24
IX.
ELECTROMAGNETIC
COMPATIBILITY
The information contained in this section (such as separation distances) is in general
specifically written with regard to this model. The numbers provided will not guarantee
faultless operation but should provide reasonable assurance of such. This information may
not be applicable to other medical electrical equipment; older equipment may be particularly
susceptible to interference.
9.0
WARNING
9.0.1
This equipment/system is intended for use by healthcare professionals only. This
equipment/system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating the Surgitron
®
Dual/EMC or shielding the location.
9.1
PRECAUTIONS
9.1.1
Interference caused by the Surgitron
®
Dual/EMC could adversely affect the
operation of other electrical equipment. In the event of interference, plug the unit in
a separate outlet or plug the unit in another room.
9.1.2
Medical electrical equipment requires special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided in this document and the remainder of the instructions for
use for this device.
9.1.3
Portable and mobile radio frequency RF communication equipment (including
peripherals, such as antenna cables and external antennas) can affect the
generator. It is recommended to keep a minimum distance of 12 inches (30 cm)
from the device.
9.1.4
Cables and accessories not specified within the instructions for use are not
authorized. Using other cables and/or accessories may adversely impact safety,
performance and electromagnetic compatibility (increased emission and decreased
immunity).
9.1.5
Care should be taken if the equipment is used adjacent to or stacked with other
equipment; if adjacent or stacked use is inevitable, the equipment should be
observed to verify normal operation in the configuration in which it will be used.