109076-kim rev b.indd 3 9/26/12 4:02...
TRANSCRIPT
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CHAPTER 1. INTRODUCTION 9
1.1. ProductDescription........................................................................ 9 1.2. GeneralWarningsandCautions.................................................... 9 1.3. IntendedUse.................................................................................. 9 1.4. SymbolDefinitions........................................................................10 1.5. SystemIndicators......................................................................... 12 A.FrontPanel............................................................................... 12 B.RearPanel............................................................................... 14 1.6. OtherIndicators(AudibleTones).................................................. 14
CHAPTER 2. OPERATING PRECAUTIONS, CHECKS & WARNINGS 15
2.1. StorageandHandling.................................................................. 15
CHAPTER 3. SET-UP PROCEDURES 16
3.1. PumpSet-up................................................................................ 16 3.2. TubingSet-up............................................................................... 17 A.InstallingtheOneDaySetIrrigationTube............................... 17 B.InstallingtheIntermediaryIrrigationTube............................... 19 C.GettingStarted......................................................................... 20 D.EndofOperation...................................................................... 21 E.Set-upforNextOperation........................................................ 22 F.EndofOperatingDay............................................................... 23
TableofContentsWARRANTy AND SERvICE 6
UNPACKING, ASSEmbLy AND INITIAL SySTEm CHECK 7
INSPECTION SCHEDULE 8
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CHAPTER 4. PUmP SySTEm FUNCTIONS 24
4.1. Run/Stop....................................................................................... 24 4.2. PresetPressure............................................................................ 24 4.3. FillingtheChamber...................................................................... 24 4.4. RecommendedInitialSettings..................................................... 25 4.5. PressureAlarm............................................................................. 25 4.6. PressureCycleMode................................................................... 26
CHAPTER 5. mAINTENANCE: CLEANING & DECONTAmINATION 27
CHAPTER 6. TROUbLESHOOTING 28
CHAPTER 7. PRODUCT SPECIFICATIONS 30
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WarrantyandServiceDePuy Mitek products are guaranteed to be free from defects in material and workmanship for the warranty period of a particular product, beginning from date of invoice.
Contact your DePuy Mitek representative for specific product warranty information.
DePuy Mitek offers an expedited service replacement program for its products to minimize downtime in your operating room. For a return authorization number or for additional information on this program, call DePuy Mitek Customer Service at +1 (800) 382-4682 and choose Option 2 in the United States or contact your DePuy Mitek representative.
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Unpacking,AssemblyandInitialSystemCheckUnpacking:
Verifythatallitemsonpackinglistmatchtheproductsyouhavereceived(verifyserialnumbersandreferences).DamageshouldbereportedimmediatelytoyourDePuyMitekSalesRepresentativeorcontactDePuyMitekCustomerServiceintheUSAat+1-800-382-4682,selectOption2.Saveallpackagingmaterial,astheywillberequiredtoshipproductsintheeventofaproductreturn.
Onceboxisopen,remove,read,andfollowtheInstructions for Use.ToremovetheFMSSOLOconsole,placehandsonbothsidesofconsole,untilyoucansecurelygrasptheunderside.Carefullyremovetheconsolefromtheboxandplaceitonalevelandsturdysurface.
Assembly:
-Connectthepowercordtothepowerconnection(14).
-Connectthefootpedaltothefootpedalconnection(16)onthebackofthepump.
Initial System Check:
- SwitchtheI/Oswitch(14)on“I”.
- TurnthedeviceONbypressingthePOWER(4)pad.
- Pressonallpads.Anaudibletoneshouldbeheardforeachpadpressed,exceptforPressureCycle,(Pad8)(PressureCycleisinactiveuntilthepumpisprimed.)
Note:numbersin(),refertodiagraminsection1.5.
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InspectionSchedule
Weekly inspection:
DePuyMitekrecommendsaweeklyinspectionofallequipment.Theseinspectionscanbeperformedonalessfrequentbasisdependingonthedurationandfrequencyofuse.
- Performavisualinspectionofthedevice.Ifdamageisnoted,contactyourDePuyMitekSalesRepresentativeorcallDePuyMitekCustomerServiceintheUSAat+1-800-382-4682.SelectOption2tospeaktoabiomed.
- Inspectthatthetransparentsafetycover(1)andblackhingesareingoodworkingorder.
- Inspectpowercordandallcablesforwearorcuts.
- Ensurethatthefootpedalandshaverinterfaceconnectorpinsarenotmissingorbent.
- Plugthepowercordtothepowerconnection.- SwitchtheI/Oswitch(14)on“I”.- TurnthedeviceONbypressingthePOWER(4)
pad.
Pressonallpads.Anaudibletoneshouldbeheardforeachpadpressed,exceptforPressureCycle,(Pad8)PressureCycleisinactiveuntilthepumpisprimed.
Annual inspection:
DePuyMitekrecommendsthatabio-medicalengineerorauthorizedservicepersonnelannuallycheckallequipmenttoassessitsfunctionalityandtechnicalsafety.
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1.1. Product Description
Irrigation system.TheFMSSOLOisanadvanced,lowercostirrigationsystemthatusespatentedtechnologytoimprovevisualizationanddistensionwhilecontrollingpressureduringarthroscopicsurgery.
Flow compensation.TheFMSSOLOcanrecognizewhenashaverisinrotationandsubsequentlyimprovebyactivatingthe"Flowcompensator"cycle.PleasecontactyourDePuyMitekrepresentativeforFMSShaverInterfaceproductsduetothevarietyofproductsoffered.
Pressure cycle red pedal.Oneofthemostcriticalaspectsofarthroscopyisvisualization.Thefieldofviewisoftenobstructedbybloodanddebris.ToalleviatethisproblemtheFMSSOLOhasapressurecyclefeature.Bysteppingontheredfootpedalyouwillactivateatimedcycleofincreasedpressuretocontrolbleeding.Oncethecycleiscompleted,theFMSSOLOwillreturntoitsoriginalconfiguration.
1.2. General Warnings and Cautions
Itisrecommendedthathospitalpersonnelreadthismanualbeforeoperatingorcleaningthisproductanditsaccessories.Failuretofollowtheseinstructionsmayresultinpotentialinjuryanddamageormalfunctionoftheequipment.
ThemanufacturerandlicensedsellerofthisdevicedonotacceptanyliabilityfordirectorconsequentialdamageorinjurycausedbyimproperuseofdisposablesotherthanFMSproducts.Anyalterationstothisdevice,repairfromanunlicensedservicecenter,oruseofnon-FMSdisposables,mayvoidCEmarking,FMSwarrantyandproductliabilitycoverage.
ThetubesetscontainDEHP,aphthalatechemicalknowntocausebirthdefectsandotherreproductiveharm,includinginchildrenandinpregnantornursingwomen.
Warning:
TheFMSSOLOisaClassITypeBdeviceaccordingtotheElectricalSafetyStandardEN60601-1formedicaldevices.Ensurethatyouareusingthecorrectinterfacecablewhenconnectingtoanothershaver.Formoredetails,refertoInterfaceCableInstructionsforUse.ContactyourDePuyMitekSalesRepresentativetoreviewShaverInterfaceCableinterfaceofferings.
Thesystemmaybeaffectedbyelectromagneticinterferencesfromotherinstruments.Verifythatallotherinstrumentsandappliances(associatedornotwiththesystem)complywiththestandardEN60601-1-2(EMC).
Ifthesystemcontinuestobeaffected,isolateitfromtheoffendinginstrumentandconnecttoadifferentmainsoutlet.
1.3. Indication for Use
TheFMSSOLOArthroscopicFluidManagementSystemisindicatedforuseinasurgicalsettingbypersonneltrainedinarthroscopy.
Chapter1.Introduction
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1.4. Symbol Definitions
Front Panel back Panel
Power pad
TurnsthepowerON&OFFifthemainpowerswitchonthebackofthepumpison(thegreenstandbylightison).
On
Off
Alarm
Theredindicatorwilllightupifasafetyparameterisviolated.
Equipotential symbol (ground)
Pressure cycle
Alleviatesbleedingduringsurgery,byincreasingbasepressurefortwominutes.
IP50 Noprotectionfromliquid
One-way foot pedal board
Usedtoactivateorcancelapressurecycle.
Type b Class 1
ConformstostandardEN60601-1.
IncreaseCaution
Seeinstructionsforuse.
Decrease
Refertoinstructionmanual/booklet
Refertoinstructionmanual/booklet
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Explosion hazard
main fuse
Replace fuses as marked
PerDirective2002/96/EC,productmustbecollectedseparately.Donotdisposeofasunsortedmunicipalwaste.Contactlocaldistributorfordisposalinformation.
Do not wet
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1 Transparent safety covers. Thiscovermustbeclosedforthe
rollerpumptorotate.
2 IRRIGATION roller pump. Providesfluidinflow.
3 Tension rocker arm. Holdsthetubingontherollerpump
head.
4 POWER pad. TurnsthepowerON & OFFifthe
mainpowerswitchinthebackofthepumpison(thegreen“standby”lightison).
5 PRESSURE display. Displaysboththepresetpressure
whenthebasepressureisbeingset,andthedynamicpressure(1sec)followingthereleaseofthepressureadjustmentpads.
6 ALARm. Theredindicatorwilllightupifa
safetyparameterisviolated.
7 Remote Control connector. Connectstheremotecontroltothe
FMSSOLO.
A – Front Panel
1.5. System Indicators
1 2 3 4 5
6
78910111213
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8 Pressure cycle. Alleviatesbleedingbyincreasingbase
pressurefora2minutecycle.
9 PRESSURE adjustment pads. Pressthearrowstoincreaseordecrease
thepressureinincrementsof5.Theinitialsettingis50.
10 Pump Run/Stop pad. TurnsthepumpONandOFF.Ifthe
pumpisactivated,<PUMP>appearsonthepressuredisplay.GreenLEDblinkswhenpumpisonstop.
11 built-in Pressure transducer connection.
ToconnecttheOneDaySetIrrigationTubeandmeasurethepressureinthepressurechamber.
12 Fill Chamber pad. Manuallyfillsthechamberandturnsoff
theLOWPRESSUREalarm.
13 Patented auto-locking device. Allowsthedisposabletubingtobe
properlypositionedandlockedinplacearoundtherollerpump.
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14 I/O switch, fuses and power connection.
15 Identification & specification.
16 Foot pedal connection. 9-pinconnectortoplugfootpedal.
17 Shaver interface connection. 25-pinhandandfootcontrolinterface
cablesconnector.ContactyourDePuyMitekSalesRepresentativeforShaverInterfaceCableorderinginformationduetothevarietyofproductsavailable.
18 Serial number.
•Thefirsttwodigitsrepresenttheyearofmanufacturing.
•Thesecondsetofdigitsrepresentstheweekofmanufacturingandserialnumber.
19 Reference number.
b – Rear Panel
14
15
16
17
18
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1.6. Other Indicators (Audible Tones)..AnaudibletonesoundswhenthePOWERpad
ispressedandthepumpturnson..AnaudibletonesoundswhenthePRESSURE
modeisactivated(seepressurecyclesectiontoactivatethecycle).
. TwoaudibletonessoundwhenthePRESSURE modeisdeactivated(seechapter4todeactivatethecycle).
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Warnings:
FactorySettings:Factorysettingsarebasedonexperience;theyshouldonlybeusedasguidelines.Thesurgeonisresponsibleforsettingsdependingonthesurgicalprocedureperformed.
Electricalsafetytestingshouldbeperformedbyabiomedicalengineerorotherqualifiedperson.
Riskofelectricalshock:Donotremovethecover.ReferservicingtoyourDePuyMitekRepresentativeorDePuyMitekCustomerServiceintheUSAat+1(800)382-4682,Option2.
Donotconnectthedevicetoapowersourcethatisnotproperlyearthed(grounded).
Disconnectthedevicefromthemainpowersourcewhencleaning,servicing,orinspecting.
Inspectallequipmentandcablesperiodicallyforwear.ContactyourDePuyMitekRepresentativeorDePuyMitekCustomerServiceintheUSAat+1(800)382-4682,Option2ifdamageisnoted.
AvoidfluidcontactwiththeFMSSOLO,anditselectricalconnectors.
DonotuseflammableagentswhencleaninganddisinfectingtheFMSSOLO.
Toavoidriskoffire,replacefuseswithsametypeandrating.
2.1. Storage and Handling: Storage temperature: DonotexposetheFMSSOLOtotemperaturesabove50°C(122°F)orbelow–10°C(14°F).
Operating Conditions: Donotoperatethepumpinconditionsabove40°C(104°F)orbelow10°C(50°F).
Damage: DonotuseaFMSSOLOthathasbeendroppedorshowssignsofdamage.
Disposal: Donotincinerate.
ContactyourDePuyMitekRepresentativeorDePuyMitekCustomerServiceintheUSAat+1(800)382-4682,Option2toarrangeforsafedisposal.
Chapter2.OperatingPrecautions,ChecksandWarnings
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Chapter3.Set-upProcedures3.1. Pump Set-up.
Poweronbackofthepumpon“I”.
PressPower pad.TheLCDwilllightup.
Openthecover.
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WARNING:Thisproductisforsingle-useonly.Ithasnotbeendesignedtobere-used/re-sterilized.Reprocessingmayleadtochangesinmaterialcharacteristicssuchasdeformationandmaterialdegradationwhichmayimpactthestrengthofthedeviceandcompromisedeviceperformance.Reprocessingofsingleusedevicescanalsocausecross-contaminationleadingtopatientinfection.Theserisksmaypotentiallyaffectpatientsafety.
Sterilityispreservedonlyifthetubechangingprocedureshavebeenperformedpreciselyaccordingtotheset-upinstructionsbelowandinSection3.2.E.
ThisproductcontainsDEHP,aphthalatechemicalknowntocausebirthdefectsandotherreproductive
harm,includinginchildrenandinpregnantornursingwomen.
Thistubeconnectsthesalinesolutionbagstotheirrigationtubing.Solutiongoesfromthespikes(A)aroundtherollerpump,throughthepressurechamber,wherethepressureisreadthroughafilter(B)byabuilt-inpressuretransducer.
A. Installing the One Day Set Irrigation Tube Ref. 284504 or 284503ContactyourDePuyMitekRepresentativefororderinginformationsincecertaintubesarenotofferedinallcountries.
3.2. Tubing Set-up.
Fromsolutionbags
TothePressuretransducer
IntermediaryIrrigationTube
(A)
(A)
Clamps(B)
GREENAuto-lockingdevice PRESSURECHAMBER
Clamps
Clamps
(C)
Filter
Closeallthreeclampsandconnecttofluidbags.
Slidethegreenpartofthetubeintotheauto-lockingdeviceonthepump.
Placeandcenterthetubearoundtherollerpump.
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Positionthepressurechamberintheholder.Connectthetransducertothepumpbyfirmlyscrewingitinclockwise.
GreenLEDblinks.PressRun/Stop.ThegreenLEDblinksinitially,thenremainson.
Closethecover.
PresstheFillchamberpadseveraltimesuntilthechamberis1/3full.ThegreenLEDblinksuntilpadispressed.
Pullonthetubeandclosethetensionrockerarmagainstthetube.
Warning:
It is mandatory that the pressure chamber remains vertical during the procedure and that the pump be positioned at the same level as the patient.
Overfillingthechambermayresultinthefilter(shownin3.2.A)becomingwetpriortothepressuretransducerandthereforeinterferewithaccuratepressuremeasurement.Shouldoverfillingofthechamberoccur,seeChapter6forTroubleshooting.
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Thistubeconnectstheirrigationtubetothesheathinasterilemanner.*Ref.281103doesnotincludetheSterileBufferZoneOne-WayValve/IntermediaryTubingwithOne-Way
CheckValve.Ref.281103isintendedforsingleuseoftheOneDaySetIrrigationtube.
b. Installing the Intermediary Irrigation Tube Ref. 281103, 281142, or 281103*
Aftercheckingthattheluer-lockisproperlytightened,thesterilenursetakestheirrigationtubeandpassestheblueend(D)toanon-sterileperson.
Thenon-sterilepersonremovesthebluecapsfromtheirrigationtube(D)andtheOneDaySetIrrigationTube(C)...
...and immediately connectstheOneDaySetIrrigationTube(C)luer-lock,totheirrigationtube(D)luer-lock.
ThepumpmustbeintheRunmode(10),withthelighton.Primetheirrigationtubebyopeningtheclampunderthepressurechamber.Whenprimed,closetheclamporthestop-cockonthearthroscope(inthesterilezone).
(D)
(C)
(C)(D)
TothearthroscopeSheath
FromtheOneDaySetIrrigationTubeRef.284504or284503
(D)
SterileBufferZoneOne-WayValve/IntermediaryTubingwith
One-WayCheckValve
White
Blue Blue Red
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C. Getting Started.
Connecttheluer-locktothearthroscope.Openthestop-cockonthescope.
Opentheclampunderthechamber.
STERILEZONE
STERILEZONE
STERILEZONE
NON-STERILEZONE
Insertthecannulatubeontothecannula. Inserttheshavertubeontotheshaversuctionport.
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Closetheclampunderthepressurechamber.
Disconnecttheblueluer-lock(E)oftheIntermediaryIrrigationtube.
PressRun/Stoppad(oropentransparentsafetycover).
D. End of the Operation.
Note: Ref. 284503 & 284504 “One Day Set” can be re-used for multiple procedures during the same surgical day. Warning: Sterility is preserved only if proper set-up and tube changing procedures have been followed.
Warning:The Sterile buffer Zone One-Way valve/Intermediary Tubing with One-Way Check valve must remain attached to the One Day Set Irrigation Tube which ensures sterility between surgeries.
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Aftercheckingthattheluer-lockistightened,thesterilenursetakestheirrigationtubeandpassestheblueend(D)toanon-sterileperson.
...and immediately connectstheblueluer-lock(D)ofthenewirrigationtubetotheblueluer-lock(C)oftheOneDaySetIrrigationTube.
Thenon-sterilepersonremovestheoldsterilebufferzonebydisconnectingtheluer-locksoftheOneDaySetIrrigationTube(C)andtheIntermediaryirrigationtube...
E. Set-up for Next Operation.
TheOneDaySetIrrigationTubecanbeleftinplaceattheendofthepreviousoperationwiththeSterileBufferZoneOne-WayValve/IntermediaryTubingwithOne-WayCheckValveattached.
Warning:Never attach one Sterile buffer Zone One-Way valve/Intermediary Tubing with One-Way Check valve to another.
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Closeallwhiteclamps. TurnoffthepumpbypressingthePOWERpad.Throwawayallofthetubing.
F. End of Operating Day.
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Chapter4.PumpSystemFunctions
4.1. Run/StopPresstheRun/Stoppadtostartallpumpsystemfunctions.
4.3. Filling the ChamberPresstheFillChamberpadtofillthepressurechamberinitially,andthroughoutthesurgeryasneeded.Thechambershouldneverbeover1/3full.
4.2. Preset PressureThepressureisdisplayedinbrackets(eg.<50>)ontheLCD(5)for2secondswhenoneofthepressurepadsispressed,thentheactualpressureisdisplayed(pressuresettingsareinlevels).
Level50,equals5feetofgravitypressureortheequivalentof112.5mmHg(±10%).
Thepumpwillmaintainthepre-setlevel.Whenoperating,usethe“+”and“–”pads(9)toincreaseanddecreasethelevel.Thefactorypresetlevelis50.
Note:numbersin(),refertodiagramonpage12.
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4.4. Recommended Initial Settings. *
High pressure alarm.
Ifthehighpressuresafetylevelof140isexceeded,thepumpstopsandtheredALARM(6)LEDlightsup.Theoperatorshouldlowerthepressuretoletthepumpautomaticallyrestart.Ifthepumpdoesnotrestartwhenthepressuredropsbelow140,restartthepumpmanuallybyturningthepumpONandOFFagainwiththePOWERpad.
Low pressure alarm.
Ifthepressurefallsbelowthelowpressuresafetylevelof10,theredALARMLEDlightsup,<PresL>flashesontheLCDdisplay,andthepumpstops.Checkthattheluer-lockandthefilternearthepressuretransducerareinproperworkingorder.IfbotharesatisfactorypressFillChambertostopthealarmandRun/Stoppadtorestarttheunit.
Note:numbersin(),refertodiagramonpage12.
4.5. Pressure Alarm
JointPressure level
with TourniquetPressure level
without TourniquetShoulderJoint
Acromioplasty
KneeJointHemarthrosis
Wrist
Elbow,AnkleHip
3050–60
30
40
60
60
6550–60
65
65
65
Warning:
If water has accidentally entered the tubing leading to the pressure transducer, change the One Day Set Irrigation Tube and restart the system.
Note:Ifbleedingoccurs,thesurgeonmaychoosetoactivatetheLavagemodeorincreasepressure.
* WARNING:Theseinitialsettingsarebasedonexperienceandshouldonlybeusedasguidelines.Thesurgeonisresponsibleforsettingdependingonthesurgicalprocedureperformed.
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4.6. Pressure Cycle mode.
Thepressurecyclemodeisactivatedeitherbypressingthe“Pressure”pad...
...orusingtheremotecontrolRef.288051,whichisconnectedonthefrontpanelofthepump...
Theremotecontrolisnotautoclavableandnotsoakable.AsteriledisposableremotecontrolcovermustbeusedRef.281087.
...orbypressingontheredfootpedalRef.284171,whichisconnectedontherearpanelofthepump(seeonpage14,n°16).
Thisfunctionincreasesthepressureby60%foratwominutecycle.Thepressurethenreturnsautomaticallytoitsoriginalsetting.Thepressurecyclemodeisactivatedwhenbleedingoccurs.ThepressurecyclecanbecanceledbypressingthePressureCyclemodeagain.
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Chapter5.Maintenance:Cleaning&DecontaminationCleaning the FmS SOLO:Attheendoftheoperatingday,switchtheFMSSOLOoff,unplugthepowercordanddiscardalltubing.Wipeofftheinstrument’ssides,frontpanelandcoverswithasoftcloththathasbeenslightlymoistenedwithaneutral-pHdetergent.Wipeagainusingdistilledwatertorinse.
Warning:
DONOTIMMERSE.DONOTAUTOCLAVE.DonotuseflammableagentswhencleaninganddisinfectingtheFMSSOLO.
Foot Pedal: Cleaning and DecontaminationAftereachoperation,cleanthefootpedalandthepowercordwithaneutral-pHdetergent.Thefootpedalboardcanbeimmersed,excepttheelectricalconnections,whichmustremaindry.
Warning:
DONOTIMMERSEELECTRICALCONNECTOROFFOOTPEDAL.DONOTAUTOCLAVE.DonotuseflammableagentswhencleaninganddisinfectingtheFootpedal.
Donottwistthecablewhenstoring.
Donotunpluginstrumentbypullingoncable.
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Chapter6.Troubleshooting
Problems Potential Causes Possible SolutionsThepumpstops.
RedALARMLEDlightsup.
TheHIGHPRESSUREsafetyhasactivated.
TheLOWPRESSUREsafetyhasactivated:“Pres.L”blinks.
Thehydrophobicfilteriswet.
Thereisnomoreirrigationfluid.
Lowerthejointpressure.
PresstheRun/Stoppadtorestartthepump.
Verifythattheluer-lockistightlyclosed.
PresstheFillChambertostopthealarm,andpresstheRun/Stoppadtorestartthepump.
ReplacetheOneDaySetIrrigationTube.Ifproblempersists,contactDePuyMitekCustomerService.
SpikethebagandpresstheFillChamberpad.
Therollerpumpheadsdonotrotate.
Thepowerison“O”orisonStop.
Checkthatthemainpowerswitchonthebackofthepumpisonthe“I”position,andthattheRun/Stoppadgreenlightison.
Thereisnoirrigation. Thestop-cockonthesheathoraclampisclosed,stoppingoutflow.
Checktheinflowlinefromthebagstothejoint.Openanyclosedclampsorstop-cocks.
Theirrigationpumpstartsspinningexcessively,emittingaloudnoise.
Thereisnomoreirrigationfluid. Replacethesalinesolutionbagsand/orchecktheclampsunderthebags.
PressFillChamberifchamberislowerthan1/3.
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Problems Potential Causes Possible SolutionsTheirrigationpumpgoesonandofferraticallycausingabnormalpressurefluctuations.
Watermayhaveenteredthepressuresensingline.
ChangetheOneDaySetIrrigationtubeifwaterhasenteredthepressuresensingline.Ifproblempersists,contactDePuyMitekCustomerService.
Thereistoomuchwaterinthepressurechamber.
Anairleakinthelinemayhavedeveloped.
Checkthattheluer-lockontheirrigationandpressuresensingtubeareclosed.Ifnecessary,changetheirrigationtubingandstartagain.
Thereisinsufficientpressureinthesystem.
Anirrigationproblemexists. Checkthestop-cockonthearthroscope,andtheclampsunderthesalinebagsandunderthepressurechamber.
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Product Specifications
CompositionRef:284590
DimensionsHeight: 16cmWidth: 39cmDepth: 30cmWeight: 11kg
Performance specificationsPressurelevels:20–140Incrementsof5Precision±10%at0flowrate
Electrical specificationsInputpower: 120/230V~Frequency: 50–60HzCurrentDraw: 500VAFuses: 5ATimeDelayConformstostandardEN60601-1(MedicalDeviceElectricalSafety)andEN60601-1-2(ElectromagneticCompatibility)
Storage conditionsTemperatures:–10°C(14°F)to+50°C(122°F)
Operating conditionsTemperatures:+10°Cto+40°CRelativehumidity:30to75%
Chapter7.ProductSpecifications
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CAPÍTULO 1. INTRODUCCIÓN 37
1.1.Descripcióndelproducto............................................................... 37 1.2. AdvertenciasgeneralesyPrecauciones...................................... 37 1.3. Usoindicado................................................................................. 37 1.4. Definicionesdesímbolos............................................................. 38 1.5. Indicadoresdesistema................................................................ 40 A.Panelfrontal............................................................................. 40 B.Paneltrasero............................................................................ 42 1.6. Otrosindicadores(tonosaudibles).............................................. 42
CAPÍTULO 2. PRECAUCIONES DE USO, vERIFICACIONES y ADvERTENCIAS 43
2.1. Conservaciónymanipulación...................................................... 43
CAPÍTULO 3. PROCEDImIENTOS DE INSTALACIÓN 44
3.1. Instalacióndelabomba............................................................... 44 3.2. Instalacióndeltubo...................................................................... 45 A.InstalacióndeltubodeirrigaciónOneDaySet...................... 45 B.Instalacióndeltubodeirrigaciónintermedio............................ 47 C.Primerospasos........................................................................ 48 D.Findelautilización................................................................... 49 E.Instalaciónparalasiguienteutilización.................................... 50 F.Últimousodeldía..................................................................... 51
TabladecontenidoGARANTÍA y SERvICIO TéCNICO 34
DESEmbALAJE, mONTAJE y vERIFICACIÓN INICIAL DEL SISTEmA 35
CALENDARIO DE INSPECCIONES 36
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CAPÍTULO 4. FUNCIONES DEL SISTEmA DE bOmbEO 52
4.1. Marcha/Parada............................................................................. 52 4.2. Presiónpredeterminada............................................................... 52 4.3. Rellenarlacámara....................................................................... 52 4.4. Parámetrosinicialesrecomendados............................................. 53 4.5. Alarmasdepresión...................................................................... 53 4.6. Mododeciclodepresión............................................................. 54
CAPÍTULO 5. mANTENImIENTO: LImPIEZA y DESCONTAmINACIÓN 55
CAPÍTULO 6. RESOLUCIÓN DE PRObLEmAS 56
CAPÍTULO 7. CARACTERÍSTICAS DEL PRODUCTO 58
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GarantíayServiciotécnicoLos productos DePuy Mitek están garantizados contra defectos de materiales y mano de obra durante el periodo de garantía de un producto concreto, que comienza en la fecha de la factura.
