025-0169-311 Revision: B
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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.
•
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.
•
Risk of Fire: 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.
•
Risk of RF burns to the patient: 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.
•
Risk of RF burns to the patient: Use only with a Baylis Pain Management Dispersive Electrode. Always select a
dispersive electrode designed to be compatible with the available contact quality monitor.
•
Risk of RF burns to the patient: 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..
•
Risk of RF burns to the patient: Skin-to-skin contact (for example between the arms and body of the PATIENT)
should be avoided, for example by insertion of dry gauze.
•
Risk of RF burns to the patient: Failure of the Generator or accessories could result in an unintended increase of
output power.
•
Risk of RF burns to the patient: Do not use the MultiRF Module with more than one of either the Baylis Pain
Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), or DREZ Probe (PME-D).
•
Risk of RF burns to the patient: Do not use the MultiRF Module with the 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
documents 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 Baylis pneumatic footswitch with the Generator.
