
Product name: MKF 2 2PW/2PW-MED GP26
Part-no.: 1236426
Created on: 17.10.2022 Revision of data sheet: A D040300
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steute Technologies
GmbH & Co. KG
Brückenstraße 91
32584 Löhne, Germany
Phone +49 (0) 5731 745-0
Fax +49 (0) 5731 745-200
info@steute.com
www.steute.com
General notes
The foot switch as a component of a medical device can be evaluated only together in the overall system of the customer. Ther
evaluation including the classification of the overall system according to the Medial Device Directive 93/42/EEC respectively EU Medical Device
Regulation 2017/745 must be carried out at the customer. In addition, validation can also only be carried out by the customer in the overall system.
Furthermore, the intended use and the basic functions are verifiable only in interaction with the overall system. As a result, the customer must involve
the footswitch in his risk management, his usability analysis, the verification of the electromagnetic compatibility and, if applicable, the verification of the
biocompatibility.
Safety instructions
Despite careful production and inspection as well as redundant design of important components, an entirely safe function cannot be guaranteed at all
times (in case of malfunction, for example, a switch contact can turn off incorrectly, or a spring may break).
A functional test must be performed before every operation.
Risk of injury due to incorrect handling!
The plug connections must not be subjected to mechanical loads!
Switch off terminal before cleaning or maintenance work!
Test functions when device is switched back on!
Moving actuating components (e.g. carrying handle) can be a crushing hazard!
Tripping hazard!
If components with reed contacts or hall sensors are used, strong magnetic fields can result in unwanted influences to the system. Additionally,
magnetically conducting materials are to be kept away from the direct foot switch area!
The electrical connection may only be carried out by authorized personnel.
Components, especially pedals or other actuating elements, may not be dissembled or dismembered under any circumstances! If this happens the
products need to be sent back immediately.
Errors and omissions excepted.