Technical Service; Distributor In The Us/Contact In Canada For Product Information And Complaints - B. Braun Aesculap Spine ProSpace SN002R Gebrauchsanweisung

Mechanical alkaline cleaning and thermal disinfection
Machine type: Single-chamber cleaning/disinfection device without ultrasound
Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).
Connect components with lumens and channels directly to the rinsing port of the injector carriage.
Keep working tips open for cleaning.
Place instruments in the tray with their hinges open.
Phase Step T
[°C/°F]
I Prerinse <25/77
II Cleaning 55/131
III Intermediate rinse >10/50
IV Thermal disinfec- 90/194
tion
V Drying -
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at
least)
Inspection, maintenance, and checks
Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrica-
tion!
Prior to function checks, lubricate moving parts (e.g. joints, pusher components, and
threaded rods) with maintenance oil suitable for the respective sterilization process
CAUTION (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 instrument is dry, clean, operational,
and free of damage (e. g. broken insulation or corroded, loose, bent, broken, cracked, worn or fractured compo-
nents).
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.
Assemble dismountable instruments, see Assembly.
Check for compatibility with associated products.
Packaging
Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
Ensure that the packaging provides sufficient protection against recontamination of the product during storage
(DIN EN ISO 11607).
Sterilization
Note
The product can be sterilized either in disassembled or in assembled condition.
Ensure that the sterilant can reach all external and internal surfaces (e.g. by opening valves and stopcocks).
Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer specified in DIN EN 285 and validated in accordance with DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum permitted
load specified by the manufacturer for the steam sterilizer is not exceeded.
Sterilization for the US market
• Aesculap does not recommend the device sterilized by flash or chemical sterilization.
• Sterilization may be accomplished by steam autoclave in a standard prevacuum cycle.
-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.
Pre-vacuum 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 instruments. Other sterilization
cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to val-
idate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain ste-
rility 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.
t Water Chemical/Note
[min] quality
3 D–W -
10 FD-W BBRAUN HELIMATIC CLEANER alcaline
with tensides, application solution 0.5%
1 FD-W -
5 FD-W -
- - According to disinfector program
Time Minimum drying time
4 min 20 min

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 Technical 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:
Aesculap Implant Systems LLC
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.
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
Aesculap Implant Systems LLC
3773 Corporate Parkway
Center Valley, PA 18034
USA
TA-Nr.: 013462 05/11