ACKERMANN Fusion 16-2091 User manual

SHAVER SYSTEM
Ackermann
www.ackermannsurgical.com
• Ackermann Fusion™ FullHD 3CMOS NTSC/PAL Camera #16-2091
User Manual
Endoscopic Camera System

ENDOSCOPIC CAMERA SYSTEM
Ackermann
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CONTENTS
1. Preface 3
2. Introduction of the unit 3
3. Safety instructions 3
4. Regulatory advice 4
4.1. Compliance 4
4.2. Electromagnetic interferences and electrostatic discharge 5
4.3. Medical device vigilance 5
4.4. End of lifecyle 5
5. Installing the unit 5
5.1. Connections 5
5.2. Activation 6
5.3. Activation of the device with a Fusion Card 7
6. Operating guidelines 7
6.1. Selecting the surgical speciality 7
 6.2.Congurationofthefunctionsofthecameraheadbuttons    7
6.3.Whitebalance 8
6.4. Focusing 9
6.5. Functionatilities 9
6.5.1. Video settings 9
6.5.2. Other parameters 10
6.6. Completion 10
6.7. General settings menu 10
6.8.Informationmenu 10
6.9. Connections menu 11
 6.10.Creatingauserprole         11
7. Description of front and back panels 11
7.1. Mains socket 11
7.2. Video outputs 11
7.3. Peripheral outputs 12
 7.4.Keysandsymbolsonthefrontandbackpanels      12
8. Suggested decontamination procedures 13
9. After-sales service and maintenance 14
10. Troubleshooting 14
11. Technical characteristics 15
12. Electromagnetic compatibility 16
12.1.Cablelength 17
12.2. Recommended separation distances 17
12.3. Electromagnetic emissions 17
 12.4.Magneticandelectromagneticimmunity      18
12.5. Electromagnetic immunity, radiofrequencies 19
13. Symbols 20
14. Appendix 21
15. Contact details 21

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1. PREFACE
We thank you for your purchase of the Ackermann Fusion™ Endoscopic Camera System.
Inordertomakethebestuseofitwhilehavingallthenecessaryprecautionsatyourdisposal,itisessentialforyouto
becomeacquaintedwiththismanual.
Thesentencesdisplayingthesymbol correspond to points requiring special attention.
The sentences displaying the symbolrepresentitemsofinformation.
To facilitate installation and use of the device, we have attempted to make the device manual more practical.
Consequently,referencestotheproductpresentationpageontheinsidecover(likeC1)forexample)willbeprovidedfor
easier viewing of the relevant product parts.
Thisusermanualisanintegralpartofthedevice.Itmustbemadeavailabletotheuser.Properuseandcorrecthandling
ofthedeviceentailfollowingtheseinstructions.Theuseraloneshallberesponsibleforanydamagethatmayresultfrom
improper use.
2. INTRODUCTION OF THE UNIT
This is a 3CMOS FULLHD medical camera.
Itsergonomicallydesignedsensor,automaticshutter,goodsensitivity,excellentresolutionandfaithful
color-renderingmakeitidealasamedicaltoolforrigidorexibleendoscopy.
This camera comes with:
• A control unit
• A camera head with integrated 15-34 mm zoom lens
•Videocables
•Apowercable
•Aperipheralcable
•Twocommunicationcables
• A set of 6 Fusion Cards
• A user manual
• A Quickstart guide
FortheUnitedStatesandCanada,the“hospitalgrade”powercordsuppliedandtheconnectormustbeusedwitha
“hospital grade” mains socket.
Thisequipmenthasbeendeliveredtoyouinpackagingtoberetainedforuseiftransportingthedevice
3. SAFETY INSTRUCTIONS
Read the User Manual.
Thisusermanualisanintegralpartofthedevice.Itmustbemadeavailabletotheuser.Properuseandcorrecthandling
ofthedeviceentailfollowingtheseinstructions.Theuseraloneshallberesponsibleforanydamagethatmayresultfrom
improper use.

ENDOSCOPIC CAMERA SYSTEM
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• Comply with the conditions of use and storage
• Do not expose the device to excessive dust
•Thedeviceshouldbeopenedonlybyacompetenttechnicianauthorizedbythemanufacturer
•Donotinsertmetalobjectsintothedevice.Thisistoavoidanyriskofelectricalshock,re,shortcircuitorhazardous
emissions
• Do not expose the device to splashed water or to damp
•Useonlytheaccessoriessuppliedwiththedeviceorrecommendedasoptionsbythemanufacturer
•Thiscameraisnotaame-proofdevice.Therefore,itmustnotbeusedinthepresenceofammableanaesthetics
•Thisdevicewasnotdesignedtobeusedinanionisingenvironment
• This device is not sterile
• The surface temperature of the camera can reach 41°C (aft er a few minutes’ use). Therefore, avoid any contact with this
area
•Thecameraisintendedforusebyqualied,trainedprofessionals,inanoperatingtheatre
• Prior to plugging in the device, check that the mains voltage and mains frequency indicated on the device correspond to
the power system values
•Priortoactivation,ensurethatneitherthedevicenorthepowercableisdamaged.Deterioratedcablesandconnectors
mustbereplacedimmediately
•Donotdropthedevice.Ifthedevicefalls,donotreconnectthedevicebutsenditbacktoyouruthoriseddistributoror
directly to the Ackermann after-sales service department
•Noadditionalmultiple-socketoutletsorextensioncordsmustbeconnectedtotheEMsystem
Toavoidanyriskofelectricalshock,thisdevicemustbeconnectedonlytoapowersystemequippedwithprotective
grounding
Devicesconnectingtotheinput/outputportsmustcomplywiththeIEC60950-1standard
 Any modication of this device without authorisation from the manufacturer is prohibited. If the medical device
ismodied, an inspectionandatest mustbe carried out toensurethatthe medicaldevice complies with thesafety
regulations
Checkwiththemanufacturerregardingthecompatibilityofyourendoscopeandyourlightsource,priortouse
Itisadvisabletohaveasecondsurgicalcameraintheoperatingtheatresothatactioncanbetakenifthedevicefails
to perform or if a deterioration in performance is noticed
Thisdeviceistobeusedonindividuals(patients)ttoundergoanendoscopicprocedure
 The potential equalization plug located at the back of the medical device can be used to equalize the grounding
potential of the medical device with that of all the devices plugged into the power main in the environment. Use the shared
groundingsysteminthehospitalorthebuilding
Deviceconnectingtotheinput/outputportsmustcomplywiththeIEC60950-1standard
4. REGULATORY ADVICE
4.1. COMPLIANCE
Thisproductwasdesignedandmanufacturedbyacompanywithacertiedqualitysystem.Itmeetstherequirementsof
European directive 93/42/CEE, on medical devices. Consequently, it particularly meets the standards of electrical safety
(IEC)andelectromagneticcompatibility(CEM)adhoc.

