Terumo Harvest SmartPReP 2, Operator'S And Service Manual

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Guidance and Manufacturer’s Declaration- Immunity
ME Equipment and ME Systems that are NOT Life-Supporting
Guidance and Manufacturer’s Declaration- Immunity
The SmartPReP2 is intended for use in the electromagnetic environment specified below. The customer or user of the SmartPReP2
should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance
Level Electromagnetic
Environment-
Guidance
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
(V1)=3Vrms
(E1)=3V/m Portable and mobile communications equipment
should be separated from the SmartPReP2 by no less
than the distance calculated/listed below:
D=(3.5/V1) (Sqrt P)
150kHz to 80MHz
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 (V1 and E1).
Interference may occur in the vicinity of equipment
containing a transmitter.
Recommended Separation Distances between portable and mobile RF Communications equipment and
the SmartPReP2
ME Equipment and ME Systems that are NOT Life-Supporting
Recommended Separations Distances for the SmartPReP2
The SmartPReP2 is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The
customer or user of the SmartPReP2 can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF Communications Equipment and the SmartPReP2 as recommended below, according to the maximum
output power of the communications equipment
Max Output Power
(Watts) Separation (m)
150 kHz to 80 MHz
D=(3.5/V1) (Sqrt P) Separation (m)
80 to 800 MHz
D=(3.5/E1) (SqrtP) Separation (m)
800MHz to 205 GHz
D=(7/E1) (Sqrt P)
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.333