Gima 28091 Manuel De L'utilisateur page 13

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documents: the Eolo device shall be installed and used away from portable and mobile RF commu-
nication 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 children; keep the
device out of reach of children.
9. Keep the accessories out of reach of children. Children and dependents shall always use the med-
ical 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 disa-
bilities.
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 / mouth-
piece and /or nosepiece. These components comply with the requirements of ISO 10993-1, there-
fore 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 stabil-
ity and resistance.
Such materials have been tested with commonly-used medications (Salbutamol, Beclomethasone
Dipropionate, Acetylcysteine, Budesonide, Ambroxol) and no interaction has been reported. None-
theless, given the variety and the ongoing evolution of the medicines 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 introduce
any solution and do not inhale. Contact the technical service, specifying the methods of use and
the type of drug used.
17. Remember to:
- use this appliance only with medicines prescribed by your doctor;
- perform the treatment by using only the accessory instructed by your doctor according to the
disease.
Under certain fault conditions, the packaging temperature can raise and there might be risk of
burns if the user comes into contact with such parts. In any event, the temperatures do not exceed
the limit of 105°C [221°F] (ref. Interpretation Sheet IEC 60601-1).
Gima S.p.A. cannot be held liable for accidental or indirect damage resulting from altera-
tions of the device, repairs and/or unauthorized technical interventions, or damage to any of its
part due to accident, misuse and/or abuse.
Any unauthorized intervention on the device, even the slightest one, will immediately inval-
idate the warranty and does not ensure the compliance with the technical and safety require-
ments provided by Directive MDD 93/42/EEC (and subsequent amendments) and by the related
reference standards.
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