Boston Scientific rezum User manual

50909085-01
Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
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 Delivery Device Kit and Generator 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 laser 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
original equipment manufacturer.
This section contains important safety information. Boston
Scientific requires that you read and understand all warnings,
cautions, and the operator’s manual prior to using the
Rez ū m Generator.
rezūm™
Generator
TABLE OF CONTENTS
WARNING ..........................................................................................1
SAFETY ...............................................................................................1
DANGER .............................................................................................2
DEVICE DESCRIPTION......................................................................2
INTENDED USE/INDICATIONS FOR USE ......................................2
CONTRAINDICATIONS.....................................................................2
WARNINGS........................................................................................2
PRECAUTIONS...................................................................................2
CAUTIONS .........................................................................................2
ADVERSE EVENTS ............................................................................2
Reported Adverse Events .........................................................2
HOW SUPPLIED.................................................................................3
Handling and Storage.................................................................3
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................................................. 4
Figure 3: Side of Generator.................................................. 4
Table 2: Back and Side of Generator Description Table. 4
Display Screen Map ...................................................................4
Figure 4: Display Screen Map .............................................4
Table 3: Display Screen Map...............................................4
Audible Tones ..............................................................................4
Table 4: Tone Description.....................................................4
Volume Control ............................................................................4
Figure 5: Volume Control ......................................................4
Detachable Parts and Accessories .........................................4
Detachable Parts - Supplied with the Rez ū m Generator .....4
Table 5: Detachable Parts....................................................4
Accessories - Supplied Separately .........................................4
Table 6: Accessories.............................................................4
USING THE REZ Ū M GENERATOR...................................................4
Overview.......................................................................................4
Step by Step Instructions ..........................................................4
Turning on the Rez ū m Generator..............................................5
To Turn On:....................................................................................5
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
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Priming the Delivery Device......................................................5
Figure 11: Ready for Priming................................................ 6
Figure 12: Priming Screen.................................................... 6
Figure 13: Priming Complete................................................ 6
Figure 14: Setup Complete Screen .....................................6
Performing the Therapy .............................................................6
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 ............6
Figure 19: New Delivery Device.......................................... 6
Turning Off the Rez ū m Generator.............................................6
Figure 20: Power Button....................................................... 7
Rez ū m Generator Options Menu Items ...................................7
Figure 21: Options Menu Button .........................................7
Figure 22: Options Menu Choices.......................................7
Drain Bladder...............................................................................7
Figure 23: Drain Bladder Confirmation...............................7
Replace Saline.............................................................................7
Figure 24: Replace Saline..................................................... 7
Remove Device............................................................................7
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 .............................8
Figure 31: Example of Exported .csv File ...........................8
More Options ...............................................................................8
Figure 32: More Options Screen .........................................8
System Status..............................................................................8
Figure 33: System Status...................................................... 8
Set Date and Time.......................................................................8
Figure 34: Set Date and Time...............................................8
Set Language...............................................................................8
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 .......................................................9
Figure 42: Export Successful ...............................................9
Procedure Summary...................................................................9
Figure 43: Procedure Summary........................................... 9
Figure 44: Populating List .....................................................9
Figure 45: Procedure Summary - View ..............................9
Treatment Monitor ......................................................................9
Treatment Config.........................................................................9
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.............................................................10
Table 7: Routine Care Checklist.........................................10
Authorized Repair or Service..................................................10
TECHNICAL SPECIFICATIONS ......................................................10
Overview.....................................................................................10
Generator Specifications.........................................................10
Table 8: Generator Specification ......................................10
Electromagnetic Compatibility Requirements...................... 10
Table 9: Electromagnetic Emissions.................................10
Table 10: Electromagnetic Immunity ................................10
Table 11: Electromagnetic Immunity ................................11
Table 12: Separation Distances.........................................11
EN 60601-1-2 COMPLIANCE..........................................................11
TROUBLESHOOTING ......................................................................12
Overview.....................................................................................12
Troubleshooting Steps..............................................................12
Error Messages.........................................................................12
Critical Error Message .............................................................12
Figure 46: Example Critical Error Message.....................12
Non-Critical Error message.....................................................12
Figure 47: Example Error Message................................... 12
Informational Error message ..................................................12
Figure 48: Example Informational Error Message..........12
Error Message Table ................................................................12
Critical Error Messages ...........................................................12
Table 13: Critical Error Message Table ............................ 12
Non-Critical Error Messages ..................................................13
Table 14: Non-Critical Error Message Table ................... 13
Informational Error Messages................................................13
Table 15: Informational Error Message Table.................13
Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information.........................14
Obtaining Technical Assistance.............................................14

