TIM Mirus MC DES, Дополнительная информация

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2 Safety
2-6 MIRUS Controller, SW 2.03.02, Additional Information Master (en-GB)
Pressurised inhalation
If the MIRUS Controller is used in combination with pressurised inhalation (metered-dose
inhaler), the device’s internal gas monitor may misinterpret the inhaler’s propellant gas as a
volatile anaesthetic, and thus reduce the dosage of volatile anaesthetic. This can result in
short-term underdosing and thus pose a risk to the patient.
Monitor the sedation of the patient.
2.1.8 Before every use
Parts of the MIRUS Controller may be damaged during preparation, or by wear and tear or
incorrect storage, and this may affect its function. This can put the patient at risk.
Before operation, please ensure that the following prerequisites have been satisfied:
All parts of the MIRUS Controller are free of cracks.
All cables are undamaged and correctly connected.
The system test has been performed. This ensures that all safety-relevant functions and
components work flawlessly.
A MIRUS Controller that clearly does not work properly must be replaced with a
functioning unit.
2.1.9 Equipment damage during use
If the touchscreen does not function correctly, there will be limited control through the MIRUS
Controller. This can put the patient at risk.
Stop the supply of anaesthetic gas into the gas flow to the patient by disconnecting the
interface connector, and continue with the sedation by other means.
If the MIRUS Controller detects a severe malfunction, and if proper function can no longer be
guaranteed, the MIRUS Controller will switch to a patient-safe state (see Chapter 2.2). Within
the fail-safe mode, no volatile anaesthetic is administered to the patient. This may put the
patient at risk due to underdosing.
A patient sedation alternative must be kept available in order to ensure sedation is
possible.
2.1.10 Monitoring the patient
An overdose or underdose during the administration of volatile anaesthetic may pose a risk to
the patient.
Monitor the dosing of the volatile anaesthetic by measuring the dosage-relevant end-
tidal concentration of anaesthetic (etVA).