Halyard CO LIEF PMG-Basic User manual

PMG
V4.2
User’s Manual
PMG-Basic
PMG-Advanced
15-H1-654-0-01 / 025-0169-420 REV B
COOLED RADIOFREQUENCY
PAIN MANAGEMENT
GENERATOR
*
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Table of Contents
1 Introduction .................................................................................................................................................................................................................... 5
1.1 Glossary of Terms ........................................................................................................................................................................................... 5
2 Indicated Use................................................................................................................................................................................................................... 6
3 Warnings And Precautions................................................................................................................................................................................................ 6
3.1 Warnings ....................................................................................................................................................................................................... 6
3.2 Precautions .................................................................................................................................................................................................... 7
4 Installation ..................................................................................................................................................................................................................... 7
4.1 Preparing The Generator For Use ..................................................................................................................................................................... 7
4.2 Mains Power Cord........................................................................................................................................................................................... 8
4.3 Generator Cleaning and Disinfection Instructions............................................................................................................................................. 8
4.4 When you get a new Generator ....................................................................................................................................................................... 8
4.5 Generator Maintenance Schedule.................................................................................................................................................................... 8
4.6 Compatible Accessories................................................................................................................................................................................... 8
5 User Interface Overview ................................................................................................................................................................................................... 8
5.1 Front Panel Displays, Controls, and Connections ............................................................................................................................................... 8
5.2 Rear Panel Displays, Controls, and Connections ................................................................................................................................................ 9
6 Factory Set Defaults ........................................................................................................................................................................................................10
7 Displays..........................................................................................................................................................................................................................11
7.1 System Initialization, Power-On-Self-Test (POST), and STANDBY States..............................................................................................................11
7.2 PLACEMENT State ..........................................................................................................................................................................................12
7.3 READY States.................................................................................................................................................................................................14
7.4 ON States......................................................................................................................................................................................................18
7.5 DONE States ..................................................................................................................................................................................................24
7.6 SAVE SETTINGS State......................................................................................................................................................................................24
7.6.1 Example Display .................................................................................................................................................................................................................25
7.7 ADVANCED SETTINGS Mode .............................................................................................................................................................................25
7.7.1 ADVANCED SETTINGS Mode – STIMULATION SETTINGS State..............................................................................................................................................25
7.7.2 ADVANCED SETTINGS Mode – LESION SETTINGS State........................................................................................................................................................26
7.7.3 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS State..............................................................................................................................................27
7.7.4.1 ADVANCED SETTINGS Mode – MULTI-COOLED RF1 SETTINGS State.....................................................................................................................................28
7.7.4.2 ADVANCED SETTING Mode – MULTI-COOLED RF2 SETTINGS State......................................................................................................................................29
7.7.5 ADVANCED SETTINGS Mode – COOLED RF SETTINGS State..................................................................................................................................................30
7.7.6 ADVANCED SETTINGS Mode – AUDIO/LANGUAGE SETTINGS State ......................................................................................................................................31
7.7.7 ADVANCED SETTINGS Mode – RFA SETTINGS State.............................................................................................................................................................32
7.7.8 ADVANCED SETTINGS Mode – IDL SETTINGS State..............................................................................................................................................................32
7.8 Special Event States.......................................................................................................................................................................................33
7.8.1 Recoverable Errors..............................................................................................................................................................................................................33
7.8.1.1 Display...........................................................................................................................................................................................................33
7.8.1.2 Settings.........................................................................................................................................................................................................33
7.8.2 Non-Recoverable Faults......................................................................................................................................................................................................33
7.8.2.1 Display...........................................................................................................................................................................................................34
7.8.2.2 Settings.........................................................................................................................................................................................................34
8 Technical Specications...................................................................................................................................................................................................34
8.1 Impedance Measurement ..............................................................................................................................................................................34
8.2 Stimulation...................................................................................................................................................................................................34
8.3 RF Output .....................................................................................................................................................................................................34
8.4 Measurement Accuracy (at time of manufacture) ............................................................................................................................................34
8.5 Software Shutdown Limits During RF Delivery or Stimulation ..........................................................................................................................34
8.6 Hardware Shutdown Limits............................................................................................................................................................................34
8.7 Mechanical Specications ..............................................................................................................................................................................35
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8.8 Environmental Specications.........................................................................................................................................................................35
8.9 Fuses.............................................................................................................................................................................................................35
8.10 Line Input Ratings .........................................................................................................................................................................................35
8.11 Footswitch Specications ...............................................................................................................................................................................35
8.12 Rated Accessory Voltage (for Associated Equipment and Active Accessories).......................................................................................................35
