Product Specifications; Equipment Required - Halyard COOLIEF Serie Instrucciones De Uso

While inserting the Probe through the Introducer watch the fluoroscope for
any buckling. Do not attempt to further insert the Probe if any buckling is
observed or significant resistance is felt.
Do not move the Introducer when the Probe is in it. If repositioning is
needed, retract the Probe from the Introducer and then reposition the
Introducer with the stylet inserted.
The "Cooled RF Temp" displayed on the COOLIEF* 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 COOLIEF* Probe is comprised of an electrically insulated shaft with an active
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 COOLIEF* Introducer includes an insulated stainless steel cannula and a
stylet.
The COOLIEF* Tube Kit is comprised of a burette and flexible tubing fitted with
luer locks for connection to the Probe.
The COOLIEF* Probe, Introducer, and Tube Kit are ethylene oxide sterilized and
supplied sterile. The devices should be stored in a cool, dry environment.
Note: Please contact Halyard Health 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:
• COOLIEF* Cooled Radiofrequency Probe
• COOLIEF* Cooled Radiofrequency Introducer(s)
• COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit and Cable
• COOLIEF* Cooled Radiofrequency Sterile Tube Kit
• COOLIEF* Cooled Radiofrequency Connector Cable (Monopolar System) or
COOLIEF* Multi-Cooled Radiofrequency (MCRF) Module (CRX-BAY-MCRF)
• Dispersive Electrode
• COOLIEF* Radiofrequency Generator (PMG-115-TD/PMG-230-TD/
PMG-ADVANCED)
Instructions for Use
Monopolar System
(Fig. 1a – 1e)
Assemble all the equipment required for the procedure. Set up the COOLIEF*
Radiofrequency Generator (PMG-115-TD/PMG-230-TD/PMG-ADVANCED) and the
COOLIEF* Pump Unit (pump), as directed in their Instructions for Use. Connect
the COOLIEF* 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.
HALYARD* Cooled Radiofrequency Sterile Tube Kit (Fig. 2)
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 COOLIEF*
Probe. Do not over tighten the connection. (Fig. 6)
Caution: Connect one Tube Kit to one Probe. (Fig. 7)
5. At the end of the procedure, discard the Tube Kit appropriately.
HALYARD* COOLIEF* Cooled Radiofrequency Introducer
1. With the stylet in the COOLIEF* Introducer, carefully insert the Introducer
into the patient using fluoroscopic guidance to place it at the desired
lesion location.
2. Once the Introducer is in the proper position, carefully remove the stylet
from the Introducer.
3. Repeat steps 1-2 with a second Introducer if necessary.
HALYARD* COOLIEF* Cooled Radiofrequency Probe
1. Insert the COOLIEF* Probes into the tissue through the Introducer. Never
force the Probe in if significant resistance is felt.
2. Connect the Probe to the Introducer using the luer lock on the Probe
Handle. (Fig. 8)
3. Attach the Dispersive Electrode to the COOLIEF* RF Generator and place
the Dispersive Electrode Pad on the patient as directed in the Instructions
for Use accompanying the package.
4. Connect the Probe to the Tube Kit.
5. Connect the 14-pin connector of the COOLIEF* Cooled RF Connector
Cable into the RF Generator. Connect the Probe to the 7-pin connector on
the Cooled RF Connector Cable.
6. 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.
7. 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.
8. After treatment remove the Probes and the 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 TROUBLESHOOTING
No temperature Ensure all connections are made:
measurement
OR
Inaccurate, erratic or
sluggish temperature
reading
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.
Water does not flow
through the COOLIEF*
Probe and Tube Kit
Probe Connector does
not fit in Probe Plug-in
• COOLIEF* Probe(s) to COOLIEF* Cooled RF
Connector Cable
• Cooled RF Connector Cable to the
COOLIEF* RF Generator
• RF Generator to power outlet
• 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.
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