Smarty Saver Plus - Battery, Backup Source, Pads, and Bluetooth

SEMI-AUTOMATIC
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10.9 Patient analysis system
Category
Rated specifications
Function
It determines patient impedance and assesses the ECG rhythm and the quality of the signal, to
determine whether administering the shock is appropriate or not.
Impedance range
20 - 200 Ω
ECG analysis time
≥4 seconds (with new, fully charged battery) in compliance with the standards IEC/EN 60601-2-4
Sensitivity
97% in compliance with the standards IEC/EN 60601-2-4
Specificity
99% in compliance with the standards IEC/EN 60601-2-4
Defibrillable rhythms
If used on a patient with the characteristics listed in the use criteria, the SMARTY Saver Plus
defibrillator is designed to suggest 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 heartbeat frequency min. 180 bpm and peak-to-peak amplitude at
least 200µVolts (including ventricular flutters and polymorphic Ventricular tachycardia)
Non-defibrillable rhythms
SMARTY Saver Plus is designed not to suggest shocks with all other rhythms, including: normal
sinus rhythm, moderate ventricular fibrillation (<200 μVolts), some slow ventricular tachycardias
and asystole.
10.10 ECG Analysis operation
ECG rhythm
Dimension
Test sample
Objective
Value detected
Rhythm to be defibrillated
Ventricular Fibrillation (VF)
500
Sensitivity > 90%
98%
Rhythm to be defibrillated
Ventricular Tachycardia (VT, bpm >140)
600
Sensitivity > 75%
92%
Rhythm not to be defibrillated
Normal sinus rhythm
1500
Specificity > 99%
100%
Rhythm not to be defibrillated
Asystole
30
Specificity > 95%
100%
Non-treatable rhythm
Generic AF, SVT, PVC
30
Specificity > 95%
100%
Positive predictive values
97.1%
False positives
4.1%
10.11 Defibrillator battery
Category
Rated specifications
Code
SMT-C14031
Type
Li-MnO₂ (Lithium - manganese dioxide) single-use, non-rechargeable
Voltage/ Capacity
12 VDC – 3000 mAh
Performance*
Standard 200J
200 full rescue cycles (shocks + CPR) at 200J.
Temp. 20°C Humidity 45%
ECG analysis
36 continuous hours
Duration in Stand-by mode
Estimated 3 (three) years supposing a battery activation test and daily self-tests,
without the AED being switched on
(at environmental conditions of temperature 20°C and humidity 45% without condensation)
*Perfo*Performance referred to a new and fully charged battery stored at a constant temperature of 20°C and relative humidity of
45 %4 45%without condensation
10.12 Internal back-up energy source
Category
Rated specifications
Type
Electric Double Layer Capacitor (Super-Cap)
Purpose
Preserving configuration data (date/time, etc.)
Voltage
3 VDC
Duration
30 minutes (with AED battery inserted at least 15 minutes earlier)