Contents; Rezūm Generator; Rezūm Delivery Device Kit; The Rezūm Procedure - Boston Scientific REZUM Mode D'emploi

CONTENTS

The Rezūm™ System consists of the following:
• Rezūm Generator (reusable)
• Rezūm Delivery Device Kit (disposable)
REZŪM GENERATOR
The portable Rezūm Generator is provided with the following reusable components
(Figure 1):
• Generator
• One Power Cord
Figure 1. Rezūm Generator.
REZŪM DELIVERY DEVICE KIT
The Rezūm Delivery Device Kit contains the following disposable components:
• One sterile Delivery Device with cable and tubing
• One sterile Syringe
• One sterile Spike Adaptor
• One Sterile Water Vial
Rezūm Delivery Device Component Functions and Specifications (Table 1).
M.
L.
A.
H.
I.
J.
K.
G.
F.
D.
Figure 2. Delivery Device Components.
Black (K) ∆E ≤5.0
B.
C.
E.
Table 1. Functional Description of the Delivery Device
Description Function
Provides enclosed channel for needle, vapor tubing,
A. Shaft
rigid scope lens and flush irrigation.
B. Tip Guides shaft into treatment area and houses needle.
Inserted into the targeted prostate tissue to deliver
C. Needle
vapor treatment.
The RF cable is the energy line and connections for
D. RF Cable
the switches and thermocouples.
Provides saline flush for irrigation through the
E. Saline Flush Line
Delivery Device.
F. Water Line Line to move water into the Delivery Device.
G. Drain Line Line to allow urine to be drained from the bladder.
Provides secure connection of rigid cystoscope lens
H. Rigid Cystoscope Lens Port
in Delivery Device.
Provides saline flush (normal, high). Top, front
I. Flush Activation Button
button (white).
Located behind the flush button, deploys the needle
J. Needle Deployment Button
into the prostate tissue. Top, back button (grey).
Activates vapor after needle has been deployed.
K. Vapor Activation Button
Bottom button (blue).
Retracts needle back into Delivery Device shaft.
L. Needle Retraction Button Grey button located on the underside of the
nose cone.
Detaches shaft from Delivery Device to allow the
M. Nose Cone Release Pin safe manual retraction of needle into shaft if Needle
Retraction Button fails.
THE REZŪM PROCEDURE

User Supplied Materials

Other materials that are typically required for the Rezūm System procedure include, but
are not limited to, the following items.
• Cart or sturdy surface for the Rezūm Generator
• Prep tray
• Topical antiseptic (e.g. Betadine)
• Patient drape
• Disposable underpads (e.g. Chux)
• Gauze squares
• Lidocaine gel anesthetic or water-soluble lubricating gel
• Saline supply at room temperature (1 L, 2 L, 3 L, 4 L, 5 L or 500 ml)
• IV pole for Saline supply
• 4 mm, 30 degree, 30 cm Storz®, InnoView® or Richard-Wolf® rigid cystoscope lens
• Light source and cord
• Video camera and display; recorder optional
• Drain bucket
• Hemostat

Preparing the Patient

1. Prior to the procedure, administer physician-preferred pain and/or anti-anxiety
medication. If using oral medications, allow sufficient time for the medications to
reach peak levels.
2. Instruct patient to completely void bladder prior to procedure.
Caution: Care should be taken during procedure to monitor the amount of saline
instilled. If bladder is not empty, overfilling of bladder may occur. The Generator helps
monitor the amount of saline instilled.
3. Ten minutes prior to the procedure, prepare and drape the patient using standard
cystoscopy guidelines.
4. Place the patient in the lithotomy position. Ensure buttocks are resting at the edge
of the table to both enable entry deep enough into the anatomy and also to allow for
easier Delivery Device rotation during the procedure.
Power Up the Rezūm Generator
1. Generator should be placed within reach of patient and an electrical outlet to
supply power to the unit.
4