Abiomed ImpellaCP Manuel D'utilisation page 12

4.
Advance the guidewire tip into the descending aorta under
fluoroscopic guidance.
5.
Loosen the anticontamination sleeve by rotating the Tuohy-Borst
valve counterclockwise.
Figure 1.22 Loosening the Tuohy-Borst Valve
6. Anchor the guidewire and repositioning unit and withdraw the
catheter until the distal end of the catheter reaches the distal tip of
the repositioning unit.
7.
With the guidewire anchored and pressure applied to the access
site, completely remove the Impella Catheter and repositioning
sheath together.
OPERATING THE IMPELLA CATHETER
WITHOUT HEPARIN IN THE PURGE
SOLUTION
The Impella Catheter is designed to be operated with a purge solution that
contains heparin. Operation of the system without heparin in the purge
solution has not been tested. In the event that a patient is intolerant to
heparin, due to heparin-induced thrombocytopenia (HIT) or bleeding,
physicians should use their clinical judgment to assess the risks versus
benefits of operating the Impella System without heparin.
If it is in the best interest of the patient to operate the system without
heparin, the glucose solution is still required, and physicians should
consider systemic delivery of an alternative anticoagulant. DO NOT add
any alternative anticoagulant (such as a direct thrombin inhibitor) to the
purge fluid. The Impella Catheter has not been tested with any alternative
anticoagulants in the purge solution.
10
ALARMS OVERVIEW
For a full list of all Impella alarms, refer to the Automated Impella
Controller Instructions for Use document.
The Automated Impella Controller monitors various functions to determine
whether specific operational parameters are within expected limits. When
a parameter goes outside of its specified limits, the controller sounds an
alarm tone and displays an alarm message that can be viewed on the
display screen on the front of the controller. The alarm tone indicates the
severity of the alarm. The alarm message on the display screen is
color-coded for severity and provides details on the cause of the alarm and
how to resolve the alarm. After muting an alarm, if another alarm occurs it
will only be heard and displayed if it is a higher priority alarm than the one
that was muted.
Category Description
Advisory Notification
Serious Abnormal
situation.
Prompt action
needed
Critical High priority.
Immediate
action needed.
* Sound pressure of audible alarm indicators is >80 dBA
Table 1.2 Alarm Levels
MUTE ALARM FUNCTION
Pressing the MUTE ALARM button on the upper right of the Automated
Impella Controller display screen will silence the audible alarm indicator
for 2 minutes (for red or yellow alarms) or 5 minutes (for white advisory
alarms). When an alarm is silenced, the words "MUTE ALARM" next to
the button are replaced by the mute alarm indicator, a crossed-out bell
icon.
The audible indicator will shut off if an alarm condition is resolved before
you press MUTE ALARM. The visual message, however, will continue to
be displayed, with the alarm header on a gray background, for 20 minutes
or until you press MUTE ALARM. This allows you to identify the alarm
that occurred.
Audible Visual
Indicator* Indicator
1 beep every Alarm header
5 minutes on white
background
3 beeps every Alarm header
15 seconds on yellow
background
10 beeps Alarm header on
every 6.7 red background
seconds
User Manual