Boston Scientific rezum G2200-003 User manual

51230807-01 Rev. A
1
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ∆E ≤5.0
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
WARNING
Users of the Rez ū m System should read this manual thoroughly
before attempting surgical procedure. Pay attention to all
warnings, contraindications, precautions, and adverse events
in this manual and other related material. Failure to thoroughly
understand and follow all instructions may result in harm to the
patient or the user of the system.
SAFETY
This section contains information about the Rez ū m Generator
including safety. Please make sure you read this entire
operator’s manual prior to using the Rez ū m Generator.
Note: Field service is not available, all repairs are done at the
manufacturer.
This section contains important safety information. Boston
Scientific requires that you read and understand all warnings,
precautions, and the operator’s manual prior to using the
Rez ū m Generator.
rezūūm™
Generator
TABLE OF CONTENTS
TABLE OF CONTENTS.......................................................................1
WARNING ..........................................................................................1
SAFETY ...............................................................................................1
DANGER .............................................................................................2
DEVICE DESCRIPTION......................................................................2
INTENDED USE/INDICATIONS FOR USE ......................................2
CONTRAINDICATIONS.....................................................................2
WARNINGS........................................................................................2
PRECAUTIONS...................................................................................2
ADVERSE EVENTS ............................................................................2
HOW SUPPLIED.................................................................................2
Handling and Storage.................................................................2
User Interface Symbols .............................................................3
OPERATOR TRAINING REQUIREMENTS.......................................3
OPERATIONAL INSTRUCTIONS......................................................3
GETTING STARTED .....................................................................3
Overview.......................................................................................3
Unpacking and Inspecting.........................................................3
Generator Controls and Connections ......................................3
Figure 1: Front and Top of Generator..................................3
Table 1: Front and Top of Generator Description Table...3
Figure 2: Back of Generator................................................. 3
Figure 3: Side of Generator.................................................. 3
Table 2: Back and Side of Generator Description Table.3
Display Screen Map ................................................................... 3
Figure 4: Display Screen Map .............................................4
Table 3: Display Screen Map...............................................4
Audible Tones ..............................................................................4
Table 4: Tone Description.....................................................4
Tone Name..............................................................................4
Volume Control ............................................................................4
Figure 5: Volume Control ......................................................4
Detachable Parts and Accessories ......................................... 4
Accessories - Supplied Separately .........................................4
Table 5: Accessories.............................................................4
USING THE REZ Ū M GENERATOR...................................................4
Overview.......................................................................................4
Step by Step Instructions ..........................................................4
Turning on the Rez ū m Generator..............................................4
To Turn ON:...................................................................................4
Figure 6: Power Button......................................................... 5
Figure 7: Start-up Screens................................................... 5
Figure 8: Test Screen ............................................................5
Figure 9: Delivery Device Setup.......................................... 5
Figure 10: Connection Message .........................................5
Priming the Delivery Device......................................................5
Figure 11: Ready for Priming................................................ 5
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Figure 12: Priming Screen.................................................... 5
Figure 13: Priming Complete................................................ 5
Figure 14: Setup Complete Screen .....................................5
Performing the Therapy ............................................................. 5
Figure 15: Setup Complete Screen .....................................6
Figure 16: Ready for Treatment Screen .............................6
Figure 17: Treatment in Progress Screen..........................6
Figure 18: Pending Ready Indicator on Screen................6
Turbo Flush...................................................................................6
Connecting New Delivery Device During
Treatment Session ......................................................................6
Figure 19: New Delivery Device.......................................... 6
Turning Off the Rez ū m™ Generator ......................................... 6
Figure 20: Power Button....................................................... 6
Rez ū m Generator Options Menu Items...................................6
Figure 21: Options Menu Button .........................................6
Figure 22: Options Menu Choices.......................................6
Drain Bladder...............................................................................6
Figure 23: Drain Bladder Confirmation...............................6
Replace Saline.............................................................................6
Figure 24: Replace Saline..................................................... 6
Remove Device............................................................................6
Figure 25: Release Syringe ..................................................7
Figure 26: Procedure Summary........................................... 7
Export Procedure Record .......................................................... 7
Figure 27: Export Procedure Records ................................7
Figure 28: Export Procedure Records Progress...............7
Figure 29: Export Procedure Records Success................7
Figure 30: Example of Exported .txt File .............................7
Figure 31: Example of Exported .csv File ...........................7
More Options ...............................................................................7
Figure 32: More Options Screen .........................................7
System Status..............................................................................7
Figure 33: System Status...................................................... 7
Set Date and Time.......................................................................7
Figure 34: Set Date and Time...............................................7
Set Language...............................................................................7
Figure 35: Language Settings ..............................................8
Figure 36: Language Selections..........................................8
Export Logs...................................................................................8
Figure 37: Select Files to Export.......................................... 8
Figure 38: Reading Files........................................................ 8
Figure 39: Export Files........................................................... 8
Figure 40: Building Archive.................................................. 8
Figure 41: Exporting File .......................................................8
Figure 42: Export Successful ...............................................8
Procedure Summary...................................................................8
Figure 43: Procedure Summary........................................... 8
Figure 44: Populating List .....................................................8
Figure 45: Procedure Summary - View ..............................8
Treatment Monitor ......................................................................8
Treatment Config.........................................................................8
Servicing.......................................................................................9
PROPER CARE AND CLEANING .....................................................9
Overview.......................................................................................9
Recommended Care ...................................................................9
Visual Inspection.........................................................................9
Cleaning the Rez ū m Generator.................................................9
Recommended Cleaning Products........................................... 9
Not Recommended Cleaning Products ...................................9
Cleaning Instructions .................................................................9
Routine Care Checklist...............................................................9
Table 6: Routine Care Checklist...........................................9
Authorized Repair or Service....................................................9
TECHNICAL SPECIFICATIONS ........................................................9
Overview.......................................................................................9
Generator Specifications...........................................................9
Table 7: Generator Specification ........................................9
Electromagnetic Compatibility and Immunity (EMC and
EMI) Requirements ...................................................................10
Table 8: Electromagnetic Emissions.................................10
Table 9: Electromagnetic Immunity ..................................10
Table 10: Electromagnetic Immunity ................................10
Table 11: Separation Distances.........................................11
EN/IEC 60601-1-2 COMPLIANCE...................................................11
ESSENTIAL PERFORMANCE.........................................................11
TROUBLESHOOTING ......................................................................11
Overview.....................................................................................11
Troubleshooting Steps..............................................................11
Error Messages.........................................................................11
Critical Error Message ............................................................. 11
Figure 46: Example Critical Error Message.....................11
Non-Critical Error Message .................................................... 11
Figure 47: Example Non-Critical Error Message............11
Informational Error Message..................................................11
Figure 48: Example Informational Error Message..........11
Error Message Table ................................................................12
Critical Error Messages ........................................................... 12
Table 12: Critical Error Message Table ............................12
Non-Critical Error Messages .................................................. 12
Table 13: Non-Critical Error Message Table ...................12
Informational Error Messages................................................13
Table 14: Informational Error Message Table.................13
Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information.........................14
Obtaining Technical Assistance.............................................14

2
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ∆E ≤5.0
DANGER
Do not take or use the device in locations where combustible
anesthetics or flammable gases are used or in high-pressure
oxygen rooms or inside oxygen tents.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
DEVICE DESCRIPTION
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 generator rapidly heats and converts sterile water into
nearly pure vapor at slightly above 100°C. The delivery device
delivers this thermal energy in the form of vapor through precise
vapor emitter openings at the tip of the Vapor Emitter Needle.
The rate and time over which the thermal energy in the form of
vapor is delivered is monitored and regulated by the generator.
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.
INTENDED USE/INDICATIONS FOR USE
The Rez ū m Generator is intended to be used with the Rez ū m
Delivery Device only. Refer to the Instructions for Use for the
Rez ū m Delivery Device for the Indications for Use/Intended
Use.
CONTRAINDICATIONS
Refer to the Instructions for Use for the Rez ū m Delivery Device
for the Contraindications.
