stazione diagnostica da parete visio 5 plus visio 5 plus … · 2020-07-17 · 2. constant output...

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STAZIONE DIAGNOSTICA DA PARETE VISIO 5 PLUS VISIO 5 PLUS WALL DIAGNOSTIC STATION STATION MURALE DE DIAGNOSTIC VISIO 5 PLUS ESTACIÓN DIAGNÓSTICO DE PARED VISIO 5 PLUS 31620 - 31621 - 31622 - 31623 M31620-rev.0-06.20 Manuale d’uso - User manual Manuel de l’utilisateur - Guía de uso • È necessario segnalare qualsiasi incidente grave verificatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello Stato membro in cui si ha sede. • All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of the member state where your registered office is located. • Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que nous avons livré au fabricant et à l’autorité compétente de l’état membre où on a le siège social. • Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el que se encuentra la sede sobre cualquier incidente grave que haya ocurrido en relación con el producto sanitario que le hemos suministrado. Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy [email protected] - [email protected] www.gimaitaly.com Made in Pakistan

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Page 1: STAZIONE DIAGNOSTICA DA PARETE VISIO 5 PLUS VISIO 5 PLUS … · 2020-07-17 · 2. Constant output voltage with integrated surge protection. 3. Soft start technology introduces voltage

STAZIONE DIAGNOSTICA DA PARETE VISIO 5 PLUSVISIO 5 PLUS WALL DIAGNOSTIC STATIONSTATION MURALE DE DIAGNOSTIC VISIO 5 PLUSESTACIÓN DIAGNÓSTICO DE PARED VISIO 5 PLUS

31620 - 31621 - 31622 - 31623

M31

620-

rev.

0-06

.20

Manuale d’uso - User manualManuel de l’utilisateur - Guía de uso

• Ènecessariosegnalarequalsiasiincidentegraveverificatosiinrelazionealdispositivomedicodanoifornitoalfabbricanteeall’autoritàcompetentedelloStatomembroincuisihasede.

• Allseriousaccidentsconcerningthemedicaldevicesuppliedbyusmustbereportedtothemanufacturerandcompetentauthorityofthememberstatewhereyourregisteredofficeislocated.

• Ilestnécessairedesignalertoutaccidentgravesurvenuetliéaudispositifmédicalquenousavonslivréaufabricantetàl’autoritécompétentedel’étatmembreoùonalesiègesocial.

• EsnecesarioinformaralfabricanteyalaautoridadcompetentedelEstadomiembroenelqueseencuentralasedesobrecualquierincidentegravequehayaocurridoenrelaciónconelproductosanitarioquelehemossuministrado.

GimaS.p.A.ViaMarconi,1-20060Gessate(MI)[email protected]@gimaitaly.comwww.gimaitaly.comMadeinPakistan

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6ENGLISH

INTENDED USE:Visio5plusisconvenient,modularpackagethatplaceseverythingneededforfast,accuratediagnosisatarm'slength.Bycombiningawalldevicewithophthalmoscope,otoscopeandspeculadispenser,Gimaplacesallthebasicdiagnostictoolswithineasyreach.TheVISIO5plusprovidesaconstant3.5Voutputvoltageindependentofmainsvoltagefluctuationsformedicaldiagnosticinstruments.Itshouldonlybeoperatedbytrainedmedicalstaffwithinaprofessionalhealthfacility.TheVISIO5plusistheconvenient,toughestandreliablemodulardiagnosticstationforhospitalsandmedicalpractices.Withitscentralizedelectricalpowersupply,theVISIO5offersthereliabilityrequired.Thisguaranteescostsavingsandeliminatestheneedforbatteries,whichisalsogoodfortheenviron-ment.

PRECAUTIONS:•Thisunitdoesnot requireanymaintenance.Donotopen thehousing.Repairsshouldonlybe carried out by qualified specialists. If the unit is damaged, disconnect the power cordimmediately.

•Ensurethatthemainsvoltagespecifiedontheinstrumentlabelconformstothelocalmainsvoltage.

•Donotuseinthepresenceofanexplosionhazardorinmagneticfields.•Checkthecorrectoperationofthedevicebeforeuse.•Usepowersupplyindryenvironmentonly.•Avoidsplashingwater.•UseonlyoriginalGimaparts,spareparts,accessoriesandpowersources.

