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

®
Aesculap activ L
activ L chisel and chisel guides
►
Press button c and remove handle 1, see Fig. 2.
Fig. 2
►
Introduce double chisel 3 or single chisel 4 via
chisel guide 2.
►
Under radiographic control, insert the chisel into
the vertebral body as far as safety stop a. In doing
so, the protective sleeve will push back automati-
cally.
►
Once safety stop a is reached, carefully withdraw
the chisel using a slotted hammer.

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.
4
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.
c
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.

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.