AED Saver One, Руководство пользователя, Страница: 43 / 55

AUTOMATIC
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11.9 Patient analysis system
Category Nominal specifications
Function
Determines the patient's impedance and evaluates the ECG rhythm and signal quality to
determine whether the shock delivery is appropriate.
Impedance range 20 - 200 Ω
ECG analysis time
≥4
seconds (with new fully charged battery) respecting IEC/EN 60601-2-4
Sensibility
97% Respects the guidelines IEC/EN 60601-2-4 2002(3) sources AHADB, MITDB and EDB
Specificity 99% Respects the guidelines IEC/EN 60601-2-4 2002(3) sources AHADB, MITDB and EDB
Shockable rhythms
If used on a patient who has the characteristics listed in the usage criteria, the Saver One
defibrillator is designed to recommend a defibrillating shock when it detects the right
impedance and when the following situations occur:
Ventricular Fibrillation peak-to-peak amplitude at least 200µVolts
Ventricular Tachycardia with cardiac rhythm frequency min. 180 bpm and peak-to-peak
amplitude at least 200µVolts (including ventricular flutter and polymorphic ventricular
tachycardia)
Non-shockable rhythms
The Saver One is designed to not recommend shocks with all other rhythms, including: normal
sinusoidal rhythm, moderate ventricular fibrillation (<200 μVolts), some slow ventricular
tachycardia and asystoles.
11.10 ECG Analysis Function
ECG rhythm
Dimension
Test sample
Objective Detected value
Shockable rhythm
Ventricular Fibrillation (VF)
500 Sensibility > 90% 98%
Shockable rhythm
Ventricular Tachycardia (VT, bpm>140)
600 Sensibility > 75% 92%
Non-shockable rhythm
Normal sinusal rhythm
1500 Specificity > 99% 100%
Non-shockable rhythm
Asystole
30 Specificity > 95% 100%
Untreatable rhythm
generic AF, SVT, PVC
30 Specificity > 95% 100%
Positive predictive values 97.1%
False positives 4.1%
11.11 Non rechargeable battery
Category Nominal specifications
REF (Model)
SAV-C0903
Type Li-SOCl
2
(lithium-thionyl chloride) disposable, non-rechargeable
Voltage
25,2 VDC – 3500 mAh
Capacity Standard 200J
300 cycles of complete rescues (shocks at 200J. and CPR)
*
Power 360J
200 cycles of complete rescues (shocks at 360J. and CPR)
*
ECG analysis 35 continuous hours
*
Duration in Standby
(installed battery)
4 years if installed in the AED, assuming an activation test, daily self-tests without turning on
the AED
*
* New and fully charged battery at a constant temperature of 20°C and relative humidity without condensation 45%