Immunity guidance, Immunity radio frequency guidance – Welch Allyn VS100 Welch Allyn Vision Screener - User Manual User Manual

Page 27

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P/N 20146 Rev A

Page 27

Immunity Guidance

The vision screener is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is
used within those environmental conditions.

Immunity Test

Test level EN 60601-1-2

Conformity Level

Electromagnetic environment guide

Electrostatic
Discharge (ESD) EN
61000-4-2

± 8kV air
± 6kV contact

Non-conforming
This unit is sensitive to ESD and
may require resetting

The floor should be in wood, concrete or ceramic tile.
If the floor is covered with synthetic material, relative
humidity should be at least 30%.

Electrical Fast
Transient/Burst EN
601000-4-4

±2 kV high voltage
power line

±2 kV high voltage
power line

The quality of the power supply should be that one
of a typical commercial or clinical environment.

Surge EN 61000-4-5

Differential mode: ±1 kV
Common mode: ±2kV

Differential mode: ±1 kV
Common mode: ±2kV

The quality of the power supply should be that one
of a typical commercial or clinical environment.

Voltage dips, short
interruptions and
voltage variations on
power supply input
lines EN 61000-4-11

<5% UT (>95% dip of UT) for 0,5 cycle
40% UT (>60% dip of UT) for 5 cycle
70% UT (>30% dip of UT) for 25 cycle
<5% UT (>95% dip of UT) for 5
seconds

<5% UT (>95% dip of UT) for 0,5 cycle
40% UT (>60% dip of UT) for 5 cycle
70% UT (>30% dip of UT) for 25 cycle
<5% UT (>95% dip of UT) for 5 seconds

The quality of the power supply should be that one
of a typical commercial or clinical environment. If the
user requests a continuous functioning during power
supply interruptions, it is recommended a backup
power supply unit (UPS) or battery.

Magnetic field at
power
frequency EN 61000-
4-8

3 A /m

3 A /m

Power frequency magnetic fields should have
characteristic levels of a typical commercial or clinical
environment.

Immunity Radio Frequency Guidance

The vision screener is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is
used within those environmental conditions.

Immunity Test

Test level EN 60601-1-2

Conformity Level

Electromagnetic environment guide

Conducted RF
EN 61000-4-6

3 Veff from 150kHz to
80MHz

3 Veff from 150kHz to 80MHz

The portable and mobile devices with RF communication
shouldn’t be used near any part of the device, including
cables, except when they follow the recommended
safety distance for separation, calculated with the
equation applicable to the frequency of the transmitter.
Recommended safety distance for separation:
D= 1,2 x

√P from 150kHz to 80MHz

D= 1,2 x

√P from 80MHz to 800MHz

D= 2,3 x

√P from 800MHz to 2,5GHz

Where P is the nominal maximum power of the
transmitter output expressed in Watts (W) as specified by
the transmitter manufacturer and d is the recommended
separation distance expressed in meters (m).

Radiated RF
EN 61000-4-3

3 V/m from 80MHz to
2.5GHz

3 V/m from 80MHz to 2.5GHz

Surge EN 61000-4-5

Differential mode: ±1 kV
Common mode: ±2kV

Differential mode: ±1 kV
Common mode: ±2kV

The field intensity of the fixed RF transmitters, as checked in an electromagnetic investigation of the locus, should be less than the conformity level
for each range of frequency.

It is possible to have interference near devices marked with the symbol:

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