Equipment Required - Halyard PMP-YYC-N Instrucciones De Uso

HALYARD* RF Generator Connector Cables
• Four models (PMX-BAY-BAY, PMX-RAD-BAY, PMX-BAY-ORA, PMX-NEU-BAY)
• Shipped non-sterile and must be sterilized as per User's Manual prior to
first use.
PMX-BAY-BAY
(Fig. 2)
The HALYARD* PMX-BAY-BAY connects the HALYARD* RF Probe to the Generator
(PMG).
• Two different connectors:
1. 4-pin female – RF Probe Connector (to connect to Probe)
2. 14-pin male – RF Generator Plug-In (to connect to Generator)
PMX-RAD-BAY
(Fig. 3)
The HALYARD* PMX-RAD-BAY connects the HALYARD* RF Probe (PMP) to a
Valleylab® RFG Series Generator.
• Two different connectors:
1. 4-pin female – RF Probe Connector (to connect to Probe)
2. 14-pin male – RF Generator Plug-In (to connect to Generator)
PMX-BAY-ORA
(Fig. 4)
The HALYARD* PMX-BAY-ORA connects the HALYARD* RF Generator to the
Smith & Nephew Probe Model: 4-Pin Intradiscal Catheter or 4-Pin Intradiscal
Catheter XL.
• Two different connectors:
1. 4-pin female – RF Probe Connector (to connect to Probe)
2. 14-pin male – RF Generator Plug-In (to connect to Generator)
Note: Cable should NOT be used with the Intradiscal decompression catheter if the
generator in use is Generator Version 1.2 or lower.
Note: If using the PMG Version 2.0, ensure that the secondary thermocouple option
is disabled. Refer to Generator-TD User Manual.
• Are used to connect an IDL probe (model 902002) to the HALYARD* RF
Generator.
• Should NOT be used with the IDL decompression catheter if the generator in
use is PMG Version 1.2 or lower.
• Have two different connectors:
1. 4-pin female – RF Probe Connector (to connect to Probe)
2. 14-pin male – RF Generator Plug-In (to connect to Generator)
PMX-NEU-BAY
(Fig. 5)
The HALYARD* PMX-NEU-BAY connects the HALYARD* RF Probes to the
Neurotherm® Generator.
• Two different connectors:
1. 4-pin female – RF Probe Connector (to connect to Probe)
2. 4-pin male (metal) – RF Generator Plug-In (to connect to Generator)
PMX-SAC-BAY
(Fig. 6)
The HALYARD* PMX-SAC-BAY connects the HALYARD* RF Probe to the STRYKER®
RF Generator or STRYKER® RF Multi-Gen.
• Two different connectors:
1. 4-pin female - RF Probe Connector (to connect to Probe)
2. 12-pin male (metal) - RF Generator Plug-In (to connect to Generator
cable)
Storage Instructions
• HALYARD* RF Generator Connector Cables should be stored in a cool, dry
place.
• Store the RF Generator Connector Cables in the Sterilization and Storage Tray
provided to reduce the risk of damage due to storage.
Autoclave Case is:
• Shipped non-sterile.
• Should be used at all times to store the HALYARD* Probe and
HALYARD* RF Generator Connector Cable.
• Steam sterilizable and should be used to hold the devices while they are
being sterilized.
• NOT to be used with STERRAD®.
Inspection Prior to Use
Perform the following checks before the patient is presented for the procedure.
These steps will allow you to verify that the equipment you will use is in proper
working order. Do these tests in a sterile environment.
• Sterility Check: The HALYARD* RF Probes and RF Generator Connector
4
Cables are shipped non-sterile. They must be sterilized prior to each use.
• Visual Inspection: Ensure RF Probes and RF Generator Connector Cables
have no visible damage such as discoloration, cracks, label fading, cable
splice, or kinks. Do NOT use damaged or defective equipment.
• Residual Moisture: Ensure the RF Probes and RF Generator Connector
Cables are dry. Residual moisture can cause malfunctions.

Equipment Required

RF lesion procedures should be performed in a specialized clinical setting with
fluoroscopic equipment. The RF equipment required for the procedure is as
follows:
• Disposable RF Cannula
• RF Probe and corresponding RF Generator Connector Cable
• RF Generator
• Disposable Indifferent (dispersive) Patch (DIP) electrode meeting ANSI/AAMI
standard HF-18 requirements for electrosurgical electrodes.
Instructions for Use
1. Assemble all required equipment for the intended procedure and posi-
tion the patient as necessary.
2. Attach the Disposable Indifferent (dispersive) Patch (DIP) electrode. Read
and follow the manufacturer's Instructions for Use of the (DIP) electrode
to determine proper placement. Always use DIP electrodes that meet or
exceed ANSI/AAMI HF-18 requirements.
3. Connect the appropriate connector cable to the connector cable connec-
tion on the RF generator. Maintain access to the RF Probe Connector on
the connector cable in order to facilitate easy attachment of the probe.
4. With the stylet in the cannula, insert the cannula into the patient
using fluoroscopic guidance to place the active tip at the desired lesion
location.
5. Once the cannula is properly placed, carefully remove the stylet from
the cannula and insert the (pre-sized) RF Electrode down the shaft of
the cannula.
6. Attach the probe to the connector cable (via the Probe Plug-In and RF
Probe Connector).
7. Stimulate and lesion as necessary. Refer to the RF Generator User's
Manual for more information.
After the Procedure
1. Remove RF electrode of the probe from the cannula.
2. Remove cannula from the patient.
3. Disconnect the RF Probe from the RF Generator Connector Cable by
pulling on the plug body.
Caution: Prevent damage to your cable and probe. When pulling
the connectors apart be sure to pull on the plug and not the cable.
4. Disconnect the RF Generator Connector Cable from the generator.
5. Discard the cannula.
6. Remove Disposable Indifferent (dispersive) Patch (DIP) electrode from
patient and discard.
7. Prepare the reusable probe and connector cable for cleaning and
sterilization. Transfer the used HALYARD* RF Probe and HALYARD* RF
Generator Connector Cable to a carrying surface and cover them with
a wet cloth to ensure that blood and other contaminants do not dry on
the surface.
Cleaning and Sterilization Instructions
Danger
The HALYARD* RF Probe and HALYARD* RF Generator Connector Cable
are shipped non-sterile and must be cleaned and sterilized as per these
Instructions for Use prior to each use. Failure to properly clean and
sterilize the device can cause patient injury and/or the communication
of infectious diseases from one patient to another.
Important
The manufacturer recommends the user follow a quality control program for
each sterilization cycle that meets or exceeds American Operating Room Nurses
(AORN) Standards, Recommended Practices & Guidelines - 2000. This program
includes, but is not limited to recording:
• Type of sterilizer and cycle used
• Lot control number
• Load contents
• Exposure time and temperature, if not provided by a recording chart