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Instructions for use: Ikus - Berlin Heart

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Apex cannula(s)<br />

Implantation – Surgical procedure<br />

Head of an apex cannula<br />

<strong>Instructions</strong><br />

1. Start fibrillation if necessary.<br />

2. Per<strong>for</strong>m the apical excision. The excision of a cone is recommended. Select the diameter<br />

of the excision so that it is slightly smaller than the cannula diameter.<br />

3. Inspect the cutting edge <strong>for</strong> cut trabeculae.<br />

On cannulas without a separate suture ring<br />

<strong>Instructions</strong><br />

a<br />

a Long side of the cannula head<br />

Circularly applied sutures at the apical incision<br />

On a cannula with an additional suture ring (apex cannula C41A-050, inner diameter 16 mm)<br />

<strong>Instructions</strong><br />

1. Induce ventricular fibrillation if necessary.<br />

2. Apply 12 - 14 felt-underlaid, double-rein<strong>for</strong>ced sutures (monofilament threads,<br />

e.g. 3-0 SH-1) circularly around the apical incision. Do not fasten.<br />

3. Pierce the suture ring with the apex sutures.<br />

4. Lead the suture ring under the sutures and fasten the sutures. Ensure that the ring lies<br />

flat and without folds.<br />

5. Introduce the inflow cannula into the apex of the ventricle.<br />

6. Stitch the apex ring with the suture ring of the inflow cannula: running suture.<br />

8.2.2 Create the transcutaneous passage <strong>for</strong> the apex cannula<br />

1. Apply 12 - 14 felt-underlaid, double-rein<strong>for</strong>ced sutures<br />

(monofilament threads, e.g. 3-0 SH-1) circularly around<br />

the apical incision. Do not fasten.<br />

2. Pierce the suture ring of the cannula with the apex<br />

sutures.<br />

3. Lead the cannula under the sutures and fasten the<br />

sutures.<br />

4. De-air the cannula and close it underneath the<br />

anastomosis with a tube clamp or vent over the cannula.<br />

Warning!<br />

• Ensure that the cannulas assume a stable and tension-free spatial end position!<br />

• Never touch silicon cannulas with pointed or sharp-edged objects (surgical instruments).<br />

• When using the dressing <strong>for</strong>ceps, always ensure that the inside of the cannula is not<br />

damaged. Place a compress over the cannula opening and then access it with the <strong>for</strong>ceps.<br />

• The incision must be smaller than the cannula diameter (<strong>for</strong> good healing), but<br />

sufficiently large to prevent necrosis.<br />

• Ensure a sufficient expanse of unbroken skin between the incision wounds.<br />

46 1000002 Rev. 4.9.1

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