Adverse Events; Product Specifications; Equipment Required - Halyard COOLIEF Instrucciones De Uso

temperature of the COOLIEF* TRANSDISCAL* Probe shaft 3 mm proximal
from the electrode and is cooled slightly. This value is not to be used to
assess the hottest tissue in the disc periphery.

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* TRANSDISCAL* 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 5-pin connector.
The COOLIEF* TRANSDISCAL* 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 COOLIEF* TRANSDISCAL* Probe.
The kit components 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 damaged. Do not use the
equipment if the packaging has been compromised.

Equipment Required

Procedures in the disc should be performed in a specialized clinical setting
equipped with a fluoroscopy unit. The equipment required to perform RF
procedures include:
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe(s)
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Introducer(s)
• COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit and Cable
• COOLIEF* Cooled Radiofrequency Sterile Tube Kit(s)
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Y-Connector Cable
• Dispersive Electrode
• COOLIEF* Radiofrequency Generator (PMG-115-TD/PMG-230-TD/
PMG-ADVANCED)
Instructions For Use
(Fig. 2)
Figure 2 is a schematic representation of the connections of the system.
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 as directed in their Instructions for Use. Connect the
COOLIEF* TRANSDISCAL* Y-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* COOLIEF* TRANSDISCAL* Cooled Radiofrequency
Introducer
1. Carefully insert the Introducer with the stylet in it, into the intervertebral
disc under fluoroscopic guidance.
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.
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit (Fig. 1)
1. Place the burette into the burette holder on the side of the COOLIEF*
Pump Unit. The side of the burette with 2 or 3 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.
After filling, ensure the lid is snapped back onto the body of the burette
it was removed from. It is important that the lid corresponds to the
original burette body it was removed from; do not mix up the lids.
Inject sterile water into burette (Fig. 4) OR remove lid and pour sterile
water. (Fig. 5)
4
3. Place the thick-walled tubing coming out of the bottom of the burette
into the pumphead of the COOLIEF* Pump Unit (Fig. 6). 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*
TRANSDISCAL* Probe (Fig. 7). Do not over tighten the connection.
Caution: Connect one Tube Kit to one COOLIEF* TRANSDISCAL* Probe.
5. At the end of the procedure, discard the Tube Kit appropriately.
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe
1. Insert the COOLIEF* TRANSDISCAL* Probes in the intervertebral disc
through the Introducers. Never force the COOLIEF* TRANSDISCAL* Probe
in if significant resistance is felt.
2. Connect the COOLIEF* TRANSDISCAL* Probe to the Tube Kit. (Fig. 8)
3. Connect the COOLIEF* TRANSDISCAL* Probes to the COOLIEF*
TRANSDISCAL* Y-Connector Cable. If the option of one COOLIEF*
TRANSDISCAL* Probe has been enabled in the COOLIEF* RF Generator,
connect the COOLIEF* TRANSDISCAL* Probe to "COOLIEF* TRANSDISCAL*
Probe A" side of the COOLIEF* TRANSDISCAL* Y-Connector Cable.
4. Select the Treatment Mode in the COOLIEF* RF Generator. Set advanced
settings and the parameters for RF delivery in the COOLIEF* RF Generator
as described in its User's Manual.
5. Perform the procedure as described in the COOLIEF* RF Generator
User's Manual. The procedure comprises pre-cooling, treatment and
post-cooling stages.
6. Temperatures at the tip of the electrode and 3 mm proximal to
the electrode of the COOLIEF* TRANSDISCAL* Probe are monitored
throughout the procedure by the COOLIEF* RF Generator.
Note: Other than reproduction of their usual back pain or irritation due
to COOLIEF* TRANSDISCAL* 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 post-cooling remove the COOLIEF* TRANSDISCAL* Probes and the
Introducer and discard as biohazards. If used, remove the Dispersive
Electrode from the patient and discard appropriately. Disconnect the
COOLIEF* TRANSDISCAL* Y-Connector Cable from the COOLIEF* 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 that all connections are made:
measurement in
treatment mode
OR
Inaccurate, erratic or
sluggish temperature
Check for an error message on the COOLIEF*
reading in treatment
RF Generator.
mode
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 COOLIEF*
TRANSDISCAL* Probe
and Tube Kit.
Probe connector does
not fit in COOLIEF*
TRANSDISCAL* Probe
plug-in
• Probe(s) to Y-Connector Cable
• Y-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 COOLIEF*
TRANSDISCAL* Probe.
• Check the COOLIEF* 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.