Hologic TruNode S-10 Manual de usuario
User Manual
Caution: Federal (USA) law restricts this device
to sale by or on the order of a physician
User Manual P/N: 110015
August 2020
User Manual P/N: MAN-07510
Revision 002
December 2020
TruNode® Gamma Probe System User Manual
2
Manufacturer
Faxitron Bioptics, LLC. (a Hologic company)
250 Campus Drive
Marlborough, MA 01752
USA
Ph: +1-877-910-0030
www.hologic.com
Copyright
© 2020 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
3
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...................................................................28
13. TECHNICAL SUPPORT & PRODUCT COMPLAINTS .....................28
4
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.
5
Standards
The TruNode®system complies with the following standards:
Safety
•IEC 60601-1 (2014) 4th 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 (Probe)
& QISCPN-W09 (Huawei Tablet) or ZCASMT-290 (Samsung
tablet)
•Wireless: Bluetooth 4.0BLE
6
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 an off-the-shelf tablet computer and
custom speaker all enclosed in a custom 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)
7
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
•announce integrated count-rate feedback*.
*see ‘Using the Controls’, Section 5.
8
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 for instructions to return for inspection.
Ph: 1. 877.910.0030.
•Securely mount the UFU to an IV pole.
9
•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.
10
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 to use.
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 40 seconds.
After another 30 seconds, the TruNode® application will launch
and the UFU will be ready to detect the TruNode®probe.
Note: If the TruNode app icon is pressed before it opens
automatically it will still launch OK, but the warning below
may appear. If so, click OK.
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.
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