B. Braun Aesculap Spine Manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
S4Instruments
Gebrauchsanweisung/Technische Beschreibung
S4-Instrumente
Mode d’emploi/Description technique
Instruments S4
Instrucciones de manejo/Descripción técnica
Instrumental S4
Istruzioni per l’uso/Descrizione tecnica
Strumenti S4
Instruções de utilização/Descrição técnica
Instrumentos S4
Gebruiksaanwijzing/Technische beschrijving
S4-Instrumenten
Bruksanvisning/Teknisk beskrivning
S4-instrument
Инструкция по примению/Техническое опи-
сание
Инструменты S4
Návod k použití/Technický popis
Nástroje S4
Instrukcja użytkowania/Opis techniczny
Instrumenty S4
Návod na použitie/Technický opis
Nástroje S4
Kullanım Kılavuzu/Teknik açiklama
S4ekipmanları

1
2
4
5
3

9
10
8
6
7

11 12
13
14
15
17
16

2625
22
23
24
21
20
19
18

2
Aesculap®
S4 Instruments
Aesculap® S4Instruments
Legend
1Set screw starter FW177R
2Counter torque FW178R (with L-handle)
3Rod persuader FW208R
4Reduction lever (consisting of inner pipe FW229R,
screwdriver FW228R, outer sleeve FW235R and
spacer FW141P or FW143P)
5Percutaneous reduction lever (consisting of lever
inner pipe FW229R, screwdriver FW228R and
outer sleeve with long slot FW353R and spacer
FW141R or FW143P)
6Counter torque FW236R
7Wrench FW237R
8Distractor (consisting of distractor FW238R and
two distraction arms FW239R)
9Rod insertion instrument FW240R
10 Distraction spindle FW241R (consisting of distrac-
tor and extension)
11 Rod length measuring instrument FW242R
12 Screw length measuring instrument FW351R
13 Slotted hammer FW243R
14 Tissue protection sleeve FW244P
15 Tissue protection sleeve FW355P
16 Kirschner wire FW247S
17 Trocar FW271M
18 Aiming device FW258M
19 Aiming device extraction tool FW274M
20 K-wire protection sleeve FW352R
21 Monoaxial screwdriver FW262R
22 Pedicle dissector FW263R
23 Tapper FW264R, FW265R, FW266R, FW267R and
FW268R
24 Polyaxial screw driver FW270R
25 Dilation tube FW272R
26 Dilation tube FW354R
Symbols on product and packages
Applicable to
►For item-specific instructions for use and informa-
tion on material compatibility, see also the
Aesculap Extranet at https://extranet.bbraun.com
Intended use
The S4instruments are used for the implantation of the
S4implants with the following systems:
■S4Spinal System
■S4CS Cannulated System
■S4FRI/S4FRI percutaneous
The S4fracture reduction instruments are used for the
reduction and stabilization of fractures with the can-
nulated S4implants of the S4spinal system.
Not for reuse in intended applica-
tions as defined by the manufac-
turer
Caution, general warning symbol
Caution, see documentation sup-
plied with the product

3
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site training, knowledge, or experience.
►Read, follow, and keep the instructions for use.
►Use the product only in accordance with its
intended use, see Intended use.
►Remove the transport packaging and clean the new
product, either manually or mechanically, prior to
its initial sterilization.
►Store any new or unused products in a dry, clean,
and safe place.
►Prior to each use, inspect the product for loose,
bent, broken, cracked, worn, or fractured compo-
nents.
►Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
►Replace any damaged components immediately
with original spare parts.
►To avoid damage to the working end: Carefully
insert the product through the working channel
(e.g. trocar).
►Read, observe and keep the operating manuals
S4Spinal System Instrumentation, S4FRI and
S4SRI.
Safe operation
DANGER
Infection hazard for patients
and/or users and impairment
of product functionality due
to reuse. Risk of injury, illness
or death due to contamination
and/or impaired functionality
of the product!
►Do not re-use the product
after use.
DANGER
Danger of death of the patient
caused by pushing the guide
wire into the aorta!
►When inserting the
S4implants or S4instru-
ments with the guide wire,
always observe the mark-
ings on the guide wire.
►Hold the guide wire with a
forceps.
►Remove the guide wire at
the right moment.
WARNING
Excessive trocar insertion
depth due to missing end stop!
►Use trocar FW271M only
in combination with aim-
ing device FW258M.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.

