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Spectra Optia Apheresis System Operator’s Manual
255
Spectra Optia System Specifications
60601-1-2 (3rd Ed.) EMC information
Emissions guidance
Electromagnetic immunity
Note:
The term “emissions” refers to the effects that the system can have on other devices in its vicinity.
Table 18-30:
EMC emissions guidance 60601-1-2 (3rd Ed.)
Emission Test
Compliance
Electromagnetic Environment
Radio frequency (RF)
emissions CISPR 11
Group 1
System uses high frequencies only for internal function
(e.g., computer timing signals and internal communication).
Device meets RF emissions requirements of standard
CISPR 11. Therefore, RF emissions are very low and are not
likely to interfere with nearby electronic equipment.
RF emissions
CISPR 11
Group 2
Seal Safe system emits RF when sealing tubing. Nearby
electronic equipment not compliant with standard
IEC 60601-1-2 or standard CISPR 24 may be affected.
RF emissions
CISPR 11
Class A
System is suitable for use in all establishments other than
residential and establishments directly connected to the
public low-voltage power supply network that supplies
power to buildings used for residential purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations and
flicker emissions
IEC 61000-3-3
Complies
Note:
The term “immunity” refers to the system’s ability to operate correctly in the presence of electromagnetic
disturbances.
Table 18-31:
Electromagnetic immunity 60601-1-2 (3rd Ed.)
Immunity Test
Test Level IEC 60601
Compliance Level
Electromagnetic Environment
Electrostatic
discharge
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input and output
lines
± 2 kV for power supply
lines
± 1 kV for input and output
lines
Quality of the main power supply should be
that of a typical blood center or a hospital
environment.
Surge IEC 61000-4-5 ± 1 kV line to line
± 2 kV line to earth
± 1 kV line to line
± 2 kV line to earth
Quality of the main power supply should be
that of a typical blood center or a hospital
environment.
SpectraOptiaOpsManual.book Page 255 Thursday, May 17, 2018 11:24 AM
