001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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1
I
NTRODUCTION
The Sirius Pintuition Detector (Pintuition Detector) is a part of the Sirius Pintuition
Localization System (Pintuition System).
The Pintuition Detector consists of a Pintuition Base Unit (SPBU), a cable-connected,
detachable Pintuition Probe (SPP) and the Pintuition Test Kit (SPTK).
The Pintuition Detector is designed to detect the distance towards a preoperatively implanted
Pintuition Seed and to provide this information to the user using a numerical representation in
millimeters shown on Base Unit display, as well as using audible feedback.
Note
: The Pintuition Seed is
not
a part of this Instructions for Use.
Warning.
The Pintuition Seed is supplied with a separate Instruction for Use
booklet that should be read completely before using the Pintuition System.
Please refer to
www.sirius-medical.com/support
The Pintuition Base Unit is a mains-connected table-top stationary device.
The Pintuition Probe is a handheld detachable device intended to be used pre-operatively to
plan the incision and intra-operatively when covered using a sterile sheath to guide surgery.
The Probe is connected to the Pintuition Base Unit with a cable.
Only approved devices manufactured by Sirius Medical Systems can be reliably detected with
the Pintuition Detector.
The intended users of the Pintuition Detector are surgeons or other appropriately qualified
operating theatre staff. The System is intended for use in operating theatres.
Warning.
The Pintuition Detector is intended for use by suitably qualified and
trained surgeons and/or operating theatre staff. Sirius Medical Systems takes no
responsibility for the possible misuse of the Pintuition Detector - or for its use by
inadequately qualified staff.
This Instructions for Use provides a detailed description of how to use the Pintuition Detector
and how to perform maintenance and troubleshooting.
It is mandatory to read these entire instructions for use, prior to using the Pintuition Detector.
1.1
I
NDICATION FOR
U
SE
The Sirius Pintuition Seed is intended to be placed percutaneously in the breast to mark
temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging
guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius
Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the
target tissue.
The Sirius Pintuition Detector is intended for the non-imaging detection and localization of the
Sirius Pintuition Seed that has been implanted in a lumpectomy site intended for surgical
removal.
1.2
C
ONTRAINDICATIONS AND
L
IMITATIONS FOR
U
SE
Warning.
Do not use the Pintuition Seed in other tissues than named under
“Indication for Use", for example do not use in organs, liver, central nervous
system, vascular system, heart, lung, eyes, or brain. Please note that this list is
not exhaustive.
Do not use the Pintuition Seed in tissue that is clinically proven to be infected.
