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Circulatory Support System Operation Manual (US) Page 2 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
TABLE OF CONTENTS
1 MANUAL OVERVIEW .....................................................................................5
2 INDICATIONS AND CONTRAINDICATIONS .................................................6
2.1 Indications for Use .............................................................................................. 6
2.2 Contraindications for Use ................................................................................... 9
3 GENERAL CONVENTIONS .......................................................................... 10
3.1 Warnings and Cautions .................................................................................... 10
3.2 Patents and Trademarks .................................................................................. 10
3.3 Conventions Used in This Manual .................................................................... 10
4 WARNINGS AND PRECAUTIONS ............................................................... 11
5 DESCRIPTION .............................................................................................. 13
5.1 General Overview ............................................................................................. 13
5.2 Required User Supplied Items .......................................................................... 32
6 SPECIFICATIONS AND GENERAL DESCRIPTION .................................... 33
6.1 Classification .................................................................................................... 33
6.2 Specifications ................................................................................................... 34
6.3 Environmental Conditions ................................................................................. 34
6.4 Essential Performance ..................................................................................... 35
6.5 EMI Considerations .......................................................................................... 35
6.6 Permanent Magnet Considerations .................................................................. 35
6.7 Operator Controls ............................................................................................. 35
6.8 Digital Display Information ................................................................................ 49
6.9 Power Assembly ............................................................................................... 49
6.10 Requirements for Connecting Additional Equipment ......................................... 49
7 SETTING UP THE SYSTEM ......................................................................... 50
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