10. Support the Cannula while removing the Trocar/VisiLoc
and inserting the Biopsy Probe into the Cannula. The tip of an E
Tri-Concave MRI probe will be 19.4 mm beyond the depth of the V
Obturator tip. The tip of an E
beyond the depth of the V
isi
2 cm
15,4 mm
®
EnCor
Blunt Tip MRI Probe
2 cm
VisiLoc™ Obturator
19,4 mm
EnCor
®
MRI Probe
Figure 3 – Cannula, V
11. Perform biopsy. Remove Biopsy Probe.
12. Perform marker placement (if indicated) according to the respective
Instructions for Use.
12.1.
To obtain post-marker images, remove marker applicator from
cannula and re-insert V
L
isi
oC
remove the obturator and cannula simultaneously
12.2.
If post-marker images are not required, remove the marker
applicator and cannula simultaneously
13. Maintain compression to the needle track to minimize bleeding. Hold
compression until bleeding has ceased.
14. Properly dispose of the Cannula, Trocar, V
Guide Insert.
Use of the Introducer with the Aurora Dedicated Breast MRI System
1.
Identify the target lesion or site in the breast.
2.
Inspect the packages to insure that the package integrity of the Introducer
Set and Aurora Needle Guide Insert (ENCARINSERTMR-10G, supplied
separately, see Figure 4) have not been compromised.
3.
Using standard aseptic technique, remove the Aurora Needle Guide Insert
from the package. Attach the Needle Guide Insert to the Aurora Needle
Guide per the Aurora instructions.
4.
Using standard aseptic technique, remove Trocar (A) from the package,
remove the tip protector (E) and inspect the Trocar tip for signs of damage.
5.
Using standard aseptic technique, remove the Cannula (B) from the
package. Remove the Cannula Stop from the Cannula. Insert the Trocar
into the Cannula.
6.
Anesthetize the area and make a skin nick.
7.
Insert the Trocar and Cannula assembly through the Needle Guide Insert
and into the breast until the Cannula Hub rests against the Needle Guide
Insert.
8.
The Trocar is replaced with V
to verify placement of the V
position, if needed.
9.
Rotate the cannula stop (D) clockwise to stabilize the cannula within the
block.
10. Support the Cannula while removing the Trocar/V
and inserting the Biopsy Probe into the Cannula. The tip of an E
Tri-Concave MRI probe will be 19.4 mm beyond the depth of the V
Obturator tip. The tip of an E
beyond the depth of the V
isi
11. Perform biopsy. Remove Biopsy Probe.
™
Obturator
®
C
Blunt Tip MRI probe will be 15.4 mm
n
or
™
L
Obturator tip. (Figure 3)
oC
Cannula
™
L
Obturator, and MRI Probe
isi
oC
™
Obturator. After images have been obtained,
™
L
Obturator, and Needle
isi
oC
™
L
Obturator (F) Re-image the breast
isi
oC
™
L
Obturator tip at the target site. Modify
isi
oC
™
L
Obturator
isi
oC
®
C
Blunt Tip MRI probe will be 15.4 mm
n
or
™
L
Obturator tip. (Fig. 3)
oC
12. Perform marker placement (if indicated) according to the respective
®
C
Instructions for Use.
n
or
™
L
isi
oC
12.1.
To obtain post-marker images, remove marker applicator from
cannula and re-insert V
remove the obturator and cannula simultaneously
12.2.
If post-marker images are not required, remove the marker
applicator and cannula simultaneously
13. Maintain compression to the needle track to minimize bleeding. Hold
compression until bleeding has ceased.
14. Properly dispose of the Cannula, Trocar, V
Guide Insert.
Figure 4 – Aurora Needle Guide Insert, ENCARINSERTMR-10G
®
C
n
or
™
L
isi
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1
Aurora Imaging Tech, Inc. N. Andover, MA, USA
2
™
L
Obturator. After images have been obtained,
isi
oC
™
L
Obturator, and Needle
isi
oC