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. Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 3 of 16...
Important for the user: When adjusting the upholstery parts, do not reach under the spacers located beneath the upholstery parts. Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 4 of 16...
It enables us to identify this table model and trace back assemblies/safety-relevant components at any time. Please always state this serial number when enquiring about spare parts. Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 5 of 16...
This will force air out of the system. 2.3 Upholstery adjustment Despite the very robust and strong design of the gas spring, the head part must not be used for sitting! Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 6 of 16...
The paper roll holder consists of a holding bar and angle mount brackets or retaining brackets. In addition to the stainless steel bar, the paper roll holding bar consists of a spring-loaded stainless steel sleeve featuring a round Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 7 of 16...
Paper roll holder • Additional foot switch or hand switch • Foot switch fixation on the underframe • Foot switch rails, for operating the height, laterally or surround Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 8 of 16...
0° / + 50° Max. patient weight (kg) Technical data subject to change for movability art. no.046: Height plus 20 mm for movability art. no. 040N: Height minus 10 mm Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 9 of 16...
For cleaning and disinfection, a selection of agents from various manufacturers has been tested for compatibility. Please refer to the separate enclosed sheet. The table is equipped as standard with the Dewert hygiene standards, which enable optimal cleaning and disinfection: •...
Lubricate the roller guides with a little bearing grease or similar using a brush, if necessary. Insufficient lubrication is noticeable through noise development. A checklist for maintenance/technical inspection can be found in the appendix. Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 11 of 16...
In other words, the active tractive force of the motor no longer acts; instead, simply the weight of the upper part of the table is applied. In the event of unforeseen entrapment, the risk of injury is significantly limited. Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 12 of 16...
8. Reporting obligation All serious incidents occurring in connection with the product shall be reported to the manufacturer (K.H. Dewert GmbH) and to the competent authority of the Member State in which the user and/or the patient resides. Member State...
We hereby declare conformity with the aforesaid directive. As the manufacturer, we bear sole responsibility for issuing this EU Declaration of Conformity. Mark: Bielefeld/Germany, 26 May 2021 K.-H. DEWERT GmbH Management Dewert User Manual DX1 Series– Updated 05.2021/1 MDR Page 14 of 16...
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Checklist for maintenance/technical inspection to IEC 62353 and DGUV Regulation 3 Device Model designation Serial no. Location Responsible person Date, inspector Actuator designation Inspections FAIL Description of defects Visual inspection Overall impression of the table OK? Labels, CE mark, type plate present? Manufacturer’s operating manual available and accessible? Sufficient space available when carrying out all adjustment functions? Mechanical structure undamaged:...
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FAIL Description of defects Height retained? Hydraulic pump leaking? Smooth lowering possible? Check by operating the pedals to lower the table Strong noise development? Wipe the piston rod with a cloth Lying surface adjustment functions: Metal ratchets - arrester - gas spring Metal ratchet inspection: Lifting the lying surface segment: Do the two metal ratchets engage properly and securely? Do they engage evenly?
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