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8

EN – ENGLISH

INSTRUCTIONS

Containment/Transportation

•  Follow health care facility protocol for 

safe containment and transport to the 

decontamination environment.

•  It is recommended that devices are cleaned 

immediately after use.

Preparation for Cleaning

•  Disassembly is required.

 

Disassembling Equipment

Inspecting for Cleanliness

Remove the gel pads from 

the unit by sliding off. Keep 

all joints in the unlocked 

position. Slide the adjust-

able headrest base until it 

comes apart.

Inspect the teeth of the 

starbursts and make sure 

to inspect all joints. Pay 

close attention to the 

area around the locking 

screw.

Cleaning – Manual Equipment: Water, Neutral pH 

Detergent, Soft Bristle Brush, Towels

Method

1.  Prepare neutral pH enzymatic detergent solution 

(e.g. Endozime® AW Triple Plus with APA (Ruhof), 

1:128 ratio)  according to detergent manufacturer’s 

instructions using lukewarm tap water. 

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 

solution for 30 minutes maximum.

5. Clean 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 give special attention to 

hard-to-reach areas.

7. Thoroughly dry equipment with soft clean towels 

and use medically compressed air if needed, to 

dry channels, crevices and lumens.

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:

Summary of Contents for MAYFIELD A1051

Page 1: ...ing 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 69...

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

Page 3: ...3 MAYFIELD Pediatric Horseshoe Headrest A1051 Instruction Manual EN ENGLISH...

Page 4: ...4 EN ENGLISH Figure 4 Figure 3 Figure 1 Figure 2 English Figure 1 MAYFIELD Pediatric Horsehoe Headrest English Figure 2 MAYFIELD Base Unit English Figure 3 Proper meshing of sunburst teeth...

Page 5: ...Product complies with the requirements of MDR 2017 745 Manufacturer Authorized Representative in the European Community Consult instructions for use Caution Federal US law restricts this device to sa...

Page 6: ...er 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 o...

Page 7: ...arm CAUTION Do not attempt to pull the Gel Pads away from the Faceplate arms Damage to the Gel Pads may occur The MAYFIELD Pediatric Horseshoe Headrest should be thoroughly cleaned after each use Clea...

Page 8: ...ft clean towels and use medically compressed air if needed to dry channels crevices and lumens 8 Inspect the equipment to make sure there is no visible organic debris or residue from cleaning agent Re...

Page 9: ...e 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...

Page 10: ...T Further this warranty shall not apply to and INTEGRA shall not be responsible for any loss arising in connection with the purchase or use of any INTEGRA product that has been repaired by anyone othe...

Page 11: ...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 12: ...12 This page is intentionally left blank EN ENGLISH...

Page 13: ...13 T ti re fer cheval p diatrique MAYFIELD A1051 Mode d emploi FR FRAN AIS...

Page 14: ...14 FR FRAN AIS Figure 4 Figure 3 Figure 1 Figure 2 Fran ais Figure 1 T ti re fer cheval p diatrique Fran ais Figure 2 Unit de base MAYFIELD Fran ais Figure 3 Adaptation correcte des dents radiales...

Page 15: ...produit est conforme aux exigences de la RDM 2017 745 Fabricant Repr sentant autoris dans la Communaut europ enne Consulter le mode d emploi Attention Selon la loi f d rale am ricaine ce dispositif n...

Page 16: ...s fonctionner correctement ne pas utiliser le dispositif et l envoyer imm diatement un centre de r paration Integra agr o il sera valu r par ou remplac Faire v rifier ce dispositif par votre repr sent...

Page 17: ...cal devices for reprocessing in Health Care facilities Rincer abondamment avec de l eau d min ralis e ou st rile pour liminer tout r sidu de d tergent ATTENTION Ne pas utiliser une solution base d alc...

Page 18: ...mat riel viter d utiliser une eau dure Utiliser la place une eau purifi e sauf mention contraire Limites du reconditionnement Un reconditionnement r p t a des effets n gatifs sur ces dispositifs et n...

Page 19: ...pas assur s des effets d l t res risquent d tre constat s la longue apr s des traitements r p t s ce qui peut conduire la r duction des performances Informations de contact Consulter la section Mainte...

