Compression system pump, intermittent

Risk Class

Class IIa

Product Type

Single Device Product

ARTG Category

General

ARTG ID

475585

Start Date

January 13, 2025

Effective Date

January 13, 2025

Name

Motion is Life Pty Ltd

Name

BOESL Medizintechnik GmbH

Country

Germany

Address

Charlottenburger Allee 13, Aachen, 52068

The control units from BÖSL Medizintechnik GmbH are active medical devices that are used alongside sleeves for intermittent pneumatic compression. Taking into account the medically coordinated treatment parameters, the control units are suitable for treating venous and lymphatic congestion problems in accordance with the following indications and while also taking the contraindications into account. The operational safety of the control units is only guaranteed when used as intended by an informed user. Users may be patients, doctors, nurses, physiotherapists and relatives, so the control units can be used both in professional health facilities and in a home setting. There are no restrictions with regard to the patient population. Children and people requiring assistance can be treated under expert instruction and supervision. Indications • Thromboembolism prophylaxis • Post-thrombotic syndrome • Leg ulcers • Venous oedema • Post-traumatic oedema • Lymphoedema • Lipoedema • Mixed forms of oedema • Peripheral arterial occlusive diseases (with strict monitoring) • Sensory disorders in cases of hemiplegia Contraindications • Decompensated heart failure • Extensive thrombophlebitis, thrombosis or suspected thrombosis • Erysipelas • Severe, uncontrolled hypertension • Acute soft tissue trauma to the extremities • Neuropathy • Occlusive processes in the sector of lymphatic drainage • Compartment syndrome • Acute phlegmon