001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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4.7.4
P
ERIOPERATIVE
–
D
URING
S
URGERY
(
USE WITHIN
S
TERILE
A
REA
)
Warning.
Be aware that the Pintuition Seed may be attracted towards and stick to
metallic objects such as knifes or scalpels when these are brought within
approximately 5 mm of the seed.
Carefully plan your surgical approach to avoid cutting too close to the seed. If
cutting near the seed is required: first excise away from the seed and secondarily
towards the seed, according to the following suggested scheme.
Caution.
The detection range may be adversely affected by metal (surgical)
instruments very close to the tip of the Probe. If detection is challenging, attempt
to keep any metal instruments, objects, or other magnetic disturbances at least
2-5 centimeters away from the tip of the Probe.
Caution.
Pintuition Seeds placed in close proximity (<50mm) may impair
detection range or accuracy. If multiple seeds are required, space them
sufficiently apart and/or proceed with care.
Warning.
The Pintuition Detector is not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or with nitrous oxide.
Warning.
Do not touch the Pintuition Probe connector port contacts and the
patient simultaneously.
1.
Use the Pintuition Detector as many times as necessary during surgery as a guidance
towards the tissue of interest.
2.
Perform an excision of the tissue of interest that is marked with the Seed.
3.
Confirm presence of the Seed within the excised specimen by gently holding the
Probe
(13)
tip against the specimen and assessing the presence of the Seed.
4.
Confirm absence of the Seed in the surgical area by scanning the Probe
(13)
in and
around the surgical area to assess the absence of a signal.
5.
Use an imaging modality such as specimen x-ray to confirm presence of the Seed
within the excised specimen(s).
Note.
If the signal from the excised specimen and/or the specimen x-ray do not
confirm presence of the Seed, users are instructed to reassess the surgical area
for remaining signal to search for, identify and remove the Seed using an
additional resection.
4.7.5
P
OSTOPERATIVE
1.
Remove the disposable sterile sheath from the Probe and discard per your facility’s
biohazardous waste procedures.
2.
Clean the Probe by following the instructions in Section 5.2 (Pintuition Probe).
3.
Transfer the specimen to the pathology department.
