B. Braun Aesculap S4 Manual

Aesculap®S4® Cervical
Aesculap Spine
en Instructions for use/Technical description
Navigated Instruments
USA Note for U.S. users
This Instructions for Use is NOT intended for United States users. Please
discard. The Instructions for Use for United States users can be obtained
by visiting our website at www.aesculapImplantsystems.com. If you wish
to obtain a paper copy of the Instructions for Use, you may request one by
contacting your local Aesculap representative or Aesculap's customer ser-
vice at 1-866-229-3002. A paper copy will be provided to you upon
request at no additional cost.
de Gebrauchsanweisung/Technische Beschreibung
Navigierte Instrumente
fr Mode d’emploi/Description technique
Instruments navigués
es Instrucciones de manejo/Descripción técnica
Instrumental con navegación
it Istruzioni per l’uso/Descrizione tecnica
Strumenti navigati
pt Instruções de utilização/Descrição técnica
Instrumentos de navegação
nl Gebruiksaanwijzing/Technische beschrijving
Genavigeerde instrumenten
da Brugsanvisning/Teknisk beskrivelse
Navigerede instrumenter
sv Bruksanvisning/Teknisk beskrivning
Navigerade instrument
lv Lietošanas instrukcijas/tehniskais apraksts
Navigācijas instrumenti
lt Naudojimo instrukcija/techninis aprašas
Navigaciniai instrumentai
ru Инструкция по примению/Техническое описание
Инструменты с навигацией
cs Návod k použití/Technický popis
Navigované nástroje
pl Instrukcja użytkowania/Opis techniczny
Instrumenty nawigowane
sk Návod na použitie/Technický opis
Navigované nástroje
hu Használati útmutató/Műszaki leírás
Navigált műszerek
sl Navodila za uporabo/Tehnični opis
Navigirani instrumenti
hr Upute za uporabu/Tehnički opis
Navođeni instrumenti
ro Manual de utilizare/Descriere tehnică
Instrumente navigate
bg Упътване за употреба/Техническо описание
Насочвани инструменти
tr Kullanım Kılavuzu/Teknik açiklama
Navigasyonlu Aletler
el Οδηγίες χρήσης/Τεχνική περιγραφή
Πλοηγούμενα εργαλεία

AB
C
DE
F
H
K
J
G
I

L
M
N
O
P
Q
R
S

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Aesculap®S4® Cervical
Navigated Instruments
Legend
ANavigated tapper ∅3.5 mm (FW655R)
BReference star unit (pre-calibrated) (Brainlab Art. no. 55830-20A)
CHandle (FW165R with ratchet or FW067R without ratchet)
DNavigated screwdriver for polyaxial screw (FW656R)
EReference star unit ML (calibration with ICM4) (Brainlab
Art. no. 55830-25A)
FNavigated drill guide ∅3.5 mm (FW664R)
GNavigated drill guide ∅4.0 mm (FW665R)
HAesculap star unit navigation attachment (FW652R)
INavigated guide sleeve ∅4.0 mm for smooth-shaft screws (FW658R)
JReduction sleeve ∅13 mm for Brainlab instrument calibration matrix
version 4 (FW657R)
KNavigated guide sleeve ∅3.5 mm/4.0 mm (FW660R)
LC1/C2 inner drill sleeve ∅4 mm (FJ985R)
MC1/C2 inner drill sleeve ∅3.5 mm (FW661R)
NC1/C2 drill ∅2.4 mm (FW662SU)
OC1/C2 tapper ∅3.5 mm (FW663R)
PCentering tool for navigated drill guide ∅3.5 mm FW664R (FW688R)
QCentering tool for navigated drill guide ∅4.0 mm FW665R (FW689R)
RDrill ∅2.4 mm for FW664R (FW666SU)
SDrill ∅2.9 mm for FW665R (FW667SU)
Contents
1. About this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 Safety messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Clinical use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1 Areas of use and limitations of use . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.2 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.3 Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2 Safety information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2.1 Clinical user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2.2 Product-specific safety information. . . . . . . . . . . . . . . . . . . . . . 3
2.2.3 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3.1 Preparing holes for S4C screws with navigation. . . . . . . . . . . . 5
2.3.2 Drilling holes for the S4C screws . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3.3 Drilling holes for S4C screws ? 3.5 mm/4.0 mm . . . . . . . . . . . . 6
2.3.4 Tapping (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3.5 Position S4C screw under navigation and temporarily fix it in
place . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3.6 Smooth-shaft screw instruments. . . . . . . . . . . . . . . . . . . . . . . . 8
2.3.7 Instruments for Favored Angle screws. . . . . . . . . . . . . . . . . . . . 9
2.3.8 Standard screw (? 3.5 mm) instrumentation with Favored
Angle instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 11
3.1 General safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.3 Single-use products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4 Reusable products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.5 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . 12
3.6 Preparing for cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7 Disassembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7.1 S4C navigated tapper ? 3.5 mm FW655R . . . . . . . . . . . . . . . . . 12
3.7.2 S4C navigated screwdriver FW656R . . . . . . . . . . . . . . . . . . . . . 12
3.7.3 S4C navigated drill sleeve ? 3.5 mm (FW664R)/? 4.0 mm
(FW665R). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.7.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R 12
3.7.5 S4C navigated guide sleeve ? 3.5 mm/4.0 mm FW660R . . . . . 13
3.8 Cleaning/Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.8.1 Product-specific safety information on the reprocessing
method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.8.2 Validated cleaning and disinfection procedure . . . . . . . . . . . . 13
3.9 Manual cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 15
3.9.1 Manual cleaning with immersion disinfection. . . . . . . . . . . . . 15
3.9.2 Manual cleaning with ultrasound and immersion disinfection 16
3.10 Mechanical cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . 17
3.10.1 Mechanical alkaline cleaning and thermal disinfecting . . . . . 17
3.11 Mechanical cleaning/disinfection with manual pre-cleaning. 18
3.11.1 Manual pre-cleaning with a brush . . . . . . . . . . . . . . . . . . . . . . 18
3.11.2 Manual pre-cleaning with ultrasound and brush . . . . . . . . . . 19
3.11.3 Mechanical alkaline cleaning and thermal disinfecting . . . . . 19
3.12 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.12.1 Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.12.2 Functional test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13 Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13.1 S4C navigated tapper ? 3.5 mm, FW655R . . . . . . . . . . . . . . . . 20
3.13.2 S4C navigated screwdriver FW656R . . . . . . . . . . . . . . . . . . . . . 20
3.13.3 S4C navigated drill sleeve ? 3.5 mm (FW664R)/? 4.0 mm
(FW665R). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.13.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R 20
3.13.5 S4C navigated guide sleeve ? 3.5 mm/4.0 mm, FW660R. . . . . 21
3.14 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.15 Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.16 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4. Technical service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

