B. Braun Aesculap S4 Manual

Aesculap®S4® Cervical
Aesculap Spine
en Instructions for use/Technical description
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
Instrumente
fr Mode d’emploi/Description technique
Instruments
es Instrucciones de manejo/Descripción técnica
Instrumental
it Istruzioni per l’uso/Descrizione tecnica
Strumenti
pt Instruções de utilização/Descrição técnica
Instrumentos
nl Gebruiksaanwijzing/Technische beschrijving
Instrumenten
da Brugsanvisning/Teknisk beskrivelse
Instrumenter
sv Bruksanvisning/Teknisk beskrivning
Instrument
fi Käyttöohje/Tekninen kuvaus
Instrumentit
lv Lietošanas instrukcijas/tehniskais apraksts
Instrumenti
lt Naudojimo instrukcija/techninis aprašas
Instrumentai
ru Инструкция по примению/Техническое описание

cs Návod k použití/Technický popis
Nástroje
pl Instrukcja użytkowania/Opis techniczny
Instrumenty
sk Návod na použitie/Technický opis
Nástroje
hu Használati útmutató/Műszaki leírás
Műszerek
sl Navodila za uporabo/Tehnični opis
Instrumenti
hr Upute za uporabu/Tehnički opis
Instrumenti
ro Manual de utilizare/Descriere tehnică
Instrumente
bg Упътване за употреба/Техническо описание
Инструменти
tr Kullanım Kılavuzu/Teknik açiklama
Aletler
el Οδηγίες χρήσης/Τεχνική περιγραφή
Όργανα

