Sirius Medical Pintuition Detector User manual

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Instructions for Use
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Sirius Pintuition Detector
Instructions for Use
This document covers:
Sirius Pintuition Base Unit (SPBU)
Sirius Pintuition Probe (SPP)
Sirius Pintuition Test Kit (SPTK)
Version: 001118v4.0
Made in the Netherlands.
Sirius Medical Systems B.V.
High Tech Campus 41
5656 AE Eindhoven
The Netherlands
Contact: [e-mail]
URL: www.sirius-medical.com.
Copyright © 2021 Sirius Medical Systems
All rights reserved. No part of this Instruction may be reproduced, stored in a retrieval system, or
transmitted, by any means or in any form, without the prior permission of Sirius Medical Systems B.V.
Sirius Medical Systems assumes no responsibility for any errors that may appear in this document.
Worldwide Patents Pending.

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Instructions for Use
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10
1
12
13
11
4
5
3
1Pintuion Detector
2Display
3Volume Knob
4Calibrate Buon
5Connector Port
10 Distance Measure
11 Pintuion Probe Status
12 Volume Status
13 Pintuion Probe
14 Pintuion Probe Cable
16 Probe Connector
16 14
2
Calibration Required
Calibration In Progress
Pintuition Probe not connected
Pintuition Probe connected
Audio muted
volume generates signal
outside of detec
-
gene
rates no
signal
Probe
SIRIUS MEDICAL SYSTEMS B.V. |High Tech Campus 41 |5656AE
Eindhoven | The Netherlands |www.sirius-medical.com
Display Icons Detection Principle
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How to calibrate?
Hold the probe vertically in the air and at least 30 centimeters away from any other
equipment. Push the calibrate button and release. Hold the probe still. The calibration
takes approximately 5 seconds
When to calibrate? Before each new patient and when the system indicates it.
No signal? Gently palpate (push) the tissue with the probe to reduce the distance between Pintuition
Probe and Seed.
Sterility? The Pintuition Probe is not a sterile medical device. Always cover with a new, legally
marketed sterile cover before each use in a sterile area.
Note: Numbering not consecutive. Numbers relate to remainder of instructions for use. See Section 3.
SIRIUS PINTUITION DETECTOR
Quick Reference Guide
Warning! This sheet is not intended as a replacement of the complete Instructions for Use. Please read the complete Instructions for Use booklet
supplied with the Pintuition Detector and Pintuition Probe before rst use, or refer to www.sirius-medical.com/support for the latest version.

