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1.4 Classification and reference norms
Reference harmonized norms:
- CEI EN 60601-1 “Safety of electromedical devices”
- CEI EN 60601-1-2 “Collateral harmonized norm for electromedical devices
- Electromagnetic compatibility.”
Classification according to safety norm EN 60601-1:
- portable device
- Class I
- type B
- ordinary protection against humidity
- do never use with inflammable anaesthetics
- voltage: 220 V +/- 10%, 50/60 Hz, with safety ground-wire.
Moreover, the particular features of this device grant adequate protection
and isolation against direct or indirect electric shocks and against electric
or mechanic surcharge.
The thermic power implied in this podoscope avoid dangerous overheating
for materials and components. Electric isolation and well-balanced distances
between the surfaces avoid the formation of electric arches.
In addition to this, the podoscope has a solid mechanical structure
and an excellent stability on the ground. It has no sharp edges, therefore
there exists no danger of mechanical nature both for operators and patients.
Each part of the inner circuits are assembled and fixed in such a solid way
so as to stand up to the often adverse transport conditions.
As to indirect shocks, this reliable device has been supplied with a safety
wire grounding: therefore it can be classified in class 1. As to current leakage
it can be classified in class B.
No essential performance is defined for this device.
22 cm
8,67 in
42,5 cm
16,75 in
43,5 cm
17,14 in
