PMG-115, PMG-115TD, PMG-230 and PMG-230TD Pain Management Generator PMG V4.0 Users Manual Rev B May 2011

8.9

Fuses...34

8.10

Line Input Ratings...34

8.11

Footswitch Specifications...34

8.12

Rated Accessory Voltage (for Associated Equipment and Active Accessories)...34

8.13

Output Power Graphs...35

8.14

IEC Electrical Safety and EMC Specifications...36

9

Standard RF Lesion Size...38

10

Labeling Symbols...39

11

Warranty...40

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 7-25 ADVANCED SETTINGS Mode – MULTI-COOLED RF SETTINGS Display... 28 Figure 7-26 ADVANCED SETTINGS Mode – COOLED RF SETTINGS Display... 29 Figure 7-27 ADVANCED SETTINGS Mode – AUDIO/LANGUAGE SETTINGS Display... 30 Figure 7-28 ADVANCED SETTINGS Mode – RFA SETTINGS Display... 31 Figure 7-29 ADVANCED SETTINGS Mode – IDL SETTINGS Display... 31 Figure 7-30 Recoverable Error Pop-Up Display... 32 Figure 7-31 Non-Recoverable Fault Pop-Up Display... 32 Figure 8-1 Power vs. Load and Peak Voltage... 35 Figure 8-2 Set Power vs. Output Power... 36

4

1

Introduction

The system presented in this User’s Manual consists of the Kimberly-Clark* Pain Management Generator (PMG) (formerly known as the Baylis Pain Management Generator) and an optional pneumatic footswitch. For the user’s convenience, the Kimberly-Clark* 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 Kimberly-Clark* Radiofrequency (RF) 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 U.S. customers please call Kimberly-Clark at 1-800-KCHELPS (800-742-1996), International customers please call +1-770-587-7200 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”, or as a “return electrode.”

DONE

State of the Generator when RF energy has been terminated.

Footswitch

A pneumatic device that connects to the back of the PMG and allows hand-free starting and stopping of RF and Stimulation output.

IDL

Intradiscal Lesioning

IFU

Instructions For Use

Impedance

The effective resistance to the flow of current in a circuit.

Lesion

A localized pathological change in a bodily organ or tissue.

Mode

A group of states (usually READY, ON, and DONE) that comprise the machine steps necessary to complete a procedure. The modes for this Generator include: Current Stimulation, Voltage Stimulation, Auto Temp Lesion, Manual Power Lesion, Auto Pulsed Lesion, Manual Pulsed Lesion, Cooled RF, TransDiscal, RFA, and IDL.

Multi-RF

Multi-Radiofrequency

ON

State of the Generator when RF energy is applied to the probes and dispersive return electrode if applicable.

PDT A

The Peripheral Disc Temperature as relating to TDP A (TransDiscal* Probe A)

PDT B

The Peripheral Disc Temperature as relating to TDP B (TransDiscal* Probe B)

PMG

Pain Management Generator

POST

The state of the Generator when Power-On-Self-Tests are performed.

PULSE DUR

A setting that applies to VOLTAGE STIMULATION, CURRENT STIMULATION, AUTO PULSED LESION, and MANUAL PULSED LESION modes. In the STIMULATION modes, it describes the length of time of one stimulus pulse. In PULSED LESION modes (MANUAL AND AUTO) it describes the length of time of the RF pulse.

PULSE RATE

A setting that applies to AUTO PULSED and MANUAL PULSED modes. It describes the number of RF bursts of duration PULSE DUR and is measured in Hz.

Pump

Refers to Pain Management Peristaltic Pump Unit (TDA-PPU-1)

RAMP RATE – COOLED RF MODE

A setting that is adjustable in ADVANCED SETTINGS mode, and applies to COOLED RF mode. It is the rate at which the Generator heats to the SET TEMP.

RAMP RATE – IDL MODE

Setting that is adjustable in ADVANCED SETTINGS mode, and applies to IDL mode. It is the rate at which the Generator heats from the INITIAL TEMP to the SET TEMP.

RAMP RATE – TRANSDISCAL MODE

A setting that is adjustable in ADVANCED SETTINGS mode, and applies to TRANSDISCAL mode. It is the rate at which the Generator heats to the SET TEMP.

