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EN – English

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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

60.0ºC 

(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 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:

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.

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.

Summary of Contents for MAYFIELD A2101

Page 1: ...es Corporation 4900 Charlemar Drive Building 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 Pa...

Page 2: ...THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 3: ...Table of Contents EN English 2 FR Fran ais 9 IT Italiano 17 DE Deutsch 25 ES Espa ol 33 NL Nederlands 41 SV Svenska 49...

Page 4: ...eceptacle 3 Shock Cushion Figure 3 1 Pressure 1 Transitional member 2 Lock lever 3 Retaining ball 4 Pull from this side 5 Push from this side Figure 2 Figure 1 Figure 4 Figure 5 6 7 1 1 1 1 2 2 2 3 3...

Page 5: ...accompanying documents Product complies with the requirements of MDR 2017 745 Manufacturer Authorized Representative in the European Community Consult Instructions for Use Caution Federal USA Law rest...

Page 6: ...red in the locked position without a transitional member in its receptacle Fig 2 Failure to do so may result in damage to the equipment NOTE It is important to periodically adjust the tension of the L...

Page 7: ...ts and solutions cause damage to the devices Channels and crevices found on this device require particular attention during cleaning Pay special attention to the water quality used throughout reproces...

Page 8: ...ash 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 wat...

Page 9: ...h has been used otherwise than in accordance with the instructions furnished by INTEGRA LIFESCIENCES THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED AND ALL O...

Page 10: ...FR Fran ais 8 CETTE PAGE EST LAISS E INTENTIONNELLEMENT VIDE...

Page 11: ...FR Fran ais 9 Unit de base Ultra MAYFIELD A2101 et A2102 Mode d emploi...

Page 12: ...Logement 3 Amortisseur Figure 3 1 Pression 1 Bras de transition 2 Levier de blocage 3 Bille de retenue 4 Tirer de ce c t 5 Pousser de ce c t Figure 2 Figure 1 Figure 4 Figure 5 6 7 1 1 1 1 2 2 2 3 3...

Page 13: ...umentation jointe Ce produit est conforme aux exigences de la RDM 2017 745 Fabricant Mandataire tabli dans la Communaut europ enne Consulter le mode d emploi Attention Selon la loi f d raleam ricaine...

Page 14: ...tif sous risque de provoquer des l sions graves chez le patient AVERTISSEMENT Ce dispositif n est pas pr vu pour tre utilis dans ou proximit d une champ magn tique intense IRM ATTENTION L unit de base...

Page 15: ...base jusqu ce qu il s enclenche en place compl tement ATTENTION Le bras de transition peut glisser hors de la poign e de la base s il n est pas compl tement engag ATTENTION Ne pas utiliser l ancien ty...

Page 16: ...tion routini re par le personnel neurosp cialiste Integra est essentielle la fr quence recommand e est de deux fois par an Voir les coordonn es INSTRUCTIONS Nettoyage automatique Fournitures D tergent...

Page 17: ...sente garantie ne s applique pas et INTEGRA LIFESCIENCES ne peut tre tenue responsable de toute perte r sultant de l achat ou de l utilisation d un quelconque produit INTEGRA LIFESCIENCES ayant fait l...

Page 18: ...IT Italiano 16 QUESTA PAGINA STATA LASCIATA INTENZIONALMENTE IN BIANCO...

Page 19: ...IT Italiano 17 MAYFIELD Unit Ultra Base A2101 A2102 Manuale di istruzioni...

Page 20: ...iamento Figura 3 1 Pressione 1 Membro di transizione 2 Leva di bloccaggio 3 Sfera di fermo 4 Tirare questo lato 5 Spingere questo lato Figura 2 Figura 1 Figura 4 Figura 5 6 7 1 1 1 1 2 2 2 3 3 3 4 4 4...

Page 21: ...corredo Il prodotto conforme ai requisiti della MDR 2017 745 Produttore Rappresentante autorizzato nella Comunit europea Consultare le istruzioni per l uso Attenzione la legge federale USA limita la...

Page 22: ...interamente per evitare di mettere a grave rischio l incolumit del paziente AVVERTENZA Questo dispositivo non previsto per l uso in o vicino a un campo magnetico RMN ATTENZIONE L Unit Ultra Base MAYF...

