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8

EN – ENGLISH

4. Follow the instructions listed below and set washer 

machine to these exact parameters:

Phase

Time 

(Min.)

Water Tem-

perature

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 Tem-

perature

Detergent and 

Concentration

Wash 1

10:00

60.0°C 

(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.

The life expectancy of the MAYFIELD products is expected 

to be as long as 7 years.

Maintenance and Care

To ensure proper function and to extend the life and 
performance of the equipment, Integra LifeSciences 
recommends the following: 

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.

NOTE

 – Any serious incident that has occurred in relation 

to the device for the user and/or the patient should 

be reported to the manufacturer and the competent 

authority of the member state in which the user and/or 

patient is established.

Device Disposal

NOTE: Follow hospital 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 from manufacturing defects in 

material and workmanship under normal use and service 

for a period of one year (except as otherwise expressly 

provided as to accessory items) from the date of delivery 

by INTEGRA to the first purchaser, but in no event beyond 

the expiration date stated on any product labeling.

•   Surgical instruments are guaranteed to be free 

from defects in material and workmanship when 

maintained and cleaned properly and used normally 

for their intended purpose.

•   Any covered product that is placed by INTEGRA 

under a lease, rental or installment purchase 

agreement and that requires repair service during 

the term of such placement agreement shall be 

repaired in accordance with the terms of such 

agreement.

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

Summary of Contents for MAYFIELD A1015

Page 1: ...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 69800...

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

Page 3: ...3 MAYFIELD Crossbar Adaptor A1015 A1016 Instruction Manual EN English...

Page 4: ...r und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MAYFIELD a...

Page 5: ...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...

Page 6: ...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 Mount MAYFIELD Universal Sid...

Page 7: ...an 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 g...

Page 8: ...ice 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...

Page 9: ...e negligence or accident or which has been used otherwise than in accordance with the instructions furnished by INTEGRA THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EXPRESSED...

Page 10: ...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...

Page 11: ...11 Barre de Croisement MAYFIELD A1015 A1016 Mode d emploi FR Fran ais...

Page 12: ...er und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MAYFIELD...

Page 13: ...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...

Page 14: ...repr sentant Integra au moins deux fois par an pour veiller son fonctionnement correct Mode d Emploi 1 Monter les fixations lat rales universelles sur la table d op ration a Desserrer la manette en T...

Page 15: ...de jusqu ce que toutes les substances visibles et les traces r siduelles de d tergent aient t limin es REMARQUE Veiller porter une attention particuli re aux endroits difficiles d acc s 7 S cher compl...

Page 16: ...ion et un entretien minutieux Une fois par an Demander ce que les sp cialistes en neurosciences d Integra proc dent des inspections de routine du dispositif Deux fois par an Si l entretien et les serv...

Page 17: ...TEGRA r par par quiconque autre qu un repr sentant INTEGRA agr ou ayant subi une quelconque alt ration qui selon INTEGRA affecte sa stabilit et sa fiabilit ou ayant t soumis une utilisation inad quate...

Page 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...

Page 19: ...19 Barra trasversale per unit di base MAYFIELD A1015 A1016 Manuale di istruzioni IT Italiano...

Page 20: ...er und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MAYFIELD...

Page 21: ...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...

Page 22: ...non usare il dispositivo e inviare immediatamente lo strumento a un centro di riparazione Integra autorizzato per essere valutato riparato o sostituito Richiedere al rappresentante Integra di ispezion...

Page 23: ...ente a pH neutro spazzola con setole morbide salviette Metodo 1 Preparare la soluzione detergente enzimatica a pH neutro ad es Endozime AW Triple Plus con APA Ruhof rapporto 1 128 in conformit alle is...

Page 24: ...iugare completamente se necessario 6 Ispezionare l apparecchiatura per verificare che non vi siano detriti organici o residui di agente pulente visibili Ripetere l operazione se vengono rilevate tracc...

Page 25: ...ritenuta valida e INTEGRA non sar responsabile per eventuali perdite verificatesi in relazione all acquisto o all uso di qualsiasi prodotto INTEGRA che sia stato riparato da soggetti diversi dal rapp...

Page 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...

Page 27: ...27 MAYFIELD Stangen Adapter A1015 A1016 Gebrauchsanleitung DE Deutsch...

Page 28: ...e Adapter und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MA...

Page 29: ...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...

Page 30: ...Damit Sie sich der ordnungsgem en Funktion dieses Instruments sicher sein k nnen lassen Sie mindestens zweimal j hrlich eine Inspektion durch Ihren Integra Repr sentanten vornehmen Gebrauchsanweisung...

Page 31: ...ung 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 rste mit weichen...

Page 32: ...fiehlt Integra LifeSciences Folgendes Empfohlene Ma nahme Empfohlene Intervalle R cksendung der Vorrichtung an die Reparaturabteilung von Integra LifeSciences zur eingehenden Inspektion und Wartung Ei...

Page 33: ...uch Fahrl ssigkeit oder Unfall ausgesetzt wurde oder das f r andere Zwecke als den in der von INTEGRA zur Verf gung gestellten Gebrauchsanleitung beschriebenen verwendet wurde DIESE EINGESCHR NKTE GAR...

Page 34: ...A 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 S...

Page 35: ...35 Adaptador de barra cruzada MAYFIELD A1015 A1016 Manual de instrucciones ES Espa ol...

Page 36: ...er und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MAYFIELD...

Page 37: ...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...

Page 38: ...uci n Permita que su representante de Integra revise el dispositivo como m nimo dos veces al a o para contribuir a su correcto funcionamiento Instrucciones de uso 1 Montaje de los accesorios universal...

Page 39: ...detergente durante 30 minutos como m ximo 5 Limpie minuciosamente con un cepillo de cerdas de nylon blando NOTA Si es posible utilice un cepillo desechable 6 Enjuague en agua purificada caliente hast...

Page 40: ...egra LifeSciences para una inspecci n y servicio detallados Una vez al a o Solicitar que los neuroespecialistas de Integra realicen inspecciones de rutina del dispositivo Dos veces al a o Si el equipo...

Page 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...

Page 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...

Page 43: ...43 43 MAYFIELD dwarsstangadapter A1015 A1016 Gebruikershandleiding NL Nederlands...

Page 44: ...ter und Sch delklemme Fran ais Figure 3 Barre de Croisement avec l Unit de Base MAYFIELD l Adaptateur Pivotant et la Pince du Cr ne Espa ol Figura 3 Adaptador de barra cruzada con unidad base MAYFIELD...

Page 45: ...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...

Page 46: ...n of niet correct lijkt te werken verstuur het dan onmiddellijk ter reparatie of vervanging Dat voorkomt verlenging van de operatieduur en onnodige levensbedreigende risico s voor de pati nt Gebruiksa...

Page 47: ...dig met een zachte nylonborstel OPMERKING Gebruik zo mogelijk een wegwerpborstel 6 Spoel in warm gezuiverd water tot alle zichtbare stoffen en reinigingsmiddelresten zijn verwijderd OPMERKING Besteed...

Page 48: ...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 verzorging...

Page 49: ...dat dit volgens het oordeel van INTEGRA op de stabiliteit of betrouwbaarheid van invloed was of dat aan misbruik onachtzaamheid of een ongeluk onderworpen is geweest of op andere wijze dan in overeens...

Page 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...

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

Page 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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