Baylis VersaCross RF Wire Bedienungsanleitung Seite 2

safety of combinations of other physiological monitoring and electrical apparatus to be used on the
patient in addition to the Baylis RF Generator.
 Adequate filtering must be used to allow continuous monitoring of the surface electrocardiogram
(ECG) during RF power applications.
 Do not attempt to insert and use the proximal end of the VersaCross
 Do not bend the VersaCross ™
RF Wire or the Connector Cable. Excessive bending or kinking of the
wire shaft, distal curve of the wire and/ or the Connector Cable may damage the integrity of the
device components and may cause patient injury. Care must be taken when handling the
VersaCross ™ RF Wire and Connector Cable.
 Careful manipulation of the VersaCross
resistance is encountered, DO NOT use excessive force to advance or withdraw the VersaCross
RF Wire or ancillary sheath and/or dilator assembly. Excessive force may lead to bending or kinking
of the device limiting advancement and retraction of sheath and/or dilator device.
 VersaCross
™ RF Wire and ancillary sheath and/or dilator assembly advancement should be done
under imaging guidance. The use of visible markers on the wire body are only an approximate guide
for positioning the wire tip with the distal end of the dilator.
 Do not attempt to deliver RF energy until the active tip of the VersaCross
be in good contact with the target tissue.
 Avoid RF energy delivery of the VersaCross™ RF Wire with incompatible dilator or cannula devices,
which may lead to patient burns, ineffective puncture or failure to puncture.
 It is recommended not to exceed five (5) RF power applications per VersaCross
 Never disconnect the Connector Cable from the Baylis RF Generator while RF power is being
delivered.
 Never disconnect the Connector Cable from the Baylis RF Generator by pulling on the cable. Failure
to disconnect the cable properly may result in damage to the cable.
 Do not twist the Connector Cable while inserting or removing it from the Isolated Patient Connector
on the Baylis RF Generator. Twisting the cable may result in damage to the pin connectors.
 The Baylis RF Generator is capable of delivering significant electrical power. Patient or operator
injury can result from improper handling of the VersaCross
particularly when operating the device.
 During power delivery, the patient should not be allowed to come in contact with ground metal
surfaces.
 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 tissue contact at
the active tip. Check for obvious equipment defects or misapplication. Attempt to better position the
™
active tip of the VersaCross RF Wire against the atrial septum. Only increase the power if low power
output persists.
 If using electroanatomical mapping guidance, it is recommended to use it along with alternative
imaging modality in the event there is loss of visibility of the device.
VI.
PRODUCT SPECIFICATIONS
™
Product VersaCross RF
Wire
Length 180 or 230cm
Wire 0.035" / 0.89mm
Diameter
Curve 9 mm J-tip or 24
Diameter mm Pigtail
VII.
ADVERSE EVENTS
Adverse events that may occur while creating an atrial septal defect include:
Tamponade Sepsis/Infection
Vessel perforation Atrial Fibrillation
Vessel spasm Sustained arrhythmias
Hemorrhage Vascular thrombosis
Hematoma Allergic reaction to contrast medium
Pain and Tenderness Arteriovenous fistula
Tachycardia Vascular Trauma
Wire entrapment/
Foreign body/wire fracture
entanglement
VIII.
EQUIPMENT REQUIRED
RF transseptal procedures should be performed in a specialized clinical setting equipped with
appropriate imaging equipment and compatible examination table, echocardiography imaging,
physiologic recorder, emergency equipment and instrumentation for gaining vascular access. Ancillary
materials required to perform this procedure include:
 RFP-100A Baylis RF Generator
 0.035" compatible transseptal sheath and/or dilator devices
 DIP electrode, meeting or exceeding IEC 60601-2-2 requirements for electrosurgical electrodes
 DuoMode Cable
TM for use with electroanatomic mapping systems
IX.
INSPECTION PRIOR TO USE
Prior to performing the procedure, the VersaCross
be carefully examined for damage or defects, as should all equipment, including the Baylis RF
Generator, used in the procedure. Do not use defective equipment. Do not reuse the VersaCross
Wire and/or 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 VersaCross
™ RF Wire and Connector Cable are supplied sterile. Use aseptic technique when
opening the package and handling the product in the sterile field.
 Connect the generator connector end of the Connector Cable to the isolated patient connector port
on the Baylis RF Generator as per the Baylis RF Generator Instructions for Use. 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 Connector Cable to the Baylis RF Generator. Use of
excessive force may result in damage to the connector pins.
 Thoroughly flush the transseptal sheath and/or dilator (not supplied).
Page 2 of 25
™ RF Wire as the active tip.
™ RF Wire must be performed to avoid vessel trauma. If
™ RF Wire is confirmed to
™ RF Wire.