32145
78
6
14 mm
12 mm

109 11 12 13 14
15 1716 18 19 20 21 22

28 29
27
30
2423 2625
3231 33 34

35 37
42
41
3938 40
36
474443 45 46

54 55 5653 5857 59
48 52515049
60 61 65646362

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en
Aesculap®S4® Cervical
Instruments
Legend
1Twist drill handle FJ839R
2Bone awl FW041R
3Depth gauge FW042R, sounder FW044R & long version sounder
FW671R
4Tap FW046R & FW047R
5Ratchet handle FW165R (non ratchet handle FW067R)
6Drill FW051SU for 3.5 mm screws (FW052SU for 4.0 mm screws)
7Variable drill guide FW053R
8Fixed drill guide FW049R (14 mm) & FW669R (12 mm)
9Ball end screwdriver FJ968R (long version for favored angle screws
FJ988R)
10 Set screw removal screwdriver FW064R
11 Self-holding polyaxial screwdriver FW070R and FW131R (long ver-
sions for favored angle screws FW069R and FW132R)
12 Threaded screwdriver FW128R
13 Set screw starters FW058R, FW059R, FW133R and FW134R
14 Counter torque FW062R
15 Torque indicating screwdriver FW061R
16 Torque limiting T-handle FW129R
17 Screw body manipulator FW065R
18 Polyaxial screw revision instrument FW135R
19 Lamina preparator FW071R
20 Rod holding forceps FW076R
21 Straight hook holding forceps FW422R
22 Curved hook holding forceps FW528R
23 Compression forceps FW427R
24 Rod cutter FW082R
25 Straight cut rod cutter FW672R
26 Rod persuader FW084R
27 Rod persuader FW077R
28 Rod persuader ME084R
29 Linear rod persuader FW673R
30 Rod templates FW078R, FW080R and FW081R
31 Rod bending plates FW036R
32 Rod bender FW037R
33 In-Situ rod benders FW073R and FW074R
34 In-Situ rod bender FW136R
35 Favored angle guide sleeve FW066R
36 Apfelbaum C1-C2 obturator FJ983R
37 Apfelbaum trocar FJ984R
38 Favored angle screw tap FW089R
39 Favored angle screw drill FW088SU
40 Apfelbaum inner sleeve guide FJ985R
41 Occipital screwdriver FW213R
42 Occipital plate bending pliers FW090R
43 Drill bit for occipital plate screws 4.5 mm FW091SU (5.5 mm
FW092SU)
44 Tap for occipital plate screws 4.5 mm FW093R (5.5 mm FW094R)
45 Occipital drill guide double ended for 4.5 mm screws FW095R (for
5.5 mm screws FW096R), Occipital tap guide double ended for 4.5 mm
screws FW097R (for 5.5 mm screws FW098R)
46 Occipital screw remover FW099R
47 Occipital screw removal shaft FW101R
48 Occipital T-handle for screw removal FW116R
49 Occipital flexible set screw starter FW109R
50 Occipital torque wrench FW103R
51 Occipital counter torque handle FW104R
52 Guide tube for smooth shank screws FW054R
53 Smooth shank bone awl FW085R
54 Smooth shank drill with depth gauge FW086SU
55 Smooth shank screw tap FW087R
56 Rod pusher FW063R
57 Distraction forceps, curved FW428R
58 Distraction forceps, straight FW523R
59 Pedicle probe FW045R
60 Bone probe straight FW674R
61 Bone probe curved FW675R
62 Bone probe blunt straight FW676R
63 Bone probe blunt curved FW677R
64 Bone probe thoracic straight FW678R
65 Bone probe thoracic curved FW679R
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.2.3 Sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.3.1 Preparing the holes for S Cervical screws . . . . . . . . . . . . . . . . 4
2.3.2 Drilling the holes for S Cervical screws . . . . . . . . . . . . . . . . . . 4
2.3.3 Tapping (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.3.4 Positioning and temporary fixation of an S Cervical screw. . 5
2.3.5 Adapting the S Cervical rods . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.6 Rod persuader (26, 27, 28, 29). . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.7 Insertion of set screw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.3.8 Removing the S4 Cervical implants. . . . . . . . . . . . . . . . . . . . . . 7
2.3.9 Pseudo rod revision instrument . . . . . . . . . . . . . . . . . . . . . . . . . 7
3. Validated reprocessing procedure . . . . . . . . . . . . . . . . . . . . . . . 7
3.1 General safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 General information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.3 Single-use products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.4 Reusable products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.5 Preparations at the place of use . . . . . . . . . . . . . . . . . . . . . . . . 8
3.6 Preparing for cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

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3.7 Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.7.1 Twist drill handle (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.7.2 S Cervical tap (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.7.3 S Cervical self holding polyaxial screwdriver (11) . . . . . . . . . . 8
3.7.4 Rod persuader (26) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.7.5 S Cervical TH Threaded screwdriver (12) . . . . . . . . . . . . . . . . . 9
3.7.6 Linear rod persuader (29) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3.7.7 Occipital drill guide and tap guide (45). . . . . . . . . . . . . . . . . . . 9
3.8 Cleaning/Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.8.1 Product-specific safety information on the reprocessing
method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.8.2 Validated cleaning and disinfection procedure. . . . . . . . . . . . . 10
3.9 Manual cleaning/disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.9.1 Manual cleaning with immersion disinfection . . . . . . . . . . . . . 12
3.9.2 Manual cleaning with ultrasound and immersion disinfection 13
3.10 Mechanical cleaning/disinfection. . . . . . . . . . . . . . . . . . . . . . . . 14
3.10.1 Mechanical alkaline cleaning and thermal disinfecting. . . . . . 14
3.11 Mechanical cleaning/disinfection with manual pre-cleaning . 15
3.11.1 Manual pre-cleaning with a brush. . . . . . . . . . . . . . . . . . . . . . . 15
3.11.2 Manual pre-cleaning with ultrasound and brush . . . . . . . . . . . 15
3.11.3 Mechanical alkaline cleaning and thermal disinfecting. . . . . . 16
3.11.4 Mechanical neutral or mild alkaline cleaning and thermal
disinfecting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.12 Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.12.1 Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.12.2 Functional test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.13 Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.13.1 Twist drill handle (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.13.2 S Cervical tap (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.13.3 S Cervical self holding polyaxial screwdriver (11). . . . . . . . . . 17
3.13.4 Rod persuader (26) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.13.5 S Cervical TH Threaded screwdriver (12) . . . . . . . . . . . . . . . . . 17
3.13.6 Linear rod persuader (29) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.13.7 Straight cut rod cutter (25) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.13.8 Occipital drill guide and tap guide (45) . . . . . . . . . . . . . . . . . . . 18
3.14 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.15 Steam sterilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.16 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4. Technical service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
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 S4® Cervical 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.

