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DMR RFP-265 3.3 V-16 07-Mar-2018
physiologic recorder, emergency equipment and instrumentation for
gaining vascular access. Ancillary materials required to perform cardiac
puncture include:
BMC Radiofrequency Puncture Generator
BMC Catheter Connector Cable (Model RFP-101 for use with
RFP-100 Generator or RFX-BAY-OTW-10-SU for use with RFP-
100A Generator)
Disposable Indifferent (dispersive) Patch (DIP) electrode that
meets or exceeds IEC 60601-2-2 requirements for
electrosurgical electrodes, such as the Valley Labs Polyhesive
Electrode #E7506.
It is recommended to use Nykanen Radiofrequency Wire with
Baylis Medical ProTrack
TM
Microcatheter (Model CIC 38-145).
IX.
SETTING UP THE SYSTEM
Please refer to the BMC Radiofrequency Puncture Generator
Instructions for Use. The Instructions for Use describe the steps
to follow to connect the system, set parameters, and deliver
radiofrequency power.
All instructions for equipment required should be carefully read,
understood, and followed. Failure to do so may result in
complications.
X.
ATTACHING THE INDIFFERENT ELECTRODE
Remove the Disposable Indifferent (dispersive) Patch (DIP)
electrode from the packaging and peel off the backing to expose
the conductive gel surface. Check to be sure the pad is moist and
sticky to the touch before placing it on the patient. A dry electrode
will have limited grounding capability.
Place the DIP electrode on a well-vascularized convex skin
surface which is in close proximity to the heart. Do not place this
electrode on the thigh, since this location is associated with higher
impedance (se
e section V, “Precautions”). Avoid scar tissue, body
prominence, adipose tissue, and areas where fluid may pool.
Shave, clean, and dry the application site as needed.
Check to be sure that excellent contact has been achieved over
the entire area of the DIP electrode. Burns can result when RF
power is delivered to a DIP electrode with poor contact.
Plug the DIP electrode connector into the appropriate port on the
BMC RF Puncture Generator as per the Generator Instructions for
Use. Make sure that the DIP electrode connector is firmly pressed
into the socket.
XI.
DIRECTIONS FOR USE
The Nykanen Radiofrequency Wire is usually inserted into the femoral
vein and is then positioned into the appropriate chamber of the heart
under fluoroscopic guidance. Once appropriate positioning has been
achieved, radiofrequency power is delivered via the BMC RF Puncture
Generator. This results in the puncture of the targeted cardiac tissue.
The Nykanen Wire is supplied sterile. Use aseptic technique
when opening the package and handling the product in the sterile
field.
Prior to the insertion of the Nykanen Wire, the usual premedication
for cardiac catheterization is necessary.
The procedure can be done percutaneously via the femoral vein.
When the procedure is performed by the percutaneous technique,
a guiding catheter is used to introduce the Nykanen Wire into the
heart to the puncture site.
Prior to the puncture procedure, both left and right atrial pressure
should be recorded and systemic saturation determined.
The Nykanen Wire is introduced into the right atrium with the
location of the wire tip confirmed by fluoroscopic examination.
Connect the Nykanen Wire to the BMC Catheter Connector Cable
ensuring that the Nykanen Wire is inserted properly into the push-
button connector. Make sure that the Connector Cable is plugged
into the appropriate port on the BMC RF Puncture Generator. Be
sure to carefully follow the Generator Instructions for Use.
Advance the Nykanen Wire so that the active tip is extended
beyond the tip of the catheter and is engaging the target tissue.
Once appropriate positioning has been achieved, RF power can
be delivered via the BMC RF Puncture Generator to the active tip.
This results in the puncture of the targeted cardiac tissue. Please
refer to the Generator Instructions for Use before using the
Generator.
NOTE: If the active tip of the Nykanen Wire becomes bent at
any time during its use, dispose of the wire immediately. Do
not attempt to straighten the active tip.
NOTE: It is recommended that the user use the least amount
of energy to achieve the desired puncture.
For RFP-100: A power setting of 10 watts has been experimentally
determined to be sufficient for successful puncture. Do not use an
initial power setting greater than 10 Watts.
For RFP-100A:
An initial setting of one (1) second on “PULSE”
mode is recommended. In subsequent punctures, the mode and
time settings can be adjusted if necessary based on the
physician’s discretion. Do not attempt to puncture with an initial
setting of greater than o
ne (1) second on “PULSE” mode.
Firm pressure must be applied to the Nykanen Wire during the
procedure to successfully advance it through the tissue.
RF power delivery can be terminated by pressing the RF ON/OFF
button on the Generator if the timer has not expired.
If septal puncture is not successful after five (5) RF power
applications, it is advised that the user proceed with an alternate
method for the procedure.
Once the initial puncture is successfully completed, the Nykanen
Wire should be advanced forward mechanically without any
radiofrequency power.
Entry into the left atrium can be confirmed by monitoring the
Nykanen Wire under fluoroscopy. Once the guiding catheter has
been advanced over the Nykanen Wire, a small injection of
contrast medium will indicate that the guiding catheter is now in
the left atrium.
The Nykanen Wire can now be removed from the patient. The
puncture should then be enlarged by any appropriate, approved
dilation methods. The appropriate user instructions supplied with
these different devices should be followed.
XII.
LABELING AND SYMBOLS
Manufacturer
EU Authorized Representative
Sterile using ethylene oxide
Use By
Caution
Follow Instructions for Use
Model number
Caution:
Federal (U.S.A.) law restricts
this device to sale by or on the order of a
physician.
Single Use
– Do not reuse
Lot Number
Do Not Use if Packaging is Damaged
Keep Away From Sunlight
Only for EU member states:
Use of this symbol indicates that the
product must be disposed of in a way
that complies with local and national
regulations. For questions regarding
recycling of this device please contact
your distributor
Non-Pyrogenic
XIII.
LIMITED WARRANTY
– Disposables and Accessories
Baylis Medical Company Inc. (BMC) warrants its Disposable and
Accessory products against defects in materials and workmanship.
BMC warrants that sterile products will remain sterile for a period of time
as shown on the label as long as the original package remains intact.
Under this Limited Warranty, if any covered product is proved to be
defective in materials or workmanship, BMC will replace or repair, in its
absolute and sole discretion, any such product, less any charges to BMC
for transportation and labor costs incidental to inspection, removal or
restocking of product. The length of the warranty is: (i) for the Disposable
products, the shelf life of the product, and (ii) for the Accessory products,
90 days from shipment date. This limited warranty applies only to new