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1.1 INTENDED USE (PATIENTS GROUP AND MEDICAL CONDITIONS)
The RESCUE LIFE 9 is a NON-INVASIVE ACTIVE MEDICAL DEVICE intended for treatment of cardiac
arrhythmias such as a) Ventricular Fibrillation (VF), b) Fast Ventricular Tachycardia (FVT). In this field is
possible the acquisition of biomedical parameters like ECG.
The RESCUE LIFE 9 can be applied to the following classes of patients:
•
Adult patients (including pregnant women, as no significant clinical data is available in the literature
to demonstrate unacceptable adversities, relating to the intended use, on the patient and her
fetus);
Pediatric patients (age <8 years or weight <25 kg).
•
Neonatal patients (<1 year of age) are not intended for treatment.
The manufacturer recommends to not use RESCUE LIFE
•
Places where high oxygen concentration is present;
•
Places where inflammable substances are present.
In manual mode the RESCUE LIFE 9 is intended to be used by health care professionals and emergency
rescue personnel who have been trained in Advanced Life Support (ALS) protocol. The user must know how
to interpret ECG's, decide the energy level required and when the defibrillation is necessary.
RESCUE LIFE 9 is designed for any group of patients to treat:
Ventricular Fibrillation (VF)
-
Fine Ventricular Fibrillation (FVF)
-
-
Ventricular Tachycardia (VT) with a rate higher than 150 bpm (beats per minute)
Used in MANUAL MODE, RESCUE LIFE 9 is designed to be used on pediatric patients
and on "special patients" (e.g. pregnancy women) according to the ECR Guidelines 2015 - Section 4
"Cardiac arrest in special circumstances" par. C - SPECIAL PATIENTS.
Moreover it is designed to treat, by means of Synchronous defibrillation (cardioversion), patients with
ECG's that show the presence of Atrial Fibrillation. It is designed to monitor patient ECG by means of the
multiple signal acquisition electrodes.
The pacing option is indicated for treating patients with symptomatic
Used in AUTOMATED MODE (AED), RESCUE LIFE 9 is designed to be used on adult patients (by use of
DISPOSABLE MULTINFUNCTIONAL ELECTRODES – ADULT PATIENTS), on pediatric patients (by use of
DISPOSABLE MULTINFUNCTIONAL ELECTRODES – PEDIATRIC PATIENTS) and special patients (e.g. pregnant
women) according to the ECR Guidelines 2015 - Section 4 "Cardiac arrest in special circumstances" par. C -
SPECIAL PATIENTS.
:
1
Pediatric patient
a person of age under 8 years and weighing less than 25 Kg.
9
Rescue Life
– Instruction For Use
1 - INTRODUCTION
9
in the following environments:
1-2
Rev.0.5 – 30/03/2022
1
, adult patients
bradycardia.
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