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The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement. Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including - Atrial fibrillation - Atrial flutter - Severe tachycardia - Pacemaker-driven rhythm - Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation. The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.