8.13 Expected Service Life .....................................................................................................................................................................................35
8.14 RoHS Compliance...........................................................................................................................................................................................35
8.15 Output Power Graphs .....................................................................................................................................................................................36
8.16 IEC Electrical Safety and EMC Specications .....................................................................................................................................................37
9 Standard RF Lesion Size...................................................................................................................................................................................................39
10 Cooled RF Lesion Size.......................................................................................................................................................................................................40
11 Labeling Symbols............................................................................................................................................................................................................41
12 Warranty........................................................................................................................................................................................................................42
Table of Figures
Figure 5-1 Generator front panel......................................................................................................................................................................................................................................................... 8
Figure 5-2 Generator rear panel ......................................................................................................................................................................................................................................................... 9
Figure 7-1 System Initialization State Display.................................................................................................................................................................................................................................... 11
Figure 7-2 POST State Display ........................................................................................................................................................................................................................................................... 11
Figure 7-3 STANDBY State Display..................................................................................................................................................................................................................................................... 11
Figure 7-4 TDP A Placement Display.................................................................................................................................................................................................................................................. 13
Figure 7-5 VOLTAGE STIMULATION – READY Display .......................................................................................................................................................................................................................... 14
Figure 7-6 MULTI-RF VOLTAGE STIMULATION – READY Display........................................................................................................................................................................................................... 14
Figure 7-7 VOLTAGE STIMULATION – ON Display................................................................................................................................................................................................................................ 18
Figure 7-8 CURRENT STIMULATION – ON Display............................................................................................................................................................................................................................... 18
Figure 7-9 AUTO TEMP LESION – ON Display...................................................................................................................................................................................................................................... 18
Figure 7-10 MANUAL POWER LESION – ON Display............................................................................................................................................................................................................................. 18
Figure 7-11 AUTO PULSED LESION – ON Display .................................................................................................................................................................................................................................. 18
Figure 7-12 MANUAL PULSED LESION – ON Display............................................................................................................................................................................................................................. 18
Figure 7-13 Multi-RF AUTO TEMP LESION – ON Display ....................................................................................................................................................................................................................... 19
Figure 7-14 Multi-RF AUTO PULSED – ON Display................................................................................................................................................................................................................................ 19
Figure 7-15 COOLED RF AUTO TEMP – ON Display................................................................................................................................................................................................................................ 19
Figure 7-16 MULTI-COOLED RF – ON Display ....................................................................................................................................................................................................................................... 19
Figure 7-17 TRANSDISCAL MONOPOLAR TREATMENT – ON Display......................................................................................................................................................................................................20
Figure 7-18 TRANSDISCAL BIPOLAR TREATMENT – ON Display ............................................................................................................................................................................................................ 20
Figure 7-19 RFA Mode TREATMENT – ON Display................................................................................................................................................................................................................................. 20
Figure 7-20 IDL Mode – ON Display (Secondary Thermocouple Disabled)............................................................................................................................................................................................ 21
Figure 7-21 Save Settings Display ....................................................................................................................................................................................................................................................... 24
Figure 7-22 ADVANCED SETTINGS Mode – STIMULATION SETTINGS Display ......................................................................................................................................................................................... 25
Figure 7-23 ADVANCED SETTINGS Mode – LESION SETTINGS Display ................................................................................................................................................................................................... 26
Figure 7-24 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS Display ......................................................................................................................................................................................... 27
Figure 7-25a ADVANCED SETTINGS Mode – MULTI-COOLED RF1 SETTINGS Display ................................................................................................................................................................................ 28
Figure 7-25b ADVANCED SETTING Mode – MULTI-COOLED RF2 SETTINGS Display.................................................................................................................................................................................. 29
Figure 7-26 ADVANCED SETTINGS Mode – COOLED RF SETTINGS Display..............................................................................................................................................................................................30
Figure 7-27 ADVANCED SETTINGS Mode – AUDIO/LANGUAGE SETTINGS Display.................................................................................................................................................................................. 31
Figure 7-28 ADVANCED SETTINGS Mode – RFA SETTINGS Display......................................................................................................................................................................................................... 32
Figure 7-29 ADVANCED SETTINGS Mode – IDL SETTINGS Display ......................................................................................................................................................................................................... 32
Figure 7-30 Recoverable Error Pop-Up Display..................................................................................................................................................................................................................................... 33
Figure 7-31 Non-Recoverable Fault Pop-Up Display............................................................................................................................................................................................................................. 33
Figure 8-1 Power vs. Load and Peak Voltage ..................................................................................................................................................................................................................................... 36
Figure 8-2 Set Power vs. Output Power.............................................................................................................................................................................................................................................. 37
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1 Introduction
The system presented in this User’s Manual consists of the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain Management Generator (PMG) (formerly known as the
KIMBERLY-CLARK®/Baylis Pain Management Generator) and an optional pneumatic footswitch. For the user’s convenience, the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain
Management Generator will be referred to in this User’s Manual as the“Generator”or“PMG”.