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4.2. ELECTROMAGNETIC INTERFERENCES AND ELECTROSTATIC DISCHARGE
Although this product complies with CEM standards, it may in very special circumstances interfere with other devices, or
itselfbetheobjectofinterferencefromotherdevicesoranunfavourableelectromagneticenvironment.
Imagetransfersfromthecameratoamonitormaybesusceptibletoelectromagneticdisturbancesandelectricsystem
disturbances.
Inordertoavoidthesesituations,itisadvisableto:
• Ensure of the quality of the electric power system (especially the grounding of all devices and medical carts
• Keep the device away from electromagnetic sources (e.g. compressors, motors, transformers, HF generators, etc.)
4.3. MEDICAL DEVICE VIGILANCE
Likeanymedicaldevice,thisdeviceissubjecttothestipulationsgoverningmedicaldevicevigilance,andthereforeany
seriousmalfunctionmustbereportedtothecompetentauthoritiesandtothemanufacturerasquicklyandasaccurately
aspossible.Formanufacturercontactdetails,refertothelastpageofthemanual.
4.4. END OF LIFECYCLE
ThisdevicecarriestherecyclingsymbolincompliancewithEuropeandirective2002/96/CEEonWasteElectricaland
Electronic Equipment (DEEE or WEEE). By correctly disposing of this device you are helping to prevent harmful eff ects on
the environment and on human health.
The symboldisplayedonthedeviceandontheaccompanyingdocumentationindicatesthatthisproductcannotunder
anycircumstancesbetreatedashouseholdwaste.Itmustthereforebedeliveredtoawastecollectioncentreforthe
recycling of electrical and electronic equipment.
Indisposingofit,pleasecomplywiththewasteeliminationnormsineffectinthecountrywhereitisinstalled.
For further details on the treatment, recovery and recycling of this device, kindly contact your nearest retailer who will
advise you on the procedure to follow.
5. INSTALLING THE UNIT
This medical device is intended for use by a qualied surgeon during endoscopic exploration. No special training is
required to install it. Kindly refer to the instructions in this manual.
Placethecontrolunitonitsbaseandhavetohandthevariousaccessoriesrequiredtooperateit.
5.1. CONNECTIONS
• Connect the power cord to the mains socket of the camera C2 and a video lead to one of the video output ports: We
recommendselectingtheDVIoutputC6forconnectingthemainsurgicalmonitor
• Connect the second end of the video lead to the video input port on the monitor
•IfyouwishtocontrolcertainfunctionalitiesoftheAckermanninsuatorortheAckermannlightsource,connectthese
totheAckermannCOMsocketonthecamera’scontrolunitC9intendedforthispurpose,usingthetwocablesprovided
Connecting the endoscope to the sensor:
• Turn the ring on the endoscope-holder on the camera head clockwise
• Once the endoscope is inserted, release the ring
•Ifthesensorhastobelockedintopositionontheendoscope,theringshouldbeturnedintheoppositedirection
•ConnectthepotentialequalizationcabletotheequipotentialplugC13atthebackofthedevice

