Aesculap
®
MACS TL®
MACS TL® Kirschner wire instrument set
Legend
1
Insertion instrument for removing Kirschner wire
2
MACS TL® insertion instrument set with screwed-on instrument for removing the Kirschner wire
Kirschner wire with thread
3
Trocar tip
4
Thread
Kirschner wire insertion instrument
5
Housing
6
Plunger
7
Stop with marking lines
8
X-ray marking
9
Handle
10
Kirschner wire removal instrument
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 MACS TL® Kirschner wire instrument set is used for positioning the MACS TL® anchoring screws in the vertebral
body. The position and direction of the anchoring screws can be determined by positioning a Kirschner wire under
X-ray control. The insertion instrument itself is not visualized by radiography.
Package includes
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Applying the MACS TL® Kirschner wire instrument set requires precise knowledge of spine stabilization and the bio-
mechanical situation at the spine. Operative use of the MACS TL® spinal system is described in detail in the relevant
O.R. manual.
►
Read the O.R. manual for the MACS TL® Kirschner wire instrument set thoroughly, prior to first application.
►
Inform the patient of the advantages and drawbacks of using the MACS TL® Kirschner wire instrument set.
►
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.
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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.
Kirschner wire set (FW343S)
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 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 product if it is damaged.
►
Do not use the product after its use-by date.
►
Use the Kirschner wire only as a temporary aid for installing the anchoring screws.
►
Do not bend the Kirschner wire.
►
Do not use the Kirschner wire in cases of severe osteopenia.
►
Take account of the position of the anchoring screws when positioning the Kirschner wire in the bone.
Safe operation
Prerequisites:
■
The Kirschner wire insertion instrument has been mounted
■
The plunger
6
has been pushed forward as far as it will go
■
A new Kirschner wire has been prepped
►
Insert a threaded Kirschner wire
4
into the insertion instrument.
►
Screw the Kirschner wire into the plunger
6
without exerting excessive force.
►
Position the insertion instrument parallel to the X-rays under radiographic control.
The insertion instrument is in parallel alignment with the direction of the X-ray as soon the metal shaft of the
housing is projected as a point in the center of the X-ray marking
8
,
A
. If the insertion instrument is not in proper
alignment, the metal shaft is projected as line,
B
.
The depth of penetration of the Kirschner wire is shown by marking lines created by the marking lines on the stop
7
.
The lines are 5 mm apart from each other. The stop with marking lines
7
limits the maximum penetration depth to
20 mm.
►
Insert the Kirschner wire by lightly tapping on the plunger
6
until the desired depth of penetration is achieved.
►
To unscrew the Kirschner wire insertion instrument: Rotate the plunger
6
in a counterclockwise direction.
►
Keep the Kirschner wire vertical when pulling it out: do not allow it to tilt.
►
Screw in the anchoring screws via along the Kirschner wire, using the special MACS TL® insertion instrument set
(see instructions for use of the MACS TL® insertion instrument set).
►
Introduce removal instrument
10
into the cannulated MACS TL® insertion instrument set and screw it onto the
Kirschner wire.
►
Pull out the Kirschner wire with removal instrument
10
through the cannulated MACS TL® insertion instrument
set.
Disassembling
►
Pull out plunger
6
from housing
5
.
►
Unscrew handle
9
from housing
5
.
Assembling
►
Insert the plunger
6
into the housing
5
.
►
Screw the handle
9
onto the housing
5
.
Validated reprocessing procedure
General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible 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 processing method is first validated. The oper-
ator/sterile processing technician 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.
Symbol
Explanation
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
FW343S
Kirschner wire set - in sterile packaging
(2 Kirschner wires with threads and 1 removal instrument)
FW330R
Insertion instrument for Kirschner wire - in unsterile packaging
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
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
WARNING
Risk of injury through contaminated cannulation of the MACS TL® insertion
instrument set!
►
Only use a MACS TL® insertion instrument set that has been reprocessed cor-
rectly.
WARNING
Risk of injury or death from improper application!
►
Apply Kirschner wires in such a way that nerve roots, the spinal column as well
as blood vessels and organs are not injured in any way!
CAUTION
The Kirschner wire will twist if the insertion instrument is tilted!
►
Do not tilt the insertion instrument and Kirschner wire assembly.
A
B
