Braun Aesculap S4 Manual

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
Návod k použití/Technický popis
S4-instrumenty

Aesculap Spine
S4instruments
2
Legend
1Set screw starter FW177R
2Counter FW178R (L handle)
3Rod persuader FW208R
4Reduction lever (consisting of threaded tube
FW233R, screw driver FW234R and outer sleeve
FW235R)
5Counter FW236R
6Wrench FW237R
7Distractor (consisting of distractor FW238R and
two distraction blades FW239R)
8Rod insertion instruments FW240R
9Spindle distractor FW241R (consisting of distractor
and extension)
10 Rod length measuring instrument FW242R
11 Slotted hammer FW243R
12 Tissue protection sleeve FW244P
13 K-wire FW257S
14 K-wire aiming device FW258R
15 Screw driver monoaxial FW262R
16 Bone probe cannulated FW263R
17 Screw taps FW264R, FW265R, FW266R, FW267R,
FW268R
18 Screwdriver polyaxial FW270R
19 Trocar FW271R
20 Tube sleeve FW272R
Symbols on product
Intended use
The S4instruments are used for the implantation of the
S4implants with the following systems:
•S
4Spinal System
•S
4CS - Cannulated System
•S
4FRI
The S4fracture reduction instruments are used for
reduction and fracture stabilization with the S4
implants of the S4Spinal System or the S4CS -
Cannulated System.
Sterilization with steam or dry
heat
Not for reuse in intended
applications as defined by the
manufacturer
Attention, see instructions for
use

3
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾Read, follow and keep the instructions for use.
¾Use the product only in accordance with its
intended use, see Intended use.
¾Clean the new product either manually or
mechanically prior to the 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
components.
¾Do not use the product if it is damaged or
defective. Set aside the product if it is damaged.
¾Replace any damaged components immediately
with original spare parts.
¾To avoid damage to the working tip: Exercise
caution when passing products through the
working channel (e.g. trocars).
¾Read, follow and keep the surgical
technics 026102/026402/026502/026702.
Safe operation
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
forceps.
¾Remove the guide wire at the
right moment.
WARNING
Trocar penetrating too deeply
because of missing depth stop!
¾Use trocar FW271R only in
combination with aiming device
FW258R.

Aesculap Spine
S4instruments
4
Disassembling
Fig. 1
Legend
AButton
¾To dismount reduction lever 4, see Fig. 1:
Firmly press button Aand remove screwdriver
FW234R.
Fig. 2
Legend
BSlide
¾To dismount distractor 7with the distraction
blades, see Fig. 2:
Actuate slide Band remove distraction blade
FW239R.
Fig. 3
¾To dismount rod insertion instrument 8, see Fig. 3:
unscrew the inner part.
Fig. 4
¾Dismount spindle distractor 9, see Fig. 4.

5
Fig. 5
¾Dismount rod length measuring instrument 10,
see Fig. 5.
Assembling
Fig. 6
¾Mount reduction lever 4, see Fig. 6.
Fig. 7
¾Mount distractor 7with the distraction blades,
see Fig. 7.
Fig. 8
¾Mount rod insertion instrument 8, see Fig. 8.

Aesculap Spine
S4instruments
6
Fig. 9
¾Mount spindle distractor 9, see Fig. 9.
Fig. 10
¾Mount rod length measuring instrument 10,
see Fig. 10.
Validated processing procedure
Note
Observe all relevant national regulations and standards
with regard to processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD),
suspected CJD or possible variants of CJD, observe the
relevant national regulations concerning the
reprocessing of the products.
Note
Mechanical processing should be preferred over
manual cleaning because of the better and more
reliable cleaning results of mechanical processing.
Note
Successful processing of this medical product can only
be ensured through a validated processing procedure.
The user/processor is responsible for the validation.
Due to process tolerances, manufacturer’s
specifications can only serve as guide values for the
processing procedures applied by the individual user.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net

