COPYRIGHT 2010 - 2020, ACCELERATED CARE PLUS CORP., ALL RIGHTS RESERVED
OMNICYCLE
®
ELITE USER MANUAL
45
APPENDIX II – ELECTROMAGNETIC COMPATIBILITY (EMC)
EMC Notes
•
The Omnicycle
®
Elite is to be used exclusively with the original power cable.
•
Only the provided cardio pulse set is to be used with the Omnicycle
®
Elite. Other pulse sensors might
damage or affect the EMC behavior.
•
Only the provided Bluetooth® printer is to be used with the Omnicycle
®
Elite.
•
The Omnicycle® Elite should not be used in close proximity with other medical devices.
•
The immunity level requirements of IEC 60601 are met.
Electromagnetic Emissions
Directives and Manufacturing Declaration – Electromagnetic Emissions
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
Compliance
Directive for electromagnetic environment
HF emissions according to CISPR 11
Group 1
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.
HF emissions according to CISPR 11
Class B
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.
Harmonics according to IEC 61000-
3-2
Class A
Voltage fluctuation/flicker according
to IEC 61000-3-3
Met
Immunity to Electromagnetic Disturbance
U
T
is the supply AC voltage before the test level is applied.
Directives and Manufacturing Declaration – Immunity to Electromagnetic Disturbance
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
Level of Conformity
Directive for electromagnetic
environment
Static Discharge
(ESD)
IEC 6100-4-2
± 6kV contact
discharge (indirect)
± 8kV air discharge
± 6kV contact
discharge
(indirect)
± 8kV air discharge
Floors should be wooden, concrete or
ceramic tiled. If the floor contains synthetic
materials, the relative air humidity must be
at least 30%.
Fast Transients
IEC 61000-4-4
± 2kV for supply lines
± 1kV for
inputs/outputs
± 2kV for supply lines
± 1kV for
inputs/outputs
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment.
Surges
IEC 61000-4-5
± 1kV differential mode
voltage (symmetrical)
± 2kV common mode
voltage (asymmetrical)
± 1kV differential mode
voltage (symmetrical)
± 2kV common mode
voltage (asymmetrical)
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment.
Voltage Dips and
Fluctuations
IEC 61000-4-11
< 5% U
T
for 0.5 periods
(> 95% dip)
40% U
T
for 5 periods
(60% dip)
70% U
T
for 25 periods
(30% dip)
< 5% U
T
for 5 s
(>95% dip)
< 5% U
T
for 0.5 periods
(> 95% dip)
40% U
T
for 5 periods
(60% dip)
70% U
T
for 25 periods
(30% dip)
< 5% U
T
for 5 s
(>95% dip)
The quality of the supply voltage should
correspond to that of a typical business or
hospital environment. If continuous
operation is required, an external non-
interruptible power system will be required.
Note:
