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

 

1. 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
Class IIB

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.

 

2.  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)

 

3. 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

 

1. 4. Expiry date

Expiry date- 5 years since the production date

1. 5. 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%.

 

1. 6. Sterility status

Optomesh^®  ULTRALIGHT meshes are sterile devices- they were sterilised in the process of ethylene oxide (EO) sterilisation. It cannot be re-sterilised.

 

1. 7. Use status

Optomesh^®  ULTRALIGHT meshes are single-use products.

 

1. 8. Packaging

Two packaging options are available dependant on the size of the mesh:

• Carton envelope which contains one piece of device, packed in the bag (paper-foil) with the tag and the instruction of use

• Carton box, in which there are 3 pieces of device, each packed in double bag (paper-foil) with a tag and instruction of use