Kimberly-Clark Baylis PMG-115 User manual

www.kchealthcare.com
Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076 USA
Kimberly-Clark N.V., Belgicastraat 13, 1930 Zaventem, Belgium
14-60-675-0-00 025-0025-311 REV. A
NOTICE:
Pain Management Generator
Kimberly-Clark Health Care has acquired the back pain management
assets from Baylis Medical Company.
All references to “Baylis Medical” in this manual will now refer to
Kimberly-Clark.
Please contact your Kimberly-Clark sales representative for the warranty
and other product information.
For product service please contact Kimberly-Clark at:
Email: InterventionalPain.K[email protected]
In the USA call 1-800-KCHELPS
International customers, please call +1-770-587-7200
0086

BAYLIS
Pain Management Generator
Model PMG - 115 (- TD) (For Domestic Use)
Model PMG - 230 (- TD) (For International Use)
USER MANUAL
Baylis Medical Company, Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada
H4T 1A1
Telephone: (514) 488-9801
(800) 850-9801
Facsimile: (514) 488-7209
EU Authorized Representative
Quality First International
20 Eversley Road
Bexhill-on-Sea
East Sussex
TN40 1HE
United Kingdom
Telephone: +44-(20)-8-522-1937
Facsimile: +44-(20)-8-522-1937

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Table of Contents
1Introduction ........................................................................................................................................................................4
1.1 Glossary Of Terms....................................................................................................................................................4
2Indicated Use.......................................................................................................................................................................5
3Warnings And Precautions...............................................................................................................................................6
3.1 Warnings....................................................................................................................................................................6
3.2 Precautions ................................................................................................................................................................ 6
4Installation...........................................................................................................................................................................7
4.1 Preparing The Generator For Use...........................................................................................................................7
4.2 Mains Power Cord ....................................................................................................................................................7
4.3 Generator Cleaning And Disinfection Instructions................................................................................................7
4.4 When you get a new Generator................................................................................................................................8
4.5 Generator Maintenance Schedule............................................................................................................................8
4.6 Compatible Accessories ............................................................................................................................................8
5User Interface Overview ....................................................................................................................................................9
5.1 Front Panel Displays, Controls, and Connections..................................................................................................9
5.2 Rear Panel Displays, Controls, and Connections.................................................................................................11
6Factory Set Defaults .........................................................................................................................................................12
7Displays..............................................................................................................................................................................13
7.1 System Initialization, Power-On-Self-Test (POST), and STANDBY States ......................................................13
7.2 PLACEMENT State................................................................................................................................................15
7.3 READY States .........................................................................................................................................................18
7.4 ON States .................................................................................................................................................................25
7.5 DONE States............................................................................................................................................................31
7.6 SAVE SETTINGS State ......................................................................................................................................... 32
7.6.1 Example Display_________________________________________________________________________32
7.7 ADVANCED SETTINGS Mode............................................................................................................................32
7.7.1 ADVANCED SETTINGS Mode - STIMULATION SETTINGS State _______________________________32
7.7.2 ADVANCED SETTINGS Mode– LESION SETTINGS State______________________________________33
7.7.3 ADVANCED SETTINGS Mode – COOLED RF SETTINGS State _________________________________34
7.7.4 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS State ______________________________35
7.7.5 ADVANCED SETTINGS Mode – RFA SETTINGS State ________________________________________36
7.7.6 ADVANCED SETTINGS Mode - IDL SETTINGS State _________________________________________37
7.7.7 ADVANCED SETTINGS Mode – AUDIO SETTINGS State______________________________________37
7.7.8 ADVANCED SETTINGS Mode – LANGUAGE SETTINGS State _________________________________38
7.8 Special Event States ................................................................................................................................................ 39
7.8.1 Recoverable Errors _______________________________________________________________________ 39
7.8.1.1 Display........................................................................................................................................................ 39
7.8.1.2 Settings ....................................................................................................................................................... 39
7.8.2 Non-Recoverable Faults ___________________________________________________________________39
7.8.2.1 Display........................................................................................................................................................ 39
7.8.2.2 Settings ....................................................................................................................................................... 39
8Technical specifications....................................................................................................................................................40
8.1 Impedance Measurement .......................................................................................................................................40
8.2 Stimulation...............................................................................................................................................................40
8.3 RF Output................................................................................................................................................................40
8.4 Measurement Accuracy (at time of manufacture) ............................................................................................... 40

