6. Insert the applicator into the biopsy probe through the
guide seal. Advance the applicator until the applicator
contacts the distal end of the biopsy probe.
7. Align the alignment indicator D on the applicator handle
E with the sample notch in the biopsy probe.
8. Immediately deploy all pads by advancing the plunger
The pads will be fully dispensed when the plunger contacts
the handle.
Note: Avoid pulling the applicator handle during deployment which
could cause deployment failure.
9.
otate the biopsy probe 180 to position the sample notch
away from the dispensed pads.
10. emove the applicator from the biopsy probe. Avoid the
use of force.
Caution: If resistance is felt while removing the applicator,
remove the entire probe/applicator assembly from the patient.
Failure to do so may result in breakage of the applicator tip.
11. Close the sample notch and remove the biopsy probe, per
manufacturer's instructions.
12. Dispose of the applicator properly.
1 . Con rm nal breast tissue marker position with imaging.
MR CONDITIONAL INFORMATION
Non-clinical testing has demonstrated that the breast tissue marker
is M Conditional. It can be scanned safely under the following
conditions:
Static magnetic eld of -Tesla or less
Spatial gradient eld of 720-Gauss cm or less
Maximum whole-body-averaged speci c absorption rate SA
of -
kg for 15 minutes of scanning.
In non-clinical testing, the breast tissue marker produced a
temperature rise of less than +0.4ºC at a maximum whole body
averaged speci c absorption rate SA
M scanning in a -Tesla, Signa M system Excite platform
G .0-052B software, GE Healthcare, Milwaukee,
M image quality may be compromised if the area of interest is in
the exact same area or relatively close to the position of the breast
tissue marker. Therefore, it may be necessary to optimize M
imaging parameters for the presence of this implant.
It is recommended that patients with a breast tissue marker
register the M conditions with the MedicAlert oundation
www.medicalert.org .
.
of -
kg of 15 minutes of
I .
2
WARRANTY
Bard Peripheral ascular warrants to the rst purchaser of this
product that this product will be free from defects in materials
and workmanship for a period of one year from the date of rst
purchase and liability under this limited product warranty will be
limited to repair or replacement of the defective product, in Bard
Peripheral ascular's sole discretion or refunding your net price
paid.
ear 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 6 months have elapsed between this
date and product use, the user should contact Bard Peripheral
ascular, Inc. to see if additional product information is available.
Assembled in Thailand.