™ RF Wire and/or DIP electrode,
Product RFP 100A Connector Cable
Useable Length 10 feet/3m
Generator 4-pin (3-pin)
Connector
Device Push Button
Connector
Thromboembolic episodes
Myocardial Infarction
Atrial Flutter
Perforation of the myocardium
Ventricular Tachycardia
Pericardial effusion
Additional Surgical Procedure
™
RF Wire and the provided Connector Cable should
 Perform a standard vein puncture at the desired access site using an access needle (not supplied).
 A transseptal sheath and/or dilator are usually inserted through the access site and are then
advanced over a guidewire to be positioned into the Superior Vena Cava (SVC) under image
™
guidance. The VersaCross
 If the VersaCross™ RF Wire was not used to advance the sheath to the SVC, remove the guidewire
and exchange for the VersaCross
 Advance the VersaCross ™
RF Wire through the transseptal sheath and/or dilator assembly until the
wire tip is just within the dilator tip. The visible markers on the wire body can be used to assist with
the positioning of the wire tip with the distal end of the dilator.
 Firmly grasp the catheter connector end of the Connector Cable in one hand. Using your thumb,
™
depress the red button on the top of the connector. Slowly insert the proximal end of the
VersaCross ™ RF 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.
 Position the tip of the transseptal assembly (RF wire, sheath and/or dilator assembly) in the right
atrium against the fossa ovalis under appropriate imaging guidance including but not limited to
fluoroscopic, echocardiographic and/or electroanatomic mapping guidance using standard
technique.
 NOTE: If using electroanatomical mapping guidance, it is recommended to confirm tip placement
and septal tenting with echocardiographic imaging or another imaging modality.
 Apply pressure to the dilator to tent the septum at the fossa ovalis.
 Advance the VersaCross
™ RF Wire so that the active tip is engaging the septum at the fossa ovalis
but still within the dilator.
 Once appropriate positioning has been achieved, deliver RF power via the Baylis RF Generator to
the active tip. This results in puncture of the targeted cardiac tissue. Please refer to the Baylis RF
Generator Instructions For Use for the correct operation of the generator.
 Apply firm pressure to the VersaCross
advance the VersaCross ™ RF Wire through the tissue.
 NOTE: Use the lowest appropriate RF settings to achieve the desired puncture.
 For RFP-100A: An initial RF setting between one (1) second on "PULSE" mode to two (2)
seconds on "CONSTANT" mode has been shown to be sufficient for successful puncture.
 RF power delivery can be terminated by pressing the RF ON/OFF button on the Baylis RF Generator
if the timer has not expired.
 Entry into the left atrium can be confirmed by monitoring the VersaCross
imaging guidance. Echocardiographic guidance is also recommended.
 If septal puncture is not successful after five (5) RF power applications, it is advised that the user
utilize an alternate method for the procedure.
 Once the puncture is successfully completed, the VersaCross
advanced without any RF power. Positioning in the left atrium is sufficient when the full distal curve
and floppy section have crossed the septum and are observed in the left atrium. Echocardiographic
guidance is also recommended.
 The dilator can then be advanced over the VersaCross
 To disconnect the VersaCross
catheter connector and gently remove the proximal end of the VersaCross
Connector Cable.
 To disconnect the Connector Cable from the Baylis RF Generator, grasp the connector firmly and
gently pull it straight out of the socket.
 Retract the VersaCross
™ RF Wire slowly through the transseptal sheath and/or dilator assembly.
Connections
Baylis RF Generator
Single-Use
Connector Cable
(Included)
DIP Grounding Pad
Foot Switch
(Optional)
XI.
CLEANING AND STERILIZATION INSTRUCTIONS
The VersaCross ™ RF Wire and Connector Cable are intended for single use only. Do not clean or re-
sterilize the VersaCross ™ RF Wire and/or Connector Cable.
XII.
TROUBLESHOOTING
The following table is provided to assist the user in diagnosing potential problems.
PROBLEM
Connector Cable The connectors are
does not fit into designed to connect in a
the Isolated specific way for safety
Patient Connector reasons. If the connector
™ RF on the front panel "keys" are out of line, the
of the generator connectors won't fit
together.
Generator Error In order to successfully
Messages perforate tissue using RF
energy, all devices must be
properly connected and in
good working order.
RF Wire may be used for this purpose.
™
RF Wire with the provided tip straightener.
™ RF Wire during the application of RF energy to successfully
™
™ RF Wire should be mechanically
™ RF Wire to enlarge the puncture.
™ RF Wire from the Connector Cable, depress the red button on the
VersaCross ™ RF Wire
(Pigtail model shown)
COMMENTS TROUBLESHOOTING
Check that the connector keys are
lined up in the proper orientation.
Ensure that all connections are made
i.e.:
- VersaCross
Connector Cable
- Connector Cable to Baylis RF
Generator
- Baylis RF Generator to power
outlet
- Baylis RF Generator to grounding
pad
DMR VXW 3.3 V-10 (Non-CE Marked)
RF Wire under appropriate
™ RF Wire from the
™
RF Wire to