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Page 5

ENGLISH

Description

The MAYFIELD

®

 Triad Skull Clamp (REF A-1108) is designed 

to give rigid skeletal fixation, allow the surgeon more 

freedom in positioning the fixation pins and show 

indication of pin force. Avoidance of critical areas of the 

skull is made possible by a swiveling rocker arm, which 

rotates 360 degrees, making application much easier. 

The swivel rocker arm can rotate 360 degrees under full 

skeletal pressure after pin impingement, making final 

patient positioning safer and easier.

The MAYFIELD Skull Clamp requires the use of three (3) 

each MAYFIELD Skull Pins.

MAYFIELD Skull Pins

MAYFIELD Reusable Adult Skull Pin - (REF A-1047)

MAYFIELD Reusable Child Skull Pin  - (REF A-1048)

MAYFIELD Disposable Adult Skull Pins - 

(REF A-1072 - Plastic)

MAYFIELD Disposable Adult Skull Pins - 

(REF A-1083 - Steel)

MAYFIELD Disposable Child Skull Pins - 

(REF A-1084 - Steel)

The MAYFIELD Ultra Base Unit (REF A-2101) and MAYFIELD 

Ball Socket Swivel Adaptor (REF A-1064), MAYFIELD Swivel 

Adaptor (REF A-1018), or MAYFIELD Tri-Star Adapter (REF 

A-2008) are required when using the MAYFIELD Skull 

Clamp. In addition, the MAYFIELD Crossbar Adaptor (REF 

A-1015) is required for use of the skull clamp for the sitting 

position. 

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:  

Non-Mayfield branded products used with 

MAYFIELD products - We caution that we 

have only validated MAYFIELD products used 

in conjunction with the MAYFIELD product line, and as 

a result, cannot advise you whether suppliers’ products 

would work properly with the MAYFIELD line of products.

WARNING:  

This device is not intended for use in or near 

the vicinity of a strong magnetic field. (MRI) 

WARNING: 

Do not alter the design of the device in part or 

whole as serious patient injury could result.

Inspection

Always inspect instruments before and after use. If a 

component appears damaged and/or does not seem to 

function properly, do not use the device and immediately 

send the instrument to an authorized Integra repair center 

for evaluation, repair or replacement. Allow your Integra 

Representative to inspect this device a minimum of two 

times per year to assist you in its proper function. 

Instructions for Use

1. Mounting of MAYFIELD Skull Pins

NOTE: 

Use only MAYFIELD brand skull pins with this skull clamp.

Seat pins so there is no gap

between the shoulder of the

pin and the face of the socket

Figure 7

CAUTION: 

Carefully inspect reusable skull pins before 

each use.  To maintain proper fixation, pins 

should be of equal length. Damaged (dull, bent, etc.) pins 

should be replaced. It is recommended that spare pins 

always be kept available.

WARNING: 

Never attempt to resharpen skull pins. Dull or 

bent pins should be replaced.

NOTE: 

When using MAYFIELD Skull Pins follow Instructions For 

Use supplied with the product.

WARNING: 

Skull pins are not recommended for use 

on children under five (5) years of age and 

extreme caution should be exercised in pediatric cases 

because of the thin skull.  MAYFIELD Child Skull Pins are 

recommended for young children over the age of five (5) 

years. It is at the discretion of the user, when the adult or 

child skull pins should be used.

2. Fixation to Patient 

WARNING: 

Failure to properly position patient and to fully 

tighten and secure all adjustable portions of 

this or any similar device may restult in skull pin slippage 

and serious patient injury, such as scalp laceration, skull 

fracture or even death.

Содержание MAYFIELD A1108

Страница 1: ...arlemar Drive Building A Cincinnati OH 45227 USA Tel 513 533 7979 Fax 513 271 1915 integralife com EC REP Integra LifeSciences Services France SAS Immeuble S quoia 2 97 all e Alexandre Borodine Parc T...

Страница 2: ...acolo dei chiodi Netherlands Figuur 1 1 Plunjer 2 Verlengconstructie 3 80 psi koppelschroef 4 Zwenkarm draait 360 5 Borgknop 6 Schedelklemvoet 7 Penhouder Figure 1 Fran ais Figure 1 1 Plongeur 2 Ensem...

