fhe featuresof the couplerarelistedin Figurc3 bckrw Additior-ral
instructions
areavailablein the "1188C-lvlountCouplcrtJscr(l-ride"(P/N 1000,400,905).
rl I
StrykerEndoscopysalesrepresentative will perform at leastone
inserviceat your convenienceto help set up your equipr-nent
inslructyou aud your staffon ifs operatiottand maintellance.
schedulean inservice,contactyour local Stryker Endoscopy
and
'lb
t represcntativeafteryour equipmenthasarrived.
SettingUp the 1188lJDCamerainvolvesthreesteps:
F 1.
2.
3.
Settingup the console
Settingup the catlerahead
Settingup the coupler
tF 1. ConnectAC power.
. Connect the AC power cord to the AC inlet on the rear consttlepanel.
. Connectthe otherend to a hospital-grade outlet.
rl
Figure3: C-iVount coupler
1. Rear Adapter: 'Ihreadsonto the canrerahead Warning Always use the hospital-p;radepower cord supplied with this
carnera.
2. FocusingRing: Adjuststhe couplerfocus
3. EndobodyClarnp:Securesthe scopeto the coupler
4. ScopeEnd: Receives
the cndoscope
II Oaution Always set up the console in a location that allows adequate
ventilation (airflow) to the console.Insufficient ventilation
II
tt
EN-TO
n EN- I I
2. Connectthevideooutput.
. f'herearpanelprovides
threeanalogandthreedigital-video
outputs, Wiring Diagram 7: Camera and Flat'Panel Monitor
whichcanbe usedtogethcror inclcpenclcntly:
Flat-Panel Monitor
Warning Do not touch the internal pin of the VIDEO-OUT BNC jack
and the patient sirnultaneously.
lf\
EN-12
EN-I3
Wiring Diagram 2: Camera, SDC Pro HD, SlDNEa,and Flat-Panel
Monitor
lr wiring Diagram 3: Camera, Flat-Panel Monitor and cRT Monitor
Flat-Panel Monitor
H Flat-Panel Monitor
r|
f,l
uutjitt;[t]"
i H
C€
; ;ij
;; \l),
l"il t-',
H
1188Camera
rH I
Irt I
ll I
n
1l
7
o
3
(D
3 N ol c If you are using any devicewith unternrinatedanalogvideo
(D o inputs,you utust comect a catrlefi'onl the VIDEO OUT of that
deviceto the VIDEO IN or-rthe monitor'
It \ol c
N ol c'
An additionalmonitor nraybe cor]nected
oulPut.
usit-tgan oPencanlela
EN-14
H EN-15
[|
Setting Up the Gamera Head
r|
Caution When attaching or rernoving the coupler, grip only the rear
1. Connectthe cameraheadto the console. adapter, as twisting other parts of the coupler may result in
rnechanicaldamage.
. Llnscrelvthe soakingcapfroni llie cableconltectorifuecessary.
r|
. Align the blue arrow on the cableconttectorwith the blue atrow on Caution Do not overtighten the coupler, as this may darnag;ethe front
the camera-connector port on the fi'ontconsolepanel(seclrigure4). window of the carnera.
. Pushin the connectoruntil it locksin place. Note For direct-cctupled C-rnount scopes(scopesthat requirencl
coupler),threadthe endoscope directlyir-rtothe camerahead
T Caution
until it foms a tight seal.
Do not overtighten a direct-coupled C-mount scope,as this
rnay darnagethe front window of the carnera.
I 2. Attachan endoscope
. Ren'rove
to the coupler.
the rcd dustcapi{'it is present.
Caution
portion of the conncctorand pull straightout.
Do not severelybend the carneracable or damageuray resttll,
1I
Setting Up the Goupler
1. Attachthe couplerto the camerahead.
II
. Grasping the rear adapter,screw the coupler onto the calltcrit ltcittl
(clockwise) until it forms a tight seal (see Figure 5). II
n
n l;igurc 6:
3.
Attntfiing ernencloscopeto the carmerahe;1dvia thq coupler
t.
camera
kcypa.lfor controllingthe 11t18 (seeFigure7). Theselruttons arelabeled
and that the camera,light sourceand r-nonitorarepoweredon
P,\\/, t)p, and f)Qwn. the white balance.
beforeadjustir-rg
1. Poir-rtthe scopeat severalstacked4 x 4 white gauzepads,a white
t
laparoscopicsponge,or any cleanwhite surface.
t
white surface.
