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