Intended Use; Indications For Use; Contraindications; Intended Users - Flaem Respirair Rf7-2 Mode D'emploi

These user instructions are provided for P0611EM F1000 and RF7-2 model devices. The FLAEM
Aerosol Therapy device consists of a compressor unit (A), a nebuliser and some accessories (B).

INTENDED USE

Medical device for the administration of medication through inhalation, with inhalation therapy and
medication prescribed by a Doctor.

INDICATIONS FOR USE

Treatment of respiratory diseases. Medications must be prescribed by a doctor who has assessed
the patient's general condition.

CONTRAINDICATIONS

• The medical device should NOT be used for patients who are unable to breathe on their own or
who are unconscious.
• Do not use the device in anaesthetic or assisted ventilation circuits.

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.

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 used by infants, children of any
age or persons with limited abilities (e.g. physical, mental or sensory). It is up to the medical personnel
to assess the patient's condition and capabilities in order to determine, 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 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, outpatient 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 and/or maintenance/hygienic preparation.
• Please also refer to the case history of faults and their resolution.

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
medicine, dosage and treatment indications.
• If you should experience allergic reactions or other problems while using the device, stop using it
immediately and consult your doctor.
• Keep this manual safe for further reference.
• If the packaging is damaged or opened, contact the distributor or service centre.
• Do 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.
Aerosol therapy device
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