3. Pressand hold the W button until "WHII'll BALANCE"beginsflashing
on the videouottitor.
4. Continuepointir-rg the scopeat thewhite surfaceur,til the videomonitor
indicatesthat white tralanceis 'tomplete."'fhe video picture rnaychange
I color.Ifyou cannotachievean acceptable
"'lioubleshooting"sectionof this rnarlual.
white balance,referto the
P (Picturel Button
r Up and Down Buttons
'l'lrcup and clownbuttonswolk togetherto increaseor decrease
the light/zoom
The P lruttort cotltrtlls LlPto twtr rclll()[e viJco accessorics
beeuslvill souud.
to scl t' lt l l t' l ttrrl e
. P r es st he P b u tto nfrtrmOt' eth a uo u es c C ol l rl -'
l tr"
tl will r:riscor k:wer the autornatic-shutter
rrrotlc, prcssing lhc arrow
I'r'cssthc irrrowbuttot.touce
buttons
to
will
adjust the
light-levelsettingir, 29 steps.In "zclon"
raise or lower the zoom levelin 8 steps.
light levelby one stepor hold clownthe
buttorr[i rra oui ckc rt r ansit ion.
EN -I8 EN-I9
;
Enhancement Buttons
T Using the Gonfiguration Menu
tt
'Ihe enhancement increaseor decreasepicturesharpr-ress.
buttor-rs Thereare l6
levelsof enhancement. levelwill be displayedbrie{1yon
The currentenhancement The ConfigulationMenu allowsadjustnentof somecalrerasettings.Settingscan
the monitor. alfectvideo quality,aud careshouldbe takerlwhen alteringthem.
+
. Arthroscopy . Shutter
. Cysktscopy . Color
t
. Flexi-Scopc 3. Pressthe Specialty
. Ilysteroscopy t1lenu.
. [ . af ilr ( ) s c ()p y 4. Usethe Up and Down buttonsto adjustthe selection.
. Laser I to returtt to the Configuratiou Menu.
Pressthe P t'rr.rtton
HI
5.
. Microscope
6. Pressthe P button againto exit the ConfigurationMenu.
. Star-rdard
The front panel LCD will displaythe current specialry. Controlling Remote Video Accessories
Selecting the Display Language
TI 'l'he 11B8llD Cameracauremotelycontrolup to two video accessclries (suchas
lhc SDC tlD, a VCR, or a photo printer),enablingthe userto captureitnagesor
fhe I 188HDhasthe capabilityof displayirgtextin the followinglanguages:
t
Dutch Greek Porluguese 1. counect the video accessory
cousolcpanel.Usethe providedrentotecables.(SceWiring l)iagratl 2 in
English Italian SimplifiedChinese
the "settingUp the Console"sectionof this manual.)
Fir-rnish Japanese Spanish
French Korean Swedish
.t.
I)ressthe P button for lessthattone secondfoselectRernote1.One beep
will sound.
lrccpswill souud.
1oselectl{emote2. Two
for more than ouesecc'rnd
I)rcssthe P buttor-r
2.
the currentlanguageider-rtifier
appears.
EN-20
EN.2I
Using the SFB Serial Interface
t Operating the Gamera with a Light Source
F
The SFBscrialconnectir'rn
on the consolerearpanelenablesFireWireconnection
to the StrykerEr-rdoscopy
SoliwareManagement Sire(SMS).Oonncctingto this
Warning IMPORTANT SAFETY NOTICE: Before operating this device,
siteenablesrcmotediagnosticsand softwareupdates.
please read this operating rnanual thoroughly and carefully.
Note This systernfeatureis not necessary
for regularcanlcrasystcltr When using this device with a light source, fire and/or severe
Nole
operation.
