Contraindications - Halyard COOLIEF TRANSDISCAL Bedienungsanleitung

HALYARD* COOLIEF* TRANSDISCAL*
e
Cooled Radiofrequency Y-Connector Cable
Rx Only: Federal (USA) law restricts this device to sale by or on the order of a
physician.
Device Description
The HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Y-Connector
Cable provides a path for delivery of radiofrequency (RF) energy and temperature
signals to/from the HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency
Probe(s). The TRANSDISCAL* Y-Connector Cable is used with one or two
TRANSDISCAL* Probes, one or two HALYARD* COOLIEF* TRANSDISCAL* Cooled
Radiofrequency Introducers and a HALYARD* COOLIEF* Cooled Radiofrequency
(RF) Pain Management Generator or K
(formerly Baylis Pain Management Generator), Version 2.0 or higher (PMG-115-
TD/PMG-230-TD/PMG-ADVANCED).
HALYARD* COOLIEF* TRANSDISCAL* Cooled
Radiofrequency Y-Connector Cable
• Shipped non-sterile and must be sterilized as per Instructions for Use prior
to use.
• Used to attach the TRANSDISCAL* Probe(s) and Introducer(s) to a RF
Generator.
• Equipped with three connectors:
• 2 x 5-Pin Female RF Probe Connectors
• 1 x 14-Pin Male HALYARD* rF Generator Connector
Indications for Use
HALYARD* COOLIEF* TRANSDISCAL* Cooled Radiofrequency Y-Connector Cables
are used in conjunction with the RF Generator 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
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 TRANSDISCAL* Y-Connector Cable is shipped non-sterile and must
be cleaned and sterilized as per the Instructions for Use before
every procedure.
The TRANSDISCAL* Y-Connector Cable is a reusable device. Failure to
properly clean and sterilize the device can cause patient infection.
The TRANSDISCAL* Y-Connector Cable must be used with the
TRANSDISCAL* Probe(s).
The RF Generator is capable of delivering significant electrical power.
Patient or operator injury can result from improper handling of the
cable, particularly when operating the device.
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.
-C ® Radiofrequency Generator
ImberLy LArK
(Fig. 1)
Do not modify HALYARD* Equipment. Any modifications may
compromise 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.
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.
Precautions
Do not attempt to use the TRANSDISCAL* Y-Connector Cable before thoroughly
reading these Instructions for Use and the Instructions for Use for the
TRANSDISCAL* Probe and TRANSDISCAL* Introducer and the User's Manual for
the RF Generator.
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 TRANSDISCAL*
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.
Adverse Events
Complications with the use of this device are those associated with the
procedures that utilize a RF probe.
Product Specifications
The TRANSDISCAL* Y-Connector Cable provides a path for delivery of RF energy
and temperature signals to/from the TRANSDISCAL* Probe(s).
Model Number TDX-Y-TSW-TDP
Length
Storage Requirements
TRANSDISCAL* Y-Connector Cable must be stored in a cool, dry environment.
Inspection Prior to Use
Perform the following checks before the patient is presented for the procedure.
These tests will allow you to verify that the equipment you will use is in proper
working order. Do these tests in a sterile environment.
1. Check that the TRANSDISCAL* Y-Connector Cable has been sterilized.
The TRANSDISCAL* Y-Connector Cable should be sterilized before each
use.
2. Visually inspect the cable for damage. Look for damage to the
insulation, connectors and part labels. Ensure that there is no visible
damage, such as discoloration, cracks, label fading or kinks. Do NOT use
damaged equipment.
3. Ensure the TRANSDISCAL* Y-Connector Cable is dry. Residual moisture
can cause improper function.
Equipment Required
RF lesion procedures should be performed in a specialized clinical setting with
fluoroscopic equipment. The equipment required for the procedure is as follows:
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Introducer(s)
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe(s)
• COOLIEF* TRANSDISCAL* Cooled Radiofrequency Y-Connector Cable
• COOLIEF* Cooled Radiofrequency Sterile Tube Kit
• COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit
• Dispersive Electrode
• Radiofrequency Generator (PMG-115-TD/PMG-230-TD/PMG-ADVANCED)
Version 2.0 or higher
Instructions for Use
(Fig. 2 and Fig. 3)
1. Assemble all required equipment for the intended procedure.
2. Perform a visual check on all of the equipment. Ensure all components
are in good working order, and have not been damaged in any way. Do
NOT use damaged equipment.
8 ft.
3