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PowerWire Pro Radiofrequency Guidewire Kit
English
Carefully read all instructions prior to use. Observe all contraindications,
warnings and precautions noted in these instructions. Failure to do so may
result in patient complications.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
I.
DEVICE DESCRIPTION
The PowerWire
Pro RF Guidewire Kit includes the PowerWire Pro
RFGuidewire and the RFP-100A Connector Cable.
The PowerWire Pro RF Guidewire must be used with an approved Baylis
Radiofrequency Puncture Generator (Baylis RF Generator) and Baylis
Connector Cable.
The PowerWire Pro RF Guidewire delivers radiofrequency (RF) power in a
monopolar mode between its distal electrode and a commercially available
external Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is
in compliance with IEC 60601-2-2 standards. The PowerWire Pro RF
Guidewire is connected to the Baylis Radiofrequency Puncture Generator
via the Baylis Connector Cable.
Dimensions for different models of the PowerWire Pro RF Guidewire are
described on the product label. The insulation on the PowerWire Pro RF
Guidewire body facilitates smooth advancement to the target location as
well as providing electrical insulation. The distal portion of the PowerWire
Pro RF Guidewire is flexible and the active tip is rounded to be atraumatic
to vessel walls.
The RFP-100A Connector Cable connects the RFP-100A BMC
Radiofrequency Puncture Generator (RFP-100A Generator) to the
PowerWire Pro RF Guidewire. This Cable enables radiofrequency (RF)
power to be delivered from the Generator to a PowerWire Pro RF
Guidewire.
Detailed information concerning the RFP-100A Generator is contained in a
separate manual that accompanies the Generator (RFP-100A Generator
Instructions for Use).
The dimensions for the PowerWire Pro RF Guidewire and the RFP-100A
Connector Cable can be found on the device label and in Section VI
"Product Specifications." The RFP-100A Connector Cable has a connector
on one end that mates with the RFP-100A Generator and a connector at
the other end, which mates with a PowerWire Pro RF Guidewire.
II.
INDICATIONS FOR USE
The PowerWire Pro RF Guidewire is indicated for creating a channel in
totally occluded peripheral vessels 3mm or greater, including vessels with
stents.
The intended use of the RFP-100A Connector Cable is to connect the RFP-
100A BMC Radiofrequency Puncture Generator to a PowerWire Pro RF
Guidewire.
III.
CONTRAINDICATIONS
The RFP-100A Connector Cable included in the PowerWire Pro Kit is not
recommended for use with any other RF generator or any other device.
IV.
WARNINGS
•
Only physicians with a thorough understanding of angiography and
percutaneous interventional procedures should use the PowerWire
Pro Radiofrequency Guidewire. It is recommended that physicians
avail themselves of pre-clinical training, a review of pertinent literature
and other appropriate education before attempting new interventional
procedures.
•
The PowerWire Pro RF Guidewire is supplied STERILE using an
ethylene oxide process. Do not use if the package is damaged.
•
The PowerWire Pro RF Guidewire and RFP-100A Connector Cable
are intended for single patient use only. Do not attempt to clean, re-
sterilize or re-use either device. Reuse can cause the patient injury
and/or the communication of infectious disease(s) from one patient to
another.
•
The PowerWire Pro RF Guidewire must be used with the Baylis
Connector Cable. Attempts to use it with other connector cables can
result in electrocution of the patient and/or operator.
•
The RFP-100A Connector Cable must only be used with the RFP-
100A Generator and the PowerWire Pro RF Guidewire. Attempts to
use it with other RF Generators and devices can result in electrocution
of the patient and/or operator.
•
The active tip of the PowerWire Pro RF Guidewire is fragile. Be careful
not to damage the tip while handling the PowerWire Pro RF Guidewire.
If the tip becomes damaged, discard the PowerWire Pro RF Guidewire
immediately.
If the active tip of the PowerWire Pro RF Guidewire becomes bent at
•
any time during its use, dispose of the PowerWire Pro RF Guidewire
immediately. Do not attempt to straighten the active tip.
•
Laboratory staff and patients can undergo significant x-ray exposure
during radiofrequency cutting procedures due to the continuous usage
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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.
•
Interaction with sharp edges may result in damage to device, which
may lead to clinical adverse events requiring additional intervention.
Navigation through occluded stents may result in device entanglement
in stent.
V.
PRECAUTIONS
•
Do not attempt to use the PowerWire Pro RF Guidewire Kit or ancillary
equipment before thoroughly reading the accompanying Instructions
for Use.
Radiofrequency interventional procedures should be performed only
•
by physicians thoroughly trained in the technique in an operating room
fully equipped for interventional procedures and/or a fully equipped
catheterization laboratory.
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.
•
Visually inspect the PowerWire Pro RF Guidewire and the RFP-100A
Connector Cable to ensure there is no cracking or damage to the
insulating material. Do not use if the equipment is damaged.
Do not use the PowerWire Pro RF Guidewire Kit after the "Use By"
•
date indicated on the label.
•
The PowerWire Pro RF Guidewire is intended for use with only those
devices listed in section VII "Equipment Required." The RFP-100A
Connector Cable is intended for use with the PowerWire Pro RF
Guidewire only.
Read and follow the manufacturer's instructions for use of the
•
Disposable Indifferent (Dispersive) Patch (DIP) electrode. Always use
DIP electrodes that meet or exceed IEC 60601-2-2 requirements.
•
Placement of the dispersive electrode on the thigh could be associated
with higher impedance.
In order to prevent the risk of ignition, make sure that flammable
•
material is not present in the room during radiofrequency power
application.
•
Take precautions to limit the effects that the electromagnetic
interference (EMI) produced by the Generator may have on the
performance of other equipment. Check the compatibility and safety
of combinations of other physiological monitoring and electrical
apparatus to be used on the patient in addition to the Generator.
Adequate filtering must be used to allow continuous monitoring of the
•
surface electrocardiogram (ECG) during radiofrequency power
applications.
•
Careful manipulation of the PowerWire Pro RF Guidewire must be
performed to avoid vessel trauma. PowerWire Pro RF Guidewire
advancement should be done under fluoroscopic guidance.
resistance is encountered, DO NOT use excessive force to advance
or withdraw the PowerWire Pro RF Guidewire.
•
Do not attempt to deliver radiofrequency energy until the tip of the
PowerWire Pro RF Guidewire is confirmed to be in good contact with
the target biological material.
Do not bend the PowerWire Pro RF Guidewire or the RFP-100A
•
Connector Cable. Excessive bending or kinking of either device may
damage the integrity of the device and may cause patient injury. Care
must be taken when handling the PowerWire Pro RF Guidewire and
the RFP-100A Connector Cable.
•
It is recommended not to exceed twenty (20) radiofrequency power
applications per PowerWire Pro RF Guidewire.
The Generator is capable of delivering significant electrical power.
•
Patient or operator injury can result from improper handling of the
PowerWire Pro RF Guidewire and/or DIP electrode, particularly when
operating the device.
•
During power delivery, the patient should not be allowed to come in
contact with ground metal surfaces.
Do not activate RF whilst tip is within catheter.
•
•
Care must be taken to verify the compatibility of the PowerWire Pro
RF Guidewire when used with catheters.
•
Never disconnect the RFP-100A Connector Cable from the RFP-100A
Generator while the Generator is delivering RF power.
Never disconnect the RFP-100A Connector Cable from the RFP-100A
•
Generator by pulling on the cable. Failure to disconnect the cable
properly may result in damage to the cable.
DMR PSK 3.3 V-1 13-Feb-2023
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