Guidance and Manufacturer’s Declaration – Immunity for ME Equipment/Systems that are NOT life
supporting.
The ClariVein
®
IC is intended for use in the electromagnetic environment specified below. The user should
ensure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment – Guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz
to 2.5 GHz
(E1)=3V/m
Portable and mobile communications equipment
should be separated from the ClariVein
®
IC by
no less than the distances calculated/listed
below:
D=(3.5/V1)(Sqrt P) 150 to 80 MHz
D=(3.5/E1)(Sqrt P) 80 to 800 MHz
D=(7/E1)(Sqrt P) 800 MHz to 2.5 GHz
where P is the max power in watts and D is the
recommended separation distance in meters.
Field strengths from fixed transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels (E1).
Interference may occur in the vicinity of
equipment containing a transmitter.
Recommended Separation Distances between portable and mobile RF Communications equipment and the
ClariVein® IC which is not NOT Life-supporting.
The
ClariVein
®
IC is intended for use in the electromagnetic environment in which radiated disturbances are
controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF Communications Equipment and the ClariVein
®
IC as recommended below, according to
the maximum output power of the communications equipment.
Max Output Power
(Watts)
Separation (m)
150 to 80MHz
D=(3.5/V1)(Sqrt P)
Separation (m)
180 to 800MHz
D=(3.5/E1)(Sqrt P)
Separation (m)
800MHz to 2.5GHz
D=(7/E1)(Sqrt P
)
0.01
0.116667
0.116667
0.233333
0.1
0.368932
0.368932
0.737865
1
1.166667
1.166667
2.333333
10
3.689324
3.689324
7.378648
100
11.66667
11.66667
23.33333
WARRANTY
Vascular Insights
™
, LLC (“Vascular Insights”) warrants that reasonable care has been used in the
design and manufacture of this instrument and that it is free from manufacturing defects resulting
from inferior workmanship or material that interferes with the ordinary use or functionality of the
instrument for which it was sold by Vascular Insights
™
or its authorized vendor. The warranty
covers only manufacturing defects that are reported to Vascular Insights
™
within one (1) year from
the date that the instrument was delivered by Vascular Insights
™
or its authorized vendor to the end
user who purchased the instrument for his/her/its or his/her/its employees’ use. This warranty is the
____________________________________________________________________
ClariVein
®
is a registered trademark of Vascular Insights
™
, LLC in the United States.
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