AED Saver One - Patient analysis system

AUTOMATIC
43
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%