Страница 3: ...companying documents Product complies with the requirements of directive 93 42 EEC Manufacturer Authorized Representative in the European Community Consult Instructions for Use Caution Federal USA Law...

Страница 4: ...art the ovals representing the patient s head have centerlines drawn on them The diagrams show selected samples of proper and improper applications of the skull clamp The direction of the single pin s...

Страница 5: ...YFIELD line of products WARNING This device is not intended for use in or near the vicinity of a strong magnetic field MRI WARNING Do not alter the design of the device in part or whole as serious pat...

Страница 6: ...re 3 NOTE The double pins on the rocker arm give the surgeon a visual indication of clamping force see Figure 5 f Clamping force is increased by turning the torque screw clockwise See Service Note 3 T...

Страница 7: ...ge the surface of the equipment Avoid using hard water Instead use purified water unless otherwise specified Limitations on reprocessing Repeated processing has minimal effects on these devices Produc...

Страница 8: ...ash 4 00 Hot water Neutral pH enzymatic e g Endozime AW Triple Plus with APA Ratio 1 128 Phase Time Min Water Temperature Detergent and Concentration Wash 1 10 00 60 0 C 140 F Neutral pH detergent e g...

Страница 9: ...er than an authorized INTEGRA LIFESCIENCES service representative or altered in any way so as in INTEGRA LIFESCIENCES judgment to affect its stability or reliability or which has been subject to misus...

Страница 10: ...Saint Priest FRANCE Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 U S Patents 6 629 982 7 229 451 Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the U...

Страница 11: ...rive 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 Techn...

Страница 12: ...mentation jointe Ce produit est conforme aux exigences de la directive 93 42 CEE Fabricant Repr sentant autoris dans la Communaut europ enne Consulter le mode d emploi Attention la loi f d rale am ric...

Страница 13: ...marque que les ovales qui repr sentent la t te du patient sont divis s par un axe central Les sch mas montrent des exemples d application correcte et incorrecte du clamp cr nien Le pointeau unique doi...

Страница 14: ...chevelu une fracture du cr ne voire la mort AVERTISSEMENT Produits qui ne sont pas de la marque Mayfield utilis s en compl ment des produits MAYFIELD nous vous informons que seuls les produits MAYFIE...

Страница 15: ...s deux moiti s du clamp cr nien en les faisant glisser pour obtenir la bonne largeur c Mettre le clamp dans la position d sir e normalement perpendiculairement au sol pour les d cubitus dorsal ou vent...

Страница 16: ...as du rochet et maintenir le corps le m canisme de d blocage tant dirig vers le sol b Exercer une pression vers le haut pour contr ler le jeu ventuel Si le m canisme de d blocage se d place de 1 6 mm...

Страница 17: ...rganiques visibles ou de r sidus de l agent de nettoyage R p ter le processus en cas de souillure visible S chage ce stade les produits doivent tre secs Si de l humidit ou un exc s de liquide est d te...

Страница 18: ...er le bon fonctionnement et prolonger la dur e de vie et les performances des quipements Integra LifeSciences recommande les actions suivantes Action recommand e Fr quence recommand e Retourner le dis...

Страница 19: ...odifi de telle fa on que l avis d INTEGRA LIFESCIENCES sa stabilit ou sa fiabilit en est affect e ou a souffert d un usage abusif de n gligence ou d un accident ou a t utilis de mani re non conforme a...

Страница 20: ...iest FRANCE Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Brevets U S 6 629 982 7 229 451 Integra et le logo Integra sont des marques d pos es d Integra LifeSciences Corporation aux tats Unis et ou...

Страница 21: ...rlemar 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 Technolog...

Страница 22: ...cumentazione allegata Il prodotto conforme ai requisiti della Direttiva 93 42 CEE Societ produttrice Rappresentante autorizzato nella Comunit Europea Consultare le istruzioni per l uso Attenzione la L...

