General information
Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking
becoming unreadable either visually or by machine.
Residues containing chlorine or chlorides, e.g., in surgical residues, medicines, saline solutions, and in the service
water used for cleaning, disinfection, and sterilization, will cause corrosion damage (pitting, stress corrosion) and
result damage to metallic products. These must be removed by rinsing thoroughly with demineralized water and then
drying.
Perform additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■
Optical changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fracturing, premature aging, or swelling.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause
corrosion
►
For further detailed information on hygienically safe and material-preserving/value-preserving reprocessing, see
www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Disassembling the product before carrying out the reprocessing procedure
►
Disassemble the product immediately after use, as described in the respective instructions for use.
►
Remove the sealing cap from the Luer lock connector.
Preparations at the place of use
►
If applicable, rinse surfaces that are not accessible to visible inspection (preferably with demineralized water),
using a disposable syringe, for example.
►
Remove any visible surgical residues as much as possible with a damp, lint-free cloth.
►
Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►
Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
►
Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/dis-
infecting.
– as an integrated mechanical support measure for mechanical cleaning/disinfecting.
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
►
Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfecting machine 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 machine used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with ultrasound and brush
D–W:
Drinking water
RT:
Room temperature
*Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)
Phase I
►
Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 15 minutes. Ensure that all
accessible surfaces are immersed and acoustic shadows are avoided.
►
Clean the product with a suitable cleaning brush (e.g. TE654202) in the solution until all visible residues have
been removed from the surface.
►
If applicable, brush non-visible surfaces for at least 1 minute with a suitable cleaning brush (e.g. TE654202).
►
Mobilize non-rigid components, such as set screws and hinges, during cleaning.
►
Then flush these areas thoroughly at least five times with the cleaning disinfectant solution using a disposable
syringe (20 ml).
Phase II
►
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws and hinges, during rinsing.
Mechanical alkaline cleaning and thermal disinfection
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)
*Prion-inactivating detergent (see Technical information Dr. Weigert neodisher® SeptoClean)
►
Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots)
►
Place instruments in the tray with their hinges open.
►
Connect components with lumens and channels directly to the rinsing port of the injector carriage.
►
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 can be sterilized either in disassembled or in assembled condition.
►
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 using fractional vacuum process
–
Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
–
Sterilization using fractional vacuum process at 134 °C, holding time 18 minutes for prion inactivation
►
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.
DANGER
Danger to the patient!
►
Reprocess the product only with manual pre-cleaning followed by mechanical
cleaning.
DANGER
Risk to patient due to cross contamination!
►
Do not clean contaminated products together with uncontaminated products
in a tray.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
–
are approved for (e.g. aluminum, plastics, high-grade steel),
–
do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum allowable temperature of 55 °C.
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemicals
I
Ultrasonic cleaning
RT
(cold)
>15
1
D–W
Dr. Weigert neodisher®
SeptoClean*
II
Rinsing
RT
(cold)
1
-
D–W
-
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemicals
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD–W
Dr. Weigert neodisher® SeptoClean 1 %*
working solution
III
Intermediate rinse
>10/50
1
FD–W
-
IV
Thermal disinfection
90/194
5
FD–W
-
V
Drying
-
-
-
In accordance with the program for the
cleaning and disinfecting machine
CAUTION
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-
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
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