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1. About this document
Note
General risk factors associated with surgical procedures are not described
in these instructions for use.
1.1 Scope
These instructions for use apply for S4Cervical – Navigated Instruments.
Note
The applicable CE mark for the product can be seen on the label or packag-
ing of the product.
►For article-specific instructions for use as well as information on mate-
rial compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com
1.2 Safety messages
Safety messages make clear the dangers to patient, user and/or product
that could arise during the use of the product. Safety messages are labeled
as follows:
DANGER
Indicates a possible threat of danger. If not avoided, death or serious
injury may result.
WARNING
Indicates a possible threat of danger. If not avoided, minor or moder-
ate injury may result.
CAUTION
Indicates a possible threat of material damage. If not avoided, the
product may be damaged.
2. Clinical use
2.1 Areas of use and limitations of use
2.1.1 Intended use
The S4Cervical system (S4C system) is used for posterior occipital cervical
and thoracic stabilization and fusion.
2.1.2 Indications
Note
The manufacturer is not responsible for any use of the product against the
specified indications and/or the described applications.
Indications are specified in the instruction for use for the implants
(TA011796).
2.1.3 Contraindications
Contraindications are specified in the instruction for use for the implants
(TA011796).
2.2 Safety information
2.2.1 Clinical user
General safety information
To prevent damage caused by improper setup or operation, and to not
compromise the manufacturer warranty and liability:
►Use the product only according to these instructions for use.
►Follow the safety and maintenance instructions.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge and experience.
►Store any new or unused products in a dry, clean, and safe place.
►Prior to use, check that the product is in good working order.
►Keep the instructions for use accessible for the user.
Note
The user is obligated to report all severe events in connection with the prod-
uct to the manufacturer and the responsible authorities of the state in
which the user is located.
Notes on surgical procedures
It is the user's responsibility to ensure that the surgical procedure is per-
formed correctly.
Appropriate clinical training as well as a theoretical and practical profi-
ciency of all the required operating techniques, including the use of this
product, are prerequisites for the successful use of this product.
The user is required to obtain information from the manufacturer if there
is an unclear preoperative situation regarding the use of the product.
2.2.2 Product-specific safety information
►Observe the surgical technique of the S4® Cervical system O34202.
The instruments listed in the key form part of this system. They are used
for the individual adaptation, positioning and insertion of S4C implants in
patients. For safe usage, follow instructions for use for S4C System Instru-
ments (TA011984) and Operating Techniques (O34202/O83002)
The instruments listed in the key may only be used with the Brainlab nav-
igation system. For safe handling prior to the operation, read Spine &
Trauma user manual for Brainlab instruments and the corresponding soft-
ware manual for the Brainlab spine application used.
Combination specifications
Note
Aesculap and Brainlab accept absolutely no responsibility if instruments,
centering tools or drills other than those named below are used with the
corresponding drill guides and guide sleeves.
■Only combine S4C navigated drill guide Fwith:
–S
4C centering tool Pfor S4C drill guide F
–S
4C drill R∅2.4 mm for ∅3.5 mm screws
■Only combine S4C navigated drill guide Gwith:
–S
4C centering tool Qfor drill guide G
–S
4C drill S∅2.9 mm for ∅4.0 mm screws
■Only combine S4C navigated guide sleeve ∅4.0 mm Ifor smoothshank
screws with:
– Smooth-shaft screw bone awl (FW085R)
– Drill for ∅2.9 mm smooth-shaft screws (FW086SU)
– Smooth-shaft (Shank) screw tapper (Tap) (FW087R)
– Polyaxial screwdriver (FW070R/FW131R)
– Navigated screwdriver for polyaxial screw (FW656R)
– Apfelbaum ball head screwdriver, short (FJ968R)

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■Only combine S4C navigated guide sleeve ∅3.5 mm/4.0 mm Kwith:
– Apfelbaum C1/C2 obturator (FJ983R)
– Apfelbaum trocar (FJ984R)
– Favored Angle screw drill ∅2.9 mm for ∅4mm screws
(FW088SU)
– Favored Angle tapper (Tap)∅4 mm (FW089R)
– C1/C2 inner drill sleeve ∅4 mm L(FJ985R)
–S
4C Favored Angle screwdriver (FW069R/FW132R)
– C1/C2 drill ∅2.4 mm for ∅3.5 mm screws (FW662SU) N
– C1/C2 tapper (Tap) ∅3.5 mm (FW663R) O
– C1/C2 inner drill sleeve ∅3.5 mm (FW661R) M
– Apfelbaum ball head screwdriver (FJ988R)
Note
K-wires generally may not be used with the S4C
2.2.3 Sterility
The product is delivered in an unsterile condition.
►Clean the new product after removing its transport packaging and prior
to its initial sterilization.
Single-use products
►Do not reuse the product.
The reprocessing of the product affects its functionality. Risk of injury, ill-
ness or death due to soiling and/or impaired functionality of the product.
►Do not reprocess the product.
The product is gamma-sterilized and supplied in sterile packaging.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►Use the product only in accordance with its intended use.
►Do not use products from open or damaged sterile packaging.
►Prior to each use, inspect the product for loose, bent, broken, cracked
or fractured components.
►Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►Do not use the product after its use-by date.
2.3 Application
WARNING
Risk of injury and/or malfunction!
►Prior to each use, inspect the product for loose, bent, broken,
cracked, worn, or fractured components.
►Always carry out a function test prior to each use of the product.
WARNING
Risk of injury to patients due to damaged instruments!
S4C instruments are extremely precise and very sensitive.
►Handle S4C instruments with the greatest of care.
►Check that dropped or damaged S4C instruments are accurately
calibrated, or send them to the Aesculap Technical Service.
WARNING
Risk of injury to patients due to interruption of the navigation!
►Prior to the operation, plan the configuration of the operating
room, the assembly of the instruments and the alignment of the
reference star.
►Ensure that the navigation camera has an unrestricted view of the
reflective marker spheres of the instruments.
WARNING
Risk of injury to patients due to imprecise instruments!
►Ensure that the instruments used are not bent or damaged.
►Before use, check the precision of the instruments, particularly
that of fine instruments. For this, hold the instrument tip in the
pivot point of the Brainlab instrument calibration matrix version 4.
WARNING
Risk of injury to patients due to incorrect navigation!
►Use navigated S4C instruments only with Brainlab disposable
reflective marker spheres.
►For further information on the correct handling of the marker
spheres, see corresponding Brainlab user manual.
Art. no. Designation
FW086SU Drill ∅2.9 mm for smooth-shaft screws
FW088SU Favored Angle screw drill ∅2.9 mm for ∅4mm
screws
FW662SU S4C1/C2 drill ∅2.4 mm
FW666SU Drill ∅2.4 mm
FW667SU Drill ∅2.9 mm

