Braun Aesculap MACS II Manual

Aesculap®
Aesculap Spine
Instructions for use/Technical description
MACS II
Gebrauchsanweisung/Technische Beschreibung
MACS II
Mode d’emploi/Description technique
MACS II
Instrucciones de manejo/Descripción técnica
MACS II
Istruzioni per l’uso/Descrizione tecnica
MACS II
Instruções de utilização/Descrição técnica
MACS II
Gebruiksaanwijzing/Technische beschrijving
MACS II
Bruksanvisning/Teknisk beskrivning
MACS II
Инструкция по примению/Техническое опи-
сание
MACS II
Návod k použití/Technický popis
MACS II
Instrukcja użytkowania/Opis techniczny
MACS II
Technical alterations reserved
MACS II
Kullanım Kılavuzu/Teknik açiklama
MACS II

1
A
2

4b
5d
5a
5c
5b
3
4a
4
B
5

6 7 9
8
C

10 11 7 1312
8
D

711
10 13
12
8
14
E

17 18 19 2015 6 16
F

13 7 21
8
G

11 13 6 15
9
20
10
22
H

13 7
1
22
8
I

25
26
28
27a 27
27b
23 24
29 30 31 32
J

2
Aesculap®
MACS II
Aesculap® MACS II
Legend
A Mounting instruments
1Torque wrench for mounting the retaining bolt
2Mounting tool for SX804T
B K-wire instruments
3K-wire protection
4K-wire set, sterile
aK-wire (x2)
b Removal instrument (x1)
5K-wire insertion instrument
aAiming tube
bHandle rod
cImpactor
dCounter holder
C Insertion instruments for polyaxial screw
6Cannulated screwdriver
7Guide tube
8Counter torque (cleaning rod, counter torque with-
out cleaning rod)
9Ball-end screwdriver
D Insertion instruments for stabilization plate
7Guide tube
8Counter torque (cleaning rod, counter torque with-
out cleaning rod)
10 Holding forceps for rods/plates
11 Socket wrench for nut
12 Torque wrench for nut
13 Screwdriver for retaining bolt (optional)
E Insertion instruments for SSE connecting rods
7Guide tube
8Counter torque (cleaning rod, counter torque with-
out cleaning rod)
10 Holding forceps for rods/plates
11 Socket wrench for nut
12 Torque wrench for nut
13 Screwdriver for retaining bolt (optional)
14 SSE rod bending pliers
F Insertion instruments for stabilization screw
6Cannulated screwdriver
15 Screw revision instrument
16 Lumbar centering tool
17 Aiming sleeve for lumbar stabilization screw
18 Aiming sleeve for thoracic stabilization screw
19 Centering tool for purple stabilization screw
20 Screwdriver for purple stabilization screw, see
TA011177
G Insertion instruments for stabilization screw
7Guide tube
8Counter torque (cleaning rod, counter torque with-
out cleaning rod)
13 Screwdriver for retaining bolt (optional)
21 Torque wrench for retaining bolt
H Revision instruments
6Cannulated screwdriver
9Ball-end screwdriver
10 Holding forceps for rods/plates
11 Socket wrench for nut
13 Screwdriver for retaining bolt (optional)
15 Screw revision instrument
20 Screwdriver for purple stabilization screw, see
TA011177
22 T-handle with ¼" coupling

3
I Instruments for intraoperative disassembly/
mounting of the pre-assembled retaining bolt
1Torque wrench for mounting the retaining bolt
7Guide tube
8Counter torque (cleaning rod, counter torque with-
out cleaning rod)
13 Screwdriver for retaining bolt (optional)
22 T-handle with ¼" coupling
J Implant components
23 SSE connecting rod, 5.2 mm
24 Stabilization plate
25 Clamping element T
26 Clamping element TL
27 Pre-assembled retaining bolt
aCentralizer
bRetaining bolt
28 Locknut
29 Stabilization screw, 4.5 mm, purple
30 Stabilization screw, 6.5 mm, yellow
31 Polyaxial screw, 7.0 mm, blue
32 Polyaxial screw XL, 10 mm, blue
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 www.extranet.bbraun.com
Intended use
The MACS II system is used for ventral monosegmental
and multisegmental stabilization of the lumbar and
thoracic vertebrae.
Sterilization using irradiation
Not for reuse in intended applica-
tions as defined by the manufac-
turer
Use by
Caution, general warning symbol
Caution, see documentation sup-
plied with the product
Date of manufacture

