Zoll AED Plus Fully Automatic Rev B User Manual Page 7

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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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