Ottobock 3R60-PRO Gebrauchsanweisung Seite 15

5.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie 93/42/EWG für Medizinpro-
dukte. Aufgrund der Klassifizierungskriterien nach Anhang IX dieser Richtlinie wurde das Produkt
in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
INFORMATION
Last update: 2016-09-02
f Please read this document carefully before using the product.
f Follow the safety instructions to avoid injuries and damage to the product.
f Instruct the user in the proper and safe use of the product.
f Please keep this document in a safe place.
1 Single components (Fig. 1)
(1) 710H10=2X3 Adjustment Wrench
(2) 4Z59=5.5X6 Extension Stop
(3) 4G444=3R60-PRO Signature Plate
(4) 4G432 Upper Protective Knee Cover
(5) 4G433 Lower Protective Knee Cover
(6) 4G70 Lamination Anchor with
4 pcs of 501T1=M5×16 Truss Head Screw (a)
4 pcs of 502R1=M5×16 Round Nut with two holes (b)
2 pcs of 506G3=M8X12-V Set Screw (c)
1 pc. of 506G3=M8X10 Set Screw (d)
2 Description
2.1 Indications for use
The EBS Knee Joint is to be exclusively used for the prosthetic fitting of amputations of the lower
PRO
limb. It is a polycentric joint offering a hydraulically controlled, ergonomically balanced stride and
hydraulic swing phase control.
2.2 Field of application
Field of application according to the Ottobock MOBIS Mobility System:
Recommended for amputees with Mobility Grades 2 and 3
(restricted outdoor walkers, non-restricted outdoor walkers).
Approved for a patient weight of up to 75 kg / 165 lbs.
EBS= Ergonomically Balanced Stride
3R60-PRO, 3R60-PRO=ST, 3R60-PRO=KD, 3R60-PRO=HD
English
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