Search Results

Nautilus Delta is indicated for navigation and positioning of central venous access devices (CVADs) of at least 3 Fr in size. Nautilus Delta provides real-time catheter tip location by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for CVAD tip placement confirmation. In adult patients and in adolescents (greater than 12 through 21 years of age), Nautilus Delta can be used with CVADs such as peripherally inserted central catheters (PICCs), central venous catheters (CVCs), implantable ports, and hemodialysis catheters; in children (greater than 2 to 12 years of age), Nautilus Delta can be used with PICCs and with centrally inserted central catheters (CICCs); in infants (greater than 1 month to 2 years of age) and in neonates (from birth to 1 month of age), Nautilus Delta can be used with CICCs. In each specific age group, the CVAD type and size must be chosen and the CVAD must be used according to the CVAD's indications and instructions for use. Limiting but not contraindicated situations for this method are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Nautilus Delta™ system consists of the following elements: single use sterile ECG extension cable (also known as Nautilus Electrical Adaptor also known as NautilusE), non-sterile ECG cable, patient module (ECG data acquisition and processing and integrated remote control), and mobile medical application running on any mobile platform which complies with the minimum requirements. Nautilus Delta™ provides real-time catheter tip location information by using the patient's cardiac electrical activity (ECG). This information can be used to position any central venous access devices (CVADs) at or around the cavo-atrial junction (CAJ). Nautilus Delta supports navigation of central venous catheters from the vascular access point towards the CAJ by computing and displaying a navigation signal. Nautilus Delta also displays on its graphical user interface the surface (skin) ECG signal, a marker identifying the R-peak, and the patient's heart rate. In order to obtain intravascular ECG information at the tip (distal end) of a catheter, a stylet or a guidewire inserted in the catheter can be connected to Nautilus Delta patient module via the sterile Nautilus Delta ECG extension cable. Nautilus Delta and NautilusE do not have any direct or indirect contact with the patient.

The Sapiens™ Tip Location System (TLS) is indicated for guidance and positioning of central venous catheters such as PICCs, CVCs, implantable ports, and hemodialysis catheters. The Sapiens™ TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity. Sapiens™ TLS is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm, and in central venous catheterization procedures performed through femoral or saphaneous vein access which change the presentation of the P wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The Sapiens™ TLS consists of the following clements: sterile electrical adaptor, ECG module and cable, laptop running Sapiens™ TLS software, label printer (optional), and remote control (optional). A stylet or a guidewire inserted in a central venous catheter can be connected to the Sapiens™ TLS system via the Sapiens™ TLS Electrical Adaptor establishing a direct electrical connection to the catheter distal tip for ECG signal measurement. A different ECG signal measurement method - the column of saline method - can be used by connecting the Sapiens™ TLS Electrical Adaptor to the Arrow- Johans Adaptor, by connecting the Arrow-Johans Adaptor to any central venous catheter and by injecting saline solution into the catheter lumen through the Arrow-Johans Adaptor, thus establishing electrical conductivity to the distal tip of the catheter. When the central venous catheter or its associated stylet or guidewire is connected to Sapiens™ TLS, the Sapiens™ TLS laptop screen displays skin ECG signals and endovascular electrograms acquired at the location of the distal tip of the catheter. The waveforms provided by Sapiens™ TLS can be used for guiding and positioning of the central venous catheter. These ECG waveforms can be printed using an optional label printer to document the catheter tip location for the patient's file.