WARNINGS
A protective ground connection by way of the grounding
conductor in the power cord is essential for safe operation.
To avoid electrical shock, plug the power cord into a properly
wired receptacle, use only the power cord supplied with the
generator, and make sure the power cord is in good condition.
After visual inspection, if the generator is damaged or a
message is indicated to not use the generator, please contact
Boston Scientific Technical Assistance and take the generator
out of service.
Before conducting routine care, turn the power off and unplug
the power cord from the outlet to prevent electric shock.
Do not modify this equipment.
Carefully read and understand all instructions, indications,
warnings, and precautions in this operator’s manual prior to
using the Rez ū m Generator. Failure to do so could result in
compromised patient safety, patient complications and/or
insufficient treatment.
Do not connect a grounding wire from a grounding stud to a gas
pipe or water pipe.
Do not connect to an electrical outlet controlled by a wall
switch because the device may be accidentally turned off.
Do not plug power cord into an outlet (or unplug it) with wet hands.
Do not submerge the device in liquids or pour cleaning liquids
over, into or onto the generator.
Do not use the generator if it is damaged, is not functioning
properly, or fails to meet an electrical safety check. Notify the
appropriate personnel to ensure the generator is removed from
service and properly repaired.
Failure on the part of all responsible individuals, hospitals,
or institutions, employing the use of Rez ū m Generator, to
implement the recommended maintenance schedule may
cause equipment failure and possible health hazards.
The manufacturer does not, in any manner, assume the
responsibility for performing the recommended maintenance
schedule. The sole responsibility rests with the individuals,
hospitals, or institutions utilizing the Rez ū m Generator.
If a critical error message is displayed, take the generator out
of service and call Boston Scientific Technical Assistance. Do
not attempt to service or maintain the generator while in use
with a patient.
If the generator measurement readings or messages seem dubious
or abnormal, check the condition of the patient first and stop using
the generator.
In the event of power failure, the generator will automatically shut
OFF. Turn the power button OFF. Please remove the Delivery Device
from the patient immediately per instructions in the Rez ū m Delivery
Device IFU. Turn on again to restart the generator to begin a new
therapy session.
No modification of this equipment is allowed. Do not attempt to
service or maintain the generator while in use with a patient.
RF Interference - Known RF sources, such as cell phones, radio or
TV stations, and 2-way radios, may cause unexpected or adverse
operation of this generator. Consult qualified personnel regarding
system configuration.
Shock Hazard - Do not open, disassemble, or alter the Rez ū m
Generator. Failure to observe this warning can result in personal injury
or death. Refer maintenance issues to authorized service personnel.
The generator contains magnets in the LCD lid. Avoid close or
prolonged contact with electrical devices or devices that have
strong magnetic fields.
The generator is not intended to be deployed in settings or
situations that promote use by untrained personnel. Operation by
untrained personnel can result in injury or death.
The generator needs special precautions regarding
Electromagnetic Compatibility (EMC) and needs to be installed and
put into service according to the EMC information provided in this
operator’s manual.
The generator should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, test the
generator to verify normal operation. Refer to the Electromagnetic
Immunity information.
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used no
closer than 30 cm to any part of the Rezūm Generator, including
cables specified for use with the system. Otherwise, degradation of
the performance of this equipment may occur.
The Rezūm Generator is equipped with a USB port that is sensitive
to ESD that may potentially result in injury or device failures.
The Rez ū m Generator is reusable but is restricted to a single patient
at a time for a therapy session.
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
Use a grounded AC outlet for the power supply and ground
this generator.
Use of accessories other than those specified in this document
may result in increased emission or decreased immunity of the
Rez ū m Generator.
Use only approved and specified parts, accessories, optional parts,
consumables, and components.
Use only specified power cord.
Use with the specified AC voltage and frequency.
When transporting the generator, it is important to position it with
the display facing away from the body.
PRECAUTIONS
After cleaning, allow complete drying before plugging into an outlet.
Before conducting maintenance work, turn the power OFF and
unplug the power cord from the outlet to prevent electric shock.
Before moving this generator, turn the power OFF, remove
all accessories from the patient, and unplug the power cord from
the outlet.
Do not install this generator in the following locations:
• Locations where gases and flames are used.
• Locations where the air includes dust, salt, or sulfur.
• Locations exposed to prolonged direct sunlight.
• Locations that vibrate or are subject to sharp impacts.
• Locations near heating equipment.
• Locations where chemicals are stored.
• This generator cannot be used in any room in which noise-
generating apparatuses are used (such as an MRI room, CT
room, X-ray room, etc.).
Do not place anything on this generator.
Do not soak the generator or accessories in any liquid. Also, keep
liquids out of the generator and accessories.
Equipment operating in close proximity may emit strong
electromagnetic or radio frequency interference (RFI), which could
affect the performance of this device. Avoid operating the Rez ū m
Generator near cauterizers, diathermy equipment, FM 2-way radios,
or cellular phones. Turn power off to radio, cellular and other like
equipment near the Rez ū m Generator. Refer to the EMI tables.
Exposing the Rez ū m Generator to extreme environmental
conditions outside of its specified parameters may compromise
the ability of the Rez ū m Generator to function properly and/or
cause the plastic to warp and/or crack.
Follow your facility’s procedures and applicable regulations
when disposing of anything that has been used on patients.
The generator should be at room temperature prior to use.
If there is condensation on the generator, dry it thoroughly
before turning the power ON.
Input voltage range is 100 to 240V at 50 to 60 Hertz. Verify this
voltage matches that of the power outlet.
Observe the following precautions when connecting this
generator with other equipment:
• Ensure that the connected equipment is in accordance
with EN/IEC 60601-1 or other applicable EN/IEC safety
standards.
• Employ additional protective measures (e.g., additional
protective earthing) as necessary.
Only approved equipment and accessories shall be connected
to the generator.
The Rez ū m Generator USB port is only intended for use by
authorized service personnel or to export treatment data.
The generator conforms to the requirements of the EMC
standards (EN/IEC 60601-1-2), so it can be used at the same
time as other electrical simulators. However, it may be affected
by electrical scalpels and microwave treatment devices and
there may be an impact on measurement precision for patients
using cardiac pacemakers and the like. Check the operation
of this generator during and after use of such equipment and
with such patients.
The Rez ū m Generator is intended to be used indoors at a
medical facility or physician office environment only.
The Rez ū m Generator power cord and delivery device cable
may cause a trip hazard while attached to the generator.
The Rez ū m Generator needs special precautions regarding
Electromagnetic Compatibility (EMC) and care should be taken
in accordance to the EMC information provided in this document.
To prevent damage to equipment, do not clean any part of the
generator with phenolic compounds. Do not use abrasive or
flammable cleaning agents. Do not steam, autoclave, or gas-
sterilize the generator.
Use of portable and mobile RF communications equipment near
the Rez ū m Generator may affect its operation.
Using this generator with the air vent blocked could cause a
breakdown. Clean this generator with care.
When any of the following occur, turn the power OFF, remove
all accessories from the patient, and unplug the power cord
from the outlet:
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
When using disinfectant solutions, follow the manufacturer’s
directions.
Input voltage is pre-selected as labeled on the generator.
Please use caution in opening the shipping box and try not
to use sharp objects (e.g. utility knives), as you risk cutting
yourself and/or product.
ADVERSE EVENTS
Refer to the Rezum Delivery Device Instructions for Use for
adverse event information.
HOW SUPPLIED
Do not use if package is opened or damaged. Do not use if
labeling is incomplete or illegible.
Handling and Storage
This product has no specific storage or handling requirements.

3
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ΔE ≤5.0 / CMYK Images
User Interface Symbols
Symbol Description
Priming the Delivery Device.
Perform a pre-treatment
vapor cycle.
Back to previous screen.
Complete
Confirmation message.
Continue
Critical error message.
Displayed for errors that are not
of critical severity.
Informational error messages.
Export
Generator question that requires
user response.
Home screen Menu.
