Essential Performance; Emi Considerations; Permanent Magnet Considerations; Operator Controls - Abbott CentriMag Operation Manual

6.4 Essential Performance

The essential performance of the System includes the following:
•
The System shall maintain Pump functionality within flow limits and defined speed set
by the operator.
•
If the flow limits are underrun/exceeded or the speed is out of range, the System shall
generate an alarm.
•
In any other case where the Pump functionality cannot be achieved anymore, the
System shall generate an alarm.
WARNING
Other equipment may interfere with the operation of the System, even if the
other equipment complies with CISPR emission requirements. Refer to the
Electromagnetic Emissions and Electromagnetic Immunity sections for
guidance.

6.5 EMI Considerations

Electromagnetic interference (EMI) sources in the vicinity of the System may interfere with
Console performance. If changes occur in the operating parameters of the Console due to
EMI sources, immediately remove the source of EMI or move the Console away from the
source of the EMI.
The Console may interfere with the operation of other equipment in proximity. Do not
place equipment, other than an additional Console, near the main Console or Motor.
For information about potential interference from Electrosurgery Units (ESU), see Section
0 for more details.
WARNING
The System is a Class A product and may cause radio interference in residential
environments.
WARNING
The System should not be used in Magnetic Resonance (MR) environments, or
in conjunction or association with computerized axial tomography (CT),
diathermy, Radio Frequency Identification (RFID), electronic article surveillance,
and electromagnetic security systems such as metal detectors.

6.6 Permanent Magnet Considerations

Permanent magnets can interfere with proper pumping operation when in proximity with
the Pump and Motor. These sources of magnetism include items such as, but not limited
to, spare Pumps and permanent magnet DC (Direct Current) Motors.

6.7 Operator Controls

6.7.1 Controls on the Console
The Console Control Panel (Figure 17) contains three rows of displays. Row 1 includes
indicators (bars and digital) for the Pump's speed (RPM), flow rate (LPM), flow limits
(LPM), and pressure measurements (mmHg). The top two lines of Row 2 on the display
are used to display System status. The bottom line displays the four soft keypad
TM
CentriMag Circulatory Support System Operation Manual (US)
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
Page 35 of 126