Classifications For Reprocessing; Classification Of Medical Devices - Dräger Babytherm 8004 Instructions For Use Manual

Reprocessing
WARNING
Risk due to inappropriately reprocessed
products
Reusable products must be reprocessed, oth-
erwise there is an increased risk of infection.
– Observe the hygiene regulations and
reprocessing regulations of the healthcare
facility.
– Observe national hygiene regulations and
reprocessing regulations.
– Use validated procedures for
reprocessing.
– Reprocess reusable products after every
use.
– Observe the manufacturer's instructions
for cleaning agents, disinfectants, and re-
processing devices.
CAUTION
Do not wash the mattress in a washing machine.
Do not autoclave.

Classifications for reprocessing

Classification of medical devices

Medical devices and their components are
classified according to the way they are used and
the resulting risk.
Classification
Non-critical
Semi-critical (A, B)
Critical (A, B, C)
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CAUTION
Do not clean the heating elements and reflectors
with a moist cloth or brush!
CAUTION
Do not use disinfectants or cleaning products that
contain alcohol.
.
NOTE
Even reusable accessories (e.g. after being pre-
pared) have a limited service life. Wear may be in-
creased and the service life reduced considerably
by various factors when handling and preparing
them (e.g. disinfectant residues corroding the ma-
terial when autoclaving them). These parts must
be replaced if signs of wear become visible, such
as cracks, deformation, discoloration, peeling,
etc.
 Before disinfecting/cleaning the radiant warmer,
allow it to cool down for about 30 minutes.
Explanation
Components that come only into contact with skin
that is intact
Components that carry breathing gas or come into
contact with mucous membranes or pathologically
altered skin
Components that penetrate skin or mucous mem-
branes or come into contact with blood
Instructions for use Babytherm 8004/8010