Indications For Use; Preparation For Use; Instructions For Use - BioSphere Medical Sequitor Manual Del Usuario

DESCRIPTION
This Sequitor Steerable Guidewire (0.014" or
0.018") is a stainless steel guidewire with a polymer
distal tip and a 3 cm radiopaque distal tip that is
shapeable for 1 cm. The distal 50 cm is coated
with a hydrophilic coating. The guidewire length
is depicted on the product label.

INDICATIONS FOR USE

The Sequitor Steerable Guidewire is intended to
facilitate the placement of catheters within the
peripheral vasculature for various diagnostic and
interventional procedures.
WARNING
• Contents supplied sterile.
• Do not use if pouch is opened or damaged.
Verify that the package integrity has been
maintained to ensure the sterility of the device.
• Do not use in case of any surface
irregularities, bends, or kinks. Any damage of
the guidewire may change its characteristics
likely to affect its performance
• Use the device prior to the "Use Before" date
noted on the package.
• For single patient use only.
Do not reuse, reprocess, or resterilize.
Reusing , reprocessing or resterilizing may
compromise the structural integrity of the
device and or lead to device failure, which
in turn may result in patient injury, illness, or
death. Reusing, reprocessing or resterilizing
may also create a risk of contamination of
the device and or cause patient infection or
cross infection including, but not limited to,
the transmission of infectious disease(s) from
one patient to another. Contamination of the
device may lead to injury, illness or death of
the patient.
• Discard the product after use.
• This device should be used only by physicians
thoroughly trained in percutaneous,
intravascular techniques and procedures
in relevant areas of the anatomy.
• Do not attempt to move the guidewire
without observing the guidewire tip. Always
maintain visualization of the guidewire under
fluoroscopy.
• Do not push, pull, or rotate the wire against
resistance. If resistance is met, discontinue
movement of the guidewire, determine the
reason for resistance, and take appropriate
action before continuing. Movement of the
catheter or guidewire against resistance
may result in separation of the catheter or
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PRECAUTIONS
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COMPLICATIONS
Procedures requiring percutaneous catheter
introduction should not be attempted by physicians
unfamiliar with the possible complications listed
below. Possible complications may include, but are
not limited to, the following:
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PREPARATION FOR USE

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INSTRUCTIONS FOR USE

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guidewire tip, damage to the catheter, or
vessel perforation.
The hydrophilic coating has an extremely
lubricious surface only when properly
hydrated.
Do not expose guidewires to extreme
temperatures or solvents.
Prior to use, carefully examine the guidewire
and packaging to verify proper function and
integrity.
Extreme care should be taken when shaping
the guidewire distal tip. Over-manipulation of
the guidewire distal tip may cause damage.
Damaged guidewires should not be used.
Hemorrhage
Infection
Ischemia
Perforation of vessel or arterial wall
Puncture site hematoma
Thrombus formation
Vasospasm
Vessel wall dissection
Open carefully the pouch and remove the
hoop from the pouch
Flush the hoop with heparinized saline prior
to guidewire removal.
Remove the guidewire from the hoop.
If the guidewire is to remain unused at
any time during the procedure, be sure to
rehydrate with heparinized saline prior to
reinsertion.
The distal tip of the guidewire can be carefully
shaped to the desired tip configuration, using
standard practices.
Insert the steerable guidewire, flexible end
first, into the catheter lumen using a guidewire
insertion tool. Test the guidewire for free
movement within the catheter. Then, advance
the catheter into the guide catheter. During
this step, exercise caution not to allow the
guidewire to protrude beyond the catheter tip,
this may damage it.