ZOLL Aed Plus - Safety Considerations

viii ZOLL AED PLUS Administrator’s Guide
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 Safe Medical Devices Act (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.
Unpacking
• Carefully inspect each packing container for damage.
• Examine the unit for any signs of damage that may have occurred during shipping.
• If the contents are incomplete or damaged or if the unit fails to pass its self test as indicated by a
Red “X” in the status indicator window after battery installation, contact ZOLL Medical
Corporation’s Technical Service Department.
• Review the shipping list to insure that all items ordered were received.
Conventions
Throughout this document, voice prompts are indicated by capital italicized letters, such as
CALL FOR HELP.
NOTE Notes contain additional information on using the defibrillator.
WARNING! Warning statements describe conditions or actions that can result in personal
injury or death.
CAUTION! Caution statements describe conditions or actions that can result in damage to the
unit.