4
Aesculap®
MACS II
System components and available
sizes
Item no. Art. no. Designation
1FW419R Torque wrench for mounting
the retaining bolt
2FW429 Mounting tool for SX804T
3FW394R K-wire protection
4FW406S K-wire set, sterile
(K-wire x2, removal instru-
ment x1)
5FW408R K-wire insertion instrument
(aiming tube, handle rod,
impactor, counter holder)
6FW398R Cannulated screwdriver
7FW397R Guide tube
8FW399R Counter torque (cleaning
rod, counter torque without
cleaning rod)
9FW396R Ball-end screwdriver
10 FW326R Holding forceps for rods/
plates
11 FW417R Socket wrench for nut
12 FW416R Torque wrench for nut (cas-
ing, handle, wrench)
13 FW411R Screwdriver for retaining
bolt
14 FW013R SSE rod bending pliers
15 FW336R Screw revision instrument
16 FW407R Lumbar centering tool
17 FW409R Aiming sleeve for lumbar
stabilization screw
18 FW413R Aiming sleeve for thoracic
stabilization screw
19 FW405R Centering tool for purple
stabilization screw
20 FW342R Screwdriver for purple stabi-
lization screw (see
TA011177 instructions for
use)
21 FW412R Torque wrench for retaining
bolt
22 FW395R T-handle, 1/4" coupling
23 SX110T
SX112T
SX115T
SX118T
SX120T
100 mm SSE connecting rod,
5.2 mm
120 mm SSE connecting rod,
5.2 mm
150 mm SSE connecting rod,
5.2 mm
180 mm SSE connecting rod,
5.2 mm
200 mm SSE connecting rod,
5.2 mm
24 SX810T
SX811T
SX812T
SX813T
SX814T
SX834T
SX835T
SX839T
SX816T
SX840T
SX817T
SX841T
SX818T
Stabilization plate, 40 mm
Stabilization plate, 45 mm
Stabilization plate, 50 mm
Stabilization plate, 55 mm
Stabilization plate, 60 mm
Stabilization plate, 65 mm
Stabilization plate, 70 mm
Stabilization plate, 75 mm
Stabilization plate, 80 mm
Stabilization plate, 85 mm
Stabilization plate, 90 mm
Stabilization plate, 95 mm
Stabilization plate, 100 mm
25 SX801T Clamping element T
26 SX800T Clamping element TL
Item no. Art. no. Designation

5
27 SX804T Pre-assembled retaining bolt
(retaining bolt, centralizer)
28 SX802T Locknut
29 SX826T
SX827T
SX828T
SX829T
Stabilization screw,
4.5 mm x 15 mm, purple
Stabilization screw,
4.5 mm x 20 mm, purple
Stabilization screw,
4.5 mm x 25 mm, purple
Stabilization screw,
4.5 mm x 30 mm, purple
30 SX782T
SX783T
SX784T
SX785T
SX786T
SX787T
Stabilization screw,
6.5 mm x 25 mm, yellow
Stabilization screw,
6.5 mm x 30 mm, yellow
Stabilization screw,
6.5 mm x 35 mm, yellow
Stabilization screw,
6.5 mm x 40 mm, yellow
Stabilization screw,
6.5 mm x 45 mm, yellow
Stabilization screw,
6.5 mm x 50 mm, yellow
Item no. Art. no. Designation
31 SX790T
SX791T
SX792T
SX793T
SX794T
SX795T
SX796T
SX797T
SX798T
Polyaxial screw,
7.0 mm x 15 mm, blue
Polyaxial screw,
7.0 mm x 20 mm, blue
Polyaxial screw,
7.0 mm x 25 mm, blue
Polyaxial screw,
7.0 mm x 30 mm, blue
Polyaxial screw,
7.0 mm x 35 mm, blue
Polyaxial screw,
7.0 mm x 40 mm, blue
Polyaxial screw,
7.0 mm x 45 mm, blue
Polyaxial screw,
7.0 mm x 50 mm, blue
Polyaxial screw,
7.0 mm x 55 mm, blue
32 SX821T
SX823T
Polyaxial screw XL,
10 mm x 30 mm, blue
Polyaxial screw XL,
10 mm x 40 mm, blue
Item no. Art. no. Designation