NOTE: The PMG is also referred to as the HALYARD* COOLIEF* Pain Management Generator on the packaging labeling.
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. For further information please call Halyard Health at 1-844-425-9273.
1.1 Glossary of Terms
Term Denition
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 ow.
COOLED RF A group of states specically 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 eective resistance to the ow 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.
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 toTDP A (TRANSDISCAL* Probe A)
PDT B The Peripheral DiscTemperature 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 toVOLTAGE 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 SETTEMP.
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 INITIALTEMP to the
SETTEMP.
RAMP RATE –
TRANSDISCAL
MODE
A setting that is adjustable in ADVANCED SETTINGS mode, and applies toTRANSDISCAL mode. It is the rate at which the Generator heats to the SETTEMP.
RAMPTIME –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 SETTEMP.
RAMPTIME – RFA
MODE
A setting that is adjustable in ADVANCED SETTINGS mode – RFA. It is the rate at which the Generator heats to the SETTEMP.
READY State of the Generator where settings can be adjusted and other modes of operation can be chosen prior to RF application.
RF Radiofrequency
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1.1 Glossary of Terms
RFA Radiofrequency Annuloplasty
RF Probe A slender, exible 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 toVOLTAGE STIMULATION and CURRENT STIMULATION modes. It describes the number of stimulus pulses delivered in a second, and
is measured in Hz.
Stylet A ne wire that is run through a cannula, to keep it sti or clear of debris.
Switching Cable Either ofTDX-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 notication if probes are in a conguration that prevents the set
temperature from being reached in the specied RampTime.
Y-Cable Any of TDX-Y-TSW-TDP (TRANSDISCAL* Y-Cable), PMX-Y-RSW-RFA (RFA Y-Cable), or PMX-Y-BAY-ORA (IDLY-Cable), resembling the characteristic shape
of the letter“Y”.
2 Indicated Use
HALYARD* Pain Management Generator Model 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 HALYARD* PMG is to be used in conjunction with separately
approved probes.
• The Generator supplies up to 50Watts of Radiofrequency energy at 460 kHz 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 specied
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.
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.
3 Warnings and Precautions
The safe and eective 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 sta. 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.
• 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 ammable anesthetics, other ammable gases, near ammable uids (such as skin prepping agents and tinctures), ammable objects,
or with oxidizing agents. Observe appropriate re 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.
• 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.
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• Use only with a HALYARD* or KIMBERLY-CLARK®/ 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 Baylis 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* or Baylis Pain Management Bipolar Adaptor (PMA-BP).
• Interference with active implants: During RF output, implanted devices such as pacemakers may be aected. Qualied 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 elds may interfere with other electrical medical
equipment.
• Unintended Neuromuscular Stimulation: The use of RF energy can produce unintended neuromuscular stimuation 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 Modications: User modications to the PMG can result in safety hazards. No user modication 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 and as close to the operating eld 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.
• Use only the KIMBERLY-CLARK®or Baylis pneumatic footswitch with the Generator.
• 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 ow 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 AccessoryVoltage equal to or greater than the Maximum OutputVoltage.
• 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 aect 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 conguration.
• Use of accessories, transducers and cables other than those specically approved by Halyard Health for use with the PMG may result in increased electromagnetic emissions
or decreased electromagnetic immunity of the PMG.
• In Multi-RF AutoTemp mode, and in Multi-Cooled RF AutoTemp 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 for a replacement. Halyard Health 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.
