Rez?m G2200 User manual

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Operator’s Manual
Rezūm®Generator
Model G2200
WARNING: Carefully read and understand all instructions, indications, warnings, and cautions
in this operator’s manual prior to using the Rezūm Generator. Failure to do so could result in
compromised patient safety, patient complications and/or insufficient treatment.

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Table of Contents
Chapter 1 About the Rezūm®Generator........................................................................................... 6
1.1 Trademark and Copyright Information.................................................................................... 7
1.2 Contact Information................................................................................................................... 7
1.3 Indications for Use/Intended Use and Contraindications ..................................................... 8
1.4 Product Description.................................................................................................................... 9
1.5 Safety.......................................................................................................................................... 10
1.5.1 Dangers, Warnings and Cautions........................................................................................10
1.5.1.1 DANGERS....................................................................................................................... 11
1.5.1.2 WARNINGS....................................................................................................................11
1.5.1.3 CAUTIONS ..................................................................................................................... 13
1.5.2 Potential Adverse Events ....................................................................................................16
1.5.3 Reported Adverse Events.................................................................................................... 16
1.5.4 Symbols ............................................................................................................................... 17
1.5.4.1 Generator Symbols....................................................................................................... 17
1.5.4.2 User Interface Symbols ................................................................................................20
1.6 Operator Training Requirements............................................................................................21
Chapter 2 Getting Started.................................................................................................................. 22
2.1 Unpacking and Inspecting....................................................................................................... 23
2.1.1 Generator Controls and Connections ................................................................................. 24
2.1.2 Display Screen Map............................................................................................................. 27
2.1.3 Audible Tones......................................................................................................................28
2.1.4 Volume Control ................................................................................................................... 29
2.1.5 Detachable Parts and Accessories ...................................................................................... 30
Chapter 3 Using the Rezūm Generator............................................................................................31
3.1 Step by Step Instructions......................................................................................................... 32
3.1.1 Connecting the Power Cord ................................................................................................ 34
3.1.2 Turning on the Rezūm Generator .......................................................................................35
3.1.3 Priming the Delivery Device................................................................................................ 39

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3.1.4 Performing the Therapy...................................................................................................... 42
3.1.4.1 Turbo Flush.................................................................................................................... 45
3.1.4.2 Connecting New Delivery Device during treatment session .................................. 45
3.1.5 Turning off the Rezūm Generator....................................................................................... 46
3.1.6 Rezūm Generator Options Menu Items.............................................................................. 47
3.1.6.1 Enter Patient Info.......................................................................................................... 48
3.1.6.1.1 Using the On-screen Keyboard ............................................................................50
3.1.6.2 Drain Bladder.................................................................................................................51
3.1.6.3 Replace Saline ...............................................................................................................51
3.1.6.4 Remove Device..............................................................................................................52
3.1.6.5 View Patient Info...........................................................................................................53
3.1.6.5.1 Delete Record ......................................................................................................... 54
3.1.6.5.2 View Record ............................................................................................................55
3.1.6.5.3 Export Record..........................................................................................................56
3.1.6.6 More Options................................................................................................................59
3.1.6.6.1 System Status..........................................................................................................59
3.1.6.6.2 Export Logs...............................................................................................................64
3.1.6.6.3 Treatment Monitor.................................................................................................66
3.1.6.6.4 Treatment Config....................................................................................................66
3.1.6.6.5 Servicing ..................................................................................................................66
Chapter 4 Maintenance and Service................................................................................................. 67
4.1 Recommended Maintenance and Care .................................................................................68
4.1.1 Visual Inspection ................................................................................................................. 69
4.1.2 Cleaning the Rezūm Generator...........................................................................................70
4.1.2.1 Recommended Cleaning Products.............................................................................70
4.1.2.2 Not Recommended Cleaning Products .....................................................................70
4.1.2.3 Cleaning Instructions.................................................................................................... 71
4.1.3 Maintenance Checklist........................................................................................................72
4.2 Authorized Repair Service .......................................................................................................73
Chapter 5 Technical Specifications ...................................................................................................74

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5.1 Generator Specifications..........................................................................................................75
5.2 Operating, Storage, and Transportation Specifications ......................................................76
5.3 Electromagnetic Compatibility Requirements ......................................................................77
5.4 EN 60601-1-2 Compliance ......................................................................................................84
Chapter 6 Troubleshooting................................................................................................................85
6.1 Troubleshooting Steps.............................................................................................................86
6.2Error Messages.......................................................................................................................... 87
6.3 Error Message Table.................................................................................................................88
6.4 Obtaining technical assistance................................................................................................ 90

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Chapter 1 About the Rezūm®Generator
Overview
This chapter contains information about the Rezūm Generator including safety. Please make
sure you read this entire instruction manual prior to using the Rezūm Generator.

