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 not easy to use.
It is light, compact and makes the bladder emptying maneuver simple, fast and safe in any place.
The packaging, in a single casing, makes it extremely practical and easy to handle and 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 to perform a truly safe catheterization, even in situations where there is no possibility of using an adequate hygienic standard.
The catheter is easy to prepare as it is sufficient to remove the sheath at the base of the connector and the one at its end.
Once this is done, the catheter is ready for use.
If the folding of the sheath is inconvenient for users with reduced manuality, part of the sheath can be removed in order to maintain a reduced stretch but able to avoid touching the catheter with the fingers during the self-catheterization procedure.

Technical information
The product consists of a Thermoplastic Polyolefin called TPO which belongs to the family of Thermoplastic Elastometers (TPF).
TPO is a family of polyolefins and elastometric polymers which gives properties similar to PVC: softness, good flexibility, without the use of plasticising additives (phthalates), good transparency and resistance to kneeling.
They have a high level of biocompatibility as they meet the following requirements:
• USP Class VI
• USP Physicochemical tests for plastics.
• ISO 10993
They do not exhibit cytotoxic activity and do not induce skin irritation.
Furthermore, they do not cause skin sensitization phenomena.
The product is provided with a hydrophilic coating consisting of glycerin and water, ready for use.
The hydrophilic coating eliminates activation times and guarantees a reduced coefficient of friction, for the entire duration of the catheterization, allowing easy and safe insertion and 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 long times to perform the self-catheterization maneuver.
The catheter appears completely and uniformly lubricated, ready for use and without the need for other additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It has atraumatic holes with smooth rounded corners to allow urine to escape quickly.
The heat-heated polyethylene sheath allows you to handle 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 catheterization maneuver.
The end of the catheter has a cone that can be connected to normal urine collection bags.
The removal of the sheath is easy and modular according to the needs of the users.
The distal end can be removed in order to keep the catheter completely protected during the catheterization maneuver (the gradual folding of the sheath frees the catheter), or a part of the sheath can be removed, so as to keep a movable portion on the catheter which allows in every case of avoiding contact with the catheter surface during the maneuver, thus preventing possible contamination.
The sheath has an eyelet near the distal end (41 cm version) that allows you to keep the catheter folded in order to reduce its bulk.
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 - Thermoplastic Polyolefins
Coating	Fle 12 - Glycerol and water (specific formulation that allows a high level of hydration)
Coating sheath (No-Touch)	Low density polyethylene (60 micron thickness)
Conical fitting	Copolymer of Ethylene and Vinyl Acetate (EVA)

Technical characteristics of the packaging
The No-Touch sheath also represents the catheter wrapping envelope.

Single use	Yup
Sterile for sale	Sterile
Disterilization method	Beta sterilization in compliance with current regulations
Months validity	When the packaging is intact and in an incorrect state of conservation: 24 months
Presence of latex	No We declare that the product is latex-free
Storage temperature	Store at room temperature away from sources of light and heat
Biocompatibility	Yup
	The devices are subjected to and subjected to biocompatibility tests according to international standards: ISO 10993 - 1 Biological Evaluation of medical devices. Part. 1: evaluation and testing
Phthalates	No

Code

Description

238108F 238110F 238112F 238114F 238116F 238208F 238210F 238212F 238214F 238216F 238306F 238308F 238310F 238312F 238314F 238316F

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