RAMP TIME –AUTO A setting that is adjustable in ADVANCED SETTINGS mode – LESION SETTINGS, and applies to the AUTO TEMP LESION and AUTO PULSED LESION modes. It TEMP LESION AND is the rate at which the Generator heats to the SET TEMP. AUTO PULSED LESION MODES RAMP TIME – RFA MODE

A setting that is adjustable in ADVANCED SETTINGS mode – RFA. It is the rate at which the Generator heats to the SET TEMP.

READY

State of the Generator where settings can be adjusted and other modes of operation can be chosen prior to RF application. 5

1.1 Glossary of Terms RF

Radiofrequency

RFA

Radiofrequency Annuloplasty

RF Probe

A slender, flexible surgical instrument used to deliver stimulation and RF output to bodily organs or tissues.

STANDBY

State of the Generator when a valid probe must be connected prior to proceeding to the applicable READY state for the probe.

STATE

A function of the Generator where a basic task is performed. For instance, the READY state for any mode allows settings to be changed and allows RF energy to be initiated. The states of the Generator include STANDBY, PLACEMENT, READY, ON, DONE, ADVANCED SETTINGS.

STIM RATE

A setting that applies to VOLTAGE STIMULATION and CURRENT STIMULATION modes. It describes the number of stimulus pulses delivered in a second, and is measured in Hz.

Stylet

A fine wire that is run through a cannula, to keep it stiff or clear of debris.

Switching Cable

Either of TDX-BAY-TSW (TransDiscal* Switching Cable) or PMX-BAY-RSW (RFA Switching Cable), used to aid in the placement of secondary probes or thermocouples.

TC

Thermocouple

TD

TRANSDISCAL

TDP

TransDiscal* Probe

TDP A

TransDiscal* Probe A

TDP B

TransDiscal* Probe B

TEMP

Temperature

Thermocouple

A thermoelectric device used to measure temperatures accurately, consisting of two dissimilar metals.

TRUE-TX Ramp Time Extension

A feature that will maintain the time at the Set Temperature and generate a notification if probes are in a configuration that prevents the set temperature from being reached in the specified Ramp Time.

Y-Cable

Any of TDX-Y-TSW-TDP (TransDiscal* Y-Cable), PMX-Y-RSW-RFA (RFA Y-Cable), or PMX-Y-BAY-ORA (IDL Y-Cable), resembling the characteristic shape of the letter “Y”.

2

Indicated Use

Kimberly-Clark* Pain Management Generator Model PMG-115 Basic, PMG-115-TD Advanced (For Domestic Use) and Model PMG-230 Basic, PMG-230-TD Advanced (For International Use) 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 Kimberly-Clark* PMG is to be used in conjunction with separately approved probes. • The Generator supplies up to 50 Watts of Radiofrequency energy at 460 kHz under power, voltage, or temperature control while continuously monitoring and displaying actual power or voltage delivered, measured probe temperature(s), time of power duration, and measured impedance. The use of a dispersive return electrode is specified in the accompanying 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

6

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 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. • 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. • Use only with a Kimberly-Clark* or Baylis Pain Management Dispersive Electrode. Always select a dispersive electrode designed to be compatible with the available contact quality monitor. • Unless a compatible Monitoring Dispersive Electrode is used with a Contact Quality Monitor, loss of safe contact between the Dispersive Electrode and the patient will not result in an auditory alarm. • Skin-to-skin contact (for example between the arms and body of the PATIENT) should be avoided, for example by insertion of dry gauze. • 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 Kimberly-Clark* or Baylis Pain Management Bipolar Adaptor (PMA-BP). • Interference with active implants: During RF output, implanted devices such as pacemakers may be affected. Qualified advice should be obtained as necessary, to minimize the risk of injury from implanted device malfunction. • Interference with other equipment: During RF output (lesion modes), the conducted and radiated electrical fields may interfere with other electrical medical equipment.

