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TRIVEX® System Illuminator
(Model Number 7210351)
Instructions for Use - English
Description
The LeMaitre Vascular TRIVEX® System Illuminator is used to instill tumescent solution and to transilluminate
the targeted varicosities. The illuminator connects with fi ber optic cables to the TRIVEX System to provide
transillumination during endoscopic resection of superfi cial varicosities of the lower extremities.
Indication for Use
The TRIVEX System Illuminator is indicated for use in ambulatory phlebectomy procedures for resection and ablation
of varicose veins.
Contraindications
None known.
Warnings
•
This product is shipped non-sterile. It must be sterilized before the fi rst use. It must be cleaned and sterilized
before every subsequent use.
•
The only method of sterilization appropriate for the illuminator is autoclave.
•
Read these instructions and the TRIVEX System Operations/Service Manual (R2601) completely prior to use.
•
Prior to use, the surgeon should become familiar with this surgical technique.
•
The high energy radiated light emitted from the illuminating fi ber at the distal end of the Illuminator may
give rise to temperatures exceeding 106 °F (41° C) within an area of 8 mm in front of the Illuminator. Do not
leave the tip of the Illuminator in direct contact with patient tissue or combustible materials or burns may
result.
•
As in conventional ambulatory phlebectomy procedures, bruising, hematoma, and hemosiderin deposits have
been observed in clinical studies utilizing the TRIVEX System.
•
To prevent a potential safety hazard to the patient caused by accidental loss of function of the device (i.e.,
front end damage by surgical instruments), it is recommended to have an additional sterile "stand-by" device
during surgical procedures.
Precautions
1.
United States Federal and other law restricts this device to sale on or by the order of a physician.
2.
Prior to each use, inspect the device to ensure it is functioning properly and not damaged. Do not use a
damaged device.
3.
Prior to each use, the outer surface of the insertion portion of the Illuminator should be checked to ensure
there are no rough surfaces, sharp edges, or protrusions.
4.
Any foreign matter present on the surface after cleaning may tend to burn and discolor the surface when the
high intensity lamp is in use.
5.
Be aware that the TRIVEX System requires a special light guide adaptor (REF 7210375) for the light source
end of the cable. Standard light guide adaptors will fi t into the light source opening, but may not transmit
adequate light from the lamp.
Instructions for Use
Follow operating room protocol for handling the tube set. Instructions are provided as reference only.
Mechanical Assembly
Place the correct adaptors on the fi ber optic light post of the Illuminator and on the instrument end of the light
guide. The light post threads may be lubricated as needed, being sure to remove any excess lubricant as required.
Make sure that the fi beroptic surface remains free of foreign matter.
Adaptors can be used to fi t most light guides. Simply attach the appropriate adaptor on or off the fi ber optic light
post to prepare the Illuminator for connection to light guides.
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