Descrizione Clinica
Act
Hi-Lite
Description
Sterile hydrophilic self-lubricating catheterism ready for use; equipped with No-Touch sheath.
Due to its structural and packaging characteristics, the product is simple to use.
It is lightweight, compact and makes the bladder emptying easy, fast and safe anywhere.
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 easily, quickly and safely carry out the intermittent catheterism manoeuvre.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath, allowing you to make a truly safe catheterism, even in situations where there is no possibility of taking advantage of a proper hygienic standard.
The catheter is of simple preparation as it is sufficient to remove the sheath at the base of the connector and that at its end.
After this operation, the catheter is ready for use.
In the case of the fold of the sheath is uncomfortable for users with reduced dexterity, part of the sheath can be removed in order to maintain a reduced trait but able to avoid touching with the fingers the catheter during the maneuver of self-cateterism.
Technical information
The product consists of a thermoplastic polyolefin called TPO that belongs to the family of Thermoplastic Elatometers (TPF).
TPO is a family of polyolefins and elastometric polymers that gives properties similar to PVC: softness, good flexibility, without the use of plasticizing additives (ftalates), good transparency and resistance to inembossing.
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 have cytotoxic activity and do not induce skin irritation.
They also do not cause skin sensitization.
The product is equipped with a hydrophilic coating consisting of glycerin and water, already ready to use.
The hydrophilic coating allows to eliminate activation times and guarantees a reduced friction coefficient, for the duration of catheterism, allowing easy and safe insertion and an atraumatic extraction.
The high hydration of the coating avoids any risk of catetere adhesion to the urethral wall: this is particularly beneficial during the extraction maneuver in subjects that, for particular functional limitations, need long times to carry out self-cateterism.
The catheter appears completely and uniformly lubricated, already ready for use and without the need for other additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It has atraumatic holes with beveled and smooth corners to allow quick release of urine.
The thermoheated polyethylene sheath allows you to manage the catheter without touching it with your hands (No-Touch technology).
This sheath allows a better grip of the catheter by all users, even those with poor dexterity and favors a reduction of possible bacterial contamination during catheterism.
The end of the catheter has a fitting cone 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 completely protected during catheterism (the gradual folding of the sheath frees the catheter), or you can remove a part of the sheath, so as to preserve a mobile portion on the catheter that allows in any case to avoid contact with the surface of the catheter during the manoeuvre, thus preventing possible contaminations.
The sheath has an eyelet close to the distal end (version of 41 cm) which allows to keep the catheter folded so as to reduce its footprint.
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 catheter
Technical characteristics of packaging
The No-Touch sheath also represents the casing with catheter packaging.
Sterile hydrophilic self-lubricating catheterism ready for use; equipped with No-Touch sheath.
Due to its structural and packaging characteristics, the product is simple to use.
It is lightweight, compact and makes the bladder emptying easy, fast and safe anywhere.
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 easily, quickly and safely carry out the intermittent catheterism manoeuvre.
The catheter packaging sheath can be used after opening as a "No-Touch" sheath, allowing you to make a truly safe catheterism, even in situations where there is no possibility of taking advantage of a proper hygienic standard.
The catheter is of simple preparation as it is sufficient to remove the sheath at the base of the connector and that at its end.
After this operation, the catheter is ready for use.
In the case of the fold of the sheath is uncomfortable for users with reduced dexterity, part of the sheath can be removed in order to maintain a reduced trait but able to avoid touching with the fingers the catheter during the maneuver of self-cateterism.
Technical information
The product consists of a thermoplastic polyolefin called TPO that belongs to the family of Thermoplastic Elatometers (TPF).
TPO is a family of polyolefins and elastometric polymers that gives properties similar to PVC: softness, good flexibility, without the use of plasticizing additives (ftalates), good transparency and resistance to inembossing.
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 have cytotoxic activity and do not induce skin irritation.
They also do not cause skin sensitization.
The product is equipped with a hydrophilic coating consisting of glycerin and water, already ready to use.
The hydrophilic coating allows to eliminate activation times and guarantees a reduced friction coefficient, for the duration of catheterism, allowing easy and safe insertion and an atraumatic extraction.
The high hydration of the coating avoids any risk of catetere adhesion to the urethral wall: this is particularly beneficial during the extraction maneuver in subjects that, for particular functional limitations, need long times to carry out self-cateterism.
The catheter appears completely and uniformly lubricated, already ready for use and without the need for other additional maneuvers to induce lubrication (activation of the hydrophilic substrate).
It has atraumatic holes with beveled and smooth corners to allow quick release of urine.
The thermoheated polyethylene sheath allows you to manage the catheter without touching it with your hands (No-Touch technology).
This sheath allows a better grip of the catheter by all users, even those with poor dexterity and favors a reduction of possible bacterial contamination during catheterism.
The end of the catheter has a fitting cone 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 completely protected during catheterism (the gradual folding of the sheath frees the catheter), or you can remove a part of the sheath, so as to preserve a mobile portion on the catheter that allows in any case to avoid contact with the surface of the catheter during the manoeuvre, thus preventing possible contaminations.
The sheath has an eyelet close to the distal end (version of 41 cm) which allows to keep the catheter folded so as to reduce its footprint.
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 catheter
| Material | TPO - Thermoplastic polyolefins |
| Coating | Fle 12 - Glicerol and water (specific formulation that allows a high level of hydration) |
| Coating Sheath (No-Touch) | Low density polyethylene (60 micron thick) |
| Conical connection | Polymer of ethylene and Vinegar (EVA) |
Technical characteristics of packaging
The No-Touch sheath also represents the casing with catheter packaging.
| Disposable | Yes |
| Sterile for sale | Sterile |
| Sterilization Method | Beta-ray sterilization in accordance with current regulations |
| Validity | Integro and in correct state of conservation: 24 months |
| Latex presence | No It is stated that the product is latex free |
| Storage temperature | Store at room temperature away from light and heat sources |
| Biocompatibility | Yes |
| Devices are subject to biocompatibility tests according to international standards: ISO 10993 - 1 Biological assessments of medical devices. Part 1: Evaluation and Test | |
| Yarn | No |
| Code | Description |
| 238108F 238110 238112 238114F 238116F 238208F 238210 238212 238214F 238216F 238306 238308F 238310 238312 238314F 238316 | Actreen Hi-Lite Cath Tiemann Ch. 08 lungh. 41 cm Actreen Hi-Lite Cath Tiemann Ch. 10 lungh. 41 cm Actreen Hi-Lite Cath Tiemann Ch. 12 lungh. 41 cm Actreen Hi-Lite Cath Tiemann Ch. 14 lungh. 41 cm Actreen Hi-Lite Cath Tiemann Ch. 16 lungh. 41 cm Actreen Hi-Lite Cath Nelaton Ch. 08 lungh. 41 cm Actreen Hi-Lite Cath Nelaton Ch. 10 lungh. 41 cm Actreen Hi-Lite Cath Nelaton Ch. 12 length. 41 cm Actreen Hi-Lite Cath Nelaton Ch. 14 lungh. 41 cm Actreen Hi-Lite Cath Nelaton Ch. 16 length 41 cm Actreen Hi-Lite Cath Nelaton Ch. 06 lungh. 20 cm Actreen Hi-Lite Cath Nelaton Ch. 08 lungh. 20 cm Actreen Hi-Lite Cath Nelaton Ch. 10 lungh. 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 lungh. 20 cm |
