PMG-115, PMG-115TD, PMG-230 and PMG-230TD Pain Management Generator User Manual Rev A

BAYLIS Pain Management Generator

Model PMG - 115 (- TD) (For Domestic Use) Model PMG - 230 (- TD) (For International Use)

USER MANUAL Baylis Medical Company, Inc. 5959 Trans-Canada Highway Montreal, Quebec, Canada H4T 1A1 Telephone: (514) 488-9801 Facsimile: (514) 488-7209 EU Authorized Representative Quality First International 20 Eversley Road Bexhill-on-Sea East Sussex TN40 1HE United Kingdom Telephone: +44-(20)-8-522-1937 Facsimile: +44-(20)-8-522-1937

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Table of Contents 1

Introduction ... 1 1.1

Glossary Of Terms ... 1

2

Indicated Use ... 2

3

Warnings And Precautions ... 2

4

5

3.1

Warnings... 2

3.2

Precautions ... 3

Installation ... 3 4.1

Preparing The Generator For Use... 3

4.2

Mains Power Cord ... 3

4.3

Generator Cleaning And Disinfection Instructions... 3

4.4

When you get a new Generator... 4

User Interface Overview ... 4 5.1

Front Panel Displays, Controls, and Connections... 4

5.2

Rear Panel Displays, Controls, and Connections ... 6

6

Factory Set Defaults ... 7

7

Displays ... 8 7.1

System Initialization, Power-On-Self-Test (POST), and STANDBY States ... 8

7.2

PLACEMENT State ... 10

7.3

READY States ... 13

7.4

ON States ... 18

7.5

DONE States... 23

7.6 SAVE SETTINGS State ... 24 7.6.1 Example Display _________________________________________________________________________ 24 7.7 ADVANCED SETTINGS Mode ... 24 7.7.1 ADVANCED SETTINGS Mode - STIMULATION SETTINGS State _______________________________ 24 7.7.2 ADVANCED SETTINGS Mode– LESION SETTINGS State______________________________________ 25 7.7.3 ADVANCED SETTINGS Mode – COOLED RF SETTINGS State _________________________________ 26 7.7.4 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS State ______________________________ 27 7.7.5 ADVANCED SETTINGS Mode – RFA SETTINGS State ________________________________________ 28 7.7.6 ADVANCED SETTINGS Mode - IDL SETTINGS State _________________________________________ 29 7.7.7 ADVANCED SETTINGS Mode – AUDIO SETTINGS State ______________________________________ 29 7.7.8 ADVANCED SETTINGS Mode – LANGUAGE SETTINGS State _________________________________ 30 7.8 Special Event States ... 31 7.8.1 Recoverable Errors _______________________________________________________________________ 31 7.8.1.1 Display... 31 7.8.1.2 Settings ... 31 7.8.2 Non-Recoverable Faults ___________________________________________________________________ 31 7.8.2.1 Display... 31 7.8.2.2 Settings ... 31 8

