Validated Reprocessing Procedure; General Safety Instructions; General Information - B. Braun Aesculap Spine S4 MIS Spyder Gebrauchsanweisung/Technische Beschreibung

Blade Handle (ME381R):
►
Insert the knob into the slot on the bottom of the
handle.
►
Insert the head/shaft until it engages the threads
inside the knob.
►
Hold the blade handle head upright.
►
Turn the knob clockwise until the head/shaft fully
engages with the handle.
►
Orient the head so that the pegs on the head will
mesh with the slots on the handle.
►
Ensure that the head is fully engaged with the han-
dle.
►
Thread the nut on the handle distally towards the
head until it is fully threaded.
►
Ensure the Blade Handle operates correctly by
turning the knob counter clockwise to spread open
the arms and clockwise to close the arms.
Table Arm Pivot Connection Block (ME381R):
►
Thread the wheel onto the block until it is fully
engaged.
►
Thread the nut on the shaft towards the connector
until it is fully engaged.

Validated reprocessing procedure

General safety instructions

Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual 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 operator/sterile processing technician is responsi-
ble for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disin-
fectant 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 temperatures >45 °C nor fixating disin-
fecting 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 fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
Additional drying, if necessary.
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