harmful concentration, i.e. the maximum acceptable level. The main chemical residue of detergent recommended here is
1,2-propanediol with residue value less than 10mg/L.
Disinfection
Disinfection must be performed no later than 2 hours after the cleaning phase. Automated disinfection is preferred if
conditions permit.
Automated disinfection – Washer-disinfector
• The washer-disinfector is proved to be valid by CE certification in accordance with EN ISO 15883.
• Use high temperature disinfection function. The temperature does not exceed 134 ° C, and the disinfection under the
temperature cannot exceed 20 minutes.
• The disinfection cycle is in accordance with the disinfection cycle in EN ISO 15883. Cleaning and disinfecting steps by
using Washer-disinfector
1. Carefully place the handpieces in the disinfection basket. Fixture of the handpiece is permissible only when they are freely
removable in the unit. The handpieces are not permitted to contact with each other.
2. Use a suitable rinsing adaptor, and connect the internal water lines to the rinsing connection of the washer-disinfector.
3. Start the program.
4. After the program is finished, remove the handpieces from the washer-disinfector, inspect (refer to section "Inspection and
Maintenance") and packaging (refer to chapter "Packaging"). Dry the handpiece repeatedly if necessary (refer to section
"Drying").
Notes
a) Before use, you must carefully read the operating instructions provided by the equipment manufacturer to familiarize
yourself with the disinfection process and precautions.
b) With this equipment, cleaning, disinfection and drying will be carried out together.
c) Cleaning: (c1) The cleaning procedure should be suitable for the product to be treated. The flushing period should be
sufficient (5-10 minutes). Pre-wash for 3 minutes, wash for another 5 minutes, and rinse it for twice with each rinse lasting
for 1 minute. (c2) In the washing stage, the water temperature should not exceed 45 °C, otherwise the protein will solidify
and it is difficult to remove. (c3) The solution used can be pure water, distilled water, deionized water or multi-enzyme
solution, etc., and only freshly prepared solutions can be used. (c4) During the use of cleaner, the concentration and time
provided by manufacturer shall be obeyed. The used cleaner is neodisher MediZym (Dr. Weigert).
d) Disinfection: (d1) Direct use after disinfection: temperature ≥ 90 ° C, time ≥ 5 min or A0 ≥ 3000.
(d2) For the disinfection here, the temperature is 93 ° C, the time is 2.5 min, and A0>3000.
e) Only distilled or deionized water with a small amount of microorganisms (<10 cfu/ ml) can be used for all rinsing steps. (For
example, pure water that is in accordance with the European Pharmacopoeia or the United States Pharmacopoeia).
f) After cleaning, the presence concentration of the process chemicals is determined to be below the prescribed potential
harmful concentration, i.e. the maximum acceptable level. The main chemical residue of detergent recommended here is
1,2-propanediol with residue value less than 10mg/L.
g) The air used for drying must be filtered by HEPA.
h) Regularly repair and inspect the disinfector.
Drying
If your cleaning and disinfection process does not have an automatic drying function, dry it after cleaning and disinfection.
Methods
1. Spread a clean white paper (white cloth) on the flat table, point the handpiece against the white paper (white cloth), and
then dry the handpiece with filtered dry compressed air (maximum pressure 3 bar). Until no liquid is sprayed onto the white
paper (white cloth), the handpiece drying is completed.
2. It can also be dried directly in a medical drying cabinet (or oven). The recommended drying temperature is 80 ºC - 120 ºC
and the time should be 15 - 40 minutes.
Notes
a)The drying of product must be performed in a clean place.
b)The drying temperature should not exceed 138 °C
c)The equipment used should be inspected and maintained regularly.
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