Technical specifications ... 32 8.1

Impedance Measurement ... 32

8.2

Stimulation... 32

8.3

RF Output... 32

8.4

Measurement Accuracy ... 32

8.5

Software Shutdown Limits During RF Delivery or Stimulation... 32

8.6

Hardware Shutdown Limits... 33

8.7

Mechanical Specifications ... 33

8.8

Environmental Specifications... 33

8.9

Fuses ... 33

8.10

Line Input Ratings ... 33

8.11

Footswitch Specifications... 33

8.12

Output Power Graphs... 34

9

Labeling Symbols... 36

10

Warranty ... 37

Table of Figures Figure 5-1 Generator front panel ... 4 Figure 5-2 Generator rear panel ... 6 Figure 7-1 System Initialization State Display... 8 Figure 7-2 POST State Display... 8 Figure 7-3 STANDBY Display ... 8 Figure 7-4 TDP A Placement Display ... 10 Figure 7-5 VOLTAGE STIMULATION – READY Display ... 13 Figure 7-6 VOLTAGE STIMULATION – ON Display... 18 Figure 7-7 CURRENT STIMULATION – ON Display... 18 Figure 7-8 AUTO TEMP LESION – ON Display ... 18 Figure 7-9 MANUAL POWER LESION - ON Display... 18 Figure 7-10 AUTO PULSED LESION – ON Display ... 18 Figure 7-11 MANUAL PULSED LESION – ON Display... 18 Figure 7-12 COOLED RF AUTO TEMP ON Display ... 19 Figure 7-13 TRANSDISCAL TREATMENT ON Display ... 19 Figure 7-14 RFA Mode – TREATMENT ON Display ... 19 Figure 7-15 IDL Mode – ON Display (Secondary Thermocouple Enabled)... 20 Figure 7-16 Save Settings Display ... 24 Figure 7-17 ADVANCED SETTINGS Mode – STIMULATION SETTINGS Display... 25 Figure 7-18 ADVANCED SETTINGS Mode- LESION SETTINGS Display ... 26 Figure 7-19 ADVANCED SETTINGS Mode – COOLED RF SETTINGS Display ... 26 Figure 7-20 ADVANCED SETTINGS Mode – TRANSDISCAL SETTINGS Display ... 27 Figure 7-21 ADVANCED SETTINGS Mode - RFA SETTINGS Display... 28 Figure 7-22 ADVANCED SETTINGS Mode – IDL SETTINGS Display... 29 Figure 7-23 ADVANCED SETTINGS Mode – AUDIO SETTINGS Display... 30 Figure 7-24 ADVANCED SETTINGS Mode - LANGUAGE SETTINGS Display ... 30 Figure 7-25 AUTO TEMP Recoverable Error Pop-Up Display ... 31 Figure 7-26 AUTO TEMP Mode Non-Recoverable Fault Pop-Up Display ... 31 Figure 8-1 Power vs. Load and Peak Voltage ... 34 Figure 8-2 Set Power vs. Output Power... 35

1 Introduction The system presented in this User’s Manual consists of the Baylis Pain Management Generator (PMG) and an optional pneumatic footswitch. For the user’s convenience, the Baylis Pain Management Generator will be referred to in this User’s Manual as the “Generator ” or “PMG”. This User’s Manual provides a description of the Generator, its controls and displays, and a sequence for its operation. This User’s Manual also supplies other information of importance to the user. Do not operate the Generator before thoroughly reading this manual. This User’s Manual and the Generator screens can be made available in other languages. Please contact Baylis Medical at 514-488-9801 for further information. 1.1

Glossary Of Terms Term Definition 1-Shot A possible value for the STIM RATE in the STIMULATION modes. If selected, only one stimulus pulse is delivered when the output is turned on. Cannula A metal tube that is electrically insulated along its length, with exception to an exposed tip from which electrical currents flow. COOLED RF A group of states specifically designed to allow for the use of water-cooled probes to allow more power to be dissipated in tissue, resulting in a larger lesion at a lower temperature. Dispersive Electrode An adhesive pad with a large electrically active surface area used in monopolar RF modes, as well as in certain Placement States. Often referred to as a “grounding pad”. DONE State of the Generator when RF energy has been terminated. Footswitch A pneumatic device that connects to the back of the PMG and allows hand-free starting and stopping of RF and Stimulation output. IDL Intradiscal Lesioning Impedance The effective resistance to the flow of current in a circuit. Lesion A localized pathological change in a bodily organ or tissue. Mode A group of states (usually READY, ON, and DONE) that comprise the machine steps necessary to complete a procedure. The modes for this Generator include: Current Stimulation, Voltage Stimulation, Auto Temp Lesion, Manual Power Lesion, Auto Pulsed Lesion, Manual Pulsed Lesion, Cooled RF, TransDiscal, RFA, and IDL. ON State of the Generator when RF energy is applied to the probes and dispersive return electrode if applicable. PDT A The Peripheral Disc Temperature as relating to TDP A (TransDiscal Probe A) PDT B The Peripheral Disc Temperature as relating to TDP B (TransDiscal Probe B) PMG Pain Management Generator POST The state of the Generator when Power On Self Tests are performed. PULSE DUR A setting that applies to VOLTAGE STIMULATION, CURRENT STIMULATION, AUTO PULSED LESION, and MANUAL PULSED LESION modes. In the STIMULATION modes, it describes the length of time of one stimulus pulse. In PULSED LESION modes (MANUAL AND AUTO) it describes the length of time of the RF pulse. PULSE RATE A setting that applies to AUTO PULSED and MANUAL PULSED modes. It describes the number of RF bursts of duration PULSE DUR and is measured in Hz. Pump Refers to Pain Management Peristaltic Pump Unit (TDA-PPU-1) RAMP RATE – A setting that is adjustable in ADVANCED SETTINGS mode, and applies to COOLED RF mode. COOLED RF MODE It is the rate at which the Generator heats to the SET TEMP. RAMP RATE – IDL Setting that is adjustable in ADVANCED SETTINGS mode, and applies to IDL mode. It is the rate MODE at which the Generator heats from the INITIAL TEMP to the SET TEMP. RAMP RATE – A setting that is adjustable in ADVANCED SETTINGS mode, and applies to TRANSDISCAL TRANSDISCAL mode. It is the rate at which the Generator heats to the SET TEMP. MODE RAMP TIME –AUTO A setting that is adjustable in ADVANCED SETTINGS mode –LESION SETTINGS, and applies to TEMP LESION AND the AUTO TEMP LESION and AUTO PULSED LESION modes. It is the rate at which the AUTO PULSED Generator heats to the SET TEMP. LESION MODES RAMP TIME – RFA A setting that is adjustable in ADVANCED SETTINGS mode - RFA. It is the rate at which the MODE Generator heats to the SET TEMP.

