[En] Instruction Manual; How It Works - Otivio FLOWOX 2.0 Bedienungsanleitung

FlowOx™ is a medical device in accordance with the Medical Device Directive 93/42/EEC, which improves blood flow to your
lower limb. The patented technology is based on several years of research and development.
Please carefully read this instruction manual before using the device. The Quick Guide [0] should be kept handy.
Otivio and its distributors decline any responsibility for any use of FlowOx™ that does not comply with this instruction manual.
The user puts the foot and leg into a Pressure Chamber [1] which is connected to the Control Unit [4]. A pump in the Control
Unit creates a pre-set cycle of 10 seconds with negative pressure of -40 mmHg and 7 seconds with ambient air pressure. The
negative pressure facilitates blood flow down into the limb and to the skin. The Control Unit [4] is a multiple patient multiple
use device; hence it may be used for multiple patients during its lifetime. The Pressure Chamber [1] directly contacts the skin;
hence it is a single patient multiple use device [59] and should be used by a single patient only.
Use FlowOx™ as recommended by your clinician, normally for 2 hours daily, divided into at least two sessions. Follow up your
clinician recommendations for treatment modalities.
INTENDED USE, INDICATIONS FOR USE AND CONTRA-
Intended Use:
The FlowOx™ System is intended to be used for the treatment of conditions and diseases of the foot, ankle and lower leg that
are associated with impaired blood flow. It enhances peripheral blood flow by application of negative pressure pulses to the
treated area. It is intended to be used in both a professional and home care environment.
Indications:
FlowOx™ is indicated for the treatment of the following conditions in adults (over 18 years of age):
• Peripheral arterial disease.
• Diabetic and non-diabetic arteriopathic foot and leg ulcers.
• Intermittent claudication and rest pain.
• Foot and lower leg ulcers of mixed aetiology associated with immobility such as paraplegia following spinal injury.
Contraindications and Warnings:
There are no known contraindications for the device. Due to a lack of clinical data, it is not indicated for use in children or
pregnant women. Caution should be taken in its use in non-adults, under the age of 18 years, and in pregnant women. Due
to the close contact of the pressure chamber and the skin, underlying local conditions such as psoriasis, eczema, varicose
veins or skin infections may become irritated or exacerbated. Should this happen, reduce or stop treatment. Due to increased
blood flow to the treated area, ulcers may experience increased exudate production or bleeding. Should these occur, a super
absorbent dressing may be required and/or dressings may need to be changed more often or treatment terminated.
Underlying conditions and co-morbidities should be stabilised and under control prior to treatment to be compatible with
the treatment period. Reperfusion pain is experienced by some patients. If any medical conditions become aggravated,
treatment should be stopped, and medical advice obtained.
Treatment Period:
FlowOx™ use is recommended for 2 hours per day and clinical improvement in symptoms usually requires a minimum of 8
weeks treatment. Treatment is applied whilst the patient is seated, and it does not interfere with other activities normally
enjoyed whilst seated.
610-00013 FLOWOX™ 2,0 Instructions for Use (IFU) Manual Rev 16
INSTRUCTION MANUAL [EN]
WELCOME

HOW IT WORKS

INDICATIONS
3
Date of Issue: 28 APR 2022