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PediMag
Instructions For Use (IFU)
READ ENTIRE CONTENTS PRIOR TO USING THE BLOOD PUMP
THIS PRODUCT IS LABELED FOR USE OUTSIDE THE UNITED STATES.
IT IS NOT AVAILABLE AS LABELED IN THE UNITED STATES.
Thoratec Clinical & Technical Support Phone number(s)
United States
Outside United
States
Manufacturer:
Thoratec Switzerland GmbH
Technoparkstrasse 1
CH-8005 Zürich
Switzerland
www.thoratec.com
®
Emergency HeartLine™ USA:
Thoratec Corporation
Main Switchboard:
Emergencies outside USA:
Urgent/24-Hour Europe:
Thoratec Switzerland
Main Switchboard:
Blood Pump
Tel:
Tel:
Fax:
Tel:
Tel:
Tel:
Fax
US Headquarters:
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
www.thoratec.com
+1-800-456-1477
+1-925-847-8600
+1-925-847-8574
+1-925-847-8600
+44 (0) 7659 877901
+41 (0) 44 275 7171
+41 (0) 44 275 7172
PL-0112, Rev 04
October 2013
DCO No 13-080
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Summary of Contents for Thoratec PediMag
- Page 1 READ ENTIRE CONTENTS PRIOR TO USING THE BLOOD PUMP THIS PRODUCT IS LABELED FOR USE OUTSIDE THE UNITED STATES. IT IS NOT AVAILABLE AS LABELED IN THE UNITED STATES. Thoratec Clinical & Technical Support Phone number(s) Emergency HeartLine™ USA: Tel:...
- Page 2 Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient. ® PediMag Blood Pump IFU Page 2 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 3 Immediately clamp Pump outlet tubing if air enters the PediMag Blood Pump as gaseous emboli may be introduced into ® PediMag Blood Pump IFU Page 3 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 4 Note: ESUs have the potential for ® PediMag Blood Pump IFU Page 4 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 5 Blood unclamping and restarting. Pump clockwise until the grooves are matched. Lift and remove the Blood Pump. ® PediMag Blood Pump IFU Page 5 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 6 Two smooth jawed tubing clamps must be volume of blood available to be available. pumped. ® PediMag Blood Pump IFU Page 6 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 7 3.9 cp at 37°C. This graph does not necessarily reflect the rates to be achieved under clinical conditions. ® PediMag Blood Pump IFU Page 7 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
- Page 8 Symbol for manufacturer. Symbol for temperature limitation/temperature range. Both upper and lower limits are indicated adjacent to horizontal lines. ® PediMag Blood Pump IFU Page 8 of 8 © 2013 Thoratec Switzerland GmbH – Document No PL-0112, Rev 04 (October 2013)
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