Berlin Heart EXCOR Adult, Instructions For Clinical Use

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Identifying Errors and Troubleshooting
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17.13 Unexpected Changes in Functionality
Sudden, unexpected changes in the functionality or performance of components could
be caused by strong electromagnetic radiation.
Electromagnetic radiation as the cause
• Are other electronic devices in the patient environment active, for example as part
of therapy?
• Is the patient in a different environment?
• Do the changes in functionality occur during mobile use?
Corrective actions
• Remove the sources of interference from the patient's environment. Observe the
minimum distances to other electronic devices, see chapter 23: EMC, page 201.
• If the source of interference cannot be removed in the short term, ensure that the
patient is being supplied adequately. Monitor the correct filling and emptying of
the blood pump. Monitor patient vital parameters.
17.14 Driving Tube Repair
A defective driving tube must be replaced immediately. If a new driving tube is not im-
mediately available, the defective driving tube can be temporarily repaired. The goal is
• to seal leakages in order to maintain the flow
• to prevent the penetration of foreign bodies into the blood pump and driving unit
Missing or illegible inscriptions or safety
symbols Notify contact person.
Display failure Replace the driving unit.
Display frozen, activity symbol showing
Failure of backlight
<Button> on driving unit does not
respond or is permanently on
Changes to audible alarms indicate fail-
ure of an alarm module. Failure can be
identified through changes in alarm vol-
ume or excessively long pauses
between alarms. Audible alarms must
be emitted as described in
section 17.3.7: Audible Alarms on the
Driving Unit, page 158.
<Charge level button> on battery does
not respond or is permanently on
Replace the battery
Error Removal
Tab. 17-7 Errors without messages