Halyard COOLIEF Serie Instrucciones De Uso página 4

HALYARD* COOLIEF*
e
Cooled Radiofrequency Kit
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit (sterile,
single use, non-body contact): It is used for closed-loop circulation of sterile
water through a HALYARD* COOLIEF* Cooled Radiofrequency (RF) Probe. It
includes a burette and tubing.
HALYARD* COOLIEF* Cooled Radiofrequency Introducer (sterile, single
use): It is to be used with the Probes only. The Cooled Radiofrequency Introducer
provides a path for the Probe to the nervous tissue.
HALYARD* COOLIEF* Cooled Radiofrequency Probe (sterile, single use):
It is inserted through a Introducer into or near nervous tissue. Sterile water
circulates internally to cool the Probe while it delivers radiofrequency energy. A
thermocouple in the Probe measures cooled electrode temperature throughout
the procedure. The "Cooled RF Set Temp" (Default Setting T = 60°C) displayed on
the COOLIEF* RF Generator refers to the cooled electrode temperature and does
not reflect the immediate surrounding tissue temperature. The heat generated
from the radiofrequency energy produces thermal energy with average
maximum tissue temperatures greater than 80°C.
Indications For Use
The HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the
HALYARD* COOLIEF* Radiofrequency (RF) Generator (PMG-115-TD/PMG-230-TD/
PMG-ADVANCED) (formerly Baylis Pain Management Generator or K
Pain Management Generator) is indicated for use to create radiofrequency
lesions in nervous tissue.
Contraindications
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
COOLIEF* 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
The Kit contains single-use devices. Do not reuse, reprocess, or
resterilize these medical devices. Reuse, reprocessing, or resterilization
may 1) adversely affect the known biocompatibility of the device,
2) compromise the structural integrity of the device, 3) lead to the
device not performing as intended, or 4) create a risk of contamination
and cause the transmission of infectious diseases resulting in a patient
injury, illness, or death.
The COOLIEF* Probe must be used with the correct connector
cable. Attempts to use it with other connector cables can result in
electrocution of the patient or operator.
Laboratory staff and patients can undergo significant x-ray exposure
during radiofrequency procedures due to the continuous use of
fluoroscopic imaging. This exposure can result in acute radiation injury
as well as increased risk for somatic and genetic effects. Therefore,
adequate measures must be taken to minimize this exposure.
Discontinue use if inaccurate, erratic or sluggish temperature readings
are observed. Use of damaged equipment may cause patient injury.
Do not modify HALYARD* Equipment. Any modifications may
compromise safety and efficacy of the device.
When the COOLIEF* RF Generator is activated, the conducted and
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radiated electrical fields may interfere with other electrical medical
equipment.
The RF Generator is capable of delivering significant electrical power.
Patient or operator injury can result from improper handling of the
Probes, particularly when operating the device.
During power delivery, the patient should not be allowed to come in
contact with grounded metal surfaces.
Do not remove or withdraw the device while energy is being delivered.
There is a rare potential for localized skin burn if RF lesion site has
insufficient subcutaneous tissue (<15mm) or is near a shallow metal
implant.
There is a rare potential for unintended nerve or vascular damage if RF
lesion is created over a nerve or vessel:
Ensure proper selection of the appropriate sized active electrode tip
to achieve the desired lesion size.
Active Tip
Size
2 mm
4 mm
5.5 mm
-C ®
ImbERLY LARK
Precautions
Do not attempt to use the Kit before thoroughly reading the accompanying
Instructions for Use and the User's Manual for the COOLIEF* RF Generator and
Dispersive Electrode (PMA-GP-BAY).
Apparent low power output or failure of the equipment to function properly at
normal settings may indicate: 1) faulty application of the dispersive electrode or
2) power failure to an electrical lead. Do not increase power level before checking
for obvious defects or misapplication.
To prevent the risk of ignition, make sure that flammable material is not present
in the room during RF power application.
Only physicians familiar with RF lesion techniques should use the COOLIEF* Kit
components.
It is the physician's responsibility to determine, assess and communicate to each
individual patient all foreseeable risks of the RF lesion procedure.
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.
Proper sterile techniques must be used when assembling and filling the Tube Kit.
Do not place the lid down on a non-sterile surface.
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit
The COOLIEF* Tube Kit is for use with a single Probe.
Care must be taken to ensure all luer fittings are secure to prevent leaking.
Do not disconnect luer fittings while the pump is running.
Arrange equipment to minimize tubing tripping hazards.
Do NOT perform cooled RF lesion procedures if water is not circulating
through the Tube Kit, water is leaking or air bubbles are seen in the tubing.
Immediately stop the procedure and correct circulation before restarting
the procedure.
Do NOT pinch the tubing of the Tube Kit.
HALYARD* COOLIEF* Cooled Radiofrequency Introducer
Be careful while handling the COOLIEF* Introducer. The sharp tip can cause
injury to the operator if handled carelessly.
Handle the Introducer safely when it is in use due to electric currents.
Do not move the Introducer without the stylet fully inserted.
Choose the properly sized Introducer.
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.
Lesion Size and Shape Typical Anatomy
(T=60°C) Placement
4 – 6 mm, Oblate Spheriod Cervical Spine
10 –12 mm, Spherical Lumbar Spine, Knee, Hip
12 mm, Spherical Thoracic Spine