Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
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
►
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.
►
Assemble dismountable products, see Assembling.
►
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.
►
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.
►
Make certain that all external and internal surfaces of the product will be exposed to the sterilizing agent.
►
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.
To achieve a sterility assurance level of 10
-6
, Aesculap recommends the following parameters:
*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.
►
Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.
Technical Service
►
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:
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.
Accessories/Spare parts
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. 011148 07/14 V6 Änd.-Nr. 48392
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
–
pH = 13
–
<5 % anionic surfactant
■
0.5 % working solution
–
pH = 11*
III
Intermediate
rinse
>10/50
1
FD-W
-
IV
Thermal disin-
fecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
and disinfection device
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/275 °F
4 min
20 min
WARNING
Risk of injury and/or malfunction!
►
Do not modify the product.
Art. no.
Designation
FW343S
Kirschner wire set — in sterile packaging
(2 Kirschner wires with threads and 1 removal instrument)
FW330R
Insertion instrument for Kirschner wire — in unsterile packaging
