HYSTEROFLATOR 100 Operators Manual Rev B

HYSTEROFLATOR 1OO INTRODUCTION

Thismanualprovidesinformation for the operationof the HYSTEROFLATOR 100,(alsoreferredto in this manualas "unit","device" or'machine").

DEFINITIONS Thefollowinglistis abbreviations of commonlyusedtermsthroughout thismanual: mmHg

millimeters of mercury

gas

COz

mUmin.

per minute milliliters

LED

lightemittingdiode

FORUSE INDICATION ANDCONTRAINDICATIONS Indicationfor Use

The HYSTEROFLATOR for useas a meansof expansionor distention 100is indicated of the uteruswith carbondioxidegasto facilitateexamination witha Hysteroscope. Thismethodof distention is usedin procedures diagnostic and minoroperativehysteroscopy of a shortdurationwherea constantintrauterin pressureis required. Contraindications for Use The HYSTEROFLATOR 100shouldbe usedonlywhendiagnostic and minoroperativehysteroscopy procedures of a shortdurationarecalledfor,andshouldthereforenotbe usedfor anyothertreatments. lt is designedto functionwith specificHysteroscopes that providepassageof gas to the uterinecavityand shouldonlybe usedwithinstruments specifically designedfor thatpurpose.lt shouldonlybe usedunder the directguidanceof a skilledphysician trainedin Hysteroscopy. OperativeHysteroscopy. Gasemboliandcardiacarresthavebeenreportedduringhysteroscopic laser procedures.Becauseof the increasedriskof gasembolization andelectrosurgical duringoperative hysteroscopy, this deviceshouldnot be usedfor suchprocedures.

Use of this devicefor intrauterinedistentionis contraindicated wheneverhysteroscopy is contraindicated See operatorsmanualof your Hysteroscope for absoluteand relativecontraindicationsThisdeviceis contraindicated for laparoscopic insutflation, i.e.,it mustnotbe usedfor intraabdominal distention.

SAFETYFEATURES The followingfeatureshelpto ensuresafeoperationof the machine: . Gasflowcanbe stoppedat anytimeby pressingthe FLOWON/OFFpush-button. o

Whenturningpoweron, gasflowis notinitiateduntiltheFLOWON/OFFpush-button is pressed.

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lf the presetpressureis exceededby 1O7",a vafuewill relievepressureuntilthe intrauterine preset pressureplus10%is reached.

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A fixedpressurereliefoccursat 160mmHg.

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An audibleandvisualalarmwill indicatea pressurein excessof 152mmHg.

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An audibleandvisualalarmwill indicatean overflowcondition.

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1OO HYSTEROFLATOR WARNINGSAND CAUTIONS 100. for safeoperation of the HYSTEROFLATOR warningandcautioninformation Thissectiondescribes and understood in thissection,shouldbe readthoroughly in thismanual,andparticularly All information beforeusingthe device. of absorption Gardiaclrregularity.Excessive Acidosisand Resultant WARNINGMetabolic flowrateand/ or excessivepressure.The CO, resultsfromeitherexcessive by pressurein the rangeof distended uterinecavitycanbe adequately pressuregreater to usean intrauterine 35-75mmHg. lt is seldomnecessary greater 100 mUmin. Little intravasation or than than75 mmHgor a flowrate Pressures over 100 mmHg levels. are passage these occur at should tubal virtuallyneverneededandwill increasethe amountandrapidityof intravasation helpavoidproblemsrelatedto andtubalpassageof gas. Adequaterespirations

coz.

