MAVIG PORTEGRA2i, Instructions For Use Manual

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Operation
Reporting requirements for non medical devices
Since the products are not a medical device in the sense of the EU Medical Device Regulation
2017/745 (MDR), there are also no statutory reporting obligations according to the EU Medical
Device Regulation 2017/745 (MDR).
3.3 Standards / CE-Marking
IEC 60601-1:2005+A1:2012
If the product bears a CE mark, it complies with the requirements of the EU Medical Device
Regulation 2017/745 (MDR) or, as partly completed machinery, it complies with the relevant
provisions of EC Directive 2006/42/EC.
3.4 Precautionary measures
Observe the following when using the system/device after successful installation in accordance
with the Portegra2i installation instructions (POI03Oxx):
1. Avoid collisions with other devices, the walls, or the ceiling.
2. Stop using the system if there is a collision or any other damage to the system.
Do not stand or work beneath the system.