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5.2. ACTIVATION
Tooptimize thequalityof theimages obtained with this product,alwaysbe suretoconnect the camera head before
turning on the control unit
•ConnectthepowercabletotheplugC2atthebackofthecamera
•ConnecttheDVI-DcabletothecorrespondingoutputportC6atthebackoftheproductandtothecorrespondinginput
port on the monitor
> TheHDSDIoutputproducesaprogressive1080signal
•Ifneeded,connectothermonitorsorperipherals,preferablyusingtheHDSDIoutputportsC8
> HDSDIoutputportsproduceaninterleaved1080signal
> HDSDIoutputportsarepreferredwhenaverylongcableisnecessary
• Turn the activation switch S2 to position “1”
> Thecameratakesabout30secondstocomeon.TheAckermannlogoisdisplayedonthe
screen during this interval
> TheashingLEDstandbybutton,andtheappearanceof“standby”onthescreenindicatethatthe
camera is properly activated
• Connect the camera head to the control unit via the dedicated connector C1
•Touchthescreen,ORpresstheStandbybuttontoaccessthemainmenu
•SelectasurgicalspecialityfromLaparoscopy,Cystoscopy,Hysteroscopy,ENT,ArthroscopyandFlexibleEndoscopy,by
clickingtheassociatedsymbol
> Once the selection is made, the camera is in surgery mode
•Afterconnectingthelightcableandtheendoscope,lmawhitesurfaceandlaunchtheWhiteBalancebypressingthe
dedicatedbuttononthetouchscreeninterface,orthecamerahead’spre-programmedbutton
> When the surgical monitor appears indicating “AWB OK” and the chronometer starts, this signals that the white
 balancehassuccessfullybeenset
> Thechronometershowstheoperatingtimebydefault(thestartingpointbeingwhenthewhitebalanceisset).
 However,thischronometercanbesetbeforehandifnecessary,independentlyofthewhitebalance
•Thevideosettingshavebeendenedforeachsurgicalspeciality.However,theycanbemodied,ifnecessary,during
surgery
> 3ofthese(Brightness,SharpnessandRedGain)canbedirectlyaccessedfromthemainscreen.Alltheothers
 (Gamma,BlueGain,Color,RedPhase,Gain,NoiseReduction,andAperture)canbeaccessedbyclickingthe
 “MoreSettings”button.Thisisadrop-downlist.Toscrollthroughtheparameters,touchtheleftsection(the
 parameterheadings)withyournger
• Press “Close settings” to exit and return to the main screen
•Youcanatanytimeduringsurgerytoreturntothefactorysettingsforthesurgicalspecialitybyclickingthe“Specialities
presets”button.
•Pressthe“STOP”buttonattheendofthesurgery
You can at this stage:
 Returntothemainmenubyclickingthe“Completed”button
OR
 Createauserprolefromthesettingsusedduringtheoperation
OR
 Loginifyouwishtoaddthissetofsettingstoyourprole

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Beforeconnectinganendoscope(orbroscopes)tothecameralens,checktheconditionofthisendoscope(clean
distal lens, setup if necessary)
5.3. ACTIVATION OF THE UNIT WITH A FUSION CARD
Scan a Fusion Card on the read area provided on the lexan housing (next to the Ackermann logo)
• Scanning a standard Fusion Card:
> Activate the camera directly on the surgical screen, in the surgical application corresponding to the Fusion Card
scanned
• Scanning a personal Fusion Card:
> Activate the camera directly on the surgical screen, in the surgical preset corresponding to the Fusion Card
 scanned.IftheuserproleassociatedwiththeFusionCardscannedshowsmorethanonepreset,then 
 anintermediatestageforselectingthedesiredpresetwillbenecessary
• Scanning an administrator Fusion Card:
> Activate the camera in the administrator menu
6. OPERATING GUIDELINES
6.1. SELECTING THE SURGICAL SPECIALITY
Thiscameracanbeusedinvariousmini-invasivesurgicaloperations.
Select the speciality from the pre-entered list. This loads the video parameters for the application accordingly:
• LAPAROSCOPY
• HYSTEROSCOPY
• CYSTOSCOPY
• ENT
• ARTHROSCOPY
•FLEXIBLEENDOSCOPY
Note 1: EachofthesespecialitiescanbeaccessedbyscanningtheFusionCardonitsdedicatedareaZ1onthe
controlunit.Thiscandedoneatanytime.IftheFusionCardisscannedwhileasurgicaloperationisinprogress,then
conrmationwillberequested
Note 2:Ifyouhaveenteredcustomizedparametersintoauserprolebeforehand,thenyoucanselectthisuserprole
eitherbyusingthe“Login”button,orbyscanningyourpersonalFusionCardonthededicatedareaZ1ofthecontrolunit
ifthecontrolunitislinkedtoyourpersonalprole
6.2. CONFIGURATION OF THE FUNCTIONS OF THE CAMERA HEAD BUTTONS
Thisoperationisperformedonthecorrespondingpageofthemenuinterface,whichcanbeaccessedfromthe
dedicated“Camerahead”button:
Clickthebuttonyouwishtocongure(B1,B2orB3).
Selectthetypeofpress(shortpressorlongpress)andthecorrespondingfunctiondesired,andconrm.
Repeatthisprocedureforeachofthethreebuttons.
Thecongurationselectedforeachofthethreebuttonswillbeenteredintotheuser’spersonalprole.

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Belowisthecomprehensivelistofthecongurablefunctions:
Short press Long press
No action No action
Brightness + Brightness +
Brightness - Brightness -
Lightsource-Intensity+ Lightsource-Intensity+
Peripheral 1 Peripheral 1
Peripheral 2 Peripheral 2
Mirror Mirror
Freeze frame Freeze frame
Recording images on the camera (if equipped with an integrated
recorder) AWB
Record / Stop video recording on the camera (if equipped with an
integrated recorder) Insuators(RUN/HighFlowRate/STOP)
Lightsource (ON/OFF)
(a) Recording images on the PC Recording images on the camera (if equipped with an integrated
recorder)
(b)Record/StopvideorecordingonthePC Record / Stop video recording on the camera (if equipped with an
integrated recorder)
(a) Recording images on the PC
(b)Record/StopvideorecordingonthePC
Bydefault,thefollowingcongurationisapplied(factorysetting):
B1 (short press / long press): Brightness - / Light source
B2(shortpress/longpress):Brightness-/Insuator
B3 (short press / long press): No action / AWB
Mirror mode: An “M” is displayed on the monitor to indicate that the mirror mode (inverted image) is active, and disappears
when it is deactivated.
Freeze mode: an «F» is displayed on the monitor to indicate that the freeze mode is active, and disappears with it is
deactivated.
6.3. WHITE BALANCE
Thewhitebalancecanbesetin2ways:
•Fromthetouchscreeninterface,clickthewhitebalancebutton
•Fromoneofthecameraheadbuttons,dependingonyourprogramming(onlypossiblewithlongpress)
You should proceed as follow:
•Oncethecameraispairedwiththeendoscope,theambientlightreducedtoaminimumandthelightsourceactive,lm
a white surface

