FAQ

OMRON Battery-operated TENS Unit
Information for Accompanying Documents in the Scope of
IEC60601-1-2:2014
Important information regarding Electromagnetic Compatibility (EMC)
This device manufactured by OMRON HEALTHCARE Co., Ltd. conforms to IEC60601-1-2:2014 Electromagnetic Compatibility
(EMC) standard. Nevertheless, special precautions need to be observed:
• TheuseofaccessoriesandcablesotherthanthosespeciedorprovidedbyOMRONcouldresultinincreased
electromagnetic emission or decreased electromagnetic immunity of the device and result in improper operation.
• During operation, the use of the device adjacent to or stacked with other device should be avoided because it could result in
improper operation. In case such use is necessary, the device and other device should be observed to verify that they are
operating normally.
• During operation, portable RF communications device (including peripherals such as antenna cables and external antennas)
shouldbeusednocloserthan12inches(30cm)toanypartofthedevice,includingcablesspeciedbyOMRON.Otherwise,
degradation of the performance of the device could result.
• Refer to further guidance below regarding the EMC environment in which the device should be used.
Table 1 - EMISSION Limits and Compliance
Phenomenon EMISSION Limits Compliance
Conducted and radiated RF EMISSIONS CISPR 11 Group1, Class B
Table 2 - IMMUNITY TEST LEVELS
Phenomenon Basic EMC standard IMMUNITY TEST LEVELS
Electrostatic discharge IEC 61000-4-2 ±8 kV contact
±2 kV,±4 kV,±8 kV,±15 kV air
for enclosure port and patient coupling port
RadiatedRFelectromagneticelds IEC 61000-4-3 10 V/m
80 MHz to 2.7 GHz
80 % AM at 1 kHz
for enclosure port
ProximityeldsfromRFwirelesscommunicationsequipment IEC 61000-4-3 See table 3
ConducteddisturbancesinducedbyRFelds IEC 61000-4-6 6 Vrms
150 kHz to 80 MHz
80 % AM at 1 kHz
for patient coupling port
Ratedpowerfrequencymagneticelds IEC 61000-4-8 30 A/m
50 Hz or 60 Hz
for enclosure port
Table 3 - Test specications for ENCLOSURE PORT IMMUNITY to RF wireless communications device
Test frequency
(MHz)
Band (MHz) Service Modulation Maximum
power (W)
Distance
(m)
IMMUNITY TEST
LEVEL (V/m)
385 380 to 390 TETRA 400 Pulse modulation 18 Hz 1.8 0.3 27
450 430 to 470 GMRS 460,
FRS 460
FM
± 5 kHz deviation
1 kHz sine
2 0.3 28
710 704 to 787 LTE Band 13, 17 Pulse modulation 217 Hz 0.2 0.3 9
745
780
810 800 to 960 GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse modulation 18 Hz 2 0.3 28
870
930
1720 1700 to 1990 GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4, 25; UMTS
Pulse modulation 217 Hz 2 0.3 28
1845
1970
2450 2400 to 2570 Bluetooth, WLAN,
802.11 b/g/n , RFID 2450,
LTE Band 7
Pulse modulation 217 Hz 2 0.3 28
5240 5100 to 5800 WLAN 802.11
a/n
Pulse modulation 217 Hz 0.2 0.3 9
5500
5785
4616797-4A