403321001_001 2016-08-31
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
CSA C22.2 No. 60601-1
Medical Electrical Equipment. Part 1: General Requirements for
Basic Safety and Essential Performance
IEC 60601-1-2
Medical Electrical Equipment, Part 1-2: Collateral Standard:
Electromagnetic Compatibility
IEC 60601-2-2
Medical Electrical Equipment, Part 2-2: Essential Performance
Particular Requirements for the Basic Safety and Essential Performance
of High Frequency Surgical Equipment and high frequency surgical
accessories
ANSI/AAMI/ISO 15223
Graphical Symbols for Use on Equipment
EN 60529
Degrees of Protection Provide by Enclosures (IP Code)
ANSI/AAMI ES-1
Safe Current Limits for Electro medical Apparatus
ASTM D4169
Standard Practice for Performance Testing of Shipping
Containers & Systems
EN 55011 (CISPR 11)
Limits and Methods of Measurement of Electromagnetic Disturbance
Characteristics of Industrial, Scientific, 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 86231000
Argentina, 2.5m, 10A, Inter Power PN 86270010
Brazil, 2.5m, 10A, Inter Power PN 86286110
China, 2.5m, 10A, Inter Power PN 86517040
India / South Africa, 2.5m, 10A, Inter Power PN 86265010
Israel, 2.5m, 10A, Inter Power PN 86275010
Italy, 2.5m, 10A, Inter Power PN 86394000
Japan, 2.3m, 7A, Inter Power PN 86589000
Switzerland, 2.5m,10A, Inter Power PN 86285010
United Kingdom / Ireland, 2.5m,10A, Inter Power PN 86240060
Hospital-Grade
Australia/New Zealand, 2.5m, 10A, Inter Power PN 86210140
Denmark, 2.5m, 10A: Inter Power PN 86280810
North America, 3.0m, 10A Inter Power 86610710 rev B
APPENDIX F TONES
Power On
– Speaker: 250Hz for 75ms, 300Hz for 100ms, 400Hz for 100ms, 500Hz for 80ms,
530Hz for 100ms, 600Hz for 100ms, 750Hz for 100ms, 900Hz for 100ms, 100ms silence, 1000Hz
110ms five times within 5 seconds, 1000Hz for 500ms tone once at power up.
RF Enabled
– Speaker: 300Hz for 200ms – once every two seconds when RF energy is
delivered in Ablation Mode.
Fault
-
High Priority tone.
Warning
-
Medium Priority tone.
Button Click
- The tone pattern shall be the following: 1000Hz for 20ms.
Temperature High
– Speaker: 600Hz for 200ms – once every two seconds when RF energy is
delivered in Ablation Mode and the corresponding TC reading is above 45 °C.
