Validated Reprocessing Procedure; General Safety Instructions; General Information - B. Braun Aesculap S4 Instructions For Use/Technical Description

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Press the button 16 on the obturator (FJ983R) and withdraw the obtu-
rator from the inner sleeve 15.
►
If necessary, slide Apfelbaum trocar (FJ984R) into the inner sleeve 15
and insert into the bone to center punch the screw entry point.
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Remove the trocar from the operating field.
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Slide the inner drill sleeve M onto the inner sleeve 15. The inner guide
sleeve engages on the inner sleeve and can still be rotated, see Fig. 13.
Insert drill ∅ 2.4 mm N with mounted handle (FJ839R) or Intra-hand-
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piece into the inner drill sleeve M.
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Drill to the pre-set depth under control with the Brainlab navigation
system. The drill depth can be read on the scale on the inner drill
sleeve M.
Note
So as not to lose the entry opening, it can be helpful to keep the drill in the
drill hole, press the button 16 on the inner drill sleeve M and push down the
guide sleeve until it reaches the stop on the bone surface. Then remove the
drill and inner drill sleeve M from the S
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Press the button 16 and remove the inner drill sleeve M from the inner
sleeve 15.
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S C screws are self-tapping screws. However, if the bone quality is found
to be hard during the operation, the surgeon can also pre-tap the thread
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with the S C tapper.
To prepare screw holes, insert the C1/C2 tapper (Tap) ∅ 3.5 mm O into
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the inner sleeve 15 and tap. The drill depth can be read on the scale on
the tapper (Tap).
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Turn the tapper (Tap) O counterclockwise until it exits the bone.
Note
So as not to lose the entry opening, it can be helpful to turn the tapper (Tap)
counterclockwise until it almost exits the bone. Then turn the inner
sleeve 15 counterclockwise and at the same time push down the S
sleeve K until it reaches the stop on the bone surface. Then unscrew the
tapper O completely from the bone and remove it together with the inner
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sleeve 15 from the S C guide sleeve K.
Inserting the screw
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Ensure that the inner sleeve 15 has been removed from the S
sleeve K by turning it counterclockwise.
Pick up a suitable standard screw ∅ 3.5 mm with the self-retaining
►
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S C screwdriver (FW069R/FW132R). When doing so, retract and hold
the black holding sleeve against the spring pressure.
Note
The self-retaining function of the instrument prevents the screw from fall-
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ing out of the S C screwdriver when it is being passed to the operating sur-
geon.
►
Press the working end of the S
the screw 11.
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Release the black holding sleeve.
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Screw in the screw under control with the Brainlab navigation system.
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Tighten the screw. When doing so, work through the S
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Activate the black holding sleeve and release the S
the screw.
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►
Remove S C guide sleeve and S
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C guide sleeve K.
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C screwdriver fully into the hexagon of
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C guide sleeve.
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C screwdriver from
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C screwdriver from the operating field.
3.

Validated reprocessing procedure

3.1

General safety instructions

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble 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 pro-
cessing method is first validated. The operator/sterile processing technician
is responsible for this.
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 B. Braun eIFU at eifu.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
3.2

General information

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C guide
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica-
tion and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting agents (active
ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in
4
C guide
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, medi-
cines, saline solutions and in the service water used for cleaning, disinfec-
tion and sterilization will cause corrosion damage (pitting, stress corro-
sion) and result in the destruction of stainless steel products. These must
be removed by rinsing thoroughly with demineralized water and then dry-
ing.
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. Failure 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 application/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 dam-
age the product surfaces and could cause corrosion.
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Further detailed advice on hygienically safe and material-/value-pre-
serving reprocessing can be found at www.a-k-i.org, link to "AKI-
Brochures", "Red brochure".
en
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