Braun Aesculap activ L User manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
activ L instruments

EG F
BA
0
H
1
3
467 8 9
10
2
5
Midline marker
FW955R
Hammer
FL045R
Slotted Hammer
FW579R
Key for inserter
FW945R
CD
Spacers
FW951R FW954R
Wedges
FW941R-FW944R
I
11
12
13
14
Trial Implants
FW922R-FW928R/
FW971RFW979R)
activ L parallel distractor FW970
activ L handle
(for chisel guide)
FW980R Chisel guides
FW981R–FW984R/
FW989R-FW996R
Double chisels
FW985R–FW988R
Single chisels
FW989R–FW992

23
24
25
26
K
27
28
29
30
31
L
32
33
34
M
41
O
37
36
38
39
35
N
40
J
16
15 17
18
19
20
21
22
activ L insertion instrument
FW961R–FW964R
activ L angled distraction
forceps FW960R
activ L angled revision
distraction forceps FW965R
activ L revision instrument
for PE inlay FW968R
activ L revision instrument for
endplates FW966R/FW967R
activ L handle for
revision instrument FW998R

2
Aesculap®
activ L instruments
Aesculap® activ L instruments
Legend
A Midline marker FW955R
B Trial Implants FW922R-FW928R/FW971R-
FW979R)
C Wedges FW941R-FW944R and shaft for wedge
FW940R
D Spacers FW951R–FW954R
E Hammer FL045R
F Key for inserter FW945R
G Slotted Hammer FW579R
H activ L parallel distractor FW970
1Cranial jaw piece
2Caudal jaw piece
3Sheath
4Scale
5Indicator pin
6Handle
7Nut cage
8Nut
9Pushing rod
10 Twist cap
I activ L handle (for chisel guide) FW980R, dou-
ble chisels FW985R–FW988R, single chisels
FW989R–FW992 & chisel guides FW981R–
FW984R/FW989R-FW996R
11 Handle (for chisel guide)
12 Chisel guide
13 Double chisel
14 Single chisel
J activ L insertion instrument FW961R–FW964R
15 Spacer
16 Clamp
17 Clamping sleeve
18 Insertion instrument handle
19 Slotted-hole pin
20 Coupling pin
21 Twist cap
22 Unlocking button
K activ L angled distraction forceps FW960R
23 Handle parts
24 Lock
25 Locking lever
26 Working tip
L activ L angled revision distraction forceps
FW965R
27 Handle parts
28 Lock
29 Locking lever
30 Working tip
31 Pins
M activ L revision instrument for PE inlay FW968R
32 Jaw piece
33 Adjustment knob
34 Tubular shaft
N activ L revision instrument for
endplates FW966R/FW967R
35 Handpiece
36 Anchoring rods
37 Hooks
38 Lock nuts
39 Pins
40 Slots
O activ L handle for revision instrument FW998R
41 Handle
Symbols on product and packages
Applicable to
►For item-specific instructions for use and informa-
tion on material compatibility, see also the
Aesculap Extranet at https://extranet.bbraun.com
Caution, general warning symbol
Caution, see documentation sup-
plied with the product

