Stryker RF MultiGen 0406-900-000 User manual

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Instructions For Use
0406-900-702 E

Instructions For Use
2014-05 0406-900-702 Rev-E www.stryker.com
Interventional Spine (IVS)
RF MultiGen® Generator
0406-900-000
5.x
Software Version
ENGLISH (EN)

0406-900-702 Rev-E EN
www.stryker.com 3
Content
Introduction .......................................................................................................................................................................................................................................................7
User/Patient Safety...........................................................................................................................................................................................................................................7
Indications For Use...........................................................................................................................................................................................................................................8
Contraindications ..............................................................................................................................................................................................................................................8
Accessories.......................................................................................................................................................................................................................................................8
System Overview ..............................................................................................................................................................................................................................................9
Procedural Overview.........................................................................................................................................................................................................................................9
Features ..........................................................................................................................................................................................................................................................10
Hardware Interface................................................................................................................................................................................................................................10
Symbol Definitions.................................................................................................................................................................................................................................10
System Components .............................................................................................................................................................................................................................11
Screen Layout........................................................................................................................................................................................................................................12
Modes of Operation and Color Codes.................................................................................................................................................................................................12
Software Button Definitions..................................................................................................................................................................................................................13
Instructions......................................................................................................................................................................................................................................................14
To Perform Initial Setup:........................................................................................................................................................................................................................14
To Connect Electrode Cable(s):...........................................................................................................................................................................................................14
To Attach Cable Identification Tags:.....................................................................................................................................................................................................14
To Connect a Ground Pad (monopolar only):......................................................................................................................................................................................15
To Connect a Printer (optional):...........................................................................................................................................................................................................15
To Connect a RF Hand Controller (optional): ......................................................................................................................................................................................15
To Select a Procedure Configuration: ..................................................................................................................................................................................................16
Procedure Configurations Table..................................................................................................................................................................................................16
To Configure a Monopolar Procedure or a Parallel Bipolar Combination Procedure Using MultiGen Cable(s)............................................................................... 17
To Configure a Parallel Bipolar Combination Procedure Using a MultiGen Cable.............................................................................................................................18
To Configure a Parallel Bipolar Procedure Using MultiGen Cable(s) .................................................................................................................................................19
To Start A Procedure.............................................................................................................................................................................................................................20
To EDIT Sensory or Motor Stimulation Settings ..................................................................................................................................................................................21
To Perform Sensory or Motor Stimulation............................................................................................................................................................................................23
To EDIT RF Output Settings: ................................................................................................................................................................................................................24
To Control RF Output............................................................................................................................................................................................................................26
To Start Single Electrode(s) - separately or staggered: ............................................................................................................................................................26
To Start Multiple Electrodes - concurrently................................................................................................................................................................................28
To Perform a Parallel Bipolar Procedure.....................................................................................................................................................................................29
To Choose a Placement Region...........................................................................................................................................................................................................30
To View a Procedure Summary:...........................................................................................................................................................................................................31
To Name (and Create) a Printout, Folder or File:................................................................................................................................................................................32
To Save or Access Saved Procedure Settings ....................................................................................................................................................................................33
To Create or Access File Settings........................................................................................................................................................................................................35
To Edit File Settings ..............................................................................................................................................................................................................................35
To Change System Settings: Registration............................................................................................................................................................................................36
To Change System Settings: Display Settings.....................................................................................................................................................................................37
To Change System Settings: Sound Settings ......................................................................................................................................................................................38
To Change System Settings: Date and Time Settings.........................................................................................................................................................................39
To Change System Settings: Language Settings.................................................................................................................................................................................40
To Change System Settings: Procedure Default Settings...................................................................................................................................................................41
To Edit Procedure Default Settings ......................................................................................................................................................................................................41

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EN 0406-900-702 Rev-E
Content (continued)
Inspection and Testing ...................................................................................................................................................................................................................................42
To Perform Check-in Procedure (optional) ..........................................................................................................................................................................................42
Storage and Handling.....................................................................................................................................................................................................................................42
Cleaning ..........................................................................................................................................................................................................................................................42
Troubleshooting...............................................................................................................................................................................................................................................43
To Replace the Fuses...........................................................................................................................................................................................................................44
Federal Communications Commission (FCC) Statement Concerning Radio Frequency Interference.......................................................................................................44
Specifications .................................................................................................................................................................................................................................................45
Disposal/Recycle............................................................................................................................................................................................................................................49
Appendix A - RF Hand Controller Instructions ..............................................................................................................................................................................................49
Intended Use .........................................................................................................................................................................................................................................49
Features and Functions ........................................................................................................................................................................................................................49
Appendix B - Maximum Frequency and Maximum Stimulation Width Graphs ............................................................................................................................................52
Appendix C - Relative Lesion Sizes and Shapes (parallel bipolar only)......................................................................................................................................................52
Appendix D - DualWave Waveform ................................................................................................................................................................................................................54
Appendix E - Radio Frequency Output Plot ..................................................................................................................................................................................................54
Appendix F - Factory Default Values.............................................................................................................................................................................................................55
Software License Notice ................................................................................................................................................................................................................................55

