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
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.
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.
6. Report all incidences of manual needle retraction to
Boston Scientific Customer Service. Clean device and return
to Boston Scientific.
Warning:
Do not remove device from the patient if the needle
is not fully retracted. In case of incomplete needle retraction,
manually retract needle before removing the device from the
patient. Do not attempt to reassemble device for reuse after
manual needle retraction.
STORAGE, HANDLING, AND DISPOSAL
Rigid Cystoscope Lens
Refer to the rigid cystoscope lens packaging insert instructions for
use for care, cleaning and handling.
Rez
ū
m™ Delivery Device
The Delivery Device is shipped sterile. If the package sterile barrier
is broken or missing, do not use the product.
The Delivery Device must not be reused or re-sterilized. It is for
single use only.
The Delivery Device is packaged for easy transfer to the sterile
field. The Delivery Device should be handled with care at all times.
The storage area should have good ventilation, store in a cool, dry,
dark place.
After use, discard the Delivery Device in accordance with local
environmental regulations for biohazards material.
Caution:
The Delivery Device is intended for single-use only.
Do not reuse, reprocess or resterilize the device. Reuse,
reprocessing or resterilization may compromise the structural
integrity of the device and/or create a risk of contamination of
the device, which could result in patient injury or illness.
Rez
ū
m Generator
1. Unplug the power cord and store the cord with the
Generator.
2. Clean the Generator as per the instructions found in the
Rez
ū
m Operator’s Manual.
3. Close the display screen to protect it from damage.
4. Store the Rez
ū
m Generator in a safe, clean and dry
location.
5. To transport the Rez
ū
m Generator, use handle to carry.
Disposal of the Product, Accessories and Packing Materials
Dispose of all products, accessories and packaging materials
in accordance with hospital, administrative and/or local
government policy.
PIVOTAL CLINICAL STUDY SUMMARY
Efficacy
The Rez
ū
m II Study was a multicenter, randomized, controlled,
double-blinded study comparing the improvement in BPH
symptoms at baseline and at 3 months post-procedure, as
measured by IPSS, for subjects in the Treatment Arm as
compared to subjects in the Control Arm. The Treatment Arm
consisted of subjects receiving injections of water vapor into
targeted zones of the prostate. The Control Arm consisted of
subjects receiving a rigid cystoscopy with simulated active
treatment sounds. The Treatment Arm demonstrated clinically,
and statistically, significant mean improvement as compared
to the Control Arm. The difference between the two arms
was highly significant and the pre-specified, 3-month primary
endpoint was met (p < 0.0001).
The graphs below summarize the Treatment Arm outcomes
through 4 years for IPSS, Qmax, and Quality of Life.
