B. Braun Aesculap Spine S4 User manual

Aesculap Spine
Bruksanvisning
S4Element-instrument - S4Element-
stavtrycktång FW285R
Инструкция по примению
Инструменты S4Element  щипцы для
прижима стержей S4Element F285R
Návod k použití
Nástroje S4Element – Kleštì k pøitlaèení
tyèinky S4Element FW285R
Instrukcja u¿ytkowania
Instrumenty elementu S4- szczypce do
dociskania prêtów S4Element
Návod na používanie
S4Element nástroje - S4Element tycové-
tlakové kliešte FW285R
Kullanım Kılavuzu
S4parça aletleri - S4Çubuk baskı elemanı
FW285R
Instructions for use
S4Element Instruments - S4Element Rod
Persuader FW285R
Gebrauchsanweisung
S4Element Instrumente - S4Element
Stabandrückzange FW285R
Mode d’emploi
Instruments S4Element - Pousse-tige
S4Element FW285R
Instrucciones de manejo
Instrumental S4Element - Pinzas de
presión en forma de barra S4Element
FW285R
Istruzioni per l’uso
Strumenti S4Element - Guida barre
S4Element FW285R
Instruções de utilização
Instrumentos do elemento S4- Impulsor
de barra S4Element FW285R
Gebruiksaanwijzing
S4Element instrumenten - S4Element
staafaandruktang FW285R

Aesculap Spine
S
4
Element Instruments - S
4
Element Rod Persuader FW285R
2
Symbols on product and packages
Intended use
FW285R is intended for the introduction of S4Element
screws into proper placement, and introduction of
S4Spinal system rods into proper location.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by or on
order of a physician!
¾Make certain that the product and its accessories
are operated and used only by persons with the
requisite training, expertise or experience.
¾Read, follow and keep safe the instructions for use.
¾Use the product only in accordance with its
intended use, see Intended use.
¾Remove the transport packaging and clean the new
product thoroughly, either by hand or mechani-
cally, prior to initial sterilization.
¾Store the new or unused product in a dry, clean and
protected place.
¾Prior to each use, visually inspect the product for:
loose, bent, broken, cracked, worn, or fractured
parts.
¾Do not use the product if it is damaged or defec-
tive. Immediately set aside the product if it is dam-
aged.
¾Immediately replace damaged components with
original spare parts.
Safe operation
Using the S4Element Rod Persuader
¾Place the S4Element Rod Persuader over the head
of the S4Element screw and press down onto the
screw body until the internal stop is fully seated on
the screw.
¾Do not use the S4Element Rod Persuader as a
counter torque device.
¾Removing the S4Element Rod Persuader from
S4Element Screw heads:
Release front actuation lever to move freely,
depress the release thumb lever on the rear of the
instrument. The actuation lever should spring for-
ward and the pusher ring on the working end
should slide proximally.
Symbol Explanation
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Date of manufacture
WARNING
Risk of injury and/or product mal-
function!
¾Always carry out a function
check before using the product.
CAUTION
Damage to the screw head/to the
instrument and/or difficulty with
instrument function and removal
due to non-engagement or not fully
seating the instrument onto the
screw head!
¾Ensure that the positive stop of
the S4Element Rod Persuader is
fully engaged with the S4Ele-
ment Screw head prior to actu-
ating the instrument.

