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9. If additional biopsies are required, pull back on the plunger to withdraw the inner stylet
and repeat steps 3 through 8.
Figure 5: Plunger retracted to energize or arm the device
Note: Once the plunger surface meets fire ready indicator,
additional pressure on the plunger will fire the cutting cannula.
BIOPSY PROCEDURE FOR THE TEMNO ELITE BIOPSY SYSTEM WITH VALVED
COAXIAL INTRODUCER NEEDLE OR STANDARD COAXIAL INTRODUCER NEEDLE
The biopsy procedure must be performed using appropriate aseptic techniques.
1.
Using aseptic technique, remove the instrument and the coaxial introducer from its
package.
2.
Remove the protective needle sheath from the instrument and the coaxial introducer.
3.
Before using the TEMNO Elite biopsy system and/or Valved or Standard Coaxial
Introducer Needle, inspect the needle for damaged point, bent shaft, or other
imperfections that would prevent proper function. If the needle is damaged or bent;
DO NOT USE.
4.
Prepare site as required. Adequate anesthesia should be administered prior to
procedure.
5.
For ease of insertion, puncture the skin with a scalpel at the entry site (OPTIONAL).
6.
If preferred, set the depth stop at the predetermined placement on the coaxial
introducer cannula.
7.
Using imaging guidance, insert the tip of the coaxial introducer proximal to the lesion
to be biopsied. The depth stop may be used as an aid for proper placement and adjust
as necessary. NOTE: The depth stop should be adjusted so that the needle is in proper
position when the depth stop is in contact with the skin. This will help stabilize the
coaxial needle.
8.
Hold the coaxial cannula hub and disconnect (squeeze or twist) the stylet hub to
remove the stylet from the outer cannula. Leave the cannula in place as a guide for the
placement of the biopsy instrument.
9.
Energize or arm the instrument by pulling back on the plunger to withdraw the
cannula and inner stylet and lock the cannula in place. The instrument can be set to
one of two penetration depths. Pulling back the plunger to the first stop, indicated by
a firm click, sets the device penetration depth to 10mm. Pulling the plunger farther
back to the second stop, indicated by a firm click, sets the device penetration depth to
20mm. See Figure 4.
NOTE: When the instrument is energized to the 10mm penetration depth, the enclosed
10mm adapter should be used. Ensure the arrow on the 10mm spacer points to the
distal needle tip. If the 10mm adapter is not used, the tip of the instrument will extend
one centimeter farther relative to the 10mm energized position. See Figure 6.
Energized to 10mm
Penetration Depth
without 10mm Adapter
Energized to 20mm
Penetration Depth or
10mm Penetration
Depth with Adapter
10. Verify the instrument is energized (armed) by looking at the penetration depth
indicator and confirming either a "10" or "20" is visible . See Figure 5.
11. With the inner stylet fully retracted so that the sample notch is covered by the cannula,
insert the tip of needle to the point to be biopsied. DO NOT advance the inner stylet by
pressing on the plunger until the instrument is in position.
12. Press the plunger to advance the inner stylet (i.e. sample notch) into tissue. At the end
of the advancement the plunger will encounter a stop and the fire ready indicator will
form a solid line. See Figure 5. With imaging verify the sample notch is in the target
area to be biopsied.
13. Fire the cutting cannula by depressing the plunger past the fire ready indicator to
capture the biopsy specimen in the sample notch.
14. Remove the needle from the coaxial introducer, leaving the coaxial introducer cannula
in place.
15. Pull the plunger back to acquire the biopsy specimen. Gently advance the plunger
forward to expose the biopsy specimen. DO NOT press the plunger past the fire ready
indicator during this step.
16. (Optional) Push the Sample Assist™ for assistance with removing the sample from the
notch.
17. If additional biopsies are required, pull back on the plunger to withdraw the inner
stylet and repeat steps 9 through 16.
18. Remove the coaxial introducer cannula from the patient.
Plunger advanced to fire the device
Figure 6
Biopsy Instrument
1 cm
Biopsy Instrument
or
or
Fire Ready Indicator
Fire Ready Indicator
Coaxial Biopsy
Needle cannula
Coaxial Biopsy
Needle cannula
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