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8.5 Software Shutdown Limits During RF Delivery or Stimulation.........................................................................41
8.6 Hardware Shutdown Limits................................................................................................................................... 41
8.7 Mechanical Specifications ......................................................................................................................................41
8.8 Environmental Specifications.................................................................................................................................41
8.9 Fuses.........................................................................................................................................................................41
8.10 Line Input Ratings .................................................................................................................................................. 41
8.11 Footswitch Specifications........................................................................................................................................ 41
8.12 Rated Accessory Voltage (for Associated Equipment and Active Accessories).................................................42
8.13 Output Power Graphs.............................................................................................................................................42
8.14 IEC Electrical Safety and EMC Specifications.....................................................................................................44
9Standard RF Lesion Size.................................................................................................................................................. 49
10 Labeling Symbols..............................................................................................................................................................50
11 Warranty...........................................................................................................................................................................52

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Table of Figures
Figure 5-1 Generator front panel ..................................................................................................................................................9
Figure 5-2 Generator rear panel ................................................................................................................................................. 11
Figure 7-1 System Initialization State Display.............................................................................................................................13
Figure 7-2 POST State Display.................................................................................................................................................... 13
Figure 7-3 STANDBY Display ..................................................................................................................................................... 13
Figure 7-4 TDP A Placement Display ......................................................................................................................................... 15
Figure 7-5 VOLTAGE STIMULATION – READY Display.......................................................................................................... 18
Figure 7-6 MULTI-RF VOLTAGE STIMULATION – READY Display.......................................................................................18
Figure 7-7 VOLTAGE STIMULATION – ON Display................................................................................................................. 25
Figure 7-8 CURRENT STIMULATION – ON Display.................................................................................................................25
Figure 7-9 AUTO TEMP LESION – ON Display ........................................................................................................................25
Figure 7-10 MANUAL POWER LESION - ON Display...............................................................................................................25
Figure 7-11 AUTO PULSED LESION – ON Display.................................................................................................................. 25
Figure 7-12 MANUAL PULSED LESION – ON Display.............................................................................................................25
Figure 7-13 Multi-RF AUTO TEMP LESION – ON Display.......................................................................................................26
Figure 7-14 Multi-RF AUTO PULSED – ON Display.................................................................................................................26
Figure 7-15 COOLED RF AUTO TEMP ON Display................................................................................................................. 26
Figure 7-16 TRANSDISCAL TREATMENT ON Display ............................................................................................................. 26
Figure 7-17 RFA Mode – TREATMENT ON Display..................................................................................................................27
Figure 7-18 IDL Mode – ON Display (Secondary Thermocouple Enabled)................................................................................27
Figure 7-19 Save Settings Display............................................................................................................................................... 32
Figure 7-20 ADVANCED SETTINGS Mode – STIMULATION SETTINGS Display................................................................... 33
Figure 7-21 ADVANCED SETTINGS Mode- LESION SETTINGS Display ................................................................................ 34
Figure 7-22 ADVANCED SETTINGS Mode – COOLED RF SETTINGS Display ...................................................................... 34
Figure 7-23 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS Display................................................................... 35
Figure 7-24 ADVANCED SETTINGS Mode - RFA SETTINGS Display......................................................................................36
Figure 7-25 ADVANCED SETTINGS Mode – IDL SETTINGS Display...................................................................................... 37
Figure 7-26 ADVANCED SETTINGS Mode – AUDIO SETTINGS Display................................................................................ 38
Figure 7-27 ADVANCED SETTINGS Mode - LANGUAGE SETTINGS Display........................................................................38
Figure 7-28 AUTO TEMP Recoverable Error Pop-Up Display.................................................................................................. 39
Figure 7-29 AUTO TEMP Mode Non-Recoverable Fault Pop-Up Display................................................................................. 39
Figure 8-1 Power vs. Load and Peak Voltage ............................................................................................................................. 42
Figure 8-2 Set Power vs. Output Power.......................................................................................................................................43

