Philips HeartStart MRx - Restrictions for Use; Emissions and Immunity; Guidance and Manufacturer’s Declaration

21 Specifications and Safety Electromagnetic Compatibility
302
Restrictions for Use
Artifact on the ECG and parameter waveforms caused by electromagnetic interference should be
evaluated by a physician or physician authorized personnel to determine if it will negatively impact
patient diagnosis or treatment.
Emissions and Immunity
The HeartStart MRx is designed and tested to comply with the radiated and conducted emissions
requirement of international and national standards IEC 60601-1-2:2001 and EN 60601-1-2:2002.
See Tables 85 through 89 for detailed information regarding declaration and guidance.
WARNING The use of accessories, transducers and cables other than those specified may result in increased
emissions or decreased immunity of the HeartStart MRx.
The list of cables, transducers, and other accessories with which Philips claims compliance with the
emissions and immunity requirements of IEC standard 60601-1-2 are listed in “Supplies and
Accessories” on page 243.
The local area network (LAN) connector of the HeartStart MRx is marked with the label. The
pins of connectors marked with this warning symbol should not be touched or connections made to
until the following precaution is taken:
Discharge yourself to a conductive metal surface which is connected to earth ground before making
connections or touching the marked connector.
All staff using the HeartStart MRx should be instructed on these precautionary measures in order to
avoid damage to this sensitive medical equipment.
The EMC standards state that manufacturers of patient-coupled equipment must specify immunity
levels for their systems. See Tables 85 through 88 for this detailed immunity information. See Table 89
for recommended minimum separation distances between portable and mobile communications
equipment and the HeartStart MRx.
Immunity is defined in the standard as the ability of a system to perform without degradation in the
presence of an electromagnetic disturbance. Degradation 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.
Guidance and Manufacturer’s Declaration
The HeartStart MRx is intended for use in the electromagnetic environment specified in the tables
below. The customer or the user of the HeartStart MRx should assure that it is used in such an
environment.