Distributor In The Us/Contact In Canada For Product Information And Complaints - B. Braun Aesculap Neuropilot IV+EA Gebrauchsanweisung/Technische Beschreibung

Validated cleaning and disinfection procedure
Validated procedure Specific requirements
■
Manual pre-cleaning with ultra-
Cleaning brush: e.g. TA007747
sound and brush, and subsequent
■
20 ml disposable syringe
mechanical alkaline cleaning and
■
thermal disinfection Place the product in a tray that
is suitable for cleaning (avoid-
ing rinsing blind spots).
■
Place products in the tray with
their hinges open.
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.
Manual pre-cleaning with ultrasound and brush
Phase Step T
[°C/°F]
I Ultrasonic RT (cold)
cleaning
II Rinsing RT (cold)
D–W: Drinking water
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
►
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.
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.
Inspection, maintenance and checks
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
CAUTION
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
►
Allow the product to cool down to room temperature.
►
After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and
free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).
►
Dry the product if it is wet or damp.
►
Repeat cleaning and disinfection of products that still show impurities or contamination.
►
Check that the product functions correctly.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►
Check for compatibility with associated products.
Reference
Chapter Mechanical cleaning/dis-
infection with manual pre-clean-
ing and sub-chapter:
■
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 concen-
trate, pH ~ 9*
1 - D–W -
t Water Chemical
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
Packaging
►
Place the product in its holder or on a suitable tray.
►
Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Steam sterilization
Note
The product may only be sterilized when dismantled (disassembled reduction sleeve).
►
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
– Disassemble the product
– Steam sterilization through fractionated 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.
Sterilization for the US market
■
Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
-6
To achieve a sterility assurance level of 10 , Aesculap recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp.
Prevacuum 270 °F/275 °F
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles
may also be suitable, however individuals or hospitals not using the recommended method are advised to validate
any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility
after processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device
cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of
crosscontamination.
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Technical Service
Risk of injury and/or malfunction!
►
Do not modify the product.
WARNING
►
For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 (7461) 95-1602
Fax: +49 (7461) 16-5621
E-Mail: ats@aesculap.de
Or in the US:
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042
Aesculap Repair Hotline
Phone: +1 (800) 214-3392
Fax: +1 (314) 895-4420
Other service addresses can be obtained from the address indicated above.
Accessories/Spare parts
Reduction sleeve Inner diameter
RT061R 4.0 mm
RT062R 6.2 mm
RT063R 3.2 mm
RT064R 4.6 mm
RT065R 6.0 mm
RT066R 3.0 mm
Disposal
►
Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Distributor in the US/Contact in Canada for product information and
complaints
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 010662 03/13 V6 Änd.-Nr. 46931
Time Minimum drying time
4 min 20 min
Compatible endoscopes/trocars
Angled neuroendoscopes PE486A, PE506A, PE526A
Ventriculoscope trocars FF370R, FF372R
Minop-trocar FF397R
Minop-trocar FF398R
Minop-trocar FF399R
PaediScope PF010A