2
11.
Support the Cannula (B) while removing the Trocar (A)/
V
ISI
L
OC
™
Obturator (F)
and insert the
E
N
C
OR
®
MRI Breast Biopsy Probe into the Cannula (B). Refer to
Figure 3 and Table 1.
Depth Beyond
V
ISI
L
OC
™
Obturator Tip
V
ISI
L
OC
™
Obturator
Trocar
Blunt Tip Probe
T
RI
C
ONCAVE
™
Tip Probe
Sample
Notch
Half
Sample
Needle Guide Block
Cannula
Figure 3. Cannula,
V
ISI
L
OC
™
Obturator, and E
N
C
OR
®
MRI Breast Biopsy Probe
Table 1. Cannula,
V
ISI
L
OC
™
Obturator, and E
N
C
OR
®
MRI Breast Biopsy
Probe
Item Description
7G
10G
Depth Beyond
V
ISI
L
OC
™
Obturator Tip
Trocar
18mm
17mm
Blunt Tip Probe
N/A
15mm
T
RI
C
ONCAVE
™ Tip Probe
21mm
20mm
Sample Notch Length
Full Sample
19mm
19mm
Half Sample
9.5mm
9.5mm
Needle Guide Block Depth
2cm
2cm
12. Perform biopsy. Remove
E
N
C
OR
®
MRI Breast Biopsy Probe.
13. Perform marker placement (if indicated) according to the respective
Instructions for Use.
•
To obtain post-marker images, remove marker applicator from Cannula (B) and
re-insert
V
ISI
L
OC
™
Obturator (F). After images have been obtained, remove the
V
ISI
L
OC
™
Obturator (F) and Cannula (B) simultaneously.
•
If post-marker images are not required, remove the marker applicator and
Cannula (B) simultaneously.
14. Maintain compression to the needle track to minimize bleeding. Hold compression
until bleeding has ceased.
15. Properly dispose of the Cannula (B), Trocar (A),
V
ISI
L
OC
™
Obturator (F), and
Needle Guide Block (C).
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 ensure that the package integrity of the Introducer Set
and Aurora™ Needle Guide Insert (ENCARINSERTMR10G, supplied separately)
have not been compromised. Refer to Figure 4.
Figure 4. Aurora™ Needle Guide Insert
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 for Use.
4. Using standard aseptic technique, remove the Trocar (A) from the package,
remove the Tip Protector (E), and inspect the Trocar (A) tip for signs of damage.
5. Using standard aseptic technique, remove the Cannula (B) from the package.
Remove the Cannula Stop (D) from the Cannula (B). Insert the Trocar (A) into the
Cannula (B).
6. Anesthetize the area and make a skin nick.
7. Insert the Trocar (A) and Cannula (B) assembly through the Needle Guide Insert
and into the breast until the Cannula Hub rests against the Needle Guide Insert.
8. The Trocar (A) is replaced with
V
ISI
L
OC
™
Obturator (F). Re-image the breast
to verify placement of the
V
ISI
L
OC
™
Obturator (F) tip at the target site. Modify
position, if needed.
9. Rotate the Cannula Stop (D) clockwise to stabilize the Cannula (B) within the
Needle Guide Block (C).
10. Support the Cannula (B) while removing the Trocar (A)/
V
ISI
L
OC
™
Obturator (F)
and inserting the
E
N
C
OR
®
MRI Breast Biopsy Probe into the Cannula (B). Refer to
Figure 3 and Table 1.
11. Perform biopsy. Remove
E
N
C
OR
®
MRI Breast Biopsy Probe.
12. Perform marker placement (if indicated) according to the respective Instructions
for Use.
•
To obtain post-marker images, remove marker applicator from Cannula (B) and
re-insert
V
ISI
L
OC
™
Obturator (F). After images have been obtained, remove the
V
ISI
L
OC
™
Obturator (F) and Cannula (B) simultaneously.
•
If post-marker images are not required, remove the marker applicator and
Cannula (B) simultaneously.
13. Maintain compression to the needle track to minimize bleeding. Hold compression
until bleeding has ceased.
14. Properly dispose of the Cannula (B), Trocar (A),
V
ISI
L
OC
™
Obturator (F), and
Needle Guide Insert.
Warranty
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product will be free from defects in materials and workmanship for a period of
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warranty will be limited to repair or replacement of the defective product, in
Bard Peripheral Vascular’s sole discretion or refunding your net price paid. Wear and
tear from normal use or defects resulting from misuse of this product are not covered
by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT
WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT
WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR
HANDLING OR USE OF THIS PRODUCT.
Some states/countries do not allow an exclusion of implied warranties, incidental or
consequential damages. You may be entitled to additional remedies under the laws of
your state/country.
An issue or revision date and a revision number for these instructions are included
for the user’s information on the last page of this booklet. In the event 36 months
have elapsed between this date and product use, the user should contact
Bard Peripheral Vascular, Inc. to see if additional product information is available.
Assembled in Thailand.
1
Aurora™ Imaging Tech, Inc. N. Andover, MA, USA