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1Introduction
The system presented in this User’s Manual consists of the Baylis Pain Management Generator (PMG) and an optional
pneumatic footswitch. For the user’s convenience, the Baylis Pain Management Generator will be referred to in this User’s
Manual as the “Generator” or “PMG”.
This User’s Manual provides a description of the Generator, its controls and displays, and a sequence for its operation. This
User’s Manual also supplies other information of importance to the user. Do not operate the Generator before thoroughly
reading this manual.
This User’s Manual and the Generator screens can be made available in other languages. Please contact Baylis Medical at
514-488-9801 for further information.
1.1 Glossary Of Terms
Term Definition
1-Shot A possible value for the STIM RATE in the STIMULATION modes. If selected, only one stimulus
pulse is delivered when the output is turned on.
Cannula A metal tube that is electrically insulated along its length, with exception to an exposed tip from
which electrical currents flow.
COOLED RF A group of states specifically designed to allow for the use of water-cooled probes to allow more
power to be dissipated in tissue, resulting in a larger lesion at a lower temperature.
Dispersive Electrode An adhesive pad with a large electrically active surface area used in monopolar RF modes, as well as
in certain Placement States. Often referred to as a “grounding pad”.
DONE State of the Generator when RF energy has been terminated.
Footswitch A pneumatic device that connects to the back of the PMG and allows hand-free starting and stopping
of RF and Stimulation output.
IDL Intradiscal Lesioning
Impedance The effective resistance to the flow of current in a circuit.
Lesion A localized pathological change in a bodily organ or tissue.
Mode A group of states (usually READY, ON, and DONE) that comprise the machine steps necessary to
complete a procedure. The modes for this Generator include: Current Stimulation, Voltage
Stimulation, Auto Temp Lesion, Manual Power Lesion, Auto Pulsed Lesion, Manual Pulsed Lesion,
Cooled RF, TransDiscal, RFA, and IDL.
ON State of the Generator when RF energy is applied to the probes and dispersive return electrode if
applicable.
PDT A The Peripheral Disc Temperature as relating to TDP A (TransDiscal Probe A)
PDT B The Peripheral Disc Temperature as relating to TDP B (TransDiscal Probe B)
PMG Pain Management Generator
POST The state of the Generator when Power On Self Tests are performed.
PULSE DUR A setting that applies to VOLTAGE STIMULATION, CURRENT STIMULATION, AUTO
PULSED LESION, and MANUAL PULSED LESION modes. In the STIMULATION modes, it
describes the length of time of one stimulus pulse. In PULSED LESION modes (MANUAL AND
AUTO) it describes the length of time of the RF pulse.
PULSE RATE A setting that applies to AUTO PULSED and MANUAL PULSED modes. It describes the number of
RF bursts of duration PULSE DUR and is measured in Hz.
Pump Refers to Pain Management Peristaltic Pump Unit (TDA-PPU-1)
RAMP RATE –
COOLED RF MODE A setting that is adjustable in ADVANCED SETTINGS mode, and applies to COOLED RF mode. It
is the rate at which the Generator heats to the SET TEMP.
RAMP RATE – IDL
MODE Setting that is adjustable in ADVANCED SETTINGS mode, and applies to IDL mode. It is the rate
at which the Generator heats from the INITIAL TEMP to the SET TEMP.
RAMP RATE –
TRANSDISCAL
MODE
A setting that is adjustable in ADVANCED SETTINGS mode, and applies to TRANSDISCAL mode.
It is the rate at which the Generator heats to the SET TEMP.
RAMP TIME –AUTO
TEMP LESION AND
AUTO PULSED
LESION MODES
A setting that is adjustable in ADVANCED SETTINGS mode –LESION SETTINGS, and applies to
the AUTO TEMP LESION and AUTO PULSED LESION modes. It is the rate at which the
Generator heats to the SET TEMP.
RAMP TIME – RFA
MODE A setting that is adjustable in ADVANCED SETTINGS mode - RFA. It is the rate at which the
Generator heats to the SET TEMP.

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READY State of the Generator where settings can be adjusted and other modes of operation can be chosen
prior to RF application.
RF Radio Frequency
RFA Radio Frequency Annuloplasty
RF Probe A slender, flexible surgical instrument used to deliver stimulation and RF output to bodily organs or
tissues.
STANDBY State of the Generator when a valid probe must be connected prior to proceeding to the applicable
READY state for the probe.
STATE A function of the Generator where a basic task is performed. For instance, the READY state for any
mode allows settings to be changed and allows RF energy to be initiated. The states of the Generator
include STANDBY, PLACEMENT, READY, ON, DONE, ADVANCED SETTINGS.
STIM RATE A setting that applies to VOLTAGE STIMULATION and CURRENT STIMULATION modes. It
describes the number of stimulus pulses delivered in a second, and is measured in Hz.
Stylet A fine wire that is run through a cannula, to keep it stiff or clear of debris.
Switching Cable Either of TDX-BAY-TSW (TransDiscal Switching Cable) or PMX-BAY-RSW (RFA Switching
Cable), used to aid in the placement of secondary probes or thermocouples.
TC Thermocouple
TD TransDiscal
TDP TransDiscal Probe
TDP A TransDiscal Probe A
TDP B TransDiscal Probe B
TEMP Temperature
Thermocouple A thermoelectric device used to measure temperatures accurately, consisting of two dissimilar metals.
TRUE-TX
Ramp Time Extension A feature that will maintain the time at the Set Temperature and generate a notification if probes are
in a configuration that prevents the set temperature from being reached in the specified Ramp Time.
Y-Cable Any of TDX-Y-TSW-TDP (TransDiscal Y-Cable), PMX-Y-RSW-RFA (RFA Y-Cable), or PMX-Y-
BAY-ORA (IDL Y-Cable), resembling the characteristic shape of the letter “Y”.
2Indicated Use
Baylis Pain Management Generator; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International
Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression
of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG is to be used in conjunction
with separately approved probes.
The Generator supplies up to 50 Watts of Radio Frequency energy at 460kHz under power, voltage, or temperature control
while continuously monitoring and displaying actual power or voltage delivered, measured probe temperature(s), time of
power duration, and measured impedance. The use of a dispersive return electrode is specified in the accompanying
documents of probes and cables.
The Generator is also intended to stimulate nerve cells by delivering low-frequency pulses in either voltage or current
controlled modes to aid in probe placement.
The Generator is rated as Class 1, Type CF (rated for continuous operation) as per IEC-60601-1:2005.
Caution!
Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
The Baylis Pain Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), and
DREZ Probe (PME-D) are not licensed for use in Canada.

