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 Specifications Guidance and manufacturer's declaration - electromagnetic immunity
The Varios350/Varios350LUX is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios350/Varios350LUX should
<Control Unit> assure that it is used in such an environment.

English
Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
Varios 350 :NE133 Temperature 0 - 40 ˚C
Type Electrostatic discharge (ESD) ±6kV contact ±6kV contact Floors should be wood, concrete or ceramic tile. If floors are
Varios 350 LUX :NE149 (The liquid must not freeze up) IEC61000-4-2 ±8kV air ±8kV air covered with synthetic material, the relative humidity should be
Use Environment at least 30%.
Power Source AC24 V 50/60 Hz Humidity 10 - 85 %
Electrical fast transient/burst ±2kV for power supply lines ±2kV for power supply lines Mains power quality should be that of a typical commercial or
Vibration Frequency 28-32 kHz Atmospheric pressure 700 - 1060 hPa IEC61000-4-4 ±1kV for input/output ±1kV for input/output hospital environment.
Maximum Output 8 W (G mode) Temperature -10 - 60 ˚C Surge ±1kV line(s) to line(s) ±1kV line(s) to line(s) Mains power quality should be that of a typical commercial or
Power Consumption Max. 30 VA Store Environment Humidity 10 - 85 % IEC61000-4-5 ±2kV line(s) to earth ±2kV line(s) to earth hospital environment.

Water Pressure 0.1-0.5 MPa (1-5 kgf/cm2 ) Atmospheric pressure 500 - 1060 hPa Voltage dips, short <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) Mains power quality should be that of a typical commercial or
interruptions and voltage for 0.5 cycle for 0.5 cycle hospital environment. If the user of the
Varios 350 :Not Available variations on power supply Varios350/Varios350LUX requires continued operation during
Lighting input lines
40% Ut (60% dip in Ut) 40% Ut (60% dip in Ut)
power mains interruptions, it is recommended that the
Varios 350 LUX :Donut-shape lighting for 5 cycles for 5 cycles
IEC61000-4-11 Varios350/Varios350LUX be powered from an uninterruptible
Dimensions W 80 x D 125 x H 32 mm 70% Ut (30% dip in Ut) 70% Ut (30% dip in Ut) power supply or a battery.
for 25 cycles for 25 cycles
<AC Adaptor> <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut)
for 5 secs for 5 sec
Type NE138
Power frequency (50/60Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at levels
Input AC120 V 50/60 Hz AC230 V 50/60 Hz magnetic field characteristic of a typical location in a typical commercial or
Output AC24 V 1.6 A IEC61000-4-8 hospital environment.
Dimensions W 70 x D 102 x H 56.5 mm NOTE : Ut is the a.c. mains voltage prior to application of the test level.

Symbols Guidance and manufacturer's declaration - electromagnetic immunity

The Varios350/Varios350LUX is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios350/Varios350LUX should
assure that it is used in such an environment.
TUV Rhineland of North America is a Nationally Recognized Testing Laboratory (NRTL) in the United States and is accredited by Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance
the Standards Council of Canada to certify electro-medical products with Canadian National Standards. Portable and mobile RF communications equipment should be used no
closer to any part of the Varios350/Varios350LUX, including cables,
than the recommended separation distance calculated from the
Follow the waste of electric and electronic equipment (WEEE) Directive (2002/96/CE) to dispose of the product and accessories. equation applicable to the frequency of the transmitter.

Recommended separation distance

Consult operation instructions. Manufacturer. Conducted RF 3Vrms 3Vrms d = 1.2 P
IEC61000-4-6 150 kHz to 80MHz
d = 1.2 P 80MHz to 800MHz
This conforms to CE European Directive of “Medical equipment directive 93/42/EEC.” Radiated RF 3V/m 3V/m d = 2.3 P 800MHz to 2.5GHz
IEC61000-4-3 80MHz to 2.5 GHz
Where P is the maximum output power rating of the transmitter in
Type BF applied part. Authorised representative in the European community. 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
Protected against vertically falling water drops. Class II equipment. electromagnetic site survey, should be less than the compliance level
in each frequency range.

Autoclavable up to Max.135°C. *for detail see Sterilization. Interference may occur in the vicinity of equipment
marked with the following symbol:

Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy NOTE 1 At 80MHz and 800MHz, 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, objects and people.
for diagnosis or treatment.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles 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
Guidance and manufacturer's declaration - electromagnetic emissions electromagnetic site survey should be considered. If the measured field strength in the location in which the Varios350/Varios350LUX is used exceeds the
The Varios350/Varios350LUX is intended for use in the electromagnetic environment specified below. The customer or the user of the Varios350/Varios350LUX should applicable RF compliance level above, the Varios350/Varios350LUX should be observed to verity normal operation. If abnormal performance is observed,
assure that is used in such an environment. additional measures may be necessary, such as reorienting or relocating the Varios350/Varios350LUX.
Emissions test Compliance Electromagnetic environment - guidance b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
RF emissions Group 1 The Varios350/Varios350LUX uses RF energy only for its internal function. Therefore, its RF
CISPR11 emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emmissions class B The Varios350/Varios350LUX is suitable for use in all establishments, including domestic
CISPR11 establishments and those directly connected to the public low-voltage power supply network that
supply network that supplies buildings used for domestic purposes.
Harmonic emissions class A
IEC61000-3-2
Voltage fluctuations/flicker emissions Complies
IEC61000-3-3

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