3.2 Precautions • Do not activate the output of the Generator until the probe is properly positioned in the patient. • In STIMULATION, LESION, COOLED RF, TRANSDISCAL and RFA modes, ensure that the dispersive return electrode is connected to the Generator and properly attached to the patient. • In Multi-RF STIMULATION mode, connect one probe at a time to the Multi-RF module to display individual impedance readings for placement purposes. • The entire area of the neutral electrode should be reliably attached to the patient’s body and as close to the operating field as possible. • The PMG may be used without a dispersive return electrode in some modes. Please refer to accompanying 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 flow through parts of the body having a relatively small cross sectional area, the use of BIPOLAR techniques may be desirable in order to avoid unwanted tissue damage. • Perform regular inspections of all accessories, including electrosurgical cables and probes, for damage to insulations. • Associated Equipment and Active Accessories should be selected that have a Rated Accessory Voltage equal to or greater than the Maximum Output Voltage. • For information on the connection and disconnection of detachable parts and accessories, refer to the Instructions for Use for the corresponding probe or cable. • Care should be taken to avoid the danger of ignition of endogenous gases. • The PMG needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. • Electronic equipment, including portable and mobile RF communications equipment, can affect the operation of the PMG. Operating non-essential equipment in the vicinity of the PMG should be avoided, if possible. • The PMG should not be used adjacent to or stacked with other equipment. If the PMG must be operated adjacent to or stacked with other equipment, the PMG should be observed to verify normal operation in that configuration. • Use of accessories, transducers and cables other than those specifically approved by Kimberly-Clark for use with the PMG may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PMG. • In Multi-RF Auto Temp mode, and in Multi-Cooled RF Auto Temp mode, maintain a minimum distance of 10 mm between probe tips and ensure that the probe tips do not touch. • When using the PMG with the pump unit accessory (TDA-PPU) refer to the pump IFU for information on proper setup and operation.

4

Installation

Inspect the Generator for any signs of physical damage to the front panel, chassis or cover. If any physical damage is found, DO NOT USE THE GENERATOR. CONTACT Kimberly-Clark for a replacement. Kimberly-Clark must approve all returns. 4.1 Preparing the Generator for Use • The Generator may be placed on a mounting cart or on any sturdy table or platform. • Provide at least 10-15 cm of space behind the rear panel of the Generator for forced air-cooling. Do NOT obstruct the vents on the underneath of the Generator. Under continuous use for extended periods of time, it is normal for the top and rear panel to be warm. 4.2 Mains Power Cord • The Generator is shipped with an approved hospital-grade mains power cord. • Do not use extension cords or three-prong to two-prong adapters. The mains power cord assembly should be periodically checked for damaged insulation or connectors.

7

4.3 Generator Cleaning and Disinfection Instructions • Use a mild detergent and damp cloth to clean the Generator cover, front panel, and power cable. The Generator cannot be sterilized. Do not allow fluids to enter the chassis. The Generator may be disinfected using a standard hospital alcohol solution applied with a cloth. • Do not spray or pour liquids directly on the Generator. • Non-flammable agents should be used for cleaning and disinfection wherever possible. • Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of high frequency surgery. 4.4 When you get a new Generator • When you open a box, you will find: • Generator • Power Cord • User’s Manual 4.5 Generator Maintenance Schedule • The Generator verifies calibration integrity during the Power-On-Self-Test (POST); maintenance is not required. • For Cleaning and Disinfection Instructions, refer to 4.3 Generator Cleaning and Disinfection Instructions. 4.6 Compatible Accessories • The Kimberly-Clark* PMG has been approved for use with all 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 flat panel display and indicate the function of the associated Mode Function Key ➂. 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 Kimberly-Clark* Pain Management Thermocouple RF probes, STIMULATION or LESION states are selected with a single press. In RFA mode, PLACEMENT or TREATMENT states are selected with a single press. In COOLED RF mode, STIMULATION or AUTO TEMP states are selected with a single press. In TRANSDISCAL mode, STIMULATION, PLACEMENT, or TREATMENT states are selected with a single press. The functions of these keys may vary between modes. The Mode Function Label ➁ above a key ➂ always describes the key function. 4. SETTINGS Window: For each state (e.g., VOLTAGE STIMULATION, AUTO TEMP LESION, TRANSDISCAL TREATMENT, etc.), the adjustable settings are shown in the SETTINGS Window. Up to 5 SETTINGS are adjustable in each state, by using the Setting Adjustment Keys ➄ and Rotary Encoder ➅, to the right of the window. 8

5. 6. 7. 8. 9. 10.

