NuVasive NVM5 Manual De Instrucciones página 35

TECHNICAL SPECIFICATIONS cont.
EMC Labeling For Camera Tracking System
Cables and Accessories
The following table lists the cable and accessories that may be used with the Polaris Vicra Tracking System while still maintaining
compliance to the emissions and immunity requirements of IEC60601-1-2:2001.
Use of cables or accessories, other than those listed in the following table, may result in increased emissions and/or decreased
immunity of the Polaris Vicra Tracking System and may result in personal injury.
Emissions Test
RF emissions - CISPR11
RF emissions - CISPR11
Harmonic emissions - IEC61000 3-2
Voltage fluctuations/ flicker emissions
IEC61000-3-3
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Immunity Test
Electrical Fast Transient
(EFT)/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Dips/Interruptions/
Variations on power
supply input
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
Manufacturer's Declaration for Electromagnetic Emissions
Compliance
Group 1
Class A
Class D
Complies
Manufacturer's Declaration for Electromagentic Immunity
IEC 60601 Test Level
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
IEC 60601 Test Level
±2 kV for power ±2 kV for power
supply lines. supply lines.
±1 kV for I/O ±1 kV for I/O
lines lines
±1 kV differential mode ±1 kV differential mode NA
±2 kV common mode ±2 kV common mode
<5% U for 0.5- cycles <5% U
t
40% U for 5- cycles 40% U
t
70% U for 25- cycles 70% U
t
<5% U for 5 sec <5% U
t
3 A/m 3 A/m
Electromagnetic Environment Guidance
The Polaris Vicra Tracking System does not emit electromagnetic
energy in order to perform all its intended functions.
The Polaris Vicra Tracking System is suitable for use in all
establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes
Compliance Level
Observe precautions when connecting or
disconnecting cables at ports identified with the ESD
warning symbol
Compliance Level
Care must be taken to route all patient-coupled
cables away from high power, high current or other
cables or sources that may induce electrical fast
transients into the patient-coupled cables. If such
interference is suspected, the cables should be re-
routed and/or the source of the interference shielded
or otherwise isolated
for 0.5- cycles NA
t
for 5- cycles
t
for 25- cycles
t
for 5 sec
t
Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical
commercial or hospital environment.
33
Electromagnetic Environment - Guidance
Electromagnetic Environment - Guidance