Indications For Use - Hologic LOCalizer Manual Del Usuario

CAUTION:
Read all warnings, cautions, and instructions provided with this equipment before using.
Read the instructions, warnings, and cautions provided with the Tag Applicator and
LOCalizer Surgical Probe before using. Specific instructions pertaining to Tag implantation
and preparation and use of the Surgical Probe are not included in this Manual.
DESCRIPTION
RFID Localization System
The Tag Applicator, LOCalizer™ Reader, and LOCalizer Surgical Probe are components of the RFID
Localization System. The Tag is intended to be placed in breast tissue, within 6 cm of the breast
surface, using the Tag Applicator. The Tags, when used in conjunction with the LOCalizer Reader and
LOCalizer Surgical Probe, can be used as a guide for the surgeon to follow in the excision of tissue.
RFID Localization System (RFLS) components are listed below:
System Component
LOCalizer Reader
LOCalizer Surgical
Probe
Tag Applicator
* XX indicates the length of the applicator needle in cm. Contact distributor for available sizes
in your area.
The LOCalizer Instrument Drape (HB120) is provided separately for use with the LOCalizer Reader
in a sterile environment.
LOCalizer Reader
The LOCalizer Reader locates and reads (RFID) Tags which have been implanted using the
Tag Applicator.
The LOCalizer Reader displays the distance between the Tag and the Probe under use.
Tag location is also indicated by an audible sound of which the pitch and volume increases in
proportion to a decrease in the "LOCalizer to Tag" distance.
The LOCalizerReader is a portable, battery-operated system and is supplied non-sterile.
The Tag Applicator and LOCalizer Surgical Probe are provided sterile.
This manual includes guidelines for the use of the Probe in the sterile field.

INDICATIONS FOR USE

The Tag of the RFLS is intended for percutaneous placement in the breast to mark ( >30 days) a lesion
intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by
non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue.
The RFLS is intended only for the non-imaging detection and localization of the Tag that has been
implanted in a lesion intended for surgical removal.
Description
RFID Reader
Attachment probe for use with LOCalizer RFID
Reader
Needle applicator with preloaded RFID Tag
EN
Part Number
HB100-EU
HB110-EU
HB200-XX-EU*
HB300-XX-EU*
User Manual 1