Treatment Instructions
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Pnn Medical SAP/Veldana Medical
Cavaterm™ Treatment Instructions Gen 3 1.
Press the blue ON/OFF key for 3 seconds to activate the Cavaterm™ 3 Central Unit.
2. 3. 4. 5. 6.
Press the green Start key and insert the catheter connector into the device pump slot (flat connector surface on the top). Adjust the balloon length (uterine cavity length = sound length – cervical anal length). Fill the syringe with 17-20 ml glucose 5%. Connect the syringe to the luer lock valve. Purge the catheter. Remove air by injecting all 17-20 ml of fluid into the catheter pointing downwards. Retrieve syringe plunger in order to empty balloon completely. Refill the syringe with 30 ml of glucose 5%, attach it to the luer lock valve.
7. Press the green Start key. 8. Insert the balloon catheter into the uterine cavity. 9. Hold the catheter in position while filling the balloon with glucose 5% until a pressure of approx. 200 mmHg is displayed. 10. Lock the plunger. Slide the syringe switch until the symbol is visible. 11. Twist the plunger to add or remove fluid until the pressure reaches 230-240 mmHg. 12. Press the green Start key to start circulation and heating of the fluid. 13. Constantly maintain a balloon pressure of 234-240 mmHg. The time countdown starts when the temperature reaches 65c. Heating & circulation continue until the treatment time has elapsed. An acoustic signal will be heard at the end of the treatment. 14. Press the yellow Stop key. 15. Release the syringe plunger until the symbol is visible. Empty the balloon and remove the catheter from the uterus. 16.
Press the yellow Stop key again to disconnect and release the catheter from the Cavaterm™ 3 Central Unit.
17.
Press the blue ON/OFF key for 3 seconds to deactivate the Cavaterm™ 3 Central Unit. 18. Turn off the main switch at the rear of the device. For more information please read the Cavaterm™ plus Instructions for use available with each catheter and the Cavaterm™ 3 Operators Manual placed in the compartment located under the device.
Endotherapeutics Pty Limited | ABN: 89 088 045 103 Suite 1 Level 1 51 Rawson Street EPPING NSW 212 | Toll Free: 1300 00 ENDO
Pnn Medical SAP/Veldana Medical
Cavaterm™ Treatment Instructions PRE-MEDS : 1. 2. 3. 4. 5. 6.
Pre-medication for patient: anti-inflammatory/anti-prostaglandin, Cavaterm unit, Catheter, D & C kit, 5% glucose – 50ml in sterile bowl, Analgesic for post op. CONTRAINDICATIONS:
Undiagnosed uterine bleeding Endometrial atypical cells Gross uterine abnormalities that would result in incomplete balloon contact with the endometrium Uterine wall weakness Pregnancy or desire to become pregnant Uterine cavity <4cm (COULD CAUSE BURNS) or >10cm (MAY BE INEFFECTIVE) Cervical canal > 6 cm Ongoing infection (resolve infection before considering a Cavaterm treatment) GENERAL NOTES:
Retroverted uterus: perform ultrasound after inflating balloon to check position before activating heat and circulation of the fluid. If temperature rises over 80deg in first minute or so – (could be small uterine cavity, fibrosis etc) - self-regulated heating elements will readjust Glucose is heat conductive but not electrically conductive and is biocompatible with silicone Destroys 5-8mm of endometrium and myometrium. Pelvic pain is usually present during the hours following the treatment. It can be managed with pre-procedure and post-procedure administration of non-steroidal anti-inflammatory drugs. IMPORTANT NOTE:
Should pressure reach 270mmHg (perhaps due to uterus suddenly contracting), acoustic signal will be heard. At 300mmHg, the unit will shut down and release liquid through overflow valve at 320mmHg. (count down will stop at this point). SOLUTION: In a clockwise position, slowly twist syringe until pressure reaches 230240mmHg again and then press green button to commence circulation and heating again. When temperature reaches 65deg again, the countdown will resume where it stopped. Endotherapeutics Pty Limited | ABN: 89 088 045 103 Suite 1 Level 1 51 Rawson Street EPPING NSW 212 | Toll Free: 1300 00 ENDO