Kernel KN-2200B User manual

ColposcopeDigitalImagingSystem
Preface
Welcomeyou touseColposcopeDigitalImagingSystem.
Dear customer,firstofall,thankyou fortrusting and usingthis
systemmanufacturedbyourcompany.It isimageworkstation
disposingsystemcombining computertechnologyandcolposcope
technology.
Foryouoperatingthissystemmoreproficiently,wemakethe
detailed usermanual.Pleaseyoumustreadthismanualandother
all information carefullywhenyour firstinstallationandusingthis
system.
Tosatisfythedemandofthe marketandthecustomer,wewill
continuouslyupgrade ourproduct(includinghardwareand
software).Wewill announceyouimmediatelyiftakesome
amendment. Thanksinadvanceifyoucorrectitafterfinding any
mistakeor oversight.
The contentsofthismanualisprotected bycopyrightlaw.
Nobodyisallowedtocopy,takephotoortranslateintoother
languagesofthismanualwithouttheprior writtenpermissionofthe
company.
Edition V2.3
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ColposcopeDigitalImagingSystem
ImportantNotice
Pleasecontactourservicecenterimmediatelyifyoufaceany
questionorneedrelevantinformation.Ourengineerwill supplyany
helpwhatyouneed.
The correctusewill extend instrumentslife,thusefficiencycan
be extended toitsgreatest extent.
Abnormaloperationwill beharmfultothe instrumentandthe
humanbody. Ourcompanywillnotbeliableforabnormalcondition
orinjurytohumanbodyor instrumentcausedbyoperationsthat
are absolutelyprohibitedasspecified inthismanual.Atthe same
time,our companyeitherwon tbe responsibilityforthepotential
safety,reliabilityor performanceinthefuture.Anyfaultsarising from
it willinvalidatethe warranty.
Need read "safetyrequirement","notice"andspecialwarning
“ ”contentcarefullybefore using.
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ColposcopeDigitalImagingSystem
Contents
CHAPTERI SAFETYREQUIREMENTAND ATTENTIONS.......................................................1
1.1SAFETY REQUIREMENT ...................................................................................................1
1.2ATTENTIONS ..................................................................................................................1
1.3INDICATIONSAND CONTRAINDICATIONS.............................................................................3
CHAPTERIISUMMARY ................................................................................................................5
2.1FUNCTIONSUMMARY ......................................................................................................5
2.2STRUCTUREANDCOMPOSITION .......................................................................................7
2.3MAINTECHNICALPARAMETERS........................................................................................7
CHAPTERIIIINSTALLATIONAND CONNECTION....................................................................9
3.1CHECK UPBEFOREINSTALLATION....................................................................................9
3.2CONNECTION .................................................................................................................9
3.2.1Rockarmassembly.........................................................................................................9
3.2.2Connection of hardwareand software........................................................................15
3.2.3ACpowerconnection...................................................................................................15
CHAPTERIVTHEPROPOSEDCLINICALOPERATION........................................................16
4.1PREPARATIONBEFORETHEEXAMINATION.......................................................................16
4.2EQUIPMENTAND REAGENTSFOREXAMINATION................................................................16
4.3EQUIPMENTOPERATIONPROCEDURESAND ATTENTIONS..................................................16
CHAPTERVSYSTEMOPERATIONAND USAGE...................................................................18
5.1OPENINGANDCLOSINGOFTHESYSTEM..........................................................................18
5.2SOFTWARE OPERATIONS ..............................................................................................19
5.2.1SystemSettings............................................................................................................20
5.2.2Imagescollection..........................................................................................................22
5.2.3Atlasanalysis................................................................................................................26
5.2.4diagnosisreport............................................................................................................28
5.3OBSERVATIONSYSTERMOPERATIONS.............................................................................36
5.3.1Basicparameters .........................................................................................................36
5.3.2Operation......................................................................................................................36
5.4LIGHTSOURCEOPERATION............................................................................................37
CHAPTERVIMAINTAINAND MAINTENANCE .....................................................................39
6.1MAINTENANCEOF EQUIPMENTAND ACCESSORIES............................................................39
6.2 CLEANINGEQUIPMENT ................................................................................................40
6.2.1Equipment.....................................................................................................................40
6.2.2Cameraset...................................................................................................................40
6.3STORAGE ....................................................................................................................41
6.4TRANSPORTANDSTORAGE............................................................................................41
6.5FUSE REPLACEMENT.....................................................................................................41
6.6LIGHTSOURCELAMPCHANGE........................................................................................42
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ColposcopeDigitalImagingSystem
CHAPTERVII TROUBLESSHOOTING .....................................................................................43
CHAPTERVIIIAFTERSERVICE................................................................................................44
APPENDIXINDIXOF COLPOSCOPE........................................................................................45
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ColposcopeDigitalImagingSystem
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ChapterISafetyRequirementandAttentions
（Readthechaptercarefullybeforeusingit）
1.1SafetyRequirement
lThedeviceisfitforthe safetyrequirment ofIEC60601-1and IEC60601-1-1.
