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7

EN – ENGLISH

Disassembling 

Equipment

Inspecting for 

Cleanliness

Completely remove the 

swivel adaptor from any 

components. The swivel 

adaptor itself cannot be 

disassembled any further.

Inspect the teeth of 

the starbursts, the area 

around the locking screw, 

and the base of the swivel 

adaptor for organic debris.

Cleaning – Manual Equipment: Water, Neutral pH 

Detergent, Soft Bristle Brush, Towels

Method

1.  Prepare neutral pH enzymatic detergent solution (e.g. 

Endozime® AW Triple Plus with APA (Ruhof), 1:128 ratio)  

according to detergent manufacturer’s instructions 

using lukewarm tap water. 

2. Prepare equipment for soaking by disassembling 

removable parts and loosening connections.

3.  Rinse equipment in warm water before placing into 

bath.

4. Completely soak equipment in water/detergent 

solution for 30 minutes maximum.

5. Clean thoroughly with a soft nylon bristle brush. 

NOTE

 

– If possible, use a disposable brush.

6. Rinse in warm purified water until all visible substances 

and residual detergent are removed. 

NOTE

 – Make sure 

to give special attention to hard-to-reach areas.

7.  Thoroughly dry equipment with soft clean towels 

and use medically compressed air if needed, to dry 

channels, crevices and lumens.

8. Inspect the equipment to make sure there is no visible 

organic debris or residue from cleaning agent.

Repeat process if any soil is detected.

Drying

•  Products should be dry at this point. If wetness or 

excess liquid is detected, dry with a soft clean towel.

•  Medically compressed air can be used if needed.

Optional Automatic Wash / Disinfect 

CAUTIONS

•  Alkaline and highly acidic detergents and solutions 

cause damage to the devices.

•  Channels and crevices found on these devices require 

particular attention during cleaning.

•  Pay special attention to the water quality used 

throughout reprocessing.  Hard water can damage 

the surface of the equipment. Avoid using hard water.  

Instead use purified water unless otherwise specified.

Limitations on Reprocessing

•  Repeated processing has negative effects on these 

devices and is not recommended for routine use.

•  It is important to have Integra NeuroSpecialists 

perform routine inspections (twice yearly is 

recommended).

See contact information.

INSTRUCTIONS

Cleaning - Automated Equipment: Neutral pH 

Detergent

Method

1.  Prepare equipment for cleaning by disassembling 

removable parts and loosening connections.

2. Rinse equipment in warm water before placing into 

washer.

3.  Load device into the washer and place small parts in 

container or tray inside the washer unit in order to 

avoid losing small components.

NOTE

 – Load devices carefully into washer in order 

to avoid collision. 

4. Follow the instructions listed below and set washer 

machine to these exact parameters:

Phase

Time 

(Min.)

Water 

Temperature

Detergent and 

Concentration

Pre-

wash 1

4:00

Cold water

N/A

Enzyme 

Wash

4:00

Hot water

Neutral pH 

enzymatic (e.g. 

Endozime® AW 

Triple Plus with 

APA, Ratio 1:128)

Wash 1

10:00

60.0

°

(140° F)

Neutral pH 

detergent

(e.g. Renu-

Klenz™ , Steris, 

Ratio 1:256)

Rinse 1

0:30

Hot water

N/A

Thermal 

Rinse**

2:00

82.2°C 

(180° F)

N/A

** Optional phase for disinfection of components – 

minimum water temperature as indicated or per worker 

manufacturer specifications for the thermal rinse cycle. 

NOTE

 – Any deviation from this guideline could result in 

damage to the equipment as well as improper cleaning 

results.

Rinse with purified water. Do not perform if parameters 

cannot be achieved.

5. Remove from washer and dry completely if needed.

6. Inspect equipment to make sure there is no visible 

organic debris or residue from cleaning agent.

Repeat process if any visible soil is detected.

Содержание MAYFIELD A1064

Страница 1: ...ng A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com Integra LifeSciences Services Immeuble S quo a 2 97 all e Alexandre Borodine Parc Technologique de la Porte des Alpes 698...

Страница 2: ...2 This page is intentionally left blank...

Страница 3: ...3 MAYFIELD Ball Socket Swivel Adaptor A1064 Instruction Manual EN English...

Страница 4: ...Product complies with the requirements of MDR 2017 745 Manufacturer Authorized Representative in the European Community Consult Instructions for Use Caution Federal USA law restricts this device to sa...

Страница 5: ...in slippage and serious patient injury such as scalp lacerations skull fracture or even death WARNING Failure to properly position patient and to fully tighten and secure all adjustable portions of th...

Страница 6: ...ould now be in the locked position WARNING The unit should be checked to insure that it has been property locked In the locked position pressure applied in any direction to the patient s head or headr...

Страница 7: ...ttention during cleaning Pay special attention to the water quality used throughout reprocessing Hard water can damage the surface of the equipment Avoid using hard water Instead use purified water un...

Страница 8: ...or damage in return shipment to INTEGRA shall be at CUSTOMER s risk INTEGRA s sole responsibility under this warranty shall be repair or replacement at INTEGRA s sole discretion at INTEGRA s expense s...