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2.3.1 Preparing holes for S4C screws with navigation
WARNING
Risk of injury to patients due to incorrect navigation!
►Observe the combination specifications
To center the screw holes in the cortical bone layer for the self-tapping
S4C screws ∅3.5 mm with navigation, use the S4C navigated drill guide
∅3.5 mm Fonly together with S4C centering tool for S4C navigated drill
guide P.
To center the screw holes for the self-tapping S4C screws ∅4.0 mm with
navigation, use the S4C navigated drill guide ∅4.0 mm Gonly together
with S4C centering tool for S4C navigated drill guide Q.
S4C navigated drill guide Gand centering tool Qhave a purple marking on
the shaft for the self-tapping S4C screws ∅4.0 mm, see Fig.1.
Fig.1 Purple markings on S4C navigated drill guide and centering tool
To center the screw holes in the cortical layer without navigation, see
instructions for use of S4Cervical instruments (TA011984).
WARNING
Risk of damage to the spinal cord, nerve roots, adjacent intervertebral
space or soft tissue when inserting the centering tool without drill
guide!
►Use the centering tool only with drill guide FW664R/FW665R.
CAUTION
Restriction of the function of the centering tool or inaccurate reading
of the depth gage!
►Do not repoint the centering tool.
►Replace blunt centering tools.
►For mounting the reflective Brainlab marker spheres 4onto Aesculap
star unit H, see Brainlab user manual.
►Retract and hold locking sleeve 1of the Aesculap star unit Hagainst
the spring pressure in the direction of the arrow.
►Push the Aesculap star unit Honto adapter 2of the S4C drill guide F/G.
When doing so, ensure that the pin of the adapter 3engages in the
recess on the star unit.
►Release locking sleeve 1.
Fig.2 Mounting the Aesculap star unit on S4C drill guide
FW664R/FW665R
►Prior to each use, check and/or validate the instrument with the
Brainlab instrument calibration matrix version 4, see Brainlab user
manual. When doing so, ensure that the centering tool for navigated
drill guide P/Qis removed.
►To ensure that the camera has an unrestricted view of the reflective
marker spheres, loosen knob 6on the S4C handle of the S4C drill guide
F/Gand rotate Aesculap star unit Hto the desired position, see Fig.2.
►Once the desired position is reached, tighten knob 6again.
►Adjust the center punch depth by turning the depth stop 5 on the S4C
drill guide F/G. The maximum depth is 6 mm.
►Insert S4C centering tool P/Qinto S4C drill guide F/G.
►Check the pre-set center punch depth with a caliper (e.g. AA845R).
►To open the cortical bone, press S4C centering tool to the preset depth
under control with the Brainlab navigation system.
2.3.2 Drilling holes for the S4C screws
DANGER
Risk of injury from an incorrectly placed hole or a hole that is too
deep!
►Do not sharpen the drill, as this would cause imprecise or incorrect
readings on the depth gauge.
►Replace blunt drills with new ones.
The drill is applied with a S4C drill guide and drilled in either manually with
the drill handle (FJ839R) or with a motor system with the Aesculap Intra-
handpiece (e.g. GD450R/GD456R).
Assembling the drill and drill handle (for manual drilling only)
DANGER
Risk of damage to the spinal cord, nerve roots, adjacent intervertebral
space or soft tissue through incorrect drilling!
►Use only the correct S4C drill guides to drill holes. Insert drill only
with the correct drill guide.
►Before drilling, the pre-set drill length must be checked with a cal-
iper (e.g. AA845R, Caspar instrument for anterior cervical fusion).
QG
1
4
F/G
H
5
6
P/Q
2
3

