Bard EnCor Manual Del Usuario página 2

11. Support the Cannula (B) while removing the Trocar (A)/V
and insert the E C
® MRI Breast Biopsy Probe into the Cannula (B). Refer to
N OR
Figure 3 and Table 1.
Needle Guide Block
V L
™ Obturator
ISI OC
Trocar
Blunt Tip Probe
C
T
RI ONCAVE
Figure 3. Cannula, V L ™ Obturator, and E
ISI OC
Table 1. Cannula, V L ™ Obturator, and E
ISI OC
Probe
Item Description
Depth Beyond V L
™ Obturator Tip
ISI OC
Trocar
Blunt Tip Probe
T C
™ Tip Probe
RI ONCAVE
Sample Notch Length
Full Sample
Half Sample
Needle Guide Block Depth
12. Perform biopsy. Remove E C
N OR
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 L ™ Obturator (F). After images have been obtained, remove the
ISI OC
V L ™ Obturator (F) and Cannula (B) simultaneously.
ISI OC
• 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
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).
L ™ Obturator (F)
ISI OC
Cannula
Sample
Notch
Half
Sample
™ Tip Probe
C
® MRI Breast Biopsy Probe
N OR
C
®
MRI Breast Biopsy
N OR
7G
18mm 17mm
N/A 15mm
21mm 20mm
19mm 19mm
9.5mm 9.5mm
2cm
® MRI Breast Biopsy Probe.
L ™ Obturator (F), and
ISI OC
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
to verify placement of the V
position, if needed.
9. Rotate the Cannula Stop (D) clockwise to stabilize the Cannula (B) within the
Depth Beyond
Needle Guide Block (C).
V L
™
ISI OC
10. Support the Cannula (B) while removing the Trocar (A)/V
Obturator Tip
and inserting the E
Figure 3 and Table 1.
11. Perform biopsy. Remove E
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
V L ™ Obturator (F) and Cannula (B) simultaneously.
ISI OC
• 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
Needle Guide Insert.
Warranty
product will be free from defects in materials and workmanship for a period of
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
10G
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.
2cm
1
Aurora™ Imaging Tech, Inc. N. Andover, MA, USA
2
L ™ Obturator (F). Re-image the breast
ISI OC
L ™ Obturator (F) tip at the target site. Modify
ISI OC
C
®
MRI Breast Biopsy Probe into the Cannula (B). Refer to
N OR
C
®
MRI Breast Biopsy Probe.
N OR
L ™ Obturator (F). After images have been obtained, remove the
ISI OC
L ™ Obturator (F)
ISI OC
L ™ Obturator (F), and
ISI OC