Engenious - Electrosurgical System
Our experience enables us to understand the unique challenges of this technology. Over their careers, our team has been part of designing 11 electrosurgical systems for various therapies ranging from vascular closure and nerve ablation to general surgery. This experience includes single-electrode, multi-electrode, monopolar and bipolar applications, ablation/cut/coag/gas plasma coagulation, and therapies involving dynamic fluid delivery and cooling.
Specification
Our team has worked with the IEC:60601-2-2 standard for over 15 years, navigating electrosurgical systems through agency approval. Our track record means we save projects from getting mired in schedule-eating safety agency trouble, or from uncovering last-minute technical surprises that catch less-experienced teams off guard.
- Contact quality monitors
- Neuromuscular stimulation
- Unique MOPP requirements
- Dielectric strength
- Creepage/clearance
- HF leakage
- Accessory insulation
- Crest factor
- Operation duty cycle
- Controls and Instrumentation Accuracy
- Monotonicity of outputs
- Protection against hazardous outputs
- Max power in single fault
- Max power during simultaneous activations
- Short circuit protections
Our unstoppable team can tackle specific issues, freeing your team for other strategic work
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- Monopolar & Bipolar
- Our team has fielded systems that are monopolar, bipolar, and systems that switch between modes
- Systems Engineering
- RFG-specific requirements, architecture, risk management, and expert technical coordination of highly integrated engineering teams
- Multiple outputs
- Multiple active outputs increase complexity of measurement and control, but we have solved these issues before
- Ablation, Cut, Coag, Gas Plasma
- We navigate amplifier and control systems requirements of all these modes – and we appreciate the differences
- Control systems
- Experienced RFG feedback control systems engineers. Temperature, power, voltage, and combination controlled. Gas plasma and fluid delivery too
- Safety isolation
- Type CF devices for defibrillator-proof direct cardiac application, and the unique isolation requirements for RF surgery equipment
- Measurement
- Instrumenting voltage, current, phase, temperature and return electrodes on isolated patient connected ESU outputs
- Cooled tips
- Fluid-cooling of electrosurgery tips and applicators, pump-controlled
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