Halyard PMG-115 Basic User manual

PAIN MANAGEMENT
GENERATOR
SERVICE MANUAL
PAIN MANAGEMENT SYSTEMS
PMG-115 Basic
PMG-115-TD Advanced
PMG-230 Basic
PMG-230-TD Advanced
PMG-Basic
PMG-Advanced

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Table of Contents
1 Introduction........................................................................................................................................................3
1.1 Glossary of Terms...........................................................................................................................................3
2 Indicated Use .....................................................................................................................................................5
3 Warnings and Precautions..............................................................................................................................6
3.1 Warnings...........................................................................................................................................................6
3.2 Precautions .....................................................................................................................................................7
4 Installation ..........................................................................................................................................................9
4.1 Preparing the Generator for Use ...............................................................................................................9
4.2 Mains Power Cord.........................................................................................................................................9
4.3 Generator Cleaning and Disinfection Instructions ...............................................................................9
4.4 When you get a new Generator................................................................................................................9
4.5 Generator Maintenance Schedule ..........................................................................................................10
4.6 Compatible Accessories ............................................................................................................................10
5 User Interface Overview................................................................................................................................10
5.1 Front Panel Displays, Controls, and Connections...............................................................................10
5.2 Rear Panel Displays, Controls, and Connections................................................................................13
6 Special Event States .......................................................................................................................................14
6.1 Recoverable Errors ......................................................................................................................................14
6.1.1 Display..........................................................................................................................................................14
6.1.2 Settings........................................................................................................................................................14
6.2 Non-Recoverable Faults............................................................................................................................15
6.2.1 Display .........................................................................................................................................................15
6.2.2 Settings .......................................................................................................................................................15
7 Testing Summary.............................................................................................................................................16
7.1 Finished Device Testing .............................................................................................................................16
8 Maintenance and Servicing.......................................................................................................................... 17
9 Generator Voltage Setting............................................................................................................................ 17
10 Error/Fault/Warning Codes ........................................................................................................................18
11 Technical Specifications ............................................................................................................................. 38
11.1 RF Output ................................................................................................................................................... 38
11.2 Mechanical Specifications ...................................................................................................................... 38
11.3 Environmental Specifications................................................................................................................. 38
Table of Figures
12 Figure 5-1 Generator front panel..........................................................................................................10
13 Figure 5-2 Generator rear panel ...........................................................................................................12
14 Figure 6-1 Recoverable Error Pop Up Display...................................................................................14
15 Figure 6-2 Non-Recoverable Fault Pop Up Display.........................................................................15
16 Figure 9-1 Fuse Drawer ........................................................................................................................... 17
17 Figure 9-2 Voltage Selector.................................................................................................................... 17

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1 Introduction
Halyard Health is a medical technology company focused on preventing infection, eliminating
pain and speeding recovery. Just as a halyard fuels forward movement, Halyard’s clinically-
superior products and remarkable service help to advance health and healthcare worldwide.
Halyard sells its recognized brands and products in more than 100 countries, and holds leading
market positions in multiple categories across the portfolio. Formerly part of Kimberly-Clark,
Halyard became an independent company on November 1, 2014. For more information, visit
www.halyardhealth.com.
The system presented in this Service Manual consists of the Halyard Health (KIMBERLY-CLARK*)
Pain Management Generator (PMG) (formerly known as the Baylis Pain Management Generator).
For the user’s convenience, the Halyard Health (KIMBERLY-CLARK*) Pain Management
Generator will be referred to in this Service Manual as the “Generator” or “PMG”. This manual
applies to the PMG and accessories.
NOTE: The PMG is also referred to as the Halyard Health (KIMBERLY-CLARK*) Radiofrequency
(RF) Generator on the packaging labeling.
This Service Manual provides a description of the Generator, its controls and displays, a list of
error messages and technical specifications.
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”, or as a “return electrode.”
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
IFU Instructions For Use
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.

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Term Definition
Multi-RF Multi-Radiofrequency
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.
READY State of the Generator where settings can be adjusted and other modes of
operation can be chosen prior to RF application.

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1.1 Glossary of Terms
RF Radiofrequency
RFA Radiofrequency 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), resembling the characteristic
shape of the letter “Y”.
2 Indicated Use
Halyard Health (KIMBERLY-CLARK*) Pain Management Generator Model PMG-115 Basic, PMG-
115-TD Advanced (For Domestic Use), Model PMG-230 Basic, PMG-230-TD Advanced (For
International Use) , PMG – Basic and PMG – Advanced are 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 PMG is to be used in
conjunction with separately approved probes.

