Philips DigiTrak XT, Instructions For Use Manual

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Appendix A
Electromagnetic Compatibility (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the
DigiTrak XT recorder.
An electronic device can either generate or receive electromagnetic interference. Testing for
electromagnetic compatibility (EMC) has been performed on the DigiTrak XT recorder
according to the international standard for EMC for medical devices (IEC 60601-1-2). This
IEC standard has been adopted in Europe as the European Norm (EN 60601-1-2).
The DigiTrak XT complies with the requirements of standard EN 60601-1, as follows:
„
The equipment is not suitable for use in the presence of a flammable anaesthetic mixture
with air or with oxygen or nitrous oxide.
„
IPX3 ordinary equipment (enclosed equipment with protection against spraying water).
The recorder will withstand exposure to liquids, such as rain, or splashing water. The
recorder will not survive full immersion or liquid spray under pressure. The patient should
be instructed not to wear the recorder in the shower or bath.
„
Internally powered equipment
„
Mode of operation - continuous operation.
The DigiTrak XT recorder should not be used adjacent to, or stacked on top of other
equipment. If the DigiTrak XT recorder must be used adjacent to or stacked on top of other
equipment, verify that the recorder operates in an acceptable manner in the configuration in
which it will be used.
Fixed, portable, and mobile radio frequency communications equipment can affect the
performance of medical equipment. For more information on troubleshooting, see
“Troubleshooting” on page 2-2.
The list of cables with which Philips claims compliance with emissions and immunity
requirements of IEC 60601-1-2 are listed on page 2-7.