Halyard COOLIEF, Инструкция по эксплуатации

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Choose the properly size FDI.
Ensure that cap or probe is connected to opposite port while fluid is being
delivered.
HALYARD* COOLIEF* Cooled Radiofrequency Probe
The Tube Kit should never be disconnected from the Probe when 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 Probe by pulling the connector, not the cable.
Handle the Probe safely when it is in use due to electric currents and the
hot tip.
While inserting the Probe through the FDI 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 FDI when the Probe is in it. If repositioning is needed,
retract the Probe from the FDI and then reposition the FDI with the stylet
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 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* Fluid Delivery Introducer (FDI) includes an insulated stainless steel
cannula, a stylet, and a fluid delivery system.
The COOLIEF* Tube Kit is comprised of a burette and flexible tubing fitted with
luer locks for connection to the Probe.
The COOLIEF* Probe, FDI, 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 Fluid Delivery 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
• Radiofrequency Generator (PMG-ADVANCED)
• Luer lock syringe (if fluid injection is desired)
Instructions for Use
Monopolar System
(Fig. 1a – 1e)
Assemble all the equipment required for the procedure. Set up the
Radiofrequency Generator (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. (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 COOLIEF*
Probe. Do not over tighten the connection.
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 Fluid Delivery
Introducer (FDI)
1. With the stylet in the COOLIEF* FDI, carefully insert the FDI into the
patient using fluoroscopic guidance to place it at the desired lesion
location.
2. Once the FDI is in the proper position, carefully remove the stylet from
the FDI.
3. Repeat steps 1-2 with a second FDI if necessary.
4. If the introduction of fluid is desired during the procedure, the FDI side or
probe port can be utilized.
Caution: Do not inject anesthetic or any other fluid through fluid
delivery port while stylet is engaged.
A. Side port with probe inserted. (Fig. 9)
1. Ensure probe is secured fully by twisting luer lock.
(Fig. 8)
2. Remove cap on side port.
3. Connect fluid-containing luer lock syringe to side port.
4. Dispense desired fluid.
5. Remove syringe.
6. Replace cap on side port.
B. Probe port with cap on side port. (Fig. 10)
1. Ensure that side port cap is present.
2. Connect fluid-containing luer lock syringe to probe port.
3. Dispense desired fluid.
4. Remove syringe.
C. Side port with cap on probe port.
(Fig 11)
1. Remove cap on side port.
2. Connect cap to probe port.
3. Connect fluid-containing luer lock syringe to side port.
4. Dispense desired fluid.
5. Remove syringe.
6. Replace cap on side port.
HALYARD* COOLIEF* Cooled Radiofrequency Probe
1. Insert the COOLIEF* Probes into the tissue through the FDI. Never force
the Probe in if significant resistance is felt.
2. Connect the Probe to the FDI by twisting the luer lock on the Probe
Handle.
(Fig. 8)
3. 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.
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 Probe(s) and the FDI 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.