Baylis Medical SupraCross Instructions For Use Manual

Instructions for Use
SupraCross
English .............................................................................................................................. 1
Francais ............................................................................................................................ 3
Deutsch ............................................................................................................................ 4
Nederlands ....................................................................................................................... 6
Italiano .............................................................................................................................. 8
Español ............................................................................................................................. 9
Português ....................................................................................................................... 11
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801
Fax: (514) 488-7209
www.baylismedical.com
EU Authorized Representative:
Quality First International
20 Eversley Road, Bexhill-on-Sea, East Sussex
TN40 1HE, United Kingdom
Tel: +44-(20)-8-522-1937 Fax: +44-(20)-8-522-1937
© Copyright Baylis Medical Company Inc., 2016-2018
The Baylis Medical Company logo and SupraCross are trademarks and/or registered
trademarks of Baylis Medical Company Inc. in the USA and/or other countries. Patents
pending and/or issued.
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
The SupraCross RF Wire is packaged with a Baylis Connector Cable. The SupraCross RF Wire must
be used with an approved Baylis Radiofrequency Puncture Generator (Baylis RF Generator) and
Baylis Connector Cable (Connector Cable).
The SupraCross RF Wire 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 IEC 60601-2-2 standards. The Connector Cable connects the
Baylis RF Generator to the SupraCross RF Wire. This Connector Cable enables RF power to be
delivered from the Baylis RF Generator to a SupraCross RF Wire.
Detailed information concerning the Baylis RF Generator is contained in a separate manual that
accompanies the Generator (entitled "Baylis Radiofrequency Puncture Generator Instructions for
Use"). Baylis RF Generators compatible with the SupraCross RF Wire include the RFP-100A.
The dimensions of the SupraCross RF Wire and the Baylis Connector Cable can be found on the
device label. The insulation on the body of the SupraCross RF Wire facilitates smooth advancement
of the device and provides electrical insulation. The floppy distal portion of the SupraCross RF Wire
has a small curve and the active tip is rounded to be atraumatic to cardiac tissue unless RF energy is
applied. A marker coil is positioned on the curve for visualization under fluoroscopy. The main body of
the SupraCross RF Wire provides a stiff rail for advancing ancillary devices into the left atrium
following creation of an atrial septal defect. The floppy proximal portion of the SupraCross RF Wire
has a large circular curve and the proximal end is bare metal to connect with the included Connector
Cable. The other end of the included Connector Cable connects to the Baylis RF Generator.
II.
INDICATIONS FOR USE
The SupraCross RF Wire is indicated for creation of an atrial septal defect in the heart.
III.
CONTRAINDICATIONS
The SupraCross RF Wire is not recommended for use with any conditions that do not require the
creation of an atrial septal defect.
The Baylis Connector Cable, packaged with the SupraCross RF Wire, 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 this device. 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.
 The SupraCross RF Wire and Baylis Connector Cable (Connector Cable) are supplied STERILE
using an ethylene oxide process. Do not use if the package is damaged.
 Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency
puncture 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.
 The SupraCross RF Wire and Connector Cable are intended for single patient use only. Do not
attempt to sterilize and reuse either device.
communication of infectious disease(s) from one patient to another. Failure to do so may result in
patient complications.
 The SupraCross RF Wire must be used with the Connector Cable provided. Attempts to use it with
other connector cables can result in electrocution of the patient and/or operator.
 The Connector Cable must only be used with Baylis Radiofrequency Puncture Generator (Baylis
RF Generator) and the included SupraCross RF Wire. Attempts to use it with other RF Generators
and devices can result in electrocution of the patient and/or operator.
 The SupraCross RF Wire must be used with 0.035" Compatible Transseptal Sheath and Dilator
devices.
Page 1 of 13
®
RF Wire
________
Reuse can cause the patient injury and/or the
 The active tip and distal curve of the SupraCross RF Wire are fragile. Be careful not to damage the
tip or the distal curve while handling the SupraCross RF Wire. If the tip or the distal curve becomes
damaged, discard the SupraCross RF Wire immediately.
 If the active tip of the SupraCross RF Wire becomes bent at any time during its use, dispose of the
SupraCross RF Wire immediately. Do not attempt to straighten the active tip.