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›The Generator supplies up to 50 Watts of Radiofrequency energy at 460 kHz under power,
voltage, or temperature control while continuously monitoring and displaying actual
power and 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 IFUs 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!
Rx Only: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
3 Warnings 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: Read the User Manual and refer to this Service Manual for additional
information where necessary.
›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. (V4.1
and older units).
›Risk of Electric Shock: To avoid risk of electric shock, this equipment must only be
connected to supply mains with protective earth.
›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.
• 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.

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• 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.
• Use only with a Halyard Health (Kimberly-Clark) or Baylis Pain Management
Dispersive Electrode. Always select a dispersive electrode designed to be
compatible with the available contact quality monitor.
• 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.
• Skin-to-skin contact (for example between the arms and body of the PATIENT)
should be avoided.
• Failure of the Generator or accessories could result in an unintended increase of
output power.
• Do not use the Multi-RF Module with the Halyard Health ( Kimberly-Clark) Pain
Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), or DREZ
Probe (PME-D).
• Do not use the Multi-RF Module with the Halyard Health (Kimberly-Clark) or 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.
• Unintended Neuromuscular Stimulation: The use of RF energy can produce
unintended neuromuscular stimulation during ablation. Appropriate precautions,
including the use of lower power settings and continuous monitoring of the patient
during treatment, should be taken to minimize the risk of patient injury.
• User Modifications: User modifications to the PMG can result in safety hazards. No
user modification of the equipment is allowed.
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

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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 IFUs 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.
›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 are 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
Halyard Health for use with the PMG may result in increased electromagnetic emissions or

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decreased electromagnetic immunity of the PMG.
›In Multi-RF Auto Temp mode, and in Multi-Cooled 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.
4 Installation
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 (Halyard Health)
Kimberly-Clark for a replacement. (Halyard Health, formerly Kimberly-Clark Health Care) 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 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.
›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:
›Generator
›Power Cord

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›User’s Manual
›PMX-BAY-19-14 Adaptor Cable
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 PMG has been approved for use with all Halyard Health (KIMBERLY-CLARK) and Baylis
accessories, transducers, and cables. This includes the PMX, PMP, PMC, PMF, TDX, TDP, TDI,
TDA, CRX, and CRP line of products.
5.User Interface Overview
Figure 5-1 Generator front panel
5.1 Front Panel Displays, Controls, and Connections
Note: The picture above depicts a typical PMG 4.1 display. The display may differ per PMG
1
2
3
9
11
8
10 4
5
6
7
1213

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version.
›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. 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
Halyard Health ( KIMBERLY-CLARK*) 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.
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/

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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 Halyard Health (KIMBERLY-CLARK*) Pain Management
Thermocouple probes.
13. Dispersive Return Electrode Connection: This patient-isolated connection is for
attachment of a Halyard Health (KIMBERLY-CLARK*) Pain Management Dispersive
Electrode (PMA-GP-BAY).
Figure 5-2 Generator rear panel

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5.2 Rear Panel Displays, Controls, and Connections
Note: The picture above depicts a typical PMG 4.1 display. The display may differ per PMG
version.
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. Device Label: This label indicates the model number of the Generator and includes
contact information for Halyard Health ( Kimberly-Clark). The unique serial number
of the Generator is marked on this label.
3. Software Version Label: This label indicates the PMG software version.
4. 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.
5. 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. (Applies only to v4.1 and older
versions).
6. 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. (Applies only to v4.1 and older versions).
7. 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.
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. 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.
10. RS-232 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.
11. RJ45 Connector: Connection to be used by authorized service personnel only.
12. Pump Module Interface Connector: For attachment of authorized cooling pump
unit only.
Note: See user manual for your specific generator version

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6 Special Event States
6.1 Recoverable Errors
Figure 6-1 Recoverable Error Pop –Up Display
6.1.1 Display
›Yellow error indicator will display on screen
›Error text will display in the center of the screen within the status window.
6.1.2 Settings
›In all modes except Multi-Cool, a 10-second time-out returns device to previous READY
mode. If the probe and cable have been detached the Generator returns to the STANDBY
state.
›In Multi-Cool, a 60-second time-out returns device to previous READY mode. If the probe
and cable have been detached the Generator returns to STANDBY state.
›Recoverable Error: measurement values are shown, and settings are greyed out.

