Berlin Heart EXCOR Adult, Instructions For Clinical Use, Page: 22 / 212

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General Information EXCOR Active
en
3.4.2 Indications, Contraindications, and Potential Therapeutic Objec-
tives
The indications, contraindications, and potential therapeutic objectives for
EXCOR VAD apply to EXCOR Active in connection with EXCOR VAD. These are de-
scribed in the
EXCOR Sterile Components instructions for use.
Heed the instructions for use on EXCOR sterile components!
3.5 EMC - Electromagnetic Compatibility
EXCOR Active is shielded against electromagnetic radiation, including both electro-
magnetic emissions and electromagnetic disturbances. Nevertheless, electromagnet-
ic radiation can cause disruptions. Disruptions may occur if the minimum distance to
a source of interference is not observed.
Potential sources of interference include
• Mobile communication
• WLAN
• Bluetooth
• Radio installations
• Insufficiently shielded electrical devices
• Security-check devices, such as security scanners
• Magnetic resonance imaging scanners
• Magnetic levitation trains
See chapter 23: EMC, page 201 for more detailed information on electromagnetic
compatibility.
Possible consequences could include
• Modified filling and emptying of the blood pump
• View on the display of the driving unit and the panel PC is modified
• Faulty alarms
Major performance characteristics are described in section 23.2: Major Performance
Characteristics, page 201.
3.6 Combination with Other Products and Procedures
Permitted combinations
The EXCOR Active system is to be operated exclusively with components of the
EXCOR VAD system. Take all indications, contraindications, and instructions for use
into account. An overview of the blood pumps and cannulae to be used, as well as in-
formation on their possible combinations, can be found in the
EXCOR Sterile Compo-
nents instructions for use.
Heed the instructions for use on EXCOR sterile components!