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•Setthewhitebalance;theBALANCINGINPROGRESSmessageisdisplayedonthescreen
•ContinuetolmthewhitesurfaceuntiltheBALANCEOKmessageisdisplayedonthescreen
Note 1: Settingthewhitebalancecausesthechronometertobeactivated,signallingthestartofthesurgeryandtherefore
theavailabilityofadditionalfunctionalities,particularlythoselinkedtotheimagequalitysettings
Note 2: IftheAckermannlightsourceisconnectedtotheAckermanncamerabythecommunicationcablesupplied,then
settingthewhitebalancewillcausetheLEDtolightupifitwaspreviouslyoff
Intheeventthatthewhitebalanceissetduringanoperation,i.e.insidethepatient,theendoscopemustbepulledout
ofthetrocarandthewhitebalancemustbesetagainusinggauze
6.4. FOCUSING
Oncetheendoscopeisconnectedandthelightsourceisactivated,slowlyturnthelensfocusringtondapositionwhere
theobjectsbeingobservedaresharp.
Focusingonafairlydistantpointhelpsobtainadequateelddepthfortheoperationandthereforeavoidshavingtodo
retouching too regularly
6.5. FUNCTIONALITIES
6.5.1. VIDEO SETTINGS
Oncethewhitebalanceisset,orthe“Start”buttonhasbeenpressed,accesstothevideosettingsisauthorised.
Inthisway,itispossibletoworkdirectlyonbrightness,sharpnessandredgain.
Additionalsettingsareavailablebyclickingthe“Moresettings”button.
Thefollowingparameterscanbemodied:
Brightness Thisparametervariesthegeneralbrightnessoftheimage
Blue gain Colorimetryshiftfromwhitetoblue
Red gain Colorimetry shift from white to red
Color Modiescolorsaturation
Noise reduction Reduces the noise in an image
Window Shutter window analysis: surface of the image on which the camera analyses the quantity of light
received,inordertoadjustthespeedoftheshuttertoobtainarightexposuretime.Usetheauto-
matic mode or change it according to the scope size
Gamma Modiesthedynamicsofthedarkareas:
+1reducesthedifferencebetweenthelightportionsandthedarkportions,thereforemakingthese
dark areas appear less so.
-1 does the opposite: the dark portions are made even darker.
Sharpness Modiesthesharpnessoftheimagetoobtaina3Deffectorontheotherhand,softenstheimagewith
theanti-moirélterforexibleendoscopes.
Gain Modiesthebrightnesslevelincasesofmediocrelightingconditions
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Red phase Colorimetry phase shift from Orange to Magenta
Clickthe“Closesettings”buttononcetoreturntothepreviousmenu.
6.5.2. OTHER PARAMETERS
HD Recording:
IfyourcameraisequippedwithanintegratedHDrecorder,youcansetHDimage/videorecordingfromtheinterfacemenu
usingthecorrespondingbuttonsorfromthebuttonsonthecameraheadifthesehavebeenprogrammedaccordingly.
Insuators:
If your camera is connected to theFusion insuator viathe communication cableprovided, youcan select fromthe
parametersmenuwhetherornottodisplayinformationabouttheoperatingstatusoftheinsuatorsonthesurgical
monitor’s OSD.
Inparticular:
Feedbackoninstantaneouspressureinthepneumoperitoneum;
Feedbackonwarningmessagesfromtheinsuators.
Inaddition,oneofthebuttonsonthecameraheadcanbecongured(longpressonly)tocontroltheFusioninsuators
accordingtothefollowingsequence:Startinsuationinlowow/Changetohighow/Stopinsuation.
6.6. COMPLETION
Oncetheoperationiscompleted,pressthe“STOP”button.Youwillbegiventheoption:
•Tocreateauserprole
• To log in, if you have not already done so
•Tosaveanymodicationstothesettingsinyourpersonalprole,ifyouhavenotalreadydoneso
• To exit
Note:Ifyouarealreadyloggedin,youcanopttosavethemodicationstoyourpersonalprole.
Inparticularyouwillbeabletosave:
•Modicationstothevideosettings
•ModicationstotheAckermannlightsourceintensitysetting(lastsettingused)
•ModicationstotheAckermanninsuatorpressuresetpoint(lastsettingused,with15mmHglimitation,andmode)
•Modicationstothesettingsonthesurgicalmonitorsupportedmodelsonly)
Oncetheselectionhasbeenmade,youcanoverwritetheexistingpreset,orcreateanotherone
6.7. GENERAL SETTINGS MENU
The general settings menu is used to:
• Set the light intensity on the touch screen
• Select the display messages and the display of the instantaneous pressure in the pneumoperitoneum from the Fusion
insuator
• Select the language
• Pause the live video when a photo is taken to verify its quality
6.8. INFORMATION MENU
The information menu is used to access a rapid start-up product guide.

