CentriMag Motor IFU Page 2 of 4
© 2018 Thoratec Switzerland GmbH – Document No PL-0069, Rev 04 (August 2018)
DESCRIPTION
The Thoratec CentriMag Motor contains a
receptacle for insertion of the Thoratec
CentriMag Blood Pump. The CentriMag Motor
induces rotation of a magnet within the rotor of
the CentriMag Blood Pump at a speed that is set
by the Thoratec CentriMagConsole. Three
bayonet sockets on top of the CentriMag Motor
allow mounting of the Blood Pump in three
directions (every 90 degrees) to allow flexibility in
the orientation of the Blood Pump outlet.
The CentriMag Blood Pump, CentriMag Motor,
CentriMag Primary Console and CentriMag
Back-Up Console, comprise core elements of the
Thoratec CentriMag Blood Pumping System.
INTENDED USE/INDICATIONS
The CentriMag Blood Pump is indicated for use
only with the Thoratec Console to pump blood
through the extracorporeal bypass circuit for
extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to six
hours). It is also indicated for use in
extracorporeal support systems (for periods up to
six hours) not requiring complete
cardiopulmonary bypass (e.g. valvuloplasty,
circulatory support during mitral valve
reoperation, surgery of the vena cava or aorta,
liver transplants etc.)
CONTRAINDICATIONS
This Thoratec CentriMag Blood Pumping System
is contraindicated for use as a cardiotomy
suction device. It is also contraindicated for
patients who are unable or unwilling to be treated
with heparin.
WARNINGS
1. The Instructions for Use and Operating
Manual for the Thoratec CentriMag Blood
Pumping System should be read prior to use.
2. The Thoratec CentriMag Motor is designed
to be operated only with the Thoratec
CentriMag Console. There are no safety or
performance data known to Thoratec which
establishes compatibility of any other
manufacturer’s devices or components to the
Thoratec CentriMag Blood Pumping System.
3. Potential risk to the patient should be
evaluated prior to changing the CentriMag
Motor.
4. Do not remove the CentriMag Motor from its
jacket. The CentriMag Motor may feel warm
to touch if removed from the jacket during
operation or immediately after use.
5. Do not operate the CentriMag Motor in the
absence of flow. The temperature within the
Blood Pump may rise and increased cellular
damage may result.
CAUTIONS
1. Caution: Federal law restricts this device to
sale by or on the order of a physician.
2. This device should only be used by trained
personnel.
3. The CentriMag Motor is a non-sterile device.
Inspect the device and package carefully
prior to use. Do not use if the unit package or
the product has been damaged or soiled.
4. The CentriMag Motor is reusable. Do not
sterilize. Sterilization by any means may
cause severe damage to the CentriMag
Motor or its components. Use standard
hospital cleaning procedures for a device of
this type. A wipe down with non-caustic
cleaning detergents followed by a wipe down
with a damp cloth is recommended. The
cleaning procedure must not submerge or
otherwise saturate the internal components
of the CentriMag Motor.
5. The CentriMag Motor is not sealed or
moisture proofed and is subject to short-
circuiting if handled improperly. Patient or
operator injury may result from improper
cleaning of the unit.
6. Do not use the CentriMag Motor if dropped.
Dropping or other severe shock may cause
damage which could lead to device
malfunction.
7. Prior to use inspect the CentriMag Motor,
cable, Console connector, and locking
mechanism for damage. If any component is
damaged do not use the CentriMag Motor.
8. There is no recommended maintenance or
consumer repairable components internal to
the CentriMag Motor. If the unit fails to
operate according to the Motor specifications
or a Console diagnostic error indicates a
CentriMag Motor malfunction (refer to
CentriMag Console Operating Manual), it
should be returned to Thoratec.
9. Always have a spare CentriMag Motor and
back-up equipment available.
10. Before each use, verify that the cable
connecting the Motor to the Console is not
kinked, which can occur with improper
handling such as wrapping the cable tightly
