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DMR EWK 3.3 V-6 08-Mar-2018
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 misapplication. Attempt to better position the active tip of
the PowerWire
TM
RF GuideWire against the target biological material.
Only increase the power if low power output persists.
Baylis Medical Company relies on the physician to determine, assess
and communicate to each individual patient all foreseeable risks of the
radiofrequency interventional procedure.
VI.
PRODUCT SPECIFICATIONS
Product
PowerWire
TM
RF
GuideWire
Product
RFP-100A
Connector Cable
Useable
Length
250cm
Useable
Length
10 feet (3m)
Outside
Diameter
0.035” / 0.89 mm
Generator
Connector
4-pin
Marker
Bands
5
Placed 1 cm apart
Device
Connector
Push Button
VII.
ADVERSE EVENTS
Adverse events that may occur while performing the radiofrequency cutting
procedure include:
Thrombosis
Pain and Tenderness
Vessel perforation
Distal embolization
Vessel dissection
Sepsis/Infection
Hemorrhage
Hematoma
Tamponade
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
TM
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
TM
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
TM
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
TM
RF GuideWire or the RFP-100A Connector Cable.
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
TM
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
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
TM
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
TM
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
TM
RF GuideWire during the
application of radiofrequency energy to successfully advance it
through the target site.
NOTE: In Baylis RF Generator units with adjustable power, use the
lowest appropriate power setting to achieve the desired effect. A
power setting of 10 Watts has been experimentally determined to be
sufficient for successful radiofrequency cutting. Therefore, do not use
an initial power setting greater than 10 Watts.
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
TM
RF GuideWire can be
confirmed by monitoring the PowerWire
TM
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
TM
RF GuideWire can now be used to exchange for or
place other interventional devices at the discretion of the physician.
The PowerWire
TM
RF GuideWire can also be used as a standard
flexible mechanical guidewire.
To disconnect the PowerWire
TM
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.
Connections
(pg. 19)
XI.
CLEANING AND STERILIZATION INSTRUCTIONS
The PowerWire
TM
RF GuideWire Kit is intended for single use only. Do
not clean or re-sterilize any device in the PowerWire
TM
RF GuideWire Kit.
Do not use solvents to clean the distal tip of the PowerWire
TM
RF
GuideWire.
The PowerWire
TM
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 Company
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
Company.
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
TROUBLESHOOTING
Connector Cable
does not fit into the
Isolated Patient
Connector
on the
front panel of the
generator
The connectors are
designed to connect in a
specific way for safety
reasons. If the connector
“keys” are out of line, the
connectors won’t fit
together
Check that the connector keys
are lined up in the proper
orientation.
Ensure that the connectors are
clean and unobstructed.
Generator Error
Messages
In order to successfully
puncture biological material
using RF energy, all
devices must be properly
connected and in good
working order.
Ensure that all connections are
made:
- PowerWire
TM
RF GuideWire
to Connector Cable
- Connector Cable to
Generator
- Generator to power outlet
- Generator to DIP electrode
Visually inspect the
PowerWire
TM
RF GuideWire or
Cable for damage.
Immediately discard any
damaged equipment. If
problem persists discontinue
use.
For error messages
encountered while attempting
radiofrequency cutting, refer to
the Instructions for Use
document that accompanies
the Generator. If errors persist,