0 Table of contents
IFU, MIRUS Controller, en-GB, N.00 3
0 Table of contents
1 Introduction ................................................................................ 6
1.1 Intended use ............................................................................................................ 6
1.2 Intended purpose ..................................................................................................... 6
1.3 Contraindications ..................................................................................................... 6
1.4 MIRUS System ........................................................................................................ 6
1.4.1 MIRUS Controller..................................................................................................... 7
1.4.2 Exchanger unit ......................................................................................................... 7
1.4.3 Device user interface ............................................................................................... 8
1.4.4 Colour code for the different volatile anaesthetic agents (VA) .................................. 8
1.4.5 Elements in touch screen ......................................................................................... 9
1.5 Symbols on the device ............................................................................................10
2 Safety ........................................................................................ 11
2.1 General safety instructions .....................................................................................11
2.1.1 Safe operation ........................................................................................................11
2.1.2 User qualification ....................................................................................................11
2.1.3 Monitoring ...............................................................................................................11
2.1.4 Electrical supply ......................................................................................................11
2.1.5 Responsibility of the manufacturer ..........................................................................12
2.1.6 Safety features .......................................................................................................12
2.2 Warning symbols used in the IFU ...........................................................................13
2.3 Patient safety ..........................................................................................................13
2.3.1 Monitoring ...............................................................................................................13
2.3.2 Volatile anaesthetic agents (VA) .............................................................................13
2.3.3 Control of patient relevant dosage ..........................................................................14
2.3.4 Combination of ventilators and MIRUS System ......................................................14
2.3.5 Triggering of ventilators ..........................................................................................14
2.3.6 Minimum tidal volume .............................................................................................14
2.3.7 MDI Applications .....................................................................................................15
2.3.8 Resistance of airway components ..........................................................................15
2.4 User’s and other patient’s safety .............................................................................15
2.5 Device ....................................................................................................................15
2.5.1 Accessories ............................................................................................................15
2.5.2 Positioning ..............................................................................................................16
2.5.3 Risk of electrical hazard ..........................................................................................16
2.5.4 Risk of fire ..............................................................................................................16
2.5.5 Electromagnetic compatibility .................................................................................17
2.6 Residual risk – Fail-safe mode ................................................................................17
3 Preparation ............................................................................... 18
3.1 Cleaning before first use .........................................................................................18
3.2 Connecting to mains supply ....................................................................................18
3.3 Connecting to MIRUS Reflector ..............................................................................19
3.4 Turning on ..............................................................................................................20