TIM Mirus MC DES, Дополнительная информация

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3 General description
3-2 MIRUS Controller, SW 2.03.02, Additional Information Master (en-GB)
3.1 Intended use
The MIRUS Controller is part of the MIRUS System. It is intended for use in the administration
of volatile anaesthetics to patients with an inspiratory tidal volume ≥ 200 mL.
The MIRUS Controller can only be operated in combination with the MIRUS Reflector. For
hygienic and safety reasons, the MIRUS System can only be connected to the patient via the
MIRUS Filter.
Comment:
Further information on the MIRUS Reflector and MIRUS Filter can be found in the
manufacturer’s Instructions for use.
3.2 Operater and user qualification
3.2.1 Qualified medical personnel
The MIRUS Controller may only be used by or on the instruction of a physician. The MIRUS
Controller may only be operated by qualified medical personnel trained in its use in order to
ensure appropriate intervention in the event of a device malfunction.
3.2.2 Preparation personnel
Hygienic preparation may only be carried out by personnel with expertise in the preparation
of medical devices.
3.2.3 Maintenance personnel
Servicing and maintenance may only be performed by the manufacturer or by qualified
personnel authorised by the manufacturer.