7
General notes
Encrusted or fixated residues from surgery can make
the cleaning process more difficult or ineffective, and
can cause corrosion of stainless steels. To avoid this,
the time interval between application and processing
should not exceed 6 h, and neither fixating pre-
cleaning temperatures > 45 °C nor any fixating
disinfecting agents (active ingredient: aldehyde,
alcohol) should be used.
Excessive doses of neutralizers or basic detergents can
cause chemical degradation and/or fading of the laser
engraving on stainless steel.
Residues containing chlorine or chlorides, as contained
e.g. in surgical residues, tinctures, medicines, saline
solutions, service water used for cleaning, and in
cleaning/disinfecting agents, will cause corrosion
damage (pitting, stress corrosion) and thereby
destruction of stainless steel products. To remove such
residues, the products must be rinsed sufficiently with
fully desalinated water and dried thoroughly.
Only use process chemicals recommended by the
chemicals’ manufacturers as effective cleaning/
disinfecting agents compatible with the materials used
in the respective product. Strictly observe all
application instructions, e.g. regarding temperatures,
concentrations, exposure times, etc. Failure to do so
can result in the following problems:
• Optical deterioration, e.g. fading or discoloration of
titanium or aluminum surfaces. For aluminum, the
application/process solution only needs to be of pH
> 8 to cause visible surface changes or
• Material damage, e.g. corrosion, cracks, fracturing,
premature aging or swelling.
• Do not use oxidizing process chemicals, which
could cause bleaching/layer loss of the product.
• Do not use process chemicals that cause stress
cracking of plastics such as PPSU, or attack and
cause brittleness e.g. of silicone softeners.
¾Clean the product immediately after use.
Encrusted debris on HF instruments is softened
most effectively and conservatively by a 5 minutes
immersion treatment in a 3 % H2O2solution.
Encrustations can be removed by hand, with a soft
brush and/or in an ultrasound bath. After that
treatment, proceed through the normal steps of
processing.
¾Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, Publications, Red
Brochure – Proper maintenance of instruments.
¾Use suitable cleaning/disinfecting agents if the
product is put away in wet condition. Prior to
mechanical cleaning and disinfecting, rinse the
product thoroughly with running water.
Preparations at the place of use
¾Disassemble the product immediately after use, as
described in the respective instructions for use.
¾Open jointed products.
¾Remove the sealing cap from the Luer lock
connector.
¾Remove visible residues as completely as possible,
using a lint-free, single-use cleaning tissue.
Preparation prior to cleaning
¾Have the product dry in a disposal container and
ready for immediate cleaning and disinfecting
within 30 min after use.

Aesculap Spine
S4instruments
8
Cleaning/Disinfecting
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual
cleaning/disinfecting.
– as a pre-cleaning procedure for products with
encrusted residues, in preparation for mechanical
cleaning/disinfecting.
– as an integrated mechanical support measure for
mechanical cleaning/disinfecting.
– for additional cleaning of products with residues
left after mechanical cleaning/disinfecting.
Manual cleaning/disinfecting
¾Clean hinged or jointed products in open and
closed positions.
¾Check visible surface for residues after manual
cleaning/disinfecting.
¾Repeat the cleaning process if necessary.
CAUTION
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive
temperatures!
¾Use cleaning and disinfecting
agents according to
manufacturer’s instructions. The
cleaning and disinfecting agent
must
- be approved for plastics and
high-grade steel,
- not attack softeners (e.g.
silicone).
¾Observe specifications regarding
concentration, temperature and
exposure time.
¾Do not exceed the maximum
allowable cleaning temperature
of 93 °C.