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6.2 Non-Recoverable Faults
Figure 6-2 Non-Recoverable Fault Pop-Up Display
6.2.1 Display
›Red “error” indicator will display on screen.
›System Fault code will display in the center of the screen within the Status window.
6.2.2 Settings
›The main power On/Off switch needs to be cycled OFF then ON to attempt to clear the
non-recoverable fault.

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7 Testing Summary
The PMG is capable of a variety of self-tests which ensure patient safety and verify proper
operation and set-up of equipment. When the main power of the PMG is turned on, the system
undergoes Power-On-Self-Tests (POST). In addition, during operation of the System, many
Continuous Tests are performed. When manufacturing of the Generator is completed, each unit
undergoes a series of Final Device Tests.
7.1 Finished Device Testing
Every Generator undergoes a Final Test before its release. The list includes:
›Fuse and line voltage settings
›Power On Self-Test sequence
›BIOS programming
›Return connector continuity
›Serial communications and software version check
›Default settings (Advanced Settings)
›Default values
›Probe/cable detection
›Front panel controls and display
›Output on/off switch
›Footswitch function
›Volume adjust setting
›Fan function
›Electrical safety tests
›Burn-in Test
›Stimulation output function
›Stimulation over-current and open-circuit detection
›Monopolar RF output and measurement
›Multi-RF output and measurement
›RF over-current shutdown
›Low and high impedance detection
›Output waveform check
›Measurement noise immunity and broken sensor detection– thermistor and thermocouple
›Temperature measurement accuracy – thermistor and thermocouple
›Bipolar RF output
›Temperature-Controlled RF delivery and timer accuracy
›POST values

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8 Maintenance and Servicing
No servicing is permitted at the operator level. The generator must be returned to the
manufacturer for all servicing and repairs. Please note that the cover of the generator should
not be removed for any reason. Also, please be aware that no preventative maintenance or
calibration is required on the PMG. Refer to the PMG User Manual for Warranty Information.
Refer servicing to a qualified
Halyard Health Technician
Email: [email protected]
U.S. Customers: 844-HALYARD (425-9273)
International Customers: 844-HALYARD (425-9273)
Note: Please request shipping address for return of Generator for servicing if not provided inside
of your Loaner PMG Packaging. Upon reporting of a complaint, the PMG shall be returned for
repairs as determined by your HYH representative. Additional information on the return process
can be provided by contacting Halyard Health at the phone number above.
9 Generator Voltage Setting
9.1 Make sure the rear panel of the PMG is facing the user (see Fig 5.2).
9.2 Check power configurations. Both fuse drawer and voltage selector switch are set
to facility outlet voltage (either 110V or 220V).
9.3 For a correct 110V setting, the appropriate 110-120V should be pointing downwards
and the 220-240V is upside down (Fig 9-1) with an upward pointed arrow.
9.4 For a correct 220V setting, the appropriate 220-240V should be pointing
downwards and the 110-120V is upside down with an upward pointed arrow.
9.5 The correct setting for the Voltage Selector shows at the top (vertically) of the
switch. See Figure 9-2 for the correct 110V setting.
9.6 Contact HYH Technical Support (844-425-9273) for support.
Note: There are no serviceable parts for the Pain Management Generator.
Fig 9-1
(Fuse Drawer)
Fig 9-2
(Voltage Selector)

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10 Error/Fault/Warning Codes
If an error/fault/warning condition should occur, a pop-up message will display an error /fault/
warning code in the center of the screen. The error/fault/warning event, text message displayed,
error/fault/warning code, and suggested actions are listed in Table 10-1 below. Warning codes
are not errors and a user could override a warning code by pressing the output on/off button
(not recommended). In the case of any error/fault/ warning event, contact HYH technical
support if the problem persists.
Note: For recoverable faults, the error code is displayed for approximately 10 seconds (NOTE:
4.1 and 4.11 multi-cool); the Generator will automatically transition back to the previous
READY state, or to the POST-COOLING state if generated from the TRANSDISCAL TREATMENT
ON state. Warning messages will clear when proper conditions are met. Error/Fault/Warning
messages and display time may differ with PMG version and treatment.
Table 10-1
Table of Error, Fault & Warning Codes
Code Message Recommended Action
(Complete List)
FAULT [H01]
▲Self-test failure: Power
Generation/Measurement
Turn AC power OFF-ON to attempt
recovery.
1. With unit “ON” allow 30-60 minutes
for generator to acclimate to ambient
temperature.
2. Turn AC power OFF-ON to attempt
recovery.
3. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [H02]
▲Self-test failure: Impedance
Measurement
Turn AC power OFF-ON to attempt
recovery.
1. Verify voltage selector and fuse
configuration match
(NOTE: see section 9)
2. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [H03]
▲Self-test failure: RF Voltage
Generation/Measurement
Turn AC power OFF-ON to attempt
recovery.
FAULT [H04]
▲Self-test failure: RF Current
Generation/Measurement
Turn AC power OFF-ON to attempt
recovery.
1. Turn unit “OFF” then “ON” to
attempt recovery
2. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [H05]
▲Self-test failure: Watchdog Timer
Turn AC power OFF-ON to attempt
recovery.

