Table of Contents
Advertisement
Quick Links
CentriMag
Instructions For Use (IFU)
READ ENTIRE CONTENTS PRIOR TO USING THIS DEVICE
CAUTION
Humanitarian Device: The CentriMag RVAS is authorized by Federal law to provide
temporary circulatory support for up to 30 days for patients in cardiogenic shock
due to acute right ventricular failure. The effectiveness of this device for this use has
not been demonstrated.
Caution: Federal law restricts this device to sale by or on the order of a physician.
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
®
RVAS (Blood Pump)
Emergency HeartLine™ USA:
Thoratec Corporation
Main Switchboard:
Emergencies outside USA:
Urgent/24-Hour Europe:
Thoratec Switzerland
Main Switchboard:
Tel:
+1-800-456-1477
Tel:
+1-925-847-8600
Fax:
+1-925-847-8574
Tel:
+1-925-847-8600
Tel:
+44 (0) 7659 877901
Tel:
+41 (0) 44 275 7171
Fax
+41 (0) 44 275 7172
US Headquarters:
Thoratec Corporation
6035 Stoneridge Dr.
Pleasanton, CA 94588
USA
www.thoratec.com
PL-0085, Rev. 09
DCO No. 15-032
May 2015
Advertisement
Table of Contents
Subscribe to Our Youtube Channel
Related Manuals for Thoratec CentriMag RVAS
Summary of Contents for Thoratec CentriMag RVAS
- Page 1 READ ENTIRE CONTENTS PRIOR TO USING THIS DEVICE CAUTION Humanitarian Device: The CentriMag RVAS is authorized by Federal law to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure. The effectiveness of this device for this use has not been demonstrated.
- Page 2 U.S. clinical studies. Ten patients received a CentriMag obtained from the CentriMag VAD worldwide RVAD after placement of a commercially available CentriMag Blood Pump IFU (RVAS HDE) Page 2 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 3 CentriMag Blood Pump IFU (RVAS HDE) Page 3 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 4 There are no safety or performance data known to the patient, with attendant risk of death or severe CentriMag Blood Pump IFU (RVAS HDE) Page 4 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 5 Follow the system preparation directions in the may cause damage which could lead to device malfunction. Operating Manual for the CentriMag Primary Console. CentriMag Blood Pump IFU (RVAS HDE) Page 5 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 6 Cut the extension tubing to length. Fully fill both the double purse string suture. Carefully bleed the inlet tubing and Blood Pump with the sterile CentriMag Blood Pump IFU (RVAS HDE) Page 6 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 7 2. Back-up sterile CentriMag Blood Pump and and restarting. supplies to prime available. CentriMag Blood Pump IFU (RVAS HDE) Page 7 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
- Page 8 (intravascular pressures, cardiac adjacent to horizontal lines output, and available volume) CentriMag Blood Pump IFU (RVAS HDE) Page 8 of 8 © 2015 Thoratec Switzerland GmbH – Document No. PL-0085, Rev. 09 (May 2015)
Need help?
Do you have a question about the CentriMag RVAS and is the answer not in the manual?
Questions and answers