Póngase en contacto con un representante de DePuy Mitek para obtener información sobre la garantía del producto.
DePuy Mitek ofrece un programa de servicio rápido de sustitución de sus productos para reducir al mínimo el tiempo sin servicio en su quirófano. Para obtener un número de autorización de devolución u otra información adicional sobre este programa, llame al Servicio de atención al cliente de DePuy Mitek en el +1 (800) 382-4682 y elija la Opción 2 en Estados Unidos o su representante de DePuy Mitek.
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Desembalaje,montajeyverificacióninicialdelsistemaDesembalaje:
Verificarquetodoslosartículosdelalistadelembalajecorrespondanalosproductosqueharecibido(comprobarlosnúmerosdeserieylasreferencias).SihaydañosdebeinformarsedeinmediatoalrepresentantedeventasdeDePuyMitekollamaralServiciodeatenciónalclientedeDePuyMitekenEE.UU.al+1-800-382-4682,Opción2.Conservetodoelmaterialdeembalajeyaquelonecesitaráparaenviarlosproductosencasodequehayaunadevolucióndelproducto.
Unavezquetengalacajaabierta,saque,leaysigalasInstrucciones de Uso.ParasacarlaconsolaFMSSOLO,coloquelasmanosaambosdelaconsolahastaquepuedatomarlaconfirmezaporlaparteinferior.Saqueconcuidadolaconsoladelacajaycolóquelaenunasuperficieniveladayresistente.
montaje:
- Conecteelcabledealimentaciónalatoma(14).- Conecteelpedalalatomadelpedal(16)enla
partetraseradelabomba.
verificación inicial del sistema:
- PongaelinterruptorI/O(14)enposición“I”.
- Enciendaelaparato(ON)pulsandoelinterruptordealimentación"POWER"(4).
- Pulsartodoslosbotones.DebeescucharseuntonocadavezquesepulsaunbotónexceptoenelCiclodePresión(Botón8)(Elciclodepresiónpermaneceinactivohastaquesecebalabomba.)
Nota:Losnúmerosentre()correspondenaldiagramadelasección1.5.
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Calendariodeinspecciones
Inspección semanal:
DePuyMitekrecomiendaunainspecciónsemanaldetodoelequipo.Estasinspeccionespuedenrealizarseconmenorregularidaddependiendodeladuraciónylafrecuenciadeuso.
- Realizarunainspecciónvisualdelaparato.SiobservaalgúndañopóngaseencontactoconsurepresentantedeDePuyMitekollamealServiciodeatenciónalclienteenEstadosUnidosdeDePuyMitekenel+1800-382-4682yelijalaOpción2parahablarconunespecialistabiomédico.
- Inspeccionequelatapadeseguridad(1)ylasbisagrasnegrasfuncionencorrectamente.
- Inspeccioneelcabledealimentaciónytodosloscablesparadetectarposibledesgasteocortes.
- Asegúresedequenofaltenpinesenelconectordelpedalydelapiezademanoyquenoesténdoblados.
- Conecteelcabledealimentaciónalatoma.- PongaelinterruptorI/O(14)enposición“I”.- Enciendaelaparato(ON)pulsandoelinterruptor
dealimentación"POWER"(4).
Pulsartodoslosbotones.DebeescucharseuntonocadavezquesepulsaunbotónexceptoenelCiclodePresión,(Botón8)Elciclodepresiónpermaneceinactivohastaquesecebalabomba.
Inspección anual:
DePuyMitekrecomiendaqueuntécnicobiomédicooalguiendelpersonaldeserviciotécnicocompruebenanualmenteelequipoparaevaluarsufuncionalidadysuseguridadtécnica.
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1.1. Descripción del producto
Sistema de irrigación.ElFMSSOLOesunavanzadosistemadeirrigacióndebajocostequeutilizatecnologíapatentadaparamejorarlavisualizaciónyladistensiónmientrascontrolalapresióndurantelacirugíaartroscópica.
Compensación de Flujo.ElFMSSOLOpuedereconocercuándoestágirandounrasuradoryporconsiguientemejorarelflujoactivandoelciclo"Flowcompensator"(Compensacióndeflujo).PóngaseencontactoconrepresentantesdeventasdeDePuyMitekparalosproductosdeinterfazdelrasuradorFMSdebidoalavariedaddeproductos.
Pedal rojo del ciclo de presión.Unodelosaspectosmáscrucialesdelaartroscopiaeslavisualización.Elcampodevisiónsueleobstruirseconsangreyresiduos.Parapaliaresteproblema,elFMSSOLOincluyeunafuncióndeciclodepresión.Alpresionarelpedalrojoseactivaunmecanismotemporizadorquehaceaumentarlapresión,loquedisminuyelahemorragia.Unavezcompletadoesteciclo,elFMSSOLOvuelveasuconfiguraciónoriginal.
1.2. Advertencias generales y Precauciones
Serecomiendaqueelpersonalhospitalarioleaestemanualantesdeutilizarolimpiaresteproductoysusaccesorios.Sinosesiguenestasinstruccionespuedenproducirsedañosmaterialesypersonalesounmalfuncionamientodelequipo.
Elfabricanteyelvendedorautorizadodeesteaparatonoaceptaningunaresponsabilidadpordañosdirectosocomoconsecuencianiporlesionesdebidasaunusoinapropiadoopor
utilizarrepuestosquenoseanproductosFMS.Cualquieralteraciónaesteaparato,cualquierreparaciónporpartedeuncentrodeserviciotécniconoautorizadooelusoderepuestosquenoseanFMS,puedeinvalidarelmarcajeCE,ylagarantíaDePuyMitekasícomolacoberturaderesponsabilidaddelproducto.
EljuegodetuboscontieneDEHP,unftalatodelquesetieneconstanciaquecausadefectoscongénitosyotrosdañosenelsistemareproductor,inclusoenniñosyenmujeresembarazadasoenperiododelactancia.
Advertencia:
ElFMSSOLOesunaparatodeClaseITipoB,segúnlaNormadeseguridadeléctricaEN60601-1paraaparatosmédicos.Asegúresedequeestáutilizandoelcabledeinterfazcorrectocuandoseconecteaotrorasurador.ParaobtenermásdetallesconsultelasInstruccionesdeusodelCabledeinterfaz.ContacteconelrepresentantedeventasDePuyMitekparaconsultarlasofertasdeCabledeinterfazdelrasurador.
Elsistemapuederesultarafectadoporlainterferenciaelectromagnéticadeotrosinstrumentos.Verifiquequeelrestodelosinstrumentosyaparatoseléctricos(asociadosonoconelsistema)cumplanconlanormaEN60601-1-2(EMC).
Sielsistemacontinúaresultandoafectado,aíslelodelinstrumentoqueprovocalainterferenciayconécteloaunatomaeléctricadiferente.
1.3. Indicaciones de uso
ElsistemadegestióndelíquidoartroscópicoFMSSOLOestáindicadoparaqueloutilicepersonalformadoenartroscopiaenunámbitoquirúrgico.
Capítulo1.Introducción
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1.4. Definiciones de símbolos
Panel frontal Panel trasero
botón de alimentación
Conectalaalimentaciónsielinterruptordealimentaciónprincipalsituadoenlapartetraseradelabombaestáencendido(estáencendidalaluzverdedeposicióndeespera).
On
Off
Alarma
Elindicadorrojoseencenderásiseviolaunparámetrodeseguridad.
Símbolo de toma equipotencial (tierra)
Ciclo de presión
Atenúalahemorragiadurantelaoperaciónaumentandolapresiónbásicadurantedosminutos.
IP50 Sinprotecciónfrentealíquidos
Panel del Pedal de una vía
Seutilizaparaactivarocancelarunciclodepresión.
Tipo b Clase 1
ConformeconlanormaEN60601-1.
AumentoPrecaución
Consultarinstruccionesdeuso.
Disminución
Consulteelmanual/folletodeinstrucciones
Consulteelmanual/folletodeinstrucciones
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Peligro de explosión
Fusible principal
Sustituir los fusibles como se indica
DeacuerdoconlaDirectiva2002/96/EC,esteproductodebedesecharseporseparado.Nodesecharcomobasuramunicipalsinclasificar.Contacteconeldistribuidorlocalparainformarsedecómodesecharlo.
No mojar
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1 Tapas de seguridad transparentes. Estatapadebe estarcerradapara
quegirelabombaderodillo.
2 bomba de rodillo de IRRIGACIÓN. Proporcionaflujodeentrada.
3 balancín de tensión. Sostieneeltubosobreelcabezalde
labombaderodillo.
4 botón de alimentación Conectaodesconectalaalimentación
(ON / OFF) sielinterruptordealimentaciónprincipalsituadoenlapartetraseradelabombaestáencendido(estáencendidalaluzverdedeposicióndeespera).
5 Pantalla PRESIÓN. Muestratantolapresiónpredefinida
cuandoseestáestableciendolapresióndebase,comolapresióndinámica(1s)despuésdeliberarlosbotonesdeajustedepresión.
6 ALARm. (Alarma) Elindicadorrojoseencenderásise
violaunparámetrodeseguridad.
7 Conector de "Remote control" (mando a distancia).
ConectaelmandoadistanciaalFMSSOLO.
A – Panel frontal
1.5. Indicadores de sistema
1 2 3 4 5
6
78910111213
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8 Ciclo de presión. Atenúalahemorragiaaumentandola
presiónbásicaduranteunciclodedosminutos.
9 botones de ajuste de PRESIÓN. Pulsarlasflechasparaincrementar
oreducirelniveldepresiónenincrementosde5.Laconfiguracióniniciales50.
10 botón de marcha/Parada de la bomba. Enciendeyapagalabomba.Siseactiva
labomba,aparece<PUMP>(bomba)enlapantalladepresión.ElLEDverdeparpadeacuandolabombaestáparada.
11 Conexión del transductor de presión incorporado.
ParaconectarelTubodeirrigaciónOneDaySetymedirlapresiónenlacámaradepresión.
12 Fill Chamber pad (botón de llenado de cámara).
LlenalacámaramanualmenteyapagalaalarmaLOWPRESSURE(bajapresión).
13 Dispositivo autobloqueante patentado.
Estedispositivopatentadopermitecolocarcorrectamenteeltuboymantenerlobloqueadoensusitioalrededordelabombaderodillo.
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14 Interruptor I/O, fusibles y conexión a la alimentación eléctrica.
15 Identificación y especificación.
16 Conexión de pedal. Conectorde9pinesparaconectarel
pedal.
17 Conexión de la interfaz del rasurador. Conectorde25pinesdeloscables
delainterfazdelcontroldelpedalydemano.PóngaseencontactoconrepresentantesdeventasdeDePuyMitekparainformacióndepedidodelcabledelrasuradorFMSdebidoalavariedaddeproductosexistentes.
18 Número de serie.
•Losdosprimerosdígitosrepresentanelañodefabricación.
•Elsegundoconjuntodedígitosrepresentalasemanadefabricaciónyelnúmerodeserie.
19 Número de referencia.
b – Panel trasero
14
15
16
17
18
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1.6. Otros indicadores (tonos audibles)..Untonoaudiblesuenacuandosepulsaelbotón
"POWER"(alimentación)yseenciendelabomba..Untonoaudiblesuenacuandoseactivaelmodo
PRESSURE (PRESIÓN)(consultarlaseccióndelciclodepresiónparaactivarelciclo).
. DostonosaudiblessuenancuandoestádesactivadoelmodoPRESSURE (PRESIÓN) (consultarelcapítulo4paradesactivarelciclo).
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Advertencias:
Configuracióndefábrica:Laconfiguracióndefábricasebasaenlaexperienciaysólodebeutilizarseatítuloorientativo.Elcirujanoesresponsabledelaconfiguracióndependiendodelprocedimientoquirúrgicorealizado.
Lapruebadeseguridadeléctricadeberealizarlauningenierobiomédicouotrapersonacalificada.
Riesgodeelectrocución:Noquitelatapa.ConsulteconsurepresentantedeDePuyMitekopóngaseencontactoconelServiciodeatenciónalclientedeDePuyMitekenEstadosUnidosenel+1(800)382-4682,Opción2.
Noconecteeldispositivoaunafuentedealimentaciónquenoestécorrectamenteconectadaatierra.
Desconectareldispositivodelaalimentaciónprincipalcuandololimpie,lehagaelmantenimientoolorevise.
Inspeccioneelequipoyloscables,periódicamente,paradetectarposibledesgaste.ConsulteconsurepresentantedeDePuyMitekopóngaseencontactoconelServiciodeatenciónalclientedeDePuyMitekenEstadosUnidosenel+1(800)382-4682,Opción2siobservadaños.
EviteelcontactodeFMSSOLOysusconectoreseléctricosconlíquidos.
NoutiliceagentesinflamablescuandolimpieydesinfecteelFMSSOLO.
Paraevitarelriesgodeincendiocambielosfusiblesporotrosdelmismotipoycalificación.
2.1. Conservación y manipulación: Temperatura de almacenamiento: NoexpongaelFMSSOLOatemperaturasporencimade50°C(122°F)opordebajo–10°C(14°F).
Condiciones de funcionamiento: Noutilicelabombaatemperaturassuperioresa40ºC(104°F)opordebajode10°C(50°F).
Daños: NoutilizarelFMSSOLOsisecaeomuestraseñalesdedaños.
Desechar: Noincinerar.
ConsulteconsurepresentantedeDePuyMitekoconelServiciodeatenciónalclientedeDePuyMitekenEstadosUnidosenel+1(800)382-4682,Opción2paraorganizarunaformaseguradedesecharlo.
Capítulo2.Precaucionesdeuso,VerificacionesyAdvertencias
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Capítulo3.Procedimientosdeinstalación3.1. Instalación de la bomba.
Alimentaciónenlapartetraseradelabombaen“I”.
PulsarelbotóndealimentaciónPower.ElLCDseiluminará.
Abrirlatapa.
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solouso.Nofuediseñadoparaserreutilizado/reesterilizado.Sureprocesamientopuedeprovocarcambiosenlascaracterísticasdelmaterial,talescomosudeformaciónydegradación,losquepuedenafectarlaresistenciadeldispositivoycomprometersurendimiento.Elreprocesamientodedispositivosparaunsolousotambiénpuedeproducircontaminacióncruzadayprovocarlainfeccióndelpaciente.Estosriesgospuedenafectarpotencialmentelaseguridaddelpaciente.
Laesterilidadsólosemantienesisehanpracticadolosprocedimientosdecambiosdetuborespetandoexactamentelasinstruccionesdeinstalaciónquefiguranmásadelante,enlaSección3.2.E.
EsteproductocontieneDEHP,unftalatodelquesetieneconstanciaquecausadefectoscongénitosyotrosdañosenelsistemareproductor,inclusoenniñosyenmujeresembarazadasoenperiododelactancia.
Estetuboconectalasbolsasdesoluciónsalinaconeltubodeirrigación.Lasoluciónfluyedelasclavijas(A)quehayalrededordelabombaderodillo,atravésdelacámaradepresión,dondeseleelapresióndeunfiltro(B)poruntransductordepresiónincorporado.
A. Instalación del tubo de irrigación One Day Set Ref. 284503 o 284504ContacteconelrepresentantedeDePuyMitekparapedirinformaciónyaquealgunostubosnoseofrecenentodoslospaíses.
Desdelasbolsasdesolución
Altransductordetransductor
Tubodeirrigaciónintermedio
(A)
(A)
Pinzas(B)
VERDEDispositivo
autobloqueante. CÁMARADEPRESIÓN
Pinzas
Pinzas
3.2. Instalación del tubo.
(C)
Filtro
Cerrarlastrespinzasyconectaralasbolsasdelíquido.
Deslizarlaparteverdedeltubodentrodeldispositivoautobloqueantedelabomba.
Colocarycentrareltuboquerodealabombaderodillo.
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Coloquelacámaradepresiónenelsujetador.Conecteeltransductoralabombaenroscándoloconfirmeza,enelsentidodelasagujasdelreloj.
ElLEDverdeparpadea.PulsarMarcha/Parada.ElLEDverdeparpadeaalprincipioypermaneceencendido.
Cerrarlatapa.
Pulsarelbotón"FillChamber"(llenarcámara)hastallenarlacámaraa1/3desucapacidad.ElLEDverdeparpadeahastaquesepresionaelbotón.
Tirardeltuboycerrarelbalancíndetensióncontraeltubo.
Advertencia:
Es obligatorio que la cámara de presión permanezca en posición vertical durante el procedimiento y que la bomba esté situada al mismo nivel que el paciente.
Sisellenaenexcesolacámarapuedeprovocarsequeelfiltro(verimagen3.2.A)semojeantesqueeltransductordepresióneinterferirasíconunamedidaprecisadelapresión.Siseproduceunllenadoexcesivodelacámara,consulteelCapítulo6paraResolucióndeproblemas.
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Estetubointermediodeirrigaciónconectaeltubodeirrigaciónalavainademaneraestéril.*LaRef.281103noincluyelaválvulaantirretornoconzonadeseparaciónestéril/tubointermediocon
válvulaantirretorno.LaRef.281103estápensadaparaunsolousodeltubodeIrrigaciónOneDaySet.
b. Instalación del tubo de irrigación intermedio Ref. 281103, 281142, o 281103*
Despuésdecomprobarqueelcierreluerestécorrectamenteapretado,laenfermerainstrumentistatomaeltubodeirrigaciónypasaelextremoazul(D)aunapersonadefueradelazonaestéril.
Lapersonadelazonanoestérilretiralastapasazulesdeltubodeirrigación(D)yelTubodeirrigaciónOneDaySet(C)...
...e inmediatamente conectaelcierreluerdelTubodeirrigaciónOneDaySet(C)alcierreluer(D).
LabombadebeestarenelModoRun(encendido)(10)cuandolaluzestáencendida.Cebeeltubodeirrigaciónabriendolapinzasituadabajolacámaradepresión.Cuandolahayaprimado,cierrelapinzaolallavedepasodelartroscopio(enlazonaestéril).
(D)
(C)
(C)(D)
Alartroscopio
DeltubodeirrigaciónOneDaySetRef.284503o284504.
(D)
Válvulaantirretornoconzonadeseparaciónestéril/Tubointermedio
conválvulaantirretorno
Blanco
Azul Azul Rojo
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C. Primeros pasos.
Conecteelcierrelueralartroscopio.Abralallavedepasodelartroscopio.
Abralapinzasituadabajolacámara.
ZONAESTÉRIL
ZONAESTÉRIL
ZONAESTÉRIL
ZONANOESTÉRIL
Introduzcaeltubodelacánulaenlacánula. Introduzcaeltubodelrasuradorenelpuertodesuccióndelrasurador.
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Cierrelapinzasituadabajolacámaradepresión.
Desconectarelcierreluerazul(E)deltubodeirrigaciónintermedio.
Pulsarelbotón“Run/Stop”(oabrirlatapadeseguridadtransparente).
D. Fin de la utilización.
Nota: El “One Day Set” con ref. 284503 & 284504 se puede reutilizar en varios procedimientos durante el mismo día de intervenciones. Advertencia: Solamente se mantendrá la esterilidad si se han seguido los procedimientos de instalación y cambio de tubos correctos.
Advertencia:La válvula antirretorno con zona de separación estéril/tubo intermedio con válvula antirretorno debe permanecer atada al tubo de irrigación One Day Set que asegura la esterilidad entre cirugías.
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Despuésdecomprobarqueelcierreluerestécorrectamenteapretado,laenfermerainstrumentistatomaeltubodeirrigaciónypasaelextremoazul(D)aunapersonadefueradelazonaestéril.
...e inmediatamente conectaelcierreluerazul(D)delnuevotubodeirrigaciónazulalcierreluerazul(C)deltubodeirrigaciónOneDaySet.
Lapersonadelazonanoestérilretiralaantiguaválvulaantirretornoconzonadeseparaciónestéril,desconectandoloscierresluerdeltubodeirrigaciónOneDaySet(C)yeltubodeirrigaciónintermedio...
E. Instalación para la siguiente utilización.
ElTubodeirrigaciónOneDaySetpuededejarsecolocadoalfinaldelusoanterior,conlaválvulaantirretornoconzonadeseparaciónestéril/tubointermedioconválvulaantirretornofijada.
Advertencia:Nunca acople una válvula antirretorno con zona de separación estéril/tubo intermedio con válvula antirretorno a otra.
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Cierretodaslaspinzasblancas.
Apaguelabombapulsandoelinterruptordealimentación"POWER".Eliminetodoslostubos.
F. Último uso del día.
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Capítulo4.FuncionesdelSistemadeBombeo
4.1. marcha/ParadaPulsarelbotón"Run/Stop"(Marcha/Parada)parainiciartodaslasfuncionesdelabomba.
4.3. Rellenar la cámara Pulseelbotón"FillChamber"(llenarcámara)paraunllenadoinicialdelacámaradepresiónycuandolonecesitedurantelaintervenciónquirúrgica.Lacámaranodebenuncaestarllenaamásde1/3desucapacidad.
4.2. Presión predeterminada Lapresiónsemuestraentreparéntesis(porejemplo<50>)enlapantallaLCD(5)durante2segundoscuandosepulsaunodelosbotonesdepresión,luegosemuestralapresiónreal(losajustesdepresiónestánenniveles).
ElNivel50equivalea5piesdegravedadoelequivalentede112.5mmHg(±10%).
Labombamantendráelnivelpredefinido.Cuandoestéenuso,utilicelosbotones“+”y“–”(9)paraincrementaryreducirelnivel.Elnivelpredefinidoenfábricaes50.
Nota:losnúmerosentre()correspondenaldiagramadelasección40.
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4.4. Parámetros iniciales recomendados. *
Alarma de alta presión.
Sisesobrepasaelniveldeseguridaddealtapresiónestablecidoen140,labombasedetieneyseiluminaelLEDrojodealarma"ALARM"(6).Eloperadordeberáreducirlapresiónparapermitirquelabombaarranquedenuevodemodoautomático.Silabombanoarrancadenuevocuandocaigalapresiónpordebajode140,arranquedenuevolabombamanualmenteutilizandoelbotóndealimentación"POWER"paraapagar(OFF)yencender(ON)denuevolabomba.
Alarma de baja presión.
Silapresióncaepordebajode10,seiluminaelLEDrojodealarma"ALARM".Enlapantallasevelaindicacióndestellante<PresL>ylabombasedetiene.Compruebequeelcierrelueryelfiltrocercanoaltransductordepresiónfuncionencorrectamente.Siambossonsatisfactorios,pulsar"FillChamber"(llenarcámara)paradetenerlaalarmayelbotón"Run/Stop"(Marcha/Parada)paraarrancardenuevolaunidad.
Nota:losnúmerosentre()correspondenaldiagramadelasección40.
4.5. Alarmas de presión
Advertencia:
Si ha entrado agua accidentalmente en el tubo que conduce hacia el transductor de presión, cambie el tubo de irrigación One Day Set y arranque de nuevo el sistema.
Nota:Sihayhemorragia,elcirujanopuedeelegiractivarelmododelavadooaumentarlapresión.
* ADvERTENCIA:Laconfiguracióndefábricasebasaenlaexperienciaysólodebeutilizarseatítuloorientativo.Elcirujanoesresponsabledelaconfiguracióndependiendodelprocedimientoquirúrgicorealizado.
ArticulaciónNivel de presióncon torniquete
Nivel de presióncon torniquete
Articulacióndelhombro 60
Acromioplastia 60
ArticulacióndelarodillaHemartrosis
3050–60
6550–60
Muñeca 30 65
Codo,Tobillo 40 65
Cadera 65
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4.6. modo de ciclo de presión.
Elmododeciclodepresiónseactivaobienpulsandoelbotón"Pressure"(Presión)...
...outilizandoelmandoadistanciaRef.288051,queestáconectadoenelpanelfrontaldelabomba...
Elmandoadistancianopuedemeterseenautoclavenisumergirseenlíquido.Debeutilizarseunatapademandoadistanciaestérilydesechable,Ref.281087.
...opulsandoelpedalrojoRef.284171,queestáconectadoalpaneltraserodelabomba(verenlapágina42,n°16).
Estafunciónaumentalapresiónenun60%duranteunciclodedosminutos.Lapresiónvuelvedespuésautomáticamenteasuconfiguraciónoriginal.Elmododeciclodepresiónseactivacuandoseproducelahemorragia,Elmododeciclodepresiónsepuedecancelarpulsandodenuevoelmododeciclodepresión.
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Capítulo5.Mantenimiento:LimpiezaydescontaminaciónLimpieza del FmS SOLO:Trasutilizarloporúltimavezdeldía,apagueelFMSSOLOydesconecteelcabledeelectricidadydesechelostubos.Limpieloslateralesdelinstrumento,elpanelfrontalylastapasconunpañosuavequesehayahumedecidoligeramenteconundetergentedepHneutro.Límpielanuevamenteenjuagandoconaguadestilada.
Advertencia:
DOSUMERGIR.NOPASARPORAUTOCLAVENoutiliceagentesinflamablescuandolimpieydesinfecteelFMSSOLO.
Pedal: Limpieza y descontaminaciónDespuésdecadauso,limpieelpedalyelcabledeelectricidadconundetergentedepHneutro.Elpaneldepedalespuedesumergirse,perosusconexioneseléctricasno,éstasdebenpermanecersecas.
Advertencia:
NOSUMERGIRELCONECTORELÉCTRICODELPEDAL.NOPASARPORAUTOCLAVENoutiliceagentesinflamablescuandolimpieydesinfecteelPedal.
Notuerzadelcablealguardarlo.
Notiredelcableparadesenchufarelinstrumento.
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Capítulo6.Resolucióndeproblemas
Problemas Causas posibles Posibles solucionesLabombasedetiene.
SeiluminaelLEDdeALARMArojo.
SehaactivadolaseguridaddeALTAPRESIÓN.
SehaactivadolaseguridaddeBAJAPRESIÓN:Parpadea“Pres.L”.
Elfiltrohidrofóbicoestámojado.
Noquedafluidodeirrigación.
Reducirlapresióndelaarticulación.
Pulsarelbotón"Run/Stop"(Marcha/Parada)parainiciartodaslasfuncionesdelabomba.
Comprobarqueelcierreluerestébiencerrado.
Pulsar"FillChamber"(llenarcámara)paradetenerlaalarmaypulsarelbotón"Run/Stop"(Marcha/Parada)paraarrancardenuevolaunidad.
SustituireltubodeirrigaciónOneDaySet.Sielproblemapersiste,contacteconelServiciodeatenciónalclientedeDePuyMitek.
Pinchelabolsaypulseelbotóndellenadodelacámara"FillChamber".
Loscabezalesdelabombaderodillonogiran.
Laalimentaciónestáapagada“O”oestáenStop.
Comprobarqueelinterruptordelaalimentaciónprincipalenlapartetraseradelabombaestéenlaposición"I"yquelaluzverdedelbotón"Run/Stop"(Marcha/Paradaestéiluminada.
Nohayirrigación. Lallavedepasodelavainaounapinzaestácerrada,impidiendoelflujohaciaafuera.
Comprobarlalíneadeentradadeflujodelasbolsasalaarticulación.Abrirtodallavedepasoopinzaqueestécerrada.
Labombadeirrigaciónempiezaagirarenexceso,emitiendounruidofuerte.
Noquedafluidodeirrigación. Cambielasbolsasdesoluciónalcalinay/ocompruebelaspinzasquehaybajolasbolsas.
Pulsar"FillChamber"(llenarcámara)silacámaraestápordebajode1/3.
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Problemas Causas posibles Posibles solucionesLabombadeirrigaciónseenciendeyapagaalazar,causandofluctuacionesanormalesdepresión.
Esposiblequehayaentradoaguaeneltubolectordepresión.
