001118v4.0 - US EN
Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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Warning.
Keep at least 5 cm distance between the Pintuition Seed and any
implanted active device such as a pacemaker, cardioverter defibrillator or other
electrically powered implant.
Use of the Pintuition System is limited to patients aged 12 or over. There are no further
restrictions on
patients’ gender, weight,
health, or condition.
1.3
P
OSSIBLE
C
OMPLICATIONS AND
A
DVERSE
E
VENTS
During routine use, complications may occur at any moment during or after the localization
procedure.
Possible complications include, but are not limited to: hematoma, seroma, bleeding, infection,
damaging of neighboring tissues, allergic reaction, and pain.
1.4
C
OMPATIBLE COMPONENTS
The following items are required for the proper use of the Pintuition Detector:
•
Pintuition Base Unit (SPBU)
•
Pintuition Probe (SPP)
•
Pintuition Test Kit (SPTK)
Use of other parts is not allowed.
1.5
P
RINCIPLE OF
O
PERATION
The Pintuition Detector is an electrical medical device, intended to detect the presence and
distance towards a Sirius Medical Systems certified magnetic implant (such as the Pintuition
Seed) during surgery.
The principle of operation is magnetism. The Pintuition Probe contains sensitive sensors
which measure the magnetic field. The Base Unit processes these measurements and
provides the distance from the Probe to the Pintuition Seed using visual and audible
feedback.
The detected distance is shown in millimeters on the display and the audio feedback changes
dependent upon the distance between the Pintuition Seed and the Probe
The Pintuition Test Kit is a device that can be used to confirm correct functioning of the
Pintuition Detector.
1.6
E
XPLANATION OF
S
YMBOLS
Symbol Description
This symbol indicates that a user of the device is required to read the entire instructions for
use before first use.
This symbol indicates that a user of the device is required to read the entire instructions for
use before first use.
This symbol indicates the temperature limits, e.g., for transport or operation.
This symbol indicates the humidity limits, e.g., for transport or operation.
This symbol indicates the pressure limits, e.g., for transport or operational use.
This symbol indicates that this device should be disposed of in accordance with the Waste
Electrical and Electronic Equipment Directive 2012/19EU (WEEE). Do not dispose of the
device as unsorted municipal waste.
This symbol indicates that the device is a
M
edical
D
evice
