6
1.1 Glossary of Terms
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
HALYARD*
Pain Management Generator Model PMG-BASIC and PMG-ADVANCED are indicated for use to create lesions during neurological lesion procedures, and for the
coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The
HALYARD*
PMG is to be used in conjunction with separately
approved probes.
• The Generator supplies up to 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
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.
• Risk of Electric Shock:
To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth.
• Risk of Fire:
• Do not use in the presence of 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 (N
2
O) 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.
Avanos Exhibit 2069 Page 6
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089
