50849555-01
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
ONLY
Caution:
Federal Law (USA) restricts this device to sale by or on
the order of a physician.
WARNING
Contents supplied STERILE using an ethylene oxide (EO)
process. Do not use if sterile barrier is damaged. If damage is
found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
SAFETY
This section contains important safety information. Boston
Scientific requires that you read and understand all warnings,
cautions, precautions and the operator’s manual prior to using
the Rez
ū
m System.
WARNINGS
Training:
Boston Scientific requires physician training specific
to the Rez
ū
m System procedure prior to use. Please contact
Boston Scientific for more information.
Familiarity with Cystoscopic Procedures:
Users should be
familiar with cystoscopic procedures and techniques for treating
benign prostatic hyperplasia before using the Rez
ū
m System.
Use Under Prescription:
Federal Law restricts this device to
sale and use by or on the order of a physician (or properly
licensed practitioner).
Tissue Healing After Biopsy or Prior Prostate Surgery:
After
biopsy or prior prostate surgery, allow tissue to heal (e.g. 30
days) prior to performing Rez
ū
m System procedure.
Priming Cycle:
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.
Flush Button Pressure:
Excessive pressure while using Flush
Activation Button may cause unintended deployment of the needle.
Needle Placement:
Proper placement of the needle is essential.
Do not direct the needle downward toward the rectum.
Location of Verumontanum:
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.
Needle Tip:
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,
deliver vapor for ~4 seconds to devascularize the site, then
retract needle by pressing upward on the Needle Retraction
Button. Reposition Delivery Device approximately 1 cm from
the partially treated site and repeat needle deployment steps.
Needle Retraction:
Prior to starting procedure, the needle
should be fully retracted. During procedure, 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.
Sterility/Damaged Packaging:
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.
Manual Needle Retraction:
Do not remove device from the patient
if the needle is not fully retracted. In case of incomplete needle
retraction, manually retract the needle before removing the device
from the patient. For instructions on how to manually retract the
needle, see Method for Manual Needle Retraction section. Do not
attempt to reassemble device for reuse after manual needle retraction.
Service or Maintenance While in Use in Patient:
No modification of
this equipment is allowed. Do not attempt to service or maintain the
Generator while in use with a patient.
Urethral Strictures:
Urethral strictures should be ruled out as a
cause of obstruction prior to treatment with Rez
ū
m.
PRECAUTIONS
Prior Radiation:
There is no data on the use of this treatment in patients
who have undergone prior radiation therapy in the pelvic region.
Single-Use Only Device:
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.
Exterior Surface of Sterile Water Vial:
The exterior of the Sterile
Water Vial is not sterile and should not be placed in the sterile field.
Positioning Saline Flush Line in Saline Pump:
Reference 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.
Remaining Saline Level in Bag:
Care should be taken during
procedure to monitor remaining saline level in bag. If saline bag
is empty, patient could experience urethral discomfort due to no
flush flow.
Movement of Delivery Device:
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, possibly
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.
Overfilling of Bladder:
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.
Continued or Worsening of LUTS:
During healing phase, patient
may experience a continued or worsening of LUTS, which may
require the use of a catheter for several days. Cystoscopic
intervention during the healing phase may also lead to continued or
worsening of LUTS. For more information on these types of events
in the clinical study, please refer to the Clinical Summary section
of the DFU.
Room Temperature Saline:
Saline should be at room temperature. Do
not use cold saline, which may reduce the effectiveness of the therapy.
Scope Lens:
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.
Priming Cycle:
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.
Vapor Activation:
Do not release Vapor Activation button during
vapor treatment cycle. If Vapor Activation Button is released before
treatment cycle is complete, vapor release will automatically stop,
which may lead to partial and incomplete treatment.
Air Bubbles in Syringe:
Ensure air bubbles are removed from the
syringe. If bubbles are trapped in the line, an insufficient treatment
may result.
Excessive Treatments:
Treatments in excess of those recommended
in the guidelines may lead to prolonged irritative symptoms
and/or catheterization.
Disposal Instructions:
After use, this product should be treated
as a potential biohazard. Handle and dispose of in accordance
with acceptable medical practices and applicable local, state and
federal guidelines.
INDICATIONS FOR USE
The Rez
ū
m System is intended to relieve symptoms,
obstructions, and reduce prostate tissue associated with
benign prostatic hyperplasia (BPH). It is indicated for men ≥
50 years of age with a prostate volume 30 cm
3
≤ 80 cm
3
. The
Rez
ū
m System is also indicated for treatment of prostate with
hyperplasia of the central zone and/or a median lobe.
CONTRAINDICATIONS
The use of the Rez
ū
m System is contraindicated for the following:
• Patients with a urinary sphincter implant
• Patients who have a penile prosthesis
• Patients who have an active urinary tract infection
THE REZ
Ū
M SYSTEM OVERVIEW
The Rez
ū
m System is designed to treat patients with
bothersome urinary symptoms associated with BPH. The
Rez
ū
m System utilizes radiofrequency current to generate
“wet” thermal energy in the form of water vapor, which is
then injected into the transition zone and/or median lobe of the
prostate tissue in controlled 9-second doses. The vapor that is
injected into the prostate tissue rapidly disperses through the
interstitial space between the tissue cells. As the vapor cools,
it condenses immediately on contact with tissue and the stored
thermal energy is released, denaturing the cell membranes and
causing cell death.
The denatured cells are absorbed by the body, which reduces
the volume of prostate tissue adjacent to the urethra. The vapor
condensation process also causes a rapid collapse of vasculature
in the treatment zone, resulting in a bloodless procedure.
CONTENTS
• Rez
ū
m Generator (reusable)
• Rez
ū
m Delivery Device Kit and Accessory (disposable)
REZ
Ū
M GENERATOR
The portable Rez
ū
m Generator is provided with the following
reusable components (Figure 1):
• Generator
• One Power Cord
Figure 1. Rez
ū
m Generator.
REZ
Ū
M DELIVERY DEVICE KIT
The Rez
ū
m Delivery Device Kit contains the following
disposable components:
• One sterile Delivery Device with cable and tubing
• One sterile Syringe
• One sterile Spike Adaptor
• One Sterile Water Vial
Rez
ū
m Delivery Device Component Functions and
Specifications (Figure 2).
rez
ū
m
™
2019-05
<
en
>
Delivery Device Kit for BPH