Navigation buttons for Back,
Forward, Up, and Down.
Options Menu
Volume Control
OPERATOR TRAINING REQUIREMENTS
WARNING: The generator is not intended to be deployed in
settings or situations that promote use by untrained personnel.
Operation by untrained personnel can result in injury or death.
Persons authorized to operate the generator must have all the
following minimum training.
• Training as required by state, province, or country regulations.
• Training on operation and use of the generator.
• Additional training as required by a physician or
Medical Director.
• A thorough understanding of the procedures in this manual.
OPERATIONAL INSTRUCTIONS
GETTING STARTED
Overview
This section contains information on how to get started with your
Rez ū m™ Generator.
Unpacking and Inspecting
Precaution: Please use caution in opening the shipping box and
try not to use sharp objects (e.g. utility knives), as you risk cutting
yourself and/or product.
Every attempt is made to ensure your order is accurate and
complete. However, to be sure that your order is correct, verify the
contents of the box against your packing slip.
The Rez ū m Generator is designed for simplicity of operation and
set-up and requires minimal assembly. The following items are
included in the Rez ū m Generator box:
One (1) Rez ū m Generator
One (1) Power cord
1. Carefully inspect each item as it is unpacked for any signs of
damage that may have occurred during shipment.
2. Check the components according to the packing list.
3. Check for any damage or defects. Do not attempt to set up the
Rez ū m Generator if anything is damaged or defective. Contact
Technical Assistance immediately if anything is damaged or
defective.
Generator Controls and Connections
Warning: The generator contains magnets in the LCD lid. Avoid
close or prolonged contact with electrical devices or devices that
have strong magnetic fields.
Warning: The Rez ū m Generator is equipped with a USB port that is
sensitive to ESD that may potentially result in injury or device failures.
Warning: Do not connect a grounding wire from a grounding stud
to a gas pipe or water pipe.
Precaution: Using this generator with the air vent blocked could
cause a breakdown. Clean this generator with care.
Precaution: Only approved equipment and accessories shall be
connected to the generator.
Precaution: The Rez ū m Generator USB port is only intended for
use by authorized service personnel or to export treatment data.
The following figures and table explain the controls, connections,
and their function.
A
B
CF
E
DG
Figure 1: Front and Top of Generator
Table 1: Front and Top of Generator Description Table
ID Item Description
A Display
Screen
Touch screen display to provide
system feedback to the user.
B Syringe
Cradle
Holds water-filled syringe for
vapor treatment.
C Delivery
Device Port
The Delivery Device cable is the RF
energy line and the connections for
the switches and thermocouples.
D Roller Pump Delivers saline during procedure.
E Power
Indicator
Displays system status.
F Power
Button
Turns system ON / OFF.
G USB Port Allows data from system to be
exported onto USB flash drive.
H
I
K
L
J
Figure 2: Back of Generator
N
M
O
P
Figure 3: Side of Generator
Table 2: Back and Side of Generator Description Table
ID Item Description
H Grounding
Stud
Grounding stud used for grounding
product (required in Europe).
I Air Vent Outgoing air vent.
J Product
Label
Provides information about
the generator.
K Fuse Box Holds generator fuses.
L Power Cord
Plug
Connection plug for electrical
power cord.
M Lid Cover to protect display screen,
syringe and pressure sensor ports.
N Handle Use to transport the device by hand.
O Air Vent and
Speaker
Incoming air vent (both sides) and
speaker (left side only).
P Rubber Feet
(On Bottom
and Side)
Allows product to be stored on base
or bottom end.
Display Screen Map
The Rez ū m Generator is equipped with a color touchscreen
that can be viewed up to 8 feet away from the generator. The
display allows interaction with the generator using screen
buttons, icons, and menus with the touch of a finger with or
without latex gloves.

4
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ΔE ≤5.0 / CMYK Images
A: Title Bar
B: Information
Screen
C: Lower Toolbar
Figure 4: Display Screen Map
Table 3: Display Screen Map
Item Description
A. Title Bar Brief title of the screen displayed.
B. Information
Screen
Main area where screen information and
error messages will be shown to the user.
Replace saline button is also available on
the saline bag.
C. Lower
Toolbar
The bottom of all screens, except the
Start-up screens, will include the same
lower bar. This will have three features
on it: Volume Adjustment, Product
Logo, and the Options Menu button (if
applicable).
Audible Tones
The generator emits different audible tones to indicate to
the user different events. These tones vary with the type of
message and its content. The description of each tone is
explained in Table 4.
Table 4: Tone Description
Tone Name Tone Description
1. Start-up A musical tone is played during
generator power ON sequence.
2. Treatment
Warning
A single quick tone played when
there is a warning after treating
- running low on treatments,
running low on treatment time, and
other alerts that may require user
intervention.
3. Partial Treatment
Tone
Tone emitted when the Delivery
Device Vapor Activation button
has been deactivated prior to the
completion of a treatment.
4. Treatment Ready Played when the system is ready
to perform a treatment.
5. Treatment and
Priming
Beep tone is repeated once per
second while performing Priming
and Treatment operations.
6. Success Tone emitted when a full treatment
has been administered, after
successful priming, and as
feedback while adjusting the
volume.
7. Error Message Two quick tones in succession are
played whenever the generator
displays an error message on the
generator screen.
8. Critical Error
Message
A single high-pitched tone is played
when the generator encounters a
critical error. In addition, three quick
tones in succession are played
whenever the generator displays
a critical error message on the
generator screen.
9. Delivery Device
Disable Tone
A high-pitched tone followed by a
low-pitched tone played when the
Delivery Device is disabled.
Volume Control
The generator has an on-screen volume control as depicted
in Figure 5.
Figure 5: Volume Control
• Touch the minus symbol to decrease or silence the volume and
touch the plus symbol to increase the volume. A tone will be
emitted upon each button press.
• The Critical Error and Delivery Device Disabled alarm tones
cannot be silenced by the volume control.
• The volume resets to the default when the generator is turned
OFF and ON again.
• Set the volume loud enough to be heard adequately in the
actual use environment.
Detachable Parts and Accessories
Warning: Use only approved and specified parts, accessories,
optional parts, consumables, and components.
Precaution: The Rez ū m™ Generator power cord and delivery device
cable may cause a trip hazard while attached to the generator.
The Rez ū m Generator is provided with a detachable, region-
specific power cord.
Accessories - Supplied Separately
Table 5: Accessories
Model Number Description, Function Type
M006D2201-003 Delivery Device
Delivers the vapor into
the tissue
Disposable,
single use
USING THE REZ Ū M GENERATOR
Overview
This section provides step by step instructions and sequence of
operation for the Rez ū m™ Generator.
Step by Step Instructions
This section contains step by step instruction on how to connect
the power cord, turn the generator ON and OFF, prime the Delivery
Device, perform treatment, and use the Options Menu.
Warning: When transporting the generator, it is important to
position it with the display facing away from the body.
Precaution: Follow your facility’s procedures and applicable
regulations when disposing of anything that has been used on
patients.
Precaution: Do not install this generator in the following locations:
• Locations where gases and flames are used.
• Locations where the air includes dust, salt, or sulfur.
• Locations exposed to prolonged direct sunlight.
• Locations that vibrate or are subject to sharp impacts.
• Locations near heating equipment.
• Locations where chemicals are stored.
This generator cannot be used in any room in which noise-
generating apparatuses are used (such as an MRI room, CT room,
X-ray room, etc.)
Precaution: Do not place anything on this generator.
Precaution: Observe the following precautions when connecting
this generator with other equipment:
• Ensure that the connected equipment is in accordance with
EN/IEC 60601-1 or other applicable EN/IEC safety standards.
• Employ additional protective measures (e.g., additional
protective earthing) as necessary.
Precaution: Exposing the Rez ū m Generator to extreme
environmental conditions outside of its normal conditions may
compromise the ability of the Rez ū m Generator to function
properly and/or cause the plastic to warp and/or crack.
Precaution: The Rez ū m Generator power cord and delivery
device cable may cause a trip hazard while attached to the
generator.