Страница 23: ...ppresentano il cranio del paziente hanno contrassegnate le linee centrali I diagrammi mostrano esempi selezionati di applicazioni della morsa ferma cranio corrette ed errate La direzione del chiodo in...

Страница 24: ...nsieme alla linea dei prodotti MAYFIELD pertanto non siamo in grado di dare informazioni sulla possibilit che la linea di prodotti MAYFIELD funzioni correttamente con i prodotti di altri fornitori AVV...

Страница 25: ...uta vedere Figura 6 d Il bilanciere viene bloccato in posizione ruotando in senso orario di 60 gradi il pomello di serraggio fino a quando la freccia del pomello allineata con quella del braccio di al...

Страница 26: ...corpo con il meccanismo di rilascio rivolto verso il pavimento b Applicare pressione verso l alto per controllare il movimento Se il meccanismo di rilascio si muove di 1 6 mm o pi l unit deve essere...

Страница 27: ...zione se vengono rilevate tracce di detriti Asciugatura I prodotti devono essere asciutti a questo punto Se si notano umidit o liquidi in eccesso asciugare con una salvietta morbida e pulita Se necess...

Страница 28: ...amento e per prolungare la durata e le prestazioni delle apparecchiature Integra LifeSciences consiglia le seguenti azioni Azione consigliata Frequenza consigliata Restituire il dispositivo al reparto...

Страница 29: ...utorizzati INTEGRA LIFESCIENCES o che sia stato alterato in qualsiasi modo tale da avere un impatto secondo il giudizio della INTEGRA LIFESCIENCES sulla sua stabilit o affidabilit o che sia stato sogg...

Страница 30: ...riest FRANCE Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Brevetti U S A 6 629 982 7 229 451 Integra e il logo Integra sono marchi registrati di Integra LifeSciences Corporation negli Stati Uniti e...

Страница 31: ...mar 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 Technolo...

Страница 32: ...t erf llt die Anforderungen der Richtlinie 93 42 EWG Hersteller Autorisierte Vertretung in der Europ ischen Gemeinschaft Gebrauchsanweisung lesen Vorsicht Gem US amerikanischer Bundesgesetzgebung darf...

Страница 33: ...n die Ovale den Kopf des Patienten mit den eingezeichneten Mittellinien dar Die Zeichnungen zeigen verschiedene Beispiele von richtigen und falschen Anwendungen der Sch delklemme Die Ausrichtung des E...

Страница 34: ...Sch delfraktur oder sogar Tod WARNUNG Gebrauch von Produkten anderer Marken als Mayfield zusammen mit MAYFIELD Produkten Wir m chten darauf hinweisen dass wir die MAYFIELD Produkte nur f r den Gebrauc...

Страница 35: ...rhergestellter oder abnorm d nner Knochen vermeiden b Den Kolben ausziehen und die beiden H lften der Sch delklemme jeweils einzeln bis zur richtigen Breite auseinanderziehen c Die Klemme in die gew n...

Страница 36: ...e sicher dass die Grundeinheit fest am OP Tisch angebracht ist Anmerkungen zum Service 1 Eine routinem ige Untersuchung vor jeder Anwendung sollte Probleme vermeiden helfen Folgende Punkte sollten dab...

Страница 37: ...chwer zu erreichende Stellen achten 7 Die Vorrichtung mit weichen sauberen Handt chern gr ndlich abtrocknen Rillen Spalte und Lumen ggf mit medizinisch reiner Druckluft trocknen 8 Die Vorrichtung insp...

Страница 38: ...ichtbaren organischen Verschmutzungen oder Reinigungsmittelr ckst nde vorhanden sind Den Vorgang wiederholen wenn sichtbare Verschmutzungen festgestellt werden Wartung und Pflege Zur Sicherstellung de...

Страница 39: ...n oder das falschem Gebrauch Vernachl ssigung oder einem Unfall ausgesetzt war oder das auf andere Weise verwendet wurde als gem den Gebrauchs anweisungen die von INTEGRA LIFESCIENCES zur Verf gung ge...

Страница 40: ...iest FRANKREICH Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 US Patentnr 6 629 982 7 229 451 Integra und das Integra Logo sind eingetragene Marken der Integra LifeSciences Corporation in den USA un...

