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Integra® CUSA® NXT Ultrasonic Tissue Ablation System
The Next Wave in Ultrasonic Aspirator Technology
The CUSA NXT™ Ultrasonic Tissue Ablation System was designed to enable surgeons and nurses to focus on patient care rather than worrying about operation of the surgical equipment. The easy-to-use system features revolutionary NXT Digital Architecture™ feature, supports current CUSA Selector® handpieces, and provides an expandable platform enabling exciting future handpiece capabilities. The touch screen user interface is easy to understand, provides rich visual feedback, and gives clinicians quick access to general system information.
NXT Digital Architecture™ Feature
The CUSA NXT System features the NXT Digital Architecture™ feature, and advanced digital control system. This proprietary ultrasonic power circuitry ensures consistent performance, giving surgeons procedural control and peace of mind. The NXT Digital Architecture feature enables features that enhance clinical performance and improve ease of use, including
Advanced Aspiration System
The NXT Digital Architecture feature also enables advanced control of the CUSA NXT aspiration system's variable vane pump technology, resulting in:
The CUSA NXT System is designed for use in suites with intraoperative Magnetic Resonance Imaging equipment. The RapidRestore™ feature returns the CUSA NXT to its most recent system settings when powered on after imaging.
Integra CUSA NXT - Intended Use
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Integra CUSA NXT - Warnings
When pressing the Power Footswitch pedal to operate the handpiece, do not allow the tip of the handpiece to come into contact with any object except for the target tissue at the operating site. Touching the tip while powered can result in personal injury.
Risk of explosion. Do not use in the presence of flammable anesthetic gases. For continued protection against fire hazard, replace fuse only with same type and rating.
To avoid personal injury or damage to the tip, do not allow the tip of the handpiece to contact any operator or hard surfaces or anything other than the target tissue when powered.
Do not operate the CUSA NXT in the presence of flammable anesthetic agents or other volatile solvents.
Using the incorrect wrench set to assemble/disassemble the handpiece may damage the handpiece.
Failure to center the shroud may cause the handpiece to overheat.
Tubing kits must never be connected directly to the vacuum source as contamination will occur.
Disinfecting solutions containing sodium hypochlorite may cause damage to the metal tip of the handpiece and are not recommended. Do not immerse the handpiece cable plug in the disinfecting solution.
When using the Integra CUSA NXT System in an interoperative MRI suite, you must place the system Console and Service Module outside the 5 gauss line for proper operation and safety. The CUSA Selector® MRI handpieces and the standard CUSA NXT Footswitch may be used in static magnetic fields up to 0.5 Tesla. The Console and Service Module are not MRI safe.
Integra CUSA NXT - Cautions
Federal (USA) law restricts this device to sale by or on the order of a physician.
Contact of the moving tip against a hard surface, e.g. a metal instrument tray, may damage the tip of the handpiece and require replacing the tip before use. Do not use a handpiece with a broken tip.
Electrical shock hazard. Do not remove cover. Refer servicing to authorized service personnel.
Pressing and releasing the Power pedal too quickly may result in a Handpiece Tip Initialization failure. If this occurs, disconnect the handpiece, verify proper tip assembly, and then reconnect the handpiece and try again.
Do not store anything in the storage area in the back of the Console while the system is running.
With correct use of the wrench, it is not possible to overtighten the joint. However, if the joint is not firmly tightened, the handpiece will not function correctly and may be noisy and overheat during use.
Do not power the CUSA Selector handpiece without fully priming the handpiece with irrigant, i.e. irrigant must flow from the tip of the handpiece. Failure to follow this instruction may result in permanent damage to the handpiece (internal and/or external components).
Do not attempt to clear a blocked handpiece by passing the stylet down the rear inlet of the handpiece. This may result in damage to the handpiece. Always pass the stylet in from the tip end.
Validation of the steam cycles described in the manual have been conducted, however, it is solely the decision of the hospital to approve the use of these cycles.