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Ergo-fit Cardio Line 1500 Manual

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A.8 Eintrag in das Medizinproduktebuch
Nach §11 Abs. 7 in Verbindung mit §7 der Verordnung über das Errichten, Betreiben und Anwenden von
Medizinprodukten (Medizinprodukte-Betreiberverordnung "MPBetreibV") vom 29.06.1998 (BGBt 1. S. 1762) hat
derjenige, der messtechnische Kontrollen durchführt, die Ergebnisse unter Angabe der ermittelten Messwerte, der
Messverfahren und sonstiger Beurteilungsergebnisse in das Medizinproduktebuch unverzüglich einzutragen. Da bei
der messtechnischen Kontrolle Ihres Medizinprodukts das Medizinproduktebuch nicht vorlag, werden Sie gebeten, die
nachstehenden Angaben für Ihre Dokumentation zu verwenden.
Name und Anschrift des Betreibers:
Hersteller: ERGO-FIT GmbH & Co. KG, Rheinstr. 21, 66955 Pirmasens
Gerätebezeichnung: ___________________________________________
Typ: ___________________________________________
Geräte Identifikation
Serien-Nummer: ___________________________________________
Messverfahren und Beurteilung nach:
Leitfaden zu messtechnischen Kontrollen (LMK)
Anlage 15 oder Anlage 23 zur Eichordnung (EQ 15 oder EQ 23)
Sonstiges: _______________________________________
Verwendete(s) Normal(e): ___________________________
Angabe der ermittelten Messwerte siehe Folgeseite(n)
Messtechnische Kontrolle i.O.: Jahresbezeichnung Stempelung:
Messtechnische Kontrolle nicht i.O.; alte Stempelung entwertet
_______________________________
Unterschrift
Cardio Line 1500/1500 MED
Technische und optische Änderungen sowie Druckfehler vorbehalten - © 2002 by ERGO-FIT GmbH & Co. KG 143
… 149 …


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