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DANGER
Injury to spinal cord and nerve roots caused by application of a drill
that is too long!
►Use the X-ray image to select an appropriate drill length prior to
the operation.
►Drill may only be aligned and inserted under radiographic control
and/or with the aid of a navigation system.
►Select a drill of a length equivalent to the intended drill hole depth.
►Insert drill in the drill handle (FJ839R), see Fig.3.
►Retract and hold locking sleeve against the spring pressure in the direc-
tion of the arrow.
►Push the drill into the receptacle of the drill handle as far as it will go
►Lightly rotate the drill and release locking sleeve.
The drill engages audibly.
Fig.3 Assembling the drill
DANGER
Risk of injury and/or damage to the drill if the drill rotation speed is
too high!
►Use the lowest drilling speed possible, so that you can control the
drilling depth.
►Do not bend the drill during the drilling process.
2.3.3 Drilling holes for S4C screws ∅3.5 mm/4.0 mm
WARNING
Risk of injury to patients due to incorrect navigation!
►Observe the combination specifications
For controlled drilling of the holes for S4C screws ∅3.5 mm with drill
∅2.4 mm R(FW666SU), the S4C navigated drill guide ∅3.5 mm F
(FW664R) must always be used.
For controlled drilling of the holes for S4C screws ∅4.0 mm with drill
∅2.9 mm S(FW667SU), the S4C navigated drill guide ∅4.0 mm G
(FW665R) must always be used.
S4C navigated drill guide Gand drill ∅2.9 mm S have a purple marking
on the shaft for the self-tapping S4C screws ∅4.0 mm screws, see Fig.4.
Fig.4 Purple marking on S4C navigated drill guide and drill
Note
The drill
∅ 2.4 mm (FW051SU) and ∅ 2.9 mm (FW052SU) must not be used
with S4C navigated drill guide F/G.
►For mounting the reflective Brainlab marker spheres 4onto Aesculap
star unit H, see Brainlab user manual.
►Retract and hold locking sleeve 1of the Aesculap star unit Hagainst
the spring pressure in the direction of the arrow.
►Aesculap star unit His then pushed onto adapter 2of the S4C drill
guide F/G. When doing so, ensure that the pin 3of the adapter engages
in the recess on the star unit.
►Release locking sleeve 1.
Fig.5 Mounting the Aesculap star unit on S4C drill guide
FW664R/FW665R
►Prior to each use, check and/or validate the instrument with the
Brainlab instrument calibration matrix version 4, see Brainlab user
manual. When doing so, ensure that the drill R/Sis removed.
►To ensure that the camera has an unrestricted view of the reflective
marker spheres, loosen knob 6on the handle of the S4C drill guide F/G
and rotate Aesculap star unit Hto the desired position, see Fig.2.
►Once the desired position is reached, tighten knob 6again.
►Adjust the drill depth by turning the depth stop 5on the S4C drill
guide F/G.
►The scale is in mm. Each half turn on the depth stop moves a distance
of 0.5 mm.
►Insert the drill with mounted handle or Intra-handpiece into S4C drill
guide F/G.
►Before drilling, the pre-set drill length must be checked with a caliper
(e.g. AA845R, Caspar instrument for anterior cervical fusion).
►Drill to the pre-set depth under control with the Brainlab navigation
system.
Click
S
G
1
4
F/G
H
6
2
3
R/S

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2.3.4 Tapping (optional)
S4C screws are self-tapping screws. However, if the bone quality is found
to be hard during the operation, the surgeon can also pre-tap the thread
with the S4C tapper.
►For tapping the drill holes for screws ∅3.5 mm with navigation, use
the S4C navigated tapper A.
►For tapping the drill holes for screws ∅4 mm, use the standard tapper
without navigation (FW047R), see TA011984.
DANGER
Risk of tissue trauma when using the S4C tapper (A) and damage to
bone thread!
►Prior to using the S4C tapper, ensure that the moveable sleeve of
the tapper retracts correctly.
►For mounting the reflective Brainlab marker spheres 4onto the refer-
ence star unit B(pre-calibrated), see Brainlab user manual.
►Push the reference star unit onto the shaft 7of the S4C tapper (Tap) A.
Ensure that the star unit is securely fitted onto the shaft of the S4C tap-
per (Tap).
Note
The star unit can be rotated on the shaft of the S4C tapper (Tap).
►Retract and hold locking sleeve 8against the spring pressure.
►Push the S4C handle FW067R/FW165R onto the shaft of the S4C
tapper A.
►Release locking sleeve 8, see Fig.6.
Check that the S4C handle is engaged.
Fig.6 Mounting the reference star unit (“pre-calibrated”) and S4C han-
dle onto the S4C tapper
WARNING
Risk of injury to the patient!
►Before use, ensure that the selected instrument has been correctly
assembled.
►Ensure that the arrow on the underside of the reference star unit
(pre-calibrated) is pointing to the tip of the tool.
►Prior to each use, check and/or validate the instrument with the
Brainlab instrument calibration matrix version 4, see Brainlab user
manual.
►To tap the thread, hold the reference star unit Bat the planned inden-
tations with one hand, and with the other hand screw in S4C thandle C
slowly and steadily under control with the Brainlab navigation system,
until the required depth is reached.
►Use the scale behind the retractable sleeve of the S4C tapper to read
the depth during the tapping process,see Fig.7.
Fig.7 Tapper with readable thread depth
2.3.5 Position S4C screw under navigation and temporarily fix it in
place
DANGER
Risk of injury to the patient!
►Use S4C screwdriver only with reference star unit ML for manual
calibration.
►If you change screws, perform the calibration again.
►To position S4C screws ∅3.5 mm and ∅4 mm with navigation, use
S4C navigated screwdriver D.
►For mounting the reflective Brainlab marker spheres 4onto the refer-
ence star unit ML E, see Brainlab user manual.
►Push the reference star unit ML Eonto the shaft 10 of the S4C
crewdriver D. Ensure that the star unit is securely fitted onto the shaft
of the S4C screwdriver.
Note
The star unit can be rotated on the shaft of the S4C screwdriver.
►Retract and hold locking sleeve 8against the spring pressure.
►Push the S4C handle FW067R/FW165R onto the shaft of the
S4C screwdriver D.
►Release locking sleeve 8, see Fig.8.
►Check that the S4C handle is engaged.
Fig.8 Mounting the reference star unit (“calibration with ICM 4”) and
S4C handle (FW067R or FW165R) onto the S4C screwdriver
Note
The S4C screwdriver is fitted with a self-retaining function to prevent the
S4C screw from falling out when it is passed to the surgeon.
►Retract and hold the holding sleeve 12 on the S4C screwdriver D, see
Fig.9.
►Insert the tip of the S4C screwdriver Dfully into the hexagon of the
screw 11.
►Release the holding sleeve 12.
Ensure that the screw 11 is securely in place on the S4C screwdriver D
and that the polyaxiality of the screw 11 is blocked.
Fig.9 Pick up the S4CscrewwithS
4C screwdriver
4
98
7
B
A
C
B
A
4
E
D
8
10
C
E
12
11
E
C
D

