16
on the adapters and on the extension cables.
5. For repair works contact only Gima’s technical service or a technical center authorized
by the manufacturer. The device requires the use of original spare parts. Failure to com-
ply with the above may compromise the safety of the appliance.
6.
This appliance shall be solely intended for the use which was designed for and
according to the instructions of this manual. Therefore, it shall be used as aerosol
therapy system.
Any other use is improper and therefore hazardous; the manufacturer
shall not be deemed responsible for damage caused by an improper use or if the appli-
ance is used in electrical installations that do not comply with the safety regulations in
force.
7. The medical device requires specific precautions in terms of electromagnetic compat-
ibility and shall be installed and used according to the instructions provided along with
the accompanying documents: the Mistral device shall be installed and used away from
portable and mobile RF communication devices (mobile phones, transceivers, etc.)
which may affect the appliance.
8. Some components of the appliance are of small size and might be swallowed by chil-
dren; keep the device out of reach of children.
9. Keep the accessories out of reach of children. Children and dependents shall always
use the medical device under the close supervision of an adult with full mental capacity.
Keep the ampoule out of reach of children under 36 months as it contains small parts
which be may swallowed.
Do not leave the device unattended in areas accessible to minors and / or people
with disabilities.
10. Do not leave the device unattended in areas accessible to minors and / or people with
limited mental capacity as they may be strangled with the air hose.
11. The patient can come into contact with the medical device through the nebulizer /
masks / mouthpiece and /or nosepiece. These components comply with the require-
ments of ISO 10993-1, therefore neither allergic reactions nor skin irritation can occur.
12. The product and its parts are biocompatible in accordance with the requirements of EN
60601-1.
13. The device is easy to use. No additional precautions other than the instructions of this
manual of use are required.
14.
WARNING
: Do not alter this appliance without the authorization of Gima S.p.A..
No electrical and / or mechanical part which the device consists of has been designed
to be repaired by the user.
Failure to do so can compromise the safety of the appliance.
15. The use of the medical device in environmental conditions other than those illustrated in
this manual may jeopardize the safety and the parameters of the appliance.
16. The materials used for the contact with drugs are thermoplastic polymers with high
chemical stability and resistance.
Such materials have been tested with commonly-used medications (Salbutamol, Be-
clomethasone Dipropionate, Acetylcysteine, Budesonide, Ambroxol) and no interaction
has been reported. Nonetheless, given the variety and the ongoing evolution of the med-
icines used, potential interactions cannot be ruled out. Therefore, it is recommended to:
- Use up the drug as quickly as possible after its opening.
- Always avoid prolonged contact of the drug with the container. Clean the container
immediately after its use.
- In the event of anomalous situations (e.g. softening or cracks) of the container, do not
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