3
Intended use
The intended use of the activ L instruments are to
allow successful implantation of the Aesculap activ L
device. These instruments aid in selecting, placing, and
revising the activ L device. The activ L device comprises
of superior and inferior endplates that are offered in
four footprint sizes (S, M, L, and XL), two footprint
shapes (Normal and S1), and two fixation options
(spiked and keeled) as well as a polyethylene core that
results in 4 possible implant heights, (8,5 mm, 10 mm,
12 mm, and 14 mm). This instructions for use docu-
ment refers to these variables, and the instruments
themselves are clearly labelled, but additional infor-
mation regarding use can be found in the surgical
technique guide.
activ L parallel distractor FW970
The activ L parallel distractor is used for distraction
and determining the correct size and height of the
intervertebral disk prosthesis.
activ L handle (for chisel guide) FW980R,
double chisels FW985R–FW988R, single
chisels FW989R–FW992 & chisel guides
FW981R–FW984R/FW989R-FW996R
activ L chisels and chisel guides are used to prepare the
keel bed in one or two vertebral bodies for anchoring
the activ L disk prosthesis with keel.
A double or single chisel is required depending on
whether the keel or combined version is being used.
activ L insertion instrument FW961R–
FW964R
The activ L insertion instrument is used for implanting
the intervertebral disc prosthesis through anterior (0°)
approach. The appropriate color-coded and labeled
insertion instrument is used according to the implant
height.
activ L revision instruments and distrac-
tion forceps
The activ L revision instruments and distraction forceps
are used for the distraction/mobilization of two adja-
cent lumbar vertebral bodies or prostheses plates, as
well as for the repositioning and revision of activ L
intervertebral disk prostheses.
activ L angled distraction forceps FW960R
The activ L angled distraction forceps is used for the
distraction/mobilization of two adjacent vertebral
bodies.
activ L angled revision distraction forceps
FW965R
The activ L angled revision distraction forceps is used
for distracting the two activ L metal plates of an
implanted activ L prosthesis in order to remove the PE
inlay in corrective surgery.
activ L revision instrument for PE
inlay FW968R
The activ L revision instrument for PE inlay is used for
the revision of the activ-L PE inlay.
activ L revision instrument for
endplates FW966R/FW967R
The activ L revision instrument for endplates and the
corresponding handle are used for the repositioning
and revision of activ L intervertebral disk prostheses.

4
Aesculap®
activ L instruments
Available sizes
Trial implants
Note
The trial implants are used with the activ L parallel dis-
tractor FW970R.
activ L wedges, spacers, chisels and chisel
guides
Art. no. Designation Size
FW922R Trial implant caudal S1 S 5°
FW923R Trial implant caudal S1 M 5°
FW924R Trial implant caudal S1 L 5°
FW925R Trial implant caudal S1 XL 5°
FW926R Trial implant caudal XL 0°
FW927R Trial implant cranial XL 6°
FW928R Trial implant cranial XL 11°
FW971R Trial implant caudal S 0°
FW972R Trial implant caudal M 0°
FW973R Trial implant caudal L 0°
FW974R Trial implant cranial S 6°
FW975R Trial implant cranial S 11°
FW976R Trial implant cranial M 6°
FW977R Trial implant cranial M 11°
FW978R Trial implant cranial L 6°
FW979R Trial implant cranial L 11°
Art. no. Designation Size
FW941R Wedge 6 mm
FW942R 8 mm
FW943R 10 mm
FW944R 12 mm
FW951R Spacer 8,5 mm
FW952R 10 mm
FW953R 12 mm
FW954R 14 mm
FW981R activ L chisel guide 8.5 mm, 6°
FW982R 10 mm, 6°
FW983R 12 mm, 6°
FW984R 14 mm, 6°
FW985R activ L double chisel 8,5 mm
FW986R 10 mm
FW987R 12 mm
FW988R 14 mm
FW989R activ L single chisel 8,5 mm
FW990R 10 mm
FW991R 12 mm
FW992R 14 mm
FW993R activ L chisel guide 8.5 mm, 11°
FW994R 10 mm, 11°
FW995R 12 mm, 11°
FW996R 14 mm, 11°

