Users Manual
28
Electromagnetic Compatibility
All electrical medical equipment requires special precautions to ensure
electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), the devices must be installed and
operated according to the EMC information provided in this manual.
Note:
• The devices have been designed and tested to comply with IEC60601-1-2
requirements for EMC with other devices.
• This equipment is for use in a professional healthcare environment. It
is not for use in the radio frequency (RF) shielded room of a medical
electrical system for magnetic resonance imaging, where the intensity of
electromagnetic disturbances is high.
• The devices are not likely susceptible to interference from high-frequency
(HF) surgical instruments in the Special Environment of being in close
proximity to an active HF surgical instrument. In the case that HF surgical
interference is observed, adjust the separation distance of the equipment.
• Do not use cables or accessories other than those
provided with the devices, as this may result in increased
electromagnetic emissions or decreased immunity to such
emissions.
• If the devices are used adjacent to or stacked with other
equipment, observe and verify normal operation of the device
in the con guration which it will be used prior to a surgical
procedure.
• Equipment which employs radio frequency (RF)
communications may a ect the normal function of the device.
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The devices are intended for use in the electromagnetic environment specifi ed below. The customer
or user of the devices should ensure that they are used in such an environment.
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions CISPR 11 Group 1 Class B The devices are suitable for use in all
establishments other than domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes,
provided the following warning is heeded:
Warning: This system is intended for use by
health care professionals only. This system
may cause radio interference or may disrupt
the operation of nearby equipment. It may be
necessary to take mitigation measures, such as
reorienting or relocating the system or shielding
the location.
Harmonic emissions
IEC61000-3-2
Class A
Voltage Fluctuations/ fl icker
emissions IEC61000-3-3
Complies
DRAFT