Baylis Medical TorFlex Instrucciones De Uso página 2

be done under fluoroscopic guidance. If resistance is encountered,
DO NOT use excessive force to advance or withdraw the device.

The sterile packaging and sheath should be visually inspected prior
to use. Do not use the device if it has been compromised or
damaged.

Only physicians thoroughly trained in the techniques of the
approach to be used should perform interventional procedures.

Note product "Use By" date.

The TorFlex™ Transseptal Guiding Sheath is compatible with
introducer sheaths 11Fr or larger.
V. ADVERSE EVENTS
Adverse events that may occur while using the TorFlex™ Transseptal
Guiding Sheath kit include:
Infection
Local nerve damage
Embolic events
AV fistula formation
Pseudoaneurysm
Arrhythmias
Hematoma
Valve damage
VI. INSPECTION PRIOR TO USE
Prior to use of the TorFlex™ Transseptal Guiding Sheath kit, the
individual components 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 device.
VII. EQUIPMENT REQUIRED
Intracardiac puncture procedures should be performed in a sterile
environment in a specialized clinical setting equipped with a fluoroscopy
unit, radiographic table, echocardiographic imaging (recommended),
physiologic recorder, emergency equipment and instrumentation for
gaining vascular access.
VIII. SUGGESTED DIRECTIONS FOR USE

Carefully read all instructions prior to use. Failure to do so may
result in complications.

Thoroughly flush the sheath, guidewire and dilator with heparinized
saline solution prior to use.

Perform a standard vein puncture of the right femoral vein using an
access needle (not supplied).

Introduce the guidewire and advance to required depth. If
resistance is encountered, DO NOT use excessive force to
advance or withdraw the guidewire. Determine the cause of
resistance before proceeding.

Leaving the guidewire in place, withdraw the needle. Enlarge the
cutaneous puncture site as necessary.

Note that a compatible access introducer sheath may be used at
the venous cutaneous puncture site if desired. Refer to the
compatible introducer sheath's Instructions for Use for details and
directions.

Assemble the dilator and sheath until the dilator hub locks into the
sheath hub.

Thread the dilator/sheath assembly over the guidewire using a
slight twisting motion into the superior vena cava (SVC) under
imaging guidance. If resistance is encountered, DO NOT use
excessive force to advance or withdraw the dilator/sheath
assembly over the guidewire. Determine the cause of resistance
before proceeding.

Use standard technique to position the sheath/dilator assembly into
the desired heart chamber.

If transseptal puncture is required, refer to the Instructions for Use
of the transseptal puncture device. Echocardiographic guidance is
also recommended.

Ensure the sheath is clear of air. To aspirate blood, use the sheath
side port.

Monitor the location of the radiopaque tip of the sheath and dilator
frequently under fluoroscopy. Echocardiographic guidance is also
recommended.

Deliver a continuous heparinized solution infusion or aspirate
periodically. This may help reduce the risk of thromboembolic
complications due to thrombus formation, as there may be a
possibility of thrombus development at the distal sheath tip or
Page 2 of 25
Air embolus
Hemorrhage
Vessel spasm
Atrial septal defect
Perforation and/or tamponade
Pericardial/pleural effusion
Vessel trauma
Catheter entrapment
inside the sheath lumen. Also aspirate when removing the
transseptal device or dilator.

After removal of the sheath, use standard technique to achieve
hemostasis.
IX. CLEANING AND STERILIZATION INSTRUCTIONS
Do not clean or re-sterilize the TorFlex™ Transseptal Guiding Sheath
kit. The TorFlex™ Transseptal Guiding Sheath kit is intended for single
use only.
X. DISPOSAL OF WASTE
Treat the used device(s) as biohazardous waste and dispose of in
compliance with standard hospital procedures.
XI. CUSTOMER SERVICE AND PRODUCT RETURN
INFORMATION
If you have any problems with or questions about Baylis Medical
Equipment contact our technical support personnel.
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Phone: (514) 488-9801 or (800) 850-9801
Fax: (514) 488-7209
www.baylismedical.com
NOTES:
1. In order to return products you must have a return authorization
number before shipping the products back to Baylis Medical
Company. Product Return Instructions will be provided to you at
this time.
2. Ensure that any product being returned to Baylis Medical has
been cleaned, decontaminated and/or sterilized as indicated in
the Product Return Instruction before returning it for warrantied
service. Baylis Medical will not accept any piece of used
equipment that has not been properly cleaned or decontaminated
as per the Product Return Instructions.
XII. LABELING AND SYMBOLS
Manufacturer
Consult Instructions
for Use
Model number
Sterile using ethylene
oxide
Non-Pyrogenic
Use By
Maximum guidewire
outside diameter that
can be used with this
device
XIII. LIMITED WARRANTY – Disposables and Accessories
Baylis Medical Company Inc. (BMC) warrants its Disposable and
Accessory products against defects in materials and workmanship.
BMC warrants that sterile products will remain sterile for a period of time
as shown on the label as long as the original package remains intact.
Under this Limited Warranty, if any covered product is proved to be
defective in materials or workmanship, BMC will replace or repair, in its
absolute and sole discretion, any such product, less any charges to BMC
for transportation and labor costs incidental to inspection, removal or
restocking of product. The length of the warranty is: (i) for the Disposable
products, the shelf life of the product, and (ii) for the Accessory products,
90 days from shipment date. This limited warranty applies only to new
original factory delivered products that have been used for their normal
and intended uses. BMC's Limited Warranty shall not apply to BMC
products which have been resterilized, repaired, altered, or modified in
any way and shall not apply to BMC products which have been
Federal (U.S.A.) law
restricts this device
to sale by or on the
order of a physician.
Caution
Lot Number
Single Use – Do not
reuse
Do not resterilize
Do Not Use if
Packaging is
Damaged
Keep Away from
Sunlight
DMR TFK-1 3.3 V-13 16-Jul-2021