Contraindications - Halyard COOLIEF TRANSDISCAL Instruction For Use

HALYARD* COOLIEF*
e
TRANSDISCAL* Cooled Radiofrequency Kit
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Introducer
(sterile, single use): It is to be used with the HALYARD* COOLIEF* TRANSDISCAL*
Cooled Radiofrequency Probes only. The COOLIEF* TRANSDISCAL* Introducer
provides a path for the COOLIEF* TRANSDISCAL* Probe to the disc.
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe
(sterile, single use): It is inserted through a COOLIEF* TRANSDISCAL* Introducer
into the intervertebral disc. Sterile water circulates internally to cool the
COOLIEF* TRANSDISCAL* Probe while it delivers radiofrequency (RF) energy.
Thermocouples in the COOLIEF* TRANSDISCAL* Probe measure cooled electrode
temperature throughout the procedure.
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit (sterile,
single use, non-body contact): It is used for closed-loop circulation of sterile
water through a COOLIEF* TRANSDISCAL* Probe. It includes a burette and tubing.
Indications For Use
The HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Kit, in
combination with the HALYARD* COOLIEF* Radiofrequency Generator
(PMG-115-TD/PMG-230-TD/PMG-ADVANCED) (formerly Baylis Pain Management
Generator or KIMBERLY-CLARK® Pain Management Generator), is indicated
for the coagulation and decompression of disc material to treat symptomatic
patients with contained herniated discs.

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 radiofrequency 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 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, it should be performed under local
anesthesia.
Systemic infection or local infection in area of the procedure.
Blood coagulation disorders or anticoagulant use.
Warnings
The COOLIEF* TRANSDISCAL* Kit contains single-use devices. Do not
reuse, reprocess, or resterilize this medical device. Reuse, reprocessing,
or resterilization may 1) adversely affect the known biocompatibility
of the device, 2) compromise the structural integrity of the device,
3) lead to the device not performing as intended, or 4) create a risk
of contamination and cause the transmission of infectious diseases
resulting in a patient injury, illness, or death.
The COOLIEF* TRANSDISCAL* Probe 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 radiofrequency 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.
Discontinue use if inaccurate, erratic or sluggish temperature readings
are observed. Use of damaged equipment may cause patient injury.
Do not modify HALYARD* Equipment. Any modifications may
compromise safety and efficacy of the device.
When the COOLIEF* 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
COOLIEF* TRANSDISCAL* Probes, particularly when operating the device.
During power delivery, the patient should not be allowed to come in
contact with grounded metal surfaces.
Do not remove or withdraw the device while energy is being delivered.
Precautions
Do not attempt to use the COOLIEF* TRANSDISCAL* Kit before thoroughly
reading the accompanying Instructions for Use and the User's Manual for the
RF Generator.
Apparent low power output or failure of the equipment to function properly at
normal settings may indicate: 1) faulty application of the dispersive electrode or
2) power failure to an electrical lead. Do not increase power level before checking
for obvious defects or misapplication.
To prevent the risk of ignition, make sure that flammable material is not present
in the room during RF power application.
Only physicians familiar with RF lesion techniques should use the COOLIEF*
TRANSDISCAL* Kit components.
It is the physician's responsibility to determine, assess and communicate to each
individual patient all foreseeable risks of the RF lesion procedure.
The sterile packaging should be visually inspected prior to use to detect any
compromise. Ensure that the packaging has not been damaged. Do not use the
equipment if the packaging has been compromised.
Proper sterile techniques must be used when assembling and filling the Tube Kit.
Do not place the lid down on a non-sterile surface.
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit
The Tube Kit is for use with a single COOLIEF* TRANSDISCAL* Probe.
Care must be taken to ensure all luer fittings are secure to prevent leaking.
Do not disconnect luer fittings while the pump is running.
Arrange equipment to minimize tubing tripping hazards.
Do NOT perform cooled RF lesion procedures if water is not circulating
through the Tube Kit, water is leaking or air bubbles are seen in the tubing.
Immediately stop the procedure and correct circulation before restarting
the procedure.
Do NOT pinch the tubing of the Tube Kit.
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency
Introducer
Be careful while handling the COOLIEF* TRANSDISCAL* Introducer. The sharp
tip can cause injury to the operator if handled carelessly.
Handle the Introducer safely when it is in use due to electric currents.
Do not remove or withdraw the Introducer while energy is being delivered.
Do not move the Introducer without the stylet fully inserted.
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe
The COOLIEF* Tube Kit should never be disconnected from the COOLIEF*
TRANSDISCAL* Probe when RF delivery is in progress. The lumen of the Tube
Kit should not be obstructed in any way during the procedure, as this will
stop cooling of the COOLIEF* TRANSDISCAL* Probe.
Disconnect the COOLIEF* TRANSDISCAL* Probe by pulling the connector,
not the cable.
Handle the COOLIEF* TRANSDISCAL* Probe safely when it is in use due to
electric currents and the hot tip.
While inserting the COOLIEF* TRANSDISCAL* Probe through the COOLIEF*
TRANSDISCAL* Introducer watch the fluoroscope for any buckling. Do not
attempt to further insert the COOLIEF* TRANSDISCAL* Probe if any buckling
is observed or significant resistance is felt.
Confirm the placement of the COOLIEF* TRANSDISCAL* Probe in the disc
with fluoroscopy. Do not apply RF energy if any segment of the COOLIEF*
TRANSDISCAL* Probe distal to the Introducer is outside the intervertebral
disc wall.
Do not move the COOLIEF* TRANSDISCAL* Introducer when the COOLIEF*
TRANSDISCAL* Probe is in it. If repositioning is needed, retract the COOLIEF*
TRANSDISCAL* Probe from the Introducer and then reposition the Introducer
with the stylet inserted.
The "COOLIEF* TRANSDISCAL* Temp" displayed on the RF Generator refers to
the cooled electrode temperature and not the hottest tissue temperature.
The "Peripheral Disc Temp" displayed on the RF Generator refers to the
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