4-4
NOTE: The sample aperture is in the CLOSED position after arming.
NOTE: The holster cannot operate the ARM/FIRE clinical functions in the variable aperture
setting. The aperture must be set to the full (open) setting for the ARM/FIRE clinical
function to be activated.
WARNING: Ensure that no hard material is forced into the aperture.
8. Once the device is ARMED (the “Engaged” message appears on the touchscreen interface), the
probe may be inserted into the percutaneous site by following one of two methods: the “Pierce”
method or the “Push-In” method.
NOTE: Take care to avoid the probe needle tip during this procedure. Failure to follow this instruction
could lead to patient or operator injury.
NOTE: The ST holster only operates and allows tissue sampling with the probe in the post-fire (fully
extended) position.
“Pierce” Method
a. Introduce the probe through the incision and position the probe tip in the target area. Imaging
guidance should be used as appropriate.
b. To fire the probe, press and hold the mechanical safety release button; then press and hold the
FIRE button on the active side of the holster at the same time. Imaging guidance should be used
as appropriate to verify the probe is in the correct location for tissue biopsy.
NOTE: The sample aperture is in the OPEN position immediately after firing.
“Push-In” Method
a. Before the probe has been inserted into the incision, first perform the DISARM function to slowly
disengage the trocar shaft to its fully extended position.
NOTE: The sample aperture is in the OPEN position immediately after disarming.
b. With the ST holster and probe in the post-fire position, ensure the ST probe cutter is CLOSED by
pressing the OPEN/CLOSE button on the input device (green LEDs on the distal end of the
holster indicate the cutter position).
c. Introduce the probe through the incision.
d. Position the probe tip in the desired position. Imaging guidance should be used as appropriate to
verify the probe is in the correct location for tissue biopsy.
Disarm
a. If the device is in the ARMED state but firing is not needed, or if using the push-in method as
previously described:
Press and hold the ARM button on the holster until the blue LED above the ARM button begins to
flash. The trocar shaft and holster firing fork slowly move to the post-fire (fully extended) position.