Faxitron Bioptics TruNode S10 User manual

User Manual
Caution: Federal (USA) law restricts this device
to sale by or on the order of a physician
User Manual P/N: 110015
November 2019
Surgical Gamma Probe
®

TruNode® Gamma Probe System User Manual
2
Manufacturer
Faxitron Bioptics, LLC. (a Hologic company)
12285 World Trade Drive, Ste. J
San Diego, CA, USA, 92128
Ph: [phone]
www.hologic.com
EU Authorized representative
EC REP
Hologic BVBA, Da Vincilaan 5, 1930 Zaventem
Belgium
Ph: [phone]
0050
Copyright
© 2019 Faxitron Bioptics, LLC. All rights reservedworldwide.
The work herein is owned exclusively by Faxitron Bioptics, LLC. No parts may be
reproduced, transmitted, or otherwise used without the express priorwritten
permission of Faxitron Bioptics, LLC.
The following are trademarks of Faxitron Bioptics, LLC.: TruNode®,TruNode®
System, TruNode®, Gamma Probe, and TruNode®Application.

TruNode® Gamma Probe System User Manual
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Table of Contents
1. INTRODUCTION ................................................................................4
2. SYSTEM OVERVIEW ..........................................................................6
3. WARNINGS and CAUTIONS...............................................................8
4. USING THE SYSTEM ........................................................................10
5. USING THE CONTROLS....................................................................13
6. IN SURGERY ....................................................................................15
7. AFTER SURGERY..............................................................................17
8. SPECIFICATIONS..............................................................................19
9. TROUBLESHOOTING .......................................................................20
10. SYMBOLS .....................................................................................21
11. EMC DECLARATION......................................................................22
12. FCC INFORMATION.....................................................................277
13. Technical support & product complaints......................................27

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1. INTRODUCTION
Description
The TruNode®Gamma Probe System is designed to detect and
quantify Technetium-99m (Tc-99m) and Iodine-125 (I-125) in radio-
guided localization medical procedures. A numeric display and
audible signal convey the relative amount of radiation detected,
allowing the user to localize radiolabeled tissue orstructures.
The system is battery-powered, wireless, and portable. It consists
of the TruNode® S-10 Gamma Probe and the TruNode® T-10 User
Feedback Unit.
Intended Use
The TruNode® Gamma Probe System is intended to detect and
quantify relative amounts of gamma radiation from Tc-99m and I-
125 radionuclides in the body or tissues.
Indications for Use
The TruNode® Gamma Probe System can be used in non-imaging
procedures to quantify relative amounts of Tc-99m or I-125
radionuclides in a particular organ or body region. It can be used in
transcutaneous, open surgical, and laparoscopicprocedures.
Potential Applications
The TruNode® Gamma Probe System can be used by physicians for
radio-guided localization of tissues containing Technetium-99m (Tc-
99m) and Iodine-125 (I-125). Potential applications include: radio-
guided ‘sentinel’ lymph node localization with Tc-99m-labeled
radiotracer, radio-guided parathyroidectomy with a Tc-99-labeled
radiopharmaceutical such as Sestamibi, and radio-guided tumor
localization with ‘seeds’ containing I-125 isotope.

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Standards
The TruNode® system complies with the following standards:
Safety
•IEC 60601-1 (2005) 3rd Ed. Medical Electrical Equipment - Part 1:
General requirements for basic safety and essential performance
Biocompatibility
•ISO 10993 (including ETO residuals): Biological evaluation of medical
devices: cytotoxicity, sensitization, irritation; externally
communicating device; <24hrs exposure
Sterilization
•ISO 11135: Validation and routine control of ethyleneoxide
sterilization
•ISO 11607-1:2009+A1:2014: Packaging for Terminally Sterilized
Medical Devices
Regulatory
•Medical Devices Directive 93/42/EEC amendment 2007/47/EC,
Class IIa
Electromagnetic Compatibility
•EMC Directive 2004/108/EC Group l, Class B
•EN ISO60601-1-2:2014 Medical Electrical Equipment - Part 1: General
Requirements For Safety - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
Wireless Operation
•Radio Equipment Directive 2014/53/EU
•FCC Part 15C: Intentional Radiators –FCC ID 2ADNA-S10
•Wireless: Bluetooth 4.0BLE

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2. SYSTEM OVERVIEW
The TruNode® T-10 User Feedback Unit is used with the
TruNode® S-10 Probe.
TruNode® User Feedback Unit (UFU)
The UFU is comprised of a tablet computer and a speaker all
enclosed in a protective silicone rubber case. An IV pole clamp is
attached to the back. The tablet computer uses the Android
operating system and runs the TruNode®Application.
TruNode®T-10 UFU
A medical-grade power supply is included for re-charging the
UFU battery.
Low-leakage Medical Grade Power Supply (EU Version
Shown)

