B. Braun Aesculap S4 Manual

Aesculap®S4® Cervical
Aesculap Spine
Instructions for use/Technical description
S4® Cervical Instruments
Gebrauchsanweisung/Technische Beschreibung
S4® Cervical Instrumente
Mode d’emploi/Description technique
Instruments S4® Cervical
Instrucciones de manejo/Descripción técnica
Instrumentos S4® Cervical
Istruzioni per l’uso/Descrizione tecnica
Strumenti S4® Cervical
Instruções de utilização/Descrição técnica
Instrumentos S4® Cervical
Gebruiksaanwijzing/Technische beschrijving
S4® Cervical Instruments
Bruksanvisning/Teknisk beskrivning
S4® Cervical Instrument
Инструкция по примению/Техническое описание
 S4® Cervical
Návod k použití/Technický popis
Nástroje S4® Cervical
Instrukcja użytkowania/Opis techniczny
Instrumenty S4® Cervical
Návod na použivanie/Technický opis
Nástroje S4® Cervical
Kullanım Kılavuzu/Teknik açiklama
S4® Cervical Aletler

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

2
Aesculap®S4® Cervical
S4® Cervical Instruments
Aesculap®S4® CervicalS4® 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
Symbols on product and packages
Sterilization using irradiation
Not for reuse in intended applications as defined by the
manufacturer
Use by
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture

3
Contents
1. Applicable to 3
2. Intended use 3
3. Safe handling and preparation 3
4. Safe operation 4
4.1 Preparing the holes for S Cervical screws 4
4.2 Drilling the holes for S Cervical screws 4
4.3 Tapping (optional) 5
4.4 Positioning and temporary fixation of an S Cervical screw 6
4.5 Adapting the S Cervical rods 6
4.6 Rod persuader (26, 27, 28, 29) 7
4.7 Insertion of set screw 7
4.8 Removing the S4 Cervical implants 8
4.9 Pseudo rod revision instrument 8
5. Disassembling 8
5.1 Twist drill handle (1) 8
5.2 S Cervical tap (4) 8
5.3 S Cervical self holding polyaxial screwdriver (11) 9
5.4 Rod persuader (26) 9
5.5 S Cervical TH Threaded screwdriver (12) 9
5.6 Linear rod persuader (5) 10
6. Assembling 11
6.1 Twist drill handle (1) 11
6.2 S Cervical tap (4) 11
6.3 S Cervical self holding polyaxial screwdriver (11) 11
6.4 Rod persuader (26) 11
6.5 S Cervical TH Threaded screwdriver (12) 11
6.6 Linear rod persuader (5) 12
6.7 Straight cut rod cutter (25) 12
7. Validated reprocessing procedure 13
7.1 General safety instructions 13
7.2 Single-use products (FW051SU, FW052SU, FW086SU,
FW088SU, FW091SU, FW092SU) 13
7.3 General information 13
7.4 Disassembling the product before carrying out the
reprocessing procedure 14
7.5 Preparations at the place of use 14
7.6 Preparation before cleaning 14
7.7 Cleaning/disinfection 14
7.8 Manual cleaning/disinfection 17
7.9 Mechanical cleaning/disinfecting 19
7.10 Mechanical cleaning/disinfection with manual pre-cleaning 20
7.11 Inspection, maintenance and checks 22
7.12 Packaging 22
7.13 Steam sterilization 22
7.14 Sterilization for the US market 22
7.15 Storage 23
8. Technical Service 23
9. Disposal 23
10. Distributor in the US/Contact in Canada for product
information and complaints 23
1. Applicable to
►For item-specific instructions for use and information on material
compatibility, see also the Aesculap Extranet at
www.extranet.bbraun.com
2. Intended use
The S4Cervical system is used for posterior occipital cervical and thoracic
stabilization and fusion. Indications and contraindications are listed in the
instructions for use for the implants (TA011796). The instruments listed in
the captions form part of this system. They are used for adapting the
S4Cervical implants to the individual patient and to position and insert
the implants.
3. Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►Always follow the instructions for use of the S4Cervical Implants
(TA011796) and the respective operating manual (O34202).
►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, see Intended
use.
►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.

4
Aesculap®S4® Cervical
S4® Cervical Instruments
Single-use products (FW051SU, FW052SU, FW086SU, FW088SU,
FW091SU, FW092SU)
The product has been radiation-sterilized and is supplied in sterile pack-
aging.
The product must not be reused.
►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, see 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.
4. Safe operation
4.1 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 2which 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
4.2 Drilling the holes for S⁴Cervical screws
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.
WARNING
Risk of injury and malfunction!
►Always carry out a function check prior to using
the product.
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.
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 fal-
sifies the reading.
►Replace blunt drills with new ones.
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 cervical fusion)
before starting to drill.

5
►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
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.
4.3 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.
►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
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.
DANGER
Risk of injury and damage to the drill if the rota-
tional speed is too high!
►Be sure to set a rotational speed appropriate for
the intended application.
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.

6
Aesculap®S4® Cervical
S4® Cervical Instruments
4.4 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.
4.5 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.
►To bend the S4Cervical rods close to their ends, use the rod bending
plates 31.
►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
cutter 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.
DANGER
Damage to and breakage of the S4Cervical rods
caused by excessive strain on the material!
►Always bend the S4Cervical rods in one direc-
tion 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, notch-
ing or scratching of S4Cervical rods.
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.

