Warnings and Precautions (Continued)
•
Care should be taken to avoid damaging the cannula. Avoid operator or instrument contact
with the TriMark for Eviva biopsy site marker system or the distal end of the device. Contact with the
distal end may result in loss of sterility.
•
The implanted TriMark for Eviva biopsy site marker is magnetic resonance imaging (MRI) conditional.
The implanted TriMark for Eviva biopsy site marker presents no additional risk to patient or operator
from magnetic forces, torque, heating, induced voltage or movement but may affect MRI image
quality.
•
Minimally invasive instruments and accessories manufactured or distributed by companies may not
be compatible with the TriMark for Eviva biopsy site marker system. Use of such products
may lead to unanticipated results and possible injury to the user or patient.
•
Instruments or devices which come into contact with bodily fluids may require special disposal
handling to prevent biological contamination.
•
Dispose of all opened instruments whether used or unused.
•
Do not resterilize and/or reuse the TriMark for Eviva biopsy site marker system. Resterilization and/or
reuse may compromise the integrity of the instrument. This may lead to potential risks of failure of the
device to perform as intended and/or cross-contamination associated with inadequately cleaned and
sterilized devices.
How Supplied
The TriMark for Eviva biopsy site marker system is sterilized by gamma radiation and supplied preloaded
for single patient use. Discard into an appropriate container after use.
As Identified on Labels:
YYYY-MM-DD
For More Information
For more information on the Eviva or the TriMark for Eviva biopsy site marker system, U.S. and Canadian
customers can contact the Customer Support Department of Hologic at: 1-877-887-8767 or CSupport@
hologic.com.
International customers, please contact your local distributor.
© 2010-2015 Hologic, Inc. All rights reserved. Hologic, Eviva and TriMark are registered trademarks and/or trademarks of Hologic, Inc. and/or its subsidiaries in
the United States and other countries.
Number of Devices Enclosed.
Expiration date is represented by the following:
YYYY represents the year
MM represents the month
DD represents the day
AW-09785-001 Rev. 002