Iridex PASCAL Synthesis - Page 129

PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 129 of 141
88292-EN, Rev D
Guidance and manufacturer's declaration - electromagnetic immunity
The PASCAL Synthesis Ophthalmic Scanning Laser System is intended for use in the electromagnetic
environment specified below. The customer or the user of the PASCAL Synthesis Ophthalmic Scanning
Laser System should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2:2014
test level
Compliance
level
Electromagnetic environment
-
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHz to 80MHz
10 V/m
80MHz to 2.7GHz
Proximity
electromagnetic field
from radio
communication
equipment a)
3 Vrms
150kHz to 80MHz
10 V/m
80MHz to 2.7GHz
Proximity
electromagnetic field
from radio
communication
equipment a)
Portable and mobile RF
communications equipment should
be used no closer to any part of the
PASCAL Synthesis Ophthalmic
Scanning Laser System, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d =
!
"
√
𝑃
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer, d is the
recommended separation distance
in meters (m), and E is the radiation
electromagnetic field level in
volt/meter (V/m).
NOTE 1
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.