Cautions, Indications for use, Contraindications for use – ZOLL AED Plus Fully Automatic Rev B User Manual

Page 7: Intended users of the device

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Fully Automatic 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. CPR

monitoring will only work if the device is configured to work with CPR-D-padz.

Indications for Use

Use the Fully Automatic AED Plus 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 Fully Automatic AED

Plus should be used with Fully Automatic AED Plus Pediatric Electrodes (pedi

-padz

®

II). Therapy

should not be delayed to determine the victim’s exact age or weight.

Contraindications for Use

Do NOT use the Fully Automatic 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 ZOLL AED Plus Fully Automatic external defibrillator is intended to be used by responders who

have been trained and certified in CPR and the use of an AED to defibrillate victims of cardiac arrest.

The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest

compressions at the AHA recommended rate of 100 compressions per minute. Voice and visual prompts

encourage a minimum compression depth of 2 inches for adult patients. The CPR monitoring function

is not intended for use on patients under 8 years of age.

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