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Instructions for use: Ikus - Berlin Heart

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15 About these instructions <strong>for</strong> <strong>use</strong><br />

The most important changes at a glance<br />

These instructions <strong>for</strong> <strong>use</strong> provide in<strong>for</strong>mation on the setup, functionality and <strong>use</strong> of the<br />

EXCOR VAD with the EXCOR stationary driving unit <strong>Ikus</strong> (referred to below as <strong>Ikus</strong>). The<br />

new <strong>Ikus</strong> (ver. 2.1 described in this manual 4.9.1) incorporates significant technical<br />

changes from the preceding model (ver. 2.0 described in manual version 4.7.1).<br />

• Please read all instructions <strong>for</strong> <strong>use</strong> carefully <strong>for</strong> your patients safety!<br />

• Always ensure that only medical personnel with product-specific training are permitted<br />

to work with the EXCOR!<br />

15.1 The most important changes at a glance<br />

Comparison of instructions <strong>for</strong> <strong>use</strong> versions 4.7.1 (<strong>Ikus</strong> ver. 2.0) and 4.9.1 (ver. 2.1)<br />

Version 4.7.1 Version 4.9.1<br />

Starting and configuring <strong>Ikus</strong><br />

6.1.1 Connecting the tank unit<br />

6.1.4 Setting test parameters<br />

6.2.1 Disconnecting the tank unit from <strong>Ikus</strong><br />

6.2.4 Setting the start parameters<br />

Surgery<br />

7Implantation 7 Implantation - Preparation in the operating room<br />

8 Implantation - surgery<br />

Error messages and measures<br />

11.1 Discharging the battery pack; no battery<br />

operation possible<br />

11.2 Updating the parameter block failed<br />

11.3 Acoustic alarm not correctly recognized<br />

11.4 Alarm circuit defective - beeper stays off (or<br />

on)<br />

11.6 Only operate driving unit with supervision<br />

10.3Left/right pump fills insufficiently 11.8 Please check tube and pump on left/right<br />

10.9.2Backup processor reports error<br />

11.12.1 Backup processor reports deviating flow<br />

measurement on left (or right)<br />

11.12.3 Backup processor reports error: flow<br />

measurement on left (or right)<br />

11.12.4 Backup processor reports incorrect testing<br />

Appendix<br />

13.8 Example: Blood pump replacement<br />

13.9 Additional in<strong>for</strong>mation: Laptop Panasonic<br />

CF29<br />

15.2 Explanations<br />

Starting and configuring <strong>Ikus</strong><br />

The most important new in<strong>for</strong>mation in chapter 6 (6: "Start up the <strong>Ikus</strong> and set the<br />

parameters", S. 31) relates to <strong>use</strong> of the tank unit, which did not exist in the previous<br />

<strong>Ikus</strong> model. Correctly configured test parameters prevent <strong>Ikus</strong> from generating false<br />

error messages.<br />

Surgery<br />

The surgical procedures are described and organized differently in the two versions of<br />

1000002 Rev. 4.9.1 105

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