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July 7, 2008
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Sharps \ ElliptiPunch Disposable

Instructions


1. Identify the lesion or area of skin to be biopsied.

2. Remove the ElliptiPunch from the sterile packaging.

3. If an exam light is in use direct the light towards the area to be biopsied.

4. Extend the blade by pushing the handle downward. This action exposes the blade so that the ElliptiPunch can easily be positioned over the lesion.

5. Position the ElliptiPunch blade at the desired location so that the desired margins around the lesion are obtained.

6. Push the barrel of the ElliptiPunch down to contact the skin and hold the ElliptiPunch perpendicular to the skin surface.

7. Begin the incision by firmly holding the barrel in contact with the skin and rotating the blade handle with a clockwise and counterclockwise motion. The motion is limited by ElliptiPunch to approximately 45 degrees of rotation in each direction.

8. Complete the incision by making the necessary number of clockwise and counterclockwise movements of the handle, while continuing to apply a downward pressure on the handle.

9. The physician is cautioned to make the incision only deep enough to penetrate the dermis. Making the incision too deep may harm the underlying tissue, blood vessels, nerves or organs. It is expected that the physician is familiar with doing dermal biopsies and the necessary procedural safeties.

10. Once the desired depth is attained, remove the ElliptiPunch, extend the barrel over the blade and discard in the proper disposal container.

11. Complete the excision of the lesion and closure of the wound in the usual manner.

Note: It is expected that the physician using the ElliptiPunch is familiar with the necessary procedural safeties.
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