2 Safety
IFU, MIRUS Controller, en-GB, N.00
11
2
Safety
2.1
General safety instructions
2.1.1
Safe operation
To ensure safe operation of the MIRUS Controller, use the system only as intended. Operators
need to be familiar with these Instructions for use (IFU) prior to operating the system. Only
trained operators should use this system. Always ensure compliance with the requirements of
this
IFU and with the local governmental or other authority’s requirements.
2.1.2
User qualification
The MIRUS Controller should be operated by or on the order of a physician. The MIRUS
Controller should only be operated by qualified medical personnel, to ensure adequate
intervention in case of a device malfunction.
2.1.3
Monitoring
The MIRUS Controller is equipped with monitoring functions that will help to observe the device
situation and thereby serve to indicate changes in the parameters.
Changes in the parameters can be caused by:
changes in the status of the patient
changes in the settings
adjustment and/or operation failures
defects and/or device malfunction
changes in the power supply
changes in the anaesthetic supply
An alternative for patient sedation should be present to maintain sedation in case of a device
malfunction.
2.1.4
Electrical supply
The MIRUS Controller is built for AC supply with electrical power from a line supply voltage of
100 to 230 V
AC
± 10%, 50 to 60 Hz ± 5%. Verify your local AC line supply voltage matches the
rated device’s voltage on the serial plate.
The MIRUS Controller is equipped with an internal backup battery (UPS battery) that provides
a defined time of operation with reduced functionality upon loss of electrical mains supply
during application (refer to chapter
10.1 General specifications
). This backup battery will
automatically switch on, whenever mains supply is lost. A symbol on the display appears to
inform the user.
Note:
The device should only be stored with a fully charged battery.