Warnings And Safety Instructions - Medela Thopaz+ Gebrauchsanweisung

1 Warnings and safety instructions

WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or
serious injury.
CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in minor or
moderate injury.
Safety related tip
Indicating useful information about the safe use of the device.
Thopaz + is approved exclusively for the use as described in these instructions for use. Medela
can only guarantee the safe functioning of the system when Thopaz + is used in combination
with the original Thopaz + accessories (canisters, tubings, carrying strap, mains adapter, docking
station – see chapter 16 – Accessories/Appendix A).
Thopaz + is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and can be
used in the vicinity of other EMC-tested devices that fulfil the requirements as outlined in the
IEC 60601-1-2 standard. Untested HF sources, radio networks or the like can impair the function
of the device and should not be operated in the vicinity of Thopaz + .
Additional equipment connected to medical electrical equipment must comply with the respec-
tive IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all con-
figurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1
or clause 16 of the 3rd Ed of IEC 60601-1, respectively). Anybody connecting additional equip-
ment to medical electrical equipment configures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical systems. Attention is
drawn to the fact that local laws take priority over the above mentioned requirements. If in doubt,
consult your local Medela customer service representative or your technical service department.
Please read and observe these warning and safety instructions before operation. These
instructions for use must be kept with the device for later reference.
Please note that these Instructions for use are a general guide for the use of the product.
Medical matters must be addressed by a physician.
Medela considers itself only responsible for the effect on BASIC SAFETY, reliability and
performance of Thopaz + if it is used in accordance with the Instructions for use.
Subject to change.
Warnings and safety instructions
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