Baylis Medical TorFlex Instrucciones De Uso

Instructions for Use
TorFlex™ Transseptal
Guiding Sheath
English .............................................................................................................. 1
Français ............................................................................................................ 3
Deutsch ............................................................................................................ 5
Nederlands ....................................................................................................... 7
Italiano .............................................................................................................. 9
Español ........................................................................................................... 11
Português ....................................................................................................... 13
Čeština ............................................................................................................ 15
Dansk .............................................................................................................. 17
Suomi .............................................................................................................. 19
Norsk .............................................................................................................. 21
Svenska .......................................................................................................... 23
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
© Copyright Baylis Medical Company Inc., 2009 – 2021
The Baylis Medical Company logo and TorFlex are trademarks and/or
registered trademarks of Baylis Medical Company Inc. in the USA and
/or other countries.
Page 1 of 25
English_______________
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 (U.S.A.) law restricts this device to sale by or on the
order of a physician.
I. DEVICE DESCRIPTION
The TorFlex™ Transseptal Guiding Sheath kit consists of three
components: a sheath, a dilator, and a J-tipped guidewire.
The TorFlex™ Transseptal Guiding Sheath kit is designed for safe and
easy catheterization and angiography of specific heart chambers and
locations. The sheath provides superior torque control and is flexible.
The sheath device shaft in its entirety is coated with a hydrophobic
lubricious coating for smoother device manipulation. No pre-conditioning
is required for this coating. The radiopaque tip maximizes visualization
of the sheath during manipulation.
The dilator provides support for the sheath and has a tapered tip.
II. INDICATIONS FOR USE
The TorFlex™ Transseptal Guiding Sheath kit is used for the
percutaneous introduction of various types of cardiovascular catheters
and guidewires to all heart chambers, including the left atrium via
transseptal perforation / puncture.
III. WARNINGS
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 TorFlex™ Transseptal Guiding Sheath kit is intended for
single patient use only. Do not attempt to sterilize and reuse the
TorFlex™ Transseptal Guiding Sheath kit. Reuse can cause
patient injury and/or the communication of infectious disease(s)
from one patient to another.

The TorFlex™ Transseptal Guiding Sheath kit is supplied STERILE
using an ethylene oxide process. Do not use if the package is
damaged.

The sheath's shaft is coated with a lubricious coating. The
following warnings must be considered:
Use of the sheath with introducer sheaths smaller than the
o
size listed in the section below may result in a tight fit that
affects device performance, including coating integrity.
Excessive wiping and/or wiping of the sheath with a dry gauze
o
may damage the coating.

Care should be taken to ensure that all air is removed from the
sheath before infusing through the side port.

Care should be taken when removing the dilator and catheters from
the sheath.

Do not attempt direct percutaneous insertion of the sheath without
the dilator as this may cause vessel injury.

Damage to guidewire may result if withdrawn through a metal
needle cannula.

Careful manipulation must be performed to avoid cardiac damage
or tamponade. Sheath advancement should be done under
fluoroscopic guidance. Echocardiographic guidance is also
recommended.
IV. PRECAUTIONS

Do not attempt to use the TorFlex™ Transseptal Guiding Sheath
kit before thoroughly reading the accompanying Instructions for
Use.

Careful manipulation must be performed to avoid cardiac damage,
or tamponade. Sheath, dilator and guidewire advancement should
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DMR TFK-1 3.3 V-13 16-Jul-2021