Description Ready-to-use sterile hydrophilic self-lubricating catheter for intermittent catheterization; equipped with No-Touch sheath.
Due to its structural and packaging characteristics, the product is easy to use.
It's lightweight, compact and makes the bladder emptying maneuver simple, fast and safe in every location.
The packaging, in single casing, makes it extremely practical and manageable and of immediate use.
Risk class Class I sterile.
Indications, contraindications and warnings The product allows you to perform the intermittent catheterization maneuver in a simple, quick and safe way.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath allowing you to perform a really safe catheterization, even in situations where there is no possibility to take advantage of an adequate standard of hygiene.
The catheter is of simple preparation as it is sufficient to remove the sheath at the base of the connector and the one at its end.
Carried out this operation, the catheter is ready for use.
If the folding of the sheath is uncomfortable for users with reduced manual skills, part of the sheath can be removed so as to maintain a reduced section but can avoid touching the catheter with your fingers during the self-catheter maneuver.
Technical information The product consists of a Thermoplastic Polyolefin called TPO which belongs to the Thermoplastic Elastometers (TPF) family.
TPO is a family of polyolefins and elastometric polymers that gives similar properties to PVC: softness, good flexibility, without the use of plasticizing additives (phthalates), good transparency and resistance to kneeling.
They have a high level of biocompatibility since they meet the requirements:
• USP Class VI
• USP Physicochemical tests for plastics.
• ISO 10993
They do not have cytotoxic activity and do not induce skin irritation.
They also do not cause skin sensitization phenomena.
The product is equipped with a hydrophilic coating consisting of glycerin and water, ready for use.
The hydrophilic coating allows to eliminate the activation times and guarantees a reduced coefficient of friction, for the entire duration of the catheterization, allowing easy and safe insertion and an atraumatic extraction.
The high hydration of the coating avoids any risk of adhesion of the catheter to the urethral wall: this is particularly advantageous during the extraction maneuver in subjects who, due to particular functional limitations, require a long time to carry out the self-catheterism maneuver.
The catheter appears completely and uniformly lubricated, ready to use and without the need for other additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It has atraumatic holes with blunt and smooth corners to allow urine to leak quickly.
The heat-heated polyethylene sheath allows you to manage the catheter without touching it with your hands (No-Touch technique).
This sheath allows a better grip of the catheter by all users, even those with poor manual skills and favors a reduction of possible bacterial contamination during the maneuver of catheterization.
The end of the catheter features a taper that can be connected with the normal urine collection bags.
The removal of the sheath is easy and modular according to the needs of the users.
You can remove the distal end so as to keep the catheter fully protected during the catheterization maneuver (the gradual folding of the sheath releases the catheter), or you can remove a part of the sheath, In order to preserve a movable portion on the catheter that allows in any case to avoid contact with the surface of the catheter during the maneuver, thus preventing possible contamination.
The sheath has an eyelet near the distal end (41 cm version) which allows the catheter to be kept folded in order to reduce its size.
Male Catheter Length: 41 cm useful length (without connector) 37 cm
Female Catheter Length: 20 cm useful length (without connector) 16 cm
Technical characteristics of the catheter
| Material |
TPO-Polyolefin Thermoplastics |
| Coating |
Fle 12-Glycerol and water (specific formulation that allows a high level of hydration) |
| Coating sheath (No-Touch) |
Low density polyethylene (60 microns thickness) |
| Conical fitting |
Copolymer of Ethylene and Vinyl Acetate (EVA) |
Technical characteristics of packaging The No-Touch sheath also represents the casing with catheter packaging.
| Disposable |
And |
| Sterile to sale |
Sterile |
| Method of sterilization |
Beta-ray sterilization in accordance with current regulations |
| Months validity |
For intact packaging and in correct state of conservation: 24 months |
| Presence of latex |
No
The product is declared to be latex-free |
| Storage temperature |
Store at room temperature away from heat and light sources |
| Biocompatibility |
And |
| |
The devices are subjected to and subject to biocompatibility tests according to international standards: ISO 10993 - 1 Biological Evaluations of Medical Devices.
Part. 1: evaluation and test |
| Phthalates |
No |
| Code |
Description |
238108F
238110F
238112F
238114F
238116F
238208F
238210F
238212F
238214F
238216F
238306F
238308F
238310F
238312F
238314F
238316F |
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