Medela Thopaz - Warnings and Safety Instructions; General Warnings and Cautions

EN
Warnings and safety instructions | 6
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 Medela accessories (canisters, tubings, carrying strap, mains adapter,
docking station – see chapter 16).
Thopaz is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and can be
u
sed 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 representative or the 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.
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.