Electromagnetic Compatibility

Guidance and Manufacturer's Declaration

The TV Pro 300 system complies with IEC 60601-1-2 4th edition, 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 TV Pro 300 for electromagnetic compatibility (EMC) are provided below:

  • Equipment in hospital environments, including the TV Pro 300 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 TV Pro 300, 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.

IEC 60601-1-2:2014/AMD1:2020 ME EQUIPMENT and ME SYSTEMS identification, marking and documents for Class A product

The ME EQUIPMENT or ME SYSTEM is suitable for professional healthcare facility.

Warnings:

  • Don’t install near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.

  • Ne pas installer à proximité d'équipements chirurgicaux HF actifs et de la salle blindée RF d'un système ME pour l'imagerie par résonance magnétique, où l'intensité des perturbations EM est élevée.

  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

  • L'utilisation de cet équipement à côté ou empilé avec d'autres équipements doit être évitée car cela pourrait entraîner un fonctionnement incorrect. Si une telle utilisation est nécessaire, cet équipement et les autres équipements doivent être observés pour vérifier qu'ils fonctionnent normalement.

  • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

  • L'utilisation d'accessoires, de transducteurs et de câbles autres que ceux spécifiés ou fournis par le fabricant de cet équipement peut entraîner une augmentation des émissions électromagnétiques ou une diminution de l'immunité électromagnétique de cet équipement et entraîner un fonctionnement incorrect.

  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the audio/video communication system (TV Pro 300), including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Les équipements de communication RF portables (y compris les périphériques tels que les câbles d'antenne et les antennes externes) ne doivent pas être utilisés à moins de 30 cm (12 pouces) de toute partie du système de communication audio/vidéo (TV Pro 300), y compris les câbles spécifiés par le fabricant. Dans le cas contraire, une dégradation des performances de cet équipement pourrait en résulter.

  • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

  • Pour éviter tout risque d'électrocution, cet équipement ne doit être connecté qu'à une alimentation secteur avec mise à la terre de protection.

Note: Teladoc recommends the use of the HDMI and power cables included with the product. The user is responsible for additional cables and connections made to TV Pro 300.

Table 1: Electromagnetic Emissions

  1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.

  2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.

The TV Pro 300 is intended for use in the electromagnetic environment specified below. The customer or the user of the TV Pro 300 should assure that it is used in such an environment.
Emissions Test Compliance
RF Emissions CISPR 11 Group 1
RF Emissions CISPR 11 Class A
Harmonic Emissions IEC 61000-3-2 Class A
Voltage Fluctuations / Flicker Emissions IEC 61000-3-3 Complies

Table 2: Electromagnetic Immunity

The TV Pro 300 system is intended for use in the electromagnetic environment specified below. The customer or the user of the TV Pro 300 should assure that it is used in such an environment.

Caution: An Electro Static Discharge (ESD) event may cause the system to lose functionality for a short amount of time. If the event does not recover automatically, power cycle the device.
Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD)

IEC 61000-4-2

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV air

±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±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

Power supply lines：±2 kV

100 kHz repetition frequency

Power supply lines：±2 kV

100 kHz repetition frequency

 Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5

line(s) to line(s)：±1 kV.

line(s) to line(s)：±1 kV.

 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

0% 0.5 cycle

At 0º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and 315 º

0% 1 cycle

And

70% 25/30 cycles

Single phase: at 0

0% 300 cycle

0% 0.5 cycle

At 0º, 45 º, 90 º, 135 º, 180 º, 225 º, 270 º and 315 º

0% 1 cycle

And

70% 25/30 cycles

Single phase: at 0

0% 300 cycle

 Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the Lite 4 with Boom Camera be powered from an uninterruptible power supply (UPS) or a battery.

Power frequency
Magnetic Field

IEC 61000-4-8

 30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conduced RF IEC61000-4-6

150KHz to 80MHz：

3Vrms

6Vrms (ISM bands between)

80% Am at 1kHz

150KHz to 80MHz：

3Vrms

6Vrms (ISM bands between)

80% Am at 1kHz

Portable and mobile RF communications equipment should be used no closer to any part of the TV Pro 300, 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 surveya, should be less than the compliance level in each frequency rangeb.

Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF IEC61000-4-3

3 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

3 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

Proximity magnetic fields

IEC 61000-4-39

30 kHz: 8A/m

134.2 kHz: 65A/m

13.56 MHz: 7.5A/m

Not application

Or 30 kHz: 8A/m

134.2 kHz: 65A/m

13.56 MHz: 7.5A/m
UT is the a.c. mains voltage prior to application of the test level.

Table 3: Electromagnetic Immunity - Enclosure Port Immunity

TV Pro 300 is intended for use in the electromagnetic environment specified below. The customer or the user of an TV Pro 300 should assure that it is used in such an environment.

Guidance and manufacturer’s declaration - electromagnetic Immunity

Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Test Frequency (MHz) Band (MHz) Service Modulation Maximum Power(W) Distance (m) IEC 60601-1-2 Test level (V/m) Compliance 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 1 700 – 1 990 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 2 400 – 2 570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation 217 Hz 2 0.3 28 28

 

 5240 5 100 – 5 800 WLAN 802.11 a/n Pulse modulation 217 Hz 0,2 0.3 9 9

 

 5500

 

 5785

Table 4: Recommended separation distances

Recommended separation distances between portable and mobile RF communications equipment and the TV Pro 300.

The TV Pro 300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the TV Pro 300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TV Pro 300 as recommended below, according to the maximum output power of the communications equipment.

Guidance and manufacturer’s declaration - electromagnetic Immunity

Test frequency

Modulation

Immunity Test Level (A/m)

30 kHz

CW

8

134,2 kHz

Pulse modulation a

2,1 kHz

65 b

13,56 MHz

Pulse modulation a

50 kHz

7,5 b

a)    The carrier shall be modulated using a 50% duty cycle square wave signal.

b)    r.m.s., before modulation is applied.

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

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