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Table of Contents
1 Important Operator/User Notes ............................................................................................................................................................................ 7
2 Safety Information.....................................................................................................................................................................................................8
3 Purpose.......................................................................................................................................................................................................................... 9
3.1 Warnings and Precautions ...........................................................................................................................................................................9
3.1.1 General Warnings ....................................................................................................................................................................................... 9
3.1.2 Hysterosocopy Specific Warnings ........................................................................................................................................................13
3.1.3 Precautions .................................................................................................................................................................................................17
3.2 Description of the Aquilex® Fluid Control System...............................................................................................................................19
4 Initial System Set-Up ...............................................................................................................................................................................................21
4.1 Preparing the System for Use ....................................................................................................................................................................21
4.2 System Components ....................................................................................................................................................................................23
5 System Operation.....................................................................................................................................................................................................24
5.1 Front of Irrigation Pump Unit ....................................................................................................................................................................24
5.2 Rear of Irrigation Pump Unit......................................................................................................................................................................24
5.3 Fluid Monitoring Unit Set-up.....................................................................................................................................................................25
5.3.1 Setting of the Container Scale...............................................................................................................................................................28
5.3.2 Connecting the Vacuum Tube...............................................................................................................................................................29
5.4 Turning On the Aquilex® System..............................................................................................................................................................30
5.5 Hanging the Fluid Bags................................................................................................................................................................................31
5.6 Using Tube Sets..............................................................................................................................................................................................32
5.7 Tube Sets Overview ......................................................................................................................................................................................33
5.8 Connecting the Outflow Tube Set............................................................................................................................................................34
5.8.1 Connecting Outflow Tube of Tissue Removal Handpiece (e.g. MyoSure®)..............................................................................35
5.9 Inserting the Inflow Tube Set ....................................................................................................................................................................36
5.10 Presetting the Intrauterine Pressure .......................................................................................................................................................38
5.11 Deficit Limit Setting......................................................................................................................................................................................38
5.12 Using the Pump during Surgery................................................................................................................................................................38
5.13 Changing Bags during Surgery..................................................................................................................................................................40
5.14 Changing Container during Surgery........................................................................................................................................................40
5.15 Changing Instrument during Surgery .....................................................................................................................................................41
5.16 Total Inflow Volume Displayed .................................................................................................................................................................42
5.17 Turning System Off.......................................................................................................................................................................................42
6 Function Tests............................................................................................................................................................................................................43
6.1 General Function Test..................................................................................................................................................................................43
6.2 Scale Test .........................................................................................................................................................................................................43
7 Safety Functions........................................................................................................................................................................................................45
8 Care and Maintenance............................................................................................................................................................................................47
8.1 Cleaning the System.....................................................................................................................................................................................47
8.2 Maintenance Intervals.................................................................................................................................................................................47
8.3 Maintenance by Authorized Service Technician ..................................................................................................................................47
8.4 Replacing of the Fuse ...................................................................................................................................................................................48
9 Annual Inspection.....................................................................................................................................................................................................49
9.1 Electrical Safety Test.....................................................................................................................................................................................49
9.2 Basic Function Tests .....................................................................................................................................................................................49
9.2.1 Flow Rate Test ............................................................................................................................................................................................50
9.2.2 Pressure Measuring Test.........................................................................................................................................................................51
9.2.3 Scale Test.....................................................................................................................................................................................................52
9.2.4 Fluid Deficit Measurement Test............................................................................................................................................................52
9.2.5 Testing the Vacuum Pump.....................................................................................................................................................................53
9.3 Determine the Software Version..............................................................................................................................................................53
10 Error and Warning Messages................................................................................................................................................................................54
11 Technical Data...........................................................................................................................................................................................................56
12 Electromagnetic Compatibility.............................................................................................................................................................................58
12.1 Electrical Connections..................................................................................................................................................................................58
12.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ....................................................................................58
12.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity ...........................................................59
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