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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 uids 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-ammable 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 nd:
• Generator
• Power Cord
• User’s Manual
4.5 Generator Maintenance Schedule
• The Generator veries 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 HALYARD* COOLIEF* Pain Management Generator has been approved for use with all HALYARD*, 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
• 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 at 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* Pain ManagementThermocouple RF probes, STIMULATION or LESION
states are selected with a single press. In RFA mode, PLACEMENT orTREATMENT 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, orTREATMENT states are selected with a single press. The functions of
these keys may vary between modes.The Mode Function Label above a key always describes the key function.
4. SETTINGS Window: For each state (e.g., VOLTAGE STIMULATION, AUTOTEMP LESION, TRANSDISCALTREATMENT, 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 and Rotary Encoder , to the right of the window.
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5. Settings Adjustment Keys: The up Vand down Wbuttons located to the right of the SETTINGSWindow are used for adjusting treatment settings in the upper
4 locations of the SETTINGSWindow.
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 o. 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 (o-on) to attempt recovery from a system fault.
10. MEASUREMENTS Window: Measured values for elapsedTIME, probeTEMPERATURE(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 theTIME duration in the SETTINGSWindow is modied. 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* Pain ManagementThermocouple probes.
13. Dispersive Return Electrode Connection: This patient-isolated connection is for attachment of a HALYARD* Pain Management Dispersive Electrode
(PMA-GP-BAY).
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. Device Label: This label indicates the model number of the Generator and includes contact information for Halyard Health. 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 proper fuses must be used, as indicated in the rear panel labeling.
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. Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction of airow is outward from the rear panel.
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8. 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
diers from the OUTPUT ON/OFF switch: the FOOTSWITCH must be held down to continue delivery of stimulus pulses or RF energy.
9. 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.
10. RJ45 Connector: Connection to be used by authorized service personnel only.
11. Pump Module Interface Connector: For attachment of authorized cooling pump unit only.
6 Factory Set Defaults
Factory Set Defaults
Mode Settings Adjustment Range “Factory Set” Value
VOLTAGE
STIMULATION
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 0.0 –10.0V 0.0V
CURRENT
STIMULATION
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 0.0 –10.0 mA 0.0 mA
AUTOTEMP LESION SETTEMP 38° – 95°C 80°C
TIME 15 – 600 s 75 s
MULTI-RF (TRUE-TX) MAX RAMPTIME EXTENSION DISABLE, 5–120 s, with 5 s interval 30 s
MANUAL POWER
LESION
TEMP LIMIT 38° – 95°C 80°C
TIME 15 – 600 s 75 s
SET POWER 0 – 50W 0W
AUTO PULSED
LESION
SETTEMP 38° – 95°C 42°C
TIME 10 – 900 s 120 s
PULSE DUR 10 – 100 ms, with 10 ms interval 20 ms
PULSE RATE 1 – 10 Hz 2 Hz
MANUAL PULSED
LESION
WARNING TEMP 38° – 95°C 42°C
TIME 10 – 900 s 120 s
PULSE DUR 10 – 100 ms, with 10 ms interval 20 ms
PULSE RATE 1 – 10 Hz 2 Hz
COOLED RF SETTEMP 30° – 90°C 60°C
TIME 15 s–30 min 2 min 30 sec
MULTI-COOLED RF
MAX RAMPTIME EXTENSION DISABLE, 5–180 s, with 5 s interval 60 s
SETTEMP 38° – 95°C 60°C
IMPEDANCE CUTOFF MULTIPLIER DISABLE, 2.0 – 4.0, with 0.1 interval 2.0
TIME (1 Probe) 15 s – 30 min with 15s interval 2 min 30 sec
TIME (2 Probes) 15 s – 30 min with 15s interval 2 min 30 sec
TIME (3 – 4 Probes) 15 s – 30 min with 15s interval 2 min 45 sec
TRANSDISCAL
SETTEMP 30° – 90°C BIPOLAR 50°C
MONOPOLAR 60°C
TIME 1 – 30 min BIPOLAR 15 min
MONOPOLAR 2 min 30 sec
RFA SETTEMP 38° – 95°C 55°C
TIME 1 – 30 min 10 min
IDL SETTEMP 40° – 95°C 90°C
TIME 30 s – 20 min 16 min 30 sec
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7 Displays
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.The FAULT indicator normally lights during a portion of the System
Initialization state.
