Boston S
cientific (Master Brand DFU
Template 8.2677in x 1
1.6929in
A4, 9223851
9A), eDFU
, MB, R
ez
ū
m, en, 50849555-0
1A
Black (K) ∆E ≤5.0
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
Figure 2. Delivery Device Components.
Table 1. Functional Description of the Delivery Device
Description
Function
A. Shaft
Provides enclosed channel for needle, vapor tubing, rigid scope lens and flush irrigation.
B. Tip
Guides shaft into treatment area and houses needle.
C. Needle
Inserted into the targeted prostate tissue to deliver vapor treatment.
D. RF Cable
The RF cable is the energy line and connections for the switches and thermocouples.
E. Saline Flush Line
Provides saline flush for irrigation through the 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.
H. Rigid Cystoscope Lens Port
Provides secure connection of rigid cystoscope lens in Delivery Device.
I. Flush Activation Button
Provides saline flush (normal, high). Top, front button (white).
J. Needle Deployment Button
Located behind the flush button, deploys the needle into the prostate tissue. Top, back button (grey).
K. Vapor Activation Button
Activates vapor after needle has been deployed. Bottom button (blue).
L. Needle Retraction Button
Retracts needle back into Delivery Device shaft. Grey button located on the underside of the
nose cone.
M. Nose Cone Release Pin
Detaches shaft from Delivery Device to allow the safe manual retraction of needle into shaft if
Needle Retraction Button fails.
USER SUPPLIED MATERIALS
Other materials that are typically required for the Rez
ū
m™ System procedure include, but are not limited to, the following items.
• Cart or sturdy surface for the Rez
ū
m 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® 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 Rez
ū
m Generator
1. Generator should be placed within reach of patient and an
electrical outlet to supply power to the unit.
2. Place prep tray or cart near the Generator.
3. Open the display screen.
4. Plug the power cord from the Generator into an electrical
outlet (Figure 3).
Figure 3. Power up the Rez
ū
m Generator.
5. Turn on the Generator.
6. The Generator is in an inactive state until a valid Delivery
Device is connected.
Prepare the Sterile Saline Bag
1. Obtain a brand new bag of saline fluid. 500 mL, 1000 mL,
2000 mL, 3000 mL, 4000 mL and 5000 mL volume options are
compatible with the Rez
ū
m Generator.
2. Hang bag on an IV pole (Figure 4).
Figure 4. Hang the saline bag on IV pole.
