Restrictions For Use; Immunity Level - Philips HEARTSTART XLT M3500B Instructions For Use Manual

NOTE
M3500B HeartStart XLT Defibrillator/Monitor
Once the source is located, attempt to attenuate the EMC coupling path by
distancing the defibrillator from the source as much as possible. If assistance
is needed, call your local service representative.

Restrictions for Use

Artifact on the ECG caused by electromagnetic interference should be evalu-
ated by a physician or physician authorized personnel to determine if it will
negatively impact patient diagnosis or treatment.

Immunity Level

The EMC standards state that manufacturers of patient-coupled equipment
must specify immunity levels for their systems. It is recognized that the Heart-
Start XLT defibrillator/monitor is designed to receive and amplify low level
signals in the same bandwidth as the interference.
Immunity is defined in the standard as the ability of a system to perform with-
out degradation in the presence of an electromagnetic disturbance. Degrada-
tion in ECG quality is a qualitative assessment which can be subjective.
Caution should, therefore, be taken in comparing immunity levels of different
devices. The criteria used for degradation is not specified by the standard and
may vary with the manufacturer.
For additional information about compliance with the EMC standards
see the Philips Medical web site at http://www.medical.philips.com/cms and
follow the regulatory link.
Electromagnetic Compatibility
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