Validated Reprocessing Procedure; General Safety Information - Braun Aesculap TSPACE PEEK Instructions For Use/Technical Description

en
►
To turn the implant a:
– Gently turn the rotary nut 3 counterclockwise
("loosen" direction). When doing so, make cer-
tain that the pin 5 remains outside of the
switch 2.
– Impact the implant a further with the hammer
until the required end position is reached.
►
Check the position of the implant a using intraop-
erative X-ray control.
►
Once the end position (see Fig. 11) is reached: turn
the rotary nut 3 counterclockwise ("loosen" direc-
tion), until the pin 5 is fully in the switch 2, see
Fig. 3. When doing so, ensure that the pin 5 does
not jam the switch 2.
A
Fig. 11 Implant in end position
►
Turn the switch 2 to the left (direction
Fig. 1.
►
Carefully remove the insertion instrument A from
the implant a. Avoid any tilting or canting of the
instrument when doing so.
►
Place bone or bone replacement material around
the implant a.
Removing the implant intraoperatively
If, in the opinion of the surgeon, it becomes necessary
to remove the implant intraoperatively, carry out the
following steps:
►
Check the position for coupling the insertion
instrument A, see Fig. 1.
►
Couple insertion instrument A to implant a in situ,
see Fig. 7.
►
Turn the switch 2 to the right (direction
Fig. 3.
►
Mounting the impact cylinder B onto the insertion
instrument A, see Fig. 5.
►
Carefully expel the implant a using the impact
cylinder C out of the intervertebral space, see
Fig. 6.
8
a
3. Validated reprocessing pro-
cedure
3.1

General safety information

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.
a
Note
Mechanical reprocessing should be favored over man-
ual cleaning as it gives better and more reliable results.
A
Note
Successful processing of this medical device can only be
ensured if the processing method is first validated. The
operator/sterile processing technician is responsible for
this.
), see
Note
If there is no final sterilization, then a virucidal disinfec-
tant must be used.
Note
For up-to-date information about reprocessing and
material compatibility,
eifu.bbraun.com
The validated steam sterilization procedure was carried
out in the Aesculap sterile container system.
), see
see B. Braun eIFU at