Table Des Matières - Boston Scientific REZUM Mode D'emploi

TABLE OF CONTENTS
WARNING ......................................................................................................................................3
SAFETY ...........................................................................................................................................3
WARNINGS ....................................................................................................................................3
PRECAUTIONS...............................................................................................................................3
INDICATIONS FOR USE ................................................................................................................3
CONTRAINDICATIONS .................................................................................................................3
THE REZŪM™ SYSTEM OVERVIEW ..........................................................................................3
CONTENTS .....................................................................................................................................4
REZŪM GENERATOR ....................................................................................................................4
Figure 1. Rezūm Generator. ...............................................................................................4
REZŪM DELIVERY DEVICE KIT ...................................................................................................4
Figure 2. Delivery Device Components. ..........................................................................4
Table 1. Functional Description of the Delivery Device ................................................4
THE REZŪM PROCEDURE ............................................................................................................4
User Supplied Materials .........................................................................................................4
Preparing the Patient .............................................................................................................4
Power Up the Rezūm Generator ...........................................................................................4
Figure 3. Power up the Rezūm Generator. ......................................................................5
Prepare the Sterile Saline Bag ..............................................................................................5
Figure 4. Hang the saline bag on IV pole. .......................................................................5
Unpack Contents of Delivery Device Kit ..............................................................................5
Prepare the Syringe ................................................................................................................5
Figure 5. Filling the syringe. ..............................................................................................5
Set Up the Rezūm Delivery Device .......................................................................................5
Figure 6. Connecting cable into Generator. ...................................................................5
Figure 7. Loading Saline Flush Line into Saline Pump. ................................................5
Figure 8. Connecting Saline Flush Line to Saline Bag. ................................................6
Figure 9. Loading Syringe. ................................................................................................6
Figure 10. Closing clamp on Drain Line. .........................................................................6
Insert the Rigid Cystoscope Lens ..........................................................................................6
Figure 11. Insert Rigid Cystoscope Lens. .......................................................................6
Priming the Delivery Device ...................................................................................................6
Figure 12. Steps for Activating Vapor Treatment. .........................................................6
Perform the Pre-Treatment Vapor Cycle ..............................................................................6
Black (K) ∆E ≤5.0
Perform the Rezūm Vapor Treatment ...................................................................................7
Figure 13. Prostatic Treatment Length. ..........................................................................7
Table 2. Guidelines for determining the number of treatments (lateral lobe). ..........7
Figure 14. Illustrative example of 6 Vapor Treatments. ................................................7
Post Procedure ........................................................................................................................8
METHOD FOR DRAINING THE BLADDER .................................................................................8
METHOD FOR CLEARING VISUAL FIELD AND/OR REMOVING A CLOT ...............................8
METHOD FOR MANUAL NEEDLE RETRACTION ......................................................................8
Figure 15. Pulling Down Release Pin. .............................................................................8
Figure 16. Holding Shaft Steady in Patient, Withdraw the Handle
Just Sufficiently to Draw the Needle into the Shaft Tip (1 inch minimum). ...............8
Figure 17. Holding Shaft Steady in Patient, Pull Needle Driver
Out of Shaft to Retract Needle Into Tip. ..........................................................................8
STORAGE, HANDLING, AND DISPOSAL ...................................................................................9
Rigid Cystoscope Lens ............................................................................................................9
Rezūm Delivery Device ...........................................................................................................9
Rezūm Generator .....................................................................................................................9
Disposal of the Product, Accessories and Packing Materials ........................................9
PIVOTAL CLINICAL STUDY SUMMARY ....................................................................................9
Efficacy ......................................................................................................................................9
Graph 1. Mean IPSS Over Time. ......................................................................................9
Graph 2. Mean Qmax Over Time. .....................................................................................9
Graph 3. Mean QoL Over Time. ........................................................................................9
REPORTED ADVERSE EVENTS ...................................................................................................9
Table 3. All Adjudicated Procedure and/or Device Related AEs for Treatment and
Crossover Subjects Through 4 Year Follow-up. ...........................................................10
Other Potential Adverse Events ..........................................................................................10
Pain Management .................................................................................................................10
Table 4. Types of Medication Used. ...............................................................................10
Catheterization .......................................................................................................................10
Table 5. Catheterization. ..................................................................................................10
Subsequent Treatments ........................................................................................................10
Graph 4. Subsequent Retreatments (Cumulative). ......................................................10
Supplier's Declaration of Conformity
47 CFR § 2.1077 Compliance Information ......................................................................10
WARRANTY .................................................................................................................................11
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