St. Jude Medical QUANTIEN, Инструкция по эксплуатации

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Emission Test Complianc
e Electromagnetic Environment
RF emissions
CISPR 11 Group 1 The QUANTIEN™ measurement system uses RF energy
only for its internal functioning. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class A
Harmonic emissions
IEC 61000-3-2 Class A
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies The QUANTIEN measurement system is suitable for use
in all establishments other than domestic and those
directly connected with the public low-voltage power
supply network that supplies buildings for domestic
purposes.
aGuidance and Manufacturer’s Declaration - Electromagnetic
Immunity
The QUANTIEN™ measurement system is intended for use in the electromagnetic environment
specified below. The customer or user of the system should assure that it is used in such an
environment.
Table 51. Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test IEC 60601
Test Level Complianc
e Level Electromagnetic Environment -
Guidance
Electrostatic discharge
(ESD)
7
IEC 61000-4-2
±6 kV contact
±8 kV air Complies Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4 ±2 kV for power supply
lines
±1 kV for input/ output
lines Complies Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5 ±1 kV differential mode
±2 kV common mode Complies Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations to
power supply input
lines
IEC 61000-4-11
<5% UT (>95% dip in
UT) for 0,5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec Complies Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the QUANTIEN measurement
system requires continued
operation during power mains
interruptions, it is recommended
that the system be powered from
an uninterruptible power supply
7
PressureWire™ guidewire is ESD sensitive and non-compliant with 6kV.
State: Released Date: 2019.03.06 22:30 GMT