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Possible interference from other devices KA450

Zeisberg GmbH

Possible interference from other devices KA450

The KA450 is a medical device and is therefore subject to special precautions regarding electromagnetic compatibility (EMC). The installation and commissioning instructions in this document must therefore be strictly observed.

Warning!

  • Portable and mobile HF communication devices (e.g. cell phones) can affect the function of the device under certain circumstances.

  • The use of accessories, transducers and cables other than those specified in this document may result in increased interference emission or reduced immunity of this device.

  • The appliance must not be placed directly next to or stacked with other appliances.

  • It cannot be ruled out that the KA450 audiometer may be disturbed by other devices, even if they fulfill the CISPR according to the interference radiation.

The following tables provide you with information on how the device has been classified and tested in accordance with the EMC standard EN60601-1-2 and contains guidelines on how to operate it in its electromagnetic environment.

 

Guidelines and manufacturer's declaration - Electromagnetic emissions

The KA450 audiometer is intended for use in the environment specified below. The customer or the user of the KA450 audiometer should assure that it is used in such an environment.

Interference emission measurements

Compliance

Electromagnetic environment - Guide

HF emissions

according to CISPR 11

Group 1

The KA450 audiometer uses RF energy exclusively for an internal function. Therefore, its RF emission is very low and it is unlikely to interfere with neighboring electronic devices.

HF emissions

according to CISPR 11

Class B

The KA450 audiometer is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Guidelines and manufacturer's declaration - Electromagnetic immunity

The KA450 audiometer is intended for use in the electromagnetic environment specified below. The customer or the user of the KA450 audiometer should assure that it is used in such an environment.

Interference immunity tests

IEC 60601 test level

Compliance level

Electromagnetic environment - Guidelines

Discharge of static electricity (ESD) according to IEC 61000-4-2

+/- 6 kV Contact discharge

+/- 8 kV air discharge

+/- 6 kV Contact discharge

+/- 8 kV air discharge

Floors should be made of wood or concrete or covered with ceramic tiles. If the floor is covered with synthetic material, the relative humidity must be at least 30%.

Fast transient electrical disturbances/bursts according to IEC 61000-4-4

+/- 2 kV for mains cables

+/- 1 kV for input and output lines

+/- 2 kV for mains cables

+/- 1 kV for input and output lines

The quality of the supply voltage should correspond to that of a typical business or hospital environment.

Surges according to IEC 61000-4-5

+/- 1 kV push-pull voltage

+/- 2 kV common mode voltage

+/- 1 kV push-pull voltage

+/- 2 kV common mode voltage

The quality of the supply voltage should correspond to that of a typical business or hospital environment.

Voltage dips, short-term interruptions and fluctuations in the supply voltage in accordance with IEC 61000-4-11

< 5 % UT

(> 95 % dip in UT) for ½ period

 

40 % UT

(60 % slump in UT) for 5 periods

 

70 % UT

(30 % slump in UT) for 25 periods

 

< 5 % UT

(> 95 % dip in UT) for 5 s

 

fulfilled

 

 

 

fulfilled

 

 

 

fulfilled

 

 

 

fulfilled (criterion B)

The quality of the supply voltage should be that of a typical commercial or hospital environment. If the user of the KA450 audiometer requires continued operation even in the event of power supply interruptions, it is recommended that the KA450 audiometer be powered from an uninterruptible power supply or a battery.

Magnetic field at the supply frequency

(50/60 Hz) according to

IEC 61000-4-8

3 A/m

3 A/m

Magnetic fields at the mains frequency should correspond to the typical values found in a business or hospital environment.

NOTE UT is the AC mains voltage before applying the test levels

Guidelines and manufacturer's declaration - Electromagnetic immunity

The KA450 audiometer is intended for use in the electromagnetic environment specified below. The customer or the user of the KA450 audiometer should assure that it is used in such an environment.

Interference immunity tests

IEC 60601 test level

Compliance level

Electromagnetic environment - Guidelines

 

 

 

Portable and mobile radio equipment should be used at no closer to the KA450 audiometer, including cables, than the recommended safety distance calculated from the equation applicable to the transmitting frequency.

Recommended safety distance:

Conducted RF disturbance quantities according to IEC 61000-4-6

 

3 Vrms

 

3 Vrms

 

d = 1,17 

Radiated RF disturbances according to IEC 61000-4-3

 

3 V/m

80 MHz to 1.0 GHz

 

3 V/m

 

d = 1,17 

 

 

 

with P as the rated power of the transmitter in watts (W) according to the transmitter manufacturer's specifications and d as the recommended safety distance in meters (m).

The field strength of stationary radio transmitters should be at all frequencies according to the on-site investigationa be lower than the compliance levelb.

Interference may occur in the vicinity of devices bearing 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. The propagation of electromagnetic quantities is influenced by absorption and reflection from buildings, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular) 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 transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the KA450 audiometer is used exceeds the applicable RF compliance level above, the KA450 audiometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the KA450 audiometer

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

Recommended safety distances between portable and mobile RF telecommunication devices and the KA450 audiometer

The KA450 audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the KA450 audiometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the KA450 audiometer as recommended below, according to the output power of the communications equipment

Rated power of the transmitter

W

Protective distance depending on the transmission frequency

m

150 kHz to 80 MHz

d = 1,17 

80 MHz to 800 MHz

d = 1,17

800 MHz to 2.5 GHz

d = 2,33 

0,01

0,12

0,12

0,233

0,1

0,37

0,37

0,74

1

1,17

1,17

2,33

10

3,7

3,7

7,40

100

11,7

11,7

23,3

For transmitters whose maximum rated power is not specified in the table above, the recommended safety distance d in meters (m) can be determined using the equation associated with the respective column, where P is the maximum rated power of the transmitter in watts (W) as specified by the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. The propagation of electromagnetic quantities is influenced by absorption and reflection from buildings, objects and people.

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