Abbott CentriMag - Warnings and Precautions

CentriMag
TM
Circulatory Support System Operation Manual (US) Page 11 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
4 WARNINGS AND PRECAUTIONS
WARNING
Read this entire manual before you use the CentriMag System. As with all
prescription medical devices, clinical procedures should be conducted under
the direction of the prescribing physician. The physician must be trained on the
use of the System before using it. The professional staff at Abbott Medical
regularly provide laboratory training and on-site, in-
service programs. For
information, please contact your local Ab
bott Medical Clinical Field
representative.
WARNING
The System is designed to be operated only with the CentriMag and PediMag
Pump
s. There are no safety or performance data that establish compatibility
with any other manufacturer’s device or components.
WARNING
One additional CentriMag Console, Motor and Flow Probe are required as
backup components
in the immediate vicinity of each patient whenever the
CentriMag or PediMag Pump is used. The backup Console must be connected to
the backup Motor and to the backup Flow Probe
, have a battery charge
sufficient for at least one hour of operation, be connected to AC power (except
during transport) and be immediately available should the main Console, Motor
or Flow Probe experience a malfunction.
WARNING
The safety and effectiveness of use of the System in an ECMO circuit (i.e.
cardiopulmonary support > 6 hours) has not been demonstrated.
WARNING
The safety and effectiveness of use of the System for use > 30 days has not
been demonstrated.