Merit Medical MetaSTAR 3195, Operator'S Manual

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403321001_001 2016-08-31
Disclaimer Merit Medical Systems, Inc. reserves the right to change its products at any time in order to incorporate
the most recent technological developments. This guide is subject to change without notice.
Although this guide has been prepared with every regard to insure the accuracy of its contents, Merit
Medical Systems, Inc. assumes no liability for any damages incurred from the application of this
information. The recommendations are designed to serve as a general guideline. They are not intended
to supersede institutional protocols or professional clinical judgment concerning patient care.
Table of Contents
Section Page
1. BRIEF DEVICE DESCRIPTION: ................................................................................................. 3
2. INDICATIONS FOR USE: ........................................................................................................... 3
3. CONTRAINDICATIONS: ............................................................................................................. 3
4. WARNINGS: ............................................................................................................................... 3
5. PRECAUTIONS: ......................................................................................................................... 4
6. ENVIRONMENTAL PROTECTION: ............................................................................................ 4
7. HOW SUPPLIED: ....................................................................................................................... 4
7.1. Accessories: ....................................................................................................................... 4
7.2. Single Use Devices
– See table below for other devices required for Tumor Ablation. .......... 4
8. INSTRUCTIONS FOR USE: ....................................................................................................... 5
8.1.
Set-Up .................................................................................. Error! Bookmark not defined.
8.2. MetaSTAR RF Generator Nomenclature ............................... Error! Bookmark not defined.
8.3. Initiation .............................................................................................................................. 7
8.4. Setting Ablation Cycle Time ................................................................................................ 7
8.5. Operation ............................................................................................................................ 7
9. PREVENTIVE MAINTENANCE, TROUBLESHOOTING AND REPAIR: ....................................... 9
9.1. Adjusting Volume ................................................................................................................ 9
9.2. Maintaining Device Effectiveness ........................................................................................ 9
9.3. Cleaning the MetaSTAR RF Generator.................................. Error! Bookmark not defined.
10. CUSTOMER SERVICE AND TECHNICAL SUPPORT, WARRANTY: ......................................... 9
10.1. Customer Service................................................................................................................ 9
10.2. Limited Warranty ................................................................................................................. 9
11. DISTRIBUTORS / AUTHORIZED REPRESENTATIVES: .......................................................... 11
11.1. North America ....................................................................... Error! Bookmark not defined.
11.2. Europe ................................................................................ Error! Bookmark not defined.
APPENDIX A PRODUCT SPECIFICATIONS ..................................................................................... 11
APPENDIX B ELECTROMAGNETIC ENVIRONMENT GUIDANCE .................................................... 12
APPENDIX C ABBREVIATIONS ........................................................................................................ 12
APPENDIX D CONFORMANCE TO STANDARDS ............................................................................. 13
APPENDIX E COMPATIBLE POWER CORDS .................................................................................. 13
APPENDIX F TONES ........................................................................................................................ 13
APPENDIX G INDICATORS / ERROR CODES AND TROUBLESHOOTING ...................................... 14