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 State Display
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Displays and Indicators
STATE
PARAMETER
RF/Stimulus Output FAULT indicator RF/Stimulus Output ON/OFF indicator
Status Description Status Description Status Description
System Initialization
OFF
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) RF and stimulus waveforms
are delivered into internal test
loads.
The output is inactive.
ON All indicators are illuminated during
POST. ON All indicators are illuminated during
POST.
STANDBY OFF (The FAULT indicator is used only in
the POST and SYSTEM FAULT states.) OFF The indicator is not illuminated
during this state.
STATE
PARAMETER
RF Audio Output Impedance Related Audio Output Graph Window
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. N/A No parameters are graphed
during this state.Power-On-Self-Test (POST) ON-POST
tone
A tone sounds for approximately 2 seconds to indicate that the system is active
and is performing self-tests.The tone also serves as a test of the audio output.
STANDBY None N/A None
STATE
PARAMETERS
Measurement Window Status Window Available States Available Settings
Status Description Status Description Status Description Status Description
System Initialization
N/A
No parameters are
measured during this
state.
None N/A
None
No other modes are
available during
Initialization and POST
states.
None
No settings are
available during this
state.
Power-On-Self-Test (POST)
STANDBY None Active
“PLEASE ATTACH
PROBETO CABLETHEN
ATTACH CABLETO
GENERATOR”message
is displayed while in
the STANDBY mode.
No operating modes
are available until a
probe is connected.
The ADVANCED
SETTINGS mode can
be entered during the
STANDBY state.
N/A
7.2 PLACEMENT State
• In theTRANSDISCAL 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 orTREATMENT READY states. The PLACEMENT state cannot be accessed during the STIMULATION ON or
TREATMENT ON states.
When in the PLACEMENT state:
• MEASURINGTDP A is the default screen when the switching cable is set to Probe A, or when a TRANSDISCAL* Y-Connecting Cable is used.
• MEASURINGTDP B is the default screen when the switching cable is set to Probe B and BIPOLAR is enabled for use in the TRANSDISCAL mode, accessible from the
ADVANCED SETTINGS mode.
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Figure 7-4 TDP A Placement Display
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 SecondaryThermocouple Placement state, Treatment mode is not selectable.
In theTDP 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 theTDP 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 RFAY-Connecting Cable is used. If the position of the switch
on the Switching Cable does not concur, TREATMENT mode is not selectable.
WhenTreatment 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
STATE
PARAMETER
RF Audio Output Impedance Related Audio Output Graph Window
Status Description Status Description Status Description
TDP A 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.
TDP B PLACEMENT
RFA MODE -
THERMOCOUPLE
Placement
RFA PLACEMENT
** Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode.
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7.3 READY States
• VOLTAGE STIMULATION Mode – READY state is the default upon connection of a HALYARD* Pain ManagementThermocouple 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 0.00 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 0.00 mA for Stimulus pulses to be delivered.
TRANSDISCAL AND COOLED RFTREATMENT –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.
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Displays and Indicators
PARAMETER STATUS DESCRIPTION
Impedance Related
Audio Output
OFF
(Default**)
ON (if enabled)
If enabled in ADVANCED AUDIO SETTINGS, impedance related audio output is generated.
Graph Window
Minimal
The time axis ( ) is indenitely scalable during the READY state, accommodating changes to treatment TIME.
The dashed line denoting SETTEMP/TEMP LIMIT/WARNING TEMP will move according to changes made to the SET
TEMP/TEMP LIMIT/WARNINGTEMP value.
TRANSDISCAL AND COOLED RFTREATMENT - Pump Status is displayed at the top of the GraphWindow.
STIMULATION
READY display Indicates the system is ready to generate stimulus pulses.
Measurement Window Impedance
Displayed
Impedance measurements are displayed for all attached thermocouples.
In Multi-RF and Multi-Cooled RF modes, the displayed value is updated every second for each attached
thermocouple.
Status Window None N/A
** Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode.
STATE
PARAMETER
Measurement Window Available States Available Settings
Status Description Status Description Status Description
VOLTAGE
STIMULATION
CURRENT
STIMULATION
ON
Impedance
measurements
are displayed.
VOLTAGE
STIMULATION
CURRENT
STIMULATION
AUTOTEMP
MANUAL
POWER
AUTO
PULSED
MANUAL
PULSED
SAVE
SETTINGS
While in the READY
state, other operating
modes for HALYARD*
Pain Management
Thermocouple probes
are available. When a
dierent mode is selected,
the Generator will enter
the READY state of the
new mode.
