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3.6
Disassembly
Note
Do not use tools during disassembling or assembling to prevent damage.
3.6.1
Instrument that cannot be taken apart, with cover tube
►
Disengage the cover tube 7 and push it forward, see Fig. 1.
3.6.2
Instrument that can be taken apart
►
Unscrew the feed spindle 4 and pull out towards the rear, see Fig. 3.
►
Detach the handle 5 and the working end 8 from the base tube 6, see Fig. 4
►
Disengage the cover tube 7 and push it forward, see Fig. 5.
3.7
Cleaning/Disinfection
3.7.1
Product-specific safety information on the reprocessing method
Hazardous to patients! The product FG045R may not be processed manually.
►
Process FG045R only by mechanical cleaning preceded by manual pre-cleaning.
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temper-
atures!
►
Use cleaning agents and disinfectants according to the manufacturer's instructions.
►
Observe specifications regarding concentration, temperature and exposure time.
►
Do not exceed the maximum allowable disinfection temperature of 95 °C.
►
For wet disposal use suitable cleaning agents/disinfectants. To prevent foam from forming and reduced effec-
tiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly
under running water
3.7.2
Validated cleaning and disinfection procedure
Validated procedure
Specific requirements
■
Manual cleaning with immersion
Use a suitable cleaning brush.
disinfection
■
20 ml disposable syringe
■
All products except for
■
Keep working ends open for clean-
BV935R, BV936R
ing purposes.
■
Drying phase: Use lint free cloth or
medical compressed air
■
Manual cleaning using ultra-
Disposable syringe 20ml
sound and immersion disinfec-
■
Keep working ends open for clean-
tion
ing purposes.
■
BV935R
■
Drying phase: Use a lint-free cloth
■
BV936R
or medical compressed air
■
Alkaline machine cleaning and
Place product on a sterile screen
thermal disinfection
basket suitable for cleaning (make
■
sure all areas will be reached by
All products except for
water jets).
BT098R, BT099R, BV935R,
■
BV936R, FG045R and FL079R
To flush the lumens/channels: Use
flush lances or flush sleeves in the
injector cart.
■
Keep working ends open for clean-
ing purposes.
■
Manual pre-cleaning with brush
Use a suitable cleaning brush.
and subsequent mechanical
■
Disposable syringe 20ml
alkaline cleaning and thermal
■
disinfection
Put jaw protecting cap on the prod-
■
uct.
BT098R
■
■
Place the product on a tray that is
BT099R
suitable for cleaning (avoid rinsing
■
BV935R
blind spots).
■
■
BV936R
To flush the lumens/channels: Use
■
FL079R
flush lances or flush sleeves in the
injector cart.
■
Keep working ends open for clean-
ing purposes.
■
Manual pre-cleaning using ultra-
20 ml disposable syringe
sound and brush and subsequent
■
Put jaw protecting cap on the prod-
alkaline machine cleaning and
uct.
thermal disinfection
■
■
Place product on a screen basket
FG045R
suitable for cleaning (make sure all
areas will be reached by water jets).
■
Keep working ends open for clean-
ing purposes.
3.8
Manual cleaning/disinfection
►
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.
3.8.1
Manual cleaning with immersion disinfection
Phase
Step
T
[°C/°F]
I
Disinfecting clean-
RT
ing
(cold)
II
Intermediate rinse
RT
(cold)
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 fresh
Reference
Chapter Manual cleaning/disin-
fection and sub-sections:
■
Chapter Manual cleaning
with immersion disinfection
Chapter Manual cleaning/disin-
fection and subsection:
■
Chapter Manual cleaning
with ultrasound and immer-
sion disinfection
Chapter Machine cleaning/disin-
fection and sub-sections:
■
Chapter Mechanical alkaline
cleaning and thermal disin-
fection
Chapter Mechanical clean-
ing/disinfection with manual
pre-cleaning and sub-sections:
■
Chapter Manual pre-cleaning
with a brush
■
Chapter Mechanical alkaline
cleaning and thermal disin-
fecting
Chapter Mechanical clean-
ing/disinfection with manual
pre-cleaning and subsection:
■
Chapter Manual pre-cleaning
with ultrasound and brush
■
Chapter Mechanical alkaline
cleaning and thermal disin-
fecting
t
Conc.
Water
Chemical
[%]
quality
[min]
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
1
-
D–W
-
5
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
1
-
FD-W
-
-
-
-
-
►
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.
3.8.2
Manual cleaning with ultrasound and immersion disinfection
Phase
Step
T
[°C/°F]
I
Ultrasonic cleaning
RT
(cold)
II
Intermediate rinse
RT
(cold)
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 fresh
►
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.
3.9
Machine cleaning/disinfection
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
-
5
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1
-
FD-W
-
-
-
-
-
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