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Table of Contents
QUICK REFERENCE GUIDE .............................................................................................................. 3
1INTRODUCTION ........................................................................................................................ 6
1.1 Indication for Use .................................................................................................................................... 6
1.2 Contraindications and Limitations for Use........................................................................................... 6
1.3 Possible Complications and Adverse Events....................................................................................... 7
1.4 Compatible components ........................................................................................................................ 7
1.5 Principle of Operation ............................................................................................................................. 7
1.6 Explanation of Symbols .......................................................................................................................... 7
2SAFETY ...................................................................................................................................... 8
2.1 Warnings................................................................................................................................................... 8
2.2 Cautions.................................................................................................................................................. 10
3INSTALLATION AND BASIC OPERATION OF THE PINTUITION DETECTOR...................... 12
3.1 Unpacking and Inspecting .................................................................................................................... 12
3.2 Device Description................................................................................................................................. 12
3.2.1 Pintuition Base Unit - Front.............................................................................................................................. 12
3.2.2 Pintuition Base Unit –Back............................................................................................................................. 13
3.2.3 Pintuition Base Unit –Display Interface ........................................................................................................ 13
3.2.4 Pintuition Probe (Applied Part, type BF) ........................................................................................................ 14
3.2.5 Pintuition Test Kit ............................................................................................................................................. 14
3.2.6 Audio.................................................................................................................................................................. 14
3.3 Transport and Storage .......................................................................................................................... 15
3.4 Installation.............................................................................................................................................. 15
3.5 Powering the Device.............................................................................................................................. 15
3.6 Turning the Device On........................................................................................................................... 15
3.7 Turning the Device Off .......................................................................................................................... 16
4USING THE PINTUITION DETECTOR..................................................................................... 17
4.1Connecting the Pintuition Probe.......................................................................................................... 17
4.2 Calibrating the Pintuition Detector ...................................................................................................... 17
4.3 System Test: Using the Test Kit........................................................................................................... 18
4.4 Adjusting the volume ............................................................................................................................ 18
4.5 Application of sterile sheath ................................................................................................................ 18
4.6 Detection, Directionality and Accuracy ............................................................................................... 19
4.7 Surgical Procedure ................................................................................................................................ 20
4.7.1 Preparing the Procedure.................................................................................................................................. 20
4.7.2 Preoperative –Surgical Planning (no sterile area)....................................................................................... 20
4.7.3 Preoperative –Sterile Draping to Prepare for Use within Sterile Area....................................................... 20
4.7.4 Perioperative –During Surgery (use within Sterile Area)............................................................................. 21
4.7.5 Postoperative –Pathological Processing ..................................................................................................... 21
4.8 Disconnecting the Probe ...................................................................................................................... 22
5REPROCESSING –CLEANING AND HIGH LEVEL DISINFECTION ....................................... 23
5.1 Pintuition Base Unit............................................................................................................................... 23
5.2 Pintuition Probe ..................................................................................................................................... 23
6MAINTENANCE AND SERVICE............................................................................................... 26
6.1 Recommended Maintenance ............................................................................................................... 26
6.2 Replacing the Fuse ................................................................................................................................ 26
6.3 Repairs .................................................................................................................................................... 26
6.4 Pintuition Detector –Disposal............................................................................................................ 26
7TECHNICAL SPECIFICATIONS............................................................................................... 27
7.1 Compliance with Standards ................................................................................................................. 27
7.2 Electromagnetic Compatibility............................................................................................................. 28
8TROUBLESHOOTING .............................................................................................................. 31
8.1 Troubleshooting Errors ......................................................................................................................... 31
8.2 Troubleshooting Tips ............................................................................................................................ 31
8.3 Obtaining Technical Assistance .......................................................................................................... 32

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1INTRODUCTION
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 INDICATION FOR USE
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 CONTRAINDICATIONS AND LIMITATIONS FOR USE
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.

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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 POSSIBLE COMPLICATIONS AND ADVERSE EVENTS
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 COMPATIBLE 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 PRINCIPLE OF OPERATION
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 EXPLANATION OF SYMBOLS
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 Medical Device

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Symbol
Description
This symbol indicates the unique device Serial number. For the Pintuition Probe, the format
contains the manufacturing date as follows: 3YYWWD.
This symbol indicates the device’s reference code or catalog number
This symbol indicates that the Pintuition Probe is a type BF applied part according to the
IEC 60601-1 standard regarding electrical safety.
This symbol indicates that the device is developed in compliance with the European
Directive 93/42/EEC regarding medical devices. “0344” is the Notified Body identification.
This symbol indicates the legal manufacturer.
This symbol indicates the date of manufacture.
This symbol indicates a warning. Users should heed any warning closely to prevent serious
user or patient injury.
This symbol indicates a caution. Users should take any precaution to prevent minor or
moderate user or patient injury.
This symbol indicates calibration, it is also visible on the of the Pintuition Base Unit.
This symbol indicates a fuse.
℞
This symbol indicates that the device is intended for Prescription Use only.
2SAFETY
This section contains important safety information.
It is required that the user has read and understood all warnings, cautions, and
the complete Instructions for Use manual prior to using the Pintuition Detector.
2.1 WARNINGS
Warning. Failure to thoroughly review and adhere to the information contained in
this Instructions for Use may pose a potential hazard to the patient and/or user.
Warning. Do not use the Pintuition Detector in other tissues than named under
“Indications for Use”. Do not use in the central nervous system, vascular system,
heart, lung, eyes, brain or in tissue that is clinically proven to be infected.
Warning. The Pintuition Base Unit must be properly grounded to ensure patient
safety. To avoid the risk of electrical shock, this equipment must only be
connected to a mains supply with protective earth. To avoid electrical shock, plug
the power cord into a properly wired receptacle, use only the power cord supplied
with the Base Unit and make sure the power cord is in good condition.

