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
Note:
Bag spike is NOT needed; spike is pre-attached to
Delivery Device Saline Line Tubing.
Caution:
Saline should be at room temperature. Do not use
cold saline, as it may reduce the effectiveness of the therapy.
Unpack Contents of Delivery Device Kit
Warning:
Do not use the Delivery Device and its contents if
the packaging’s sterile barrier is broken, the seal is damaged,
or the device is damaged.
Caution:
The exterior of the Sterile Water Vial is not sterile and
should not be placed in the sterile field.
1. Prior to opening, inspect the integrity of the outside and
inside packaging to ensure sterility. Do not use if the
packaging is damaged.
2. Lay out sterile field and place lubricating gel in sterile field.
3. Remove the Sterile Water Vial from the corner of the box.
Remove the cover from the water vial and wipe with a
sterile wipe. Place bottle outside of the sterile field.
4. Using sterile technique, remove the Tyvek® cover from the
tray and remove and discard retainer tray.
Prepare the Syringe
1. Using appropriate aseptic practices, remove Syringe and
Spike adaptor.
2. Connect Spike adaptor to Syringe. Ensure connection ends
remain sterile.
3. Remove protective cover from Spike and insert Spike into
Sterile Water Vial.
4. Invert Sterile Water Vial and slowly pull back plunger
shaft to fill Syringe (Figure 5). Remove plunger shaft once
Syringe is filled.
50 mL Single-dose
FOR DRUG DILUGNT USE
1
50 m
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FOR
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UG D
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2
50 m
L Si
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FOR
DR
UG D
ILU
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E
4
50 m
L Si
ngle
-do
se
FOR
DR
UG D
ILU
GNT
US
E
3
50 m
L Si
ngle
-do
se
FOR
DR
UG D
ILU
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6
50 m
L Si
ngle
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FOR
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UG D
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5
Figure 5. Filling the syringe.
Caution:
Ensure air bubbles are removed from the syringe.
If bubbles are trapped in the line, an insufficient treatment
may result.
5. Keeping the Syringe connected to the Spike Adaptor and
Sterile Water Vial, set aside outside the sterile field.
Set Up the Rez
ū
m™ Delivery Device
1. Remove the Delivery Device RF cable and plug into
generator, ensuring white dot on the top of the plug is
aligned with red dot on the generator port (Figure 6).
Figure 6. Connecting cable into Generator.
2. Ensure needle has retracted on Delivery Device.
3. Remove Saline Flush Line and Water Line from tray.
4. Place the Saline Flush Line in the Saline Pump. Ensure
Saline Flush Line is seated such that the Saline Pump
door can close smoothly. Align the color indicators on the
generator and saline flush line (Figure 7).
Figure 7. Loading Saline Flush Line into Saline Pump.
Caution:
Use indicators on Generator to ensure Saline Flush Line is
positioned in the correct direction. If Saline Flush Line is placed in
a backwards direction within the Saline Pump, saline will not flow
during procedure.
5. Close Saline Pump door prior to attaching Saline Flush Line tip
to the Saline bag.
Note:
If Saline Flush Line tip is attached to Saline bag prior to
placing Saline Flush Line in the Saline Pump and closing the Saline
Pump door, saline may leak.
6. Remove cap from tip of Saline Flush Line and attach to the saline
source (Figure 8). Ensure clamp on Saline Flush Line is open.
Figure 8. Connecting Saline Flush Line to Saline Bag.
7. Remove Spike Adaptor and Sterile Water Vial from Syringe.
8. Load the filled Syringe into the Syringe cradle (Figure 9).
2
1
Figure 9. Loading Syringe.
Note:
Syringe luer should be positioned on top of the Syringe to
push fluid out of the Syringe.
9. Remove cap from Water Line luer and connect Syringe to
Water Line by twisting the luer on the prefilled Syringe.
Pressure relief valve on Water Line should be pointing down.
10. Using sterile technique, close clamp on Drain Line to ensure
saline flows through Delivery Device during the procedure
(Figure 10).
Figure 10. Closing clamp on Drain Line.
11. Using sterile technique, remove Delivery Device from
packaging tray.
Insert the Rigid Cystoscope Lens
The Delivery Device is compatible with a 4 mm, 30 degree, 30
cm length Storz® or Richard-Wolf® rigid cystoscope lens.
The lens provides direct or video display visualization to help
the physician position the Delivery Device needle within the
prostatic urethra.
Caution:
The Delivery Device is compatible with a 4 mm, 30
degree, 30 cm Storz or Richard-Wolf cystoscopic lens.
Use of other scope lenses may impact performance of the
Delivery Device.
1. Inspect and ensure lens is cleaned and prepared per
manufacturer’s instructions prior to use.
2. Coat lens shaft near lens tip with lidocaine gel anesthetic
or water soluble lubrication to ensure smooth insertion
into Delivery Device. Do not coat the lens itself, as this may
impede visualization (Figure 11).
RX
Figure 11. Insert Rigid Cystoscope Lens.
3. Gently insert the lens into the lens port and advance into
position until it snaps into place.
Priming the Delivery Device
Warning:
Point the Delivery Device tip away from patient or
personnel during the priming cycle. Vapor coming out of the
tip is hot and can burn the skin.
1. Prime the Delivery Device using the following steps (Figure 12):
Figure 12. Steps for Activating Vapor Treatment.
A. Hold tip of Delivery Device over a liquid waste container.
Note:
Ensure tip remains sterile.
B. Pull in Flush Activation Button (1) and Needle
Deployment Button (2) until needle is deployed. Release
both buttons once needle is deployed.
C. Pull in Vapor Activation Button (3) and hold to activate
the vapor until the display screen indicates the priming
cycle is complete (approximately 30 seconds).
D. Toward the end of the priming cycle, visually verify
vapor is coming out of the needle tip.
E. When priming cycle is complete, release the Vapor
Activation Button and retract the Needle by pushing
upward on the Needle Retraction Button.
