Instruction manual

192
SECTION 9
Guidance and manufacturer’s declaration – electromagnetic
immunity - Part 1
Guidance and manufacturer’s declaration – electromagnetic immunity - Part I
e Tono-Pen is intended for use in the electromagnetic environment speci ed below.
e customer or the user of the Tono-Pen® XL should assure that it is used in such an
environment.
Immunity test
EN 60601
test level
Compliance level
Electromagnetic
environment -
guidance
Electrostatic dis-
charge (ESD)
EN 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete, or ceramic tile.
If fl oors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
Power frequency
(50/60 Hz) mag-
netic fi eld
EN 61000-4-8
3 A/m
3 A/m
Power frequency mag-
netic fi elds should be at
levels characteristic of
a typical location in a
typical commercial or
hospital environment.