FLAEM Aspira Go P1611EM-20 Instrucciones De Uso página 16

These operating instructions are provided for the FLAEM aspirator consisting of a depressor unit model P1611EM-20 or
P1611EM-30 and the secretion collection vessel model ASP-2 and piping model A005 accessories.
INTENDED USE
Medical Device, aspirator for medical and surgical use, for the aspiration of bodily fluids, pharyngeal aspiration and permanent
tracheotomy. Its use must be prescribed by a doctor.
INDICATIONS FOR USE
Treatment of pathologies requiring the aspiration of body fluids (saliva, secretions, post tracheotomy fluids, etc.).
CONTRAINDICATIONS
The device must NOT be used in operating theatres, for chest drainage or on transport vehicles such as ambulances or emergency
vehicles.
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 for home use, but under the guidance of medical personnel.
TARGET GROUP OF PATIENTS
Adults, children of all ages. 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 children of any age or persons with limited abilities (e.g. physical, mental or sensory). 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, incapacitated persons or persons with limited physical capabilities. All this must take place under the guidance of medical
personnel.
It is up to the medical personnel to assess the patient's condition and capabilities in order to determine, when prescribing the
device, whether the patient is able to operate the aspirator safely on their own or whether the therapy should be administered by a
responsible person.
OPERATING ENVIRONMENT
All devices 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 hygienic preparation.
• Please also refer to the case history of faults and their resolution.
WARNINGS
• For correct operation and to prolong the life of the device, the operating instructions must be strictly followed.
• If the packaging is damaged or opened, contact the distributor or service centre.
• The manufacturer, the seller and the importer are only responsible for safety, reliability and performance if: a) the appliance is used
in accordance with the operating instructions, b) the electrical installation in the room where the appliance is used is in accordance
with the regulations and complies with the laws in force.
• The 12V DC power cable for cigarette lighter socket is equipped with a safety fuse that can be inspected in the event of a fault.
• If the aspirator is not used for a long period (6 months), it is advisable to remove the battery before storing it.
• It is forbidden to access the device opening in any way. Repairs may only be carried out by authorised FLAEM personnel following
the information provided 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 pipes and cables outside of their intended use, they could cause a strangulation hazard, take special care
for children and people with special difficulties, often these people are not able to correctly assess the dangers.
• Fire risk:
- The use of batteries other than those supplied with the device is prohibited.
- Do not expose the appliance to temperatures other than those indicated in the chapter ''technical specifications''
- The aspirator is only intended for the collection of NON-flammable fluids, not suitable for use in the presence of flammable anaes-
thetic mixture 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, the supplied
power supply unit, 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.
- Do not carry out any hygienic preparation when the device is in use on a patient.
- In the presence of children and care-dependent persons, the appliance must be used under the close supervision of an adult who
has read these operating instructions.
- Keep the power cable of the power supply unit away from animals (e.g. rodents), otherwise such animals could damage the insu-
lation of the power cable.
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