Electromagnetic Compatibility (EMC)
Install and operate the device according to the EMC information presented in this section.
The device is designed to function under a wide range of environmental conditions without compromise to Safety or Essential Performance.
Warnings:
- Proper use of this device depends on careful reading of all instructions and labels.
- DO NOT modify the device or any components.
- An internal battery is used for normal operation of this device. To avoid abnormal operation of this device, do not place the device next to or beneath other
equipment; or, if such placement is necessary, verify normal operation of this device and the other equipment.
- Use of accessories or components other than those specified or provided could result in increased electromagnetic emissions or decreased electromagnetic
immunity of the device, which may result in abnormal operation.
- Performance of this device may degrade if any part of the device is used closer than 12 in. (30cm) to portable RF communications equipment (including
peripherals such as antenna cables and external antennas). Placement closer than 12 in. (30cm) is neither specified nor permitted for this device.
Declaration of compliance to IEC 60601-1-2: Ed. 4.0 (2014): The device has been tested to verify essential performance in the presence of electromagnetic
disturbances as outlined in the summary of tests below.
Electromagnetic Emissions
Emissions Test
Radiated RF emissions - CISPR 11
Conducted RF emissions - CISPR 11
Harmonic emissions - IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Electromagnetic Immunity
Immunity Test Levels – Enclosure Port
Phenomenon
Electrostatic Discharge
Radiated RF EM Fields
Proximity Fields from RF Wireless
Communications Equipment
Rated Power Frequency Magnetic Fields
Immunity Test Levels – Input A.C. Power Port – N/A
Immunity Test Levels – Patient Coupling Port – N/A
Immunity Test Levels – Signal Input / Output Parts Port – N/A
Associated cables – none
Notice: No deviations from the collateral standard IEC 60601-1-2:2014 were performed.
Notice: All necessary instruction for maintaining compliance can be found in the safety and maintenance sections in this manual. No further steps are required.
Limited Warranty
Limited Warranty Term: 24 months from the date the product was originally purchased. See also the Limited Warranty supplement provided with
your product, or contact Customer Support.
Smart Check Operation Manual
Compliance
Electromagnetic environment – guidance
Group 1 Class B
According to CISPR 11 group 1, Class B.
N/A
This equipment/system is suitable for use in healthcare professional and home health care
N/A
establishments and uses only RF energy for its internal function. Therefore, its RF emissions
N/A
are very low and are not likely to cause any interference in nearby electronic equipment.
Basic EMC Standard
Immunity Test Levels – Home Healthcare Environment
IEC 61000-4-2
± 2 kV, ± 4 kV, ± 6 kV, ± 8 kV contact discharges
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air discharges
IEC 61000-4-3
10 V/m; 80 MHz – 2.7 GHz; 80% 1 kHz amplitude modulation
IEC 61000-4-3
Frequency (MHz) Modulation
385
450
710
745
780
810
870
930
1720
1845
1970
2450
5240
5500
5785
IEC 61000-4-8
30 A/m; 50 Hz and 60 Hz
18Hz PM 50%
FM ± 5 kHz dev,1kHz (or 18Hz PM 50%)
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
18Hz PM 50%
18Hz PM 50%
18Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
217Hz PM 50%
9
Level (V/m) Distance (m)
27
0.3
28
0.3
9
0.3
9
0.3
9
0.3
28
0.3
28
0.3
28
0.3
28
0.3
28
0.3
28
0.3
28
0.3
9
0.3
9
0.3
9
0.3