Precaution: If the Rez ū m Generator is stored in an
environment with a temperature below the operating
temperature, the unit should be allowed to warm up to the
needed operating temperature before using.
Precaution: Equipment operating in close proximity may emit
strong electromagnetic or radio frequency interference (RFI),
which could affect the performance of this device. Avoid
operating the Rez ū m Generator near cauterizers, diathermy
equipment, FM 2-way radios, or cellular phones. Turn power
off to radio, cellular and other like equipment near the Rez ū m
Generator. Refer to the EMI tables.
Precaution: The Rez ū m Generator is intended to be used
indoors at a medical facility or physician office environment
only.
Connecting the Power Cord
Warning: Do not connect to an electrical outlet controlled
by a wall switch because the generator may be accidentally
turned off.
Warning: Do not plug power cord into an outlet (or unplug it)
with wet hands.
Warning: Use only specified power cord.
Warning: To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with protective earth.
Warning: A protective ground connection by way of the
grounding conductor in the power cord is essential for safe
operation. To avoid electrical shock, plug the power cord
into a properly wired receptacle, use only the power cord
supplied with the generator, and make sure the power cord is
in good condition.
Warning: Use a grounded AC outlet for the power supply and
ground this generator.
Warning: Use only approved and specified parts, accessories,
optional parts, consumables, and components.
Warning: Use with the specified AC voltage and frequency.
• Make sure that the AC outlet is properly grounded and
supplies the specified voltage and frequency.
• Connect the female connector end of the power cord to the
AC power connector on the back of the generator.
• Plug the male connector end of the power cord into a
properly grounded AC power outlet.
Turning on the Rez ū m Generator
Danger: Do not take or use the device in locations where
combustible anesthetics or flammable gases are used or in
high-pressure oxygen rooms or inside oxygen tents.
Warning: The Rez ū m Generator is reusable but is restricted to
a single patient at a time for a therapy session.
Precaution: If there is condensation on the generator, dry it
thoroughly before turning the power ON.
Precaution: When any of the following occur, turn the power
OFF, remove all accessories from the patient, and unplug the
power cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
To Turn ON:
1. Open the lid of the generator to show the display screen
and make sure it is fully open.
2. Turn on the generator by pushing the top of the power
button located on the front of the generator as depicted in
Figure 6.

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Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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I
O
Power
Button
Figure 6: Power Button
3. While the generator is powering up, it initially displays two
Start-up screens and a Test screen.
Warning: In the event of power failure, the generator will
automatically shut off. Turn the power button OFF. Please
remove the Delivery Device from the patient immediately per
instructions in the IFU. Turn ON again to restart the generator
to begin a new therapy session.
Figure 7: Start-up Screens
Figure 8: Test Screen
4. It will automatically run the Start-up Diagnostics. During
this time the Test screen is displayed, and a bar and text
will indicate status of the tests on the screen.
5. After the Start-up Diagnostics are completed, the
generator will display the Delivery Device Setup screen.
Figure 9: Delivery Device Setup
After all connections are properly made, a message will be
displayed for 5 seconds letting the user know that items have been
connected and then the Priming screen will be displayed.
Figure 10: Connection Message
Priming the Delivery Device
Precaution: When any of the following occur, turn the power OFF,
remove all accessories from the patient, and unplug the power
cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
Figure 11: Ready for Priming
When the operator starts priming the Delivery Device, a progress
bar will be initiated and displayed. The text will change, and a tone
will be generated to indicate that the operation is in progress.
Priming is initiated by deploying the needle and holding the Delivery
Device vapor activation button for the priming duration, which lasts
approximately 30 seconds. A message will be displayed indicating
when priming is complete.
If the vapor activation trigger is activated while the needle is being
deployed, priming, pretreatment, or treatment operation will not be
initiated until the vapor trigger is released and reengaged.
Figure 12: Priming Screen
Figure 13: Priming Complete
The Setup Complete screen will be displayed when the Delivery
Device has been successfully primed. There will also be an
audible tone that indicates success. Pre-Treatment Vapor
Cycle shall be performed prior to treatment.
Figure 14: Setup Complete Screen
If the device is not properly primed, an error message will be
displayed to the user. Upon resolution of the issue and closure
of the error message, the screen will display the Priming
screen and the steps should be repeated.
Performing the Therapy
Warning: If the generator measurement readings or messages
seem dubious or abnormal, check the condition of the patient
first and stop using the generator.
Precaution: When any of the following occur, turn the power
OFF, remove all accessories from the patient, and unplug the
power cord from the outlet.
• There is smoke or a strange odor leaking out of the generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
After setup is complete, perform a Pre-Treatment Vapor Cycle
immediately prior to procedure to initiate treatment stage.

6
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Figure 15: Setup Complete Screen
After performing a Pre-Treatment Vapor Cycle, a screen will be
displayed indicating the generator is ready for treatment.
Figure 16: Ready for Treatment Screen
A treatment is initiated by activating flush, deploying the needle,
and pulling in and holding the vapor activation button. When
a treatment is in progress, the time clock will count in whole
seconds to the maximum preset treatment time. After treatment
time has elapsed, the generator will automatically end the
treatment and will once again be ready for treatment. Releasing
and reactivating the vapor activation button will initiate another
treatment after the required rest period has elapsed.
Figure 17: Treatment in Progress Screen
If at any time the generator is not ready to perform a treatment
(e.g. rest period between treatments is in effect, etc.) the
screen specified Waiting as depicted below and is grayed out.
Figure 18: Pending Ready Indicator on Screen
The generator will automatically be ready for treatment (Figure 16)
when the pending condition is resolved. Monitor the ALERTS message
area during treatment and take action when specified to do so.
Turbo Flush
If visualization becomes cloudy during the procedure, Turbo
Flush can be activated to improve the visualization by increasing
the saline flow rate. To activate Turbo Flush, double tap the Flush
Activation button and hold. Treatments will not be performed during
this mode.
When visualization has been cleared, turn off Turbo Flush by
releasing the Flush Activation button.
Connecting New Delivery Device During Treatment Session
The generator can detect if a new Delivery Device has been
connected to the generator during a therapy session.
If a new Delivery Device is connected during the therapy session,
select New to create a new procedure record or Continue to
continue with current procedure record.
Figure 19: New Delivery Device
Turning Off the Rez ū m™ Generator
In the event of power failure, the generator will automatically shut
OFF. Turn the power button OFF. Please remove the Delivery Device
from the patient immediately per instructions in the IFU. Turn on
again to restart the generator to begin a new therapy session.
Precaution: Before moving this generator, turn the power OFF,
remove all accessories from the patient, and unplug the power
cord from the outlet.
1. Turn OFF the generator by pushing the bottom power button
located on the front of the generator.
I
O
Power
Button
Figure 20: Power Button
Note: In the event of loss of power, a new procedure record is
created. Previously completed treatments will be saved in the prior
procedure record.
Rez ū mGenerator Options Menu Items
To configure the generator and setup before the therapy session
begins, select the Options button on the lower toolbar.
Figure 21: Options Menu Button
The following options (if applicable) are available and described in
further detail in the sections below:
Figure 22: Options Menu Choices
Drain Bladder
When 750 ml of saline has been used, a message will be
displayed to the physician to drain the bladder. When this
has occurred, select from the Options Menu, Drain Bladder.
A Confirm Bladder Drain dialog box shall appear when Drain
Bladder is selected. Select Confirm to confirm the physician
has done so.
Note: When the saline limit is reached (750 ml), flush and
needle deployment are disabled until the physician confirms
the patient’s bladder has been drained.
Figure 23: Drain Bladder Confirmation
Replace Saline
When saline is replaced, select the Replace Saline from the
Options Menu and select the appropriate size saline from the
available options. The saline source volume will be set to the
previously selected value upon power up of the generator.
Figure 24: Replace Saline
Remove Device
From the Options Menu, select Remove Device. A Confirm
Syringe Release dialog box shall appear when Remove Device
item is selected. If the user selects Release, then the syringe
shall be released. If the user selects Cancel, no action shall
be taken.