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Warning. No modification of this equipment is allowed, do not open or repair the
Pintuition Base Unit or Pintuition Probe. Opening may expose dangerous
electrical components. Always contact Sirius Medical Systems for service.
Warning. The use of accessories, transducers, sensors, and cables other than
those specified may result in increased electromagnetic emission and/or
decreased electromagnetic immunity of the equipment and/or Pintuition
Detector.
Warning. The Pintuition Detector should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, the Pintuition Detector
shall be observed to verify normal operation in the configuration in which it will
be used.
Warning. Always turn off and unplug the Pintuition Base Unit and Pintuition
Probe before cleaning.
Warning. Do not attempt to perform service or maintenance while the Pintuition
Detector is in use.
Warning. Do not pour cleaning liquids over, into or onto the Pintuition Base Unit
Warning. Do not connect a wet Pintuition Probe to the Pintuition Base Unit.
Warning. Always check the instrument before use for signs of damage. If the
instrument is damaged or gives unexpected performance or operation, then
cease using the device and ensure that it is serviced before recommencing use
of the device.
Warning. Always follow instructions supplied with cleaning and disinfection
agents. Wait for cleaning or disinfection agent to dry before applying sterile
sheath. Only use legally marketed cleaning and disinfection agents.
Warning. Always apply a suitable and legally marketed sterile sheath before
using the Pintuition Probe in a sterile field
Warning. The Pintuition Probe is not suitable for autoclaving, which would result
in serious damage to the Pintuition Probe. Autoclaving the detachable Pintuition
Probe will void its warranty.

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Warning. Always replace any external fuse with the type and rating specified in
Section 7 (Technical Specifications).
Warning. Be aware that the Pintuition Seed may be attracted towards and stick to
metallic objects such as knifes or scalpels when brought within approximately 5
mm of the seed.
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.
2.2 CAUTIONS
Caution. Care should be taken to remove all magnetic disturbances from the
vicinity of the Probe during routine use.
Caution. Calibrate the Pintuition Detector before each clinical use and when the
device provides unexpected output.
Caution. Care should be taken not to drop the Pintuition Probe, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Probe is dropped confirm correct functioning each with
the supplied Test Kit following the System Test Procedure.
Caution. Care should be taken not to drop the Pintuition Base Unit, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Pintuition Base Unit is dropped confirm correct
functioning with a specialist.
Caution. Handle the Pintuition Probe with care, do not bend the cable sharply.
This could lead to cable damage.
Caution. For best results, care should be taken when using the Pintuition
Detector in the proximity of foreign magnetic or metallic objects, as they may
generate confounding signals. If in doubt, the user should undertake an in situ
assessment of the operating environment before using the instrument.
Caution. The detection distance of the Pintuition Detector is up to 50mm.
Caution. The Pintuition Detector is intended for use by suitably qualified, trained,
and authorized physicians and/or operating room staff.
Caution. Use the Pintuition Base Unit only with the Pintuition Probe and Pintuition
Seed manufactured by Sirius Medical Systems.

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Caution. Operate the Pintuition Detector within the specified operating
temperature range, see Section 7 (Technical Specifications). Operation outside of
the specified operating temperature range could lead to decreased accuracy
Caution. Operate the Pintuition Detector within the specified operating humidity
range see Section 7 (Technical Specifications).
Caution. The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
Caution. In the unlikely event that the Pintuition Detector is locked inoperable
during use due to electromagnetic disturbances from other devices, disconnect
and reconnect the Pintuition Probe. Make sure the distance to the other device
including any cables is enlarged.
Caution. The Pintuition Base Unit is disconnected through use of the Power
Switch on the back of the device, followed by the mains connector. Do not
position the device such that it is difficult to carry out disconnection.
Caution. In the unlikely event that the Pintuition Detector is locked inoperable
during use due to an electrostatic discharge, disconnect and reconnect the
Pintuition Probe. Make sure to prevent any charge build up during operation.
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.

