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Instructions for use: Ikus - Berlin Heart

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Table of contents<br />

First page................................................................................................................................................ 3<br />

New structure of the safety in<strong>for</strong>mation ............................................................................................... 3<br />

Safety in<strong>for</strong>mation.................................................................................................................................. 4<br />

1 Important safety in<strong>for</strong>mation................................................................................................................. 4<br />

Warranty ................................................................................................................................................. 6<br />

2.5 Manufacturer's warranty........................................................................................................................ 6<br />

Start menu.............................................................................................................................................. 7<br />

5.1 Start menu.............................................................................................................................................. 7<br />

Unintended change of the operating mode .......................................................................................... 7<br />

5.3.1 Pa<strong>use</strong> drive: stop the <strong>Ikus</strong> temporarily.................................................................................................. 7<br />

5.5 Switching from univentricular to biventricular operation..................................................................... 7<br />

New transport crate ............................................................................................................................... 8<br />

5.8 Packaging and transport ........................................................................................................................ 8<br />

De-airing hammer ................................................................................................................................ 13<br />

7.1.1 Preparing components and materials................................................................................................. 13<br />

Cannula position and transcutaneous exit sites................................................................................. 13<br />

8 Surgery.................................................................................................................................................. 13<br />

Transcutaneous tunnel and cannula tunneling tip ............................................................................. 14<br />

8 Surgery.................................................................................................................................................. 14<br />

Using the connecting set ..................................................................................................................... 15<br />

8 Surgery.................................................................................................................................................. 15<br />

Anastomosis of inflow cannula with apex........................................................................................... 16<br />

8.2.1 Anastomosis of inflow cannula with apex........................................................................................... 16<br />

Securing the connections..................................................................................................................... 18<br />

8.8 Securing the connections .................................................................................................................... 18<br />

Tie-band gun......................................................................................................................................... 19<br />

8.8 Securing the connections .................................................................................................................... 19<br />

Anticoagulation therapy in young persons and adults ....................................................................... 21<br />

9 Intensive care and post-operative care................................................................................................ 21<br />

9.1 Postoperative anticoagulation therapy................................................................................................ 21<br />

9.2 Postoperative platelet aggregation inhibition therapy........................................................................ 21<br />

Replacing the driveline......................................................................................................................... 24<br />

11.5.1 Replacing the driveline......................................................................................................................... 24<br />

Messages.............................................................................................................................................. 24<br />

11.8 Please check left/right pump and tube ............................................................................................... 24<br />

11.15 The error is only detected by the active (or passive) computer ......................................................... 24<br />

11.20 Processor failure. Contact customer service!...................................................................................... 24<br />

11.27.3 Additional messages during the start test .......................................................................................... 25<br />

Replacing the blood pump................................................................................................................... 25<br />

12.1 Replacing the blood pump(s).............................................................................................................. 25<br />

12.1.1 Replacing the blood pump beca<strong>use</strong> of growth of the patient ............................................................ 25<br />

Emergency pulse mode........................................................................................................................ 26<br />

12.3 Emergency pulse mode........................................................................................................................ 26<br />

12.3.2 <strong>Ikus</strong> start test after emergency pulse mode ........................................................................................ 26<br />

Reading out the log files/data storage media: USB stick ................................................................... 27<br />

12.7 Reading out the log files ...................................................................................................................... 27<br />

Discontinuation of the mandrin .......................................................................................................... 28<br />

13.1 Overview: product range and combination options ........................................................................... 28<br />

Technical specifications ....................................................................................................................... 28<br />

13.2 Technical specifications....................................................................................................................... 28<br />

2/28 1000095x14 Rev. 8

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