 The SupraCross RF Wire is not intended for use with neonatal patients (less than one month of
age). Do not attempt to treat neonatal patients with the SupraCross RF Wire.
V.
PRECAUTIONS
 Do not attempt to use the SupraCross RF Wire and Baylis Connector Cable (Connector Cable) or
ancillary equipment before thoroughly reading the accompanying Instructions for Use.
 Radiofrequency puncture procedures should be performed only by physicians thoroughly trained in
the techniques of radiofrequency powered puncture in a fully equipped catheterization laboratory.
 The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure
that the packaging has not been damaged. Do not use the equipment if the packaging has been
compromised.
 Visually inspect the SupraCross RF Wire and Connector Cable prior to use to ensure there is no
cracking or damage to the insulating material. Do not use the wire or the cable if there is any
damage.
 Do not use the SupraCross RF Wire and/or Connector Cable after the USE BY date indicated on
the label.
 The SupraCross RF Wire and Connector Cable is intended for use with only those devices listed in
Section VIII, Equipment Required.
 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, ensure that flammable materials are not present in the room
during RF power application.
 Take precautions to limit the effects that the electromagnetic interference (EMI) produced by the
Baylis Radiofrequency Puncture Generator (Baylis RF Generator) may have on the performance of
other equipment. Check the compatibility and 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 radiofrequency power applications.
 Do not attempt to insert and use the proximal end of the SupraCross RF Wire as the active tip.
 Do not bend the SupraCross RF Wire or the Connector Cable. Excessive bending or kinking of the
wire shaft, distal curve, or proximal curve may damage the integrity of the SupraCross RF Wire and
may cause patient injury. Care must be taken when handling the RF Wire and Connector Cable.
 Careful manipulation of the SupraCross RF Wire must be performed to avoid vessel trauma.
SupraCross RF Wire and Dilator advancement should be done under imaging guidance.
resistance is encountered, DO NOT use excessive force to advance or withdraw the SupraCross
RF Wire or Dilator.
 Do not attempt to deliver radiofrequency energy until the active tip of the SupraCross RF Wire is
confirmed to be in good contact with the target tissue.
 It is recommended not to exceed five (5) RF power applications per SupraCross RF Wire.
 Never disconnect the Connector Cable from the Baylis RF Generator while the Generator is
delivering RF power.
__  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 SupraCross RF Wire and/or DIP electrode,
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 SupraCross RF Wire against the atrial septum. 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 Baylis Medical Radiofrequency Puncture System.
VI.
PRODUCT SPECIFICATIONS
Product SupraCross RF Wire
Useable Length 180cm
0.035" / 0.89mm
Outside
Diameter
Marker Coil 1 x 30mm Coil
Proximal of Electrode
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
VIII.
EQUIPMENT REQUIRED
Radiofrequency transseptal procedures should be performed in a specialized clinical setting equipped
with a fluoroscopy unit, radiographic table, echocardiography imaging, physiologic recorder,
emergency equipment and instrumentation for gaining vascular access. Ancillary materials required to
perform this procedure include:
 Baylis Radiofrequency Puncture Generator (RFP-100A)
 0.035" Compatible Transseptal Sheath/Dilator kit
 Disposable Indifferent (dispersive) Patch (DIP) electrode must meet or exceed IEC 60601-2-2
requirements for electrosurgical electrodes
IX.
INSPECTION PRIOR TO USE
Prior to performing the procedure, the individual components including the Baylis Radiofrequency
Puncture Generator, SupraCross RF Wire and the Baylis Connector Cable (Connector Cable) should
be carefully examined for damage or defects, as should all equipment used in the procedure. Do not
use defective equipment. Do not reuse the RF 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 SupraCross RF Wire and Baylis Connector Cable (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 Radiofrequency Puncture RF Generator (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.
Product RFP 100A Connector Cable
Useable Length 10 feet/3m
Generator 4-pin (1-pin)
Connector
Device Connector Push Button
Thromboembolic episodes
Myocardial Infarction
Atrial Flutter
Perforation of the myocardium
Ventricular Tachycardia
DMR SPW 3.3 V-3.01 06-Jun-2018
If