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WRO 300 H
HCEN12481-02/2012
Technical data
55
4.5 Safety
4.6 Others
The machine complies with the following standards:
IEC 60601-1 General requirements for basic safety and essential perform-
ance, Class I, type B, and IP21
IEC 60601-1-2 Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6 Usability
IEC 60601-1-8 General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
IEC 60601-1-11 Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
WRO 300 H shelf life
Validated up to one (1) year, during
the following conditions;
•
The device shall be filled with
Memstor™ solution according
to
“Long time Storage” on
page 38
.
or
•
If the storage temperature is
below the freezing point, the
device shall be filled with a
preservation solution of 2 %
Memstor™, at least 9 % gly-
cerol and remaining part RO-
water.
WRO 300 H expected service life
At least eight (8) years when
handled and maintained according
to procedures recommended by
the manufacturer.