4
Aesculap®
S4 Instruments
Disassembly
►Dismantle the set screw starter with an SW6 open-
ended spanner, see Fig.1.
Fig.1
Note
The set screw starter does not need to be dismantled for
cleaning.
►Disassembling reduction lever 4, see Fig.2. Fully
disassemble reduction lever and unscrew lock nut.
Fig.2
►Disassembling percutaneous reduction lever 5, see
Fig.3. Fully disassemble reduction lever and
unscrew lock nut.
Fig.3
►Dismantle distractor 8with the distraction blades,
see Fig.4: Activate slider Band remove distraction
blade FW239R.
Fig.4
Legend
BSlider
►Dismantle rod insertion instrument 9, see Fig.5:
Unscrew the inner part.
Fig.5
►Dismount distraction spindle 10, see Fig.6.
Fig.6
5

5
►Dismount rod length measuring instrument 11, see
Fig.7.
Fig.7
Assembly
Assembling the set screw starter
►Screw together the set screw and the starter so
that they are hand-tight, see Fig.8.
Fig.8
Note
The set screw starter is not intended for loosening set
screws. If the working end becomes loose, it can be
tightened until hand-tight, without tools. Use the revi-
sion screwdriver FW193R to loosen the set screws.
Mounting the reduction lever
►Mount reduction lever 4, see Fig.9.
Fig.9

6
Aesculap®
S4 Instruments
Mounting the reduction lever percutane-
ous
►Screw lock nut Conto the inner sleeve, see Fig.10.
Fig.10
Legend
CLock nut
►Insert screwdriver into inner sleeve, secure with
spacer and apply set screw D, see Fig.11.
Fig.11
►Insert the subassembly into the FRI outer sleeve,
see Fig.12.
Fig.12
Mounting other product components
►Mount distractor 8with the distraction blades, see
Fig.13.
Fig.13
►Mount rod insertion instrument 9, see Fig.14.
Fig.14
►Mount distraction spindle 10, see Fig.15.
Fig.15
C
D

7
►Mount rod length measuring instrument 11, see
Fig.16.
Fig.16
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 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.

8
Aesculap®
S4 Instruments
Single-use products
K-wire FW247S
►Do not reprocess single-use products that have
been directly or indirectly contaminated with
blood.
►Do not reprocess or re-use any used, damaged or
contaminated single-use products.
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.
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’ recommen-
dations 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 discol-
oration 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, fractur-
ing, premature aging or swelling.
►Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
►Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, link to Publications, Red
Brochure – Proper maintenance of instruments.
Disassembling the product before carry-
ing out the reprocessing procedure
►Disassemble the product immediately after use, as
described in the respective instructions for use.
Preparations at the place of use
►If applicable, rinse non-visible surfaces preferably
with deionized water, with a disposable syringe for
example.
►Remove any visible surgical residues to the extent
possible with a damp, lint-free cloth.
►Transport the dry product in a sealed waste con-
tainer for cleaning and disinfection within 6 hours.
Preparation before cleaning
►Dismantle the product prior to cleaning, see Disas-
sembly.
WARNING
Risk of infection for patients
and/or users and impairment
of product functionality due
to reuse. Risk of injury, illness
or death due to contamination
and/or impaired functionality
of the product!
►Do not re-use the product
after use.

