Medela Thopaz+ Gebrauchsanweisung Seite 9

CAUTIONS
– No modification of this equipment is allowed.
– Before connecting Thopaz + to the power supply, please verify that the supply voltage
corresponds to that given on the device specification plate.
– Incorrect use of Thopaz + can cause pain and injury to the patient.
– Do not use sterile accessories when the sterile packaging is damaged.
– Non sterile and reusable accessories must be cleaned and disinfected according to
chapter 13 – General cleaning guidelines.
– For the initial startup do not switch Thopaz + on before first charging the battery.
– The Thopaz + 2 l canisters are not intended for portable use (not by hand and not using
the carrying strap).
– For safety reasons canister changes within the appropriate fluid level shall be recorded.
– Before diagnosing controll detected fluid value for plausability.
– For patients for whom a breakdown of the device can lead to a critical situation a
replacement device must always be available.
– Federal US law restricts this device to sale by or on the order of a health professional.
Safety related tip
– Never place Thopaz + with an attached 2 l canister on the docking station without
attaching the optional adapter docking station 079.0038 for Thopaz + 2 l canister first.
– The acoustic alarm «Leak in system – 301» is deactivated for approximately 6 minutes
after Thopaz + is switched on.
– Everytime a new patient is connected, it is recommended to carry out the functional
check.
– Before the first application in accordance with the intended use, an inspection according
to IEC 62353 (see Appendix B) is recommended to acquire the reference values.
Warnings and safety instructions
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