5
Note
The chisels and chisel guides are used with activ L han-
dle for chisel guide FW980R.
The wedges are used with activ L shaft for wedge
FW940R.
activ L insertion instrument
activ L revision instruments and distrac-
tion forceps
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
Use of the activ L instruments requires precise knowl-
edge about spine surgery and the stabilization and bio-
mechanical situation at the spine.
Operative use of the activ L instruments is described in
detail in the relevant surgical technique guide.
►Ensure that the product and its accessories are
operated and used only by persons with the requi-
site 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 thoroughly
clean the new product manually, prior to its initial
sterilization, see Validated reprocessing procedure.
►Store any new or unused products in a dry, clean,
and safe place.
►Prior to each use, inspect the product for loose,
bent, broken, cracked, worn, or fractured compo-
nents.
►Do not use the product if it is damaged or defec-
tive. Set aside the product if it is damaged.
►Replace any damaged components immediately
with original spare parts.
Art. no. Size
FW961R 8.5 mm
FW962R 10 mm
FW963R 12 mm
FW964R 14 mm
Art. no. Designation
FW960R activ L angled distraction forceps
FW965R activ L angled revision distraction
forceps
FW966R activ L revision instrument for end-
plates; size S/M
FW967R activ L revision instrument for end-
plates; size L/XL
FW968R activ L revision instrument for PE
inlay
FW998R activ L handle for revision instru-
ment

6
Aesculap®
activ L instruments
Disassembling for reprocessing
activ L parallel distractor FW970R
►Turn twist cap 10 counterclockwise until scale 4
reads “R” (Release), see Fig. 1.
►Laterally pull out indicator pin 5from the parallel
distractor.
►Detach twist cap 10.
Fig. 1 Dismounting the indicator pin
►Turn nut 8counterclockwise until the pushing
rod 9protrudes from the end of the handle 6by
approximately 3 mm, see Fig. 2.
►Pull out complete pushing rod 9from the parallel
distractor.
►Remove nut 8, which now lies unscrewed in nut
cage 7, either upward or downward.
Fig. 2 Dismounting the pushing rod
activ L double chisels FW985R–FW988R
& single chisels FW989R–FW992R
►Slide cage lback and rotate counterclockwise by
90°, see Fig. 3.
►Position guideway mon cage lin the chisel bridge.
Fig. 3 Preparing the double and single chisels
Legend
lCage
mGuideway
4
5
78910
7
89
6
l
m

7
activ L chisel guides FW981R–FW984R/
FW989R-FW996R
►Push irrigation tube (outer diameter 7 mm/inner
diameter 4 mm) at least 20 mm onto the end of the
guide. In doing so, ensure that guideway nis cov-
ered by the tube.
►Adjust the safety stop to the central position o,
see Fig. 4.
Fig. 4 Preparing the chisel guide
Legend
nGuideway
oCentral position of safety stop
activ L insertion instruments FW961R–
FW964R
►Turn twist cap 21 clockwise until it can be
removed, see Fig. 5.
►Hold unlocking button 22 pressed down.
►Pull out spacer 15 to the front.
Fig. 5 Disassembling insertion instruments
activ L revision instrument for PE inlay
FW968R
►Turn the adjustment knob 33 counterclockwise
and gently pull on the jaw piece 32 until the jaw
part comes out, see Fig. 6.
Fig. 6 Disassembling revision instrument for PE inlay
n
o
32
34
33

8
Aesculap®
activ L instruments
activ L revision instruments for endplates
FW966R & FW967R
►Unscrew handle 39 of revision instrument, see Fig.
7.
►Turn the anchoring rods 36 so that the hooks 37
are positioned in the direction of the slots 40.
►Slide the anchoring rods 36 behind the handpiece
until the hooks 37 are positioned on the middle
section of the revision instrument. When doing so,
slide the hooks 37 through the slots 40.
►Turn the lock nuts 38 counterclockwise until they
are fully undone.
►Slide the lock nuts 38 along the anchoring rods
behind the handpiece.
Fig. 7 Disassembling revision instruments for end-
plates
Validated reprocessing procedure
General safety instructions
Note
Adhere to national statutory regulations, national and
international standards and directives, and local, clini-
cal hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), sus-
pected CJD or possible variants of CJD, observe the rel-
evant national regulations concerning the reprocessing
of products.
Note
Mechanical reprocessing should be favored over man-
ual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only
be ensured if the processing method is first validated.
The operator/sterile processing technician is responsi-
ble for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disin-
fectant 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.
General information
Dried or affixed surgical residues can make cleaning
more difficult or ineffective and lead to corrosion.
Therefore the time interval between application and
processing should not exceed 6 h; also, neither fixating
pre-cleaning temperatures >45 °C nor fixating disin-
fecting 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 fad-
ing and the laser marking becoming unreadable visu-
ally or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgi-
cal residues, medicines, saline solutions and in the ser-
vice water used for cleaning, disinfection and steriliza-
tion will cause corrosion damage (pitting, stress
corrosion) and result in the destruction of stainless
steel products. These must be removed by rinsing thor-
oughly with demineralized water and then drying.
Additional drying, if necessary.
40
37
38 39
36

