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
Caution:
If finger is released from Vapor Activation Button
before the priming cycle is complete, vapor will automatically
stop, and the priming steps will have to be repeated.
F. If the Vapor Activation Button is released before the
end of the priming cycle, repeat the priming cycle
(steps A to E).
G. If priming cycle is not successfully completed, repeat
steps a to e or replace Delivery Device.
Perform the Pre-Treatment Vapor Cycle
1. Activate idle feature by running a pre-treatment vapor
cycle. Idle feature heats coil to keep water in a ready
state so vapor delivery is immediate. If this step is
not completed, condensation may build up between
treatments, which may lead to insufficient treatment.
2. Pull in Flush Activation Button (1) Needle Deployment
Button (2) and then Vapor Activation (3) (Figure 12).
3. During pre-treatment vapor cycle, observe flush exiting tip.
4. When pre-treatment vapor cycle is complete, release the
Vapor Activation Button and retract the needle by pushing
upward on the Needle Retraction Button.
Note:
Pre-treatment vapor cycle must be completed prior to
inserting Delivery Device into the patient.
Perform the Rez
ū
m™ Vapor Treatment
1. Confirm the Generator display is showing the Therapy Screen.
2. Coat the shaft of the Delivery Device with water-soluble
lubricating or anesthetizing gel.
3. Attach light cord and video camera to the scope lens.
4. Using finger, activate the saline flush by applying gentle
pressure to the Flush Activation Button.
5. Carefully insert the Delivery Device into the urethra
through the meatus.
Warning:
Excessive pressure while using Flush Activation
Button may cause unintended deployment of the needle.
Warning:
Ensure needle is fully retracted by viewing needle
position through scope lens. If needle is not retracted prior to
insertion of the Delivery Device, damage to urethra may occur.
Warning:
No modification of this equipment is allowed. Do not
attempt to service or maintain the generator while in use with
a patient.
6. While examining prostatic urethra, locate the apex of the
prostate and the bladder. A TRUS and/or cystoscopy prior
to the procedure can help obtain prostate measurements
to determine the appropriate number of treatments.
7. Estimate the prostatic treatment length (i.e. from bladder
neck to verumontanum). This length is considered the
vapor treatment zone (Figure 13).
Bladder Neck
Verumontanum
Figure 13. Prostatic Treatment Length.
8. Based on the length of the vapor treatment zone, determine
the number of treatments per lobe (Table 2). A treatment
consists of a single 9-second delivery of vapor.
Table 2. Guidelines for determining the number of treatments
(lateral lobe).
Distance from Bladder Neck
to Veru
Estimated Number of
Treatments per Lobe
< 2.0 cm
1-2
2.0 – 3.0 cm
2-3
> 3.0 cm
3-4
9. If a median lobe is present and judged to be in need of
treatment, deliver one treatment if median lobe is < 2 cm and
two or more treatments if median lobe is > 2 cm. If central zone
hyperplasia contributes to an elevated bladder neck with a
prostatic urethral ≥ 35 degrees, as evidenced by sagittal TRUS,
deliver one treatment for an enlarged central zone < 2 cm and
two treatments for an enlarged central zone > 2 cm.
Caution:
Treatments in excess of those recommended in the guidelines
may lead to prolonged irritative symptoms and/or catheterization.
Note:
A maximum number of 15 full treatments can be delivered
with each Delivery Device.
Figure 14. Illustrative example of 6 Vapor Treatments.
Warning:
Proper placement of the needle is essential. Do not
direct the needle downward toward the rectum.
10. Start the procedure by positioning the tip of the device just
inside the bladder. Rotate the Delivery Device 90 degrees
(horizontal) and bring device shaft just off floor of urethra.
11. While maintaining the 90 degree rotation, pull Delivery Device
back into the urethra and position 1 cm back from the bladder
neck. If treatment occurs within 1 cm of the bladder neck,
short-term irritative symptoms may be experienced by the
patient. Place the distal tip of the Delivery Device shaft against
the lateral urethral wall.
Note:
Optimal placement for the vapor treatment is in the crest of
the lateral lobe. Ensure the shaft of the device is not close to the
anterior surface, as this may lead to a sub-optimal treatment.