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6.9. CONNECTIONS MENU
Theconnectionsmenuisusedtoobtaintheconnectionstatusofallofthesystem’sdevices.
Inparticular,thecamerahead,theAckermannlightsource,theAckermanninsuators,theAckermannPCPanelandthe
Surgical Monitor.
Note: The icon for this menu changes to orange when at least one of the products on the system is disconnected.
6.10. CREATING USER PROFILES
•Clickthe“Loginorcreateaprole”button
•Clickthe“Createaprole”button
> ActivatingthecamerawithablankFusionCardgivesdirectaccesstothefollowingstage
•Clickthetexteldandenterthedesiredprolename
•Clickthe“Return”button
•Selectasurgicalspeciality.Thiswillformthebasisforthevideoparameters
•Clickthe“Createaprole”buttonORscanablankFusionCardontheareaprovidedforthispurposeonthelexanhousing
(next to the Ackermann logo)
•Amessageisdisplayedforafewsecondsindicatingthatthedevicesupportsthecreationofaprole
• You can then:
> Renametheproleand/orthepresetbyclickingthe“Manage”button
> Deleteone(ofthe)prolepreset(s)byclicking“Manage”
> Usethepresetcreatedbyclickingonit
> Logoutbyclickingthe“Logout”button
Notes:IfablankFusionCardhasbeenscannedatleastonce(duringactivationand/orwhilesavingacreatedprole),then
theprole(andthepresets)createdwillbeautomaticallylinkedtothisFusionCcard.Apadlockiconwillbedisplayedon
thisprole.Thismeansthat:
> ThepresetslockedinthisprolecannotbemodiedwithoutthecorrespondingFusionCard
> ThenamesofthepresetsandtheprolenamecannotbemodiedwithoutthecorrespondingFusionCard
7. DESCRIPTION OF FRONT & BACK PANELS
7.1. MAINS SOCKET
ThecamerareceiveselectricalpowerbymeansofthemainspluglocatedonthebackpanelC2,whichmustbeconnected
tothemainspowersupplybytheleadsuppliedwiththecamera.Thisplugcarriesafusetrapaswellasamasterswitchfor
turning on the device.
The camera uses T2.5AL - 250V fuses.
Whenreplacingafuse,thecameramustbeunpluggedandthesametypeoffusemustbeused.
The T in “T2.5A” means “time-delay”. Only use fuses marked UL/CSA.
7.2. VIDEO OUTPUTS
Thefollowingvideooutputportsareavailableonthiscamera:DVIC6,HD-SDIC8,RGBSC5,Y/CC10andcompositeC11.
The DVI output port provides the best image quality in 1080p format over short distances.
HD-SDI output ports are used to transport the video signal over long distances (screen at a distance of up to 50 m).

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7.3. PERIPHERAL OUTPUTS
Two(2)peripheraloutputportsareavailableC12andtheseareusedwitha3.5mmjackleadformanagingtwoperipherals
(forexample:aprinterandavideorecorder)fromthebuttonsonthecamerahead.
Thedevicesconnectingtothe“VIDEOOUT”and“PERIPHERAL”portsmustbecompliantwithstandardIEC60950.
7.4. KEYS & SYMBOLS ON THE FRONT & BACK PANELS
ThekeysandsymbolsonthebackpanelareforidentifyingthecamerainaccordancewithinternationalstandardsIEC
60601-1,IEC60601-2-18,IEC60417andEN980(SeeAppendix1)
Thetablebelowdescribesthebackandfrontcomponents:
C1 Connector for the camera head
C2 Main power socket
C3 RS232 output
C4 Service line
C5 RGBS video output
C6 DVI-Dvideooutput
C7 Ethernet output
C8 SDIoutput
C9 ConnectionstoAckermannproduct(lightsourceandinsuator)
C10 Y / C video output
C11 Composite video output
C12 Peripheral connections
C13 Equipotential plug
C14 USB storage device port
L1 Touchscreen
S1 Standbybutton
S2 Powerbutton
Z1 Read area of Fusion Card

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8. SUGGESTED DECONTAMINATION PROCEDURES
Disinfecting the camera control unit
Thecameracontrolunitisanon-heat-resistantmedicaldeviceanddoesnotwithstandimmersion;consequently,it
shouldbedisinfectedusinganon-wovenmediumsaturatedwithadisinfectantdetergent
This device is not drip-proof. Do not splash liquid on this product
Asdecontaminationislinkedtotheproducts,methodsand/ortoolsused,decontaminationisthesoleresponsibility
of the staff concerned
Thedevicemustalwaysbedisconnectedbeforeanycleaningprocedureiscarriedout
Thisdeviceisnotautoclavable
Existing alkaline solutions for the disinfection of certain medical devices are NOT RECOMMENDED for disinfecting
this device
Disinfecting the camera head
Pre-disinfection cleaning Disinfection Sterilization
Immersioninanenzymatic
cleaning solution (Aniosyme
DD1, Hexanios G + R or surface
cleaning ((Anios wipes)).
Immersioninaglutaraldehydesolution(Anios
Laboratory-Steranios2%)
Low-temperature sterilisation
with hydrogen peroxide or oxide
Anyotherdisinfectionmethodsareprohibited,andthemanufactureracceptsnoliabilityforanydamagecausedby
using such methods
Itisadvisabletouseadisposable,sterile,protectivecoveronthecameraregardlessofthesterilisationprocedure
followed and throughout the surgical operation
Thecameraisnotautoclavable
Thecameraisnotcompatiblewithautomaticwasher-disinfectors
Existing alkaline solutions for the pre-disinfection of certain medical devices are NOT RECOMMENDED for pre-
disinfecting our cameras
Itisessentialforthepartscomingintocontactwiththedisinfectanttobethoroughlyrinsed
Use soft non-woven cloths for wiping the lenses dry so as not to scratch them
Theproceduresdescribedinthissectionaregivenasguidance,andcannotunderanycircumstancesbesubstituted
forocialrecommendationsordirectives
Theconnectoronthecameraequippedwithitssealingcapcanbeimmersed.Tracesofwaterarevisiblejustasthe
connectorsealisremoved(runoffandcondensation).Itisthereforeessentialtodrytheinsideofthecapwellbefore
reusing it