8
en
DANGER
Risk of injury to the patient!
►Before use, ensure that the selected instrument has been correctly
assembled. Ensure that the arrow on the underside of the reference
star unit ML is pointing to the tip of the tool.
►Prior to using the instrument with the correctly held screw, perform
manual calibration with the Brainlab instrument calibration matrix
version 4, see Brainlab user manual.
►Screw in the screw under control with the Brainlab navigation system.
When doing so, hold reference star unit ML at the planned indentations
with one hand, and turn the S4C handle Cto screw in the screw 11
with the other hand.
2.3.6 Smooth-shaft screw instruments
WARNING
Risk of injury to patients due to incorrect navigation!
►Observe the combination specifications
Instruments for smooth-shaft screws are marked with a light-blue ring.
They are used to center punch, drill and tap holes for smooth-shaft screws
∅4 mm.
DANGER
Serious complications for the patient can be caused by incorrect posi-
tioning of instruments or implants!
►Carry out operative steps with radiographic visualization.
►When removing the smooth-shaft screw awl (FW085R) and during
the further operating steps, ensure that the S4C navigated smooth-
shaft screw guide sleeve remains securely fixed in place.
►Ensure that the window on the S4C navigated smooth-shaft screw
guide sleeve is closed during the preparation of the screw hole and
while the screw is being inserted, see laser marking on the inner
sleeve.
►Take care that no tissue gets caught when opening and closing the
window on the S4C navigated smooth-shaft screw guide sleeve,
after the screw has been put in place.
►For mounting the reflective Brainlab marker spheres 4onto Aesculap
star unit H, see Brainlab user manual.
►Retract and hold locking sleeve 1against the spring pressure in the
direction of the arrow.
►Aesculap star unit His then pushed onto adapter 2. When doing so,
ensure that the recess on the star unit is seated over the pin 3of the
adapter.
►Release locking sleeve 1.
Fig.10 Mounting the Aesculap star unit on the S4C guide sleeve for
smooth-shaft screws
DANGER
Risk of injury to patients due to incorrect navigation!
►Slide reduction sleeve into the Brainlab instrument calibration
matrix version 4, until you hear an audible click.
►Prior to each use, check and/or validate the instrument with special
reduction sleeve J with the Brainlab instrument calibration matrix ver-
sion 4, see Brainlab user manual. Ensure that all other instruments
(centering tool, drill, tapper etc.) are removed for the instrument vali-
dation.
Fig.11 Reduction sleeve for validation/verification with the Brainlab
instrument calibration matrix version 4
►To ensure that the camera has an unrestricted view of the reflective
marker spheres, loosen knob 6on the S4C handle of the S4C guide
sleeve I and rotate Aesculap star unit Hto the desired position, see
Fig.10.
►Once the desired position is reached, tighten knob 6again.
►Place S4C guide sleeve Ifor smoothshank screws in the operating field.
When doing so, ensure that the window of the guide sleeve is closed
during the preparation and insertion of the screw with the guide sleeve,
see laser marking on the inner sleeve 13.
►Center punch the cortical layer of the vertebral body with the smooth-
shank screw aw (FW085R), see TA011984 and Operating Technique
(O34202).
►If necessary, insert the awl into the inner sleeve 13 and center punch
the bone as far as the stop-position. The stop-position is indicated with
a marking on the awl.
►Remove the awl from the operating field.
►Insert the smooth-shaft screw drill (FW086SU) 14 with mounted han-
dle (FJ839R) or Intra-handpiece into the inner sleeve 13.
►Before drilling, the pre-set drill length must be checked with a caliper
(e.g. AA845R, Caspar instrument for anterior cervical fusion).
4
13
14
6
1
2
3
H
H
I
J

9
en
►Under control with the Brainlab navigation system, drill a hole in the
bone until the adjustable stop-position is reached. For further informa-
tion on drilling, see instructions for use of the S4Cervical instruments
(TA011984) and Operating Technique (O34202).
►Remove the drill from the operating field.
►To prepare the drill holes for the screws, tap the thread with the
smooth-shaft screw tapper (FW087R).
►Insert the smooth-shaft screw tapper into the inner sleeve and slowly
and steadily tap in until the desired depth is reached. When doing so,
read the thread depth on the tapper scale.
►Remove smooth-shaft screw tapper from the operating field.
Note
If the S4C screw is to be inserted under navigation with the S4C screwdriver
FW656R using the guide sleeve I, remove the Aesculap star unit on the
S4C guide sleeve for smoothshank screws.
DANGER
Risk of injury to patients due to incorrect navigation!
►The navigated S4C screwdriver FW656R or other S4Cscrewdrivers
are only intended for navigation in the non-navigated S4Cguide
sleeve FW658R.
►For navigating the S4C screwdriver FW656R, see section on posi-
tioning the S4C screw under navigation and temporarily fixing it in
place.
DANGER
Risk of injury to the patient through freely rotating screws!
►Do not screw in screw so far that the screw head comes into con-
tact with the S4C guide sleeve.
Note
Use the navigated S4C screwdriver FW656R only with non-navigated
S4C guide sleeve FW658R.
►Navigate S4C screwdriver, see Position S4C screw under navigation and
temporarily fix it in place.
►Insert the screw through the S4C guide sleeve but do not screw it in
completely (smooth shaft must remain free). Remove
S4C screwdriver Dfrom the operating field.
►Remove instrument from the screw:
– Turn the blue inner sleeve 13 and open the window on the
S4C guide sleeve.
– Carefully push away S4C guide sleeve Ilaterally from the screw.
– Remove S4C guidesleeve Ifrom the operating field.
2.3.7 Instruments for Favored Angle screws
WARNING
Risk of injury to patients due to incorrect navigation!
►Observe the combination specifications
Favored Angle instruments are marked with a gold-colored ring.
DANGER
Serious complications for the patient can be caused by incorrect posi-
tioning of instruments or implants!
►Carry out operative steps with radiographic visualization.
►When removing the obturator (FJ983R) and during the further
operating steps, ensure that the S4C guide sleeve remains securely
fixed in place.
Drilling holes for Favored Angle screws
►For mounting the reflective Brainlab marker spheres 4onto Aesculap
star unit H, see Brainlab user manual.
►Aesculap star unit His mounted onto S4C navigated guide sleeve
∅3.5/4.0 mm K. When doing so, retract and hold the locking sleeve 1
against the spring pressure in the direction of the arrow.
►Push the Aesculap star unit Honto adapter 2 of the S4C guide sleeve K.
When doing so, ensure that the recess is seated over the pin 3of the
adapter.
►Release locking sleeve 1.
Fig.12 Mounting the Aesculap star unit onto the S4C guide sleeve;
Inserting the S4C inner drill sleeve
►Prior to each use, check and/or validate the instrument with the
Brainlab instrument calibration matrix version 4, see Brainlab user
manual. Ensure that the inner drill sleeve Lis mounted prior to this
check.
►To ensure that the camera has an unrestricted view of the reflective
marker spheres, loosen knob 6 on the S4C handle of the S4C guide
sleeve Kand rotate Aesculap star unit H to the desired position, see
Fig.12.
►Once the desired position is reached, tighten knob 6again.
►Remove inner drill sleeve Lfrom the S4C guide sleeve K.
►Insert obturator (FJ983R) into the inner sleeve 15 of the S4C guide
sleeve K.
►The obturator engages in the inner sleeve and can still be rotated.
►Bring S4C guide sleeve Kwith mounted obturator into the operating
field through the stab incision and position it in place.
►Press the button 16 on the obturator (FJ983R) and withdraw the obtu-
rator from the inner sleeve 15.
4
15
L
16
6
1
2
3
K
H
K