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3INSTALLATION AND BASIC OPERATION OF THE PINTUITION DETECTOR
3.1 UNPACKING AND INSPECTING
The following items are included in the Pintuition Base Unit packaging:
•Pintuition Base Unit (SPBU)
•Power cord
•Instructions for Use (this document)
The following items are included in the Pintuition Probe storage case:
•Pintuition Probe
•Pintuition Test Kit
•Instructions for Use (this document)
Carefully inspect each item as it is unpacked for any signs of damage that may have occurred
during shipment.
Do not attempt to set up the Pintuition Detector if anything is damaged or defective.
It is recommended to clean and disinfect the Probe before first use according to the
instructions in Section 5 (Reprocessing –Cleaning and Disinfection).
Contact Sirius Medical Systems if anything is damaged or defective.
3.2 DEVICE DESCRIPTION
3.2.1 PINTUITION BASE UNIT -FRONT
Figure 1: Pintuition Base Unit - Front
ID
Item
Description
1
Pintuition Base Unit
The device
2
Display
To provide feedback to the user. Indication of errors
and version of software
3
Volume control knob
To control volume, see Section 4.4 (Adjusting the
volume)
4
Calibration button
To start calibration, see Section 4.2 (Calibrating the
Pintuition Detector)
5
Connector port
To connect Pintuition Probe, see Section 4.1
(Connecting the Pintuition Probe)

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3.2.2 PINTUITION BASE UNIT –BACK
Figure 2: Pintuition Base Unit - Back
ID
Item
Description
6
Power switch
Switch to power on/off Pintuition Base Unit
7
External fuse
User accessible cover containing fuse
8
Power inlet
Connection inlet for electrical power cord, see Section
3.5 (Powering the Device).
9
Product Label Pintuition
Base Unit
Provides information on the Pintuition Base Unit
3.2.3 PINTUITION BASE UNIT –DISPLAY INTERFACE
Figure 3: Pintuition Base Unit - Display Interface
ID
Item
Description
10
Distance Measure
Distance towards implanted seed in millimeters
11
Pintuition Probe identifier
Identification of correctly connected and functioning
Pintuition Probe
12
Volume status
Identification of volume status (on or muted and
current volume).

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3.2.4 PINTUITION PROBE (APPLIED PART,TYPE BF)
Figure 4: Pintuition Probe
ID
Item
Description
13
Pintuition Probe
To detect Pintuition Seed
14
Cable
To provide a connection between Pintuition Base
Unit and Pintuition Probe.
15
Product Label Pintuition
Probe
Provides information on the Pintuition Probe
16
Connector
To connect Pintuition Base Unit with Pintuition
Probe, see Section 4.1 (Connecting the Pintuition
Probe)
3.2.5 PINTUITION TEST KIT
Figure 5: Pintuition Test Kit
3.2.6 AUDIO
The Base Unit generates different audible tones according to the table below.
ID
Item
Description
A1
Startup
A beep is generated to indicate successful startup
and successful connection of Probe after startup.
ID
Item
Description
17
Pintuition Test Kit
To be brought in contact with Pintuition Probe
head during system test, see Section 4.3 (System
Test: Using the Test Kit).
18
Product Label Test Kit
Provides information on the Test Kit