Note:
On occasion, patient prostatic anatomy may restrict the
Delivery Device tip from reaching the bladder neck. This may be
due to an elevated bladder neck from central zone hyperplasia
or a median lobe. On these occasions, do not force the device
through tissue. Ensure the Delivery Device tip is proximal to the
verumontanum and treat the bulk of the lateral lobe proximal to the
verumontanum. Advance the Delivery Device in 1 cm increments
toward the bladder neck to deliver subsequent vapor treatments.
This may relax the tissue to allow the Delivery Device to reach the
bladder neck. If the Delivery Device still cannot reach the bladder
neck, treat the area that is proximal to the verumontanum.
12. Stabilize the Delivery Device before deploying the needle and
remain completely still throughout the treatment.
13. While holding the Flush Activation Button, continue to pull in
the Needle Deployment Button until the needle is deployed.
14. Visually verify the needle is fully inserted into the prostate by
inspecting to see that the black depth marker just proximal to
the emitter holes is not visible (no black should be seen).
Warning:
Do not start treatment if the black depth marker on the
needle is still visible after needle deployment. If the marker is still
visible, push the needle deeper into the prostate until no black
is visible through the lens. If unable to position correctly retract
needle. Reposition Delivery Device approximately 1 cm from the
partially treated site and repeat needle deployment steps.
15. Using finger, pull in Vapor Activation Button and hold to
activate the vapor until treatment cycle is complete.
Caution:
Once needle is deployed, hold the Delivery Device
steady. Movement of the Delivery Device may stretch tissue and
cause vapor to leak into the urethra, causing urethral irritation.
Extreme movement may also cause pressure on the needle
resulting in difficulty with needle retraction. Needle must be
returned to the original insertion position to facilitate retraction.
Note:
When the vapor treatment begins, the Rez
ū
m System
automatically tracks the time until the programmed treatment
is complete and then automatically shuts off the vapor.
Vapor can be stopped prior to treatment completion if Vapor
Activation Button is released.
Caution:
Do not release Vapor Activation Button during vapor
treatment cycle. If Vapor Activation Button is released before
the cycle is complete, vapor release will automatically stop,
which may lead to partial and incomplete treatment.
16. The display screen will show each individual treatment time
and count the number of full treatments that were completed.
17. Release Vapor Activation button and push upward on the
Needle Retraction Button to retract the needle.
Warning:
Ensure needle is fully retracted by viewing needle
position through scope lens. If needle is not retracted prior to
repositioning Delivery Device, damage to urethra may occur.
18. Reposition the Delivery Device for the next treatment by
moving the device tip approximately 1 cm distal to the
previous needle placement. The objective is to create
contiguous, overlapping lesions, 1 cm apart, and running
parallel to the prostatic urethra.
19. Maintain device rotation at 90 degrees between treatments
to avoid losing sight of previous treatment location.
20. Follow the natural slope of the urethra to avoid being too
close to the ceiling, i.e. too anterior. Center the needle
between the floor and ceiling of the urethra and target the
bulk of the adenoma directly if it is not centered.
21. Complete steps 10-20 until all treatments in the first lateral
lobe are complete. The final treatment location within each
lobe should be on the proximal side of the verumontanum.
Warning:
Prior to each treatment, know where the
verumontanum is in relation to the tip of the shaft. All
treatments should be placed proximal to the verumontanum.
22. Return Delivery Device to the start position at the bladder
neck for treatments in the contralateral lobe. Rotate the
Delivery Device 90 degrees to enable needle insertion at
desired location on opposite lobe.
23. Repeat steps 10 through 20 until second lobe is fully treated.
24. For intravesical prostatic protrusions of either the lateral
or median lobes, position Delivery Device 1 cm from the
proximal edge of the protrusion and deliver the vapor
treatment with the needle positioned approximately 45
degrees toward the midline. One treatment for a small
median lobe (< 2 cm) and two or more treatments for a
larger median lobe (> 2 cm). For an enlarged central zone,
deliver treatments 1 cm from the bladder neck with the
needle positioned at 45 degrees toward the midline of the
tissue. Do not treat on the floor of the urethra within at
least 1 cm of the verumontanum.
Caution:
Care should be taken during procedure to monitor
remaining saline level. If saline source is empty, patient could
experience urethral discomfort due to no flush flow.
25. With lens in place, visually inspect the urethra and bladder
at the end of the treatment and withdraw the Delivery
Device from the urethra.
26. To conclude procedure, select Remove Device on
Generator screen and follow instructions.
