Bard UltraClip Dual Trigger Instrucciones De Uso página 4

3. After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical
practice and applicable local, state, and federal laws and regulations.
G. Potential Complications:
Complications may occur at any time during or after the procedure. Potential complications of breast tissue marker
placement may include, but are not limited to: hematoma, hemorrhage, infection, adjacent tissue injury and pain.
H. Equipment Required:
The following equipment is required to place the marker:
Appropriate imaging modality and accessories
Surgical gloves and drapes
Local anesthetic
ther equipment as necessary
I. Directions for Use:
1. Prepare the site as required. Adequate anesthesia should be administered, as required.
2. Inspect the package and product for damage. If undamaged, open the package and transfer the U
Trigger Breast Tissue Marker onto the sterile eld utilizing aseptic technique.
NOTE: Lift up either one of the yellow side tabs to remove the protective needle sheath and yellow guard (Figure 2).
3. Locate the target area for deployment using the appropriate imaging technique.
4. Insert the introducer needle into the breast, directing it to the target. Use the 1 cm reference markings to position the
needle point just proximal to the target.
ARD ®
NOTE: The B logo and the front trigger line up with the bevel of the needle to help in needle placement.
5. Con rm needle placement with the appropriate imaging technique. If necessary, reposition the needle and recon rm
placement.
6. To deploy the marker, slide the front trigger forward (Figure 3) or rmly depress the rear trigger with the thumb or index
nger (Figure 4) until a rm click is heard or felt and both triggers are locked in place.
7. Remove the introducer and con rm placement of the marker using the appropriate imaging technique.
MRI Information
MR Conditional
Non-clinical testing demonstrated that the Breast Tissue Marker is MR Conditional. A patient with this device can be
scanned safely immediately after placement under the following conditions:
- Static magnetic eld of 3-Tesla or less
- Maximum spatial gradient magnetic eld of 720- auss cm or less
- Maximum MR system reported, whole body averaged speci c absorption rate (SAR) of 4-W kg for 15 minutes of
scanning (i.e., per pulse sequence)
- First Level Controlled perating Mode of operation for the MR system
MRI-Related Heating
In non-clinical testing, the Breast Tissue Marker produced the following temperature rise during MRI performed for 15-min
of scanning (i.e., per pulse sequence) in a 3-Tesla MR system (3-Tesla 128-MHz, xcite, HDx, Software 14 .M5, eneral
lectric Healthcare, Milwaukee, WI):
MR system reported, whole body averaged SAR
Calorimetry measured values, whole body averaged SAR
Highest temperature change
Temperature scaled to whole body averaged SAR of 4-W kg
Artifact Information
MR 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, optimization of MR imaging parameters to compensate for the presence of this device
may be necessary.
Warranty
Bard Peripheral Vascular 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 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.
Figure 2
1
1. Needle guard holder
2. Side tabs
Figure 3 Figure 4
2. -W kg
2.7-W kg
1.7°C
2.3°C
2
LIP ®
C Dual
LTRA