CARDIO LINE 400/400 MED
Technical and optical modifications as well as misprints reserved - © 2019 by ERGO-FIT GmbH & Co. KG
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A.9 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. p. 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, we ask you 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 oliterated
_______________________________
Signature
