Description Integra® McGivney Hemorrhoid Ligator is a device consisting of a straight sheath with a built-in ligator head and pistol grip handle for actualization. The ligature is applied by compressing the handle. The McGivney Hemorrhoid Ligators are made of stainless steel, reusable and are supplied non-sterile. Indications For Use Integra® McGivney Hemorrhoid Ligator is indicated for use to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Contraindications Hemorrhoid ligation is contraindicated, if: • Patient is using anticoagulants • Septic conditions in the anorectal region are present • Any large grade IV hemorrhoids are evident • Cases of hypertrophied anal papilla and/or chronic anal fissure Warning DO NOT flash sterilize the Integra® McGivney Hemorrhoid Ligators. These instruments have not been validated for flash sterilization. Discard instrument aſter suspected Creutzfeldt-Jakob Disease (CJD) exposure; the Integra® McGivney Hemorrhoid Ligators have not been validated to withstand the chemical and thermal exposures recommended to eradicate prions. Damage to the product may occur if inappropriate cleaning/disinfecting agents are used or if exposed to excessive temperatures. Instructions For Use: Ligation procedures are a frequently used treatment option for hemorrhoids due to its simple and effective application which does not require anesthesia. 1. Load the ligator with a latex-free o-ring by using the loading cone. Place the loading cone onto the ligator barrel and roll o-ring down the tip of the loading cone until it is seated evenly around the end of the ligator barrel in the maximum expanded diameter. Remove the loading cone. 2. A proctoscope/anoscope should be inserted into the anal opening to provide site visualization. The largest hemorrhoid should be treated first. 3. Grasp the hemorrhoid with forceps approximately 1 centimeter proximal of the dentate line and pull the hemorrhoid into the drum of the ligator. If the patient indicates there is pain, a more proximal position for the band ligation should be selected. 4. With the hemorrhoid pulled taut through the drum of the ligator and the ligator pressed up against the base of the hemorrhoid, the trigger should be squeezed to apply the ligation o-ring to the base of the hemorrhoid. Integra ® McGivney Hemorrhoid Ligator Rx Only CAUTION: Federal (USA) law restricts this device to sale by or on the order of a surgeon. Instructions for Use/English 5. Remove the ligator from the hemorrhoid and repeat as necessary to treat any additional hemorrhoids present. 6. Remove the proctoscope/anoscope from the anal opening. Provide patient with instructions for follow-up visits and possible complications of band ligation procedures. Pre-Use, Handling, and Inspection of Instruments • Read the Instructions for Use and keep them in a safe place. • Use the product only in accordance with its intended use, see Indications For Use. • Use of an instrument for a task other than that for which it is intended could result in a damaged or broken instrument, or one which provides an unsatisfactory performance. • Instruments should be handled and operated by personnel completely familiar with their use, assembly and disassembly. • Instruments must be rendered safe for handling, inspection and assembly by wearing appropriate personal protection equipment (PPE) as promulgated by OSHA and AORN. • Inappropriate use of instruments will lead to damage that is usually not repairable. • Instruments must be thoroughly inspected upon receipt and prior to use to assure proper functioning. Failure to make a complete inspection to assure proper operation and function of instrument may result in unsatisfactory performance. • Integra® McGivney Hemorrhoid Ligators are supplied non-sterile and must be pre-cleaned, cleaned, visually examined and sterilized prior to use. Please see pre-cleaning, cleaning, visual examination, and sterilization procedures below. • Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components. • Do not use the product if it is damaged or defective. Set aside the product if it is damaged. • Replace any damaged components immediately with original spare parts. • Store products in a dry, clean and safe place. • General Working Conditions: Temperature: +7°C to +30°C Humidity: 40% to 60% relative humidity Pre-Cleaning, Cleaning, and Sterilization Procedures Before using the instruments pre-clean, clean (manual or automated), dry, visually examine, and sterilize following the procedures below. Personnel should follow accepted guidelines as recommended in ANSI/AAMI ST79:2006, A1:2008, A2:2009 -Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Precleaning: Pre-cleaning should occur as soon as possible aſter instrumentation is used. 1. Remove gross debris from surgical instruments with a sponge and sterile water aſter use to prevent drying of blood and body fluids on the instruments. 2. Place instruments in an instrument tray/container and saturate all surfaces for five (5) minutes with a pre-cleaning enzymatic product such as Miltex® Instrument Prep Enzyme Foam. Cleaning: Cleaning should occur as soon as possible aſter instrumentation is pre-cleaned. Aſter performing steps 1-6 below, perform either “Manual Cleaning” or “Automated Cleaning”. 1. Rinse instrument with deionized water for two (2) minutes. 2. Use a clean, soſt bristled brush to clean and remove visible soil from the lumens and other surfaces of the instruments. 3. Vigorously flush lumens with 50ml of deionized water using a syringe or similar apparatus. 4. Prepare enzymatic solution (e.g., Integra EZ-Zyme® All-Purpose Enzyme Cleaner) per manufacturer’s recommendations/instructions for correct dilution and temperature. 5. Immerse fully opened instruments in the prepared enzymatic solution for ten (10) minutes. 6. Rinse instrument and flush lumens with deionized water for two (2) minutes. 7. Proceed either to “Manual Cleaning” or “Automated Cleaning” procedures below: Manual Cleaning 1. Prepare enzymatic solution (e.g., Integra EZ-Zyme All-Purpose Enzyme Cleaner) per manufacturer’s recommendations/instructions for correct dilution and temperature. 2. Using a small, clean hand-held brush, remove soil from all surfaces of instrument while fully immersed in solution. 3. Use a soſt bristled brush to clean the lumens. Note: Never use steel wool, wire brushes, scalpel blades or highly abrasive detergent or cleansers to remove soil as these will damage the instruments’ protective surface and lead to corrosion. 4. Vigorously flush channels with deionized water. Rinse thoroughly and aggressively for two (2) minutes with deionized water. 5. Using an ultrasonic cleaner sonicate instruments for ten (10) minutes. • Prepare enzymatic solution per manufacturer’s recommendations/instructions for correct dilution and temperature and place in the ultrasonic cleaner. • Condition (de-gas) ultrasonic cleaner for 5 minutes. • Place instruments in the ultrasonic cleaner manufacturer’s instrument tray. • Ensure instruments are in the open position. • Keep different metal types separated (i.e., separate stainless steel from non-anodized aluminum, brass, copper and chrome-plating to avoid possible transfer of one metal plating to another). • Place tray with the instruments into the ultrasonic cleaner. • Sonicate instruments for ten (10) minutes. 6. Remove instruments from sonicator and rinse for two (2) minutes with deionized water. 7. Visually inspect instruments for cleanliness and ensure all parts are in proper working order. 8. Force air though inner lumen until excess water can no longer be visually seen evacuating the device before allowing instruments to dry on lint-free cloth for at least twenty (20) minutes at a temperature of not more than 110°C (230°F). 9. Inspect instruments for visual dryness.