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1.1 Trademark and Copyright Information
Rezūm is a registered trademark of the NxThera Corporation.
© NxThera Corporation 2018. All rights reserved.
1.2 Contact Information
NxThera, Inc.
7351 Kirkwood Lane North
Suite 138
Maple Grove, MN 55369
USA
www.nxthera.com
Phone: [phone]
Toll Free: [phone]
Fax: [phone]
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands

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1.3 Indications for Use/Intended Use and Contraindications
The Rezūm generator is intended to be used with the NxThera Rezūm Delivery Device Kit, Model
D2201 only. Refer to the Instructions for Use for the Rezūm Delivery Device Kit for the
Indications for Use/Intended Use and Contraindications.

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1.4 Product Description
The Rezūm 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 or “dry vapor” at slightly
above 100°C. The generator delivers this thermal energy in the form of dry vapor at
temperatures 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.

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1.5 Safety
This section contains important safety information. NxThera requires that you read and
understand all warnings, cautions, and the operator’s manual prior to using the Rezūm
Generator.
1.5.1 Dangers, Warnings and Cautions
The symbol and signal words shown below identify potential hazard categories. The definition
of each category is as follows:
DANGER
This alert identifies hazards that will cause serious personal injury or death.
WARNING
This alert identifies hazards that may cause serious personal injury or death.
CAUTION
This alert identifies hazards that may cause minor personal injury, product damage, or property
damage.

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1.5.1.1 DANGERS
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.
1.5.1.2 WARNINGS
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:
After visual inspection, if the generator is damaged or a message is indicated to
not use the generator, please contact Customer Service and take the generator out
of service.
WARNING:
Before conducting maintenance work, turn the power off and unplug the power
cord from the outlet to prevent electric shock.
WARNING:
Do not modify this equipment without authorization of NxThera.
WARNING:
Carefully read and understand all instructions, indications, warnings, and cautions
in this operator’s manual prior to using the Rezūm Generator. Failure to do so
could result in compromised patient safety, patient complications and/or
insufficient treatment.
WARNING:
Do not connect a grounding wire from a grounding stud to a gas pipe or water
pipe.
WARNING:
Do not connect to an electrical outlet controlled by a wall switch because the
device may be accidentally turned off.
WARNING:
Do not plug power cord into an outlet (or unplug it) with wet hands.
WARNING:
Do not submerge the device in liquids or pour cleaning liquids over, into or onto
the generator.
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.

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WARNINGS CONTINUED
WARNING:
Failure on the part of all responsible individuals, hospitals, or institutions,
employing the use of Rezūm 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 Rezūm Generator.
WARNING:
If a critical error message is displayed, take the generator out of service and call
NxThera Customer Service. Do not attempt to service or maintain the generator
while in use with a patient.
WARNING:
If the generator measurement readings or messages seem dubious or abnormal,
check the condition of the patient first and stop using the generator.
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, 3032-0XX Section 9. Turn on again to restart the
generator to begin a new therapy session.
WARNING:
No modification of this equipment is allowed. Do not attempt to service or
maintain the generator while in use with a patient.
WARNING:
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.
WARNING:
Shock Hazard - Do not open, disassemble, or alter the Rezūm Generator! Failure to
observe this warning can result in personal injury or death. Refer maintenance
issues to authorized service personnel.
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 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.
WARNING:
The generator needs special precautions regarding Electromagnetic Compatibility
(EMC) and needs to be installed and put into service according to the EMC
information in Chapter 5 provided in this operator’s manual.
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 in Chapter 5.
WARNING:
The Rezūm Generator is equipped with a USB port that is sensitive to ESD that may
potentially result in injury or device failures.

