WI-25023
7
PAIN MANAGEMENT SYSTEMS
Generator Service Manual
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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.
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Use only with a Halyard Health (Kimberly-Clark) or Baylis Pain Management
Dispersive Electrode. Always select a dispersive electrode designed to be
compatible with the available contact quality monitor.
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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.
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Skin-to-skin contact (for example between the arms and body of the PATIENT)
should be avoided.
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Failure of the Generator or accessories could result in an unintended increase of
output power.
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Do not use the Multi-RF Module with the Halyard Health ( Kimberly-Clark) Pain
Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), or DREZ
Probe (PME-D).
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Do not use the Multi-RF Module with the Halyard Health (Kimberly-Clark) or Baylis
Pain Management Bipolar Adaptor (PMA-BP).
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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.
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Interference with other equipment:
During RF output (lesion modes), the
conducted and radiated electrical fields may interfere with other electrical medical
equipment.
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Unintended Neuromuscular Stimulation:
The use of RF energy can produce
unintended neuromuscular stimulation during ablation. Appropriate precautions,
including the use of lower power settings and continuous monitoring of the patient
during treatment, should be taken to minimize the risk of patient injury.
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User Modifications:
User modifications to the PMG can result in safety hazards. No
user modification of the equipment is allowed.
3.2 Precautions
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Do not activate the output of the Generator until the probe is properly positioned in the
patient.
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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.
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In Multi-RF STIMULATION mode, connect one probe at a time to the Multi-RF module to
display individual impedance readings for placement purposes.
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The entire area of the neutral electrode should be reliably attached to the patient’s body