B.Braun Aesculap BA720R Instrucciones De Manejo/Descripción Técnica página 10

en
6.9 Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
►
Set aside the product if it is damaged.
6.10 Packaging
►
Follow the instructions for use for the applied packaging and storage
systems (e.g. instructions for use TA009721 for Aesculap Eccos storage
system).
►
Insert the product in its proper position in the Eccos holder, or put it on
a tray in such a way that the product is protected against damage.
Ensure that all cutting edges are protected.
►
Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►
Ensure that the packaging will prevent a recontamination of the prod-
uct.
6.11 Steam sterilization
Note
The carrier plates BA721, BA722 and BA723 are gamma-sterilized single-
use products. These products must not be steam-sterilized and are intended
for single use only.
Note
The product may only be sterilized with the upper part 17 open and the cut-
ting cylinder 2 removed.
►
Sterilize the skin mesh dermatome immediately after cleaning.
►
Store the skin mesh dermatome in a suitable wire basket (e.g. JF214R).
►
Check to ensure that the sterilizing agent will come into contact with
all external and internal surfaces (e.g. by opening any valves and fau-
cets).
►
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
8. Troubleshooting list
Malfunction
Cutting cylinder 2 fails to rotate
Cutting cylinder 2 stiff
Skin not cut through completely
8
Detection
Foreign body in device
–
Excessive axial slack of cutting cyl-
inder
Strong force required on hand
ratchet 12
Incorrect symbol on fine adjust-
ment scale 18
–
Cutting tips shiny, hand ratchet 12
stiff
Cutting tips broken off
►
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.
6.12 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
following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization Temp.
method
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 alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
6.13 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
7. Maintenance
In order to ensure reliable operation, the product must be maintained after
300 reprocessing cycles or at least once a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Cause
Cutting cylinder jammed
Hand ratchet 12 not engaged
Cutting cylinder loose
Defective bearing
Incorrect setting
Screws 11 loose
Cutting cylinder 2 worn
Cutting cylinder 2 defective
-6
, Aesculap recommends the
Time Minimum drying time
4 min 20 min
Remedy
Remove foreign body
Engage hand ratchet 12
Engage cutting cylinder and secure
with lock 8
Repair by manufacturer
Select the required fine adjustment,
see Safe operation
Tighten screws by hand or with screw-
driver 13
Replace cutting cylinder 2, see Safe
operation
Replace cutting cylinder 2, see Safe
operation