Training Manual

General Reference

Preparation

1. Apply clean medical gloves to hands
2. Unpack balloon – check labeling for lot number and expiration
3. Apply a generous amount of lubricant to the balloon surface
4. Place device aside
5. Grasp syringe and pull back the plunger to fill the barrel to the prescribed volume with the prescribed content
6. Volume must be consistent with prescribed volume used during simulation
7. Volume prescribed by the physician typically ranges between 60 cc and 90 cc (volume should not exceed 90 cc)
8. Connect syringe to the end of the central lumen (twist clockwise to ensure proper connection)
9. SEE CATEGORY BELOW FOR NEXT INSTRUCTION (Simulation OR Daily Treatment)

During Preparation for Simulation

• “Click” the base of the stopper on the central lumen of the device with the rounded edge of the ring facing the balloon surface; place stopper at the 20cm depth mark (keep edges separated, unlocked)

During Preparation for Daily Treatment

• Snap the stopper on the central lumen with the rounded edge facing the balloon and slide to the prescribed depth (measured at simulation)
• Lock the stopper into place by clasping edges together with thumb and forefinger (physician/therapist will hear edges click together when properly locked)

Insertion

1. Prepare treatment couch with standard materials
2. Instruct patient to lay supine on the treatment couch
3. Raise treatment couch to waist level (or desired height for physician/therapist comfort)
4. Instruct patient to bend and slightly separate knees, placing bottom of feet flat on the table
5. Firmly grasp the central lumen of the device near the inferior balloon edge and grasp the syringe with the other hand
6. Place the tip of the balloon at the external anal sphincter
7. Gently advance the balloon until it is superior to the internal anal sphincter (approximately to the 12 cm depth mark)
8. Twist the blue valve to the open position (perpendicular to the central lumen)
9. Grasp the syringe; with the thumb, push the plunger to expel contents from the barrel and inflate the balloon
10. Hold thumb on the plunger to ensure total removal of syringe contents and return the valve to the closed position (parallel to the central lumen)
11. SEE CATEGORY BELOW FOR NEXT INSTRUCTION (Simulation OR Daily Treatment)

During Insertion for Simulation

• Gently pull the device inferior until minimal tension; this ensures the inferior balloon edge is properly positioned against the internal anal verge
• Slide the stopper to the outside of the external anal sphincter
• Lock the stopper into place by clasping edges together with thumb and forefinger (physician/therapist will hear edges click together when properly locked)
• Disconnect the syringe (twist counter-clockwise) and set aside
• Continue with normal patient set-up and perform imagine or treatment

During Insertion for Daily Treatment

• Already positioned at the prescribed depth, the stopper should be resting securely against the external anal sphincter
• Disconnect the syringe (twist counter-clockwise) and set aside
• Continue with normal patient set-up and perform imagine or treatment

Removal

1. Apply clean medical gloves to hands
2. Bring treatment couch to waist level (or desired height for physician/therapist comfort)
3. With volume at 0 cc, reconnect syringe to central lumen and twist the valve to the open position (perpendicular to central lumen)
4. Slowly pull back the plunger to extract all balloon contents into the syringe barrel
5. Return the valve to the closed position (parallel to the central lumen)
6. SEE CATEGORY BELOW FOR NEXT INSTRUCTION (Simulation OR Daily Treatment)

During Removal for Simulation

• Gently remove the balloon and locate the measurement at the rounded edge of the stopper (this measures the depth of balloon insertion)
• Record this measurement in order to reproduce balloon depth during daily treatment (place stopper at this measurement for every treatment unless otherwise specified by the physician)
• After the depth is measured, properly dispose of the device

During Removal for Daily Treatment

• Gently remove the device and properly dispose