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Instructions for use - Tiva2 - Tiva2H Thermodisinfector
2.4 Product analysis
The disinfector was tested by applying
«IEC EN 61010-2-040
Safety requirements for electrical equipment for measurement,
control, and laboratory use Part 2-040 Particular requirements
for sterilizers and washer-disinfectors used to treat medical
materials»
, where the thermodisinfector is expected to:
•
be used exclusively for internal uses;
•
be operational up to a maximum altitude of 2000 metres;
•
be operational at a temperature between 5 and 40°C;
•
operate in an environment with a maximum humidity of 80%
for temperatures up to 31°C, decreasing linearly to 50% at
40°C;
•
with a mains voltage fluctuation up to +/-10% compared to
the nominal voltage;
•
temporary type overvoltages:
- of short duration, which may occur between the line conduc-
tor and the system earthing, which may have a voltage equal
to the power supply voltage on the line-n1200V, and
a duration up to 5s;
- of long duration which may occur between the line conductor
and the system earthing, which may have a voltage equal
to the power supply voltage on the line-n250V, and
a duration greater than 5s;
- pollution degree 2.
• The validation of the product was made by the man-
ufacturer in compliance with standard ISO 15883; the
validation of the disinfection process is borne by the
user.
• The machine does not cause harmful vibrations.
• The residual radiation emitted within the limits is
non-ionising.
• The useful life cycle of the device is 10 years.
⇒