This systemfeaturerequiresan additionaldevice(thatis, a It injury rnay result to the patient, user or inanimate objects, if
the instructions in this manual are not followed. All light
sourcescan generatesignificant amounts ofheat at the scope
conputer) to cc'rnnect
+
t. Connect four ir-rdividualfibers (telnir-ratedin Lucentconnectors)kr the necessaryto adequatelyillurninate the surgical site. In
red (R), green(G), blue (B) and clock (C) laserdiodeson the console addition, adjust the internal shutter of the camera higher in
rearpanel. order to run the light source at a lower intensity. Avoid
+
2. Connect the four fibers to a cor-npatible touching the scope tip or the light cable tip to the patient, and
fiberoptic DVI rc'ceiver.
never place thern on top of the patient, as doing so rnay result
. 'l'lic four flbersshould[:reconnectedto the carleracor.rsole in thcr
in burns to the patient or user.In addition, never place the
labeledorder:RGBC
scopetip, the scopelight post, the light cable adapter,or the
. 'l'he fll'rersshould be connectedto the mor.ritorir-rone of fwo
H
light cable tip on the surgical drapes or other flarnrnable
configurations: CBGR (rcverseorder)or ll(lRC (U./Bswitchcel). material, as doing so rnay result in fire. Always place the light
3. Bnsurethe fiberopticoutputis enatrled(on) via the OptionsSubrnenuir-r sourcein standby rnode whenever the scopeis removed frorn
the ConfigurationMenu.(Seethe section"tlsing the Cor-rfiguration the light cable or the deviceis unattended.The scopetip, scope
Menu'l) light post,light cable adapter,and light cable tip will take
* several rninutes to cool off after being placed in standby rnode,
Note Ihe 1l tt8HD Camerais a Class1 laserprroductper i[C 60825-1 I
and therefore rnay still result in fire or burns to the patient,
rF
and 21C IrR . .i
user,or inanirnate obiects.
Warning Using controls or adjustrnentsor perforrning procedures
n
differently than specified in this rnanual rnay result in
hazardousradiation exposure.
tr
lI
I
EN-22
EN-23
Troubleshooting n
t
Problem Possible Solution
Problern PossibleSolution Noise or snow ol1 . Plug the electrocauterygeneratorinto a seParate
"SysternError" . Camerahead temporarilyshut down due to picture when using the 1l88HD powercord
electricaloutletand separate
message overcurrent. electrocautery from the electrocauterypower cord.
(Color bar . Turn off the console,wait 3 seconds,and turn it back probes . Separatethe cameracablefrom the electrocautery
background) ol1. cable.
. Repositionthe electrocauterygrounding pad on the
"System
Error" . No video detected. oatient.
message(Lightblue
. Return the systemfor repair.
background) Noiseor snow on
picture when not . ReduceEnhancement.
No color bar . Ensurethe video-outfrom the consoleis connectedIo
th e v i d e o -i no n l h c n ro n i to r . using electrocauterY . Check for and replacefaulty video cables.
probes
. Ensureall video systemsare poweredon.
No video picture . Check to ensurethat all devicesin the video systen are
. Ensurethat the caffreraheadis not connectedto the
when the calnera pluggedin and poweredon.
console.
head is pluggedin . Check the connectoron the camera-headcablefor
. Turn off the console,wait 3 seconds,and turn it back
broken pins.
ol1.
. Detachthe cameraheadfrom consoleand reconnect
No color bar . Santeas above.
or
(Oprical DVt only) . Seethe "Usingthe DVI FiberOutputs"sectiono{'lhis and turn it back
. Turn offthe console,wait 3 seconds,
manual. otl.
Incorrectpicture a Performthewhitebalance procedure.(Secthc "W . Releasethe scopefrom the couplerand then reconnect
Inrageis not well
color Buttorisection
of thismanual.) ccrrtcred it. Make sure the scopeis seatedcorrectlyin the
Checkthecolorsettinqson themot-titclr. couoler,
White balance(WB) . Seethe solution for "Pictureis too dark." Vrrriability in color . Perform the white-balanceprocedure.(Seethe "W
quality not good . Seethe solution for "Pictureis too bright." lcplocluction Button' sectionof this manual.)
. Perform the white-balanceprocedurewith the light hc(wcern different . Check the settingson video peripherals.
sourceconnectedto the scope.Usemetal-halideor l i gl rlsources or . Ensurethe light sourcehas a proper infrared filter
xenon lighting (no fluorescentlightir-rg). li
Ic Phcrals (checkwith manufacturerspecifications).
