Thoratec CentriMag User manual

CentriMag®Motor
INSTRUCTIONS FOR USE (IFU)
READ ENTIRE CONTENTS PRIOR TO USING THE MOTOR
Thoratec Clinical & Technical Support Phone number(s)
United States Emergency HeartLine™ USA: Thoratec Corporation
Main Switchboard:
Tel: [phone]
Tel: [phone]
Fax: [phone]
Outside United
States
Emergencies outside USA:
Urgent/24-Hour Europe:
Thoratec Switzerland
Main Switchboard:
Tel: [phone]
Tel: [phone]
Tel: [phone]
Fax [phone]
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
www.thoratec.com
US Headquarters:
Thoratec Corporation
6035 Stoneridge Dr.
Pleasanton, CA 94588
USA
www.thoratec.com
PL-0069 Rev 04
August 2018
DCO No 18-093

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

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© 2018 Thoratec Switzerland GmbH – Document No PL-0069, Rev 04 (August 2018)
around the Motor. If the cable is kinked,
replace the Motor.
Figure 1. CentriMag Motor with a Kinked
Cable
INSTALLATION
Follow the system preparation directions in the
Operating Manual for the Thoratec CentriMag
Console. Inspect the complete system. Do not
use a malfunctioning or damaged system.
Figure 2. CentriMag Motor with CentriMag
Blood Pump installed
1. Remove the CentriMag Motor from its
packaging and examine for any sign of
damage.
2. Insert the LEMO connector on the CentriMag
Motor cable into the Motor connection on the
rear of the Console.
3. After the Blood Pump has been primed and
is connected to the extracorporeal circuit,
mount the Blood Pump on the CentriMag
Motor. This is accomplished by unscrewing
the locking screw and matching the grooves
on the circumference of the Blood Pump with
the fittings on the CentriMag receptacle.
ROTATE BLOOD PUMP
COUNTERCLOCKWISE until the matching
groove on the Blood Pump body is located in
front of the locking screw. Turn the locking
screw clockwise until it is completely seated
into the groove and the Blood Pump is
secured in place. The Blood Pump must be
fully seated into the receptacle to function
properly.
4. Follow the instructions in the Thoratec
CentriMag Console Operating Manual to
operate the CentriMag Motor and the
system.
5. To remove the Blood Pump from the
CentriMag Motor, locate the locking screw on
the topside of the CentriMag Motor; unscrew
it counterclockwise until it clears the Blood
Pump groove completely. Rotate the Blood
Pump clockwise until the Blood Pump can be
lifted from the receptacle by grasping the
body of the Blood Pump and lifting straight
up away from the CentriMag Motor.
SYMBOLS ON THE PRODUCT PACKAGE
The following table describes the symbols used
on Thoratec CentriMag Motor package:
Symbol Description
Catalog Number
Serial Number
Manufacture Date
Caution: Federal law restricts
this device to sale by or on
the order of a physician.
See Instructions for Use.
Manufacturer
Do not dispose with normal
waste. Disposal of this device
is governed by the European
Union (EU) WEEE Directive
(2002/96/EC) and local
electronic waste disposal
legislation.

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© 2018 Thoratec Switzerland GmbH – Document No PL-0069, Rev 04 (August 2018)
PRODUCT RETURNS
Prior to returning any product, contact your
Thoratec Customer Service Representative for a
return authorization number and instructions.
Note: Thoratec®is a registered trademark and
HeartLine™ is a trademark of Thoratec
Corporation. CentriMag®is a registered
trademark of Thoratec Corporation.