5
1 Introduction
The system presented in this User’s Manual consists of the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain Management Generator (PMG) (formerly known as the
K
IMBERLY
-C
LARK
®
/Baylis Pain Management Generator) and an optional pneumatic footswitch. For the user’s convenience, the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain
Management Generator will be referred to in this User’s Manual as the “Generator” or “PMG”.
NOTE:
The PMG is also referred to as the HALYARD* COOLIEF* Pain Management Generator on the packaging labeling.
This User’s Manual provides a description of the Generator, its controls and displays, and a sequence for its operation. This User’s Manual also supplies other information of
importance to the user. Do not operate the Generator before thoroughly reading this manual.
This User’s Manual and the Generator screens can be made available in other languages. For further information please call Halyard Health at 1-844-425-9273.
1.1 Glossary of Terms
Term
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
TEMP LESION AND
AUTO PULSED
LESION MODES
A setting that is adjustable in ADVANCED SETTINGS mode – LESION SETTINGS, and applies to the AUTO TEMP LESION and AUTO PULSED LESION modes. It
is the rate at which the Generator heats to the SET TEMP.
RAMP TIME – RFA
MODE
A setting that is adjustable in ADVANCED SETTINGS mode – RFA. It is the rate at which the Generator heats to the SET TEMP.
READY
State of the Generator where settings can be adjusted and other modes of operation can be chosen prior to RF application.
RF
Radiofrequency
Avanos Exhibit 2069 Page 5
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089
