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General Description of Performance Requirements and Features of the System:
Laparoscopic ergonomic take-apart instruments. The instruments need to have the ability to be taken apart, separating the handle, shaft and insert to aid visual inspection during cleaning. Contain a 360° rotation knob that is effectively sized and contoured to enable easy instrument rotation. Must have thumb actuation ridges to facilitate actuating the instrument using the thumb. Gripping flares to facilitate palm-grip applications. Integrated ratchet and ratchet defeat mechanism positioned to give fingertip access. Large double front ring to help improve stability with removable cushioned insert which will aid to reduce thumb pressure and accommodate both larger and smaller hands. Ergonomic contouring to uniformly distribute pressure on hands, decreasing the potential for intraoperative hand fatigue. Ring handle design to work with both a traditional precision grip or palm grip. Ratchet function mechanism should allow easy and quick adjustment. The same instrument should be able to be used with or without the ratchet function. Instruments should feature a tungsten-carbide insert where appropriate to ensure durable performance, but contain the capability of disassembly, separating the handle, shaft and insert to aid visual inspection during cleaning.
Double-layer Halar® insulation to reduce the potential for cracks and defects in the shaft insulation.
Dual assembly/release buttons to aid assembly and help eliminate unintended disengagement during use. Electrosurgical post to allow monopolar cutting and coagulation. Fully insulated durable polymer handle to protect against aggressive cleaning and sterilization. Validated to be reprocessed by both manual cleaning methods and automatic washer/disinfector. Validated to be sterilized containerized via prevacuum steam sterilization at a temperature of 270 degrees Fahrenheit with exposure time of at least 4 minutes.
Site Specific Requirements: