Table Des Matières - Boston Scientific Rezum Manuel D'utilisation

TABLE OF CONTENTS
WARNING ......................................................................................................................................4
SAFETY ...........................................................................................................................................4
DANGER .........................................................................................................................................4
DEVICE DESCRIPTION .................................................................................................................4
INTENDED USE/INDICATIONS FOR USE ..................................................................................4
CONTRAINDICATIONS .................................................................................................................4
WARNINGS ....................................................................................................................................4
PRECAUTIONS...............................................................................................................................4
CAUTIONS .....................................................................................................................................4
ADVERSE EVENTS ........................................................................................................................5
Reported Adverse Events ......................................................................................................5
HOW SUPPLIED.............................................................................................................................5
Handling and Storage .............................................................................................................5
User Interface Symbols ..........................................................................................................5
Symbol ..................................................................................................................................5
Description ...........................................................................................................................5
OPERATOR TRAINING REQUIREMENTS ...................................................................................5
OPERATIONAL INSTRUCTIONS..................................................................................................6
GETTING STARTED ..................................................................................................................6
Overview ...................................................................................................................................6
Unpacking and Inspecting .....................................................................................................6
Generator Controls and Connections ...................................................................................6
Figure 1: Front and Top of Generator ...............................................................................6
Table 1: Front and Top of Generator Description Table ................................................6
Figure 2: Back of Generator ..............................................................................................6
Figure 3: Side of Generator ...............................................................................................6
Table 2: Back and Side of Generator Description Table ...............................................6
Display Screen Map ................................................................................................................6
Figure 4: Display Screen Map ...........................................................................................7
Table 3: Display Screen Map ............................................................................................7
Audible Tones ...........................................................................................................................7
Table 4: Tone Description ..................................................................................................7
Volume Control .........................................................................................................................7
Figure 5: Volume Control ....................................................................................................7
Detachable Parts and Accessories ......................................................................................7
Detachable Parts - Supplied with the Rezūm™ Generator ..............................................7
Table 5: Detachable Parts .................................................................................................7
Accessories - Supplied Separately ......................................................................................7
Table 6: Accessories ..........................................................................................................7
USING THE REZŪM GENERATOR ...............................................................................................7
Overview ...................................................................................................................................7
Step by Step Instructions .......................................................................................................7
Turning on the Rezūm Generator ..........................................................................................8
To Turn On: ................................................................................................................................8
Figure 6: Power Button ......................................................................................................8
Figure 7: Start-up Screens ................................................................................................8
Figure 8: Test Screen ..........................................................................................................8
Figure 9: Delivery Device Setup .......................................................................................9
Figure 10: Connection Message .......................................................................................9
Priming the Delivery Device ...................................................................................................9
Figure 11: Ready for Priming .............................................................................................9
Figure 12: Priming Screen .................................................................................................9
Figure 13: Priming Complete .............................................................................................9
Figure 14: Setup Complete Screen ...................................................................................9
Performing the Therapy ..........................................................................................................9
Figure 15: Setup Complete Screen .................................................................................10
Figure 16: Ready for Treatment Screen .........................................................................10
Figure 17: Treatment in Progress Screen .....................................................................10
Figure 18: Pending Ready Indicator on Screen ...........................................................10
Turbo Flush ..............................................................................................................................10
Black (K) ∆E ≤5.0
Connecting New Delivery Device During Treatment Session ........................................10
Figure 19: New Delivery Device .....................................................................................10
Turning Off the Rezūm Generator........................................................................................10
Figure 20: Power Button ..................................................................................................10
Rezūm Generator Options Menu Items ..............................................................................10
Figure 21: Options Menu Button .....................................................................................10
Figure 22: Options Menu Choices ..................................................................................11
Drain Bladder .........................................................................................................................11
Figure 23: Drain Bladder Confirmation ..........................................................................11
Replace Saline .......................................................................................................................11
Figure 24: Replace Saline ................................................................................................11
Remove Device ......................................................................................................................11
Figure 25: Release Syringe ..............................................................................................11
Figure 26: Procedure Summary ......................................................................................11
Export Procedure Record .....................................................................................................11
Figure 27: Export Procedure Records ............................................................................11
Figure 28: Export Procedure Records Progress ..........................................................12
Figure 29: Export Procedure Records Success ...........................................................12
Figure 30: Example of Exported .txt File .........................................................................12
Figure 31: Example of Exported .csv File .......................................................................12
More Options ..........................................................................................................................12
Figure 32: More Options Screen .....................................................................................12
System Status .........................................................................................................................12
Figure 33: System Status .................................................................................................12
Set Date and Time ..................................................................................................................12
Figure 34: Set Date and Time ..........................................................................................12
Set Language ..........................................................................................................................12
Figure 35: Language Settings ..........................................................................................13
Figure 36: Language Selections .....................................................................................13
Export Logs .............................................................................................................................13
Figure 37: Select Files to Export .....................................................................................13
Figure 38: Reading Files ...................................................................................................13
Figure 39: Export Files ......................................................................................................13
Figure 40: Building Archive .............................................................................................13
Figure 41: Exporting File ...................................................................................................13
Figure 42: Export Successful ...........................................................................................13
Procedure Summary .............................................................................................................13
Figure 43: Procedure Summary ......................................................................................14
Figure 44: Populating List .................................................................................................14
Figure 45: Procedure Summary - View ..........................................................................14
Treatment Monitor .................................................................................................................14
Treatment Config ....................................................................................................................14
Servicing .................................................................................................................................14
PROPER CARE AND CLEANING ...............................................................................................14
Overview .................................................................................................................................14
Recommended Care ..............................................................................................................14
Visual Inspection ...................................................................................................................14
Cleaning the Rezūm Generator ...........................................................................................14
Recommended Cleaning Products .....................................................................................14
Not Recommended Cleaning Products ..............................................................................15
Cleaning Instructions ............................................................................................................15
Routine Care Checklist ..........................................................................................................15
Table 7: Routine Care Checklist ......................................................................................15
Authorized Repair or Service ...............................................................................................15
TECHNICAL SPECIFICATIONS ..................................................................................................15
Overview .................................................................................................................................15
Generator Specifications .....................................................................................................15
Table 8: Generator Specification ....................................................................................15
Electromagnetic Compatibility Requirements ...................................................................15
Table 9: Electromagnetic Emissions ..............................................................................15
Table 10: Electromagnetic Immunity ..............................................................................16
Table 11: Electromagnetic Immunity ..............................................................................16
Table 12: Separation Distances ......................................................................................17
2