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Figures
Figure 1 Block Diagram....................................................................................................................................................................................................................................9
Figure 2 Hardware Interface...........................................................................................................................................................................................................................10
Figure 3 System Components........................................................................................................................................................................................................................11
Figure 4 Screen Layout ..................................................................................................................................................................................................................................12
Figure 5 Cable Identification Tags .................................................................................................................................................................................................................14
Figure 6 Pad Placement.................................................................................................................................................................................................................................15
Figure 7 Monopolar or Monopolar and Parallel Bipolar Configuration.........................................................................................................................................................17
Figure 8 Monopolar or Monopolar and Parallel Bipolar Combination Configuration ...................................................................................................................................18
Figure 9 Parallel Bipolar Configuration ..........................................................................................................................................................................................................19
Figure 10 Home Screen..................................................................................................................................................................................................................................20
Figure 11 Typical Stimulation Sensory Screen - INACTIVE..........................................................................................................................................................................21
Figure 12 Typical Stimulation Motor Screen - INACTIVE ..............................................................................................................................................................................21
Figure 13 Typical Stimulation Screen - INACTIVE.........................................................................................................................................................................................22
Figure 14 Typical Stimulation Preset Dashboard [FREQUENCY].................................................................................................................................................................22
Figure 15 Typical Stimulation Keypad Dashboard [AMPLITUDE].................................................................................................................................................................22
Figure 16 Typical Parallel Bipolar Stimulation Screen - ACTIVE..................................................................................................................................................................23
Figure 17 Typical Stimulation Screen - ACTIVE ............................................................................................................................................................................................23
Figure 18 RF Output Screen in THERMAL Mode - INACTIVE ......................................................................................................................................................................24
Figure 19 Typical Keypad Dashboard [HOLD TIME] .....................................................................................................................................................................................24
Figure 20 RF Output Screen in PULSE Mode - INACTIVE ...........................................................................................................................................................................25
Figure 21 RF Output PULSE Preset Dashboard............................................................................................................................................................................................25
Figure 22 RF Output Screen - START CONFIRM Dashboard ......................................................................................................................................................................26
Figure 23 RF Output Screen THERMAL mode - ACTIVE .............................................................................................................................................................................27
Figure 24 RF Output Screen PULSE mode - ACTIVE...................................................................................................................................................................................27
Figure 25 RF Output Screen THERMAL mode - INACTIVE - SELECTED AND LOCKED ELECTRODES 1, 2, and 3................................................................................28
Figure 26 RF Output Screen THERMAL mode - PARALLEL BIPOLAR ACTIVE...........................................................................................................................................29
Figure 27 RF Output Screen PULSE mode - PARALLEL BIPOLAR ACTIVE ................................................................................................................................................29
Figure 28 Choose Placement Region Dashboard.........................................................................................................................................................................................30
Figure 29 Typical CHOOSE PLACEMENT Dashboard [LUMBAR]................................................................................................................................................................30
Figure 30 Procedure Summary Screen .........................................................................................................................................................................................................31
Figure 31 Typical Keyboard Screen...............................................................................................................................................................................................................32
Figure 32 Select Folder Screen.....................................................................................................................................................................................................................33
Figure 33 Select File Screen .........................................................................................................................................................................................................................34
Figure 34 File Settings Screen.......................................................................................................................................................................................................................35
Figure 35 Typical Edit File Settings Screen ..................................................................................................................................................................................................35
Figure 36 System Settings Screen [REGISTRATION] ...................................................................................................................................................................................36
Figure 37 Display Settings Screen.................................................................................................................................................................................................................37
Figure 38 Sound Settings Screen..................................................................................................................................................................................................................38
Figure 39 Date and Time Screen...................................................................................................................................................................................................................39
Figure 40 Language Settings Screen ............................................................................................................................................................................................................40
Figure 41 Set Procedure Default Screen ......................................................................................................................................................................................................41
Figure 42 Typical Edit Procedure Default Settings Screen ..........................................................................................................................................................................41
Figure 43 Fuse Replacement.........................................................................................................................................................................................................................44
Figure 44 Hand Controller Features...............................................................................................................................................................................................................49
Figure 45 Maximum Frequency vs. Stimulation Width Graph.......................................................................................................................................................................52

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Figures (continued)
Figure 46 Maximum Stimulation Width vs. Frequency Graph.......................................................................................................................................................................52
Figure 47 Contiguous Lesion 4.2 mm x 5.8 mm (width x length) ................................................................................................................................................................52
Figure 48 Contiguous Lesion 7.8 mm x 9.6 mm (width x length).................................................................................................................................................................52
Figure 49 Non-contiguous Lesions 4.4 mm x 7.5 mm (width x length) 5.0 mm x 8.2 mm (width x length)...............................................................................................53
Figure 50 Non-contiguous Lesions 4.7 mm x 8.5 mm (width x length) 5.1 mm x 8.2 mm (width x length)..............................................................................................53
Figure 51 DualWave Waveform ......................................................................................................................................................................................................................54
Figure 52 RF Output Plot ...............................................................................................................................................................................................................................54