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Integra McGivney Hemorrhoid Ligator · Integra® McGivney Hemorrhoid Ligator is a device consisting of a straight sheath with a built-in ligator head and pistol grip handle for actualization.
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Description
Integra® McGivney Hemorrhoid Ligator is a device consisting of a straight sheath with a built-in ligator head and pistol grip handle for actualization. The ligature is applied by compressing the handle. The McGivney Hemorrhoid Ligators are made of stainless steel, reusable and are supplied non-sterile. Indications For Use
Integra® McGivney Hemorrhoid Ligator is indicated for use to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Contraindications
DO NOT flash sterilize the Integra® McGivney Hemorrhoid Ligators. These instruments have not been validated for flash sterilization.
DiscardinstrumentaftersuspectedCreutzfeldt-JakobDisease(CJD)exposure;theIntegra® McGivney Hemorrhoid Ligators have not been validated to withstand the chemicalandthermalexposuresrecommendedtoeradicateprions.
Ligation procedures are a frequently used treatment option for hemorrhoids due to its simple and effective application which does not require anesthesia.
1. Loadtheligatorwithalatex-freeo-ringby usingtheloadingcone.Placetheloading cone onto the ligator barrel and roll o-ring down the tip of the loading cone until it is seated evenly around the end of the ligator barrelinthemaximumexpandeddiameter. Remove the loading cone.
2. Aproctoscope/anoscopeshouldbeinserted into the anal opening to provide site visualization. The largest hemorrhoid shouldbetreatedfirst.
3. Grasp the hemorrhoid with forceps approximately1centimeterproximalof the dentate line and pull the hemorrhoid into the drum of the ligator. If the patient indicatesthereispain,amoreproximalpositionforthebandligationshould be selected.
4. With the hemorrhoid pulled taut through the drum of the ligator and the ligator pressed up against the base of the hemorrhoid, the trigger should be squeezed to apply the ligation o-ring to the base of the hemorrhoid.
Integra® McGivney Hemorrhoid LigatorRxOnlyCAUTION:Federal(USA)lawrestricts this device to sale by or on the order of a surgeon.
Instructions for Use/English
5. Remove the ligator from the hemorrhoid and repeat as necessary to treat any additional hemorrhoids present.
6. Removetheproctoscope/anoscopefromtheanalopening.Providepatient with instructions for follow-up visits and possible complications of band ligation procedures.
• Instrumentsmustbethoroughlyinspecteduponreceiptandpriortousetoassure properfunctioning.Failuretomakeacompleteinspectiontoassureproper operation and function of instrument may result in unsatisfactory performance.
Pre-Cleaning, Cleaning, and Sterilization Procedures Beforeusingtheinstrumentspre-clean,clean(manualorautomated),dry,visuallyexamine,andsterilizefollowingtheproceduresbelow.
PersonnelshouldfollowacceptedguidelinesasrecommendedinANSI/AAMIST79:2006,A1:2008,A2:2009-Comprehensiveguidetosteamsterilizationandsterility assurance in health care facilities.
1. Remove gross debris from surgical instruments with a sponge and sterile water after use to prevent drying of blood and body fluids on the instruments.
7. Proceedeitherto“Manual Cleaning” or “Automated Cleaning” procedures below:
Manual Cleaning
1. Prepareenzymaticsolution(e.g.,IntegraEZ-ZymeAll-PurposeEnzymeCleaner) permanufacturer’srecommendations/instructionsforcorrectdilution and temperature.
2. Usingasmall,cleanhand-heldbrush,removesoilfromallsurfacesofinstrument while fully immersed in solution.
3. Useasoftbristledbrushtocleanthelumens.
Note: Never use steel wool, wire brushes, scalpel blades or highly abrasive detergent or cleansers to remove soil as these will damage the instruments’ protective surface and lead to corrosion.
• Keepdifferentmetaltypesseparated(i.e.,separatestainlesssteelfrom non-anodized aluminum, brass, copper and chrome-plating to avoid possible transferofonemetalplatingtoanother).
