Stephan EVETR, Instructions For Use Manual, Page: 236 / 254

12 Electromagnetic emissions and immunity
236 GA-070T-0518V2.7-HAO-EN

Fritz Stephan GmbH
WARNING
Portable and mobile RF communications equipment can affect electrical medical
devices!
Electrical medical devices or systems should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the electrical medical device
or system should be monitored to verify its intended operation in the configuration in
which it will be used.
12.2 Electromagnetic immunity
The
EVE ventilator is intended for use in the electromagnetic
environment specified below. The customer or user of the EVE ventilator
should ensure that it is used in such an environment.
Immunity test IEC60601 test level Compliance level Electromagnetic
environment guideline
Electrostatic discharge
(ESD) as defined in
IEC 61000-4-2:2008 +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 as
defined in
IEC 61000-4-4:2012 +2 kV for mains cables
+1 kV for input and
output cables
+2 kV for mains cables
+1 kV for input and
output cables
Mains power quality should be
that of a typical commercial or
hospital environment.
Surges as defined in
IEC 61000-4-4:2012 +1 kV
Line-to-line
+2 kV
Line-to-earth
+1 kV
Line-to-line
+2 kV
Line-to-earth
Mains power quality should be
that of a typical commercial or
hospital environment.