0406-900-702 Rev-E EN
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Introduction
This Instructions For Use manual is the most comprehensive source of
information for the safe and effective use of your product. This manual may
be used by in-service trainers, physicians, nurses, surgical technologists,
and biomedical equipment technicians.
Keep and consult this reference manual during the life of the product.
The following conventions are used in this manual:
• AWARNING highlights a safety-related issue. ALWAYS comply with this
information to prevent patient and/or healthcare staff injury.
• ACAUTION highlights a product reliability issue. ALWAYS comply with
this information to prevent product damage.
• ANOTE supplements and/or clarifies procedural information.
If additional information, especially safety information, or in-service training
is required, contact your Stryker sales representative or call Stryker
customer service.
User/Patient Safety
WARNINGS:
• Onlytrainedandexperiencedhealthcareprofessionalsshouldusethis
equipment.
• Beforeusinganysystemcomponentoranycomponentcompatible
with this system, read and understand the instructions. Pay special
attention to WARNING information. Become familiar with the handling
characteristics, the intended use(s) of this equipment, and system
components prior to use. Contact your Stryker sales representative or
customer service for in-service training.
• Thehealthcareprofessionalperforminganyprocedureisresponsible
for determining the appropriateness of this equipment and the specific
technique for each patient. Stryker, as a manufacturer, DOES NOT
recommend surgical procedure.
• Uponinitialreceiptandbeforeeachuse,operatetheequipmentand
inspect each component for damage. DO NOT use any component
if damage is apparent. Only trained and experienced healthcare
professionals should maintain this equipment. See the Interventional
Spine (IVS) Care Instructions.
• DONOTusethisequipmentinareasinwhichflammableanestheticsor
flammable agents are mixed with air, oxygen or nitrous oxide.
• DONOTusethisequipmentinthepresenceofendogenousgases.
• DONOTusethisequipmentinthepresenceofcotton,woolorgauze
that is saturated with oxygen.
• Takespecialprecautionsregardingelectromagneticcompatibility
(EMC) when using medical electrical equipment like this system. Install
and place this system into service according to the EMC information
contained in this manual. Portable and mobile RF communications
equipment can affect the function of this system.
• DONOTusethisequipmentwithpatientshavingacardiacpacemaker
or pacemaker electrodes unless otherwise directed by the cognizant
cardiology department.
WARNINGS:
• Patientstakingsteroidsandpatientswithpacemakers,lupus,gout,
uncontrolled diabetes, Ehlers-Danlos syndrome, prior open capsular
procedures, autoimmune disease, or etiologies where their immune
systems are compromised require special consideration.
• Topreventasystemfailurethatcoulddelaysurgery,DONOToperate
the generator outside of its prescribed environmental conditions. See the
Specifications section.
• Wipeawayanypotentiallyflammableliquidsunderneaththepatientorin
body recesses or cavities before using the equipment.
• Applydrygauzeasrequiredtoavoidskin-to-skincontactbetweenthe
patient’s arms and body.
• DONOTallowthepatienttocomeincontactwithmetalpartsthatare
grounded or have a large capacitance with respect to ground (operating
table, supports). Use antistatic covers as required.
• WhenRFelectro-surgicalandphysiologicalmonitoringequipment
are used simultaneously on the same patient, position the monitoring
electrodes as far away from the surgical electrodes as possible,
especially if no protective resistors or RF chokes are present. DO NOT
use needle electrodes for monitoring.
• ALWAYSusepatientmonitoringsystemsthatincludehighfrequency
current limiting devices. Failure to comply may cause the patient
monitoring equipment to malfunction.
• DONOTallowtheleadstothesurgicalelectrodestotouchthepatientor
other leads.
• Placetemporarilyunusedelectrodesconnectedtothegeneratorin
an electrically-insulated container. Never place an unused, connected
electrode on the patient.
• ALWAYSuseparallelbipolartechniquesforsurgicalprocedureswhere
high frequency current could flow through parts of the body that have
a relatively small cross sectional area. Failure to comply may cause
undesirable tissue damage and result in patient injury.

