Braun Aesculap S4 User manual

Aesculap Spine
Gebruiksaanwijzing
S4percutaan-instrumenten
Инструкция по примению
S4инструменты для чрескожных
вмешательств
Návod k použití
S4Perkutánní nástroje
Instrukcja u¿ytkowania
S4Instrumenty przezskórne
Instructions for use
S4percutaneous instruments
Gebrauchsanweisung
S4perkutan-Instrumente
Mode d’emploi
Instruments percutanés S4
Instrucciones de manejo
Instrumentos percutáneos S4
Istruzioni per l’uso
S4strumenti percutanei
Instruções de utilização
Instrumentos percutâneos S4

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percutaneous instruments
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Legend
1Cleaning instrument FW692R
2Clamping sleeve FW693R
3Inner sleeve FW694R
4Screwdriver FW695R
(for polyaxial S4screws)
5Screwdriver FW696R
(for monoaxial S4screws)
6Axial spacer FW143P
7Insertion instrument for locking screws FW697R
Symbols on product and packages
Intended use
S4percutaneous instruments are used for the implan-
tation of cannulated S4implants of the S4Spinal Sys-
tem in percutaneous operating technique.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾Ensure that the product and its accessories are
operated and used only by persons with the requi-
site training, knowledge or experience.
¾Read, follow and keep the instructions for use.
¾Use the product only for its intended purpose, see
Intended use.
¾Remove the transport packaging and thoroughly
clean the new product, either manually or mechan-
ically, prior to its initial sterilization.
¾Store any new or unused products in a dry, clean,
and safe place.
¾Prior to each use, inspect the product for loose,
bent, broken, cracked, worn, or fractured compo-
nents.
¾Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
¾Replace any damaged components immediately
with original spare parts.
¾Read, observe and keep the operating manuals for
S4Spinal System Instrumentation, S4FRI and, if
applicable, S4SRI.
Safe operation
Symbol Explanation
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Date of manufacture DANGER
Danger of death of the patient
caused by pushing the guide wire
into the aorta!
¾When inserting the S4implants
or S4instruments with the
guide wire, always observe the
markings on the guide wire.
¾Hold the guide wire with a for-
ceps.
¾Remove the guide wire at the
right moment.
WARNING
Risk of injury and/or malfunction!
¾Always carry out a function
check prior to using the prod-
uct.

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Cleaning instrument FW692R
The cleaning instrument is used for cleaning/clearing
the cannulation, if a cannulated instrument becomes
blocked intra-operatively with soft tissue or bone
chips.
¾Disassemble the instrument as far as possible on a
separate sterile table, if applicable, see Disassem-
bling.
¾Carefully insert the cleaning instrument into the
cannulation from the handle side in the direction
of the working end.
¾Remove the obstruction by applying mild pressure
with the handle part. Ensure that the cannulation
does not become occluded.
¾Assemble the instrument, if applicable, see Assem-
bling.
Clamping sleeve FW693R and screwdriver
FW695R/FW696R
Screwdrivers facilitate the percutaneous application of
pedicle screws from the S4Spinal System. Depending
on the type of screw, the corresponding screwdriver for
monoaxial or polyaxial screws must be chosen.
¾Assemble the clamping sleeve, see Assembling.
Inserting the pedicle screws in the clamping sleeve
¾Turn fixing screw Cin the direction of the arrow
until the thread in the direction of the working end
becomes visible, see Fig. 1.
Fig. 1
¾Pull back outer sleeve Aas far as possible in the
direction of fixing screw C, see Fig. 2.
Fig. 2
¾Insert screwdriver Finto clamping sleeve 2from
the rear end. Ensure that the lateral lugs slide into
the grooves right to the bottom, see Fig. 3.
Fig. 3
WARNING
Risk of injury if cannulated instru-
ments are punctured with the
cleaning instrument!
¾Remove the obstruction care-
fully with mild pressure.
¾Always insert the cleaning
instrument in the direction of
the working end.
¾Do not obstruct the outlet with
your hand.
CAUTION
Damage to cannulated instruments
if the cleaning instrument is incor-
rectly applied!
¾Always insert the cleaning
instrument in the direction of
the working end.
¾Check the cleaning instrument
for bending, kinks and other
damage before use.
C
CA
F

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¾Insert the working ends of the pedicle screws into
tension sleeve B, see Fig. 4.
When using polyaxial pedicle screws: Ensure that
the hexagon of the screwdriver is fully inserted in
the hexagon of the polyaxial pedicle screw.
When using monoaxial pedicle screws: Ensure
that the dihedron sits securely in the screw head.
Fig. 4
¾Slide outer sleeve Ain the direction of the pedicle
screw and with fixing screw Cclamp pedicle screw
in clamping sleeve 2, see Fig. 5.
¾Check to ensure that the implant is properly seated
in the clamping sleeve 2.
Fig. 5
¾For implanting the pedicle screw and inserting the
rod, see operating technique or operating manual
for the S4Spinal System, S4FRI and S4SRI.
Removing the clamping sleeve from the applied
pedicle screw
¾Turn fixing screw Cin the direction of the arrow
until the thread in the direction of the working end
becomes visible, see Fig. 6.
Fig. 6
¾Pull back outer sleeve Ain the direction of fixing
screw C.
¾Completely remove clamping sleeve 2, see Fig. 7.
Fig. 7
Disassembling
Clamping sleeve FW693R
¾Remove outer sleeve Aover collet Bin the direc-
tion of the working end.
¾Unscrew fixing screw Cfrom the rear end and
remove from collet B, see Fig. 8.
Fig. 8
Inner sleeve FW694R
¾Unscrew nut Dfrom inner sleeve E, see Fig. 9.
Fig. 9
B
C
C
CA
CB
BA
E D