lDevicecan assurethe safetyandcorrectiononlywhen it isconnectedtodevice
supplied byOurcompany,cannotassuresafetyforotherdevicesupplied by
othercompany.
lThedevicecan beusedforone patient once.
lThedevicemustbeconnect totheground toavoidthe dangerouscircuit.
lTheelectricalequipment ofthe devicecan beused inthe patientenvironment .
lPhysiologicaleffect: Coldlightsourcecannotbeturned on beforeinsertinginto
the beamoflight toavoidthe light damagingthe eyes
lBeforeusingthe equipment, pleaseconfirmstrictlyindications,contraindications
and possibleadversereactions.
lElectromagneticfieldsmayinterferewiththenormalworkofthe system.
Therefore,makesurethatthe externaldevicecomplywithEMCrequirements.
X-raymachine ormagneticresonancedeviceispossibleinterferencesource,
becausetheycan producehighintensityelectromagneticradiation.Meanwhile,
farawayfrommobilephonesorothercommunicationsequipment.
1.2Attentions
lDevicecan onlybeused bytrained medicalpersonnel.Skilled operation ida
mustformedicalpersonnel,andshouldhavethebasicclinicalknowledge.
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ColposcopeDigitalImagingSystem
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lThegynecologicalexamination shouldnotbe donebeforecolposcope
examination.
lCervicalcancerprevention smear,cleanliness,and trichomoniasis,mold
inspection shall becompleted aheadofscheduleinthe generalout-patient.
lColposcopeexamination isonlyasecondarymeans,theresultsarenottheend
result, othertestsshouldbecombined todetermine the result,ultimately
determine the cause.
lInordertoavoidelectricshock andreducedevicefailure,can notmakewater
intodevice.Ifliquidisfallen ontothe machine,shutdownmachine immediately,
and contact withourservicepeopleimmediately.
lNeed check all cablebeforeusing,need noticetoavoidmakecableintertwine on
the neck ofpatient, needreplacebad cableand connectorimmediately.
lColposcopelensareprecision opticalinstruments,anylanding,collision may
causelensoropticalaxisoffset, resultingimageisnotclearand cannotbeused.
lIncorrectmethod toclosethe mainframewill affectthe softwaretobeused
normally,even damagethe system'ssoftwarefunctions.
lAvoidusingcameraequipmenton the strongbrightplacetoimageacquisition
suchasstronglight source, theSunetc.
lIntheprocess ofusingcameraequipment, awayfromthe RFlinesasfaras
possiblesuchasaudioorvideo source.
lDonot saverecordsinthesystemdisk and install directory.
lWhen backupdata,otheroperationsarenotallowed,orelseaffectsthespeedor
even lead tocrashes.