10
en
►If necessary, slide Apfelbaum trocar (FJ984R) into the inner sleeve 15
and insert into the bone to center punch the screw entry point.
►Remove the trocar from the operating field.
►Slide the inner drill sleeve L onto the inner sleeve 15.
►The inner drill sleeve engages on the inner sleeve and can still be
rotated, see Fig.12.
►Insert drill for Favored Angle screws (FW088SU)with mounted handle
(FJ839R) or Intra-handpiece into the inner drill sleeve L.
►Drill to the pre-set depth under control with the Brainlab navigation
system. The drill depth can be read on the scale on the inner drill
sleeve L.
Note
So as not to lose the entry opening, it can be helpful to keep the drill in the
drill hole, press the button 16 on the inner drill sleeve Land push down the
guide sleeve until it reaches the stop on the bone surface. Then remove the
drill and inner drill sleeve Lfrom the S4C guide sleeve K.
►Press the button 16 and remove the inner drill sleeve Lfrom the inner
sleeve 15.
S4C screws are self-tapping screws. However, if the bone quality is found
to be hard during the operation, the surgeon can also pre-tap the thread
with the S4C tapper.
►To prepare screw holes, insert the Favored Angle tapper ∅4 mm
(FW089R) into the inner sleeve 15 and tap. The drill depth can be read
on the scale on the tapper (Tap).
►Turn the tapper (Tap) counterclockwise until it exits the bone.
Note
So as not to lose the entry opening, it can be helpful to turn the tapper (Tap)
counterclockwise until it almost exits the bone. Then turn the inner
sleeve 15 counterclockwise and at the same time push down the S4C guide
sleeve Kuntil it reaches the stop on the bone surface. Then unscrew the
Favored Angle tapper ∅ 4 mm (FW089R) completely from the bone and
remove it together with the inner sleeve 15 from the S4C guide sleeve K.
Inserting the screw
►Ensure that the inner sleeve 15 has been removed from the S4C guide
sleeve Kby turning it counterclockwise.
►Pick up a suitable Favored Angle screw ∅4.0 mm with the self-retain-
ing S4C screwdriver (FW069R/FW132R). When doing so, retract and
hold the black holding sleeve against the spring pressure.
Note
The self-retaining function of the instrument prevents the screw from fall-
ing out of the S4C screwdriver when it is being passed to the operating sur-
geon.
►Press the working end of the S4C screwdriver fully into the hexagon of
the screw 11.
►Release the black holding sleeve.
►Screw in the screw under control with the Brainlab navigation system.
►Tighten the screw. When doing so, work through the S4C guide
sleeve.Activate the black holding sleeve and release the
S4C screwdriver from the screw.
►Remove S4C guide sleeve S4C from the operating field.
2.3.8 Standard screw (∅3.5 mm) instrumentation with Favored
Angle instruments
WARNING
Risk of injury to patients due to incorrect navigation!
►Observe the combination specifications
To insert standard screws ∅3.5 mm with the Favored Angle instruments,
the instruments M, Nand Omust also be used. These instruments are
marked with a black ring.
DANGER
Serious complications for the patient can be caused by incorrect posi-
tioning of instruments or implants!
►Carry out operative steps with radiographic visualization.
►When removing the obturator (FJ983R) and during the further
operating steps, ensure that the guide sleeve remains securely fixed
in place.
►For mounting the reflective Brainlab marker spheres 4onto Aesculap
star unit H, see Brainlab user manual.
►Aesculap star unit His mounted onto S4C navigated guide sleeve
∅3.5/4.0 mm K. When doing so, retract and hold the securing sleeve 1
against the spring pressure in the direction of the arrow.
►Aesculap star unit His then pushed onto adapter 2of the S4C guide
sleeve K. When doing so, ensure that the recess is seated over the pin 3
of the adapter.
►Release locking sleeve 1.
Fig.13 Mounting the Aesculap star unit onto the S4C guide sleeve;
Inserting the S4C drill guide
►Prior to each use, check and/or validate the instrument with the
Brainlab instrument calibration matrix version 4, see Brainlab user
manual. Ensure that the inner drill sleeve Mis mounted prior to this
check.
►To ensure that the camera has an unrestricted view of the reflective
marker spheres, loosen knob 6on the S4C handle of the S4C guide
sleeve Kand rotate Aesculap star unit Hto the desired position, see
Fig.13.
►Once the desired position is reached, tighten knob 6again.
►Remove inner drill sleeve Mfrom the guide sleeve K.
►Insert obturator (FJ983R) into the inner sleeve 15 of the S4C guide
sleeve K. The obturator engages in the inner sleeve and can still be
rotated.
►Bring S4C guide sleeve Kwith mounted obturator into the operating
field through the stab incision and position it in place.
4K
15
M16
6
1
2
3
K
H
H

