AtriCure Switch Matrix ASB3 Instructions for Use

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AtriCure Switch Matrix ASB3 Instructions For Use The AtriCure ASB3 Switch Matrix is a reusable accessory interface module that allows simultaneous connection of AtriCure® Isolator™ Transpolar™ ablative handpiece and pen devices to the ASU RF generator. Devices will be operational only when the ASB3 selector switch is set to the device specific position. Please refer to the applicable handpiece and pen device Instructions For Use. Please refer to the ASU User’s Manual for descriptions of RF energy delivery, modes of operation, output power, operating frequency, and approved temporary cardiac pacing and stimulating accessories.

Type CF Defibrillation-Proof Applied Part Patient Isolated Equipment Type CF Applied Part Not Defibrillation-Proof Patient Isolated Equipment Alternating Current Equipotential Footswitch Fuses

The ASB3 has been tested and found to comply with the limits Power OFF for medical devices in IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful Power ON interference in a typical medical installation. The ASB3 generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, Environmental Conditions: (1) operational temperature +10°C to there is no guarantee that interference will not occur in a particular installation. If the ASB3 does cause harmful interfer- +40°C, (2) storage temperature -35°C to +54°C, and (3) humidity 15% ence to other devices, which can be determined by turning the to 90% relative humidity. ASB3 off and on, the user is encouraged to try to correct the Perform annual preventative maintenance procedures to ensure all interference by one or more of the following measures; (1) ASB3 components are functioning properly, including but not limited reorient or relocate the receiving device, (2) increase the to: (1) electrical power cords for fraying, damage, and proper groundseparation between the ASB3 and the other devices, (3) ing, (2) AC power switch, (3) indicator damage (Power On, Footswitch connect the ASB3 into an outlet on a circuit different from that to which the other device(s) are connected, and (4) contact the Present, or Handpiece Select), (4) handpiece connector damage, cracking or inability to insert and latch handpiece plug, (5) carrying AtriCure service representative for assistance. handle damage, inability to latch or rotate, (6) rubber feet damage, cracking or inability for the ASB3 to remain stabile on a flat surface, Inspect the following interface cables for any signs of physical (7) interface cable fraying or damage, and (8) footswitch connector damage to the cable and connectors. If physical damage is damage cracking or inability to insert and latch footswitch plug. found or the interface cables do not perform within specification, notify AtriCure. All returns must have approval from The ASB3 does not have any serviceable parts. For servicing issues, AtriCure. The cables include: (1) A000442-ASB/ASU RF contact AtriCure, Inc. Interface Cable, (2) C001237-ASB/ASU Footswitch Interface Cable, and (3) A000434-ASB3 PSS Interface Cable. The ASB3 Accessory Cleaning and Disinfection Instructions; (1) use a mild detergent (prepared to its specifications) and a damp cloth to Caution: Federal (U.S.A.) law restricts this device to sale by clean the exterior of the Switch Matrix, (2) do not submerge or allow or on the order of a physician. fluids to enter the chassis, (3) do not use caustic, corrosive, or Manufactured for: abrasive cleaning materials, and (4) the ASB3 and auxiliary device AtriCure, Inc. cable cannot be sterilized. 6217 Centre Park Dr. West Chester, Ohio 45069 Customer Service: 866-349-2342 [email protected] www.atricure.com European Representative: 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]

Types and rating of fuses: (1) 100-120V, 220-240V, ~50/60 Hz, and (2) 1.25A/250V, T-lag, 5 x 20mm, UL Recognized, IEC Approved. Replace fuses as marked. Follow local governing ordinances and recycling plans regarding disposal or recycling of device components. Information in this document is subject to change without notice. Reproduction in any manner whatsover without the written permission of AtriCure, Inc. is strictly forbidden. AtriCure and the AtriCure Logo are trademarks of AtriCure, Inc. AtriCure disclaims proprietary interest in the marks and names of others. January 2009 Printed in the USA. P000402.H