Descrizione Clinica
Orthopedia Speedicath flex autolub ch12 n Coloplast
SpeediCath Flex
Disposable product.
It does not contain natural rubber latex, PVC and phthalates.
EC class (Directive 93/42/EEC): The sterile.
Standard
ISO 9001:2000, DS/EN ISO 9001:2000, ISO 13485:2003 and DS/EN ISO 13485:2003
Description
SpeediCath Flex is a vescic catheter with a flexible body for intermittent catheterism.
Like the other devices in the SpeediCath range, it is self-lubricating, sterile and disposable.
The catheter is already immersed in sterile physiological solution for the activation of the lubricating coating.
SpeediCath Flex is a flexible tip catheter that facilitates the passage in the sphincter and urethra.
The catheter is entirely covered by a protective guide, which provides protection from possible external contamination during insertion (e.g. by contact with the user's hands or other external bodies).
Within the primary packaging SpeediCath Flex is a closed system as the ends of the catheter are screwed together.
The lubricant liquid is inserted between the catheter and the protective guide and for this it is possible to manipulate the catheter without contacting the liquid.
The catheter has a universal connection to be connected to a urine collection bag.
The primary packaging is designed to ensure maximum discretion and locking is a sterile barrier for the device.
After use, the catheter can be reinserted inside.
Catetere
The body of the catheter has beveled holes and a flexible tip to guide the insertion into the urethra.
Grip and external connector
The external grip and connector are welded to the protective guide that covers the catheter.
When the catheter is closed the connector and the grip are screwed, ensuring that the lube does not escape.
During catheterism the user can grab the soft grip to slide the protective guide and insert the catheter.
Protective guide
The translucent protective guide is welded to the external connector and turquoise socket.
The user can touch and grasp the protective guide without contaminating the catheter below.
Dimensions
Below are the overall dimensions of the open product and body of the catheter when the protective guide is accumulated at the end.
Exclusive Features
The SpeediCath catheters line is characterized by internally lubricated and bevelled holes.
This detail makes the catheter delicate on the urethral mucosa.
Moreover SpeediCath is the only self-lubricating catheter on the market already immersed in physiological solution (European patent issued for Italy No.935478).
This system is aimed at making catheter preparation faster (normally other catheters require several seconds to activate the lubricant) and maintain the same lubrication for a long time.
Indications
SpeediCath Flex is a disposable sterile self-lubricating vescic catheterism cattheterism.
The use of this catheter is indicated in cases of urinary retention.
The catheter is ready for connection with bags for urine collection.
The catheter is particularly suitable for emptying the bladder in patients who are unable to urinate spontaneously.
The use of SpeediCath Flex is simple, fast and atraumatic, also indicated for those who have a permanent need to resort to this type of aid.
Contraindications and incompatibility
Not indicated in those patients with a medical evaluation not suitable for treatment.
Composition
The SpeediCath Flex catheter consists of PU (polyurethane) and has a PVP hydrophilic coating (polyvinylpyrrolidone).
The liquid in which the catheter is immersed is sterile physiological solution to 0.9%, with addition of PVP to 6%.
The primary package of the catheter consists of a multilayer of PETP, Aluminium and Polyethylene.
Sterilization
The catheter is sterilized by irradiation with electronic beam.
Validity
2 years from the date of production.
Packaging
Unit of use: 1 catheter enclosed in a sealed and sterile container.
Ordering units: 30 units of use in cardboard box containing instructions for use in italian.
Packaging: 3 order units in cardboard box.
Product preservation
SpeediCath Flex must be kept in a dry environment, at room temperature and sheltered from direct sunlight.
However, exposure to extreme temperatures for a maximum of 24 hours does not cause damage to the catheter.
Disposal
The product does not contain ecotoxic components therefore it does not need special disposal protocols. Do not disperse in the environment as it is not biodegradable.
It does not contain natural rubber latex, PVC and phthalates.
EC class (Directive 93/42/EEC): The sterile.
Standard
ISO 9001:2000, DS/EN ISO 9001:2000, ISO 13485:2003 and DS/EN ISO 13485:2003
Description
SpeediCath Flex is a vescic catheter with a flexible body for intermittent catheterism.