lEquipmentpowerissudden offduringnormaluse,itwill notmakeoperatoror
patientinjury,Pleaseclick manualsteps,andclosethe proceedings,when power
ison again, operatethe equipment normallyinaccordancewiththe manual.
lRemovableporousplugcannotbeplaced on theground,the MAX load:AC
10A/250V.
lRemovableporousoutletonlytobeused tothesystemequipment, notconnect
externalequipment. Ifconnectothers,, theremayleadtothesecurityrisks
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ColposcopeDigitalImagingSystem
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becauseofthe superposition ofthe leakage.
lOtheradditionalremovableporousplugorextension cordcan notbeaccessed
the system.
lToensurethe safeoperation ofequipment, all possiblereplacementparts ，
accessoriesand all kindsofsuppliesthatthe instrumentsareequipped with,
pleaseusetheproduct modelsprovided ordesignated bythe company.
lHandling ofaccessories and device
Need tohandlepackingmaterialsaccordinglytolocalwastedisposalrules,
avoidtolet childtouch.
Devicelifeis5year.Need tohandledeviceandaccessoriesaccordingto
relativerules.Anyquery, pleasecontactourcompanyorouragency.
lUsermanual
Inordertoassureusingthisdevicesafety,mustobeythismanual.Butthis
manualcan not replaceacknowledged plasticexperienceofpatientnursed.
lDatalost
The devicemaybelosedatainanytime.Need tocheck patientcarefullyoruse
replaced devicebeforerecovering.Ifdevicecan notberestartedin60second,
need tousepowerswitchforrestarting.
1.3Indicationsand contraindications
lIndications
ØVaginalfallen offcytologysmearexamination morethan three levelor
persistentmildabnormalcell:suchaspicturesfound atypicalinflammation,
nowknownasASCUS(AtypicalSquamousCell OfUndermined
Significance),thisisatypicalsquamouscellsorPapII levelthatcan notbe
sure.
ØAlthoughcytologyexamination isnegative, the nakedeyesuspectedcancer
ØLong-termtreat it asthecervicitis, but the resultswerepoor.
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ØNaked eyeisdifficulttodetermine the fine shapestructure,and needthe
colposcopetomagnifythe lesionsforobservation.
ØBeforethe cervicalcancersurgery,need tousecolposcopetoobservethe site
lesion spreadingtoguide surgical.
lContraindications:
ØOthergynecologicalvaginaloperationsarenotallowbeforeformerone dayof
colposcopeexamination
ØVaginalmedication areprohibittwodaysago beforethe colposcope
examination.
ØCan not beallowed todo colposcopeexamination inthe menstrualperiod.
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ColposcopeDigitalImagingSystem
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ChapterIISummary
ColposcopeDigitalImagingSystemisresearched andproduced byourcompany.It is
imageworkstation managementsystemcombiningcomputertechnologyandelectric
colposcope.It isanewproductcollectsdigitalimagingtechnologyandcolposcope
technology.Itisapplied forgynecologyinspection.Thistechnologyisdifferentfrom
traditionalcolposcopeinspection.It cancelsocularand breaks throughlimitofoptic
colposcopeinspection.Doctorsobservefocusonlythroughcolordisplay.Itsgood
lamp-houseand highpowermagnified imagesenabledoctortofind tinydetailsandcan
collect, magnify,freeze,store,pathologicallyanalyzeand printthe imagesobserved on
the screen. It can beused incourseofdiagnosis, supplyinghigh-qualityservicetodoctors
andpatients.It improvesfunction ofcolposcopeinspection andsatisfydeveloping
requirement offuture “digital”medicalimage.
2.1Functionsummary
Scopeofapplication
Onthe clinical, checkupwithvulva,vagina, cervixand otherparts.
Device features
lHigh resolution and high-resolution observationsystem
Ø1/3′High-resolution colordigitalCCD.
ØVideo output.
ØFast auto-focusandmanualfocuscontrol.
ØAutomaticallyadjust whitebalance.
