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2 The Basics
2.1 Intended Use
2.1.1 Intended Purpose Statement
The equipment is intended for external defibrillation, internal defibrillation, synchronized cardioversion and
semi-automated external defibrillation (AED). It can also be used for non-invasive external pacing as well as ECG,
Resp, SpO
2
, PR, NIBP, IBP, Temp and CO
2
monitoring.
2.1.2 Indication for Use
■ External defibrillation/AED/internal defibrillation
The external defibrillation, AED and internal defibrillation modes are intended for patients with ventricular
fibrillation, pulseless ventricular tachycardia and ventricular flutter.
■ Synchronized cardioversion
Synchronized cardioversion is intended for the treatment of atrial fibrillation and atrial flutter.
■ Non-invasive external pacing
Non-invasive external pacing is intended for the treatment of bradycardia and asystole.
■ Monitoring
Monitoring is intended for the monitoring of ECG, Resp, SpO
2
, PR, NIBP, IBP, Temp and CO
2
parameters.
2.1.3 Intended Users
The Defibrillator/Monitor is for by qualified medical personnel trained in the operation of the equipment and
qualified by training in basic life support, advanced cardiac life support or defibrillation.
2.1.4 Intended Patient Population
■ AED Mode
The AED mode is to be used only on patients in cardiac arrest. The patients must be:
◆ Unconsciousness
◆ Absence of normal breathing
◆ Absence of a pulse or signs of circulation
■ Manual Defibrillation Mode
Manual defibrillation is intended for the initial treatment of ventricular fibrillation and ventricular
tachycardia in patients that are pulseless and unresponsive. Synchronized cardioversion is intended for
termination of atrial fibrillation.
■ Noninvasive Pacing Mode
Noninvasive pacing therapy is intended for patients with symptomatic bradycardia.
■ Monitoring Mode
All the parameters can be monitored on single adult, pediatric and neonatal patients.
2.1.5 Intended Medical Conditions
The Defibrillator/Monitor is for use in hospital and pre-hospital areas.
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