ATEC
®
Breast Biopsy and Excision System:
Sapphire
™
Unit
Operator’s Manual
15
Using the ATEC
®
Breast Biopsy and
Excision System:
Sapphire
™
Unit
Using the System
(MRI)
v
When the console is in “Biopsy” mode, depressing the footswitch will activate the vacuum
and operation of the handpiece.
v
When the console is in “Lavage” mode, the user can automatically aspirate and irrigate
the biopsy cavity. It is not necessary to depress the footswitch.
v
When the console is in “Manual Aspiration” mode, depressing the footswitch allows the
user to independently control aspiration without taking a tissue sample. This function may
be used to vacuum or irrigate the biopsy cavity.
Additional operating instructions for an MRI-guided breast biopsy are outlined below.
Performing a Biopsy Using MRI Guidance
After setting up the ATEC
®
Breast Biopsy and Excision System per the steps outlined in this
manual or in the ATEC
®
Easy-Guide Console Instructions Card, MRI-guided breast biopsy
using the ATEC
®
may be performed by following the steps below:
v
Once the area to be biopsied has been identified, prepare the area for biopsy utilizing
standard facility techniques.
v
Insert the sterile Needle Guide into the compression grid at the identified target area in
the appropriate “cube.”
v
Insert the Introducer Stylet that is hubbed to the Introducer Sheath. The depth stop on the
Introducer Sheath is placed in the appropriate location according to the pre-determined “Z” axis.
v
Insert the Introducer Sheath, with the Introducer Stylet, while rotating the sheath / stylet
assembly into and through the Needle Guide to the depth stop, allowing for a pathway
to the target area.
v
Remove the stylet from the Introducer Sheath while leaving the Introducer Sheath in place.
v
Insert the Localizing Obturator into the sheath.
v
With MR image guidance, identify the location of the Localizing Obturator to the area
to be biopsied.
v
If location of Localizing Obturator is not accurate, reposition. If it is accurate, continue
to step below.
v
Remove Localizing Obturator from introducer sheath.
v
Insert and hub the ATEC
®
handpiece into the Introducer Sheath and to the biopsy site in
preparation for the biopsy to be performed.
v
Once the biopsy is complete, remove the ATEC
®
biopsy handpiece, leaving the Introducer
Sheath in place.
v
After imaging to confirm acquisition of the target area and with the Introducer Sheath still
in place, remove the patient from the MRI bore and place a biopsy site marker in the target
area cavity to later identify the biopsy site.