9
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’ recommen-
dations 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 discol-
oration of titanium or aluminum. For aluminum,
the application/process solution only needs to be
of pH >8 to cause visible surface changes.
■Material damage such as corrosion, cracks, fractur-
ing, premature aging or swelling.
►Do not use metal cleaning brushes or other abra-
sives that would damage the product surfaces and
could cause corrosion.
►Further detailed advice on hygienically safe and
material-/value-preserving reprocessing can be
found at www.a-k-i.org, link to Publications, Red
Brochure – Proper maintenance of instruments.
Preparations at the place of use
►Clean instruments as quickly as possible after
usage.
►Prevent contamination from drying on the instru-
ments prior to cleaning.
Preparation before cleaning
►Clean container system components under water
with a soft sponge and mild detergent until all vis-
ible debris has been removed from the surfaces.
►Inspect tray to insure all debris has been removed.
►Repeat as many times as necessary until no visible
debris remains.
►If not already done, dismantle the individual
instruments prior to cleaning, see Disassembling
for reprocessing.
►Open all products with hinges.
Cleaning/disinfection
Product-specific safety notes on the repro-
cessing procedure
CAUTION
Damage to the product due to
inappropriate cleaning/disin-
fecting agents and/or exces-
sive temperatures!
►Use cleaning and disinfect-
ing agents according to the
manufacturer’s instruc-
tions which
–are approved for plas-
tics and high-grade
steel,
–do not attack softeners
(e.g. in silicone).
►Observe specifications
regarding concentration,
temperature and exposure
time.
►Do not exceed the maxi-
mum allowable washing
temperature of 60 °C.

10
Aesculap®
activ L instruments
Manual cleaning/disinfection
Manual cleaning with ultrasound and immersion disinfection
D–W: Drinking water
RT: Room temperature
1Recommended: Steris Prolystica enzymatic presoak and cleaner - manual cleaning
2Recommended: Steris Prolystica neutral detergent - manual cleaning
3Prepare according to manufactures instructions
Suitable cleaning brushes Phase I
►Fully immerse the product in a prepared room tem-
perature enzymatic detergent solution (Recom-
mended "Prolystica enzymatic presoak and
cleaner - manual cleaning" prepared according to
the manufacturers recommendations).
►Rinse lumens at least five times with a disposable
syringe (20 ml). Ensure that all accessible surfaces
are moistened.
►Thoroughly clean the product with a suitable soft-
bristled brush in the solution until all discernible
residues have been removed from the surface.
►Brush any non-visible surfaces with a suitable soft-
bristled brush (see reference table above) for at
least 1 min.
►Mobilize non-rigid components, such as set screws,
links, etc. during cleaning.
Phase Step T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I Pre-Cleaning RT (cold) >15 See #3D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 91
II Intermediate rinse RT (cold) 1 - D–W -
III Ultrasonic Cleaning RT (cold) 15 See #3D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 92
IV Final rinse RT (cold) 1 - Distilled
water
-
VDrying RT - - - -
Instru-
ment
Recommended lumen brush dimensions
Diameter Min. length, overall
FW985R-
FW992R
4.8 mm
(3/16 in.)
450 mm (18 in.)
FW980R,
FW981R-
FW996R
6.35 mm
(1/4 in.)
450 mm (18 in.)
FW961R-
FW964R
5mm 450mm(18in.)
FW966R-
FW968R
7mm 450mm(18in.)
FW970R 10 mm 450 mm (18 in.)
All other 4.5 mm 450 mm (18 in.)

