Zoll R Series Defibrillator

Defibrillator Function

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 oris

ventricular arrhythmias. A qualified physician must decide when synchronized cardioversion

appropriate.

The advisory function should be used to confirm ventricular fibrillation and 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)

The 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 EGG rhythm analysis function are provided in the section, "EGG Rhythm

Analysis Algoirhtm Accuracey" on page A-26.

When the patient is less than 8 years of age or weighs less than 55 lbs (25 Kg), you must use ZOLL

pediatric defibrillation electrodes. Do not delay therapy to determine the patient's exact age or

weight.

Intended-Use - IEGG Monitoring

The unit is intended for use when EGG monitoring is indicated to evaluate the patient's heart rate or

EGG 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

othier physician-authorized emergency medical training.

Intended-Use - GPR Monitoring

The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to

perform chest compressions at the AHAJERC recommended rate of 100 compressions per minute.

Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult

patients.

The CPA monitoring function is not intended for use on patients under 8 years of age.

External Pacemaker (Pacer Version Only)

Intended Use - Pacemaker

This product can be used for temporary external cardiac pacing in conscious or unconscious

patients as an alternative to endlocardial stimulation.

The purposes of pacing include:

Resuscitation from standstill or bradycardia of any etiology:

INoninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill,

drug induced standstill (due to procainamide, quinidline, digitalis, b- blockers, verapamil, etc.) and

unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or

diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-

Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an

emergency than endlocardial or other temporary electrodes.

As a standby when standstill or bradycardia might be expected:

Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia

might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is

also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of

transvenous therapy. In standby pacing applications, noninvasive pacing may provide an

alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage,

embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular

tachycardia or fibrillation associated with endocardial pacing.

Suppression of tachycardia:

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and

may prevent tachycardia.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 331b. (15kg) or less using ZOLL pediatric hands-free

therapy electrode pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause

burns. Periodic inspection of the underlying skin is recommended.

Intended-Use - SP0 2 Monitoring

The R Series pulse oximeter, with the Masimo® SET® technology and the LNOP® series of oximeter

sensors, is indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SP0 2)

and pulse rate during both no-motion and patient motion conditions for adult patients, and no motion

conditions for pediatric and neonatal patients in a hospital or prehospital environment.