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Amplifier curves disturbance should be max 5µVpp. However, during Fast Transients and ESD, much higher disturbances are allowed and
immunity level shall not be noted.
C3) Compliance for LEAKAGES currents after immunity test:
Maximum Patient Leakage current:
NC
0.01mAdc 0.1mA ac
SFC
0.1mAdc 0.5mA ac
Maximum Patient Leakage current, mains on patient:
5 mA
Maximum Patient auxiliary current:
NC
0.01mAdc 0.1mA ac
SFC
0.1mAdc 0.5mA ac
Maximum Earth leakage current:
NC
0.5 mA
SFC
1 mA
(NC = Normal Condition, SFC = Single Fault Condition)
C4) Compliance for the no damage:
Keypoint G4 power up test performs without errors.
C5) Compliance for the not losing stored patient data:
No change allowed. Check normal program start up before and after immunity tests.
Test proves safe storing of data.
C6) Compliance for the not burning:
No fire or smoke allowed. During all immunity tests observe that the system is not in fire or exposes smells from burned or overheated
components.
C7) Compliance for intended operation:
Keypoint G4 shall remain safe and be restorable in case of cessation or interruption of any intended operation during immunity tests.
Disturbance of display, reconnections of PC USB keyboard and USB mouse or loss of USB connection to Main Unit does not constitute
noncompliance.
The Essential performance is verified after the tests.
Deviations from collateral standard
Acceptance criteria during immunity testing allowed per particular standard IEC 60601-2-40 (2
nd
. ed.) section 202.8.1.101 (A, B and C) are used.
Electromagnetic Emission
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
Keypoint G4 uses RF energy only for its internal function.
Therefore its RF emission is very low and is not likely to cause
any interference in nearby electronic environment.
RF emissions
CISPR 11
Class A
Keypoint G4 is suitable for use in all establishments other than
domestic, and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
Electromagnetic Immunity
Enclosure Ports
Phenomenon
Standard
Immunity test level
