Device Description

Urosmart provides a fully automated continuous bladder irrigation (CBI) system that can quantitatively and automatically adjust the rate of CBI. The device consists of a color sensor, a weight sensor, an inflow valve, and an accompanying app. The color sensor and the flow sensor read the drainage outflow from the catheter and send the data to our algorithm, which analyzes the solution color and flow rate and determines if the inflow flow rate should be changed. It also displays the current status of the CBI on the app, monitors the completion status of the CBI, and notifies nurses in one of two situations: 1) there is clotting in the patient's bladder and 2) the CBI is completed. The inflow valve opens and closes according to the readings from the two aforementioned sensors which then changes the inflow flow rate of the CBI. 

Caution Statements

1. UroSmart does not fully replace the clinicians' supervision. It is recommended that clinicians can still check on the device every 1-2 hours if available. It is also advised you check on the patient:

   1. When you get a notification that the color grade has changed. 

   2. Every 30-60 minutes when their color grade is a 5.

   3. If their color grade worsens after 4+ hours on CBI. 

2. The UroSmart algorithm follows a preset protocol. If the user would like a personalized parameter, please go to the UroSmart App info page to redo the customized setup. 

3. UroSmart Automated CBI does not automatically empty the drainage bag. Manual replacement of the drainage bag is required. The app will notify clinicians when the bag is getting full. 

4. Do not operate the device without any prior training experience on CBI setup.

5. UroSmart cannot unclog CBI. Should clotting occur, clinicians will be notified via the app and the CBI will stop until the clinician can come unclog the device (done according to industry protocol).  

Procedure

1. Thread the tubing from the IV bag through the inflow valve (A).

2. Thread the outflow tubing through the color sensor (B) and flow sensor (C) to the drainage bag. Hang the drainage bag on the bed as is standard procedure. 

3. Insert catheter according to standard procedure. Connect the tubing to the catheter ports. 

4. Open the app (D). Press start. Follow the given instructions to start CBI. 

5. Allow saline to flow freely through the inflow tube.

   1. Caution: Make sure there is no is fully closed at the beginning. No saline should flow into the catheter. If trouble occurs, see #2 in troubleshooting.

6. Confirm that you have completed the steps above on the app. 

7. Device will continue to run CBI. Be sure to check the app to monitor the patient's progress. 

Troubleshooting

1. If the device is not connecting to the app, make sure the power source is connected properly and check all WiFi signals. There will be a warning message on the screen that your WiFi is not working. 

2. If the inflow valve is allowing saline to flow when it should be fully closed, check that the tubing is properly aligned in the case and that the lid is on tight. To do this, clamp the IV so that fluid does not flow and adjust the linear actuator to be fully open on the app. Check that the IV tube is flush to the wall of the case and the linear actuator. 

Device care, maintenance, cleaning, and repair 

1. If CBI lasts longer than 3 days, switch out the batteries (2 for the inflow valve, 1 for the outflow, and 1 for the color sensor). These are standard 9V batteries. 

2. The inflow valve and color sensor are non-critical reusable medical devices as classified by the FDA. They should be wiped down externally with hospital grade cleanser, as you would clean the IV pole. Avoid wetting the electronics.