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XRCISE STRESS ECHO MED
Technical and visual modifications as well as misprints reserved - © 2019 by ERGO-FIT GmbH & Co. KG
83
A.8 Entry in Medical Devices Registry
In compliance with §11 section 7 and §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:
Facility: ___ __ _____ _____ _____ __ ___ __ ___ __ _____ _____
Contact: _____ __ ___ __ ___ __ _____ _____ _____ __ ___ __ ___
Adress: _ _____ _____ __ ___ __ _____ _____ _____ _____ __ __
Zip, City: _____ _____ _____ __ ___ __ ___ __ _____ _____ _____
Manufacturer:
ERGO-FIT GmbH & Co. KG, Blocksbergstraße 165, D-66955 Pirmasens
Device Identification
Device name: ___ __ _____ _____ _____ _____ __ ___ __ _____ _____ _
Model: _ _____ _____ _____ __ ___ __ _____ _____ _____ _____
Serial-number: ____ __ _____ _____ _____ __ ___ __ ___ __ _____ _____
___________________________________________
Measuring method and evaluation:
 Guide to metrological controls (LMK)
 Appendix 15 or Appendix 23 of calibration regulations (EQ 15 or EQ 23)
 Remarks: _ _____ _____ _____ _____ __ ___ __ _____ _____ _
Used standards: ____ __ ___ __ _____ _____ _____ _
Measured values see following page(s)
 Metrological control i.o.; annual designation of sealing:
 Metrological control not i.o.; old sealing obliterated
_______________________________
Signature
89


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