It is characterized by softness and poor abrasiveness. Latex and phthalates free.
MD Class I according to Regulation (EU) 2017/745 of the European Parliament and Council.
INSTRUCTION SHEET
The target audience of this device is health professionals or people with relevant knowledge in the area, so given the intended use of the device, it can be used safely with-out instructions, so instruction sheets are not available with the device.
INTENDED USE
Non-invasive device, as mechanical barrier, for compression or for absorption of exudates in daily curative procedures of chronic wounds, minor burns or other injuries with skin damage.
HOW TO USE
This dressing has several dimensions and different number of layers, to allow a better adaptation to the injured surface or to the surgical procedure.
For this reason it should always be used in its final fold, and should never be unfolded.
SINGLE USE DEVICE
This device is a single-use device and does not have reprocessing instructions. The risk associated to reprocessing of the product, is very high due the biological contamination of the patient, and to the impossibility of total elimination of biological material.
Using disposable items eliminates the risk of patient-to- -patient contamination because the item is discarded and not used anymore.
RISK ANALYSIS
Although the residual risks founded are so low that they are negligible, in the case of an invasive medical device, there is always the probability, even insignificant, of undesirable side effects like allergies. However, there is no history of side effects with this product