CentriMag
TM
Circulatory Support System Operation Manual (US)
Page 48 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
WARNING
DO NOT attempt to restart the Pump after it has been stopped for more than 5
minutes without adequate anticoagulation, as the risk of thromboembolism is
increased after blood has remained stagnant in the Pump, extracorporeal
circuit, and Cannulas.
WARNING
DO NOT restart the Pump if it has stopped due to Motor overheating.
Overheating is confirmed by a MOTOR OVER TEMP alert message and
temperature sufficient to prevent the user from placing and holding a hand on
the Motor housing. Clamp the return tubing and switch to the backup System
according to the procedure described in Section 10.1. Resume support. Record
the alarm message and contact your local Abbott Medical representative.
WARNING
A Pump stoppage will create a reverse flow shunt through the Pump, as well as
limit the body’s ability to maintain adequate arterial pressure. If the Pump is off
or stopped, clamping the return tubing from the Pump is necessary to prevent a
low flow, low pressure, and reverse flow condition. The tubing clamp must be
removed before returning to normal pumping activity.
CAUTION
Accessory equipment connected to the System must be certified to their
respective IEC standards (e.g. IEC 60950-1 for data processing equipment and
IEC 60601-1 for medical equipment). Furthermore, the user is reminded that any
person who connects additional equipment to the System is creating a medical
electrical system and is, therefore, responsible for ensuring that the system
complies with the system standard IEC 60601-1. If in doubt, consult your local
Abbott Medical representative prior to connecting any accessory to the System.