The reprocessing procedure was validated as fol-
lows:
– Pre-cleaning:
– Monarch surface disinfection wipes (Air
Techniques)
– Cleaning brush
– Manual cleaning:
– Monarch enzymatic cleaner 2.0 % (v/v) (Air
Techniques)
– Manual disinfection:
– Monarch surface disinfection wipes (Air
Techniques)
– Automated cleaning and disinfection was per-
formed in accordance with EN ISO 15883 with
tested efficacy:
– Washer-disinfector PG 8536 CD (Miele,
Gütersloh, Germany)
– Cleaning agent: Neodisher MediClean Forte
– Programs: Cleaning without neutralization
and THERMAL DES
– Steam sterilization:
– Steam sterilizer Systec DX-45 (Systec
GmbH, Linden, Germany)
9.3
General information
Comply with all national directives, standards
❯
and specifications for the cleaning, disinfection
and sterilization of medical devices as well as
the specific specifications for dental practices
and clinics.
Comply with the specifications (in "9.5 Manual
❯
cleaning, intermediate rinsing, disinfection, dry-
ing" and "9.6 Automatic cleaning, intermediate
rinsing, disinfection, final rinse, drying") when
you select the cleaning agents and disinfec-
tants to be used.
Comply with the concentrations, temperatures,
❯
residence times and post-rinsing specifications
issued by the manufacturer of the cleaning
agent and disinfectant.
Only use cleaning agents that are non-fixing
❯
and aldehyde-free and display material com-
patibility 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 resi-
❯
due on the components).
Only use freshly-produced solutions.
❯
2210200496L41 1911V006
Only use distilled or de-ionized water with a low
❯
bacterial count (at least drinking water quality)
that is free from facultatively pathogenic micro-
organisms (e.g. Legionella bacteria).
Use clean, dry, oil- and particle-free com-
❯
pressed air.
Do not exceed temperatures of 281 °F.
❯
Subject all devices used (e.g. ultrasonic bath,
❯
cleaning and disinfection device (washer-disin-
fector), sealing device, steam sterilizer) to regu-
lar maintenance and inspections.
9.4
Preparation at the operating
location
Wear hand protection.
Wear eye protection.
Use a mask.
Wear protective clothing.
WARNING
Risk of infection from contaminated
products
Risk of cross contamination
Reprocess the product correctly and
❯
promptly before its first use and after
every subsequent use.
Protect the unit from contamination when
❯
transporting it from the treatment chair to the
reprocessing location.
Brush off all surfaces below the water surface
❯
with a soft hygienic brush until they are clean to
the eye.
Wipe off all surfaces for at least one minute
❯
with a disinfection wipe.
9.5
Manual cleaning, intermedi-
ate rinsing, disinfection, dry-
ing
Cleaning
Place individual parts in a cleaning agent bath
❯
making sure that all parts are covered.
Usage
EN-
US
43