reactions.Patientswithsicklecelldiseaseor pulmonary WARNINGldiosyncratic insufficiency mayposeincreasedrisksof metabolicimbalancerelatedto excessiveCO2absorPtion. is associated withhighflow rates.As such, Thisphenomena WARNINGCO2Embolization. 100 mlimin. above insufflators shouldnotbe used whichprovide WARNINGThisdeviceis designedto functionwithspecifichysteroscopes passageof gasto the uterinecavityandshouldbe usedonlywith hysteroscopes specifically designedfor thatpurpose. to a powersource. WARNINGNeverattemptto servicethe devicewhenit is connected voltagesinsidethedevicecancausesevereelectricalshock. Hazardous Disconnect the powercordbeforeservicing. WARNINGTo avoidthe riskof explosionor fire,do notusethisdevicein the presenceof flammableanesthetics. gaslineconnections aresecurebeforeopeningthe WARNINGEnsurethatall high-pressure withgreatforce, gassource.Looseconnections couldseparateunexpectedly causingpersonalinjury. could shouldnotbe exposedor storedwheretemperatures WARNINGThe gascartridges exceed160'F(71"C). of a WARNINGThisdeviceshouldbe operatedonlyby or underthedirectsupervision The usershouldbe physicianexperienced fundamentals. withhysteroscopic familiarwiththe operationof thisdevicepriorto use. thoroughly WARNINGTo avoidthe riskof electricalshock,connecithepowercordto a properlywired groundingreceptacle only. to tubalobstruction, WARNINGTo avoidthe riskof ruptureof a fallopiantubesecondary pressures above150mmHgshouldbe avoided.

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HYSTEROFLATOR 1OO CAUTION Federallawrestrictsthisdeviceto saleby or on the orderof a physician. CAUTION Do notallowfluidsto enterthe device.Damagecanresult. CAUTION Thecabinetshouldnotbe openedexceptby a qualifiedserviceperson. personscandamagethe unit. Tampering by unqualified CAUTION Verifyproperconnection of tubingbeforeusingthe machine. CAUTION Thisdeviceallowsfor theventingof gas in the conditionthatthe intrauterine pressureis exceeded.An Olympustubingkit (8313036)with an integral filtershouldbe usedat all timesto prevent 0.2 micronhydrophobic of the device. contamination

DESCRIPTION OF EQUIPMENT The HYSTEROFLATOR 100is indicated for useas a meansof expansion or distention of the uteruswith is usedin diagnostic carbondioxidegas.Thismethodof distention andoperativehysteroscopy procedures.

SPECIFICATIONS Si ze:

13.25 wX 6 . 2 5 h X1 1 d in . 337x 159x 279 mm

Weight:

12 lb.(s.4kg).

ControlPanel:

Pressureis displayedin a threedigitdisplay.LED'sindicatethe statusof the gassupply,flowconditions andoverpressureconditions.

Gas FlowLimit:

Adjustable from0-100ml/min.

Pressure:

Adjustable from0-150mmHg.

PressureReliefValve:

reliefof pressureat 10%abovethe presetvalue.Fixed Electronic controlled reliefof pressurewilloccurat 160mmHgandan audiblealarmwillsoundat >152mmHg.Bothpressurerelieffeaturesare activewhethergasflowis on or off for addedprotection.

Operatingmodes:

FLOWON/OFF.

GasSupply:

MedicalGradeE-cylinder or disposable 16 litercartridge.

Gas InputPressure:

0 to 2200PSl.

ELECTRICAL REOUIREM ENTS lnputVoltage:

100,120,220,240VAC;50/60Hz. Linevoltagetoleranceis *10% of nominal.

Power:

15 watts,fuseprotected,with removablepowercord.

Standards:

UL544;lEG601-1;lEC€01-2

ENVIRONMENTAL REQUIREMENTS is acceptable.lf a sterileunitis required,drapethe unit Any normaloperatingroomor officeenvironrnent with sterilecoversthat allowaccessto he controls. periodiccalibration of the uniton an annualbasisis recommended, As withany precisioninstrument, or require. on a morefrequentbasisif conditions 8S14901-0REV B

HYSTEROFLATOR 1OO SETUPAND OPERATION HYSTEROFLATOR 1OOFRONTPANELCONTROLS AND INDICATORS

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POWERSWTTCH Turnsthe poweron/offto the machine.

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GASOUTPUTTOPAT|ENTCONNECTTON Gonnector for tubingkit.

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PRESSURESELECT Allowsthe userto selectthe maximumpressureof distention. Rangeis from0 to 150mmHg.

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FLOWRATELtMtT Allowsthe userto selectthe maximumflowratefrom0 to 100milliliters per minute.

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TNTRA-UTERINE PRESSURE DtSpLAy pressureis displayedin mmHgwiththreedigits. The intrauterine

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OI'|/OFFFLOWCONTROL Startsor stopsthe flowof gas.

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ovERPRESSURE pressureexceedsthe preselected ThisLEDis turnedon anytimethe intrauterine pressuresetting by 1O%or more. GASSUPPLYTNDTCATORS The NORMALLEDis turnedon anytimethe gassupplyis greaterthan300 mlwitha cartridge. The LOWLEDis turnedon anytimethe supplyis lessthan300 mlwitha cartridge.

FLowcoNTRoLtNDtcAToRs The ON LEDindicatestheflowmodeis activated. The FLOWLEDindicatesgas is actually flowing.Whengas is flowingnormally,the FLOWLEDwill be green.Whenthe gasflow exceedsthe FLOWRATELlMlT,the FLOWLEDwillberedandthealarmwillsound.lf this conditionoccurs,the unitshouldbe removedfromserviceand sentto an authorized service centerfor repair.

HOLDER 110l GASCARTRIDGE

gascartridge. Thisis the accessopeningfor the disposable

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HYSTEROFLATOR lOO lOOBACKPANELCONTROLS ANDINDICATORS HYSTEROFLATOR

GASINLET

CAUTION

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A WARNINGA

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TO REDUCETHE RISKOF ELECTRICAL RISKOF FIRE. SHOCK,DO NOT REMOVETHE COVER. REPLACEFUSEAS ilARKED REFERSERVICINGTO QUALIFIEDPERSONNEL.W;1H SLGBLOW OR TltE DELAy

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DANGER

60 to 2200 PSI PRE-FILTERGAS

EXPLOSION RISKIF USEDINTHE PRESENCEOF FLAMMABLEANESTHETICS.

WARNING

orvilPus CYMS

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RELIABILIWCANONLYBE ACHIEVED GROUNDING WHENCONNECTEDTO AN EQUIVALENTRECEPTACLE MARKED'HOSPITALONLY' OR'HOSPITALGMDE'

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CAUTION

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GASINLETPORT Forconnecting usinga highpressurehoseandyokeassembly.Gassupplymust an E-cylinder be filteredto 25 microns.

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AC POWERCONNECTION powercord. voltagerange.AC inputis witha standardhospitalgrade Userselectable

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HYSTEROFLATOR 1OO

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GASSUPPLY ll an E-cylinder is usedthe gassupplyshouldbe pre-filtered to 25 micronsto protectthe device.The Olympushigh-pressure hoseandyokeassembly(8313065)hasa prefilter. An E-cylinder connection is madeby attachingoneendof a medical-grade high-pressure hoseto a tankor hospitalgassource. Reqovethe capfromthe machine's Gas InletPort. Attachthe threadedend0f the high-pressure hoseto the Gas lnletPorton the rearof the unit. Tightenthe connection witha wrench,takingcarenotto over-tighten.

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Correctconnection of thetubingkit is essentialfor properoperation.

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Onlytubingkitsthathavebeendesignedto filterCO2gasto 0.2 micronshouldbe used.Foroptimum performance usean Olympustubingkit.

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ESTABLISHING DISTENTION

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lf disposable (8313066) cartridges are used,insertthe cartridgeintothesuppliedholderandthenscrew the holderintothe openingon the frontpanelof the unit.To insurea tightseal,turnthe holdera 114of a turnafterthegas is heardenteringthe system.Handtightenonly. Turnon thefrontpanelPowerSwitch.lf eitherthe FLOWLEDor the FLOWON remainson. havethe unitserviced. lf an E-cylinder is used,openthevalveon the gassupplysourceor tankwhilewatchingfor gasleaks. ObservethefrontpanelGasSupplyIndicator for the NORMALLEDto light.lf the pressureis not adequate, the LOWLEDwill light.lf thishappens,replacethe gassource.lf the gassourceis knownto be adequate,havethe unitserviced.

