Gima Nébuliseur Mistral Mode D'emploi page 12

GB
mental faculties as there is a risk of strangulation with the air tube;
11. The medical device may come into contatct with the patient via the nubuliser / masks / mouthpiece and / or
nosepiece, components compliant with the requirements of regulation ISO 10993-1: therefore, no allergic reaction
and skin irritation may occur.
12. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.
13. Operation of the device is very simple and therefore no further explanations are required other than those indicated
in the following user manual.
14. Using the device in environmental conditions different than those indicated in this manual may harm seriously the
safety and the technical characteristics of the same;
15. The materials used to contain the drugs are made with highly stable thermoplastic polymers that are resistant
against chemicals. Such materials were tested with commonly used drugs (Salbutamol, Beclametasone dipropionate,
Acetylcysteine, Budesonide, Ambroxol) and no interaction phenomenon was observed. Interactions cannot however
be excluded given the variety and the continuous evolution of the drugs that are used. Remember to:
 To consume the drugs as quickly as possible after opening its package;
 To avoid keeping the drug in the tray-like container for too long and to clean it immediately after every
application;
 If the tray-like container presents any abnormal situation (such as softening or cracks), do not introduce any
solution and do not proceed with the inhalation. Contact the technical service and describe the methods and type
of drugs used.
16. Remember to:
 Only use this device with medicines prescribed by your doctor;
 Carry out the treatment only using the accessory indicated by the doctor according to the pathology.
Under certain failure conditions the temperature of the casing may become hot and there may be a
risk of burns if you touch those parts. In any case, the temperatures do not exceed the limit of 105°C
(ref. Interpretation Sheet IEC 60601-1).
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC
DIRECTIVE 2012/19/UE-WEEE:
The symbol on the device indicates the separated collection of electric and electronic equipment. At the
end of life of the device, don't dispose it as mixed solid municipal waste, but dispose it referring to a
specific collection centre located in your area or returning it to the distributor, when buying a new device
of the sample type to be used with the same functions.
This procedure of separated collection of electric and electronic devices is carried out forecasting a
European environmental policy aiming at safeguarding, protecting and improving environment quality, as
well as avoiding potential effects on human health due to the presence of hazardous substances in such
equipment or to an improper use of the same or of parts of the same Caution: The wrong disposal of
electric and electronic equipment may involve sanctions.
UNDER NEW EUROPEAN RULES, GIMA REQUIRES THE FOLLOWING PROCEDURES TO BE CARRIED OUT TO PROTECT
THE INSTRUMENT AND THE SAFETY OF ALL WHO COME IN CONTACT WITH IT.
GIMA warrants it's product for 36 months after purchasing date.
Before returning an instrument for repair, the external surfaces and all accessories MUST be carefully disinfected with a
cloth soaked in methylated spirits or hypochlorite-based solution. The instrument and accessories should then be placed
in a bag with a note outlining the disinfection undertaken.
Instruments returned for repair MUST be accompanied by a description of the problem. GIMA will not be responsible for
Failure to follow this procedure will result in the instrument being returned to the purchaser unrepaired.
Where GIMA determines that an instrument is faulty, a replacement will be provided only if a SALES RECEIPT and
damage caused through improper use. To avoid such damage, please read the instruction carefully.
STAMPED GUARANTEE are provided. GIMA will not be responsible for damage accessories. These may be replaced at the
customer's expence.
RULES FOR RETURNING AND REPAIRING
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