Medela Basic 30 Mode D'emploi page 6

Safety tests
lV
For safety tests (STK), it is assumed that the device is serviced and repaired throughout its
service life in accordance with the service manual.
Because the Basic 30 is a device of safety class II (EN IEC 60601-1, A1, A2:1995), the safety
tests (STK) are confined to visual inspection of the housing and power cord. This test must be
carried out before each use.
Devices of protection class II do not have a protective earth conductor, therefore a check of
the earth leakage current is not necessary!
The housing of the Basic 30 is made entirely of insulating material. Tests of the housing leak-
age current using common measuring instruments will therefore not reveal measurable values.
The applied parts of the Basic 30 are connected to the Basic 30 with non-conductive hoses,
containers and intermediate hoses.
Even when suctioning a conductive fluid until the overflow protection device activates (9 g / L
NaCl; EN ISO 10079-1;1999), measurements of the patient leakage current using common
measuring instruments will not reveal measurable values
The Basic 30 does not have patient leakage current, signal input and output parts and func-
tional earth leakage current.
Occupational health and safety
V
Guidelines for Medela and agency workshops.
We recommend a hepatitis B vaccination for all persons who have to deal with potentially
contaminated devices.
Further safety measures with regard to further vaccinations or other safety precautions are to
be observed individually depending on the region.
When devices are returned to workshops for repair, the devices / components have to be
considered as being dangerous and potentially infectious.
Such devices must be stored separately, specially marked and at an isolated location until they
are disinfected.
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EN