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Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Figure 25: Release Syringe
If the Delivery Device is primed and a release syringe operation
occurs, then the Delivery Device shall require re-priming
before treatments can be resumed.
After the device is removed, Procedure Summary will be
displayed. From this screen, Procedure Summary and Options
to Continue, Complete or Export are available.
Figure 26: Procedure Summary
Export Procedure Record
Precaution: Only approved equipment and accessories shall
be connected to the generator.
Precaution: The Rez ū m™ Generator USB port is only intended
for use by authorized service personnel or to export treatment
data.
This option is used to export selected procedure records.
Therapy information can be exported to a USB flash drive.
Touch the desired folder to select the location on the USB flash
drive to export the procedure records. Touch Save to export the
procedure records.
Figure 27: Export Procedure Records
Figure 28: Export Procedure Records Progress
When the records are properly transferred to the USB flash drive, a
confirmation message will be displayed on the screen.
Figure 29: Export Procedure Records Success
The device will store up to a maximum of 1000 procedure records.
Once the generator reaches it maximum record capacity, the
generator will automatically delete the oldest record to perform
another therapy session.
The procedure records are saved in both a .csv and .txt format. The
serial number plus date/time, and unique number are saved as the
file name. The .txt file contains all the user viewable information
stored in the procedure record (Figure 30). The .csv file contains
details of individual treatments stored in that procedure record
(Figure 31). Specifically, each comma separated line of data
contains: serial number of the Delivery Device, treatment start date/
time stamp, treatment duration.
Figure 30: Example of Exported .txt File
Figure 31: Example of Exported .csv File
More Options
From the Options Menu, select More Options. The More
Options screen allows the 6 options that can be selected.
Figure 32: More Options Screen
System Status
The System Status screen contains information.
• Information on the generator and Delivery Device internal
device identifiers.
• Software versions.
• Ability to set date and time.
• Ability to set language.
Figure 33: System Status
Set Date and Time
The Select New Date and Time screen allows the date and
time of generator to be updated from factory defaults for time
zone or daylight-saving time changes. The generator does not
automatically adjust for daylight savings time changes. Valid
dates are between 1900 and the current year.
Figure 34: Set Date and Time
Set Language
The Language Settings screen allows the language to be
updated from English to preloaded language options and
desired number format. These settings do not change when
powering the generator ON and OFF.

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Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Figure 35: Language Settings
Select the desired language from the dropdown language list
and click OK to change the language from English to desired
language. Use the scroll bar to display more languages.
Figure 36: Language Selections
Export Logs
Precaution: Only approved equipment and accessories shall
be connected to the generator.
Precaution: The Rez ū m™ Generator USB port is only intended
for use by authorized service personnel or to export treatment
data.
Encrypted log files can be exported to a USB flash drive for use
by service personnel only. Select files to export from the list of
options and click OK.
Figure 37: Select Files to Export
Figure 38: Reading Files
Select export path and select Save.
Figure 39: Export Files
After saving the files, the generator will build the archive, export the
files, and prompt when it is successful.
Figure 40: Building Archive
Figure 41: Exporting File
Figure 42: Export Successful
Procedure Summary
The Procedure Summary screen displays a sortable list of
recently used devices.
Figure 43: Procedure Summary
Select devices from the list using the check boxes on the left of
the screen, and then select View. The generator will populate
the summary report with the list of selected devices.
Figure 44: Populating List
Figure 45: Procedure Summary - View
Use the scroll bar to view the entire summary.
Treatment Monitor
This screen is password protected and accessed by Boston
Scientific personnel only.
Treatment Config
This screen is password protected and accessed by Boston
Scientific personnel only.

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Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Servicing
This screen is password protected and accessed by Boston
Scientific personnel only.
PROPER CARE AND CLEANING
Overview
Proper care of the Rez ū m™ Generator is very simple, yet it is
an important factor in its reliability. This section describes the
proper care and cleaning required for the generator.
Warning: No modification of this equipment is allowed. Do not
attempt to service or maintain the generator while in use with a
patient.
Precaution: When any of the following occur, turn the power
OFF, remove all accessories from the patient, and unplug the
power cord from the outlet.
• There is smoke or a strange odor leaking out of the
generator.
• The generator has been dropped or impacted by an object.
• Liquid or foreign matter gets inside the generator.
• Damage to the generator is suspected.
Recommended Care
Warning: Failure on the part of all responsible individuals,
hospitals, or institutions, employing the use of Rez ū m
Generator, to implement the recommended cleaning schedule
may cause equipment failure and possible health hazards.
The manufacturer does not, in any manner, assume the
responsibility for performing the recommended maintenance
schedule. The sole responsibility rests with the individuals,
hospitals, or institutions utilizing the Rez ū m Generator.
Warning: Do not submerge the device in liquids or pour
cleaning liquids over, into or onto the generator.
Warning: Before conducting proper care and cleaning, turn
the power OFF and unplug the power cord from the outlet to
prevent electric shock.
Precaution: To prevent damage to generator, do not clean
any part of the device with phenolic compounds. Do not
use abrasive or flammable cleaning agents. Do not steam,
autoclave, or gas-sterilize the generator.
Precaution: Using this generator with the ventilation ports
blocked could cause a breakdown. Clean this generator with
care.
Precaution: Only approved equipment and accessories shall be
connected to the generator.
Precaution: The Rez ū m Generator USB port is only intended for
use by authorized service personnel or to export treatment data.
To ensure the Rez ū m Generator is always functional when
required, Boston Scientific recommends performing the
following routine activities:
• Performing a Visual Inspection.
• Cleaning the Rez ū m Generator.
• Routine Care per checklist in this section.
It is important that the generator is stored at room temperature if
it is expected to be used.
The Rez ū m Generator requires no calibration.
Visual Inspection
Warning: After the visual inspection, if the device is damaged
or a message indicating the generator is not to be used, take
the generator out of service and call Technical Assistance.
The generator should be carefully inspected prior to installation
and use.
• Carefully inspect the generator case for stress or physical
damage.
• Inspect all external connections for loose connectors.
• Inspect the external power cord for damage or cracking.
• Inspect the display for marks, scratches, or other damage.
• Verify that the product label on the device is clearly legible
and present.
Cleaning the Rez ū m Generator
It is recommended that the generator be inspected after each
use according to the Routine Care Checklist in this manual and
cleaned when appropriate. Listed below are recommendations
for cleaning the generator. The generator does not need to be
sterilized before or after use.
Warning: Do not submerge the device in liquids or pour
cleaning liquids over, into or onto the generator.
Precaution: After cleaning, allow complete drying before
plugging in to an outlet by wiping with a dry, soft cloth.
Precaution: Do not soak the generator or accessories in any
medical liquid. Also, keep liquids out of the generator and
accessories.
Precaution: When using disinfectant solutions, follow the
manufacturer’s directions.
Precaution: Using this generator with the air vent blocked could
cause a breakdown. Clean this generator with care.
Precaution: To prevent damage to equipment, do not clean
any part of the generator with phenolic compounds. Do not
use abrasive or flammable cleaning agents. Do not steam,
autoclave, or gas-sterilize the generator.
Recommended Cleaning Products
The following cleaning products may be used to clean the
exterior surfaces of the generator:
• Water
• 70% Isopropyl Alcohol
• Super Sani-Cloth® Germicidal Disposable Wipes by PDI only
Not Recommended Cleaning Products
• Do not use abrasive cleaners or strong solvents such as
acetone or acetone-based cleaners.
• Do not mix disinfecting solutions (such as bleach and
ammonia) as hazardous gases may occur.
• Do not clean electrical contacts or connectors with bleach.
Cleaning Instructions
1. Before cleaning the generator, turn the generator OFF and
disconnect the power cord.
2. To remove any foreign material and fluid (e.g. dust, paper,
etc.), wipe thoroughly with a soft cloth lightly dampened
with water or 70% isopropyl alcohol. Super Sani-Cloth
wipes may be used per manufacturer instructions. To
prevent scratching the display, the use of a soft cloth is
recommended.