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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
Product-specific safety information
►Always follow the instructions for use of the S4Cervical Implants
(TA011796) and the respective operating manual.
►Observe the surgical technique of the S4Cervical system O34202.
►Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►Store any new or unused products in a dry, clean, and safe place.
►Inspect the product after each cleaning and disinfecting cycle to be
sure that it is clean, functioning properly and not damaged.
►Prior to each use, inspect the product for loose, bent, broken, cracked,
worn, or fractured components.
►Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►Replace any damaged components immediately with original spare
parts.
►To avoid damage to the working end: Carefully insert the product
through the working channel (e.g. trocar).
►Do not use products that are in open or damaged sterile packaging.
►Do not use the product after its use-by date.
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 (FW051SU, FW052SU, FW086SU, FW088SU,
FW091SU, FW092SU)
The product has been radiation-sterilized and is supplied in sterile packag-
ing.
►Do not reuse the product.
►Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►Read, follow, and keep the instructions for use.
►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.
2.3.1 Preparing the holes for S⁴Cervical screws
The holes for self-tapping S4Cervical screws are started using the
S4Cervical bone awl 2. The cortical layer of the vertebral body is pene-
trated in this process. A raised edge is provided on the standard bone awl 2
which provides an indication as to when the ideal depth has been reached.
Fig.1 Awl fully inserted
Opening the cortical layer with the bone awl 2
DANGER
Risk of damage to the spinal cord, nerve roots, adjacent intervertebral
space or soft tissue when inserting the bone awl!
►Never insert the awl beyond the raised edge, see Fig 1.
2.3.2 Drilling the holes for S⁴Cervical screws
DANGER
Risk of injury from an incorrectly placed hole or a hole that is too
deep!
►Do not sharpen the drill, as this makes it the reading on the depth
gauge inaccurate and falsifies the reading.
►Replace blunt drills with new ones.
The drill is applied with a drill guide and can be driven manually with twist
drill handle 1or with a motor system and Aesculap intra handpiece (e.g.,
GD45OR/GD456R).
Mounting the drill and handle (only for manual drilling)
Fig.2 Mounting the drill
►Use twist drill handle 1for manual drilling.

