LeMaitre Periscope Instrucciones De Uso página 3

• Wound infection (incisional)
• Vessel injury, dissection, perforation, rupture or pseudoaneurysm
• Vessel spasm
• Emboli, thrombosis or acute occlusion
• Fever, drug reactions or allergic reactions to contrast medium
• Conversion to bypass
• Limb loss due to distal embolization
• Renal failure
• Death
How Supplied
STERILE: Each Periscope Dissector is sterilized using Ethylene Oxide (EO) and is
supplied sterile for single use only. Do not reuse or resterilize. Resterilization
may adversely affect proper mechanical function and could result in patient
injury.
CONTENTS:
One (1) Sterile Periscope Dissector with an Integrated Hollow Needle
One (1) Instructions for Use
STORAGE: Store in a cool, dry place.
Inspection
Carefully inspect the sterile package for damage or defects before opening. Do
not use product after the "Use By" date on the package. If the integrity of the
sterile package has been compromised or the package or product is defective,
do not use the product and contact LeMaitre Vascular for return information.
Recommended Material
Prepare the following material using sterile technique:
• 10cc syringe filled with sterile saline
• Up to a 0.018" guidewire of appropriate length
• 10cc syringe filled with sterile contrast solution
Directions For Use
Specific patient preparation and procedural techniques are determined by the
physician. One suggested technique is as follows:
1. Patient preparation and administration of anticoagulation/antiplatelet
regimen is left to the discretion of the physician.
2. Use sterile surgical precautions and standards.
3. Using appropriate anesthesia, gain access at the appropriate site through
an arteriotomy to expose the atheroma.
4. Make a slanting, bevel-type incision of the proximal atheroma to start a
cleavage plane between the atheroma and surrounding media.
Note:
5. Insert the Periscope Dissector into the cleavage plane of the vessel. Using a
gentle pushing motion around the atheroma core, advance the device to a
point distal to the occluded segment.
6. Under fluoroscopic guidance, position the Periscope Dissector at the end of
the dissection plane.
7. While advancing the needle, flush the needle with contrast medium under
fluoroscopy to verify proper penetration of the intimal layer into the true
lumen of the vessel.
8. Insert a 0.018" guidewire into the Periscope Dissector needle and advance
until the distal tip of the wire is sufficiently anchored into the true vessel
lumen. Anchoring of the guidewire will allow retraction of the Periscope
Dissector while maintaining guidewire position.
Note: 1. Do not use polymer covered hydrophilic guidewires.
2. Optimum guidewire performance is achieved with the use of flex
The following procedure steps should be performed under
fluoroscopic guidance.
wires or wires with very long flexible tips.