FLAEM Rhino Clear RC1-1 Manual De Instrucciones De Uso página 13

These user instructions are provided for device model RC1-1.
The nasal douche may be combined with a: Flaem compressor unit, non-
Flaem compressor unit, centralised compressed air systems; in the latter
two cases the working pressure must fall within the range of values
defined in the paragraph TECHNICAL SPECIFICATIONS provided below in
the manual.
INTENDED USE
Medical Device for washing and treatment of the nasal cavities using saline solutions and/
or medicines, the treatment and medicines must be prescribed by a doctor.
INDICATIONS FOR USE
Treatment of upper airway disorders, via the endonasal route (rhinitis, rhinosinusitis,
sinusitis, and or as indicated by the treating physician).
Physiological washing of the nasal cavities (with saline, isotonic, hypertonic solutions, or
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hot spring water). In children it helps with nasal hygiene, in adults it aids physiological
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nasal washing and can be used before therapy of the upper airways to assist drug
administration.
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CONTRAINDICATIONS
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• The medical device should NOT be used for patients who are unable to breathe on their
own or who are unconscious.
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• Do not use the device in anaesthetic or assisted ventilation circuits.
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INTENDED USERS
The device is 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
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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 in-
fants, children of any age or persons with limited abilities (e.g. physical, mental, or sen-
sory). It is the responsibility of 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 device safely on their own or whether the therapy should be administered
by a responsible person.
Medical personnel should be responsible for assessing the use of the device on specific
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.,
Nasal douche
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