Restarting the monitor, Software license, Notification of adverse events – ZOLL Propaq M Rev B User Manual

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9650-0803-01 Rev. B

Restarting the Monitor

Certain events require the Propaq M products to be restarted after they shut off or become
inoperative (for example, when the battery runs down and the unit shuts off).

In such a case, always try to restore monitor operation as follows:

1. Press the power switch on the top of the unit to turn it off.

2.

If necessary, replace a depleted battery with a fully charged pack, or connect the monitor to
auxiliary power.

3.

Press the power switch on the top of the unit to turn it back on.

This sequence is necessary to restart the monitor and can also be used to clear some fault
messages when immediate use of the monitor is required.

If the Propaq M unit is powered off for less than 2 minutes, all patient monitoring parameter
settings will be retained. If the unit has been powered off for at least two minutes, it will be
considered a New Patient and all of the patient-specific parameters (alarm limits, etc.) will be
reset to their default values.

Notification of Adverse Events

As a health care provider, you may have responsibilities under the Safe Medical Devices Act
(SMA), for reporting to ZOLL Medical Corporation, 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 addition, as part of our Quality Assurance Program, ZOLL Medical Corporation
requests to be notified of device failures or malfunctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality products.

Software License

Note:

Read this Operator’s Guide and License agreement carefully before operating any of
the Propaq M 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, sublicense or otherwise transfer or share its
rights under the license without the express written permission of ZOLL Medical
Corporation.

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