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Zamenix The Advanced Robotic Flexible Ureteroscopy System

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Product Description
Zamenix by Roen Surgical is an advanced robotic flexible ureteroscopy system for retrograde intrarenal surgery (RIRS). It works with commercial flexible ureteroscopes, so urologists can break up and extract kidney stones with greater precision, stability, and efficiency, operating from an ergonomic console placed away from the radiation source.

Zamenix tackles the main challenges of manual ureteroscopy. Tremor filtering and respiration sync give precise laser targeting. An intuitive basket controller and automated scope driving give efficient stone retrieval. An intelligent interface puts instrument status, navigation guidance, and external imaging on a single screen. A multi-center pivotal trial reported a 93.48% stone-free rate and no ureteral injury related to the robotic procedure.

Key features

  • Robotic platform compatible with commercial flexible ureteroscopes
  • Enhanced precision through an ergonomic controller, sensitivity adjustment, and hand-tremor mitigation
  • Respiration Sync keeps the distance to the stone optimal, increasing laser hit rate and reducing mucosal injury risk
  • Intuitive basket controller for stone capture without additional assistance
  • Stone Size Guidance measurement technology for efficient extraction
  • Auto Driving for automated scope insertion and extraction within the access sheath
  • Seated console that reduces surgeon fatigue and radiation exposure

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Technical Specification
Power
Rated voltage: 220 V
Rated frequency: 60 Hz
Power consumption: 1.04 kVA

Weight
Master Console: 200 kg
Slave Robot: 220 kg

Dimensions – Master Console
Height: 1270 mm (min) – 1520 mm (max)
Width: 760 mm
Depth: 905 mm (min) – 1035 mm (max)

Dimensions – Slave Robot
Height: 1425 mm
Length: 1472 mm (min) – 1572 mm (max)
Arm height: 975 mm (min) – 1210 mm (max)
Width: 847 mm
Storing mode: 1853 mm height × 877 mm

Environmental conditions
Operating temperature: 10–30°C (50–86°F)
Operating humidity: 10–85% (non-condensing)
Operating atmospheric pressure: 760–1115 hPa
Storage temperature: 0–50°C (32–122°F)
Storage humidity: 5–90% (non-condensing)
Storage atmospheric pressure: 760–1115 hPa

Intelligent interface
Instrument status: Scope forward/backward movement, degree of bending, and status of installed tools
Navigation assistance: Orientation ring around the scope image for guidance within the kidney
External image casting: Fluoroscopy, CT, and patient data displayed on the console
Safety: Real-time access sheath force monitoring, plus an alarm when the basket or laser fiber extends beyond the scope’s reach
Controls: Compact interactive action buttons for quick actions and customization

Standards & certifications
Testing: IEC 60601-1 (Safety), EMC (Electromagnetic Compatibility), Biocompatibility, Usability
Certifications: Korea GMP (MFDS), ISO 13485 (SGS, UKAS)

Clinical results
Stone-free rate: 93.48%
Postoperative complications: 6.52% (Clavien-Dindo Grade II)
Ureteral injury: None related to the robotic procedure
Study: Multi-center, prospective, single-arm pivotal study of 47 patients with 5–30 mm stones; stone-free defined as no stone or fragment <4 mm on 1-month CT (Cho S.Y. et al., 38th Annual EAU Congress, 2023 – First Prize, Best Video Abstract)

Surgeon benefits
Less fatigue: Ergonomic controllers, seating, and adjustable pedals for long, consecutive sessions
Less radiation exposure: Seated console away from the radiation source, with an optional radiation barrier