Baylis Medical VersaCross HF-Draht Bedienungsanleitung

Instructions for Use
VersaCross
[English ...........................................................................................................................1]
[Francais ..........................................................................................................................3]
[Deutsch ..........................................................................................................................5]
[Nederlands .....................................................................................................................7]
[Italiano ............................................................................................................................9]
[Español ........................................................................................................................11]
[Português.....................................................................................................................13]
[Czech ............................................................................................................................15]
[Danish ..........................................................................................................................17]
[Finnish ..........................................................................................................................19]
[Norwegian ....................................................................................................................20]
[Swedish ........................................................................................................................22]
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 OÜ
Laki 30, 12915 Tallinn
Estonia
Telephone: +372 610 41 96
Email: enquiries@qualityfirstint.ee
EU Importer:
MedEnvoy
Prinses Margrietplantsoen 33 – Suite 123
2595 AM The Hague
The Netherlands
© Copyright Baylis Medical Company Inc., 2008-2021
The Baylis Medical Logo and VersaCross are trademarks and/or registered trademarks
of Baylis Medical Company Inc. in the USA and/or other countries. Patents pending
Page 1 of 24
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RF Wire
and/or issued.
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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.
Baylis Medical Company relies on the physician to determine, assess and communicate to each
individual patient all foreseeable risks of the procedure.
I.
DEVICE DESCRIPTION
®
The VersaCross RF Wire is packaged with a single-use VersaCross
Connector Cable (Connector Cable) The VersaCross
RFP-100A Radiofrequency Puncture Generator (Baylis RF Generator) and the Connector Cable.
®
The VersaCross 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 current IEC 60601-2-2 requirements. The Connector Cable
connects the Baylis RF Generator to the VersaCross
power to be delivered from the Baylis RF Generator to the VersaCross
concerning the Baylis RF Generator is contained in a separate manual that accompanies the equipment
(entitled "Baylis Medical Company Radiofrequency Puncture Generator Instructions for Use").
®
The dimensions of the VersaCross RF Wire and the Connector Cable can be found on the device
labels. The insulation on the body of the VersaCross
device and provides electrical insulation. The floppy distal portion of the VersaCross
curve and the active tip is rounded to be atraumatic to cardiac tissue unless RF energy is applied. A
radiopaque and echogenic marker coil is positioned on the distal section for visualization during
manipulation. The main body of the VersaCross
devices into the left atrium following the creation of an atrial septal defect. The VersaCross
features visible markers along its length to assist with aligning the wire tip in a compatible transseptal
sheath and dilator assembly (e.g., the VersaCross
®
VersaCross RF Wire is bare metal to connect only with the provided Connector Cable and not with
electrocautery or electrosurgery devices . The other end of the Connector Cable connects to the Baylis
RF Generator.
II.
INDICATIONS FOR USE
®
The VersaCross RF Wire is indicated for creation of an atrial septal defect in the heart.
III.
CONTRAINDICATIONS
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The VersaCross RF Wire is not recommended for use with any conditions that do not require the
creation of an atrial septal defect. The Connector Cable is not recommended for use with any other
Baylis RF Generator or any other device.
In the EU: The VersaCross® RF Wire is not intended for use with neonatal patients that are less than
one month of age.
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 VersaCross
®
RF Wire and 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 RF 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 VersaCross
®
RF Wire and Connector Cable are intended for single patient use only. Do not
attempt to sterilize and reuse either devices. Reuse can cause patient injury and/or the
communication of infectious disease(s) from one patient to another. Reuse may result in patient
complications.
• The VersaCross
®
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.
• Do not use the VersaCross
®
RF Wire with electrocautery or electrosurgery generators, connector
cables or accessories as attempted use can result in patient and/or operator injury.
• The Connector Cable must only be used with the RFP-100A Baylis RF Generator and the included
®
VersaCross RF Wire. Attempts to use it with other RF Generators and devices can result in
electrocution of the patient and/or operator.
• The VersaCross
® RF Wire must be used with 0.035" compatible transseptal sheath and dilator
devices. Use of incompatible accessory devices may damage the integrity of the VersaCross® RF
Wire or accessory devices and may cause patient injury.
• The VersaCross
®
RF Wire has only been validated for transseptal puncture use through VersaCross
dilators which have been demonstrated to provide the required support for optimal function.
• The active tip and distal curve of the VersaCross
tip or the distal curve while handling the VersaCross
damaged at any time during its use, discard the VersaCross
to straighten the active tip if bent. Damage to device can lead to patient injury.
• The VersaCross
®
RF Wire is not intended for use with neonatal patients (i.e. less than one month of
age). Do not attempt to treat neonatal patients with the VersaCross
• Do not attempt to insert or retract the VersaCross
percutaneous needle, which may damage the device and may cause patient injury.
V.
PRECAUTIONS
• Do not attempt to use the VersaCross
®
the accompanying Instructions for Use.
• RF puncture procedures should be performed only by physicians thoroughly trained in the techniques
of RF-powered puncture in a fully equipped catheterization laboratory.
• The sterile packaging should be visually inspected prior to use. Do not use the devices if the
packaging has been damaged or compromised.
• Visually inspect the VersaCross
®
RF Wire and Connector Cable prior to use to ensure there are no
cracks or damage to the insulating material. Do not use the wire or the cable if there is any damage.
• Do not use the VersaCross
®
RF Wire and/or Connector Cable after the use-by date indicated on the
label.
• The VersaCross
®
RF Wire and Connector Cable are intended for use with only those devices listed
in Section VIII, Equipment Required.
• Read and follow the manufacturer's Instructions For Use for the DIP electrode. Always use DIP
electrodes that meet or exceed IEC 60601-2-2 requirements.
• Placement of the DIP 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 RF Generator may have on the performance of other equipment. Check the compatibility and
DMR VXW 3.3 V-4 07-Jun-2021 (CE Marked)
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RF Wire and a Baylis single-use
®
RF Wire must be used with an approved Baylis
®
RF Wire. This Connector Cable enables RF
®
RF Wire. Detailed information
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RF Wire facilitates smooth advancement of the
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RF Wire provides a stiff rail for advancing ancillary
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Transseptal Sheath kit). The proximal end of the
®
RF Wire are fragile. Be careful not to damage the
®
RF Wire. If the tip or the distal curve becomes
®
RF Wire immediately. Do not attempt
®
RF Wire.
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RF wire through a metal cannula or a
RF Wire and the Connector Cable before thoroughly reading
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RF Wire has a
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RF Wire
®