8.12
Instructions for Use & Clinical Reference Manual (US)
PATIENT ENVIRONMENT
The Automated Impella® Controller and the components of the Impella® RP System are approved
for use within the patient environment defined in IEC 60601-1-1 and in the figure below.
Figure 8.1 Automated Impella
®
Controller Patient Environment
For some Automated Impella
®
Controller alarms, there is a short delay between the triggered
event and the audible annunciation and visual display of the alarm.
ALARM DELAY INFORMATION
Impella Defective
Controller Error
Emergency Shutdown Imminent
Battery Failure
Controller Failure
Battery Comm. Failure
Purge System Blocked
8 second delay
12±3 second delay
15±1 second delay
28±8 second delay
38±8 second delay
40±10 second delay
75±45 second delay
