Instructions For Use; Powerwire Radiofrequency Guidewire Kit; English - Baylis Medical PowerWire Instructions For Use Manual

TM
PowerWire 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
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The PowerWire RF GuideWire Kit includes the PowerWire
GuideWire and the RFP-100A Connector Cable.
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The PowerWire Radiofrequency GuideWire must be used with an
approved Baylis Radiofrequency Puncture Generator (Baylis RF Generator)
and Baylis Connector Cable.
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The PowerWire Radiofrequency 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 the IEC 60601-2-2 standards. The
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PowerWire RF GuideWire is connected to the Baylis Radiofrequency
Puncture Generator via the Baylis Connector Cable.
Dimensions for different models of the PowerWire
described on the product label. The insulation on the PowerWire
GuideWire body facilitates smooth advancement to the target location as
well as providing electrical insulation. The distal portion of the PowerWire
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
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PowerWire RF GuideWire.
power to be delivered from the Generator to a PowerWire
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
Connector Cable can be found on the device label and in Section VI
"Product Specifications." The RFP-100A Connector Cable has a four-pin
connector on one end that mates with the RFP-100A Generator and a
connector at the other end, which mates with a PowerWire
II. INDICATIONS FOR USE
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The PowerWire RF GuideWire is indicated for creating a channel in totally
occlusive peripheral vascular disease, for enhancing the potential for limb
preservation.
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In the USA, the PowerWire
channel in totally occluded peripheral vessels 3mm or greater.
The intended use of the RFP-100A Connector Cable is to connect the RFP-
100A BMC Radiofrequency Puncture Generator to a PowerWire
GuideWire.
III. CONTRAINDICATIONS
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The PowerWire RF GuideWire is not recommended for use with any
conditions that do not require creation of a channel in biological material.
The RFP-100A Connector Cable included in the Power Wire 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
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.

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The PowerWire RF GuideWire is supplied STERILE using an
ethylene oxide process. Do not use if the package is damaged.

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The PowerWire 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.
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The PowerWire 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
it with other RF Generators and devices can result in electrocution of
the patient and/or operator.

For Baylis RF Generator units where power is adjustable, do not
attempt to deliver radiofrequency energy with an initial power setting
of greater than 10 Watts. In subsequent attempts, the power setting
can be increased, if necessary.

The active tip of the PowerWire
not to damage the tip while handling the PowerWire
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Radiofrequency
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RF GuideWire are
This Cable enables radiofrequency (RF)
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RF GuideWire.
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RF GuideWire and the RFP-100A
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RF GuideWire.
RF GuideWire is cleared for creating a
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RF GuideWire. Attempts to use
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RF GuideWire is fragile. Be careful
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RF GuideWire.
If the tip becomes damaged, discard the PowerWire
immediately.

If the active tip of the PowerWire
any time during its use, dispose of the PowerWire
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
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.
V. PRECAUTIONS

Do not attempt to use the PowerWire
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
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RF
detect any compromise. Ensure that the packaging has not been
damaged. Do not use the equipment if the packaging has been
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compromised.

Visually inspect the PowerWire
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
date indicated on the label.

The PowerWire
devices listed in section VII "Equipment Required." The RFP-100A
Connector Cable is intended for use with the PowerWire
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
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RF
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
performed to avoid vessel trauma.
advancement should be done under fluoroscopic guidance.
resistance is encountered, DO NOT use excessive force to advance
or withdraw the PowerWire
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
Do not attempt to deliver radiofrequency energy until the tip of the
PowerWire
the target biological material.

Do not bend the PowerWire
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
RFP-100A Connector Cable.

It is recommended not to exceed twenty (20) radiofrequency power
applications per PowerWire

The Generator is capable of delivering significant electrical power.
Patient or operator injury can result from improper handling of the
PowerWire
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
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.
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RF GuideWire becomes bent at
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RF GuideWire Kit or ancillary
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RF GuideWire and the RFP-100A
RF GuideWire Kit after the "Use By"
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RF GuideWire is intended for use with only those
PowerWire
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RF GuideWire.
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RF GuideWire is confirmed to be in good contact with
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RF GuideWire or the RFP-100A
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RF GuideWire.
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RF GuideWire and/or DIP electrode, particularly when
DMR EWK 3.3 V-6 08-Mar-2018
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RF GuideWire
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RF GuideWire
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RF
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RF GuideWire must be
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RF GuideWire
If
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RF GuideWire and the
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RF