Rez?m G2200 User manual

3033-001 Revision D January 2018
©NxThera 2018
Page 1 of 90
Operator’s Manual
Rezūm®Generator
Model G2200
WARNING: Carefully read and understand all instructions, indications, warnings, and cautions
in this operator’s manual prior to using the Rezūm Generator. Failure to do so could result in
compromised patient safety, patient complications and/or insufficient treatment.

3033-001 Revision D January 2018
©NxThera 2018
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3033-001 Revision D January 2018
©NxThera 2018
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Table of Contents
Chapter 1 About the Rezūm®Generator........................................................................................... 6
1.1 Trademark and Copyright Information.................................................................................... 7
1.2 Contact Information................................................................................................................... 7
1.3 Indications for Use/Intended Use and Contraindications ..................................................... 8
1.4 Product Description.................................................................................................................... 9
1.5 Safety.......................................................................................................................................... 10
1.5.1 Dangers, Warnings and Cautions........................................................................................10
1.5.1.1 DANGERS....................................................................................................................... 11
1.5.1.2 WARNINGS....................................................................................................................11
1.5.1.3 CAUTIONS ..................................................................................................................... 13
1.5.2 Potential Adverse Events ....................................................................................................16
1.5.3 Reported Adverse Events.................................................................................................... 16
1.5.4 Symbols ............................................................................................................................... 17
1.5.4.1 Generator Symbols....................................................................................................... 17
1.5.4.2 User Interface Symbols ................................................................................................20
1.6 Operator Training Requirements............................................................................................21
Chapter 2 Getting Started.................................................................................................................. 22
2.1 Unpacking and Inspecting....................................................................................................... 23
2.1.1 Generator Controls and Connections ................................................................................. 24
2.1.2 Display Screen Map............................................................................................................. 27
2.1.3 Audible Tones......................................................................................................................28
2.1.4 Volume Control ................................................................................................................... 29
2.1.5 Detachable Parts and Accessories ...................................................................................... 30
Chapter 3 Using the Rezūm Generator............................................................................................31
3.1 Step by Step Instructions......................................................................................................... 32
3.1.1 Connecting the Power Cord ................................................................................................ 34
3.1.2 Turning on the Rezūm Generator .......................................................................................35
3.1.3 Priming the Delivery Device................................................................................................ 39

3033-001 Revision D January 2018
©NxThera 2018
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3.1.4 Performing the Therapy...................................................................................................... 42
3.1.4.1 Turbo Flush.................................................................................................................... 45
3.1.4.2 Connecting New Delivery Device during treatment session .................................. 45
3.1.5 Turning off the Rezūm Generator....................................................................................... 46
3.1.6 Rezūm Generator Options Menu Items.............................................................................. 47
3.1.6.1 Enter Patient Info.......................................................................................................... 48
3.1.6.1.1 Using the On-screen Keyboard ............................................................................50
3.1.6.2 Drain Bladder.................................................................................................................51
3.1.6.3 Replace Saline ...............................................................................................................51
3.1.6.4 Remove Device..............................................................................................................52
3.1.6.5 View Patient Info...........................................................................................................53
3.1.6.5.1 Delete Record ......................................................................................................... 54
3.1.6.5.2 View Record ............................................................................................................55
3.1.6.5.3 Export Record..........................................................................................................56
3.1.6.6 More Options................................................................................................................59
3.1.6.6.1 System Status..........................................................................................................59
3.1.6.6.2 Export Logs...............................................................................................................64
3.1.6.6.3 Treatment Monitor.................................................................................................66
3.1.6.6.4 Treatment Config....................................................................................................66
3.1.6.6.5 Servicing ..................................................................................................................66
Chapter 4 Maintenance and Service................................................................................................. 67
4.1 Recommended Maintenance and Care .................................................................................68
4.1.1 Visual Inspection ................................................................................................................. 69
4.1.2 Cleaning the Rezūm Generator...........................................................................................70
4.1.2.1 Recommended Cleaning Products.............................................................................70
4.1.2.2 Not Recommended Cleaning Products .....................................................................70
4.1.2.3 Cleaning Instructions.................................................................................................... 71
4.1.3 Maintenance Checklist........................................................................................................72
4.2 Authorized Repair Service .......................................................................................................73
Chapter 5 Technical Specifications ...................................................................................................74

3033-001 Revision D January 2018
©NxThera 2018
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5.1 Generator Specifications..........................................................................................................75
5.2 Operating, Storage, and Transportation Specifications ......................................................76
5.3 Electromagnetic Compatibility Requirements ......................................................................77
5.4 EN 60601-1-2 Compliance ......................................................................................................84
Chapter 6 Troubleshooting................................................................................................................85
6.1 Troubleshooting Steps.............................................................................................................86
6.2Error Messages.......................................................................................................................... 87
6.3 Error Message Table.................................................................................................................88
6.4 Obtaining technical assistance................................................................................................ 90