Equipment Required - Halyard COOLIEF Instrucciones De Uso

HALYARD* COOLIEF*
e
Multi-Cooled Radiofrequency Module
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
The HALYARD* COOLIEF* Multi-Cooled Radiofrequency (RF) Module is used
in conjunction with a HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain
Management Generator V4.0 or higher or K
Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/PMG-ADVANCED)
and COOLIEF* Cooled Radiofrequency Probe(s) (SIP/LUP/THP) to create
radiofrequency (RF) lesions in nervous tissue. (Fig. 1)
Indications For Use
The HALYARD* COOLIEF* Multi-Cooled Radiofrequency Module will be used in
conjunction with a radiofrequency generator to create 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
radiofrequency lesion 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* Multi-Cooled RF Module is a reusable device. Failure
to properly clean the device can cause patient injury and/or the
communication of infectious diseases from one patient to another.
The COOLIEF* Multi-Cooled RF Module must be used with the correct
version of the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain
Management Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/
PMG-ADVANCED). 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 the safety and efficacy of the device.
When the RF Generator is activated, the conducted and radiated
electrical fields may interfere with other electrical medical equipment.
Do not use the COOLIEF* Multi-Cooled RF Module with the Bipolar
Adaptor (PMA-BP).
Precautions
• Do not attempt to use the COOLIEF* Multi-Cooled RF Module before
thoroughly reading these Instructions For Use and the User's Manual for the
RF Generator.
• The COOLIEF* Multi-Cooled RF Module should be used by physicians familiar
with radiofrequency lesion techniques.
• Apparent low power output or failure of the equipment to function properly
at normal settings may indicate: 1) faulty connection of the system or
2) power failure to an electrical lead. Do not increase power level before
checking for obvious defects or misapplication.
-C ® Radiofrequency
ImbERLY LARK
• In order to prevent the risk of ignition make sure that flammable material is
not present in the room during RF power application.
• The RF Generator is capable of delivering significant electrical power. Patient
or operator injury can result from improper handling of the Probe and DIP
electrode, particularly when operating the device.
• During power delivery, the patient should not be allowed to come in contact
with ground metal surfaces.
• It is the physician's responsibility to determine, assess and communicate
to each individual patient all foreseeable risks of the radiofrequency lesion
procedure.
Adverse Events
Complications with the use of this device are associated with the procedures that
utilize a RF Probe.
Product Specifications
HALYARD* COOLIEF* Multi-Cooled Radiofrequency
Module
Model
Enclosure Dimensions
COOLIEF* Multi-Cooled RF Cable (Length) 8 ft.
Number of Connections
Operational temperature
Storage temperature
Humidity
Inspection Prior To Use
Prior to use the following inspections should be completed:
1. Inspect the COOLIEF* Multi-Cooled RF Module for any signs of physical
damage to the enclosure or to the Cable.
2. Inspect the COOLIEF* Multi-Cooled RF Module for damaged insulation
or connectors.
3. Inspect both the COOLIEF* Multi-Cooled RF Enclosure and Cable to see
that labels are present and legible.

Equipment Required

The COOLIEF* Multi-Cooled RF Module is for use in RF procedures performed in
specialized clinical settings. The equipment required for these procedures are
as follows:
• Radiofrequency Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/
PMG-ADVANCED)
• COOLIEF* Cooled RF Probe (SIP/THP/LUP)
• COOLIEF* Cooled RF Introducer (SII/THI/LUI)
• Disposable Indifferent (dispersive) Patch (DIP) Electrode
Instructions For Use
Carefully read all instructions prior to use. Observe all contraindications,
warnings and precautions noted in these instructions. Failure to properly follow
instructions may lead to improper functioning of the device and result in patient
injury.
1. Place the COOLIEF* Multi-Cooled RF Module on a mounting cart or on
any sturdy table or platform. Attach the COOLIEF* Multi-Cooled RF Cable
to the RF Generator.
2. Connect the COOLIEF* Cooled RF Probe(s) to the connectors on the
COOLIEF* Multi-Cooled RF Module. Up to four COOLIEF* Cooled RF
Probes (SIP/THP/LUP) may be connected to the COOLIEF* Multi-Cooled
RF Module. (Fig. 2-5)
Follow the Instructions For Use for the COOLIEF* Cooled-RF Probe
(SIP/THP/LUP) when connecting and placing the probes, as well as
during the placement of the Disposable Indifferent (dispersive) Patch
(DIP) Electrode.
3. Stimulate each probe individually as necessary by following the RF
Generator V4.0 User's Manual.
4. Lesion as necessary by switching the RF Generator to the lesion mode.
Refer to the RF Generator V4.0 User's Manual for more information on
lesioning.
5. Set up the rest of the System as per the COOLIEF* Cooled RF Probe
(SIP/THP/LUP) Instructions for Use.
CRX-BAY-MCRF
3.3 in. x 2.5 in. x 0.9 in.
4
10°C to 40°C
-40°C to 70°C
15-80% non-condensing
3