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Page 8

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 loosing 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)

Phase

Time 

(Min.)

Water 

Temperature

Detergent and 

Concentration

Wash 1

10:00

60.0ºC  

(140º F)

Neutral pH 

detergent

(e.g. Renu-

Klenz™ , Steris, 

Ratio 1:256)

Rinse 1

0:30

Hot water

N/A

Thermal 

Rinse**

2:00

82.2ºC  

(180º 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.

Maintenance and Care

To ensure proper function and to extend the life and 

performance of the equipment, Integra LifeSciences 

recommends the following:

Recommended Action

Recommended 

Frequency

Return the device to the Integra 

LifeSciences Repairs department 

for detailed inspection and 

servicing.  

Once / year

Request that Integra 

NeuroSpecialists perform routine 

inspections of the device

Twice / year

In the absence of proper care and servicing of the device, 

negative effects may be seen after repeated processing 

over time which may lead to reduced performance. 

Contact information:  See the Service and Repair section 

for contact information on how to return your device for 

periodic servicing and to request periodic inspections.

See Inspection and/or Service Notes section for routine 

checks to be performed on the device.

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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