TRIVEX® Illuminator Inflow Tube Set
Contents
1. Follow operating room protocol for handling the tube set Instructions are provided as reference only 1 Circulator nurse Offer packaged contents to scrub nurse 2 Scrub nurse Remove tube set from package Attach tube set to illuminator inflow port by inserting female luer fitting into male luer fitting and turning clockwise 3 Circulator nurse e Close pinch clamps on tube set Spike fluid bag 4 Scrub nurse Open tube set clamp to establish flow To regulate fluid flow 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 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 LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND HEREBY DISCLAIMS THE SAME LeMaitre Vascular makes no representation regarding the suitability for any particular treatment in which this device is used which determination is the sole responsibility of the purchaser This limited warranty does not apply to the extent of any abus2. a LeMaitre VASCULAR TRIVEX Illuminator Inflow Tube Set Instructions for Use English TRIVEX Illuminator Inflow Tube Set TRIVEX Illuminator Inflow Tube Set Model Number 7209513 Instructions for Use English STERILE EO Rx only Q 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 Asin 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 inflow tube set ref 7209513 to irrigated illuminator ref 7210351
3. e or misuse of or failure to properly store this device by the purchaser or any third party The sole remedy for a breach of this limited warranty shall be replacement of or refund of the purchase price for this device at LeMaitre Vascular s sole option following the purchaser s return of the device to LeMaitre Vascular This warranty shall terminate on the expiration date for this device IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT INDIRECT CONSEQUENTIAL SPECIAL PUNITIVE OR EXEMPLARY DAMAGES IN NO EVENT WILL THE AGGREGATE LIABILITY OF LEMAITRE VASCULAR WITH RESPECT TO THIS DEVICE HOWEVER ARISING UNDER ANY THEORY OF LIABILITY WHETHER IN CONTRACT TORT STRICT LIABILITY OR OTHERWISE EXCEED ONE THOUSAND DOLLARS US 1 000 REGARDLESS OF WHETHER LEMAITRE VASCULAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY REMEDY THESE LIMITATIONS APPLY TO ANY THIRD PARTY CLAIMS A revision or issue date for these instructions is included on the back page of these Instructions for Use for the user s information If twenty four 24 months has elapsed between this date and product use the user should contact LeMaitre Vascular to see if additional product information is available For Further Information For further information if further information on this product is needed please contact LeMaitre Vascular customer service at 1 800 628 9470 in the U S or your author
4. ized representative Symbol Legend Rx only English SymbolLegend Distributed By Caution U S Federal and other law restricts this device to sale by or on the order of a physician ay LeMaitre VASCULAR Bo LeMaitre Vascular Inc LeMaitre Vascular GmbH Customer Service Otto Volger Str 5a b Tel 781 221 2266 65843 Sulzbach Ts Germany Fax 781 221 2223 Tel 49 0 6196 659230 LeMaitre Vascular GK ea 1F Kubodera Twin Tower Bldg LeMaitre Vascular Inc 2 9 4 Kudan minami Chiyoda ku 63 Second Avenue Tokyo 102 0074 Japan Burlington MA 01803 Tel 81 0 3 5215 5681 LeMaitre Vascular ULC 5915 Airport Road Suite 608 Mississauga Ontario Canada L4V 1T1 Tel 1 905 673 2266 LeMaitre and TRIVEX are registered trademarks of LeMaitre Vascular Inc Patents See www lemaitre com patents asp 2014 LeMaitre Vascular Inc All rights reserved Printed in the USA R2593 01 Rev B 07 14 088 0
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