Boston Scientific rezum G2200-003 Manual

51230807-01 Rev. A
rezū ū m
™
Generator

TABLE OF CONTENTS

TABLE OF CONTENTS....................................................................... 1
WARNING ..........................................................................................1
SAFETY ...............................................................................................1
DANGER .............................................................................................2
DEVICE DESCRIPTION...................................................................... 2
INTENDED USE/INDICATIONS FOR USE ...................................... 2
CONTRAINDICATIONS ..................................................................... 2
WARNINGS ........................................................................................2
PRECAUTIONS...................................................................................2
ADVERSE EVENTS ............................................................................2
HOW SUPPLIED.................................................................................2
Handling and Storage .................................................................2
User Interface Symbols .............................................................3
OPERATOR TRAINING REQUIREMENTS ....................................... 3
OPERATIONAL INSTRUCTIONS...................................................... 3
GETTING STARTED .....................................................................3
Overview .......................................................................................3
Unpacking and Inspecting .........................................................3
Generator Controls and Connections ...................................... 3
Figure 1: Front and Top of Generator .................................. 3
Table 1: Front and Top of Generator Description Table ... 3
Figure 2: Back of Generator ................................................. 3
Figure 3: Side of Generator .................................................. 3
Table 2: Back and Side of Generator Description Table . 3
Display Screen Map ...................................................................3
Figure 4: Display Screen Map ............................................. 4
Table 3: Display Screen Map ............................................... 4
Audible Tones ..............................................................................4
Table 4: Tone Description ..................................................... 4
Tone Name .............................................................................. 4
Volume Control ............................................................................4
Figure 5: Volume Control ...................................................... 4
Detachable Parts and Accessories ......................................... 4
Accessories - Supplied Separately ......................................... 4
Table 5: Accessories ............................................................. 4
USING THE REZŪM GENERATOR ................................................... 4
Overview .......................................................................................4
Step by Step Instructions ..........................................................4
Turning on the Rezūm Generator ..............................................4
To Turn ON: ...................................................................................4
Figure 6: Power Button ......................................................... 5
Figure 7: Start-up Screens ................................................... 5
Figure 8: Test Screen ............................................................ 5
Figure 9: Delivery Device Setup .......................................... 5
Figure 10: Connection Message ......................................... 5
Priming the Delivery Device ......................................................5
Figure 11: Ready for Priming ................................................ 5
Figure 12: Priming Screen .................................................... 5
Figure 13: Priming Complete ................................................ 5
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Figure 14: Setup Complete Screen ..................................... 5
Performing the Therapy .............................................................5
Figure 15: Setup Complete Screen ..................................... 6
Figure 16: Ready for Treatment Screen ............................. 6
Figure 17: Treatment in Progress Screen .......................... 6
Figure 18: Pending Ready Indicator on Screen ................ 6
Turbo Flush ...................................................................................6
Connecting New Delivery Device During
Treatment Session ......................................................................6
Figure 19: New Delivery Device .......................................... 6
Turning Off the Rezūm™ Generator ......................................... 6
Figure 20: Power Button ....................................................... 6
Rezūm Generator Options Menu Items ................................... 6
Figure 21: Options Menu Button ......................................... 6
Figure 22: Options Menu Choices ....................................... 6
Drain Bladder ...............................................................................6
Figure 23: Drain Bladder Confirmation ............................... 6
Replace Saline .............................................................................6
Figure 24: Replace Saline ..................................................... 6
Remove Device ............................................................................6
Figure 25: Release Syringe .................................................. 7
Figure 26: Procedure Summary ........................................... 7
Export Procedure Record ..........................................................7
Figure 27: Export Procedure Records ................................ 7
Figure 28: Export Procedure Records Progress ............... 7
Figure 29: Export Procedure Records Success ................ 7
Figure 30: Example of Exported .txt File ............................. 7
Figure 31: Example of Exported .csv File ........................... 7
More Options ...............................................................................7
Figure 32: More Options Screen ......................................... 7
System Status ..............................................................................7
Figure 33: System Status ...................................................... 7
Set Date and Time .......................................................................7
Figure 34: Set Date and Time ............................................... 7
Set Language ...............................................................................7
Figure 35: Language Settings .............................................. 8
Figure 36: Language Selections .......................................... 8
Export Logs ...................................................................................8
Figure 37: Select Files to Export .......................................... 8
Figure 38: Reading Files ........................................................ 8
Figure 39: Export Files ........................................................... 8
Figure 40: Building Archive .................................................. 8
Figure 41: Exporting File ....................................................... 8
Figure 42: Export Successful ............................................... 8
Procedure Summary ...................................................................8
Figure 43: Procedure Summary ........................................... 8
Figure 44: Populating List ..................................................... 8
Figure 45: Procedure Summary - View .............................. 8
Treatment Monitor ......................................................................8
Treatment Config .........................................................................8
Servicing .......................................................................................9
PROPER CARE AND CLEANING ..................................................... 9
Overview .......................................................................................9
Recommended Care ...................................................................9
Visual Inspection .........................................................................9
Cleaning the Rezūm Generator .................................................9
Recommended Cleaning Products ........................................... 9
Not Recommended Cleaning Products ................................... 9
Cleaning Instructions .................................................................9
Routine Care Checklist ...............................................................9
Authorized Repair or Service ....................................................9
TECHNICAL SPECIFICATIONS ........................................................ 9
Overview .......................................................................................9
Generator Specifications ...........................................................9
Electromagnetic Compatibility and Immunity (EMC and
EMI) Requirements ...................................................................10
EN/IEC 60601-1-2 COMPLIANCE ................................................... 11
ESSENTIAL PERFORMANCE ......................................................... 11
TROUBLESHOOTING ......................................................................11
Overview .....................................................................................11
Troubleshooting Steps ..............................................................11
Error Messages .........................................................................11
Critical Error Message .............................................................11
Non-Critical Error Message ....................................................11
Informational Error Message ..................................................11
Error Message Table ................................................................12
Critical Error Messages ...........................................................12
Non-Critical Error Messages ..................................................12
Informational Error Messages ................................................13
Obtaining Technical Assistance ............................................. 14
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.

WARNING

Users of the Rezūm System should read this manual thoroughly
before attempting surgical procedure. Pay attention to all
warnings, contraindications, precautions, and adverse events
in this manual and other related material. Failure to thoroughly
understand and follow all instructions may result in harm to the
patient or the user of the system.

SAFETY

This section contains information about the Rezūm Generator
including safety. Please make sure you read this entire
operator's manual prior to using the Rezūm Generator.
Note: Field service is not available, all repairs are done at the
manufacturer.
This section contains important safety information. Boston
Scientific requires that you read and understand all warnings,
precautions, and the operator's manual prior to using the
Rezūm Generator.
1
Table 6: Routine Care Checklist........................................... 9
Table 7: Generator Specification ........................................ 9
Table 8: Electromagnetic Emissions ................................. 10
Table 9: Electromagnetic Immunity .................................. 10
Table 10: Electromagnetic Immunity ................................ 10
Table 11: Separation Distances......................................... 11
Figure 46: Example Critical Error Message ..................... 11
Figure 47: Example Non-Critical Error Message ............ 11
Figure 48: Example Informational Error Message .......... 11
Table 12: Critical Error Message Table ............................ 12
Table 13: Non-Critical Error Message Table ................... 12
Table 14: Informational Error Message Table ................. 13
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information ......................... 14
Black (K) ∆E ≤5.0