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TRIVEX® Illuminator Infl ow Tube Set
(Model Number 7209513)
Instructions for Use - English
Please see the TRIVEX System Illuminator instructions for use (R2596).
Indications for Use
See the TRIVEX System Illuminator instructions for use (R2596).
Contraindications
See the TRIVEX System Illuminator instructions for use (R2596).
Warnings
•
Do not resterilize. This product is provided sterile, for single use only. Do not reuse. Do not use
after the expiration date. Prior to use, inspect the product package for structural integrity. Discard
any opened and unused product. By purchasing any product designated for "single use," "multiple
use in a single procedure," "do not resterilize," or the like, the customer agrees to limit that
product's use in accordance with those express designations.
•
As in conventional ambulatory phlebectomy procedures, bruising, hematoma, and hemosiderin
deposits have been observed in clinical studies utilizing the TRIVEX system.
Precautions
•
U.S. Federal law restricts this device to sale by or on the order of a physician.
•
Prior to use, surgeons should become familiar with this surgical technique and the TRIVEX system.
Instructions for Use
Attaching disposable infl ow tube set (ref 7209513) to irrigated illuminator (ref 7210351)
Follow operating room protocol for handling the tube set. Instructions are provided as reference only.
1. Circulator nurse
• Off er packaged contents to scrub nurse.
2. Scrub nurse
• Remove tube set from package.
• Attach tube set to illuminator infl ow port by inserting female luer fi tting into male luer fi tting
and turning clockwise.
3. Circulator nurse
• Close pinch clamps on tube set.
• Spike fl uid bag.
4. Scrub nurse
• Open tube set clamp to establish fl ow.
• To regulate fl uid fl ow please see the TRIVEX system operations/service manual (R2601) for
detailed instructions for use.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device
and that this device is suitable for the indication(s) expressly specifi ed in these instructions for use.
Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERM
INCLUDES LEMAITRE VASCULAR, INC., ITS AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES, OFFICERS,
DIRECTORS, MANAGERS, AND AGENTS) MAKES NO EXPRESS OR IMPLIED WARRANTIES WITH RESPECT
TO THIS DEVICE, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE (INCLUDING, WITHOUT
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