Abiomed Impella 2.5 Manual Del Usuario página 13

2.
Aspirate using a syringe to ensure that the line is patent; confirm
pulsatile blood flow from entrance port.
3.
Advance the 0.035"(or smaller) guidewire with an atraumatic tip
through the guidewire port using the supplied cheater.
Inserting the Guidewire with the Cheater
4. Advance the guidewire tip into the descending aorta under
fluoroscopic guidance.
5. Loosen the anticontamination sleeve by rotating the Tuohy-Borst
valve counterclockwise.
Loosening the Tuohy-Borst Valve
6.
Anchor the guidewire and repositioning sheath and withdraw the
catheter until the distal end of the catheter reaches the distal tip
of the repositioning sheath.
7. With the guidewire anchored and pressure applied to the access
site, completely remove the Impella Catheter and repositioning
sheath together.
OPERATING THE IMPELLA
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.
Impella 2.5 ® and Impella CP ®
CATHETER
®
Circulatory Support Systems
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.
ALARM LEVELS
Category Description Audible Indicator*
Advisory Notification 1 beep every 5 minutes
Abnormal
situaton. 3 beeps every
Serious
Prompt action 15 seconds
needed.
High priority.
10 beeps every
Critical Immediate
6.7 seconds
action needed.
* Sound pressure of audible alarm indicators is >80 dBA
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.
Visual Indicator
Alarm header on
white background
Alarm header on
yellow background
Alarm header on
red background
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