Guidance and manufacturer’s declaration – electromagnetic immunity

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

Immunity test

IEC60601-1-2 test

Compliance level

Electromagnetic environment – guidance

level

 

 

 

 

 

 

 

 

Electrostatic

±6 kV contact

±6 kV contact

Floors should be wood, concrete or ceramic tile. If

discharge (ESD)

±8 kV air

±8 kV air

floors are covered with synthetic material, the relative

IEC 61000-4-2

 

 

humidity should be at least 30%.

 

 

 

 

Electrical fast

±2 kV for power

±2 kV

Mains power quality should be that of a typical

transient/burst

supply lines

 

commercial or hospital environment.

IEC 61000-4-4

±1 kV for input/

Not Applicable

 

 

 

output lines

 

 

 

 

 

 

 

Surge

±1 kV differential

±1 kV differential

Mains power quality should be that of a typical

IEC 61000-4-5

mode

mode

commercial or hospital environment.

 

±2 kV common

±2 kV common

 

 

 

mode

mode

 

 

 

 

 

 

Voltage dips, short

<5% Ut (>95% dip in

< 12V (>95% dip in

Mains power quality should be that of a typical

interruptions and

Ut) for 0.5 cycle

240V) for 0.5 cycle

commercial or hospital environment.

voltage variations

40% Ut (60% dip in

96V (60% dip in

If the user of the VPAP device requires continued

on power supply

Ut) for 5 cycles

240V) for 5 cycles

operation during power mains interruptions, it is

input lines.

70% Ut (30% dip in

168V (30% dip in

recommended that the VPAP device be powered from

IEC 61000-4-11

Ut) for 25 cycles

240V) for 25 cycles

an uninterruptible power source.

 

<5% Ut (>95%dip in

<12V (>95%dip in

 

 

 

Ut) for 5 sec

240V) for 5 sec

 

 

 

 

 

 

Power frequency

3 A/m

3 A/m

Power frequency magnetic fields should be at levels

(50/60Hz) magnetic

 

 

characteristic of a typical location in a typical

field IEC 61000-4-8

 

 

commercial or hospital environment.

 

 

 

 

 

 

 

Portable and mobile RF communications equipment

 

 

 

should be used no closer to any part of the VPAP

 

 

 

device, including cables, than the recommended

 

 

 

separation distance calculated from the equation

 

 

 

applicable to the frequency of the transmitter.

 

 

 

Recommended separation distance

Conducted RF

3 Vrms

3 Vrms

d = 1.17 P

 

IEC 61000-4-6

150 kHz to 80 MHz

 

 

 

Radiated RF

10 V/m

10 V/m

d = 0.35 P 80 MHz to 800 MHz

IEC 61000-4-3

80 MHz to 2.5 GHz

 

d = 0.70 P 800 MHz to 2.5 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,a

 

 

 

should be less than the compliance level in each

 

 

 

frequency range.b

 

 

 

 

Interference may occur in the vicinity of equipment

 

 

 

marked with this symbol

.

 

 

 

 

 

NOTE 1: Ut is the AC mains voltage prior to application of the test level.

NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

aField 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 VPAP device is used exceeds the applicable RF compliance level above, the VPAP device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VPAP device.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

18

Page 21
Image 21
ResMed VPAP IV ST manual