Deviations From Collateral Standard; Electromagnetic Emission; Electromagnetic Immunity - natus Dantec Keypoint G4 User's And Service Manual

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
Maximum Patient Leakage current, mains on patient:
5 mA
Maximum Patient auxiliary current:
NC 0.01mAdc 0.1mA ac
SFC 0.1mAdc
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

Electromagnetic Emission

Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3

Electromagnetic Immunity

Enclosure Ports
Phenomenon
0.5mA ac
0.5mA ac
Compliance
Group 1
Class A
Class A
Complies
Standard
. ed.) section 202.8.1.101 (A, B and C) are used.
nd
Electromagnetic environment – guidance
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.
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.
Immunity test level
55