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OPERATIONAL, TRANSPORT AND STORAGE SAFETY
REQUIREMENTS
The ECOlite
®
4000 may only be used with approved accessories and in a mode prescribed by
the physician. Using it for a therapy other than oxygen therapy is not permitted. Connection
of the device to the oxygen source must conform to applicable national standards.
Never use a lubricant or oils with the oxygen supply device since spontaneous ignition may
occur. Do not put the ECOlite
®
4000 into operation with the presence of open flames, e.g.
during smoking, and do not use humidifiers.
The ECOlite
®
4000 must be used in accordance with the information for EMC given in this
Instruction for use.
Transportable and mobile high-frequency equipment can have influence on the ECOlite
®
4000.
Various equipment can influence each other during operation. To mitigate the influence it
might be necessary, for example, to change the position of such equipment or to shield it.
The product and the related equipment must be protected from mechanical damage and
kept out of the reach of unauthorised persons.
KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
•
heat sources (fire, cigarettes, ...)
•
flammable materials,
•
oil or grease (especially be careful if hand cream is used),
•
water,
•
dust.
National laws, decrees and regulations in relation to the prevention of accidents due to pressure
equipment and environmental protection must be observed.
OXYGEN CONTRA-INDICATIONS
At atmospheric pressure, up to 60% oxygen is harmless. 100% oxygen produces a cough
after 6 hours and increasing breathlessness after 25 hours.
PERSONNEL INSTRUCTIONS AND TRAINING
According to Medical Devices Directive 93/42/EEC the product provider must ensure that all
personnel handling the product are provided with the operating instructions & performance data
and are fully trained to carry out that operation. Trainees need to be supervised by an experienced
person.
Do not use the device without being trained. Training can be only done by a person with
an appropriate education, experience and knowledge that has been also trained by the
manufacturer.
For further information about training programs, please contact GCE.
PRODUCT DESCRIPTION
The ECOlite
®
4000 is an electronic oxygen-dosing device with a built-in alarm function.
The ECOlite
®
4000 has a built-in regulator that partially regulates the pressure. In order to work,
it requires the supply of medical oxygen with a pressure of 1.6-5 bar and a minimum flow 4 litres
per minute.
Oxygen flows from a cylinder (reservoir) through a pressure-reducing valve before entering he
ECOlite
®
4000 device and then onto the patient via a nasal cannula.
The incorporated microprocessor in the ECOlite
®
4000 regulates and controls the oxygen flow to
the patient.
The valve, which allows the oxygen to flow, is open only for a very short time until the next time
when the patient inhales. This leads to the optimization of the amount of oxygen considering the
course of inhalation and, thus, a considerable saving (by up to 2/3 of the volume), and mucous
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