Outlines: Original Artwork: LeMaitre. Light Post Adapter. Light Post Adapter. Fits Olympus, Storz, and Stryker Equipment* English Instructions for Use

Transcription

1 Outlines: Original Artwork: LeMaitre VASCULAR Fits Olympus, Storz, and Stryker Equipment* English Instructions for Use

2 Fits Olympus, Storz, and Stryker Equipment* Instructions for Use - English Model Numbers A5401, ea5401 INDICATIONS: Adapters provide connection to the light post of LeMaitre Vascular Angioscope when non-acmi type light cables are used. DESCRIPTION: Adapters are available to connect to Olympus/Storz/Stryker* (Model Number: A5401) type light cables. The adapters are simply screwed onto the existing light post. The adapters are intended for use only with LeMaitre Vascular Angioscope. The adapters and associated instrumentation should be used only by physicians adequately trained in the proper techniques for performing the intended procedure. WARNINGS: 1. The adapters are supplied non-sterile and must be sterilized by autoclave, ethylene oxide or the STERIS SYSTEM 1 prior to each use. 2. Do not use the adapter if any damage has occurred. PRECAUTIONS: 1. For adequate illumination, the light cable must be properly connected to the light source and the light post of the instrument. Water and/or other liquids present on either connector will result in decreased light transmission. 2. All electrical apparatus used with the instrument must be in safe working order. INSPECTION PRIOR TO USE: 1. Verify the adapter has been properly cleaned and sterilized. 2. Prior to each procedure, the adapter must be checked for any damage. Do not use if visible damage is present. 3. Connect the appropriate end of any compatible light cable to the instrument light post. Insert the other end into the light source. Check for adequate light intensity. A 300 watt Xenon light is recommended as a minimum light source. 4. Do not use system if light intensity is not adequate for the scheduled procedure. INSTRUCTIONS FOR USE: 1. Thread appropriate adapter onto light post. Do not over tighten. 2. Connect the appropriate end of the light cable to the instrument light post (with adapter on) and verify it is secure. 3. Insert the other end into the light source. Check for adequate light intensity. A 300 watt Xenon light is recommended as a minimum light source. 4. Do not use system if light intensity is not adequate for the scheduled procedure. CLEANING AND STERILIZATION: 1. The adapter, immediately following a procedure, should be removed from the immersed in a basin of water. Soaking will prevent body fluids from drying onto the surface(s) prior to cleaning and sterilization. 2. Prior to sterilization, meticulously clean and remove all adherent patient material by using a soap solution and soft brushes as required. Do not use steel wool, wire brushes or highly abrasive detergent cleaners. Soak for 3 to 5 minutes in proteolytic or hemolytic enzymatic solution as required. The clean adapter should be thoroughly rinsed in water and inspected for cleanliness prior to sterilization. 3. Simulated use testing has demonstrated the adapters are compatible with the STERIS Process and can be sterilized with the STERIS SYSTEM 1. Refer to the STERIS SYSTEM 1 Operator Manual for instructions on sterile processing of

3 instruments. 4. The adapter must be completely dried prior to sterilization. Dry the exterior with clean lint free wipes. FOR EtO STERILIZATION Place the adapter in the appropriate pouch or wrap and follow the recommended EtO sterilization parameters: Exposure Time Temperature Gas Concentration Humidity Humidity Dwell Time FOR AUTOCLAVE STERILIZATION Place the adapter in the appropriate wrap or container and follow the recommended sterilization parameters: Standard Autoclave Normal Flash 30 minutes at 250 F (121 C) 4 minutes at 270 F (132 C) HOW SUPPLIED: This device is supplied non-sterile and must be sterilized prior to use. See Cleaning and Sterilization. STORAGE AND HANDLING: Handle with care. Product should be stored in a clean, cool, dry area away from chemical fumes. 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, MANAG- ERS, 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 MERCHANT- ABILITY 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 abuse 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.

4 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. Catalog Number Batch Code Caution, consult accompanying documents CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Date of manufacture Non-sterile Non-sterile

5 Outlines: LeMaitre Vascular, Inc. Customer Service: Tel: (781) Fax: (781) Original Artwork: LeMaitre Vascular ULC 5915 Airport Road, Suite 608 LeMaitre VASCULAR Mississauga, Ontario Canada L4V 1T1 Tel: LeMaitre is a registered trademark of LeMaitre Vascular, Inc. * Olympus is a registered trademark of Olympus Corporation. Storz is a trademark of Karl Storz GMBH & Co. Stryker is a registered trademark of Stryker Corporation LeMaitre Vascular, Inc. All rights reserved. LeMaitre Vascular GmbH Otto-Volger-Str. 5a/b Sulzbach/Ts., Germany Tel: +49-(0) LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA R Rev. A 03/15