FEATURES:1. Ergonomicdesignednon-sliphandle.2. Constantoutputvoltagewithintegratedsurgeprotection.3. Softstarttechnologyintroducesvoltagegentlyintoinstrument'sbulb/LEDwhenturnedonandelim-

inatescold-shockandgreatlyincreasesbulb/LEDlife.4. Theunitprovidesaconstant3.5Voutputvoltageindependentofmainsvoltagefunction.5. ThehandleswitchesONandOFFautomaticallyonceremovedorreplacedinthecradle.6. Theadjustablelightintensityensuresthatwheneverthehandleispickedfromcradle,thebrightness

isatmaximumandcanbelowered/decreasebyclickingthebuttondownandcanbeincreasedbyclickingbuttonup.

7. Veryprecisebrightnesscontrol,between3%and100%.8. Spiralcordstretchedto3metersensuretheinstrumenttobeusedcomfortablyfromdifferentangles.9. Lowpowerconsumption.10.ThehandleworkoptimallywellwithLEDand/orXenon-Halogeninstrumentheads.11.TheproductiscomplieswithIEC-60601-1standard.12.Handlecomeswithanti-theftfeaturesothatinstrumentheadissecuredonthehandleandcannotbe

removedwithoutspecialAllenkey,providedwiththeunit.13.Handleequippedwithabrightnesscontrolmechanismforvariableregulationoflight

SPECIFICATIONS:Input:100-250V50/60HzPower:34VAMaxFastFuse:2x250V/2APolyFuse:8V/2.20AOutput1:5V/2000mAOutput2:3,5V/800mA(forunitwith1handle)3,5V/800mA(forunitwith2handles)Operation:Continuouswithintermittentloading,continuousoperationtimeforhandleis1minon&10minoff.Dimensions:290.50mmx180mmx75mm

UNPACKING:After opening the packages, first of all it is necessary to check all pieces and parts composing theproduct.Checkthattheyareallpresentandinperfectcondition.Themaincomponentsarethemainunit,wallplateandscrews.

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ASSEMBLY AND DISASSEMBLY:UseonlythemountingplatesuppliedwiththeVISIO5plus1. Holdthemountingplatehorizontallyinplacewheretheunitshouldbemountedandmarktheholes

tobedrilledinthewall.2. Drillaholewithdrillbitandinsertthefixingplugs.3. Screwthemountingplateinwithasuitablescrewdriver.4. Presstheunitintothefourmountingpinsanddown.5. Checkthatallfourpinshaveengaged.Todisassemble,disconnectthepowercordandpushtheunituptoremoveitfromthemountingplate.

OPERATING PROCEDURE:1. InsertthePowercableinthewallsocket.2. DonotswitchtheUnitOnuntiltheinstrumentHeadisproperlyconnectedtotheHandle.3. LoosenthescrewinupperpartofhandleusingthespecialAllenkeyprovidedwiththeunitasshown

inbelowfigure1.4. HoldtheHandleandHeadineachhand,inserttheheadintoHandleandmatchthebayonetgrooves

ontheHandleandHead,pushtheheaddownandturnitclockwise.5. Tightenthescrewthroughtheinstrumentheadwithbayonetmountofthehandleasshowninbelow

figure2andfinalviewisshowninfigure3.6. Turnthepowerswitchto“I”andthentightenthescrewmakingtheheadmoresecureasexplained

inbelowdiagramthatisonposition,theIndicationLEDswillglowmakingsurethatunitisinworkingconditionnow.

7. TheattachedinstrumentHeadwillautomaticallylightupwhentheHandleisremovedfromHandlecradle.

8. InstrumentHeadbrightnesscanbeadjustedbyusingtheAdjustmentbuttonontheHandle.9. BrightnesscanbeincreasedanddecreasedbypressingtheAdjustmentbuttonon'+'and'‐'position

respectively.10.TheHandlecanbesimultaneouslyusedindependentofeachotherbecauseofgalvanicisolation.11.TheAdjustmentbuttondoesnotturntheinstrumentcompletelyOff,Placingthehandleontocradle

willturntheinstrumentcompletelyoff.12.KindlyswitchofftheunitfromPowerswitch(i.e.at'0'position)incaseitisnotinoperationinorder

toensurelongoperatinglife.

Note:Theotoscopeandophthalmoscopeareintendedforshort-termtreatments≤1minutewithabreakof10minutesbetweenapplications.Themaximumtemperatureattheapplicationpointatanambienttemperatureof40°Candincontinuousoperationis48°C.

TheVISIO5plushandlesareequippedwithVISIOConnectorsforusewithalltheVISIO2000andVisio5instruments.

