Instructions for Use
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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: Tel: Fax:
+1-800-456-1477 +1-925-847-8600 +1-925-847-8574
Outside United States
Emergencies outside USA: Urgent/24-Hour Europe: Thoratec Switzerland Main Switchboard:
Tel: Tel: Tel: Fax
+1-925-847-8600 +44 (0) 7659 877901 +41 (0) 44 275 7171 +41 (0) 44 275 7172
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-0273, Rev 02_English April 2016 DCO No 16-026
DESCRIPTION The CentriMag Motor contains a receptacle for insertion of the 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 CentriMag Console. Three bayonet sockets on top of the CentriMag Motor allow flexibility in mounting of the Blood Pump and orientation of the Blood Pump outlet. INTENDED USE/INDICATIONS The CentriMag Motor is indicated for use only with the CentriMag System. This device is not designed, sold, or intended for use except as indicated.
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. 4. 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. 5. Do not use the CentriMag Motor if dropped. Dropping or other severe shock may cause damage which could lead to device malfunction.
CONTRAINDICATIONS The CentriMag 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 CentriMag Blood Pump Instructions for Use as well as the Operating Manuals for the CentriMag Primary and Back-Up Consoles should be read prior to use. 2. The CentriMag Motor is designed to be operated only with the 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 CentriMag System. 3. Potential risks to the patient should be evaluated prior to changing the CentriMag Motor.
6. Prior to use inspect the CentriMag Motor, jacket, cable, Console connector, and locking mechanism for damage. If any component is damaged do not use the CentriMag Motor. 7. There are 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. 8. Always have a back-up CentriMag Motor available. INSTALLATION Follow the system preparation directions in the Operating Manual for the CentriMag Console. Inspect the complete system. Do not use a malfunctioning or damaged system.
4. 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. This device should only be used by trained personnel. 2. 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. 3. The CentriMag Motor is reusable. Do not sterilize. Sterilization by any means may cause
Figure 1.
CentriMag® Motor with Blood Pump installed.
CentriMag Motor IFU © 2016 Thoratec Switzerland GmbH – Document No. PL-0273, Rev 02_English (April 2016)
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1. Remove the CentriMag Motor from its packaging and examine for any sign of damage.
Symbol
CE (Conformity European) Mark with Notified Body designation
2. Connect 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 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 CentriMag Motor package: Symbol
Description
Manufacturer
Manufacture Date
PRODUCT RETURNS Prior to returning any product, contact your Thoratec Corporation Customer Service Representative for a return authorization number and instructions. DISPOSAL OF EQUIPMENT This device is designed and manufactured with materials and components that can be recycled and reused and therefore, it must be treated differently from normal household waste. In the European Union (EU), when a CentriMag Motor has reached end of life, it must be treated as an electronic waste and disposed of in accordance with the European Directive 2002/96/EC, “Waste Electrical and Electronic Equipment (WEEE)”, and also in accordance with applicable local legislation. Please comply with local waste collection system for electrical and electronic products. For more information and further assistance about where you can drop off electronic waste for recycling, please contact your local distributor.
Description Catalog Number
Please act according to your local rules and do not treat electronic waste as normal household waste. Proper disposal of electronic waste helps prevent potential negative consequences for the environment and human health.
Serial Number
See Instructions for Use.
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.
CentriMag Motor IFU © 2016 Thoratec Switzerland GmbH – Document No. PL-0273, Rev 02_English (April 2016)
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