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Term READY RF RFA RF Probe STANDBY STATE

STIM RATE Stylet Switching Cable TC TD TDP TDP A TDP B TEMP Thermistor Thermocouple Y-Cable

Definition State of the Generator where settings can be adjusted and other modes of operation can be chosen prior to RF application. Radio Frequency Radio Frequency Annuloplasty A slender, flexible surgical instrument used to deliver stimulation and RF output to bodily organs or tissues. State of the Generator when a valid probe must be connected prior to proceeding to the applicable READY state for the probe. 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. 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. A fine wire that is run through a cannula, to keep it stiff or clear of debris. 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. Thermocouple TransDiscal TransDiscal Probe TransDiscal Probe A TransDiscal Probe B Temperature A resistor made of semiconductors having resistance that varies rapidly and predictably with temperature. A thermoelectric device used to measure temperatures accurately, consisting of two dissimilar metals. Any of TDX-Y-TSW-TDP (TransDiscal Y-Cable), PMX-Y-RSW-RFA (RFA Y-Cable), or PMXY-BAY-ORA (IDL Y-Cable), resembling the characteristic shape of the letter “Y”.

2 Indicated Use Baylis Pain Management Generator; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG is to be used in conjunction with separately approved probes. The Generator supplies up to 50 Watts of Radio Frequency energy at 460kHz under power, voltage, or temperature control while continuously monitoring and displaying actual power or voltage delivered, measured probe temperature(s), time of power duration, and measured impedance. The 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. Caution! 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: Do not operate the Generator before thoroughly reading this manual. Improper line voltage selection may cause malfunction or damage to the instrument: The Voltage Selector and Fuse Drawer must BOTH be set to the same voltage. They are located on the rear panel of the instrument (the fuse drawer is located in the power entry module). An improper voltage setting may result in Generator

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• • • • • • •

3.2

malfunction and potential instrument damage. The Voltage Selector is factory set and should not be changed by the user. Risk of Fire: Do not use in the presence of flammable anesthetics, other flammable gases, near flammable fluids (such as skin prepping agents and tinctures), flammable objects, or with oxidizing agents. Observe appropriate fire precautions at all times. Risk of Fire: Do not use this device in oxygen-enriched atmospheres, nitrous oxide (N2O) atmospheres, or in the presence of other oxidizing agents. Risk of RF burns to the patient: While using this device during a procedure, the patient should not be allowed to come into direct contact with grounded metal objects such as surgical table frame, the instrument table, etc. Risk of RF burns to the patient: Place monitoring electrodes as far away from the treatment site as possible, to avoid burns or interference with other equipment. The use of needle monitoring electrodes (or other small-area electrodes) during RF output is not recommended. Risk of RF burns to the patient: Use only with a Baylis Pain Management Dispersive Electrode. 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.

