Cautions, Indications for use, Contraindications for use – ZOLL AED Plus Rev V User Manual

Page 7: Intended users of the device

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ZOLL AED PLUS Administrator’s Guide

vii

Cautions

• Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel.

• Use only commercially available type 123A lithium manganese dioxide batteries. Discard batteries

properly after removal from unit. Use only batteries from recommended manufacturers.

• If the device is stored outside the recommended environmental conditions, the electrode pads and/

or batteries may be damaged or their useful life reduced.

• Safety and effectiveness data submitted by ZOLL Medical Corporation to the Food and Drug

Administration (FDA) under section 510(K) of the Medical Device Act to obtain approval to

market are based upon the use of ZOLL accessories such as disposable electrodes. The use of

electrodes from sources other than ZOLL is not recommended. ZOLL makes no representations or

warranties regarding the performance or effectiveness of its products when used in conjunction

with electrodes from other sources. If unit failure is attributable to the use of accessories not

manufactured by ZOLL, this may void ZOLL's warranty.

• The CPR-D

-

padz electrode can be connected to other ZOLL Defibrillators with Multifunction

Cables. Defibrillation can be administered when connected to other ZOLL Defibrillators. The CPR

function does not operate with any device other than the AED Plus and AED Pro

®

.

Indications for Use

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as

indicated by:

• Unconsciousness and

• Absence of normal breathing and

• Absence of a pulse or signs of circulation.

When the victim is less than 8 years of age, or weighs less than 55 lbs (25 kg), the ZOLL AED Plus

should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to

determine the victim’s exact age or weight.

Contraindications for Use

Do NOT use the AED Plus when the victim:

• Is conscious; or

• Is breathing; or

• Has a detectable pulse or other signs of circulation.

Intended Users of the Device

The AED Plus external defibrillator is intended to be used by personnel who are qualified by training in

the use of the AED Plus device, basic life support, advanced life support, or other physician-authorized

emergency medical response to defibrillate victims of cardiac arrest. The Real CPR Help

®

function

provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC

recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum

compression depth of 2 inches for adult victims. The Real CPR Help function is not intended for use on

victims under 8 years of age.

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