FLAEM NUOVA P0709EM Notice D'utilisation page 12

These user instructions are provided for the device model P0709EM.
INTENDED USE
Medical device for the washing and treatment of the nasal cavities using saline solutions and/or medi-
cation, the treatment and medication of which must be prescribed by a doctor.
INDICATIONS FOR USE
Treatment, via the endonasal route, of upper airway pathologies (rhinitis, rhinosinusitis, sinusitis, and or
as indicated by the treating physician).
Physiological washing of the nasal cavities (with saline, isotonic, hypertonic solutions, or thermal water).
In children it helps with nasal hygiene, in adults it aids physiological nasal washing and can be used
before upper airway therapy to assist drug administration.
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, nurs-
es, 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 device safely on their own or whether the therapy should be admin-
istered by a responsible person.
Please refer to medical personnel for the evaluation of the use of the device on particular types of pa-
tients such as pregnant women, lactating women, infants, incapacitated persons or persons with limit-
ed 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 oper-
ation 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 for therapeutic purposes only. This medical device is not intended as a life-saving de-
vice. 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 your doctor's or therapist's instructions regarding the possible use of types of medication, dos-
age and indications for treatment.
• Pay attention to the indications provided with the drug and avoid using the devices with substances
and dilutions other than those recommended.
• 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.
• The time required to switch from storage to operating conditions is about 2 hours.
Nasal wash
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