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SAM 500P Gebrauchsanweisung
25
Das SAM 500P verwendet den samaritan® EKG-Arrhythmie-Analysealgorithmus von HeartSine. Dieser Algorithmus bewertet
das EKG der Patienten, um festzustellen, ob ein therapeutischer Schock notwendig ist. Falls ein Schock erforderlich ist, lädt
sich das SAM 500P auf und fordert den Benutzer auf, die Schock-Taste zu drücken. Falls kein Schock notwendig ist, wird der
Anwender dazu aufgefordert, mit HLW-Massnahmen zu beginnen.
Die Leistung des HeartSine samaritan®-EKG-Arrhythmie-Analysealgorithmus wurde umfassend bewertet, indem
verschiedene Datenbanken von echten EKG-Spuren, darunter die Datenbank der American Heart Association (AHA) und
die NST-Datenbank des Massachusetts Institute of Technology MIT, verwendet wurden. Die Sensitivität und Spezität
des HeartSine samaritan®-EKG-Arrhythmie-Analysealgorithmus erfüllt die Anforderungen aus AAMI DF80a2003 und
die Empfehlungen der AHA. Die Leistung des HeartSine samaritan®-EKG-Arrhythmie-Analysealgorithmus ist in der
nachfolgenden Tabelle zusammengefasst:
* Keine Fehlermessung
a Association for the Advancement of Medical Instrumentation. DF-80 - 2003 Standard für medizinische
Elektrogeräte Teil 2 - 4 ; Besondere Anforderungen für die Sicherheit von Herzdebrillatoren (einschliesslich
automatischer externer Debrillatoren).
EKG Arrhythmie-Analysealgorithmus
Rhythmusklasse
Probengröße
EKG-Test
Leistungsdaten
Leistung-
sergebnisse
90 % einseitige untere
Kondenzgrenze
Per Schock zu behan-
delnder Rhythmus:
Kammerimmern und
Ventrikuläre Tachykardie
2453 Sensitivität > 90 % 93,48 % 90,58 %
Nicht per Schock zu
behandelnder Rhythmus:
Asystolie
1902 Spezität > 95 % 100% 100*%
Nicht per Schock zu be-
handelnder Rhythmus: alle
anderen Rhythmen
46711 Spezität > 95 % 99,11 % 95,04 %
27


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