Hologic TruNode S-10 Manuale utente

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

Manufacturer

Faxitron Bioptics, LLC. (a Hologic company)

250 Campus Drive

Marlborough, MA 01752

USA

Ph: +1-877-910-0030

www.hologic.com

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 

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.

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

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)

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.

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.

•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.

USING THE SYSTEM

Setting up the UFU (to be done prior to starting

the procedure)

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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