Manual Cleaning/Disinfecting; Wipe Disinfection For Electrical Devices Without Sterilization; Steam Sterilization - Aesculap FLEXHeart system Instrucciones De Manejo

Validated cleaning and disinfection procedure
FLEXHeart clamp FC561
Validated procedure Special features
■
Manual cleaning with
Cleaning brush
immersion disinfection
■
Disposable syringe
■
Keep working ends open for cleaning.
■
When cleaning products with movable hinges,
ensure that these are in an open position and, if
applicable, move the joint while cleaning.
■
Drying phase: Use a lint-free cloth or compressed
air for medical purposes
■
Drying phase: Use a lint-free cloth
■
Mechanical alkaline
Concentrate, alkaline:
cleaning and thermal
– ph -13
disinfecting
– <5 % anionic surfactant
■
0.5 % working solution
– ph -11
■
Inspect visible surfaces for residues after clean-
ing/disinfection
FLEXHeart adapter FC562
Validated procedure Special features
■
Wipe disinfection for
Keep working ends open for cleaning.
electrical devices with-
■
When cleaning products with movable hinges,
out sterilization
ensure that these are in an open position and, if
applicable, move the joint while cleaning.

Manual cleaning/disinfecting

►
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.
Manual cleaning with immersion disinfection
Phase Step T
[°C/°F]
I Disinfecting 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
►
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.
Reference
Chapter Manual clean-
ing/disinfecting and sub-
section:
■
Chapter Manual clean-
ing with immersion
disinfection
Chapter Mechanical clean-
ing/disinfecting and sub-
section:
■
Chapter Mechanical
alkaline cleaning and
thermal disinfecting
Reference
Chapter Wipe disinfection
for electrical devices with-
out sterilization
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 -
- - - -
Mechanical cleaning/disinfecting
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.
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.

Wipe disinfection for electrical devices without sterilization

Phase Step T t
[°C/°F] [min]
≥1
I Wipe disin- RT
fection
RT: Room temperature
Phase I
►
Remove any visible residues with a disposable disinfectant wipe.
►
Wipe all surfaces of the optically clean product with a fresh, disposable disinfectant wipe.
►
Observe the specified application time (1 min minimum).
Single-use products
Infection hazard for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product!
WARNING
Art. no. Designation
FC560SU FLEXHeart tissue stabilizer
Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged.
►
Check the product for any damage, abnormal running noise, overheating or excessive vibration.
►
Set aside the product if it is damaged.
Packaging
►
Place the product in the correct position on the tray in such a way that it is protected against damage.
►
Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging will prevent a recontamination of the product.

Steam sterilization

►
Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets).
►
Validated sterilization process
– Steam sterilization using fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►
When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity
of the steam sterilizer specified by the manufacturer is not exceeded.
t Water Chemical/Note
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
Conc. Water Chemical
[%] quality
- - Meliseptol HBV wipes 50 %
Propan-1-ol