The present SETTINGS can
be saved as defaults by
holding down the SAVE
SETTINGS key.
VOLTAGE/CURRENT
STIMULATION – The
setting is saved to the
ADVANCED STIMULATION
SETTINGS State, in the
MOTOR and SENSORY
toggle elds.
SELECT PROBE
(Multi-RF) Available Values A, B, C or D
STIM RATE
Range 1-Shot – 200 Hz
Available Values†1-Shot, 2, 5, 10, 20, 50, 75, 100, 150,
180 and 200 Hz
Default** 2 Hz -OR- as set in ADVANCED
STIMULATION SETTINGS State MOTOR
PULSE DUR
Range 0.1–1.0 ms
Available Values†0.1, 0.2, 0.5 and 1.0 ms
Default** 1.0 ms
VOLTAGE /
CURRENT
Range 0.00 – 10.0V/mA (Only adjustable
when STIM RATE is 1-Shot)
Increment 0.01V/mA
Default** 0.00 V/mA (cannot be overwritten when
the SAVE SETTINGS function is used)
PRESETS
Toggle between MOTOR and SENSORY as specied in the
STIMULATION SETTINGS state, accessible from the ADVANCED
SETTINGS mode. Selecting a Preset modies the STIM RATE.
** Defaults are factory-set, and are overwritten when the SAVE SETTINGS function is used.
†Time Range set by user does not include factory-set PRE-TREATMENT COOLING Time (45 seconds) or POST-TREATMENT COOLING Time (10 seconds).
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STATE
PARAMETER
Measurement Window Available States Available Settings
Status Description Status Description Status Description
AUTO TEMP
LESION
ON
Temperature
and Impedance
measurements are
displayed whileTime
and Power are not
displayed (dashed
lines replace values).
VOLTAGE
STIMULATION
CURRENT
STIMULATION
AUTOTEMP
MANUAL
POWER
AUTO PULSED
MANUAL
PULSED
SAVE
SETTINGS
While in the READY state,
other operating modes for
HALYARD* Pain Management
Thermocouple probes are
available. When a dierent
mode is selected, the Generator
will enter the READY state of
the new mode.
The present SETTINGS can be
saved as defaults by holding
down the SAVE SETTINGS key.
Multi-Cooled RF only supports
AUTOTEMP LESION mode.
SETTEMP
Range 38° – 95°C
Increment 1°C
Default** 80°C
TIME
Range 15 – 600 s
Increment 1 s
Default** 75 s
MANUAL
POWER
LESION
TEMP
LIMIT
Range 38° – 95°C
Increment 1°C
Default** 80°C
TIME
Range 15 – 600 s
Increment 1 s
Default** 75 s
POWER
LIMIT
Range 0 – 50W
Increment N/A
Default 0 W (Cannot be overwritten by SAVE SETTINGS function)
AUTO
PULSED
LESION
SETTEMP
Range 38° – 95°C
Increment 1°C
Default** 42°C
TIME
Range 10 – 900 s
Increment 1 s
Default** 120 s
PULSE
DUR
Range 10 –100 ms
Increment 10 ms
Default** 20 ms
PULSE
RATE
Range 1 –10 Hz
Increment 1 Hz
Default** 2 Hz
MANUAL
PULSED
LESION
WARNING
TEMP
Range 38° – 95°C
Increment 1°C
Default** 42°C
TIME
Range 10 – 900 s
Increment 1 s
Default** 120 s
PULSE
DUR
Range 10 –100 ms
Increment 10 ms
Default** 20 ms
PULSE
RATE
Range 1 – 10 Hz
Increment 1 Hz
Default** 2 Hz
Note: Multi-RF Manual Power and Manual Pulsed modes support 1 probe connected to the Multi-RF module.
** Defaults are factory-set, and are overwritten when the SAVE SETTINGS function is used.
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STATE
PARAMETER
Measurement Window Available Modes Available Settings
Status Description Status Description Status Description
COOLED RF
TREATMENT
ON
The temperature of the Cooled RF probe(s)
are displayed in the COOLED RFTEMP box.
Impedance measurement between the
Cooled RF probes are displayed. Time and
Power are not displayed (dashed lines
replace values).
