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Restarting the defibrillator, Fda tracking requirements – ZOLL X Series Monitor Defibrillator Rev H User Manual

Page 37

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Restarting the Defibrillator

9650-001355-01 Rev. H

X Series Operator’s Guide

1-25

Restarting the Defibrillator

Certain events require the X Series 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 defibrillator 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 defibrillator
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 defibrillator and can also be used to clear some fault
messages when immediate use of the defibrillator is required.

If the X Series 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, defibrillator
energy, etc.) will be reset to their default values.

FDA Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of defibrillators. Under this law, owners
of this defibrillator must notify ZOLL Medical Corporation if this product is

received

lost, stolen, or destroyed

donated, resold, or otherwise distributed to a different organization

If any such event occurs, 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 of the defibrillator

3.

Disposition of the defibrillator (for example, received, lost, stolen, destroyed, distributed to
another organization), new location and/or organization (if known and different from
originator’s organization) – company name, address, contact name, and contact phone
number

4.

Date when the change took effect

Please address the information to:

ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-4105

Fax:

(978) 421-0025

Telephone: (978) 421-9655