403321001_001 2016-08-31
APPENDIX B ELECTROMAGNETIC ENVIRONMENT GUIDANCE
APPENDIX C ABBREVIATIONS
LED
Light Emitting Diode
RF
Radio Frequency
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
RF emissions CISPR 11
Class A
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/ flicker emissions IEC 61000-
3-3
AC Input
The System does not require interconnection with other equipment.
Portable and mobile RF communications equipment can affect operation of the System.
The System intentionally radiates RF in normal operation.
Electromagnetic Immunity
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.
Immunity test
IEC 60601 test level
Compliance
level
Environmental
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
Contact:
±2kV, ±4kV±6kV
Air:
±2kV, ±4kV ,±6kV ±8 kV
Per test level
Radiated RF Electromagnetic
Fields IEC 61000-4-3
80 to 1000Mhz 3V/m
AM 80%
3 sec dwell
Per test level
Electrical fast transient/burst
IEC 61000-4-4
Test at AC Port for both
230Vac/50hz and
120Vac/60hz input voltages
Per test level
Surge IEC 61000-4-5
Test at AC Port for both
230Vac/50hz and
120Vac/60hz input voltages
Per test level
Conducted disturbances,
Induced by RF Fields
IEC 61000 -4 -6
0.15Mhz to80Mhz 3V/m AM
3 sec dwell
Per test level.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11 UT
= 230 Vac
Test at AC Port for both
230Vac/50hz and 120Vac/60
hz input
Power frequency (50 Hz)
magnetic field IEC 61000-4-8
Test at AC Port for both
230Vac/50hz and
120Vac/60hz input 3A/m
Per test level