9
Cleaning/disinfection
Product-specific safety notes on the repro-
cessing procedure
►To prevent increased contamination of loaded
instrument trays during use, please ensure that
contaminated instruments are collected separately
and not returned to the instrument tray.
►Use suitable cleaning/disinfecting agents if the
product is put away in a wet condition. To prevent
foam formation and reduced effectiveness of the
process chemicals: Prior to mechanical cleaning
and disinfection, rinse the product thoroughly with
running water.
►Carry out ultrasound cleaning:
– as an effective mechanical supplement to man-
ual cleaning/disinfecting.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechan-
ical cleaning/disinfecting.
– as an integrated mechanical support measure
for mechanical cleaning/disinfecting.
– for additional cleaning of products with resi-
dues left after mechanical cleaning/disinfect-
ing.
►Clean and disinfect microsurgical products
mechanically if they can be placed securely in the
machine or on the positioning aids.
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents and/or exces-
sive temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instruc-
tions which
–are approved for use,
for example, on alumi-
num, plastic materials,
and high-grade steel,
–do not attack softeners
(e.g. in silicone).
►Observe specifications
regarding concentration,
temperature, and exposure
time.

10
Aesculap®
S4 Instruments
Validated cleaning and disinfection procedure
Validated procedure Specific requirements Reference
Manual cleaning with
immersion disinfection
only:
FW141P, FW143P,
FW178R, FW228R,
FW229R, FW235R,
FW236R–FW239R,
FW241R, FW243R,
FW244P, FW247S,
FW258M, FW258R,
FW262R–FW268R,
FW270R, FW271M,
FW271R, FW272R,
FW274M, FW351R–
FW354R, FW355P
■Cleaning brush:
TA011994/TE654202, GK469200
■20 ml disposable syringe
■Keep working ends open for
cleaning.
■When cleaning products with
movable hinges, ensure that these
are in an open position and, if
applicable, move the joint while
cleaning.
■Dryingphase: Use a lint-free cloth
or medical compressed air
■Check visible surfaces for residues
after manual cleaning/disinfect-
ing.
■Repeat the cleaning process if
necessary.
Chapter Manual cleaning/disinfection and
sub-chapter:
■Chapter Manual cleaning with immer-
sion disinfection
Manual cleaning with
ultrasound and immer-
sion disinfection
only:
FW177R, FW208R,
FW240R, FW242R
■Cleaning brush:
TA011994/TE654202, GK469200
■20 ml disposable syringe
■Keep working ends open for
cleaning.
■When cleaning products with
movable hinges, ensure that these
are in an open position and, if
applicable, move the joint while
cleaning.
■Dryingphase: Use a lint-free cloth
or medical compressed air
Chapter Manual cleaning/disinfection and
sub-chapter:
■Chapter Manual cleaning with ultra-
sound and immersion disinfection

11
Mechanical alkaline
cleaning and thermal
disinfection
only:
FW141P, FW236R–
FW239R, FW243R,
FW247S, FW271R,
FW274M
■Place the product in a tray that is
suitable for cleaning (avoiding
rinsing blind spots).
■Connect components with lumens
and channels directly to the rins-
ing port of the injector carriage.
■Keep working ends open for
cleaning.
■Place products in the tray with
their hinges open.
Chapter Mechanical cleaning/disinfecting
and sub-chapter:
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Manual pre-cleaning
with brush and subse-
quent mechanical alka-
line cleaning and ther-
mal disinfection
only:
FW143P, FW178R,
FW208R, FW228R,
FW229R, FW235R,
FW241R, FW244P,
FW258M, FW258R,
FW262R–FW268R,
FW270R, FW271M,
FW272R, FW351R–
FW354R, FW355P
■20 ml disposable syringe
■Place the product in a tray that is
suitable for cleaning (avoiding
rinsing blind spots).
■Connect components with lumens
and channels directly to the rins-
ing port of the injector carriage.
■Keep working ends open for
cleaning.
■Place products in the tray with
their hinges open.
Chapter Mechanical cleaning/disinfection
with manual pre-cleaning and sub-chap-
ter:
■Chapter Manual pre-cleaning with a
brush
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Manual pre-cleaning
with ultrasound and
brush, and subsequent
mechanical alkaline
cleaning and thermal
disinfection
only:
FW177R, FW240R,
FW242R
■20 ml disposable syringe
■Mount jaws protection on the
product.
■Place the product in a tray that is
suitable for cleaning (avoiding
rinsing blind spots).
■Connect components with lumens
and channels directly to the rins-
ing port of the injector carriage.
■Keep working ends open for
cleaning.
■Place products in the tray with
their hinges open.
Chapter Mechanical cleaning/disinfection
with manual pre-cleaning and sub-chap-
ter:
■Chapter Manual pre-cleaning with
ultrasound and brush
■Chapter Mechanical alkaline cleaning
and thermal disinfecting
Validated procedure Specific requirements Reference

