ZOLL E Series Monitor Defibrillator Rev R - Manual (Page 23)

General Information
9650-1210-01 Rev. R 1-15
FDA Regulations
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
• 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. Model Number and Serial Number
3. Disposition of Device (e.g., received, lost, stolen,
destroyed, distributed to another organization), New
Location and/or Organization (if known and different
from #1 above) — Company Name, Address, Contact
Name, and Contact Phone Number
4. Date change took effect
5. Other information or comments
Please address your information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-4105
Fax: (978) 421-0010
Tel: (978)
421-9655
Notification of Adverse Events
Under the Safe Medical Devices Act (SMDA), health
care providers are responsible 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 malfunctions.
This information is required to assure that ZOLL provides
only the highest quality products.
Software License
Note: Read this Operator’s Manual and License
agreement carefully before operating any of the
E Series products.
Software incorporated into the system is protected by
copyright laws and international copyright treaties as well
as other intellectual property laws and treaties. This
software is licensed, not sold. By taking delivery of and
using this system, the Purchaser signifies agreement to
and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the
software license fee which is part of the price paid for
this product, ZOLL Medical Corporation grants the
Purchaser a non-exclusive license, without right to
sublicense, to use the system software in object-code
form only.
2. Ownership of Software/Firmware: Title to,
ownership of and all rights and interests in the system
software and all copies thereof remain at all times
vested in the manufacturer and Licensors to ZOLL
Medical Corporation and they do not pass to
Purchaser.
3. Assignment: Purchaser agrees not to assign, sub-
license or otherwise transfer or share its rights under
the license without the express written permission of
ZOLL Medical Corporation.
4. Use Restrictions: As the Purchaser, you may
physically transfer the products from one location to
another provided that the software/firmware is not
copied. You may not disclose, publish, translate,
release, or distribute copies of the software/firmware
to others. You may not modify, adapt, translate,
reverse engineer, decompile, crosscompile,
disassemble, or create derivative works based on the
software/firmware.
Service
The device does not require periodic recalibration or
adjustment. Appropriately trained and qualified
personnel should, however, perform periodic tests of the
device to verify proper operation. (See “General
Maintenance” on page 11-1).
Returning a unit for service
Before sending a unit to the ZOLL Technical Service
Department for repair, obtain a service request (SR)
number from the service representative.
Remove the battery pack from the unit, and pack the unit
with its cables in the original containers (if available) or
equivalent packaging. Be sure the assigned service
request number appears on each package.