11
Phase II
►Rinse/flush the product thoroughly (all accessible
surfaces) under running water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during rinsing.
►Drain any remaining water fully.
Phase III
►Prepare neutral detergent (recommended "Prolys-
tica neutral detergent - manual cleaning" prepared
according to the manufacturers recommendations)
in an ultrasonic cleaning bath.
►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.
►Visually inspect all lumens and gaps to ensure
there is no remaining contamination.
►Thoroughly rinse through these components with
the cleaning solution (at least five times), using a
disposable syringe (20 ml).
Phase IV
►Rinse/flush the product thoroughly (all accessible
surfaces) under running distilled water.
►Mobilize non-rigid components, such as set screws,
joints, etc. during final rinse.
►Rinse lumens with a disposable syringe (20 ml) at
least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable
equipment (e.g. lint-free cloth, compressed filtered
air).
Inspection, maintenance and checks
►Allow the product to cool down to room tempera-
ture.
►After each complete cleaning, disinfecting and dry-
ing cycle, check that the product is dry, clean,
operational, and free of damage (e.g. broken insu-
lation or corroded, loose, bent, broken, cracked,
worn, or fractured components).
►Dry the product if it is wet or damp.
►Repeat cleaning and disinfection of products that
still show impurities or contamination.
►Check that the product functions correctly.
►Immediately put aside damaged or inoperative
products and send them to Aesculap Technical Ser-
vice, see Technical Service.
►Assemble disassembled products, see Assembling
prior to sterilization and see Assembling after ster-
ilization.
►Check for compatibility with associated products.

12
Aesculap®
activ L instruments
Packaging
►Appropriately protect products to prevent damage
of fine working tips.
►Place the product in its holder or on a suitable tray.
Ensure that all cutting edges are protected.
►Pack trays appropriately for the intended steriliza-
tion process (e.g. in Aesculap sterile containers).
►Ensure that the packaging provides sufficient pro-
tection against recontamination of the product
during storage.
Storage
►Store sterile products in sterile barrier packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
Assembling prior to sterilization
activ L double chisels (FW985R–
FW988R) & single chisels FW989R–
FW992R
►Slide cage lback.
►Rotate cage lclockwise by 90°, see Fig. 8.
Fig. 8 Assembling double and single chisels
Legend
lCage
►Assemble double and single chisels in reverse order,
see activ L double chisels FW985R–FW988R & sin-
gle chisels FW989R–FW992R.
activ L chisel guides FW981R–FW984R/
FW989R-FW996R
►Remove the irrigation tube A∅7/I∅4 from the end
of the guide.
activ L revision instrument for PE inlay
FW968R
►Insert the jaw piece 32 into the tubular shaft 34 of
the revision instrument until it engages, see Fig. 9.
When doing so, ensure that the “caudal” marking
on the tubular shaft is aligned with the edge of the
jaw piece 31.
►Push the jaw piece 31 in the direction of the
adjustment knob 33 and turn the adjustment knob
clockwise until the jaw part is positioned just in
front of the tubular shaft. When doing so, ensure
that the jaw part is not compressed by the tubular
shaft.
Fig. 9 Assembling revision instrument for PE inlay
l
32
34
33

13
activ L revision instruments for endplates
FW966R & FW967R
►Slide the lock nuts 38 along the anchoring rods 36
as far as the threaded rods, see Fig. 10.
►Turn the lock nuts 38 clockwise onto the threaded
rods.
►Turn the anchoring rods 36 so that the hooks 37
are positioned in the direction of the slots 40.
►Slide the hooks 36 through the slots 40.
Fig. 10 Assembling revision instruments for endplates
Sterilization
■Aesculap advises against sterilizing the device by
immediate use steam sterilization (IUSS) or chem-
ical sterilization.
■Sterilization may be accomplished by a standard
prevacuum cycle in a steam autoclave.
►Do not stack containers during sterilization.
To achieve a sterility assurance level of 10-6, Aesculap
recommends the following parameters:
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or sus-
pected of having Creutzfeldt-Jakob Disease (CJD),
the device cannot be reused and must be destroyed
due to the inability to reprocess or sterilize to elim-
inate the risk of crosscontamination.
40
37
38 39
36
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Steriliza-
tion method
Temp. Time Minimum
drying
time
Prevacuum 270 °F 4 min 30 min

