Insertion Of Set Screw; Removing The S4 Cervical Implants; Pseudo Rod Revision Instrument; Validated Reprocessing Procedure - B. Braun Aesculap S4 Instructions For Use/Technical Description

2.3.7

Insertion of set screw

CAUTION
4
Damage to the S Cervical screw caused by incorrectly applying the
torque indicating screwdriver 15 when driving in the set screws!
This screwdriver is an indicating instrument. Align the two opposing
arrows to apply the proper torque.
►
Always use the counter torque instrument 14 when tightening the
4
S Cervical set screw in the S
►
Refer to TA011947 for further information.
CAUTION
4
Damage to the S Cervical screw caused by incorrectly applying the set
screw removal screwdriver 10 and torque limiting T-handle 16 when
driving in the set screws!
►
Ensure that the set screw removal screwdriver 10 is securely con-
nected to the torque limiting T-handle 16.
►
Always use the counter torque instrument 14 when tightening the
4
S Cervical set screw in the S
CAUTION
4
Damage to the S Cervical implants caused by incorrectly applying the
occipital flexible set screw starter 49 when driving in the set screws!
4
►
Refer to TA012676 S Cervical occiput mini set screw starter flex-
ible shaft.
4
2.3.8 Removing the S Cervical implants
CAUTION
4
Damage to the S Cervical torque indicating screwdriver 15!
4
►
Never use the S Cervical torque indicating screwdriver 15 for
extracting screws.
4
►
Use the S Cervical set screw removal screwdriver 10 together with
the handle 5 and counter torque 14 when extracting set screws.
CAUTION
4
Damage to the S Cervical implants caused by incorrectly applying the
occipital torque wrench 50 when driving in the set screws!
►
When tightening the set screw always apply counter torque using
the countering instrument for this purpose.
4
►
Refer to TA012367 S Cervical Spinal System - torque wrenches
with click function.
2.3.9

Pseudo rod revision instrument

CAUTION
Damage to and breakage of the pseudo rod revision instrument!
►
Never use the pseudo rod revision instrument to release a locked
4
S Cervical polyaxial screw tulip.
4
Cervical screw body.
4
Cervical screw body.
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

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
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.
►
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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