6.6
Cleaning/disinfection
6.6.1
Product-specific safety instructions for the reprocessing procedure
►
Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the
risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately.
►
Tools: Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/
disinfection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
6.6.2
Validated cleaning and disinfection procedure
6.7
Manual cleaning/disinfecting
►
Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►
After manual cleaning/disinfection, check visible surfaces visually for residues.
►
Repeat the cleaning/disinfection process if necessary.
6.7.1
Manual cleaning and wipe disinfecting
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT:
Room temperature
Phase I
►
Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been
removed from the surfaces.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
Phase II
►
Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
Phase III
►
Wipe all surfaces of the product with a single-use disinfectant wipe.
Phase IV
►
After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water.
►
Drain any remaining water fully.
Phase V
►
Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
6.7.2
Manual cleaning with ultrasound and immersion disinfection
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT:
Room temperature
*Recommended: BBraun Stabimed
►
Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►
Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►
If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the product in the disinfectant solution.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►
Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
►
Rinse lumens with an appropriate disposable syringe at least five times.
►
Drain any remaining water fully.
Phase V
►
Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfection procedure.
6.8
Mechanical cleaning/disinfecting
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
6.8.1
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents!
►
Only use cleaning/disinfecting agents approved for surface cleaning. Follow
the manufacturer’s instructions for the respective cleaning/disinfecting agent.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
–
are approved for high-grade steel.
–
do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum allowable temperature of 60 °C.
Validated procedure
Special features
Reference
Manual cleaning and
wipe disinfection
■
micro-Line straight
handpiece/angled
handpiece
■
Open and close the tool coupling.
■
Drying phase: Use a lint-free cloth
■
Ensure that the product is positioned in such a
way that water will not enter the product e.g.
through coupling interfaces. (Immediately
remove any fluid that entered the product
inadvertently.)
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
and wipe disinfecting
Manual cleaning and
wipe disinfection
■
Spray nozzle
■
20 ml disposable syringe
■
After use, rinse with demineralized water.
■
Drying phase: Use a lint-free cloth or com-
pressed air for medical purposes
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
and wipe disinfecting
Manual cleaning with
ultrasound and immer-
sion disinfection
■
Tool
■
20 ml disposable syringe
■
Drying phase: Use a lint-free cloth or com-
pressed air for medical purposes
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
with ultrasound and immer-
sion disinfection
Mechanical alkaline
cleaning and thermal
disinfecting
■
micro-Line straight
handpiece/angled
handpiece
■
Tool/spray nozzle
■
Close the tool coupling.
■
micro-Line straight handpiece/angled hand-
piece: Insert the product in its proper position
in the Eccos holder.
■
Tool/spray nozzle: Place the instrument in a
tray that is suitable for cleaning (avoiding
rinsing blind spots).
Chapter Mechanical cleaning/
disinfecting and subsection:
■
Chapter Mechanical alka-
line cleaning and thermal
disinfecting
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Cleaning
RT (cold)
-
-
D–W
-
II
Drying
RT
-
-
-
-
III
Wipe disinfec-
tion
-
>1
-
-
Meliseptol HBV wipes
50 % Propan-1-ol
IV
Final rinse
RT (cold)
0.5
-
FD-W
-
V
Drying
RT
-
-
-
-
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Ultrasonic
cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
II
Intermediate
rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
– pH = 13
– <5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
III
Intermediate
rinse
>10/50
1
FD-W
-
IV
Thermal disin-
fecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
