57
10.4 ECG INTERPRETATION AND PERFORMANCE
SENSITIVITY AND SPECIFICITY OF RHYTHM RECOGNITION DETECTOR
Shockable Rhythm – VF
Meets IEC/EN 60601-2-4 requirement
Sensitivity > 90%
Shockable Rhythm – VT
Meets IEC/EN 60601-2-4 requirement
Sensitivity > 75%
Non-shockable Rhythm – Normal Sinus Rhythm
Meets IEC/EN 60601-2-4 requirement
Specificity > 95%
Non-shockable Rhythm – Asystole
Meets IEC/EN 60601-2-4 requirement
Specificity > 95%
Non-shockable Rhythm – all other rhythms
Meets IEC/EN 60601-2-4 requirement
Specificity > 95%
When placed on a patient meeting the indication
for use criteria, the CellAED® is designed to
recommend a defibrillation shock when it detects
proper pad impedance and one of the following
shockable rhythms:
SHOCKABLE RHYTHMS
VF with peak-to-peak amplitudes of at least 200
µ
V
and VT (monomorphic and polymorphic) of at least
130 bpm and peak-to-peak amplitudes of at least
200
µ
V.
NON-SHOCKABLE RHYTHMS
All other rhythms, including Normal Sinus Rhythms,
fine VF with peak-to-peak amplitudes less than
200
µ
V, some slow VT and Asystole.
The patient’s transthoracic impedance is measured through the defibrillation electrode pads. If the baseline impedance is higher than a maximum limit, it is determined
that the electrodes have not made sufficient contact, and ECG analysis and shock delivery are inhibited. In this instance please check the electrodes and improve contact.
