The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration in which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Emissions All Equipment and Systems
This device is intended for use in the electromagnetic environment specified below. The customer or user of this device should assure that it is used in such an environment.
Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics IEC 61000-3-2
Flicker IEC 61000-3-3
Immunity Test
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical Fast Transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
Immunity Test
Power Frequency 50/60Hz
Magnetic Field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
For transmitters rated at a maximum output power not listed above, the recommended separation distance D in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: T hese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Recommended Separation Distances Between Portable and Mobile RF communications Equipment and
this device. This device and system are NOT Life-Supporting
This device is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the device as recommended below,
according to the maximum output power of the communications equipment.
Maximum Output Power
(Watts)
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance D in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: T hese guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
EN - 8
Compliance
Electromagnetic Enforcement – Guidance
This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not
Group 1
likely to cause any interference in nearby electronic equipment.
Class B Radiated and
Conducted Emissions
This device is suitable for use in all establishments including domestic, and those directly connected to the
Class A
public low-voltage power supply network that supplies buildings used for domestic purposes.
Complies
IEC 60601 Test Level
Compliance Level
±6kV contact
±6kV contact
±8kV air
±8kV air
±2kV on AC Mains
±2kV on AC Mains
±1kV Differential
±1kV Differential
±2kV Common
±2kV Common
>95% Dip for 0.5 Cycle
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
60% Dip for 5 Cycles
30% Dip for 25 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
>95% Dip for 5 Seconds
IEC 60601 Test Level
Compliance Level
3A/m
3A/m
3 Vrms from
V1 = 3 Vrms
150 kHz to 80 MHz
3 V/m
E1 = 3V/m
80 MHz to 2.5 GHz
Recommended Separation Distances for the device (meters)
150 kHz to 80 MHz
80 to 800MHz
P
D=(1.1667)
D=(1.1667)
√
0.11667
0.11667
0.36894
0.36894
1.1667
1.1667
3.6894
3.6894
11.667
11.667
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative
humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
If the user of this device requires continued operation during power mains
interruptions, it is recommended that the device be powered from an uninterruptible
power supply or battery.
Electromagnetic Environment - Guidance
Power frequency magnetic fields should be that of a typical location in a typical
commercial or hospital environment.
Portable and mobile RF communications equipment should be separated from the
device by no less than the recommended separation distances calculated/listed
below:
D=(3.5/V1)
√ P
D=(3.5/E1)√ P 80 to 800 MHz
D=(7/E1)√ P
800 MHz to 2.5 GHz
Where P is the maximum power rating in watts and D is the recommended
separation distance in meters.
Field strengths from fixed transmitters, as determined by an electromagnetic site
survey, should be less than the compliance levels (V1 and E1).
Interference may occur in the vicinity of equipment containing a transmitter.
800 MHz to 2.5 GHz
P
P
D=(2.3333)
√
√
0.23333
0.73785
2.3333
7.3785
23.333
A-704