CambiareltubodeirrigaciónOneDaySetsihaentradoaguaeneltubolectordepresión.Sielproblemapersiste,contacteconelServiciodeatenciónalclientedeDePuyMitek.
Haydemasiadoaguaenlacámaradepresión.
Puedequehayaunafugadeaireenelconducto.
Comprobarqueloscierresluerdeltubolectordepresiónydeirrigaciónesténcerrados.Siesnecesario,cambiareltubodeirrigaciónOneDaySetyempezardenuevo.
Nohaypresiónsuficienteenelsistema.
Hayunproblemadeirrigación. Comprobarlallavedepasodelartroscopioylaspinzassituadasbajolasbolsasdesoluciónsalinaybajolacámaradepresión.
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Características del producto
ComposiciónRef:284590
DimensionesAltura: 16cmAnchura: 39cmProfundidad: 30cmPeso: 11kg
Características de rendimientoNiveldepresión:20-140Incrementosde5Precisión±10%convelocidaddeflujo0
Características eléctricasPotenciadeentrada: 120/230V~Frecuencia: 50-60HzConsumodecorriente: 500VAFusibles: RetardodeTiempode5ACumpleconlasnormasEN60601-1(Seguridadeléctricadelosaparatosmédicos)yEN60601-1-2(CompatibilidadElectromagnética)
Condiciones de almacenamientoTemperaturas:–10°C(14°F)a+50°C(122°F)
Condiciones de funcionamientoTemperaturas:+10°Ca+40°CHumedadrelativa:30a75%
Capítulo7.Característicasdelproducto
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CAPITOLO 1. INTRODUZIONE 65
1.1. Descrizionedelprodotto.............................................................. 65 1.2. Avvertenzeeprecauzionigenerali............................................... 65 1.3. Usoprevisto.................................................................................. 65 1.4. Definizionideisimboli.................................................................. 66 1.5. Indicatoridelsistema................................................................... 68 A.Pannelloanteriore.................................................................... 68 B.Pannelloposteriore.................................................................. 70 1.6. Altriindicatori(toniacustici)........................................................... 70
CAPITOLO 2. PRECAUZIONI, CONTROLLI E AvvERTENZE OPERATIvE 71
2.1. Conservazioneemanipolazione................................................ 71
CAPITOLO 3. PROCEDURE DI INSTALLAZIONE 72
3.1. Installazionedellapompa............................................................ 72 3.2. Installazionedeitubi..................................................................... 73 A.InstallazionedeltubodiirrigazioneOneDaySet................... 73 B.Installazionedeitubidiirrigazione.......................................... 75 C.Attivitàpreliminari..................................................................... 76 D.Finedell’intervento................................................................... 77 E.Preparazionedell’interventosuccessivo................................. 78 F.Finedellagiornataoperatoria.................................................. 79
IndiceGARANZIA E ASSISTENZA 62
DISImbALLAGGIO, ASSEmbLAGGIO E CONTROLLO INIZIALE DEL SISTEmA 63
PROGRAmmA DI ISPEZIONE 64
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CAPITOLO 4. FUNZIONI DEL SISTEmA POmPA 80
4.1. Avvio/Arresto................................................................................ 80 4.2. Pressionepreimpostata................................................................ 80 4.3. Riempimentodellacamera.......................................................... 80 4.4. Impostazioniinizialiraccomandate............................................... 81 4.5. Allarmepressione......................................................................... 81 4.6. ModalitàCiclodipressione........................................................... 82
CAPITOLO 5. mANUTENZIONE: PULIZIA E DECONTAmINAZIONE 83
CAPITOLO 6. RISOLUZIONE DEI PRObLEmI 84
CAPITOLO 7. SPECIFICHE DEL PRODOTTO 86
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GaranziaeassistenzaI prodotti DePuy Mitek sono garantiti privi di difetti di fabbricazione e dei materiali per il periodo di garanzia definito per un determinato prodotto, il quale decorre dalla data della fattura.
Rivolgersi al proprio rappresentante DePuy Mitek per informazioni specifiche sulla garanzia dei prodotti.
DePuy Mitek offre un programma di sostituzione rapida per i suoi prodotti, onde minimizzare il tempo di inattività in sala operatoria. Per ottenere un numero di autorizzazione al reso o per informazioni aggiuntive su questo programma, chiamare l’Assistenza Clienti DePuy Mitek al numero +1 (800) 382-4682 e selezionare l’Opzione 2 negli Stati Uniti oppure contattare il proprio rappresentante DePuy Mitek.
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Disimballaggio,assemblaggioecontrolloinizialedelsistemaDisimballaggio:
Verificarechetuttigliarticolielencatineldocumentoditrasportocorrispondanoaiprodottiricevuti(verificareinumeridiserieeiriferimenti).NotificareimmediatamenteilpropriorappresentantecommercialeDePuyMitekdieventualidannioppurechiamarel’AssistenzaClientidiDePuyMiteknegliUSAalnumero+1-800-382-4682eselezionarel’opzione2.Conservaretuttiimaterialidiimballaggio,inquantosarannonecessariperlaspedizioneincasodireso.
Dopoaverapertolascatola,rimuovereleIstruzioni per l'uso,leggerleeattenersiaquantoriportato.PerrimuoverelaconsoleFMSSOLO,posizionarelemanisuentrambiilatidellaconsoleinmododaafferraresaldamentelaparteinferiore.Estrarreconattenzionelaconsoledallascatolaecollocarlasuunasuperficierobustaepiana.
Assemblaggio:
-Collegareilcavodialimentazionealconnettoredialimentazione(14).
-Collegareilpedalealconnettoreperpedale(16)sulretrodellapompa.
Controllo iniziale del sistema:
- Spostarel’interruttoreI/O(14)su“I”.
- Accendereildispositivopremendoiltastodiaccensione/spegnimentocontrassegnatoPOWER(4).
- Premeretuttiitasti.Sidevesentireuntonoacusticoperognitastopremuto,adeccezionediPressureCycle(ciclodipressione)(Tasto8)(ilciclodipressioneèinattivofinchénonsiriempielapompa.)
Nota:inumeritra()fannoriferimentoaldiagrammanellasezione1.5.
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Programmadiispezione
Ispezione settimanale:
DePuyMitekraccomandaun’ispezionesettimanaledell’apparecchiatura.Questeispezionisipossonoeseguiresubasemenoregolare,asecondadelladurataedellafrequenzadiutilizzo.
- Ispezionarevisivamenteildispositivo.Sesiosservanosegnididanneggiamento,contattareilpropriorappresentantecommercialeDePuyMitekoppurechiamarel’AssistenzaClientidiDePuyMiteknegliStatiUnitialnumero+1(800)382-4682.Selezionarel’opzione2,perparlareconuningegnerebiomedico.
- Ispezionareilcoperchiodisicurezzatrasparente(1)elecernierenereperaccertarechesianoinbuonecondizioni.
- Ispezionareilcavodialimentazioneetuttiglialtricaviperrilevareeventualisegnidiusuraolacerazioni.
- Accertarecheipindeiconnettoridelpedaleedell’interfacciadelloshavernonsianonémancantinépiegati.
- Inserireilcavodialimentazionenelconnettoredialimentazione.
- Spostarel’interruttoreI/O(14)su“I”.- Accendereildispositivopremendoiltasto
diaccensione/spegnimentocontrassegnatoPOWER(4).
Premeretuttiitasti.Sidevesentireuntonoacusticoperognitastopremuto,adeccezionediPressureCycle(ciclodipressione)(Tasto8).Ilciclodipressioneèinattivofinchénonsiriempielapompa.
Ispezione annuale:
DePuyMitekraccomandadifarecontrollareannualmentetutteleapparecchiaturedauningegnerebiomedicoodapersonaletecnicoautorizzatoperdeterminarnelafunzionalitàelasicurezzatecnica.
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1.1. Descrizione del prodotto
Sistema di irrigazione.FMSSOLOèunavanzatosistemadiirrigazione,economicamenteconveniente,cheusatecnologiabrevettatapermigliorarelavisualizzazioneeladistensione,controllandonelcontempolapressionedurantel’interventoartroscopico.
Compensazione del flusso.IlsistemaFMSSOLOèingradodicapirequandounoshaverèinrotazioneequindimigliorarneleprestazioniattivandoilciclodi“Compensazionedelflusso”.ContattareilpropriorappresentantecommercialeDePuyMitekperinformazionisuiprodottiinterfacciabiliconloshaverFMS,inquantol’offertadiprodottièampia.
Pedale rosso del ciclo di pressione.Unodegliaspettipiùcriticidell’artroscopiaèrappresentatodallavisualizzazione.Ilcampovisivoèspessoostacolatodasangueedetriti.Peralleviarequestoproblema,ilsistemaFMSSOLOèdotatodiunciclodipressione.Premendosulpedalerosso,siattivaunciclotemporizzatodiaumentodellapressionecheserveacontrollareilsanguinamento.Alcompletamentodelciclo,ilsistemaFMSSOLOtorneràallaconfigurazioneoriginale.
1.2. Avvertenze e precauzioni generali
Siraccomandaalpersonaleospedalierodileggereilpresentemanualeprimadifarefunzionareepulirequestoprodottoeirelativiaccessori.Lamancataosservanzadiquesteistruzionipotrebbeprovocarepossibililesionioppureildanneggiamentooilmalfunzionamentodell’apparecchiatura.
Ilproduttoreeilrivenditoreautorizzatideldispositivononaccettanoalcunaresponsabilitàperdanniolesionidirettioconseguenticausatidaunusoimpropriodiaccessoridiconsumomonouso
diversidaiprodottiFMS.Eventualialterazionialdispositivo,riparazionieseguitedauncentrodiassistenzanonautorizzatool’usodiaccessoridiconsumomonousononFMS,possonocomportarel’annullamentodelmarchioCEedellagaranziaFMS,nonchédellacoperturaassicurativaperidannicausatidalprodotto.
Isetditubicontengonounoftalato(DEHP),sostanzachimicanotaperesserecausadidifettidelfetoedialtridanniacaricodell'apparatoriproduttivo,acuisonosoggetti,adesempio,ibambinieledonneingravidanzaedurantel'allattamento.
Avvertenza:
L’FMSSOLOèundispositivodiClasseI,TipoB,secondolanormaperlasicurezzaelettricaEN60601-1relativaaidispositivimedici.Verificarechesistautilizzandoilcavodiinterfacciacorrettoquandosieffettualaconnessioneadunaltroshaver.Permaggioridettagli,consultareleIstruzioniperl’usodelcavod’interfaccia.ContattareilpropriorappresentantecommercialeDePuyMitekperesaminareleoffertedicavid’interfacciaperloshaver.
Ilsistemapuòesseredisturbatodainterferenzeelettromagneticheprovenientidaaltristrumenti.Controllarechetuttiglialtristrumentielealtreapparecchiature(associateomenoalsistema)sianoconformiallanormaEN60601-1-2(EMC).
Seilsistemacontinuaadesseredisturbato,isolarlodallostrumentofontedeldisturboecollegarloadunapresadiretediversa.
1.3. Indicazioni per l'uso
IlsistemadigestionedeifluidiartroscopiciFMSSOLOèindicatoperl'usoinambientechirurgicodapartedipersonaleespertoinartroscopia.
Capitolo1.Introduzione
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1.4. Definizioni dei simboli
Pannello anteriore Pannello posteriore
Tasto di accensione/spegnimento
ACCENDE/SPEGNEildispositivosel’interruttoreprincipalesulretrodellapompaèacceso(laspiaverdedistandbyèaccesa).
Acceso
Spento
Allarme
Laspiarossasiaccendesevieneviolatounparametrodisicurezza.
Simbolo di equipotenziale (massa)
Ciclo di pressione
Riduceilsanguinamentodurantel’interventochirurgico,incrementandolapressionedibaseperdueminuti.
IP50 Nessunaprotezionedaliquidi
Pedale a una via
Usatoperattivareoannullareilciclodipressione.
Tipo b Classe 1
ConformeallanormaEN60601-1.
IncrementaAttenzione
Vedereleistruzioniperl’uso.
Decrementa
Consultareilmanuale/librettodiistruzioni
Consultareilmanuale/librettodiistruzioni
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Rischio di esplosione
Fusibile di rete
Sostituire i fusibili come indicato
ConformementeallaDirettiva2002/96/CE,ilprodottodeveesseresmaltitosecondoicriteridiraccoltadifferenziata.Nonsmaltireinsiemeairifiutiurbaninondifferenziati.Contattareunrappresentantelocaleperinformazionisullosmaltimento.
Non bagnare
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1 Coperchi di sicurezza trasparenti. Questocoperchiodeveesserechiuso
perconsentirealrotoredellapompadiruotare.
2 Rotore della pompa di IRRIGATION (IRRIGAZIONE).
Forniscel’afflussodifluido.
3 bilanciere a tensione. Reggeitubisullatestadelrotoredella
pompa.
4 POWER pad (Tasto di accensione/spegnimento POWER).
Accende/spegne ildispositivosel’interruttoreprincipalesulretrodellapompaèacceso(laspiaverdedi“standby”èaccesa).
5 PRESSURE display (Display della PRESSIONE). Visualizzasialapressione
preimpostata,quandosistaimpostandolapressionedibase,sialapressionedinamica(1sec)dopoilrilasciodeipulsantidiregolazionedellapressione.
6 ALARm (ALLARmE). Laspiarossasiaccendeseviene
violatounparametrodisicurezza.
7 Connettore del telecomando. Collegailtelecomandoalsistema
FMSSOLO.
A – Pannello anteriore
1.5. Indicatori del sistema
1 2 3 4 5
6
78910111213
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8 Ciclo di pressione. Riduceilsanguinamento,incrementando lapressionedibaseperunciclodi2 minuti.
9 Tasti di regolazione della PRESSURE (PRESSIONE). Premerelefrecceperincrementareo
decrementarelapressioneinincrementidi5.L’impostazioneinizialeè50.
10 Tasto di Run/Stop (avvio/arresto) della pompa. Accendeespegnelapompa.Sela
pompaèattivata,<PUMP>(POMPA)comparesuldisplaydellapressione.IlLEDverdelampeggiaquandolapompaèferma.
11 Connessione del trasduttore di pressione integrato.
PercollegareiltubodiirrigazioneOneDaySetemisurarelapressionenellacameradipressione.
12 Tasto di riempimento della camera Riempiemanualmentelacamerae
arrestal’allarmedipressionebassa(LOWPRESSURE).
13 Dispositivo autobloccante brevettato. Consentediposizionarecorrettamente
ebloccareinposizioneitubimonousoattornoalrotoredellapompa.
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14 Interruttore I/O, fusibili e connessione di alimentazione.
15 Identificazione e specificazione.
16 Connessione pedale. Connettorea9pinperilcollegamento
delpedale.
17 Interfaccia di connessione dello shaver. Connettorea25pinpericavi
d’interfacciadelcomandomanualeeapedale.ContattareilpropriorappresentantecommercialeDePuyMitekperinformazionisull’ordinazionedeicavid’interfacciadelloshaverinquantol’offertadiprodottièampia.
18 Numero di serie.
•Leprimeduecifrerappresentanol’annodiproduzione.
•Lasecondaseriedicifrerappresentalasettimanadiproduzioneeilnumerodiserie.
19 Numero di riferimento.
b – Pannello posteriore
14
15
16
17
18
19
1.6. Altri indicatori (toni acustici)..Untonoacusticovieneemessoquandosi
premesultastodiaccensione/spegnimentoPOWEResiaccendelapompa.
.UntonoacusticovieneemessoquandosiattivalamodalitàPRESSURE(PRESSIONE)(vedereilciclodipressioneperattivareilciclo).
. DuetoniacusticivengonoemessiquandosidisattivalamodalitàPRESSIONE(vedereilcapitolo4perdisattivareilciclo).
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Avvertenze:
Impostazionidifabbrica:leimpostazionidifabbricasibasanosull’esperienzaevannousateunicamentecomelineeguida.Ilchirurgoèresponsabiledellasceltadelleimpostazioniinbaseall’interventochirurgicodaeseguire.
Itestrelativiallasicurezzaelettricadevonoessereeseguitidauningegnerebiomedicoodaun’altrapersonaqualificata.
Rischiodiscosseelettriche:nonrimuovereilcoperchio.Perleriparazioni,contattareilpropriorappresentanteDePuyMitekoppurechiamarel’AssistenzaClientidiDePuyMiteknegliStatiUnitialnumero+1(800)382-4682,opzione2.
Noncollegareildispositivoadunasorgentedialimentazionenoncorrettamentemessaaterra.
Scollegareildispositivodall’alimentazionediretedurantegliinterventidipulizia,riparazioneoispezione.
Ispezionareperiodicamentetuttal’apparecchiaturaeicaviperrilevareeventualisegnidiusura.Sesiosservanosegnididanneggiamento,contattareilpropriorappresentanteDePuyMitekoppurechiamarel’AssistenzaClientidiDePuyMiteknegliStatiUnitialnumero+1(800)382-4682,opzione2.
Evitareilcontattodell’FMSSOLOedeirelativiconnettorielettriciconliquidi.
NonusareagentiinfiammabiliquandosipulisceesidisinfettailsistemaFMSSOLO.
Perevitareilrischiodiincendio,sostituireifusibiliconaltridellostessotipoecalibro.
2.1. Conservazione e manipolazione Temperatura di conservazione: nonesporreilsistemaFMSSOLOatemperaturesuperioria50°C(122°F)oinferioria–10°C(14°F).
Condizioni di funzionamento: nonfarefunzionarelapompaatemperaturesuperioria40°C(104°F)oinferioria10°C(50°F).
Danneggiamento: nonusareunsistemaFMSSOLOcheèstatofattocadereochemostrasegnididanneggiamento.
Smaltimento: nonincenerire.
ContattareilpropriorappresentanteDePuyMitekoppurechiamarel’AssistenzaClientidiDePuyMiteknegliStatiUnitialnumero+1(800)382-4682,opzione2,perpredisporrelosmaltimentosicuro.
Capitolo2.Precauzioni,controllieavvertenzeoperative
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Capitolo3.Procedurediinstallazione
3.1. Installazione della pompa.
Premerel’interruttore“I”sulretrodellapompa.
Premereiltastodiaccensione/spegnimentoPOWER. LoschermoLCDsiillumina.
Aprireilcoperchio.
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AVVERTENZA:ilprodottoèunicamentemonousoenonèindicatoperessereriutilizzato/risterilizzato.Ilritrattamentopuòindurremodifichedellecaratteristichedeimateriali,comelalorodeformazioneedegradazione,chepossonoavereimpattosullaresistenzadeldispositivoecomprometternelaprestazione.Ilritrattamentodidispositivimonousopuòanchecausarelacontaminazionecrociata,provocandoinfezioniaipazienti.Questirischipossonopotenzialmentepregiudicarelasicurezzadelpaziente.
LasterilitàvienemantenutasolosesiosservanoconprecisioneleprocedureperlasostituzionedeltuboriportatenelseguitoenellaSezione3.2.E.
Questoprodottocontieneunoftalato(DEHP),sostanzachimicanotaperesserecausadidifettidelfetoedialtridanniacaricodell'apparatoriproduttivo,acuisonosoggetti,adesempio,ibambinieledonneingravidanzaedurantel'allattamento.
Questotubocollegalesacchedisoluzionesalinaaltubodiirrigazione.Lasoluzionevadallepuntediperforazione(A)attornoalrotoredellapompa,attraversolacameradipressionedovelapressionevienelettaattraversounfiltro(B)dauntrasduttoredipressioneintegrato.
A. Installazione del tubo di irrigazione One Day Set Rif. 284504 o 284503RivolgersialpropriorappresentantecommercialeDePuyMitekperinformazionisull’ordinazioneinquantonontuttiitubisonodisponibiliintuttiPaesi.
Dallesacchedisoluzione
Altrasduttoredipressione
Tubointermediodiirrigazione
(A)
(A)
Morsetti(B)
VERDEDispositivoautobloccante CAMERADIPRESSIONE
Morsetti
Morsetti
3.2. Installazione dei tubi.
(C)
Filtro
Chiuderetuttietreimorsettiecollegareallesacchedifluido.
Farescorrerelaparteverdedeltuboneldispositivoautobloccantesullapompa.
Posizionareecentrareiltuboattornoalrotoredellapompa.
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Collocarelacameradipressionenelcontenitore.Connettereiltrasduttoreallapompaavvitandolosaldamenteinsensoorario.
IlLEDverdelampeggia.Premereilpulsantediavvio/arrestocontrassegnatoRun/Stop(avvio/arresto).IlLEDverdelampeggiainizialmente,quindirimaneaccesofisso.
Chiudereilcoperchio.
PremerediversevolteiltastodiriempimentodellacameracontrassegnatoFillchamberfinchélacameranonraggiunge1/3dellasuacapacitàdiriempimento.IlLEDverdelampeggiafinchésitienepremutoiltasto.
Tiraresultuboechiudereilbilanciereatensionecontroiltubo.
Avvertenza:
È imperativo che la camera di pressione rimanga verticale durante l’intervento e che la pompa sia posizionata allo stesso livello del paziente.
Ilsovrariempimentodellacamerapotrebbecomportarecheilfiltro(mostratoin3.2.A)vengabagnatoprimadeltrasduttoredipressioneequestopotrebbeinterferireconl’accuratezzadellamisurazionedellapressione.Incasodisovrariempimentodellacamera,vedereilCapitolo6perlaRisoluzionedeiproblemi.
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Questotubocollegailtubodiirrigazioneallaguainainmodosterile.*IlRif.281103nonincludeilgrupposteriledivalvolaunidirezionaleperzonatamponesterile/tubiintermediconvalvoladiritegnounidirezionale.IlRif.281103èindicatoperununicoutilizzodeltubodiirrigazionegiornaliero.
b. Installazione del tubo intermedio di irrigazione Rif. 281103, 281142 o 281103*
Dopoaverecontrollatocheilluerlocksiasaldamenteserrato,l’assistentedisalaoperatoriaprendeiltubodiirrigazioneenepassal’estremitàblu(D)adunapersonanonsterile.
Lapersonanonsterilerimuoveitappibludaltubodiirrigazione(D)edaltubodiirrigazioneOneDaySet(C)...
...econnetteimmediatamenteilraccordoluerlockblu(D)delnuovotubodiirrigazionealraccordoluerlockblu(C)deltubodiirrigazioneOneDaySet.
LapompadeveessereinmodalitàRun(10),conlaspiaaccesa.Riempireiltubodiirrigazioneaprendoilmorsettosottolacameradipressione.Alterminedelriempimento,chiudereilmorsettooilrubinettodiarrestosull’artroscopio(nellazonasterile).
(D)
(C)
(C)(D)
Allaguainaartroscopica
DaltubodiirrigazioneOneDaySetRif.284504oppure284503
(D)
Bianco
Blu Blu Rosso
Grupposteriledivalvolaunidirezionaleperzonatampone/
tubiintermediconvalvoladiritegnounidirezionale
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C. Attività preliminari.
Collegareilraccordoluerlockall’artroscopio.Aprireilrubinettodiarrestosull’artroscopio.
Aprireilmorsettosottolacamera.
ZONASTERILE
ZONASTERILE
ZONASTERILE
ZONANONSTERILE
Inserireiltubodellacannulasullacannula. Inserireiltubodelloshaversullaportadiaspirazionedelloshaver.
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Chiudereilmorsettosottolacameradipressione.
Scollegareilraccordoluerlock(E)bludeltubointermediodiirrigazione.
Premereiltastodiavvio/arrestocontrassegnatoRun/Stop(oaprireilcoperchiodisicurezzatrasparente).
D. Fine dell’intervento.
Nota: Rif. 284503 & 284504 Il One Day Set giornaliero può essere riutilizzato per diversi interventi durante la stessa giornata di interventi chirurgici. Avvertenza: la sterilità viene mantenuta unicamente se sono state osservate le procedure corrette per l'installazione e il cambio dei tubi.
Avvertenza: il gruppo sterile di valvola unidirezionale per zona tampone sterile/tubi intermedi con valvola di ritegno unidirezionale resta collegato al tubo di irrigazione giornaliero. Questo garantisce la sterilità tra un intervento e l’altro.
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Dopoaverecontrollatocheilraccordoluerlocksiaserrato,l’assistentedisalaoperatoriaprendeiltubodiirrigazioneenepassal’estremitàblu(D)adunapersonanonsterile.
...econnette immediatamente ilraccordoluerlockblu(D)delnuovotubodiirrigazionealraccordoluerlockblu(C)deltubodiirrigazioneOneDaySet.
LapersonanonsterilerimuovelavecchiavalvolaunidirezionaledallazonatamponesterilescollegandoiraccordiluerlockdeltubodiirrigazioneOneDaySet(C)edeltubointermediodiirrigazione...
E. Preparazione dell’intervento successivo.
Alterminedell’intervento,èpossibilelasciareinposizioneiltubodiirrigazionegiornaliero,conilgrupposteriledivalvolaunidirezionaleperzonatamponesterile/tubiintermediconvalvoladiritegnounidirezionalecollegati.
Avvertenza:Non collegare mai un gruppo sterile di valvola unidirezionale per zona tampone / tubi intermedi con valvola di ritegno unidirezionale ad un altro.
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Chiuderetuttiimorsettibianchi.
Spegnerelapompapremendoiltastodiaccensione/spegnimentocontrassegnatoPOWER.Smaltiretuttiitubi.
F. Fine della giornata operatoria.
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Capitolo4.Funzionidelsistemapompa
4.1. Avvio/ArrestoPremereiltastodiavvio/arrestoRun/Stop(Avvio/Arresto)perattivaretuttelefunzionidisistemadellapompa.
4.3. Riempimento della cameraPremereiltastodiFillChamber(riempimentodellacamera)perriempirelacameradipressione,all’inizioe,secondonecessità,nelcorsodell’intervento.Lacameranondevemaiesserepienaoltre1/3.
4.2. Pressione preimpostataLapressionevienevisualizzatatraparentesi(ades.<50>)sulloschermoLCD(5)per2secondiquandounodeitastidellapressionevienepremuto,vienequindivisualizzatalapressioneeffettiva(leimpostazionidellapressionesonoinlivelli).
Livello50,ugualea5piedidigravità/pressioneovverol’equivalentedi112,5mmHg(±10%).
Lapompamanterràillivellopreimpostato.Durantel’intervento,usareitasti“+”e“–”(9)perincrementareedecrementareillivello.Illivellopreimpostatoinfabbricaè50.
Nota:inumeritra()fannoriferimentoaldiagrammaapagina68.
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4.4. Impostazioni iniziali raccomandate. *
Allarme pressione alta.Sevienesuperatoillivellodisicurezzadellapressionealtaparia140,lapompasiarrestael’indicatoreLEDrossocontrassegnatoALARM(ALLARME)(6)siaccende.L’operatoredeveabbassarelapressioneperlasciarechelapompasiriavviiautomaticamente.Selapompanonsiriavviaquandolapressionescendesotto140,riavviarelapompamanualmentespegnendolaequindiriaccendendolamedianteiltastodiaccensione/spegnimento(POWER).
Allarme pressione bassa.Selapressionescendesottoillivellodisicurezzaparia10,l’indicatoreLEDrossocontrassegnatoALARM(ALLARME)siaccende,<PresL>(pressionebassa)lampeggiasuldisplayLCDelapompasiarresta.Controllarecheilraccordoluerlockeilfiltroaccantoaltrasduttoredipressionesianoinbuonecondizionidifunzionamento.Seentrambirisultanoincondizionisoddisfacenti,premereiltastodiFillChamber(riempimentodellacamera)perarrestarel’allarmeeiltastodiRun/Stop(avvio/arresto)perriavviarel’unità.
Nota:inumeritra()fannoriferimentoaldiagrammaapagina68.
4.5. Allarme pressione
Avvertenza:
se dell’acqua penetra accidentalmente nel tubo che conduce al trasduttore di pressione, sostituire il tubo di irrigazione One Day Set e riavviare il sistema.
Nota:Incasodisanguinamento,ilchirurgopotrebbesceglierediattivarelamodalitàdilavaggiooppureincrementarelapressione.
* Avvertenza:Questeimpostazioniinizialisibasanosull’esperienzaevannousateunicamentecomelineeguida.Ilchirurgoèresponsabiledellasceltadelleimpostazioniinbaseall’interventochirurgicodaeseguire.
ArticolazioneLivello di pressione
con laccio emostaticoLivello di pressione
senza laccio emostatico
Articolazionedellaspalla 60
Acromioplastica 60
ArticolazionedelginocchioEmartrosi
3050–60
6550–60
Polso 30 65
Gomito,caviglia 40 65
Anca 65
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4.6. modalità Ciclo di pressione.
LamodalitàCiclodipressionesiattivapremendoiltasto“Pressure”...
...oppureusandoiltelecomandoRif.288051,cheèconnessoalpannelloanterioredellapompa...
Nonsterilizzareinautoclaveenonimmergereiltelecomando.ÈnecessariousareunaprotezionesterilemonousopertelecomandoRif.281087.
...oppurepremendosulpedalerossoRif.284171,cheèconnessoalpannelloposterioredellapompa(vedereapagina70,n°16).
Questafunzioneincrementalapressionedel60%perunciclodidueminuti.Lapressionetorneràquindiautomaticamentealleimpostazionioriginali.LamodalitàCiclodipressionevieneattivataincasodisanguinamento.ÈpossibileannullareilciclodipressionepremendonuovamentelamodalitàPressureCycle(ciclodipressione).
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Capitolo5.Manutenzione:puliziaedecontaminazionePulizia dell’FmS SOLO:
Alterminedellagiornataoperatoria,spegnerel’FMSSOLO,disinserireilcavodialimentazioneegettaretuttiitubi.Pulireilatidellostrumento,ilpannelloanterioreeicoperchiconunpannomorbido,leggermenteinumiditoconundetergenteapHneutro.Pulirenuovamenteconunpannoinumiditodiacquadistillataperrisciacquare.
Avvertenza:
NONIMMERGERE.NONSTERILIZZAREINAUTOCLAVE.NonusareagentiinfiammabiliquandosipulisceesidisinfettailsistemaFMSSOLO.
Pedale: pulizia e decontaminazioneDopoogniintervento,pulireilpedaleeilcavodialimentazioneconundetergenteapHneutro.Lapedalierapuòessereimmersa,adeccezionedelleconnessionielettrichechedevonorimanereasciutte.
Avvertenza:
NONIMMERGEREILCONNETTOREELETTRICODELPEDALE.NONSTERILIZZAREINAUTOCLAVE.Nonusareagentiinfiammabilidurantelapuliziaeladisinfezionedelpedale.
Nontorcereilcavodurantelostoccaggio.
Nondisinserirelaspinadellostrumentotirandoilcavodiquest’ultimo.
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Capitolo6.Risoluzionedeiproblemi
Problema Possibili cause Possibili soluzioniLapompasiarresta.
L’indicatoreLEDrossocontrassegnatoALARM(ALLARME)siaccende.
ÈscattatoillivellodisicurezzaHIGHPRESSURE(PRESSIONEALTA).
ÈscattatoillivellodisicurezzaLOWPRESSURE(PRESSIONEBASSA):.“Pres.L”(pressionebassa)lampeggia.
Ilfiltroidrofoboèbagnato.
Nonc’èpiùfluidodiirrigazione.
Ridurrelapressionesull’articolazione.
PremereiltastoRun/Stop(avvio/arresto)perriavviarelapompa.
Verificarecheilluerlocksiabenchiuso.
PremereiltastoFillChamber(riempimentodellacamera)perarrestarel’allarmeeiltastoRun/Stop(avvio/arresto)perriavviarelapompa.
SostituireiltubodiirrigazioneOneDaySet.Seilproblemapersiste,contattarel’AssistenzaClientidiDePuyMitek.
PerforarelasaccaepremereiltastoFillChamber(riempimentodellacamera).
Letestedelrotoredellapompanonruotano.
L’interruttoredell’alimentazioneèsu“O”osuArresto.
Verificarechel’interruttoreprincipaledell’alimentazionesulretrodellapompasiasullaposizione“I”echelaspiaverdedeltastoRun/Stop(avvio/arresto)siaaccesa.
L’irrigazioneèassente. Ilrubinettodiarrestosullaguainaoppureunmorsettoèchiuso,bloccandol’efflusso.
Controllarelalineadiafflussodallesaccheall’articolazione.Aprireeventualimorsettiorubinettidiarrestochiusi.
Lapompadiirrigazioneiniziaaruotareeccessivamente,emettendounforterumore.
Nonc’èpiùfluidodiirrigazione. Sostituirelesacchedisoluzionesalinae/ocontrollareimorsettisottolesacche.
PremereiltastoFillChamber(riempimentodellacamera)selacameranonraggiunge1/3dellasuacapacitàdiriempimento.
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Problema Possibili cause Possibili soluzioniLapompadiirrigazionesiaccendeesispegneinmanieradiscontinua,provocandofluttuazionianomaledellapressione.
Èpossibilechedell’acquasiapenetratanellalineadirilevamentodellapressione.
SostituireiltubodiirrigazioneOneDaySetsedell’acquaèpenetratanellalineadirilevamentodellapressione.Seilproblemapersiste,contattarel’AssistenzaClientidiDePuyMitek.
Èpresentetroppaacquanellacameradipressione.
Potrebbeessersisviluppataunaperditad’arianellalinea.
Controllarecheiluerlocksultubodiirrigazioneedirilevamentodellapressionesianochiusi.Senecessario,sostituireiltubodiirrigazioneericominciare.
Lapressionenelsistemaèinsufficiente.
Sitrattadiunproblemadiirrigazione.
Controllareilrubinettodiarrestosull’artroscopioeimorsettisottolesacchedisoluzionesalinaesottolacameradipressione.
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Specifiche del prodotto
ComposizioneRif:284590
DimensioniAltezza: 16cmLarghezza: 39cmProfondità: 30cmPeso: 11kg
Specifiche prestazionaliLivellidipressione:da20a140inincrementidi5Precisione±10%adunaportatadi0
Specifiche elettrichePotenzainingresso: 120/230V~Frequenza: 50–60HzAssorbimentodicorrente: 500VAFusibili: da5AritardatiConformeallenomeEN60601-1(Sicurezzaelettricaneidispositivimedici)eEN60601-1-2(Compatibilitàelettromagnetica)
Condizioni di stoccaggioTemperature:da–10°C(14°F)a+50°C(122°F)
Condizioni operativeTemperature:da+10°Ca+40°CUmiditàrelativa:da30a75%
Capitolo7.Specifichedelprodotto
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KAPITEL 1 - EINFÜHRUNG 93
1.1. Produktbeschreibung.................................................................... 93 1.2. AllgemeineWarnhinweiseundVorsichtsmaßnahmen................ 93 1.3. Verwendungszweck...................................................................... 93 1.4. DefinitionderSymbole................................................................. 94 1.5. Systemanzeigen........................................................................... 96 A.Frontpanel................................................................................ 96 B.Rückwand................................................................................. 98 1.6. WeitereAnzeigen(Signaltöne)...................................................... 98
KAPITEL 2 - vORSICHTSmASSNAHmEN FÜR DEN bETRIEb, PRÜFUNGEN UND WARNHINWEISE 99
2.1. LagerungundHandhabung......................................................... 99
KAPITEL 3 - vORbEREITUNG 100
3.1. VorbereitungderPumpen.......................................................... 100 3.2. VorbereitungderSchläuche.......................................................101 A.InstallierendesOneDaySet-Spülschlauchs.........................101 B.InstallierendeszwischengeschaltetenSpülschlauchs.......... 103 C.ErsteSchritte.......................................................................... 104 D.EndedesEingriffs.................................................................. 105 E.VorbereitungfürdennächstenEingriff.................................. 106 F.EndedesArbeitstagesimOP................................................ 107
InhaltsverzeichnisGARANTIE UND KUNDENDIENST 90
ENTPACKEN, mONTAGE UND ERSTE SySTEmPRÜFUNG 91
INSPEKTIONSPLAN 92
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KAPITEL 4 - FUNKTIONEN DES PUmPENSySTEmS 108
4.1. Starten/Stoppen.......................................................................... 108 4.2. Druckvoreinstellung.................................................................... 108 4.3. BefüllenderKammer................................................................. 108 4.4. EmpfohleneAusgangseinstellungen........................................... 109 4.5. Druckalarm................................................................................. 109 4.6. Druckzyklus-Modus.....................................................................110
KAPITEL 5 - WARTUNG: REINIGUNG UND DEKONTAmINIERUNG 111
KAPITEL 6 - FEHLERAbHILFE 112
KAPITEL 7 - PRODUKTSPEZIFIKATIONEN 114
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GarantieundKundendienstEs wird garantiert, dass die Produkte von DePuy Mitek über den Gewährleistungszeitraum des jeweiligen Produkts hinweg frei von Material- und Herstellungsfehlern sind. Der Gewährleistungszeitraum beginnt mit dem Rechnungsdatum.
Garantieinformationen zu spezifischen Produkten erhalten Sie von Ihrem DePuy Mitek-Repräsentanten.
DePuy Mitek bietet für seine Produkte einen optimierten Austauschservice, um die Ausfallzeiten in Ihrem OP zu vermindern. Wenn Sie eine Rücksendegenehmigungsnummer oder weitere Informationen zu diesem Programm erhalten möchten, rufen Sie den DePuy Mitek-Kundendienst unter +1 (800) 382-4682 an und wählen Sie Option 2 (innerhalb USA), oder wenden Sie sich an Ihren DePuy Mitek-Repräsentanten.
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Entpacken,MontageundersteSystemprüfungEntpacken:
ÜberprüfenSie,dassalleElementeaufderPacklistemitdenerhaltenenProduktenübereinstimmen(ÜberprüfenSiedieSerien-undArtikelnummern).MeldenSieSchädenunverzüglichIhremDePuyMitek-VertriebsrepräsentantenoderrufenSiedenDePuyMitek-KundendienstindenUSAunter+1-800-382-4682,Option2an.BewahrenSiesämtlichesVerpackungsmaterialauf,daesfürdenVersandimFalleinerRücksendungvonProduktenbenötigtwird.
NachÖffnungderPackungentnehmenSiedieGebrauchsanweisung.BittelesenundbefolgenSiediesesorgfältig.UmdieFMSSOLO-Konsolezuentnehmen,legenSiedieHändeaufbeideSeitenderKonsole,bisSiedieUnterseitesichergreifenkönnen.NehmenSiedieKonsolevorsichtigausderPackungundstellenSiesieaufeineebeneundfesteUnterlage.
montage:
- SchließenSiedasNetzkabelandenNetzanschlussan(14).
- SchließenSiedenFußschalterandenFußschalter-Anschluss(16)aufderRückseitederPumpean.
Erste Systemprüfung:
- SchaltenSiedenE/A-Schalter(14)auf"I".
- SchaltenSiedasGerätEIN,indemSiedenPOWER-Taster(4)drücken.
- DrückenSieaufalleTaster.BeijederBetätigungeinesTasterssollteeinSignaltonzuhörensein(außer"PressureCycle"(Druckzyklus,Taster8).DerDruckzyklusistdeaktiviert,währenddiePumpeeingespültwird.)
Hinweis:ZahleninKlammern()beziehensichaufdieAbbildunginAbschnitt1.5.
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Inspektionsplan
Wöchentliche Inspektion:
DePuyMitekempfiehltwöchentlicheInspektionendergesamtenAusrüstung.DieseInspektionenkönnenjenachderNutzungsdauerund-häufigkeitseltenerdurchgeführtwerden.
- FührenSieeineSichtprüfungdesGerätsdurch.WennSieSchädenfeststellen,wendenSiesichanIhrenDePuyMitek-VertriebsrepräsentantenoderrufenSiedenDePuyMitek-KundendienstindenUSAunter+1-800-382-4682an.WählenSieOption2,ummiteinemMedizintechnikerzusprechen.
- VergewissernSiesich,dassdietransparenteSicherheitsabdeckung(1)unddieschwarzenScharniereineinemordnungsgemäßenBetriebszustandsind.
- ÜberprüfenSiedasNetzkabelundalleweiterenKabelaufAbnutzungundEinschnitte.
- StellenSiesicher,dassdieAnschlussstiftedesFußschaltersunddesShaver-Interface-Kabelsvorhandenundnichtverbogensind.
- SchließenSiedasNetzkabelandenNetzanschlussan.
- SchaltenSiedenE/A-Schalter(14)auf"I".- SchaltenSiedasGerätEIN,indemSieden
POWER-Taster(4)drücken.
DrückenSiealleTaster.BeijederBetätigungeinesTasterssollteeinSignaltonzuhörensein(außer"PressureCycle"(Druckzyklus,Taster8)).DerDruckzyklusistdeaktiviert,währenddiePumpeeingespültwird.
Jährliche Inspektion:
DePuyMitekempfiehlt,diegesamteAusrüstungjährlichvoneinemMedizintechnikerodereinemzugelassenenWartungstechnikerüberprüfenzulassen,umdieFunktionsbereitschaftundtechnischeSicherheitzubeurteilen.
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1.1. Produktbeschreibung
Spülsystem.FMSSOLOisteinfortschrittliches,kostengünstigesSpülsystem,daspatentierteTechnologieverwendet,umdieDarstellungundDistensionunterkontrolliertemDruckbeiderarthroskopischenChirurgiezuverbessern.
Flusskompensation.DasFMSSOLO-Systemkannerkennen,wenneinShaversichdrehtunddieFunktiondurchAktivierungdesFlusskompensatorzyklusverbessern.BittewendenSiesichbezüglichFMSShaver-Interface-ProduktenanIhrenDePuyMitek-Vertriebsrepräsentanten.
Roter Fußschalter für Druckzyklus.EinerderwichtigstenAspektebeiderArthroskopieistdieVisualisierung.DasSichtfeldisthäufigdurchBlutundRückständeversperrt.UmdiesesProblemzubeseitigen,verfügtdasFMSSOLO-SystemübereineDruckzyklus-Funktion.IndemSiedenrotenFußschalterbetätigen,aktivierenSieeinenzeitlichbegrenztenZyklusmiterhöhtemDruck,umdieBlutungzukontrollieren.WennderZyklusabgeschlossenist,kehrtdasFMSSOLO-SystemautomatischzurursprünglichenKonfigurationzurück.
1.2. Allgemeine Warnhinweise und vorsichtsmaßnahmen
DasKrankenhauspersonalmussdieseAnleitungvorderVerwendungoderReinigungdieserProdukteunddesZubehörslesen.AndernfallsbestehtVerletzungsgefahrsowiedieGefahrvonBeschädigungenoderFehlfunktionenderAusrüstung.
DerHerstellerundderlizenzierteVerkäuferdiesesGerätsübernehmenkeineHaftungfürjeglichedirekteoderFolgeschädenbzw.Verletzungen,dieinfolgederVerwendungvon
Einwegmaterialienentstehen,beidenenessichnichtumFMS-Produktehandelt.JeglicheVeränderungenandiesemGerät,ReparaturendurcheinnichtlizenziertesService-CenteroderdieVerwendungvonEinwegartikeln,dienichtvonFMShergestelltwurden,führenzumVerfallderCE-KennzeichnungundderFMS-GarantiesowiejeglicherProdukthaftung.
DieSchlauchsetsenthaltenDEHP,einPhthalat,vondembekanntist,dassesbeiKindern,schwangerenundstillendenFrauenGeburtsfehlerundandereFortpflanzungsschädenhervorruft.
Warnhinweis:
FMSSOLOisteinGerätderKlasseI,TypBgemäßderNormEN60601-1fürdieelektrischeSicherheitvonmedizinischenGeräten.StellenSiesicher,dassSiedasrichtigeInterface-Kabelverwenden,wennSieeinenanderenShaveranschließen.NähereEinzelheitenfindenSieinderGebrauchsanweisungzumInterface-Kabel.WendenSiesichzwecksInformationenzumAngebotanInterface-KabelnanIhrenDePuyMitek-Vertriebsrepräsentanten.
DasSystemkanndurchelektromagnetischeStöreinflüssevonanderenGerätengestörtwerden.StellenSiesicher,dassalleanderenInstrumenteundGeräte(separatodermitdemSystemverbunden)dieNormEN60601-1-2(EMV)erfüllen.
WenndasSystemweiterhingestörtwird,isolierenSieesvonderStörquelle,undschließenSieesaneineandereSteckdosean.
1.3. Anwendungsbereich
DasArthroskopiesystemFMSSOLOfürFlüssigkeitsmanagementundGewebedebridementistzurAnwendungdurcharthroskopieerfahreneFachkräfteimchirurgischenBereichindiziert.
Kapitel1-Einführung
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1.4. Definition der Symbole
Frontpanel Rückseite
Power-Taster
SchaltetdasGeräteinoderaus,wennderHauptnetzschalteraufderRückseitederPumpeeingeschaltetist(diegrüneStandby-Leuchteleuchtet).
Ein
Aus
Alarm
DieroteAnzeigeleuchtetauf,wenneinSicherheitsparameterverletztwird.
massesymbol (Erde)
Druckzyklus
VerringertdieBlutungwährenddesEingriffs,indemderBasisdruckfürzweiMinutenerhöhtwird.
IP50 KeinSchutzvorFlüssigkeiten
1-Weg-Fußschalter
Wirdverwendet,umeinenDruckzykluszuaktivierenoderabzubrechen.
Typ b, Klasse 1
EntsprichtderNormEN60601-1.
Erhöhenvorsicht
SieheGebrauchsanweisung.
verringern
WeitereHinweiseimderGebrauchsanweisung/Benutzerhandbuch
WeitereHinweiseimderGebrauchsanweisung/Benutzerhandbuch
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Explosionsgefahr
Hauptsicherung
Sicherungen wie gekennzeichnet ersetzen
GemäßderRichtlinie2002/96/EGmussdasProduktseparatentsorgtwerden.NichtalsunsortiertenHausmüllentsorgen.WendenSiesichzwecksInformationenzurEntsorgunganIhrenHändler.
vor Nässe schützen
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1 Transparente Sicherheitsabdeckungen.
DieseAbdeckungmussgeschlossenwerden,damitdieRollenpumpesichdreht.
2 SPÜLUNGS-Rollenpumpe. SorgtfürdenFlüssigkeitszufluss.
3 Spannkipphebel. FixiertdieSchläucheaufdemKopf
derRollenpumpe.
4 POWER-Taster. SchaltetdasGerätEIN oder AUS,
wennderHauptnetzschalteraufderRückseitederPumpeeingeschaltetist(diegrüne"Standby"-Leuchteleuchtet).
5 DRUCK-Anzeige. ZeigtdenvoreingestelltenDruckan,
wennderAusgangsdruckeingestelltwird,sowiedendynamischenDruck(1s)nachderFreigabederDruckeinstellungstaster.
6 ALARm. DieroteAnzeigeleuchtetauf,wenn
einSicherheitsparameterverletztwird.
7 Fernbedienungsanschluss. ZumAnschließenderFernbedienung
andasFMSSOLO-System.
A – Frontpanel
1.5. Systemanzeigen
1 2 3 4 5
6
78910111213
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8 Druckzyklus. VerringertdieBlutung,indemder
BasisdruckfürzweiMinutenerhöhtwird.
9 DRUCK-Einstelltaster. DrückenSiediePfeile,umden
DruckinSchrittenvon5Einheitenzuerhöhenoderzuverringern.DieAusgangseinstellungist50.
10 Taster "Pump Run/Stop" (Pumpe ein/aus).
SchaltetdiePumpeEINoderAUS.WenndiePumpeaktiviertist,erscheintaufderDruckanzeige<PUMP>.DiegrüneLEDblinkt,wenndiePumpegestopptist.
11 Integrierter Drucktransducer-Anschluss.
ZumAnschließendesOneDaySet-SpülschlauchsundMessendesDrucksinderDruckkammer.
12 Taster "Fill Chamber" (Kammer füllen).
FülltdieKammermanuellundschaltetdenNiederdruck-Alarm(LOWPRESSURE)aus.
13 Patentierte automatische Sperrvorrichtung.
ErmöglichtdieordnungsgemäßePositionierungundFixierungderEinwegschläucheumdieRollenpumpeherum.
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14 E/A-Schalter, Sicherungen und Netzanschluss.
15 Kennzeichnung und Spezifikation.
16 Fußschalter-Anschluss. 9-poligerAnschlusszumAnschließen
desFußschalters.
17 Shaver-Interface-Kabelanschluss. 25-poligerSteckerfürInterface-
KabelderHand-undFußsteuerung.BittewendenSiesichbezüglichBestellinformationenzuFMSShaver-Interface-KabelnaufgrundderVielzahlderverfügbarenProdukteanIhrenDePuyMitek-Vertriebsrepräsentanten.
18 Seriennummer.
•DieerstenbeidenZahlengebendasHerstellungsjahran.
•DerzweiteZahlenblockgibtdieHerstellungswocheunddieSeriennummeran.
19 Referenznummer.
b – Rückwand
14
15
16
17
18
19
1.6. Weitere Anzeigen (Signaltöne).EinSignaltonertönt,wennderPOWER-Taster
gedrücktwirdundsichdiePumpeeinschaltet.
EinSignaltonertönt,wennderDRUCK-Modusaktiviertwird(HinweisezurAktivierungdesZyklussieheAbschnittzumDruckzyklus).
. ZweiSignaltöneertönen,wennderDRUCK-Modusdeaktiviertwird(HinweisezurDeaktivierungdesZyklussieheKapitel4).
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Warnhinweise:
Werkseinstellungen:DieWerkseinstellungenbasierenaufErfahrungswertenundsolltennuralsungefähreRichtwerteverwendetwerden.DerChirurgmussdieEinstellungeninAbhängigkeitvomdurchzuführendenoperativenVerfahrenwählen.
DieelektrischeSicherheitsprüfungmussvoneinemMedizintechnikerodersonstigemqualifiziertenPersonaldurchgeführtwerden.
Stromschlaggefahr:Abdeckungnichtentfernen.WendenSiesichwegenWartungsarbeitenanIhrenDePuyMitek-RepräsentantenoderrufenSiedenDePuyMitek-KundendienstindenUSAunter+1(800)382-4682,Option2an.
SchließenSiedasGerätstetsanordnungsgemäßgeerdeteStromquellenan.
TrennenSiedasGerätzurReinigung,WartungoderInspektionvonderStromquelle.
ÜberprüfenSiedieAusrüstungundKabelregelmäßigaufAbnutzung.WennSieSchädenfeststellen,wendenSiesichanIhrenDePuyMitek-RepräsentantenoderrufenSiedenDePuyMitek-Kundendienstunter+1-800-382-4682,Option2an.
AchtenSiedarauf,dasskeineFlüssigkeiteninKontaktmitdemFMSSOLO-SystemunddenelektrischenAnschlüssenkommen.
VerwendenSiezurReinigungundDesinfektiondesFMSSOLO-SystemskeineentflammbarenReinigungs-undDesinfektionsmittel.
UmBrandgefahrzuvermeiden,ersetzenSieSicherungenstetsdurchSicherungendesselbenTypsundmitderselbenLeistung.
2.1. Lagerung und Handhabung: Lagertemperatur: SetzenSiedasFMSSOLO-SystemkeinenTemperaturenüber50°C(122°F)oderunter–10°C(14°F)aus.
betriebsbedingungen: BetreibenSiediePumpenichtbeiTemperaturenüber40°C(104°F)oderunter10°C(50°F).
beschädigung: VerwendenSiedasFMSSOLO-Systemnicht,wennesheruntergefallenistoderAnzeichenvonBeschädigungenaufweist.
Entsorgung: Nichtverbrennen.
WendenSiesichanIhrenDePuyMitek-RepräsentantenoderdenDePuyMitek-KundendienstindenUSAunter+1(800)382-4682,Option2,umeinesichereEntsorgungzuveranlassen.
Kapitel2-VorsichtsmaßnahmenfürdenBetrieb,PrüfungenundWarnhinweise
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Kapitel3-Vorbereitung3.1. vorbereitung der Pumpen.
StellenSiediePower-TasteaufderRückseitederPumpeauf"I".
DrückenSiedenPower-Taster.DasLCDleuchtetauf.
ÖffnenSiedieAbdeckung.
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Warnhinweis:DiesesProduktistnurfürdenEinmalgebrauchbestimmt.EsistnichtfüreineWiederverwendungodereineerneuteSterilisationvorgesehen.EineWiederaufarbeitungkannzuVeränderungenderMaterialeigenschaftenführen,wiez.B.VerformungoderZersetzung,diedieHaltbarkeitunddieLeistungsfähigkeitdesGerätsbeeinträchtigenkönnen.DieWiederaufarbeitungvonfürdenEinmalgebrauchvorgesehenenGerätenkanndarüberhinauszuKreuzkontaminationundzurInfektiondesPatientenführen.DieseRisikenkönnendieSicherheitdesPatientengefährden.
DieSterilitätistnurgewährleistet,wenndieVerfahrenzumWechselnderSchläucheexaktgemäßdenfolgendenAnweisungenzurVorbereitungundinAbschnitt3.2.Edurchgeführtwurden.
DiesesProduktenthältDEHP,einPhthalat,vondembekanntist,dassesbeiKindern,schwangerenundstillendenFrauenGeburtsfehlerundandereFortpflanzungsschädenhervorruft.
DieserSchlauchverbindetdieKochsalz-InfusionsbeutelmitdenSpülschläuchen.DieLösungfließtvondenDornen(A)umdieRollenpumpeherumdurchdieDruckkammer,inwelcherderDruckdurcheinenFilter(B)voneinemintegriertenDruck-Transducergemessenwird.
A. Installieren des One Day Set-Spülschlauchs Ref. 284504 oder 284503WendenSiesichzwecksBestellinformationenanIhrenDePuyMitek-Repräsentanten,dabestimmteSchläuchenichtinallenLändernangebotenwerden.
3.2. vorbereitung der Schläuche.
VonInfusions-beuteln
ZumDruck-Transducer
Zwischengeschal-teterSpülschlauch
(A)
(A)
Klemmen(B)
GRÜNAutomatischeSperrvorrichtung DRUCKKAMMER
Klemmen
Klemmen
(C)
Filter
SchließenSiealledreiKlemmen,undbringenSiedieSchläucheandenFlüssigkeitsbeutelnan.
SchiebenSiedengrünenTeildesSchlauchsaufdieautomatischeSperrvorrichtungaufderPumpe.
PlatzierenundzentrierenSiedenSchlauchumdieRollenpumpeherum.
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PlatzierenSiedieDruckkammerinderHalterung.SchließenSiedenTransducerandiePumpean,indemSieihnimUhrzeigersinnfesteinschrauben.
DiegrüneLEDblinkt.DrückenSiedenTaster"Run/Stop"(Starten/Stoppen).DiegrüneLEDblinktzunächstundleuchtetdannkonstant.
SchließenSiedieAbdeckung.
DrückenSiedenTaster"FillChamber"(Kammerfüllen)mehrmals,bisdieKammerzu1/3gefülltist.DiegrüneLEDblinkt,bisderTastergedrücktwird.
ZiehenSieamSchlauch,undschließenSiedenSpannkipphebelso,dasseramSchlauchanliegt.
Warnhinweis:
Die Druckkammer muss während des Eingriffs senkrecht bleiben und die Pumpe muss auf derselben Höhe wie der Patient aufgestellt werden.
WennSiedieKammerüberbefüllen,kannderFilter(in3.2.Agezeigt)vordemDruck-TransducernasswerdenundsomiteinepräziseDruckmessungverhindern.WenndieKammerüberbefülltwird,sieheKapitel6fürHinweisezurFehlerabhilfe.
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DieserSchlauchverbindetdenSpülschlauchsterilmitderHülse.*Ref.281103umfasstnichtdasEinwegventilfürdiesterilePufferzone/denZwischenschlauchmitEinweg-
Rückschlagventil.Ref.281103istfürdieeinmaligeVerwendungdesOneDaySet-Spülschlauchsvorgesehen.
b. Installieren des zwischengeschalteten Spülschlauchs Ref. 281103, 281142 oder 281103*
NachderÜberprüfung,dassderLuer-Lock(E)ordnungsgemäßfestgezogenist,nimmtdieInstrumentierschwesterdenSpülschlauchundübergibtdasblaueEndean(D)eineunsterileOP-Kraft.
DieunsterileOP-KraftentferntdieblauenKappenvomSpülschlauch(D)undOneDaySet-Spülschlauch(C)...
...und schließt denLuer-LockdesOneDaySet-Spülschlauchs(C)unmittelbarandenLuer-LockdesSpülschlauchs(D)an.
DiePumpemusssichimRun-Modusbefinden(10),d.h.dieLampemussleuchten.SpülenSieFlüssigkeitindenSpülschlauchein,indemSiedieKlemmeunterderDruckkammeröffnen.WennderSpülschlaucheingespültist,schließenSiedieKlammeroderdenAbsperrhahnaufdemArthroskop(indersterilenZone).
(D)
(C)
(C)(D)
ZumArthroskopHülse
OneDaySet-SpülschlauchRef.284504oder284503
(D)
EinwegventilfürdiesterilePufferzone/ZwischenschlauchmitEinweg-
Rückschlagventil
Weiß
Blau Blau Rot
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C. Erste Schritte.
SchließenSiedenLuer-LockandasArthroskopan.ÖffnenSiedenAbsperrhahnaufdemArthroskop.
ÖffnenSiedieKlemmeunterderKammer.
STERILEZONE
STERILEZONE
STERILEZONE
UNSTERILEZONE
SetzenSiedenKanülenschlauchaufdieKanüleauf.
SetzenSiedenShaver-SchlauchaufdenShaver-Absauganschlussauf.
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SchließenSiedieKlemmeunterderDruckkammer.
TrennenSiedenblauenLuer-Lock(E)vomzwischengeschaltetenSpülschlauch.
DrückenSiedenTaster"Run/Stop"(oderöffnenSiedietransparenteSicherheitsabdeckung).
D. Ende des Eingriffs.
Hinweis: Das One Day Set, Ref. 284503 und 284504, kann bei mehreren Eingriffen am selben Operationstag verwendet werden. Warnung: Die Sterilität ist nur gewährleistet, wenn die Schläuche vorschriftsmäßig vorbereitet und ausgewechselt werden.
Warnhinweis:Das Einwegventil für die sterile Pufferzone/der Zwischenschlauch mit Einweg-Rückschlagventil müssen mit dem One Day Set-Spülschlauch verbunden bleiben, was die Sterilität zwischen den Eingriffen gewährleistet.
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NachderÜberprüfung,dassderLuer-Lock(E)ordnungsgemäßfestgezogenist,nimmtdieInstrumentierschwesterdenSpülschlauchundübergibtdasblaueEnde(D)aneineunsterileOP-Kraft.
...und schließtdenblauenLuer-Lock(D)desneuenSpülschlauchssofortandenblauenLuer-Lock(C)desOneDaySet-Spülschlauchsan.
DieunsterileOP-KraftentferntdasalteRückschlagventilfürdiesterilePufferzonedurchTrennenderLuer-LocksdesOneDaySet-Spülschlauchs(C)unddeszwischengeschaltetenSpülschlauchs...
E. vorbereitung für den nächsten Eingriff.
DerOneDaySet-SpülschlauchkannmitangebrachtemEinwegventilfürdiesterilePufferzone/ZwischenschlauchmitEinweg-RückschlagventilnachEndedesEingriffsmontiertbleiben.
Warnhinweis:Niemals ein Einwegventil für die sterile Pufferzone/einen Zwischenschlauch mit Einweg-Rückschlagventil mit einem anderen verbinden.
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SchließenSiealleweißenKlemmen.
SchaltenSiediePumpeaus,indemSiedenTasterPOWERdrücken.EntsorgenSiealleSchläuche.
F. Ende des Arbeitstages im OP.
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Kapitel4-FunktionendesPumpensystems
4.1. Starten/StoppenDrückenSiedenTaster"Run/Stop",umalleFunktionendesPumpensystemszustarten.
4.3. befüllen der Kammer DrückenSiedenTaster"FillChamber"(Kammerfüllen),umdieDruckkammervorBeginndesEingriffs(undwährenddesEingriffsnachBedarf)zubefüllen.DieKammerdarfnichtmehralszu1/3gefülltsein.
4.2. DruckvoreinstellungDerDruckwirdaufdemLCD(5)zweiSekundenlanginKlammern(z.B.<50>)angezeigt,wenneinerderDrucktastergedrücktwird.DanachwirddertatsächlicheDruckangezeigt(dieDruckeinstellungenwerdeninStufenangegeben).
Stufe50entspricht5FußSchwerkraft-Druckoder112,5mmHg(±10%).
DiePumpehältdievoreingestellteStufeaufrecht.VerwendenSieimBetriebdieTaster"+"und"-"(9),umdieStufezuerhöhenbzw.zuverringern.DieWerksvoreinstellungist50.
Hinweis:ZahleninKlammern()beziehensichaufdieAbbildungaufSeite96.
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4.4. Empfohlene Ausgangseinstellungen.*
Hochdruckalarm
WenndieHochdruck-Sicherheitsstufevon140überschrittenwird,stopptdiePumpe,unddieroteALARM-LED(6)leuchtetauf.DerBedienermussdenDruckherabsetzen,damitdiePumpeautomatischneustartet.WenndiePumpenichtneustartet,wennderDruckunter140fällt,startenSiediePumpemanuellneu,indemSiesiemitdemPOWER-Tasteraus-undwiedereinschalten.
Niederdruckalarm
WennderDruckunterdieNiederdruck-Sicherheitsstufevon10fällt,leuchtetdieroteALARM-LEDauf,<PresL>erscheintaufdemLCD,unddiePumpestoppt.StellenSiesicher,dassderLuer-LockundderFilternebendemDruck-Transducerordnungsgemäßfunktionieren.Wennbeideordnungsgemäßarbeiten,drückenSiedenTaster"FillChamber"(Kammerfüllen),umdenAlarmzubeendenunddenTaster"Run/Stop",umdieEinheitneuzustarten.
Hinweis:ZahleninKlammern()beziehensichaufdieAbbildungaufSeite96.
4.5. Druckalarm
Warnhinweis:
Wenn Wasser in den Schlauch eingedrungen ist, der zum Druck-Transducer führt, wechseln Sie den One Day Set-Spülschlauch aus, und starten Sie das System neu.
Hinweis:WenneszuBlutungenkommt,kannderChirurgdenSpülmodusaktivierenoderdenDruckerhöhen.
* WARNHINWEIS:DieseAusgangseinstellungenbasierenaufErfahrungswertenundsolltennuralsungefähreRichtwerteverwendetwerden.DerChirurgmussdieEinstellunginAbhängigkeitvomdurchzuführendenoperativenVerfahrenwählen.
GelenkDruckstufe
mit TourniquetDruckstufe
ohne Tourniquet
Schultergelenk 60
Akromioplastik 60
KniegelenkHämarthrose
3050–60
6550–60
Handgelenk 30 65
Ellenbogen,Knöchel 40 65
Hüfte 65
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4.6. Druckzyklus-modus.
DieAktivierungdesDruckzyklus-ModuserfolgtentwederdurchDrückendesTasters"Pressure"(Druck)...
...odermitderFernbedienung(Ref.288051),dieandasFrontpanelderPumpeangeschlossenist...
DieFernbedienungistnichtautoklavierbarunddarfnichtinFlüssigkeiteneingetauchtwerden.EsmusseinesterileEinweg-Fernbedienungsabdeckung(Ref.281087)verwendetwerden.
...oderdurchBetätigungdesFußschalters(Ref.284171),derandieRückwandderPumpeangeschlossenist(sieheSeite98,Nr.16).
DieseFunktionerhöhtdenDruckfürzweiMinutenum60%.DerDruckwirddanachautomatischaufdieursprünglicheEinstellungzurückgesetzt.DerDruckzyklus-Moduswirdaktiviert,wenneszueinerBlutungkommt.DerDruckzyklus-ModuskanndurcherneutesDrückendesTastersfürdenDruckzyklus-Modusdeaktiviertwerden.
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Kapitel5-Wartung:ReinigungundDekontaminierungReinigen des FmS SOLO-Systems:SchaltenSieamEndedesArbeitstagesdasFMSSOLO-Systemaus,ziehenSiedasNetzkabelabundentsorgenSiealleSchläuche.WischenSiedieSeiten,dasFrontpanelunddieAbdeckungendesInstrumentsmiteinemweichen,leichtmiteinempH-neutralenReinigungsmittelbefeuchtetenTuchab.WischenSiemitdestilliertemWassernach.
Warnhinweis:
NICHTINFLÜSSIGKEITENEINTAUCHEN.NICHTAUTOKLAVIEREN.VerwendenSiezurReinigungundDesinfektiondesFMSSOLO-SystemskeineentflammbarenReinigungs-undDesinfektionsmittel.
Fußschalter: Reinigung und DekontaminierungReinigenSienachjedemEingriffdenFußschalterunddasNetzkabelmiteinempH-neutralenReinigungsmittel.DieFußschalterplattekanninReinigungsflüssigkeiteingetauchtwerden,dieelektrischenAnschlüssemüssenjedochtrockenbleiben.
Warnhinweis:
DIEELEKTRISCHENANSCHLÜSSEDESFUSSSCHALTERSNICHTINFLÜSSIGKEITENEINTAUCHEN.NICHTAUTOKLAVIEREN.VerwendenSiezurReinigungundDesinfektiondesFußschalterskeineentflammbarenReinigungs-undDesinfektionsmittel.
DrehenSiedasKabelzurLagerungnichtauf.
TrennenSiedasGerätnichtvomNetz,indemSieamKabelziehen.
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Kapitel6-FehlerabhilfeProbleme mögliche Ursachen mögliche LösungenDiePumpestoppt.
DieroteALARM-LEDleuchtetauf.
DieHOCHDRUCK-Sicherheitsvorrichtungwurdeausgelöst.
DieNIEDERDRUCK-Sicherheitsvorrichtungwurdeausgelöst:"Pres.L"blinkt.
DerFilteristnass.
EsistkeineSpülflüssigkeitmehrvorhanden.
VerringernSiedenDruckimGelenk.
DrückenSiedenTaster"Run/Stop",umdiePumpeneuzustarten.
PrüfenSie,dassderLuer-Lockfestgeschlossenist.
DrückenSiedenTaster"FillChamber"(Kammerfüllen),umdenAlarmzubeendenunddenTaster"Run/Stop",umdiePumpeneuzustarten.
ErsetzenSiedenOneDaySet-Spülschlauch.WenndasProblemfortbesteht,wendenSiesichandenDePuyMitek-Kundendienst.
StechenSiedenBeutelan,unddrückenSiedenTaster"FillChamber"(Kammerfüllen).
DieKöpfederRollenpumpedrehensichnicht.
DasGerätistausgeschaltet(Power-Schalterauf"O")odergestoppt.
VergewissernSiesich,dassderHauptnetzschalteraufRückseitederPumpesichinderStellung"I"befindetunddiegrüneLeuchtedesTasters"Run/Stop"leuchtet.
EsfindetkeineSpülungstatt. DerAbsperrhahnaufderHülseodereineKlemmeistgeschlossen,sodassderAbflussverhindertwird.
ÜberprüfenSiedieZuflussleitungvondenBeutelnzumGelenk.ÖffnenSieallegeschlossenenKlemmenoderAbsperrhähne.
DieSpülpumpebeginnt,übermäßigschnellzudrehenunderzeugteinlautesGeräusch.
EsistkeineSpülflüssigkeitmehrvorhanden.
TauschenSiedieInfusionsbeutelmitKochsalzlösungausund/oderüberprüfenSiedieKlemmenunterdenBeuteln.
DrückenSiedenTaster"FillChamber"(Kammerfüllen),wenndieKammerwenigeralszu1/3gefülltist.
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Probleme mögliche Ursachen mögliche LösungenDieSpülpumpeschaltetsichaufgrundvonabnormenDruckschwankungenunregelmäßigeinundaus.
MöglicherweiseistWasserindieDruckmessleitungeingedrungen.
TauschenSiedenOneDaySet-Spülschlauchaus,wennWasserindieDruckmessleitungeingedrungenist.WenndasProblemfortbesteht,wendenSiesichandenDePuyMitek-Kundendienst.
InderDruckkammerbefindetsichzuvielWasser.
MöglicherweiseisteineLuftleckageinderLeitungentstanden.
ÜberprüfenSie,dassdieLuer-LocksaufdemSpülschlauchundderDruckmessleitunggeschlossensind.TauschenSiedenSpülschlauchbeiBedarfausundstartenSiediePumpeneu.
DerDruckimSystemistnichtausreichend.
EinProblemmitderSpülungliegtvor.
ÜberprüfenSiedenAbsperrhahnaufdemArthroskopunddieKlemmenunterdenKochsalz-InfusionsbeutelnsowieunterderDruckkammer.
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Produktspezifikation
bestandteileRef.:284590
AbmessungenGröße: 16cmBreite: 39cmTiefe: 30cmGewicht: 11kg
LeistungsdatenDruckstufen:20-140(inSchrittenvon5Einheiten)Genauigkeit:±10%beiFlussratevon0
Elektrische SpezifikationenLeistungsaufnahme: 120/230VWechselstromFrequenz: 50-60HzStromverbrauch: 500VASicherungen: 5AzeitverzögertErfülltdieNormenEN60601-1(elektrischeSicherheitvonmedizinischenGeräten)undEN60601-1-2(ElektromagnetischeVerträglichkeit)
LagerbedingungenTemperaturen:–10°C(14°F)bis+50°C(122°F)
betriebsbedingungenTemperaturen:+10°Cbis+40°CRelativeLuftfeuchtigkeit:30bis75%
Kapitel7-Produktspezifikationen
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CHAPITRE 1. INTRODUCTION 121
1.1. Descriptionduproduit................................................................ 121 1.2. Avertissementsetmisesengardegénérales............................ 121 1.3. Application.................................................................................. 121 1.4. Définitionsdessymboles........................................................... 122 1.5. Indicateursdusystème.............................................................. 124 A.Façade..................................................................................... 124 B.Panneauarrière..................................................................... 126 1.6. Autresindicateurs(sonores)....................................................... 126
CHAPITRE 2. PRéCAUTIONS D’UTILISATION, véRIFICATIONS ET AvERTISSEmENTS 127
2.1. Stockageetmanipulation........................................................... 127
CHAPITRE 3. PROCéDURES D’INSTALLATION 128
3.1. Installationdelapompe............................................................. 128 3.2. Installationdestubulures........................................................... 129 A.Installationdelatubulured'irrigationOneDaySet............... 129 B.Installationdelatubulured'irrigation..................................... 131 C.Débutdel’intervention........................................................... 132 D.Findel’intervention................................................................ 133 E.Miseenplacepourl’interventionsuivante............................ 134 F.Findelajournéeopératoire................................................... 135
TabledesmatièresGARANTIE ET RévISION 118
DébALLAGE, ASSEmbLAGE ET véRIFICATION INITIALE DU SySTÈmE 119
PROGRAmmE D'INSPECTION 120
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CHAPITRE 4. FONCTIONS DE LA POmPE 136
4.1. Marche/Arrêt(Run/Stop)............................................................. 136 4.2. Pré-réglagedelapression.......................................................... 136 4.3. Remplissagedelachambredepression................................... 136 4.4. Réglagesinitiauxdepressionreccommandés........................... 137 4.5. Alarmesdepression.................................................................. 137 4.6. Modecycledepression............................................................. 138
CHAPITRE 5. ENTRETIEN : NETTOyAGE & DéCONTAmINATION 139
CHAPITRE 6. RéSOLUTION DES PANNES 140
CHAPITRE 7. CARACTéRISTIQUES TECHNIQUES 142
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GarantieetrévisionLes produits DePuy Mitek sont garantis sans défaut de matériau et de fabrication pour la période de garantie d'un produit spécifique, à partir de la date de facturation.
Contacter votre représentant DePuy Mitek pour des renseignements spécifiques relatifs à la garantie.
DePuy Mitek propose un programme de remplacement rapide de ses pièces pour réduire le temps d'arrêt dans votre salle d’opération. Pour obtenir un numéro d'autorisation de retour ou des informations supplémentaires sur ce programme, veuillez contacter le Service client de DePuy Mitek au +1 (800) 382-4682 et choisir l'option 2 (Etats-Unis d’Amérique seulement) ou contacter votre représentant DePuy Mitek.
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Déballage,AssemblageetVérificationInitialeduSystèmeDéballage :
Vérifierquetouslesélémentssurlebondelivraisoncorrespondentauxproduitsquevousavezreçus(vérifierlesnumérosdesérieetlesréférences).ToutdéfautdoitêtreimmédiatementsignaléauServiceclientdeDePuyMitekau+1-800-382-4682,Option2(Etats-Unisd’Amériqueseulement)ouàvotreReprésentantCommercialdeDePuyMitek.Conservertouslesemballages,ilsservirontencasderetourdesproduits.
Unefoislaboîteouverte,enleverlesinstructions d'utilisation,leslireetsuivrelesinstructions.PourretirerlaconsoleFMSSOLO,placerlesmainsdepartetd'autredelaconsolejusqu'àcequevousparveniezàsaisirlefond.Sortirlaconsoleavecprécautiondesaboîteetlaplacersurunesurfaceplaneetsolide.
Assemblage :
- Brancherlecâbled'alimentationàlaprise(14).- Brancherlapédaleàlaprisedeconnexion
prévueàceteffet(16)àl'arrièredelapompe.
vérification initiale du système :
- Mettrel’interrupteurI/O(14)(Marche/Arret)sur«I»(Marche).
- Mettrel'appareilsoustensionappuyantsurleboutonPOWER(Alimentation)(4).
- Appuyersurtouslesboutons.Unsignalsonoredoitêtreentendupourchaqueboutonappuyé,saufpourleboutonPRESSURECYCLE(CycledePression),(bouton8)(LeboutonCycledePressionestinactifjusqu'àcequelapompesoitamorcée.)
Remarque:lesnumérosentre()seréfèrentauxschémasdanslasection1.5.
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Programmed'inspection
Inspection hebdomadaire :
DePuyMitekrecommandeuneinspectionhebdomadairedetoutlematériel.Cesinspectionspeuventêtreréaliséesdemanièremoinsrégulièreenfonctiondeladuréeetdelafréquenced'utilisation.
- Réaliseruneinspectionvisuelledel'appareil.Encasdedommage,appelezleServiceclientDePuyMitekau+1-800-382-4682,Option2pourparleràuningénieurbiomédical(Etats-Unisd’Amériqueseulement)oucontactezvotreReprésentantDePuyMitek.
- Vérifierquelecapotdeprotectiontransparent(1)etlescharnièresnoiressoientenbonétatdemarche.
- Inspecterlecâbled'alimentationettouslescâblespourdétecterdessignesd'usureoud’entailles.
- Vérifierquelesbrochesdeconnexiondel'interfacedelapédaleetdushaversoienttoutesprésentesetnesoientpaspliées.
- Brancherlecâbled'alimentationàlaprise.- Mettrelel’interrupteurI/O(14)(Marche/Arrêt)sur
«I»(Marche).- Mettrel'appareilsoustensionappuyantsurle
boutonPOWER(Alimentation)(4).
Appuyersurtouslesboutons.Unsignalsonoredoitêtreentendupourchaqueboutonappuyé,saufpourleboutonPRESSURECYCLE(CycledePression),(bouton8)lequelestinactifjusqu'àcequelapompesoitamorcée.
Inspection annuelle :
DePuyMItekrecommandequ’uningénieurbiomédicalouqu’unepersonneautoriséeduservicedemaintenancevérifieunefoisparantoutl’équipementafind’évaluersafonctionnalitéetsasécuritétechnique.
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1.1. Description du produit
Système d'irrigation.FMSSOLOestundispositifd'irrigationavancéàfaiblecoûtutilisantunetechnologiebrevetéepouraméliorerlavisualisationetladilatation,toutencontrôlantlapressiondurantlachirurgiearthroscopique.
Compensation du débit.FMSSOLOreconnaîtlorsqu’unshaverestenactionetpermetdoncuneaméliorationenactivantlecycle«Flowcompensator(Compensationdedébit)».VeuillezcontactervotrereprésentantDePuyMitekpourdesinformationssurtoutelagammedesproduitsd'interfaceShaverFMS.
Cycle de pression, pédale rouge (mode lavage).Lavisualisationestl’undesaspectslesplusimportantsdelachirurgiearthroscopique.Lechampdevisionestsouventobstruépardusangetdesdébris.Pourremédieràceproblème,FMSSOLOdisposed'unefonctiondecycledepression(lavage).Enappuyantsurlapédalerouge,vousactivezuncyclechronométréd'augmentationdelapressionpourcontrôlerlesaignement.Unefoislecycleterminé,FMSSOLOrétablitlesréglagesprécédents.
1.2. Avertissements et mises en garde générales
Ilestrecommandéquelepersonnelhospitalierlisecemoded'emploiavantd'utiliseroudenettoyercetappareiletsesaccessoires.Lenon-respectdecesinstructionspeutprovoquerdesblessuresetendommagerlematérielouentrainersadéfaillance.
Lefabricantetlerevendeuragréédecetappareiln'acceptentaucuneresponsabilitépourtout
dommageindirectoublessureconsécutiveàuneutilisationinappropriéededispositifsjetablesautresquelesproduitsFMS.Toutemodification,réparationparunepersonnenonagrééedecedispositifouutilisationdedispositifsjetablesnon-FMS,peutannulerlemarquageCE,lagarantieFMSetlacouverturedelaresponsabilitéduproduit.
LestubulurescontiennentduDEHP,unproduitchimiqueàbasedephtalate,connupourprovoquerdesanomaliescongénitalesetd’autresdommagessurlesystèmereproducteur,notammentchezlesenfantsetlesfemmesenceintesouallaitantes.
Avertissement :
FMSSOLOestunappareildeClasseITypeB,selonlanormedesécuritéélectriqueEN60601-1pourlesdispositifsmédicaux.S'assurerd'utiliserl’interfaceadéquatelorsduraccordementàunautreshaver.Pourplusdedétails,consulterlemoded'emploidel’interface.ContactezvotrereprésentantDePuyMitekpourconnaîtrelesoffressurlesinterfaces.
Lesystèmepeutêtreaffectéparlesinterférencesélectromagnétiquesd'autresappareils.Vérifierquetouslesautresinstrumentsetappareils(associésounonausystème)sontconformesàlanormeEN60601-1-2(EMC/-CEM-).
Silesystèmeresteaffecté,l'isolerdel'instrumentcausantleproblèmeetleconnecteràuneautreprisesecteur.
1.3. Indication d’emploi
LesystèmearthroscopiqueFMSSOLOdegestiondesfluidesestconçupourêtreutilisédansuncadrechirurgicalpardupersonnelforméàl’arthroscopie.
Chapitre1.Introduction
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1.4. Définitions des symboles
Façade Panneau arrière
bouton alimentation
Metl'appareilenmarche/arrêtsil'interrupteurprincipalàl'arrièredelapompeestenmarche(lumièrevertedeveilleallumée).
marche
Arrêt
Alarme
Levoyantrouges'allumesiunparamètredesécuritéestenfreint.
Symbole d’équipotentialité (terre)
Cycle de pression (mode lavage)
Diminuelesaignementdurantl'interventionenaugmentantlapressiondebasependantdeuxminutes.
IP50 Aucuneprotectioncontrelesliquides
Carte pour pédale à une fonction
Utiliséepouractiverouannuleruncycledepression.
Classe 1 Type b
ConformeàlanormeEN60601-1.
AugmenterAttention
Voirlesinstructionsd’utilisation.
Diminuer
Consulterlesinstructionsdumanuel/brochure
Consulterlesinstructionsdumanuel/brochure
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Risque d’explosion
Fusible principal
Remplacer les fusibles comme indiqué
Conformémentàladirective2002/96/EC,ceproduitdoitêtrecollectéséparément.Nepasjeteraveclesorduresmunicipalesnon-triées.Contactezvotredistributeurlocalpourobtenirdesinformationsrelativesàl’élimination.
Ne pas mouiller
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1 Capot de Protection transparent. Cecapotdoitêtrefermépourquela
pompeàgalettourne.
2 Pompe d'IRRIGATION à galets. Permetl'arrivéedufluide.
3 bras presseur. Maintientletuyausurlatêtedela
pompeàgalets.
4 bouton POWER (ALImENTATION). Metl'appareilenmarche & arrêtsi
l'interrupteurprincipalàl'arrièredelapompeestenmarche(lumièrevertedeveilleallumée).
5 Affichage de la pression PRESSION. Affichelapressioninitialelorsdu
réglageetlapressiondynamique(1sec)aprèslerelâchementdesboutonsd'ajustementdelapression.
6 ALARmE. Levoyantrouges'allumesiun
paramètredesécuritéestenfreint.
7 Connecteur de télécommande. Connectelatélécommandeàla
consoleFMSSOLO.
A – Façade
1.5. Indicateurs du système
1 2 3 4 5
6
78910111213
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8 Cycle de pression (PRESSURE CyCLE).
Diminuelesaignementenaugmentantlapressiondebasependant2minutes.
9 boutons d’ajustement de la pression (PRESSURE).
Appuyersurlesflèchespouraugmenteroudiminuerleniveaudepressionparincrémentsde5.Leréglageinitialest50.
10 bouton RUN/STOP (marche/arrêt) de la pompe.
Allumeetéteintlapompe.Silapompeestactivée,<PUMP>(POMPE)apparaîtsurl'écrand’affichagedelapression.Levoyantvertclignotelorsquelapompeestarrêtée.
11 Raccordement du capteur de pression
Pourconnecterlatubulured'irrigationOneDaySetetmesurerlapressiondanslachambredepression.
12 bouton FILL CHAmbER (Remplissage de la Chambre).
Remplitmanuellementlachambreetéteintl'alarmedebassepression(LOWPRESSURE).
13 Système auto-bloquant breveté. Permetdepositionneretdeverrouiller
correctementlatubulurejetableautourdelatêtedelapompeàgalet.
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14 Interrupteur I/O (marche/Arrêt), fusibles et alimentation secteur.
15 Identification & spécification.
16 Connexion de la pédale. Ficheà9brochespourbrancherla
pédale.
17 Connexion de l'interface du shaver. Ficheà25brochespourlesinterfaces
delapièceàmainetdelapédale.ContactezvotrereprésentantDePuyMitekpourdesinformationssurlesinterfacespourshaveretpourconnaîtretoutelagammedenosproduits.
18 Numéro de série.
•Ledeuxpremierschiffrescorrespondentàl'annéedefabrication.
•Ledeuxièmeensembledechiffrescorrespondàlasemainedefabricationetaunumérodesérie.
19 Numéro de référence.
b – Panneau arrière
14
15
16
17
18
19
1.6. Autres indicateurs (sonores)..Unetonalitéestémiselorsquelebouton
POWER(ALIMENTATION)estenfoncéetquelapompesemetenmarche.
.UnetonalitéestémiselorsquelemodePRESSION (PRESSURE) estactivé(voirlasectionsurlecycledepressionpourl'activer).
. DeuxtonalitéssontémiseslorsquelemodePRESSION (PRESSURE) estdésactivé(voirchapitre4pourdésactiverlecycle).
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mises en garde :
Réglagesinitiaux:lesréglagesinitiauxsebasentsurl'expérienceetdoiventuniquementêtreutiliséscommedeslignesdirectrices.Lechirurgienestresponsabledesréglagesenfonctiondelaprocédurechirurgicaleréalisée.
Lavérificationdelasécuritéélectriquedoitêtreréaliséeparuningénieurbiomédicalouunepersonnequalifiée.
Risqued’électrocution:Nepasretirerlecouvercle.Confierlarévisiondel'appareilàvotrereprésentantDePuyMitekoucontacterleServiceclientDePuyMitekau+1800382-4682,option2.
Nepasconnecterledispositifàuneprisedecourantnepossédantpasdeprisedeterre.
Débrancherledispositifdelasourced'alimentationprincipalelorsdunettoyage,del'entretienoudel'inspection.
Inspecterlematérieletlescâblesdefaçonpériodique.Confierlarévisiondel'appareilàvotrereprésentantDePuyMitekoucontacterleServiceclientDePuyMitekau+1800382-4682,option2(Etats-Unisd’Amériqueseulement).
ÉvitertoutcontactliquideaveclaconsoleFMSSOLO,ainsiqu'avecsesconnecteursélectriques.
NepasutiliserdesagentsinflammableslorsdunettoyageetdeladésinfectiondelaconsoleFMSSOLO.
Pourévitertoutrisqued'incendie,remplacerlesfusiblespard’autresfusiblesdumêmetypeetdemêmetension.
2.1. Stockage et manipulation : Température de stockage : NepasexposerlaconsoleFMSSOLOàdestempératuressupérieuresà50°C(122°F)ouinférieuresà–10°C(14°F).
Conditions de fonctionnement : nepasfairefonctionnerlapompeàdestempératuressupérieuresà40°C(104°F)ouinférieuresà10°C(50°F).
Dommage : NepasutiliseruneconsoleFMSSOLOencasdechuteoud'endommagement.
élimination des déchets : Nepasincinérer.
ContactezleServiceclientDePuyMitekau+1800382-4682,Option2(Etats-Unisd’Amériqueseulement),ouunreprésentantDePuyMitekpourorganiserunemiseaurebutsécurisée.
Chapitre2.Précautionsd’utilisation,vérificationsetavertissements
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Chapitre3.Procéduresd’installation3.1. Installation de la pompe.
Pourmettresoustensionappuyersur«I»placésurl’interrupteursituésurlepanneauarrière.
Appuyersurlebouton Power(Alimentation).L'écrand’affichage'allume.
Ouvrirlecapot.
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MISEENGARDE:Ceproduitestseulementàusageunique.Iln’apasétéconçupourêtreréutilisé/restérilisé.Leretraitementrisquedemodifierlescaractéristiquesdesmatériaux,notammentlesdéformeretlesdégrader,cequipeutavoirdesconséquencessurlarésistancedudispositifetcompromettresesperformances.Leretraitementdedispositifsàusageuniquepeutégalementprovoqueruneinfectioncroiséedespatients.Cesrisquessontsusceptiblesdenuireàlasécuritédespatients.
Lastérilitéestgarantieuniquementsilesprocéduresdechangementdetubulureontétéréaliséesensuivantprécisemmentlesinstructionsci-dessousetdanslaSection3.2.E.
CeproduitcontientduDEHP,unproduitchimiqueàbasedephtalate,connupourprovoquerdesanomaliescongénitalesetd’autresdommagessurlesystèmereproducteur,notammentchezlesenfantsetlesfemmesenceintesouallaitantes.
Cettetubulurerelielespochesdesolutionsalineàlatubulured’irrigation.Lasolutioncirculeàtraverslespercuteurs(A),autourdelapompeàgaletsetjusqu’àlachambredepressiond’oùlapressionestlueàtraversunfiltre(B)paruncapteurintégré.
A. Installation de la tubulure d’irrigation One Day Set Réf. 284504 ou 284503ContactezvotrereprésentantDePuyMitekpourdesinformationssupplémentairesétantdonnéquecertainestubuluresnesontpasdistribuéesdanstouslespays.
DepuislesPochesd’irrigation
Verslecapteurdepression
Tubulured'irrigationintermédiaire
(A)
(A)
Clamps(B)
Systèmeautobloquantvert Chambredepression
Clamps
Clamps
3.2. Installation des tubulures.
(C)
Filtre
Fermerlestroisclampsetraccorderauxpochesd’irrigation.
Glisserlapartievertedelatubuluredansledispositifauto-bloquantsurlapompe.
Placeretcentrerlatubulureautourdelatêtedepompeàgalet.
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Installerlachambredepressiondanslesupport.Connecterlecapteuràlapompeenlevissantfermementdanslesensdesaiguillesd'unemontre.
Levoyantvertclignote.AppuyersurleboutonRun/Stop(Marche/Arrêt).Levoyantvertcommenceparclignoterpuisresteallumé.
Fermerlecapot.
AppuyerplusieursfoissurleboutonFillChamber(RemplissagedelaChambre)jusqu'àcequeleréservoirsoitrempliautiersdesacapacité.Levoyantvertclignotejusqu'àcequeleboutonsoitpressé.
Tirersurlatubulureetfermerlebraspresseurcontreletuyau.
Avertissement :
Il est impératif que la chambre de pression soit maintenue vertical ement durant l’intervention et que la pompe soit positionnée au même niveau que le patient.
Unremplissageexcessifdelachambrepeutfairequelefilre(montréàlafigure3.2.A)deviennemouilléavantlecapteurdepressionetqu'ilinterfèreavecunemesureprécisedelapression.Encasderemplissageexcessifdelachambre,voirleChapitre6surlarésolutiondespannes.
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Cettetubulureconnectel’arthroscopeàlatubulured’irrigationdemanièrestérile.*Réf.281103n’inclutpaslavalveantiretour/letuyauintermédiaireàzonetamponstérileavecclapetde
non-retour.Réf.284510estdestinéeàunusageuniquedelatubulured’irrigationOneDaySet.
b. Installation de la tubulure d'irrigation intermédiaire Réf. 281103, 281142 ou 281103*
AprèsavoirvérifiéqueleraccordLuerLock(E)estbienserré,l’instrumentiste“stérile”prendlatubulured’irrigationetpassel’extrémitébleue(D)àunepersonne“non-stérile”.
Lapersonne“non-stérile”retirelescapuchonsbleusdelatubulured'irrigation(D)etceluidelatubulured'irrigationOneDaySet(C)...
...etconnecteimmédiatementleraccordluer-lockdelatubulure“OneDaySetTM”(C)auraccordluer-lockdelatubulured’irrigation(D).
LapompedoitêtreenmodeRun(10)(Marche),aveclevoyantallumé.Purgerlatubulured'irrigationenouvrantleclampsouslachambredepression.Unefoislatubulureamorcée,fermerleclampoulerobinetd'arrêtdel'arthroscope(danslazonestérile).
(D)
(C)
(C)(D)
Verslachemisedel'arthroscope
Depuislatubulured’irrigationOneDaySetRéf.284503ou284504
(D)
Valveantiretour/tuyauintermédiaireàzonetamponstérileavecclapet
denon-retour
Blanc
Bleu Bleu Rouge
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C. Début de l’intervention.
ConnecterleraccordLuerLockàl'arthroscope.Ouvrirlerobinetd'arrêtdel'arthroscope.
Ouvrirleclampsouslachambredepression.
ZONESTERILE
ZONESTERILE
ZONESTERILE
ZONENON-STERILE
Insérerlatubulure“CANNULA”danslacanule. Insérerlatubulure“SHAVER”surlaprised’aspirationdelapièceàmaindushaver.
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Fermerleclampsouslachambredepression.
DébrancherleraccordLuerLockbleu(E)delatubulured'irrigationintermédiaire.
AppuyersurleboutonRun/Stop(Marche/Arrêt)(ououvrirlecapottransparentdesécurité).
D. Fin de l’intervention.
Remarque : Les « One Day Set » réf. 284503 et 284504 peuvent être réutilisés au cours de plusieurs interventions chirurgicales d’une même journée. Avertissement : La stérilité n’est conservée que si les procédures appropriées d’installation et de remplacement des tuyaux ont été respectées.
Avertissement : La zone tampon stérile de valve antiretour/tuyau intermédiaire avec clapet de non-retour doit restée attachée à la tubulure d’irrigation One Day Set qui garantit la stérilité entre les interventions.
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AprèsavoirvérifiéqueleraccordLuerLockestbienserré,l’instrumentiste“stérile”prendlatubulured’irrigationetpassel’extrémitébleue(D)àunepersonne“non-stérile”.
...etconnecteimmédiatementleraccordluer-lockbleu(D)delanouvelletubulured’irrigationsurleraccordluer-lockbleu(C)delatubulured’irrigation“OneDaySet”
Lapersonne“non-stérile”retirel'anciennezonetamponstérileendébranchantlesraccordsLuerLockdelatubulured'irrigationOneDaySet(C)etdelatubulured'irrigationintermédiaire...
E. mise en place pour l’intervention suivante
Latubulured’irrigationOneDaySetpeutêtrelaisséeenplaceàlafindel’interventionprécédenteaveclavalveantiretour/letuyauintermédiaireavecclapetdenon-retourattachée).
Avertissement :Ne jamais attacher un(e) valve antiretour/tuyau intermédiaire à zone tampon stérile avec clapet de non-retour à un(e) autre.
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Fermertouslesclampsblancs.
ÉteindrelapompeenappuyantsurleboutonPOWER(ALIMENTATION).Jetertouteslestubulures.
F. Fin de la journée opératoire.
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Chapitre4.Fonctionsdelapompe
4.1. Run/Stop (marche/Arrêt)AppuyersurleboutonRun/Stop(Marche/Arrêt)pourdémarrertouteslesfonctionsdelapompe.
4.3. Remplissage de la chambre de pressionAppuyersurleboutonFillChamber(RemplissagedelaChambre)pourremplirunepremièrefoislachambredepression,puistoutaulongdel'intervention,enfonctiondesbesoins.Lachambrenedoitjamaisêtreremplieaudelàdutiersdesacapacité.
4.2. Préréglage de la pressionLapressionestaffichéeentreparenthèses(ex.<50>)surl'écran(5)pendantdeuxsecondeslorsqu'undesboutonsdepressionestenfoncé,puislapressionréelleestaffichée(lesréglagesdepressionsontenniveaux).
Leniveau50estégalà5piedsdegravitédepressionouà112,5mmHg(±10%).
Lapompemaintientleniveaupréréglé.Pendantutilisation,utiliserlesboutons«+»et«–»(9)pouraugmenteroudiminuerleniveaudepression.Leréglageinitialestà50.
Remarque:lesnumérosentre()seréfèrentauxschémasàlapage124.
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4.4. Réglages initiaux recommandés. *
Alarme de haute pression.
Sileniveaudesécurité<140>dehautepressionestdépassé,lapompes'arrêteetlevoyantrougeALARM(6)s'allume.L'opérateurdoitalorsdiminuerlapressionpourquelapomperedémarreautomatiquement.Silapompeneredémarrepaslorsquelapressionredescendendessousde140,éteindreetrallumerlapompeenappuyantsurleboutonPOWER(ALIMENTATION).
Alarme de basse pression.
Silapressionpasseendessousduniveaudesécurité<10>debassepression,levoyantrougeALARMs'allume,<PresL>(<PressionBasse>)clignotesurl'écrand’affichageetlapompes'arrête.VérifierqueleraccordLuer-Locketlefiltresetrouvantavantlecapteurdepressiondelapompesontenétatdefonctionnement.Silesdeuxsontsatisfaisants,appuyersurlatoucheFillChamber(RemplissagedelaChambre)pourarrêterl’alarmeetsurleboutonRun/Stop(Marche/Arrêt)pourredémarrerl’unité
Remarque:lesnumérosentre()seréfèrentauxschémasàlapage124.
4.5. Alarme de pression
Avertissement :
Si l'eau est entrée accidentellement dans la tubulure reliant la chambre au capteur de pression, remplacer la tubulure d'irrigation One Day Set et redémarrer l'appareil.
Remarque:encasdesaignement,lechirurgienpeutchoisird'activerlemodeLavageoud’augmenterlapression.
* AvERTISSEmENT :cesréglagesinitiauxsebasentsurl'expérienceetdoiventuniquementêtreutiliséscommedeslignesdirectrices.Lechirurgienestresponsabledesréglagesenfonctiondelaprocédurechirurgicaleexécutée.
ArticulationNiveau de pression
avec garrotNiveau de pression
sans garrot
Articulationdel'épaule 60
Acromioplastie 60
ArticulationdugenouHémarthrose
3050–60
6550–60
Poignet 30 65
Coude,cheville 40 65
Hanche 65
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4.6. mode cycle de pression (pedale rouge).
Lemodedecycledepressionestactivésoitenappuyantsurlebouton«Pressure»(Pression)...
...soitenutilisantlatélécommandeRéf.288051,quiestconnectéesurlafaçadedelapompe...
Nepasautoclaverniimmergerlatélécommande.Uneprotectionstérilejetablepourtélécommandedoitêtreutilisée(réf281087).
...ouenappuyantsurlapédalerougeRéf.284171,quiestconnectéeaupanneauarrièredelapompe(voirenpage126,n°16).
Cettefonctionaugmentelapressionde60%pendantuncyclededeuxminutes.Lapressionretourneensuiteautomatiquementàsonréglageinitial.Lemodedecycledepressionestactivéencasdesaignement.LecycledepressionpeutêtreannuléenappuyantdenouveausurleboutonPressure(Pression)Cycle.
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Chapitre5.Entretien:nettoyage&décontaminationNettoyage de la console FmS SOLO :Àlafindelajournéed’intervention,éteindrelaconsoleFMSSOLO,débrancherlecordond'alimentationetjetertouteslestubulures.Essuyerlescôtésdel'instrument,lafaçadeetlescapotsavecuntissudouxlégèrementhumidifiéavecundétergentdepHneutre.Essuyerànouveauavecdel'eaudistilléepourrincer.
Avertissement :
NEPASIMMERGER.NEPASSTÉRILISERENAUTOCLAVE.NepasutiliserdesagentsinflammableslorsdunettoyageetdeladésinfectiondelaconsoleFMSSOLO.
Pédale : nettoyage et décontaminationAprèschaqueintervention,nettoyerlapédaleetlecordond'alimentationavecundétergentdepHneutre.Lacommandedelapédalepeutêtreimmergée,àl'exceptiondesconnexionsélectriquesquidoiventresterausec.
Avertissement :
NEPASIMMERGERLESCONNECTEURSÉLECTRIQUESDELAPÉDALE.NEPASSTÉRILISERENAUTOCLAVE.Nepasutiliserdesagentsinflammableslorsdunettoyageetdeladésinfectiondelapédale.
Nepastordrelecâblependantlerangement.
Nepasdébrancherentirantsurlecordon.
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Chapitre6.Résolutiondespannes
Problèmes Causes potentielles Solutions possiblesLapompes'arrête.
VoyantrougeALARMs’allume.
LasécuritéHAUTEPRESSIONestactivée.
LasécuritéBASSEPRESSIONestactivée:<Pres.L>(Pressionbasse)clignote.
Lefiltrehydrophobeestmouillé.
Iln'yaplusdeliquided'irrigation.
Diminuerlapressiondansl’articulation.
AppuyersurleboutonRun/Stop(Marche/Arrêt)pourredémarrerlapompe.
VérifierqueleraccordLuer-Lockestfermementfermé.
AppuyersurleboutonFillChamber(RemplissagedelaChambre)pourarrêterl'alarmeetappuyersurleboutonRun/Stop(Marche/Arrêt)pourredémarrerlapompe.
Remplacerlatubulured’irrigationOneDaySet.Sileproblèmepersiste,contacterleServiceclientDePuyMitek.
Remplacerlapochedesolutionsaline,laperceretappuyersurleboutonFillChamber(RemplissagedelaChambre).
Lestêtesdelapompeàgaletnetournentpas.
L'interrupteurestsur«O»ousurlapompeestsurSTOP(Arrêt).
Contrôlerquel'interrupteurprincipalàl'arrièredelapompesoitsur«I»etquelevoyantvertduboutonRun/Stop(Marche/Arrêt)estallumé.
Pasd'irrigation. Lerobinetd'arrêtsurlachemiseouunclampsontfermés,interrompantleflux.
Contrôlerlatubulured'arrivéeentrelespochesetl’articulation.Ouvrirtoutclampourobinetd'arrêtfermés.
Lapomped'irrigationtournedemanièreexcessiveetémetunsonbruyant.
Iln'yaplusdeliquided'irrigation. Remplacerlespochesdesolutionsalineet/oucontrôlerlesclampssouslespoches.
AppuyersurFillChamber(RemplissagedelaChambre)silachambreestremplieàmoinsde1/3.
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Problèmes Causes potentielles Solutions possiblesLapomped'irrigationdonnedesà-coupsetprovoquedesfluctuationsdepressionanormales.
Del'eauestpeut-êtreentréedanslatubulureallantaucapteurdepression.
Changerlatubulured'irrigationOneDaySetsidel'eauestentréedanslatubulureallantaucapteurdepression.Sileproblèmepersiste,contacterleServiceclientDePuyMitek.
Ilyatropd'eaudanslachambredepression.
Ilpeutyavoirunefuited'airdanslatubulure.
VérifierquelesraccordsLuer-Locksurlatubulured'irrigationetlatubulureallantaucapteurdepressionsontfermés.Sinécessaire,changerlatubulured'irrigationetredémarrer.
Lapressionestinsuffisantedanslesystème.
Ilyaunproblèmed'irrigation. Contrôlerlerobinetd’arrivéedel'arthroscopeetlesclampssouslespochesdesolutionsalineetsouslachambredepression.
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Spécifications du produit
CompositionRéf.:284590
DimensionsHauteur: 16cmLargeur: 39cmProfondeur: 30cmPoids: 11kg
PerformancesNiveauxdepression:20–140(incrémentsde5)Précision±10%àdébit0
Caractéristiques électriquesAlimentation: 120/230V~Fréquence: 50-60HzPuissance: 500VAFusibles: 5A(retardés)ConformeauxnormesEN60601-1(SécuritéElectriquedesAppareilsMédicaux)etEN60601-1-2(CompatibilitéElectromagnétique)
Conditions de stockageTempératures:–10°C(14°F)à+50°C(122°F)
Conditions d’utilisationTempératures:+10°Cà+40°CHumiditérelative:de30à75%
Chapitre7.Caractéristiquestechniques
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HOOFDSTUK 1. INLEIDING 149
1.1. Productbeschrijving.................................................................... 149 1.2. Algemeenwaarschuwingenenvoorzichtigheidswaarschuwingen.. 149 1.3. Bedoeldgebruik......................................................................... 149 1.4. Symbooldefinities....................................................................... 150 1.5. Systeemindicatielampjes............................................................ 152 A.Frontpaneel............................................................................ 152 B.Achterpaneel.......................................................................... 154 1.6. Overigeindicators(auditievetonen)........................................... 154
HOOFDSTUK 2. vOORZORGSmAATREGELEN vOOR bEDRIJF, CONTROLES EN WAARSCHUWINGEN 155
2.1. Opslagenhantering................................................................... 155
HOOFDSTUK 3. INSTALLATIEPROCEDURES 156
3.1. Pompinstallatie........................................................................... 156 3.2. Slanginstallatie........................................................................... 157 A.InstallerenvandeOneDaySetirrigatieslang....................... 157 B.Installerenvandetussenliggendeirrigatieslang.................... 159 C.Beginnen................................................................................ 160 D.Eindevandeoperatie............................................................ 161 E.Installatievoordevolgendeoperatie...................................... 162 F.Eindevanoperatiedag........................................................... 163
InhoudsopgaveGARANTIE EN SERvICE 146
UITPAKKEN, mONTAGE EN INITIEEL SySTEEm CONTROLEREN 147
INSPECTIESCHEmA 148
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HOOFDSTUK 4. POmPSySTEEmFUNCTIES 164
4.1. Run/stop..................................................................................... 164 4.2. Vooringesteldedruk................................................................... 164 4.3. Vullenvandekamer.................................................................. 164 4.4. Aanbevoleninitiëleinstellingen................................................... 165 4.5. Drukalarm................................................................................... 165 4.6. Drukcyclusmodus........................................................................ 166
HOOFDSTUK 5. ONDERHOUD: REINIGEN & DECONTAmINATIE 167
HOOFDSTUK 6. PRObLEmEN OPSPOREN EN OPLOSSEN 168
HOOFDSTUK 7. PRODUCTSPECIFICATIES 170
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GarantieenServiceDePuy Mitek producten zijn gegarandeerd vrij van defecten in materiaal en afwerking gedurende de garantieperiode van een specifiek product, beginnend vanaf de factuurdatum.
Neem contact op met uw DePuy Mitek vertegenwoordiger voor specifieke productgarantieinformatie.
DePuy Mitek biedt een servicevervangingsprogramma voor zijn producten om de uitvaltijd in uw operatiekamer te minimaliseren. Voor een retourautorisatienummer of voor AANVULLENDE INFORMATIE over dit programma, bel DePuy Mitek klantenservice op +1 (800) 382-4682 en kies optie 2 in de Verenigde Staten of neem contact op met uw DePuy Mitek vertegenwoordiger.
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Uitpakken,montageeninitieelsysteemControlerenUitpakken:
Verifieerdatallepuntenopdepaklijstovereenkomenmethetproductdatuheeftontvangen(verifieerserienummersenreferenties).BeschadigingenmoetendirectwordengerapporteerdaanuwDePuyMitekVerkoopvertegenwoordigerofneemcontactopmetDePuyMitekklantenserviceindeVSop+1-800-382-4682,selectieoptie2.Bewaaralleverpakkingsmateriaal,daarditisvereistvoorhetretournerenvanproductenindienditnodigis.
Alsdedoosopenis,verwijdert,leestenvolgtudeaanwijzingenindeGebruiksaanwijzing.OmdeFMSSOLOconsoleteverwijderen,plaatstuuwhandenaandezijkantenvandeconsoleindeopenruimtestussendetweestukkenpiepschuimtotdatudeonderkantstevigkuntvastpakken.Verwijderdeconsolevoorzichtiguitdedoosenplaatshemopeenvlakenstevigoppervlak.
montage:
-Verbindhetnetsnoermetdevoedingsaansluiting(14).
-Verbindhetvoetpedaalmetdevoetpedaal-verbinding(16)opdeachterzijdevandepomp.
Initiële systeemcontrole:
- SchakeldeI/Oschakelaar(14)op“I”.
- SchakelhetapparaatAANdoorindrukkenvandeVOEDING(4)/pad.
- Drukopallepads.Ermoeteenhoorbaretoonklinkenvoorelkeingedruktepad,behalvevoorDrukcyclus,(Pad.8)(Drukcyclusisinactieftotdepompisgeprepareerd.)
Opmerking:getallentussen(),ziediagraminsectie1.5.
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Inspectieschema
Wekelijkse inspectie:
DePuyMitekadviseerteenwekelijksinspectievanalleapparatuur.Dezeinspectieskunnenwordenuitgevoerdopeenminderfrequentebasisafhankelijkvandeduurenfrequentievanhetgebruik.
- Voereenvisueleinspectieuitvanhetapparaat.Alsbeschadigingenwordengeconstateerd,neemdancontactopmetuwDePuyMitekVerkoopvertegenwoordigerofbelDePuyMitekklantenserviceindeVSop+1-800-382-4682.Selecteeroptie2ommeteenbiomedicustespreken.
- Inspecteerofdetransparanteveiligheidsafdekkingen(1)enzwarteschanierengoedwerken.
- Inspecteerhetnetsnoerenallekabelsopslijtageofinsnijdingen.
- Verzekeruervandathetvoetpedaalendeschaafinterfaceconnectorpennennietontbrekenofverbogenzijn.
- Plughetnetsnoerindevoedingsaansluiting.- SchakeldeI/Oschakelaar(14)op“I”.- SchakelhetapparaatAANdoorindrukkende
VOEDING(4)-pad.
Drukopallepads.Ermoeteenhoorbaretoonklinkenvoorelkeingedruktepad,behalvevoorDrukcyclus,(Pad.8)(Drukcyclusisinactieftotdepompisgeprepareerd.
Jaarlijkse inspectie:
DePuyMitekadviseertdateenbio-medischeingenieurofgeautoriseerdservicepersoneeljaarlijksalleapparatuurcontroleertomdefunctionaliteitentechnischeveiligheidtebepalen.
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1.1. Productbeschrijving
Irrigatiesysteem.DeFMSSOLOiseengeavanceerd,goedkoopirrigatiesysteemdatgeoctrooieerdetechnologiegebruiktvoorhetverbeterenvandevisualisatieenzwellingterwijldedruktijdensartroscopischechirurgiegeregeldwordt.
Doorstromingscompensatie.DeFMSSOLOkanherkennenwanneereenschaafroteertenvervolgensverbeterendoorde"Door-stromingscompensatie"-cyclusteactiveren.NeemcontactopuwDePuyMitekvertegenwoordigervoorFMSSchaafinterfaceproductenvanwegedeverscheidenheidvandeaangebodenproducten.
Drukcyclus rode pedaal.Eénvandemeestkritiekeaspectenvanartroscopieisvisualisatie.Hetgezichtsveldwordtvaakbelemmerddoorbloedenafvalstoffen.Omditprobleemteverlichten,heeftdeFMSSOLOeendrukcyclusmogelijkheid.Doordrukkenophetrodevoetpedaalactiveertueentijdcyclusvanverhoogdedrukomdebloedingteregelen.Wanneerdecyclusisbeëindigd,keertdeFMSSOLOterugnaardeoorspronkelijkeconfiguratie.
1.2. Algemene waarschuwingen en voorzichtigheidswaarschuwingen
Hetwordtaanbevolendathospitaalpersoneeldezehandleidingleestvoorhetbedienenofreinigenvanditproductendeaccessoiresdaarvan.Hetnietopvolgenvandezeinstructieskanleidentotpotentiëleverwondingenenbeschadigingofstoringvandeapparatuur.
DefabrikantengelicenceerdeverkopervanditapparaataccepterengeenenkeleaansprakelijkheidvoordirecteofgevolgschadeofverwondingenveroorzaaktdooronjuistgebruikvanwegwerpproductenandersdanFMS-
producten.Enigewijzigingaanditapparaat,reparatiedooreenongelicenseerdservicecenter,ofgebruikvanniet-FMSwegwerpproducten,kanhetCE-merkteken,deFMS-garantieendeproductaan-sprakelijkheidsdekkingongeldigmaken.
DeslangensetsbevattenDEHP,eenftalaathoudendechemischestofwaarvanbekendisdatdezegeboorteafwijkingenenanderevoortplantingsproblemenveroorzaakt,onderanderebijkinderenenzwangerevrouwenofvrouwendieborstvoedinggeven.
Waarschuwing:
DeFMSSOLOiseenKlasseITypeBapparaatvolgensdeElektrischeVeiligheidsstandaardEN60601-160601-1voormedischeapparaten.Zorgervoordatudejuisteinterfacekabelgebruiktwanneerueenandereschaafaansluit.Voormeerdetails,zieInterfacekabelgebruiksaanwij-zing.NeemcontactopmetuwDePuyMitekVerkoopvertegenwoordigervooreenoverzichtvandeaanbiedingenvoorSchaafinterfacekabelinterf-ace.
Hetsysteemkanbeïnvloedwordendoorelectromagnetischeinterferentievanandereinstrumenten.Controleerofalleandereinstrumentenenapparaaten(diealdannietbijhetsysteemhoren)voldoenaandenormEN60601-1-2(EMC).
