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The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave: - Atrial fibrillation - Atrial flutter - Severe tachycardia - Pacemaker-Driven Rhythm - Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory. The device is only provided in one configuration, and non-sterile. The system is composed of: - . A medical tablet with a kickstand attached on the back - . The medical tablet's power supply - . A Pilot TLS module attached to a USB-A cable - A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector - An ECG cable with 4 leads (red, white, green, black) - 2 USB flash drives Vygocard is an accessory provided sterile.