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20

Guidance and manufacturer’s declaration – Immunity Emissions
The VEGA SUCTION UNIT is intended for use in the electromagnetic environment specified below. The customers or the 

user of the VEGA SUCTION UNIT should make sure that it’s used in such an environment.
Immunity Test

Level indicated by the

EN 60601-1-2

Compliance Level

Electromagnetic environment - guidance 

Electrostatic

discharge (ESD)

EN 61000-4-2

+/-8kV on contact 

+/-15kV in air

The device doesn’t

change its state

Floors should be wood, concrete or ceramic 

tile. If floors are covered with synthetic ma-

terial, the relative humidity should be at least 

30%.

Electrical fast

transient / burst

EN 61000-4-4

± 2kV power supply

lines

± 1kV for input /

output lines

The device doesn’t

change its state

Mains power quality should be that of a typical 

commercial environment or hospital.

Surge 

EN 61000-4-5

± 1kV differential mode

+/-2 kV ordinary mode

The device doesn’t

change its state

Mains power quality should be that of a typical 

commercial environment or hospital.

Loss of voltage, brief

voltage interruptions

and variations

EN 61000-4-11

<5% U

T

 (>95% dip U

T

for 0,5 cycle 

40% U

T

 (60% dip U

T

for 5 cycle 

70% U

T

 (30% dip U

T

for 25 cycle 

<5% U

T

 (>95% dip U

T

for 5 sec

- -

Mains power quality should be that of a typi-

cal commercial environment or hospital If the 

user of the VEGA SUCTION UNIT  request 

that the appliance operates continuously, the 

use of a continuity unit is recommended.

Magnetic field with 

network frequency 

(50/60 HZ)

EN 61000-4-8

30A/m

The device doesn’t

change its state

The  power  frequency  magnetic  field  should 

be  measured  in  the  intended  installation  lo-

cation to make sure that it’s sufficiently low.

Note U

T

 is the value of the power supply voltage

ENGLISH

Guidance and manufacturer’s declaration – Immunity Emissions
The VEGA SUCTION UNIT is intended for use in the electromagnetic environment specified below.

The customers or the user of the VEGA SUCTION UNIT should make sure that it’s used in such an environment.
Immunity Test

Level indicated by the

EN 60601-1-2

Compliance 

Level

Electromagnetic environment - guidance 

Conducted 

Immunity

EN 61000-4-6

Radiated 

Immunity

EN 61000-4-3

3Vrms 150kHz 

to 80Mhz

(for non life-supporting

devices)

10V/m 80MHz 

to 2.7GHz

(for non life-supporting

devices)

V1 = 3 V rms

E1 = 10 V / m

The  portable  and  mobile  RF  communication  devices, 

including cables, must not be used closer to the VEGA 

SUCTION UNIT device, than the separation distance 

calculated by the equation applicable to the transmitter 

frequency.

Recommended separation distance

 

from 80 MHz to 800MHz
 

from 800 MHz to 2.7 GHz

3,5

 V

1

√P

d

=

12

 E

1

√P

d=

 

23

 E

1

√P

d=

Summary of Contents for 28210

Page 1: ...HIRURGISCHER ABSAUGER VEGA ASPIRADOR QUIR RGICO VEGA APARELHO DE SUC O CIR RGICO VEGA M28210 M Rev 7 12 20 PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly...

Page 2: ...rtment Do not attempt to make the device work before it has been thorough ly checked by qualified personnel and or the GIMA technical service department Position the device on stable and flat surfaces...

Page 3: ...nce they contain small parts that may be swallowed 14 Do not leave the device unattended in places accessible to children and or persons not in full possession of mental facultiesas they may strangle...

Page 4: ...on pump is used on patients in unknown pathological situations and where an assess ment of indirect contamination is not possible The filter is not manufactured to be decontaminated dismantled and or...

Page 5: ...of local laws and regulations The jug and lid can be further disinfected using a common disinfectant strictly following the instructions and dilution values provided by the manufacturer At the end of...

Page 6: ...nents list descriptions setting in structions and any other information that can help the technical assistance staff for product repair BEFORE EVERY CHECKING OPERATION IN CASE OF ANOMALIES OR BAD FUNC...

Page 7: ...the presence of liquids or other visible contamination secretions In the presence of liquids or other visible contamination immediately replace the medical device due to the risk of an insufficient v...

Page 8: ...d cables sold by the appliance and system manufacturer as spare parts can lead to an increase in emissions or in a decrease of the immunity of the device or system The following tables supply informat...

Page 9: ...ains power quality should be that of a typi cal commercial environment or hospital If the user of the VEGA SUCTION UNIT request that the appliance operates continuously the use of a continuity unit is...

Page 10: ...es such as changing the device s direction or positioning may be necessary b The field intensity on an interval frequency of 150 kHz to 80 MHz should be less than 3 V m Recommended separation distance...

Page 11: ...EEE disposal Class II applied Serial number Temperature limit Fuse Atmospheric Pressure limit IP21 Covering Protection rate Alternating current ON Hz Mains frequency OFF Humidity limit SYMBOLS Disposa...

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