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FAULT [H06]
▲Low Power Impedance
Measurement
Turn AC power OFF-ON to attempt
recovery.
1. Turn unit “OFF” then “ON” to
attempt recovery
2. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [H07]
▲Corrupted Flash Disk
Turn AC power OFF-ON to attempt
recovery.
Table of Error, Fault & Warning Codes
Code Message Recommended Action
(Complete List)
FAULT [H08]
▲ Self-test failure: RF Current 2
Generation/Measurement
Turn AC power OFF-ON to attempt
recovery.
1. Turn AC power OFF-ON to attempt
recovery.
2. Allow 30-60 minutes with
generator in “ON” to acclimate the
unit to ambient temperature.
3. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [H09]
▲Self-test failure: Cold Junction
Reference Error
Turn AC power OFF-ON to attempt
recovery.
Operational temperature may be
outside 10-40°C range.
FAULT [E10]
▲Internal Reference Calibration
Fault
Turn AC power OFF-ON to attempt
recovery.
Contact technical support if
problem persists.
1. Turn AC power OFF-ON to attempt
recovery.
2. Allow 30-60 minutes with
generator in “ON” to acclimate the
unit to ambient temperature.
3. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [E11]
▲Duplicate variable storage
Turn AC power OFF-ON to attempt
recovery.
Contact technical support if
problem persists.
1. Turn AC power OFF-ON to attempt
recovery.
2. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [E12]
▲Software Error Detected
Turn AC power OFF-ON to attempt
recovery.
Contact technical support if
problem persists.

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FAULT [E13]
▲Multiple Hardware RF Limits
Exceeded
Turn AC power OFF-ON to attempt
recovery. Check probe and cable
connections. Possible poor tissue
contact, or defective probe or cable.
1. Carefully reposition and stabilize
cannula or introducer
2. Check probes, cables and
grounding pad connection
3. Swap out probe, cable and
grounding pad as appropriate
4. Try new probe(s) and cable(s)
5. Turn unit “OFF” then “ON” attempt
recovery
6. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
FAULT [E14]
▲Hardware RF Voltage Limit
Exceeded
Turn AC power OFF-ON to attempt
recovery. Possible intermittent tissue
contact, or defective probe or cable.
FAULT [E15]
▲Hardware RF Current Limit
Exceeded
Turn AC power OFF-ON to attempt
recovery. Possible intermittent tissue
contact, or defective probe or cable.
FAULT [E16]
▲Hardware RF Power Limit
Exceeded
Turn AC power OFF-ON to attempt
recovery. Possible intermittent tissue
contact, or defective probe or cable.
ERROR [E18]
▲Stimulus Voltage Limit Exceeded
Contact technical support if
problem persists
1. Carefully reposition and stabilize
cannula or introducer
2. Check probes, cables and
grounding pad connection
3. Swap out probe, cable and
grounding pad as appropriate
4. Try new probe(s) and cable(s)
5. Turn unit “OFF” then “ON” attempt
recovery
6. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3
ERROR [E19]
▲Stimulus Current Limit Exceeded
Tissue impedance may be too low
for stimulus voltage level. Try a
lower voltage
Table of Error, Fault & Warning Codes
Code Message Recommended Action
(Complete List)
ERROR [E20]
▲Stimulus Pulse Duration Limit
Exceeded
Contact technical support if
problem persists
1. Turn unit “OFF” then “ON” to
attempt recovery
2. Contact HYH Technical Support
if problem persists (844-425-9273)
option 1 then option 3