Appendix Ii - Electromagnetic Compatibility - ACP OMNICYCLE ELITE User Manual

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OMNICYCLE ELITE USER MANUAL
APPENDIX II – ELECTROMAGNETIC COMPATIBILITY (EMC)
EMC Notes
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The Omnicycle
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Only the provided cardio pulse set is to be used with the Omnicycle
damage or affect the EMC behavior.
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Only the provided Bluetooth® printer is to be used with the Omnicycle
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The Omnicycle® Elite should not be used in close proximity with other medical devices.
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The immunity level requirements of IEC 60601 are met.
Electromagnetic Emissions
Directives and Manufacturing Declaration – Electromagnetic Emissions
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The Omnicycle Elite is designed for operation in an electromagnetic environment as described below. The customer or
the user should make sure that the unit is used in such an environment.
Emission measurement
HF emissions according to CISPR 11
HF emissions according to CISPR 11
Harmonics according to IEC 61000-
3-2
Voltage fluctuation/flicker according
to IEC 61000-3-3
Immunity to Electromagnetic Disturbance
Directives and Manufacturing Declaration – Immunity to Electromagnetic Disturbance
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The Omnicycle Elite is designed for operation in an electromagnetic environment as described below. The customer or
the user should make sure that the unit is used in such an environment.
Immunity Test IEC 60601 Test Level
Static Discharge ± 6kV contact
(ESD) discharge (indirect)
IEC 6100-4-2 ± 8kV air discharge
Fast Transients ± 2kV for supply lines
± 1kV for
IEC 61000-4-4
inputs/outputs
± 1kV differential mode
Surges
IEC 61000-4-5 voltage (symmetrical)
± 2kV common mode
voltage (asymmetrical)
Voltage Dips and
< 5% U
Fluctuations
(> 95% dip)
IEC 61000-4-11
40% U
(60% dip)
70% U
(30% dip)
< 5% U
(>95% dip)
Note:
U is the supply AC voltage before the test level is applied.
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Elite is to be used exclusively with the original power cable.
Compliance
Group 1
Class B
Class A
Met
Level of Conformity
± 6kV contact
discharge
(indirect)
± 8kV air discharge
± 2kV for supply lines
± 1kV for
inputs/outputs
± 1kV differential mode
voltage (symmetrical)
± 2kV common mode
voltage (asymmetrical)
for 0.5 periods < 5% U
T
(> 95% dip)
for 5 periods 40% U
T
(60% dip)
for 25 periods 70% U
T
(30% dip)
for 5 s < 5% U
T
(>95% dip)
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Elite. Other pulse sensors might
®
Elite.
Directive for electromagnetic environment
This device uses HF energy exclusively for internal functions.
This incurs very low HF emissions so it is unlikely to interfere
with any nearby electronic device.
This device is designed for use in all kinds of facilities,
including:
- Residential buildings
- Facilities that are directly connected to a public mains
which also supplies residential buildings.
Directive for electromagnetic
environment
Floors should be wooden, concrete or
ceramic tiled. If the floor contains synthetic
materials, the relative air humidity must be
at least 30%.
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment.
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment.
The quality of the supply voltage should
for 0.5 periods
T
correspond to that of a typical business or
hospital environment. If continuous
for 5 periods
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operation is required, an external non-
for 25 periods interruptible power system will be required.
T
for 5 s
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