3. When cleaning, do not immerse.
4. Wring any excess moisture from the cloth before and during
cleaning.
5. Avoid pouring fluids on the generator, and do not allow fluids
to penetrate the exterior surfaces of the generator.
6. To dry the generator after cleaning, wipe with a dry, soft cloth.
Routine Care Checklist
Routine Care activities involve verifying operation and safety.
Maintenance should always be performed by the customer
at least once every 12 months. The following checklist is
recommended to be utilized when checking the generator:
Table 6: Routine Care Checklist
Visual Inspection
Warning: After the visual inspection, if the generator is
damaged or a message indicates to not use, take the
generator out of service and call Boston Scientific Technical
Assistance.
• Carefully inspect the generator case for stress or
physical damage.
• Inspect all external connections for loose connectors.
• Inspect the external power cord for damage or cracking.
• Inspect the display for marks, scratches, or other damage.
• Verify that the product label on the device is clearly
legible and present.
Operating Test
Warning: If a Critical Error message is displayed, take the
generator out of service and call Technical Assistance.
• Set-up generator and turn ON power to check the start-
up diagnostics.
Authorized Repair or Service
Warning: Shock Hazard - Do not open, disassemble, or alter
the Rez ū m Generator. Failure to observe this warning can
result in personal injury or death. Refer maintenance issues to
authorized service personnel.
Warning: Do not use the generator if it is damaged, is not
functioning properly, or fails to meet an electrical safety check.
Notify the appropriate personnel to ensure the generator is
removed from service and properly repaired. The generator
has no user-serviceable internal components. Try to resolve
any maintenance issues with the generator by using the
Troubleshooting Table presented in Section 6, Troubleshooting.
If you are unable to resolve the problem, contact Technical
Assistance.
The warranty will be void upon unauthorized disassembly or
service of the Rez ū m Generator.
TECHNICAL SPECIFICATIONS
Overview
This section contains specifications for the Rez ū m Generator
and EMC information.
Generator Specifications
Precaution: Exposing the Rez ū m Generator to extreme
environmental conditions outside of normal parameters may
compromise the ability of the Rez ū m Generator to function
properly and/or cause the plastic to warp and/or crack.
Precaution: If the Rez ū m Generator is stored in an environment
with a temperature below the room temperature, the unit should be
allowed to warm up to the needed operating temperature before
using.
Table 7: Generator Specification
Description Specification
Protection Against
Electric Shock
Class I equipment (generator)
Model Number G2200-003
Voltage and Frequency 100-240 VAC, 50-60HZ
Power Input 10 amps maximum
External Fuses Two, 10ah-250v, 5 x 20mm
Mode of Operation Continuous operation
System Control Provides controlled flow of water
vapor at ambient temperatures
below 25˚C
Case Dimensions 23L x 16W x 9H inches
Weight 50 pounds or less (generator only)
Power Cord Length 2.5 m to 3.05 m
Applied Parts
Protection Type BF

10
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Electromagnetic Compatibility and Immunity (EMC and EMI) Requirements
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential ENVIRONMENT (for which CISPR
11 class B is normally required) this equipment may not offer adequate protection from radio-
frequency communication services. The user may need to take mitigation measures, such as
relocating or re-orienting the equipment.
The Rez ū m Generator requires special precautions regarding Electromagnetic Compatibility
(EMC) and must be installed and placed into service according to the EMC information provided
below. The Rez ū m Generator complies with EN/IEC 60601-1-2 and EN 55011. Portable and mobile
radiofrequency (RF) communications equipment can affect the Rez ū m Generator, causing it to
operate improperly.
Warning: Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm to any part of the Rez ū m Generator,
including cables specified for use with the system. Otherwise, degradation of the performance of
this equipment may occur.
Warning: Use of accessories other than those specified in this document may result in increased
emission or decreased immunity of the Rez ū m Generator.
Warning: The Rez ū m Generator should not be used adjacent to or stacked with other equipment
and, if necessary, observe its operation to verify its normal operation during use. Refer to the
Electromagnetic Immunity information in this section.
Precaution: The Rez ū m Generator needs special precautions regarding Electromagnetic
Compatibility (EMC) and care should be taken in accordance to the EMC information provided in
this document.
Precaution: Use of portable and mobile RF communications equipment near the Rez ū m Generator
may affect its operation.
Precaution: Observe the following precautions when connecting this generator with other
equipment:
• Ensure that the connected equipment is in accordance with EN/IEC 60601-1 or other applicable EN/
IEC safety standards.
Employ additional protective measures (e.g., additional protective earthing) as necessary.
Table 8: Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
The Rez ū m Generator is intended for use in the electromagnetic environment specified below. The
customer or the user of the Rez ū m Generator should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
Radiated emissions
CISPR 11
Group 2
Class A
The Rez ū m Generator uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
Conducted
emissions
CISPR 11
Class A The Rez
ū m Generator is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purpose.
Harmonic current
emissions
EN/IEC 61000-3-2
Class A
Voltage fluctuations
and flicker
EN/IEC 61000-3-3
Complies
Table 9: Electromagnetic Immunity
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
EN/IEC 61000-4-2
±8 kV contact
±15 KV AIR
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast
transient/burst
immunity
EN/IEC 61000-4-4
±2 kV common mode;
100kHZ
Mains power quality should be that of a
typical commercial or hospital environment.
Surge immunity
EN/IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency
magnetic field
EN/IEC 61000-4-8
30 A/m, 50/60 HZ Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Voltage dips and
interruptions
immunity
EN/IEC 61000-4-11
Six dips each at
100%, 60%, 30%
voltage reduction;
one interrupt
Three 100% dips
each at phase
angles of 0, 45,
90, 135, 180, 225,
270, and 315; one
interrupt
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Rez ū m Generator requires
continued operation during power mains
interruptions, it is recommended that the
Rez ū m Generator be powered from an
uninterruptible power supply.
Table 10: Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Rez ū m Generator is intended for use in the electromagnetic environment specified below.
The customer or the user of the Rez ū m Generator should assure that it is used in
such an environment.
Immunity Test Compliance Electromagnetic Environment - Guidance
Conducted RF
EN/IEC 61000-4-6
Radiated RF
EN/IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bandsa
3 V/m
80 MHz to 2.7 GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the Rez ū m Generator, including power
cord and delivery device cable, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.57GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and is the recommended separation
distance in meters (m)b.
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency ranged.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz
to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 to 40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/
portable communications equipment could cause interference if it is inadvertently brought
into patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Rez ū m Generator
is used exceeds the applicable RF compliance level above, the Rez ū m Generator should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Rez ū m Generator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.

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Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Table 11: Separation Distances
Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the Rez ū m Generator
The Rez ū m™ Generator is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Rez ū m Generator can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and Rez ū m Generator as recommended
below, according to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter (m)
Rated Maximum Output
Power of Transmitter
(W)
150 kHz to 80 MHz
D = 1.2√P
80 MHz to 800 MHz
D = 1.2√P
800 MHz to 2.7 GHz
D = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 to 40.70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance
for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
EN/IEC 60601-1-2 COMPLIANCE
Warning: RF Interference - Known RF sources, such as cell phones, radio or TV stations, and
2-way radios, may cause unexpected or adverse operation of this generator. Consult qualified
personnel regarding system configuration.
Warning: The generator should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, test the generator to verify normal operation. Refer to the
Electromagnetic Immunity information provided in this operator’s manual.
Warning: The generator needs special precautions regarding Electromagnetic Compatibility
(EMC) and needs to be put into service according to the EMC information provided in this
operator’s manual.
Precaution: The generator conforms to the requirements of the EMC standard (EN/IEC 60601-
1-2). However, it may be affected by electrical scalpels and microwave treatment devices and
there may be an impact on measurement precision for patients using cardiac pacemakers and
other similar devices. Check the operation of this generator during and after use of the above-
mentioned equipment and with patients potentially affected.
