Electromagnetic compatibility
Instructions for use • S-PILOT
®
• PYB194_EN_V1.0_02-2021_IFU_CE-MDR 33
Accessories and cables for EMC compliance
Type Shield Length [m] Ferrite Use
Triad or Covidien
Valleylab Force
FX
9.3 Table 1 – Compliance level for immunity tests
Guidelines and manufacturer’s declaration– electromagnetic immunity
The product is intended for use in the electromagnetic environment specified below. The user
of the product should make sure that it is used in such an environment.
Interference im-
munity tests
EN/IEC60601 test
level
Compliance level Electromagnetic envi-
ronment – guidelines
Electrostatic dis-
charge (ESD) acc.
to IEC 61000-4-2
±8kV contact dis-
charge
±15kV air discharge
±8kV contact dis-
charge
±15kV air discharge
Floors should be made
of wood, concrete or
covered with ceramic
tiles. If floors are cov-
ered with synthetic ma-
terial, the relative hu-
midity should be at
least 30%.
Rapid transient
electrical interfer-
ences/bursts acc.
to IEC 61000-4-4
±2kV for power lines
±1kV for input and
output lines
100kHz repetition
±2kV for power lines
±1kV for input and
output lines
100kHz repetition
The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Surges acc. to
IEC 61000-4-5
± 1kV voltage outer
conductor – outer con-
ductor
±2kV voltage outer
conductor – ground
± 1kV voltage outer
conductor – outer con-
ductor
±2kV voltage outer
conductor – ground
The power supply qual-
ity should be that of a
typical commercial or
hospital environment.
Voltage dips,
short interrup-
tions, and fluctua-
tions of the power
supply acc. to
IEC61000-4-11
Voltage dip:
Dip to 0% for 1 cycle
@ 0° phase angle
Dip to 70% for 25/30
cycles @ 0° phase an-
gle
Dropout to 0% for 0.5
cycles @ 0°, 45°, 90°,
135°, 180°, 225°, 270°,
& 315° phase angles
Voltage interruption:
100% for 250/300cy-
cles
Voltage dip:
Dip to 0% for 1 cycle
@ 0° phase angle
Dip to 70% for 25/30
cycles @ 0° phase an-
gle
Dropout to 0% for 0.5
cycles @ 0°, 45°, 90°,
135°, 180°, 225°, 270°,
& 315° phase angles
Voltage interruption:
100% for 250/300cy-
cles
The power supply qual-
ity should be that of a
typical commercial or
hospital environment. If
the user of the product
requires continued op-
eration during power
mains interruptions, it is
recommended that the
product be powered
from an uninterruptible
power supply or a bat-
tery.