Idiomas disponibles
Idiomas disponibles
•
Do not twist the RFP-100A Connector Cable while inserting or
removing it from the Isolated Patient Connector on the Generator.
Twisting the cable may result in damage to the pin connectors.
Apparent low power output or failure of the equipment to function
•
properly at normal settings may indicate faulty application of the DIP
electrode, failure to an electrical lead, or poor contact with the target
biological material at the active tip. Check for obvious equipment
defects or misapplications. Attempt to better position the active tip of
the PowerWire Pro RF Guidewire against the target biological
material. Only increase the power if low power output persists.
Baylis Medical Technologies relies on the physician to determine,
•
assess, and communicate to each individual patient all foreseeable
risks of the radiofrequency interventional procedure.
VI.
PRODUCT SPECIFICATIONS
PowerWire Pro RF
Product
Guidewire
Useable
250cm
Length
Outside
0.035" / 0.89 mm
Diameter
Marker
5
Bands
Placed 1 cm apart
The PowerWire Pro RF Guidewire is a defibrillation-proof type CF applied
part.
VII.
ADVERSE EVENTS
Adverse events that may occur while performing the radiofrequency cutting
procedure include:
Thrombosis
Vessel perforation
Vessel dissection
Hemorrhage
Tamponade
Effusion
Damage to Stent
:
VIII.
EQUIPMENT REQUIRED
Radiofrequency cutting procedures should be performed in a specialized
clinical setting equipped with a fluoroscopy unit, radiographic table,
physiologic recorder, emergency equipment and instrumentation for gaining
vascular access. Ancillary materials required to perform this procedure
include:
•
Baylis Radiofrequency Generator
•
Disposable Indifferent (dispersive) Patch (DIP) electrode
IX.
INSPECTION PRIOR TO USE
Prior to performing the radiofrequency cutting procedure, the individual
components including the Baylis Radiofrequency Generator, PowerWire
Pro RF Guidewire, and the RFP-100A Connector Cable should be carefully
examined for damage or defects, as should all equipment used in the
procedure.
Inspect the packaging of the PowerWire Pro Radiofrequency Guidewire Kit
to ensure the package has not been damaged, sterility has not been
compromised, and that a product label is present. Ensure that the RFP-
100A Connector Cable and the PowerWire Pro Radiofrequency Guidewire
have no visible damage, such as discoloration, cracks, label fading, splicing,
or kinks. Do not use damaged or defective equipment. Do not reuse the
PowerWire Pro RF Guidewire or the RFP-100A Connector Cable. In cases
of use in vessels with stents, observe any significant stent irregularities (e.g.
kinks, fractures, etc.) by angiography prior to insertion into vasculature.
X.
DIRECTIONS FOR USE
All instructions for equipment required should be carefully read, understood,
and followed. Failure to do so may result in complications.
•
The PowerWire Pro RF Guidewire Kit is supplied sterile. Use aseptic
technique when opening the package and handling the product in the
sterile field.
Connect the generator connector end of the cable to the isolated
•
patient connector port on the RFP-100A Generator as per the
Generator Instructions for Use. The RFP-100A Connector Cable uses
a circular connector, keyed for proper alignment. Gently line up the
connector pins with the socket and push in until the connector fits
Page 3 of 12
RFP-100A
Product
Connector
Cable
Useable
10 feet (3m)
Length
Generator
Multi-pin
Connector
Device
Push Button
Connector
Pain and Tenderness
Distal embolization
Sepsis/Infection
Hematoma
Arrhythmias
Death
Entanglement of device in stent
firmly into the socket. Any attempt to connect the cable otherwise will
damage the pins on the connector.
•
Do not use excessive force in connecting the cable to the generator.
Use of excessive force may result in damage to the connector pins.
Once access to the target site has been gained using standard
•
interventional techniques, the PowerWire Pro RF Guidewire can be
introduced to the target site.
•
Firmly grasp the catheter connector end of the cable in one hand.
Using your thumb depress the red button on the top of the connector.
Slowly insert the proximal end of the RF puncture wire into the opening
of the catheter connector. Once the exposed portion of the proximal
end of the device is no longer visible release the red button on the
connector. Gently tug on the device to ensure that you have a secure
connection.
•
With the tip of the PowerWire Pro RF Guidewire in good contact with
the target site, radiofrequency power can be delivered via the BMC
Radiofrequency Generator to the distal tip. This results in thermal
necrosis (cutting) of the target site. Please refer to the Generator
Instructions for Use before using the Generator.
•
Apply firm pressure to the PowerWire Pro RF Guidewire during the
application of radiofrequency energy to successfully advance it
through the target site.
Radiofrequency power delivery can be terminated by pressing the RF
•
ON/OFF button on the Generator if the timer has not expired.
•
Successful advancement of the PowerWire Pro RF Guidewire can be
confirmed by monitoring the PowerWire Pro RF Guidewire under
fluoroscopy.
If advancement through the target site is not successful after twenty
•
(20) radiofrequency power applications, it is advised that the user
utilize an alternate method for the procedure.
•
The PowerWire Pro RF Guidewire can now be used to exchange for
or place other interventional devices at the discretion of the physician.
•
The PowerWire Pro RF Guidewire can also be used as a standard
flexible mechanical Guidewire.
To disconnect the PowerWire Pro RF Guidewire from the RFP-100A
•
Connector Cable, depress the red button on the catheter connector
and gently remove the proximal end of the puncture device from the
connector cable.
To disconnect the cable from the generator, grasp the connector firmly
•
and gently pull it straight out of the socket.
In cases of occluded stents, lack of advancement through occluded
•
stents may be attributed to device interaction with strut of stent. In this
case, halt application of radiofrequency energy, reposition the distal
end of the device by torquing and retracting slightly. Ensure good
contact with the target site and then repeat application of
radiofrequency energy while avoiding contact with stent struts.
Connections (pg. 19)
XI.
CLEANING AND STERILIZATION INSTRUCTIONS
The PowerWire Pro RF Guidewire Kit is intended for single use only. Do
not clean or re-sterilize any device in the PowerWire Pro RF Guidewire Kit.
Do not use solvents to clean the distal tip of the PowerWire Pro RF
Guidewire.
The PowerWire Pro RF Guidewire Kit can be considered sterile only if the
package is not opened or damaged prior to use.
XII.
CUSTOMER SERVICE AND PRODUCT RETURN
INFORMATION
If you have any problems with or questions about Baylis Medical
Technologies equipment, contact technical support personnel.
NOTES:
1.
In order to return products you must have a return authorization
number before shipping the products back to Baylis Medical
Technologies.
2.
Baylis Medical will not accept any piece of used equipment without a
sterilization certificate. Ensure that any product being returned to
Baylis Medical has been cleaned, decontaminated and sterilized as
per user instructions before returning it for warrantied service.
XIII.
TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential
problems.
PROBLEM
COMMENTS
Connector Cable
The connectors are
does not fit into the
designed to connect in a
Isolated Patient
specific way for safety
Connector on the front
reasons. If the connector
panel of the generator
"keys" are out of line, the
connectors won't fit
together
DMR PSK 3.3 V-1 13-Feb-2023
TROUBLESHOOTING
Check that the connector
keys are lined up in the
proper orientation.
Ensure that the connectors
are clean and unobstructed.
