The TruNode® Gamma Probe System is a battery-powered, wireless, and portable medical device designed for radio-guided localization procedures. It detects and quantifies Technetium-99m (Tc-99m) and Iodine-125 (I-125) radionuclides in the body or tissues, providing a numeric display and audible signal to help users localize radiolabeled tissue or structures. The system is intended for non-imaging procedures and can be used in transcutaneous, open surgical, and laparoscopic settings. Potential applications include radio-guided sentinel lymph node localization, parathyroidectomy with Tc-99m-labeled radiopharmaceuticals (e.g., Sestamibi), and tumor localization with I-125 isotope seeds.
The system comprises two main components: the TruNode® S-10 Gamma Probe and the TruNode® T-10 User Feedback Unit (UFU).
TruNode® S-10 Gamma Probe
Function Description:
The TruNode® S-10 Gamma Probe is a wireless, battery-powered (4.5V) device that detects and quantifies gamma rays ('counts') from Tc-99m and I-125 isotopes. It communicates this information wirelessly to the UFU via Bluetooth Low Energy (BLE) for user feedback. The probe is supplied sterile in a Tyvek™ peel-pouch for single-patient use and is designed for immediate use after activation. It can be used in the pouch without breaking the seal prior to setting up the sterile field, but must be stored in its unit box to prevent damage to the sterile pouch.
Important Technical Specifications:
- Overall Dimensions: 17mm X 226mm
- Reach: 103mm
- Operative Diameter: 10mm
- Weight: 70g
- Wireless: Bluetooth® Smart
- Collimator: Integrated Tungsten
- External Materials: Stainless Steel, Tungsten, Silicone Rubber
- 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: 13mm FWHM
- Spatial Resolution @1cm in Air, Scan Mode: 14mm FWHM
- 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 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 to 50°C
- FCC ID: 2ADNA-S10
Usage Features:
The Probe keypad provides control over:
- Activation status
- Detection energy window mode ('Scan', 'Point', 'Seed')
- Audio count-rate feedback volume
- Audio count-rate range scaling
- Announce instantaneous count-rate feedback
- Announce integrated count-rate feedback
Modes of Operation:
- Scan Mode: Provides higher sensitivity by counting more scattered gamma photons, allowing for quicker surveying of wider areas. Useful for surveying larger areas with less background radiation or for accurate ex-vivo specimen count rates.
- Point Mode: Offers higher spatial resolution by rejecting low-energy scattered gamma photons. This allows for more precise localization of gamma photon sources, reducing the influence of background and scattered radiation. Ideal for identifying hotspots or localizing small radioactive areas.
- Seed Mode: Preferentially accepts photons from I-125 while rejecting most Tc-99m photons, useful for detecting I-125 seeds or other I-125 isotope sources.
Important Usage Notes:
- Do not activate the Probe until ready for immediate use.
- Keep a spare Probe available due to its limited life (100 minutes of continuous use, 4 hours total, or one patient procedure).
- Do not reuse or re-sterilize the Probe.
- Avoid dropping or striking the Probe tip, as this can damage the detector element.
- Do not use the Probe simultaneously with an electro-surgery device or touch it to an energized electro-surgery device, as this can disrupt the detector and produce spurious counts or damage the probe.
- The Probe will hibernate after 10 minutes of inactivity; press and hold the 'M' button to awaken it.
Maintenance Features:
- Dispose of the Probe in an appropriate bio-hazardous waste container after surgery.
TruNode® T-10 User Feedback Unit (UFU)
Function Description:
The UFU is an off-the-shelf tablet computer with a custom speaker, housed in a protective silicone rubber case, and includes an IV pole clamp. It runs the TruNode® Application on an Android operating system. The UFU communicates bi-directionally with the Probe via Bluetooth Low Energy (BLE), providing visual display, sound feedback, and redundant controls for operating the probe. It displays the gamma photon count rate numerically and with a log-scale meter, and provides audio feedback (pitch and beat frequency). The UFU can also announce the count rate upon user request.
Important Technical Specifications:
- Overall Dimensions: 25cm x 18cm x 2.3/13cm (without/with clamp)
- Weight: 1.4kg (with clamp)
- Operating System: Android
- Power Supply: 100-240VAC, 56/60Hz input; 1A, 5VDC output
- Storage & Transit Condition Limitation: -15 to 50°C
- FCC ID: QISCPN-W09 (Huawei Tablet) or ZCASMT-290 (Samsung tablet)
Usage Features:
- Power On/Off: Press the ON-OFF switch on the top-left edge for ~5 seconds to turn on.
- Battery Status: Displays a battery-charge icon; if fully depleted, the UFU must be recharged. A full charge takes about three hours.
- Probe Connection: Displays a flashing 'M' button image when ready to link with a Probe.
- Audio Volume Adjustment: Use '+' or '-' buttons on the probe to adjust audio count-rate feedback volume (announcement volume is fixed). A slider bar on the UFU displays the volume.
- Audio Mute: Repeatedly click the '-' button until "Muting Probe" is announced; the speaker icon will turn red.
- Mode Change: Click the 'M' button on the Probe handle to toggle between 'Scan' and 'Point' modes. Hold 'M' for 2 seconds to switch to 'Seed' mode.
- Instantaneous Count Rate: Click the 'C' button to continuously display and announce the instantaneous count rate.
- Averaged Count Rate: Hold the 'C' button for 2 seconds to initiate an averaged count rate acquisition. The UFU will announce "Recording Counts," countdown to "Zero," and then announce and display the averaged count rate. Up to 6 recent average count rates can be displayed and removed by touching them.
- Audio Scale Adjustment: Hold the '+' button for 2 seconds to switch to "High Range" audio feedback (for count rates up to 10,000 CPS). Clicking '-' toggles back to "Low Range" (up to 2,000 CPS). Note: This does not affect the digital count display or meter.
Important Usage Notes:
- Use only the Faxitron Power Supply for recharging to avoid electric shock risk.
- Fully charge the UFU before use.
- Do not use the Charger in the operating room or in oxygen-enriched/flammable anesthetic environments.
- Keep the UFU off when charging and remove the Charger when fully charged.
- The UFU and Charger are non-sterile; do not sterilize them.
- If liquid is spilled, remove from service and contact Faxitron.
- Securely mount the UFU to an IV pole.
- After connecting to a probe, the UFU must be turned 'off' then 'on' again to connect to a new probe.
- If battery charge is below 50%, turn off and charge the UFU before use; do not use the Charger in the operating room.
Maintenance Features:
- Wipe UFU surfaces with a damp cloth or disinfectant wipe if soiled. Clean the display screen with a dry cloth.
- Charge the UFU for maximum battery life, removing the charger when fully charged.
- The Android operating system is maintenance-free and requires no calibration.
General Warnings and Cautions:
- Failure to follow the User Manual may pose a hazard and void the warranty.
- The system is not intended for use in the central nervous system.
- Do not modify the equipment without manufacturer authorization.
- Portable and mobile RF communications equipment should be used no closer than 30cm (12 inches) to any part of the system.
Compliance:
The TruNode® system complies with IEC 60601-1 (2014) 4th Ed. for safety, ISO 10993 for biocompatibility, ISO 11135 and ISO 11607-1 for sterilization, Medical Devices Directive 93/42/EEC (amendment 2007/47/EC, Class IIa) for regulatory, EMC Directive 2004/108/EC Group I, Class B, EN ISO 60601-1-2:2014 for electromagnetic compatibility, and Radio Equipment Directive 2014/53/EU and FCC Part 15C for wireless operation (Bluetooth 4.0BLE).
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