Страница 41: ...harlemar 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 Techno...

Страница 42: ...umentos adjuntos 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 fede...

Страница 43: ...tan la cabeza del paciente y tienen l neas dibujadas en su centro Los diagramas muestran ejemplos seleccionados de aplicaciones correctas e inco rrectas del fijador craneal Para obtener el grado m s a...

Страница 44: ...ncluso la muerte ATENCI N Uso de productos de marcas distintas a Mayfield con productos MAYFIELD Advertimos que solo hemos validado los productos MAYFIELD para su uso en conjunto con la gama de produc...

Страница 45: ...finos b Tire del mecanismo de liberaci n y separe las dos mitades del clamp craneal a la anchura adecuada c Coloque el clamp en la posici n deseada normalmente perpendicular al suelo para posiciones d...

Страница 46: ...otas de Servicio 1 Una buena comprobaci n de rutina antes de cada uso ayudar a evitar problemas El chequeo deber a incluir lo siguiente Verifique el tirador de cierre del brazo con muescas para preven...

Страница 47: ...ces 8 Inspeccione el equipo para asegurarse de que no hay residuos org nicos o residuos del producto de limpieza visibles Repita el proceso si se detecta cualquier suciedad Secado Los productos deben...

Страница 48: ...zar un funcionamiento adecuado y ampliar la vida til y el rendimiento del equipo Integra LifeSciences recomienda lo siguiente Acci n recomendada Frecuencia recomendada Devolver el dispositivo al depar...

Страница 49: ...ESCIENCES ni que haya sido alterado de cualquier forma que al criterio de INTEGRA LIFESCIENCES afecte su estabilidad o confiabilidad ni que se haya sometido a uso indebido negligencia o accidente ni q...

Страница 50: ...ne 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Patentes EE UU 6 629 982 7 229 451 Integra y el logotipo de Integra son marcas comerciales registradas de Integra LifeSciences Corporation en Estados Unido...

Страница 51: ...emar 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 Technolo...

Страница 52: ...eleverde documentatie 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 Volgens...

Страница 53: ...voor het hoofd van de pati nt waarop centerlijnen zijn getekend De tekeningen tonen enige voorbeelden van juist en foutief aanbrengen van de schedelklem De lijn in het verlengde van de enkele pen die...

Страница 54: ...uur of zelfs de dood WAARSCHUWING Producten van een ander merk gebruikt met producten van het merk MAYFIELD Wij hebben enkel producten van het merk MAYFIELD gevalideerd voor het gebruik met andere pro...

Страница 55: ...en van de schedelklem van elkaar totdat de gewenste tussenafstand is verkregen c Zet de klem op de gewenste positie doorgaans haaks ten opzichte van de vloer bij pati nten in supiene of geproneerde po...

Страница 56: ...a Verwijder de ratelarm en houd het hoofdgedeelte met het vrijgavemechaniek omlaag gericht b Oefen opwaartse druk uit en let op eventuele speling Als het vrijgavemechaniek een speling van meer dan 1...

Страница 57: ...n nu droog te zijn Als u vocht of overmatige vloeistof vaststelt droogt u de producten af met een zachte schone handdoek Zo nodig kan er medische perslucht worden gebruikt Optioneel geautomatiseerd wa...

Страница 58: ...rhoud en zorg Om een juiste werking te garanderen en de levensduur en prestaties van de instrumenten te verlengen beveelt Integra LifeSciences het volgende aan Aanbevolen actie Aanbevolen frequentie H...

Страница 59: ...gd dat zulks volgens de mening van INTEGRA LIFESCIENCES van invloed is op de stabiliteit of betrouwbaarheid of dat onderhevig is geweest aan onjuist gebruik nalatigheid of ongelukken of dat op andere...

Страница 60: ...Phone 33 0 4 37 47 59 00 Fax 33 0 4 37 47 59 99 Amerikaans octrooien 6 629 982 7 229 451 Integra en het Integra logo zijn geregistreerde handelsmerken van Integra LifeSciences Corporation in de Veren...

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