11
en
►Press the button 16 on the obturator (FJ983R) and withdraw the obtu-
rator from the inner sleeve 15.
►If necessary, slide Apfelbaum trocar (FJ984R) into the inner sleeve 15
and insert into the bone to center punch the screw entry point.
►Remove the trocar from the operating field.
►Slide the inner drill sleeve Monto the inner sleeve 15. The inner guide
sleeve engages on the inner sleeve and can still be rotated, see Fig.13.
►Insert drill ∅2.4 mm Nwith mounted handle (FJ839R) or Intra-hand-
piece into the inner drill sleeve M.
►Drill to the pre-set depth under control with the Brainlab navigation
system. The drill depth can be read on the scale on the inner drill
sleeve M.
Note
So as not to lose the entry opening, it can be helpful to keep the drill in the
drill hole, press the button 16 on the inner drill sleeve Mand push down the
guide sleeve until it reaches the stop on the bone surface. Then remove the
drill and inner drill sleeve Mfrom the S4C guide sleeve K.
►Press the button 16 and remove the inner drill sleeve Mfrom the inner
sleeve 15.
S4C screws are self-tapping screws. However, if the bone quality is found
to be hard during the operation, the surgeon can also pre-tap the thread
with the S4C tapper.
►To prepare screw holes, insert the C1/C2 tapper (Tap) ∅3.5 mm Ointo
the inner sleeve 15 and tap. The drill depth can be read on the scale on
the tapper (Tap).
►Turn the tapper (Tap) Ocounterclockwise until it exits the bone.
Note
So as not to lose the entry opening, it can be helpful to turn the tapper (Tap)
counterclockwise until it almost exits the bone. Then turn the inner
sleeve 15 counterclockwise and at the same time push down the S4C guide
sleeve Kuntil it reaches the stop on the bone surface. Then unscrew the
tapper Ocompletely from the bone and remove it together with the inner
sleeve 15 from the S4C guide sleeve K.
Inserting the screw
►Ensure that the inner sleeve 15 has been removed from the S4C guide
sleeve Kby turning it counterclockwise.
►Pick up a suitable standard screw ∅3.5 mm with the self-retaining
S4C screwdriver (FW069R/FW132R). When doing so, retract and hold
the black holding sleeve against the spring pressure.
Note
The self-retaining function of the instrument prevents the screw from fall-
ing out of the S4C screwdriver when it is being passed to the operating sur-
geon.
►Press the working end of the S4C screwdriver fully into the hexagon of
the screw 11.
►Release the black holding sleeve.
►Screw in the screw under control with the Brainlab navigation system.
►Tighten the screw. When doing so, work through the S4C guide sleeve.
►Activate the black holding sleeve and release the S4C screwdriver from
the screw.
►Remove S4C guide sleeve and S4C screwdriver from the operating field.
3. Validated reprocessing procedure
3.1 General safety instructions
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives
better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing technician
is responsible for this.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility,
see B. Braun eIFU at eifu.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
3.2 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica-
tion and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting 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 fading and the laser marking becoming
unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medi-
cines, saline solutions and in the service water used for cleaning, disinfec-
tion and sterilization will cause corrosion damage (pitting, stress corro-
sion) and result in the destruction of stainless steel products. These must
be removed by rinsing thoroughly with demineralized water and then dry-
ing.
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’ recommendations
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 discoloration 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, fracturing, premature aging
or swelling.
►Do not use metal cleaning brushes or other abrasives that would dam-
age the product surfaces and could cause corrosion.
►Further detailed advice on hygienically safe and material-/value-pre-
serving reprocessing can be found at www.a-k-i.org, link to "AKI-
Brochures", "Red brochure".

12
en
3.3 Single-use products
►Do not reuse the product.
The reprocessing of the product affects its functionality. Risk of injury, ill-
ness or death due to soiling and/or impaired functionality of the product.
►Do not reprocess the product.
3.4 Reusable products
Influences of the reprocessing which lead to damage to the product are
not known.
A careful visual and functional inspection before the next use is the best
opportunity to recognize a product that is no longer functional, see
Inspection.
3.5 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 container for cleaning and
disinfection within 6 hours.
3.6 Preparing for cleaning
►Disassemble the product prior to cleaning, see Disassembly.
►Disassemble the product prior to cleaning.
►Open up product with hinges.
►Open all valves/faucets.
3.7 Disassembly
3.7.1 S4C navigated tapper ∅3.5 mm FW655R
►Loosen nut 19 and unscrew from the sleeve 17.
►Remove sleeve 17 in the direction of the arrow.
Note
Spring 18 is fixed on shaft.
Fig.14 Disassembling the S4C tapper (Tap)
3.7.2 S4C navigated screwdriver FW656R
►Retract and hold green holding sleeve 22 against the spring pressure.
►Unscrew screw sleeve 20 at the working end of the S4C screwdriver
and remove from the shaft.
►Release the green holding sleeve 22.
►Push the green holding sleeve 22 with the retaining tongues in the
direction of the instrument's working end and remove from the screw-
driver shaft.
Fig.15 Disassembling the S4C screwdriver
3.7.3 S4C navigated drill sleeve ∅3.5 mm (FW664R)/∅4.0 mm
(FW665R)
►Turn guide sleeve 24 clockwise and remove. Be aware that it is a left-
handed thread.
►Loosen knob 25 counterclockwise, unscrew and remove from the han-
dle by pulling in the direction of the arrow.
Fig.16 Disassembling the S4C drill guide
3.7.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R
►Turn inner sleeve 26 to the "remove" position and remove from the
outer sleeve in the direction of the arrow.
►Loosen knob 25 counterclockwise, unscrew and remove from the han-
dle by pulling in the direction of the arrow.
Fig.17 Disassembling the guide sleeve for smoothshank screws
Art. no. Designation
FW086SU Drill ∅2.9 mm for smooth-shaft screws
FW088SU Favored Angle screw drill ∅2.9 mm for ∅4 mm
screws
FW662SU S4C1/C2 drill ∅2.4 mm
FW666SU Drill, ∅2.4 mm
FW667SU Drill, ∅2.9 mm
19
18
17
A
20 21
22 23
D
25
24
F/G
25
26
I

