Intended Use; Operating Environment; Operation Principle - Flaem Pro OxyLast Med Easy P0613EM User Instruction Manual

INTENDED USE:

Device for the treatment, with the combined effect of TPN and hyper-oxygenation, of wounds / injuries
and adjuvant to postoperative healing (see operating instructions).

OPERATING ENVIRONMENT:

The medical device must be used in healthcare facilities, such as hospital outpatient clinics, cosmetic
medicine centres, NOT at home. It can only be used by Medical personnel.
It must be used with certified cylinders or certified centralised systems which supply oxygen with fea-
tures indicated in the user manual of this medical device.

OPERATION PRINCIPLE:

The device has the purpose of simulating a miniature hyperbaric chamber which may be positioned on
a limited skin surface (buttocks, abdomen, thighs, etc.). It acts via a cap placed on the injured part to be
treated, on which a given vacuum time is generated and immediately afterwards oxygen is injected, via
the same tubes.
OxyLast® Med Easy amplifies the benefits of oxygen therapy combined with negative pressure therapy.
OxyLast® Med Easy acts on the area to be treated in two STAGES as shown below:
STEP 1
OxyLast® Med Easy
creates a negative pressure zone
in the area to be treated, as well as acting as negative
pressure therapy, promoting optimal oxygen absorp-
tion.
In the presence of an abundant exudate, it is therefore necessary to have a gauze, which should not protrude from
the edges of the cap.
STEP 2
OxyLast® Med Easy
of the cap with oxygen.
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enriches the internal atmosphere