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5.3
Safety features
5.3.1
Air infusion
5.3.2
Maximum infused volume under single fault
conditions
5.3.3
Temperature of applied parts to patient
The
Ambix
activ
has an integrated air sensor that stops the infusion if
an air bubble higher than 0.75 ml is detected.
In addition every
activ
set has a particulate and air filter.
Warning
High-lipid-containing solutions could impair the air removal function of
the filter!
The
Ambix
activ
administers a maximum of 10 ml under single fault
conditions.
The
Activ
set is a Type CF applied part. It can be in contact with the
patient without time limitation during the operating life of the
Activ
set.
Warning
The outer enclosure of
AMBIX
Activ
pump and HOLDER are also
considered to be applied parts. When operating at max ambient
temperature as defined in Section 7.1, page 42, accessible parts of
outer enclosure will be below 60°C and contact limited to 1min.
