Halyard COOLIEF SINERGY, Инструкция по эксплуатации

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HALYARD* COOLIEF* SI NERGY * Cooled Radiofrequency Kit
Rx Only: Federal Law (USA) 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 * SINERGY* Cooled Radiofrequency (RF)
Probe. It includes a burette and tubing.
HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Introducer (sterile,
single use): It is to be used with the HALYARD* COOLIEF * SINERGY* Probes only.
The COOLIEF * SINERGY* Introducer provides a path for the COOLIEF * SINERGY*
Probe to the nervous tissue.
HALYARD* COOLIEF* SINERGY* Cooled Radiofrequency Probe (sterile,
single use): It is inserted through a COOLIEF * SINERGY* Introducer into or near
nervous tissue. Sterile water circulates internally to cool the COOLIEF * SINERGY*
Probe while it delivers radiofrequency energy. A thermocouple in the COOLIEF *
SINERGY* 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.
HALYARD* COOLIEF* SINERGY* EPSILON* Ruler (sterile, single use): It is a
stainless steel, circular, ruler with a 10 mm radius. It is placed on the skin over
the treatment site during the procedure.
HALYARD* COOLIEF* Radiofrequency QUICKCLAMP* Device (sterile, single
use): It is placed on the skin over the treatment site during the procedure. It can
be optionally used to support the COOLIEF * SINERGY* Introducer and Probe.
Indications for Use
The HALYARD* COOLIEF * SINERGY* Cooled Radiofrequency (RF) Kit, in
combination with the HALYARD* COOLIEF * Radiofrequency (RF) Generator
(PMG-115-TD/PMG-230-TD/PMG-ADVANCED) (formerly Baylis Pain Management
Generator or KIMBERLY-CLARK® Pain Management Generator) is indicated for use
to create RF 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 RF 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
The COOLIEF* SINERGY* Kit contains single-use devices. Do not reuse,
reprocess, or resterilize this medical device. 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* SINERGY* 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
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.
Precautions
Do not attempt to use the COOLIEF * SINERGY* Kit before thoroughly reading the
accompanying Instructions for Use and the User’s Manual for the COOLIEF * RF
Generator and HALYARD* 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 *
SINERGY* Kit components.
It is the physician’s responsibility to determine, assess and communicate to each
individual patient all forseeable 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.
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.
HALYARD* COOLIEF* Cooled Radiofrequency Sterile Tube Kit
The COOLIEF * Tube Kit is for use with a single COOLIEF * SINERGY* 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* SINERGY* Cooled Radiofrequency Introducer
Be careful while handling the COOLIEF * SINERGY* 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* SINERGY* Cooled Radiofrequency Probe
While inserting the Probe through the COOLIEF * SINERGY* Introducer
watch the fluoroscope for any buckling. Do not attempt to further insert
the COOLIEF * SINERGY* Probe if any buckling is observed or significant
resistance is felt.
Do not move the
COOLIEF * SINERGY* Introducer when the Probe is in it.