025-0169-311 Revision: B
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READY
State of the Generator where settings can be adjusted and other modes of operation can be chosen
prior to RF application.
RF
Radio Frequency
RFA
Radio Frequency 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
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 use of a dispersive return electrode is specified in the accompanying
documents 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!
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.