Like the other devices in the SpeediCath range, it is self-lubricating, sterile and disposable.
The catheter is already immersed in sterile physiological solution for the activation of the lubricating coating.
SpeediCath Flex is a flexible tip catheter that facilitates the passage in the sphincter and urethra.
The catheter is entirely covered by a protective guide, which provides protection from possible external contamination during insertion (e.g. by contact with the user's hands or other external bodies).
Within the primary packaging SpeediCath Flex is a closed system as the ends of the catheter are screwed together.
The lubricant liquid is inserted between the catheter and the protective guide and for this it is possible to manipulate the catheter without contacting the liquid.
The catheter has a universal connection to be connected to a urine collection bag.
The primary packaging is designed to ensure maximum discretion and locking is a sterile barrier for the device.
After use, the catheter can be reinserted inside.
Catetere
The body of the catheter has beveled holes and a flexible tip to guide the insertion into the urethra.
Grip and external connector
The external grip and connector are welded to the protective guide that covers the catheter.
When the catheter is closed the connector and the grip are screwed, ensuring that the lube does not escape.
During catheterism the user can grab the soft grip to slide the protective guide and insert the catheter.
Protective guide
The translucent protective guide is welded to the external connector and turquoise socket.
The user can touch and grasp the protective guide without contaminating the catheter below.
Dimensions
Below are the overall dimensions of the open product and body of the catheter when the protective guide is accumulated at the end.
Exclusive Features
The SpeediCath catheters line is characterized by internally lubricated and bevelled holes.
This detail makes the catheter delicate on the urethral mucosa.
Moreover SpeediCath is the only self-lubricating catheter on the market already immersed in physiological solution (European patent issued for Italy No.935478).
This system is aimed at making catheter preparation faster (normally other catheters require several seconds to activate the lubricant) and maintain the same lubrication for a long time.
Indications
SpeediCath Flex is a disposable sterile self-lubricating vescic catheterism cattheterism.
The use of this catheter is indicated in cases of urinary retention.
The catheter is ready for connection with bags for urine collection.
The catheter is particularly suitable for emptying the bladder in patients who are unable to urinate spontaneously.
The use of SpeediCath Flex is simple, fast and atraumatic, also indicated for those who have a permanent need to resort to this type of aid.
Contraindications and incompatibility
Not indicated in those patients with a medical evaluation not suitable for treatment.
Composition
The SpeediCath Flex catheter consists of PU (polyurethane) and has a PVP hydrophilic coating (polyvinylpyrrolidone).
The liquid in which the catheter is immersed is sterile physiological solution to 0.9%, with addition of PVP to 6%.
The primary package of the catheter consists of a multilayer of PETP, Aluminium and Polyethylene.
Sterilization
The catheter is sterilized by irradiation with electronic beam.
Validity
2 years from the date of production.
| Type | Code trade | Measures | Code CND | Code ISO | Code GMDN | Code PARAF |
| SpeediCath Flex SpeediCath Flex SpeediCath Flex SpeediCath Flex | 28920 28922 28924 28916 | CH 10 CH 12 CH 14 CH 16 | MANUFACTURE FROM MATERIALS OF ANY HEADING MANUFACTURE FROM MATERIALS OF ANY HEADING MANUFACTURE FROM MATERIALS OF ANY HEADING MANUFACTURE FROM MATERIALS OF ANY HEADING | 09.24.06.012 09.24.06.012 09.24.06.012 09.24.06.012 | 45603 45603 45603 45603 | 970928166 970928178 970928180 970928141 |
Packaging
Unit of use: 1 catheter enclosed in a sealed and sterile container.
Ordering units: 30 units of use in cardboard box containing instructions for use in italian.
Packaging: 3 order units in cardboard box.
Product preservation
SpeediCath Flex must be kept in a dry environment, at room temperature and sheltered from direct sunlight.
However, exposure to extreme temperatures for a maximum of 24 hours does not cause damage to the catheter.
Disposal
The product does not contain ecotoxic components therefore it does not need special disposal protocols. Do not disperse in the environment as it is not biodegradable.
