Restarting the defibrillator, Fda tracking requirements – ZOLL R Series Monitor Defibrillator Rev K Operators Guide User Manual

Page 28

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C

HAPTER

1

G

ENERAL

I

NFORMATION

1–20

www.zoll.com

9650-0904-01 Rev. K

To protect the unit from damage during defibrillation, for accurate ECG information, and to
protect against noise and other interference, use only internal current-limiting ECG cables
specified or supplied by ZOLL.

For continued safety and EMI performance, use only the line cord supplied by ZOLL.

Dispose of battery packs in accordance with national, regional and local regulations. Battery
packs should be shipped to a reclamation facility for recovery of metal and plastic compounds
as the proper method of waste management.

Restarting the Defibrillator

Certain events require the R 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. Turn the Mode Selector to OFF.

2.

If necessary, replace a depleted battery with a fully charged pack, or connect the defibrillator
to AC mains.

3.

Turn the Mode Selector to the desired operating mode to restart the unit.

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 restarted after a shutdown period of 10 seconds or more, the unit restores all settings (such as
ECG lead, ECG size, and alarm state and limits) to their power-up default values. After
restoring device operation, you might need to reinstate previously selected, non-default
settings.

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:

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