Paceart Optima System

Transcription

1 Paceart Optima System Implantable Cardiac Device Guide Supplement Updates to October 2012 Guide and July 2013 Supplement Effective Date: April 2014

2 Table of Contents Page Boston Scientific, Inc Medtronic, Inc Trademarks The following are trademarks of Boston Scientific Inc.: Autogen, Dynagen, Inogen, Origen. The following is a trademark of Medtronic, Inc.: Reveal LINQ. Implantable Cardiac Device Guide Supplement 2014 Medtronic, Inc. i

3 BOSTON SCIENTIFIC The following lists Boston Scientific implantable cardiac devices supported by Boston Scientific programmer import on the Paceart Optima System. Note: Information transfer is dependent upon programmer export and Paceart System supported fields. Earlier releases of the Paceart System may not support all the devices listed. Supported Implantable Cardiac Devices G160 AUTOGEN G161 AUTOGEN G164 AUTOGEN G166 AUTOGEN X4 G168 AUTOGEN X4 G172 AUTOGEN G173 AUTOGEN G175 AUTOGEN G177 AUTOGEN X4 G179 AUTOGEN X4 G150 DYNAGEN G151 DYNAGEN G154 DYNAGEN G156 DYNAGEN X4 G158 DYNAGEN X4 G140 INOGEN G141 INOGEN G146 INOGEN X4 Locations United States Boston Scientific Corporate Headquarters One Boston Scientific Place Natick, MA USA Tel: (508) Boston Scientific 6430 Vipond Drive Mississauga, Ontario L5T 1W8 Tel: (905) G148 INOGEN X4 G050 ORIGEN G051 ORIGEN G056 ORIGEN X4 G058 ORIGEN X4 D160 AUTOGEN D161 AUTOGEN D162 AUTOGEN D163 AUTOGEN D174 AUTOGEN D175 AUTOGEN D176 AUTOGEN D177 AUTOGEN D030 AUTOGEN MINI D031 AUTOGEN MINI D032 AUTOGEN MINI D033 AUTOGEN MINI D044 AUTOGEN MINI Boston Scientific ANZ Level 5, 247 Coward Street MASCOT NSW 2020 Tel: (61-2) D045 AUTOGEN MINI D046 AUTOGEN MINI D047 AUTOGEN MINI D150 DYNAGEN D151 DYNAGEN D152 DYNAGEN D153 DYNAGEN D020 DYNAGEN MINI D021 DYNAGEN MINI D022 DYNAGEN MINI D023 DYNAGEN MINI D140 INOGEN D141 INOGEN D142 INOGEN D143 INOGEN D010 INOGEN MINI D011 INOGEN MINI D012 INOGEN MINI D013 INOGEN MINI D050 ORIGEN D051 ORIGEN D052 ORIGEN D053 ORIGEN D000 ORIGEN MINI D001 ORIGEN MINI D002 ORIGEN MINI D003 ORIGEN MINI Supports direct data transfer from the Boston Scientific LATITUDE Patient Management System to the Paceart System. Implantable Cardiac Device Guide Supplement 2014 Medtronic, Inc. 2

4 MEDTRONIC The following lists Medtronic implantable cardiac devices supported by the Medtronic CareLink 2090 Programmer import on the Paceart Optima System. Note: Information transfer is dependent upon programmer export and Paceart System supported fields. Earlier releases of the Paceart System may not support all the devices listed. Supported Implantable Cardiac Devices LNQ11 Reveal LINQ ICM/ILR Supports direct data transfer from the programmer to the Paceart System. Supports direct data transfer from the Medtronic CareLink Network to the Paceart System. Implantable Cardiac Device Guide Supplement 2014 Medtronic, Inc. 3

5 Brief Statement Medtronic Paceart For further information regarding Paceart, please call Medtronic at 1 (800) and /or consult Medtronic s website at Medtronic CareLink Monitor and Medtronic CareLink Network Intended Use The Medtronic CareLink Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability may be unavailable at times due to maintenance or updates. Contraindications There are no contraindications for the Medtronic CareLink Monitor. Warnings and Precautions The Medtronic CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The Medtronic CareLink Monitor is intended for use within the prescribing country. The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient s condition and pacing system used. The Medtronic CareLink programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron. See the device manuals for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please call Medtronic at 1 (800) and/or consult Medtronic s website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Medtronic USA, Inc. Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) Europe Medtronic International Trading Sàrl Route du Molliau 31 Case postale CH-1131 Tolochenaz Tel: +41 (0) Fax: +41 (0) United Kingdom/Ireland Medtronic Limited Building 9 Croxley Green Business Park Hatters Lane Watford, Hertfordshire WD18 8WW Tel: +44 (0) Fax: +44 (0) Distributor Medtronic of Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Tel: 1 (800) Fax: (905) Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde NSW 2113 PO Box 945 North Ryde NSW 1670 Tel: (61-2) Fax: (61-2) Medtronic, Inc. Cardiac Rhythm Disease Management 8200 Coral Sea Street NE Mounds View, MN USA 1 (800) PACEART UC EN Medtronic, Inc Minneapolis, MN. All Rights Reserved. Printed in USA. 04/2014