Merit Medical MetaSTAR 3195 Operator's Manual

Rf generator

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OPERATOR'S MANUAL

MetaSTAR™ RF Generator

Manufactured By:

Merit Medical Systems, Inc.

1600 West Merit Parkway

South Jordan, Utah 84095 U.S.A.

1-801-253-1600

U.S.A. Customer Service 1-800-356-3748

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

403321001_001 2016-08-31

Catalog No. 3195

P a t e n t s p e n d i n g

Authorized Representative:

Merit Medical Ireland Ltd.

Parkmore Business Park West

Galway, Ireland

+31 43 358 82 22

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Page 1 OPERATOR’S MANUAL MetaSTAR™ RF Generator Catalog No. 3195 Manufactured By: Authorized Representative: Merit Medical Systems, Inc. Merit Medical Ireland Ltd. 1600 West Merit Parkway Parkmore Business Park West South Jordan, Utah 84095 U.S.A. Galway, Ireland 1-801-253-1600 +31 43 358 82 22 U.S.A.
Page 2: Table Of Contents
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.
Page 3: Brief Device Description
MetaSTAR RF Generator User Manual Catalog No. 3195 (English) (EN) CAUTION: Federal law (US) restricts this device to sale by or on the order of a physician. BRIEF DEVICE DESCRIPTION: The MetaSTAR RF Generator is a microprocessor controlled low power radiofrequency (RF) generator used for percutaneous delivery of bi-polar radiofrequency energy intended to heat the target tissue of the SpineSTAR™...
Page 4: Precautions
PRECAUTIONS: Caution: Removing screws and opening of this device may invalidate the warranty. Caution: ”. Caution: It is important to read these instructions for use and these precautions prior to device operation. Caution: Replace fuses only with the same type and rating: 5 x 20 mm 3.15A/250V(2 each). Caution: Do not sterilize the MetaSTAR RF Generator.
Page 5: Instructions For Use
DEVICE PREPARATION: 8.1. Cleaning the MetaSTAR RF Generator Clean the MetaSTAR RF Generator prior to use with a damp cloth and water, isopropyl alcohol, 1.5% hydrogen peroxide, or a mild bleach solution after each use. Prolonged exposure to any corrosive solvents or disinfectants should be avoided.
Page 6 Indicators and Sockets 1. Graphical Display Soft Key Button 1 12. Fuse Drawer 2. FAULT RED LED Soft Key Button 2 13. ON/OFF Main Switch 3. WARNING YELLOW LED Soft Key Button 3 14. Power Socket Equipotential 4. RF ON BLUE LED Soft Key Button 4 15.
Page 7: Metastar Rf Generator Nomenclature
INSTRUCTIONS FOR USE: 9.1. Initiation Once the device Preparation (8.0) is complete and power is turned on using the ON/OFF Main Switch at the back of the MetaSTAR RF Generator, the system performs a self-check. All LEDs and pixels on the graphics display will be on and the speaker will sound for a few seconds upon initiation (Power- On Tone).
Page 8 Ablation Zone Dimensions The below table depicts the ablation zone sizes for each device: Ablation Zone Dimensions Proximal Distal Width 5mm TC 10mm TC Length 5│10 SpineSTAR Ablation Instrument (Note: All lengths have a tolerance of ±1mm) Proximal Distal Width 10mm TC 15mm TC Length...
Page 9: Preventive Maintenance, Troubleshooting And Repair
RGA number on all packaging, and adequately insured, to the following address: Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095 U.S.A. A written statement must also be included that reasonably describes the defect(s) with the MetaSTAR RF Generator and indicates the appropriate return address to ship the replaced MetaSTAR RF Generator, as well as a copy of a receipt showing proof of purchase.
Page 10 Manufactured By: Authorized Representative: Merit Medical Systems, Inc. Merit Medical Ireland Ltd. 1600 West Merit Parkway Parkmore Business Park West South Jordan, Utah 84095 U.S.A. Galway, Ireland 1-801-253-1600 +31 43 358 82 22 U.S.A. Customer Service 1-800- 356-3748 403321001_001 2016-08-31...
Page 11: Distributors / Authorized Representatives
APPENDIX A PRODUCT SPECIFICATIONS Specifications Mode of Operation: ................Continuous Input: ................ 100-240VAC, 50-60Hz, 120VA Dimensions: ..........6 ”(H) x 11”(W) x 18”(D) (15 x 28 x 46cm) Weight: ....................6.6 lbs (3kg) Output: ............10W , 480kHz, 140V 250Ω load PPMax Fuses: ........
Page 12: Appendix Belectromagnetic Environment Guidance
APPENDIX B ELECTROMAGNETIC ENVIRONMENT GUIDANCE Electromagnetic Environmental Guidance Electromagnetic Emissions The MetaSTAR RF Generator and SpineSTAR Ablation Instrument are intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. Emissions test Compliance Environmental guidance...
Page 13: Appendix Dconformance To Standards
APPENDIX D CONFORMANCE TO STANDARDS The MetaSTAR RF Generator conforms to the following International Standards:  EN 60601-1 Medical Electrical Equipment. Part 1: General Requirements for Basic Safety and Essential Performance  AAMI ES 60601-1 Medical Electrical Equipment. Part 1: General Requirements for Basic Safety and Essential Performance ...
Page 14: Appendix Gindicators / Error Codes And Troubleshooting
APPENDIX G INDICATORS / ERROR CODES AND TROUBLESHOOTING  In event of Hand Switch Cable failure – e.g. Hand Switch is stuck – remove Hand Switch Cable connector from MetaSTAR RF Generator.  If stuck in “ON” position turn off MetaSTAR RF Generator. ...
Page 15 Provided below is a list of Warning and Fault messages, listed in ascending order. Message Fault (F) / What Fault Message Means User Actions Number Warning (W) Turn Power off for 10 minutes to let generator cool Load impedance too high, RF down.