3
Validated processing procedure
Note
Adhere to national statutory regulations, international
standards and guidelines, and local, clinical 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 the products.
Note
Mechanical processing should be preferred over man-
ual cleaning because of the better and more reliable
cleaning results of mechanical processing.
Note
Successful processing of this medical product can only
be ensured if processing is performed through a vali-
dated processing procedure.
The user/processor is responsible for the validation.
Note
Up-to-date information on processing can be found on
the Aesculap Extranet at www.aesculap-extra.net
General notes
To avoid unnecessary, excessive contamination of the
entire instrument tray, care must be taken at the stage
of application that contaminated instruments are col-
lected separately and not put back into the instrument
tray.
Encrusted or fixated surgical residues can make clean-
ing more difficult or ineffective, and can cause corro-
sion of stainless steel products. Therefore the time
interval between application and processing should
not exceed 6 h; also, neither fixating pre-cleaning
temperatures >45 °C nor fixating disinfecting agents
(active ingredient: aldehyde, alcohol) should be used.
Excessive doses of neutralizers or basic detergents can
cause chemical degradation and/or fading and obliter-
ation of laser inscriptions, in terms of visual reading
and machine-readability, on stainless steel surfaces.
Residues containing chlorine or chlorides, e.g. surgical
residues or residues from medicines, saline solutions
and service water used for cleaning, disinfecting and
sterilizing will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. To remove such residues, the products
must be adequately rinsed with fully desalinated
water, followed by thorough drying.

Aesculap Spine
S
4
Element Instruments - S
4
Element Rod Persuader FW285R
4
Only tested and approved process chemicals (e.g. VAH/
DGHM or FDA approval or CE mark) that are, according
to the chemical manufacturers' recommendations,
compatible with the product's materials may be used
for processing the product. All application parameters
specified by the chemical's manufacturer, such as tem-
peratures, concentrations and exposure times must be
observed under all circumstances. Failure to do so can
have the following adverse effects:
• 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.
¾Do not use oxidizing process chemicals (e.g. H2O2),
as these can cause bleaching or layer loss.
¾Do not use process chemicals that cause stress
cracking or brittleness of plastics.
¾Clean the product immediately after use.
Further detailed advice on hygienically safe and mate-
rial-preserving/value-preserving reprocessing can be
found at www.a-k-i.org
¾Use suitable cleaning/disinfecting agents if the
product is to be put away in wet condition. To pre-
vent foam formation and reduced effectiveness of
the process chemicals: Prior to mechanical clean-
ing and disinfecting, thoroughly rinse the product
with running water.
Preparations at the place of use
¾Rinse surfaces that cannot be visually inspected,
e.g., on products with hidden gaps or lumens or
products with complex geometries, preferably with
distilled water, using e.g. a disposable syringe.
¾Remove visible residues as completely as possible,
using a lint-free wet wipe.
¾Have the product transferred, in dry condition and
stored in a closed disposal container, for cleaning
and disinfecting within 6 h.
Cleaning/Disinfecting
¾Carry out ultrasound cleaning:
– as an effective mechanical supplement to man-
ual cleaning/disinfecting.
– as a pre-cleaning procedure for products with
encrusted residues, prior to mechanical cleaning/
disinfecting.
– as an integrated mechanical supplement to
mechanical cleaning/disinfecting.
– as an additional process to remove residues left
on products after mechanical cleaning/disinfect-
ing.
CAUTION
Damage to the product due to
inappropriate cleaning/disinfecting
agents and/or excessive tempera-
tures!
¾Use cleaning/disinfecting agents
according to the manufacturer’s
instructions that
- are approved for high-grade
steel
- do not attack softeners (e.g.,
silicone).
¾Observe specifications regarding
concentration, temperature and
exposure time.

5
Manual cleaning/disinfecting
¾Keep working ends open during cleaning.
¾Clean products featuring movable links with the
links opened or being moved.
¾Prior to manual disinfecting, allow water to drip off
for a sufficient length of time to prevent dilution of
the disinfecting solution.
¾Inspect visible surfaces for residues after manual
cleaning/disinfecting.
¾Repeat the cleaning process if necessary.
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
Stage Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
ICleaning RT
(cold)
>15 2 D–W BBraun Stabimed; aldehyde-,
phenol- and QAV-free
II Intermediate rinse RT
(cold)
1—D–W—
III Disinfecting RT
(cold)
15 2 D–W BBraun Stabimed; aldehyde-,
phenol- and QAV-free
IV Final rinse RT
(cold)
1 — FD–W —
VDrying RT — — — —