8. Forceairthoughinnerlumenuntilexcesswatercannolongerbevisuallyseen evacuating the device before allowing instruments to dry on lint-free cloth for at leasttwenty(20)minutesatatemperatureofnotmorethan110°C(230°F).
• Keepdifferentmetaltypesseparated(i.e.,separatestainlesssteelfrom non-anodized aluminum, brass, copper and chrome-plating to avoid possible transferofonemetalplatingtoanother).
Recommended steam sterilization parameter to achieve SterilityAssuranceLevel(SAL)of10-6:
Note:Makecertainthatallsurfacesoftheproductwillbeexposedtothe sterilizing agent. When sterilizing several products at the same time in one steam sterilizer:Makesurethatthemaximumallowableloadcapacityofthesteam sterilizer,asspecifiedbythemanufacturer,isnotexceeded.
Anykindofcorrosionwillleadtorustonsteel.Rustparticlescanbetransferredfromone instrument to another, therefore, remove corroding instruments from service to prevent formation of rust on other instruments.
DiagnosingSpotsandStains:Itiscommonforinstrumentstobecomestainedorspotted.Adheringtopropertechniqueduringcleaningandsterilizingprocedureswillpreventmoststainingoccurrences.Thefollowingidentifiessomeofthevariousinstrument-related problems hospitals may encounter.
• LightorDarkSpots:Spotsareoftentheresultofthemineralcontentinthewater used for rinsing, use of non-neutral instrument or an unclean sterilizer chamber.
• RustDeposits:Itisveryunlikelyforsurgicalgradesteeltorust.Rustcoloredspots usually appear in localities where water has high iron content.
Returned Goods Policy
Productsmustbereturnedinunopenedpackageswithmanufacturer’ssealsintacttobe accepted for replacement or credit unless returned due to a complaint of product defect.DeterminationofaproductdefectwillbemadebyIntegra.Productswillnotbeaccepted for replacement if they have been in the possession of the customer for more than90days.
Repairs and Maintenance
Shouldyourinstrumentsrequirerepairormaintenance,contactIntegraforreturnauthorization and address. Instruments returned to Integra for repair must have a statement testifying that each instrument has been thoroughly cleaned and sterilized. Failuretosupplyevidenceofcleaninganddisinfectionwillresultinacleaningchargeand delayed processing of your instrument repair.
Warranties and Guarantees
In order to ensure warranties and guarantees, instruments in need of repair should be sent to Integra.
Failuretofollowtheseprocedureswillinvalidateinstrument’swarrantyandcancausean instrument to fail.
ManufacturerIntegraYorkPA,Inc.i589DaviesDrive,York,PA17402 866-854-8300USA i +1717-840-2763outsideUSA i +1717-840-9347faxintegralife.com/integra-miltex
Sterilizer Type Configuration Temperature Exposure Time
Pre-Vacuum Wrapped 134°C(273.2°F) 5 minutes
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Sterilizer Type Configuration Temperature Exposure Time
Pre-Vacuum Wrapped 134°C(273.2°F) 5 minutes
Descripción
ElligadordehemorroidesIntegra®McGivneyesundispositivoqueconsisteenunavaina recta con un cabezal ligador y una empuñadura tipo pistola incorporados paralarealizacióndelprocedimiento.Laligaduraseaplicacomprimiendolamanija.LosligadoresdehemorroidesMcGivneyestánhechosdeaceroinoxidable,sonreutilizables y se suministran sin esterilizar.
Indicaciones de uso
ElligadordehemorroidesIntegra®McGivneyesindicadoparacortarelflujosanguíneoalostejidoshemorroidalesmedianteunaligaduraoanillocolocadoalrededordelabase de la hemorroide.
Contraindicaciones
La ligadura de hemorroides está contraindicada si:
NO realice la esterilización rápida de los ligadores de hemorroides Integra® McGivney. Estosinstrumentosnohansidovalidadoscomoaptosparaesterilizaciónrápida.
DesecheelinstrumentodespuésdeunasospechadeexposiciónalaEnfermedaddeCreutzfeldt-Jakob(CJD);losligadoresdehemorroidesIntegra®McGivneynohansidovalidadoscomoaptosparasoportarlasexposicionesalosquímicosylastemperaturasrecomendados para eliminar los priones.
Los procedimientos de ligadura son una opción de tratamiento usada frecuentemente paralashemorroidesdebidoasuaplicaciónsimpleyeficaz,quenorequiereanestesia.
1. Cargueelligadorconunajuntatóricasinlátexusandoelconodecarga.Coloqueelconode carga en el cilindro del ligador y mueva haciaabajolajuntatóricahaciéndolarodardesde la punta del cono de carga hasta que estéasentadauniformementealrededordelextremodelcilindrodelligadoreneldiámetroexpandidomáximo.Quiteelconodecarga.
2. Sedebecolocarunproctoscopio/anoscopioen la abertura del ano para proporcionar una mejorvisualizacióndelsitio.Lahemorroidemás grande se debe tratar primero.
3. Tome la hemorroide con un fórceps a aproximadamente1centímetrocercadelalíneadentadaytirelahemorroidehaciaeltambordelligador.Sielpacienteindicaquesientedolor,sedebeseleccionarunaposiciónmásproximalparalaligadurade banda elástica.
4. Conlahemorroidetensadaatravésdeltambordelligadoryelligadorpresionadocontralabasedelahemorroide,sedebepresionarelgatilloparaaplicarlajuntatórica de ligadura a la base de la hemorroide.
