FLAEM NebulFlaem 4.0 Bedienungsanleitung Seite 11

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These user instructions are provided for CONDOR F2000 and RF9-1 model devices. The FLAEM
Aerosol Therapy device consists of a compressor unit (A), a nebuliser and some accessories (B).
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INTENDED USE. Medical device for the administration of medication through inhalation, with inhala-
on tion therapy and medication prescribed by a Doctor.
INDICATIONS FOR USE. Treatment of respiratory diseases. Medications must be prescribed by a
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doctor who has assessed the patient's general condition.
CONTRAINDICATIONS. • The medical device should NOT be used for patients who are unable to
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breathe on their own or who are unconscious. • Do not use the device in anaesthetic or assisted venti-
lation circuits.
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INTENDED USERS. The devices are intended for use by legally authorised medical personnel/health
workers (doctors, nurses, therapists, etc.). The device can be used directly by the patient.
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TARGET GROUP OF PATIENTS. Adults, children of all ages, infants. Before using the device, the
user manual must be read carefully and an adult responsible for safety must be present if the device is
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used by infants, children of any age or persons with limited abilities (e.g. physical, mental or sensory). It
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is up to the medical personnel to assess the patient's condition and capabilities in order to determine,
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when prescribing therapy, whether the patient is able to operate the aerosol safely on their own or
whether the therapy should be administered by a responsible person. Please refer to medical personnel
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for the evaluation of the use of the device on particular types of patients such as pregnant women,
lactating women, infants, incapacitated persons or persons with limited physical capabilities.
OPERATING ENVIRONMENT. This device can be used in healthcare facilities, such as hospitals, outpa-
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tient clinics, etc., or even at home.
WARNINGS CONCERNING POSSIBLE MALFUNCTIONS. • Should your appliance fail to perform,
please contact the authorised service centre for clarification. • The manufacturer should be contacted to
report problems and/or unexpected events relating to operation and if necessary for clarification of use
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and/or maintenance/hygienic preparation. • Please also refer to the case history of faults and their reso-
lution.
WARNINGS. • Use the device only as a therapeutic inhaler. This medical device is not intended as a
life-saving device. Any other use is considered improper and can be dangerous. The manufacturer is not
liable for any improper use. • Always consult your general practitioner for identification of treatment. •
Follow the instructions of your doctor or respiratory rehabilitation therapist regarding the type of med-
icine, dosage and treatment indications. • If you should experience allergic reactions or other problems
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while using the device, stop using it immediately and consult your doctor. • Keep this manual safe for
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further reference. • If the packaging is damaged or opened, contact the distributor or service centre. • Do
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not expose the device to particularly extreme temperatures. • Do not place the device near heat sources,
in sunlight or in an excessively hot environment. • The time required to switch from storage to operating
conditions is about 2 hours. • It is forbidden to access the compressor unit opening in any way. Repairs
may only be carried out by personnel authorised by the manufacturer. Unauthorised repairs invalidate
the warranty and may pose a danger to the user.
Suffocation risk: - Some components of the appliance are small enough to be swallowed by children, so
keep the appliance out of the reach of children.
Strangulation risk : Do not use the supplied connecting hose and cables outside of their intended use,
they could cause a strangulation hazard, take special care for children and people with special difficul-
ties, often these people are not able to correctly assess the dangers.
Fire risk: This device is not suitable for use in the presence of an anaesthetic mixture that is flammable
with air, or with oxygen or nitrous oxide.
Risk of electrocution: - Before first use, and periodically during the life of the product, check the integrity
of the structure of the appliance and the power cord to ensure that there is no damage; if it is damaged,
do not plug it in and immediately take the product to an authorised service centre or your dealer. - Keep
the power cable away from animals (e.g. rodents), otherwise such animals could damage the insulation
of the power cable. - Always keep the power cable away from hot surfaces. - Never obstruct the venti-
lation slots located on both sides of the compressor unit. - Do not handle the compressor unit with wet
hands. Do not use the compressor unit in humid environments (e.g. while bathing or showering). Do
not immerse the compressor unit in water; if this happens, pull the plug immediately. Do not pull out or
touch the compressor unit while immersed in water, unplug it first. Take it immediately to an authorised
FLAEM service centre or your dealer.
Risk of ineffectiveness of therapy: - Performance may vary with particular types of drugs (e.g. those with
Aerosol therapy device
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