Halyard CO LIEF PMG-Basic User Manual
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Halyard CO LIEF PMG-Basic User Manual

Cooled radiofrequency pain management generator
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User's Manual
PMG-Basic
PMG-Advanced
15-H1-654-0-01 / 025-0169-420 REV B
COOLED RADIOFREQUENCY
PAIN MANAGEMENT
GENERATOR
Avanos Exhibit 2069 Page 1
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-00895
PMG
V4.2

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Summary of Contents for Halyard CO LIEF PMG-Basic

  • Page 1 COOLED RADIOFREQUENCY PAIN MANAGEMENT V4.2 GENERATOR User’s Manual PMG-Basic PMG-Advanced 15-H1-654-0-01 / 025-0169-420 REV B Avanos Exhibit 2069 Page 1 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-00895...
  • Page 2 Avanos Exhibit 2069 Page 2 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-0089...

  • Page 3: Table Of Contents

    Table of Contents Introduction ............................................ 5 Glossary of Terms ......................................5 Indicated Use ........................................... 6 Warnings And Precautions ........................................ 6 Warnings ........................................6 Precautions ........................................7 Installation ............................................. 7 Preparing The Generator For Use ..................................7 Mains Power Cord ......................................8 Generator Cleaning and Disinfection Instructions .............................
  • Page 4 Environmental Specifications ..................................35 Fuses..........................................35 8.10 Line Input Ratings ......................................35 8.11 Footswitch Specifications ....................................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 Specifications ..............................37 Standard RF Lesion Size ........................................39 Cooled RF Lesion Size........................................40 Labeling Symbols ..........................................41...

  • Page 5: Introduction

    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 ®/Baylis Pain Management Generator) and an optional pneumatic footswitch. For the user’s convenience, the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain...

  • Page 6: 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.

  • Page 7: Precautions

    • Use of accessories, transducers and cables other than those specifically approved by Halyard Health for use with the PMG may result in increased electromagnetic emissions or decreased electromagnetic immunity of the PMG.

  • Page 8: Mains Power Cord

    If no label is present, the associated button is not used in the present mode. Mode Function Keys: These keys select and change the state of operation. For HALYARD* Pain Management Thermocouple RF probes, STIMULATION or LESION states are selected with a single press.

  • Page 9: Rear Panel Displays, Controls, And Connections

    Volume Adjustment: This knob adjusts the volume of the system’s audio output. 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.

  • Page 10: Factory Set Defaults

    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.

  • Page 11: Displays

    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 •...

  • Page 12: Placement State

    Displays and Indicators PARAMETER STATE RF/Stimulus Output FAULT indicator RF/Stimulus Output ON/OFF indicator Status Description Status Description Status Description No RF or stimulus waveforms Only Power On is illuminated during Only Power On is illuminated during System Initialization are generated. Initialization.
  • Page 13 Figure 7-4 TDP A Placement Display Displays and Indicators PARAMETER STATUS DESCRIPTION RF/Stimulus Output RF power is not delivered during this state. FAULT Indicator (The FAULT indicator is used only in the POST and SYSTEM FAULT states.) RF/Stimulus Output ON/OFF The indicator is not illuminated during this state, as there is no RF power delivery.

  • Page 14: Ready States

    7.3 READY States • VOLTAGE STIMULATION Mode – READY state is the default upon connection of a HALYARD* 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...
  • Page 15 Description While in the READY SELECT PROBE Available Values A, B, C or D state, other operating (Multi-RF) modes for HALYARD* VOLTAGE Range 1-Shot – 200 Hz STIMULATION Pain Management 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, Thermocouple probes Available Values †...
  • Page 16 (Cannot be overwritten by SAVE SETTINGS function) Range 38° – 95°C While in the READY state, other operating modes for Increment 1°C SET TEMP AUTO TEMP HALYARD* Pain Management Default** 42°C Thermocouple probes are Temperature available. When a different Range 10 – 900 s and Impedance...
  • Page 17 PARAMETER STATE Measurement Window Available Modes Available Settings Status Description Status Description Status Description Range 38° – 95°C VOLTAGE SET TEMP Increment 1°C The temperature of the Cooled RF probe(s) STIMULATION are displayed in the COOLED RF TEMP box. Default** 60°C *** CURRENT COOLED RF Impedance measurement between the...

