Meaning Of The Labels; Declaration Of Conformity - SORG Dynamis TSD Instructions For Use Manual

5 Technical data

5.2 Meaning of the labels

The meaning of the individual labels results directly from the respective text at the relevant
place.
If the label is damaged or lost, a new label can be obtained from SORG Rollstuhltechnik.
Label:
Reference to
manufacturer
serial number
Seat width
Type numberr

5.3 Declaration of conformity

SORG Rollstuhltechnik declares that the Dynamis TSD product is a class 1 device and that it com-
plies with the relevant provisions of EU Guideline (EU) 2017/745 on medical products.
This has been verified by a conformity assessment procedure in accordance with
the medical device guideline.
This declaration loses its validity if changes are made to the product that have
not been approved by SORG Rollstuhltechnik.
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Manufacturer
Manufacturer address
logo
Seat
Model weight
capacity
depth
Instructions for use Dynamis TSD
Reference to
product literature
Reference to a
passed Crash Test
according to ISO
7176-19
CE mark
construc- Back height
tion year
2021-05-26