001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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4.7
S
URGICAL
P
ROCEDURE
Caution.
Care should be taken to remove all magnetic disturbances from the
vicinity of the Probe during routine use.
Caution.
Always
calibrate the Pintuition Detector before each use by following
the instructions in Section 4.2 (Calibrating the Pintuition Detector).
Note.
The calibration procedure may be repeated during use if the system
provides insufficient detection range.
4.7.1
P
REPARING THE
P
ROCEDURE
1.
Clean the Probe before each use by following the instructions in Section 5.2
(Pintuition Probe).
1.
Make sure the Probe is correctly connected to the system by following the
instructions in Section 4.1 (Connecting the Pintuition Probe).
2.
Calibrate the Detector by following the instructions in Section 4.2 (Calibrating the
Pintuition Detector).
3.
Make sure the audio is turned on following the instructions Section 4.4 (Adjusting the
volume) and that the Display
(2)
is clearly legible.
4.7.2
P
REOPERATIVE
–
S
URGICAL
P
LANNING
(
NO STERILE AREA
)
1.
Apply the Probe
(13)
tip to the skin near the location of the tissue of interest. Scan the
Probe tip over the area until a stable signal is obtained.
2.
When a signal is obtained, the display
(2)
will show the distance between the Probe
tip and Pintuition Seed and the Base Unit will provide audible feedback. For guidance,
please refer to the detection characteristics in Section 4.6 (Detection, Directionality
and Accuracy).
3.
Verify detection of the seed and plan the surgical incision.
Note.
If no signal is detected, apply gentle pressure (palpate) using the Probe to
reduce the distance between Probe (
13
) head and Pintuition Seed, also see
Section 4.6 (Detection, Directionality and Accuracy).
4.7.3
P
REOPERATIVE
–
S
TERILE
D
RAPING TO
P
REPARE FOR
U
SE WITHIN
S
TERILE
A
REA
Warning.
Always apply a suitable and legally marketed sterile sheath before
using the Pintuition Probe in a sterile field.
1.
Apply a sterile sheath according to the instructions in Section 4.5 (Application of
sterile sheath).