  • Page 18: On States

    7.4 ON States 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 –...
  • Page 19 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 —...
  • Page 20 Figure 7-17 TRANSDISCAL MONOPOLAR TREATMENT — ON Display Figure 7-18 TRANSDISCAL BIPOLAR TREATMENT — ON Display Figure 7-19 RFA MODE TREATMENT — ON Display Avanos Exhibit 2069 Page 20 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-0089...
  • Page 21 Figure 7-20 IDL MODE – ON Display (Secondary Thermocouple Disabled) Avanos Exhibit 2069 Page 21 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-0089...
  • Page 22 Displays and Indicators PARAMETER STATUS DESCRIPTION Stimulus Output ON 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. RF/Stimulus Output RF Output ON COOLED RF AND TRANSDISCAL —...
  • Page 23 PARAMETER STATE Measurement Window Available Modes Available Settings Status Description Status Description Status Description Range A, B, C or D SELECT PROBE** Increment VOLTAGE Range 1-Shot –200 Hz STIMULATION STIM RATE** Impedance † Available Values 1-Shot, 2, 5, 10, 20, 50, 75, 100, 150, 180 and 200 Hz measurements CURRENT Range...

  • Page 24: Done States

    PARAMETER STATE Measurement Window Available Modes Available Settings Status Description Status Description Status Description Range 30° – 90°C TEMP Increment 1°C COOLED RF Range 15 s – 30 min TREATMENT 15 s (between 15 s and 5 min) TIME Increment 30 s (between 5 min and 30 All measurements are displayed.

  • Page 25: Example Display

    7.6.1 Example Display • When the Save Settings button is pressed and held for 5 seconds the setting values in the current mode will become the new default values for those settings. 7.7 ADVANCED SETTINGS Mode • The ADVANCED SETTINGS mode is accessible only from the STANDBY state. •...

  • Page 26: Advanced Settings Mode - Lesion Settings State

    Settings Affected Mode Parameter DESCRIPTION Available Values Default Value** Disable or enable selection of the MOTOR and SENSORY parameters. If “NO” is selected, LOCK AVAILABLE VALUES? Yes/No the MOTOR and SENSORY parameters are greyed out and not selectable. STIMULATION Modes †...

  • Page 27: Advanced Settings Mode - Transdiscal Settings State

    Settings Affected Mode Parameter DESCRIPTION Range/Units Default Value Increment Auto Temp LESION RAMP TIME Ramp-up interval to temperature set point. 10–60 s 15 s AUTO TEMP LESION, POWER LIMIT Maximum allowable power for temperature control. 1–50 W 50 W AUTO PULSED LESION AUTO PULSED LESION RAMP TIME Ramp-up interval to temperature set point.

  • Page 28: Advanced Settings Mode - Multi-Cooled Rf1 Settings State

    7.7.4.1 ADVANCED SETTINGS Mode – MULTI-COOLED RF1 SETTINGS State The following screen appears when MULTI-COOLED RF1 SETTINGS is selected from the ADVANCED SETTINGS Mode: • This screen allows adjustment of POWER LIMIT in AUTO TEMP mode. • This screen allows adjustment of the initial RAMP RATE taken by the AUTO TEMP mode to attain the SET TEMPERATURE. •...

  • Page 29: Advanced Setting Mode - Multi-Cooled Rf2 Settings State

    7.7.4.2 ADVANCED SETTINGS Mode – MULTI-COOLED RF2 SETTINGS State The following screen appears when MULTI-COOLED RF2 SETTINGS State is selected from the ADVANCED SETTINGS Mode: • This screen allows adjustment of the IMPEDANCE CUTOFF MULTIPLIER in AUTO TEMP mode. • The END OF RAMP IMPEDANCE is multiplied by the IMPEDANCE CUTOFF MULTIPLIER to determine the impedance value that will generate Warning (W221) and Discontinue a Probe (RF OFF) for RISING IMPEDANCE.

  • Page 30: Advanced Settings Mode - Cooled Rf Settings State

    7.7.5 ADVANCED SETTINGS Mode – COOLED RF SETTINGS State The following screen appears when COOLED RF SETTINGS is selected from the ADVANCED SETTINGS Mode: • This screen allows adjustment of the RAMP RATE used by the COOLED RF mode to attain the SET TEMPERATURE. •...

