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
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
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
►
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
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.
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion
disinfection
■
All products except for
BV935R, BV936R
■
Use a suitable cleaning brush.
■
20 ml disposable syringe
■
Keep working ends open for clean-
ing purposes.
■
Drying phase: Use lint free cloth or
medical compressed air
Chapter Manual cleaning/disin-
fection and sub-sections:
■
Chapter Manual cleaning
with immersion disinfection
Manual cleaning using ultra-
sound and immersion disinfec-
tion
■
BV935R
■
BV936R
■
Disposable syringe 20ml
■
Keep working ends open for clean-
ing purposes.
■
Drying phase: Use a lint-free cloth
or medical compressed air
Chapter Manual cleaning/disin-
fection and subsection:
■
Chapter Manual cleaning
with ultrasound and immer-
sion disinfection
Alkaline machine cleaning and
thermal disinfection
■
All products except for
BT098R, BT099R, BV935R,
BV936R, FG045R and FL079R
■
Place product on a sterile screen
basket suitable for cleaning (make
sure all areas will be reached by
water jets).
■
To flush the lumens/channels: Use
flush lances or flush sleeves in the
injector cart.
■
Keep working ends open for clean-
ing purposes.
Chapter Machine cleaning/disin-
fection and sub-sections:
■
Chapter Mechanical alkaline
cleaning and thermal disin-
fection
Manual pre-cleaning with brush
and subsequent mechanical
alkaline cleaning and thermal
disinfection
■
BT098R
■
BT099R
■
BV935R
■
BV936R
■
FL079R
■
Use a suitable cleaning brush.
■
Disposable syringe 20ml
■
Put jaw protecting cap on the prod-
uct.
■
Place the product on a tray that is
suitable for cleaning (avoid rinsing
blind spots).
■
To flush the lumens/channels: Use
flush lances or flush sleeves in the
injector cart.
■
Keep working ends open for clean-
ing purposes.
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
Manual pre-cleaning using ultra-
sound and brush and subsequent
alkaline machine cleaning and
thermal disinfection
■
FG045R
■
20 ml disposable syringe
■
Put jaw protecting cap on the prod-
uct.
■
Place product on a screen basket
suitable for cleaning (make sure all
areas will be reached by water jets).
■
Keep working ends open for clean-
ing purposes.
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
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Disinfecting clean-
ing
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)
5
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]
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)
5
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
IV
Final rinse
RT
(cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
