Safety Test - Medela Thopaz Instrucciones De Uso

Safety test

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EN IEC 62353: 2008-8 Recurrent Test and Test after Repair
For safety tests, it is assumed that Thopaz is maintained and repaired throughout its service life
strictly and exclusively by Medela authorised service centres.
For Thopaz as a device in protection class II (EN IEC 60601-1), the safety tests are confined to
visual inspection of the housing and mains power cord for damage. This check must be perfor-
med 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 Thopaz enclosure is made entirely of insulating material. Tests of the enclosure leakage cur-
rent using common measuring instruments will therefore not reveal measurable values.
The applied parts of Thopaz are connected to Thopaz via non-conductive vacuum hoses,
collection jars and intermediate tubings.
Even when suctioning a conductive fluid until the overflow protection device activates (9g/L NaCl;
EN ISO 10079-1;1999), measurements of the patient leakage current using common measuring
instruments will not reveal measurable values.
Thopaz pumps do not have patient circuits and functional earth connections.
Instructions for safety test:
1. Start safety test (press buttons simultaneously).
2. Follow the instructions on the display.
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EN
Patient must not be connected!
Thopaz must be disconnected from the mains (battery operation).
Additional tubing
(e.g. ø 12x7 mm)
(not included in the
scope of delivery)