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WARNINGS CONTINUED
WARNING:
The Rezūm Generator is reusable, but is restricted to a single patient at a time for a
therapy session.
WARNING:
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
WARNING:
Use a grounded AC outlet for the power supply and ground this generator.
WARNING:
Use of accessories other than those specified in this document may result in
increased emission or decreased immunity of the Rezūm Generator.
WARNING:
Use only NxThera approved and specified parts, accessories, optional parts,
consumables, and components.
WARNING:
Use only NxThera specified power cord.
WARNING:
Use with the specified AC voltage and frequency.
WARNING:
When transporting the generator, it is important to position it with the display
facing away from the body.
1.5.1.3 CAUTIONS
CAUTION:
After cleaning, allow complete drying before plugging into an outlet.
CAUTION:
Before conducting maintenance work, turn the power OFF and unplug the power
cord from the outlet to prevent electric shock.
CAUTION:
Before moving this generator, turn the power OFF, remove all accessories from the
patient, and unplug the power cord from the outlet.
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.)
CAUTION:
Do not place anything on this generator.
CAUTION:
Do not soak the generator or accessories in any medical liquid. Also, keep liquids
out of the generator and accessories.

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CAUTIONS CONTINUED
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 Rezūm Generator near cauterizers, diathermy equipment, FM
2-way radios, or cellular phones. Turn power off to radio, cellular and other like
equipment near the Rezūm Generator. Refer to the EMI tables in Chapter 5.
CAUTION:
Exposing the Rezūm Generator to extreme environmental conditions outside of its
specified parameters may compromise the ability of the Rezūm Generator to
function properly and/or cause the plastic to warp and/or crack.
CAUTION:
Follow your facility’s procedures and applicable regulations when disposing of
anything that has been used on patients.
CAUTION:
If the Rezūm 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:
If there is condensation on the generator, dry it thoroughly before turning the
power on.
CAUTION:
Input voltage range is 100 to 240V at 50 to 60 Hertz. Verify this voltage matches
that of the power outlet.
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:
Only NxThera approved equipment and accessories shall be connected to the
generator.
CAUTION:
The Rezūm Generator USB port is only intended for use during maintenance by
authorized service personnel or to export therapy data.
CAUTION:
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.
CAUTION:
The Rezūm Generator is intended to be used indoors at a medical facility or
physician office environment only.

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CAUTIONS CONTINUED
CAUTION:
The Rezūm Generator cables may cause a trip hazard while cables are attached to
the generator.
CAUTION:
The Rezūm Generator needs special precautions regarding Electromagnetic
compatibility (EMC) and care should be taken in accordance to the EMC
information provided in Chapter 5 of this document.
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.
CAUTION:
Use of portable and mobile RF communications equipment near the Rezūm
Generator may affect its operation.
CAUTION:
Using this generator with the air vent blocked could cause a breakdown. Clean this
generator with care.
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.
CAUTION:
When using disinfectant solutions, follow the manufacturer’s directions.
CAUTION:
Input voltage is pre-selected as labeled on the generator
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.

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1.5.2 Potential 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.
1.5.3 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 NxThera clinical studies is presented in the Rezūm
Delivery Device Kit Instructions for Use for the Rezūm Delivery Device Kit, 3032-0XX.

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1.5.4 Symbols
The following symbols may appear in this manual, on the generator labeling and/or packaging.
Some of the symbols represent standards and compliances associated with the generator and its
use.
1.5.4.1 Generator Symbols
Symbol
Description of the Symbol
Standard
Title of symbol and
(reference number)
Indicates on the rating plate that the
equipment is suitable for alternating
current only; to identify relevant
terminals
IEC 60417
Alternating current
(5032)
Manufacturer’s catalog number, so that
the medical device can be identified
ISO 15223-1:2016
Catalog number
(5.1.6)
Electrostatic sensitive device
Caution: Contains parts and assemblies
susceptible to damage by electrostatic
discharge (ESD)
Contact with generator package should
be avoided at low levels of relative
humidity, especially if insulating
footwear is being worn or the
ground/floor is nonconductive. Low
levels of relative humidity must in
particular be expected on hot, dry
summer days and very cold winter
days.
IEC 60417
Electrostatic sensitive
devices (5134)
CE Marked per the Medical Device
Directive 93/42/EEC of the European
Union. The Notified Body is SEMKO
(ID#0413)
MDD 93/42/EEC
Compliance with
MDD 93/42/EEC
Consult accompanying documents
(Printed in blue on generator label)
ISO 7010:2011
Refer to instruction
manual/booklet
(M002)
Indicates the date when the medical
device was manufactured
ISO 15223-1:2016
Date of Manufacture
(5.1.3)

