Product Specifications; Storage Instructions - Halyard PMP-YYC-N Instrucciones De Uso

HALYARD* Radiofrequency Probe
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& Radiofrequency Generator Connector Cable
Rx Only: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
Device Description
The HALYARD* Radiofrequency (RF) Probes (Fig. 1) are individual electrodes that
are used with a disposable radiofrequency (RF) cannula (sold separately) of the
corresponding gauge and length. The HALYARD* Radiofrequency (RF) Generator-
Connector Cables [PMX-BAY-BAY (Fig.2), PMX-RAD-BAY (Fig. 3), PMX-BAY-ORA
(Fig. 4), PMX-NEU-BAY (Fig. 5) and PMX-SAC-BAY (Fig. 6)] respectively connect
the HALYARD* RF Probes to the RF Generator, connect the HALYARD* RF Probes
to the Valleylab® RFG Series Generator, connect the HALYARD* RF Probes to the
Neurotherm® Generator or connect the HALYARD* RF Generator or K
Radiofrequency Generator (formerly Baylis Pain Management Generator) to
the Smith & Nephew® Probe Model: 4-Pin Intradiscal Catheter, 4-Pin Intradiscal
Catheter XL or 4-Pin Intradiscal Decompression Catheter.
Indications For Use
HALYARD* Radiofrequency Probe and HALYARD* Radiofrequency Generator
Connector Cable 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 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 lesion 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 stimula-
tion 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, treatment should be performed under local
anesthesia.
Systemic infection or local infection in area of the procedure.
Blood coagulation disorders or anticoagulant use.
Warnings
• The HALYARD* RF Probes and RF Generator Connector Cables are
shipped non-sterile and must be cleaned and sterilized prior to use
as instructed in the Instructions for Use.
• The HALYARD* RF Probes and RF Generator Connector Cables are
reusable devices. Failure to properly clean and sterilize the device
can cause patient injury and/or the communication of infectious
diseases from one patient to another.
• The HALYARD* RF Probes and RF Generator Connector Cables must
be used with the correct connector cable. Attempts to use it with
other RF Generator Connector Cables can result in electrocution of
the patient or operator.
• Laboratory staff and patients can undergo significant x-ray expo-
sure during RF 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 an RF Generator is activated, the conducted and radiated elec-
trical 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 han-
dling of the RF Probe, 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 (<15 mm) or is near a shallow
metal implant.
Precautions
• Do not attempt to use the HALYARD* RF Probes and RF Generator Connector
Cables before thoroughly reading the Instructions for Use and the User's
Manual for the RF Generator.
• The HALYARD* RF Probes and RF Generator Connector Cables should be used
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by physicians familiar with RF lesion techniques.
• 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 adjust treament
parameters before checking for obvious defects or misapplication.
• In order to prevent the risk of ignition make sure that flammable material is
not present in the room during RF power application.
• It is the physician's responsibility to determine, assess and communicate to
each individual patient all foreseeable risks of the RF lesion procedure.
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 HALYARD* RF Probes should be used by physicians familiar with RF lesion
techniques.
HALYARD* RF Probe
The HALYARD* RF Probes (PMP) are individual electrodes that are used with
disposable RF cannula (sold separately) of the corresponding gauge and length.
• Available with straight and curved cannulae.
• Model number indicates cannula information.
Model Number Probe-XX-YYC, where:
XX: indicates gauge of cannula associated with the probe
YY: indicates length of cannula associated with the probe
C: if present, indicates that cannula is curved.
Note: Please contact Halyard Health for a list of all model numbers and sizes.
• RF Probes are shipped non-sterile and must be sterilized as per Instructions
for Use prior to use.
• Are supplied non-pyrogenic.
• Are supplied with the following additional parts:
• protective tubing, to prevent bending or kinking of the RF Electrode
during handling.
• Black 4-pin, male connector (Probe Plug-In) to connect the
HALYARD* RF Probe to the RF Generator Connector Cable.
• Color-coded bend relief which corresponds to the gauge of the cannula they
should be used with:
• Black probe cable for use with straight cannula and a white probe cable for
use with curved cannula.

Storage Instructions

• HALYARD* RF Probes should be stored in a cool, dry place.
• Store the RF Probes in the Sterilization and Storage Tray provided to reduce
the risk of damage due to storage.
Special Handling Instructions
The HALYARD* RF Probe is delicate due to its small diameter RF electrode. Do
not bend, kink, or stress the RF electrode. Do not crush or splice the probe cable.
Doing so could damage the temperature sensing mechanism in the device and
lead to improper temperature measurement.
(Fig. 1)
White = 16G
Pink = 18G
Yellow = 20G
Green = 21G
Black = 22G
3