Radian Heart Guardian AED, Руководство пользователя

Страница: 32 / 36

7.4 Applicable standards
Type Detail
General
KGMP by KCL
(KCLAAB-140053)
Safety and performance
IEC60601-1H (Basic safety & essential performance)
IEC60601-1-2CEMC (EMC)
IEC60601-2-4:2011
EN 1041:2008
EN 980:2008
Shock IEC60068-2-27
Vibration IEC60068-2-64 (10Hz to 2,000Hz)
Free fall drop IEC60068-2-32 (1m)
Enclosure
(Particle and water ingress)
IEC 60529, IP54
EMC IEC60601-1-2CEMC (EMC)
Sensitivity and
Specificity of
Rhythm Detection
(FFT ECG Analysis)
•
Shockable Rhythm-VF:
(IEC 60601-2-4, AHA’s recommend: >90%)
•
Shockable Rhythm-VT:
(IEC 60601-2-4, AHA’s recommend: >75%)
•
Non-shockable—Rhythm-NSR:
(IEC 60601-2-4, AHA’s recommend: >95%)
•
Non-shockable-Asystole:
(IEC 60601-2-4, AHA’s recommend: >95%)
•
Non-shockable-all other rhythms:
(IEC 60601-2-4, AHA’s recommend: >95%)