ENDOSCOPIC CAMERA SYSTEM
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Disinfecting the lens surfaces
Adirtylenssurfacecaninterferewithobservation.Thelenssurfacemustnothaveanymarksorsmudges.
Toavoidscratchingthelenssurface,neveruseabrasiveclothsorspongestocleanit
To remove dust, dirt and other impurities not originating from the patient, wipe clean with a soft , lint-free cloth
moistenedwithethanolor70%iAckermannpylalcohol.Whencleaning,wearglovesforprotectionfromchemical
products.
Ensurethattheequipmentiscompletelydrybeforeuse.
Use soft non-woven cloths to clean the lenses so as to avoid scratching them.
Please read the cleaning, disinfection and sterilization instructions given in the “General Reprocessing Instructions”
procedure
9. AFTER-SALES SERVICE & MAINTENANCE
This device does not require any special maintenance operations.
Note:Misuseofthedeviceisnotcoveredbythewarranty.
Ifafaultpersistsandthedevicehastobereturnedtotheafter-salesservicedepartment,ensurethatitisshippedinits
original packaging.
Similarly,itisadvisabletoreturnthedeviceinitsentirety(controlunit,powercables).
Kindlyattachtotheshippingorderashortexplanatorynoteaboutthefaultnoted.Theequipmentmustbedisinfected
beforeitisreturnedforrepair.Whenreturningtheequipment,checkitsconditionandnoteanyexceptionsontheshipping
orderifnecessary,andconrmthesewiththeshipperbyregisteredmailwithin48hours.Ifanyequipmentshippedbyus
suffersdamageduringtransport,thetotalamountforrepairswillbechargedeithertotheshipperifnoticationofthe
exceptionshasbeengivenwithinthedeadline,orfailingsuch,totherecipient.Intheeventofanincident,kindlycontact
our customer service department or your nearest sales representative.
10. TROUBLESHOOTING
The indicator light on the standby switch S1 does not light up on start-up:
•Checkthatthemainssocketatthebackofthecameraisproperlyconnectedtothepowersupplyandthatthegeneral
switchatthebackofthecameraisintheoperatingposition(“I”)
•Checkthatthefusesareingoodcondition(onlyusethefusesspeciedonthebackpanel).
The indicator light on the standby button S1 comes on but no image appears on the screen:
•Checkthatthesensorisproperlyconnectedtothecontrolunit(ifnot,acolorbarwillbedisplayed),andthatitislming
aworkableimage
•Checkthatthecontrolunitonthecameraiscorrectlyconnectedtothemonitor(cableingoodcondition,plugscorrectly
pushed in)
•Ifthevideochannelhasseveralcomponents,connectthecameradirectlytothemonitortoverifythattheproblemisnot
with one of the peripherals
• Check that the monitor is in fact switched on, wired to the correct video input and that the image settings are at the mid-
point position (color, light and contrast)
•Checkthelightsource,thelightcableandtheendoscope
The image is blurred and white all over:
• Check that there is no condensation on the lens
•Checkthatthesensorisnotaimedatanobjectthatistoobright

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SHAVER SYSTEM
• Check the lens setup
Ifthereisnoimageoriftheimageisnotdisplayed,unplugandre-plugyourdeviceorresetthecameratothefactory
settings
The image is extremely light or dark:
•CheckthattheBRIGHTNESSparameterisnotatthemaximumorminimumsetting
• Check that the APERTURE used is not too wide or too narrow
• Check that the camera head is correctly connected to the control unit
• Check that the light intensity from the light source is not too low or too high
•Turnoffandturnbackonthecontrolunit
Ifthefaultpersistsanditbecomesnecessarytoreturnthecameratotheafter-salesservicedepartment,besuretoship
itinitsoriginalpackagingafterdisinfectingit.Similarly,itisadvisabletoreturnthecamerainitsentirety(controlunit,
sensor,lens,cables).Kindlyattachtotheshippingorderanexplanationconcerningthefaultnoted.
Theequipmentmustbedisinfectedbeforeitisreturnedforrepair.
When returning the equipment, check its condition and note any exceptions on the shipping order if necessary, and
conrmthesewiththeshipperbyregisteredmailwithin48hours.Ifanyequipmentshippedbyussuffersdamageduring
transport,thetotalamountforrepairswillbechargedtotheshipperifnoticationoftheexceptionshasbeengivenwithin
the deadline, or otherwise to the recipient.
11. TECHNICAL SPECIFICATIONS
Control unit
Main functions:
• Class 1 device, CF-type applied part
•3programmablebuttons
• Application and user MENUS
• Automatic compensation function for defective pixels
- RF transmitter:
•Type:RFID
• Frequency : 13,56 MHz
• Modulation feature : OOK
•Transmitterpower:70mW(+18dBm)
Video output:
• CVBS: 1.0 V [P-P] / 75 ohms Negative Sync,
•Y/C:Y:1.0V[P-P]/75ohms,C:0.286V[P-P](NTSC),C:300Vp-pV[P-P](PAL)/75ohmsNegativeSync,
• RGB: 3x0.7 V [P-P] & 0.3V [P-P] / 75 ohms
•HD-SDI:0.8V[P-P]/75ohmsSMPTE292M
•DVI-D3x0.7Vcc/&0,.3Vcc/75Ω)
Environment:
• Operating temperature: +10°C / +40°C
•Operatinghumidity:30%to75%
• Transport and storage temperature: -10°C / +45°C
•Transportandstoragehumidity:20to85%
• Operating, storage and transport atmospheric pressure: 700hPa to 1 060hPa
•Controlunitisnotdrip-proof(IPXO)
•Notsuitableforuseinpresenceofammablegaz.Recommendationofuseinanoperatingroominaccordancewith
applicableregulations
• Compliant with European directive 93/42/CEE.

