User's Manual

E-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below. The user of this
device should make sure it is used in such an environment.
Immunity test IEC 60601
Test Level
Compliance
Level (FDA)
Electromagnetic Environment -
Guidance
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical home or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150kHzto80
MHz
3 V/m
80MHzto
2.5GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
It is noted certification to IEC 60601-1-2
isobtainedrecognizingthatinterruption
of the download of data to the reader due
to EMI is not considered to cause harm.
When a download is stopped, the user is
prompted that and error has occurred and
the user would then reinitiate the download.
Interference that would interrupt a download
is anticipated to be of short duration such
that the subsequent download would be
successful.
Recommended Separation Distance
Pd 2.1=
Pd 2.1=
80MHzto800MHz
Pd 3.2=
800MHzto2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following
symbol: