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403321001_001 2016-08-31 

 

   

3. 

Proximal Thermocouple (TC) on the SpineSTAR Ablation Instrument reaches 50ºC.   

The RF Cycle Time can be reset to the pre-set value by pressing and releasing the Reset Cycle 
Button. 
The RF Total Time, number of Cycles, and RF Cycle Time can be reset together by pressing and 
holding the Reset All button for 2 seconds. 

 
Completion of Procedure 

Turn off MetaSTAR RF Generator using the power button. Unplug the controller from the electrical 
outlet (Mains) and remove the power cord from the back of the controller. 

10. 

PREVENTIVE MAINTENANCE, TROUBLESHOOTING AND REPAIR: 

10.1. 

Adjusting Volume 

The MetaSTAR RF Generator has an adjustable volume control (Section 8.2 item 16) on the back of 

the unit.  

Twisting the adjustor clockwise will increase the volume. 

10.2. 

Maintaining Device Effectiveness 

In the event of a blown fuse, only 5x20mm 3.15A/250VAC Type “T” (slow blow) fuses should be used 
as replacements. Turn power off and disconnect the power cord from the electrical outlet.  Remove 
fuse holder by opening the Power Entry Module’s Fuse Drawer (Section 8.2 item 12) on the back of 
the MetaSTAR RF Generator. Replace both fuses. 
Besides the fuses there are no other user serviceable parts. No servicing or preventive maintenance 
is  required  for  this  device.    For  servicing,  replacement  or  repair,  return  cleaned  unit  (9.3)  to 
manufacturer.  

11. 

CUSTOMER SERVICE AND TECHNICAL SUPPORT, WARRANTY: 

11.1. 

Customer Service 

Contact MERIT’s Customer Service for any customer or technical support.  
Call 

+1-800-356-3748

 or e-mail us at 

[email protected]

. 

11.2. 

Limited Warranty 

Merit  Medical  Systems,  Inc.  (“MERIT”)  warrants  to  the  original  purchaser  of  the  MetaSTAR  RF 
Generator (“MetaSTAR RF Generator”) that the MetaSTAR RF Generator will be free of defects in 
material and workmanship for a period of one year after the date of purchase when used as intended 
under  normal  operating  conditions  and  in  conformance  with  their  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  to  the  original 
purchaser and at the option of MERIT, during the warranty period but only if examination reveals to 
the  satisfaction  of  MERIT  that  the  MetaSTAR  RF  Generator  contains  a  defect  in  material  or 
workmanship. 
This warranty is made in lieu of all other warranties, expressed, implied or statutory, including, but 
not limited to the implied warranties of merchantability and fitness for a particular purpose and all 
other obligations and liabilities on the part of MERIT. MERIT neither assumes nor authorizes any 
other  person  to  assume for  it  any  other liability  in  connection  with the  sale  of  the  MetaSTAR  RF 
Generator. This warranty shall not apply to MetaSTAR RF Generator or any other part thereof that 
has been subject to accident, negligence, alteration, abuse, or misuse.  MERIT makes no warranty 
whatsoever with regard to accessories or parts used in conjunction with the MetaSTAR RF Generator 
and not supplied and manufactured by MERIT. 
The term “original purchaser,” as used in the warranty means that person or organization and its 
employees, if applicable, to whom the MetaSTAR RF Generator was sold by MERIT. This warranty 
may not be assigned or transferred in any manner. 
In order to make a warranty claim, the original customer must obtain a Return Good Authorization 
Number  (“RGA  Number”)  and  return instructions  from  MERIT’s  Customer  Service  Department  or 
authorized  representative.  The  allegedly  defective  MetaSTAR  RF  Generator  must  be  returned, 
cleaned, repackaged, clearly marked with the 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. 

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...

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