CER FISS TNT ESTENS CM10X10M

FOR THE PURPOSES OF THIS REGULATION, THE FOLLOWING DEFINITIONS SHALL APPLY:
ESTENSIBLE NOT EXTERNAL

Disposable Medical Device

Class of membership: legislative Decree 46/97 on Medical Devices classifies this product in class I for the purposes of CE marking.

Destination: non-invasive type device, to be used for fixing medications, bandages, catheters, drainage tubes, probes, gauze with vaseline, cotton gauze on sensitive skin.

Features: retinate tnt patch roller is made with the use of aerated medical grade nonwoven fabric, light and thin, extendable. Permeable to air and water vapor, radiant, sterilisable and latex free. Covered with polyacrylate and hypoallergenic adhesive. Equipped with pre-cut silicone protective paper in a longitudinal sense, easily removable keeping the dressing integrated. Removable atraumatically without release of residues.

FEATURES AND PROPERTY
Composition	Medical nonwoven fabric: 70% viscose + 30% polyester
Colour	natural white
Weight [g/m2]	75
Wall decal
Composition	acrylic and hypoallergenic adhesive
Weight [g/m2]	25 ±
Wall decal on steel for peeling [N/cm]	≥ 1
Longitudinal stretchability [%]	880 ±100
Water vapour permeability [g/m2/24 h	3700 ±500
Air permeability [g/m2/24 h	1250 ±100
Protective paper
Composition	silicone paper
Colour	white background, grid centimetre in blue

Reference Standard:
- complies with the standards of the Official Pharmacopoeia Vigente;
- compliant with EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes;
- compliant with ISO 9001:2008 standards Quality management systems-Requirements;
- in accordance with Directive 93/42/EEC on Medical Devices as amended by 2007/47/EEC, implemented with D.Lgs. 24 february 1997 s.m.i.

Packaging: single in cardboard boxes that allow to preserve the content from any pollutants and to optimally store the devices within the departments. The characteristics and performance are not altered during the conservation and transport phases, thanks to the packaging that allows storage. The rigid cardboard packaging are shock resistant, closed with adhesive tape, dust seal and suitable for overlay storage.

Labeling in Italian: labelling in accordance with Directive 93/42/EEC on “Medicial Devices”, implemented with Legislative Decree no. 24 February 1997 46 and subsequent amendments and additions. Labeling is placed on the box and cardboard.

Box - primary packaging
- Product description
- Product code
- Number of pieces
- Destination to use
- Disposable (symbol)
- Measures, dimensions, length
- CE marking
- Name and address of the manufacturer
- Lotto, date of production and expiry
- Specific instructions for use
- EAN 13 barcode
- Storage

Carton
- Product description
- Number of pieces
- Product code
- Disposable (symbol)
- Measures, dimensions, length
- CE marking
- Name and address of the manufacturer
- Lotto, date of production and expiry
- EAN 128 barcode
- Storage

Methods of use: disposable medical device. In case of reuse, infections can be found: consult a doctor. Before use check the expiration date and the integrity of the packaging. Do not use if the packaging is damaged.
The patch can be fixed on the skin of any part of the body with slight pressure and can be left for long periods without causing mechanical irritation or allergies, ensuring total freedom in movements. To ensure better fixing, it is recommended to clean and dry the skin well. Cut the plaster in the desired size for the required use. Do not apply directly to the skin.

Product stability and storage mode: store in dry place sheltered from light and heat at temperature
Description and Measurements:

CODE RAYS	MISURA	RM	QUESTIONS	CARTONE DIMENSIONS
FIX25NB	2,5x10000 cm	735428	100	44,5x53x20
FIX07NB	5x10000 cm	773509	100	42x32x42
FIX08NB	10x10000 cm	773511	50	44,5x53x20
FIX09NBSP	15x10000 cm	773513	50	42x32x42
FIX10NB	20x10000	773527	25	42x24x42,5

Commercial name: Bio Fix

Brand: RAYS

Duration: 5 years from the date of manufacture.
Disposal: to be carried out in compliance with the national rules in force. Incineration or disposal in landfill must be carried out under controlled conditions. The product that has not come into contact with infectious agents or other risky materials does not produce toxic residue.

It is stated that the medical device does not contain latex (latex free).

Manufacturer: RAYS SPA - Via Francesco Crispi 26 - 60027 OSIMO (AN) - ITALY