B. Braun Aesculap Gebrauchsanweisung Seite 4

6.6 Cleaning/disinfection
6.6.1 Product-specific safety instructions for the reprocessing procedure
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
CAUTION
– 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.
►
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
Validated procedure Special features
■
Manual cleaning and
Open and close the tool coupling.
wipe disinfection
■
Drying phase: Use a lint-free cloth
■
micro-Line straight
■
Ensure that the product is positioned in such a
handpiece/angled
way that water will not enter the product e.g.
handpiece
through coupling interfaces. (Immediately
remove any fluid that entered the product
inadvertently.)
■
Manual cleaning and
20 ml disposable syringe
wipe disinfection
■
After use, rinse with demineralized water.
■
Spray nozzle
■
Drying phase: Use a lint-free cloth or com-
pressed air for medical purposes
■
Manual cleaning with
20 ml disposable syringe
ultrasound and immer-
■
Drying phase: Use a lint-free cloth or com-
sion disinfection
pressed air for medical purposes
■
Tool
■
Mechanical alkaline
Close the tool coupling.
cleaning and thermal
■
micro-Line straight handpiece/angled hand-
disinfecting
piece: Insert the product in its proper position
■
micro-Line straight
in the Eccos holder.
handpiece/angled
■
Tool/spray nozzle: Place the instrument in a
handpiece
tray that is suitable for cleaning (avoiding
■
Tool/spray nozzle
rinsing blind spots).
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
Phase Step T
[°C/°F]
I Cleaning RT (cold)
II Drying RT
III Wipe disinfec- -
tion
IV Final rinse RT (cold)
V Drying RT
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.
Reference
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
and wipe disinfecting
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
and wipe disinfecting
Chapter Manual cleaning/disin-
fecting and subsection:
■
Chapter Manual cleaning
with ultrasound and immer-
sion disinfection
Chapter Mechanical cleaning/
disinfecting and subsection:
■
Chapter Mechanical alka-
line cleaning and thermal
disinfecting
t Conc. Water Chemical
[%] quality
[min]
- - D–W -
- - - -
>1 - - Meliseptol HBV wipes
50 % Propan-1-ol
0.5 - FD-W -
- - - -
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
Phase Step T
[°C/°F]
I Ultrasonic RT (cold)
cleaning
II Intermediate RT (cold)
rinse
III Disinfection RT (cold)
IV Final rinse RT (cold)
V Drying RT
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
Phase Step T
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Intermediate >10/50
rinse
IV Thermal disin- 90/194
fecting
V Drying -
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.
t Conc. Water Chemical
[%] quality
[min]
>15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - D–W -
15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - FD-W -
- - - -
t Water Chemical/Note
quality
[min]
3 D–W -
■
10 FD-W
Concentrate, alkaline:
– pH = 13
– <5 % anionic surfactant
■
0.5 % working solution
– pH = 11*
1 FD-W -
5 FD-W -
- - According to the program for cleaning
and disinfection device