ØUnique spectralgratingand CCD imagingdeviceunique fine-tuningmake
the screenshowindependentbodyimaging,sothatLesionsobserved at
different levelscan get the best results
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ColposcopeDigitalImagingSystem
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ØObservation systembuilt-inscalecan measurethe sizeoflesions
lUniquelightsource design
ØFive-timeszoomfocus,three-dimensionalsenseofstrong,distinct, large
vision.
ØIntegrated designofthe dualopticallightsourceandfiberoptic
transmission systemscan adjust thebrightness.
Øwithagreen filter, tofacilitateobservation ofcapillarylesions.
lStand
Øflexible,convenient, lockablecantileversupport, barrier-free design,easy
adjustment at anyangle.
lComputerimaging,datamanagementand diseaseanalysiscapabilities
integrated
ØWithINTELprocessorcomputerprocessingsystem.
ØHigh-resolution colordisplay.
ØWithclearinkjet colorimageoutput.
ØSetof imageacquisition,display,processing,recording,reportprintingand
storagefunctionsforthe integrated managementWINDOWSoperation
system.
ØVersatileimageprocessingand managethe specialpackage, allowstotag,
add annotation, zoominand out, partialzoominandotheroperations.
ØRichmapdatabaseof cases(upto175 kinds),providingalargenumberof
casesmapstofacilitatecomparativeanalysistohelpdoctorsaccurately
diagnosecases.
ØSupportthe Chinesereportofdiagnosisresult,and true colorimageoutput.
ØCan storelargeamountsofimagedata,withthe fuction ofdatabackup,
storagecapacitywill beunrestricted.
ØNewdatastoragemethod toimprovethe user'ssearchspeed.
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2.2Structureand composition
Thesystemisconsistsofcameraequipment, lightsource,computers,monitors,
printer.Computermainframe, displayscreen andprinterareoptional
Pic2-1
2.3Maintechnicalparameters
lDisplay screen：Resolution isnot less than 1024 ×768 pixel.
lPowersupply：AC220V±10%，50Hz±2%。
lInputpower the totalpowerisnotmorethan 420VA。
ØCameraequipment：20VA.
ØLight source：150VA.
lFuse specifications, ratings：Light source: F2AL/250V Φ5×20.
lCamera: Horizontalresolution isno less than 480 lines.
lWorkdistance：200mm～400mm.
lLightsource:
Computermainframe
Displaysreen
Printer
C
ameraequipment
Stand
Lightsource
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ØLightsourcebrightness isadjustable,withthe function offiltertransfer.
Withinthe workingdistance, illumination isnot less than 1200Lux.
ØTheirradiated surfacetemperaturedoesnotexceed41 .
ØGuide beamplugdiameter：>ф10 ㎜.
lSecurityCategory: cameraequipment: Class , light source: Class .ⅡⅠ
lIntermittent load continuousoperation equipment.
lCommon equipment (not anti-progress solution).
lCan notusethe equimentinaflammableanestheticmixturewithairorwith
oxygen ornitrousoxide gasmixtureofflammablegasunderanesthesia.
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ColposcopeDigitalImagingSystem
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ChapterIIIInstallationandConnection
3.1Checkup beforeinstallation
lTakeouttheinstrumentfromthe box,and layitinasafe,secureand easyto
observeposition, then lock the universalwheel. ofthe bottom
lCheck the randompartsinaccordancewiththepackinglisttoensurethe
integrityofparts.
