Synergo® Radiofrequency Thermochemotherapy Device 

UDI-DI 07290010121045

Accessory: Transurethral RF Applicator: Bio-compatible, single-use, 18F, silicone, custom-made, loaded with antenna and thermocouples

Drug Circulating Unit: Tubing Line PVC, single-use with reservoir
Heat Exchanger Temperature: controlled Peltier system
Pump Peristaltic (variable flow) Steps: 4, 6, 8, 10, 12 and 14 mL/min

RF Generator Frequency 915 MHz (+ 50 KHz)
Maximum Power 60W Range 0-36W in increments of 1W

Thermometry System: Sensors T-type thermocouples Resolution 0.1°C (0.18°F)

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Intended Use

The Synergo System is intended for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). The device was extensively tested with success in treating NMIBC by instillations of specifically tested pharmaceutical products, to be synergistic with transurethral RF (radio frequency) ablation applicator. Each session takes 40-70 minutes, during which an applicator including antenna and thermocouples is introduced into the bladder through the urethra. A solution of chemotherapeutic drug dissolved in sterile distilled water is instilled into the bladder and RF energy is then applied to the bladder walls. The choice of chemotherapeutic agents is the responsibility of the prescribing physician, who should be aware of the licensed indications and doses.

User population

The Synergo RITE treatment should be performed by medical personnel (e.g. physician, nurse, medical technician, etc.) who have undergone training by Medical Enterprises Group in the use of the Synergo® equipment, including practical hands-on training. The System should only be operated by trained, qualified, and authorised health professionals. These persons should read and understand this User Manual before using the System.

 

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Compliance with Standards

Electrical Safety IEC 60601-1: Edition 3.2 AMD1:2012 AMD2:2020

EN 60601-2-24:2015

Software – Life cycle IEC 62304:2006 AMD12015

Electromagnetic Compatibility IEC 60601-1-2: 2015 +A1:2021

IEC 60601-2-6:2012 AMDl:2016

Graphic Symbols: ISO 15223-1:2021

Usability: IEC 60601-1-6:2010/AMDl:2013

Biocompatibility: ISO 10993-5:2009; ISO 10993-10:2010; ISO 10993-11:2017

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