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3Warnings And Precautions
The safe and effective use of RF energy is highly dependent upon factors under the control of the operator. There is
no substitute for a properly trained operating room staff. It is important that the operating instructions supplied with the
Generator be read and understood before use.
3.1 Warnings
•Read before use: Do not operate the Generator before thoroughly reading this manual.
•Improper line voltage selection may cause malfunction or damage to the instrument: The Voltage Selector and
Fuse Drawer must BOTH be set to the same voltage. They are located on the rear panel of the instrument (the fuse
drawer is located in the power entry module). An improper voltage setting may result in Generator malfunction and
potential instrument damage. The Voltage Selector is factory set and should not be changed by the user.
•Risk of Fire: Do not use in the presence of flammable anesthetics, other flammable gases, near flammable fluids
(such as skin prepping agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire
precautions at all times.
•Risk of Fire: Do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the
presence of other oxidizing agents.
•Risk of RF burns to the patient: While using this device during a procedure, the patient should not be allowed to
come into direct contact with grounded metal objects such as surgical table frame, the instrument table, etc. The use
of antistatic sheeting is recommended for this purpose.
•Risk of RF burns to the patient: Place monitoring electrodes as far away from the treatment site as possible, to
avoid burns or interference with other equipment. The use of needle monitoring electrodes (or other small-area
electrodes) during RF output is not recommended. In all cases, monitoring systems incorporating HIGH
FREQUENCY current limiting devices are recommended.
•Risk of RF burns to the patient: Use only with a Baylis Pain Management Dispersive Electrode. Always select a
dispersive electrode designed to be compatible with the available contact quality monitor.
•Risk of RF burns to the patient: Unless a compatible Monitoring Dispersive Electrode is used with a Contact
Quality Monitor, loss of safe contact between the Dispersive Electrode and the patient will not result in an auditory
alarm..
•Risk of RF burns to the patient: Skin-to-skin contact (for example between the arms and body of the PATIENT)
should be avoided, for example by insertion of dry gauze.
•Risk of RF burns to the patient: Failure of the Generator or accessories could result in an unintended increase of
output power.
•Risk of RF burns to the patient: Do not use the MultiRF Module with more than one of either the Baylis Pain
Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), or DREZ Probe (PME-D).
•Risk of RF burns to the patient: Do not use the MultiRF Module with the Baylis Pain Management Bipolar
Adaptor (PMA-BP).
•Interference with active implants: During RF output, implanted devices such as pacemakers may be affected.
Qualified advice should be obtained as necessary, to minimize the risk of injury from implanted device malfunction.
•Interference with other equipment: During RF output (lesion modes), the conducted and radiated electrical fields
may interfere with other electrical medical equipment.
3.2 Precautions
•Do not activate the output of the Generator until the probe is properly positioned in the patient.
•In STIMULATION, LESION, COOLED RF, TRANSDISCAL and RFA modes, ensure that the dispersive return
electrode is connected to the Generator and properly attached to the patient.
•In Multi-RF STIMULATION mode, connect one probe at a time to the Multi-RF module to display individual
impedance readings for placement purposes.
•The entire area of the neutral electrode should be reliably attached to the patient’s body and as close to the operating
field as possible.
•The PMG may be used without a dispersive return electrode in some modes. Please refer to accompanying
documents for related probes and cables.
•The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the
activation audible tone.
•Do not remove the cover of the Generator, as there is a potential for electrical shock. Refer to authorized personnel
for service.
•Use only the Baylis pneumatic footswitch with the Generator.