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•CompliantwithinternationalstandardsIEC60601-1;IEC601-2-18;IEC60417andEN980
•Dimensions(WxHxD):310x136x385mm
• Control unit weight: 4300g
• Electric power supply: 100 - 230 VAC @ 50 Hz-60 Hz
•Electricityconsumption:38-50VA
• Two T2.5AL - 250V fuses (Marked UL/CSA only)
• Continuous operation
Camera head
• CF-type applied part
• Sensor: 3 CMOS
• Acquisition in native 16:9 format
• Progressive scan technology
•Resolution:HDTV1080pformat:1920x1080pixels
•Denition:1080lines
• Sensitivity: 5 lux
• Signal/Noise ratio: 54dB
•Cablelength:3m
• Sensor dimensions (D x H): 149 x 53 mm
• Sensor weight: 270g
12. ELECTROMAGNETIC COMPATIBILITY
Alltheinformationbelowisbasedontherequirementsofstandardstowhichthemanufacturersofelectricalmedical
devicesmustadhere(asstatedinstandardIEC60601-1Ed4).
Themedicaldevicecomplieswiththeelectromagneticcompatibilitystandardsinforce.However,theusermustmake
sure that any electromagnetic interference does not create an additional risk, such as radiofrequency transmitters, or
other electronic devices.
This chapter contains the information required for you to install and use your medical device in optimum conditions in
termsofelectromagneticcompatibility.Thedifferentmedicaldevicecordsmustbekeptawayfromeachother.
Some types of mobiletelecommunicationdevicessuchas mobile phones mayinterferewith themedicaldevice.The
separationdistancesrecommendedinthischapterMUSTbecompliedwith.Themedicaldevicemustnotbeusednear
anotherdeviceorplacedontopofit.Ifthiscannotbeavoided,correctoperationofthedeviceinoperatingconditions
mustbecheckedpriortouse.
TheuseofaccessoriesotherthanthosespeciedorsoldbyAckermannasreplacementpartsmayincreasetheemission
or reduce the immunity of the medical device.

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SHAVER SYSTEM
12.1. CABLE LENGTH
Cables and accessories Maximum length Test type In compliance with
Videocables
Mainscable
Mainsboundarycable
Communicationcable
< 3 meters
RFemissionCISPR11,ClassB CISPR11,ClassB
Harmonic current emission IEC61000-3-2
Voltagechangesandicker IEC61000-3-3
Electrostatic discharge immunity IEC61000-4-2
Transient electromagnetic immunity IEC61000-4-3
Electricalfasttransient/burstimmunity IEC61000-4-4
Surge immunity IEC61000-4-5
Immunitytoconducteddisturbances,
inducedbyradio-frequencyelds IEC61000-4-6
Radiatedimmunity–magneticelds IEC61000-4-8
Voltage dips, short interruptions and
voltage variation immunity IEC61000-4-11
12.2. RECOMMENDED SEPARATION DISTANCES
ThemedicaldeviceisdesignedtobeusedinanelectromagneticenvironmentinwhichinterferencescausedbyRF
radiation are controlled.
Theuserorinstallerofthemedicaldevicemayhelptopreventelectromagneticinterferencebymaintainingaminimum
distance, depending on the maximum power of the radiofrequency transmission equipment.
RFmobilecommunicationdevices(includingperipheralssuchasantennacablesandexternalantennas)should
notbeusednearerthan30cm(12inches)fromanypartofthemedicaldevice,includingthecablesspeciedbythe
manufacturer.Ifthisisnotrespected,theperformanceofthesedevicesmaybeimpaired.
12.3. ELECTROMAGNETIC EMISSIONS
Themedicaldeviceisdesignedforuseintheelectromagneticenvironmentdescribedinthetablebelow.Theuserand/
orinstallermustensurethatthemedicaldeviceisusedintheenvironmentdescribedbelow.
Emission test Conformity Electromagnetic environment – comments
Electromagnetic radiation dis-
turbance(radiatedemissions)
(CISPR11)
Group 1 The medical device uses RF energy for its internal operation.