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
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™ Generator is designed to heat the RF coil within
the hand-held Delivery Device rapidly. The device uses radio
frequency (RF) energy to heat water into vapor outside the body.
The vapor is injected into the tissue and rapidly disperses
through the interstitial spaces between the tissue cells. The
vapor begins to cool and condenses immediately on contact with
tissue. The stored heat energy is released, gently denaturing the
cell membranes and causing instantaneous cell death.
The denatured tissue is absorbed by the body over time. The
vapor condensation process also causes a rapid collapse of
blood vessels in the ablation treatment zone, resulting in a
bloodless procedure.
The generator rapidly heats and converts sterile water into
nearly pure vapor at slightly above 100°C. The generator
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.
INTENDED USE/INDICATIONS FOR USE
The Rez ū m Generator is intended to be used with the Rez ū m
Delivery Device Kit, Model D2201 only. Refer to the Directions
for Use for the Rez ū m Delivery Device Kit for the Indications for
Use/Intended Use.
CONTRAINDICATIONS
Refer to the Directions for Use for the Rez ū m Delivery Device
Kit 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 Service 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 cautions 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 Services. 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 DFU. 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 two-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.
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.
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
None.
CAUTIONS
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 medical 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 cautions when connecting this generator
with other equipment:
• Ensure that the connected equipment is in accordance
with the IEC60601-1 or 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 (IEC 60601-1-2:2007 and IEC 60601-1-2:2014), 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.
• If you think the generator may have been damaged.
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 utility knives and such, as you risk cutting into
yourself and/or product.
ADVERSE EVENTS
The following adverse events have not been reported in the
clinical trials: erectile dysfunction, pelvic abscess, rectal wall
injury, and fistula. Delivering a form of thermal therapy or misuse
of the device has potential for producing these adverse effects.
Reported Adverse Events
The types of device related, or procedure related adverse
events reported are typical of thermal BPH ablation
procedures. There were no clinically significant complications
resulting from the treatment.
A summary of the adverse events observed in clinical studies is
presented in the Rez ū m Delivery Device Kit DFU.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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.
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
Caution: Please use caution in opening the shipping box and try
not to use sharp utility knives and such, as you risk cutting into
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
Customer Service 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.
Caution: Using this generator with the air vent blocked could
cause a breakdown. Clean this generator with care.
Caution: Only approved equipment and accessories shall be
connected to the generator.
Caution: 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
Switch
Turns system on / off.
G USB Port Allows data from system to be
exported onto USB device.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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.
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 for 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.
Caution: 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 has the following detachable parts
and accessories:
Detachable Parts - Supplied with the Rez ū m Generator
Table 5: Detachable Parts
Model Number Description,
Function
Type
1519-001 Power Cord
3.05 meter hospital
grade power cord
North American,
15 amp
Reusable
1519-002 Power Cord
3.05 meter hospital
grade power cord
Continental Europe,
10 amp
Reusable
1519-003 Power Cord
2.50 meter hospital
grade power cord
Swiss, 10 amp
Reusable
1519-004 Power Cord
3.00 meter hospital
grade power cord
United Kingdom/
Ireland, 10 amp
Reusable
1519-005 Power Cord
2.50 meter hospital
grade power cord
Italian, 10amp
Reusable
1519-006 Power Cord
3.00m hospital
grade power cord
Australian, 10amp
Reusable
Accessories - Supplied Separately
Table 6: Accessories
Model Number Description,
Function
Type
D2201 Delivery Device Kit
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 on and off the generator, prime the delivery
device, perform treatment, and use the option menu.
Warning: When transporting the generator, it is important to
position it with the display facing away from the body.
Caution: Follow your facility’s procedures and applicable
regulations when disposing of anything that has been used
on patients.
Caution: 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.)

