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�
The Dominant Flex is approved exclusively for the use as described in these instructions for use�
Medela can only guarantee the safe functioning of the system when the Dominant Flex is used in
combination with the original Medela accessories (collection system, tubings, filters etc� – see
annex "II List of accessories")�
The Dominant Flex is EMC-tested in conformity with the requirements of IEC 60601-1-2:2007 and
IEC 60601-1-2:2014 4th Edition according to clause 7 and 8�9 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�
HF (high-frequency) surgical equipment, radio networks or the like can influence the operation of
the device and may not be operated in combination with the Dominant Flex pump�
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 is only responsible for the
effect on BASIC SAFETY, reliability and performance of the Dominant Flex 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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