Description
Balloon catheter for routine transurethral drainage or for postoperative transurethral drainage and bladder irrigation under medical supervision.
These catheters are made of silicone. Only use sterile water or a sterile 10% glycerine solution to inflate the balloons. The pre-filled syringe should only be used to inflate the balloons, not for injections.
Catheters designed for postoperative drainage following continent urinary diversion procedures using neobladders or orthotopic pouches.

Instructions for use
Equipped with a hydrophilic coating. It is recommended to moisten with sterile water or sterile physiological saline solution before use.
Refer to the product's instructions for use.
Dwell time: 30 days.
From a clinical point of view, the actual indwelling time is closely related mainly to the patient's condition, such as urine concentration and pH, infections, the patient's tendency to form stones and metabolic deficiency. Based on these parameters, the indwelling time can vary from patient to patient.

Composition
The construction material is SILASIL (silicone-latex-silicone).
Important: the latex layer is located in the inner portion of the catheter; the urethral wall and urine are always in contact with a silicone layer.
DEHP-free, drug-free, substance-free, and biological tissue-free.

Warnings
Possible complications
In the case of non-deflatable balloons, cut the catheter shaft at the bifurcation or puncture the balloon according to established procedures. If the balloon ruptures, all fragments must be removed from the bladder.
Catheter-associated urinary tract infections, urgency and tenesmus, urethral mucosal irritation, and catheter blockage due to encrustation are documented complications. Incorrect catheter placement can cause urethral damage if the balloon is inflated inside the urethra.
Do not use silicone-based lubricants for silicone catheters. Given the possibility of diffusion, it is recommended to check the volume of balloons inflated with sterile water at least once a week.
These products are made of natural latex and may be sources of allergic reactions. Do not use petroleum-based lubricants. Only use sterile water to inflate the balloons.
Before use, visually inspect the catheter for any mechanical damage and check for leaks.
Do not overinflate the balloons. Excessive aspiration can cause the inflation channel to collapse. Sterility is guaranteed only if the packaging is unopened and intact.
Single-use: do not reuse, reprocess, or re-sterilize. Reuse of the device may expose to the risk of injury and/or severe infections which may be fatal. Reprocessing of single-use medical devices may result in degraded performance or loss of functionality.

Contraindications
Latex allergy. Insurmountable urethral passages. Excessive urethral stricture, false passage.

Storage
Keep away from sunlight and keep dry.
Store at room temperature, away from direct light exposure. Prolonged exposure to fluorescent light, sunlight, or heat will damage the device.
Sterilisation shelf life: 5 years from the date of manufacture.

Format

Product code	CH	number of lumens	tip	balloon ml	length cm	number of holes	number of pieces
850241	12-24	2	cylindrical	10	40	2	1
850243	18-22	3	cylindrical	10	40	2	1