Indications For Use; Contraindications For Use; Intended Users Of The Device; Tracking Requirements - ZOLL AED PLUS Administrator's Manual

• 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.

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.

Contraindications for Use

Do NOT use the AED when the patient is:
• Conscious; or
• Breathing; or
• Has a detectable pulse or other signs of circulation.
The ZOLL AED PLUS is not indicated for use on patients under 8 years of age (Per AHA Guidelines
2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, I-64, 2000).

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 AED PLUS, basic life support, or 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.

Tracking Requirements

U.S Federal Law (21 CFR 821) requires the tracking of defibrillators. As an owner of this device, you
have the responsibility under this law to notify ZOLL Medical Corporation if this product has been
received, lost, stolen or destroyed or has been donated, resold or otherwise distributed to a different
organization.
If any of the events described above occur, please contact ZOLL Medical Corporation in writing with
the following information:
1.Originator's organization - Company Name, Address, Contact Name and Contact Phone Number.
2.Part Number/Model Number and Serial Number.
3.Disposition of Device (e.g. received, lost, stolen destroyed, distributed to another organization).
4.New Location and/or Organization (if different from #1 above) - Company Name, Address, Contact
Name and Contact Phone number.
5.Date change took effect.

Notification of Adverse Events

As a health care provider, you may have responsibilities under the SMDA for reporting to ZOLL and
possibly to the FDA, the occurrence of certain events. These events, described in 21 CFR Part 803,
include device related death and serious injury or illness. In any event, as part of our Quality Assurance
Program, ZOLL should be notified of any device failures or malfunction. This information is required
to assure that ZOLL provides only the highest quality products.
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