Page 20: ...garantie ne s applique pas et INTEGRA ne peut tre tenue pour responsable de toute perte r sultant de l achat ou de l utilisation d un quelconque produit INTEGRA ayant fait l objet de r parations effe...

Page 21: ...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 22: ...22 22 FR FRAN AIS Cette page est laiss e intentionnellement vide...

Page 23: ...23 23 Poggiatesta pediatrico a ferro di cavallo MAYFIELD A1051 Manuale di istruzioni IT ITALIANO...

Page 24: ...IANO 24 Figura 4 Figura 3 Figura 1 Figura 2 Italiano Figura 1 Poggiatesta Pediatrico a Ferro di Cavallo MAYFIELD Italiano Figura 2 L unit di base MAYFIELD Italiano Figura 3 Corretto innesto dei denti...

Page 25: ...conforme ai requisiti della direttiva MDR 2017 745 Societ produttrice Rappresentante autorizzato nella Comunit Europea Consultare le istruzioni per l uso Attenzione la legge federale USA limita la ve...

Page 26: ...n zionare correttamente non usare il dispositivo e inviare immediatamente lo strumento a un centro di riparazione Integra autorizzato per essere valutato riparato o sosti tuito Richiedere al rappresen...

Page 27: ...piastre per evitare di danneggiarli Pulire bene il Poggiatesta a ferro di cavallo pediatrico MAYFIELD dopo l uso Pulire tutte le componenti inclusi i cuscinetti di gel con un detersivo dal pH neutro...

Page 28: ...arecchiatura per verificare che non vi siano detriti organici o residui di agente pulente visibili Ripetere l operazione se vengono rilevate tracce di detriti Asciugatura I prodotti devono essere asci...

Page 29: ...ELD fino a 7 anni Manutenzione e cura Per assicurarsi che lo strumento funzioni come previsto e per prolungare la vita utile e il rendimento dello strumento Integra LifeSciences raccomanda quanto segu...

Page 30: ...O INTEGRA In aggiunta questa garanzia non sar valida e INTEGRA non sar responsabile per perdite connesse all acquisto o uso di un prodotto INTEGRA che sia stato riparato da un ente che non sia un rapp...

Page 31: ...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 32: ...32 IT ITALIANO 32 Questa pagina stata lasciata intenzionalmente in bianco...

Page 33: ...33 33 P diatrische Hufeisen Kopfst tze von MAYFIELD A1054 Gebrauchsanleitung DE DEUTSCH...

Page 34: ...Abbildung 4 Abbildung 3 Abbildung 1 Abbildung 2 Deutsch Abbildung 1 Die MAYFIELD P diatrische Hufeisen Kopfst tze Deutsch Abbildung 2 Die MAYFIELD Basiseinheit Deutsch Abbildung 3 Richtige Verzahnung...

Page 35: ...ngen der MDR 2017 745 Hersteller Autorisierte Vertretung in der Europ ischen Gemeinschaft Gebrauchsanweisung lesen Vorsicht Gem US amerikanischer Bundesgesetzgebung darf dieses Produkt nur durch eine...

Page 36: ...funktioniert das Produkt nicht verwenden und das Instrument umgehend zu einer autorisierten Integra Reparaturzentrale zwecks Evaluierung Reparatur oder Ersatz senden Damit Sie sich der ordnungsgem en...

Page 37: ...nnte die Gelpolster besch digen Die MAYFIELD Kopfst tze f r p diatrische Anwendungen muss nach jedem Gebrauch gr ndlich gereinigt werden Reinigen Sie alle Komponenten einschlie lich Gelpolster mit eie...

Page 38: ...ggf mit medizinisch reiner Druckluft trocknen 8 Die Vorrichtung inspizieren um sicherzustellen dass keine sichtbaren organischen Verschmutzungen oder Reinigungsmittelr ckst nde vorhanden sind Den Vor...

Page 39: ...YFIELD Produkte betr gt voraussichtlich bis zu 7 Jahre Wartung und Pflege Damit die Ausr stung sachgerecht funktioniert und die Lebensdauer und Leistung der Ausr stung verl ngert wird empfiehlt Integr...

Page 40: ...Gebrauch eines INTEGRA Produkts das von einer anderen als von einer von INTEGRA autorisierten Service Vertretung repariert bzw so abgewandelt wurde dass nach Beurteilung von INTEGRA dessen Stabilit t...

