Description
Actreen
Hi-Lite
Description
Sterile, ready-to-use, hydrophilic, self-lubricating catheter for intermittent catheterization; equipped with a No-Touch sheath.
Due to its structural and packaging characteristics, the product is easy to use.
It is light, compact and makes emptying the bladder simple, fast and safe anywhere.
The packaging, in a single wrapper, makes it extremely practical and easy to handle and ready to use.
Risk class
Class I sterile.
Indications, contraindications and warnings
The product allows for the simple, rapid and safe performance of intermittent catheterization.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath, allowing for truly safe catheterization, even in situations where there is no possibility of enjoying adequate hygiene standards.
The catheter is simple to prepare as it is sufficient to remove the sheath at the base of the connector and the one at its end.
Once this operation is completed, the catheter is ready for use.
If folding the sheath is uncomfortable for users with limited manual dexterity, part of the sheath can be removed to maintain a short section that avoids touching the catheter with the fingers during self-catheterization.
Technical information
The product is made of a Thermoplastic Polyolefin called TPO which belongs to the Thermoplastic Elastomers (TPF) family.
TPO is a family of polyolefins and elastometric polymers that give properties similar to PVC: softness, good flexibility, without the use of plasticizing additives (phthalates), good transparency and resistance to kinking.
They have a high level of biocompatibility as they meet the 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 made of glycerin and water, ready for use.
The hydrophilic coating eliminates activation times and guarantees a reduced friction coefficient for the entire duration of the catheterization, allowing for 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 procedure in subjects who, due to particular functional limitations, require a long time to perform the self-catheterization procedure.
The catheter appears completely and uniformly lubricated, ready for use and without the need for any additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It features atraumatic holes with smooth, rounded corners to allow urine to drain quickly.
The heat-heated polyethylene sheath allows you to manage the catheter without touching it with your hands (No-Touch technique).
This sheath allows for a better grip of the catheter by all users, even those with poor manual skills, and promotes a reduction in possible bacterial contamination during the catheterization procedure.
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 can be adjusted according to the needs of the users.
The distal end can be removed to keep the catheter completely protected during the catheterization procedure (the gradual folding of the sheath frees the catheter), or part of the sheath can be removed to keep a mobile portion on the catheter which in any case allows contact with the surface of the catheter to be avoided during the procedure, thus preventing possible contamination.
The sheath features an eyelet near the distal end (41 cm version) that allows the catheter to be kept folded to reduce its bulk.
Male catheter length: 41 cm, usable length (without connector) 37 cm
Female catheter length: 20 cm, usable length (without connector) 16 cm
Technical characteristics of the catheter
Technical characteristics of the packaging
The No-Touch sheath also represents the catheter packaging envelope.
Sterile, ready-to-use, hydrophilic, self-lubricating catheter for intermittent catheterization; equipped with a No-Touch sheath.
Due to its structural and packaging characteristics, the product is easy to use.
It is light, compact and makes emptying the bladder simple, fast and safe anywhere.
The packaging, in a single wrapper, makes it extremely practical and easy to handle and ready to use.
Risk class
Class I sterile.
Indications, contraindications and warnings
The product allows for the simple, rapid and safe performance of intermittent catheterization.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath, allowing for truly safe catheterization, even in situations where there is no possibility of enjoying adequate hygiene standards.
The catheter is simple to prepare as it is sufficient to remove the sheath at the base of the connector and the one at its end.
Once this operation is completed, the catheter is ready for use.
If folding the sheath is uncomfortable for users with limited manual dexterity, part of the sheath can be removed to maintain a short section that avoids touching the catheter with the fingers during self-catheterization.
Technical information
The product is made of a Thermoplastic Polyolefin called TPO which belongs to the Thermoplastic Elastomers (TPF) family.
TPO is a family of polyolefins and elastometric polymers that give properties similar to PVC: softness, good flexibility, without the use of plasticizing additives (phthalates), good transparency and resistance to kinking.
They have a high level of biocompatibility as they meet the 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 made of glycerin and water, ready for use.
The hydrophilic coating eliminates activation times and guarantees a reduced friction coefficient for the entire duration of the catheterization, allowing for 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 procedure in subjects who, due to particular functional limitations, require a long time to perform the self-catheterization procedure.
The catheter appears completely and uniformly lubricated, ready for use and without the need for any additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It features atraumatic holes with smooth, rounded corners to allow urine to drain quickly.
The heat-heated polyethylene sheath allows you to manage the catheter without touching it with your hands (No-Touch technique).
This sheath allows for a better grip of the catheter by all users, even those with poor manual skills, and promotes a reduction in possible bacterial contamination during the catheterization procedure.
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 can be adjusted according to the needs of the users.
The distal end can be removed to keep the catheter completely protected during the catheterization procedure (the gradual folding of the sheath frees the catheter), or part of the sheath can be removed to keep a mobile portion on the catheter which in any case allows contact with the surface of the catheter to be avoided during the procedure, thus preventing possible contamination.
The sheath features an eyelet near the distal end (41 cm version) that allows the catheter to be kept folded to reduce its bulk.
Male catheter length: 41 cm, usable length (without connector) 37 cm
Female catheter length: 20 cm, usable 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 connection | Ethylene Vinyl Acetate Copolymer (EVA) |
Technical characteristics of the packaging
The No-Touch sheath also represents the catheter packaging envelope.
| Disposable | Yes |
| Sterile for sale | Sterile |
| Sterilization method | Beta ray sterilization in compliance with current regulations |
| Months of validity | If packaged intact 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 sources of light and heat |
| Biocompatibility | Yes |
| The devices are subjected to and undergo biocompatibility tests according to international standards: ISO 10993 - 1 Biological Evaluations 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 |
Actreen Hi-Lite Cath Tiemann Ch. 08 length 41cm Actreen Hi-Lite Cath Tiemann Ch. 10 length. 41cm Actreen Hi-Lite Cath Tiemann Ch. 12 length. 41cm Actreen Hi-Lite Cath Tiemann Ch. 14 length. 41cm Actreen Hi-Lite Cath Tiemann Ch. 16 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 08 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 10 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 12 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 14 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 16 length. 41cm Actreen Hi-Lite Cath Nelaton Ch. 06 length 20cm Actreen Hi-Lite Cath Nelaton Ch. 08 length. 20cm Actreen Hi-Lite Cath Nelaton Ch. 10 length. 20cm Actreen Hi-Lite Cath Nelaton Ch. 12 length. 20cm Actreen Hi-Lite Cath Nelaton Ch. 14 length. 20cm Actreen Hi-Lite Cath Nelaton Ch. 16 length. 20cm |