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DANGER
Risk of damage to the spinal cord, nerve roots, adjacent intervertebral
space or soft tissue when drilling the holes!
►Always use the correct S4Cervical drilling guides when drilling the
holes. Do not combine drills and guides incorrectly.
►Always check the drill lengths with the guide sleeve being used
using a caliper (e.g., AA845R, Caspar instrument for anterior cer-
vical fusion) before starting to drill.
DANGER
Injury to spinal cord and nerve roots caused by application of a drill
that is too long!
►Use x-ray image to select an appropriate drill length prior to the
operation.
►Alignment and insertion of the drills may only be executed under
radiographic monitoring and/or aided by a navigation system.
►Select a drill of a length equivalent to the intended drill hole depth.
►To insert drill in twist drill handle 1:
– Pull back locking sleeve against the spring pressure, in the direction
indicated by the arrow and hold it there.
– Push drill into the adapter of twist drill handle as far as it will go.
– Slightly twist drill while releasing locking sleeve.
Fig.3 Drill engages audibly
DANGER
Risk of injury and damage to the drill if the rotational speed is too
high!
►Be sure to set a rotational speed appropriate for the intended
application.
Fig.4 Drilling with the drill guide (FW053R, FW049R or FW669R)
►For the variable drill guide 7, set the depth to be drilled on the depth
stop by rotating the plastic collar on the guide sleeve. The fixed drill
guide (14 mm) 8has a green handle. The fixed drill guide (12 mm) 8
has a red handle.
►Check the length to be drilled prior to drilling by inserting the drill in
the guide and measuring the cutting depth with a caliper (e.g.,
AA845R).
►Drill to the preset depth. The stop unit stops the drill on the guide
sleeve.
2.3.3 Tapping (optional)
S4Cervical screws are self-tapping screws. However, if the bone quality is
found to be hard, the operating surgeon can decide to pre-tap the thread
with the S4Cervical tap.
DANGER
Risk of tissue injury when inserting the S4Cervical tap or stripping
bone threads!
►Always check if the sleeve retracts correctly prior to applying the
S4Cervical tap.
►To tap the thread:
– Slowly drive the S4Cervical tap 4in steadily until the required
depth is reached.
– The depth is read from the scale as the sleeve retracts during tap-
ping.
Fig.5 Depth is read from scale
2.3.4 Positioning and temporary fixation of an S⁴Cervical screw
Picking up the S⁴Cervical screw
►Pick up the S4Cervical screw with the S4Cervical self holding polyaxial
screwdriver 11.
Fig.6 Picking up the S4Cervical screw
►To prevent the S4Cervical screw from dropping out of the S4Cervical
self holding polyaxial screwdriver 11 during transfer to the operating
surgeon, lock the instrument by pulling back and releasing the blue
knob.
►Make sure that the S4Cervical screw is firmly seated on the S4Cervical
self holding polyaxial screwdriver and the polyaxiality of the screw is
blocked for insertion.
Using the S⁴Cervical TH threaded screwdriver 12
►Hold the S4Cervical screw body in one hand.
►Insert the S4Cervical TH threaded screwdriver 12 into the S4Cervical
screw hex.
►To affix the S4Cervical TH threaded screwdriver 12 to the screw, rotate
the blue handle clockwise until the screwdriver thread engages the
screw thread.
►Tighten until resistance is felt. Do not overtighten as this can cause dif-
ficulty disengaging the screwdriver after screw placement.
►After insertion of the S4Cervical screw into the patient: Rotate the
blue handle counter-clockwise to release the S4Cervical TH threaded
screwdriver 12.

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2.3.5 Adapting the S⁴Cervical rods
The Aesculap S4Cervical rods are supplied straight (excluding pre-bent for
occipital plate). Their curvature can be adjusted to the situation or to the
required spine lordosis using the S4Cervical bending instruments.
►Use the rod templates 30 for examining the degree of rod bend
required.
Note
For long S4Cervical rods, bending should be carried out in several steps in
order to avoid excessive or insufficient lordosis.
DANGER
Damage to and breakage of the S4Cervical rods caused by excessive
strain on the material!
►Always bend the S4Cervical rods in one direction only. Do not bend
back the S4Cervical rods.
►Always use S4Cervical bending instruments (e.g., 31, 32, 33, 34)
for bending S4Cervical rods.
►Avoid small bending radii, bending back, notching or scratching of
S4Cervical rods.
►To bend the S4Cervical rods close to their ends, use the rod bending
plates 31.
DANGER
Risk of damage to patient, personnel or equipment in the operating
room due to flying fragment from cut rod!
►Always hold the piece of rod to be cut at both ends.
►To cut the S4Cervical rods use the rod cutter 24 or 25.
►To cut the S4Cervical rods with rod cutter 25:
– Ensure that the handles of the rod cutter are in the free, relaxed and
open position.
– Rotate the large knob clockwise until both lines match between the
body of the device and the rotating knob.
– Mark the cutting location on the rod.
– Slide the rod into the center hole of the rod cutter through the
rotating knob until the mark on the rod is approximately at the
location of the cut line. The rod will be cut at the side of the rod cut-
ter marked with “cut location”.
– Squeeze handles together until they come close together.
– Release pressure on the handles and allow them to fully open again
to the relaxed position.
– Repeat several times until the rod is fully cut and can easily be
removed from the rod cutter.
If desired, sharp edges left after cutting the rod can be filed with a suitable
instrument such as the Aesculap durogrip file OL429R.
►Hold the rod during insertion using the S4Cervical rod holding
forceps 20.
Fig.7 Holding the rod
►Likewise hold the S4Cervical hooks using the S4Cervical hook holding
forceps 21,22.
2.3.6 Rod persuader (26, 27, 28, 29)
CAUTION
Damage to and breakage of the rod persuader!
►Never use the rod persuader to bend the S4Cervical rod.
►Never use the rod persuader to act as a counter torque for the
S4Cervical set screws.
►To persuade with rod persuader 28 or 29:
– Make sure that the persuader is placed axial to the screw head.
– Slide the persuader blades over the screw head so that the per-
suader reaches its operational point.
– Make sure that the pins of the persuader blades interface with the
holes in the head of the polyaxial screw.
– Make sure that both pins of the persuader blades engage the holes
of the polyaxial screw.
– Make sure to hold the persuasion knob as the passage of the set
screw may be obstructed by deflection of the hinge when holding
the linear rod persuader 29 by the outer sleeve.