8 www.stryker.com
EN 0406-900-702 Rev-E
Indications For Use
The Stryker RF MultiGen (generator), in combination with the Stryker RF
Electrodes and Cannulae, are intended for coagulation of soft tissues in
orthopedic, spinal, and neurosurgical applications. Examples include, but
are not limited to: Facette Denervation, Trigeminus Neuralgia, Peripheral
Neuralgia and Rhizotomy.
The Stryker MultiGen Cable is intended for coagulation of soft tissues
in orthopedic, arthroscopic, spinal, and neurosurgical applications in
combination with the separately cleared Stryker RF MultiGen, Electrodes
and Cannulae. Examples of procedures include, but are not limited to,
Facette Denervation, Trigeminus Neuralgia, and Rhizotomy.
Contraindications
None known.
Accessories
WARNINGS:
• UseonlyStryker-approvedsystemcomponentsandaccessories,unless
otherwise specified. Other system components and accessories may not
properly fit into connectors or operate with the generator, and may result
in increased emissions or decreased immunity of the generator.
• DONOTmodifyanysystemcomponentoraccessory,includingthe
ground connection of the power cord.
Specifically:
• UseonlyStryker-approvedcannulae.
• UseonlyStryker-approvedgroundpads.
• CannulaeareSINGLEUSEONLY.DONOTuseifpackageisdamaged.
DO NOT reuse. DO NOT resterilize single use accessories.
• GroundpadsareSINGLEUSEONLY.DONOTreuse.
• DONOTreuse,reprocess,orrepackageasingleusedevice.Asingle
use device is intended for a single use only. A single use device may
not withstand chemical, chemical vapor, or high temperature sterilization
reprocessing. Design features may make cleaning difficult. Reuse
may create a serious risk of contamination and may compromise the
structural integrity of the device resulting in operational failure. Critical
product information may be lost if the device is re-packaged. Failure to
comply may lead to infection or cross-infection and result in patient and/
or healthcare staff injury.
DESCRIPTION REF
MultiGen Cable 0406-900-100
RF Hand Controller 0406-850-100
Cable Identification Tags 0406-900-200
Ground Pad (neutral electrode) 0406-650-205
Ground Pad Cable (monopolar return electrode
cable) 0406-850-200
Sterile Plastic Bag 0406-001-000
Venom®Nitinol Electrodes 0406-825-01X series
Venom RF Cannulae 0406-XXX-XXX series
Additional Electrodes, Cannulae, and Catheters See below.
NOTES:
• Ifyouneedmoreinformation,contactyourStrykersalesrepresentative
for a complete list of accessories, including Stryker-approved electrodes,
cannulae and catheters.
• SeetheinstructionsforusesuppliedwiththeVenomelectrodesand
cannulae for important safety and compatibility information.
• Strykerdoesnotsellprintersforthegenerator.Asaminimum
requirement, any printer used with the generator must be printer
command language level 3 (PCL3) compatible. Printers using versions
of PCL greater than 3 may also work. See your printer manual for
compatibility information. Incompatible printers will not work with the
generator.
Trademarks not the property of Stryker Corporation are the property of their
respective owners.

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System Overview (see figure 1)
The generator applies temperature-controlled, radio frequency (RF) energy
to targeted nerve tissue using an active electrode. The generator is capable
of supplying RF energy to a maximum of four electrodes concurrently using
a timed-delivery method. Using monopolar electrode(s), parallel bipolar
electrode(s), or NiTRODETM coaxial bipolar electrode(s), the application of
RF energy causes a thermal reaction in the body to create a lesion at the
targeted site. The generator monitors impedance of the targeted site during
lesion creation. Lesion creation inhibits the nerve tissue’s ability to conduct
electrical signals. Pain relief is achieved when these transmitted electrical
signals are interrupted.
Key user interface features include the display, software, and remote
operation.
The display, with its color, touch-sensitive screen, provides an intuitive
graphical user interface that allows the operator to select settings and enter
data.
The software has a modular structure that includes sensory stimulation,
motor stimulation, lesion creation, and a procedure summary. To enhance
usability and promote safety, these screens are color-coded. The system
settings screens include registration, display, sound, date and time,
language, and procedure defaults. These screens allow the operator to
modify such settings as display brightness and speaker volume for audio
output. The file/folder management screens allow the operator to create
and modify folders and files that contain preferred procedures and settings.
Up to 25 files may be stored electronically to improve efficiency. Patient
information displayed on a procedure summary screen may be saved to a
file or printed.
A RF Hand Controller may also be used to provide basic remote operation
of the generator. See Appendix A - RF Hand Controller Instructions section.
RF MultiGen
Control Circuitry
Printer
Interface
RF Amp, Stim
Pulse Generator
Speaker
Touch
Sensitive
Screen
Monopolar/
Bipolar
Electrode(s)
Bipolar
Electrode(s)
Ground
Pad
(monopolar)
Color
Display
Printer
100-120 VAC, 50-60 Hz
230 VAC, 50 Hz
Facility Power
Finger/Stylus
Input
Graphical/
Audio Output
Hand
Controller Input
Service Use
Only
RS-232 Data
Port
Monopolar/
Figure 1 Block Diagram
NiTRODE is a trademark of the Stryker Corporation.
Procedural Overview
The patient’s pain is localized using various diagnostic techniques. An
assessment is made that RF treatment of the affected nerve tissue will
improve the patient’s symptoms. Reusable system components that will
contact the sterile field are sterilized in advance of the procedure. The
patient is positioned on a fluoroscopic imaging table and the surgical
site is prepped using standard techniques. The system is turned on, and
accessories are connected to the generator. To start a procedure, either a
saved file is selected, or the system default settings are used. The desired
cannula is placed in the target tissue region under fluoroscopic guidance.
After the cannula has been placed in the general location, the electrode is
inserted into the cannula.
Sensory stimulation and motor stimulation are used to facilitate the proper
placement of the electrode/cannula before lesion creation. Targeting
information is provided by monitoring tissue impedance and providing low
frequency stimulating signals to obtain additional information. Sensory
stimulation controls are used to control the nerve stimulator output and
help position the active tip of the electrode/cannula next to the target
nerve tissue. Motor stimulation controls are used to help the clinician rule
out proximity of the electrode/cannula active tip to motor nerves. During
this stimulation, impedance is displayed to assist the clinician in the proper
placement of the electrode/cannula active tip.
The RF energy output (THERMAL/PULSE) screen is used to control
the RF energy output to an active electrode tip. During output, targeted
nerve tissue is exposed to RF energy. A temperature sensor built into the
electrode tip measures the temperature in the surrounding tissue. The
generator monitors temperature and adjusts RF energy based on the
temperature readings. The generator monitors and displays various key
parameters in real time continuously to help maximize safety and operating
efficiency during all phases of the procedure. Temperature and impedance
values are updated continuously and displayed on the generator screen.
When the active electrode tip temperature reaches the set temperature
value, the RF power output is reduced to prevent significant overshoot.
When a procedure is complete, the key parameter information used during
the procedure may be viewed on a summary screen and printed.
A SET TEMPerature value and HOLD TIME (TIME) value are selected
by the clinician. The set temperature value is not exceeded during either
thermal or pulse modes.
In thermal mode, RF energy output is monitored and controlled by a hold
time/set temperature feedback mechanism. An optimal temperature-rise
rate is achieved and the desired set temperature value is maintained. The
TIME value displayed begins to count down when the temperature value of
the active electrode tip is within 2 degrees of the set temperature value. RF
energy output is removed when the TIME value reaches zero. RF energy
output may be removed at any time if the rate of temperature rise, the
impedance, or the temperature value of the active electrode tip indicates a
safety concern.
In pulse mode, the amplitude (voltage) of the RF energy pulses will be
adjusted automatically to achieve the set temperature value of the active
electrode tip while maintaining the set frequency and width. The TIME value
begins to count down when the START button is touched and confirmed.
When the TIME value reaches zero, the RF energy output is removed.
The pulse mode creates a significant electrical field to interact with the
target nerve. This interaction is usually at a temperature value lower than
the temperature necessary to cause cellular necrosis. Temperature rise is
a by-product of the clinical application of RF energy. Therefore, the time
required to reach the set temperature value during the pulse mode may be
longer than during the thermal mode.

