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USER'S MANUAL
EVOLUTION VETERINARY DENTAL UNITS
7. REPROCESSING
39 � EN
General information
» Comply with all national directives, standards and
7.1
Risk analysis and categorisation
A risk analysis and categorisation of medical products
often used in dentistry must be performed before their
reprocessing by the operator. Comply with all national
directives, standards and specifications such as, for
example, the“Recommendations from the Commission
for Hospital Hygiene and Infection Prevention".
Accessories of the medical device are also subject to
reprocessing.
Classification recommendation given proper use of the
product: semi-critical B.
Semi-critical medical device
A medical product that comes into contact with mucous
membranes or pathologically affected skin. The operator
is responsible for correct classification of the medical
products, defining the reprocessing steps and performing
the reprocessing.
specifications for the cleaning, disinfection and
sterilisation of medical products as well as the specific
specifications for dental practices and clinics.
» When selecting the cleaning and disinfecting agents
to be used, observe the specified information (see
“Manual cleaning, intermediate rinsing, disinfection,
final rinse, drying” and “Automatic cleaning,
intermediate rinsing, disinfection, final rinse, drying”).
» Comply with the concentrations, temperatures,
residence times and post-rinsing specifications issued
by the manufacturer of the cleaning and disinfectant
agent.
» Only use cleaning agents that are non-protein-fixing,
aldehyde-free and display material compatibility with
the product.
» Only use disinfectants that are aldehyde-free and
display material compatibility with the product.
» Do not use any rinse aid (danger of toxic residue on
7.2
Preparation process in accordance with
EN ISO 17664
» The reprocessing procedure after each treatment is
carried out according to the reprocessing procedure
established by EN ISO 17664.
Important information!
The reprocessing notes in accordance with EN ISO 17664
have been independently tested by iM3 for the
preparation of the device and its components for their
reuse.
The person conducing the reprocessing is responsible
for ensuring the reprocessing performed using the
equipment, materials and personnel achieves the desired
results. This requires validation and routine monitoring
of the reprocessing process. Any deviation from the
procedures described following by preparation staff
is solely the responsibility of the personnel in terms of
effectiveness and the possible adverse consequences.
Frequent reprocessing has little effect on the device
components. The end of the product life cycle is
especially influenced by the amount of wear and tear
or damage resulting from its use. The use of soiled,
contaminated and damaged components is at the sole
responsibility of the person performing the reprocessing
and the operator.
the components).
» Only use freshly-produced solutions.
» Only use distilled or deionised water (not sterile water)
with a low bacterial count (at least drinking water
quality) that is free from facultative pathogenic microorganisms (e.g. legionella bacteria).
» Use clean, dry, oil and particle-free compressed air.
» Do not exceed temperatures of 93 °C.
» All devices used (e.g. ultrasonic bath, cleaning and
disinfection device (washer-disinfector) must be
regularly serviced and inspected.
7.3
Preparation at the operating location
Wear protective gloves
Wear protective goggles.
Use mouth and nose protection
Use protective clothing