7
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2.3.7 Insertion of set screw
CAUTION
Damage to the S4Cervical screw caused by incorrectly applying the
torque indicating screwdriver 15 when driving in the set screws!
This screwdriver is an indicating instrument. Align the two opposing
arrows to apply the proper torque.
►Always use the counter torque instrument 14 when tightening the
S4Cervical set screw in the S4Cervical screw body.
►Refer to TA011947 for further information.
CAUTION
Damage to the S4Cervical screw caused by incorrectly applying the set
screw removal screwdriver 10 and torque limiting T-handle 16 when
driving in the set screws!
►Ensure that the set screw removal screwdriver 10 is securely con-
nected to the torque limiting T-handle 16.
►Always use the counter torque instrument 14 when tightening the
S4Cervical set screw in the S4Cervical screw body.
CAUTION
Damage to the S4Cervical implants caused by incorrectly applying the
occipital flexible set screw starter 49 when driving in the set screws!
►Refer to TA012676 S4Cervical occiput mini set screw starter flex-
ible shaft.
2.3.8 Removing the S4Cervical implants
CAUTION
Damage to the S4Cervical torque indicating screwdriver 15!
►Never use the S4Cervical torque indicating screwdriver 15 for
extracting screws.
►Use the S4Cervical set screw removal screwdriver 10 together with
the handle 5 and counter torque 14 when extracting set screws.
CAUTION
Damage to the S4Cervical implants caused by incorrectly applying the
occipital torque wrench 50 when driving in the set screws!
►When tightening the set screw always apply counter torque using
the countering instrument for this purpose.
►Refer to TA012367 S4Cervical Spinal System - torque wrenches
with click function.
2.3.9 Pseudo rod revision instrument
CAUTION
Damage to and breakage of the pseudo rod revision instrument!
►Never use the pseudo rod revision instrument to release a locked
S4Cervical polyaxial screw tulip.
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".

8
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3.3 Single-use products
■FW051SU
■FW052SU
■FW086SU
■FW088SU
■FW091SU
■FW092SU
►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 and
TA012367.
►Open up product with hinges.
3.7 Disassembly
3.7.1 Twist drill handle (1)
Fig.8 Disassembling of twist drill handle
►Pull off twist drill handle 1from collar in the direction indicated by the
arrow.
3.7.2 S⁴Cervical tap (4)
Fig.9 Disassembling of taps
►Loosen and unscrew nut and remove it from the sleeve in the direction
of the arrow.
►Remove sleeve together with the spring in the direction of arrow.
3.7.3 S⁴Cervical self holding polyaxial screwdriver (11)
Fig.10 Exploded view of S4Cervical self holding polyaxial screwdriver
Note
These instructions are also valid for FW070R, FW131R, FW069R, FW132R.
CAUTION
The screwdriver will not function properly if the retaining tongues are
bent or crimped!
►Do not bend or crimp the retaining tongues.
►Pull back on blue knob (black for FW069R and FW132R).
►Loosen and unscrew the screw sleeve at the working end of the instru-
ment.
►Keep the blue knob (black for FW069R and FW132R) pulled back until
the screw sleeve is completely unscrewed.
►Slide the knob and the retaining tongues towards the working end of
the instrument and off the screwdriver shaft.
►Remove the spring.
3.7.4 Rod persuader (26)
Fig.11 Disassembling of rod persuader
►Pull the release mechanism on the back handle to the downward posi-
tion and maintain this position until the rear handle has been removed.
►Holding the outer shaft pull the front handle towards the rear of the
persuader until fully disassembled.

