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6

EN – ENGLISH

WARNING: 

Failure to read and follow instructions furnished in 

this product insert may result in skull pin slippage 

and serious patient injury, such as scalp lacerations, skull 

fracture, or even death.

WARNING: 

This device is not intended for use in or near the 

vicinity of a strong magnetic field. (MRI) 

WARNING: 

Failure to properly position patient and to fully tighten 

and secure all adjustable portions of this or any similar 

device may result in skull pin slippage and serious patient 

injury, such as scalp laceration, skull fracture, or even death.

WARNING: 

Do not alter the design of the device in 

part or whole as serious patient injury could result.

Make certain to securely attach the base unit to the operating 

room table. 

Instructions for Use

1.  Mount the MAYFIELD Ultra Base Unit with Transitional 

Member on to operating room table.

2.  Attach MAYFIELD Tri-Star Swivel Adaptor to Transitional 

Member of Base Unit.

a.  Insert small ratchet Torque Screw (Figure 1) on Adaptor 

into threaded hole of Transitional Member (Figure 2).

Transitional member

Figure 2

b.  Turn Torque Screw clockwise to fully tighten.

CAUTION: 

Before fully tightening, always be certain that the 

starburst teeth of the Swivel Adaptor and other 

starburst fittings are the same size and properly mesh. 

Failure to do so may damage fittings. Figure 3 shows a typical 

starburst connection and proper meshing of teeth.

c.  The Swivel Adaptor will no longer swivel as it is now in 

the locked position. 

3.  Mount Headrest on Swivel Adaptor.

a.  Insert large ratchet Torque Knob (Figure 1) into the 

threaded hole on the MAYFIELD Skull Clamp or 

appropriate headrest.  

Figure 3

b.  Turn Torque Knob clockwise a few turns.

c.  Position headrest and tighten Torque Knob fully by 

turning clockwise until tight. Be sure the two sets of 

sunburst teeth mesh properly. 

4.  Rotation of Swivel Adaptor.

a.  Loosen the Torque Screw (Figure 1) and turn 

counterclockwise to UNLOCK the Adaptor.

CAUTION: 

Care should be taken to stabilize the patient’s head 

and headrest while the Swivel Adaptor is being 

unlocked and repositioned.

b.  Rotate the Swivel Adaptor until desired position is 

obtained.

c.  Again, tighten the small ratchet Torque Screw  applying 

as much pressure as possible. The Adaptor should now 

be in the locked position (Figure 4).

WARNING: 

The unit should be checked to ensure that it has 

been properly locked.  In the locked position, 

pressure applied in either direction to the headrest 

WILL NOT result in movement of the Swivel Adaptor.

5.  Rotation and Locking of dual Starburst Bar.

a.  Rotate Bar to desired position. 

b.  Depress Locking Lever (Figure 1).

CAUTION: 

The Dual Starburst Bar should not rotate once 

locked, if any movement occurs, send to an 

authorized Integra Repair Facility for service.

Figure 4

Содержание MAYFIELD A2008

Страница 1: ...g 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 6980...

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

Страница 3: ...3 MAYFIELD Tri Star Swivel Adaptor A2008 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: ...MAYFIELD Skull Clamp fixation devices are not recommended for use on children under five 5 years of age Extreme caution should be exercised in pediatric cases because of the thin skull Inspection Alw...

Страница 6: ...y mesh Failure to do so may damage fittings Figure 3 shows a typical starburst connection and proper meshing of teeth c The Swivel Adaptor will no longer swivel as it is now in the locked position 3 M...

Страница 7: ...ater 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...

Страница 8: ...l procedures for disposal of this device Integra LifeSciences Warranty Statement INTEGRA LIFESCIENCES CORPORATION INTEGRA warrants to the original purchaser only that each new MAYFIELD product is free...

Страница 9: ...POSE OR APPLICATION OR WARRANTY OF QUALITY AS WELL AS ANY EXPRESSED OR IMPLIED WARRANTY TO PATIENTS No warranty or guarantee may be created by any act or statement nor may this Standard Warranty be mo...

Страница 10: ...in the 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...

Страница 11: ...Drive Building A Cincinnati OH 45227 tats Unis T l 513 533 7979 T l copie 513 271 1915 integralife com Integra LifeSciences Services France SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc Tec...