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•The mains power cord of the Generator must be connected to a properly grounded receptacle. Extension cords and/or
adapter plugs must not be used.
•Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous
currents.
•The cables to the surgical electrodes should be positioned in such a way that contact with the PATIENT or other leads
is avoided. Temporarily unused ACTIVE ELECTRODES should be stored in a location that is isolated from the
PATIENT.
•Avoid high frequency output settings where the Maximum Output Voltage may exceed the rated accessory voltage
•The output power should be as low as possible for intended purpose (Applies to Manual modes)
•The application of the Neutral Electrode and its connections to be checked before selecting a higher output power
•For surgical procedures where the high frequency current could flow through parts of the body having a relatively
small cross sectional area, the use of BIPOLAR techniques may be desirable in order to avoid unwanted tissue
damage.
•Perform regular inspections of all accessories, including electrosurgical cables and probes, for damage to insulations
•Associated Equipment and Active Accessories should be selected that have a Rated Accessory Voltage equal to or
greater than the Maximum Output Voltage
•For information on the connection and disconnection of detachable parts and accessories, refer to the Instructions for
Use for the corresponding probe or cable
•Care should be taken to avoid the danger of ignition of endogenous gases
•The PMG needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided in this document.
•Electronic equipment, including portable and mobile RF communications equipment, can affect the operation of the
PMG. Operating non-essential equipment in the vicinity of the PMG should be avoided, if possible.
•The PMG should not be used adjacent to or stacked with other equipment. If the PMG must be operated adjacent to
or stacked with other equipment, the PMG should be observed to verify normal operation in that configuration.
•Use of accessories, transducers and cables other than those specifically approved by Baylis for use with the PMG
may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PMG.
•In Multi-RF Auto Temp mode, maintain a minimum distance of 10 mm between probe tips and ensure that the probe
tips do not touch.
•When using the PMG with the pump unit accessory (TDA-PPU) refer to the pump IFU for information on proper
setup and operation
4Installation
Inspect the Generator for any signs of physical damage to the front panel, chassis or cover. If any physical damage is
found, DO NOT USE THE GENERATOR. CONTACT Baylis Medical for a replacement. Baylis Medical must
approve all returns.
4.1 Preparing The Generator For Use
•The Generator may be placed on a mounting cart or on any sturdy table or platform.
•Provide at least four to six inches (10-15 cm) of space behind the rear panel of the Generator for forced air-cooling.
Do NOT obstruct the vents on the underneath of the Generator. Under continuous use for extended periods of time, it
is normal for the top and rear panel to be warm.
4.2 Mains Power Cord
•The Generator is shipped with an approved hospital-grade mains power cord.
•Do not use extension cords or three-prong to two-prong adapters. The mains power cord assembly should be
periodically checked for damaged insulation or connectors.
4.3 Generator Cleaning And Disinfection Instructions
•Use a mild detergent and damp cloth to clean the Generator cover, front panel, and power cable. The Generator
cannot be sterilized. Do not allow fluids to enter the chassis. The Generator may be disinfected using a standard
hospital alcohol solution applied with a cloth.
•Do not spray or pour liquids directly on the Generator.

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•Non-flammable agents should be used for cleaning and disinfection wherever possible.
•Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate
before the application of high frequency surgery.
4.4 When you get a new Generator
•When you open a box, you will find:
oGenerator
oPower Cord
oUser Manual
4.5 Generator Maintenance Schedule
•The Generator verifies calibration integrity during the Power-On-Self-Test (POST); maintenance is not required.
•For Cleaning and Disinfection Instructions, refer to 4.3 Generator Cleaning And Disinfection Instructions
4.6 Compatible Accessories
•The Baylis PMG has been approved for use with all Baylis accessories, transducers, and cables. This includes the
PMX, PMP, PMC, PMF, TDX, TDP, TDI, TDA, CRX, and CRP line of products.

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5User Interface Overview
Figure 5-1 Generator front panel
5.1 Front Panel Displays, Controls, and Connections
•Descriptions of front panel features and their functions are given below. Please refer to Figure 5-1 for location of
each item on the front panel.
(1) Status Window: This window is used to display messages (e.g., Error, Fault, Save Settings).
(2) Mode Function Labels: These “labels” are part of the flat panel display and indicate the function of the
associated Mode Function Key (3). Labels highlight to indicate the current operating mode. If no label is
present, the associated button is not used in the present mode.
(3) Mode Function Keys: These keys select and change the state of operation. For Baylis Pain Management
Thermocouple RF probes, STIMULATION or LESION states are selected with a single press. In RFA mode,
PLACEMENT or TREATMENT states are selected with a single press. In COOLED RF mode,
STIMULATION or AUTO TEMP states are selected with a single press. In TransDiscal mode,
STIMULATION, PLACEMENT, or TREATMENT states are selected with a single press. The functions of
these keys may vary between modes. The Mode Function Label (2) above a key (3) always describes the key
function.
13
12
11
10
9
8
7
6
5
4
3
2
1