13
en
3.7.5 S4C navigated guide sleeve ∅3.5 mm/4.0 mm FW660R
►Loosen inner sleeve 27 counterclockwise, unscrew and remove from
the handle by pulling in the direction of the arrow.
►Loosen knob 25 counterclockwise, unscrew and remove from the han-
dle by pulling in the direction of the arrow.
Fig.18 Disassembling the guide sleeve ∅3.5 mm/4.0 mm
3.8 Cleaning/Disinfection
3.8.1 Product-specific safety information on the reprocessing
method
Damage to or destruction of the product due to inappropriate clean-
ing/disinfecting agents and/or excessive temperatures!
►Following the manufacturer's instructions, use cleaning and disinfect-
ing agents.
►Observe specifications regarding concentration, temperature and
exposure time.
►Do not exceed the maximum allowable disinfection temperature of
95 °C.
Note
For cleaning and disinfecting the reference star unit (pre-calibrated) and
the reference star unit ML (calibration with ICM4), see Brainlab user man-
ual.
3.8.2 Validated cleaning and disinfection procedure
25
27
K
Validated procedure Specific requirements Reference
Manual cleaning with
immersion disinfection
■FW655R to FW657R
■FW663R
■FW688R to FW689R
■Cleaning brush: 30 mm/∅: 4.5 mm, e.g. TA011944 and cleaning
brush: 20 mm/∅:2.5 mm, e.g. TE654202 and cleaning brush:
50 mm/∅: 10 mm, e.g. TA007747
■Disposable syringe 20 ml
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges, ensure that these
are in an open position and, if applicable, move the hinge while
cleaning.
■Drying phase: Use a lint-free cloth or medical compressed air
Chapter Manual cleaning/disinfection and sub-
section:
■Chapter Manual cleaning with immersion dis-
infection
Manual cleaning with
ultrasound and immersion
disinfection
■FJ985R
■FW067R
■FW165R
■FW652R
■FW658R
■FW660R to FW661R
■FW664R to FW665R
■Cleaning brush: 30 mm/∅: 4.5 mm, e.g. TA011944 and cleaning
brush: 20 mm/∅:2.5 mm, e.g. TE654202 and cleaning brush:
50 mm/∅: 10 mm, e.g. TA011327
■Disposable syringe 20 ml
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges, ensure that these
are in an open position and, if applicable, move the hinge while
cleaning.
■Drying phase: Use a lint-free cloth or medical compressed air
Chapter Manual cleaning/disinfection and sub-
section:
■Chapter Manual cleaning with ultrasound and
immersion disinfection

14
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Mechanical alkaline
cleaning and thermal dis-
infection
■FW657R
■FW663R
■FW688R–FW689R
■Connect components with lumens and channels directly to the rins-
ing port of the injector carriage.
■To flush the product: Use a flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place the product on the tray with all product links and joints open.
Chapter Mechanical cleaning/disinfection and
subsection:
■Chapter Mechanical alkaline cleaning and
thermal disinfecting
Manual pre-cleaning with
brush and subsequent
mechanical alkaline clean-
ing and thermal disinfec-
tion
■FW652R
■FW655R–FW656R
■FW658R
■FW660R
■FW664R–FW665R
■Cleaning brush: 30 mm/∅: 4.5 mm, e.g. TA011944 and cleaning
brush: 20 mm/∅:2.5 mm, e.g. TE654202 and cleaning brush:
50 mm/∅: 10 mm, e.g. TA007747
■Disposable syringe 20 ml
■Place the product on a tray that is suitable for cleaning (avoid rinsing
blind spots).
■FW664R, FW665R, FW658R, FW660R: To flush the product: Use a
flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place the product on the tray with all product links and joints open.
Chapter Mechanical cleaning/disinfection with
manual pre-cleaning and subsection:
■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 ther-
mal disinfection
■FW067R
■FW165R
■FJ985R
■FW661R
■Cleaning brush: 30 mm/∅: 4.5 mm, e.g. TA011944 and cleaning
brush: 20 mm/∅:2.5 mm, e.g. TE654202 and cleaning brush:
50 mm/∅: 10 mm, e.g. TA007747
■Disposable syringe 20 ml
■Place the product on a tray that is suitable for cleaning (avoid rinsing
blind spots).
■To flush the product: Use a flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place the product on the tray with all product links and joints open.
Chapter Mechanical cleaning/disinfection with
manual pre-cleaning and subsection:
■Chapter Manual pre-cleaning with ultrasound
and brush
■Chapter Mechanical alkaline cleaning and
thermal disinfecting
Validated procedure Specific requirements Reference

15
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3.9 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 necessary.
3.9.1 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 fresh
►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/disinfectant 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 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during
cleaning.
►Thoroughly rinse through these components with the cleaning disin-
fectant solution (at least five times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under run-
ning 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 solution.
►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 sur-
faces 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 Validated cleaning and disinfection procedure.
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) 5 2 D–W Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV Final rinse RT (cold) 1 - FD-W -
VDrying RT - - - -

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3.9.2 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 fresh
►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 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during
cleaning.
►Thoroughly rinse through these components with the cleaning disin-
fectant solution (at least five times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under run-
ning 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 solution.
►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 sur-
faces are moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible surfaces) under run-
ning 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 Validated cleaning and disinfection procedure.
Phase Step D
[°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) 5 2 D–W Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV Final rinse RT (cold) 1 - FD–W -
VDrying RT - - - -

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3.10 Mechanical cleaning/disinfection
Note
The cleaning and disinfection device must be of tested and approved effec-
tiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced
and checked at regular intervals.
3.10.1 Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
DW: 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 mechanical cleaning/disinfect-
ing.
Phase Step T
[°C/°F] t [min] Water quality Chemistry/Note
I Pre-rinse <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 disinfection 90/194 5 FD-W -
VDrying - - - According to the program for cleaning and disinfection device

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3.11 Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested and approved effec-
tiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced
and checked at regular intervals.
3.11.1 Manual pre-cleaning with a brush
D–W: Drinking water
RT: Room temperature
*Recommended: BBraun Stabimed fresh
►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/disinfectant 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 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during
cleaning.
►Thoroughly rinse through these components with the cleaning disin-
fectant solution (at least five times), using a disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under run-
ning 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 Disinfecting cleaning RT (cold) >15 2 D–W Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II Rinsing RT (cold) 1 - D–W -