Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
Instructions for use: Ikus - Berlin Heart
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Preparing the components and materials<br />
7 Implantation: Preparation in the operating room<br />
7.1 Preparing the components and materials<br />
General<br />
• 500 ml sterile saline solution<br />
• 2 conical metal beakers<br />
• Disposable syringe 50 ml<br />
• Ligature (<strong>for</strong> de-airing nipples)<br />
• Shears<br />
• Towel clamp<br />
• Instruments and equipment as usual <strong>for</strong> open-heart surgery<br />
EXCOR components and accessories<br />
• Blood pump(s), each with a pump seal<br />
• One driving tube per blood pump<br />
• univentricular: Red driving tube<br />
• biventricular: One red driving tube and one blue driving tube<br />
• Inflow cannula(s) (atrial or apex cannula)<br />
• Outflow cannula(s)<br />
• Accessory set T00L-001 / T00L-002 (<strong>for</strong> blood pumps with tilting-disk valves / PU valves)<br />
• Pressure gauge set with pressure valve (T00L-001)/ membrane set (T00L-002)<br />
• De-airing set (2 x trocar, 2 x de-airing tube)<br />
• De-airing hammer<br />
• Tube attachment set (cable tie strap, cable tie pliers)<br />
Note<br />
• Selection of the blood pump(s): See“Overview: Ratio of body weight - pump size” on<br />
page 87.<br />
Recommendation<br />
• In addition, provide a sterile table to prepare the components.<br />
7.2 Unpacking the sterile components<br />
Warning!<br />
• Use only sterile components with intact sterile packaging (undamaged sterile package,<br />
unexpired <strong>use</strong>-by date)!<br />
• Only <strong>use</strong> blood pumps with intact aluminum-coated outer packaging.<br />
<strong>Instructions</strong><br />
1. Pump: Nonsterile person opens aluminum-coated outer packaging and removes<br />
double-sterile-packaged pump.<br />
2. Nonsterile person opens outer sterile package.<br />
3. Sterile person removes and opens inner sterile package and prepares components.<br />
7.3 Atrial cannulas with mandrin: Prepare the cannula<br />
Note<br />
• Atrial cannulas with mandrins are recommended <strong>for</strong> the cannulation of the left atrium.<br />
For the cannulation of the right atrium, a cannula with a mandrin is not required.<br />
1000002 Rev. 4.9.1 41
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