  • Page 31: Advanced Settings Mode - Audio/Language Settings State

    7.7.6 ADVANCED SETTINGS Mode – AUDIO/LANGUAGE SETTINGS State The following screen appears when AUDIO/LANGUAGE SETTINGS is selected from the ADVANCED SETTINGS Mode: • The AUDIO/LANGUAGE SETTINGS state in the ADVANCED SETTINGS mode allows the user to enable/disable the impedance-related audio output during STIMULATION modes as well as during PLACEMENT and READY states (with exception to IDL mode).

  • Page 32: Advanced Settings Mode - Rfa Settings State

    7.7.7 ADVANCED SETTINGS Mode – RFA SETTINGS State The following screen appears when RFA SETTINGS is selected from the ADVANCED SETTINGS Mode: • This screen allows the option of disabling the SECONDARY THERMOCOUPLE probe used in the RFA mode • If the SECONDARY THERMOCOUPLE is disabled, the corresponding temperature measurement window in RFA – TREATMENT Mode will be inactive. •...

  • Page 33: Special Event States

    Settings Affected Mode Parameter DESCRIPTION Range/Units Default Value Increment SECONDARY THERMOCOUPLE Disable optional Thermocouple Probe ENABLE/ DISABLE DISABLE INITIAL TIME Ramp-up interval to INITIAL TEMP set point 15 – 120 s 30 s INITIAL TEMP Initial target for temperature ramping. 40°...

  • Page 34: Display

    7.8.2.1 Display • Red “error” indicator will display on screen. • System Fault code will display in the center of the screen within the Status window. 7.8.2.2 Settings • The main power On/Off switch needs to be cycled OFF then ON to attempt to clear the non-recoverable fault. Technical Specifications 8.1 Impedance Measurement •...

  • Page 35: Mechanical Specifications

    8.7 Mechanical Specifications • Size: 9.5 x 12.5 x 14.0” (24 x 32 x 35 cm) maximum • Weight: 21.0 lb (9.5 kg) maximum (not including power cord or shipping box) • Moisture protection rating: IPX0 (ordinary, per IEC601) 8.8 Environmental Specifications •...
  • Page 36 8.15 Output Power Graphs Figure 8-1 Power vs. Load and Peak Voltage Avanos Exhibit 2069 Page 36 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-0089...
  • Page 37 Dielectric withstanding voltage conforms to IEC 60601-1 EMC Emissions and Susceptibility: The HALYARD* Pain Management System has been tested and found to comply with the limits for medical devices to the IEC 60601-1- 1-2:2007-03. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This system generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instruction given below, may cause harmful interference to other devices in the vicinity.
  • Page 38 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HALYARD* Pain Management System or any of its components are used exceeds the applicable RF compliance level above, the HALYARD* Pain Management System should be observed to verify normal operation.
  • Page 39 Recommended separation distances between portable and mobile RF communications equipment and the HALYARD* Pain Management System The HALYARD* Pain Management System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the...
  • Page 40 10 Cooled RF Lesion Size Lesion size and shape is determined by numerous factors including: • probe active tip length • impedance of tissue • current intensity • length of time that energy is applied • water flow rate • water temperature Ensure proper slection of the appropriate sized active electrode tip to achieve the desired lesion size.
  • Page 41 11 Labeling Symbols Alternating Current Attention: Consult accompanying documents Authorized Representative in the European Community Catalogue Number Connector Cable connection Consult Instructions for Use Dangerous Voltage Defibrillator-proof, Patient Isolated connections Isolated Patient Circuit Dispersive Return Electrode connection Down Earth Ground Federal law (U.S.A) restricts this device to sale by or on the order of a physician Rx ONLY Footswitch...
  • Page 42 The customer is responsible for returning the defective equipment to the factory at his or her own expense. The customer needs to get a return authorization number before shipping the unit back. Halyard Health at its sole discretion can repair the unit or ship a new one. The units are to be shipped freight pre-paid for both the warranty period and out of warranty.
  • Page 43 Avanos Exhibit 2069 Page 43 Medtronic, Inc. v. Avanos Medical Sales, LLC Case IPR2020-0089...
  • Page 44 Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004; In USA, please call 1-844-425-9273 • halyardhealth.com Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004 USA Halyard Belgium BVBA, Leonardo Da Vincilaan 1, 1930 Zaventem, Belgium Registered Trademark or Trademark of Halyard Health, Inc., or its affiliates. © 2015 HYH. All rights reserved.

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