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CHANGING THE LAMP IN OTOSCOPE HEAD:WiththeVisioOtoscope,firstloosenthescrewandthenunmounttheheadfromhandlebyrotatinginclockwisedirectionasshowninfigure-4.Nowpullthelampdownwardsasshowninfigure-5andwipetheglassofnewlampmakingsurethatitiscleanandthenpushitinsidetheotoscopehead.AfterthatlocktheOtoscopeheadontohandlebyrotating(Anti-clockwise)andtightenthescrewwithheadandhandle.Useoriginallampsonly.SwitchofftheunitcompletelybeforeremovingtheInstrumenthead.

CHANGING THE LAMP/LED IN OPHTHALMOSCOPE HEAD:WiththeVisioophthalmoscope,firstloosenthescrewandthenunmounttheheadfromhandlebyrotatinginclockwisedirectionasshowninfigure-6.Nowpullthelamp/LEDdownwardsasshowninfigure-7andwipetheglassofnewlampmakingsurethatitiscleanandthenpushitinsidetheophthalmoscopehead.Afterthatlocktheophthalmoscopeheadontohandlebyrotating(Anti-clockwise)andtightenthescrewwithheadandhandle.

EAR TIP DISPENSER (PER CODES 31620 – 31621):Donotreusethedispsablespecula!Donotsterilizethespeculainanautoclaveorwithdisinfectants!Operatingprocedure:1. TheVisio5PlusEarTipDispensercanholdupto100speculawithtwodifferentsizes:2.5mmand

4.0mm.2. Insertthespeculafromthetopbyremovingthecoveringcap.3. The2.5mmspeculacanbefetchedfromthefirsttwoslotsonthebottompartofthedispenser.The

nexttwoslotsareforthe4.0mmspecula.4. Theholdingdevicemakesiteasytofetchonespeculumatatime.Cleaningofthedispenser:1. TheVisio5PlusEarTipDispensercanbecleanedusingthefollowingmethod.2. Slightlymoistenacottonswaborclothwithisopropylorethylalcoholandgentlywipethesurfaceof

thecover.3. Wipefromsidetosideratherthaninacircularmotion.

STORAGE:Sincetheproductismadeofcorrosion-proofmaterialssuitablefortheenvironmentalconditionsforeseenforitsnormaluse,itdoesnotrequireanyspecialcare,however,itmustbestoredinsuchawayastomakesureitisprotectedfromdustandwatertoensureitshygienicconditionsandprotectionagainstshortcircuitsduringoperation.

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USE AND MAINTENANCE:

Beforeremovingthediagnosticunit,makesuretheswitchisintheOFFposition.

Anyunauthorizedchangesmaycauseashortcircuitthatmaydamagetheunit,thereforealwayscontacttheauthorizedpersonorsendtheunitbacktothemanufacturer.

Switchofftheunitcompletelybeforechangingthelamp.

CLEANING:Donotsterilizetheproduct.Itcanbecleanedanddisinfectedusing70%isopropylalcohol.Avoidusingabrasivecleaningmaterials.1)Lens:Thelenscanbecleanedusingamoistenedcotton-tippedapplicatorwithasolutionofwaterwithmilddetergent.Donotuseabrasiveultrasoniccleaners,alcoholorotherchemicalstocleanthelensesasthisdegradesthelensormirrorqualitybyscratchingthecoatedsurfaceofthelenses.2)handlewithmainunit:Disconnecttheunitfromthemainsbeforecleaning.Thehandlecanbecleanedwithamoistcloth.Thehandleshouldnotbedippedintowater.Whilecleaning,makesurethatthelampisnotsoakedwithwater.

Periodicallycheckthehandleandunit.

Autoclavingandflashsterilizingthehandlewillresultinsevereelectricaldamage.

RECOMMENDED OPERATING ENVIRONMENTOperationTemperature0°Cto40°CHumidity10%to90%AirPressure700hPato1000hPa

StorageandTransportTemperature-20°Cto50°CHumidity15%to95%AirPressure700hPato1000hPa

Caution:readinstructions(warnings)carefully

MedicalDevicecompliantwithRegulation(EU)2017/745

Productcode

Manufacturer Dateofmanufacture Lotnumber

Keepawayfromsunlight Keepinacool,dryplace WEEEdisposal

TypeBFappliedpart Followinstructionsforuse MedicalDevice

Serialnumber ClassIIapplied

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specific recycling point for electric and elec-tronic equipment.

GIMA WARRANTY TERMSTheGima12-monthstandardB2Bwarrantyapplies.