Pictureis too dark . Increasethe cameralight levelwith the camerahead.
. Increasethe light-sourceoutput. I Iroggypictr"rre
ol tl c' l i tti ti ou
(loss
attd
. Refocusthe camera.
. Refocusthe coupler.
n
. Check the fiber-optic light cablefor excessive
broken t l rrl i ty) . Cleanand dry both the scopeand the couplerwindows.
fibers. . Removethe couplerfrom the camerahead and refiIove
Pictureis too bright . l)ecreasethe cameralight level. any moisturethat hasbuilt up betweenfhe two
. Decreasethe light-sourceoutput. conlponents.
. Ensurethat Shuttersubmenuin the Cor-rfiguration
menu has the fclllowingsettings: ;
n
AGC Autcr
ShutterOn
EN-24
t 8N.25
H
T
Possible Solution
Problem
Gleaning and Sterilization
Optics are dirtY Rcltatethe scope.Ifdust particlesin the picture rotate'
the dust is locatedon the scopeitself.Follow the
manufacturer'sinstructionsfor cleaningthe eyepiece
and negativelens.
H Gleaning the Gamera Console
Warning Disconnect the console from the AC power source before
If particlesin the picturedo not movewhett you rotate
thc scope,the particlesarelocatedotl the couplcror A cleaning.
+
cotton swab. mild cleaningsolution.
If dust particleslie betweenthe couplerand camera, Caution Never irnmerse or sterilize the carnera console as this will
removethe couplerand cleatlthe couplerand camera damage the carnera and void the warranty.
windows.
+
Ensureall componeutsare completelydry lrefore
reassemblingthem, or fbggingmay result'
Gleaning the Gamera Head
Blurrypicture . Ensurethe coupleror C-Mount scopeis in focus' Warnin g The camerahead and cable must be cleanedand sterilized
+
prior to the first use and after every subsequent use.
. Increasethe enhancement.
. Ensurethe specialtyswitch is not set to FLEXI-SCOPI A
unlessyou are using a flexiblescope. Imrrediately after use,unplug the camera-headconnectorfrom the
+
1.
consoleand protect it with the soakingcap.Placethe cap over the
Note If this troubleshootingguide doesnot resolvethe problem, call connectorand screwit on clockwiseuntil secure.
StrykerTechnicalSupportat l-877-478-7953(inside the U'S') or
+
ref'erto the "serviceand Claims" sectionof this manual' Caution Always install the soaking cap before rinsinp; the camera.
Failure to properly tighten the soakingJcap will corrode the
connector pins and void the warranty.
2. Rinsethe cameraheadand cablein lukewarm tap water.Use a rnild
t
enzyrnaticdetelgentand a soft brush to removeresistantdeblis and
bioburdenfrom all surfaces.
3. Rinseoff all soapresiduewith water.
4. Dry the camerahead and cablethoroughlywith a soft towel or gauze
surgicalspongc.
rt
5. Cleanglasssurfaceswith alcohol.
6. Preparethe cameraheadand cablefor disinfectionby coiling the camera
in diameter,avoidingany kir-rksor
cableinto a loop about ten ir-rches
twistsin the cable.
I
EN-26 EN-27
Disinfecting the Gamera Head
Caution Before soaking, inspect the carnera cable for cuts and breaks.
Sterilizing the Gamera Head
Never soak a cut or broken cable becausernoisture will seep Caution The carnerais not autoclavable. Do not autoclave the carnera or
into the carnera head and causedamage. Return any carnera darnagewill result.
with a darnaged cable to the Stryker Endoscopy Repair Do not sterilize the camera head and coupler as a single unit.
Caution
Department for service. Never soak the carnera and cable in Each devicehas its own set of pararnetersthat must be
the sarnetray with sharp instrurnents. followed to ensure proper sterilization.
Caution Separatethe carnerahead, coupler, and scopeprior to
Ifthe coupler and carnerahead are sterilized as a single unit,
disinfection. Refer to the coupler and scopeproduct rnanuals
disconnecting the coupler will compromise the sterility of the
for disinfection instructions.
two products.
Caution Always install the soaking cap prior to disinfection.
