3Shape TRIOS 5 Safety & Setup Instructions - Page 6

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1. Trios Scanner Tip: Cleaning and Sterilization

4.16 Declaration – Electromagnetic Emissions

The TRIOS system complies with the requirements EN/(IEC) 60601-1-2 (Edition 4.0)

clause 7 Emissions.

The TRIOS system is intended for use in the electromagnetic environment specified below.

The user or users of the TRIOS system should assure that it is used in such an environment.

Emission

Conformity

measurement

RF emission

Group 1

CISPR11

RF emission

Class B

CISPR11

Harmonic

emission

Class A

IEC 61000-3-2

Voltage

fluctuation and

Complies

flicker

IEC 61000-3-3

4.17 Electromagnetic Immunity

The TRIOS system complies with the requirements EN/(IEC) 60601-1-2 (ed. 4.0)

clause 8 Immunity. The test levels for immunity to RF electromagnetic fields are selected

according to general test conditions for medical equipment.

The TRIOS system is intended for use in a Professional Healthcare Facility Environment with

the electromagnetic environment specified below. The user of The TRIOS system should

assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Electrostatic

Contact +/-

discharge ESD

8kV.

IEC 61000-4-2

Air:

+/-15kV.

Electrical fast

+/- 2 kV for

transients/burst

power supply

lines

IEC 61000-4-4

+/-1 kV for

input/ output

lines

Surge

+/-1 kV Line(s)

to earth:

IEC 61000-4-5

+/-2 kV. Line

to line.

Voltage

0 % UT for 0.5

dips, short

cycle (1 phase)

interruption

0 % UT

and voltage

for 1 cycle

variations

70 % UT for

IEC 61000-4-11

25/30 cycles

(50/60 Hz)

Power frequency

30 A/m.

(50/60Hz)

Magnet field IEC

61000-4-8

Note: U

is the ac mains voltage prior to application of the test level

Immunity test

IEC 60601 test level

Conducted RF

3 Vrms

IEC 61000-4-6

150 kHz to 80 MHz.

6 Vrms in ISM bands

between 0,15 MHz and

80 MHz (Note b)

Radiated RF

3 V/m

IEC 61000-4-3

80 MHz to 2.7 GHz.

E lectromagnetic

environment – guidelines

The TRIOS system uses RF energy only for its

internal functions. Therefore, Its RF emissions

are very low and are not likely to cause any

interference in nearby electronic equipment.

The TRIOS system is intended for use

in dental clinical settings, including domestic

establishments and those directly connected

to the public low-voltage power supply

network that supplies buildings used

for domestic purposes

Compliance

Electromagnetic

level

environment – guidelines

Contact

Floors should be wood,

+/-8kV.

concrete or ceramic tile. If floors

are covered with synthetic

Air:

materials, the relative humidity

+/-15kV.

should be at least 30 %.

The TRIOS system is allowed

to have a temporary loss

of function, which requires

operator intervention or

system reset.

+/- 2 kV for

Mains power quality should be

power supply

that of a typical commercial

lines

or hospital environment.

+/-1 kV for

During electrical fast

input/ output

transient/burst the TRIOS

lines

system is allowed to have a

temporary loss of function,

which requires operator

intervention or system reset.

+/-1 kV Line(s)

Mains power quality should be

to earth:

that of a typical commercial or

hospital environment.

+/-2 kV. Line

to line.

0 % UT for 0.5

During the testing the TRIOS

cycle (1 phase)

system is allowed to have a

temporary loss of function

0 % UT for

which requires operator

1 cycle

intervention or reset.

70 % UT for

25/30 cycles

(50/60 Hz)

30 A/m.

Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical domestic

or hospital environment.

Compliance level

[V1] 3 Vrms

[V2] 6 Vrms (Note b)

[E1] 3 V/m

80 MHz to 2.7 GHz.

Electromagnetic environment – guidelines

Portable and mobile RF communications equipment should be used no closer to any

part of the TRIOS system, including cables, than the recommended separation distance

calculated from the equation applicable to the frequency of transmitter.

Recommended separation distance

d = 1,2 √P

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 manufacture and d is the recommended separation distance in meter

(m), V1 is the conducted RF compliance level, and E1 is the RF radiated compliance level.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

(note a, b and c) should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment

marked with the following symbol:

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, object and people.

Note a: 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 transmitter, an electromagnetic site survey

should be considered. If abnormal performance of the TRIOS system is observed, additional

measures may be necessary, such as re-orienting or relocating the TRIOS system.

Note b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Note c: The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz

are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and

40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are

1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz

to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz,

24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

Enclosure port immunity to RF wireless communications equipment

Band (MHz)

Service

380-390

TETRA 400

GMRS460,

430-470

FRS 460

704-787

LTE Band 13, 17

GSM 800/900,

TETRA 800,

800-960

iDEN 820,

CDMA 850,

LTE Band 5

GSM 1800;

CDMA 1900;

1700-1990

GSM 1900;

LTE Band 1,3,4, 25;

UMTS

Bluetooth,

WLAN,

2400-2570

802.11 b/g/n,

RFID 2450

LTE Band 7

5100-5800

WLAN 802.11 a/n

4.18 Distances Between System and Other Equipment

The TRIOS system is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the TRIOS system

can help prevent electromagnetic interference by maintaining a minimum distance

between portable or mobile RF communications equipment (transmitters) and the

TRIOS system as recommended below, according to the maximum output power of the

communication equipment.

Rated maximum output

Separation distance according to frequency

power of transmitter, W

of transmitter, m

150 kHz

to 80 MHz

d = 1,2 P

0,01

0,12

0,1

0,38

1,2

3,8

100

Immunity test level (V/m)

80 MHz

800 MHz to 2,5

to 800 MHz

GHz

d = 1,2 P

d = 2,3 P

0,12

0,23

0,38

0,73

1,2

2,3

3,8

7,3