Product Specifications - Kimberly-Clark CerviCool Manual De Usario

K
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e
Pain Management
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
K
-C
* C
C
* Cooled Radiofrequency Sterile Tube Kit (sterile,
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single use, non-body contact): It is used for closed-loop circulation of sterile
water through a K -C * C
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includes a burette and tubing.
K -C * C C * Cooled Radiofrequency Introducer (sterile,
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single use): It is to be used with the C
Radiofrequency Introducer provides a path for the C
nervous tissue.
K -C * C C * Cooled Radiofrequency Probe (sterile, single
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use): It is inserted through a C
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Sterile water circulates internally to cool the C
radiofrequency energy. A thermocouple in the C
electrode temperature throughout the procedure.
Indications For Use
The K -C * C C * Cooled Radiofrequency Kit, in combination with
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the K -C * Radiofrequency (RF) Generator (PMG-115-TD/PMG-230-TD)
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(formerly Baylis Pain Management Generator) is indicated for use to create
radiofrequency lesions in nervous tissue.
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 C C * Kit contains single-use devices. Do not reuse, reprocess,
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or resterilize these medical devices. 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 C C * Probe must be used with the correct connector
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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 K -C * Equipment. Any modifications may
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compromise 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.
-C
C C Cooled Radiofrequency Kit
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C * Cooled Radiofrequency (RF) Probe. It
ool
C * Probes only. The C
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C * Probe to the
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C * Introducer into or near nervous tissue.
ool
C * Probe while it delivers
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C * Probe measures cooled
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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 C
accompanying Instructions for Use and the User's Manual for the RF Generator
and Dispersive Electrode (PMA-GP-BAY).
Apparent low power output or failure of the equipment to function properly at
C * Cooled
normal settings may indicate: 1) faulty application of the dispersive electrode or
ool
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 C
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.
K -C
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The Tube Kit is for use with a single C
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.
K -C
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Be careful while handling the C
injury to the operator if handled carelessly.
Handle the C
currents.
Do not move the C
Choose the properly sized C
K -C
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The Tube Kit should never be disconnected from the C
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 Probe.
Disconnect the C
Handle the C
and the hot tip.
While inserting the C
watch the fluoroscope for any buckling. Do not attempt to further insert the
C C * Probe if any buckling is observed or significant resistance is felt.
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Do not move the C
If repositioning is needed, retract the C
Introducer and then reposition the C
inserted.
The "Cooled RF Temp" displayed on the RF Generator refers to the cooled
electrode temperature and not the hottest tissue temperature.
Adverse Events
Potential complications associated with the use of this device include but are
not limited to: infection, nerve damage, increased pain, visceral injury, failure of
technique, paralysis, and death.

Product Specifications

The C C * Probe is comprised of an electrically insulated shaft with an active
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tip that functions as an electrode for RF energy delivery, a handle, tubes with
luer locks and a cable with a 7-pin connector.
The C C * Introducer includes an insulated stainless steel cannula and a
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stylet.
C * Kit before thoroughly reading the
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* Cooled Radiofrequency Sterile Tube Kit
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C
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* C C * Cooled Radiofrequency Introducer
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C * Introducer. The sharp tip can cause
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C * Introducer safely when it is in use due to electric
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C * Introducer without the stylet fully inserted.
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C * Introducer.
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* C C * Cooled Radiofrequency Probe
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C * Probe by pulling the connector, not the cable.
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C * Probe safely when it is in use due to electric currents
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C * Probe through the C
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C * Introducer when the C
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C
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C * Introducer with the stylet
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C * Kit
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* Probe.
C * Probe when
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C * Introducer
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C * Probe is in it.
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* Probe from the C C *
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