User's Manual

viii
Electromagnetic Compatibility (EMC)
Electromagnetic compatibility with surrounding devices should be assessed when using the device.
An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic
compatibility (EMC) has been performed on the device 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 device should not be used adjacent to, or stacked on top of other equipment. If the device must be used
adjacent to or stacked on top of other equipment, verify that the device 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. See Table X-4 for recommended separation distances between the radio equipment and the device.
Table X-1 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF Emissions
CISPR 11
Group 2 The equipment must emit electromagnetic energy in order to
perform its intended function. Nearby electronic equipment may
be affected.
RF Emissions
CISPR 11
Class B
Harmonic Emissions
IEC 61000-3-2
Not Applicable
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Not Applicable
The equipment is suitable for use in all establishments including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
Table X-2 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The equipment is intended for use in the electromagnetic environment specified in the table below. The customer or
the user of the equipment should ensure that it is used in such an environment.
Emissions Test Compliance Compliance
Level
Electromagnetic Environment: Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+/- 2 kV for
power supply lines
+/- 1 kV for
input/output lines
Not Applicable
Surge
IEC 61000-4-5
+/- 1 kV
differential mode
+/- 2 kV
common mode
Not Applicable