Medela Thopaz+ Gebruiksaanwijzing pagina 48
Safety check
There are no prescribed or recommended safety checks to be carried out�
Rationales
– The engineering of the Medela Thopaz + has been verified by independent test institutes for
compliance with the EN / IEC 60601-1 standard� Copies of such certificates may be obtained
on request� Because of the method of construction used, Medela does not expect electrical
safety to be affected at any time during the life of the product – provided that Thopaz + is
repaired throughout its service life strictly and exclusively by Medela authorized service centers
and that it is used properly in accordance with the intended use�
– For Thopaz + as a device in protection class II (EN IEC 60601-1), there is no protective earth
conductor; protective earth related tests (protective earth resistance, earth leakage current
etc�) are not applicable�
– Thopaz + enclosure is made entirely of insulating material� Tests of the touch current using
common measuring instruments will therefore not reveal measurable values�
– The applied parts of Thopaz + are connected to Thopaz + via non-conductive vacuum hoses,
canisters and tubings� Even when suctioning a conductive fluid (9 g/L NaCl; EN ISO 10079-
1;1999) until the overflow protection device activates, measurements of the patient leakage
current using common measuring instruments will not reveal measurable values�
– Thopaz + systems do not have patient connections and functional earth conductors; tests
related to those connections and currents are not applicable�
48 |
Warranty, maintenance and checks
1� Connect the tubing
079�0016 to Thopaz + � For guidance to connect the
system refer to chapter 7 – Preparation for use�
2� Connect vacuum gauge with tube to the patient connector�
3�
1
Press simultaneously
079�0021 and the 0�8 l canister
2
3�1 Press and hold [
[
] simultaneously� Press
additionally [
3�2 The safety test starts�
3�3 Follow the instructions on
the display
1
] and
]�
