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APPENDIX: ELECTROMAGNETIC COMPATIBILITY
TABLE 1: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC EMISSIONS
The CELU M6 ALLIANCE
®
MEDICAL device is intended for use in the electromagnetic environment specified below. The CELLU M6
®
ALLIANCE
customer or patient should ensure that it is used in such an environment.
Emissions test
Conformity
Electromagnetic Environment - Directives
RF emissions CISPR 11
Group 1
The CELU M6 ALLIANCE
®
MEDICAL device uses RF energy only for
its internal functions. Therefore, its RF emissions are very low and
unlikely to cause interference in nearby electronic devices.
RF emissions CISPR 11
Class B
The CELU M6 ALLIANCE
®
MEDICAL device may be used in all
establishments, including domestic sites and sites that are
directly connected to the low voltage public power grid, which
supplies domestic buildings.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations and flicker IEC 61000-3-3
Conforms
TABLE 2: IMMUNITY
Test
Requirements
Level of conformity
Electrostatic discharge (DES)
IEC 61000-4-2
± 8 kV on contact
± 2/4/8/15 kV in the air
± 8 kV on contact
± 2/4/8/15 kV in the air
Radiated RF electromagnetic fields
IEC 61000-4-3
10V/m
80MHz - 2.7 GHz
80% AM at 1 kHz
10V/m
80MHz - 2.7 GHz
80% AM at 1 kHz
Proximity fields issued by
RF wireless communication devices
IEC 61000-4-3
Frequency (MHz)
Modulation
Requirements
(V/m)
Conformity
(V/m)
385
Pulsed modulation: 18 Hz
27
27
450
Pulsed modulation: 18 Hz
28
28
710 – 745 - 780
Pulsed modulation: 217 Hz
9
9
810 – 870 - 930
Pulsed modulation: 18 Hz
28
28
1720 – 1845 - 1970
Pulsed modulation: 217 Hz
28
28
2450
Pulsed modulation: 217 Hz
28
28
5240 – 5500 - 5785
Pulsed modulation: 217 Hz
9
9
Fats transient / burst
IEC 61000-4-4
Power lines: ± 2 kV
Input/output lines: ± 1 kV
Repetition frequency: 100 kHz
Power lines: ± 2 kV
Input/output lines: ± 1 kV
Repetition frequency: 100 kHz
Surges
IEC 61000-4-5
Between phases:
± 0.5 kV, ± 1 kV
Between phases and ground
± 0.5 kV, ± 1 kV, ± 2 kV
Between phases
± 0.5 kV, ± 1 kV
Between phases and ground
± 0.5 kV, ± 1 kV, ± 2 kV