10 www.stryker.com
EN 0406-900-702 Rev-E
Features
Hardware Interface (see figure 2)
3-4
1- 2
Figure 2 Hardware Interface
A
B
C
D
E
F
G
H
I
AON/OFF Button
Press to apply power. Press to remove power.
BColor, Touch-sensitive Screen
Provides graphical user interface to select active electrodes and
adjust setting values.
CInstrument Connector (two)
Allows installation of electrode.
DGround Pad Connector
Allow installation of the ground pad cable.
ERF Hand Controller Connector
Allows installation of the RF Hand Controller.
FRS-232 Data Port (back panel)
Allows for software service updates installed by a Stryker-approved
technician.
GParallel Printer Cable Port (back panel)
Allows the installation of a PCL3 compliant printer.
HPower Receptacle (back panel)
Allows the installation of a power cord.
IEquipotential Grounding Lug (back panel)
Allows the installation a equipotential ground connection.
Symbol Definitions
The symbols located on the equipment and/or labeling are defined in this
section or in the Symbol Definition Chart. See the Symbol Definition Chart
supplied with the equipment.
SYMBOL DEFINITION
Electrode(s) Port 1 (logical ports one
and two)
Electrode(s) Port 2 (logical ports three
and four)
Ground Pad Port
SYMBOL DEFINITION
RF Hand Controller Port
"ON" / "OFF" (push-push)
General Warning Sign
Alternating Current (AC)
Type BF Applied Part
Printer Cable Port (PCL3)
Floating Output
Equipotentiality (equipotential ground)
Refer to Instruction Manual/Booklet
Fuse

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System Components (see figure 3)
Figure 3 System Components
H
I
J
C
D
B
A
G
F
E
ARF MultiGen (generator)
Provides a controlled energy source for surgical purposes using a
color-coded touch screen.
BPrinter Cable
Provides the connection interface between the generator and a
PCL3 compatible printer.
CEquipotential Grounding Cable
Provides the connection interface between the generator and a
facility equipotential ground.
DPower Cord
Provides the connection interface between the generator and
facility power.
EMonopolar Cannula
Provides targeted energy to the treatment site. (applied part)
FMonopolar Electrode
Delivers energy to the monopolar cannula and measures the
temperature at the treatment site. (applied part)
GMultiGen Cable
Provides the connection interface between the generator and a
maximum of two electrodes.
HGround Pad (Neutral Electrode)
Used with monopolar electrode configurations only, the pad is
placed securely on the patient's body in proximity to the site of the
operation. (applied part)
IGround Pad Cable (Monopolar Return Electrode Cable)
Provides the connection interface between the generator and the
ground pad.
JRF Hand Controller
Provides basic remote control of the generator. See Appendix A -
RF Hand Controller Instructions section.
NOTE: The designated applied parts as defined by the manufacturer.
See the Product Safety Certification standards listed in the Specifications
section.

