Dentsply Sirona ProTaper Universal A0409 Protocole D'utilisation page 11

III - STEP-BY-STEP INSTRUCTIONS
Operation Activities
1. Disassembling - Disassemble the device, if
2. Pre-Disinfection - Soak all devices immediately
3. Rinsing - Abundant rinsing (at least 1 min)
4a. Automated - Place the devices in a kit,
Cleaning with
washer- disinfector
- Place the devices in the
- Use a detergent solution
OR
4b.i Manual Cleaning - Place the devices in a kit,
assisted by an
ultrasonic device
- Immerse in the detergent
4b.ii Rinsing - Abundant rinsing (at least 1 min)
B EN PTU0 DFU WEB / Rev.12 / 11-2017
applicable.
after use in a disinfection
solution (We recommend the use
of Prolystica 2X Concentrate
®
Enzymatic Presoak and Cleaner
at 0.4% for a minimum of
15 minutes). Use a tray made
from high density polyethylene
or stainless steel.
under running water (ambient
temperature).
support, or container (made
from stainless steel or titanium)
to avoid any contact between
devices or posts.
washer-disinfector and execute
the defined cycle (Ao value >
3000 or, at least 5 min at 90°C
(194°F)).
with cleaning properties
(we recommend Neodisher
Mediclean Forte at 0.4%).
support or container (made from
stainless steel, polypropylene
or titanium) to avoid any contact
between devices.
solution with cleaning properties
(we recommend Neodisher
Mediclean Forte at 2%), assisted
by an ultrasonic device if suitable
for at least 15 min.
under running water (ambient
temperature).
Warning and remarks
- Remove and discard silicone stops.
- Follow instructions and respect concentrations and immersion times given by the
manufacturer (an excessive concentration may cause corrosion or others defects
on devices).
- The pre-disinfection solution should be a specific solution targeted by the supplier
for pre-disinfection. It should be used at the dilution specified by the supplier. It
should contain, or be combined with a proteolytic enzyme.
- The pre-disinfection solution should be aldehyde free (to avoid blood impurities
fixation) and without di- or triethanolamines as corrosion inhibitor. Change the
pre-disinfection solution regularly i.e. When it becomes soiled, or when efficacy is
diminished due to exposure to microbial loads.
- Do not use pre-disinfecting solutions containing Phenol or any products, which are
not compatible with the devices.
- For visible impurities observed on instruments a pre-cleaning is recommended
with a soft brush (made from either nylon, polypropylene, acrylic). Manually brush
the device until visible impurities are removed.
- Use tap water for rinsing.
- If a pre-disinfectant solution contains a corrosion inhibitor, it is recommended to
do the rinsing step just before starting the cleaning step.
- Discard any devices with defects (broken, bent,...).
- Avoid any contact between instruments or posts when placing in the washer-
disinfector use kits, supports or containers.
- Follow instructions and concentrations given by the manufacturer of the detergent
solution.
- Follow the instructions of the washer-disinfector and verify the success criteria
after each cycle have been met as stated by the manufacturer.
- The final rinse step should be with deionised water. For other steps follow the
water quality defined by the manufacturer.
- Use only approved washer-disinfector according to EN ISO 15883, maintained
and validated regularly.
- It is recommended to use an alkaline detergent with tensides, which has
grease removal, disinfection (against bacteria/ fungi) and corrosion inhibition
properties. The detergent should be approved for its efficacy (VAH/DGHM-listing,
CE marking, FDA approval) and used in accordance with its DFU The detergent
should be aldehyde free and without di- or triethanolamines as corrosion inhibitor.
- No visible impurities should be observed on the devices.
- If visible impurities are observed on the devices, the device must be manually
brushed with a soft brush (made from either nylon, polypropylene, acrylic) until
visible impurities are removed.
- Discard any devices with defects (broken, bent, and unwound).
- Follow instructions, observe water quality, concentrations and cleaning time stated
by the manufacturer of the cleaning solution.
- It is recommended to use an alkaline detergent with tensides, which has grease
removal, disinfection (against bacteria/ fungi) and corrosion inhibition properties.
The detergent should be approved for its efficacy (VAH/DGHM-listing,
CE marking, FDA approval) and used in accordance with the DFU of the
detergent solution manufacturer).
- The detergent should be aldehyde free and without di- or triethanolamines as
corrosion inhibitor.
- Use deionised water for rinsing.
- If the previously used cleaning solution contains a corrosion inhibitor, it is
recommended to do the rinsing step just before starting the autoclaving.
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