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 [phone]
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: [phone]
[phone]
Facsimile: [phone]
EU Authorized Representative
Quality First International
20 Eversley Road
Bexhill-on-Sea
East Sussex
TN40 1HE
United Kingdom
Telephone: [phone]
Facsimile: [phone]

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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.