Baylis Medical VersaCross Connect Bedienungsanleitung

Instructions for Use
VersaCross Connect™ Access Solution for
FARADRIVE™
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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
© 2023 Baylis Medical Company Inc. or its affiliates
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All trademarks are property of their respective owners.
Carefully read all instructions prior to use. Observe all warnings and precautions
noted in these instructions. Failure to do so may result in patient complications.
Baylis Medical Company relies on the physician to determine, assess and
communicate to each individual patient all foreseeable risks of the procedure.
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
DEVICE DESCRIPTION
The VersaCross Connect™ Access Solution for FARADRIVE™ consists of 3
components: a VersaCross Connect Transseptal Dilator, a VersaCross RF Wire
and a Baylis single-use Connector Cable (Connector Cable). The VersaCross RF
Wire must be used with an approved Baylis RFP-100A Radiofrequency Puncture
Generator (Baylis RF Generator) and the Connector Cable.
The VersaCross Connect Transseptal Dilator is designed for safe and easy
catheterization and angiography of specific heart chambers and locations. The
dilator provides torque control and is flexible. The dilator features a tapered tip and
a shaft that can be reshaped manually. The echogenic shaft and tip and
radiopaque tip maximize visualization of the dilator during manipulation.
The VersaCross Connect Transseptal Dilator is for use with a 13F ID FARADRIVE
Steerable Sheath that is 74cm in length, specifically models: M004PF21M402
(USA), M004PFCE21M402 (Canada).
Carefully read the applicable FARADRIVE Steerable Sheath instructions prior to
use. Observe all warnings and precautions noted in these instructions. Failure to
do so may result in patient complications.
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 RF Wire. This Connector Cable enables RF power
to be delivered from the Baylis RF Generator to the VersaCross RF Wire. Detailed
information concerning the Baylis RF Generator is contained in a separate manual
that accompanies the equipment
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 RF Wire
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(entitled "Baylis Medical Company
facilitates smooth advancement of the device and provides electrical insulation.
The floppy distal portion of the VersaCross RF Wire has a 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 RF Wire
provides a stiff rail for advancing ancillary devices into the left atrium following the
creation of an atrial septal defect. The VersaCross RF Wire features visible
markers along its length to assist with aligning the wire tip in a compatible
transseptal sheath and/or dilator assembly (e.g., the VersaCross Transseptal
Sheath kit). The proximal end of the 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.
INDICATIONS FOR USE
The VersaCross Connect Access Solution for FARADRIVE is indicated for creation
of an atrial septal defect in the heart and for the percutaneous introduction of
various types of cardiovascular catheters and guidewires to all heart chambers,
including the left atrium via transseptal perforation / puncture.
United States: The VersaCross Connect Access Solution for FARADRIVE is
indicated for creation of an atrial septal defect in the heart and for use in
procedures where access to the left atrium via the transseptal technique is desired.
CONTRAINDICATIONS
The included 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.
WARNINGS
•
Only physicians with a thorough understanding of angiography, aseptic
technique 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.
•
Laboratory staff and patients can undergo significant x-ray exposure
during interventional 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 use
of echocardiography is recommended.
•
The VersaCross Connect Access Solution for FARADRIVE is intended
for single patient use only. Do not attempt to sterilize and reuse any
component of the VersaCross Connect Access Solution for
FARADRIVE. Reuse can cause the patient injury and/or the
communication of infectious disease(s) from one patient to another.
Failure to follow this instruction may result in patient complications.
•
The VersaCross Connect Access Solution for FARADRIVE is supplied
STERILE using an ethylene oxide process. Do not use if the package
is damaged.
•
Manual shaping of the distal curve shall be done with smooth motions
along the curve. Do not use excessive force and/or pressure when
reshaping.
•
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/or 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 RF Wire are fragile.
Be careful not to damage the tip or the distal curve while handling the
VersaCross RF Wire. If the tip or the distal curve becomes damaged
at any time during its use, discard the VersaCross RF Wire
immediately. Do not attempt 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 RF Wire.
DMR VXAK-FD (PCS) 3.3 V-A NA