Caution To rninirnize galvanic corrosion, avoid soaking dissirnilar Steris System I
metals in close proxirnity. Caution Always install the soaking cap prior to sterilization.
Caution Avoid leaving the camera in sterilization solutions longer than 1. Cleanand preparethe cameraheadand cableasrecommendedin the
necessary,as this will acceleratenorrnal product aging. Carnera cleaning and Disinf'ectionsections.Ensurethe soakingcap is installed.
life is extended by the consistent use of a single sterilization
method. 2. Sterilizethe camerahead and cableusing Steris^Systeml with steris"
Sterilant20.
1. Cleanand preparethe cameraheadand cableasrecommendedin thc
Cleaningsectior-r.
Ensurethe soakingcapis installed. 3. and scopeto cornpletelydry
Allow the camerahead,catrle,cc'rupler,
beforereassemtrly.
2. Immersethe cameraheadand cablein Cidex Plus'glutaraldehyclc
Note dry before
Be surethe threadson the couplerare con-rpletely
solution or Cidex OPA" solution for disinfecting.Specificatiouslirr cach
are as follows: reattachingthe couplerto the camerahead.Any moistureon the
threadswill causethe cameraand couplerwiudows to fog during
use.
Cidex Plus' disinfection:
Sclaktime: 20 minutesrlinimum, asrec()uuler)dcdlly
the sterilantmanufitcturer(24 hours Sterrad System
maximum) ( lrrution Always install the soaking cap prior to sterilization.
Temperature: 25"C (77"F)
l. Cleanand preparethe cameraheadand cableasrecommendedin the
Cidex OPA" disinfection: and Sterilizatiori'section.Ensurethe soakingcap is ir-rstalled.
"Clear-ring
Soaktime: 12ninutes minimurrr,asrccolnllcneieel lrv 2, Stcrilizethe carnerahead and calrleusing the Sterrad"'Sterilizatior-r
th es te ri l a nnt a n ufacturcr(24hours S ystcm.
maxirlurl)
Temperature: 20"c (68"F) .1. Allow the camerahead,cable,coupler,and scopeto completelydry
bclirrcrcassembly.
3. After soaking,rinsethe cameiaheadand cablein sterilewatcr,agitatirrg
Nolc []c surethe threadson the couplerarecompletelydry before
the.mto removeall tracesof glutaraldehydescllution.
rcattachingthe couplerto the camerahead.Arry moistureon the
4. Dry all parts thoroughlywith a steriletowel. tltrcaclswill causethe cameraand couplerwir-rdowsto fog during
EN-28
EN-29
rrilr
I
a sterilizethe cameraheadand cablewith an ethyleneoxidesterilization the cameraconsole.
unit accordingto the following paranleters:
I 2. Unlatch the fusehcllderatrovethe AC inlet and rernoveit. (Youmay
Jl'i
Temperature: need to pressthe tab on the fuseholder with a slenderscrewdriverto'
5 5 ' C (1 3 l .F )
Hunidity: releasethe latch.)
7 0 r5 % R H
; 3. Replacethe fusewith the samevalue and rating.
Preconditioningtirne: 60 minutes
Sterilantmixture: 100%ethyleneoxide Warning To avoid the risk of fire, use only fuses of the value specified on
Sterilantconcentration: 725 rng/L ethyleneoxide the fuse label located on the rear panel of the camera console.
Exposuretime: 60 minutes
Aeration: 1 2h o u rs ,3 5 -5 4 ' C 4. Reinstallthe fuseholder until the tab snapsin place.
J. Allow the camerahead,cable,coupler,and scopeto cornpletelydry
beforereassembly. Periodic Maintenance Schedule
Note Ensurethe threadson the couplerare completelydry beforc
Warnin g To ensuresafeoperation of the Model l188HD Medical Video
reattachingthe couplerto the camerahead.Any rnoistureon the
Camera you should periodically perform the following
threadswill causethe cameraa'd couplerwi'd.ws to fog duri'g iN procedure:
use.
livcry 12nonths, checkthe earthleakagecurrentto <500pA(<300prA in U.S.A.),
Using Sterile Drapes glound protectiveearth impedanceto <0.1 ohrls, and Powerconsumptionless
lhln or equalto rated power.Usea true RMS digital t-nultimeterand safety
Usir-rgsteriledrapeswill ensurernaximurnlongevifyof your I I stJll D Carrcra
irrralyzer
to performthis test.
