The main material of the sheet is made of two-layer material:
– top layer – non-woven polypropylene (absorbent layer);
– lower layer – polyethylene film (barrier layer);
The technical parameters of the base material (blue) comply with the highest requirements of GOST R EN 13795 for the critical area of surgical underwear:
1. The density of the base material is not less than 60 g/m².
2. Water resistance not less than 100cm H2O and more than 200cm H2O.
3. Wet tensile strength H in the longitudinal direction is not less than 20 and not more than 98, in the transverse direction is not less than 20 and not more than 74.
4. Minimal lint, moisture and micro-impermeable, abrasion resistant, latex free.
Kit composition:
Sheet for caesarean section 254x307cm±5cm – 1 pc. The sheet in the patient's abdomen has a pocket with an integrated cutable, highly stretchable, breathable film (the cutable film is located and covered with laminated paper with logos on top to protect the film before applying to the patient). In the upper and lower parts of the pocket there are holders for 4 tubes d up to 2.5 cm;
Sheet for tool table 200x150cm±5cm – 1 pc.
Hand towel - 4 pcs.
Mayo table bag 78x144cm±3cm – 1 pc.
Sheet 100x100cm±5cm – 1 pc.
Operating tape 10x55cm±0.5cm – 1 pc.
Adhesive layer - hypoallergenic polyacrylate adhesive, has good adhesion, it is possible to re-glue, covered with protective paper. When removing surgical linen, it does not leave marks on the patient's skin and operating room equipment.
3. Kits must be supplied sterile and protected by Level 2 protection.
Packaging I level of protection (outer): combined packaging (opaque side - Tyvek / special non-woven material or similar, size 32.5x51cm ± 1cm; transparent side - multilayer polymer film, which are connected by an industrial thermal seam, the width of the thermal seam is at least 1 cm). This package allows you to protect sterile surgical linen from accidental wetting, protects against the penetration of chemical reagents, and is resistant to mechanical stress: abrasion, tearing, punctures with piercing and cutting instruments. On the opaque side of the package, there are: the expiration date, the necessary information about the kit, as well as three barcodes: one on the package, two with an adhesive layer for transferring to medical records to ensure accounting. The packaging is easy to open, by the efforts of one person, without the use of scissors, there is no fluff when opening.
II level of protection (internal): the product is packed in crepe paper, on which the catalog number of the kit is applied.
4. General shelf life - 3 years, the expiration date is indicated on each package.
5. Desired sterilization method: ethylene oxide, as the most gentle sterilization method for this medical device.
6. Sheets are packed in 5 pieces. in a convenient dispenser cardboard for easy storage and 10 pcs in a factory carton for protection from environmental influences.