12
Aesculap®
S4 Instruments
Manual cleaning/disinfection
►Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution.
►After manual cleaning/disinfection, check visible
surfaces visually for residues.
►Repeat the cleaning /disinfection process if neces-
sary.
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning
brushes and disposable syringes, see Validated
cleaning and disinfection procedure.
Phase I
►Fully immerse the product in the cleaning/disinfec-
tant for at least 15 min. Ensure that all accessible
surfaces are moistened.
►Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
►If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1min.
►Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
►Thoroughly rinse through these components with
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I Disinfecting
cleaning
RT (cold) >15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
II Intermediate rinse RT (cold) 1 - D–W -
III Disinfection RT (cold) 15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
IV Final rinse RT (cold) 1 - FD-W -
VDrying RT - - - -

13
Phase II
►Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solu-
tion.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
►Rinse lumens at least 5 times at the beginning of
the exposure time using an appropriate disposable
syringe. Ensure that all accessible surfaces are
moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible
surfaces).
►Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse.
►Rinse lumens with an appropriate disposable
syringe at least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.
Manual cleaning with ultrasound and immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
RT: Room temperature
*Recommended: BBraun Stabimed
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I Ultrasonic cleaning RT (cold) >15 2 D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II Intermediate rinse RT (cold) 1 - D–W -
III Disinfection RT (cold) 15 2 D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
IV Final rinse RT (cold) 1 - FD-W -
VDrying RT - - - -

14
Aesculap®
S4 Instruments
►Note the information on appropriate cleaning
brushes and disposable syringes, see Validated
cleaning and disinfection procedure.
Phase I
►Clean the product in an ultrasonic cleaning bath
(frequency 35 kHz) for at least 15 min. Ensure that
all accessible surfaces are immersed and acoustic
shadows are avoided.
►Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
►If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1min.
►Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
►Thoroughly rinse through these components with
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solu-
tion.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
►Rinse lumens at least five times at the beginning of
the exposure time with an appropriate disposable
syringe. Ensure that all accessible surfaces are
moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse.
►Rinse lumens with an appropriate disposable
syringe at least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable
equipment (e.g. cloth, compressed air), see Vali-
dated cleaning and disinfection procedure.

15
Mechanical cleaning/disinfecting
Note
The cleaning and disinfection device must be of tested
and approved effectiveness (e.g. FDA approval or CE
mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for process-
ing must be serviced and checked at regular intervals.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water
quality at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►Check visible surfaces for residues after mechani-
cal cleaning/disinfecting.
Phase Step T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
IPrerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD-W ■Concentrate, alkaline:
–pH=13
– <5 % anionic surfactant
■0.5 % working solution
– pH = 11*
III Intermediate rinse >10/50 1 FD-W -
IV Thermal disinfect-
ing
90/194 5 FD-W -
VDrying - - - According to the program for cleaning
and disinfection device

16
Aesculap®
S4 Instruments
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested
and approved effectiveness (e.g. FDA approval or CE
mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for process-
ing must be serviced and checked at regular intervals.
Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning
brushes and disposable syringes, see Validated
cleaning and disinfection procedure.
Phase I
►Fully immerse the product in the cleaning/disinfec-
tant for at least 15 min. Ensure that all accessible
surfaces are moistened.
►Clean the product with a suitable cleaning brush in
the solution until all discernible residues have been
removed from the surface.
►If applicable, brush through non-visible surfaces
with an appropriate cleaning brush for at least
1min.
►Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
►Thoroughly rinse through these components with
the cleaning disinfectant solution (at least five
times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I Disinfec-
tant
cleaning
RT (cold) >15 2 D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II Rinsing RT (cold) 1 - D–W -