9
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3.7.5 S⁴Cervical TH Threaded screwdriver (12)
Fig.12 Disassembling the threaded screwdriver
►Hold the screwdriver 12 at the distal or hex end.
►Turn the adapter for handle Aon the back end of instrument counter-
clockwise.
►Remove the screwdriver shaft Bthrough the handle-sleeve assembly C.
3.7.6 Linear rod persuader (29)
►Ensure the proximal knob is in the unlock extended position.
This will retract the locking sleeves from the inner sleeve.
Fig.13 Proximal knob is in the unlock extended position
►Turn the persuasion nut as if persuading the rod until the screw threads
are no longer engaged.
Fig.14 Turning the persuasion nut
►Press the circular tabs of the hinge.
This will lift the pins out of the inner sleeve, enabling it to be pulled out
of the outer sleeve.
Fig.15 Pulling out the inner sleeve
►Remove the locking sleeves by rotating them out from under the knob.
Fig.16 Removing the locking sleeves
3.7.7 Occipital drill guide and tap guide (45)
Fig.17 Removing the sleeves
►Remove the sleeves by rotating them out clockwise.
A
ACB

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3.8 Cleaning/Disinfection
3.8.1 Product-specific safety information on the reprocessing
method
Danger to the patient! FW672R must not be manually reprocessed.
►Reprocess FW672R only by manually pre-cleaning followed by cleaning
in a mechanical washer/disinfector.
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
– that are approved for aluminium, plastics, high-grade steel,
– that do not attack softeners (e.g., in silicone).
►Observe specifications regarding concentration, temperature and
exposure time.
►Do not exceed the maximum allowable disinfection temperature of
95 °C.
►If the microsurgical products can be securely fixed in machines or stor-
age devices in such a way that they will be cleaned thoroughly, clean
and disinfect them mechanically.
3.8.2 Validated cleaning and disinfection procedure
Validated procedure Specific requirements Reference
Manual cleaning with
immersion disinfection
■For FJ839R, FJ968R, FJ983R, FJ984R, FJ988R, FW036R, FW037R, FW041R, FW042R,
FW044R, FW045R, FW046R, FW047R, FW049R, FW053R, FW058R, FW059R, FW061R,
FW062R, FW063R, FW064R, FW065R, FW066R, FW069R, FW070R, FW071R, FW073R,
FW074R, FW076R, FW078R, FW080R, FW081R, FW085R, FW087R, FW089R, FW093R,
FW094R, FW095R, FW096R, FW097R, FW098R, FW099R, FW101R, FW103R FW104R,
FW109R, FW131R, FW132R, FW133R, FW134R, FW135R, FW136R, FW213R, FW422R,
FW427R, FW528R, FW669R, FW671R, FW674R, FW675R, FW676R, FW677R, FW678R,
FW679R
■Cleaning brush: e.g., TA011327, TA006874 for FW095R, FW096R, FW097R, FW098R
■Disposable syringe 20 ml
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges, ensure that these are in an open posi-
tion and, if applicable, move the hinge while cleaning.
■Drying phase: Use a lint-free cloth or medical compressed air
Chapter Manual cleaning/disin-
fection and subsection:
■Chapter Manual cleaning with
immersion disinfection
Manual cleaning with
ultrasound and immer-
sion disinfection
■For FJ985R, FW054R, FW067R, FW077R, FW082R, FW084R, FW090R, FW116R, FW128R,
FW129R, FW165R, FW428R, FW523R, FW673R, ME084R
■Cleaning brush: e.g. TA011944
■Disposable syringe 20 ml
■Keep working ends open for cleaning.
■When cleaning instruments with movable hinges, ensure that these are in an open posi-
tion and, if applicable, move the hinge while cleaning.
■Drying phase: Use a lint-free cloth or medical compressed air
Chapter Manual cleaning/disin-
fection and subsection:
■Chapter Manual cleaning with
ultrasound and immersion
disinfection

