Post Procedure; Method For Draining The Bladder; Method For Clearing Visual Field And/Or Removing A Clot; Method For Manual Needle Retraction - Boston Scientific REZUM Mode D'emploi

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.

Post Procedure

1. Remove the Delivery Device from the urethra.
2. Remove the cystoscopic lens for cleaning and reprocessing.
3. Transfer procedure summary information to a portable USB memory device (Optional).
4. Disconnect the Delivery Device electrical cable from the Generator.
5. Open roller pump door and remove Saline Flush Line from pump.
6. Remove Syringe and Water Line from syringe cradle.
7. Dispose of Delivery Device and Syringe.
Caution: After use, this product may be a potential biohazard. Handle and dispose of
in accordance with acceptable medical practices and applicable local, state, and
federal guidelines.
8. Turn the Generator off.
9. Disconnect the Generator from the electrical outlet.

METHOD FOR DRAINING THE BLADDER

If necessary during treatment, the bladder can be drained through the Delivery Device.
1. Ensure needle is retracted.
2. Place the tip of the Delivery Device in the bladder to drain.
3. Unclamp the drain line.
4. Remove scope lens to expedite draining of the bladder.
5. Select Drain Bladder on Generator to reset Saline Instilled.
6. When finished draining the bladder, reclamp the drain line.

METHOD FOR CLEARING VISUAL FIELD AND/OR REMOVING A CLOT

1. To clear bubbles from the field of vision and/or to remove a clot, activate the Turbo
Flush feature by double tapping and holding the Flush Activation Button.
2. When visualization is cleared, release Flush Activation Button. Flush will run at
normal rate the next time the Flush Activation Button is engaged.
Black (K) ∆E ≤5.0

METHOD FOR MANUAL NEEDLE RETRACTION

In the event the Needle Retraction Button fails to retract the needle fully into the Delivery
Device shaft, follow the steps below to manually retract the needle into the Delivery
Device shaft before removing the Delivery Device from the urethra. This should not
occur under normal use and is designed only as a backup in case of device malfunction.
1. Disconnect Delivery Device Electrical Cable from the Generator.
2. Using a hemostat or other device, pull down and remove the release pin located
below the nose cone to disengage the shaft assembly from the Delivery Device
handle (Figure 15).
Figure 15. Pulling Down Release Pin.
3. Hold the shaft firmly in position and withdraw the handle just sufficiently to draw
the needle into the shaft tip (1 inch minimum) (Figure 16).
Figure 16. Holding Shaft Steady in Patient, Withdraw the Handle

Just Sufficiently to Draw the Needle into the Shaft Tip (1 inch minimum).

Figure 17. Holding Shaft Steady in Patient, Pull Needle Driver

Out of Shaft to Retract Needle Into Tip.

Note: As the handle is being withdrawn, if the distal end of the needle body (in the
handle) detaches from the handle and the proximal end of the needle is not drawn into
the shaft tip, pull on the beige, right-angled plastic tube protruding from the shaft to
manually retract the proximal end of the needle into the shaft tip (Fig. 17).
4. While maintaining the needle tip within the shaft, remove Delivery Device from patient.
5. If treatment is incomplete, re-start procedure with new Delivery Device and
complete procedure.
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