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Symbol
Description of the Symbol
Standard
Title of symbol and
(reference number)
Authorized Representative in the
European Union
ISO 15223-1:2016
Indicates the
Authorized
representative in the
European Community
(5.1.2)
Indicates a medical device that can be
broken or damaged if not handled
carefully.
The generator package should be
handled carefully and should never be
tipped over or slung
ISO 15223-1:2016
Fragile, handle with
care (5.3.1)
Indicates a medical device that needs
to be protected from moisture.
The generator package must be
protected from excessive humidity and
must accordingly be stored under
cover.
ISO 15223-1:2016
Keep dry (5.3.4)
Indicates the medical device
manufacturer
ISO 15223-1:2016
Manufacturer (5.1.1)
Manufacturing internal part number
reference
Not Applicable
Not Applicable
Model Number
Not Applicable
Not Applicable
Indicates generally elevated,
potentially hazardous, levels of non-
ionizing radiation, or to indicate
equipment or systems e.g. in the
medical electrical area that include RF
transmitters or that intentionally apply
RF electromagnetic energy for
diagnosis or treatment.
IEC 60417
Non-Ionizing
electromagnetic
radiation (RF) (5140)
Indicates disconnection from the
mains, at least for mains switches or
their positions, and all those cases
where safety is involved.
IEC 60417
“OFF” (power)
(5008)
Indicates connection to the mains, at
least for mains switches or their
positions, and all those cases where
safety is involved.
IEC 60417
“ON” (power)
(5007)

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Symbol
Description of the Symbol
Standard
Title of symbol and
(reference number)
US Federal law restricts this device to
sale by or on the order of a physician.
FDA Register Vol. 81,
No. 115
Prescription device
(IIG, page 38919)
IPx0
Protection against Ingress of Solids
and Liquids
IEC 60529
Non-protected
Identifies any terminal which is
intended for connection to an external
conductor for protection against
electric shock in case of a fault, or the
terminal of a protective earth (ground)
electrode.
IEC 60417
Protective earth;
protective ground
(5019)
Indicates the range of humidity to
which the medical device can be safely
exposed.
Relative Humidity limits (non-
condensing)
ISO 15223-1:2016
Humidity limitation
(5.3.8)
Indicates the manufacturer's serial
number so that a specific medical
device can be identified.
ISO 15223-1:2016
Serial number (5.1.7)
Temperature limitations
This symbol will specify an upper ("...°C
max.") and lower ("...°C min.")
temperature limit.
ISO 15223-1:2016
Temperature limit
(5.3.7)
This symbol indicates that the waste of
electrical and electronic equipment
must not be disposed as unsorted
municipal waste and must be collected
separately. Please contact an
authorized representative of the
manufacturer for information
concerning the decommissioning of
your equipment.
BS EN 50419:2006
WEEE wheeled bin
Identifies a type BF applied part
complying with IEC 60601-1.
IEC 60417:2002
ANSI/AAMI/IEC
TIR60878:2003
IEC 60601-1
Type BF applied part
(5333)
Universal Serial Bus (USB) port
connector
Not Applicable
Not Applicable

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Symbol
Description of the Symbol
Standard
Title of symbol and
(reference number)
Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warnings and precautions that
cannot, for a variety of reasons, be
presented on the medical device itself.
ISO 15223-1:2016
Caution (5.4.4)
Medical Equipment as to electrical
shock, fire and mechanical hazards
only in accordance with ANSI/AAMI ES
60601-1 AMD 1 (2012), CAN/CSA
C22.2 No 60601-1 (2014)
ANSI/AAMI ES 60601-
1 AMD 1 (2012),
CAN/CSA C22.2 No
60601-1 (2014)
Medical Equipment
recognized by
Underwriters
Laboratory Inc.
Table 1: Generator Symbols
1.5.4.2 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.
Export