Warnings And Precautions - Hologic TriMark Instructions D'utilisation

Device Preparation and Use
1. Prior to use of the TriMark for Eviva biopsy site marker system, inspect the protective packaging and
device to verify that neither has been damaged during shipment. If it appears that the packaging has
been compromised, do not use the device.
2. Remove the TriMark for Eviva biopsy site marker system from its protective packaging using sterile
technique.
3. Remove the biopsy device from the introducer sheath.
4. Place the TriMark for Eviva biopsy site marker system through the hub of the introducer sheath.
5. Advance the TriMark for Eviva biopsy site maker system until the handle snaps to the hub.
6. Deploy the TriMark for Eviva biopsy site marker by advancing the deployment plunger all the way
forward until it latches
onto the handle.
7. Slowly remove the deployment device and introducer sheath as one unit from the breast
and properly dispose.

Warnings and Precautions

• The TriMark for Eviva biopsy site marker system is not recommended for use within the bore of an
MRI magnet.
• The TriMark for Eviva biopsy site marker system is not intended for use in patients with breast
implants.
• The TriMark for Eviva biopsy site marker system should be used only by persons having adequate
training and familiarity with this procedure. Consult medical literature relative to techniques,
complications, and hazards prior to performance of any minimally invasive procedure.
• This TriMark for Eviva biopsy site marker system should be used only by physicians trained in open or
percutaneous biopsy procedures.
Rx Only
• Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
• The TriMark for Eviva biopsy site marker should be deployed into the cavity created during the biopsy
procedure. Deployment into tissue outside of the biopsy cavity is not recommended.
• Marker position relative to established landmarks may change under mammography upon subsequent
breast compressions.
• The TriMark for Eviva biopsy site marker is not intended to be repositioned or recaptured after it
has been deployed.
• Excess hematoma within the biopsy device can lead to marker adhesion, increasing the risk of marker
drag out.