Electromagnetic Compatibility - Guidance and Manufacturer's Declaration

The VITA system complies with IEC 60601-1-2 , General Requirements for Safety — Collateral standard: Electromagnetic compatibility. Performance of the device is unaffected by exposure to the compliance levels described in Tables 1, 2, 3 and 4 in the following section.

Special precautions and installation information for the VITA for electromagnetic compatibility (EMC) are provided below:

Equipment in hospital environments, including the VITA and other portable or mobile communications equipment, can produce Electromagnetic Interference (EMI), that may affect the function of these devices. Such effects are prevented by use of equipment with EMI characteristics proven below recognized limits, as identified in the tables below.
In the event of suspected interference from other equipment, which prevents the proper functioning of the VITA, contact Teladoc Health and discontinue use of the system until the problem can be remedied.

The following tables contain the Manufacturer’s declaration and additional information required by IEC 60601-1-2.

warning: Leakage current from interconnected electrical equipment may exceed safe levels. In order to maintain patient and user safety, it is important to interconnect only with devices in compliance with IEC 60601-1-1 requirements. It is the responsibility of the user to ensure that any interconnected equipment not supplied by Teladoc Health maintains compliance with IEC 60601-1-1 requirements.

Table 1: Electromagnetic Emissions

The VITA is intended for use in the electromagnetic environment specified below. The customer or the user of the VITA should assure that it is used in such an environment.
Emissions Test	Compliance	Electromagnetic Environment
RF Emissions CISPR 11	Group 1	The VITA uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11	Class A	The VITA 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	Class A
Voltage Fluctuations / Flicker Emissions IEC 61000-3-3	Complies

Table 2: Electromagnetic Immunity

The VITA system is intended for use in the electromagnetic environment specified below. The customer or the user of the VITA should assure that it is used in such an environment.

Immunity Test	EC 60601 Test Level	Compliance Level	Electromagnetic Environment - Guidance
Electrostatic Discharge (ESD) IEC 61000-4-2	±6 kV Contact ±8 kV Air	±6 kV Contact ±8 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	±1 kV Line(s) to Line(s) ±2 kV Line(s) to Earth	±1 kV Line(s) to Line(s) ±2 kV Line(s) to Earth	Mains power quality should be that of a typical commercial or hospital environment.
Voltage Dips, Short Interruptions, and Voltage Variations on Power Supply Input Lines IEC 61000-4-11	<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec	<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec	Main power quality should be that of a typical commercial or hospital environment. If the user of the requires continued operation during power mains interruptions, it is recommended that the VITA be powered from an uninterruptible power supply (UPS) or a battery.
Power frequency (50 / 60 Hz) Magnetic Field IEC 61000-4-8	3 A/m	3 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
U_T is the a.c. mains voltage prior to application of the test level.

Table 3: Electromagnetic Immunity

VITA is intended for use in the electromagnetic environment specified below. The customer or the user of an VITA should assure that it is used in such an environment.

Immunity Test	Conducted RF IEC 61000-4-6 Radiated FR IEC 61000-4-3
EC 60601 Test Level	3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz
Compliance Level	3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz
Electromagnetic Environment - Guidance	Portable and mobile RF communications equipment should be used no closer to any part of the VITA, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d= 1.2 80 MHz to 800 MHz 800 MHz to 2.5 GHz d= 1.2 d= 2.3 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^a, should be less than the compliance level in each frequency range^b. Interference may occur in the vicinity of equipment marked with the following symbol:

NoteS:

At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur 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 VITA is used exceeds the applicable RF compliance level above, the VITA should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VITA.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

Table 4: Recommended separation distances

Recommended separation distances between portable and mobile RF communications equipment and the VITA.

The VITA is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VITA can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VITA 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 (m)
	150 kHz to 80 MHz d =1.2	80 MHz to 800 MHz d =1.2	800 MHz to 2.5 GHz d= 2.3
0.01	0.12	0.12	0.23
0.1	0.38	0.38	0.73
1	1.2	1.2	2.3
10	3.8	3.8	7.3
100	12	12	23

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.

NOTEs

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.