3
e
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
The HALYARD* Radiofrequency Version 3 Adapter Cable allows connection of
HALYARD* 14-pin Radiofrequency Generator Connector Cables to the HALYARD*
COOLIEF* Cooled Radiofrequency (RF) Pain Management Generator or
K
imberly
-C
larK
®
Radiofrequency Generator (formerly Baylis Pain Management
Generator), Version 3.0 or higher (PMG-115/PMG-115-TD/PMG-230/PMG-230-
TD/PMG-BASIC/PMG-ADVANCED).
Indications for Use
The HALYARD* Radiofrequency Version 3 Adapter Cable will be used in
conjunction with a Radiofrequency (RF) Generator to create radiofrequency
lesions in nervous tissue.
The HALYARD* Radiofrequency Version 3 Adapter Cable will be used in
conjunction with a Radiofrequency Generator Version 3.0 or higher, a 14-pin
Radiofrequency Generator Connector Cable (HALYARD* Radiofrequency
Generator Connector Cables, e.g., PMX, CRX, TDX Cables) and corresponding
probe (e.g., HALYARD* Radiofrequency Probe).
Contraindications
For patients with cardiac pacemakers, a variety of changes can occur during and
after the treatment. In sensing mode the pacemaker may interpret the RF signal
as a heartbeat and may fail to pace the heart. Contact the pacemaker company
to determine if the pacemaker should be converted to a fixed-rate pacing during
the RF procedure. Evaluate the patient’s pacing system after the procedure.
Check the compatibility and safety of combinations of other physiological
monitoring and electrical apparatus to be used on the patient in addition to the
RF lesion generator.
If the patient has a spinal cord, deep brain, or other stimulator, contact
the manufacturer to determine if the stimulator needs to be in the bipolar
stimulation mode or in the OFF position.
This procedure should be reconsidered in patients with any prior neurological
deficit.
The use of general anesthesia is contraindicated. To allow for patient feedback
and response during the procedure, treatment should be performed under local
anesthesia.
Systemic infection or local infection in area of the procedure.
Blood coagulation disorders or anticoagulant use.
Warnings
• The HALYARD* RF Version 3 Adapter Cable must be used with the
correct connector cable. Attempts to use it with other connector
cables can result in electrocution of the patient or operator.
• Laboratory staff and patients can undergo significant x-ray
exposure during RF procedures due to the continuous use of
fluoroscopic imaging. This exposure can result in acute radiation
injury as well as increased risk for somatic and genetic effects.
Therefore, adequate measures must be taken to minimize this
exposure.
• Do not modify HALYARD* Equipment. Any modifications may
compromise the safety and efficacy of the device.
• When the
RF
Generator is activated, the conducted and radiated
electrical fields may interfere with other electrical medical
equipment.
• The RF Generator is capable of delivering significant electrical
power. Patient or operator injury can result from improper
handling of the Probes, particularly when operating the device.
• During power delivery, the patient should not be allowed to come
in contact with grounded metal surfaces.
Precautions
• Do not attempt to use the HALYARD* RF Version 3 Adapter Cable before
thoroughly reading these Instructions for Use and the HALYARD* RF
Generator User’s Manual.
• HALYARD*
RF Version 3 Adapter Cable is to be used with the Radiofrequency
Generator Version 3.0 or higher.
• The HALYARD* System should be used by physicians familiar with RF lesion
techniques.
• Apparent low power output or failure of the equipment to function properly
at normal settings may indicate: 1) faulty connection of the system or
2) power failure to an electrical lead. Do not increase power level before
checking for obvious defects or misapplication.
• In order to prevent the risk of ignition make sure that flammable material is
not present in the room during RF power application.
• It is the physician’s responsibility to determine, assess and communicate to
each individual patient all foreseeable risks of the RF lesion procedure.
Adverse Events
Complications with the use of this device are associated with the procedures that
utilize a RF probe.
HALYARD* RF Version 3 Adapter Cable
(Fig. 1)
Product Specifications
PMX-BAY-19-14:
Use to attach HALYARD* 14-pin RF Generator Connector Cable
to the Radiofrequency Generator Version 3.0 or higher.
• Shipped non-sterile
• Connect the HALYARD* 14-pin RF Generator Connector Cable to the
Radiofrequency Generator Version 3.0 or higher
• Two different connectors:
1. RF Generator Plug-In – Gray 19-pin male connector (end used to
connect to generator)
2. RF Cable Connector – Black 14-pin female connector (end used to
connect to 14-pin RF Generator Connector Cable)
Special Handling Instructions
Store the RF Version 3 Adapter Cable carefully to reduce the risk of damage due
to storage.
Inspection Prior To Use
Perform the following checks before the patient is presented for the procedure.
These tests will allow you to verify that the equipment you will use is in proper
working order.
KEY ITEMS
WARNINGS AND EXPLANATIONS
Visual
Check
Ensure connectors, cable and probes have no visible
damage, such as cable splice or kinks. Do not use
damaged equipment.
Equipment Required
RF lesion procedures should be performed in a specialized clinical setting with
fluoroscopic equipment. The RF equipment required for the procedure is as
follows:
• Radiofrequency Generator Version 3.0 or higher
• HALYARD*
RF Version 3 Adapter Cable
• Other equipment can be used. Refer to Instructions for Use of required
equipment, connecting the HALYARD*
RF Version 3 Adapter Cable between
the Radiofrequency Generator Version 3.0 or higher and desired equipment.
Instructions for Use
1. Assemble all required equipment for the intended procedure.
2. Position the patient as necessary for the intended procedure.
3. Attach Grounding Pad to the Return Electrode Connection site on the
HALYARD* RF Generator.
4. Attach HALYARD*
RF Version 3 Adapter Cable to the Connector Cable
Connection site on the Radiofrequency Generator Version 3.0 or higher.
5. Attach the 14-pin cable to the HALYARD* RF Version 3 Adapter Cable.
6. Refer to Instructions for Use of the 14-pin connector cable for further
instructions.
7. Stimulate and/or lesion as necessary. Refer to the HALYARD* RF
Generator User’s Manual for more information.
After the Procedure
Caution:
Prevent damage to your cable and probe. When
pulling the connectors apart, be sure to pull on the plug and
not the cable.
HALYARD* Radiofrequency Version 3
Adapter Cable
