Object ID: 00000018WIA30702870GYZ
Topic ID: id_40024904 Version: 1.9
Date: Jul 7, 2022 7:19:41 PM

IEC/EMC compliance

Per IEC 60601-1-2, Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the following tables. The tables below provide details about the level of compliance and provide information about potential interactions between devices.

Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

Warning

The MR System may be interfered with by other equipment, even if that other equipment complies with CISPR EMISSION requirements.

Warning

The MR System should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the MR System should be observed in order to verify normal operation in the configuration in which it will be used.

Warning

The MR System should be used only in a shielded location named as the Magnet Room. Magnetic and RF Shielded Room requirements are defined in the Preinstallation Manual.

Warning

The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by GE or replacement parts for internal components, may result in increased emissions or decreased immunity of the MR system.

Adhering to the recommendations provided herein for the interaction of the MR System with other electrical devices within the electromagnetic environment may not eliminate all the disturbances.

The MR system has no essential performance per IEC 60601 standards, however, the MR system will maintain its critical functions by continuing to acquire, display, and store scanning images safely.

The MR system complies with emissions limits (Group 2, Class A) Medical devices as stated in IEC 60601-1-2.

Table 1. Guidance And Manufacturer’s Declaration – Electromagnetic Emissions
The MR System is intended for use in a typical health care electromagnetic environment specified below. The customer or the user of the MR System should assure that it is used in such an environment.
Emissions Test	Compliance Level	Electromagnetic Environment - Guidance
RF emissions CISPR 11	Group 2	The MR system must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF emissions CISPR 11	Class A	The MR system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2	Not Applicable
Voltage fluctuations/flicker emissions IEC 61000-3-3	Not Applicable
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Table 2. Guidance And Manufacturer’s Declaration – Electromagnetic Immunity
The MR System is intended for use in a typical health care electromagnetic environment specified below. The customer or the user of the MR System should assure that it is used in such an environment.
Immunity Test	IEC 60601-1-2 Test Level	Compliance Level	Electromagnetic Environment – Guidance
Electrostatic discharge (ESD) IEC 61000-4-2	±8 kV contact ±15 kV air	±8 kV contact ±15 kV air	Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient/burst IEC 61000-4-4	±2 kV for power supply lines ±1 kV for input/output lines	±2 kV for power supply lines ±1 kV for input/output lines	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	±0.5 kV, ±1 kV Line to line	±0.5 kV, ±1 kV Line to line	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	±0.5, ±1 kV, ±2 kV Line to ground	±0.5, ±1 kV, ±2 kV Line to ground
Voltage dips IEC 61000-4-11	U_t = 0%, 0.5 cycle (0, 45, 90, 135, 180, 225, 270, and 315 degrees) U_t = 0%, 1 cycle U_t = 70%, 25/30 cycles (0 degrees)	Not applicable	Mains power quality should be that of a typical commercial or hospital environment. If the user of the MR System requires continued operation during power mains interruptions, it is recommended that the MR System be powered from an uninterruptible power supply.
Short interruptions and voltage variations on power supply input lines IEC 61000-4-11	U_t = 0%, 250/300 cycles	U_t = 0%, 250/300 cycles
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	30 A/m 50 Hz or 60 Hz	30 A/m 50 Hz or 60 Hz	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF IEC 61000-4-6	3 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz at ISM bands^a	3 Vrms 150 kHz to 80 MHz 6 Vrms 150 kHz to 80 MHz at ISM bands	Portable and mobile RF communications equipment should not be used closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance. d = 1.2 √P 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHz. d = 2.3 √P 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey^c should be less than the compliance level in each frequency range^d. Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC 61000-4-3	3 V/m^b 80 MHz to 2.7GHz	3 V/m 80 MHz to 2.7GHz
Note: U_t is the AC mains voltage prior to application of the test level. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. b For more information, see section Proximity field immunity compliance. c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MR equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the equipment. d Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

Table 3. Recommended Separation Distances between portable and mobile RF communications equipment and the MR system
TheMR System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MR System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MR System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter stated in meters
Rated maximum output power of transmitter W	150 kHz to 80 MHz	80 MHz to 800 MHz	800 MHz to 2.7GHz
	d = 1.2 √P	d = 1.2 √P	d = 2.3 √P
0.01	0.12	0.12	0.23
0.1	0.37	0.37	0.74
1	1.17	1.17	2.33
10	3.69	3.69	7.38
100	11.67	11.67	23.33
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 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Table 4. Proximity field immunity compliance
The MR System is intended for use in a typical health care electromagnetic environment specified below. The customer or the user of the MR System should assure that it is used in such an environment.
Test Frequency [MHz]	Band [MHz]	Service	Modulation	Maximum power [w]	Distance [m]	Immunity compliance level [V/m]	Immunity test level [V/m]
385	380 ~ 390	TETRA 400	Pulse Modulation 18 Hz	1.8	0.3	27	27
450	430 ~ 470	GMRS 460, FRS 460	FM ±5 kHz deviation 1 kHz sine	2	0.3	28	28
710	704 ~ 787	LTE Band 13, 17	Pulse Modulation 217 Hz	0.2	0.3	9	9
745
780
810	800 ~ 960	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5	Pulse Modulation 18 Hz	2	0.3	28	28
870
930
1720	1700 ~ 1990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS	Pulse Modulation 217 Hz	2	0.3	28	28
1845
1970
2450	2400 ~ 2570	Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7	Pulse Modulation 217 Hz	2	0.3	28	28
5240	5100 ~ 5800	WLAN 802.11 a/n	Pulse Modulation 217 Hz	0.2	0.3	9	9
5500
5785
Note: The distance values represent the recommended separation distance between interfering equipment and components of the MR system.