Halyard COOLIEF SINERGY, Инструкция по эксплуатации

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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 Tube Kit is comprised of a burette and flexible tubing fitted with luer locks for
connection to the COOLIEF * SINERGY* Probe.
The COOLIEF * SINERGY* Introducer includes an insulated stainless steel cannula
and a stylet.
The COOLIEF * SINERGY* 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 * SINERGY* EPSILON* Ruler is comprised of a circular stainless steel
ruler with radius 10 mm and spoke length 10 mm.
The
COOLIEF * SINERGY* Probe, COOLIEF * SINERGY* Introducer, Tube Kit,
COOLIEF * SINERGY* EPSILON* Ruler and COOLIEF * QUICKCLAMP* Device 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 should be performed in a specialized clinical setting equipped with a
fluoroscopy unit. The equipment required to perform RF procedures include:
• COOLIEF* SINERGY* Cooled Radiofrequency Probe
• COOLIEF* SINERGY* Cooled Radiofrequency Introducer(s)
• COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit and Cable
• COOLIEF* Cooled Radiofrequency Sterile Tube Kit
• COOLIEF* SINERGY* EPSILON* Ruler (optional)
• COOLIEF * Radiofrequency QUICKCLAMP* Device (optional)
• 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. 1)
Assemble all the equipment required for the procedure. Set up the COOLIEF *
Radiofrequency Generator (PMG-115-TD/PMG-230-TD/PMG-ADVANCED) and the
Pump Unit, as directed in their Instructions for Use. Connect the 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* SINERGY* Cooled Radiofrequency Sterile Tube
Kit (Fig. 2)
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.
Ensure the lid is snapped back onto the body of the burette
after filling.
Inject sterile water into burette OR remove lid and pour sterile water.
(Fig. 4-5)
3. Place the thick-walled tubing coming out of the bottom of the burette
into the pumphead of the COOLIEF * 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.
(Fig. 6)
4. Remove the caps on the male and female luer locks. Connect the
appropriate luer lock to the corresponding luer lock on the Probe. Do not
over tighten the connection.
Caution!
Connect one Tube Kit to one COOLIEF * SINERGY* Probe.
(Fig. 7)
5. At the end of the procedure, discard the Tube Kit appropriately.
HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Introducer
1. With the stylet in the 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* SINERGY* Cooled Radiofrequency Probe
1. Insert the 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 and User’s Manual accompanying the package.
4. Connect the Probe to the Tube Kit.
5. Connect the 14-pin connector of the Connector Cable into the
COOLIEF *
RF Generator. Connect the Probe to the 7-pin Connector on the
Connector Cable.
6. Select the Treatment Mode in the COOLIEF * 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 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
measurement
OR
Inaccurate,
erratic or sluggish
temperature
reading
Ensure all connections are made:
• Probe(s) to Connector Cable
• Connector Cable to the
COOLIEF * 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.
Water does not
flow through the
COOLIEF* SINERGY*
Probe and Tube Kit
• 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.
COOLIEF* SINERGY*
Probe Connector
does not fit in Probe
Plug-in
Check that the connector’s keys are lined up in the
proper orientation.
Ensure that the connectors are clean and
unobstructed.