Technical Specifications:
The document outlines the specifications for a pneumatic compression device, classified as a Medical Device Class IIA and II, compliant with ISO 13485 and other international standards such as Annex IX rules 9 93/42 CEE and 21 CFR part 870 § 870.5800. The device is designed for pressotherapy with a weight of 9 kg and dimensions of 37 x 33 x 18 cm. It operates at a power of 40 W and a voltage/frequency range of 100 to 240 V / 47-63 Hz. The sound level is between 49 dB and 52 dB, with a pressure range of 20 to 150 mBar (15-112 mmHg).

Operating Conditions:
The device functions optimally at temperatures between 0°C to 40°C, with relative humidity from 30% to 80%, and atmospheric pressure from 70kPa to 106kPa. Storage conditions are slightly broader, with temperatures from -5°C to +45°C.

Features:
The device includes an Automated Double Gradient Pressure (A.D.G.P.) system with international patent, offering 9 preset protocols and 3 customizable programs. It supports simultaneous inflation of 1 or 2 accessories through two rows of 7 connectors. The device is classified as Class II, Type BF, with an IP20 rating.

Materials and Construction:
The outer material is nylon, and the inner material is polyurethane, with thermo-welded closures. Accessories include 7 chambers sleeve, boot, waist boot, and a 5 chambers abdominal strap, all designed to prevent air leakage.

Indications and Contraindications:
The device is indicated for conditions such as lymphoedema, phleboedema, prevention of deep venous thrombosis (DVT), post-thrombotic syndrome, chronic venous insufficiency symptoms, and recovery after sports or surgery. Contraindications include acute DVT, acute infections like erysipelas or lymphangitis, systemic decompensation, and pressure urticaria.

Accessories:
Additional accessories include hygienic sheaths and a mobil stand with garment support. The document provides detailed dimensions for various garment components.