INTELLIGO IGF 2.1 - EMC Statement

33
9 EMC Statement
Guidance and Manufacture's declaration – electromagnetic emissions
The Continuous Glucose Monitoring Systems is suitable for use in the specified
electromagnetic environment (s) and it has met the following standard’s emission
requirements.
Phenomenon
Home healthcare environment
Conducted and radiated RF emissions
CISPR 11, Group 1, Class B
Harmonic distortion
N/A
Voltage fluctuations and flicker
N/A
Guidance and manufacture's declaration – electromagnetic immunity
The Continuous Glucose Monitoring Systems is suitable for use in the specified
electromagnetic environment (s) and it has met the following immunity test levels.
Higher immunity levels may cause the Continuous Glucose Monitoring Systems
essential performance lost or degraded.
Phenomenon
Basic EMC standard
or test method
Home healthcare facility environment
Electrostatic discharge
IEC 61000-4-2
+/- 8 kV contact
+/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV
air
Radiated RF EM fields
IEC 61000-4-3
10V/m
80MHz-2.7GHz
80%AM at 1kHz
Proximity fields from
RF
wireless
communications
equipment
IEC 61000-4-3
See the RF wireless communication
equipment table in "Recommended
minimum separation distances".
Rated power frequency
magnetic fields
IEC 61000-4-8
30A/m; 50 Hz or 60Hz
Electric fast transients
bursts
IEC 61000-4-4
N/A
Surges
IEC 61000-4-5
N/A
Conducted disturbances
induced by RF fields
IEC 61000-4-6
N/A
Voltage dips
IEC 61000-4-11
N/A
N/A
Voltage interruptions
IEC 61000-4-11
N/A