Safety Check - Medela Thopaz Instrucciones De Uso

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 com-
mon 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.
Warranty, maintenance and checks
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