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Table of Contents
1 Important User Notes ...............................................................................................................................................................................................7
2 Safety Information..................................................................................................................................................................................................... 8
3 General Information..................................................................................................................................................................................................9
3.1 Description of the Device........................................................................................................................................................................ 9
3.2 Intended Use and Contraindications................................................................................................................................................... 9
3.2.1 Intended Use............................................................................................................................................................................................... 9
3.2.2 Contraindications....................................................................................................................................................................................10
3.3 General Warnings and Precautions ...................................................................................................................................................10
3.3.1 General Warnings ...................................................................................................................................................................................10
3.3.2 Precautions................................................................................................................................................................................................13
3.4 Device-Specific Warnings: Arthroscopy Indication .......................................................................................................................15
4 Device Setup...............................................................................................................................................................................................................17
4.1 Scope of Delivery .....................................................................................................................................................................................17
4.2 Setting up and Connecting the Device..............................................................................................................................................17
4.3 Mounting the Pump ...............................................................................................................................................................................20
4.3.1 Mounting on Stand.................................................................................................................................................................................20
4.3.2 Positioning in Device Rack ....................................................................................................................................................................21
5 Operating the Device...............................................................................................................................................................................................22
5.1 Front of the Device..................................................................................................................................................................................22
5.2 Device Side ................................................................................................................................................................................................22
5.3 Rear of the Device ...................................................................................................................................................................................22
5.4 Turning the Device On ...........................................................................................................................................................................23
5.5 Irrigation Tube Sets Overview .............................................................................................................................................................23
5.6 Using the Irrigation Tube Sets.............................................................................................................................................................24
5.7 Inserting the Irrigation Tube Sets.......................................................................................................................................................25
5.8 Connecting the Irrigation Fluid Bags.................................................................................................................................................28
5.9 Setting Nominal Values.........................................................................................................................................................................29
5.10 Starting the Device .................................................................................................................................................................................29
5.11 Using the WASH Function ....................................................................................................................................................................30
5.12 Switching the Device Off.......................................................................................................................................................................30
6 Safety Functions........................................................................................................................................................................................................32
6.1 Device Self-Test........................................................................................................................................................................................32
6.2 Exceeding Nominal Pressure................................................................................................................................................................32
7 Function Test .............................................................................................................................................................................................................33
7.1 Preparing the Function Test.................................................................................................................................................................33
7.2 Performing the Function Test..............................................................................................................................................................33
7.3 Checking the WASH Function.............................................................................................................................................................. 34
7.4 Ending the Function Test ......................................................................................................................................................................34
8 Using the Device during Surgery .........................................................................................................................................................................35
9 Care and Maintenance............................................................................................................................................................................................37
9.1 Maintenance Intervals...........................................................................................................................................................................37
9.2 Cleaning the Device................................................................................................................................................................................37
9.3 Maintenance by Authorized Service Technician ............................................................................................................................37
9.4 Replacing the Fuse ..................................................................................................................................................................................38
9.5 Care of the Reusable Tube Set (NOT FOR SALE IN USA)................................................................................................................39
9.5.1 General Notes...........................................................................................................................................................................................39
9.5.2 Reprocessing.............................................................................................................................................................................................40
10 Annual Inspection.....................................................................................................................................................................................................46
10.1 Electrical Safety Test...............................................................................................................................................................................46
10.2 Basic Function Test .................................................................................................................................................................................46
10.3 Pressure Measuring Test.......................................................................................................................................................................47
11 Accessory List.............................................................................................................................................................................................................48
12 Electromagnetic Compatibility.............................................................................................................................................................................49
12.1 Electrical Connections............................................................................................................................................................................49
12.2 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ..............................................................................49
12.3 Guidelines and Manufacturer's Statement - Electromagnetic Interference Immunity .....................................................50
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