A.M.I Italia Saver One P, User Manual

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13.10 P
ATIENT ANALYSIS SYSTEM IN SEMI
-
AUTOMATIC MODE
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)
Sensitivity 97% Complies with IEC/EN60601-2-4 guidelines
Specificity 99% Complies with IEC/EN60601-2-4 guidelines
Shockable rhythms
If used on a patient with the characteristics listed in the use criteria, the Saver One P
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 heartbeat frequency min. 180 bpm and peak-to-peak amplitude
at least 200µVolts (including ventricular flutters and polymorphic Ventricular tachycardia)
Non-shockable rhythms
The Saver One P is designed to not recommend shocks with all other rhythms, including:
normal sinusoidal rhythm, moderate ventricular fibrillation (<200 μVolts), some slow
ventricular tachycardias and asystoles.
13.11 ECG A
NALYSIS 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%
13.12 ECG M
ONITORING
Category Rated specifications
Type of protection
BF with defibrillation PADs
CF only with SAV-C0017 cable
Intended use
The ECG Monitoring function is intended to be used in situations where the patient is
always followed by an operator and is never left alone
Bandwidth 0.5 at 40Hz (default) with defibrillation PADs or ECG cable SAV-C0017
Lead ECG Lead II
ECG Amplitude Range 10 mm/mV
Heart Rate Range 30 – 200 bpm
Heart Rate Resolution 1 bpm
Heart Rate Alarm (*) Threshold MIN = 30 bpm; Threshold MAX 120 bpm
(*)
The alarm thresholds are set by the Manufacturer and cannot be changed locally. On request it is possible to have different
threshold values