11.

12. 13.

Settings Adjustment Keys: The up ▲ and down ▼ buttons located to the right of the SETTINGS Window ➃ are used for adjusting treatment settings in the upper 4 locations of the SETTINGS Window. 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. 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. POWER Indicator: This green LED indicates that system power is on. 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. MEASUREMENTS Window: Measured values for elapsed TIME, probe TEMPERATURE(S), RF POWER, RF VOLTAGE and/or IMPEDANCE are displayed during and after RF output in both STIMULATION and LESION states and during treatment states for COOLED RF, TRANSDISCAL, RFA and IDL modes. During all READY states (prior to RF output), TEMPERATURE and IMPEDANCE are displayed. In LESION READY states for AUTOTEMPERATURE, AUTOPULSED, MANUAL POWER, AND MANUAL PULSED, IMPEDANCE is displayed according to LOW/OK/HIGH range. In PLACEMENT states for TRANSDISCAL and RFA modes, only the IMPEDANCE between the probe and the dispersive return electrode will be displayed. 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). Connector Cable Connection: This patient-isolated connection is for attachment of the connector cable for Kimberly-Clark* Pain Management Thermocouple probes. Dispersive Return Electrode Connection: This patient-isolated connection is for attachment of a Kimberly-Clark* 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 Kimberly-Clark. The unique serial number of the Generator is marked on this label. 3. Software Version Label: This label indicates the PMG software version. 4. AC MAINS SWITCH: This switch controls the initial AC power input to the system, and is part of the power entry module, which integrates the AC power inlet and Fuse Drawer. 5. Fuse Drawer: The orientation of the fuse drawer, in conjunction with the AC CONFIGURATION SWITCH, determines the AC input voltage range (100-120V~ or 220-240V~). For each voltage setting the proper, corresponding fuses must be used, as indicated in the rear panel labeling.

9

6.

AC CONFIGURATION SWITCH: The orientation of this switch, in conjunction with the Fuse Drawer, determines the AC input voltage range (100-120V~ or 220240V~). Do not change the position of the voltage selector while the system is plugged in. 7. Equipotential Ground Connection: This connector is attached to the chassis/earth ground. It is intended for earth reference connection in environments where equipotential ground cabling is used. 8. Fan: A brushless DC fan is used to exhaust warm air from the Generator. The direction of airflow is outward from the rear panel. 9. FOOTSWITCH Connection: This pneumatic barb connects to the hose of the pneumatic footswitch. Like the OUTPUT ON/OFF switch, the FOOTSWITCH controls stimulus output in the STIMULATION modes and controls RF output in the LESION, COOLED RF, TRANSDISCAL, RFA and IDL modes. The action of the FOOTSWITCH differs from the OUTPUT ON/OFF switch: the FOOTSWITCH must be held down to continue delivery of stimulus pulses or RF energy. 10. RS-232 Connection: This is an isolated connection to a standard 9-pin COM port. It is provided for passive data acquisition, and cannot be used to control the system. 11. RJ45 Connector: Connection to be used by authorized service personnel only. 12. Pump Module Interface Connector: For attachment of authorized cooling pump unit only.

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 –10.0 V

0.0 V

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

SET TEMP

38° – 95°C

80°C

TIME

15 – 600 s

75 s

MAX RAMP TIME EXTENSION

DISABLE, 5–120 s, with 5 s interval

30 s

TEMP LIMIT

38° – 95°C

80°C

TIME

15 – 600 s

75 s

AUTO TEMP LESION MULTI-RF (TRUE-TX) MANUAL POWER LESION

AUTO PULSED LESION

MANUAL PULSED LESION

COOLED RF MULTI-COOLED RF (TRUE-TX)

SET POWER

0 – 50 W

0W

SET 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

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

SET TEMP

30° – 90°C

60°C

TIME

15 s–30 min

2 min 30 sec

MAX RAMP TIME EXTENSION

DISABLE, 5–180 s, with 5 s interval

60 s

SET TEMP

38° – 95°C

60°C

TIME

15 s – 30 min with 15 s interval

2 min 30 sec

SET TEMP

30° – 90°C

BIPOLAR 50°C MONOPOLAR 60°C

TIME

1 – 30 min

BIPOLAR 15 min MONOPOLAR 2 min 30 sec

SET TEMP

38° – 95°C

55°C

TRANSDISCAL

RFA IDL 10

TIME

1 – 30 min

10 min

SET TEMP

40° – 95°C

90°C

TIME

30 s – 20 min

16 min 30 sec

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

11

Displays and Indicators PARAMETER STATE

RF/Stimulus Output Status

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

OFF

STANDBY

FAULT indicator

RF/Stimulus Output ON/OFF indicator

Description

Status

Description

Status Description

No RF or stimulus waveforms are generated.

