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auris Monarch Platform - Declaration of Immunity

auris Monarch Platform
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300-002547-00 rev7 19
Declaration of Immunity
The Monarch Platform is to be used per the specified guidance and only in the
electromagnetic environment listed below.
Table 2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity – For All ME
EQUIPMENT and ME SYSTEMS
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ME System is intended for use in the electromagnetic environment specified below. The
customer or the user of the ME System should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment –
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
During an electrical fast transient
event, the system may fault in the
"Image Frozen" or "Robot Controller
Error" states as described in
Appendix B.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be that of
a typical commercial or hospital
environment.
During a surge event, the system
may fault in the "Image Frozen" or
"Robot Controller Error" states as
described in Appendix B.

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