Ligador de hemorroides Integra® McGivneyPRECAUCIÓN,sóloconrecetamédica:LasLeyesFederalesdeEE.UU.restringenlaventadeestedispositivoporprescripcióndeuncirujano.
6. Quiteelproctoscopio/anoscopiodelaaberturadelano.Proporcioneinstruccionesal paciente para visitas de seguimiento y posibles complicaciones de los procedimientos de ligadura de banda elástica.
Pre-utilización, manipulación e inspección de los instrumentos
• Losinstrumentossedebeninspeccionarcompletamentedespuésdeserrecibidosyantesdesuuso,afindeasegurarsufuncionamientocorrecto.Norealizarunainspección completa para garantizar una función y un funcionamiento correctos del instrumento puede tener como resultado un funcionamiento incorrecto.
Procedimientos de pre-limpieza, limpieza y esterilización Antesdeusarlosinstrumentos,realicesupre-limpieza,limpieza(manualo automática),secado,examenvisualyesterilizaciónsiguiendolosprocedimientosa continuación.
Elpersonaldebeseguirlasdirectricesaceptadas,talycomoserecomiendaenlanormaANSI/AAMIST79:2006,A1:2008,A2:2009-Guíacompletaparalaesterilizaciónconvapor y aseguramiento de la esterilidad en los centros de salud.
Pre-limpieza:
Lapre-limpiezadeberealizarsetanprontocomoseaposibledespuésdelautilizaciónde los instrumentos.
1. Eliminelasuciedadmásimportantedelosinstrumentosquirúrgicosconunacompresayaguaestérildespuésdesuuso,afindeevitarquelasangreylosfluidoscorporales se sequen sobre los instrumentos.
4. Preparelasoluciónenzimática(porejemplo,lasoluciónlimpiadoraenzimáticamultiusoIntegraEZ-Zyme®)segúnlasrecomendaciones/instruccionesdelfabricante para obtener la dilución y la temperatura correctas.
5. Sumerjadurantediez(10)minutoslosinstrumentoscompletamenteabiertos en la solución limpiadora enzimática preparada.
7. Continúeconlosprocedimientosde“Limpieza manual” o “Limpieza automática” a continuación:
Limpieza manual
1. Preparelasoluciónenzimática(porejemplo,lasoluciónlimpiadoraenzimáticamultiusoIntegraEZ-Zyme)segúnlasrecomendaciones/instruccionesdel fabricante para obtener la dilución y la temperatura correctas.
• Preparelasoluciónenzimáticasegúnlasrecomendaciones/instruccionesdelfabricante para obtener la dilución y la temperatura correctas, y colóquela en el limpiador ultrasónico.
2. Coloqueloscanastosdealambreenunalavadora-esterilizadoraautomática o enunalavadora-desinfectadora.Sigalosparámetrosylasrecomendacionesdel detergente proporcionados por el fabricante de la lavadora-desinfectadora.
Protejalosinstrumentos:Elusodeaguadesionizada,lalimpiezapreviacuidadosa,usarsoluciones con pH neutro, seguir las instrucciones del fabricante y la inspección visual ayudarán a mantener la precisión de funcionamiento de los componentes y a evitar que aparezcan manchas en ellos.
Sedebenevitarlassiguientessustanciassiemprequeseaposible;enjuaguedeinmediatoconabundantecantidaddeaguasilosinstrumentosseexponenporaccidente a cualquiera de las siguientes sustancias:
Protejalosbordescortantesafiladosylosextremosdelosinsertosquefuncionanbiendurantetodoslosprocedimientosdemantenimiento.Evitecargarobjetospesadosenla parte superior de los instrumentos delicados y huecos.
Diagnósticodepuntosymanchas:Escomúnquelosinstrumentossemanchen oseensucien.Observarlatécnicaapropiadadurantelosprocedimientosdelimpiezayesterilizaciónevitarálamayorpresenciademanchas.Acontinuaciónsedescribendiversos problemas relacionados con los instrumentos que se pueden encontrar en los hospitales.
• Manchasdecolormarrón:Losdetergentesconpolifosfatospuedendisolverloselementos de cobre dentro del esterilizador, lo que produce manchas marrones. Unamanchaazulomarrónsinbrilloesresultadodelaoxidacióndelasuperficie.
• Manchasclarasuoscuras:Lasmanchasamenudosonelresultadodelcontenidodemineralesenelaguaqueseusóparaelenjuague,delusodeuninstrumentono neutro o de una cámara esterilizadora sucia.
• Depósitosdeóxido:Esmuyimprobablequeelacerodecalidadquirúrgicaseoxide.Generalmente,lasmanchasdecolordelóxidoaparecenenlocalidadesenlasque el agua tiene un alto contenido de hierro.
Política de productos devueltos
Los productos deben devolverse en paquetes sin abrir, con los sellos del fabricante intactosparaseraceptadosparareemplazoocrédito,amenosquesedevuelvandebido a defecto del producto. Integra determinará si el producto es defectuoso. Los productos no se aceptarán para reemplazo si han estado en manos del cliente por másde90días.
Reparaciones y mantenimiento
Sisusinstrumentosnecesitanreparaciónomantenimiento,comuníqueseconIntegrapara obtener autorización de devolución y la dirección. Los instrumentos devueltos a Integra para reparación deben incluir una declaración que atestigüe que cada instrumento ha sido limpiado y esterilizado minuciosamente. No proporcionar prueba de limpieza y desinfección derivará en un cargo de limpieza y demora al procesar la reparación de su instrumento.
