Berlin Heart EXCOR Adult, Instructions For Clinical Use, Page: 201 / 212

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WARNING
23 EMC
23.1 Safety Information
Use of EXCOR Active with accessories or components (e.g., power
supply cables) that have not been specified and supplied by the
EXCOR Active system manufacturers could create increased electro-
magnetic disturbances or reduce the electromagnetic immunity of
EXCOR Active. This may lead to malfunctions.
Ensure that a distance of at least 30 cm is maintained between
EXCOR Active and any active mobile phones or portable HF commu-
nication equipment (including accessories such as antenna cables or
external antennas). Otherwise, electromagnetic disturbances may oc-
cur, and the functionality of EXCOR Active cannot be guaranteed.
Additional devices connected to medical electrical equipment must
comply with IEC or ISO standards (e.g. IEC 60950 or IEC 62368 for
data processing equipment). In addition, all configurations must meet
the requirements for medical electrical systems (see section 16 of the
latest valid version of IEC 60601-1). Anyone who connects additional
devices to medical electrical equipment configures a medical system
and is therefore responsible for ensuring that the system meets the re-
quirements for medical electrical systems. In case of doubt, please
contact Berlin Heart.
23.2 Major Performance Characteristics
The following essential performance characteristics have been tested, and are valid
even under the influence of electromagnetic disturbances:
• Automatic start of a configured driving unit when connected to a power supply
• Blood pump operation using the set parameters
• Continuous monitoring of driving unit pressures and blood flow in order to detect
changes in patient care and emit any necessary alarms.
• Audible and visible emission of high-priority alarms
The following parameters can be set on EXCOR Active to the specified degrees of ac-
curacy (for right and left in BVAD mode, if applicable):
• The Rate can be set within a range of 5 bpm to 130 bpm. The parameter does
not deviate from the set value by more than ± 5%.
• Duration systole can be set within a range of 30% to 60%. The parameter does
not deviate from the set value by more than ± 5%.
• The Average driving pressure does not deviate from the set value by more than
± 10 mmHg.
• The Piston stroke does not deviate from the set value by more than ± 2 mm.
• The Flow does not deviate from the set value by more than ± 10%.
• Synchronization does not deviate by more than ± 8%.
Even under the influence of interference, the following apply:
• In normal operation, no false positive alarms of low, medium, or high priority oc-
cur. Electromagnetic radiation has no effect on the driving unit’s capability of emit-