FLAEM LightNeb P0318EM Manual De Instrucciones De Uso página 20

VMT electronic aerosol device (Vibrating Mesh Technology).
These user instructions are provided for the device model P0318EM.
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. This device is suitable for nebulising drugs in solution
(mucolytics in general), drugs in suspension (e.g. corticosteroids, such as beclomethasone
dipropionate and budesonide) and saline. 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 the medical personnel's responsibility to assess the patient's condition and
capabilities in order to determine, when prescribing use of the device, whether the patient
is able to operate the aerosol device 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 per-
sons 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/hy-
gienic preparation.
Ultrasound aerosol therapy device
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