Inspection Prior To Use; Equipment Required - Kimberly-Clark CerviCool Manual De Usario

The Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for
connection to the C C * Probe.
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The C C * Probe, C C * Introducer, and Tube Kit are ethylene oxide
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sterilized and supplied sterile. The devices should be stored in a cool, dry
environment.
Note: Please contact Kimberly-Clark for a list of all model numbers and sizes.

Inspection Prior To Use

The sterile packaging should be visually inspected prior to use to detect any
compromise. Ensure that the packaging has not been opened or damaged. Do
not use the equipment if the packaging has been compromised.

Equipment Required

Procedures should be performed in a specialized clinical setting equipped with a
fluoroscopy unit. The equipment required to perform RF procedures include:
• C C * Cooled Radiofrequency Probe
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• C C * Cooled Radiofrequency Introducer(s)
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• Cooled Radiofrequency Peristaltic Pump Unit and Cable
• Cooled Radiofrequency Sterile Tube Kit
• Cooled RF Connector Cable
• Radiofrequency Dispersive Electrode
• Radiofrequency Generator (PMG-115-TD/PMG-230-TD)
Instructions for Use
Monopolar System
(Fig. 1)
Assemble all the equipment required for the procedure. Set up the
Radiofrequency Generator (PMG-115-TD/PMG-230-TD) and the Pump Unit
(pump), as directed in their Instructions for Use. Connect the Cooled RF
Connector Cable to the RF Generator as described in its Instructions for Use.
Open the package in the sterile field using appropriate sterile techniques. Inspect
the devices visually to make sure there is no damage to them. Do NOT perform
the procedure with any damaged equipment.
K -C * Cooled Radiofrequency Sterile Tube Kit (Fig. 2)
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1. Place the burette into the burette holder on the side of the Pump Unit.
The side of the burette with two or three ports indicates the top of the
burette. (Fig. 3)
2. Fill the burette with room temperature sterile water. Use sterile handling
techniques. Fill the burette to the 70 mL mark. Burette can be filled
by injecting sterile water through a port in the lid, or by temporarily
removing the lid and pouring sterile water in.
Warning: BE SURE TO FILL THE BURETTE TO THE 70 mL MARK.
Not filling the burette to the 70 mL mark will result in an
inadequate supply of water for circulation.
Use ONLY sterile, room temperature water.
Ensure the lid is snapped back onto the body of the burette
after filling. (Figs. 4-5)
Inject sterile water into burette OR remove lid and pour sterile water.
3. Place the thick-walled tubing coming out of the bottom of the burette
into the pumphead of the Pump Unit. Place the tubing in the channels
of the L-shaped bracket to ensure that the tubing is not obstructed while
closing the pumphead. Close the lid on the pumphead to clamp down
on the tubing.
4. Remove the caps on the male and female luer locks. Connect the
appropriate luer lock to the corresponding luer lock on the C
Probe. Do not over tighten the connection. (Fig. 6)
Caution: Connect one Tube Kit to one C
5. At the end of the procedure, discard the Tube Kit appropriately.
K -C * C C * Cooled Radiofrequency Introducer
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1. With the stylet in the Introducer, carefully insert the C
Introducer into the patient using fluoroscopic guidance to place it at the
desired lesion location.
2. Once the C C * Introducer is in the proper position, carefully remove
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the stylet from the C
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3. Repeat steps 1-2 with a second C
K -C * C C * Cooled Radiofrequency Probe
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1. Insert the C C * Probes into the tissue through the
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C C * Introducer. Never force the C
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resistance is felt.
2. Attach the Dispersive Electrode to the RF Generator and place the
Dispersive Electrode Pad on the patient as directed in the Instructions for
Use accompanying the package.
3. Connect the C C * Probe to the Tube Kit.
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4
C * Probe. (Fig. 7)
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C * Introducer.
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C * Introducer if necessary.
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C * Probe in if significant
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4. Connect the 14-pin connector of the Cooled RF Connector Cable into the
RF Generator. Connect the C
Cooled RF Connector Cable.
5. Select the Treatment mode in the RF Generator. Set advanced settings
and the parameters for RF delivery in the RF Generator as described in
the User's Manual.
6. Perform the procedure as described in the RF Generator User's Manual.
The procedure comprises pre-cooling, treatment and optional post-
cooling stages.
Note: Other than reproduction of their usual referred pain or irritation
due to probe introduction, monitor the patient for unexpected symptoms
that may indicate, for example, spinal cord or nerve root irritation. If these
indications are suspected, discontinue energy delivery.
7. After treatment remove the C
Introducer and discard as biohazards. Remove the Dispersive Electrode
from the patient and discard appropriately. Disconnect the Cooled
RF Connector Cable from the RF Generator. Follow standard hospital
techniques to handle reusable items.
Troubleshooting
The following table is provided to assist the user in diagnosing potential
problems.
PROBLEM
No temperature
measurement
OR
Inaccurate, erratic or
sluggish temperature
reading
Water does not flow
through the Probe and
Tube Kit.
Probe Connector does
not fit in Probe Plug-in.
Damage to Insulation
on Probe or Introducer
Water is not circulating
through tubing during
C C
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C *
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ON and post-cooling
states.
C *
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Water is not dripping
into the burette.
Float is stuck on
bottom port of the
burette.
C * Probe to the 7-pin connector on the
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C
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TROUBLESHOOTING
Ensure all connections are made:
• Probe(s) to Cooled RF Connector Cable
• Cooled RF Connector Cable to the RF
Generator
• RF Generator to power outlet
Check for an error message on the RF
Generator
Visually inspect the Probe or Cable for
damage. Ensure that devices are dry and
at room temperature. If problem persists,
discontinue use.
• Stop the procedure immediately.
• Check the luer lock connections to ensure
the Tube Kit is connected to the Probe.
• Check the Pump to ensure the lid is
not open.
• Check RF Generator for any error
messages.
• Check that the connector's keys are lined
up in the proper orientation.
• Ensure that the Connectors are clean and
unobstructed.
Do not use. Discard immediately.
• Ensure the Tube Kit is correctly connected
to the Probe.
* pre-cooling,
• Ensure the Tube Kit has been correctly
placed in the pumphead.
• Ensure the burette reservoir has been
filled.
• Visually inspect the Tube Kit tubing and
joints for leaks and occlusions.
• Ensure that the float ball in the burette is
floating and not occluding the outflow of
water from the burette.
• Ensure the pump tubing (thick-walled
tubing that is coming directly out of the
bottom port of the burette) is placed in
the pumphead.
Check to see if water is running down the wall
of the burette.
Close the pumphead lid. Gently shake the
burette to try and loosen the ball from the
bottom of the burette.
* Probes and the C C *
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