Страница 12: ...ne peut tre vendu que par ou sur ordonnance d un professionnel de sant agr Il est d conseill d utiliser cet appareil pour la r sonance magn tique R f rence catalogue Date de fabrication JJ MM AAAA Nu...

Страница 13: ...tion est n cessaire pour utiliser l adaptateur pivotant MAYFIELD Tri Star V rification Toujours v rifier les instruments avant et apr s leur utilisation Si un l ment semble endommag et ou ne pas fonct...

Страница 14: ...lles d une montre et serrer fond ATTENTION Avant de proc der au serrage complet toujours s assurer que les dents Starburst de l adaptateur pivotant et des autres raccords Starburst sont de la m me tai...

Страница 15: ...ecter le protocole de l tablissement hospitalier concernant le confinement et le transport en toute s curit du mat riel jusqu la zone de d contamination Il est recommand de nettoyer les dispositifs im...

Страница 16: ...use et placer les petites pi ces dans un contenant ou dans un plateau l int rieur de la laveuse de fa on viter de perdre ces petits l ments REMARQUE Charger les dispositifs avec soin dans la laveuse d...

Страница 17: ...dommages sont aux risques du CLIENT En vertu de cette garantie la seule responsabilit d INTEGRA est la r paration ou le remplacement la seule discr tion d INTEGRA et aux frais d INTEGRA conform ment a...

Страница 18: ...Saint Priest FRANCE Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Brevet U S 7 544 007 Integra et le logo Integra sont des marques d pos es d Integra LifeSciences Corporation aux tats Unis et ou da...

Страница 19: ...Charlemar Drive Building A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com Integra LifeSciences Services France SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc Techn...

Страница 20: ...ita di questo dispositivo tramite o su ordine di un medico regolarmente iscritto all albo Questo dispositivo non indicato per l uso in ambiente RM Numero di catalogo Data di fabbicazione AAAA MM GG Nu...

Страница 21: ...Ultra MAYFIELD REF A 2101 o A 2102 insieme al suo elemento di raccordo Ispezione Ispezionare sempre gli strumenti prima e dopo l uso Se un componente appare danneggiato e o non sembra funzionare corr...

Страница 22: ...laafondo ATTENZIONE Prima di stringerli completamente assicurarsi sempre che i denti a stella dell adattatore a perno girevole e gli accessori della parte di transizione siano della stessa misura e in...

Страница 23: ...di routine si consiglia due volte all anno Fare riferimento alle informazioni di contatto pi avanti ISTRUZIONI Contenimento Trasporto Attenersi al protocollo della struttura sanitaria relativo al cont...

Страница 24: ...a pH neutro Metodo 1 Preparare l apparecchiatura per la pulizia smontando i componenti amovibili e allentando le connessioni 2 Risciacquare l apparecchiatura in acqua calda prima di metterla nella lav...

Страница 25: ...e restituito immediatamente imballato correttamente e con spedizione prepagata Perdite o danni durante una spedizione di restituzione a INTEGRA saranno a rischio del CLIENTE La sola responsabilit di I...

Страница 26: ...Saint Priest FRANCE Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Brevetto U S A 7 544 007 Integra e il logo Integra sono marchi registrati di Integra LifeSciences Corporation negli Stati Uniti e o...

Страница 27: ...r Drive Building A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com Integra LifeSciences Services Frankreich SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc Technologi...

Страница 28: ...es Ger t nur durch eine lizenzierte medizinische Fachkraft oder auf deren Anordnung verkauft werden Dieses Produkt ist nicht f r die Verwendung in einem MR Umfeld bestimmt Katalog Nr Herstellungsdatum...

Страница 29: ...t ck erforderlich Inspektion Das Instrument vor und nach dem Gebrauch immer inspizieren Bei der Vermutung dass eine Komponente besch digt ist oder nicht ordnungsgem funktioniert das Produkt nicht verw...

Страница 30: ...st ndig festziehen VORSICHT Vor dem Festziehen immer sicherstellen dass die Strahlenkranzz hne des Drehadapters und andere Strahlenkranz Armaturen die gleiche Gr e haben und ordnungsgem ineinander gre...

Страница 31: ...minimale Auswirkung auf diese Ger te Die Produktlebensdauer wird in der Regel durch verwendungsbedingte n Verschlei und Besch digung bestimmt Es ist wichtig regelm ige Pr fungen durch Integra NeuroSp...

