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ANNEX 1. Technical data
TECHNICAL DATA
Usage environment
Indoor
Electrical supply:
Nominal voltage:
Max. current:
220 V version
200 - 240 VAC – 50/60 Hz, single - phase
200 - 240 V AC ±10%
8.75 A
Sterilizer
:
Working temperature:
Working relative humidity:
Storage temperature /rel. humidity:
Max altitude:
Min. atmospheric pressure:
Overall dimensions:
Min. space required (feetin forwardposition)
Min. space required (feetin rearwardposition)
Sizeofthe doormovement:
Weight empty:
Max. weight (fully loaded):
Max. weight per support area:
Max. heat output:
Max noise level:
from +5°C to +40°C
Max. RH 80% up to 31°C, linearly decreasing to 50% at 40°C
-20°C to +60°C/0-90% (with empty tanks)
3000m asl
0.6 barA
W: 45 cm/H: 44cm/D: 60cm
W: 47cm/H: 49 cm/D: 53 cm
W: 47cm/H: 49 cm/D: 46 cm
W: 36cm/H: 38 cm/D: 34 cm
38 kg
53 kg
30.9 kN/m2
3000 KJoule/hour
63 dB
Pressure safety valve:
Safety thermostat
2.6 bar
330°C
Sterilizer chamber:
Total volume:
Usable space (for all cycles)
Bacteriological filter:
22 l/Ø 250 mm x D 440 mm
W 195 mm x H 195 mm x D 390 mm
0.3 µm
Distilled or demineralized water:
Water quality:
Average water consumption:
Tank volume:
Fulfilling EN 13060 Ann. C (conductivity < 15μS/cm)
0.7 litres/cycle
2 x 3.6 litres
External water supply:
Pressure:
Flow:
Temperature:
To be compliant with IEC61770
min. 2 bar – max. 8.6 bar
min. 0.25 – max 0.5 l/min
Max. 35 °C
Communication with other devices:
1 serial port on the back side of the sterilizer
Other
Fully micro-processor controlled, process evaluation system
according to EN13060.
Programmable sleep-mode.
CONFORMITY
STERILIZER featuring type S sterilization cycles conform with the following standards:
93/42/EEC Medical Device Directive (MDD)
PED 2014/68/EU Pressure Equipment Directive (PED)
2012/19/EU Waste Electrical and Electronic Equipment (WEEE)
EN 13060 Small steam sterilizers
ANSI-AAMI ST55 Table-top steam sterilizers
IEC 61010-1
Safety requirements for electrical equipment for measurement, control
and laboratory use, general requirements
IEC 61010-2-040
Safety requirements for electrical equipment for measurement, control
and laboratory use; particular requirements for sterilizers and washer-
disinfectors used to treat medical materials.
IEC 61326-1
Electrical equipment for measurement, control and laboratory use: EMC
requirements; general requirements.
MS sterilizers can be validated in accordance with EN ISO 17665-1.
RECOMMENDATIONS FOR VALIDATION
Coldest point
Hottest point
For further details please refer to the Qualification / Validation guide for
sterilization cycles of W&H sterilizers.
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