Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■
Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fracturing, premature aging or swelling.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
►
Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at
www.a-k-i.org, link to "AKI-Brochures", "Red brochure".
3.3
Reusable products
■
No maximum number of applications and processing cycles has been specified for the product.
■
The service life of the product is limited by damage, normal wear, the type and duration of usage, as well as the
handling, storage and transportation of the product.
■
Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.
3.4
Preparations at the place of use
►
If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
►
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
3.5
Preparing for cleaning
►
Do not disassemble any anchoring screws/bolts that permanently connect the various components.
►
Disassemble the product prior to cleaning, see Disassembly.
3.6
Disassembly
►
Remove the movable measuring arm
a
from the rod length measuring instrument.
3.7
Cleaning/Disinfection
3.7.1
Product-specific safety information on the reprocessing method
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temper-
atures!
►
Use cleaning agents and disinfectants in accordance with the manufacturer's instructions.
►
Observe specifications regarding concentration, temperature and exposure time.
►
Do not exceed the maximum allowable disinfection temperature of 95 °C.
►
Use suitable cleaning/disinfectants for wet disposal. To prevent foam from forming and reduced effectiveness 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.
3.9
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.
3.9.1
Mechanical alkaline cleaning and thermal disinfection
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 alcaline
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
3.10
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.
3.10.1 Manual pre-cleaning with a brush
D–W:
Drinking water
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.
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion
disinfection
■
FW728R to FW729R
■
FW731R to FW733R
■
FW737R to FW739R
■
Suitable cleaning brush
■
20 ml disposable syringe
■
Clean products having movable
hinges in the open position or while
moving the joints.
■
Drying phase: Use a lint-free cloth or
medical compressed air
Chapter Manual clean-
ing/disinfection and subsec-
tion:
■
Chapter Manual cleaning
with immersion disinfec-
tion
Alkaline machine cleaning and
thermal disinfection
■
FW729R
■
FW732R
■
FW733R
■
FW738R
■
Place product on a screen basket
suitable for cleaning (make sure all
areas will be reached by water jets).
■
Connect components with lumens
and channels directly to the rinsing
port of the injector carriage.
■
Open the links and joints before plac-
ing the product on the screen basket.
Chapter Machine clean-
ing/disinfection and sub-sec-
tions:
■
Chapter Mechanical alka-
line cleaning and thermal
disinfection
Manual pre-cleaning with brush
and subsequent mechanical alka-
line cleaning and thermal disinfec-
tion
■
FW728R
■
FW731R
■
FW737R
■
FW739R
■
Suitable cleaning brush
■
20 ml disposable syringe
■
Place the product on a tray that is
suitable for cleaning (avoid rinsing
blind spots).
■
Connect the lumens and channels of
individual parts directly to the injec-
tor unit's special flushing connectors.
■
Open the links and joints before plac-
ing the product on the screen basket.
Chapter Mechanical clean-
ing/disinfection with manual
pre-cleaning and subsection:
■
Chapter Manual pre-
cleaning with a brush
■
Chapter Mechanical alka-
line cleaning and thermal
disinfecting
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]
Water
quality
Chemical/Note
I
Pre-rinse
<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 disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Disinfec-
tant
cleaning
RT
(cold)
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT
(cold)
1
-
D–W
-
