1. General description of the product
2. Intended use
3. Technical parameters
4. Expiry date
5. Storage and transport conditions
6. Sterility status
7. Use status
8. Packaging
- General description of the product
Optomesh® ULTRALIGHT is a non-resorbable, ultralight surgical mesh. They are produced from high-quality monofilament polypropylene yarn in transparent and blue colour.
Optomesh® ULTRALIGHT is the state-of-the-art implant used in the surgical abdominal hernia repair. Its weave is characterised by big pores and very low weight thanks to which the mesh is exceptionally delicate, elastic and easy to handle during operation.
Large pores allow for proper overgrowth of the scar tissue without the ‘bridging’ effect, which is total overgrowth of tissue. Meshes are characterised by high mechanical properties both in the longitudinal and lateral directions, so they can be safely used for the supply of different kinds of hernia. The implant has atraumatic edges due to the use of thin yarn and special weave which results in no shredding or crumbing while cutting. All the implants may be adjusted during operation and there is no need for the use of special tools.
Security and effectiveness of Optomesh® is confirmed. The research was conducted in compliance with the PN-EN ISO 10993 norm in terms of: cytotoxicity, irritation and sensitisation,
Genotoxicity and sub-chronic and general toxicity, as well as the local post-implantation effect.
Optomesh® ULTRALIGHT device meets the biological safety requirements.
There are three Optomesh® ULTRALIGHT meshes available: L-Pore, M-Pore and S-Pore.
L-Pore is the device with very large pores (surface approx. ) with blue orienting lines
M-Pore is the device with large pores (surface)
S-Pore is the device with small pores (surface) with blue orienting lines
S-Pore |
M-Pore |
L-Pore |
In L-Pore and S-Pore the blue orienting lines were added so that the implant would be more visible and handy to implement during the procedure.
- Intended Use
Optomesh® ULTRALIGHT surgical meshes are recommended for reconstruction procedures in order to supplement/reinforce soft tissue defects. They are intended for primary and recurrent hernias, post-operational hernias, inguinal, umbilical hernias.
L-Pore is recommended for hernias with small connective tissue loss (hernia ring diameter up to 5cm)
M-Pore is recommended for hernias with small and medium connective tissue loss (hernia ring diameter up to 10 cm) and as well as in large hernias (hernia ring diameter above 10 cm)
S-Pore is recommended for small and medium hernias (hernia ring diameter up to 10 cm)
- Technical parameters
No. | Parameter | unit | Requirements | ||
L-Pore | M-Pore | S-Pore | |||
1. | Average surface weight | g/m2 | Approx. 24 | Approx. 35 | Approx. 34 |
2. | Average mesh thickness | mm |
Approx. 0,36 |
Approx. 0,42 |
Approx. 0,35 |
3. | Pore surface | mm2 | Min. 6 | Min. 4 | Min.1,3 |
4. | Average breaking force | N | Approx. 80 | Approx. 180 | Approx. 160 |
Sizes [mm] | ||
The most popular- 3 items in the packaging | Rare- 1 item in the packaging | |
50×60 | 20×100 | 150×300 |
60×110 | 20×80 | 250×250 |
75×150 | 50×120 | 300×450 |
80×130 | 50×300 | 350×300 |
100×150 | 60×90 | 200×150 |
125×200 | 60×300 | 200×250 |
150×150 | 80×150 | |
200×300 | 90×130 | |
300×300 | 150×250 |
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- Expiry date
Expiry date- 5 years since the production date
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- Storage and transport conditions
Optomesh® ULTRALIGHT surgical meshes should be stored and transported in conditions which prevent them from sun exposition, mechanical damage, soaking or biological contamination. Temperature conditions for storage are 15-35̊ C degree and humidity level within 25-65%.
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- Sterility status
Optomesh® ULTRALIGHT meshes are sterile devices- they were sterilised in the process of ethylene oxide (EO) sterilisation. It cannot be re-sterilised.
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- Use status
Optomesh® ULTRALIGHT meshes are single-use products.
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- Packaging
Two packaging options are available dependant on the size of the mesh:
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Carton envelope which contains one piece of device, packed in the bag (paper-foil) with the tag and the instruction of use
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Carton box, in which there are 3 pieces of device, each packed in double bag (paper-foil) with a tag and instruction of use