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F.
Precautions:
1.
Use caution when handling the device to prevent premature deployment of the marker.
2.
This product should only be used by a physician who is completely familiar with the indications, contraindications,
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, marker migration, misdiagnosis, 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
• Other equipment as necessary
I.
Directions for Use:
1.
Prepare the site as required. Adequate anesthesia should be administered, as required.
Inspect the package and product for damage. If undamaged, open the package and transfer the U
2.
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.
placement.
6.
To deploy the marker, slide the front trigger forward (Figure 3)
(Figure 4)
MRI Information
MR Conditional
Non-clinical testing demonstrated that the U
A patient with this device can be scanned safely in an MR system under the following conditions:
scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR system
produce a maximum temperature rise of 1.3°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the U
extends approximately 5-mm from the U
gradient echo pulse sequence and a 3-Tesla MR system.
Non-clinical testing demonstrated that the U
with this device can be scanned safely in an MR system under the following conditions:
scanning (i.e., per pulse sequence) in the Normal Operating Mode of operation for the MR system
maximum temperature rise of 1.3°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the U
approximately 15-mm from the U
pulse sequence and a 3-Tesla MR system.
Non-clinical testing demonstrated that the U
with this device can be scanned safely in an MR system under the following conditions:
scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system.
Figure 2
1
1.
Needle guard holder
2.
Side tabs
Figure 3
C
LIP ®
Dual Trigger Breast Tissue Marker Ribbon or Wing is MR Conditional.
LTRA
U
C
LIP ®
Dual Trigger Breast Tissue Marker Ribbon or Wing is expected to
LTRA
LTRA
C
LIP ®
Dual Trigger Breast Tissue Marker Ribbon or Wing when imaged using a
LTRA
C
LIP ®
Dual Trigger Breast Tissue Marker Coil is MR Conditional. A patient
LTRA
U
C
LIP ®
Dual Trigger Breast Tissue Marker Coil is expected to produce a
LTRA
LTRA
C
LIP ®
Dual Trigger Breast Tissue Marker Coil when imaged using a gradient echo
LTRA
C
LIP ®
Dual Trigger Breast Tissue Marker Heart is MR Conditional. A patient
LTRA
Figure 4
C
LIP ®
Dual Trigger Breast Tissue Marker Ribbon or Wing
C
LIP ®
Dual Trigger Breast Tissue Marker Coil extends
2
C
LIP ®
Dual
LTRA
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