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EN 0406-900-702 Rev-E
Features
Screen Layout (see figure 4)
ParallelParallel
Summary
START
1x3 4
STOP
Lesion
Motor
Sensory
Print Save
Home
2 3 4
TAB #2
TAB #3
TAB #4
DASHBOARD
EDIT EDIT EDIT
1
TAB #1
Figure 4 Screen Layout
AElectrode Identifier Numbers
The number corresponds to the electrode connected to the
corresponding port. During the lesion mode, these identifier
numbers become buttons that may be used to lock multiple
procedure tabs. Locking multiple tabs and touching the START
button will apply RF energy to each electrode simultaneously.
BProcedure Tab Area
Touch to select a tab that represents a connected electrode. The
area will display electrode procedure information for the treatment
site in real time.
CEDIT Button
Touch to access the dashboard area and edit specific electrode
setting values.
DBridge
When a procedure tab is selected, a connection or bridge is
formed between the tab and the dashboard area.
EDashboard Area
Displays the electrode information for the selected procedure tab.
Access this color-coded area to edit the electrode setting values of
the selected tab.
FPARALLEL Button
Touch to select the parallel bipolar mode to ON or OFF. When ON,
two procedure tabs will merge (1,2) or (3,4). Two parallel bipolar
stimulations cannot be performed at one time. Each parallel bipolar
stimulation must be performed separately.
GSTART /STOP (ALL) Buttons Area
Touch to initiate or remove the application of RF energy. When RF
energy is applied, the START button is gray. When RF energy is not
applied, the STOP button is gray.
HProcedure Navigation Buttons Area
Touch to select sensory, motor, and lesion modes of operation.
See Modes of Operation and Color Codes section. Touch the
summary button to access procedural summary information. A
visually depressed button indicates the current mode of operation.
ISystem Navigation Buttons Area
Touch to load and SAVE files, PRINT procedure information or
access the HOME screen.
Modes of Operation and Color Codes
COLOR CODE MODE
Sensory Stimulation
Motor Stimulation
Lesion Creation/RF Output
A
B
C
D
E
F
G
H
I

0406-900-702 Rev-E EN
www.stryker.com 13
Software Button Definitions
BUTTON NAME DEFINITIONS
1
SELECTED
ELECTRODE
(INACTIVE)
Indicates the electrode has
been selected and locked
in lesion mode. Multiple
electrodes may be selected
and locked to apply energy
concurrently or in a staggered
manner.
1
UNSELECTED
ELECTRODE
(INACTIVE)
Indicates the electrode is not
selected and not locked. No
energy is applied.
1
ACTIVE
ELECTRODE
(NUMBER
FLASHING)
Indicates the electrode is
applying energy. During
stimulation, only one
procedure tab will indicate the
application of energy.
1&2
MERGED
ELECTRODE
TABS
(ACTIVE)
Indicates tabs are merged
and the electrodes are
operating in the parallel
bipolar mode. Energy will
travel between the two
electrode tips.
CANCEL CANCEL
Touch to exit a screen and
return to the previous screen
without saving changes.
ENTERENTER Touch to apply a new or
edited setting value.
EDITEDIT EDIT Touch to edit an electrode
setting value.
DELETE Touch to delete a file, folder,
or setting value.
START
x2xx
START
Touch to apply energy to
the assigned electrode(s).
The numbers indicate the
electrodes that will apply
energy. Touch the START
button in the dashboard area
to apply energy.
STOP STOP (ALL)
Touch to remove energy
from active electrode(s).
During lesion creation ALL
will appear on the button to
indicate the use of more than
one electrode.
BUTTON NAME DEFINITIONS
Sensory SENSORY Touch to access the sensory
stimulation screen.
Sensory
Indicates the sensory
stimulation screen is
displayed.
MotorMOTOR Touch to access the motor
stimulation screen.
Motor
Indicates the motor
stimulation screen is
displayed.
Lesion LESION Touch to access the RF
Output screen.
Lesion Indicates the RF Output
screen is displayed.
Summary SUMMARY Touch to access the
procedure summary screen.
Summary Indicates the summary
screen is displayed.
HOME
Touch to access the home
screen. A new procedure may
be initiated from the home
screen.
PRINT
Only available from a
procedure screen or a
procedure summary screen,
touch to print procedure
summary information.
SAVE Touch to save the procedure
file setting information.

