TECHNICAL RESOURCES | SYNERGO RITE

Synergo® SB-TS 101.3

Disposable sets: LI932B, LI932B-S, CDS932B

Basic UDI-DI:

7290010121SYN101VJ (SB-TS 101.3 & LI932B/LI932B-S) - Device classification IIb

7290010121CDS932BPM (CDS932B) - classification IIa

Intended Use

Localized, radiofrequency-induced bladder wall hyperthermia combined with concurrent intravesical instillation of Mitomycin C or Epirubicin for the treatment of Non-Muscle Invasive Bladder Cancer.

Indications

Non-muscle-invasive bladder cancer (NMIBC).

Prevention of recurrence and progression of NMIBC
Chemoablation of NMIBC lesions

Intended Users
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.

Contraindications

The Synergo system should not be used in patients with:

Tumor stage T>T1 (Muscle invasive);
UCC outside the urinary bladder (urethra, ureters, kidneys, distant organs);
Any concurrent tumor that requires active or concurrent treatment;
Non transitional cell carcinoma of the bladder;
Intramural tumors (eg, in ostium);
Urinary bladder diverticulum/diverticula with a cumulative diameter larger than 1cm;
Abnormal bladder contour;
Bladder volume < 150cc (mL);
Contracted bladder;
Significant urinary incontinence (spontaneous, requiring use of > 1 pad/day (PPD);
Gross hematuria;
Pregnancy, nursing mothers,
UTI (urinary tract infection),
Inability to pass an 18-F catheter (until stricture/stenosis treated);
Urethral stricture;
Fistula;
Significant residual bladder volume;
Partial cystectomy,
Previous pelvic irradiation therapy;
Known allergy to chemotherapy;
Inflammation of the bladder;
Low blood count;
Severe liver function disorder;
History of pelvic irradiation;
Artificial penile implant;
Patients with any type of electronic devices implanted in abdominal cavity;
Cardiac disease unless authorized by cardiologist.

2797

SYN-010-01 UserManual 101.3 EN Ver 6.4

SYN-010-01 UserManual 101.3 Ver 7.0

If you experience a problem with one of our medical devices or wish to report a product complaint, please contact our team as soon as possible. To help us investigate your report promptly, include the clinic/hospital name, contact details, product name and model or catalog number, LOT or serial number, a description of the issue, the date the event occurred, and your contact information. If the event involved a patient or user, please include a brief description of the outcome, without providing personally identifiable information.

Email: info[at]synergo-medical.com or contact us by phone: +31 20 6423719 or +972 3 9244830

Our team will acknowledge your report and may contact you for additional information to support our investigation.

By contacting our team, you acknowledge that your email may be retained for quality assurance purposes. We may collect and process your personal information to respond to your inquiry, comply with legal obligations (including product safety requirements), investigate reported issues, and improve our products. Your information may be shared with regulatory authorities and affiliated entities, including those in the United States, where different data protection standards may apply.