OFF

Only Power On is illuminated during Initialization.

OFF

Only Power On is illuminated during Initialization.

All indicators are illuminated during POST.

ON

All indicators are illuminated during POST.

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

OFF

The indicator is not illuminated during this state.

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

PARAMETER STATE

System Initialization

RF Audio Output

Impedance Related Audio Output

Status

Description

Status

Description

OFF

RF audio output is not generated during Initialization.

OFF

Impedance related audio output is not generated during Initialization.

Graph Window Status Description

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

N/A

No parameters are graphed during this state.

None PARAMETERS

STATE

Measurement Window

Status Window

Available States

Available Settings

Status

Status

Status Description

Status Description

Description

Description

None

N/A

No other modes are available during Initialization and POST states.

Active

“PLEASE ATTACH None PROBE TO CABLE THEN ATTACH CABLE TO 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.

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

N/A No parameters are measured during this state.

STANDBY

None

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* Y-Connecting Cable is used. • MEASURING TDP 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

Measurement Window

ON

Status Window

None

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

TREATMENT MODE None for RFA MODE – THERMOCOUPLE Placement state

Available Modes

In the Secondary Thermocouple Placement state, Treatment mode is not selectable. In the TDP A Placement state, Treatment mode is available. If the position of the switch on the Switching Cable changes to TDP B, the Generator changes to the TDP B Placement state, and the Treatment mode key is not selectable and the mode select key is greyed out. In the RFA Placement state, Treatment mode is available if the position of the switch on the Switching Cable concurs, or if only the RFA Y-Connecting Cable is used. If the position of the switch on the Switching Cable does not concur, TREATMENT mode is not selectable. When Treatment mode is selected, the Generator will enter the READY state of that mode. The Generator dynamically changes the selection availability of the Placement mode and Treatment mode key via monitoring the switch position in the switching cable, and displaying the appropriate text in the Graph Window.

Available Settings

None

N/A PARAMETER

STATE

RF Audio Output Status

None

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

TDP B PLACEMENT

RFA PLACEMENT

N/A

Description

Graph Window

Status Description TDP A PLACEMENT RFA MODE THERMOCOUPLE Placement

Impedance Related Audio Output Status

Description

Indicates the system is measuring the selected probe impedance.

** Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode.

13

7.3 READY States • VOLTAGE STIMULATION Mode – READY state is the default upon connection of a Kimberly-Clark* Pain Management Thermocouple probe and cable.

Figure 7-5 VOLTAGE STIMULATION – READY Display

Figure 7-6 MULTI-RF VOLTAGE STIMULATION – READY Display

Displays and Indicators PARAMETER

STATUS

DESCRIPTION RF 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.

RF/Stimulus Output

OFF

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 RF TREATMENT – When Output ON/OFF is pressed; the Generator will enter the PRETREATMENT COOLING state.

14

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.

Displays and Indicators PARAMETER Impedance Related Audio Output

STATUS

DESCRIPTION

OFF (Default**) If enabled in ADVANCED AUDIO SETTINGS, impedance related audio output is generated. ON (if enabled) 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.

