Validated Reprocessing Procedure; General Safety Notes; General Information - B. Braun Aesculap Spine MACS II Gebrauchsanweisung/Technische Beschreibung

Aesculap ®
MACS II

Validated reprocessing procedure

General safety notes

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 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.
26
Single-use products
Infection hazard for patients
and/or users and impairment
of product functionality due
WARNING
to reuse. Risk of injury, illness
or death due to contamination
and/or impaired functionality
of the product!
►
Applies to:
Art. no. Designation
SX804T Pre-assembled retaining bolt
(retaining bolt, centralizer)
FW406S K-wire set, sterile
(K-wire x2, removal instrument x1)
►
Before reprocessing the guide tube 7, make sure
that the centralizer 27a has been removed from
the working end and discarded.

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.
Do not reprocess the prod-
uct!