7
• Use only with a
HALYARD*
or
K
IMBERLY
-C
LARK
®/ Baylis Pain Management Dispersive Electrode. Always select a dispersive electrode designed to be compatible with the
available contact quality monitor.
• 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.
• Skin-to-skin contact (for example between the arms and body of the PATIENT) should be avoided.
• Failure of the Generator or accessories could result in an unintended increase of output power.
• Do not use the Multi-RF Module with the Baylis Pain Management Brain Lesion Probe (PME-B), Cordotomy Probe (PME-C), or DREZ Probe (PME-D).
• Do not use the Multi-RF Module with the
HALYARD*
or 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.
• Unintended Neuromuscular Stimulation:
The use of RF energy can produce unintended neuromuscular stimuation 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.
• User
Modifications:
User modifications to the PMG can result in safety hazards. No user modification of the equipment is allowed.
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 IFUs 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
K
IMBERLY
-C
LARK
®
or Baylis pneumatic footswitch with the Generator.
• The mains power cord of the Generator must be connected to a properly grounded receptacle. Extension cords and/or adapter plugs must not be used.
• Do not wrap instrument cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.
• The cables to the surgical electrodes should be positioned in such a way that contact with the PATIENT or other leads are avoided. Temporarily unused ACTIVE ELECTRODES
should be stored in a location that is isolated from the PATIENT.
• Avoid high frequency output settings where the Maximum Output Voltage may exceed the rated accessory voltage.
• The output power should be as low as possible for intended purpose (applies to Manual modes).
• The application of the Neutral Electrode and its connections to be checked before selecting a higher output power.
• For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area, the use of BIPOLAR techniques
may be desirable in order to avoid unwanted tissue damage.
• Perform regular inspections of all accessories, including electrosurgical cables and probes, for damage to insulations.
• Associated Equipment and Active Accessories should be selected that have a Rated Accessory Voltage equal to or greater than the Maximum Output Voltage.
• For information on the connection and disconnection of detachable parts and accessories, refer to the Instructions for Use for the corresponding probe or cable.
• Care should be taken to avoid the danger of ignition of endogenous gases.
• The PMG needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document.
• Electronic equipment, including portable and mobile RF communications equipment, can affect the operation of the PMG. Operating non-essential equipment in the
vicinity of the PMG should be avoided, if possible.
• The PMG should not be used adjacent to or stacked with other equipment. If the PMG must be operated adjacent to or stacked with other equipment, the PMG should be
observed to verify normal operation in that configuration.
• Use of accessories, transducers and cables other than those specifically approved by Halyard Health for use with the PMG may result in increased electromagnetic emissions
or decreased electromagnetic immunity of the PMG.
• In Multi-RF Auto Temp mode, and in Multi-Cooled RF Auto Temp mode, maintain a minimum distance of 10 mm between probe tips and ensure that the probe tips do not
touch.
• When using the PMG with the pump unit accessory (TDA-PPU) refer to the pump IFU for information on proper setup and operation.
4 Installation
Inspect the Generator for any signs of physical damage to the front panel, chassis or cover.
If any physical damage is found, DO NOT USE THE GENERATOR. Contact
Halyard Health for a replacement.
Halyard Health must approve all returns.
4.1 Preparing the Generator for Use
• The Generator may be placed on a mounting cart or on any sturdy table or platform.
• Provide at least 10-15 cm of space behind the rear panel of the Generator for forced air-cooling. Do NOT obstruct the vents on the underneath of the Generator. Under
continuous use for extended periods of time, it is normal for the top and rear panel to be warm.
Avanos Exhibit 2069 Page 7
Medtronic, Inc. v. Avanos Medical Sales, LLC
Case IPR2020-0089
