1. Product characteristics
2. Sterilisation
3. Technical parameters
4. Chemical parameters
5. Packaging
- Product characteristics
The Dallop® NM urological tape is knitted of transparent monofilament polypropylene yarn. On both endings, the tape has blue loop handles which enable its safe fixing on an appropriate applicator. The handles are also made of monofilament polypropylene yarn. Each handle has additional protection against pulling the tape out when applying force necessary to put it through anatomical structures.
Dallop® NM urological tape characterises with:
- low linear mass,
- safe and atraumatic edges,
- biostability, thanks to which it does not lose physical properties while long-term contact with tissues and systemic fluids,
- monofilament structure which minimises the risk of bacterial infection,
- optimally elaborated spatial structure, where the size of pores makes it possible for quick overgrowth with connecting tissue,
- lack of irritating and allergic influence,
- lack of cytotoxicity and genotoxicity,
- lack of systemic toxicity,
- minimum reaction to foreign body confirmed in long-term in vivo tests.
The Dallop® NM urological tape does not contain substances of allogenic or animal origin.
- Sterilisation
The tapes are sterilised with ethylene oxide (EO). According to EN ISO 10993-7 a patient’s average daily dose of EO must not exceed 0.1 mg per day or 4 mg in the first 24 hours. The EO residue for the tapes introduced to the market is less than 0.004 mg/device. This type of sterilisation is typical for medical devices made of polypropylene.
- Technical parameters
- linear density and mass per unit area
The low mass value ensures patient comfort. Design trends for innovative medical implants tend to use as little amount of foreign material as possible.
- the choice of two sizes (lengths) of the tape: 60 cm and 45 cm
- optimal width
Due to an appropriately chosen width low linear density can be obtained, which prevents the erosion of the urethra.
- high porosity and varied pore size
The porosity of the tape and varied pore size (alternately large and small pores) with an averaged dimension enables appropriate healing-in while improving the functioning of the urethra. This parameter is related to the linear density and mass per unit area. The varied pore size provides small flexibility, and therefore better adjustment of the tape. Such a weave enables to reduce a standard few per cent shrinkage of polypropylene in a remote period.
- thickness of the thread
The tape is made of polypropylene monofilament yarn. The thickness of the yarn suitable for large-pore structure, providing high durability. This parameter provides relatively large contact surface with soft tissue, thus preventing the ingrowth of the tape, its cutting, as well as erosion of the urethra and the bladder.
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Chemical parameters
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permanganate oxidability – important parameter of chemical purity. This parameter shows the lack (or very low content) mainly of organic pollutants, but also some inorganic ones such as iron salts (II), sulphides, nitrates (III).
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UV absorbance at a particular wavelength – this parameter indicates the absence (or very low content) mainly of organic pollutants.
- Packaging
The tape is packed in double medical gusseted packaging for sterilisation with a TAG label (with removable stickers identifying the device). The sterile product is packed into a cardboard box.