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The UFU communicates bi-directionally with the TruNode® Probe
over a Bluetooth Low Energy (‘BLE’) wireless link. It provides the
visual display, sound feedback, and redundant controls for
operating the probe.
The rate of gamma photons entering the Probe is displayed on the
UFU in digits and with a log-scale meter. This rate is also
represented by the audio feedback (pitch and beat frequency)
coming from the speaker. The UFU will also announce the count rate
upon request by the user via pushbutton on the Probe hand- piece.
The tablet computer controls for changing parameters such as the
time zone or the announcements are accessed through the touch
screen interface, as with any Android operating system. The ON/OFF
control that turns launches the TruNode® application is located on
the top of the UFU enclosure.
TruNode® Probe
The wireless TruNode® Probe is battery-powered (4.5V). It is
completely sealed and supplied sterile for a single-patient use in a
TyvekTM peel-pouch. The pouch is designed for sterile handoff. The
Probe can also be used in the pouch without breaking the seal prior
to setting up the sterile field. Prior to use, the Probe must be stored
in its unit box to prevent damage to the sterilepouch.
The Probe detects and quantifies gamma rays (‘counts’) from Tc-
99m and I-125 isotopes and communicates this information to the
UFU over the wireless link for user feedback. The Probe keypad
provides the user with control of:
•activation status,
•detection energy window mode*,
•audio count-rate feedback volume,
•audio count-rate range scaling,
•announce instantaneous count-rate feedback,and

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•announce integrated count-rate feedback*.
*see ‘Using the Controls’, Section 5.
3. WARNINGS and CAUTIONS
General
•Failure to thoroughly review and adhere to the
information contained in this User Manual may pose a
potential hazard to the patient and/or the user and may
void the warranty.
•The TruNode®Gamma Probe System is not intended for
use in the central nervous system.
•Do not modify this equipment without authorization of
the manufacturer
User Feedback Unit
•Use only the Faxitron Power Supply provided with the
UFU for recharging. Use of another power supply may
increase the risk of electric shock
•Fully charge the UFU before using the system.
•Do not use the Charger in the operating room.
•Do not use the Charger in the presence of an oxygen-
enriched environment or in the presence of a
flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
•Keep the UFU off when charging.
•Remove the Charger when the UFU is fully charged.
•The UFU and Charger are non-sterile. Do not sterilize
these components.
•If liquid is spilled on the UFU, remove it from service and
contact Faxitron Bioptics for instructions to return for
inspection. Ph: 1.520.399.8180.

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•Securely mount the UFU to an IV pole.
•After connecting to a probe, the UFU must be turned ‘off’
then back ‘on’ before attempting to connect to a new
probe.
Probe
•DO NOT activate the Probe until it is ready to be used. It is
designed to be used immediately after activation.
•Keep a spare Probe at the ready in case of a failure, or
of exceeding its 100-minute life after activation, or of
exceeding its 4-hour life window.
•DO NOT reuse the Probe. It can be used on a single patient
in a single surgical procedure only. Reuse poses a risk of
cross-infection and cross-contamination.
•DO NOT attempt to re-sterilize the Probe.
•DO NOT drop the Probe. It may damage the detector
element.
•DO NOT strike the Probe tip against a hard surface. It may
damage the detector element.
•DO NOT simultaneously use the probe together with
an electro-surgery device. It can disrupt the detector
and produce spurious counts.
•DO NOT touch the probe to an energized electro-
surgery device. It can damage the probe.

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4. USING THE SYSTEM
Setting up the UFU (to be done prior to starting
the procedure)
1. Turn on the UFU by pressing down on the ON-OFF control
switch located on its top-left edge for approximately 5 seconds,
until the boot screen appears.
If only the battery-charge ICON appears, the battery is
fully depleted and the UFU must be recharged prior touse.
NOTE: A full charge for a fully-discharged UFU takes about three
hours.
Unless the UFU is fully-depleted, the Android ‘Home’ screen
will appear after 20 seconds.
After another 10 seconds, the TruNode® application will launch
and the UFU will be ready to detect the TruNode®probe.
Caution: If the battery charge is below 50%, turn off the
UFU and charge it prior to use. Do not use the Charger in
the operating room.
1. The UFU will announce a greeting followed by its charge
status. Verify the UFU is at least 50% charged prior to starting
the procedure.
2. When an image of the probe keypad with a flashing ‘M’
button is displayed, the UFU is ready to link with a TruNode®
Probe.
3. Clamp the UFU securely to an IV pole in a location that is easy
to see by the user.

