B. Braun Aesculap MINOP TREND FH615 Gebrauchsanweisung/Technische Beschreibung Seite 4

3.10.1 Mechanical alkaline cleaning and thermal disinfection
Machine type: single-chamber cleaning/disinfection device without ultrasound
Phase Step T
[°C/°F]
I Pre-rinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfecting 90/194
V Drying -
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.
3.11 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.
3.11.1 Manual pre-cleaning with ultrasound and brush
Phase Step T
[°C/°F]
I Ultrasonic cleaning RT
(cold)
II Rinsing RT
(cold)
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
►
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.
3.11.2 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 rinse >10/50
IV Thermal disinfecting 90/194
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.
3.12 Inspection
►
Allow the product to cool down to room temperature.
►
Dry the product if it is wet or damp.
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
t Conc. Water Chemical
[%] quality
[min]
>15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
1 - D–W -
t Water Chemical
quality
[min]
3 D–W -
■
10 FD-W
Concentrate, alkaline:
– pH ~ 13
– <5 % anionic surfactant
■
working solution 0.5%
– pH = 11*
1 FD-W -
5 FD-W -
- - In accordance with the program for the
cleaning and disinfecting machine
3.12.1 Visual inspection
►
Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts, recessed
areas, drill grooves and the sides of the teeth on rasps.
►
If the product is dirty: repeat the cleaning and disinfection process.
►
Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely
scratched and fractured components.
►
Check the product for missing or faded labels.
►
Check the products with long, slim shapes (in particular rotating instruments) for deformities.
►
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.
3.12.2 Functional test
CAUTION
Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with
maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil
spray JG600 or STERILIT® I drip lubricator JG598).
►
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.
3.13 Assembly
3.13.1 Insert MINOP TREND endoscope into the MINOP TREND suction/irrigation sheath
CAUTION
Damage to components caused by excessive force!
►
Handle the components with appropriate care.
►
Insert MINOP TREND Endoscope 5 axially into the MINOP TREND suction/irrigation sheath 2, see Fig. 2. Whilst
completing this step, ensure that the lever of the MINOP TREND suction/irrigation sheath 2 is open and the peg
fits into the groove on the bayonet of the MINOP TREND Endoscope 5.
►
Turn the locking lever of the MINOP TREND suction/irrigation sheath 2 as far as it will go.
The MINOP TREND Endoscope 5 has been securely locked.
3.13.2 Connecting the tubes and the irrigation button
CAUTION
Restricted functionality of the MINOP TREND (TRansnasal ENDoscopy System) if the irrigation button is not
screwed in completely!
►
Make certain that the irrigation button in the MINOP TREND handle is screwed into handle down to the
stop.
CAUTION
Restricted functionality of the MINOP TREND (TRansnasal ENDoscopy System) due to incorrect connecting
direction of the tubes!
►
Note the arrow direction on the MINOP TREND handle.
►
Carry out function checks before using the product.
►
Verify that the irrigation button 4 does not show any damage (valve seals, surfaces, etc.).
►
Screw the irrigation button 4 all the way into the MINOP TREND handle 3, see Fig. 3.
►
Connect the suction tube to the suction connector, making certain that the arrow points away from the
MINOP TREND handle 3.
►
Connect the irrigation tube to the irrigation connector, making certain that the arrow points towards the
MINOP TREND handle 3.
Note
In order to facilitate connection, a MINOP TREND suction/irrigation tube is available, the irrigation tube of which is
identified along its entire length with a blue line running through it. The suction tube is not marked.
3.13.3 Connect the MINOP TREND suction/irrigation sheath with the MINOP TREND handle
►
Insert the MINOP TREND suction/irrigation sheath 2 with the MINOP TREND endoscope 5 from the rear into the
MINOP TREND handle, until the MINOP TREND suction/irrigation shaft 2 engages, see Fig. 4.
The MINOP TREND suction/irrigation sheath 2 is rotatable.
►
Check the irrigation and suction tubes and the conical seating for any leaks.
►
Press irrigation button 4 to check that it functions properly.
3.13.4 Mounting adapter for holding arm RT099R
►
Unscrew the cap nut of the adapter for holding arm 6.
►
Insert adapter for holding arm 6 from either side (left/right) into the borehole until the flange engages in the
provided groove, see Fig. 5.
►
Screw on the cap nut and tighten it until adapter for holding arm 6 is fixed, see Fig. 6.
The MINOP TREND ( TRansnasal ENDoscopy System) is ready for connection to the holding arm.
3.14 Packaging
►
Appropriately protect products with fine working tips.
►
Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered.
►
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.
3.15 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
►
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.
3.16 Storage
►
Store sterile single-use products in germ-proof packaging in a dust-protected, dry, dark and temperature-con-
trolled room.