Cautions; Indications For Use; Contraindications For Use; Intended Users Of The Device - ZOLL Aed Plus Administrator's Manual

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 ZOLL AED Plus.

Indications for Use

Use the ZOLL 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 ZOLL AED Plus
should be used with ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine
the patient's exact age or weight.

Contraindications for Use

Do NOT use the ZOLL AED Plus when the patient:
• Is conscious; or
• Is breathing; or
• Has a detectable pulse or other signs of circulation.

Intended Users of the Device

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by
training in the use of the ZOLL AED Plus device, basic life support, advanced life support, or other
physician-authorized emergency medical response to defibrillate victims of cardiac arrest. The CPR
monitoring 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 compression depth of 1½ - 2 inches for adult patients. The CPR monitoring
function is not intended for use on patients under 8 years of age.
ZOLL AED PLUS Administrator's Guide vii