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!
►
Observe specifications regarding concentration, temperature and exposure time.
►
Do not exceed the maximum allowable disinfection temperature of 95 °C.
►
Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and
degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the
product thoroughly with 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
Mechanical 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
Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
3.10.1 Visual inspection
►
Make sure all contamination has been removed. In particular, pay attention for instance to mating surfaces,
shafts, recessed areas and drilled grooves.
►
If the product is dirty: repeat the cleaning and disinfection process.
►
Check the product for damage, in particular:
–
Cracks and holes, in particular in the shaft and handle area
–
Bending or breakage of the mallet handle
–
Massive deformation of the mallet head, resulting in risk of chipping
►
Check the surfaces for rough spots.
►
Check the product for burrs that could damage tissue or surgical gloves.
►
Check the product for loose or missing parts.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical service.
3.10.2 Functional test
►
Assemble disassembled products, see Assembly.
►
Check that the product functions correctly.
►
Check for compatibility with associated products.
►
Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.
3.11
Assembly
►
For FL062, FL062NR, FL045R and FL046NR: Screw end caps to the mallet head using wrench FL062206 .
►
In case of other mallets having replaceable end caps: screw end caps to the mallet head by hand or using the vise.
3.12
Packaging
►
Allocate product to dedicated storage or place on suitable screen basket.
►
Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against contamination of the product during storage.
3.13
Steam sterilization
Note
FL062NR: The product can be sterilized in both a disassembled and an assembled state.
►
Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent.
►
Validated sterilization process
–
Steam sterilization in the fractionated vacuum process
–
Steam sterilizer in accordance with DIN EN 285 and validated in accordance with DIN EN ISO 17665
–
Sterilization in the fractionated vacuum process at 134 °C, holding time 5 min
►
If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted
load according to the manufacturers’ specifications is not exceeded.
3.14
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
4.
Technical service
CAUTION
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and
forfeiture of applicable licenses.
►
Do not modify the product.
►
For service and repairs, please contact your national B. Braun/Aesculap agency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone:
+49 7461 95-1601
Fax:
+49 7461 16-2887
E-Mail:
Other service addresses can be obtained from the address indicated above.
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion
disinfection
■
Suitable cleaning brush
■
Drying phase: Use a lint-free
cloth or medical compressed air
Chapter Manual cleaning/disinfec-
tion and subsection:
■
Chapter Manual cleaning with
immersion disinfection
Mechanical alkaline cleaning and
thermal disinfection
■
Place the product on a tray that
is suitable for cleaning (avoid
rinsing blind spots).
Chapter Mechanical cleaning/dis-
infection and subsection:
■
Chapter Mechanical alkaline
cleaning and thermal disinfec-
tion
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
