Otto Bock 4R57 Instructions For Use Manual
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- Instructions for use manual (220 pages)
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Summary of Contents for Otto Bock 4R57
- Page 1 4R57, 4R57=ST Instructions for use (qualified personnel) ................
- Page 2 Documentu 647G258 Versionu 16 SCAN ME httpsu//product-documents.ottobock.com/IFU/INT/4R57/647G258/16/O/S/F DE | Weisen Sie den Benutzer in den sicheren Gebrauch des Produkts ein. Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos als gedrucktes Exemplar bestellt werden (siehe Seite 2). EN | Instruct the user how to use the product safely.
- Page 3 PL | Poinotruować użytkownika na temat bezpiecznego używania produktu. Niniejozą inotrukcję używania w innych językach można przeczytać online lub zamówić bezpłatnie w weroji drukowanej (patrz otrona 2). HU | Oktassa ki a felhasználót a termék biztonságos használatáról. A használati útmutató további nyelvi változatai az interneten elérhetők, vagy nyomtatott példányként ingyenesen megrendelhetők (lásd a 2.
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Page 4: Product Description
Please keep this document for your records. ► The product "4R57/4R57=ST rotation adapter" is referred to simply as the product/adapter/rota tion adapter below. These instructions for use provide you with important information on the use, adaptation and handling of the product. - Page 5 The product is recommended for mobility grade 1 (indoor walker), mobility grade 2 (restricted outdoor walker), mobility grade 3 (unrestricted outdoor walker) and m° mobility grade 4 (unrestricted outdoor walker with particularly high demands). Approved for a body weight of max. 150 kg. 3.3 Indications • For patients with a transfemoral amputation, hip disarticulation •...
- Page 6 Manipulations to the product other than the tasks described in these instructions for use are ► not permitted. Only Ottobock Service Centres may open the product or replace damaged components. ► 4.4 Information on Alignment/Adjustment CAUTION Incorrect alignment or assembly Falling due to damage to the prosthesis components.
- Page 7 Apply the specified tightening torque values for installation (see the section "Technical data" ► see page 10). Observe the instructions for securing the screw connections and the use of the correct ► length. 4.5 Patient information CAUTION Penetration of dirt and moisture into the product Falling due to unexpected product behaviour as the result of a malfunction.
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Page 8: Scope Of Delivery And Accessories
5 Scope of Delivery and Accessories 5.1 Scope of delivery • 1 pc. 4R57 Rotation adapter or 1 pc. 4R57=ST Rotation adapter • 1 pc. Instructions for use (qualified personnel) 5.2 Accessories The following components are not included in the scope of delivery and must be ordered separ... -
Page 9: Maintenance
INFORMATION 4X46=ST lamination dummy for lamination process In order to properly screw the rotation adapter with threaded connector into the lamination anchor, the 4X46=ST lamination dummy must be used for laminating. It must be ordered separ ately. 1) Screw the rotation adapter completely into the thread of the lamination anchor. 2) Unscrew the rotation adapter out of the thread by no more than a 3/4 turn. -
Page 10: Legal Information
11.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. The full text of the regulations and requirements is available at the following Internet address: http://www.ottobock.com/conformity... - Page 11 Product 4R57 4R57=ST Rotation range [°] Liefetime [years] Approved set 506G3=M8x1 506G3=M8x1 506G3=M8x1 506G3=M8x1 506G3=M8x2 screws Length [mm] Quantity [pieces] Maximum tightening torque [Nm] A 20 mm long set screw has to be used in the position marked in the figure.
- Page 12 Manufacturer...
- Page 16 Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 info.austria@ottobock.com · www.ottobock.com...