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. The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the activation audible tone. Do not remove the cover of the Generator, as there is a potential for electrical shock. Refer to authorized personnel for service. Use only the Baylis pneumatic footswitch with the Generator. 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.

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 Baylis Medical for a replacement. Baylis Medical must approve all returns. 4.1

Preparing The Generator For Use • •

4.2

Mains Power Cord • •

4.3

The Generator may be placed on a mounting cart or on any sturdy table or platform. Provide at least four to six inches (10-15 cm) of space behind the rear panel of the Generator for forced air-cooling. Do NOT obstruct the vents on the underneath of the Generator. Under continuous use for extended periods of time, it is normal for the top and rear panel to be warm.

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.

Generator Cleaning And Disinfection Instructions • •

Use a mild detergent and damp cloth to clean the Generator cover, front panel, and power cable. The Generator cannot be sterilized. Do not allow fluids to enter the chassis. The Generator may be disinfected using a standard hospital alcohol solution applied with a cloth. Do not spray or pour liquids directly on the Generator.

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4.4

When you get a new Generator •

When you open a box, you will find: o Generator o Power Cord o User Manual

5 User Interface Overview

10

4

8 5

11 9 1

6 2 3

7

13

12 Figure 5-1 Generator front panel

5.1

Front Panel Displays, Controls, and Connections •

Descriptions of front panel features and their functions are given below. Please refer to Figure 5-1 for location of each item on the front panel. (1) Status Window: This window is used to display messages (e.g., Error, Fault, Save Settings). (2) Mode Function Labels: These “labels” are part of the flat panel display and indicate the function of the associated Mode Function Key (3). Labels highlight to indicate the current operating mode. If no label is present, the associated button is not used in the present mode. (3) Mode Function Keys: These keys select and change the state of operation. For Baylis Pain Management Thermocouple or Thermistor 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.

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

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1

9

8 7

3

4

2 11 10

12

5

6 13

Figure 5-2 Generator rear panel 5.2

Rear Panel Displays, Controls, and Connections •

Descriptions of rear panel features and their functions are given below. Please refer to Figure 5-2 for corresponding locations on the rear panel. (1) Volume Adjustment: This knob adjusts the volume of the system’s audio output. (2) RS232 connection: This is an isolated connection to a standard 9-pin COM port. It is provided for passive data acquisition, and cannot be used to control the system. (3) FOOTSWITCH connection: This pneumatic barb connects to the hose of the pneumatic footswitch. Like the OUTPUT ON/OFF switch, the FOOTSWITCH controls stimulus output in the STIMULATION modes and controls RF output in the LESION, COOLED RF, TRANSDISCAL, RFA and IDL modes. The action of the FOOTSWITCH differs from the OUTPUT ON/OFF switch: the FOOTSWITCH must be held down to continue delivery of stimulus pulses or RF energy. (4) Fuse Drawer: The orientation of the fuse drawer, in conjunction with the AC CONFIGURATION SWITCH, determines the AC input voltage range (100-120V~ or 220-240V~). For each voltage setting the proper, corresponding fuses must be used, as indicated in the rear panel labeling. (5) AC CONFIGURATION SWITCH: The orientation of this switch, in conjunction with the Fuse Drawer, determines the AC input voltage range (100-120V~ or 220-240V~). Do not change the position of the voltage selector while the system is plugged in. (6) Equipotential Ground Connection: This connector is attached to the chassis/earth ground. It is intended for earth reference connection in environments where equipotential ground cabling is used. (7) AC MAINS SWITCH: This switch controls the initial AC power input to the system, and is part of the power entry module, which integrates the AC power inlet and Fuse Drawer. (8) Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction of airflow is outward from the rear panel. (9) Device Label: This label indicates the model number of the Generator and includes contact information for Baylis Medical Company. The unique serial number of the Generator is marked on this label. (10) RWTUV Safety Mark Certification Label (11) CE 0120 CE Mark Label (12) RJ45 Connector: Connection to be used by authorized service personnel only. (13) Pump Module Interface Connector: For attachment of authorized cooling pump unit only. 025-0164-000 Revision A Page 6 of 37