Garantías y avales
Afindeasegurarlasgarantíasyavales,losinstrumentosquesedebanreparardebenser enviados a Integra.
1. À l'aide du cône de chargement, charger l'instrument de ligature d'un anneau sans latex.Placerlecônedechargementsur le barillet de l'instrument de ligature et déroulerl'anneausurl'extrémitéducônedechargementjusqu'àcequ'ilsoituniformémentpositionnéautourdel'extrémitédubarilletdel'instrumentdeligatureàsondiamètreleplusétendu.Retirerlecônedechargement.
Procédures de pré-nettoyage, de nettoyage et de stérilisation Avantd'utiliserlesinstruments,lespré-nettoyer,nettoyer(nettoyagemanuelouautomatique),sécher,examinervisuellement,lubrifieretstériliserselonlesprocéduresdécritesci-dessous.
Remarque :Nejamaisutiliserdelained’acier,debrossesmétalliques,delamesdescalpelnidedétergentsounettoyantsextrêmementabrasifspouréliminerlasaletédesinstrumentschirurgicaux,cequiendommageraitgravementlasurfacedesinstruments tout en favorisant la corrosion.
Éviterautantquepossibletouteexpositionauxsubstancessuivantes;rincerimmédiatementàgrandeeausilesinstrumentssontaccidentellementexposésàl'unede ces substances :
Diagnostic des salissures et taches : il n'est pas rare que les instruments se salissent ousetachent.L'applicationdetechniquesadéquatesdenettoyageetdestérilisationéviteralamajoritédecesproblèmes.Lalistesuivanteindiquecertainsdesproblèmesliésauxinstrumentsquirisquentdeseprésenterenenvironnementhospitalier.
• Dépôtsderouille:ilesttrèsrarequel'acierdequalitéchirurgicalerouille. Lestachesdecouleurrouilleapparaissentgénéralementdansleslieuxoùl'eaucontient beaucoup de fer.
Sivosinstrumentsnécessitentuneréparationouuneinterventiondemaintenance,contactez Integra pour obtenir une autorisation et une adresse de renvoi. Les instrumentsrenvoyésàIntegrapourréparationdoiventêtreaccompagnésd'unedéclarationcertifiantquechaqueinstrumentaétésoigneusementnettoyéetstérilisé.Siaucunepreuvedenettoyageetdedésinfectionn'estfournie,desfraisdenettoyageserontfacturésetlaréparationdel'instrumentseraretardée.
DerIntegra®McGivneyHämorrhoiden-LigatoristzurUnterbrechungdesBlutflusseszudemhämorrhoidalenGewebedurcheineLigaturodereinenRingindiziert,die/derum die Hämorrhoidenbasis gelegt wird.
4. Mit dem stramm durch die Trommel des Ligators gezogenen Hämorrhoiden unddemLigatorgegendieBasisdesHämorrhoidengedrücktwirdderAuslöserzusammengedrückt,umdenLigations-O-RinganderBasisdesHämorrhoidenanzubringen.
• DieIntegra®McGivneyHämorrhoiden-Ligatorenwerdennicht-sterilgeliefertundmüssen vor Gebrauch vorgereinigt, gereinigt, sichtgeprüft und sterilisiert werden. NachfolgendfindenSiedieVerfahrenzurVorreinigung,Reinigung,SichtprüfungundSterilisierung.
• ÜberprüfenSiedasProduktvorjedemGebrauchauf:lose,verbogene,zerbrochene,gerissene, abgenutzte oder gebrochene Bestandteile.
Vorreinigungs-, Reinigungs- und Sterilisationsverfahren BevorSiedieInstrumenteverwenden,müssendiesegemäßdennachfolgendenVerfahrenvorgereinigt,gereinigt(manuelloderautomatisch),getrocknet,optischüberprüft und sterilisiert werden.
JeglicheArtvonKorrosionhatdasRostenvonStahlzurFolge.DaRostteilchenvoneinemInstrumentaufdasandereübertragenwerdenkönnen,dürfenkorrodierendeInstrumente nicht mehr verwendet werden, um die Rostbildung an anderen Instrumenten zu verhindern.
SchützenSiescharfeSchneidekantenundfeineArbeitsspitzenvonEinsätzenwährendsämtlicherWartungsverfahren.VermeidenSiedieBeladungvonempfindlichenundhohlen Instrumenten mit schweren Teilen.
SolltenIhreInstrumentereparatur-oderwartungsbedürftigsein,wendenSiesichanIntegra,umeineRücksendegenehmigungund-adressezuerhalten.DenanIntegrazurReparaturzurückgesendetenInstrumentenmusseineBescheinigungdarüberbeiliegen,dassjedesInstrumentsorgfältiggereinigtundsterilisiertwurde.BeiNichterbringungdesNachweises,dasseineReinigungundDesinfektionvorgenommen wurde, wird Ihnen die Reinigung in Rechnung gestellt und die Bearbeitung Ihrer Instrumentenreparatur dauert länger.
Il Dispositivo di legatura delle emorroidi McGivney Integra® consiste in un manicotto dritto con una testa di legatura integrata e un'impugnatura per l'azionamento. La legatura viene applicata premendo l'apposito dispositivo presente sull'impugnatura. I dispositivi di legatura per emorroidi McGivney sono realizzati in acciaio inossidabile, sono riutilizzabili e vengono forniti non sterili.