Страница 32: ...en Gebrauch nicht empfohlen Es ist wichtig regelm ige Pr fung durch Integra NeuroSpecialists vornehmen zu lassen zwei pro Jahr werden empfohlen Siehe Kontaktinformationen ANWEISUNGEN Reinigung Automat...

Страница 33: ...s ordnungsgem verpackt und mit im Voraus bezahltem Porto umgehend zur ckgeschickt werden Ein bei der R cksendung an INTEGRA eintretender Verlust oder Schaden ist das Risiko des KUNDEN Im Rahmen dieser...

Страница 34: ...Saint Priest FRANKREICH Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 US Patentnr 7 544 007 Integra und das Integra Logo sind eingetragene Marken der Integra LifeSciences Corporation in den USA und...

Страница 35: ...00 Charlemar Drive Building A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com Integra LifeSciences Services Francia SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc Te...

Страница 36: ...El producto cumple con los requisitos de la directiva 93 42 CEE Fabricante Representante autorizado en la Comunidad Europea Consulte las instrucciones de uso Precauci n Las leyes federales EE UU restr...

Страница 37: ...Adaptador giratorio Tri Star de MAYFIELD Inspecci n Examine siempre los instrumentos antes y despu s de utilizarlos Si un componente parece que est deteriorado o que no funciona correctamente no utili...

Страница 38: ...dientes de la conexi n en estrella del adaptador del pivote giratorio y las otras piezas de acople de conexi n en estrella son del mismo tama o y engranan adecuadamente Si no se comprueba esto podr a...

Страница 39: ...itivos se limpien inmediatamente despu s del uso Preparaci n para la limpieza Es necesario desmontarlo Desmontaje del equipo Inspecci n de limpieza Saque completamente el adaptador giratorio de cualqu...

Страница 40: ...ara evitar choques 4 Siga las instrucciones indicadas abajo y ajuste la lavadora a estos par metros exactos Fase Tiempo min Temperatura del agua Detergente y concentraci n Pre lavado 1 4 00 Agua fr a...

Страница 41: ...RA es un riesgo a cargo del CLIENTE La nica responsabilidad de INTEGRA bajo esta garant a ser la de reparar o reemplazar el producto a la sola discreci n de INTEGRA y a sus expensas sujeto a los t rmi...

Страница 42: ...ANCIA Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Patente EE UU 7 544 007 Integra y el logotipo de Integra son marcas comerciales registradas de Integra LifeSciences Corporation en Estados Unidos...

Страница 43: ...ar Drive Building A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com Integra LifeSciences Services FRANKRIJK SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc Technologi...

Страница 44: ...hebber Attentie Het product voldoet aan de eisen van richtlijn 93 42 EEG Fabrikant Gevolmachtigd vertegenwoordiger in de Europese Unie Raadpleeg v r gebruik de gebruiksaanwijzing Let op Amerikaanse f...

Страница 45: ...ruik van de MAY FIELD Tri Star zwenkadapter Inspectie De instrumenten v r en na gebruik altijd inspecteren Indien een onderdeel beschadigd lijkt te zijn en of niet goed lijkt te werken mag het apparaa...

Страница 46: ...n VOORZICHTIG V r het vastdraaien altijd controleren of de stervormig uitgetande tanden van de warteladapter en andere fittingen van dezelfde maat zijn en goed in elkaar grijpen Nalaten dit te doen ka...

Страница 47: ...Zie de contactgegevens hieronder INSTRUCTIES Insluiting vervoer Volg het protocol van de zorginstelling voor veilig e insluiting en vervoer naar de ontsmettingsomgeving Er wordt geadviseerd hulpmiddel...

Страница 48: ...g door verwijderbare onderdelen te demonteren en aansluitingen los te maken 2 Spoel de apparatuur in warm water alvorens deze in het wastoestel te plaatsen 3 Laad het hulpmiddel in het wastoestel en p...

Страница 49: ...NTEGRAgeretourneerdworden Hetdefecteproductmoet onmiddellijkfrancoenindejuisteverpakkinggeretourneerdworden VerliesofbeschadigingvanderetourzendingaanINTEGRAisvoor risicovandeKLANT Deenigeverantwoorde...

Страница 50: ...e 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Amerikaans octrooi 7 544 007 Integra en het Integra logo zijn geregistreerde handelsmerken van Integra LifeSciences Corporation in de Verenigde Staten en of...

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

Страница 52: ...pes 69800 Saint Priest France Tel 33 0 4 37 47 59 10 U S Patent 7 544 007 Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and or other c...

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