Alshetsysteemnogsteedswordtbeïnvloed,isoleertuhetvanhetbetreffendeinstrumentensluituhetopeenanderewandcontactdoosaan.
1.3. Indicatie voor gebruik
HetFMSSOLOarthroscopischvloeistofbeheersysteemisgeïndiceerdvoorgebruikineenchirurgischeomgevingdoorpersoneeldatgetraindisinhetgebruikvanarthroscopie.
Hoofdstuk1.Inleiding
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1.4. Symbooldefinities
Frontpaneel Achterpaneel
voedingpad
SchakeltdevoedingAAN&UITindiendehoofdvoedingsschakelaaropdeachterzijdevandepompAANis(degroeneSTANDBY-indicatorisAAN).
Aan
Uit
Alarm
Derodeindicatorlichtopindieneenveiligheidsparameterovertredenwordt.
Equipotentiaalsymbool (aarde)
Drukcyclus
Verlichthetbloedentijdenschirurgie,doorverhogenvandebasisdrukgedurendetweeminuten.
IP50 Geenbeschermingtegenvloeistof
voetpedaal (1 pedaal)
Gebruiktvoorhetactiverenofannulerenvaneendrukcyclus.
Type b Klasse 1
VoldoetaanstandaardEN60601-1.
verhogenLet op
ZieGebruiksaanwijzing.
verlagen
Raadpleegdegebruikershandleiding
Raadpleegdegebruikershandleiding
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Explosiegevaar
Hoofdzekering
vervang zekeringen als gemarkeerd
VolgensRichtlijn2002/96/EC,moethetproductgescheidenwordenverzameld.Nietverwijderenalsongesorteerdhuisvuil.Neemcontactopmetdeplaatselijkedistributeurvoorverwijderingsinformatie.
Niet natmaken
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1 Transparante veiligheidsafdekkingen.
Dezeafdekkingmoetwordengeslotenvoorderollenpompkandraaien.
2 IRRIGATIE-rollenkoppomp. Levertvloeistofinstroming.
3 Kantelspanarm. Houddeslangopderollenpompkop.
4 vOEDING-pad. SchakeltdevoedingAAN & UIT
indiendehoofdvoedingsschakelaaraandeachterzijdevandepompAANis(hetgroen“stand-by”lichtisAAN).
5 DRUK-display. Toontzoweldevooringesteldedruk
wanneerdebasisdrukwordtingesteld,endedynamischdruk(1sec)nahetloslatenvandeDRUK-instellingspads.
6 ALARm. Derodeindicatorlichtopindieneen
veiligheidsparameterovertredenwordt.
7 Afstandsbedieningsconnector. Verbindtdeafstandsbedieningmetde
FMSSOLO.
1.5. Systeemindicatielampjes
A – Frontpaneel
1 2 3 4 5
6
78910111213
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8 Drukcyclus. Verlichthetbloedendoorverhogen
vandebasisdrukgedurendeeen2minutencyclus.
9 DRUK-instellingspads. Drukopdepijlenomdedrukinstappen
van5teverhogenofteverlagen.Deinitiëleinstellingis50.
10 Pomp Lopen/stoppen-pad. SchakeltdepompAANenUITAlsde
pompisgeactiveerd,verschijnt<POMP>ophetdrukdisplay.GroeneLEDknippertwanneerpompstopstaat.
11 Ingebouwde druktransduververbin-ding.
VoorhetaansluitenvandeOneDaySetirrigatieslangenhetmetenvandedrukindedrukkamer.
12 vul kamerpad. Vultdekamerhandmatigenschakelthet
LAGEDRUK-alarmuit.
13 Geoctrooieerd automatisch vergrendelingsapparaat.
Biedtdemogelijkheiddewegwerpslangensetopdejuistewijzetepositionerenenopzijnplaatstehoudenrondderollenpomp.
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14 I/O schakelaar, zekeringen en voedingsverbinding.
15 Identificatie & specificatie.
16 voetpedaalverbinding. 9-pensconnectornaarplugvoetpedaal.
17 Schaaf-interfaceaansluiting. 25-penshand-envoetbedienings-
interfacekabels-connector.NeemcontactopmetuwDePuyMitekVerkoopvertegenwoordigervoorbestelinformatieSchaafinterfacekabelvanwegedeverscheidenheidvanbeschikbareproducten.
18 Serienummer.
•Deeerstetweeeenhedenrepresenterenhetjaarvanfabricage.
•Detweedeseteenhedenrepresenteertdeweekvanfabricageenhetserienummer.
19 Referentienummer.
b – Achterpaneel
14
15
16
17
18
19
1.6. Overige indicators (auditieve tonen)..Eenhoorbaretoonklinktwanneerde
VOEDING-padwordtingedruktendepompinschakelt.
.EenhoorbaretoonklinktwanneerdeDRUK-moduswordtgeactiveerd(ziedrukcyclussectieomdecyclusteactiveren).
. TweehoorbaretonenklinkenwanneerdeDRUK-moduswordtgedeactiveerd(ziehoofdstuk4omdecyclustedeactiveren).
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Waarschuwingen:
Fabrieksinstellingen:Fabrieksinstellingenzijngebaseerdopervaring,zijmoetenalleenwordengebruiktalsrichtlijnen.Dechirurgisverantwoordelijkvoorinstellingenafhankelijkvandeuitgevoerdechirurgischeprocedure.
Elektrischeveiligheidstestenmoetenwordenuitgevoerddooreenbiomedischingenieurofeenanderegekwalificeerdpersoon.
Risicoopeenelektrischeschok:Verwijderdeafdekkingniet.ZievoorservicinguwDePuyMitekVertegenwoordigerofDePuyMitekklantenserviceindeVSop+1(800)382-4682,optie2.
Hetapparaatnietaansluitenopeenvoedingsbrondienietcorrectisgeaard.
Hetapparaatloskoppelenvandewandcontactdoos,wanneeruhetreinigt,repareertofinspecteert.
Inspecteeralleapparatuurenkabelsperiodiekopslijtage.NeemcontactopmetuwDePuyMitekVertegenwoordigerofDePuyMitekklantenserviceindeVSop+1(800)382-4682,optie2indienbeschadigingisgeconstateerd.
VoorkomdatvloeistofcontactmaaktmetdeFMSSOLOendeelektrischeaansluitingendaarvan.
GebruikgeenontvlambarereinigingsmiddlenbijhetreinigenendesinfecterenvandeFMSSOLO.
Dezekeringenvervangenmethetzelfdetypeenvermogenomhetrisicoopbrandtevoorkomen.
2.1. Opslag en hantering: Opslagtemperatuur: SteldeFMSSOLOnietblootaantemperaturenboven50°C(122°F)ofonder10°C(14°F).
Werkomstandigheden: Laatdepompnietwerkeninconditiesboven40°C(104°F)ofonder10°C(50°F).
Schades: GebruikeenFMSSOLOnietalsdieisgevallenoftekenenvanbeschadigingvertoont.
verwijdering: Nietverbranden.
NeemcontactopmetuwDePuyMitekVertegenwoordigerofDePuyMitekklantenserviceindeVSop+1(800)382-4682,optie2voorveiligeverwijdering.
Hoofdstuk2.Voorzorgsmaatregelenvoorbedrijf,Controlesenwaarschuwingen
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Hoofdstuk3.Installatieprocedures
3.1. Pompinstallatie.
Voedingaanachterzijdevandepompop“I”.
DrukopVoedingspad.DeLCDlichtop.
Opendeafdekking.
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WAARSCHUWING:Ditproductisslechtsbedoeldvooreenmaliggebruik.Hetisnietontworpenomtewordenhergebruikt/hergesteriliseerd.Hergebruikkanleidentotwijzigingeninmateriaalkarakteristiekenzoalsdeformatieenmateriaaldegradatiedieinvloedkunnenhebbenopdesterktevanhetapparaatennegatieveinvloedkunnenhebbenopdeprestatievanhetapparaat.Hergebruikvanvooreenmaliggebruikbedoeldeapparatenkanookkruiscontaminatieveroorzaken,watkanleidentotinfectiebijdepatiënt.Dezerisico’skunnenpotentiëelinvloedhebbenopdepatiëntveiligheid.
SteriliteitblijftalleenbehoudenindiendeslangomwisselingproceduresexactwordenuitgevoerdvolgensdeInstallatie-instructieshierondereninsectie3.2.E.
DitproductbevatDEHP,eenftalaathoudendechemischestofwaarvanbekendisdatdezegeboorteafwijkingenenanderevoortplantingsproblemenveroorzaakt,onderanderebijkinderenenzwangerevrouwenofvrouwendieborstvoedinggeven.
Dezeslangverbindtdezoutoplossingzakkenmetdeirrigatieslang.Deoplossinggaatvandenagels(A)rondderollenpomp,doordedrukkamer,waardedrukwordtgelezendooreenfilter(B)dooreeningebouwdedruktransducer.
A. Installeren van de One Day Set Irrigatieslang ref. 284504 of 284503NeemcontactopmetuwDePuyMitekVertegenwoordigervoorbestelinformatie,daarbepaaldeslangennietinallelandenwordenaangeboden.
Vanoplos-singzakken
Naardedruktransducer
Tussenlig-gendeirrigatieslang
(A)
(A)
Klemmen(B)
GROENAutomatischvergrendelingsapparaat DRUKKAMER
Klemmen
Klemmen
3.2. Slanginstallatie.
(C)
Filter
Sluitalledrieklemmenenverbindmetdevloeistofzakken.
Schuifhetgroenedeelvandeslanginhetautomatischvergrendelingsapparaatopdepomp.
Plaatsencentreerdeslangrondderollenpomp.
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Positioneerdedrukkamerindehouder.Draaidetransducermetdeklokmeeopdeconnector.
GroeneLEDknippert.Drukoprun/stop.DegroenLEDstoptmetknipperenen,blijftdanaan.
Sluitdelinkerbeschermkop.
DrukverscheidenekerenopdeVulkamer-padtotdekamer1/3volis.DegroeneLEDknipperttotdepadwordtingedrukt.
Trekaandeslangensluitdespanarmtegendeslang.
Waarschuwing:
Het is verplicht dat de drukkamer verticaal blijft tijdens de procedure en dat de pomp wordt gepositioneerd op hetzelfde niveau als de patiënt.
Overvullenvandekamerkanertoeleidendathetfilter(getoondin3.2.A)natwordtvoorafgaandeaandedruktransducerendaardoorinterfereertmeteennauwkeurigedrukmeting.Wanneerovervullenvandekameroptreedt,zieHoofdstuk6voorProblemenopsporenenoplossen.
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Dezeslangverbindtdeirrigatieslangmetdehulsopeensterielemanier.*Ref.281103omvatnietdeSterieleBufferZoneéénwegklep/tussenliggendeslangenmetéénweg-
controleklep.Ref.281103isbedoeldvooreenmaliggebruikvandeOneDaySetirrigatieslang.
b. Installeren van de tussenliggende irrigatieslang Ref. 281103, 281142, of 281103*
Nacontrolerenofdeluer-lockopdejuistewijzeisvastgedraaid,neemtdesterieleverpleegkundigedeirrigatieslangenhetblauweeinde(D)aandeomloopmedewerker.
Deomloopmedewerkerverwijdertdeblauwekappenvandeirrigatieslang(D)endeOneDaySetirrigatieslang(C)...
...en verbindtdirectdeOneDaySetirrigatieslang(C)leur-lockmetdeirrigatieslang(D)luer-lock.
DepompmoetindeRun-moduszijn(10),metdelampaan.Prepareerdeirrigatieslangdoordeklemonderdedrukkamerteopenen.Wanneerdezeisgeprepareerd,sluitudeklemofdeafsluitkraanopdeartroscoop(indesterielezone).
(D)
(C)
(C)(D)
Naardeatroscoop-huls
VandeOneDaySetirrigatieslangRef.284504of284503
(D)
SterieleBufferZoneéénwegklep/tussenliggendeslangenmet
éénweg-controleklep
Wit
Blauw Blauw Rood
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C. beginnen.
Verbindderodeluer-lock.deartroscoop.Opendekraan.
Opendeklemonderdedrukkamer.
STERIELEZONE
STERIELEZONE
STERIELEZONE
NIET-STERIELEZONE
Sluithetcanuleuiteindevandeslangaanopdecanule.
Sluithetshaveruiteindevandeslangaanopdeshaverslangaansluiting.
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Sluitdeklemonderdedrukkamer.
Ontkoppeldeblauweluer-lock(E)vandetussenliggendeirrigatieslang.
Drukoprun/stoppad(ofopendetransparanteveiligheidsafdekking).
D. Einde van de operatie.
Opmerking: De “One Day Set” met ref. 284503 & 284504 kan op dezelfde operatiedag voor meerdere procedures gebruikt worden. Waarschuwing: voor het handhaven van de steriliteit moeten de juiste installatie- en uitwisselingsprocedures voor de slangen opgevolgd worden.
Waarschuwing:De Steriele buffer Zone éénwegklep/tussenliggende slangen met éénweg-controleklep dienen bevestigd te bijven aan de One Day Set irrigatieslang die de steriliteit tussen ingrepen waarborgt.
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Controleerofdeluer-lockvastzitengeefdezeaandeomloopmedewerker.
...en verbindt direct deblauweluer-lock(D)vandenieuweirrigatieslangmetdeblauweluer-lock(C)vandeOneDaySetirrigatieslang.
Deomloopmedewerkerverwijdertdeoudesterielebufferzonedoordeluer-lockvandeOneDaySetirrigatieslangteontkoppelen(C)endetussenliggendeirrigatieslang...
E. Installatie voor de volgende operatie.
DeOneDaySetirrigatielsangkanaanheteindvandeeerdereingreepopzijnplekbevestigdblijvenmetdeSterieleBufferZoneéénwegklep/tussenliggendeslangenmetéénweg-controleklepbevestigd.
Waarschuwing:bevestig nooit een Steriele buffer Zone éénwegklep/tussenliggende slangen met éénweg-controleklep aan een ander exemplaar.
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Sluitallewitteklemmen. SchakeldepompuitdoorindrukkenvandeVOEDING-pad.Gooialleslangenweg.
F. Einde van operatiedag.
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Hoofdstuk4.Pompsysteemfuncties
4.1. Run/stopDrukopderun/stoppadomallepompsysteemfunctiestestarten.
4.3. vullen van de kamerDrukopdeVulkamerpadomdedrukkamerinitieeltevullen,entijdensdeoperatieindiennodig.Dekamermagnooitboven1/3volzijn.
4.2. vooringestelde drukDedrukwordtgetoondtussenhaakjes(bv.<50>)opdeLCD(5)gedurende2seconden.Wanneeréénvandedrukpadswordtingedrukt,wordtdeactueledrukgetoond(drukinstellingenzijninniveaus).
Niveau50komtovereenmet5voetverdringingsdrukofhetequivalentvan112,5mmHg(±10%).
Depompzalhetvooringesteldeniveauvasthouden.Tijdensbedrijfgebruiktude“+”en“–”pads(9)omhetniveauteverhogenenteverlagen.Hetvooringesteldefabrieksniveauis50.
Opmerking:getallentussen(),ziediagramoppagina152.
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4.4. Aanbevolen initiële instellingen. *
Hogedruk-alarm.
Alshethogedrukveiligheids-niveauvan140wordtoverschreden,stoptdepompenderodeALARM(6)LEDlichtop.Deoperatormoetdedrukverlagenomdepompautomatischtelatenherstarten.Alsdepompnietherstartwanneerdedrukonder140valt,herstartdepompdanhandmatigdoordepompAANenUITteschakelenmetdeVOEDING-pad.
Lagedruk-alarm.
Alsdedrukonderhetlage-drukveiligheidsniveauvan10valt,lichtderodeALARMLEDop,<drukL>knippertophetLCD-display,endepompstopt.Controleerofdeluer-lockenhetfilterbijdedruktransducerjuistwerken.Alsbeidegoedzijn,drukdanopVulkameromhetalarmtestoppenendrukopLopen/stoppenomdeunitteherstarten.
Opmerking:getallentussen(),ziediagramoppagina152.
4.5. Drukalarm
Waarschuwing:
Als water per ongeluk in de slang naar de druktransducer terechtgekomen is, vervang dan de One Day Set irrigatieslang en herstart het systeem.
Opmerking:Alsbloedingoptreedt,kandechirurgkiezenomdeLavagemodusteactiverenofdedrukteverhogen.
* WAARSCHUWING:Dezeinitiëleinstellingenzijngebaseerdopervaring,enmoetenalleenwordengebruiktalsrichtlijnen.Dechirurgisverantwoordelijkvoordeinstellingafhankelijkvandeuitgevoerdechirurgischeprocedure.
GewrichtDrukniveau
met tourniquetDrukniveau
zonder tourniquet
Schoudergewricht 60
Acromioplastie 60
KniegewrichtHemarthrosis
3050–60
6550–60
Pols 30 65
Elleboog,enkel 40 65
Heup 65
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4.6. Drukcyclusmodus.
Dedrukcyclusmoduswordtgeactiveerddoorindrukkenvande“Druk”-pad...
...ofmetbehulpvandeafstandsbedieningRef.288051,dieisverbondenmethetfrontpaneelvandepomp...
Deafstandsbedieningisnietautoclaveerbaarennietonderdompelbaar.ErmoeteensterielewegwerpafdekkingvoordeafstandsbedieningwordengebruiktRef.281087.
...ofdoorindrukkenvanhetrodevoetpedaalRef.284171,datisverbondenmethetachterpaneelvandepomp(zieoppagina154,n°16).
Dezefunctieverhoogtdedrukmet60%gedurendeeentweeminutencyclus.Dedrukkeertdanautomatischterugnaardeoorspronkelijkeinstelling.Dedrukcyclusmoduswordtgeactiveerdwanneerbloedingoptreedt.DedrukcycluskanwordengeannuleerddooropnieuwindrukkenvandeDrukcyclusmodus.
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Hoofdstuk5.Onderhoud:Reinigen&decontaminatieReiniging van de FmS SOLO:AanheteindvandeoperatiedagschakeltudeFMSSOLOuit,trektdestekkeruitdewandcontactdoosengooitalleslangenweg.Veegdezijkantenvandeinstrumenten,frontpaneelenafdekkingenafmeteenzachtedoekdieenigzinsbevochtigdismeteenneutraal-pHwasmiddel.Veegnogmaalsafmetgedestilleerdwater.
Waarschuwing:
NIETONDERDOMPELEN.NIETAUTOCLAVEREN.GebruikgeenontvlambarereinigingsmiddelenbijhetreinigenendesinfecterenvandeFMSSOLO.
voetpedaal: Reiniging en ontsmettingReingnaelkeoperatiehetvoetpedaalenhetnetsnoermeteenneutraal-pHwasmiddel.Hetvoetpedaalbordkanwordenondergedompeld,behalvedeelektrischeverbindingen,diemoetendroogblijven.
Waarschuwing:
ELEKTRISCHECONNECTORVANVOETPEDAALNIETONDERDOMPELEN.NIETAUTOCLAVEREN.Gebruikgeenontvlambarereinigingsmiddelenbijhetreinigenendesinfecterenvanhetvoetpedaal.
Twistdekabelnietbijopslag.
Trekdestekkernietuitdewandcontactdoosdoortrekkenaandekabel.
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Hoofdstuk6.Problemenopsporenenoplossen
Problemen Potentiële oorzaken mogelijke oplossingenDepompstopt.
RoodALARMLEDlichtop.
DeHOGEDRUK-veiligheidisgeactiveerd.
DeLAGEDRUK-veiligheidisgeactiveerd:“DrukL”knippert.
Hethydrofobischefilterisnat.
Erisgeenirrigatievloeistofmeer.
Verlaagdegewrichtsdruk.
DrukopdeLopen/stoppen-padomdepompteherstarten.
Verifieerdatdeluer-locksteviggeslotenis.
DrukopVulkameromhetalarmtestoppen,endrukopdeLopen/stoppen-padomdepompteherstarten.
VervangdeOneDaySetirrigatieslang.Alshetprobleemnogsteedsaanwezigis,neemdancontactopmetDePuyMitekklantenservice.
VernageldezakendrukopdeVulkamer-pad.
Derollenpompkoppendraaienniet.
Devoedingisop“O”ofstaatopStop.
Controleerofdehoofdvoedings-schakelaaropdeachterzijdevandepompinde“I”positieis,endathetgroenelichtvandeLopen/stoppen-padAANis.
Erisgeenirrigatie. Deafsluitkraanopdehulsofeenklemisgesloten,enstoptdeuitstroming.
Controleerdeinstroomlijnvandezakkennaarhetgewricht.Openallegeslotenklemmenofafsluitkranen.
Deirrigatiepompbegintexcessiefsneltedraaien,engeefteenluidgeluid.
Erisgeenirrigatievloeistofmeer. Vervangdezoutoplossingzakkenen/ofcontroleerdeklemmenonderdezakken.
DrukopVulkamerindiendekamerlagerisdan1/3.
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Problemen Potentiële oorzaken mogelijke oplossingenDeirrigatiepompgaatonregelmatigaanenuitenveroorzaaktdaardoorabnormaledrukfluctuaties.
Erkanwaterterechtzijngekomenindedruksensorlijn.
VervangdeOneDaySetirrigatieslangindienwaterindedruksensorlijnisgekomen.Alshetprobleemnogsteedsaanwezigis,neemdancontactopmetDePuyMitekklantenservice.
Eristeveelwaterindedrukkamer.
Erkaneenluchtlekkageindelijnzijngekomen.
Controleerofdeluer-locksopdeirrigatie-endruksensorslangzijngesloten.Indiennodig,vervangdeirrigatieslangenstartopnieuw.
Erisonvoldoendedrukinhetsysteem.
Eriseenirrigatieprobleem. Controleerdeafsluitkraanopdeartroscoop,endeklemmenonderdezoutoplossingzakkenenonderdedrukkamer.
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Productspecificaties
SamenstellingRef:284590
AfmetingenHoogte: 16cmBreedte:39cmDiepte: 30cmGewicht:11kg
PrestatiespecificatiesDrukniveaus:20–140Stappenvan5Precisie±10%bij0doorstromingswaarde
Elektrische specificatiesIngangsvoeding: 120/230V~Frequentie: 50–60HzVermogensafname: 500VAZekeringen: 5AtijdvertragingVoldoetaanstandaardEN60601-160601-1(MedischInstrumentElektrischeVeiligheid)enEN60601-1-2(ElectromagnetischeCompatibiliteit)
OpslagomstandighedenTemperaturen:–10°C(14°F)tot+50°C(122°F)
GebruikTemperaturen:+10°Ctot+40°CRelatievevochtigheid30tot75%
Hoofdstuk7.Productspecificaties
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CAPÍTULO 1. INTRODUÇÃO 177
1.1. DescriçãodoProduto................................................................. 177 1.2. AvisoseAdvertênciasGerais.................................................... 177 1.3. UsoPrevisto............................................................................... 177 1.4. DefiniçõesdosSímbolos........................................................... 178 1.5. IndicadoresdoSistema............................................................. 180 A.PainelFrontal......................................................................... 180 B.PainelTraseiro........................................................................ 182 1.6. OutrosIndicadores(sinaissonoros)........................................... 182
CAPÍTULO 2. PRECAUÇÕES, INSPECÇÕES E ADvERTÊNCIAS DE FUNCIONAmENTO 183
2.1. ArmazenamentoeManuseamento........................................... 183
CAPÍTULO 3. PROCEDImENTOS DE CONFIGURAÇÃO 184
3.1. ConfiguraçãodaBomba............................................................ 184 3.2. ConfiguraçãodadosTubos........................................................ 185 A.InstalaçãodoTubodeIrrigaçãoOneDaySet...................... 185 B.InstalaçãodoTubodeIrrigaçãoIntermediário....................... 187 C.ComoComeçar...................................................................... 188 D.FimdaOperação................................................................... 189 E.ConfiguraçãodaOperaçãoSeguinte.................................... 190 F.FimdoDiadeFuncionamento............................................... 191
ÍndiceGARANTIA E ASSISTÊNCIA 174
DESEmbALAmENTO, mONTAGEm E INSPECÇÃO INICIAL DO SISTEmA 175
CALENDáRIO DA INSPECÇÃO 176
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CAPÍTULO 4. FUNÇÕES DO SISTEmA DA bOmbA 192
4.1. Ligar/Desligar............................................................................. 192 4.2. PressãoPredefinida................................................................... 192 4.3. EncheraCâmara....................................................................... 192 4.4. DefiniçõesIniciaisRecomendadas............................................. 193 4.5. AlarmedaPressão..................................................................... 193 4.6. MododoCiclodePressão.......................................................... 194
CAPÍTULO 5. mANUTENÇÃO: LImPEZA E DESCONTAmINAÇÃO 195
CAPÍTULO 6. RESOLUÇÃO DE PRObLEmAS 196
CAPÍTULO 7. ESPECIFICAÇÕES DO PRODUTO 198
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GarantiaeAssistênciaOs produtos da DePuy Mitek possuem uma garantia de que estão livres de defeitos de materiais e de mão-de-obra durante o período de duração da garantia de um determinado produto, a partir da data da factura.
Contacte o Representante da DePuy Mitek para obter informações específicas acerca da garantia do produto.
A DePuy Mitek disponibiliza um programa de substituição com serviço expresso para os seus produtos para minimizar o tempo de indisponibilidade no bloco operatório. Para obter um número de autorização da devolução ou para obter informações adicionais acerca deste programa, contacte o Serviço de Apoio ao Cliente da DePuy Mitek através do número +1 (800) 382-4682 e seleccione a Opção 2 nos Estados Unidos ou contacte o Representante Comercial da DePuy Mitek.
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Desembalamento,MontagemeInspecçãoInicialdoSistemaDesembalar:
Certifique-sedequetodosositensnalistadaembalagemcorrespondemaosprodutosquerecebeu(verifiqueosnúmerosdesérieereferências).QuaisquerdanosdevemserimediatamentereportadosaoRepresentanteComercialdaDePuyMitekoucontacteoServiçodeApoioaoClientedaDePuyMiteknosEUAatravésdonúmero+1-800-382-4682,seleccionandoaOpção2.Guardetodoomaterialdaembalagem,vistoqueeleseránecessáriocasotenhadeefectuaradevoluçãodoproduto.
Depoisdeabriracaixa,remova,leiaesigaasInstruções de utilização.PararemoveraconsolaFMSSOLO,coloqueasmãosemambososladosdaconsolaatéconseguiragarraroladoinferiorcomsegurança.Removacuidadosamenteaconsoladacaixaecoloque-anumasuperfícieniveladaeestável.
montagem:
- Ligueocaboeléctricoàligaçãodaalimentação(14).
- Ligueopedalàligaçãodopedal(16)napartedetrásdabomba.
Inspecção Inicial do Sistema:
- LigueointerruptorI/O(14)colocando-onaposição“I”.
- Ligue(ON)odispositivopremindoateclaPOWER(Alimentação)(4).
- Primatodasasteclas.Deveseremitidoumsinalsonoroparacadateclapremida,exceptonocasodafunçãoPressureCycle(CiclodePressão),(Tecla8)(AfunçãodoCiclodePressãoéactivadaapenasquandoseencheabomba.)
Nota:osnúmerosentre()referem-seaodiagramanasecção1.5.
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CalendáriodaInspecção
Inspecção semanal:
ADePuyMitekrecomendaarealizaçãodeumainspecçãosemanaldetodooequipamento.Estasinspecçõespodemserefectuadasmenosfrequentementedependendodaduraçãoefrequênciadeutilização.
- Efectueumainspecçãovisualdodispositivo.Seobservardanos,contacteoRepresentanteComercialdaDePuyMitekouligueparaoServiçodeApoioaoClienteDePuyMiteknosEUAatravésdonúmero+1-800-382-4682,seleccionandoaOpção2parafalarcomumengenheirobiomédico.
