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Restrictions For Use; Immunity Level (devices With Serial Numbers Us001xxxxx); Emissions And Immunity (devices With Serial Numbers Us002xxxxx) - Philips M4735A HeartStart XL Service Manual

Defibrillator/monitor.
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Electromagnetic Compatibility
NOTE
WARNING
7-22

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 (Devices with Serial Numbers US001XXXXX)

The EMC standards state that manufacturers of patient-coupled equipment
must specify immunity levels for their systems. It is recognized that the Heart-
Start XL 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 and the
Declaration of Conformity Statement
at http://powerstation.medical.philips.com.Click the Business Data Viewer
Tab, and then select the Declaration of Conformity link listed under Regula-
tory.
Emissions and Immunity (Devices with Serial Numbers
US002XXXXX)
The HeartStart XL is designed and tested to comply with the radiated and con-
ducted emissions requirement of EN 60601-1-2:2002. See Tables 7-5 through
7-9 for detailed information regarding declaration and guidance.
The use of accessories, transducers and cables other than those specified below
may result in increased emissions or decreased immunity of the HeartStart XL.
Fixed, portable, and mobile frequency communications equipment can affect the per-
formance of medical equipment. See Table 7-9 for the minimum recommended sepa-
ration distance between RF communications equipment and the HeartStart XL.
The list of cables, transducers, and other accessories with which Philips
claims compliance with the emissions and immunity requirements of EN
60601-1-2 are listed in "Maintaining the HeartStart XL" .
The EMC standards state that manufacturers of patient-coupled equipment
must specify immunity levels for their systems.
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.
, p
lease see the Philips Medical web site
Specifications

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