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
Page: 2 // 22
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

Ackermann
Page: 3 // 22
SHAVER SYSTEM
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
Ackermann
Page: 4 // 22
• 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.

Ackermann
Page: 5 // 22
SHAVER SYSTEM
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

ENDOSCOPIC CAMERA SYSTEM
Ackermann
Page: 6 // 22
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

Ackermann
Page: 7 // 22
SHAVER SYSTEM
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.

ENDOSCOPIC CAMERA SYSTEM
Ackermann
Page:8//22
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

Ackermann
Page: 9 // 22
SHAVER SYSTEM
•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
0483

ENDOSCOPIC CAMERA SYSTEM
Ackermann
Page: 10 // 22
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.