Spectra Optia System Specifications
252
Spectra Optia Apheresis System Operator’s Manual
Electromagnetic Compatibility (EMC)
The Spectra Optia system complies with either the 60601-1-2 (4th Ed.) emission limits described in Tables 18-27
through 18-29, or the 60601-1-2 (3rd Ed.) emission limits described in the Tables 18-30 through 18-35.
Operators should ensure that the system is used in an environment that complies with these specifications. If you
are unsure which set of EMC information applies to your Spectra Optia system, contact your Terumo BCT
representative.
60601-1-2 (4th Ed.) EMC information
Note:
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this
equipment might not offer adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the equipment.
Table 18-27:
Emissions tests 60601-1-2 (4th Ed.)
Emissions Test
Compliance
Electromagnetic Environment–Guidance
Conducted and radiated
radio frequency (RF)
emissions
CISPR 11
Group 1
The system uses high frequencies only for internal function
(e.g., computer timing signals and internal communication).
The RF emissions meet the requirements of standard
CISPR 11. Therefore, RF emissions are very low and are not
likely to interfere with nearby electronic equipment.
Conducted and radiated RF
emissions
CISPR 11
Group 2
Class A
The Spectra Optia system emits RF for the Seal Safe
system, so the Seal Safe can perform its intended function.
The RF is only emitted when sealing tubing. Nearby
electronic equipment may be affected.
Harmonic distortion
IEC 61000-3-2
Class A
Not applicable
Voltage fluctuations and
flicker emissions
IEC 61000-3-3
Complies
Table 18-28:
Immunity tests and test levels 60601-1-2 (4th Ed.)
Immunity Test
Test Level IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
Radiated RF EM
fields
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz
For proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
See immunity test levels and test frequencies in Table 18-29
Electrical fast
transients/bursts
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input and output lines
100 kHz repetition frequency
SpectraOptiaOpsManual.book Page 252 Thursday, May 17, 2018 11:24 AM