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(4) SETTINGS Window: For each state (e.g. VOLTAGE STIMULATION, AUTO TEMP LESION,
TRANSDISCAL TREATMENT, etc.), the adjustable settings are shown in the SETTINGS Window. Up to 5
SETTINGS are adjustable in each state, by using the Setting Adjustment Keys (5) and Rotary Encoder (6), to the
right of the window.
(5) Settings Adjustment Keys: The up and down buttons located to the right of the SETTINGS window (4)
are used for adjusting treatment settings in the upper 4 locations of the SETTINGS window.
(6) Rotary Encoder: This encoder is used for adjusting the bottom parameter in the SETTINGS Window. The
parameter in the window depends upon the current mode.
(7) OUTPUT ON/OFF Button and Indicator: This button controls STIMULATION, LESION, COOLED RF,
TRANSDISCAL, RFA and IDL outputs. In STIMULATION modes, this button toggles the output on and off.
In all other modes, this button control initiates or terminates RF output. The indicator is ON during RF delivery,
and also when in the STIMULATION: ON state.
(8) POWER Indicator: This green LED indicates that system power is on.
(9) FAULT Indicator: This red LED indicates a system fault has occurred. System faults include: self-test failure,
hardware protection (such as short-circuit shutdown), and software failure. Main power to the system must be
cycled (off-on) to attempt recovery from a system fault.
(10)MEASUREMENTS Window: Measured values for elapsed TIME, probe TEMPERATURE(S), RF POWER,
RF VOLTAGE and/or IMPEDANCE are displayed during and after RF output in both STIMULATION and
LESION states and during treatment states for COOLED RF, TRANSDISCAL, RFA and IDL modes. During all
READY states (prior to RF output), TEMPERATURE and IMPEDANCE are displayed. In LESION READY
states for AUTOTEMPERATURE, AUTOPULSED, MANUAL POWER, AND MANUAL PULSED,
IMPEDANCE is displayed according to LOW/OK/HIGH range. In PLACEMENT states for TRANSDISCAL
and RFA modes, only the IMPEDANCE between the probe and the dispersive return electrode will be displayed.
(11)Graph Window: This window is used for graphing temperature, power and voltage data acquired during RF
output in lesion states for ON states when in the LESION mode and treatment states when in COOLED RF,
TRANSDISCAL, RFA and IDL modes. The horizontal axis is time ( ), corresponding to the treatment duration
in the SETTINGS Window. The display will rescale if the TIME duration in the SETTINGS Window is
modified. The vertical axis represents temperature (°C) and either power (W) or voltage (V).
(12)Connector Cable Connection: This patient-isolated connection is for attachment of the connector cable for
Baylis Pain Management Thermocouple probes.
(13)Return Electrode Connection: This patient-isolated connection is for attachment of a Baylis Pain Management
Dispersive Electrode (PMA-GP-BAY).

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Figure 5-2 Generator rear panel
5.2 Rear Panel Displays, Controls, and Connections
•Descriptions of rear panel features and their functions are given below. Please refer to Figure 5-2 for corresponding
locations on the rear panel.
(1) Volume Adjustment:This knob adjusts the volume of the system’s audio output.
(2) RS232 connection: This is an isolated connection to a standard 9-pin COM port. It is provided for passive data
acquisition, and cannot be used to control the system.
(3) FOOTSWITCH connection: This pneumatic barb connects to the hose of the pneumatic footswitch. Like the
OUTPUT ON/OFF switch, the FOOTSWITCH controls stimulus output in the STIMULATION modes and
controls RF output in the LESION, COOLED RF, TRANSDISCAL, RFA and IDL modes. The action of the
FOOTSWITCH differs from the OUTPUT ON/OFF switch: the FOOTSWITCH must be held down to continue
delivery of stimulus pulses or RF energy.
(4) Fuse Drawer: The orientation of the fuse drawer, in conjunction with the AC CONFIGURATION SWITCH,
determines the AC input voltage range (100-120V~ or 220-240V~). For each voltage setting the proper,
corresponding fuses must be used, as indicated in the rear panel labeling.
(5) AC CONFIGURATION SWITCH: The orientation of this switch, in conjunction with the Fuse Drawer,
determines the AC input voltage range (100-120V~ or 220-240V~). Do not change the position of the voltage
selector while the system is plugged in.
(6) Equipotential Ground Connection: This connector is attached to the chassis/earth ground. It is intended for
earth reference connection in environments where equipotential ground cabling is used.
(7) AC MAINS SWITCH: This switch controls the initial AC power input to the system, and is part of the power
entry module, which integrates the AC power inlet and Fuse Drawer.
(8) Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction of airflow is outward
from the rear panel.
(9) Device Label: This label indicates the model number of the Generator and includes contact information for
Baylis Medical Company. The unique serial number of the Generator is marked on this label.
(10)RWTUV Safety Mark Certification Label
(11)CE 0120 CE Mark Label
(12)RJ45 Connector: Connection to be used by authorized service personnel only.
(13)Pump Module Interface Connector: For attachment of authorized cooling pump unit only.
(14) WEEE Directive Label

