Bard Solo Flex Instrucciones De Uso

CAUTION
Federal (USA) law restricts this device to sale by or on the order of a physician.
Carefully read and understand instructions, intended use, warnings, contraindications and precautions
noted in this Instructions for Use (IFU) manual. Failure to do so may result in complications.
WARNING
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If
damage is found call B
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization 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. Reuse, reprocessing or resterilization 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.
DEVICE DESCRIPTION
The B S ™ F
®
ard olo lex
and therapeutic catheters. These guidewires are offered in a variety of sizes (diameters), tip designs and stiffness.
The B S ™ F
®
ard olo lex
0.038" (0.965 mm) guidewires that are designed to facilitate the placement of diagnostic and therapeutic devices
and catheters. The Hybrid Guidewire has a 5 cm (1.96") hydrophilic coated polymer tip to facilitate access and a
PTFE coated body to aid in handling and manipulation of the guidewire.
INDICATIONS FOR USE
The B S ™ F
®
ard olo lex
of endourological instruments during diagnostic or interventional procedures. These guidewires are not intended for
coronary artery, vascular or neurological use.
CONTRAINDICATIONS
None known.
WARNINGS
• A thorough understanding of the technical principles, clinical applications, and risks associated with the use of
guidewires is necessary before using this product. Use of this device should be restricted to use by or under
the supervision of physicians trained in urologic endoscopic procedures. Care should be exercised to prevent
perforation or trauma of the linings and associated tissue, channels or ducts.
• Failure to abide by the following warnings might result in damage to the channel or duct, abrasion of the
hydrophilic coating, release of plastic fragments from the guidewire, damage to or breakage/separation of the
guidewire, that may necessitate intervention.
• Do not withdraw the guidewire through a metal cannula or needle. Withdrawal through a metal device may
result in disposition of these materials in the urinary system and destruction and/or separation of the outer
polymer jacket requiring retrieval. Extreme caution should be observed when used with one-wall puncture style
needle.
• Use extreme caution when using a laser or electrocautery, making sure to avoid contact with the guidewire.
Direct contact may cause damage to the wire and/or sever the wire.
• Do not reshape the guidewire in any way. Attempting to reshape the wire may cause damage, resulting in the
release of wire fragments to the urinary system.
• When exchanging or withdrawing a catheter over the guidewire, secure and maintain the guidewire in place
under fluoroscopy to avoid unexpected guidewire advancement. Otherwise damage to the urinary channel by
the wire's tip may occur.
B S
®
ard olo
B S ™ P
®
ard olo
INSTRUCTIONS FOR USE
customer service.
ard
and B S ™ P
®
ard olo
and B S ™ P
®
ard olo luS
and B S ™ P
®
ard olo luS
™ F Hybrid Guidewire
lex
Stiff Hybrid Guidewire
luS
Hybrid Guidewires are used to provide a foundation for diagnostic
luS
Hybrid Guidewires are high-performance, 0.035"(0.889 mm) or
Hybrid Guidewires are intended for use in facilitating the placement
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