6
Aesculap®
MACS II
System configurations
■Polyaxial Twin Screw system TL 26, 30, 31 with
stabilization plate 24 or two SSE 5.2 mm connect-
ing rods 23
■Polyaxial Twin Screw system T 25, 29, 31 with sta-
bilization plate 24 or two SSE 5.2 mm connecting
rods 23
■Polyaxial Twin Screw system XL 30, 32 with stabi-
lization plate 24 or two SSE 5.2 mm connecting
rods 23
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on
order of a physician!
►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 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.
►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.
►Do not use products that are in open or damaged
sterile packaging.
►Do not use the product after its use-by date.
WARNING
System incompatibility may
result in increased operating
time or abortion of the proce-
dure!
►Follow only these instruc-
tions for use and the
TA013373 instructions for
use when using the pre-
assembled retaining bolt
SX804T.
►Do not use MACS II in con-
junction with the HMA
monoaxial or polyaxial
screws of MACS TL®.
WARNING
Risk of injury caused by incor-
rect operation of the product!
►Attend appropriate prod-
uct training before using
the product.
►For information about
product training, please
contact your national
B. Braun/Aesculap agency.

7
Pre-assembled retaining bolt and sterile K-wire set
The product is gamma-sterilized and supplied in sterile
packaging.
The product must not be reused.
►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.
►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 defec-
tive. Set aside the product if it is damaged.
►Do not use the product after its use-by date.
Safe operation
Note
For a detailed description of the operating procedure,
see MACS II operating technique, brochure number
O42702.
Mounting the clamping element and
7.0 mm blue polyaxial screw or 10 mm
blue polyaxial screw XL with pre-assem-
bled retaining bolt
►Select either clamping element TL, T 25, 26 or
10 mm blue polyaxial screw XL 32.
►Select 7.0 mm blue polyaxial screw 31 and stabili-
zation screw 29, 30 (this step is missed out if the
10 mm blue polyaxial screw XL is used 32).
DANGER
Infection hazard 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 prod-
uct.
WARNING
Risk of injury and/or malfunc-
tion!
►Always carry out a func-
tion check prior to using
the product.
WARNING
Risk of injury when using the
product beyond the field of
view!
►Apply the product only
under visual control.

8
Aesculap®
MACS II
►Screw the 7.0 mm blue polyaxial screw 31 into the
clamping element 25, 26.
►Insert the assembled 7.0 mm blue polyaxial
screw 31 and clamping element 25, 26 or XL screw
32 into the mounting tool for SX804T 2.
►Remove the pre-assembled retaining bolt 27 from
the packaging using the torque wrench for mount-
ing the retaining bolt 1.
►Screw the pre-assembled retaining bolt 27 onto
the clamping element 25, 26 with 1.8 Nm.
WARNING
Risk of injury if incorrect
anchoring screws are selected!
►To ensure safe implanta-
tion of the anchoring
screws, ensure that the
diameter of the vertebral
body is carefully measured
in the planned screw posi-
tion and direction.
►Choose a screw length
shorter than the diameter
measured.
WARNING
Risk of injury if centralizer
comes loose during the proce-
dure!
►If the 10 mm blue polyax-
ial screw XL is used, insert
this in the appropriate side
of the mounting tool for
SX804T (labeled with XL).
►If the 7.0 mm blue polyax-
ial screw is used, insert this
in the appropriate side of
the mounting tool for
SX804T (labeled with
POLY).
WARNING
Take care not to drop the pre-
assembled retaining bolt!
►Open the packaging cor-
rectly and do not turn it to
prevent the retaining bolt
from falling out.
►Apply the torque wrench
for mounting the retaining
bolt as far as it will go onto
the pre-assembled retain-
ing bolt.
WARNING
Risk of injury if pre-assembled
retaining bolt comes loose
during the procedure!
►To mount the pre-assem-
bled retaining bolt, use the
mounting tool for SX804T
and the torque wrench for
mounting the retaining
bolt and tighten with
1.8 Nm.
►Prior to applying the
torque wrench, make cer-
tain the display arrow
points to zero.
►Replace the torque wrench
if it is damaged.