14
Aesculap®
activ L instruments
Assembling after sterilization
activ L parallel distractor FW970R
►Put nuts 8into nut cage 7.
►Slide pushing rod 9, with the two flat sides at right
angles to the parallel distractor, through nut 8into
sheath 3as far as it will go, see Fig. 11.
►Apply mild pressure on the protruding end of push-
ing rod 9and, at the same time, turn nut 8clock-
wise until both of the drill holes in pushing rod 9
can be seen through the slotted hole of the sheath.
Fig. 11 Inserting the pushing rod
►Push indicator pin 5from one side through the drill
holes of pushing rod 9, see Fig. 12.
► Press the plastic body of indicator pin 5 onto sheath
3 and make certain that it clicks into position.
►Install twist cap 10 until it engages and turn it
clockwise until scale 4reads “8.5 mm”.
Fig. 12 Assembly
activ L insertion instruments FW961R–
FW964R
►Insert spacer 15 from the front through clamp 16
and, with unlocking button 22 pressed down, push
in the clamp as far as it will go, see Fig. 13.
►Release unlocking button 22.
►Attach twist cap 21 and screw it on counterclock-
wise for at least half a turn.
►To position spacer 15 as required: Turn twist cap
21 accordingly.
Fig. 13 Assembling insertion instruments
3
8
9
7
9
310
5
4
12
11
10

15
Safe operation
activ L parallel distractor FW970R
Coupling the trial implants for anterior
access (0°)
►Turn twist cap 10 counterclockwise until jaw
pieces 1and 2are in contact with each other and
the scale 4reads less than 8.5 mm, see Fig. 14.
►Put cranial trial implant aonto cranial jaw piece 1
in such a way that the small guide pin on the cra-
nial trial implant engages in central guide hole bof
the cranial jaw piece and audibly clicks into posi-
tion.
►Put caudal trial implant donto caudal jaw piece 2
in such a way that the small guide pin con the
caudal trial implant engages in central guide hole
of the caudal jaw piece and audibly clicks into
position.
Fig. 14 Coupling the trial implants
Legend
aCranial trial implant
bCentral guide hole
cSmall guide pin
dCaudal trial implant
►To distract, turn twist cap 10 clockwise.
►Read the distraction height from scale 4.
Decoupling the trial implants
The trial implants can be decoupled with jaw pieces 1
and 2opened to any width.
►Pull at the right and left sides of trial implant aor
d, respectively while simultaneously applying
counterforce on sheath 3of the parallel distractor,
see Fig. 14.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
a
b
1
2
c
d

16
Aesculap®
activ L instruments
activ L handle (for chisel guide) FW980R,
double chisels FW985R–FW988R, single
chisels FW989R–FW992 & chisel guides
FW981R–FW984R/FW989R-FW996R
►Mount chisel guide 12 with the desired implant
height and angle onto the handle 11, see Fig. 15.
►Turn wheel eclockwise and adjust safety stop fto
the shortest chisel length.
►Insert chisel guide 12 centrally into the disk space
and adjust safety stop fto the desired chisel depth
while monitoring radiographically.
Fig. 15
Legend
eWheel
fSafety stop
►Press button gand remove handle 11, see Fig. 16.
Fig. 16
Legend
gButton
►Introduce double chisel 13 or single chisel 14 via
chisel guide 12.
►Under radiographic control, insert the chisel into
the vertebral body as far as safety stop f. In doing
so, the protective sleeve will push back automati-
cally.
►Once safety stop fis reached, carefully withdraw
the chisel using a slotted hammer.
WARNING
Risk of injury when using the
product beyond the field of
view!
►Apply the product only
under visual control.
►Handle the chisel with
utmost care in order to
prevent injuries to the ves-
sels and nerve structures,
as well as to surgical staff.
WARNING
Damage to the implant from
bone residues!
►Prior to inserting the
implant, ensure that no
residual bone can be found
in the intervertebral space
and slits.
11
12
ef
g
11