I{ead. For best results,follow the instructionsprovided by the drapc
manufacturer.sterile cameradrapesfor usewith the l lgsllD camera Head can Nolc Refercalibrationand operatingdifficultiesnot detailedin this
be orderedunderStrykerproductnumber240-010-200. salesrepresentative.
manual to your Stryker Er-rdoscopy
EN-30
EN-37
Technical Specifications t Input Electrical Ratings
6{)kIJzsettingsare displayedfirst. (50H2seftingsfollow in parentheses.)
n
1/3"Progressive ScanCCI)s 13lbs.(6.0kg) Cameracousole
lligh Definition 0.5l bs.(0.226kg) Coupler
Scanning Systern 1.5lbs.(0.6S0kg) (lan-rcra
head
Horizontal: 64.00kllz (60.00kt{z) Dirnensions
Vertical:
Video Outputs
60.02I lz (50.00[Iz)
t CameraCousole: 12.5"wx3.3"hx15.25"d
(31.8cmw x 8.4cm h x 38.7cm d)
CameraFIead(lableto CameraConsole:
t
[ ) igit al/ A nit)g
l, : Two l)igital VideoInterface(DVI)/RGBHV
10.3ft (3.15nr) sealedcable
12t10 x 1024(SXGA)formiit
(lonnector: 20.7ft (6.30r-r.r)
cableextensionavailal'rle
2 9 -p i nD V I-I
+
Compctsite: One NTSC standard(PAL standard) Enhancernent
Connector: BNC coaxial 16levels(switchable)
Y/C: lwo S-VIJS
Classification
Connector: 4-pin mini-DIN
+
ClassI Equipment
Digifal Fiber: One I)VI (R, G, B, Clk) 'Iype BF-ApPlied Part
SX (l A l i rru ra t
WaterIngressProlection,IPXO-Ordinary Equipnlent
Connec t or : Four Lucentfitrerconnectors
+
with 1.25rnm
ContinuousOPeratiot-t
ferrules
Oornplieswith Medical SafetyStandards
Resolution
IIIC 60601- 1: 1988+ A1: 1991+ 1\ 2: 1995
Ilorizontal: I 1 0 0l i n e s
18: 1996
IE C 60601- 2- + A1: 2000
Vertical;
t
600 lir-res
C A N /C S AC22. 2No 601. 1- M 90
Mountin6; LIL 60601 - 1: 2003
r
Eudoscopeeycpieceusedwith C-mount couplcr A S /N ZS32 00. 1. 0: 199f 4
C-mount callera hcadusedwith C-ntountscoDcrs I C S A22.2. 601. 1. 1: 2002
(C-mounfcoupler/scope threatl:1"-32UN-2A) 1990
C A N /C S AC22. 2No. 601. 2. 18:
Auto Shutter Range Oomplieswith Medical EMC Standard
l/ 60 ( 1/ 50)- 1 i 5 0 ,0 0 s0e c o n d + A 1: 2004
Il i (l 60601 -1- 2: 2001
Operating Conditions
Ter.nperature: 10 - 40'C F ( )ornplieswith LaserProduct Standards
(ilassI l.aserProduct
n
RelativeHumidiry: 30 - 75oh (lontair.rsfour 850-nmlaserdiodes
' I'hisproductcomplieswith Itlc 60825-1: I 993+A1: 1997+A2:200 I.
Transport and StorageConditions
't'hisproductconplieswith 2icFR, Subchapter and
J,Parts1040.1()
Temperature: -20 - 60'C
pursuallttci [,aserNoticeNo. 50,dated
l()40.1l, exceptfor deviatior-rs
;r
RelativeIlumidity: 10 * 75o1,
AtmosphericPressure: 700- 1060hpa ful Y26,2()t ) 1.
l,lcirsc,corr(irc( for infortlatiorl
your localStrykerEndoscopysalesrepresetttative
i ttt.lttcwpr oduct s.
,,rrr l ri tttgcs
r|
EN-32
r EN-33
r
Electromagnetic Gompatibility
Like other electricalmedical equipment,the l lggHD Camerarequiresspecial
t
precaulionsto ensureelectrornagnetic Guidance and Manutacturer'sDeclaration:Electromagneticlmmunily
conrpatibilitywith otherelectricailre.lical
devices.To ensureelectromagneticcompatibility (EMC), the ilggHD camera ; 1188HD Camera is intendedfor Use in the eleclromagnelicenvironmentspecified below.
must be installedand operatedaccordingto the EMC information provided The cuslomeror lhe user of 1188HD Camerashouldensurethal it is used in such an environmenl.
in
this manual.
Note The I l88lID Camerahasbeendesignedanil testedto conrply
with IEC 60601-1-2:2001
requirements
for EMC with othei
il I
lmmunity Tesl
IEC 60601 Test
Level
Compliance Level
Eleclromagnetic
Environment:
Guidance
devices. Floorsshouldbe
wood,concrete,or
Caution Equiprnent which ernploys RF comrnunications may affect the * ElectrostaticDischarge ceramictile. lf lloors
r6kv contacl !2,4,6kV conlact are coveredwith
(ESD)
norrnal function of the ll88HD Camera. J synthetic malerial,
il
, tSkV air r2.4.8k Vai r
1Ec61000-4-2 the relativehumidity
Warning shouldbe al least
Do not use cables or accessoriesother than those provided 30"/".
with the l188HD Carnera, as this rnay result in increased
+
electromagnetic ernissions or decreasedimmunity to such t2kV lor power Mainspowerquality
Eleclricalfasltransient/ supplylines r2kv linelo ground shouldbe that of a
ernissions. burst typicalcommercial
tl k V for i nput/ rl kV line to line or hospital
+
1Ec61000-4-4 outpullines environmenl.
Warning If the 1f 88HD Camera is used adjacentto or stackedwith
other equiprnent, observe and verify nonnal operation of the Mains power quality
rl kV differential t0.5, l k V
lf 88HD Carnera in the configuration in which it will be used Surge mooe differentialmode shouldbe that of a
typicalcommercial
prior to using it in a surgical procedure. Consult the tables
+
tEc6 t0004-5 r2kv common r0.5, 1, 2k V or hospital
belowfor guidance in placing the llggHD Camera. mode common mode environment.
Mainspowerquality
shouldbe that ol a
+
Guidance and Manufacrurer'sDecraration:ErectromagneticEmissions
typical commercial
<5% Ut (>95"/.dip <5% Ut (>95"/odip or hospilal
1188HDcamera is intendedfor use in the eleclromagnetic
environmentspecifiedbelow.The in Ut) for 0.5 cycle in Ut) for 0.5 cycle environmenl.lf lhe
customeror the user ot .118gHDcamera shouldensuie that it is used in
such an environmenr. Voltagedips, short us erot 1188H D
40% Ut (60"/. dip in 40% Ut (60'l. dip in Camera requires
interruplionsand voltage Ut) lor 5 cycles Ut) for 5 cycles
Emissions test Compliance ElectromagneticEnvironment - guidance continuedoperalion
variationson power supply
t inputlines duringpowermains
70oloUt (30o/.diP in 70oloUt (30o/odip in
Ut) for 25 cycles interruptions,il is
1188HDCamerauses RF energyonly for its Ut) for 25 cycles
RF emissionsCISPR 1
1E c61000-4-1 recommendedthal
Group1 internaltunctioni therefore,ils RF emissionsare
11 <5oloUl (>95% diP <5oloUt (>95% diP 1188HDCamerabe
. .very low and are not likely to cause any powered lrom an
tr
interferencein nearbyeleclronicequipm6nl. in Ut) for 5 sec. in Ut) for.5sec.
uninlerruptible
RF emissionsCISPR power supply or a
Class A The 1188HDCamerais suitablefor use in all battery.
