Medtronic Hancock II Gebrauchsanweisung Seite 28

■ Nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other)
■ Structural deterioration (calcification, leaflet tear, stenosis, other)
■ Thromboembolism
■
Valve thrombosis
■
Angina
■ Infection other than endocarditis
■ Heart failure
■ Hemolytic anemia
■
Myocardial infarction
6. Instructions for Use
6.1. Handling and preparation instructions
Proper size selection of the bioprosthesis is critical to heart valve replacement. Use Hancock™ II aortic obturators,
Model 7505, Hancock II Ultra™ Supra-X™ aortic sizers, Model 7505UX, or Hancock™ II mitral obturators,
Model 7510, to select the appropriately sized bioprosthesis. For further information, refer to the appropriate
instructions for use.
Within the sterile operative field, prepare 2 rinse basins each containing 500 mL of sterile normal saline solution.
26 Instructions for Use English
The exterior of the device container and lid are nonsterile. Examine the tamper strips to verify that the container
has not been damaged or previously opened. Do not use the bioprosthesis if all the tamper strips are damaged.
Turn the lid counterclockwise and open the container (Figure 1).
The bioprosthesis and all packaging components inside the container are sterile and must be handled accordingly.
With the thumb and index finger, grasp the retainer and slowly lift the bioprosthesis out of the container allowing for
drainage of the glutaraldehyde storage solution (Figure 2).
Verify that the serial number on the retainer matches the serial number on the container lid, shelf carton, and
Patient Registration Form. Record the serial number of the bioprosthesis in the patient's record using the stickers
provided on the Patient Registration Form.
Hold the retainer upright. Remove the retainer cap by turning it counterclockwise using the thumb and index finger
(Figure 3). The valve holder will be visible.
While grasping the retainer, insert a sterile Medtronic Valve Handle into the holder. To secure the handle, rotate
the handle clockwise into the threaded opening of the holder until resistance is felt. Stop rotation when a first click
is heard (Figure 4).
Caution: Do not overtighten the handle, as this will actuate the ratchet mechanism.
Pull upward on the handle to remove the bioprosthesis from the retainer (Figure 5).