11
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Mechanical alkaline
cleaning and thermal
disinfection
■For FJ968R, FJ983R, FJ984R, FJ988R, FW037R, FW041R, FW042R, FW044R, FW045R,
FW058R, FW059R, FW061R, FW062R, FW063R, FW064R, FW065R, FW066R, FW071R,
FW073R, FW074R, FW076R, FW078R, FW080R, FW081R, FW085R, FW087R, FW089R,
FW093R, FW094R, FW098R, FW101R, FW103R, FW109R, FW133R, FW134R, FW135R,
FW136R, FW422R, FW528R, FW671R, FW674R, FW675R, FW676R, FW677R, FW678R,
FW679R
■Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■Connect components with lumens and channels directly to the rinsing port of the injec-
tor carriage.
■To flush the product: Use a flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place products in the tray with their hinges open.
Chapter Mechanical clean-
ing/disinfection and subsection:
■Chapter Mechanical alkaline
cleaning and thermal disin-
fecting
Manual pre-cleaning
with brush and subse-
quent mechanical
alkaline cleaning and
thermal disinfection
■For FJ839R, FW036R, FW046R, FW047R, FW049R, FW053R, FW054R, FW069R, FW070R,
FW077R, FW095R, FW096R, FW097R, FW099R, FW104R, FW131R, FW132R, FW213R,
FW427R, FW428R, FW523R, FW669R
■Cleaning brush: e.g. TA011327, TA006874 for FW095R, FW096R, FW097R, FW098R
■Disposable syringe 20 ml
■Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■Connect components with lumens and channels directly to the rinsing port of the injec-
tor carriage.
■To flush the product: Use a flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place products in the tray with their hinges open.
Chapter Mechanical clean-
ing/disinfection with manual pre-
cleaning and subsection:
■Chapter Manual pre-cleaning
with a brush
■Chapter Mechanical alkaline
cleaning and thermal disin-
fecting
Manual pre-cleaning
with brush and subse-
quent mechanical neu-
tral or mild alkaline
cleaning and thermal
disinfection
■For FW672R
■Suitable cleaning brush
■Disposable syringe 20 ml
■Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
Chapter Mechanical clean-
ing/disinfection with manual pre-
cleaning and subsection:
■Chapter Manual pre-cleaning
with a brush
■Chapter Mechanical neutral or
mild alkaline cleaning and
thermal disinfecting
Manual pre-cleaning
with ultrasound and
brush, and subsequent
mechanical alkaline
cleaning and thermal
disinfection
■For FJ985R, FW067R, FW082R, FW084R, FW090R, FW116R, FW128R, FW129R, FW165R,
FW673R, ME084R
■Cleaning brush: e.g. TA011944
■Disposable syringe 20 ml
■Mount jaws protection on the product.
■Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).
■Connect components with lumens and channels directly to the rinsing port of the injec-
tor carriage.
■To flush the product: Use a flushing nozzle or flushing sleeve.
■Keep working ends open for cleaning.
■Place products in the tray with their hinges open.
Chapter Mechanical clean-
ing/disinfection with manual pre-
cleaning and subsection:
■Chapter Manual pre-cleaning
with ultrasound and brush
■Chapter Mechanical alkaline
cleaning and thermal disin-
fecting
Validated procedure Specific requirements Reference

12
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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 - - - -

13
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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 - - - -

14
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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