Berlin Heart EXCOR Adult, Instructions For Clinical Use

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Identifying Errors and Troubleshooting
en
WARNING
17 Identifying Errors and Troubleshooting
17.1 Safety Information
Immediately replace any components if they malfunction in a manner
that cannot be rectified by the user!
Replace components even if the malfunction does not put patient sup-
port at immediate risk. If the system emits an alarm indicating that a
component is defective, replace the component.
The use of defective components puts the safety of the patient at risk.
Consult your contact person regarding the malfunction.
Immediately replace any driving unit with a malfunction that cannot be
rectified by the user that may result in insufficient patient support!
After hearing an alarm, press the <button> or press A
UDIO PAUSED
!
Otherwise, additional alarms may not be heard or may be heard too
late.
Replace the driving unit if its audible signals are inaudible or incorrect!
Otherwise, the user or caregiver might not react to an error, or might
react incorrectly. This could impair the safety of the patient.
Alarms signaled on the driving unit take priority over alarms signaled by
other components (panel PC, alarm via external alarm (nurse call)).
If several alarms are being signaled at once, take note of all alarm mes-
sages. Monitor both driving unit displays / monitor all alarms on the
panel PC. Follow the instructions for action given.
17.2 Contact Person in Case of Error
17.2.1 Contact Person Regarding Errors
If you cannot remedy an error yourself or you need more information regarding the
system, speak to your contact person.
17.2.2 Reporting Serious Incidents
Report serious incidents that occur in relation to the product to the manufacturer, as
well as to the government office responsible in that country.
Patients and
caregivers
→
Contact person in the treating
hospital
Hospital
→
Manufacturer’s hotline