B. Braun Aesculap MINOP TREND FH615 Gebrauchsanweisung/Technische Beschreibung Seite 3

3.7.4 Remove MINOP TREND endoscope out of the MINOP TREND suction/irrigation sheath
►
Unscrew the light cable from the MINOP TREND Endoscope 5.
►
Take the camera from the eyepiece of the MINOP TREND Endoscope 5.
►
Unlatch the locking lever of the MINOP TREND suction/irrigation sheath 2 and remove the MINOP TREND
Endoscope 5.
3.8 Cleaning/Disinfection
3.8.1 Product-specific safety information on the reprocessing method
Danger to the patient! The product must not be manually processed.
►
Process the product only with mechanical or manual pre-cleaning followed by mechanical cleaning.
WARNING
Inadequate cleaning result if the irrigation button remains screwed in!
►
Remove the irrigation button prior to cleaning.
Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temper-
atures!
►
Following the manufacturer's instructions, use cleaning and disinfecting agents
– that are approved for plastic material and high-grade steel.
– that do not attack softeners (e.g., in silicone).
►
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.
3.8.2 Validated cleaning and disinfection procedure
Validated procedure Specific requirements
■
Manual cleaning with immersion
Cleaning brush PM995200
disinfection
■
20 ml disposable syringe
■
MINOP TREND-handle
■
When cleaning instruments
■
MINOP TREND suction/irriga-
with movable hinges, ensure
tion shafts
that these are in an open posi-
tion and, if applicable, move
the hinge while cleaning.
■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Manual cleaning with ultrasound
Cleaning brush PM995200
and immersion disinfection
■
20 ml disposable syringe
■
Adapter for holding arm
■
When cleaning instruments
■
Irrigation button
with movable hinges, ensure
that these are in an open posi-
tion and, if applicable, move
the hinge while cleaning.
■
Drying phase: Use a lint-free
cloth or medical compressed air
■
Mechanical alkaline cleaning and
Cleaning brush PM995200
thermal disinfection
■
20 ml disposable syringe
■
MINOP TREND-handle
■
Place the product on a tray that
■
MINOP TREND suction/irriga-
is suitable for cleaning (avoid
tion shafts
rinsing blind spots).
■
Connect components with
lumens and channels directly to
the rinsing port of the injector
carriage.
■
Keep working ends open for
cleaning.
■
Place the product on the tray
with all product links and joints
open.
■
Manual pre-cleaning with ultra-
Cleaning brush PM995200
sound and brush, and subsequent
■
20 ml disposable syringe
mechanical alkaline cleaning and
■
thermal disinfection
Place the product on a tray that
■
is suitable for cleaning (avoid
Adapter for holding arm
rinsing blind spots).
■
Irrigation button
■
Connect components with
lumens and channels directly to
the rinsing port of the injector
carriage.
■
Keep working ends open for
cleaning.
■
Place the product on the tray
with all product links and joints
open.
3.9 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.
3.9.1 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
Reference
Chapter Manual cleaning/disinfec-
tion and subsection:
■
Chapter Manual cleaning with
immersion disinfection
Chapter Manual cleaning/disinfec-
tion and subsection:
■
Chapter Manual cleaning with
ultrasound and immersion dis-
infection
Chapter Mechanical cleaning/dis-
infection and subsection:
■
Chapter Mechanical alkaline
cleaning and thermal disinfec-
tion
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and subsection:
■
Chapter Manual pre-cleaning
with ultrasound and brush
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
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 -
- - - -
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.
3.9.2 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.
3.10 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.
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 -
- - - -