ESSENTIAL PERFORMANCE
The Rez ū m System essential performance is defined as:
• Enable visualization of intraurethral anatomy and treatment procedure
• Placement and positioning of the treatment device within the urethra
• Needle Deployment/Retraction
• Vapor Initiation/Treatment
• Saline Delivery
Warning: The Rez ū m System conforms to the requirements of the EMC standard (EN/IEC 60601-
1-2 and EN/IEC 60601-1) and will maintain essential performance under the limits expressed. The
limits are designed to provide reasonable protection against harmful interference in a typical
medical installation. If not used in accordance with the manufacturer’s instructions, harmful
interference to other equipment in the vicinity may occur. Alternatively, such interference may
affect the Rez ū m Generator display or the system’s ability to deliver the intended therapy. If issues
occur, correct the interference by increasing the separation between the equipment and the
Rez ū m System. Consult Technical Assistance if the issue is not resolved.
Warning: In order to maintain the essential performance over the service life of the Rez ū m
Generator, the following instructions must be followed:
• Use of accessories other than those specified in this document may result in increased
emission or decreased immunity of the Rez ū m Generator.
• Do not use the Rez ū m System if is visibly damaged e.g., exposed internal components, sharp
edges.
• Do not use the Rez ū m Generator if any moisture or condensation is visible on the surfaces
of the System. Powering up the Generator with moisture present could result in permanent
damage to the electrical boards, rendering the System to be inoperable.
• Handle the Rez ū m Generator and all accessory components with care. Rough handling may
damage the system and render the System inoperable.
• If any of the components are damaged, contact Technical Assistance. Do not use damaged
components.
• Do not modify the Rez ū m Generator in any way. Only authorized Boston Scientific personnel
are to service the Rez ū m Generator.
TROUBLESHOOTING
Overview
This section contains troubleshooting steps, error message description, error message table, and
how to obtain technical assistance.
Troubleshooting Steps
If you experience a problem while using the generator, please use the following Error Message
tables to troubleshoot the issues. If you are unable to correct it, write down the error message
and error code, if applicable, and contact qualified service personnel in your institution or contact
Boston Scientific Technical Assistance.
Error Messages
Error messages will be displayed on the screen. There are 3 types of error messages - Critical Error,
Non-Critical Error, and Informational Error.
Critical Error Message
Figure 46: Example Critical Error Message
Non-Critical Error Message
Figure 47: Example Non-Critical Error Message
Informational Error Message
Figure 48: Example Informational Error Message

12
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ΔE ≤5.0 / CMYK Images
Error Message Table
The following tables list all error messages that are displayed by the generator. Follow error message instructions to resolve the error.
Critical Error Messages
Table 12: Critical Error Message Table
Code Error Title Error Cause Text Error Message Instructions
400 Generator Error RF Power Supply Error Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
405 Generator Error Power Supply Initialization Error Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
425 Generator Error SBC Communications Critical Timeout Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
430 Generator Error RF Power Supply Communication Error Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
435 Generator Error MCU Processing Error Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
440 Generator Error CPLD Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
450 Generator Error Delivery Device Interface Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
455 Generator Error Saline Pump Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
460 Generator Error Syringe Pump Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
465 Generator Error Water Pressure Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
470 Generator Error Delivery Device Temperature Excessive Retract the needle and remove the Delivery Device from patient. Power off/on the Generator. Replace Delivery
Device.
475 Generator Error Software Compatibility Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
480 Generator Error Sensor Interface Error Retract the needle and remove the Delivery Device from patient. If problem persists, contact Technical
Support.
485 Generator Error Internal Generator Temperature Error Retract the needle and remove the Delivery Device from patient. Power off the Generator and allow it to cool
down before using again.
490 Generator Error RF Power Supply Operational Error Retract the needle and remove the Delivery Device from patient. If problem persists, contact Technical
Support.
495 Generator Error RF Power Supply Self-Test Error Power off/on the Generator. If problem persists, contact Technical Support.
35000 Generator Error GUI Program Files Corrupted Power off/on the Generator. If problem persists, contact Technical Support.
35001 Generator Error Unexpected GUI Program Exit Power off/on the Generator. If problem persists, contact Technical Support.
35002 Generator Error Unable to Start GUI Program Power off/on the Generator. If problem persists, contact Technical Support.
40000 Generator Error GUI Unable to Communicate with MCU Power off/on the Generator. If problem persists, contact Technical Support.
41020 Generator Error MCU Reboot Detected Retract the needle and remove the Delivery Device from patient. Remove the Generator from service and
contact Technical Support.
Non-Critical Error Messages
Table 13: Non-Critical Error Message Table
Code Error Title Error Cause Text Error Message Instructions
200 Faulty Delivery Device Unable to Read from Delivery Device Memory Remove and reconnect Delivery Device electrical cable. If problem persists, replace Delivery Device.
205 Faulty Delivery Device Unable to Write to Delivery Device Memory Remove and reconnect Delivery Device electrical cable. If problem persists, replace Delivery Device.
210 Faulty Delivery Device Faulty Delivery Device Thermocouple Replace Delivery Device.
211 Faulty Delivery Device Faulty Delivery Device Trigger Signals Replace Delivery Device.
215 Faulty Delivery Device Invalid Therapy Code Remove and reconnect Delivery Device electrical cable. If problem persists, replace Delivery Device.
218 Faulty Delivery Device Delivery Device Impedance Error Replace Delivery Device.
219 Faulty Delivery Device Delivery Device Frequency Error Replace Delivery Device.
220 Expired Delivery Device Maximum Full Treatments Exceeded Replace Delivery Device.
225 Faulty Delivery Device Delivery Device is Permanently Disabled Replace Delivery Device.
230 Expired Delivery Device Maximum Vapor Time Exceeded Replace Delivery Device.
235 Prime Failed Low Temperature (Prime) Replace Delivery Device.
236 Pre-Treatment Failed Low Temperature (Pre-Treatment) Replace Delivery Device.
240 Prime Failed Low Water Pressure (Prime) Check syringe and water line for bubbles or leaks. If bubbles are found, replace syringe and reprime Delivery
Device. If leaks are found, replace Delivery Device. If no bubbles or leaks are observed, replace Delivery Device.
241 Prime Failed High Water Pressure (Prime) Check water line for kinks. Resume priming. If problem persists, replace Delivery Device.
242 Pre-Treatment Failed Low Water Pressure (Pre-Treatment) Check syringe and water line for bubbles or leaks. If bubbles are found, replace syringe and reprime Delivery
Device. If leaks are found, replace Delivery Device. If no bubbles or leaks are observed, replace Delivery Device.
243 Pre-Treatment Failed High Water Pressure (Pre-Treatment) Check water line for kinks. Resume pre-treatment vapor cycle. If problem persists, replace Delivery Device.
245 Prime Failed High Temperature (Prime) Check syringe and water line for bubbles or leaks. If bubbles are found, replace syringe and reprime Delivery
Device. If leaks are found, replace Delivery Device. If no bubbles or leaks are observed, replace Delivery Device.

13
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ∆E ≤5.0
Code Error Title Error Cause Text Error Message Instructions
246 Pre-Treatment Failed High Temperature (Pre-Treatment) Check syringe and water line for bubbles or leaks. If bubbles are found, replace syringe and reprime Delivery
Device. If leaks are found, replace Delivery Device. If no bubbles or leaks are observed, replace Delivery Device.
255 Treatment Halted Low Temperature (Treatment) Retract the needle and remove the Delivery Device from patient. Replace Delivery Device.
260 Treatment Halted High Water Pressure (Treatment) Check water line for kinks. Resume treatment. If problem persists, replace Delivery Device.
265 Treatment Halted Low Water Pressure (Treatment) Check syringe and water line for bubbles or leaks. If bubbles are found, replace syringe and reprime Delivery
Device. If leaks are found, replace Delivery Device. If no bubbles or leaks are observed, replace Delivery Device.