- Inspeccioneecertifique-sedequeatampadesegurançatransparente(1)eascharneiraspretasestãoafuncionardevidamente.
- Inspeccioneocaboeléctricoetodososcabosparadetectarsinaisdedesgasteoucortes.
- Certifique-sedequeospinosdoconectordopedaledainterfacedoshaver(dispositivodecorte)nãoestãoemfaltaoudobrados.
- Ligueocaboeléctricoàligaçãodaalimentação.- LigueointerruptorI/O(14)colocando-ona
posição“I”.- ON(LIGUE)odispositivopremindoatecla
POWER(Alimentação)(4).
Primatodasasteclas.Deveseremitidoumsinalsonoroparacadateclapremida,exceptonocasodafunçãoPressureCycle(CiclodePressão),(Tecla8).AfunçãodoCiclodePressãoéactivadaapenasquandoabombaéenchida.
Inspecção anual:
ADePuyMitekrecomendaqueumengenheirobiomédicoouumfuncionáriodeassistênciaautorizadoinspeccionetodooequipamentoparaavaliarasuafuncionalidadeesegurançatécnica.
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1.1. Descrição do Produto
Sistema de irrigação.OFMSSOLOéumsistemadeirrigaçãoavançadodebaixocustoqueusatecnologiapatenteadaparamelhoraravisualizaçãoedistensãoenquantocontrolaapressãoduranteacirurgiaartroscópica.
Compensação do fluxo.OFMSSOLOconseguereconhecerquandooshaver(dispositivodecorte)estáemrotaçãoesubsequentementemelhorarodesempenhoactivandoociclo"Flowcompensator"(CompensafordoFluxo).ContacteoRepresentantedaDePuyMitekparaobterinformaçõeseprodutosdaInterfacedoShaver(dispositivodecorte)FMSdevidoàvariedadedosprodutosoferecidos.
Pedal vermelho do ciclo de pressão.Umdosaspectosmaisessenciaisdaartroscopiaéavisualização.Ocampodevistaéfrequentementeobstruídoporsangueedetritos.Paraaliviaresteproblema,oFMSSOLOtemumafunçãodeciclodapressão.Quandoprimeopedalvermelhoactivaumciclotemporizadodeaumentodapressãoparacontrolarahemorragia.Depoisdeocicloestarcompleto,oFMSSOLOiráregressaràsuaconfiguraçãooriginal.
1.2. Avisos e Advertências Gerais
Érecomendávelqueosfuncionáriosdohospitalleiamestemanualantesdeutilizaroulimparesteprodutoeosseusacessórios.Onãocumprimentodestasinstruçõespodeoriginarpotenciaislesõesedanosouavariasdoequipamento.
Ofabricanteevendedorlicenciadodestedispositivonãoaceitamqualquerresponsabilidadeporquaisquerdanosoulesõesdirectosouconsequenciaiscausadosporumautilizaçãoindevidadeoutrosprodutosdescartáveisque
nãoosprodutosFMS.Quaisqueralteraçõesaestedispositivo,reparaçõesdeumcentrodeassistêncianãolicenciadoouusodeprodutosdescartáveisnãoFMS,podeanularamarcaCE,eagarantiaFMSeacoberturadaresponsabilidadedoproduto.
OsconjuntosdetuboscontêmDEHP,umprodutoquímicoàbasedeftalatoconhecidoporcausarmalformaçõescongénitaseoutrosefeitosadversosnareprodução,incluindonascriançaseemmulheresgrávidaseaamamentar.
Atenção:
OFMSSOLOéumdispositivodeTipoBClasseI,deacordocomaNormadeSegurançaEléctricaEN60601-1paradispositivosmédicos.Certifique-sedequeestáautilizarocabodeinterfacecorrectoaoefectuaraligaçãoaoutroshaver.Paraobtermaisdetalhes,consulteasInstruçõesdeUtilizaçãodoCabodeInterface.ContacteoRepresentanteComercialdaDePuyMitekparareverasofertasdeinterfacedoCabodeInterfacedoShaver(dispositivodecorte).
Osistemapodeserafectadoporinterferênciaselectromagnéticasdeoutrosinstrumentos.Certifique-sedequetodososoutrosinstrumentoseaparelhos(associadosounãoaosistema)cumpremostermosdaNormaEN60601-1-2(EMC).
Seosistemacontinuaraserafectado,isole-odoinstrumentoofensivoeligue-oaumasaídadealimentaçãodiferente.
1.3. Indicações de utilização
OsistemaartroscópicoFMSSOLOdegestãodefluidoséindicadoparaserutilizadoemambientecirúrgicoporclínicoscomformaçãoemartroscopia.
Capítulo1.Introdução
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1.4. Definições dos Símbolos
Painel frontal Painel traseiro
Tecla da Alimentação
ON&OFF(LIGAEDESLIGA)aalimentaçãoseointerruptordaalimentaçãoprincipalnapartedetrásdabombaestiveractivado(aluzverdedomodoemesperaestáacesa).
Ligado
Desligado
Alarme
Oindicadorvermelhoiráacender-seseumparâmetrodesegurançaforviolado.
Símbolo de Equipotencial (ligação à terra)
Ciclo de pressão
Aliviaahemorragiaduranteacirurgia,aumentandoapressãodabasedurantedoisminutos.
IP50 Semprotecçãodelíquidos
Placa unidireccional do pedal
Usadaparaactivaroucancelarumciclodepressão.
Tipo b Classe 1
EmconformidadecomanormaEN60601-1.
AumentarAtenção
ConsultarasInstruçõesdeUtilização.
Diminuir
Consulteomanualdeinstruções/folheto
Consulteomanualdeinstruções/folheto
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Perigo de explosão
Fusível principal
Substituir os fusíveis conforme assinalado
DeacordocomostermosdaDirectiva2002/96/EC,oprodutodeveserrecolhidoseparadamente.Nãodescartarcomoresíduosmunicipaisdomésticos.Contacteodistribuidorlocalparaobterinformaçõessobreasnormasdeeliminaçãoaplicáveis.
Não molhar
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1 Tampas de segurança transparentes.
Estatampadeveestarfechadaparaabombadecilindrorodar.
2 bomba de cilindro de IRRIGAÇÃO. Fornecefluxodeentradadolíquido.
3 braço oscilante de tensão. Seguraotubonacabeçadabomba
decilindro.
4 Tecla POWER (Alimentação). ON & OFF (LIGA E DESLIGA)
aalimentaçãoseointerruptordaalimentaçãoprincipalnapartedetrásdabombaestiveractivado(aluzverdedomodo"emespera"estáacesa).
5 Ecrã da PRESSÃO. Apresentatantoapressãopredefinida
quandoapressãobaseestáaserconfigurada,comoapressãodinâmica(1seg.)apósalibertaçãodasteclasdeajustedapressão.
6 ALARmE. Oindicadorvermelhoiráacender-se
seumparâmetrodesegurançaforviolado.
7 Conector do Controlo Remoto. LigaocontroloremotoaoFMSSOLO.
A – Painel frontal
1.5. Indicadores do Sistema
1 2 3 4 5
6
78910111213
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8 Ciclo de pressão. Aliviaahemorragiaaumentandoa
pressãodebaseduranteumciclode2minutos.
9 Teclas de ajuste da PRESSÃO. Primaassetasparaaumentarou
diminuirapressãoemincrementosde5.Adefiniçãoinicialé50.
10 Tecla Pump Run/Stop (Ligar/Desligar bomba).
ON(LIGA)eOFF(DESLIGA)abomba.Seabombaforactivada,aindicação<PUMP>(Bomba)surgenoecrãdapressão.OLEDverdepiscaquandoabombaestáparada.
11 Ligação do transdutor da pressão integrada.
ParaligaroTubodeIrrigaçãoOneDaySetemedirapressãonacâmaradepressão.
12 Tecla Fill Chamber (Encher Câmara). Enchemanualmenteacâmarae
desactivaoalarmeLOWPRESSURE(Pressãobaixa).
13 Dispositivo de auto-bloqueio patenteado.
Permiteoposicionamentocorrectoeobloqueiodotubodescartávelnadevidaposiçãoemtornodabombadecilindro.
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14 Interruptor I/O, fusíveis e ligação da alimentação.
15 Identificação e especificações.
16 Ligação do pedal. Conectorde9pinosparafichadopedal.
17 Ligação de interface do Shaver (dispositivo de corte).
Conectorde25pinosdoscabosdeinterfacedecontrolomanualouporpedal.ContacteoRepresentanteComercialdaDePuyMitekparaobterinformaçõesparaencomendadeCabosdeInterfacedoShaverporcausadavariedadedeprodutosdisponíveis.
18 Número de série.
•Osdoisprimeirosdígitosrepresentamoanodefabrico.
•Osegundoconjuntodedígitosrepresentaasemanadefabricoenúmerodesérie.
19 Número de referência.
b – Painel traseiro
14
15
16
17
18
19
1.6. Outros Indicadores (sinais sonoros)..Éemitidoumsinalsonoroquandoatecla
POWER(Alimentação)épremidaeabombaéactivada.
.ÉemitidoumsinalsonoroquandoomododePRESSURE(Pressão)éactivado(consultarasecçãodociclodepressãoparaactivarociclo).
. SãoemitidosdoissinaissonorosquandoomododePRESSURE (Pressão)édesactivado(consultarocapítulo4paradesactivarociclo).
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Advertências:
Predefiniçõesdefábrica:Aspredefiniçõesdefábricabaseiam-seemexperiênciaesódevemserusadascomodirectrizes.Ocirurgiãoéresponsávelpelasdefiniçõesdependendodoprocedimentocirúrgicoefectuado.
Ostestesdesegurançaeléctricadevemserefectuadosporumengenheirobiomédicoououtrapessoadevidamentequalificada.
Riscodechoqueeléctrico:Nãoremovaacobertura.ContacteoRepresentantedaDePuyMiteklocalouoServiçodeApoioaoClientedaDePuyMiteknosEUAatravésdonúmero+1800382-4682,Opção2comvistaaobterassistência.
Nãoligueodispositivoaumafontedealimentaçãosemumaligaçãoàterraapropriada.
Desligueodispositivodafontedealimentaçãoprincipalquandoolimpar,efectuartarefasdeassistênciaouoinspeccionar.
Inspeccionetodooequipamentoeoscabosperiodicamenteparadetectarsinaisdedesgaste.ContacteoRepresentantedaDePuyMiteklocalouoServiçodeApoioaoClientedaDePuyMiteknosEUAatravésdonúmero+1800382-4682,Opção2seobservarqualquerdano.
EviteocontactodelíquidoscomoFMSSOLO,eosseusconectoreseléctricos.
NãoutilizeagentesinflamáveisquandolimparedesinfectaroFMSSOLO.
Paraevitaroriscodeincêndios,substituaosfusíveisporunsdomesmotipoeclassificação.
2.1. Armazenamento e manuseamento: Temperatura de armazenamento: NãoexponhaoFMSSOLOatemperaturassuperioresa50°C(122°F)ouabaixode–10°C(14°F).
Condições Operacionais: Nãoutilizeabombaemcondiçõesacimados40°C(104°F)ouabaixode10°C(50°F).
Danos: NãouseumFMSSOLOquetenhacaídoaochãooumostresinaisdedanos.
Eliminação: Nãoincinerar.
ContacteoRepresentantedaDePuyMitekouoServiçodeApoioaoClientedaDePuyMiteknosEUAatravésdonúmero+1800382-4682,Opção2,paragarantirumaeliminaçãosegura.
Capítulo2.Precauções,InspecçõeseAdvertênciasdeFuncionamento
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Capítulo3.ProcedimentosdeConfiguração
3.1. Configuração da bomba.
Ligueaalimentaçãonapartedetrásbombaem“I”.
PrimaateclaPower (Alimentação).OecrãLCDiráacender-se.
Abraatampa.
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ATENÇÃO:Esteprodutodestina-seaumaúnicautilização.Nãofoiconcebidoparaserreutilizado/reesterilizado.Oreprocessamentopodecausaralteraçõesnascaracterísticasdomaterialcomo,porexemplo,deformaçãoedegradação,quepodemafectararesistênciadodispositivoecomprometerodesempenhododispositivo.Oreprocessamentodedispositivosdeutilizaçãoúnicatambémpodecausarcontaminaçãocruzadalevandoainfecçãodopaciente.Estesriscospodem,potencialmente,afectarasegurançadopaciente.
AesterilidadesóémantidaseosprocedimentosdemudançadotubotiveremsidoefectuadosexactamentedeacordocomasinstruçõesdeconfiguraçãodescritasaseguirenaSecção3.2.E.
EsteprodutocontémDEHP,umprodutoquímicoàbasedeftalatoconhecidoporcausarmalformaçõescongénitaseoutrosefeitosadversosnareprodução,incluindonascriançaseemmulheresgrávidaseaamamentar.
Estetuboligaossacosdesoluçãosalinaaostubosdeirrigação.Asoluçãopassaespigões(A)emtornodabombadecilindro,atravésdacâmaradepressão,ondeapressãoélidaatravésdeumfiltro(B)porumtransdutordapressãointegrado.
A. Instalação do Tubo de Irrigação One Day Set Ref. 284504 ou 284503ContacteoRepresentantedaDePuyMitekparaobterinformaçõesacercadaencomendavistoquedeterminadostubosnãosãodisponibilizadosemtodosospaíses.
3.2. Configuração dos Tubos.
Dossacosdesolução
ParaoTransdutorda
pressão
TubodeIrrigaçãoIntermediário
(A)
(A)
Clamps(B)
Dispositivodeauto-bloqueio
VERDE CÂMARADEPRESSÃO
Clamps
Clamps
(C)
Filtro
Fecheostrêsclampseligueaossacosdelíquido.
Deslizeaparteverdedotuboparadentrododispositivodeauto-bloqueionabomba.
Coloqueecentreotuboemtornodabombadecilindro.
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Posicioneacâmaradepressãonosuporte.Ligueotransdutoràbombaenroscando-ofirmemente,rodando-onosentidodosponteirosdorelógio.
OLEDverdepisca.PrimaateclaRun/Stop(Ligar/Desligar).OLEDverdepiscainicialmente,edepoisficaacesocontinuamente.
Fecheatampa.
PrimaateclaFillchamber(EncherCâmara)váriasvezesatéacâmaraestar1/3cheia.OLEDverdepiscaatéateclaserpremida.
Puxeotuboefecheobraçooscilantedetensãocontraotubo.
Atenção:
é obrigatório que a câmara de pressão permaneça na vertical durante o procedimento e que a bomba seja posicionada ao mesmo nível que o paciente.
Osobreenchimentodacâmarapodefazercomqueofiltro(ilustradoem3.2.A)fiquemolhadoantesdotransdutordepressão,einterferirassimcomamediçãoprecisadapressão.Seacâmaraencheremdemasia,consulteoCapítulo6paraobterinformaçõesdeResoluçãodeProblemas.
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Estetuboligaotubodeirrigaçãoàbainhadeumamaneiraesterilizada.*Ref.ª281103nãoincluiaVálvulaUnidireccionaldaZonaTampãoEsterilizada/Tubagemintermédiacom
Válvuladeinspecçãounidireccional.Ref.ª281103destina-seaumaúnicautilizaçãodoTubodeIrrigaçãoOneDaySet.
b. Instalação do Tubo de Irrigação Intermediário Ref.ª 281103, 281142 ou 281103*
Depoisdesecertificardequeofecholuerseencontradevidamenteapertado,aenfermeiraretiraotubodeirrigaçãoepassaaextremidadeazul(D)aumapessoaforadocampooperatório.
Apessoaforadocampooperatórioretiraastampasazuisdotubodeirrigação(D)eoTubodeIrrigaçãoOneDaySet(C)...
...e ligaimediatamente ofecholuerdoTubodeIrrigaçãoOneDaySetIrrigationTube(C),aofecholuerdotubodeirrigação(D).
AbombatemdeestarnomodoRun(Funcionar)(10),comaluzacesa.Enchaotubodeirrigaçãoabrindooclampdebaixodacâmaradepressão.Quandoestivercheio,fecheoclampouatorneiradeparagemnoartroscópio(nazonaesterilizada).
(D)
(C)
(C)(D)
ParaaBainhadoartroscópio
DoTubodeIrrigaçãoOneDaySetRef.ª284504ou284503
(D)
VálvulaunidireccionalcomZonatampãoestéril/Tubagemintermédia
comVálvuladeinspecçãounidireccional
Branco
Azul Azul Vermelho
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C. Como Começar.
Ligueofecholueraoartroscópio.Abraatorneiradeparagemnoartroscópio.
Abraoclampdebaixodacâmara.
ZONAESTERILIZADA
ZONAESTERILIZADA
ZONAESTERILIZADA
ZONANÃOESTERILIZADA
Introduzaotubodacânuladentrodacânula. Introduzaotubodoshaver(dispositivodecorte)dentrodaportadeaspiraçãodoshaver.
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Fecheoclampdebaixodacâmaradepressão.
Desligueofecholuer(E)azuldotubodeirrigaçãointermediário.
PrimaateclaRun/Stop(Ligar/Desligar)(ouabraatampadesegurançatransparente).
D. Fim da Operação.
Nota: Os produtos “One Day Set”, Ref. 284503 e 284504, podem ser reutilizados para múltiplos procedimentos durante o mesmo dia de cirurgia. Atenção: A esterilidade só é mantida caso tenham sido seguidos os procedimentos adequados de configuração e mudança dos tubos.
Atenção:A válvula unidireccional com Zona tampão estéril /Tubagem intermédia com válvula de inspecção unidireccional deve permanecer ligada ao Tubo de irrigação do Conjunto para um dia para assegurar a esterilidade entre as cirurgias.
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Depoisdesecertificardequeofecholuerseencontraapertado,aenfermeiraretiraotubodeirrigaçãoepassaaextremidadeazul(D)aumapessoaforadocampooperatório.
...eimediatamenteligaofecholuer(D)azuldonovotubodeirrigaçãoaofecholuer(C)azuldotubodeirrigaçãoOneDaySet.
ApessoaforadocampooperatórioremoveaantigazonatampãoesterilizadadesligandoosfechosluerdoTubodeIrrigaçãoOneDaySet(C)eotubodeirrigaçãointermediário...
E. Configuração da Operação Seguinte.
OTubodeIrrigaçãoOneDaySetpodeficarnasuadevidaposiçãonofinaldacirurgiaanteriorcomaválvulaunidireccionaldazonatampãoesterilizada/TubagemintermédiacomVálvuladeinspecçãounidireccionalligadas.
Atenção:Nunca encaixe uma válvula unidireccional com Zona tampão estéril/Tubagem intermédia com válvula de inspecção unidireccional noutra.
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Fechetodososclampsbrancos.
DesligueabombapremindoateclaPOWER(Alimentação).Descartetodosostubos.
F. Fim do Dia de Funcionamento.
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Capítulo4.FunçõesdoSistemadaBomba
4.1. Ligar/DesligarPrimaateclaRun/Stop(Ligar/Desligar)parainiciartodasasfunçõesdosistemadabomba.
4.3. Encher a CâmaraPrimaateclaFillChamber(EncheraCâmara)paraencheracâmaradepressãoinicialmente,eduranteacirurgiaconformesejanecessário.Acâmaranuncadeveestarmaisde1/3cheia.
4.2. Pressão PredefinidaApressãoéapresentadaentreparêntesis(porex.,<50>)noecrãLCD(5)durante2segundosquandoumadasteclasdepressãoépremida,edepoisapressãorealéapresentada(asdefiniçõesdapressãoencontram-seemníveis).
Nível50,éiguala5pésdepressãodegravidadeouoequivalentea112.5mmHg(±10%).
Abombairámanteronívelpredefinido.Aooperar,useasteclas“+”e“–”(9)paraaumentaroudiminuironível.Onívelpredefinidodefábricaéde50.
Nota:osnúmerosentre()referem-seaodiagramanapág.180.
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4.4. Definições Iniciais Recomendadas. *
Alarme de alta pressão.
Seoníveldesegurançadaaltapressãode140forexcedido,abombapáraeoLEDALARM(Alarme)(6)vermelhoacende-se.Ooperadordevebaixarapressãoparadeixarabombareiniciar-seautomaticamente.Seabombanãosereiniciarquandoapressãodescerabaixode140,reinicieabombamanualmenteON(LIGANDO)eOFF(DESLIGANDO)abombanovamenteutilizandoateclaPOWER(Alimentação).
Alarme de baixa pressão.
Seapressãodescerabaixodoníveldesegurançadabaixapressãode10,oLEDALARM(Alarme)vermelhoacende-se,aindicação<PresL>(Pressãobaixa)piscanoecrãLCDeabombapára.Certifique-sedequeofecholuereofiltropertodotransdutordapressãoestãoafuncionardevidamente.Seambosestiveremsatisfatórios,primaateclaFillChamber(EncherCâmara)parainterromperoalarmeeateclaRun/Stop(Ligar/Desligar)parareiniciaraunidade.
Nota:osnúmerosentre()referem-seaodiagramanapág.180.
4.5. Alarme da Pressão
Atenção:
Se tiver entrado água acidentalmente nos tubos que vai até ao transdutor da pressão, mude o Tubo de Irrigação One Day Set e reinicie o sistema.
Nota:Seocorrerhemorragia,ocirurgiãopodeoptarporactivaromododeLavagemouaumentarapressão.
* ATENÇÃO:Estasdefiniçõesiniciaisbaseiam-seemexperiênciaesódevemserusadascomodirectrizes.Ocirurgiãoéresponsávelpelasdefiniçõesdependendodoprocedimentocirúrgicoefectuado.
ArticulaçãoNível da pressãocom Torniquete
Nível da pressãosem Torniquete
ArticulaçãodoOmbro 60
Acromioplastia 60
ArticulaçãodoJoelhoHemartrose
3050–60
6550–60
Pulso 30 65
Cotovelo,Tornozelo 40 65
Anca 65
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4.6. modo do Ciclo de Pressão.
Omododociclodepressãoéactivadopremindoatecla"Pressure"(Pressão)...
...ouusandoocontroloremotoRef.288051,queéligadoaopainelfrontaldabomba...
Ocontroloremotonãopodeseresterilizadoporautoclaveenãopodeserimersível.DeveserutilizadaumacoberturadescartáveldocontroloremotoRef.281087.
...oupremindoopedalvermelhoRef.284171,queseencontraligadoaopaineltraseirodabomba(consultarnapág.182,n°16).
Estafunçãoaumentaapressãoem60%duranteumciclodedoisminutos.Apressãoregressadepoisautomaticamenteàsuadefiniçãooriginal.Omododociclodepressãoéactivadoquandoocorrehemorragia.OciclodepressãopodesercanceladopremindoomodoPressureCycle(CiclodePressão)novamente.
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Capítulo5.Manutenção:LimpezaeDescontaminaçãoLimpeza do FmS SOLO:Nofinaldodiadefuncionamento,desligueoFMSSOLO,desligueocabodealimentaçãoedescartetodosostubos.Limpeoslados,painelfrontaletampasdoinstrumentocomumpanosuavequefoiligeiramentehumedecidocomumdetergentedepHneutro.Limpenovamenteutilizandoáguadestiladaparaenxaguar.
Atenção:
NÃOSUBMERGIR.NÃOESTERILIZARPORMEIODEAUTOCLAVE.NãoutilizaragentesinflamáveisaolimparedesinfectaroFMSSOLO.
Pedal: Limpeza e DescontaminaçãoApóscadaoperação,limpeopedaleocabodealimentaçãocomumdetergentecompHneutro.Opaineldopedalpodesersubmergido,exceptoasligaçõeseléctricasquedevempermanecersecas.
Atenção:
NÃOSUBMERGIROCONECTORELÉCTRICODOPEDAL.NÃOESTERILIZARPORMEIODEAUTOCLAVE.Nãoutilizaragentesinflamáveisaolimparedesinfectaropedal.
Nãotorcerocaboaoarmazenar.
Nãodesligaroinstrumentopuxandoocabo.
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Capítulo6.ResoluçãodeProblemas
Problemas Potenciais Causas Possíveis SoluçõesAbombapára.
OLEDALARM(Alarme)vermelhoacende-se.
AfunçãodesegurançadaPRESSÃOALTAfoiactivada.
AfunçãodesegurançadaPRESSÃOBAIXAfoiactivada.Aindicação“Pres.L”(Pressãobaixa)piscanoecrã.
Ofiltrohidrofóbicoestámolhado.
Jánãohámaislíquidodeirrigação.
Reduzapressãodaarticulação.
PrimaateclaRun/Stop(Ligar/Desligar)parareiniciarabomba.
Certifique-sedequeofecholuerestádevidamentefechado.
PrimaateclaFillChamber(EncherCâmara)paradesligaroalarme,eprimaateclaRun/Stop(Ligar/Desligar)parareiniciarabomba.
SubstituaoTubodeIrrigaçãoOneDaySet.Seoproblemapersistir,contacteoServiçodeApoioaoClientedaDePuyMitek.
PerfureosacoeprimaateclaFillChamber(EncherCâmara).
Ascabeçasdabombadecilindronãorodam.
Aalimentaçãoestánaposição“O”ounaposiçãoStop.
Certifique-sedequeointerruptorprincipaldealimentaçãonapartedetrásdabombaseencontranaposição“I”,equealuzverdedateclaRun/Stop(ligar/Desligar)estáacesa.
Nãoexisteirrigação. Atorneiradeparagemnabainhaouumclampestáfechado,interrompendoofluxodesaída.
Verifiquealinhadofluxodeentradadossacosatéàarticulação.Abraquaisquerclampsoutorneirasdeparagemqueestejamfechados.
Abombadeirrigaçãocomeçaarodarexcessivamente,emitindoumruídoalto.
Jánãohámaislíquidodeirrigação.
Substituaossacosdasoluçãosalinae/ouverifiqueosclampsdebaixodossacos.
PrimaateclaFillChamber(EncherCâmara)seacâmaraestivercheiaamenosde1/3.
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Problemas Potenciais Causas Possíveis SoluçõesAbombadeirrigaçãoliga-seedesliga-seerraticamentecausandoflutuaçõesanómalasdapressão.
Podeterentradoáguadentrodalinhadosensordapressão.
MudeoTubodeirrigaçãoOneDaySetcasotenhaentradoáguadentrodalinhadosensordapressão.Seoproblemapersistir,contacteoServiçodeApoioaoClientedaDePuyMitek.
Existedemasiadaáguadentrodacâmaradepressão.
Pode-seterdesenvolvidoumafugadearnalinha.
Certifique-sedequeofecholuernotubodeirrigaçãoenotubosensordapressãoseencontrafechado.Sefornecessário,mudeotubodeirrigaçãoecomecenovamente.
Nãoexistepressãosuficientenosistema.
Existeumproblemadeirrigação. Verifiqueatorneiradeparagemnoartroscópio,eosclampsdebaixodossacosdesoluçãosalinaedebaixodacâmaradepressão.
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Especificações do Produto
ComposiçãoRef:284590
DimensõesAltura: 16cmLargura: 39cmProfundidade: 30cmPeso: 11kg
Especificações do desempenhoNíveisdapressão:20–140Incrementosde5Precisão±10%ataxadefluxo0
Especificações eléctricasPotêncianominal: 120/230V~Frequência: 50–60HzPuxadadaCorrente: 500VAFusíveis: 5ATempodeatrasoEmconformidadecomasNormasEN60601-1(SegurançaEléctricadeDispositivosMédicos)eEN60601-1-2(CompatibilidadeElectromagnética)
Condições de armazenamentoTemperaturas:–10°C(14°F)a+50°C(122°F)
Condições operacionaisTemperaturas:+10°Ca+40°CHumidaderelativa:30a75%
Capítulo7.EspecificaçõesdoProduto
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