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ID
Item
Description
A2
Distance to Seed
A beeping sound is generated, the pause between
beeps is dependent on the detected distance
between the Seed and the Probe
3.3 TRANSPORT AND STORAGE
Caution. Care should be taken not to drop the Pintuition Probe, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Probe is dropped, confirm correct functioning with the
supplied Test Kit.
Caution. Care should be taken not to drop the Pintuition Base Unit, or subject it to
any form of rough physical handling, either during normal use or during storage
and transportation. If the Pintuition Base Unit is dropped confirm correct
functioning with a specialist
3.4 INSTALLATION
The Pintuition Base Unit (1) should be placed on a stable and level working surface, preferably
out of direct sunlight. Refer to Section 7 (Technical Specifications) for environmental
limitations of use.
Warning. The Pintuition Detector should not be used adjacent to or stacked with
other equipment; if adjacent or stacked use is necessary, the Pintuition Detector
needs to be observed to verify normal operation in the configuration in which it
will be used.
3.5 POWERING THE DEVICE
Warning. The Base Unit must be properly grounded to ensure patient safety. To
avoid the risk of electrical shock, this equipment must only be connected to
mains supply with protective earth. To avoid electrical shock, plug the power cord
into a properly wired receptacle, use only the power cord supplied with the Base
Unit and make sure the power cord is in good condition.
1. Make sure that the Pintuition Base Unit (1) is switched off before connecting the
power cord, by switching the Power Switch (6) on the back side to ‘Off’ (or O).
2. The instrument is powered via a standard mains outlet supply. Make sure that the AC
outlet is properly grounded and supplies the specified voltage and frequency, see
Section 7 (Technical Specifications) for details.
3. Connect the female connector end of the power cord to the AC power inlet (8) on the
back of the Base Unit (1). Plug the male connector end of the power cord into a
properly grounded AC power outlet.
3.6 TURNING THE DEVICE ON
To turn the instrument on:
1. Push the Power Switch (6) at the back of the Pintuition Base Unit (1) from the ‘0’
position to the ‘1’ position.
2. While the Pintuition Base Unit (1) is powering up, the display (2) will show a start-up
screen containing the Sirius Medical Systems logo and the Base Unit software version
(left bottom corner) and Probe software version (right bottom corner).

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Note. It is not required to connect the Probe before turning the device on. Please
see section 4.1 - Connecting the Pintuition Probe for instructions.
3.7 TURNING THE DEVICE OFF
To turn the instrument off:
1. Push the Power Switch (6) at the back of the Base Unit from the ‘1’ position to the ‘0’
position. The Base Unit display (2) will go black, and the system will shut down.
2. Unplug from power supply.
The Base Unit can now be safely transported and stored.

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4USING THE PINTUITION DETECTOR
4.1 CONNECTING THE PINTUITION PROBE
To use the Pintuition Detector, the Probe must be connected to the Base Unit:
1. Align the white arrow on the connector (16) with the white arrow on the Probe
connector port (5).
2. Gently push the connector into the port until a locking click is felt.
Figure 6: Connector (16) with white alignment arrow indicated.
If the Probe is correctly connected, the right bottom corner (11) of the Base Unit display (2)
will show a blue check mark and beep A1 is generated (see Section 3.2.6 (Audio)).
If the Probe is not (correctly) connected, the right bottom corner of the Base Unit display (2)
will show a red ‘X’.
If this occurs, connect, or reconnect the Probe until the display (2) shows that the Probe has
been correctly connected in the right bottom corner (11).
If a problem persists, see Section 8 (Troubleshooting).
Figure 7: Display info when the Probe is correctly connected (left) and not (correctly) connected (right).
4.2 CALIBRATING THE PINTUITION DETECTOR
Caution. Calibrate the Pintuition Detector before each clinical use and when the
device provides unexpected output.
If the Pintuition Probe (13) is correctly connected and the Pintuition Base Unit (1) is turned on,
the Pintuition Base Unit (1) will require calibration before performing measurements. The
screen will indicate this by showing a red scale icon.
Figure 8: Display info when the Detector requires calibration (left) and when the calibration is in progress (right)
To perform calibration:
1. Hold the Probe vertically in the air and at least 30 centimeters away from any
electrical equipment or other magnetic disturbances.
2. Push the calibrate button (4) on the Base Unit (1) once and release.