14 www.stryker.com
EN 0406-900-702 Rev-E
Instructions (see figures 2 and 3)
To Perform Initial Setup:
WARNINGS:
• ALWAYSfollowtherecommendeddutycycletopreventtheequipment
from overheating. See the Specifications section.
• ALWAYSoperatetheequipmentwithinthespecifiedenvironmental
condition values. See the Specifications section.
NOTE: To check the accuracy of the generator's displayed values
including temperature, impedance and power output, see the To Perform
Check-in Procedure section. These procedures may be performed in
addition to any existing facility check-in protocol.
1. Place the generator on a flat, sturdy surface.
2. Connect one end of the equipotential bonding cable to the equipotential
grounding lug on the generator and the other end to the facility
grounding busbar (optional).
WARNING: To avoid the risk of electric shock, ALWAYS
connect this equipment to a hospital-grade, facility power
receptacle with protective earth.
NOTE: The universal power supply will automatically adjust to
accommodate the voltage and frequency of facility power.
3. Connect the power cord between the power receptacle on the generator
and a hospital-grade facility power receptacle with protective earth.
4. Press the ON/OFF button to apply power to the generator.
NOTE: When power is applied, the generator performs a self-diagnostics
test to verify internal components, software, and connected components
are working correctly. If the generator and components are operating
correctly, the HOME screen will appear. If any fault occurs, an error
message will appear on the display. As components are connected,
additional testing occurs. If the generator does not power up, see the
Troubleshooting section.
To Connect Electrode Cable(s):
WARNINGS:
• Ifusingmultipleelectrodes,verifyeachcabletagnumberonthe
electrode matches the number on the port of the generator. Incorrectly
matched cable and port numbers will misdirect applied RF energy. See
To Attach Cable Identification Tags section before proceeding.
• DONOTconnectaMultiGencableinserieswithanotherMultiGen
cable.
CAUTIONS:
• Whenconnectingordisconnectinganyofthetwotypesofcablestothe
front of the generator, always hold the cable by its connector (the plug,
not the cord). The locking sleeve is the ridged portion of the connector.
During removal, this ridged portion should be pinched and pulled straight
back.
• Cablesthatareconnectedtothefrontofthegeneratorhavekeyed,
push-pull type connectors that lock into place. DO NOT attempt to force
a connector into a generator port. Each connector and port has an
alignment dot to indicate proper cable orientation.
NOTE: See the Procedure Configurations Table to select the appropriate
connection configuration. See the instructions associated with the selected
connection configuration.
1. Align the dot on the black end of the cable with the dot on the generator
port and connect the cable to the generator.
2. Use the electrode port symbol as reference and match the color-coded
black band on the port with the black cable strain relief.
To Attach Cable Identification Tags:
WARNING: During multiple electrode use, verify each number
on the tag of an electrode matches and corresponds to the
number on the port of the generator. Incorrectly matched cable
and port numbers will misdirect applied RF energy.
NOTES:
• Thecableidentificationtagnumberprovidesamatchedlinkbetween
the tagged physical electrode and the electrode identifier number on the
display.
• Ifthetagsrequiresterilization,thetagsmayremainonthecableduring
sterilization. See the IVS Care Instructions.
• ThetagsmaybeconnectedtotheelectrodecableandtheMultiGen
cable.
• WhenconnectingaMultiGencabletothegenerator,verifythecabletag
numbers match the numbers on the port of the generator.
• WhenconnectinganelectrodecabletotheMultiGencable,verifythe
cable tag numbers on the electrode cable match the cable tag numbers
on the MultiGen cable.
1. Slide the cable loop over and onto the cable. See figure 5 for suggested
placement locations of the tags.
2. Snap the numbered base onto the cable loop. The numbered base
should rotate freely on the loop.
3. To remove the numbered base, squeeze the cable loop and pull down
on the numbered base. A new numbered base may be attached to the
cable loop.
Figure 5 Cable Identification Tags

0406-900-702 Rev-E EN
www.stryker.com 15
To Connect a Ground Pad (monopolar only):
1. Plug the generator end of the ground pad cable into the designated port
on the generator. Use the ground pad port symbol as reference and
match the white band on the port to the white cable strain relief.
2. Raise the connector latch at the other end of the cable, insert the
ground pad tabs into the connector and close the latch to secure the
ground pad.
WARNINGS:
• Placethegroundpadwithitsentiresurfacesecurelyonthepatient’s
body in proximity to the treatment site.
• Properlyaffixthegroundpadtothepatient.Alcoholmaybeusedto
clean the site and eliminate poor adhesion caused by a wet surface
or the use of lotion. Verify proper contact exists between the patient
and the ground pad whenever the patient is repositioned after the initial
application of the ground pad.
• ALWAYSmakesureasafecontactexistsbetweenthegroundpadand
the patient. An auditory alarm will not occur if safe contact between
the ground pad (neutral electrode) and the patient is not established or
maintained.
• Properlylocateandorientthegroundpadonthepatienttocontrolthe
size and shape of the lesion during its creation.
NOTE: ALWAYS use and properly connect a ground pad to the generator
for monopolar electrode configurations. The generator will not energize
the monopolar electrode if a ground pad is not adequately connected and
applied to the patient. If a ground pad is not connected or the connection
is interrupted, an error message will appear on the display.
3. Place the pad portion of the ground pad onto the patient, in proximity to
the treatment site (see figure 6). The entire pad should adhere to the
patient's body.
Figure 6 Pad Placement
To Connect a Printer (optional):
NOTE: As a minimum requirement, any printer used with the generator
must be PCL3 compatible. Printers using versions of PCL greater than 3
may also work.
1. If using a printer, connect the printer cable to the parallel printer cable
port on the generator and the appropriate printer receptacle.
2. Connect facility power to the printer.
To Connect a RF Hand Controller (optional):
1. If a RF Hand Controller is used (see Appendix A - RF Hand Controller
Instructions section), align the dot on the cable connector end with the
dot on the generator port and connect the cable to the generator.
2. Use the RF Hand Controller port symbol as a reference and match the
color-coded gray band on the port with the gray cable strain relief to
ensure the installation is correct.

16 www.stryker.com
EN 0406-900-702 Rev-E
Instructions (continued)
To Select a Procedure Configuration:
Procedure Configurations Table
NOTES:
• Themulti-lesioncapabilityallowsthegeneratortolesiontissueusingmultipleelectrodes.TheRFenergyisprovidedinshortburststhataretimedtoallowall
the electrodes to heat at the same time. RF energy and voltages for stimulation are never supplied concurrently. Voltages used for stimulation may only be
applied to one electrode at a time.
• RFenergyisdeliveredthroughtwoelectrodeconnectorports,eachofwhichissegmentedintotwologicalportsprovidingatotaloffourlogicalports.The
generator can support several combinations of electrode configurations. These combinations may be mixed between the two electrode connector ports.
• DONOTuseconfigurationsotherthanthosedescribedbelow.Failuretocomplywillresultinasystemerror.
PROCEDURE
TYPE
NUMBER OF
ELECTRODE(S)
GENERATOR CONNECTOR 1-2 GENERATOR CONNECTOR 3-4 GROUND PAD
CONNECTOR
FIGURE
NUMBER
Monopolar Procedure Configurations: capability allows the generator to create a lesion using a monopolar electrode with a ground pad.
Single Monopolar 1 MultiGen Cable (0406-900-100) Empty Ground Pad Cable
(0406-850-200)
7
Empty MultiGen Cable (0406-900-100)
Two Concurrent
Monopolar 2 MultiGen Cable (0406-900-100) Empty Ground Pad Cable
(0406-850-200)
7
Empty MultiGen Cable (0406-900-100)
Three Concurrent
Monopolar 3 MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100) Ground Pad Cable
(0406-850-200)
7 and 8
MultiGen Cable 0406-900-100) MultiGen Cable (0406-900-100)
Four Concurrent
Single Monopolar 4 MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100) Ground Pad Cable
(0406-850-200)
7
Parallel Bipolar Procedures Configurations: capability allows the generator to create a lesion using two monopolar electrodes. The generator monitors the
temperatures of both electrodes and controls the higher of the two electrode temperatures. Both temperatures are displayed on the screen.
Single Parallel
Bipolar 2 MultiGen Cable (0406-900-100) Empty Empty 9
Empty MultiGen Cable (0406-900-100)
Two Concurrent
Bipolar 4 MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100) Empty
Monopolar and Parallel Bipolar Combination Procedure Configurations
Monopolar and a
Parallel Bipolar 3 MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100) Ground Pad Cable
(0406-850-200)
7 and 9
MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100)
Two Concurrent
Monopolar and a
Parallel Bipolar
4 MultiGen Cable (0406-900-100) MultiGen Cable (0406-900-100) Ground Pad Cable
(0406-850-200)
7

0406-900-702 Rev-E EN
www.stryker.com 17
To Configure a Monopolar Procedure or a Parallel Bipolar Combination Procedure Using MultiGen
Cable(s)
1. See To Perform Initial Setup section.
2. See To Connect Electrode Cable(s) section.
3. See To Attach Cable Identification Tags section.
4. See To Connect a Ground Pad (monopolar only) section.
5. See To Connect a Printer (optional) section.
6. See To Connect a RF Hand Controller (optional) section.
Figure 7 Monopolar or Monopolar and Parallel Bipolar Configuration

18 www.stryker.com
EN 0406-900-702 Rev-E
Instructions (continued)
To Configure a Parallel Bipolar Combination Procedure Using a MultiGen Cable
NOTE: The MultiGen Cable may be connected to either generator port.
1. See To Perform Initial Setup section.
2. See To Connect Electrode Cable(s) section.
3. See To Attach Cable Identification Tags section.
4. See To Connect a Ground Pad (monopolar only) section.
5. See To Connect a Printer (optional) section.
6. See To Connect a RF Hand Controller (optional) section.
Figure 8 Monopolar or Monopolar and Parallel Bipolar Combination Configuration

0406-900-702 Rev-E EN
www.stryker.com 19
To Configure a Parallel Bipolar Procedure Using MultiGen Cable(s)
1. See To Perform Initial Setup section.
2. See To Connect Electrode Cable(s) section.
3. See To Attach Cable Identification Tags section.
4. See To Connect a Printer (optional) section.
5. See To Connect a RF Hand Controller (optional) section.
Figure 9 Parallel Bipolar Configuration