Minimal Graph Window

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

Measurement Window

Impedance Displayed

Status Window

None

Indicates the system is ready to generate stimulus pulses. 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. N/A

** Impedance Related Audio Output can be disabled in the AUDIO SETTINGS, accessible from the ADVANCED SETTINGS mode. PARAMETER STATE

Measurement Window Status

Description

Available States Status

VOLTAGE STIMULATION CURRENT STIMULATION

VOLTAGE STIMULATION

AUTO TEMP ON

CURRENT STIMULATION

MANUAL Impedance measurements POWER are displayed. AUTO PULSED MANUAL PULSED SAVE SETTINGS

Description

Available Settings Status

SELECT PROBE While in the READY (Multi-RF) state, other operating modes for Kimberly-Clark* Pain Management Thermocouple probes STIM RATE are available. When a different mode is selected, the Generator will enter the READY state of the new mode. PULSE DUR The present SETTINGS can be saved as defaults by holding down the SAVE SETTINGS key. VOLTAGE / VOLTAGE/CURRENT CURRENT STIMULATION – The setting is saved to the ADVANCED STIMULATION SETTINGS State, in the PRESETS MOTOR and SENSORY toggle fields.

Description

Available Values

A, B, C or D

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

Range

0.1–1.0 ms

Available Values†

0.1, 0.2, 0.5 and 1.0 ms

Default**

1.0 ms

Range

0.00 – 10.0 V/mA (Only adjustable when STIM RATE is 1-Shot)

Increment

0.01 V/mA

Default**

0.00 V/mA (cannot be overwritten when the SAVE SETTINGS function is used)

Toggle between MOTOR and SENSORY as specified in the STIMULATION SETTINGS state, accessible from the ADVANCED SETTINGS mode. Selecting a Preset modifies 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).

15

PARAMETER STATE

Measurement Window Status

Description

Available States Status

Description

Available Settings Status

Description Range

SET TEMP

38° – 95°C

Increment 1°C Default** 80°C

AUTO TEMP LESION

Range TIME

15 – 600 s

Increment 1 s Default** 75 s

TEMP LIMIT

VOLTAGE STIMULATION

MANUAL POWER LESION

Default** 80°C

ON

Temperature and Impedance measurements are MANUAL displayed while Time POWER and Power are not displayed (dashed lines replace values).

POWER LIMIT While in the READY state, other operating modes for Kimberly-Clark* Pain Management Thermocouple probes are available. When a different 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.

AUTO PULSED Multi-Cooled RF only supports AUTO TEMP LESION mode. MANUAL PULSED

SET TEMP

Range

0 – 50 W

Increment N/A Default

0 W (Cannot be overwritten by SAVE SETTINGS function)

Range

38° – 95°C

Increment 1°C Default** 42°C Range

TIME

10 – 900 s

Increment 1 s Default** 120 s Range

PULSE DUR

Default** 20 ms

Default** 2 Hz 38° – 95°C

Increment 1°C Default** 42°C Range

TIME

1 –10 Hz

Increment 1 Hz Range

SAVE SETTINGS

10 –100 ms

Increment 10 ms Range

PULSE RATE

WARNING TEMP

10 – 900 s

Increment 1 s Default** 120 s Range

PULSE DUR

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.

10 –100 ms

Increment 10 ms Default** 20 ms Range

PULSE RATE

16

15 – 600 s

Increment 1 s Default** 75 s

AUTO TEMP

MANUAL PULSED LESION

38° – 95°C

Increment 1°C Range

TIME CURRENT STIMULATION

AUTO PULSED LESION

Range

1 – 10 Hz

Increment 1 Hz Default** 2 Hz

PARAMETER STATE

Measurement Window Status

The temperature of the Cooled RF probe(s) are displayed in the COOLED RF TEMP box. Impedance measurement between the Cooled RF probes are displayed. Time and Power are not displayed (dashed lines replace values).

COOLED RF TREATMENT

The temperature of the TransDiscal* probe(s) is displayed in the TRANSDISCAL TEMP box. The temperature of Peripheral Disc Temperature is displayed in the PERIPHERAL DISC TEMP box.

TRANSDISCAL TREATMENT

ON

RFA TREATMENT MODE

IDL MODE

Description

Impedance measurement between TransDiscal* probes are displayed. Time and Power are not displayed (dashed lines replace values). 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.