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Assembling
Clamping sleeve FW693R
¾Screw fixing screw Conto collet Buntil the thread
of the collet is no longer visible.
¾Push on outer sleeve Afrom the front end over col-
let B, see Fig. 10. Ensure that the slots are aligned
with the slot nuts. The grooved end of the clamping
sleeve should point in the direction of fixing
screw Cfor improved usability.
Fig. 10
Inner sleeve FW694R
¾Screw nut Donto inner sleeve E, see Fig. 11.
Fig. 11
Validated reprocessing procedure
Note
National laws, national and international standards
and directives, and product-specific hygiene regula-
tions for reprocessing must be observed.
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
It should be noted that successful reprocessing of this
medical device can only be guaranteed following prior
validation of the reprocessing method. The operator/
sterile processing technician is responsible for this.
Note
Up-to-date information on reprocessing can be found
on the Aesculap Extranet at www.aesculap-extra.net
B
CB
A
E D

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General information
To prevent increased contamination of loaded instru-
ment trays during use, please ensure that contami-
nated instruments are collected separately and not
returned to the instrument tray.
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion of
stainless steel. Consequently, the time interval
between application and processing should not exceed
6 hours, pre-cleaning fixating temperatures >45 °C
should not be used, and no fixating disinfectants (con-
taining 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 chloride - e.g. in surgi-
cal residues, drugs, saline solutions and water for
cleaning, disinfection and sterilization - may cause
corrosion damage to stainless steel (pinholing, stress
corrosion), thus rendering the products unusable.
These must be removed by rinsing thoroughly with
demineralized water and then drying.
Only use process chemicals that have been tested and
approved (with VAH, DGHM or FDA approval, for
instance, or feature a CE mark) and are recommended
by the chemical manufacturer as being compatible
with the materials. All the chemical manufacturer's
application specifications regarding temperature, con-
centration and contact time should be strictly
observed. Failure to do so can result in the following
problems:
• Visible changes to materials e.g. fading or changes
in the color of titanium or aluminum. As regards
aluminum, visible changes to the surface may
already occur at a pH level of >8 in the application/
working solution.
• Material damage such as corrosion, cracks, frac-
tures, premature deterioration or swelling.
¾Do not use process chemicals that cause stress
cracks or brittleness in plastics.
¾Clean the product immediately after use.
Please see www.a-k-i.org for more detailed informa-
tion on hygienically safe reprocessing which is protec-
tive of materials and retains their value.
¾Use 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.

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Preparation at the place of use
¾Disassemble the product immediately after use, as
described in the respective instructions for use.
¾Rinse non-visible surfaces such as those in instru-
ments with concealed crevices, lumens or complex
geometries, preferably with distilled water, using a
disposable syringe for instance.
¾Remove any visible surgical residues to the extent
possible with a damp, lint-free cloth.
¾Transport the dry product in a sealed waste con-
tainer for cleaning and disinfection within 6 hours.
Preparation before cleaning
¾Disassemble the product prior to cleaning, see Dis-
assembling.
Cleaning/disinfection
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to man-
ual cleaning/disinfection.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechanical
cleaning/disinfection.
– as an integrated mechanical support measure for
mechanical cleaning/disinfection.
– for additional cleaning of products with residues
left after mechanical cleaning/disinfection.
Manual cleaning/disinfection
¾Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution.
¾After manual cleaning/disinfection, check visible
surfaces visually for residues.
¾Repeat the cleaning process if necessary.
CAUTION
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive tempera-
tures!
¾Use cleaning and disinfecting
agents approved for aluminum,
plastics, and high-grade
steel, for example, according to
the manufacturer's instructions.
¾Observe specifications regarding
concentration, temperature and
exposure time.

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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
Phase I
¾Fully immerse the product in the cleaning/disin-
fecting solution for at least 15 minutes. Ensure
that all accessible surfaces are moistened.
¾Clean the instrument under running tap water with
a suitable cleaning brush where necessary for as
long as it takes to remove all discernable residues.
¾Brush through all surfaces not accessible to visual
inspection, e.g. in products with hidden crevices,
lumens or complex geometries, for at least 1 min or
until no more residues can be removed, using a
suitable cleaning brush (TA007747 or TE654202).
¾Maneuver non-rigid components, such as adjust-
able screws, hinges etc during cleaning.
¾Then flush these areas thoroughly at least five
times with the cleaning solution using a disposable
syringe (20 ml).
¾Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
Phase II
¾Rinse/flush the instrument thoroughly (all accessi-
ble surfaces) under running water.
¾Maneuver non-rigid components, such as adjust-
able screws, hinges, etc. during rinsing.
¾Drain any remaining water fully.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
>15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
II Intermediate
rinse
RT
(cold)
1-D–W-
III Disinfection RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde-free,
phenol-free and QUAT-free
IV Final rinse RT
(cold)
1-FD-W-
VDrying RT - - - -