Page 23: ...di transizione di modello vecchio possono non bloccarsi in posizione sicuramente 4 Riposizionare l Unit Ultra Base MAYFIELD come desiderato e premere la leva di bloccaggio per fissare il sistema Puliz...

Page 24: ...ositivi nella lavatrice in modo di evitare che si urtino 4 Seguire le istruzioni qui di seguito e impostare la lavatrice su questi esatti parametri Fase Tempo Min Temperatura acqua Detergente e Concen...

Page 25: ...zio autorizzato INTEGRA LIFESCIENCES o alterato in qualsiasi modo che a giudizio di INTEGRA LIFESCIENCES comprometta la sua stabilit o affidabilit o sottoposto a maltrattamento negligenza o incidenti...

Page 26: ...DE Deutsch 24 DIESE SEITE WURDE ABSICHTLICH FREI GELASSEN...

Page 27: ...DE Deutsch 25 MAYFIELD Ultra Basiseinheit A2101 und A2102 Bedienungsanleitung...

Page 28: ...l bergang 2 Anschlussbuchse 3 Polster Abb 3 1 Druck 1 bergangsarm 2 Verriegelungshebel 3 Sperrkugel 4 Von dieser Seite ziehen 5 Von dieser Seite dr cken Abb 2 Abb 1 Abb 4 Abb 5 6 7 1 1 1 1 2 2 2 3 3 3...

Page 29: ...odukt erf llt die Anforderungen der MDR 2017 745 Hersteller Bevollm chtigter in der Europ ischen Gemeinschaft Gebrauchsanweisung beachten Vorsicht Nach US amerikanischem Recht darf dieses Produkt nur...

Page 30: ...Das Design des Ger ts darf weder teilweise noch im Ganzen ver ndert werden da dies andernfalls zu schweren Verletzungen des Patienten f hren kann WARNHINWEIS Das Ger t ist nicht zur Benutzung in oder...

Page 31: ...und abgenommen werden wenn er w hrend dieses Schritts nach oben oder unten gedreht wird 3 Den gew nschten bergangsarm in eine der beiden Seiten des Basisgriffs einschieben bis er h rbar einrastet VORS...

Page 32: ...ders angegeben Einschr nkungen bei der Aufbereitung Wiederholte Aufbereitung wirkt sich auf diese Ger te negativ aus und wird nicht f r den routinem igen Gebrauch empfohlen Es ist wichtig dass Integra...

Page 33: ...INSCHLIESSENDEN SCHADENERSATZ IM ZUSAMMENHANG MIT DEM ERWERB ODER GEBRAUCH EINES INTEGRA LIFESCIENCES PRODUKTS Ferner ist diese Garantie nicht anwendbar auf Verluste im Zusammenhang mit dem Kauf oder...

Page 34: ...ES Espa ol 32 P GINA DEJADA INTENCIONALMENTE EN BLANCO...

Page 35: ...ES Espa ol 33 Unidad Ultrabase MAYFIELD A2101 y A2102 Manual de instrucciones...

Page 36: ...3 1 Presi n 1 Accesorio transicional 2 Palanca de fijaci n 3 Bola de retenci n 4 Tirar a partir de este lado 5 Empujar a partir de este lado Figura 2 Figura 1 Figura 4 Figura 5 6 7 1 1 1 1 2 2 2 3 3...

Page 37: ...producto cumple con los requisitos de MDR 2017 745 Fabricante Representante autorizado en la Comunidad Europea Consultar las Instrucciones de uso Precauci n La ley federal EE UU permite que la venta d...

Page 38: ...en o cerca de los alrededores de un campo magn tico intenso RMN PRECAUCI N La Unidad ultrabase MAYFIELD nunca debe guardarse en la posici n de fijaci n sin un Accesorio transicional en su recept culo...

Page 39: ...ango de la base hasta que encaje completamente haciendo clic PRECAUCI N El Accesorio transicional puede zafarse del Mango de la base si no ha encajado completamente PRECAUCI N No utilizar el estilo an...

Page 40: ...o INSTRUCCIONES Limpieza Equipos autom ticos Detergente con pH neutro M todo 1 Preparar el equipo para limpieza desarmando las piezas desmontables y aflojando las conexiones 2 Enjuagar el equipo en ag...

Page 41: ...INTEGRA LIFESCIENCES que haya sido reparado por cualquier persona o entidad que no sea un representante de servicio autorizado de INTEGRA LIFESCIENCES o alterado de cualquier manera de modo que a jui...

