CHAPTER 1GENERAL INFORMATION
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Intended Use — Manual Operation
Use of the R Series products in the manual mode for defibrillation is indicated on victims of
cardiac arrest where there is apparent lack of circulation as indicated by:
• Unconsciousness.
• Absence of breathing.
• Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular
fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable
of producing hemodynamically significant heart beats.
In manual mode, the unit can also be used for synchronized cardioversion of certain atrial or
ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion is
appropriate.
The advisory function should be used to confirm ventricular fibrillation or wide complex
ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three
conditions indicating lack of circulation (listed above).
Intended Use — Semiautomatic Operation (AED)
R Series products are designed for use by emergency care personnel who have completed
training and certification requirements applicable to the use of a defibrillator where the device
operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a
defibrillator shock during resuscitation involving CPR, transportation, and definitive care are
incorporated into a medically-approved patient care protocol.
Use of the R Series in the Semiautomatic mode for defibrillation is indicated on victims of
cardiac arrest where there is apparent lack of circulation as indicated by:
• Unconsciousness.
• Absence of breathing.
• Absence of pulse.
Specifications for the ECG rhythm analysis function are provided in the section, “ECG Rhythm
Analysis Algorithm Accuracy” on page A-30.
When the patient is less than 8 years of age or weighs less that 55 lbs. (25 Kg), you must use
ZOLL pediatric defibrillation electrodes. Do not delay therapy to determine patient’s exact age
or weight.
Intended Use — ECG Monitoring
The unit is intended for use when ECG monitoring is indicated to evaluate the patient’s heart
rate or ECG morphology. In ECG monitoring mode, the unit is intended to be used by
personnel who are qualified by training in the use of the R Series defibrillator, basic life and/or
advanced life support, or other physician-authorized emergency medical training.
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