9
Manual cleaning with immersion disinfecting and cleaning with brush
FW233R, FW234R, FW235R, FW238R, FW239R, FW241R, FW244P, FW258R, FW262R, FW263R,
FW264R, FW265R, FW266R, FW267R, FW268R, FW270R, FW271R, FW272R
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
¾Clean the product under running tap water, if
necessary with a suitable cleaning brush
(TA no. 011944/TE654202, GK469200), until all
visible residues have been removed from the
surface.
¾Brush through all surfaces that are not accessible
to visual inspection, e.g. in products with hidden
crevices, lumens or complex geometries, for at
least 5 min or until no more residues can be
removed. Mobilize non-rigid components, e.g. set
screws, links, etc. during cleaning.
¾After that, thoroughly rinse (at least 5 times) with
the cleaning solution these difficult to access areas
of the product, using a single-use syringe (20 ml).
¾To avoid the risk of corrosion, do not use a metal
brush or other abrasives, which would damage the
surfaces, for cleaning the product.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage III
¾Carry out a full rinse of the product (all accessible
surfaces) under running water.
¾Allow water to drip off for a sufficient length of
time.
Stage IV
¾Dry the product completely with compressed air.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfecting
cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
II Intermediate rinse RT
(cold)
1-D–W-
III Final rinse RT
(cold)
0.5 - FD–W -
IV Drying RT - - - -

Aesculap Spine
S4instruments
10
Manual cleaning with immersion disinfecting and cleaning with brush and ultrasound
FW177R, FW208R, FW240R, FW242R
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
RT: Room Temperature
Stage I
¾Clean the product in an ultrasound cleaning bath
(frequency 35 kHz). Make certain that all
accessible surfaces are moistened.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage III
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
¾Clean the product with a suitable cleaning brush
(TA no. 011944/TE654202, GK469200) until all
visible residues have been removed from the
surface.
¾Brush through all surfaces that are not accessible
to visual inspection, e.g. in products with hidden
crevices, lumens or complex geometries, for at
least 5 min or until no more residues can be
removed. Mobilize non-rigid components, e.g. set
screws, links, etc. during cleaning.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfecting
ultrasound cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
II 1st Intermediate
rinse
RT
(cold)
1-D–W-
III Disinfecting
cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
IV 2nd Intermediate
rinse
RT 1 - D–W -
VIntermediate drying --- --
VI Final rinse RT
(cold)
0.5 - FD–W -
VII Drying --- --

11
¾After that, thoroughly rinse (at least 5 times) with
the cleaning solution these difficult to access areas
of the product, using a single-use syringe (20 ml).
¾To avoid the risk of corrosion, do not use metal
brushes or other abrasives for cleaning the product.
Stage IV
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage V
¾Dry the product with compressed air.
Stage VI
¾Rinse the product completely (all accessible
surfaces) under running water.
¾Allow water to drip off for a sufficient length of
time.
Stage VII
¾Dry the product completely with compressed air.

Aesculap Spine
S4instruments
12
Mechanical cleaning/disinfecting
¾Place the product on a tray that is suitable for
cleaning (avoid rinsing blind spots).
¾Connect components with lumens and channels
directly to the injector carriage attachment.
¾Store any products with hinges or joints on the tray
in such a way that the joints are kept open.
Mechanical alkaline cleaning and thermal disinfecting
FW234R, FW238R, FW239R, FW241R, FW271R
Machine type: Single-chamber cleaning/disinfecting machine without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Stage Step T
[°C/°F]
t
[min]
Water
quality
Chemical
IPrerinse < 25/77 3 D–W -
II Cleaning 55/131 10 FD–W - Concentrate, alkaline:
pH = 10.9
< 5 % anionic tensides
- 1 % solution: pH = 10.5
III Neutralization 20/68 2 FD–W - Concentrate, acid:
pH = 2.6
Basis: Citric acid
- 0.2 % solution: pH = 3.0
IV Intermediate rinse 70/158 1 FD–W -
VThermal
disinfecting
94/201 10 FD–W -
VI Drying 90/194 40 - -

