Hologic LOCalizer Manual Del Usuario página 5

WARNINGS
General
The LOCalizer Reader is designed only for use with the LOCalizer Surgical Probe and Tags.
Tag Applicator and Surgical Probe
The Tag Applicator is intended for sterile use. Do NOT use this product on a non-sterile surface
prior to use internally.
Caution should be exercised with using the device on patients with prostheses so as to not puncture
the prosthesis during placement.
If any resistance is felt during advancement of the Surgical Probe or Tag Applicator (during
implantation), carefully correct the orientation but never apply strong forces in order to overcome the
obstacle.
Exercise caution when placing the Tag near the chest wall. Insert the Needle applicator parallel to the
chest wall so as to not puncture the chest wall during placement.
To avoid confusion between signals produced by both Tags, it is recommended that no more than one
Tag is implanted in the same operative breast.
Exercise caution during surgical excision of the lesion to avoid cutting or damaging the Tag. When
using electrosurgical tools, avoid direct contact with the Tag as thermal damage can result. If the Tag
is inadvertently damaged, ensure all parts of the Tag are retrieved from the surrounding tissue.
When using the Surgical Probe intraoperatively, avoid touching or moving the Tag with the Surgical
Probe.
Do NOT use the Tag Applicator or Surgical Probe if the package is open or damaged.
Use the Tag Applicator and Surgical Probe prior to the expiration date shown on the product label.
The Tag Applicator with Tag and Surgical Probe have been designed for SINGLE USE only. Reusing
this medical device bears the risk of cross-patient contamination. The residue of biologic material
can promote the contamination of the device with pyrogens or microorganisms which may lead to
infectious complications.
DO NOT RESTERILIZE. After sterilization, the sterility of the product is not guaranteed because of an
indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious
complications. Cleaning, reprocessing and/or re-sterilization of the present medical device increases
the probability that the device will malfunction due to potential adverse effects on components that
are influenced by thermal and/or mechanical changes.
User Manual 3