Medela Invia Vario 18 AC/DC c/i Instrucciones De Uso página 5

Safety-related checks
IV
For the safety-related checks, it is assumed that the device is maintained and repaired throughout
its service life in compliance with the Service procedures (See Service procedures - page 6).
For the Vario as a device in protection class II (EN IEC 60601-1, A1, A2:1995), the safety-related
checks are confined to visual inspection of the housing and main power cord for damage. This
check must be performed prior to each use.
Devices of protection class II do not have a protective earth conductor; there is therefore no need
to check the earth leakage current!
The Vario enclosure is made entirely of insulating material. Tests of the enclosure leakage
current using common measuring instruments will therefore not reveal measurable values.
The applied parts of the Vario are connected to the Vario via non-conductive vacuum hoses,
collection jars and intermediate tubings.
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 Vario pumps do not have patient circuits, signal input and output parts and functional
earth connections.
Guarantee
V
There is a two year guarantee for the device, and a six month guarantee for the rechargeable
battery and the QuatroFlex aggregate. The manufacturer is not liable for any damage or conse-
quential damage caused by incorrect operation, inappropriate usage as well as use by unautho-
rized persons.
3
EN