Indicazioni per l'uso
IldispositivodilegaturadelleemorroidiMcGivneyIntegra®èindicatoperinterrompere il flusso sanguigno verso il tessuto emorroidario per mezzo di una legatura o un di un anello posti intorno alla base delle emorroidi.
NONsterilizzareconcicloFlashidispositividilegaturadelleemorroidiMcGivney Integra®. Gli strumenti in questione non sono stati convalidati per la sterilizzazioneconcicloFlash.
SmaltirelostrumentodoposospettaesposizioneallamalattiadiCreutzfeldt-Jacob(MCJ);i dispositivi di legatura delle emorroidi McGivney Integra® non sono stati convalidati per resistere all'esposizione chimica e termica raccomandata per debellare i prioni.
Potrebberoverificarsidannialprodottonelcasovenganousatiagentidetergenti/disinfettanti inappropriati oppure se il prodotto viene esposto a temperature eccessive.
Istruzioni per l'uso:
Le procedure di legatura vengono usate frequentemente quale opzione di trattamento delle emorroidi a causa della semplice ed efficace applicazione che non richiede anestesia.
1. Caricareildispositivodilegaturaconuno-ring privo di lattice utilizzando il cono di caricamento.Porreilconodicaricamentosulcilindrodeldispositivodilegaturafinoa quando esso non sia posizionato in modo uniforme intorno alla parte terminale del cilindro del dispositivo di legatura nel diametro massimo in posizione estesa. Rimuovere il cono di caricamento.
2. Ènecessarioinserireunproctoscopio/anoscopio nell'apertura anale per offrire una visualizzazione della sede. Devono essere trattateprimaleemorroidipiùgrandi.
3. Afferrareleemorroidimediantepinzeacirca1centimetroprossimalmentedallalinea dentata e tirare le emorroidi nel cilindro del dispositivo di legatura. Seilpazienteindicalapresenzadidolore,ènecessarioselezionareunaposizione piùprossimaleperlalegaturadellabanda.
4. Conleemorroiditeseetiratenelcilindrodeldispositivodilegaturaeconildispositivostessopostoacontattoconlabasedelleemorroidi,ènecessariopremereil dispositivo di attivazione per applicare l'o-ring di legatura alla base delle emorroidi.
Integra® Dispositivo di legatura delle emorroidi McGivneyATTENZIONEsolosuprescrizionemedica:laleggefederaledegliStati Unitilimitalavenditadelpresentedispositivoaisolimedici o su presentazione di prescrizione medica.
Istruzioni per l'uso/Italiano
5. Rimuovere il dispositivo di legatura dalle emorroidi e ripetere la procedura in base alle esigenze, per trattare eventuali altre emorroidi presenti.
6. Rimuovereilproctoscopio/anoscopiodall'aperturaanale.Fornirealpazienteleistruzioni relative alle visite di follow-up e alle possibili complicanze relative alle procedure di legatura.
Informazioni preliminari all'uso e per la manipolazione e ispezione degli strumenti
• Usareilprodottounicamentesecondolasuadestinazioned'uso,facendoriferimento alle Indicazioni per l'uso.
• L'usodiunostrumentoperunoscopodiversodaquellopercuièindicatopotrebbeprovocare il danneggiamento o la rottura dello stesso, oppure fornire prestazioni non soddisfacenti.
• Glistrumentidevonoesseremanipolatieusatidapersonalecompetentenellorouso, montaggio e smontaggio.
• Glistrumentidevonoessereresisicuriperlamanipolazione,l'ispezionee l'assemblaggio indossando apparecchiatura di protezione personale idonea (PPE,personalprotectionequipment)comepromulgatodaOSHAeAORN.
• Pergarantirneilcorrettofunzionamentoglistrumentidevonoessereattentamenteispezionati quando vengono ricevuti e prima dell'utilizzo. La mancata completa ispezionevoltaadassicurareilcorrettofunzionamentodellostrumentopuòesserecausa di prestazioni non soddisfacenti.
• IDispositividilegaturadelleemorroidiMcGivneyIntegra®vengonofornitinon sterili e devono essere pre-puliti, puliti, esaminati visivamente e sterilizzati primadell'uso.Consultareleproceduredipre-pulizia,pulizia,esamevisivoe sterilizzazione qui di seguito.
• Primadiciascunutilizzo,ispezionareilprodottoperverificarechenonpresenticomponenti allentati, piegati, rotti, spaccati, usurati o fratturati.
Procedure di pre-pulizia, pulizia e sterilizzazione
Primadiutilizzareglistrumenti,pre-pulirli,pulirli(mediantepuliziamanualeo automatica),asciugarli,esaminarlivisivamenteesterilizzarliseguendoleprocedureriportate di seguito.
È necessario eseguire la pre-pulizia non appena possibile dopo aver usato lo strumento.
1. Rimuovere i residui evidenti dagli strumenti chirurgici con una spugna chirurgica e acqua sterile dopo l'uso per evitare che il sangue e i fluidi corporei si secchino sugli strumenti.
• Prepararelasoluzionedidetergenteenzimaticoinbasealleraccomandazioni/istruzioni del produttore relative alla diluizione e alla temperatura corrette e porla nel dispositivo di pulizia a ultrasuoni.
• Tenereseparatiglistrumentidimetallidiversi(ovvero,separareglistrumentiinacciaio inossidabile da quelli in alluminio non anodizzato, ottone, cromati per evitare il potenziale trasferimento del rivestimento metallico dell'uno sugli altri strumenti).
6. Rimuovere gli strumenti dal dispositivo di pulizia a ultrasuoni e sciacquare perdue(2)minuticonacquadeionizzata.
7. Ispezionare visivamente che gli strumenti siano puliti ed assicurarsi che tutte le parti siano in buone condizioni di funzionamento.
8. Insufflarearianellumeinternofinoaquandononsiapiùpossibilevedereacquain eccesso uscire dal dispositivo, prima di lasciare lo strumento ad asciugare su unpannoprivodipelucchiperalmenoventi(20)minutiaunatemperaturanonsuperiorea110°C(230°F).
• Tenereseparatiglistrumentidimetallidiversi(ovvero,separareglistrumentiinacciaio inossidabile da quelli in alluminio non anodizzato, ottone, cromati per evitare il potenziale trasferimento del rivestimento metallico dell'uno sugli altri strumenti).
2. Porreicestellidifilometallicoinundispositivodilavaggio-sterilizzazioneo dilavaggio-disinfezione.Seguireleraccomandazionirelativeaparametrie detergente fornite dal produttore del dispositivo di pulizia-disinfezione.
Nell'eseguire il ciclo di ritrattamento, sono raccomandati quali requisiti minimi:
• Utilizzareunagentedipulizia/disinfezioneappropriatoconformementealleistruzioni del produttore.
Conservareglistrumenticorrettamenteconfezionatiesterilizzatiinunambientepulito, asciutto e senza polvere.
Procedure di manutenzione:
Unamanutenzionenoncorretta,inefficaceoinsufficientepuòridurrelavitautiledi uno strumento e rendere nulla la garanzia dello stesso.
Proteggereglistrumenti:l'usodiacquadeionizzata,un'attentapuliziapreliminare,l'uso di soluzioni a pH neutro, l'aderenza alle istruzioni del produttore e l'ispezione visiva contribuiscono a mantenere gli strumenti in perfetto stato di funzionamento e privi di macchie.
Determinati composti sono altamente corrosivi per l'acciaio inossidabile e causano seri danni. Non esporre mai gli strumenti a:
• Acquaregia • Acidosolforico
• Iodio • Acidocloridrico
• Cloruroferrico
Lesostanzecheseguonodevonoessere,sepossibile,evitate;seglistrumentivengonoinavvertitamente esposti a queste sostanze, risciacquare immediatamente con acqua abbondante:
• Clorurodialluminio • Clorurodicalcio
• Clorurodimercurio • Soluzionesalina
• Clorurodibario • Fenolo
• Permanganatodipotassio • Ipocloritodisodio
• Biclorurodimercurio • Calce
• Tiocianatodipotassio • Clorurostannoso
• SoluzionediDakin
Qualunquetipodicorrosioneportaallarugginedell'acciaio.Leparticelledirugginepossonoesseretrasferitedaunostrumentoall'altro;èquindinecessariointerromperel'uso degli strumenti che presentano corrosione, onde evitare la formazione di ruggine su altri strumenti.
Diagnosisupuntiemacchie:ènormalechesuglistrumentiappaianopuntiomacchie.Sesieseguelatecnicadipuliziaesterilizzazionecorrettaèpossibileprevenirelamaggiorpartedellemacchie.Quantosegueindividuaalcunideivariproblemilegatiagli strumenti che possono presentarsi agli ospedali.
• Macchiemarroni:detergentichecontengonopolifosfatipossonodissolvereglielementi del rame nello sterilizzatore causando la formazione di macchie marroni. Solitamenteunamacchiaopacadibluscuroomarroneèilrisultatodiossidazionesullasuperficie.
• Puntichiarioscuri:ipuntisonospessoilrisultatodicontenutomineralenell'acquautilizzata per il risciacquo, l'utilizzo di uno strumento non neutro o di una camera non pulita di sterilizzatore.
• Depositidiruggine:èmoltoimprobabilechel’acciaiodigradochirurgicosi arrugginisca.Ipunticoloratidirugginenormalmenteappaionoinlocalità in cui l'acqua ha un elevato contenuto ferroso.
Direttive per il reso delle merci
I prodotti devono essere restituiti in confezioni chiuse con i sigilli del produttore intatti per essere accettati per la restituzione o il credito a meno che non siano restituiti per unreclamooundifetto.SpettaaIntegrastabilireseilprodottoèdifettoso.Iprodottinonsarannoaccettatiperlasostituzioneseinpossessodelclientedaoltre90giorni.
Riparazione e manutenzione
Seglistrumentirichiedonoriparazioniomanutenzione,contattareIntegraperottenere l’autorizzazione alla restituzione e l’indirizzo. Gli strumenti restituiti a Integra per la riparazione devono essere accompagnati da una dichiarazione a testimonianza checiascunostrumentoèstatopulitoesterilizzatoattentamente.Lamancatafornituradiunaprovadipuliziaedisinfezioneavràcomeconseguenzaunaddebitoper la pulizia e un ritardo nel trattamento della riparazione dello strumento.
Garanzie di buon funzionamento e per difetti di conformità
Perconservarelegaranzieeidirittiderivanti,glistrumentichenecessitanodiriparazione devono essere inviati a Integra.
La mancata osservanza di queste procedure rende nulla la garanzia dello strumento e puòcausarneilguasto.
DeIntegra®McGivneyhemorroïdenligatoriseeninstrumentdatbestaatuiteenrechteschachtmeteeningebouwdeligatorkopeneenpistoolhandgreepomdeze te activeren. De ligatuur wordt aangebracht door de handgreep in te duwen. McGivney hemorroïdenligatorszijngemaaktvanroestvrijstaal,zijnmeermaligte gebruikenenwordennietsterielgeleverd.