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
Caution: Do not place anything on this generator.
Caution: Observe the following cautions when connecting this
generator with other equipment:
• Ensure that the connected equipment is in accordance
with the IEC60601-1 or IEC safety standards.
• Employ additional protective measures (e.g., additional
protective earthing) as necessary.
Caution: 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.
Caution: The Rez ū m Generator power cord and delivery device
cable may cause a trip hazard while attached to the generator.
Caution: 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.
Caution: 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.
Caution: 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.
Caution: If there is condensation on the generator, dry it
thoroughly before turning the power on.
Caution: 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.
• If you think the generator may have been damaged.
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.
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 DFU. 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
Caution: 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.
• If you think the generator may have been damaged.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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 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.
Caution: 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.
• If you think the generator may have been damaged.
After setup is complete, perform a pre-treatment vapor cycle
immediately prior to procedure to initiate treatment stage.
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 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 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
DFU. Turn on again to restart the generator to begin a new
therapy session.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
Caution: 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 m™ Generator 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 750ml 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.
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.
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
Caution: Only approved equipment and accessories shall be
connected to the generator.
Caution: 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 memory stick.
Touch the desired folder to select the location on the USB 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 memory
stick, 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.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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 Set Language screen allows the language to be updated
from English to preloaded language options and desired number
format. These settings do not change when powering on and off
the generator.
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
Caution: Only approved equipment and accessories shall be
connected to the generator.
Caution: 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 drive for use by
service personal 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

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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 personal only.
Treatment Config
This screen is password protected and accessed by Boston
Scientific personal only.
Servicing
This screen is password protected and accessed by Boston
Scientific personal 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.
Caution: 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.
• If you think the generator may have been damaged.
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.
Caution: 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.
Caution: Using this generator with the ventilation ports blocked
could cause a breakdown. Clean this generator with care.
Caution: Only approved equipment and accessories shall be
connected to the generator.
Caution: 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 Customer service.
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 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.
Caution: After cleaning, allow complete drying before plugging
in to an outlet by wiping with a dry, soft cloth.
Caution: Do not soak the generator or accessories in any medical
liquid. Also, keep liquids out of the generator and accessories.
Caution: When using disinfectant solutions, follow the
manufacturer’s directions.
Caution: Using this generator with the air vent blocked could
cause a breakdown. Clean this generator with care.
Caution: 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.

Boston Scientific (Master Brand DFUTemplate 8.2677in x 11.6929in A4, 92238519A), eOP MANUAL, MB, Rezūm, en, 50909085-01A
Black (K) ∆E ≤5.0
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 7: 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 Service.
• 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 Safety 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
Customer Service.
• 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 Service.
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
Caution: 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.
Caution: 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 8: Generator Specification
Description Specification
Protection Against Electric Shock Class I Equipment (generator)
Model Number G2200
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 9 feet
Applied Parts Protection
Type BF
Electromagnetic Compatibility Requirements
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 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.
Caution: 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.
Caution: Use of portable and mobile RF communications equipment near the Rez ū m Generator
may affect its operation.
Caution: Observe the following cautions when connecting this generator with other equipment:
• Ensure that the connected equipment is in accordance with the IEC60601-1 or IEC safety standards.
Employ additional protective measures (e.g., additional protective earthing) as necessary.
Table 9: 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 11:2015
Group 2 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 11:2015
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
IEC 61000-3-2:2014
Class A
Voltage fluctuations
and flicker
IEC 61000-3-3:2013
Complies
Table 10: Electromagnetic Immunity
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2:2008
±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
IEC 61000-4-4:2012
±1 kV common mode;
5kHz and 100KHZ
Mains power quality should be that of a
typical commercial or hospital environment.
Surge immunity
IEC 61000-4-5:2014
±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
IEC 61000-4-8:2009
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
61000-4-11:2004
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.