TUBINGCONNECTION

Positionthe HYSTEROFLATOR 10Osuchthatthe frontpaneldisplaysareeasilyvisibleduringthe procedure. Selectan operatingflowrateusingthe FLOWRATELIMITcontrol. S-elect an operatingpressureusingthe PRESSURE SELECTcontrollocatedbelowthe pressuredigital display. Insertthe hysteroscope into the patient. Pressthe FLOWON/OFFpush-button. The FLOWON LEDwill be illuminated. Whengas is ftowing,the FLOWLEDwillbe green, lf the gasflowexceedsthe FLOWRATELlMtT,the FLOWleO wiltbe redand the alarmwillsound.lf thisconditionoccurs,the unitshouldbe removedfromseruiceandsentto an authorized servicecenterfor repair. As the pressurein the uterusincreases, the pressurewillbe displayedon the digitalreadout. To adjustflowlimit,simplychangethe desiredflowlimitusingthe FLOWRATELIMtTcontrot.

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Continuously monitorthe pressureandadjustas necessary. lf the pressureneedsto be reduced,setthe newpressuredesiredwiththe PRESSURE SELECTcontrol.lf thevaluedesiredis lowerthanthe previousvalueby morethan10%,the unitwill releasepressureuntilthe newvalueplus10olo is reached.

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HYSTEROFLATOR lOO THEORYOF OPERATION PNEUMATIC SYSTEM fittingor froma CO2gascartridge. Thefirststageregulator Gasinputis froma standardcompression A fixed the statusof the gassourcepressure. regulates the gasto allowa pressureswitchto determine setto 100"PSlprotectsthe pneumatic PressureReliefValveon the outputof the firststageregulator systemfroma faultin thefirststageregulator.Whenthe pressureswitchsensesthe pressureis LEDon thefrontpanelwillturn the NORMAL on andthe to provide300mlfroma cartridge, adequate LOWLEDwillturnoff.Whenthe pressureswitchsensesthe pressureis notadequateto provide300 ml offandthe LOWLEDwillturnon.The froma cartridge, the NORMALLEDon thefrontpanelwillturn A 25 secondstagegas regulatoris setto providea maximumof 110ml/min.flowto the outputconnector. micronfilteris in lineto protectthe controlorificesandvalves.Theflowof gas is sensedby a differential pressuretransducer flowcontrolvalveanda acrossa precisionorifice.A proportional connected to pressuretransducer A normallyclosedvalveis connected the outputpressure. is usedto "regulate" pressure panel pressure port the front setting by when the output exceeds to allowventing the output to the outputportto provide morethan10%.A fixed160mmHgPressureReliefValveis alsoconnected fail safe protectionagainstoverpressureat the output.

PRESSURE CONTROL of a reference(frontpanelcontrol), Theoutputpressureis controlled by a closedloopsystemconsisting pressuretransducer flowcontrolvalve)andfeedback(differential amplifier,controlvalve(proportional and amplifier).As the pressuresettingis variedon thefrontpanel,the systemwillcontroltheflowof gas to providethe desiredpressureat the output.

FLOWLIMITCONTROL pressuresensorconnected acrossa precisionorifice.Thiswill The gasflow is sensedby a differential providea signalthat is representative of the rateof flow. An analogcomparator comparesthissignalto the flowlimitsettingon the frontpanel.Whentheflowrateexceedsthe frontpanelsetting,the reference signalusedby the closedlooppressurecontrolsystemwill be reducedto restrictthe flow rateto the front panelsetting.A secondpressuresensoris connected acrossthe precisionorificeto provideredundant sensing.

MODES OPERATING ThefrontpanelFLOWON/OFFswitchis usedto controltheflowof gas. Whenthe switchis OFFthe is interrupted andthevalvewillbe fullyofi. Whenthe switchis ON, currentthroughthe proportionalvalve valveis allowedto flow. Themodeis setto OFFwhenpoweris first the currentthroughthe proportional applied.