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NOTE: After connecting to a probe, the UFU must be turned ‘off’
then back ‘on’ before attempting to connect to a new probe.
Deploying the Probe
1. Remove the Probe from the sterile peel-pouch, using
aseptic technique.
2. Activate the Probe by pressing and holding ‘M’ button until the
light on the Probe keypad flashes. This indicates the Probe has
been activated. The live TruNode® application will start when the
UFU senses the Probe.
NOTE: The TruNode®Probe can be used preoperatively in its sterile
pouch, prior to sterile deployment. Simply press through the clear
poly film to access the controls. Use care not to damage the pouch
seals, as this could disrupt its sterile barrier.
Flashing ‘M’ button on UFU indicates ready to link
Flashing light indicates probe is active

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Note: The battery charge in the TruNode® Probe can also be tested
as in step 2 by first assuring that there is no UFU in ‘Ready’ state
nearby –a flashing light indicates the battery is not discharged. If
no UFU is detected, the probe will turn off in 30 seconds.
NOTE: The useful life of the TruNode®Probe is the lesser of 100
minutes of continuous use, one patient procedure, or 4 hours,
including preoperative use.
NOTE: The TruNode® Probe will hibernate after 10 minutes of
inactivity. To awaken the probe, simply press and hold the ‘M’
button until the light on the keypad flashes.
NOTE: The UFU will display the life of the probe when 15 minutes
of use or less remain.

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5. USING THE CONTROLS
NOTE: Each button can be: 1) momentarily ‘clicked’ or 2) held
down for ~2 seconds to initiate a function. The UFU will announce
the function.
To adjust the audio count-rate feedback volume: Click the ‘+’
or ‘-‘ button on the probe. A slider bar on the UFU displays the
volume. The volume of the announcements cannot be
adjusted.
To mute the audio feedback volume: Repeatedly click the ‘-‘
button on the Probe until the UFU announces “Muting Probe.”
The audio level slider bar will be minimized and the speaker icon
will be displayed in red.
To change the mode of the Probe from ‘Scan’ to ‘Point’: Click
the ‘M’ button on the Probe handle. The selected mode is
displayed on UFU.
To change the mode of the Probe to ‘Seed’ from ‘Scan’ or
‘Point’: Hold the ‘M’ button down 2 seconds. Seed mode is
displayed on UFU.
Audio Level
Slider Bar

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To announce the instantaneous count rate: Click the ‘C’
button. The UFU continuously displays the instantaneous
count rate.
To get an averaged count rate: Hold the ‘C’ button for 2seconds
–at which time “Recording Counts” will be announced –then a
countdown to “Zero” while the integration completes –and
finally the averaged count rate is announced and displayed on
Scan
Mode
Point
Mode
Seed
Mode

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the UFU. Up to 6 of the most recent average count rates can be
displayed, and they can be removed by touching the stored
count rate on the display.
To change the audio scale to match the count range: Hold the
‘+’ button for 2 seconds –at which time “High Range” will be
announced, and the audio feedback will reflect the higher
range. Clicking the ‘-’ button will toggle back to lowRange.
6. IN SURGERY
CHANGING MODES
Three photon energy-resolving modes are available -- ‘Scan’ and
‘Point’ modes are used for detecting Tc-99m and ‘Seed’ mode is
used for detecting I-125.
Scan mode provides higher-sensitivity because it counts
more gamma photons that have been scattered while in
transit from their source to the probe’s detector. This allows
the user to survey wider areas more quickly than Point mode.
The relatively higher number of gamma photons that are
detected produce more rapid count-rate feedback
information, and Scan mode accepts scattered gamma
photons with lower energy than Point mode, and thus could
have emanated from a wider region. Scan mode can be used
for surveying larger areas, more quickly, especially when
there is less background or scattered radiation (e.g. from the
injection site or from nearby organs that uptake radiotracer).
Scan mode can also be used to obtain more accurate ex-vivo
specimen count rates because of its wider angle of
acceptance for scattered gamma photons that may be
emanating from the specimen.

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Point mode provides higher-spatial resolution because it
rejects low energy gamma photons that have beenscattered
while in transit from their source to the probe’sdetector.
This allows the user to more precisely locate the source of
the gamma photons: only those photons that have been
minimally-scattered between their source and the probe’s
detector are counted, so the influence of background and
scattered radiation is reduced. Point mode can be used
when searching for hotspots where there is predominate
background or scattered radiation (e.g. from the injection
site or from nearby organs that uptake radiotracer), and
when attempting to more accurately localize small
radioactive hotspots.
Seed mode preferentially accepts photons from I-125, while
rejecting the majority of photons from nearby Tc-99m. This
can be useful for detecting I-125 seeds or other sources of I-
125 isotope.
CHANGING THE AUDIO SCALE TO MATCH THE INCOMING
COUNT RATE
A range of audio feedback is produced in proportion to the range of
detected count rates. An increase in pitch and beat frequency
indicates an increase in detected count rate. Two audio ranges are
used to cover the range of count rates detectable by the TruNode®
system. When the Probe is initialized, it defaults to the low range,
producing audio feedback for count rates up to 2,000 counts per
second. When more than 2,000 counts per second are detected, the
very high pitched sound alerts the user that the high range may be
needed. High range detects photons up to 10,000 counts per
second.
NOTE: The selected range does not affect the digital count display
or the count rate-meter.

