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Aesculap
Eccos
Holder system for processing of motor components
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
1.
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
2.
Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►
Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
►
Prior to use, check that the product is in good working order.
►
To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-
ufacturers liability:
– Use the product only in accordance with these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
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Keep the instructions for use accessible for the user.
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Follow the instructions for use of the components to be processed.
3.
Product description
3.1
Components required for operation
The GB459R mounting tool is required to mount the holder system in the tray.
3.2
Intended use
The holding system is used for mechanical cleaning, disinfection and sterilization of Aesculap motor components.
3.3
Operating principle
The storage system has been designed to cover critical openings and to ensure immediate drainage of fluids that
might enter the components to be able to be cleaned.
With their rounded screw heads, the holder system is suitable for soft wrappings as well.
4.
Working with the holder system
4.1
System set-up
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When inserting the motor components in the trays, remember that components inserted in a slanted position
will take more space.
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When installing several holders, select the tray following the holder with the greatest space (greatest height).
4.2
Mounting the holder in the tray
Risk of corrosion deposits on motors/handpieces!
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Only use tools made from high-grade steel (such as Aesculap mounting tool
GB459R) to mount the holder systems.
CAUTION
Note
In order that the spray jet of the washing machine reaches all sides of the components and the components can be
easily removed from the holder, a sufficient distance between the components and between the components and the
tray must be observed.
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Use the Aesculap GB459R mounting tool.
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Select the appropriate tray, see System set-up.
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Mount the holder system, see Fig. 1. In so doing, ensure that there is sufficient distance between the individual
components and between the components and the tray.
5.
Validated reprocessing procedure
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Observe the instructions for use for motor components for preparation.
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Observe the preparation cycle as follows:
1. Operative procedure
2. Disposal in the tray with holders in the OP
3. Mechanical cleaning and disinfecting
4. Maintenance of the handpieces
5. Sterilization in the tray with holders
6. Provision for operative procedure
5.1
General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
5.2
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 measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
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 in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
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 of 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.
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Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
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Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
5.3
Preparation of motor components for mechanical preparation
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Remove all attached components, such as tools, tubes and adapters.
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Only use holders intended for the respective components. Observe the symbol marking on the holder (see instruc-
tions for use of the component to be processed).
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Mount all components on their respective holders, see Fig. 2.
For components that are exceedingly encrusted e.g. with coagulated proteins, the mechanical cleaning process may
not always lead to acceptable results.
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For components that are highly contaminated, manual pre cleaning is required (see instructions for use of the
components to be processed).
Some holders are designed for internal rinsing.
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For holders which require internal rinsing, close the unused jet opening of the cleaning machines in order to
achieve sufficient jetting pressure.
5.4
Inspection, maintenance and checks
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Carry out control, maintenance and checks in accordance with the instructions for use of the components.
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Set aside the product if it is damaged.
5.5
Packaging
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Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
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Ensure that the packaging will prevent a recontamination of the product.
5.6
Steam sterilization
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Carry out sterilization in accordance with instructions for use of the components.
5.7
Storage
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Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
6.
Technical Service
Risk of injury and/or malfunction!
►
Do not modify the product.
WARNING
►
For service and repairs, please contact your national B. Braun/Aesculapagency.
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 -1601
Fax:
+49 (7461) 14 -939
E-Mail:
ats@aesculap.de
Or in the US:
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone:
+1 (800) 214 -3392
Fax:
+1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.
7.
Disposal
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Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
agency, see Technical Service.
8.
Distributor in the US/Contact in Canada for product information
and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 009721
2017-09
V6
Änd.-Nr. 57453
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