Merit Medical MetaSTAR 3195 Operator'S Manual Download

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403321001_001 2016-08-31

OPERATOR’S MANUAL

MetaSTAR™ RF Generator

Catalog No. 3195

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

Authorized Representative:
Merit Medical Ireland Ltd.
Parkmore Business Park West
Galway, Ireland
+31 43 358 82 22

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

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

Summary of Contents for MetaSTAR 3195

Page 1: ...West Merit Parkway South Jordan Utah 84095 U S A 1 801 253 1600 U S A Customer Service 1 800 356 3748 Authorized Representative Merit Medical Ireland Ltd Parkmore Business Park West Galway Ireland 31...

Page 2: ...PPLIED 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 Generat...

Page 3: ...FU for the applicable device s used during the procedure Warning Hazardous electrical output This equipment is for use only by qualified medical personnel trained in the use of the MetaSTAR RF Generat...

Page 4: ...istatic sheeting is recommended Caution Cables to the surgical electrodes are recommended to be positioned such that contact with patient or other leads is avoided Caution Do not continue to deliver R...

Page 5: ...SpineSTAR Ablation Instrument Hand Switch Cable andAE Cable are available as backup prior to use 8 3 MetaSTAR RF Generator Nomenclature Symbols ON power Type BF Applied Part Volume Control OFF power W...

Page 6: ...LOW LED 4 RF ON BLUE LED 5 POWER ON GREEN LED 6 Soft Key Button 1 7 Soft Key Button 2 8 Soft Key Button 3 9 Soft Key Button 4 10 Hand Switch Cable Socket 11 AE Cable Socket 12 Fuse Drawer 13 ON OFF Ma...

Page 7: ...be connected to the AE Cable socket on the MetaSTAR RF Generator using the AE Cable inspect the AE Cable for damage If the SpineSTAR Ablation Instrument is connected properly Distal and Proximal tempe...

Page 8: ...TAR Ablation Instrument is properly placed 1 Both thermocouple temperatures are displayed in amber 30 C Note temperatures are displayed in blue when temperature is 30 C 2 Electrode is extended to the...

Page 9: ...instructions for use and maintenance instructions The sole obligation of MERIT under this warranty shall be limited to the replacement of the MetaSTAR RF Generator or equivalent models at no charge t...

Page 10: ...erit 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 Authorized Representative Merit Medical Ireland Ltd Parkmore Busines...

Page 11: ...operation Enclosure IP 21 III Operating Conditions Temperature 59 F to 104 F 15 C to 40 C Relative Humidity 30 to 75 non condensing Atmospheric Pressure 878 to 1082cmH2O 86 to 106kPa Whenever the tem...

Page 12: ...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 Immunity test IEC 60601...

Page 13: ...ntific and Medical ISM RF Equipment MDD 93 42 EEC Medical Device Directive Council Directive Concerning Medical Devices APPENDIX E COMPATIBLE POWER CORDS Continental Europe 2 0m 10A Inter Power PN 862...

Page 14: ...in a particular installation If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the...

Page 15: ...e 39 F Watchdog Fault Turn Power off Turn Power back on If error persists contact MERIT Customer Service 41 53 W RAM Power On Self Test Turn Power off Turn Power back on If error persists contact MERI...