Page 41: ...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 42: ...42 DE DEUTSCH 42 Diese Seite wurde absichtlich frei gelassen...

Page 43: ...43 43 Apoyacabezas pedi trico en forma de herradura MAYFIELD A1051 Manual de instrucciones ES ESPA OL...

Page 44: ...OL 44 Figura 4 Figura 3 Figura 1 Figura 2 Espa ol Figura 1 Apoyacabezas pedi trico en forma de herradura MAYFIELD Espa ol Figura 2 Unidad base MAYFIELD Espa ol Figura 3 Encaje correcto de los dientes...

Page 45: ...con los requisitos de MDR 2017 745 Fabricante Representante autorizado en la Comunidad Europea Consulte las instrucciones de uso Precauci n La ley federal EE UU permite que la venta de este producto...

Page 46: ...inmediato a un centro de reparaci n autorizado de Integra para su evaluaci n reparaci n o sustituci n Permita que su representante de Integra revise el dispositivo como m nimo dos veces al a o para co...

Page 47: ...i trico MAYFIELD en forma de herra dura debe limpiarse a fondo despu s de cada utilizaci n Limpiar todos los componentes incluyendo los cojines de gel usando un detergente con un pH neutro Si es neces...

Page 48: ...o Si se detecta humedad o exceso de l quido seque con una toalla limpia suave Se puede usar el aire comprimido m dicamente si es necesario Lavado Desinfecci n autom tico opcional ADVERTENCIAS Los dete...

Page 49: ...oducto al Departamento de reparaciones de Integra LifeSciences para inspecci n minuciosa y servicio de mantenimiento Una vez por a o Solicitar que los neu roespecialistas de Integra realicen inspeccio...

Page 50: ...a no ser aplicable a e INTEGRA no ser responsable por cualquier p rdida surgida en rel aci n con la compra o la utilizaci n de cualquier producto de INTEGRA que haya sido reparado por cualquier per so...

Page 51: ...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 comer...

Page 52: ...52 ES ESPA OL 52 P gina dejada intencionalmente en blanco...

Page 53: ...53 53 MAYFIELD pediatrische hoefijzervormige hoofdsteun A1051 Gebruikershandleiding NL NEDERLANDS...

Page 54: ...EDERLANDS 54 Figuur 4 Figuur 3 Figuur 1 Figuur 2 Nederlands Figuur 1 MAYFIELD pediatrische hoefijzervormige hoofdsteun Nederlands Figuur 2 MAYFIELD basisunit Nederlands Figuur 3 Goed grijpen van de ta...

Page 55: ...tentie Het product voldoet aan de eisen van richtlijn MDR 2017 745 Fabrikant Gevolmachtigd vertegenwoordiger in de Europese Unie Raadpleeg de gebruiksaanwijzing Let op Volgens de Amerikaanse federale...

Page 56: ...lijkt te zijn en of niet goed lijkt te werken mag het apparaat niet gebruikt worden en moet het onmiddellijk naar een erkend Integra repa ratiecentrum worden verzonden voor evaluatie reparatie of verv...

Page 57: ...sable medical devices for reprocessing in Health Care facilities Spoel grondig met gede oniseerd of steriel water om alle detergensresten te verwijderen VOORZICHTIG Gebruik geen alcoholoplossing op de...

Page 58: ...et gebruik van hard water Gebruik in plaats daarvan gezuiverd water tenzij anders vermeld Beperkingen bij de herverwerking Herhaalde verwerking heeft negatieve effecten op deze hulpmiddelen en wordt n...

Page 59: ...n routine inspectie van het hulpmiddel uit te voeren Tweemaal per jaar Bij gebrek aan juiste verzorging van en service aan het instrument kan de herhaalde behandeling mettertijd ongunstige resultaten...

Page 60: ...DEVERGOEDING IN VERBAND MET DE AANSCHAF OF HET GEBRUIK VAN EEN INTEGRA PRODUCT Deze garantie is tevens niet van toepassing op en INTEGRA zal niet verantwoordelijk zijn voor enigerlei ver lies dat word...

Page 61: ...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 62: ...NL NEDERLANDS 62 Deze pagina is bewust leeg gelaten...

Page 63: ...NL NEDERLANDS 63 Deze pagina is bewust leeg gelaten...

Page 64: ...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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