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3. The system will start the calibration procedure and the balance icon on the display (2)
will turn blue. The calibration procedure takes approximately 5 seconds.
4. After successful calibration, the Pintuition Base Unit (1) will proceed to normal
operation and the display (2) will show a millimeter indication (‘mm’) (10)
Note. Take care to hold the Probe still during calibration, otherwise performance
may deteriorate.
Note. The calibration procedure may be repeated during use if the system
provides insufficient detection range.
4.3 SYSTEM TEST:USING THE TEST KIT
The Pintuition Detector is supplied with a Pintuition Test Kit (17).
The Pintuition Test Kit (17) contains a Pintuition seed at a fixed and predetermined distance
of 20 mm. The device can be used to confirm correct functioning of the Pintuition Detector.
To perform the System Test, see Figure 9:
1. Calibrate the Detector following the
instructions in Section 4.2 (Calibrating the
Pintuition Detector).
2. Place the Probe tip (13) in the cavity of the
Test Kit (17).
3. Hold the Probe with Test Kit in the air.
4. The base unit display (2) provides a distance
in millimeters.
4a. If the distance on the display (2) deviates
less than 2mm (acceptable range: 18 –
22mm) from the distance indicated on the
Test Kit label (18), the system is
performing correctly.
4b. If the detected distance deviates more than prescribed, please repeat the System
Test procedure. If the problem persists, see Section 8 (Troubleshooting).
4.4 ADJUSTING THE VOLUME
Output volume of the Pintuition Base Unit can be adjusted by turning the volume control knob
(3) on the Base Unit (1).
A clockwise motion will increase the volume.
A counterclockwise motion will decrease volume.
If the volume is fully turned down, the left bottom screen volume indicator (12) will show that
the audio is muted.
4.5 APPLICATION OF STERILE SHEATH
Warning. Always apply a suitable and legally marketed sterile sheath before
using the Pintuition Probe in a sterile field.
The Pintuition Probe (13) may only be used without a sterile sheath on the intact skin prior to
the start of surgery, for example to plan the incision.
The Probe (13) is not a sterile medical device and should always be covered using a legally
marketed, suitable sterile sheath for use within the sterile field.
To use the sterile sheath:
Figure 9: Performing a System Test (inset: display (2))

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Instructions for Use
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1. Unpack and transfer the sterile sheath to the sterile area in an aseptic manner.
2. Cover the Probe (13) and the Probe Cable (14) with the sterile sheath at least over the
length of the sterile area.
3. Fix the sheath to a point outside of the sterile field to prevent unwanted
contamination of the sterile area.
The Probe (13) is now ready for use within the sterile area.
4.6 DETECTION,DIRECTIONALITY AND ACCURACY
Caution. The detection distance of the Pintuition Detector is up to 50mm.
The Pintuition Detector provides detection feedback in millimeters towards the implanted
Pintuition Seed.
The Pintuition Detector has a detection distance up to 50 mm.
The Pintuition Detector has a detection accuracy that is dependent upon the distance
between the Seed and the Pintuition Probe, according to the following table:
Distance (mm)
Accuracy
0 –20 mm
± 1mm
20 –30 mm
± 2mm
30 –40 mm
± 4mm
40 –50 mm
± 5mm
The Pintuition Detector is designed for directional detection. The system will only provide
detection feedback when the position of the Pintuition Seed is within a detection cone going
outward from the Probe. The cone is narrow when near the seed (<35mm) and widens at
further distances:
Figure 10: Directional detection principle of the Pintuition Detector

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Sirius Medical Systems
Sirius Pintuition Detector
Instructions for Use
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4.7 SURGICAL PROCEDURE
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 PREPARING THE PROCEDURE
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 PREOPERATIVE –SURGICAL PLANNING (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 PREOPERATIVE –STERILE DRAPING TO PREPARE FOR USE WITHIN STERILE AREA
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).