Aesculap
®
activ C
Distraction set with lockable distraction screws
Legend
1
activ C distractor for lockable distraction screws, right
2
activ C distractor for lockable distraction screws, left
3
activ C screwdriver for lockable distraction screws
4
activ C lockable offset distraction screw
5
Hexagon
6
Shaft
7
activ C lockable distraction screw
8
Thumb screw
9
Ratchet lever
10
Toothed rack
11
Guide
12
Distraction arm (at guide)
13
Buttons (for locking and release)
14
Distraction arm (at toothed rack)
Symbols on product and packages
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
Intended use
The activ C distractor for lockable distraction screws is used in combination with the corresponding activ C lockable
distraction screws for the parallel distraction of adjacent vertebral bodies in the cranial section for the purpose of
extending the height of the intervertebral disk space.
Available sizes
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 requisite training,
knowledge, or experience.
►
Read, follow, and keep the instructions for use.
►
Observe the instructions for use of the activ C intervertebral disk prosthesis, TA011995.
►
Follow the operating manual 031302.
►
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 components.
►
Do not use the product if it is damaged or defective. Set aside the product 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.
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
►
Do not use the product after its use-by date.
Safe operation
In the text below, short designations are used for the following components:
■
activ C distractor for lockable distraction screws is referred to as "distractor"
■
activ C distraction screwdriver for lockable distraction screws is referred to as "distraction screwdriver"
■
activ C lockable distraction screws are referred to as "distraction screws"
■
activ C lockable offset distraction screws are referred to as “offset distraction screws”
Note
Any application of the distraction screw includes the application of the offset distraction screw, even if the latter is
not mentioned explicitly!
Applying the distraction screw, see Fig. A
Note
For very small vertebral bodies, offset distraction screws must be used to ensure that there is sufficient space for the
implantation instruments!
►
Choose distraction screw
7
or offset distraction screw
4
.
►
Insert distraction screw
7
or offset distraction screw
4
in distraction screwdriver
3
.
►
Place distraction screwdriver
3
on hexagon
5
of distraction screw
7
and make sure it engages.
►
Check the self-holding function of distraction screw
7
in distraction screwdriver
3
.
- or -
►
Place distraction screwdriver
3
on hexagon
5
of offset distraction screw
4
and make sure it engages.
Inserting the distraction screw into the vertebral body under X-ray control, see
Fig. B
Note
For very small vertebral bodies, offset distraction screws must be used to ensure that there is sufficient space for the
implantation instruments!
►
Position and screw in distraction screw
7
/offset distraction screw
4
at the center of the vertebral body.
►
Remove distraction screwdriver
3
from distraction screw
7
/offset distraction screw
4
.
►
Apply second distraction screw
7
/offset distraction screw
4
, ensuring that the distraction screw
7
/offset distrac-
tion screw
4
is positioned in parallel.
Mounting the distractor and carrying out the distraction, see Fig. C/D
►
Select distractor right
1
or distractor left
2
.
►
Turn thumb screw
8
to transfer the distance of parallel distraction screws
4
/
7
to distraction arms
12
/
14
.
The distance between distraction arms
12
/
14
corresponds to the distance between distraction screws
4
/
7
.
►
Mount distractor right
1
or distractor left
2
on parallel distraction screws
4
/
7
so that they click into position.
►
Distract with the distraction forceps.
►
While distracting with the distraction forceps, extend distractor right
1
or distractor left
2
by turning thumb
screw
8
.
►
Once the distraction process carried out with the distraction forceps is complete, lock distractor right
1
or dis-
tractor left
2
and hold the vertebrae in the distracted position.
Removing the distractor, see Fig. E
►
To release the distraction after the implantation in the intervertebral disk space, press ratchet lever
9
at the dis-
tractor.
Distraction arms
12
/
14
move toward each other.
The distractor is fully released from any load.
►
Press buttons
13
at the side of distraction arm
12
/
14
and slide off the distractor from distraction screws
4
/
7
.
►
Remove distraction screws
4
/
7
from the vertebrae, using distraction screwdriver
3
.
Disassembling
►
Pull distraction arm
12
(labeled "RIGHT/LEFT") along toothed rack
10
until toothed rack
10
is not seated in
guide
11
anymore.
Assembling
Note
Combine distraction arm
12
labeled "RIGHT" only with distraction arm
14
labeled "FW848R"!
Combine distraction arm
12
labeled "LEFT" only with distraction arm
14
labeled "FW849R"!
►
Push the ratchet lever
9
.
►
Mount distraction arm
12
(labeled "RIGHT/LEFT") with guide
11
on the toothed rack, ensuring the correct orien-
tation of the distraction arms
12
/
14
.
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
Art. no.
Designation
FW848R
activ C distractor for lockable distraction screws, right
FW849R
activ C distractor for lockable distraction screws, left
FW850R
activ C distraction screwdriver for lockable distraction screws
FW851SU
activ C lockable offset distraction screw, 12 mm
FW852SU
activ C lockable offset distraction screw, 14 mm
FW853SU
activ C lockable offset distraction screw, 16 mm
FW854SU
activ C lockable offset distraction screw, 18 mm
FW855SU
activ C lockable distraction screw, 16 mm
FW856SU
activ C lockable distraction screw, 18 mm
FW861SU
activ C lockable distraction screw, 12 mm
FW862SU
activ C lockable distraction screw, 14 mm
DANGER
Infection hazard for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product.
WARNING
Compression of or damage to the spinal canal due to selection of a distraction
screw of excessive length!
►
Use the radiographic image to determine the correct length of the distraction
screw according to the vertebral body.
►
Always maintain x-ray control when applying the distraction screw.
WARNING
Risk of loosening/tear-out of the distraction screws when distracting with the dis-
tractor and the distraction screws!
►
Use the distraction forceps for the distraction process.
►
Do not use the distractor and the distraction screws for the actual distraction
process.
►
Lock the distractor in the extended condition.
WARNING
Irritation of the facet joints/strain on spinal cord and nerve roots due to excessive
distraction!
►
Extend the distraction forceps slowly and carefully under X-ray control.
►
Observe the tactile response.
►
Use the heights of adjacent (healthy) disks as a guide for the required degree
of distraction.