Berlin Heart EXCOR Pediatric VAD, Manual, Page: 241 / 250

Chapter 17 EMC tables
17 EMC tables
17.1 Essential Performance
The following essential performance was verified in the electromagnetic immunity
tests: The driving unit must drive the EXCOR blood pumps with the set parameters.
This was controlled by monitoring the following acceptance criteria:
• The pump rate may not deviate by more than 10% or 50 ms (the higher value is
valid).
• The relative systolic duration may not deviate by more than 10% or 50 ms (the
higher value is valid).
• The driving pressure in engaged condition at the end of the systole or diastole
may not deviate by more than 10% or 20 mmHg (the higher value is valid).
• No failure alarms may occur.
• No undesired change may occur between mains and battery operation.
• In battery operation the battery alarms must occur correctly.
• No switch to emergency pulse mode may occur.
17.2 Electromagnetic emissions
The Ikus is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ikus should ensure that Ikus is used in such an
environment
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11 Group 1 The Ikus uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11 Class B The Ikus is suitable for use in all
establishments, including domestic
establishments 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
Tab. 17-1 Emissions characteristics
17.3 Electromagnetic immunity - part 1
The Ikus is intended for use in the electromagnetic environment specified below. The
customer or the user of the Ikus should ensure that it is used in such an environment.
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