4
1.
Intended use
a)
Indications
Breast pumps are designed to be used by lactating women in order to extract their maternal milk. They help
them to relieve their mastitis or breast engorgement and facilitate their healing. They also help mothers to
relieve cracked or painful nipples or when breastfeeding is insufficient or impossible (inverted or painful
nipples, etc.). Furthermore, they give the possibility to mothers to breastfeed their baby if they cannot be
directly breastfed (preterm birth or neonatal pathologies (cleft lip and/or palate), difficulty of the baby to
suck, etc.). Finally, they allow to initiate or maintain lactation, especially in case of a medical treatment
incompatible with breastfeeding.
b)
Contraindications and adverse events
There are no known contraindications for the use of the FISIO electric breast pump.
Adverse event:
a risk of allergy with the materials (thermoplastic elastomer) in contact with the body parts
can appear.
2.
Product description
The FISIO breast pump is an electric pump. It can be used in case of temporary separation or any other reason
making breastfeeding impossible or not sufficient. Easy to use, it is ideal for active mothers.
The FISIO pump can be used in single or double pumping and should be plugged into to the power supply. It
combines a suction power adjustment with a set-up rhythm. The rhythm and the suction power are
simultaneously
adjusted. It tends to reproduce the baby’s sucking rhythm: the mother experiences the
stimulation and expression phases.
All KOLOR breast shield sizes connect to the breast pump. The mother can thus have a suitable sized breast
shield for her breast morphology to provide optimal comfort for an effective, long-lasting breastfeeding
experience.
The breast shield is a one-piece which favours an optimized hygiene, and makes it possible not to touch the
thread nor the internal parts of the feeding collection container and the breast shield.
a)
Detailed view and description
The breast pump design is presented on the first page. The user interface is presented as below:
Single KIT EXPRESSION:
contains 1 KOLOR breast shield, 1 collection container, 1 cap, 1 interface bottle and 1
PVC tube.
Double KIT EXPRESSION:
contains 2 KOLOR breast shields, 2 collection containers, 1 interface bottle, 2 PVC
tubes and 2 caps.
Collection container
for breast milk
collecting and
storing, 100 mL
KOLOR® breast shield
Tube connection
Interface
bottle
Cap for closing the collection
container and keeping the
milk after using the breast
pump
Tube connected to the breast pump
“I/O” interrupter
Fuse
Setting button
Tube nozzle