VOLTAGE
STIMULATION
CURRENT
STIMULATION
SAVE
SETTINGS
While in the READY state,
Placement is available. When
Placement mode is selected,
the Generator will enter the
READY state of that mode.
The present SETTINGS can be
saved as defaults by holding
down the SAVE SETTINGS key.
SETTEMP
Range 38° – 95°C
Increment 1°C
Default** 60°C ***
TIME
Range†15 s – 30 min
Increment
15 s (between 15 s and
5 min) 30 s (between 5
min and 30 min)
Default** 2 min 30 sec
TRANSDISCAL
TREATMENT
The temperature of the TRANSDISCAL*
probe(s) is displayed in the TRANSDISCAL
TEMP box.The temperature of Peripheral
DiscTemperature is displayed in the
PERIPHERAL DISCTEMP box.
Impedance measurement between
TRANSDISCAL* probes are displayed.Time
and Power are not displayed (dashed lines
replace values).
VOLTAGE
STIMULATION
CURRENT
STIMULATION
PLACEMENT
MODE
SAVE
SETTINGS
SETTEMP
Range 30° – 90°C
Increment 1°C
Default** BIPOLAR 50°C
MONOPOLAR 60°C
TIME
Range†1 – 30 min
Increment 30 s
Default**
BIPOLAR 15 min
MONOPOLAR
2 min 30 sec
RFA
TREATMENT
MODE
If enabled,Temperature of RFA and
Thermocouple Probe are displayed.
Impedance measurement for RFA is
displayed. Time and Power are not displayed
(dashed lines replace values). If the
Thermocouple Probe is disabled via RFA
SETTINGS in the ADVANCED SETTINGS state,
that measurement is greyed out and the
value replaced with dashed lines.
PLACEMENT
MODE
SAVE
SETTINGS
SETTEMP
Range 38° – 95°C
Increment 1°C
Default** 55°C
TIME
Range 1 – 30 min
Increment 30 s
Default** 10 min
IDL MODE
Temperature of IDL andThermocouple
Probe are displayed. Impedance
measurement for IDL is displayed.Time
and Power are not displayed (dashed lines
replace values). If the Thermocouple Probe
is disabled via IDL SETTINGS state, accessible
from the ADVANCED SETTINGS mode, that
measurement is greyed out and the value
replaced with dashed lines.
SAVE
SETTINGS
While in the READY state,
other operating modes are
not available.
The present SETTINGS can be
saved as defaults by holding
down the SAVE SETTINGS key.
SETTEMP
Range 40° – 95°C
Increment 1°C
Default** 90°C
TIME
Range 30 s – 20 min
Increment 00:30 s
Default** 16:30 min
** Defaults are factory-set, and are overwritten when the SAVE SETTINGS function is used.
*** The “Cooled RF Set Temp” (Default Setting T = 60°C) displayed on the COOLIEF* RF Generator refers to the cooled electrode temperature and does not reect the immediate
surrounding tissue temperature. The heat generated from the radiofrequency energy produces thermal energy with average maximum tissue temperatures greater than 80°C.
†Time Range set by user does not include factory-set PRE-TREATMENT COOLING Time (45 seconds) or POST-TREATMENT COOLING Time (10 seconds).
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7.4 ON States
Figure 7-7 VOLTAGE STIMULATION – ON Display
Figure 7-8 CURRENT STIMULATION – ON Display
Figure 7-9 AUTO TEMP LESION – ON Display
Figure 7-10 MANUAL POWER LESION - ON Display
Figure 7-11 AUTO PULSED LESION – ON Display
Figure 7-12 MANUAL PULSED LESION – ON Display
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Figure 7-13 Multi-RF AUTO TEMP LESION – ON Display Figure 7-14 Multi-RF AUTO PULSED – ON Display
• COOLED RF AUTOTEMP ANDTRANSDISCALTREATMENT states consist of: PRE-TREATMENT COOLING,TREATMENT ON, and POST-TREATMENT COOLING, if enabled from
ADVANCED SETTINGS.
Figure 7-15 COOLED RF AUTO TEMP — ON Display
Figure 7-16 MULTI-COOLED RF — ON Display
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Figure 7-17 TRANSDISCAL MONOPOLAR TREATMENT — ON Display
Figure 7-18 TRANSDISCAL BIPOLAR TREATMENT — ON Display
Figure 7-19 RFA MODE TREATMENT — ON Display
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