EN 3
Warnings /Safety instructions
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Thopazis approved exclusivelyfor the use as described in these instructions. If Thopazis not
used in combination with the original Medela accessories (disposable canisters; tubing set; car-
rying strap; mains adapter; and docking station), Medela cannot guarantee the safe function of
the system.
Thopazis EMC-tested in conformitywith the requirements of IEC 60601-1-2:2001. It shall be
used in the vicinityof other EMC-tested devices that fulfill the requirements as outlined in the
IEC 60661-1-2 standard. Untested HF sources, radio networks or the like can influence the
operation of the device and should not be operated in the vicinityof Thopaz.
Please read and observe these warnings and safety instructions before operation.
Warnings
•Beforeyou plug the device into the power supply,please verifythe voltage at the local
power supplyis the same as given on the specification plate of Thopaz.
•Data transfer via USB is not possible while the pump is connected to the patient.
•The device is not for use while bathing, showering nor suitable for ahazardous explosive
environment.
•Donot use Thopazin MRT(Magnetic Resonance Tomography).
•Donot dryThopazwith microwaves.
Safety instructions
•Thopazmust remain in an upright position during use.
•The patient should be regularlymonitored according to internal hospital guidelines.
•Thopazis amedical device that requires special safetyprecautions and must be installed
and placed in operation in accordance with the attached EMC information. Portable and
mobile RF communication devices (mobile telephones) can affect Thopaz.
•Areplacement device must alwaysbeavailable for patients for whom abreakdown of the
device can lead to acritical situation.
•Innone of the following cases mayThopazbe placed in operation:
−Ifthe power cordorplug is damaged
−Ifthe device is not functioning properly
−Ifthe device is damaged
−Ifthe device has apparent safetydefects
•Keep the power cordawayfrom hot surfaces.
•Keep the AC adapter connector awayfrom moisture.
•Separation from the power supplyoccurs byunplugging the mains adapter.
These instructions for use must be kept for later reference.