025-0169-311 Revision: B Page 12 of 52
6Factory Set Defaults
FACTORY SET DEFAULTS
Mode Settings Adjustment Range “Factory Set” Value
STIM RATE 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180, 200 Hz 2 Hz
PULSE DUR 0.1, 0.2, 0.5, 1.0 ms 1.0 ms
VOLTAGE
STIMULATION
VOLTAGE 0.0–10.0 V 0.0 V
STIM RATE 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180, 200 Hz. 2 Hz
PULSE DUR 0.1, 0.2, 0.5, 1.0 ms 1.0 ms
CURRENT
STIMULATION CURRENT 0.0–10.0 mA 0.0 mA
SET TEMP 38–95 °C 80 °C
AUTO TEMP LESION TIME 15–600 s 75 s
Multi-RF (TRUE-TX) MAX RAMP
TIME
EXTENSION DISABLE, 5–120 s, with 5 s interval 30 s
TEMP LIMIT 38–95 °C 80 °C
TIME 15–600 s 75 s
MANUAL POWER
LESION SET POWER 0–50 W 0 W
SET TEMP 38–95 °C 42 °C
TIME 10–900 s 120 s
PULSE DUR 10–100 ms, with 10 ms interval 20 ms
AUTO PULSED
LESION PULSE RATE 1–10 Hz 2 Hz
WARNING
TEMP 38–95°C 42 °C
TIME 10–900 s 120 s
PULSE DUR 10–100 ms, with 10 ms interval 20 ms
MANUAL
PULSED
LESION PULSE RATE 1–10 Hz 2 Hz
SET TEMP 30–90 ºC 60 ºC
COOLED RF TIME 15s–30 min 2 min 30 sec
SET TEMP 30–90 ºC 45 ºC
TRANSDISCAL TIME 1–30 min 15 min
SET TEMP 38–95 ºC 55 ºC
RFA TIME 1–30 min 10 min
SET TEMP 40–95 °C 90 °C
IDL TIME 30s–20 min 16 min 30 sec

025-0169-311 Revision: B Page 13 of 52
7Displays
7.1 System Initialization, Power-On-Self-Test (POST), and STANDBY States
•The System Initialization state is initiated when the system is turned on and it lasts about 40 seconds.
Figure 7-1 System Initialization State Display
•The POST state is initiated after System Initialization is completed. It lasts about 30 seconds.
Figure 7-2 POST State Display
•The STANDBY state is initiated upon successful completion of the POST state.
Figure 7-3 STANDBY Display

025-0169-311 Revision: B Page 14 of 52
Displays and Indicators: PARAMETER
RF/Stimulus Output FAULT indicator RF/Stimulus Output ON/OFF
indicator
STATE
Status Description Status Description Status Description
System
Initialization
No RF or stimulus
waveforms are
generated. OFF Only Power On is
illuminated during
Initialization. OFF Only Power On is
illuminated during
Initialization.
Power-On-Self-
Test
(POST) ON All indicators are
illuminated during POST. ON All indicators are
illuminated during
POST.
STANDBY
OFF RF and stimulus
waveforms are
delivered into
internal test loads.
The output is
inactive. OFF
(The FAULT indicator is
used only in the POST and
SYSTEM FAULT states.)
OFF The indicator is not
illuminated during this
state.
PARAMETER
RF Audio Output Impedance Related Audio Output
Graph Window
STATE Status Description Status Description Status
Description
System
Initialization OFF RF audio output is
not generated during
Initialization. OFF Impedance related audio
output is not generated
during Initialization.
Power-On-Self-
Test
(POST) ON - POST
tone
A tone sounds for approximately 2 s to indicate that the
system is active and is performing self-tests. The tone also
serves as a test of the audio output.
N/A
STANDBY None N/A None
No parameters are
graphed during this
state.
PARAMETERS
Measurement
Window Status Window Available States Available Settings
STATE
Status Description
Status
Description Status
Description Status
Description
System
Initialization
Power-On-Self-
Test
(POST)
N/A None N/A
No other modes
are available
during
Initialization and
POST states.
No settings are
available
during this
state.
STANDBY None
No
parameters
are
measured
during this
state. Active
“PLEASE
ATTACH
PROBE TO
CABLE THEN
ATTACH
CABLE TO
GENERATOR”
message is
displayed while
in the
STANDBY
mode.
None
No operating
modes are
available until a
probe is
connected. The
ADVANCED
SETTINGS mode
can be entered
during the
STANDBY state.
None
N/A