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OBTAINING AN AVERAGED COUNT RATE
The user can initiate the acquisition of an averaged,
statistically- significant count-rate to improve the accuracy of
the count rate reading for an exact target region. The user
must hold the probe perfectly steady during this acquisition.
When this feature is initiated, the TruNode®System will:
For count rates greater than or equal to 40 counts per
second. The system will count for 2-10 seconds and return a
count rate measurement with better than or equal to ±10%
accuracy with 95% confidence. Very high count rates will be
measured very quickly to very high accuracy (e.g.
1,000CPS target: 2 seconds counting time, ±10%
accuracy with 99% confidence).
Or
For count rates below 40 counts per second. The system
will count for 10 seconds and return a count rate
measurement that is more accurate than the instantaneous
reading but to less than +/-10% accuracy with 95%
confidence. Very low count rates will have much lower
accuracy (e.g. 5CPS target: 25% accuracy with 95%
confidence).
7. AFTER SURGERY
Dispose of the Probe in an appropriate bio-hazardous waste
container.
Turn off the UFU:
•Press the ON-OFF control switch located on its top-left
edge for approximately 2 seconds, until the power off
options appear.
•Follow the instructions that appear for powering off the
UFU.
NOTE: The UFU must be turned off before the next procedure or it
will not connect with another Probe.

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•Wipe the surfaces of the UFU with a damp cloth or
disinfectant wipe if they are soiled. Clean the display
screen with a dry cloth to remove smudges.
•Charge the UFU. For maximum battery life, remove the
charger when the UFU is fully charged.

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TruNode® Gamma Probe System User Manual
8. SPECIFICATIONS
TruNode® S-10 Probe
Overall Dimensions: 17mm X 226mm
Reach: 103mm, Operative Diameter: 10mm
Weight: 70g
Wireless: Bluetooth®Smart
Integrated Tungsten Collimator
External Materials: Stainless Steel, Tungsten, SiliconeRubber
Shielding Efficiency: >99.9%
Energy Resolution: 10% FWHM (Tc-99m)
Selectable Energy Windows: Tc-99 ‘Point’ Mode, Tc-99 ‘Scan’ Mode, I-125
‘Seed’ Mode
Angular Resolution in Air: 46 degrees FWHM
Spatial Resolution @1cm in Air, Point Mode: 13mmFWHM
Spatial Resolution @1cm in Air, Scan Mode: 14mmFWHM
Sensitivity in Air, Point Mode: 18,000CPS/MBq max; 3,400 /MBq @1cm
Sensitivity in Air, Scan Mode: 27,000CPS/MBq max; 4,800CPS/MBq@1cm
Probe-Mounted Controls:
Activate & Connect to UFU
Mode (Hi-Sensitivity ‘Scan’, Hi-Resolution ‘Point’, I-125 ‘Seed’),
Count Rate Reporting,
Count Rate Averaging,
Audio Feedback Scaling,
Volume and Mute.
Probe Life: Lesser of 100-min continuous use, or 4-hr intermittent use, or 1-procedure
Use Condition Limitation: 15 to 37°C
Storage & Transit Condition Limitation: -15 to50°C
TruNode® T-10 User FeedbackUnit
Overall Dimensions: 25cm x 18cm x 2.3/13cm (without/with clamp)
Weight 1.4kg (with clamp)
Android operating system Maintenance free, no calibration
Power Supply: 100-240VAC, 56/60Hz input; 1A, 5VDC output
Storage & Transit Condition Limitation: -15 to 50°C

TruNode® Gamma Probe System User Manual
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9. TROUBLESHOOTING
Symptom: radiation count rate greater than zero even when
no radiation present after contacting radioactivetissue
Resolution: decontaminate probe tip of radioactive material
using sterile process
Symptom: spurious radiation counts in conjunction with
energizing electrocautery device or other radio-frequency
emitter
Resolution: move electrocautery device cable or other radio-
frequency emitter away from probe
Symptom: spurious radiation counts not associated with
radiation contamination or electrocautery device or other
radio-frequency emitter
Resolution: replace probe
Symptom: insufficient or complete lack of radiation counts
when locating the probe over a known source of high
radioactivity
Resolution: replace probe
Symptom: new probe or probe that hasn’t expired won’t
connect with a UFU.
Resolution: turn the UFU off then back on –the UFU must be
turned off prior to connecting to a new probe.