7
►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 23,24.
4.6 Rod persuader (26, 27, 28, 29)
►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.
4.7 Insertion of set screw
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.
CAUTION
Damage to the S4Cervical screw caused by incor-
rectly 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 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 Flexible Shaft.

8
Aesculap®S4® Cervical
S4® Cervical Instruments
4.8 Removing the S4Cervical implants
4.9 Pseudo rod revision instrument
5. Disassembling
5.1 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.
5.2 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.
CAUTION
Damage to the S4Cervical Torque Indicating
Screwdriver 15 or 16!
►Never use the S4Cervical Torque Indicating
Screwdriver 15 or 16 for extracting screws.
►Use the S4Cervical set screw removal
screwdriver 10 together with the handle 5 and
counter torque 14 when extracting set screws.
►Refer to TA011948 for further information.
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.
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.

9
5.3 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.
►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.
5.4 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.
5.5 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.
CAUTION
The screwdriver will not function properly if the
retaining tongues are bent or crimped!
►Do not bend or crimp the retaining tongues.
A
ACB

10
Aesculap®S4® Cervical
S4® Cervical Instruments
5.6 Linear rod persuader (5)
►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

11
6. Assembling
6.1 Twist drill handle (1)
►Push handle onto collar against the direction indicated by the arrow,
see Fig. 8.
6.2 S⁴Cervical tap (4)
►Slide guide sleeve with spring over the tap against the direction of the
arrow and fasten it by turning the nut clockwise, see Fig. 9.
6.3 S⁴Cervical self holding polyaxial screwdriver (11)
Note
These instructions are also valid for FW070R, FW131R, FW069R, FW132R.
►Replace the spring on the shaft.
►Slide the knob with retaining tongues onto the screwdriver shaft in
such a way that the retaining tongues engage the grooves of the
screwdriver shaft, see Fig. 10.
►Pull back on blue knob (black for FW069R and FW132R).
►Screw the screw sleeve onto the tip of the screwdriver and tighten it
down.
►Keep the blue knob (black for FW069R and FW132R) pulled back until
the screw sleeve is completely tightened.
6.4 Rod persuader (26)
Fig. 17 Assembling of rod persuader
►Align the gripping end with the outer shaft and carefully depress the
gripping fingers inward until secured in the outer shaft.
►Position the rear handle concentrically with the outer shaft and apply
pressure until an audible click is heard confirming locking.
►Squeeze the handle to verify successful assembly.
6.5 S⁴Cervical TH Threaded screwdriver (12)
►Slide screwdriver shaft Bthrough the handle-sleeve assembly C, see
Fig. 12.
►Insert the adapter for handle Aonto screwdriver shaft B.
►Turn the adapter for handle Aclockwise and fully tighten thread.
►Make certain the adapter for handle Ais threaded onto screwdriver
shaft B.
CAUTION
The screwdriver will not function properly if the
retaining tongues are bent or crimped!
►Do not bend or crimp the retaining tongues.

12
Aesculap®S4® Cervical
S4® Cervical Instruments
6.6 Linear rod persuader (5)
►Engage the locking sleeves into the proximal nut by rotating them into
the groove of the knob.
Fig. 18 Engaging the locking sleeves
►Slide the inner assembly into the outer sleeve.
Fig. 19 Sliding the inner assembly into the outer sleeve
►Press the circular tabs of the hinge to lift the pins and slide the inner
tube into position.
Fig. 20 Sliding the inner tube into the position
►Re-engage the persuasion nut and thread completely to the starting
position to prepare for use.
Fig. 21 Re-engaging the persuasion nut
6.7 Straight cut rod cutter (25)
►Apply Aesculap STERILIT® lubricant as needed.
Fig. 22 Applying lubricant

13
7. Validated reprocessing procedure
7.1 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 techni-
cian is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For the latest information on reprocessing and material compatibility see
also the Aesculap extranet at www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
7.2 Single-use products (FW051SU, FW052SU,
FW086SU, FW088SU, FW091SU, FW092SU)
7.3 General information
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation 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 Publica-
tions, Red Brochure – Proper maintenance of instruments.
WARNING
Risk of infection for patients and/or users and
impairment of product functionality due to reuse.
Risk of injury, illness or death due to contamination
and/or impaired functionality of the product!
►Do not reprocess the product!

14
Aesculap®S4® Cervical
S4® Cervical Instruments
7.4 Disassembling the product before carrying out the
reprocessing procedure
►Disassemble the product immediately after use, see Disassembling and
TA012367.
►Open up instruments with hinges.
7.5 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.
7.6 Preparation before cleaning
►Disassemble the product prior to cleaning, see Disassembling.
7.7 Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►Mount jaws protection on the product.
►Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disin-
fection.
– as a pre-cleaning procedure for products with encrusted residues,
in preparation for mechanical cleaning/disinfection.
– as an integrated mechanical support measure for mechanical
cleaning/disinfection.
– for additional cleaning of products with residues left after mechan-
ical cleaning/disinfection.
►Clean and disinfect microsurgical products mechanically if they can be
placed securely in the machine or on the positioning aids.
CAUTION
Damage to the product due to inappropriate clean-
ing/disinfecting agents and excessive tempera-
tures!
►Use cleaning and disinfecting agents according
to the manufacturer’s instructions which
–are approved for e.g. aluminum, plastics,
high-grade steel,
–do not attack softeners (e.g. in silicone).
►Observe specifications regarding concentration,
temperature and exposure time.
►Do not exceed the maximum allowable washing
temperature of 60 °C.