GASSUPPLYINDICATORS SYSTEM'fora description. See"PNEUMATIC

SAFETY The patientis protectedfromexcessiveprassuresby a fixedreliefvalveset to 160mmHgand by a ventingvalvethatwill openwhenthe pressureexceedsthefrontpanelsettingby morethan10%.The flowis limitedto 110mUmin.When gasflowis limitedto the frontpanelsetting.The maximumavailable the FLOW gas LlMlT, LED will be red,the alarmwillsoundandthe FLOW RATE flowexceedsthe the gasflowat theouput. lf thisconditionoccurs,the internalblowoff valvewillopento preventexcessive servicecenterfor repair.At poweron,the unitshouldbe removedfromserviceandsentto an authorized operatingmodeis set to OFFto preventgas flow untilthe operatorpressesthe FLOWON/OFFswitchto initiategasflow.

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MAINTENANCE, CLEANINGAND STORAGE

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CHECKOUT (OU|CKCHECK) PROCEDURE Performthefollowingprocedure to verifyproperoperation: . Applypowerto the unitandverifythatthe INTRAUTERINEPRESSURE displayindicatesEEE tor approximately /z second. . Afterthe secondINTRAUTERINEPRESSURE displaytest,verifythatbothof the FLOWcontrol LEDs(FLOW '/2 & ON)are off,if not,the unitshouldbe removedfromserviceandsentto an authorized servicecenterfor repair. . Witha gassourcenotconnected, verifythe GASSUPPLYLOWLEDis on. Connecta gas source andverifythatthe GASSUPPLYNORMALLEDis on. lf eitherof theseconditions are nottruethe unitshouldbe removedfromserviceandsentto an authorized servicecenterfor repair. . Pressthe FLOWON/OFFpush-button. The FLOWON LEDwillbe illuminated.Whengas is flowing,the FLOWLEDwillbe green, lf the gasflowexceedsthe FLOWRATELlMlT,the FLOW LEDwillbe redandthealarmwillsound.lf thiscondition occurs,theunitshouldbe removed from serviceandsentto an authorized servicecenterfor repair. andsetthe PRESSURE SELECTto 100mmHg. 'Set the FLOWRATELIMITto maximum or the endof tubingif attached). 'S!9p t[e flowof gasby blockingthegasoutput(eitherthe connector TheOVERPRESSURE LEDshouldturnon andtheblowotfshouldexhaustthegas. lf the pressuredisplayexceeds120mmHg,the unitshouldbe removedfromserviceandsentto an authorized servicecenterfor repair.

CLEANING WARNINGTurnthe powerofi anddisconnect the powercordbeforecleaningthe machine. Failureto do so can resultin deathor severeelectricalshock. CAUTION Neverimmersethe machinein liquids.Doingso candamagethe machine. The unitshouldbe routinelycleaned.To removedust,dirt,andothernon-patient debris,wipeusinga soft,lint-freeclothmoistened with7O"/"ethylor isopropylalcohol.lf soiledwithpotentially infectious patientmaterial,the equipment shouldbe decontaminated. Shouldthe unitbecomesoiledwithbloodor otherpotentially infectious materials, firstwipeoff all gross debrisandthendecontaminate the unitusinga surfacedisinfectant (e.g.one registered by the U.S. Environmental Protection Agency(EPA)).Alwaysfollowthe manufacturer's recommendations for surlace disinfection.Makesurethatthe unitis completely dry beforeuse. Thefrontdisplayis protected withan anti-glare coating.DO NOTUSEABRASIVECLEANERS.

STORAGE The machinecanbe safelystoredwithoutspecialpreparation otherthanensuringthegas is purgedfrom the HYSTEROFLATOR 1@. Ensurethatit is keptin a clean,dryareaawayfromdirectsunlight,Cover the machineand plugthe gasportfor storage.Testthe machinethoroughly beforeoperation.

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REPAIR Thereare no useradjustments insidethe cabinet.Repairsandadjustments are to be performed onlyby OlympusAmerica,Inc.

CUSTOMER SERVICE ANDORDERING INFORMATION PleasecontactyourOlympusrepresentative or an authorized Olympusservicecenter.

Repairitemsmustbe properlycleaned,repackaged, and returnedto an authorized Olympusservice center.

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