025-0169-311 Revision: B Page 15 of 52
7.2 PLACEMENT State
•In the TRANSDISCAL mode, TREATMENT state is the default screen upon connection of a valid TransDiscal cable
and probe, or when a TransDiscal Y-Connecting Cable is used. The PLACEMENT state can be accessed from the
STIMULATION or TREATMENT READY states. The PLACEMENT state cannot be accessed during the
STIMULATION ON or TREATMENT ON states.
When in the PLACEMENT state:
•MEASURING TDP A is the default screen when the switching cable is set to Probe A, or when a TransDiscal Y-
Connecting Cable is used.
•MEASURING TDP B is the default screen when the switching cable is set to Probe B and two probes are enabled for
use in the TRANSDISCAL mode, accessible from the ADVANCED SETTINGS mode.
Figure 7-4 TDP A Placement Display

025-0169-311 Revision: B Page 16 of 52
Displays and Indicators:
PARAMETER STATUS DESCRIPTION
RF/Stimulus Output OFF RF power is not delivered during this state.
FAULT Indicator OFF (The FAULT indicator is used only in the POST and SYSTEM
FAULT states.)
RF/Stimulus Output
ON/OFF Indicator OFF The indicator is not illuminated during this state, as there is no RF
power delivery.
Measurement Window ON Active impedance measurement is displayed. The display will read
HIGH for high impedances (e.g. open circuits).
Status Window None N/A
Available Modes
TREATMENT MODE
None for RFA MODE –
THERMOCOUPLE
Placement state
In the Secondary Thermocouple Placement state, Treatment mode is
not selectable.
In the TDP A Placement state, Treatment mode is available. If the
position of the switch on the Switching Cable changes to TDP B, the
Generator changes to the TDP B Placement state, and the Treatment
mode key is not selectable and the mode select key is greyed out.
In the RFA Placement state, Treatment mode is available if the
position of the switch on the Switching Cable concurs, or if only the
RFA Y-Connecting Cable is used. If the position of the switch on
the Switching Cable does not concur, TREATMENT mode is not
selectable.
When Treatment mode is selected, the Generator will enter the
READY state of that mode.
The Generator dynamically changes the selection availability of the
Placement mode and Treatment mode key via monitoring the switch
position in the switching cable, and displaying the appropriate text
in the Graph Window.
Available Settings None N/A

025-0169-311 Revision: B Page 17 of 52
PARAMETER
RF Audio Output Impedance Related Audio Output Graph Window
STATE Status Description Status Description Status Description
TDP A
PLACEMENT
TDP B
PLACEMENT
RFA MODE -
THERMOCOUPLE
Placement
RFA PLACEMENT
None N/A ON (Default*)
OFF (if disabled)
Continuous audio output is generated for placement.
Frequency of output is related to active impedance
measurement. No audible tone if selected probe is
an open circuit – replace with warning message.
This feature can be disabled in the AUDIO
SETTINGS state, accessible from the ADVANCED
SETTINGS mode.
PLACEMENT
MEASUREMENT
Indicates the system
is measuring the
selected probe
impedance.
*
Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode

025-0169-311 Revision: B Page 18 of 52
7.3 READY States
•VOLTAGE STIMULATION Mode – READY state is the default upon connection of a Baylis Pain Management
Thermocouple probe and cable.
Figure 7-5 VOLTAGE STIMULATION – READY Display
Figure 7-6 MULTI-RF VOLTAGE STIMULATION – READY Display
Displays and Indicators:
PARAMETER STATUS DESCRIPTION
RF/Stimulus Output OFF
RF power is not delivered during the READY state. When Output ON/OFF is
pressed, RF power is delivered and the Generator automatically transitions to
the ON state.
VOLTAGE STIMULATION – During the ON state, Voltage must be greater
than 0.0 V for Stimulus pulses to be delivered.
CURRENT STIMULATION – Stimulus pulses are not delivered during the
READY state. During the ON state, Current must be greater than 0.0 mA for
Stimulus pulses to be delivered.
TRANSDISCAL AND COOLED RF TREATMENT - When Output ON/OFF
is pressed; the Generator will enter the PRE-TREATMENT COOLING state.
FAULT Indicator OFF (The FAULT indicator is used only in the POST and SYSTEM FAULT states.)
RF/Stimulus Output
ON/OFF Indicator OFF The indicator is not illuminated during the READY state, as there is no
Stimulus/RF power delivery.
RF Audio Output None RF audio output is not generated during the READY state.
This manual suits for next models
3
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