17
activ L insertion instruments FW961R–
FW964R
Coupling the implant
►Select the appropriate insertion instrument
according to the height of the intervertebral disc
prosthesis.
►Completely assemble the intervertebral disc pros-
thesis.
►Extend spacer 15 as far as possible. If necessary,
change the position of the spacer by turning twist
cap 21.
►Put the intervertebral disc prosthesis honto
clamp 16 of the insertion instrument, observing
the marking on the insertion instrument, see Fig.
17. The inferior prosthesis plate must abut the part
of the insertion instrument clamp 16 marked
“CAUDAL”; the superior prosthesis plate must abut
the part marked “CRANIAL”.
Fig. 17 Coupling for anterior access (0°)
Legend
hIntervertebral disc prosthesis
►Guide the prosthesis plates on the spacer 15 onto
coupling pins 19 and 20 of the clamp 16.
►Make certain that the coupling pins of the clamp
fully engage in the coupling holes of the prosthesis
plates.
►Turn clamping sleeve 17 clockwise until the inter-
vertebral disc prosthesis is securely couples.
Decoupling the implant
►Release clamping sleeve 17.
►Carefully detach the insertion instrument from the
implant.
►If the insertion instrument cannot be detached
without applying force: Turn twist cap 21 anti-
clockwise to move back spacer 15.
activ L revision instruments and distrac-
tion forceps
Distracting/mobilizing vertebral bodies with
the activ L angled distraction forceps
FW960R
Note
Mobilization of the intervertebral disk space is a critical
process and should be performed under X-ray control.
Note
The intervertebral space distraction is often wedge-
shaped. Sufficient load relief in the posterior interver-
tebral disk space is required so that parallel distraction
can be performed over the entire intervertebral space.
15 16h
DANGER
Risk of fracture of the verte-
bral body endplates and/or
injury to surrounding struc-
tures due to overdistraction!
►Apply proper care when
distracting.
►Avoid excessive distrac-
tion.
CAUTION
Damage to the product caused
by actuation of the locking
lever!
►To release lock, gently
press the handle parts
together and actuate lock-
ing lever.

18
Aesculap®
activ L instruments
►Insert the working tip 26 into the intervertebral
space, see Fig. 18. When doing so, ensure that the
instrument is pushed as dorsally as possible into
the intervertebral disk space.
Fig. 18 Inserting working tip into intervertebral space
►Distract/mobilize the distraction forceps by press-
ing the handle parts 23 together as required.
Note
Lock 24 engages automatically when handle parts 23
are released.
Removing the activ L angled distraction for-
ceps FW960R
►Gently press the handle parts 23 together and
actuate locking lever 29.
This releases the lock 28 of the distraction forceps.
Applying the activ L angled revision distrac-
tion forceps FW965R
►Insert pins 31 of the distraction forceps into the
holes on the right-hand side of the implant,
see Fig. 19.
Fig. 19 Applying the activ L angled revision distrac-
tion forceps
►Open the distraction forceps by pressing the handle
parts 27 together as required.
Note
Lock 28 engages automatically when handle parts 27
are released.
26
DANGER
Injury to surrounding blood
vessels and soft tissue!
Damage to the product or to
the activ L disk prosthesis!
►To protect the blood ves-
sels, always use a retractor
in conjunction with this
product.
►Always insert the product
into the two holes at the
right-hand side of the
prosthesis.
CAUTION
Damage to the product caused
by actuation of the locking
lever!
►To release the lock, gently
press the handle parts
together and actuate lock-
ing lever.
31