9
►Check that the retaining lug of the centralizer 27a
is correctly positioned in the clamping element 25,
26.
Applying the K-wires
►Assemble the K-wire insertion instrument 5.
►Insert the threaded end of the K-wire 4a into the
end of the aiming tube 5a and screw tight.
►Position the K-wire 4a correctly and drive it in
under radiographic control.
►Unscrew the impactor 5c counterclockwise.
►Open the cortical bone.
WARNING
Risk of injury if the necessary
counter torque is not applied
when tightening the locknut
or pre-assembled retaining
bolt SX804T!
►Make sure that the retain-
ing lugs of the centralizer
engage fully in the appro-
priate grooves in the
clamping element.
WARNING
Damage to the K-wire inser-
tion instrument if the thread
of a K-wire is damaged!
►Do not re-use a sterile K-
wire set.
WARNING
Risk of injury if K-wires are
positioned incorrectly!
►Always use radiographic
control when positioning
K-wires.
►Use radiographic control to
constantly monitor the
position of the K-wires
throughout the operation.
►Apply K-wires in such a
way that neither nerve
roots, the spinal column,
nor blood vessels or organs
are injured in any way!
WARNING
The K-wire will twist if the
aiming tube is tilted!
►Do not tilt the K-wire
insertion instrument and
K-wire assembly.

10
Aesculap®
MACS II
►Insert the counter holder 5d into the K-wire inser-
tion instrument 5.
►Remove the K-wire insertion instrument 5from the
K-wire 4a. While doing so, use the counter
holder 5d to apply counterforce to the K-wire 4a.
►Attach K-wire protection 3if desired, using the
holding forceps for rods/plates 10 in order to pro-
tect the adjacent soft tissue.
Implanting the 7.0 mm blue polyaxial
screw or the 10 mm blue polyaxial screw
XL
►Remove K-wire protection 3using the holding for-
ceps for rods/plates 10.
►Attach the counter torque 8onto the guide tube 7.
WARNING
Risk of injury if incorrect
instruments are used!
►Do not use the screw revi-
sion instrument to apply
counterforce at the K-
wires.
►Only use the counter
holder to apply counter-
force at the K-wires.
WARNING
Risk of injury if K-wire is
driven forwards with counter
holder!
►Remove the K-wire inser-
tion instrument from the
K-wire under radiographic
control.
WARNING
Risk of injury if K-wire is
driven forwards with K-wire
protection!
►When attaching the
K-wire protection, ensure
that the K-wire is not
pushed forwards.
►Attach the K-wire protec-
tion under radiographic
control.
WARNING
Risk of injury caused by the tip
of the K-wire!
►Ensure that, when the
K-wire protection is being
removed with the holding
forceps for rods/plates, the
K-wire is not withdrawn
from the vertebral body.
WARNING
Damage to the guide tube
caused by incorrect operation!
►Fit the counter torque onto
the guide tube until it
clicks into position.
►To detach the counter
torque from the guide
tube, release the snap con-
nection by pulling the han-
dle of the cleaning rod, and
pull the counter torque up
and out.
►Fit the counter torque onto
the correct side of the
guide tube. Look for the
gold marking.