35 | Safety test
14 Safety test
Important: Patient must not be connected! Thopaz must be
disconnected from the mains (battery operation) and turned off.
Instructions for safety test
CAUTIONS
– For safety reasons, Thopaz shall be maintained and repaired strictly and exclusively by
Medela authorised service centres.
– For Thopaz as a device in protection class II (EN IEC 60601-1), a visual inspection of
the housing and mains power cor
d for damage must be performed. This check must
be performed prior to each use.
– Devices of protection class II do not have a protective earth conductor; there is there-
fore no need to check the earth leakage current.
– Thopaz enclosure is made entirely of insulating material. Tests of the enclosure leakage
current using common measuring instruments will therefore not reveal measurable val-
ues. 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
(9 g/L NaCl; EN ISO 10079-1;1999), measurements of the patient leakage current using
common measuring instruments will not reveal measurable values.
– Thopaz systems do not have patient circuits and functional earth connections.
– (EN IEC 62353: 2008-8 Recurrent Test and Test after Repair).
1. Connect the tubing (079.0021) and the 0.8L (079.0016)
canister to Thopaz according to chapter 8.
2. Connect vacuum gauge with tube to the patient connector.
(Tube e.g. ø 12 x 7 mm, not inclu-
ded in the scope of delivery)
0.8 L
3.
3.1 Press and hold [
], [ ]
simultaneously, then…
3.2 Press additionally [
] to
start safety test.
3.3 Follow the instructions
on the display.
Press simultaneously
Operation
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