Available Modes Status

Description

Available Settings Status Range

VOLTAGE STIMULATION

SET TEMP

Increment 1°C Range†

TIME

SAVE SETTINGS

15 s (between 15 s and Increment 5 min) 30 s (between 5 min and 30 min) Range

SET TEMP

The present SETTINGS can be saved as defaults by holding down the SAVE SETTINGS key. TIME

SET TEMP

PLACEMENT MODE

30° – 90°C

Increment 1°C Default**

BIPOLAR 50°C MONOPOLAR 60°C

Range†

1 – 30 min

Increment 30 s BIPOLAR 15 min Default** MONOPOLAR 2 min 30 sec Range

38° – 95°C

Increment 1°C Default** 55°C Range

SAVE SETTINGS

Temperature of IDL and Thermocouple Probe are displayed. Impedance measurement for IDL is displayed. Time and Power are not displayed (dashed lines SAVE replace values). If the Thermocouple Probe SETTINGS is disabled via IDL SETTINGS state, accessible from the ADVANCED SETTINGS mode, that measurement is greyed out and the value replaced with dashed lines.

15 s – 30 min

Default** 2 min 30 sec

While in the READY state, VOLTAGE STIMULATION Placement is available. When Placement mode is selected, CURRENT the Generator will enter the STIMULATION READY state of that mode.

SAVE SETTINGS

38° – 95°C

Default** 60°C

CURRENT STIMULATION

PLACEMENT MODE

Description

TIME

1 – 30 min

Increment 30 s Default** 10 min Range

While in the READY state, other operating modes are not available.

SET TEMP

The present SETTINGS can be saved as defaults by holding down the SAVE SETTINGS key. TIME

40° – 95°C

Increment 1°C Default** 90°C 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. Time Range set by user does not include factory-set PRE-TREATMENT COOLING Time (45 seconds) or POST-TREATMENT COOLING Time (10 seconds).

†

17

7.4 ON States

18

Figure 7-7 VOLTAGE STIMULATION – ON Display

Figure 7-10 MANUAL POWER LESION - ON Display

Figure 7-8 CURRENT STIMULATION – ON Display

Figure 7-11 AUTO PULSED LESION – ON Display

Figure 7-9 AUTO TEMP LESION – ON Display

Figure 7-12 MANUAL PULSED LESION – ON Display

Figure 7-13 Multi-RF AUTO TEMP LESION – ON Display

Figure 7-14 Multi-RF AUTO PULSED – ON Display

• COOLED RF AUTO TEMP AND TRANSDISCAL TREATMENT 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

19

Figure 7-17 TRANSDISCAL MONOPOLAR TREATMENT - ON Display

Figure 7-18 TRANSDISCAL BIPOLAR TREATMENT - ON Display

Figure 7-19 RFA MODE TREATMENT - ON Display 20

Figure 7-20 IDL MODE – ON Display (Secondary Thermocouple Disabled)

21

Displays and Indicators PARAMETER

STATUS Stimulus Output ON

RF/Stimulus Output

RF Output ON

FAULT Indicator

OFF

RF/Stimulus Output ON/OFF Indicator

ON

RF Audio Output Impedance Related Audio Output

DESCRIPTION Stimulus pulses are delivered during the ON state. RF power is delivered during the ON state. SET TEMP/TEMP LIMIT/WARNING LIMIT and treatment TIME remain modifiable during RF power delivery. COOLED RF AND TRANSDISCAL - RF power is delivered during the TREATMENT ON state. If the procedure is stopped while in TREATMENT ON state, the Generator enters POST-TREATMENT COOLING state if enabled in ADVANCED SETTINGS mode. The FAULT indicator is used only in the POST and SYSTEM FAULT states. The indicator is illuminated during Stimulus pulse/RF power delivery.

ON

RF audio output is generated for RF power delivery. A tone is generated for two seconds at the conclusion of the procedure.

None

RF audio output is not generated during Stimulus pulse delivery. A tone is generated for two seconds at the conclusion of the procedure.

OFF

Impedance related audio output is not generated during the ON state. Data is displayed. The time axis ( ) is indefinitely scalable during the ON 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.

ON Graph Window

Status Window

22

COOLED RF – graphed temperatures should be the maximum Cooled RF probe temperature. Pump Status is displayed at the top of the Graph Window. TRANSDISCAL – graphed temperatures should be the maximum TRANSDISCAL temperature and the maximum peripheral disc temperature, unless modified in TRANSDISCAL SETTINGS state, accessible from the ADVANCED SETTINGS mode. Pump Status is displayed at the top of the Graph Window.

STIMULATION ON display

The waveform “flashes” to indicate the system is generating stimulus pulses.

None

N/A