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B. Braun Aesculap Spine activ L FW960R Gebrauchsanweisung/Technische Beschreibung Seite 4

Activ l-revisionsinstrumente und -spreizzangen
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Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.
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 5 times at the beginning of the exposure time using an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
Rinse/flush the product thoroughly (all accessible surfaces).
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.
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.
Mechanical cleaning/disinfection with manual pre-cleaning
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.
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
-
-
-
-
-
Manual pre-cleaning with a brush
Phase
Step
T
[°C/°F]
I
Disinfec-
RT (cold)
tant
cleaning
II
Rinsing
RT (cold)
D–W:
Drinking water
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
Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.
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.
Manual pre-cleaning with ultrasound and brush
Phase
Step
T
[°C/°F]
I
Ultrasonic
RT (cold)
cleaning
II
Rinsing
RT (cold)
D–W:
Drinking water
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.
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.
Inspection, maintenance and checks
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
CAUTION
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
Allow the product to cool down to room temperature.
After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured compo-
nents).
t
Conc.
Water
Chemical
[%]
quality
[min]
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1
-
D–W
-
t
Conc.
Water
Chemical
[%]
quality
[min]
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concen-
trate, pH ~ 9*
1
-
D–W
-
t
Water
Chemical
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

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