Hologic LOCalizer User Manual page 6

LOCALIZATION PROCEDURE
1
Power on the LOCalizer Reader.
The rmware version number is displayed.
There is a brief delay while the integrated loop probe is tested.
If the Surgical probe is installed, there is a corresponding delay while it is tested.
2 Use the up and down arrows on the brightness control to adjust the screen to the desired intensity.
3
Check the battery charge indicator to ensure there is adequate charge. It is highly encouraged to change the
batteries before each procedure.
Batteries can be replaced following directions in the "CARE AND MAINTENANCE" section.
NOTE: The LOCalizer Reader may turn ON with a critically low battery, but will not continue operation normally.
4 Use the Loop Probe on the LOCalizer Reader to identify the general location of the Tag from the surface of
the breast. The sound level and pitch increases as the LOCalizer Reader approaches the Tag. The scale shows the
approximate distance to the nearest point of the Tag in millimeters. When using the Loop probe the range of the
LOCalizer Reader is at least 60 mm.
LOCalizer Reader (Loop)
Probe perpendicular to Tag
Weakest or no response
Figure 3. Assessing Tag location/position with Loop Probe using signal strength (not to scale)
NOTE: The sound and distance display rise to a maximum when the Tag is in line with and directly under the
sensing head surface (Figure 3). Identi cation of the Tag location can be re ned by moving the Probe until both
ends of the Tag are detected.
NOTE: The Tag's unique identi cation number is displayed once the probe is close enough to the implanted Tag.
9
Direction of decreasing response
LOCalizer Reader (Loop)
Probe in line with Tag
Strongest response and most
accurate distance reading
5
Use the up and down arrows on the volume control to adjust the audio tone to the desired volume.
6 If excising the Tag and lesion, plan and mark the surgical area with the approximate location of the Tag.
7
In preparation for surgery, place the sterile LOCalizer Instrument Cover over the LOCalizer Reader per the
Instrument Cover Instructions for Use.
NOTE: The LOCalizer Reader can be used on an un-breached breast surface in a non-sterile setting. In a sterile
setting, use of the Instrument Cover is required. The Surgical Probe is only intended for sterile use.
8 Connect the Surgical Probe into the receptacle on the LOCalizer Reader by introducing it through the cover
connector hole. When connected, the LOCalizer Reader automatically identi es the Surgical Probe as the active
probe, performs a self-test and the LOCalizer Reader screen displays the Surgical Probe icon. When the Surgical
Probe is attached, the range of LOCalizer Reader is at least 30 mm.
LOCalizer Surgical Probe
perpendicular to Tag
Weakest or no response
Figure 4. Assessing Tag location/position with Surgical Probe using signal strength (not to scale)
NOTE: Readings will vary depending on the orientation of the Tag, because the signal emitted is directional along
the long axis of the Tag. The LOCalizer Reader will receive the strongest response and most accurate distance
reading when the Surgical Probe is parallel with the Tag. Signal strength decreases as the Surgical Probe head
moves toward perpendicular to the Tag and the distance accuracy may decrease.
9
During the surgical approach, the LOCalizer Reader may be toggled between the Loop Probe and Surgical Probe
by depressing the probe toggle switch. The active probe is indicated on the display.
10
Excise intended tissue with implanted Tag.
11 Con rm the Tag is present in the excised specimen using the LOCalizer Reader or imaging (ultrasound or radiography).
Direction of decreasing response
LOCalizer Surgical Probe
parallel with Tag
Strongest response and most
accurate distance reading
10