WerphetinstrumentwegbijeenvermoedenvanblootstellingaandeziektevanCreutzfeldt-Jakob(CJD);dehemorroïdenligatorsvanIntegra®zijnnietgevalideerdvoor het doorstaan van de chemische en thermische behandeling die wordt aanbevolen voor de vernietiging van prionen.
1. Plaatsmetbehulpvandeopbrengkegeleenlatexvrijeo-ringopdeligator.Zetdeopbrengkegelopdeloopvandeligatoren rol de o-ring langs het uiteinde van de opbrengkegelnaarbenedentotdatderinggelijkmatigentotdemaximalediameteruitgerekt,omhetuiteindevandeloopvandeligatorzit.Neemdeopbrengkegelvandeloop.
2. Ermoeteenproctoscoop/anoscoopindeanaalopening worden aangebracht zodat het gebied zichtbaar is. Behandel de grootste hemoroïdealseerste.
• Integra®McGivneyhemorroïdenligatorswordenniet-sterielgeleverdenmoetenvoorafgaandaanhetgebruikwordenvoorgereinigd,gereinigd,visueelwordengecontroleerd en worden gesteriliseerd. Raadpleeg onderstaande procedures voor voorreiniging, reiniging, visuele controle en sterilisatie.
Procedures voor voorreiniging, reiniging en sterilisatie Voervóórhetgebruikvandeinstrumenten,volgensonderstaandeprocedureseenvoorreiniging,reiniging(handmatigofautomatisch),droging,visueelonderzoekensterilisatie uit.
DegeaccepteerderichtlijnenzoalsaanbevoleninANSI/AAMIST79:2006,A1:2008,A2:2009-Uitvoerigeleidraadvoorstoomsterilisatieenwaarborgenvansteriliteitinmedische instellingen moeten gevolgd worden.
1. Verwijdernahetgebruikgroverestenvanoperatie-instrumentenmeteensponsdoekjeensterielwateromtevoorkomendatbloedenlichaamsvloeistoffenopdrogen op de instrumenten.
4. Prepareereenoplossingvaneenuniverseelenzymatischreinigingsmiddel(bijvoorbeeldIntegraMiltexEZ-Zyme®All-Purposeenzymatischreinigingsmiddel)volgensdeaanbevelingen/instructiesvandefabrikantbetreffendede juisteverdunning en temperatuur.
7. Ga nu naar de procedure “Handmatige reiniging” of “Automatische reiniging” hieronder.
Handmatige reiniging
1. Prepareereenoplossingvaneenuniverseelenzymatischreinigingsmiddel(bijvoorbeeldIntegraMiltexEZ-ZymeAll-Purposeenzymatischreinigingsmiddel)volgensde aanbevelingen/instructiesvandefabrikantbetreffendedejuisteverdunning en temperatuur.
Let op:Gebruiknooitstaalwol,staalborstels,scalpelsnijbladenofsterkschurendedetergentiaofreinigingsmiddelenvoorhetverwijderenvanvuil,wantdaardoorwordthetbeschermendeoppervlakvandeinstrumentenbeschadigdenontstaatcorrosie.
• Prepareereenoplossingvaneenuniverseelenzymatischreinigingsmiddelvolgensdeaanbevelingen/instructiesvandefabrikantbetreffendedejuisteverdunningen temperatuur en doe de oplossing in het ultrasone reinigingstoestel.
Type sterilisatietoestel Configuratie Temperatuur Blootstellingsduur
Pre-vacuüm Verpakt 134 °C(273,2°F) 5 minuten
Let op:Zorgervoordatalleoppervlakkenvanhetproductaanhetsterilisatiemiddelwordenblootgesteld.Wanneermeerdereproductentegelijkwordengesteriliseerdinéénautoclaaf:Zorgervoordatdedoordefabrikantopgegeven,maximalebeladingscapaciteit van de autoclaaf niet wordt overschreden.
Elkesoortcorrosieheeftroestopstaaltotgevolg.Roestdeeltjeskunnenvanhetene op het andere instrument overgebracht worden, corroderende instrumenten moetendanookdirectbuitengebruikgesteldwordenomroestvormingopandereinstrumententevoorkomen.
Alleenproductendieinongeopendeverpakkingmetongebrokenverzegelingteruggestuurdworden,wordenvervangenofgecrediteerd,tenzijzeteruggezondenzijnalsgevolgvaneenklachtofproductdefect.Integrabepaaltofeenproductdefectis.Alsproductenlangerdan90dageninhetbezitvandeklantzijngeweest,wordenze niet vervangen.
Reparatie en onderhoud
Neem contact op met Integra voor een terugzendautorisatie en adres als uw instrumenten gerepareerd of onderhouden moeten worden. De aan Integra teruggezondeninstrumentenmoetenvergezeldgaanvaneenverklaringdatelkinstrumentgrondiggereinigdengesteriliseerdis.Alsugeenbewijsvanreinigingen desinfectiemeestuurt,wordenreinigingskosteninrekeninggebrachtenduurthet langer voordat uw instrument gerepareerd wordt.
Garanties
Omtezorgendatdegarantiegeldigblijft,moeteninstrumententerreparatienaarIntegra gestuurd worden.
Het niet volgen van deze procedures zal de garantie van het instrument doen vervallenenkanleidentotstoringinhetinstrument.