6 Factory Set Defaults Mode VOLTAGE STIMULATION

CURRENT STIMULATION AUTO TEMP LESION MANUAL POWER LESION AUTO PULSED LESION

MANUAL PULSED LESION COOLED RF TRANSDISCAL RFA IDL

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Settings

FACTORY SET DEFAULTS Adjustment Range

“Factory Set” Value 2 Hz

STIM RATE

1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180, 200 Hz

PULSE DUR

0.1, 0.2, 0.5, 1.0 ms

VOLTAGE STIM RATE PULSE DUR CURRENT SET TEMP TIME TEMP LIMIT TIME SET POWER SET TEMP TIME PULSE DUR PULSE RATE WARNING TEMP TIME PULSE DUR PULSE RATE SET TEMP TIME SET TEMP TIME SET TEMP TIME SET TEMP TIME

0.0–10.0 V 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180, 200 Hz. 0.1, 0.2, 0.5, 1.0 ms 0.0–10.0 mA 38–95 °C 15–180 s 38–95 °C 15–180 s 0–50 W 38–95 °C 10–300 s 10 - 100 ms, with 10 ms interval 1–10 Hz

0.0 V 2 Hz 1.0 ms 0.0 mA 80 °C 75 s 80 °C 75 s 0W 42 °C 120 s 20 ms 2 Hz

38–95° C

42 °C

10–300 s 10–100 ms, with 10 ms interval 1–10 Hz 30–90 ºC 15s–30 min 30–90 ºC 1–30 min 38–95 ºC 1–30 min 40–95 °C 30s–20 min

120 s 20 ms 2 Hz 60 ºC 2 min 30 sec 45 ºC 15 min 55 ºC 10 min 90 °C 16 min 30 sec

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1.0 ms

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.

Figure 7-1 System Initialization State Display •

The POST state is initiated after System Initialization is completed. It lasts about 2 seconds.

Figure 7-2 POST State Display •

The STANDBY state is initiated upon successful completion of the POST state.

Figure 7-3 STANDBY Display

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Displays and Indicators: PARAMETER STATE

RF/Stimulus Output Status

System Initialization Power-On-Self-Test (POST)

OFF

STANDBY

STATE

FAULT indicator

Description

Status

Description

No RF or stimulus waveforms are generated.

OFF

Only Power On is illuminated during Initialization.

OFF

ON

All indicators are illuminated during POST.

ON

RF and stimulus waveforms are delivered into internal test loads. The output is inactive.

OFF

(The FAULT indicator is used only in the POST and SYSTEM FAULT states.)

OFF

OFF

RF audio output is not generated during Initialization.

OFF

Impedance related audio output is not generated during Initialization.

N/A

A tone sounds for approximately 2 s to indicate that the Power-On-Self-Test ON - POST system is active and is performing self-tests. The tone also tone (POST) serves as a test of the audio output. None

STANDBY

STATE

System Initialization Power-On-Self-Test (POST)

N/A

STANDBY

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None

The indicator is not illuminated during this state.

“PLEASE ATTACH PROBE TO CABLE THEN ATTACH CABLE TO Active GENERATOR” message is displayed while in the STANDBY mode.

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No parameters are graphed during this state.

None

PARAMETERS Measurement Status Window Available States Window Status Description Status Description Status Description No other modes are available N/A None N/A during Initialization and POST states. No parameters are measured during this state.

Only Power On is illuminated during Initialization. All indicators are illuminated during POST.

PARAMETER Impedance Related Audio Output Graph Window Status Description Status Description

RF Audio Output Status Description

System Initialization

RF/Stimulus Output ON/OFF indicator Status Description

None

No operating modes are available until a probe is connected. The ADVANCED SETTINGS mode can be entered during the STANDBY state.

Available Settings Status

Description No settings are available during this state.

None N/A

7.2

PLACEMENT State •

In the TRANSDISCAL mode, TREATMENT state is the default screen upon connection of a valid TransDiscal cable and probe, or when a TransDiscal Y-Connecting Cable is used. The PLACEMENT state can be accessed from the STIMULATION or TREATMENT READY states. The PLACEMENT state cannot be accessed during the STIMULATION ON or TREATMENT ON states.

When in the PLACEMENT state: • MEASURING TDP A is the default screen when the switching cable is set to Probe A, or when a TransDiscal YConnecting Cable is used. •

MEASURING TDP B is the default screen when the switching cable is set to Probe B and two probes are enabled for use in the TRANSDISCAL mode, accessible from the ADVANCED SETTINGS mode.

Figure 7-4 TDP A Placement Display

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Displays and Indicators: PARAMETER

STATUS

RF/Stimulus Output

OFF

FAULT Indicator

OFF

RF/Stimulus Output ON/OFF Indicator

OFF

Measurement Window

ON

Status Window

None

DESCRIPTION RF power is not delivered during this state. (The FAULT indicator is used only in the POST and SYSTEM FAULT states.) The indicator is not illuminated during this state, as there is no RF power delivery. Active impedance measurement is displayed. The display will read HIGH for high impedances (e.g. open circuits). N/A In the Secondary Thermocouple Placement state, Treatment mode is not selectable. In the TDP A Placement state, Treatment mode is available. If the position of the switch on the Switching Cable changes to TDP B, the Generator changes to the TDP B Placement state, and the Treatment mode key is not selectable and the mode select key is greyed out.

TREATMENT MODE Available Modes

None for RFA MODE – THERMOCOUPLE Placement state

In the RFA Placement state, Treatment mode is available if the position of the switch on the Switching Cable concurs, or if only the RFA Y-Connecting Cable is used. If the position of the switch on the Switching Cable does not concur, TREATMENT mode is not selectable. When Treatment mode is selected, the Generator will enter the READY state of that mode.

Available Settings

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None

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. N/A

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STATE

RF Audio Output Status Description

Status

PARAMETER Impedance Related Audio Output Description

Graph Window Status Description

TDP A PLACEMENT TDP B PLACEMENT None RFA MODE THERMOCOUPLE Placement

N/A

Continuous audio output is generated for placement. Frequency of output is related to active impedance Indicates the system PLACEMENT measurement. No audible tone if selected probe is ON (Default*) is measuring the an open circuit – replace with warning message. MEASUREMENT OFF (if disabled) selected probe This feature can be disabled in the AUDIO impedance. SETTINGS state, accessible from the ADVANCED SETTINGS mode.

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 Baylis Pain Management Thermocouple or Thermistor probe and cable.

Figure 7-5 VOLTAGE STIMULATION – READY Display Displays and Indicators: PARAMETER

STATUS

DESCRIPTION RF power is not delivered during the READY state. When Output ON/OFF is pressed, RF power is delivered and the Generator automatically transitions to the ON state. VOLTAGE STIMULATION – During the ON state, Voltage must be greater than 0.0 V for Stimulus pulses to be delivered.

RF/Stimulus Output

OFF CURRENT STIMULATION – Stimulus pulses are not delivered during the READY state. During the ON state, Current must be greater than 0.0 mA for Stimulus pulses to be delivered.

FAULT Indicator RF/Stimulus Output ON/OFF Indicator RF Audio Output Impedance Related Audio Output

OFF OFF None OFF (Default*) ON (if enabled)

Minimal

TRANSDISCAL AND COOLED RF TREATMENT - Pump Status is displayed at the top of the Graph Window.

Graph Window

STIMULATION READY display Status Window

TRANSDISCAL AND COOLED RF TREATMENT - When Output ON/OFF is pressed; the Generator will enter the PRE-TREATMENT COOLING state. (The FAULT indicator is used only in the POST and SYSTEM FAULT states.) The indicator is not illuminated during the READY state, as there is no Stimulus/RF power delivery. RF audio output is not generated during the READY state. If enabled in ADVANCED AUDIO SETTINGS, impedance related audio output is generated. The time axis ( ) is indefinitely scalable during the READY state, accommodating changes to treatment TIME. The dashed line denoting SET TEMP/TEMP LIMIT/WARNING TEMP will move according to changes made to the SET TEMP/TEMP LIMIT/WARNING TEMP value.