270 Syringe is Empty Syringe Empty Retract the needle and remove the Delivery Device from patient. Replace syringe and reprime Delivery Device.
275 Prime Failed Syringe Water Fill Error Refill syringe and reprime Delivery Device.
280 Treatment Halted Elevated Coil Temperature Partial treatment delivered. Check syringe and water line for bubbles or leaks. If no bubbles or leaks are
found, resume treatment. If problem persists, replace Delivery Device. If bubbles are found, replace syringe
and reprime Delivery Device. If leaks are found, replace Delivery Device.
290 Faulty Delivery Device High Temperature (Idling) Replace Delivery Device.
291 Faulty Delivery Device High Water Pressure (Idling) Replace Delivery Device.
295 Faulty Delivery Device Needle Deployment Error Ensure needle is retracted. Replace Delivery Device.
296 Faulty Delivery Device Needle Retraction Error Reattempt needle retraction. If problem persists, retract needle manually and replace Delivery Device.
300 Saline Pump Error Saline Pump Encoder Error Ensure Delivery Device saline flush line is correctly inserted into saline pump and pump door is closed.
If problem persists, contact Technical Support.
325 Confirm Bladder Drain Saline Instilled Limit Exceeded Saline instilled limit exceeded. Please confirm the physician has drained the bladder.
Informational Error Messages
Table 14: Informational Error Message Table
Code Error Title Error Cause Text Error Message Instructions
250 Prime Paused Vapor Activation Button Released Delivery Device button was released before priming completed. Press and hold Vapor Activation Button (blue)
to continue priming.
251 Pre-Treatment Paused Vapor Activation Button Released Delivery Device button was released before pre-treatment vapor cycle completed. Press and hold Vapor
Activation Button (blue) to restart pretreatment vapor cycle.
341 Prime Paused RF Power Tolerance Limit Exceeded Wait for RF Power Supply reset to complete.
342 Pre-Treatment Paused RF Power Tolerance Limit Exceeded Wait for RF Power Supply reset to complete.
343 Treatment Halted RF Power Tolerance Limit Exceeded Wait for RF Power Supply reset to complete.
41000 Export Error USB Drive Not Present or Invalid Re-insert USB flash drive and try again. If problem persists, replace USB flash drive.
41002 Export Error USB Drive Export Error Insert a valid USB flash drive with sufficient available memory.
Note: The error message dialog boxes associated with errors 250 and 251 close when the user engages the Delivery Device vapor button. The error message dialog boxes associated with errors 341,
342, and 343 close automatically when the RF Power Supply reset is complete.

14
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
Black (K) ∆E ≤5.0
Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Unique Identifier: Rez
ū m™ Delivery Device
Rez ū m Generator
Model: M006D2201-003
Model: G2200-003
Responsible Party
– U.S. Contact
Information
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
508-382-9555
www.bostonscientific.com
FCC Compliance
Statement:
This device complies with Part 18 of the FCC Rules
For further information, see FCC web site for a complete description of all requirements.
Obtaining Technical Assistance
For technical information and assistance, contact:
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752
USA
USA Customer Service 888-272-1001
US Technical Assistance Center (TAC)
(+) 1-800-949-6708
Monday - Friday: 4:30 a.m. to 5:00 p.m. PT
CET[email protected]
European Technical Assistance Center (TAC)
(+) 31 45.546.7707
Monday - Friday: 8:30 a.m. to 5:00 p.m. CET
[email protected]
WARRANTY
These warranties cover the following Boston Scientific products (Warranted Product):
Equipment
• Rez ū m Generator
Disposable Devices
• Rez ū m Delivery Device
Equipment Warranty. Except as indicated otherwise below, Boston Scientific warrants for one year
from the Warranty Commencement Date (as defined below) that the Equipment will be free from
defects in title, material and workmanship under normal use and service. This warranty covers
parts and is available only to end-users that purchase the Equipment from Boston Scientific or its
authorized distributors. Any sale, rental or other transfer or use of Equipment Warranted Product to
or by a user other than the original purchaser shall cause this warranty to terminate immediately.
Customers purchasing through an authorized distributor must contact Boston Scientific promptly
following such purchase to enable this warranty.
Customers purchasing Boston Scientific’s Service Plans extend their Equipment Warranted
Product coverage beyond the one year Warranty period (Total Care Plan; Essential Care Plan).
Disposable Device Warranty. Disposable Devices carry a warranty of the earlier of first use
or expiration date of the products. The reuse of Disposable Devices voids this warranty for all
Warranted Product (including Equipment) otherwise covered. Any sale or other transfer or use
of Disposable Devices Warranted Product to or by a user other than the original purchaser shall
cause this warranty to terminate immediately.
Warranty Commencement. The warranty period begins (the “Warranty Commencement Date”)
on the date Warranted Product is sold to the Customer. The warranty period for any Warranted
Product or component furnished to address a warranty claim will be the longer of the unexpired
term of the warranty applicable to the repaired or replaced Warranted Product or 90 days. Boston
Scientific warrants all Equipment that is loaned or otherwise remains the property of Boston
Scientific as part of Boston Scientific’s Agreement with the Customer.
Remedies. If Customer promptly notifies Boston Scientific of Customer’s warranty claim during
the warranty period and makes the Warranted Product available for inspection and service,
Boston Scientific will, at its option replace (with new or exchange replacement parts) the non-
conforming Warranted Product or components of the Warranted Product. The foregoing remedies
are Customer’s exclusive remedies and Boston Scientific’s sole liability for warranty claims.
Limitations. Boston Scientific shall not have any obligation to Customer hereunder if the warranty
claim results from or arises out of (i) the use of the Warranted Product in a manner or environment,
or for any purpose for which Boston Scientific did not design it, or in violation of Boston Scientific’s
recommendations or FDA cleared Instructions For Use; or (ii) any alteration, modification or revision
of the Warranted Product by Customer or any third party. In addition, these warranties do not cover:
(i) any defect or deficiency that results, in whole or in part, from any improper storage or transport
from location to location, use or handling, failure to maintain the Warranted Products in the manner
described in any applicable instructions or specifications or any cause external to the Warranted
Products or other causes beyond Boston Scientific’s reasonable control; (ii) the payment or
reimbursement of any facility costs arising from repair or replacement of the Warranted Products.
THIS WARRANTY AND REMEDIES SET FORTH ABOVE ARE EXCLUSIVE AND IN LIEU OF ALL OTHER
WARRANTIES, REMEDIES AND CONDITIONS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED.
BOSTON SCIENTIFIC SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES, INCLUDING,
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE. IF BOSTON SCIENTIFIC CANNOT LAWFULLY DISCLAIM IMPLIED WARRANTIES
UNDER THIS LIMITED WARRANTY, ALL SUCH WARRANTIES, INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE LIMITED IN DURATION TO THE
DURATION OF THIS WARRANTY. NO BOSTON SCIENTIFIC AGENT OR EMPLOYEE IS AUTHORIZED TO
MAKE ANY MODIFICATION, EXTENSION, OR ADDITION TO THIS WARRANTY.
BOSTON SCIENTIFIC IS NOT RESPONSIBLE FOR DIRECT, SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR CONDITION,
OR UNDER ANY OTHER LEGAL THEORY, INCLUDING BUT NOT LIMITED TO LOST PROFITS,
DOWNTIME, GOODWILL, DAMAGE TO OR REPLACEMENT OF EQUIPMENT AND PROPERTY OR
FROM DELAYS IN SERVICE OR THE INABILITY TO RENDER SERVICE.
Super Sani-Cloth is a registered trademark of PDI, Inc.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), EOP MANUAL, MB, REZUM, EN, 51230807-01A
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Alternating Current
Electrostatic Sensitive Device
Date of Manufacture
Non-Ionizing Electromagnetic Radiation
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Power On
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Separate Collection
Type BF Applied Part
USB Connection
CAUTION. Attention: Consult
ACCOMPANYING DOCUMENTS.
Medical Equipment ANSI/AAMI ES
60601-1 CAN/CSA C22.2 No. 60601-1
E352516
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