Halyard COOLIEF Instrucciones Para El Uso página 3

HALYARD*
e
COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit
Rx Only: Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
Device Description
The HALYARD COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit (Fig. 1)
circulates sterile water through the closed-loop system (including HALYARD*
TRANSDISCAL* System, SINERGY* System and other cooled radio-frequency
(RF) systems) during pain management RF lesioning procedures. The Pump Unit
is to be used in conjunction with a HALYARD COOLIEF* Cooled Radiofrequency
Generator or K -C ® Cooled Radiofrequency Generator (PMG-115-TD/
imberly larK
PMG-230-TD/PMG-ADVANCED) (formerly Baylis Pain Management Generator),
various cooled RF probes and accessories. The HALYARD COOLIEF* Cooled
Radiofrequency Peristaltic Pump Unit is controlled by the RF Generator
through a connection at the rear of the pump. The HALYARD COOLIEF* Cooled
Radiofrequency Peristaltic Pump Connector Cable is used to transfer control
signals from the RF Generator to the Pump Unit.
Indications for Use
The HalyarD* COOliEF* Cooled Radiofrequency Peristaltic Pump Unit is to be
used in conjunction with a COOLIEF* Cooled RF Generator and with the COOliEF*
TraNSDiSCal* Cooled Radiofrequency Kit for coagulation and decompression
of disc material for symptomatic patients with contained herniated discs. It is
also to be used with the COOliEF* SiNerGy* Cooled Radiofrequency Kit and
other cooled RF probes to create RF lesions in nervous tissue including use in the
sacral region. HalyarD* COOliEF* Cooled Radiofrequency Peristaltic Pump Unit
is used for closed-loop circulation of sterile water through the system during RF
lesioning procedures.
Contraindications
The Pump Unit should be used as stated in the Indications for Use and only with
COOliEF* Cooled Radiofrequency Sterile Tube Kits.
For patients with cardiac pacemakers, a variety of changes can occur during and
after the treatment. In sensing mode the pacemaker may interpret the RF signal
as a heartbeat and may fail to pace the heart. Contact the pacemaker company
to determine if the pacemaker should be converted to a fixed-rate pacing during
the radiofrequency procedure. Evaluate the patient's pacing system after the
procedure.
Check the compatibility and safety of combinations of other physiological
monitoring and electrical apparatus to be used on the patient in addition to the
RF Generator.
If the patient has a spinal cord, deep brain, or other stimulator, contact
the manufacturer to determine if the stimulator needs to be in the bipolar
stimulation mode or in the OFF position.
This procedure should be reconsidered in patients with any prior neurological
deficit.
The use of general anesthesia is contraindicated. To allow for patient feedback
and response during the procedure, it should be performed under local
anesthesia.
Systemic infection or local infection in area of the procedure.
Blood coagulation disorders or anticoagulant use.
Warnings
Ensure the RF Generator is OFF before connecting the Pump Unit.
Failure to do so could result in damage to the RF Generator.
Do NOT service the Pump Unit. If servicing is required, please contact
technical support.
Do NOT place the Pump Unit on top of the RF Generator or in an area
with inadequate ventilation.
Do NOT modify the HALYARD* COOLIEF* Equipment. Any modifications
may compromise the safety and efficacy of the device.
Do NOT use in the presence of flammable anesthetics.
Precautions
Do not use the Pump Unit before thoroughly reading the Pump Unit, Tube Kit,
TRANSDISCAL*/SINERGY* or any other cooled RF probe and RF Generator
Instructions for Use and User's Manual.
Before RF procedures, ensure that the tubing of the Tube Kit has been properly
placed in the Pump Unit.
Ensure that the pump has completely stopped before inserting or removing
tubing from the Pump Unit.
Do not unplug the Pump Unit during RF energy application.
Adverse Events
Complications with the use of this device are those associated with the
procedures that utilize a RF Probe.
Inspection Prior to Use
Prior to use the following inspections should be completed:
1. Inspect the Pump Unit for damage.
2. Inspect the Pump Unit to see that all labels are present and legible.
Equipment Required
The Pump Unit is for use in RF pain management procedures performed
in specialized clinical settings. The equipment required for the Cooled
Radiofrequency procedure are as follows:
• COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable
• COOLIEF* Cooled Radiofrequency Sterile Tube Kit(s)
• COOLIEF* Cooled Radiofrequency Probe(s)
• COOLIEF* Cooled Radiofrequency Introducer(s)
• COOLIEF* Cooled Radiofrequency Y-Connector Cable (for bipolar procedure)
• Dispersive Electrode
• Radiofrequency Generator (PMG-115-TD/PMG-230-TD/PMG-ADVANCED)
Instructions for Use
(Fig. 2 and 3)
1. Plug the male end of the Connector Cable (TDX-PMG-PPU) into the back of
the RF Generator. Ensure the RF Generator is OFF before connecting
the Pump Unit. Failure to do so could result in damage to the RF Generator.
Plug the female end into the back of the Pump Unit. Screw down both
of the connections completely to ensure that the cable does not become
disconnected during use. The connection on the RF Generator and the Pump
Unit is labeled with the icon below.
2. The pump should be placed
3. Set up the rest of the system as per the TRANSDISCAL*/SINERGY*/Cooled RF
Kit Instructions for Use.
Note: The Pump Unit will be controlled by the RF Generator during treatment.
The user is not required to activate the pump.
Cleaning and Sterilization Instructions
The Pump Unit and Connector Cable are non-body contact devices and therefore
are NOT sterile and cannot be sterilized. If cleaning is necessary, the surface of
the Pump and/or Connector Cable can be cleaned with a damp lint-free cloth
with non-abrasive detergent dissolved in water. Dry the surface after wiping
down. NEVER immerse the Pump Unit in water.
Troubleshooting
PROBLEM TROUBLESHOOTING
The pump is not • Immediately stop the procedure.
working when in
• Check to ensure that the Pump Unit is connected
TRANSDISCAL*
to the RF Generator.
Disc Biacuplasty
• Check if the pump lids are completely closed.
Treatment Mode
• Check for debris in the pumphead.
The pump will
Fully open the cover for the pump and place the
not accept the
tubing coming from the bottom of the burette of the
Tube Kit tubing
Tube Kit into the L-shaped tube guides.
on a flat surface.
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