Page 42: ...NL Nederlands 40 DEZE PAGINA IS BEWUST LEEG GELATEN...

Page 43: ...NL Nederlands 41 MAYFIELD Ultra basisunit A2101 A2102 Instructiehandleiding...

Page 44: ...er Afbeelding 3 1 Druk 1 Overgangsarm 2 Borggreep 3 Bevestigingskogel 4 Vanaf deze kant trekken 5 Vanaf deze kant duwen Afbeelding 2 Afbeelding 1 Afbeelding 4 Afbeelding 5 6 7 1 1 1 1 2 2 2 3 3 3 4 4...

Page 45: ...egde documentatie Het product voldoet aan de eisen van richtlijn MDR 2017 745 Fabrikant Gevolmachtigd vertegenwoordiger in de Europese Gemeenschap Raadpleeg de gebruiksaanwijzing Let op Volgens de Ame...

Page 46: ...erp van dit instrument mag niet gedeeltelijk of geheel worden aangepast omdat dit zou kunnen resulteren in ernstig letsel van de pati nt WAARSCHUWING Dit instrument is niet bestemd voor gebruik in of...

Page 47: ...p zijn plaats te vergrendelen Reiniging en sterilisatie Maak de basisunit na elk gebruik grondig schoon en neem hem af met een antiseptische oplossing NIET MET STOOM STERILISEREN De kunststof onderdel...

Page 48: ...de instrumenten zorgvuldig in de wasmachine om te voorkomen dat ze tegen elkaar aan stoten 4 Volg de onderstaande instructies en stel de wasmachine precies in op de volgende parameters Fase Tijd min W...

Page 49: ...CES of dat zodanig is gewijzigd dat zulks volgens de mening van INTEGRA LIFESCIENCES van invloed is op de stabiliteit of betrouwbaarheid van het product of dat onderworpen is geweest aan onjuist gebru...

Page 50: ...SV Svenska 48 DENNA SIDA HAR AVSIKTLIGEN L MNATS BLANK...

Page 51: ...SV Svenska 49 MAYFIELD Ultra basenhet A2101 A2102 Instruktionshandbok...

Page 52: ...skruv 1 6 tums verg ng 2 Uttag 3 St tkudde Figur 3 1 Tryck 1 verg ngsarm 2 L sspak 3 F stkula 4 Dra fr n denna sida 5 Tryck fr n denna sida Figur 2 Figur 1 Figur 4 Figur 5 6 7 1 1 1 1 2 2 2 3 3 3 4 4...

Page 53: ...medf ljande dokumentation Produkten uppfyller kraven i f rordningen om medicintekniska produkter MDR 2017 745 Tillverkare Auktoriserad EU representant Se bruksanvisningen Obs Enligt federal USA lag f...

Page 54: ...skada VARNING Denna enhet r inte avsedd f r anv ndning i eller i n rheten av ett starkt magnetf lt MR F RSIKTIGHET MAYFIELD Ultra basenhet f r aldrig f rvaras i l st position utan att en verg ngsarm s...

Page 55: ...och l sningar kan skada enheterna H ligheter och f rdjupningar i denna enhet kr ver s rskild uppm rksamhet vid reng ring Var s rskilt uppm rksam p vattenkvaliteten som anv nds under hela reng rings oc...

Page 56: ...op 4 F lj nedanst ende anvisningar och st ll in diskmaskinen exakt enligt dessa parametrar Fas Tid min Vattentem peratur Reng ringsmedel och koncentration F rdisk 1 4 00 Kallt vatten Ej till mpligt En...

Page 57: ...A LIFESCIENCES servicerepresentant eller ndrats p ett s tt som enligt INTEGRA LIFESCIENCES bed mning p verkat dess stabilitet eller tillf rlitlighet eller som varit f rem l f r felaktig anv ndning v r...

Page 58: ...SV Svenska 56 DENNA SIDA HAR AVSIKTLIGEN L MNATS BLANK...

Page 59: ...SV Svenska 57 DENNA SIDA HAR AVSIKTLIGEN L MNATS BLANK...

Page 60: ...orporation Renu Klenz is a trademark of Steris Corporation 2021 Integra LifeSciences Corporation All Rights Reserved 451A2101 Rev DAB 2021 03 0689698 3 Manufacturer Integra LifeSciences Corporation 49...

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