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403321001_001 2016-08-31 

 

   

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. 

 

In the event of a thermal shut down (ambient temperature is above 50°C or below 10°C) the 
MetaSTAR RF Generator stays in Warning mode until temperature returns to normal operating 
conditions.  Resolve by turning off and on when temperature is between 10°C-50°C. 

 

This equipment has been tested and found to comply with the limits for medical devices to the IEC 
60601-1-2. These limits are designed to provide reasonable protection against harmful interference 
in a typical medical installation.  This equipment generates; uses and can radiate radiofrequency 
energy and, if not installed and used in accordance with the instructions, may cause harmful 
interference to other devices in the vicinity. However, there is no guarantee that interference will not 
occur 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 interference by one or more of the following measures:  

 

Reorient or relocate the receiving device.  

 

Increase the separation between the equipment.  

 

Connect the MetaSTAR RF Generator to an electrical outlet on a circuit different from the 
affected equipment.  

 

In case of unsuccessful Self-Test FAULT LED or WARNING LED will be on, continuous alarm 
Fault or Warning Tone 

– Requires System Restart. 

 

In case of Error State, the unit will remain in that Fault or Warning condition until the unit is 
switched off using the MAIN ON/OFF POWER SWITCH. 

 

In the event the MetaSTAR RF Generator does not recognize the SpineSTAR Ablation 
Instrument it will flash “Connect Device.” 

 

Warnings and Fault Messages 

Warning Messages displayed on MetaSTAR RF Generator 

All the Warning messages follow the basic form below: 

Example of Warning message (in Yellow outlined triangle and text): 

 

Fault Messages displayed on MetaSTAR RF Generator 

All the Fault messages follow the basic form below: 

Example of Fault message (in Red outlined triangle and text): 

 

 

 

 

 

 

 

 

 

 

 

 

 

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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