Warnings And Safety Instructions - Medela Thopaz+ Instrucciones De Uso

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).
Additional equipment connected to medical electrical equipment must comply with the respective
IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configura-
tions 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 equipment
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.
CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician.
Subject to change.
Warnings and safety instructions
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