Bard SenoMark UltraCor Gebrauchsanweisung Seite 2

®
E C Ultrasound Introducers – Use with Ultrasound Length Adapter
N OR
®
E C MRI Introducers – Use with MRI Length Adapter
N OR
Insert to First Step
™
Eviva Biopsy Probe Cannula – Use with Eviva Length Adapter (Stereo)
1. After biopsy sampling is complete and you are ready to place the marker, remove
biopsy device or obturator making sure to leave in place the cannula or introducer.
2. Inspect the marker package to ensure package integrity has not been
compromised. The product is sterile unless the seal is broken.
3. Using standard aseptic technique, open the package and remove the applicator
(B). Select the appropriate length adapter indicated in Figure 2. Remove the
applicator's tip protector (D) and apply the length adapter if required as shown
in Figure 3. Ensure adapter is fully seated.
4. Insert the applicator needle (C) into the introducer or cannula until fully seated.
See Figure 3.
Figure 4 below.
Locked
6. With the plunger in the unlocked position, immediately deploy the marker by
advancing the plunger (A) until it contacts the applicator handle.
7. Remove the applicator and the cannula or introducer together as one unit.
8. Hold compression on the skin breach until bleeding has ceased.
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:
(SAR) of 4-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
- First Level Controlled Operating Mode of operation for the MR system
Figure 3
Unlocked
Figure 4
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, Excite, HDx, Software 14X.M5, General Electric
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
product will be free from defects in materials and workmanship for a period of one year
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.
2
2.9-W/kg
2.7-W/kg
1.7°C
2.3°C