Validated Reprocessing Procedure; Safe Operation - B. Braun Aesculap Gebrauchsanweisung/Technische Beschreibung

®
Aesculap
Triangular bracket bending pliers in accordance with KÖHLER
Symbols on product and packages
Symbol Explanation
Caution, general warning symbol
Caution, see documentation supplied with the product
Intended use
The triangular bracket bending pliers in accordance with KÖHLER are used in orthodontics for bending spring-hard
wire ∅ 0.7 mm.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
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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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Read, follow, and keep the instructions for use.
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Use the product only in accordance with its intended use, see Intended use.
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Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
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Store any new or unused products in a dry, clean, and safe place.
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Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Replace any damaged components immediately with original spare parts.

Safe operation

Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
WARNING
Note
The inner side of the forceps contains guide grooves for intake of the wire. These milled slots allow exact bending of
the triangle if the instructions in the diagram are followed and the wire is always gripped in the respective groove, see
Fig. 1.
Insert the wire, length 6 cm ∅ 0.7 mm, spring-hard, into the diagonal groove in the forceps and close the forceps
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firmly, see Fig. 2.
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Guide the wire with your thumb firmly against the forceps.
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Turn the forceps against the wire and pressure of the thumb until a sharp kink occurs at an angle of 60°, see
Fig. 3.
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Open the forceps.
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Lie the wire in the diagonal groove. When doing so, ensure that the first kinking remains in the horizontal plane
and the forceps touches the opposite side, see Fig. 4.
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Close the forceps.
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Guide the wire with your thumb firmly against the forceps.
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Turn the forceps against the wire and the pressure of the thumb until a kink occurs at an angle of 60°, see Fig. 3
When doing so, guide the wire slightly upwards or downwards by approximately 2° from the horizontal plane,
see Fig. 5.
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Open the forceps.
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Lie the wire in the diagonal groove.
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Remain in the horizontal plane with the triangular form that has developed.
The opposite angle touches the forceps, see Fig. 6.
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When bending again, guide the wire quickly under or over the start of the wire.
There is now an equilateral triangle.
The start of the wire and the ongoing end are touching and are running parallel to one another, see Fig, 7 and
see Fig. 8.
Bending the vertical part
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Insert the triangle into the forceps so that the wire engages exactly in the grooves, on the right or left hand side,
see Fig. 9 and see Fig. 10.
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Close the forceps firmly.
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Quickly bend the end of the wire on the "triangle section" to a right angle, see Fig. 9 and see Fig. 10.
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Tilt the end of the wire by 10° to the tip of the triangular bracket that has already developed, see Fig. 11.
Aligning the triangle to the horizontal plane
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Insert half of the triangle into the designated milled slot of the forceps, see Fig. 12.
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Lie your thumb on the other half of the triangle.
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In order to parallelize, move thumb and forceps against each other, until the basal area of the triangle forms a
plane.
The vertical part of the wire is at a 90° angle to the basal area of the triangle, see Fig. 12 and see Fig. 13.
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Insert the triangle section into the the triangle that has developed so that the vertical part in perpendicular mill-
ing and the buccal side of the later triangular bracket is in the diagonal groove, see Fig. 14.
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Close the forceps firmly.
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Bend the transversal part of the triangular section to the tip of the triangle until the basal area of the triangle
and the transversal part run almost parallel.
Note
A slight divergence is good for later support of the triangular bracket on the teeth, see Fig. 15 and see Fig. 16.
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Ensure that the transversal part of the bracket runs exactly bisecting the angle over the tip of the triangle, see
Fig. 17.
Note
The rigid part of a triangular bracket is, as a rule, distally against the physiological mesial drift of the teeth.
Note
Triangular bracket for the right and left side respectively of an upper or lower jaw, see Fig. 18 and see Fig. 19 respec-
tively.
Finished triangular bracket, see Fig. 20.

Validated reprocessing procedure

General safety notes
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 the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
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:
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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.
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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.
Disassembling the product before carrying out the reprocessing procedure
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Disassemble the product immediately after use, as described in the respective instructions for use.
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Open up products with hinges.
Preparations at the place of use
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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
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Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
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Disassemble the product prior to cleaning.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
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Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which
CAUTION
– are approved for (e.g. aluminum, plastics, high-grade steel),
– do not attack softeners (e.g. in silicone).
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Observe specifications regarding concentration, temperature and exposure
time.
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Do not exceed the maximum permissible cleaning temperature of 90 °C.
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Do not use oxidizing chemicals (e.g. H O ), which could cause bleaching/layer loss of the product.
2 2
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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.
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Mount jaws protection on the product.
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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/
disinfecting.
– as an integrated mechanical support measure for mechanical cleaning/disinfecting.
– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
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Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.