SKF Matrix Series User Manual

Table 5
Enclosure port
Phenomenon Basic EMC standard
or testmethod
Immunity test levels
Professional healtcare Home healthcare
facility environment environment
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fields
a)
IEC 61000-4-3 3 V/m
f)
10 V/m
f)
80 MHz – 2,7 GHz
b)
80 MHz – 2,7 GHz
b)
80% AM at 1 kHz
c)
80% AM at 1 kHz
c)
Proximity fields from RF wireless
communication equipments
IEC 61000-4-3 (→ table 10 on page 23) (→ table 10 on page 23)
Rated power frequency
magnetic fields
d), e)
IEC 61000-4-8 30 A/m
g)
50 Hz or 60 Hz
30 A/m
g)
50 Hz or 60 Hz
a)
The interface between the patient physiological signat simulation, if used, and the ME equipment or ME system shall be located within 0,1 m of the vertical plane of uniform field area in one
orientation of the ME equipment or ME system
b)
ME equipment and ME system that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the frequency of reception. Testing may be performed
at other modulation frequencies identified by the risk management process. This test assesses the basic safety and essential performance of an intentional receiver when an ambient
signal is in the passband. It is understood that the receiver might not achieve normal reception during the test.
c)
Testing may be performed at other modulation frequencies identified by the risk management process.
d)
Applies only to ME equipment an ME systems with magnetically sensitive components or circuitry.
e)
During the test, the ME equipment or ME system may be powered at any nominal input voltage, but with the same frequency as the test signal († IEC60601-1-2:2014 / table 1)
f)
Before modulation is applied
g)
This test level assumes a minimum distance between the ME equipment or the ME system and sources of power frequency magnetic field of at least 15 cm. If the RISK ANALYSIS shows that the
ME equipment or ME system will be used closer than 15 cm to sources of power frequency magnetic field, the immunity test level shall be adjusted as appropriate for the minimum expected
distance.
Table 4
Deviations from Standard 5.2.2.1b)
Test type Value Sample Remark
60601-1-2:2014 9.1 Interference voltage emission
requirement 0 dB QP margin
measurement –1,8 dB / 154 kHz MAX 30 FAIL
–0,9 dB /172 kHz MAX 30 FAIL
9.2 Discontinous disturbance (clicks) emission high click rate MAX 11, MAX 30 FAIL (both actuator types)
PASS with Control unit KOM
10.4 Surges immission
requirement L-L (AC) ±1 kV, ± 2 kV MAX 11, MAX 30
N/A (only product for 24 VDC)
requirement L-PE (AC) ±1 kV, ± 2 kV MAX 11, MAX 30 N/A (only product for 24 VDC)
requirement L-L (DC) ±0,5 kV
requirement L-PE (DC) ±0,5 kV
measurement ±0,5 kV MAX 11, MAX 30 PASS with DC power
61000-6-3 9.2 Discontinous disturbance (clicks) emission high click rate MAX 11, MAX 30 FAIL (both actuator types)
PASS with Control unit KOM
Action plan according the deviations:
In the applications the MAX1 and MAX3 are operated with a Control unit supplied by mains.
Therefore we accept the deviations.
The end user must secure compliance to the applicable EMC requirements.
Immunity Test levels (IEC 60601-1-2:2014)
19

SKF Matrix Series Specifications

General

Brand	SKF
Model	Matrix Series
Category	Controller
Language	English