11 establishmentsother than domeslic
establishments
n
and thosedirecilvconnectedto Power-lrequency
Harmonicemissions lhe public low-voltagepower sripply network
lEc6 t 000-3-2 ClassA magneticfields
that supplies buildings used for domestic
[)owerlrcquency(50/60H2) shouldbe at levels
purposes,providedthe followingwarningis
magneticfield characlerislicof a
heeded: typical locationin a
Warning: This systemis intendedtor use bv
l E c 61000-4-8 typicalcommercial
VoltageFluctuations/ healthcarep_rofessionals only.This system miy or hospital
flickeremissions cause radio interferenceor may disrupl the
Complies environmenl.
tEc61000-3-3 operalion of nearby equipment.lt may be
necessaryto lake mitigationmeasures,such as
reorienlingor relocalingthe systemor shielding
; NO I t:: tJt ls the AC mains vollage prior lo applicationol the tesl level.
the location. I
t
EN-34
# EN-35
lrr.*
Guidanceand Manutacturer's
Declaration:
Electromagnetic
lmmunity
Guidance and Manutacturer'sDeclaration:Electromagneticlmmunity
1188HDCamerais intendedtor usein the.erectromagnetic
environment
Thecusromer specitiedberow
or theuseror 118gHDcamerasnouuensuieinatit is usedin environmentspecifiedbelow
suchanenvironmenr. 1188HDCamerais intendedlor use in lhe electromagnetic
The cuslomeror the user of 1188HD Camerashouldensurethat it is used in such an environment.
(a) Field strengthsfrom lixed transmitters,such as base stations for radio (cellular/cordless)
ieiepnonesan-dland mobile radios,amateur radio,AM and FM radio broadcast'and TV broadcast,
Portableand mobileRF communications cannot be predictedtheoreticallywith accuracy.To assess the eleclromagneticenvironment.due to
equipmentshouldbe used no closerlo lixed RF transmitters,an electromagnelic site surveyshouldbe considered.ll the measuredlield
any part of the 1188HDCamerasvstem. strenglhin the localionin whichthe 1188HDCamerasyslem is usedexceedslhe applicableRF
.ornpiiun"" levelabove,the 1'l88HDCamerasystemshouldbe observedlo verifynormaloperation. ll
includingits cables,than the
recommendedseparaliondistance abnormalperformanceis observed, additionalmeasures may be necessary,such as reorientingor
calculaledfrom the equation applicableto relocatingthe 1188HDCameraunit.
lhe trequency ot the transmitter. (b) over the frequencyrange150 kHz to 80 MHz, f ieldstrengthsshouldbe less than 3 v/m.
NoTE 2: These guidelinesmav not apply in all situations. f.tltl l : 11,,,,,,r 1;,,kki l I
Electromagneticpropagationis affectedby - r slructures,obiecls,and People.
absorptionand reflectiontromltructdred, oniecfs,anOpeopfi. nl rr('l l ,l l i l i lrtrrlt0l l tr:l l onl ron
EN-37
F
If upon examinationby authorizeclservicepersonnel,it is .letermir-re.lthat the 2. Package all the componcutscarefullyin the originalshippingcontainer
rnalfunctionis due to misuseor abuse,warranry provisionswill not apply.An if possible.
estimateof the costof repair work will be given to the customerprior to servicing 3. and insuredto:
Ship lhe caurcra,prerpaid
and repairing the unit.
StrykcrIrndoscopyCustouer Service
The customeris responsiblefor returning the defectiveequipmentto the factory Attctttion:I{cpairl)cpartment
at his clrher own expense.StrykerEndoscrlpyor its representative will servicethe 590 0( ) pt icalO our t
unit, repair clr replaceany defectiveparts thereof,and return the unit. S attJose, ( lA 95l3f t
USA
If, upclnexamination,it is determinedthat the fault hasbeen causedby misuseor
abnormalconditionsof operation,the repairswill lre billed to the customeras (0 Strykerand Stryker Endoscopyare registeredtradernarksofStryker
out-of-warrantyrepairs. Corporation.
n
repairedat no chargeto the customer.
The warranty as setforth herein is exclusiveand in lieu of all other warranties,
remedies,obligationsand liabilitiesof StrykerEndoscopyInc., expressedor
r
implied, including the implied warrantiesof merchantabilityand fitnessfor use
and of consequentialdarnages. Theseproductsarebeir-rgsold only for the purpose
describedherein,and suchwarranty only runs to the purchaser.In no eventshall
Stryker Endoscopybe liatrlefor arrybreachof warranty in any amount exceeding
the purchaseprice of the product.