Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 3 of 16
1. Safety information
1.1 Applied symbols
Safety instructions and key sections in these operating instructions are marked with the exclamation mark
symbol on the left. Please pay particular attention to these instructions and sections.
Other symbols possibly used on the device:
Observe instructions for use:
Risk of pinching when adjusting:
Risk of hazard zone:
1.2 Applied standards
This device has been designed and manufactured in accordance with national and international
regulations. This ensures a very high level of equipment safety.
The models described here comply with the following regulations and directives:
Regulation (EU) 2017/745
DIN EN IEC 60601-1
DIN EN ISO 14971
DIN EN 60601-2-52 partly based on
DIN EN IEC 62353
DIN EN ISO 10993-5/-10
DGUV Regulation 3
This device is a Class 1 medical device according to Regulation (EU) 2017/745 (MDR).
1.3 Safety regulations
This section contains a summary of the most important safety information.
Correct operation of the device is essential for safe operation. Therefore, please familiarise yourself with the
contents of these instructions for use before using the device. We recommend that you keep these
instructions for use near the device for future reference. The device may only be used by authorised,
instructed and competent persons who are sufficiently familiar with its adjustment mechanism or have read
and understood the operating manual fully. The manufacturer cannot be held responsible for damage caused
by or involving unauthorised persons.
The user must ensure that the device is not accessible to unauthorised persons or cannot be operated by
unauthorised persons even when left unattended. When leaving the device, it should be secured in such a
way that unauthorised adjustment is impossible.
Keep a sufficient safety distance to the device during all adjustment procedures. Special attention
must be paid to the arms, hands, legs and feet of the user and the patient -
RISK OF CRUSHING!
Make sure that there are no objects located directly around or underneath the device!
1.4 Intended purpose
The table is used for the ideal positioning of patients for the purpose of curative and disease treatment,
examination, massage and health therapy.
Table operation and patient positioning on the table may only be performed by professionally trained persons
who have been instructed in its use or who, through experience with other similar medical devices, have
knowledge of its proper use, taking into account possible hazards.
