Actreen Hi Lite Autol Ch12 N41

Description
Hydrophilic sterile self-lubricating catheter ready to use for intermittent catheterization; equipped with No-Touch sheath.
Due to its structural and packaging characteristics, the product is easy to use.
It is lightweight, compact, and makes bladder emptying simple, quick, and safe everywhere.
The packaging, in a single wrapper, makes it extremely practical and manageable and ready for immediate use.

Risk class
Class I sterile.

Indications, contraindications and warnings
The product allows performing the intermittent catheterization maneuver easily, quickly, and safely.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath, allowing for truly safe catheterization, even in situations where a proper hygienic standard cannot be guaranteed.
The catheter is simple to prepare as it is sufficient to remove the sheath at the base of the connector and at its end.
After this operation, the catheter is ready for use.
If the folding of the sheath is inconvenient for users with limited manual dexterity, part of the sheath can be removed to keep a reduced length but still avoid touching the catheter with fingers during the self-catheterization maneuver.

Technical information
The product consists of a Thermoplastic Polyolefin called TPO, belonging to the family of Thermoplastic Elastomers (TPF).
TPO is a family of polyolefins and elastomeric polymers that confer properties similar to PVC: softness, good flexibility, without the use of plasticizers (phthalates), good transparency, and resistance to kinking.
They exhibit a high level of biocompatibility because they meet the requirements:
• USP Class VI
• USP Physicochemical tests for plastics.
• ISO 10993
They show no cytotoxic activity and do not cause skin irritation.
Furthermore, they do not provoke skin sensitization phenomena.
The product is coated with a hydrophilic layer made of glycerin and water, ready to use.
The hydrophilic coating eliminates activation times and ensures a low coefficient of friction throughout the catheterization, allowing easy and safe insertion and atraumatic removal.
The high hydration level of the coating prevents any risk of the catheter adhering to the urethral wall: this is particularly advantageous during removal, especially in subjects with particular functional limitations, requiring longer times to perform self-catheterization.
The catheter appears completely and uniformly lubricated, ready for use without additional steps to induce lubrication (activation of the hydrophilic substrate).
It has atraumatic holes with smooth, beveled angles for quick urine exit.
The polyethylene sheath, heat-shrunk, allows handling the catheter without touching it with hands (No-Touch technique).
This sheath provides a better grip for all users, even those with limited manual skills, and helps reduce possible bacterial contamination during catheterization.
The end of the catheter features a cone connecting to standard urine collection bags.
The removal of the sheath is easy and can be adapted based on users' needs.
The distal end can be removed to fully protect the catheter during the maneuver (gradual folding of the sheath frees the catheter), or part of the sheath can be removed to keep a mobile portion that prevents contact with the catheter surface, thus reducing contamination risk.
The sheath has a small eyelet near the distal end (version 41 cm) that allows folding the catheter 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 - Thermoplastic Polyolefins
Coating	Fle 12 - Glycerin and water (specific formulation that allows a high level of hydration)
Sheath coating (No-Touch)	Low-density polyethylene (60 microns thick)
Conical fitting	Copolymer of Ethylene and Vinyl Acetate (EVA)

Technical characteristics of the packaging
The No-Touch sheath also serves as the catheter packaging.

Disposable	Yes
Sterile upon sale	Sterile
Sterilization method	Beta-ray sterilization according to current regulations
Validity months	With intact packaging and proper storage: 24 months
Lattice presence	No The product is declared lattice-free
Storage temperature	Keep at room temperature away from light and heat sources
Biocompatibility	Yes
	The devices undergo and are subject to biocompatibility testing according to international standards: ISO 10993 - 1 Biological evaluation of medical devices. Part 1: assessment and testing
Phthalates	No

Code

Description

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

Actreen Hi-Lite Cath Tiemann Ch. 08 length 41 cm Actreen Hi-Lite Cath Tiemann Ch. 10 length 41 cm Actreen Hi-Lite Cath Tiemann Ch. 12 length 41 cm Actreen Hi-Lite Cath Tiemann Ch. 14 length 41 cm Actreen Hi-Lite Cath Tiemann Ch. 16 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 08 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 10 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 12 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 14 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 16 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 06 length 20 cm Actreen Hi-Lite Cath Nelaton Ch. 08 length 20 cm Actreen Hi-Lite Cath Nelaton Ch. 10 length 20 cm Actreen Hi-Lite Cath Nelaton Ch. 12 length 20 cm Actreen Hi-Lite Cath Nelaton Ch. 14 length 20 cm Actreen Hi-Lite Cath Nelaton Ch. 16 length 20 cm