Nautilus Delta (CVAD Guidance)

Nautilus Delta is indicated for navigation and positioning of central venous catheters such as PICCs, CVCs, implantable ports, brachial ports, and hemodialysis catheters. Nautilus Delta provides real-time catheter tip location information by using the patient’s cardiac electrical activity. Nautilus Delta is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous catheter tip placement confirmation. 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. 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. There are no contraindications specific to Nautilus Delta.

ECG signals are transmitted through the ECG cable from the patient and any commercially available catheter using the sterile Nautilus Adaptor to the Nautilus Delta Patient Module (purchased separately), where these signals are converted into digital data and processed. The information is then sent via Bluetooth to the Nautilus Delta mobile medical application running on the mobile platform. The Nautilus Delta mobile medical application displays the following relevant information screen:

• Intravascular ECG waveforms in real time at the tip of the catheter

• Computed navigation signal in real time

• External (skin) ECG waveforms in real time

• Heart rate in real time

• Frozen (reference) intravascular ECG waveforms or navigation signal on demand

• Red marks on the R peak of the QRS complex

The Nautilus Delta mobile medical application can be used in real-time during clinical procedures together with the Nautilus Delta Patient Module and can be used in play-back mode for educational purposes. In playback mode the majority of the real time functionality is available in order to allow for clinically significant review of stored information.

The following functions can be performed using the touchscreen interface:

a. To freeze the ECG signal, tap once in the window of the screen displaying the intravascular ECG waveform or navigation signal. The waveform will be copied and displayed in the reference window of the screen. This allows a particular waveform to be studied, compared, captured or printed

b. To empty the reference window, double tap in the reference window.

c. To enlarge/decrease the ECG signal, use the finger zoom in/out function on the intravascular ECG waveform or navigation signal window and the signal amplitude will be increased/decreased.

d. To scroll up/down the baseline of the ECG signal, drag the ECG waveform up and down in the corresponding window with one finger.

The following menus are available through the menu tree using touchscreen icons:

a. Real time / playback modes

b. Print / Save / Archive

c. Patient information

d. System and application settings

In order to play back and/or review clinical cases performed and archived with Nautilus Delta, tapping the Folder icon opens a dialog box which allows for the selection of one of the following two options:

a. Play Back: ECG data of any of the recorded cases can be played back.

b. Open Image: Saved printouts in png format can be reviewed.

If desired, the frozen waveforms can be printed by a label printer which communicates via Bluetooth with the mobile platform.

The minimum requirements for the Nautilus Delta mobile platform are:

a) Android 4.0

b) Processor: single core at 1.6 GHz or dual core at 1 GHz

c) Display: 5”

d) Touch screen

e) Internal memory: 8 GB

f) Bluetooth 2.1 + EDR