Страница 9: ...e United States and or other countries MAYFIELD is a registered trademark of SM USA Inc and is used by Integra under license Endozime is a trademark of Ruhof Corporation Renu Klenz is a trademark of S...

Страница 10: ...10 EN ENGLISH This page is intentionally left blank...

Страница 11: ...11 FR FRAN AIS Adaptateur rotule MAYFIELD A1064 Mode d emploi FR Fran ais...

Страница 12: ...roduit est conforme aux exigences de la RDM 2017 745 Fabricant Repr sentant autoris dans la Communaut europ enne Consulter le mode d emploi Attention Conform ment la loi f d rale am ricaine ce disposi...

Страница 13: ...ni suivies la tige m tallique permettant de maintenir le cr ne pourrait glisser et le patient pourrait subir de graves blessures telles que des lac rations du cuir chevelu une fracture du cr ne voire...

Страница 14: ...position d sir e c Ici encore tourner le manchon du pivot dans le sens horaire en exer ant autant de pression que possible L adaptateur devrait maintenant tre en position bloqu e AVERTISSEMENT L unit...

Страница 15: ...ivent tre secs Si de l humidit ou un exc s de liquide est d tect s cher en utilisant un linge propre et doux De l air comprim m dical peut tre utilis si besoin Lavage d sinfection automatique optionne...

Страница 16: ...rd d Integra INTEGRA LIFESCIENCES CORPORATION INTEGRA garantit uniquement l acqu reur initial que chaque produit neuf MAYFIELD est exempt de vices de fabrication et de d fauts de mat riaux sous r serv...

Страница 17: ...e peut tre cr e par acte ou d claration et cette garantie standard ne peut tre modifi e d aucune fa on sauf en vertu d un document crit sign par un responsable d INTEGRA Il n est pas possible de renon...

Страница 18: ...ou dans d autres pays MAYFIELD est une marque d pos e de SM USA Inc et est utilis e par Integra sous licence Endozime est une marque commerciale de Ruhof Corporation Renu Klenz est une marque commerc...

Страница 19: ...IT ITALIANO 19 Adattatore MAYFIELD con snodo a giunto sferico A1064 Manuale di istruzioni IT Italiano...

Страница 20: ...to conforme ai requisiti della MDR 2017 745 Societ produttrice Rappresentante autorizzato nella Comunit Europea Consultare le istruzioni per l uso Attenzione la Legge Federale degli Stati Uniti limita...

Страница 21: ...one 4 Manopola di rotazione 5 Vite di torsione 6 Manicotto di rotazione a sfere AVVERTENZA La mancata lettura e osservanza delle istruzioni fornite in questo inserto del prodotto potrebbero causare lo...

Страница 22: ...one N 5 nella Figura 1 nel foro filettato della Testiera MAYFIELD o dell appropriato poggiatesta b Girare in senso orario di qualche giro la vite di torsione c Posizionare il poggiatesta e avvitare a...

Страница 23: ...n APA Ruhof rapporto 1 128 in conformit alle istruzioni del produttore usando acqua di rubinetto tiepida 2 Preparare l apparecchiatura per l ammollo smontando i componenti amovibili e allentando le co...

Страница 24: ...7 anni Manutenzione e cura Per garantire il corretto funzionamento e per prolungare la durata e le prestazioni delle apparecchiature Integra LifeSciences consiglia di eseguire le seguenti azioni Azio...

Страница 25: ...asi prodotto INTEGRA che sia stato riparato da soggetti diversi dal rappresentante di assistenza autorizzato INTEGRA o che sia stato alterato in maniera tale a parere di INTEGRA da comprometterne la s...

Страница 26: ...Uniti e o in altri Paesi MAYFIELD un marchio registrato di SM USA Inc ed utilizzato da Integra su licenza Endozime un marchio registrato di Ruhof Corporation Renu Klenz un marchio registrato di Steri...

Страница 27: ...DE DEUTSCH 27 MAYFIELD Sch delklemmenadapter mit Kugelgelenk A1064 Gebrauchsanleitung DE Deutsch...

Страница 28: ...ie Anforderungen der MDR 2017 745 Hersteller Autorisierte Vertretung in der Europ ischen Gemeinschaft Gebrauchsanweisung lesen Vorsicht Gem US amerikanischer Bundesgesetzgebung darf dieses Ger t nur d...

Страница 29: ...5 3 2 1 Abbildung 1 6 1 Sprengring 2 Befestigungsschraube 3 Schwenkbare Basis 4 Befestigungsschraube 5 Drehbare Manschette 6 D belnadel WARNUNG Bei Nichtbeachtung der Anweisungen in dieser Produktbeil...

Страница 30: ...gneten Kopfhalterung einsetzen b Die Befestigungsschraube um einige Umdrehungen anziehen c Die Kopfhalterung positionieren und die Befestigungsschraube durch Drehung im Uhrzeigersinn festziehen VORSIC...

