Compliances And Standards; Safety Instructions - human care Roomer S 55300H Mode D'emploi

Compliances and Standards

Human Care is an ISO 13485:2016 certified
Swedish medical device company. The Quality
Management System is in compliance with US
21 CFR part 820.
The product is CE marked in accordance with EU
Safety instructions
Before using for the first time, make sure
that:
• you have read and understood the user ma-
nual for the lift and all of its accessories
• t he lift has been installed in accordance with
the installation instructions
• t he lift accessories are intended for use with
the lift and are correctly fitted
• B efore use: charge battery upon arrival. To
ensure battery capacity is maintained, the
new ceiling lift must be charged for 8 hours
immediately upon arrival before it is put in
use or stored. This is because the ceiling lift
may have been stored for some time and
during that period not been charged regularly.
• C heck to see if there is a distance strap
suspended from the rail or if there is a hook
fitted to the rail roller. The recommended
minimum height from the floor to the dis-
tance strap is 1850 mm.
• R emove the lift and charger from the
p ackaging.
• R emove the seal from the lift belt after first
reading the user manual.
• Plug the charger in at an easily accessible
wall socket.
• Plug the hand control into the charger (see
page 8). If the indicator light on the charger
is glowing yellow, charge until the indicator
light turns green.
Important! The lift is designed ex-
clusively for lifting people, and only
one at a time.
Directive 93/42/EEC (MDD) and/or EU Regula-
tion 2017/745 (MDR), as class I medical device.
The CE mark is on the product.
This product has been tested in accordance
with ISO 10535.
Before use, always ensure that:
• personnel who use the equipment have
been given adequate tuition and training in
use of the lift and its accessories
• t he lift belt is not twisted or worn and that it
can move freely in and out of the lift
• l ift accessories, e.g. sling, distance strap and
rail roller, are showing no signs of wear or
other damage
• t he lift is correctly suspended in the distance
strap, rail roller and rail
• t he right types, sizes, materials and designs
of the accessories have been selected with
respect to the client's safety and needs
• t he lift accessories have been correctly
installed.
• T he sling's strap loops and suspension must
Right
be checked once the loops are fully exten-
ded when lifting but before the client is lifted
from the underlying surface
• It is important to always check that the loops
are at the bottom of all hooks (see picture
below), securely placed below the locking pin.
www.humancaregroup.com
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