Description
SpeediCath Flex
Disposable product.
Contains no natural rubber latex, PVC or phthalates.
CE Class (Directive 93/42/EEC): I sterile.
Standard
ISO 9001:2000, DS/EN ISO 9001:2000, ISO 13485:2003 and DS/EN ISO 13485:2003
Description
SpeediCath Flex is a flexible-bodied bladder catheter for intermittent catheterization.
Like the other devices in the SpeediCath range, it is self-lubricating, sterile and single-use.
The catheter is already immersed in sterile saline solution to activate the lubricating coating.
SpeediCath Flex is a catheter with a flexible tip that facilitates passage through the sphincter and urethra.
The catheter is entirely covered by a protective guide, which provides protection from possible external contamination during insertion (caused for example by contact with the user's hands or other external bodies).
Inside the primary packaging, SpeediCath Flex is a closed system as the ends of the catheter are screwed together.
The lubricating liquid is inserted between the catheter and the protective guide and therefore it is possible to manipulate the catheter without coming into contact with the liquid.
The catheter is equipped with a universal connector so that it can be connected to a urine collection bag.
The primary packaging is designed to ensure maximum discretion and when closed constitutes a sterile barrier for the device.
After use, the catheter can be reinserted inside.
Catheter
The catheter body has beveled holes and a flexible tip to guide insertion into the urethra.
External grip and connector
The external grip and connector are welded to the protective guide that lines the catheter.
When the catheter is closed the connector and grip are screwed on, ensuring that the lubricating fluid does not leak out.
During catheterization the user can grasp the soft grip to slide the protective guide and insert the catheter.
Protective guide
The translucent protective guide is soldered to the external connector and the turquoise socket.
The user can touch and grasp the protective guide without contaminating the catheter underneath.
Dimensions
Below are the overall dimensions of the opened product and catheter body when the protective guide is stacked at the end.
Exclusive Features
The SpeediCath line of catheters features internally lubricated and beveled holes.
This feature makes the catheter gentle on the urethral mucosa.
Furthermore, 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 designed to speed up the preparation of the catheter (other catheters normally require several seconds to activate the lubricant) and to keep it lubricated for a long time.
Directions
SpeediCath Flex is a sterile, disposable, self-lubricating bladder catheter for intermittent catheterization.
The use of this catheter is indicated in cases of urinary retention.
The catheter is designed for connection to urine collection bags.
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 suitable for those who have a permanent need to use this type of aid.
Contraindications and incompatibilities
Not indicated in those patients with a medical evaluation unsuitable for treatment.
Composition
The SpeediCath Flex catheter is made of PU (polyurethane) and has a hydrophilic PVP (polyvinylpyrrolidone) coating.
The liquid in which the catheter is immersed is 0.9% sterile saline solution, with the addition of 6% PVP.
The primary packaging of the catheter is composed of a multilayer of PETP, Aluminum and Polyethylene.
Sterilization
The catheter is sterilized by electron beam irradiation.
Validity
2 years from date of manufacture.
Packaging
Unit of use: 1 catheter enclosed in a sealed, sterile container.
Order unit: 30 units of use in a cardboard box containing instructions for use in Italian.
Packaging: 3 order units in cardboard box.
Product storage
SpeediCath Flex should be stored in a dry environment, at room temperature and away from direct sunlight.
However, exposure to extreme temperatures for up to 24 hours will not cause damage to the catheter.
Disposal
The product does not contain ecotoxic components and therefore does not require special disposal protocols. Do not dispose of in the environment as it is not biodegradable.
Contains no natural rubber latex, PVC or phthalates.
CE Class (Directive 93/42/EEC): I sterile.
Standard
ISO 9001:2000, DS/EN ISO 9001:2000, ISO 13485:2003 and DS/EN ISO 13485:2003
Description
SpeediCath Flex is a flexible-bodied bladder catheter for intermittent catheterization.
Like the other devices in the SpeediCath range, it is self-lubricating, sterile and single-use.
The catheter is already immersed in sterile saline solution to activate the lubricating coating.
SpeediCath Flex is a catheter with a flexible tip that facilitates passage through the sphincter and urethra.
The catheter is entirely covered by a protective guide, which provides protection from possible external contamination during insertion (caused for example by contact with the user's hands or other external bodies).
Inside the primary packaging, SpeediCath Flex is a closed system as the ends of the catheter are screwed together.
The lubricating liquid is inserted between the catheter and the protective guide and therefore it is possible to manipulate the catheter without coming into contact with the liquid.
The catheter is equipped with a universal connector so that it can be connected to a urine collection bag.
The primary packaging is designed to ensure maximum discretion and when closed constitutes a sterile barrier for the device.
After use, the catheter can be reinserted inside.
Catheter
The catheter body has beveled holes and a flexible tip to guide insertion into the urethra.
External grip and connector
The external grip and connector are welded to the protective guide that lines the catheter.
When the catheter is closed the connector and grip are screwed on, ensuring that the lubricating fluid does not leak out.
During catheterization the user can grasp the soft grip to slide the protective guide and insert the catheter.
Protective guide
The translucent protective guide is soldered to the external connector and the turquoise socket.
The user can touch and grasp the protective guide without contaminating the catheter underneath.
Dimensions
Below are the overall dimensions of the opened product and catheter body when the protective guide is stacked at the end.
Exclusive Features
The SpeediCath line of catheters features internally lubricated and beveled holes.
This feature makes the catheter gentle on the urethral mucosa.
Furthermore, 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 designed to speed up the preparation of the catheter (other catheters normally require several seconds to activate the lubricant) and to keep it lubricated for a long time.
Directions
SpeediCath Flex is a sterile, disposable, self-lubricating bladder catheter for intermittent catheterization.
The use of this catheter is indicated in cases of urinary retention.
The catheter is designed for connection to urine collection bags.
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 suitable for those who have a permanent need to use this type of aid.
Contraindications and incompatibilities
Not indicated in those patients with a medical evaluation unsuitable for treatment.
Composition
The SpeediCath Flex catheter is made of PU (polyurethane) and has a hydrophilic PVP (polyvinylpyrrolidone) coating.
The liquid in which the catheter is immersed is 0.9% sterile saline solution, with the addition of 6% PVP.
The primary packaging of the catheter is composed of a multilayer of PETP, Aluminum and Polyethylene.
Sterilization
The catheter is sterilized by electron beam irradiation.
Validity
2 years from date of manufacture.
| Type | Code commercial |
Measure | CND Code | Code ISO |
Code GMD |
Code PARAF |
| SpeediCath Flex SpeediCath Flex SpeediCath Flex SpeediCath Flex |
28920 28922 28924 28916 |
CH 10 CH 12 CH 14 CH 16 |
U01010501 U01010501 U01010501 U01010501 |
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, sterile container.
Order unit: 30 units of use in a cardboard box containing instructions for use in Italian.
Packaging: 3 order units in cardboard box.
Product storage
SpeediCath Flex should be stored in a dry environment, at room temperature and away from direct sunlight.
However, exposure to extreme temperatures for up to 24 hours will not cause damage to the catheter.
Disposal
The product does not contain ecotoxic components and therefore does not require special disposal protocols. Do not dispose of in the environment as it is not biodegradable.