Страница 31: ...3 Die Vorrichtung mit warmem Wasser sp len bevor sie in das Bad gelegt werden 4 Die Vorrichtung maximal 30 Minuten lang komplett in Wasser Reinigungsmittell sung einweichen 5 Gr ndlich mit einer B rs...

Страница 32: ...gew hrleisten und seine Lebensdauer und Funktionst chtigkeit zu verl ngern empfiehlt Integra LifeSciences Folgendes Empfohlene Ma nahme Empfohlene Intervalle R cksendung der Vorrichtung an die Repara...

Страница 33: ...on INTEGRA seine Stabilit t oder Zuverl ssigkeit beeintr chtigt wurde oder das Missbrauch Fahrl ssigkeit oder Unfall ausgesetzt wurde oder das f r andere Zwecke als den in der von INTEGRA zur Verf gun...

Страница 34: ...USA und oder anderen L ndern MAYFIELD ist eine eingetragene Marke von SM USA Inc und wird von Integra unter Lizenz verwendet Endozime ist eine Marke der Ruhof Corporation Renu Klenz ist eine Marke der...

Страница 35: ...ES ESPA OL 35 Adaptador giratorio de r tula esf rica MAYFIELD A1064 Manual de instrucciones ES Espa ol...

Страница 36: ...oducto cumple con los requisitos de MDR 2017 745 Fabricante Representante autorizado en la Comunidad Europea Consulte las instrucciones de uso Precauci n Las leyes federales EE UU restringen la venta...

Страница 37: ...Tornillo de torsion 6 Manguito de rotula giratoria ATENCI N Si no se leen y siguen las instrucciones incluidas en este prospecto podr a producirse un deslizamiento del clavo craneal y ocasionar lesio...

Страница 38: ...correspondiente b Gire el tornillo de reglaje unas cuantas vueltas hacia la derecha c Coloque el cabezal y gire el tornillo hacia la derecha apretando a fondo PRECAUCI N Aseg rese siempre de que las...

Страница 39: ...ntando las piezas desmontables y aflojando las conexiones 3 Enjuague el equipo en agua caliente antes de colocarlo en el ba o 4 Sumerja el equipo completamente en la soluci n de agua detergente durant...

Страница 40: ...del equipo Integra LifeSciences recomienda lo siguiente Acci n recomendada Frecuencia recomendada Devuelva el dispositivo al departamento de reparaciones de Integra LifeSciences para una inspecci n y...

Страница 41: ...ue no sea el representante de servicio t cnico autorizado por INTEGRA o se haya alterado en alguna forma que a juicio de INTEGRA haya afectado a su estabilidad o fiabilidad o se haya sido sujeto a uso...

Страница 42: ...s Unidos o en otros pa ses MAYFIELD es una marca comercial registrada de SM USA Inc e Integra la utiliza bajo licencia Endozime es una marca comercial de Ruhof Corporation Renu Klenz es una marca come...

Страница 43: ...NL NEDERLANDS 43 MAYFIELD lagerzwenkadapter A1064 Gebruikershandleiding NL Nederlands...

Страница 44: ...tentie Het product voldoet aan de eisen van richtlijn MDR 2017 745 Fabrikant Gevolmachtigd vertegenwoordiger in de Europese Unie Raadpleeg v r gebruik de gebruiksaanwijzing Let op Amerikaanse federale...

Страница 45: ...1 Borgringen 2 Koppelschroef 3 Spilvoet 4 Spilhendel 5 Koppelschroef 6 Lagerhuls WAARSCHUWING Indien de instructies in de productbijsluiter niet worden gelezen en opgevolgd kan dit ertoe leiden dat d...

Страница 46: ...lpmiddel beschadigen Figuur 3 4 Draaien van de lagerzwenkadapter a Draai de spilhendel nr 4 in fig 1 linksom om de adapter te ontgrendelen VOORZICHTIG Zorg dat het hoofd van de pati nt en de hoofdsteu...

Страница 47: ...MERKING Besteed speciale aandacht aan moeilijk te bereiken plaatsen 7 Droog de apparatuur grondig af met zachte schone handdoeken en gebruik zo nodig medische perslucht om kanaaltjes spleten en lumina...

Страница 48: ...Integra LifeSciences voor nauwkeurige inspectie en onderhoud Eenmaal per jaar Verzoek aan Integra NeuroSpecialists om een routinematige inspectie van het instrument Tweemaal per jaar Zonder goede ver...

Страница 49: ...vicevertegenwoordiger dat zodanig gewijzigd is dat dit volgens het oordeel van INTEGRA op de stabiliteit of betrouwbaarheid van invloed was of dat aan misbruik onachtzaamheid of een ongeluk onderworpe...

Страница 50: ...Staten en of andere landen MAYFIELD is een geregistreerd handelsmerk van SM USA Inc en wordt gebruikt door Integra onder licentie Endozime is een handelsmerk van Ruhof Corporation Renu Klenz is een h...

Страница 51: ...NL NEDERLANDS 51 Deze pagina is bewust leeg gelaten...

Страница 52: ...orte des Alpes 69800 Saint Priest France Tel 33 0 4 37 47 59 10 Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and or other countries M...

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