Indicates the system is ready to generate stimulus pulses.

None

N/A

* Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode 025-0164-000 Revision A

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STATE

Measurement Window Status Description

VOLTAGE STIMULATION

CURRENT STIMULATION

ON

AUTO TEMP LESION

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PARAMETER Available States Status Description

Available Settings Status Description Range 1-Shot –200 Hz Available 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180, and 200 Hz Values† STIM RATE While in the READY 2 Hz -OR- as set in ADVANCED VOLTAGE state, other operating Default* STIMULATION SETTINGS State STIMULATION modes for Baylis Pain STIM RATE 1 Management Range 0.1–1.0 ms CURRENT Thermocouple or Available STIMULATION Thermistor probes are 0.1, 0.2, 0.5, and 1.0 ms † available. When a PULSE DUR Values 1.0 ms -OR- as set in ADVANCED different mode is Default* STIMULATION SETTINGS State AUTO TEMP selected, the Generator will enter the READY PULSE DUR 1 Impedance measurements state of the new mode. 0.0–10.0 V/mA (Only adjustable Range are displayed. MANUAL when STIM RATE is 1-Shot) POWER The present VOLTAGE / Increment 0.1 V/mA SETTINGS can be CURRENT 0.0 V/mA (cannot be overwritten saved as defaults by Default when the SAVE SETTINGS function AUTO PULSED holding down the is used) SAVE SETTINGS key. Toggle between PRESET 1 and PRESET 2 as MANUAL VOLTAGE/CURREN specified in the STIMULATION SETTINGS PULSED T STIMULATION state, accessible from the ADVANCED PRESETS The settings are saved SETTINGS mode. Selecting a Preset modifies to the ADVANCED the STIM RATE and PULSE DUR to their SAVE SETTINGS STIMULATION corresponding values. SETTINGS State, in both STIM RATE 1 Range 38–95 ºC Temperature and and PULSE DUR 1 SET TEMP Increment 1 ºC Impedance measurements toggle fields. are displayed while Time Default* 80 ºC and Power are not displayed Range 15–180 s (dashed lines replace TIME Increment 1s values). Default* 75 s

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STATE

Measurement Window Status Description

PARAMETER Available States Status Description

Status TEMP LIMIT

TIME

MANUAL POWER LESION

AUTO PULSED LESION

ON

POWER LIMIT CURRENT STIMULATION While in the READY state, other operating modes for Baylis Pain SET TEMP AUTO TEMP Management Thermocouple or Thermistor probes are Temperature and TIME MANUAL available. When a Impedance measurements different mode is POWER are displayed while Time selected, the Generator and Power are not displayed will enter the READY PULSE DUR (dashed lines replace AUTO PULSED state of the new mode. values). MANUAL PULSED

PULSE RATE The present SETTINGS can be saved as defaults by WARNING holding down the TEMP SAVE SETTINGS key.

SAVE SETTINGS TIME MANUAL PULSED LESION

PULSE DUR

PULSE RATE

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Available Settings Description Range 38–95 ºC Increment 1 ºC Default* 80 ºC Range 15–180 s Increment 1s Default* 75 s Range 0 – 50 W Increment N/A 0 W (Cannot be overwritten Default by SAVE SETTINGS function) Range 38–95 ºC Increment 1 ºC Default* 42 ºC Range 10–300 s Increment 1s Default* 120 s Range 10–100 ms Increment 10 ms Default* 20 ms Range 1–10 Hz Increment 1 Hz Default* 2 Hz Range 38–95 ºC Increment 1 ºC Default* 42 ºC Range 10–300 s Increment 1s Default* 120 s Range 10–100 ms Increment 10 ms Default* 20 ms Range 1–10 Hz Increment 1 Hz Default* 2 Hz