13
Mechanical cleaning/disinfecting with manual pre-cleaning
Manual pre-cleaning with brush
FW178R, FW208R, FW233R, FW235R, FW244P, FW258R, FW262R, FW263R, FW264R, FW265R,
FW266R, FW267R, FW268R, FW270R, FW272R
D–W: Drinking water
RT: Room Temperature
Stage I
¾Fully immerse the product in the disinfecting
solution. Make certain that all accessible surfaces
are moistened.
¾Clean the product with a suitable cleaning brush
(TA no. 011944/TE654202, GK469200) until all
visible residues have been removed from the
surface.
¾Brush through all surfaces that are not accessible
to visual inspection, e.g. in products with hidden
crevices, lumens or complex geometries, for at
least 5 min or until no more residues can be
removed. Mobilize non-rigid components, e.g. set
screws, links, etc. during cleaning.
¾After that, thoroughly rinse (at least 5 times) with
the cleaning solution these difficult to access areas
of the product, using a single-use syringe (20 ml).
¾To avoid the risk of corrosion, do not use a metal
brush or other abrasives that would damage the
surfaces for cleaning the product.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfecting
cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
II Intermediate rinse RT
(cold)
1-D–W-

Aesculap Spine
S4instruments
14
Manual pre-cleaning with ultrasound
FW177R, FW240R, FW242R
D–W: Drinking water
RT: Room Temperature
Stage I
¾Mount mouth protection on the product.
¾Clean the product in an ultrasound cleaning bath
(frequency 35 kHz). Make certain that all
accessible surfaces are moistened.
Stage II
¾Rinse the product completely (all accessible
surfaces) under running water.
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
IDisinfecting
ultrasound cleaning
RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde phenol
and QAV free; pH = 9
II Intermediate rinse RT
(cold)
1-D–W-

15
Mechanical alkaline cleaning and thermal disinfecting
Machine type: Single-chamber cleaning/disinfecting
machine without ultrasound
¾Place the product on a tray that is suitable for
cleaning (avoid rinsing blind spots).
¾Connect components with lumens and channels
directly to the injector carriage attachment.
¾Store products with hinges or joints on the tray in
such a way that the joints are kept open.
D–W: Drinking water
FD–W: Fully desalinated water (demineralized)
Stage Step T
[°C/°F]
t
[min]
Water
quality
Chemical
IPrerinse < 25/77 3 D–W -
II Cleaning 55/131 10 FD–W - Concentrate, alkaline:
pH = 10.9
< 5 % anionic tensides
- 1 % solution:
pH = 10.5
III Neutralization 20/68 2 FD–W - Concentrate, acid:
pH = 2.6
Basis: Citric acid
- 0.1 % solution:
pH = 3.0
IV Intermediate rinse 70/158 1 FD–W -
VThermal
disinfecting
94/201 10 FD–W -
VI Drying 90/194 40 - -

Aesculap Spine
S4instruments
16
Control, care and inspection
¾Allow the product to cool down to room
temperature.
¾Lightly lubricate moving parts (e.g. joints and links)
with a maintenance oil suitable for the respective
sterilization process (e.g. Aesculap STERILIT® spray
JG600 or maintenance oil JG598).
¾Assemble the separable product, see Assembling.
¾Mount reduction lever 4, see Fig. 6.
¾Inspect the product after each cleaning and
disinfecting cycle to be sure it is clean, functioning
properly, not damaged, has intact insulation and
does not have any loose, bent, broken, cracked,
worn, or fractured components.
¾Check for compatibility with associated products.
¾Set aside the product if it is damaged.
Packaging
¾Appropriately protect products with fine working
tips.
¾Secure product with retractor in the first notch.
¾Sort the product into its appropriate storage device
or put it on a suitable tray. Make certain that all
cutting edges are protected.
¾Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
¾Pack the product in such a way that the packaging
will prevent recontamination of the product in the
period between reprocessing and reuse.
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or
in assembled condition.
Note
To prevent breakage due to stress crack corrosion,
sterilize the instruments with the locking mechanism
open, or locked on the first ratchet tooth.
¾Make certain that all external and internal surfaces
will be exposed to the sterilizing agent (e.g. by
opening all valves and faucets).
¾Validated sterilization process
– Steam sterilization through fractionated vacuum
process
– Steam sterilization acc. to EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST 46-1993,
validated acc. to EN ISO 17665 or EN 554/
ISO 13683
– Sterilization through fractionated vacuum process
at 134 °C/holding time 5 min
¾When sterilizing several products at the same time
in one steam sterilizer: Make certain that the
maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not
exceeded.