Technical Specifications:
The Venolymphatic Drainage System is classified as a Medical Device class IIA under Annex IX rule 9 93/42 EEC, class II under Annex I rule 9(1) SOR/98-282, and class II under 21 CFR part 870 § 870.5800. The device weighs 21.5 kg (47.40 lbs) or 6.15 kg (13.56 lbs) for the appliance only, with a power consumption of 30 W. Its dimensions are 38x42x160 cm (15’’x16 1/2"x 63’’) and 38x43x17 cm (15’’x16 7/8"x 6 3/4’’) for the appliance only. It operates at 230 V / 50 Hz.

The pressure range is adjustable from 20 to 200 mB (15-150 mmHg), with a sound level between 50 dB and 54 dB. The device operates under atmospheric pressure of 70kPa to 106kPa, at temperatures from 0°C to 40°C, and relative humidity from 30% to 80%. Storage conditions are -5°C to 45°C, with the same atmospheric pressure and humidity range. It complies with IEC 60601-1 standards, classified as Device class I Type B, IP20.

Features:
The device includes an Automated Double Gradient of Pressure (A.D.G.P.) with 37 preset programs and 10 customizable programs. It can inflate two accessories simultaneously using two 7-connection levels.

Materials and Construction:
The outer fabric is Nylon, and the inner fabric is Polyurethane, with welded parts for fastening. Accessories include 7-chamber sleeves, boots, and waist boots.

Main Indications:
The device is indicated for limb edemas, lymphedema, phlebedema, thrombosis prevention, phlebitis after-effects, circulatory problems, heavy legs, post-operative recovery, and body profiling.

Main Contraindications:
It is contraindicated in cases of acute venous thrombosis, inflammatory or infectious states, and cardiac insufficiency.

Accessories:
Various accessories are available, including sleeves, boots, waist boots, abdominal straps, hygiene sheaths, and trolleys, with some available in customizable sizes.

Programs and Options:
The device offers therapeutic and health and beauty programs for lower limbs, upper limbs, and abdominals. Options include language settings (French, English, Spanish), sound settings, and clock functions.

Contact Information:
Eureduc, 19 rue de Clairefontaine, 78120 Rambouillet, France. Tel: +33 (0)1 34 61 01 61, Fax: +33 (0)1 34 61 40 61, Email: [email protected], Website: www.eureduc.eu.