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Disrupting voltage on the power
terminals (Conducted emis-
sions)(CISPR11)
Class B
TheEMISSIONScharacteristicsofthisdeviceallowittobeusedinindustrial
areasandinhospitalenvironments(classAdenedinCISPR11).Whenitis
usedinaresidentialenvironment(forwhichclassBdenedinCISPR11is
normally required), this device may not off er adequate protection for radio
frequency communication services.
The user may need to take corrective actions, such as relocating or redirect-
ing the device.
A professional healthcare environment.
Harmonic current emission
(IEC61000-3-2)
Conforming
Voltage variations, voltage
uctuationsandicker
(IEC61000-3-3)
Conforming
12.4. MAGNETIC & ELECTROMAGNETIC IMMUNITY
Themedicaldeviceisdesignedforuseinthemagneticandelectromagneticenvironmentdescribedinthetablebelow.
The user and/or installer must ensure conformity of the electromagnetic environment.
Immunity test Test level according to
IEC 60601
Conformity level Electromagnetic
environment / comments
Electrostatic discharge (ESD)
(IEC61000-4-2)
±8kVcontact
± 15 kV in the air
±8kVcontact
± 15 kV in the air
A professional healthcare
environment
Electricalfasttransientbursts
(IEC61000-4-4)
± 2 kV for electricity supply
lines
± 2 kV for electricity
supply lines
± 1 kV for signal ports
A professional healthcare
environment
A professional healthcare
environment
Shockwaves(IEC61000-4-5) ± 1 kV in diff erential mode
± 2 kV in common mode
± 1 kV in diff erential mode
± 2 kV in common mode
A professional healthcare
environment
Magneticeldatassigned
industrial frequency
(IEC61000-4-8)
30 A/m 30 A/m A professional healthcare
environment
Voltage dips, short interruptions
and voltage variations
(IEC61000-4-11)
0%UTfor0.5cycles
A0°,45°,90°,135°,180°,225°,
270°and315°0%UTfor1cycle
70%UTfor25cyclesat50Hz
For 30 cycles at 60 Hz
Single-phase: at 0
0%UTfor0.5cycles
A0°,45°,90°,135°,180°,225°,
270°and315°0%UTfor1cycle
70%UTfor25cyclesat50Hz
For 30 cycles at 60 Hz
Single-phase: at 0
A professional healthcare
environment
Iftheuseofthesystemrequires
continuous operation during
mains power outages, it is
advisabletosupplythemedical
device using a separate current
source (UPS, etc.).

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SHAVER SYSTEM
12.5. ELECTROMAGNETIC IMMUNITY, RADIOFREQUENCIES
Themedicaldeviceisdesignedforuseinthemagneticandelectromagneticenvironmentdescribedinthetablebelow.
The user and/or installer must ensure conformity of the electromagnetic environment.
Immunity test Test level Conformity level Electromagnetic
environment / comments
CAUTION:RFmobilecommunicationdevices(includingperipheralssuchasantennacablesandexternalantennas)shouldnotbeused
nearerthan30cm(12inches)fromanypartofthemedicaldevice,includingthecablesspeciedbythemanufacturer.Ifthisisnot
respected,theperformanceofthesedevicesmaybeimpaired.
Radiated radiofrequency
electromagneticeld
(IEC61000-4-3)
10 V/m
80MHzat2.7GHz
80%MAat1kHz
10 V/m
80MHzat2.7GHz
80%MAat1kHz
A professional healthcare
environment
Neareldsemittedbywireless
RF communication devices
(IEC61000-4-3provisional
method)
9 V/m
710 MHz, 745 MHz,
780MHZ,5240MHz,
5550MHz,5785MHz
27 V/m
385MHz
28V/m
450MHz,810MHz,
870MHz,930MHz,
1720MHz,1845MHz,
1970 MHz, 2450 MHz
9 V/m
710 MHz, 745 MHz,
780MHZ,5240MHz,
5550MHz,5785MHz
27 V/m
385MHz
28V/m
450MHz,810MHz,
870MHz,930MHz,
1720MHz,1845MHz,
1970 MHz, 2450 MHz
A professional healthcare
environment
Conducteddisturbances,
inducedbyRFelds
(IEC610004-6)
3 V
150KHzat80MHz
6VinISMfrequencybandand
bandbetween0.15MHZand80
MHZ,
80%MAat1KHz
3 V
150KHzat80MHz
6VinISMfrequencybandand
bandbetween0.15MHZand80
MHZ,
80%MAat1KHz
A professional healthcare
environment

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13. SYMBOLS
Symbol Description
S
L
C
I
Button
Screen
Socket
Label(rearpaneloftheunit)
Formedicaldevices,thissymbolisassociatedwiththeyearofmanufacture.Thelatterisdenoted
byfourgures
Formedicaldevices,thissymbolisassociatedwiththenameandaddressofthemanufacturer
Protective grounding
Class 1 product
Compliant with European directive 93/42/CEE
An equipotential grounding socket conductor other than protective grounding or a neutral conductor,
fordirectconnectionbetweentheelectricalequipmentandthepotentialequalisationbusbar.Kindly
refertostandardIEC60601-1,3rdedition
T UL/CSA time-delay fuses
Video output ports and peripheral control output port
Data input and peripheral output
CF-type device
Electronicandelectricalequipmentmarketedafter13/08/2005.Thissymbolindicatesthatthis
productisnottobetreatedwithhouseholdwaste.
Read the user manual
RF transmitter
Upper and lower temperature limit of the medical device
Humidityrangewithinwhichthemedicaldevicecanbesafelyexposed
Atmosphericpressurelimit.Indicatestherangeofatmosphericpressurewithinwhichthemedical
devicecanbesafelyexposed
Cataloguenumber
Serialnumber