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Instructions for use: Ikus - Berlin Heart

Instructions for use: Ikus - Berlin Heart

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During implantation: ensure that the connection between the pump<br />

and cannula is stable and airtight. Always secure each connection with<br />

at least one cable tie, using a tie-band gun. See section 8.8 of the<br />

instructions <strong>for</strong> <strong>use</strong>.<br />

Immediately after implantation: visually inspect the cannulae and their<br />

connections.<br />

Post-operative care: check the blood pumps and the visible parts of<br />

the cannulae at least 3 times a day <strong>for</strong> thrombi and deposits. Check<br />

the cannulae at least once a day <strong>for</strong> damage. See section 9.5 of the<br />

instructions <strong>for</strong> <strong>use</strong>.<br />

Post-operative care: ensure that the pumps, cannulae and drivelines<br />

are never exposed to tension, version and kinks. Otherwise there is a<br />

risk that the patient will receive inadequate support. Use a mirror to<br />

avoid unnecessary kinking in the cannulae when visually inspecting<br />

the underside of the pump.<br />

Cleaning: do not <strong>use</strong> acetone or mineral oil products in the immediate<br />

vicinity of the blood pump and driveline. Do not <strong>use</strong> corrosive agents,<br />

solutions containing dyes, or organic solvents <strong>for</strong> cleaning the blood<br />

pump and drivelines, since they may alter the surface of the product.<br />

We recommend using only water or alcohol to clean the blood pump<br />

and driveline.<br />

Cleaning: Do not <strong>use</strong> corrosive agents, solutions containing dyes, or<br />

organic solvents <strong>for</strong> cleaning the cannulae and transcutaneous exit<br />

site, since they may alter the surface of the product.<br />

We recommend using chlorhexidine solution to clean the cannulae<br />

and transcutaneous exit site.<br />

Monitoring program: To save data, <strong>use</strong> only the data storage media<br />

supplied (disks/USB sticks). Otherwise there is a risk that the data<br />

storage medium is not recognized and data are lost.<br />

End the monitor program only in an emergency. Since the text of a<br />

message is displayed only in the monitor program, there is no possibility<br />

of determining the type of the message when the monitor program<br />

is ended. When the monitor program is shut down, the only indications<br />

that there is an error message are an acoustic signal and the fact that<br />

the indicator lamp on the <strong>Ikus</strong> handle lights up.<br />

1000095x14 Rev. 8 5/28

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