Safety; General Safety Rules - Tecno-gaz MasterFlux Smart Mode D'emploi

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SAFETY

3.1 GENERAL SAFETY RULES

The MASTER FLUX SMART must only be used by specially trained medical
personnel. (*)
Use is only permitted in the areas indicated in the intended use
The use of nitrous oxide (N2O) in the out-of-hospital setting should not be combined with the use of
other anaesthetic drugs, hypnotics, sedatives or major painkillers except in the presence of a
resuscitating anaesthetist. On the other hand, the use of nitrous oxide may precede or follow the
infiltration of local anaesthetics, such as in dentistry.
Please read this user manual carefully. The user manual is an integral part of the
equipment. Keep it close to the unit for reference at all times.
(*) The text is valid for devices sold in Italy.
TECNO-GAZ recommends the application of this text for all users of the device, integrating it with the
regulations in force in the country of use.
AIFA - DDL guidance on the extra-hospital use of nitrous oxide
The use of nitrous oxide (N2O) is only permitted through specific equipment that prevents the delivery of
hypoxic mixtures and only in specific environments with adequate air circulation.
The drug is to be used in an out-of-hospital setting at a maximum concentration of 50% oxygen (i.e. no
more than 50% nitrous oxide and at least 50% oxygen).
The only exception is conscious sedation practised by experienced sedationists who, with the patient
definitely conscious (as documented by the opening of the mouth), can set up, for short periods of time,
a delivery at concentrations of up to 70%.
Nitrous oxide has been widely used for decades in non-hospital settings, particularly in dentistry, as an
anxiolytic analgesic. No serious complications secondary to its use as an anxiolytic analgesic in out-of-
hospital settings have been described to date.
Nitrous oxide must only be used in the presence of medical or dental personnel who are trained in
cardiopulmonary resuscitation (BLS-D) and who are aware that A) in the event of loss of consciousness,
nitrous oxide should be immediately discontinued and B) in the event of apnoea, the patient's airway
should be immediately opened (e.g. with the threefold manoeuvre of extending the head, subluxating the
jaw and opening the mouth) and, if necessary, ventilation support should be provided (e.g. with a self-
expanding balloon and a face mask).
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