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Technical and optical modifications as well as misprints reserved. - © 2020 by ERGO-FIT GmbH & Co. KG
TORSO LINE
A.5 Entry in the Registry of medical devices
In compliance with Art. 11 para. 7 and Art. 7 of the regulation on the erection, operation and use of medical devices
("MPBetreibV") as of June 29, 1998 (BGBt 1. S. 1762), the person who carries out metrological controls must
immediately record the measured values, the measuring method as well as other evaluation results into the registry
of medical devices. As during metrological control of your medical device the registry of medical devices was not
available, you are asked to use the following data for your documentation.
Operator:
Company: __________________________________________
Contact person: __________________________________________
Street: __________________________________________
Post code, place: __________________________________________
Manufacturer:
ERGO-FIT GmbH & Co. KG, Blocksbergstraße 165, D-66955 Pirmasens
Device identification
Device designation: ___________________________________________
Model: ___________________________________________
Serial number: ___________________________________________
______________________________________________________________
Measuring method and evaluation:
Leitfaden zu messtechnischen Kontrollen (LMK)
Appendix 15 or appendix 23 of calibration regulations (EQ 15 or EQ 23)
Remarks: _______________________________________
Applied perpendicular: ___________________________
Entry of measured results: see following page(s)
□ Metrologicalcontrolo.k.;annualdesignationofsealing:
□ Metrologicalcontrolnoto.k.;old sealing obliterated
_______________________________
Signature
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