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Type Plate Information; Standards Used - Sport-Tec LOJER DOPPELZUGAPPARAT SPEED PULLEY 100 Bedienungsanleitung

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Instructions for use
11.1

Type plate information

See Chapter 4.1 Symbols for explanations of symbols used in the type plate.
Image 24. Type plate (Note! Image referential)
The type plate is located on two different spots on the frame of the Lojer Pulley
depending on the Pulley model. For Pulley 14 & 20, Speed Pulley 50, 80 & 100
and Vertical Pull it is located at the bottom of the left side frame. For Mobile Speed
Pulley it is behind the device at the lower back support connection point.
Image 25. Location of type plate (from left: Pulley 14 & 20 and Speed Pulley 50;
11.2

Standards used

The device is in conformity with requirements of the EU Medical Device
Regulation 2017/745. The device is marked with CE marking. The device is
classified as Class I medical device.
The following harmonized standards have been used in the design, testing and
manufacturing of the Lojer Pulleys:
• EN ISO 14971:2012
• EN ISO 13485:2016
• EN ISO 15223-1:2016
Copyright © Lojer Oy, 2021
Lojer Pulleys for Medical Training Therapy / Version 4.0
Speed Pulley 80 & 100 and Vertical Pull; Mobile Speed Pulley)
31

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