iM3 EVOLUTION Serie Instrucciones Para El Uso página 39

USER'S MANUAL
7. REPROCESSING
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.
7.2 Preparation process in accordance with
EN ISO 17664
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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.
EVOLUTION VETERINARY DENTAL UNITS
The reprocessing method was validated as follows:
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Pre-cleaning
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FD 366 sensitive top wipes
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Cleaning brush
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Manual cleaning
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FD 366 sensitive top wipes
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FD 366 sensitive ready-to-use solution
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Cleaning brush
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Manual disinfection
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FD 366 sensitive top wipes
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Bilpron
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BC-San 100 (only for the bottle)
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Automatic cleaning and disinfection
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was performed in accordance with
EN ISO 15883 with tested efficacy.
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Cleaning agent: Neodisher MediClean Forte
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Washer-disinfector: PG 8535 (Miele)
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Programmes: "Cleaning without neutralisation"
and "THERMAL DESotro"
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Cleaning/disinfection temperature: 90 °C
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Cleaning/disinfection time: 5 minutes
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Cleaning brush
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Bottle brush with silicone bristles
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Bristle material: silicone
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Brush head: Ø 60 mm
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Temperature resistance up to 300 °C
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Brush length: 350 mm
Example:
Culinaris bottle brush, sterilisable, anthracite REF 227721
39 � EN