2/12
FOREWORD
•
The GCE ECOlite
®
4000 unit is a medical device for conserving oxygen, classifi ed as Class IIa
pursuant to
•
Directive 93/42/EEC, concerning medical devices.
•
Compliance with the basic requirements of Directive 93/42/EEC is on the basis of EN ISO
18779.
•
According to the type of protection from electrical shock, the product is included in Class BF.
•
The product can be used simultaneously with a pacemaker.
INTENDED USE
ECOlite
®
is for use by patients who have been prescribed oxygen therapy by a health professional.
Oxygen therapy is intended for the treatment of a wide range of pulmonary diseases and support
treatment for cardiovascular diseases.
The ECOlite
®
equipment enables efficient dispensing of oxygen to the patient, by eliminating the
wastage of oxygen which normally occurs with constant flow systems.
In principle a controlled pulse of oxygen is delivered to the patient in the initial phase of inspiration.
This ensures the oxygen gas reaches the alveoli in the initial phase of inspiration and the remaining
airways are not unnecessarily filled with oxygen. The oxygen saving is substantial and the mucous
membrane is proportionally less stressed due to the reduced drying out effect from the oxygen.
The dosage and timing of oxygen delivery is controlled by a microprocessor in accordance with the
chosen setting. Dosage per breath is independent of breathing rate, therefore additional oxygen is
automatically delivered to the patient when breathing rate increases.
2.1 IDENTIFIED PATIENT POPULATION
•
Age
not specified
•
Weight
not specified
•
Health status
the user should not show signs of contra-indications associated with
the application of medical oxygen
2.2 THE DESIGNATED BODY PART OR TISSUE TYPE , WHICH THE
APPLICATION RELATES OR TO WHICH IT IS TO OPERATE
•
Oxygen therapeutic substance passes into the airways of the lungs and acts through the
cardiovascular system
•
Cannula for application of the oxygen in contact with the skin of the face
2.3 INTENDED CONDITIONS OF USE
•
Environment - designed for outdoor and indoor use (see conditions Chapter 9.5)
•
Frequency of use: Designed for multiple uses, daily use , one time use is limited by battery
capacity and oxygen bottles .
•
Location : Protect from physical damage.
•
Mobility: The device is portable, battery-powered .
2.4 INTENDED PROFILE
•
The device is intended for home using
•
Education:
are not subject to requirements for specialized education
•
Knowledge:
training of doctors prescribing therapy , the study and knowledge of
the user manual
•
Skills:
Ability to operate electronic devices
2.5 OPERATING PRINCIPLES
•
It must not come into contact with grease.
1
.
2
.
