AtriCure Inc
Artial Rake Accesssory
Reusable Atrial Rake Accessory Attachments for Universal Stabilizer Arms
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Instructions for Use Reusable Attachments for Universal Stabilizer Arms Catalog Numbers 400-441, 400-442, 400-443, 400-451, 400-452, 400-453 Non-Sterile Product Description Universal Stabilizer Arm Accessory Attachments are reusable accessory devices for use with the ESTECH 401-161 Universal Stabilizer Arms™. The Attachments provide cardiac retraction and surgical exposure. Use of Device 1. Attach Accessory Device to the ESTECH 401-161 Universal Stabilizer Arms™ by sliding sleeve of the quick connection away from flexible arm and inserting Attachment Shaft into the connector with the detent lined up to the screw hole. See Figures 1 and 2. 2. Position Device as required and as per instructions for use of the ESTECH 401-161 Universal Stabilizer Arms™. CLEANING Disassemble and scrub the instruments and parts thoroughly using a soft brush and mild detergent. Remove all traces of blood and debris. Make sure all parts are cleaned thoroughly. It is recommended that the instruments and parts be ultrasonically cleaned. STERILIZATION The instruments may be steam or gas sterilized. Refer to the sterilizer manufacturer’s instructions for correct time, temperature and pressure settings.
Align Detent of attachment with Flat Area with logo on sleeve Sleeve Detent Accessory Device Shaft
Slide Sleeve towards arm to attach or remove accessory device
401-161
Figure 1
WARRANTY AtriCure warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular use. Handling, storage, cleaning and 430-10376-01-Rev J
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sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond AtriCure control directly affect the instrument and the result obtained from its use. AtriCure’s obligation under this warranty is limited to the repair or replacement of this instrument and AtriCure shall not be liable for any incidental or consequential loss, damage, or expense directly or indirectly arising from the use of this instrument. AtriCure neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. AtriCure assumes no liability with respect to instruments reused, reprocessed or re-sterilized and makes no warranties expressed or implied, including but not limited to merchantability or fitness for intended use, with respect to such instrument. For technical information contact:
AtriCure, Incorporated 7555 Innovation Way Mason, Ohio 45040 USA Customer Service: 1-866-349-2342 (toll phone) 1-513-755-4100 (phone)
Köntges SPRL Avenue Hellevelt 35 B-1180 Brussels Belgium Tel: +32 (0) 2 375 51 63 FAX: +32 (0) 2 375 89 06 e-mail: [email protected]
Graphic Symbols for Device Labeling Catalogue Number
Batch Code
Quantity
Date of Manufacture
Manufacturer/Company Address
Authorized Representative in the European Union
Instrument supplied Non-Sterile
Does not contain Natural Rubber Latex
Contains no di (2-ethylhexyl) phthalate (DEHP) released from polyvinyl chloride (PVC)
Consult Instructions For Use
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CE mark, Product conforms with the essential requirements in the European Medical Devices Directive 93/42/EEC.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.
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