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Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude. Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - · Otolaryngology - Oral/maxillofacial - · Hand and foot - · Neurosurgery - · Spine - · Plastic/reconstructive.

Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage. Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling. The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.

XD880A Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive.

XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.

Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery. Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.

PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use. PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips. The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values). The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications. The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving. The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth. Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.

The Piezosurgery® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: - Otolaryngology - Oral/maxillofacial - Hand and foot - Neurosurgery - Spine - Plastic/reconstructive, and - Orthopedic surgery. The device may also be used with endoscopic visual assistance to perform the above listed procedures.

The Piezosurgery Plus device is a surgical system that uses ultrasonic energy to generate mechanical micro-vibration of associated inserts, to perform cutting of bony structures in the procedures defined by its intended use. The Piezosurgery Plus system consists of a control unit which provides control and power functions, two different detachable surgical handpieces which provide the ultrasonic mechanical energy, two peristaltic irrigation pumps, two irrigation tubing systems, a range of single use insert tips, torque wrenches, and a foot-pedal. The control unit has a color LCD touch screen user interface for the selection/visualization of device functional parameters. Inside the control unit are located two ultrasonic generators which drive the two handpieces, the electrical power supply modules and the microprocessor electronic board that controls and supervises the functional parameters of the device. The two piezoelectric ultrasonic handpieces available for the Piezosurgery Plus are identified as 'Piezosurgery Medical' and 'Piezosurgery Medical +'. The handpieces are reusable and capable of being reprocessed by autoclaving. The handpiece labeled 'Piezosurgery Medical +', uses identical technology to the 'Piezosurgery Medica' handpiece but differs from it as it contains larger piezoceramic rings in its transducer, allowing more efficient cutting of thick bony structures, and also use with extended reach for minimally invasive bone surgery in long narrow access path, in small cavities and other hard to reach areas. The two peristaltic pumps, which provide, through the two single-use irrigation tubing sets, sterile fluid to the surgical site, are mounted on the two lateral panels of the control unit. The control unit includes connectors for the handpieces and for the foot-pedal. Each handpiece receives the functional drive signals from the control unit. Each irrigation tubing set connects each handpiece irrigation connector to a sterile fluid bag (not supplied with the device) via the associated peristaltic pump. The user may select either of the two handpieces for activation from the LCD touch-screen. Ultrasonic power and irrigation flow are simultaneously activated for the selected handpiece by pressing the foot-pedal. The ultrasonic generator(s) provides electrical energy at a specific range of frequency. The generator must drive the transducer at or near its anti-resonance frequency for optimal operation. A key function of the generator is to locate the anti-resonant frequency and drive the output at this frequency. In particular, the generator conducts an automatic frequency sweep across a frequency interval of 36 kHz - 24 kHz to locate and lock the electrical resonance frequency of the transducer/insert system. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery Plus handpieces transducers and family of inserts are designed to resonate in this range of frequencies. The ultrasonic signal can be modulated in amplitude, generating a sinusoidal signal with alternative amplitudes of high and low value that creates a hammer effect that enhances cutting and minimizes insert stalling. The Piezosurgery Plus complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

The Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and paalstic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Piezosurgery FLEX is a piezoelectric ultrasonic device that uses ultrasonic energy to generate mechanical micro-vibration of tip inserts intended for bone cutting. The device consists of a base control unit with intearated peristaltic pump, a sterilizable handpiece with connecting cord, a range of sterile, single use tip inserts, a torque wrench, a foot-pedal, an irrigation set, and other minor attachments. The console is equipped with a touch panel that allows the surgeon to control device operation. The control panel also provides monitoring information, by means icons, in case of malfunction of the device. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the foot-pedal. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the foot-pedal. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. The touch panel of the console allows the operator to set the treatment parameters, as follows: - Seven levels of power: . - Six levels of irrigation: . - Three ultrasonic output modes; . - · The pump function. The Piezosurgery FLEX uses piezoelectric ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.

The Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord, a foot pedal, a wrench and a handpiece. The PIEZOELECTRIC SYSTEM device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue. A variety of attachments will be available for the Piezoelectric System for cutting bone, bone substitutes, osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of bones and teeth in a variety of surgical procedures. These attachments will be available "Sterile" -Single Use only (do not re-use).

The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.

The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing. The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console. The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.