CardioFocus HeartLight X3 Manual De Instrucciones página 8

 Warning: Use only CardioFocus supplied Balloon Fill Media.
2. Set up a sterile compatible deflectable sheath capable of 180-degree deflection with an inner diameter (ID) of
≥12F, a usable length of 75cm and an overall length of not more than 94cm. Consult IFU included with sheath's
packaging.
3. Deliver the sterile Balloon Catheter and Endoscope to the sterile field. The Gowned Sterile Technician (GST)
will hand the proximal ends of Balloon Catheter back to the Non-Sterile Technician (NST) for connection to the
Console.
4. Un-cap both illumination fiber connectors on the Balloon Catheter and immediately connect them to the
illumination adapters taking care not to allow the optical connectors' face to contact anything.
5. Connect Balloon Catheter's electrical cable connector to the Console.
Caution: Do not use if Balloon Catheter package is opened or damaged.

Caution: Use prior to the "Use Before" date on the package.

7.2 COOLING LOOP SET-UP
1. Clip the burette into the two C-shaped clips on the front of the Console.
2. Open the pump head by using the lever on the right side of the pump head.
3. Insert the rubber tube into the pump head and then carefully close the pump head.
4. Press the Balloon Fill Media tube into the bubble detector.
5. Aseptically attach the Balloon Fill Media filled syringe to the end of the burette feed tube.
6. Fill the burette with Balloon Fill Media to the dotted line using the filled syringe.
7. Ensure at least 20cc of additional Balloon Fill Media is available in the syringe. This may require refilling the
syringe.
8. Always be sure to monitor and maintain the minimum Balloon Fill Media level slightly above the level sensor
located in the center of the lower C-shaped clip on the front of the console throughout the entire procedure.
7.3 PURGE COOLING LOOP
1. Hold the shaft of the Balloon Catheter near the Balloon with the distal tip pointing downward.
2. On the Console, navigate to the Catheter Preparation screen, which will allow the pump to run while
disregarding any air present at the bubble detector. Start the pump.
3. On the Balloon Remote press the '+' side of the rocker switch to inflate the balloon to a diameter just beyond
wrinkle free balloon surface.
4. Release the switch to evacuate any air in the balloon.
5. The pump may be running or stopped during the endoscope installation.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
Page 8
ECN-4541