3.2Connection
3.2.1Rockarm assembly
1.Fixthe basetothe casterbracket accordingthe basenotch：
Pic3-1
2.Insert thestrut tothe base：
Pic3-2
Base
casterbracket
strut
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ColposcopeDigitalImagingSystem
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3.Fixthe screwAtothe position ofthebottomwhichthe redarrowsindicate,and
tighten：
Pic3-3
4.Removethe screwsBinthe bottomoflight source:
Pic3-4
5.Fixthe light sourcetothetopofstrut：
Pic3-5
ScrewA
螺钉螺钉螺钉ScrewB
Lightsource
strut
Lightsource
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6.Fixthe strut andlight sourcewiththe fourremoved screws：
Pic3-6
7.Removethe screwsofthe bottomofrockerarm：
Pic3-7
8.Fixthe rockerarmtothe front oflight sourcefixed hole:
Pic3-8
ScrewB
ScrewC
Rockerarm
Coldlightsource
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9.Fixthe screwCtothe bottomofrockerarm：
Pic3-9
10.Removethe screwDfromthe bottomofeyepiecestand：
Pic3-10
11.Fixthe eyepiecetothe front ofrockerarm：
Pic3-11
ScewC
ScrewD
Eyepiece stand
Rockerarm
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12.Install thescrewDtothe bottomofrockerarmand fixthe eyepiecestand：
Pic3-12
13.Fixthe eyepiecetothe standandtighten the screwE ：
.
Pic.3-13
14.Fixthe digitalCCD tothe eyepiecestand：
Pic3-14
ScrewD
Eyepiece
ScrewE
DigitalCCD
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ColposcopeDigitalImagingSystem
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15.Insert thefiberportAtothe output holeofcoldlight source：
Pic3-15
16.Lead the fiberintothe rockerarmfixed deductioncard：
Pic3-16
17.InsertfiberportBintolightinputholeinthe bottomofeyepiecestand，fixed the screw
F：
Pic3-17
FiberportA
fixeddeductioncard
ScrewF
FiberportB
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ColposcopeDigitalImagingSystem
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3.2.2Connectionofhardwareandsoftware
Pleaserefertoinstallationmanual.
3.2.3ACpowerconnection
lInsert thethree corepowercordintothedevice'sACpowersocket, andinsert the
plugend intotheremovableporousthree-corepowersocket matchingthe device.
lInsertthe removableporousthree-corepowerplugintothe AC220V50Hzthree
coreACpoweroutletToensurereliablegrounding.
NOTE: Equipmentmustbeindividuallyconnectedtotheplug,theplug cannot
besharedwithotherelectricalequipment.Intheareasthatvoltageis
instability,pleaseuse theregulatedpowersupply.
electricalequipmentthatarenotstatedshouldnotbeconnectedwith
theapparatus.
Instrumentsshouldbeplacedineasyvibration orshaking place.
Enoughspace around theinstrumentislefttoensurethenormal
ventilation oftheequipment.
Normalworking conditionsshouldberequiredwhendevice isrunning.
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ColposcopeDigitalImagingSystem
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ChapterIV Theproposedclinical operation
4.1Preparation beforetheexamination
1.Askingaboutthecasehistory,menstrualhistorytoselectthe appropriateinspection
time.
2. Doingthe trichomonas, fungal, Papsmearscreening.
3.Forthesuspected infection patient,shoulddothe culturingofvagina,cervix
secretions,andthepositivediscoverershouldbefirstlycured accordingtothe
diseasecondition.
4.Preoperative24-hour,vaginalgynecologicalexamination andotheroperations
shouldbeban.
5.48hoursbeforesurgery,vaginalmedication areban,forfearthatthedrugsare
adheredtothe surfaceofthe vagina andcervixand affect the examination results.
4.2Equipmentand reagentsforexamination
1.Device:Vaginal,biopsyforceps,curette,gauzeforceps,retractors,gauze,cotton
swabsand soon.
2. Reagent: 3%aceticacidand1%iodine solution.
4.3Equipmentoperationprocedures andAttentions
lEquipmentoperationprocedures(take thecervical forexample)
Patientstakethebladderlithotomyposition,placetheexpansion device, and then
gentlywipethe mucuson thecervixsurfacewiththesterilized gauze.Adjustthe
cameraposition and check thedistance(20 ~40cm)and then adjustthefocallengthof
colposcope,sequentialexposureexamined positionschange,thatisconverted zone,
epithelial, vascular, etc.
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