Safe Operation - B. Braun Aesculap Spine activC FW647R Gebrauchsanweisung/Technische Beschreibung

®
Aesculap activC
activC handle, reamer guide, chisel guide, trial implants
Legend
1 Trial implant
2 Handle
3 Reamer guide
4 Mounting block (for reamer guide)
5 Reamer
6 Reamer handpiece
7 HiLAN pneumatic motor
8 activC Chisel insert
9 Chisel holder
10 Chisel guide
11 Locking pipes
12 Adjusting wheel
13 Locking clip
Symbols on product and packages
Not for reuse in intended applications as defined by the manufacturer
Caution, general warning symbol
Caution, see documentation supplied with the product
"Closed" position
"Open" position
Ready
Applicable to
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For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use
The trial implants are used in conjunction with the handpiece to verify the size, height and shape of the activC inter-
vertebral disk prosthesis to be implanted, and in conjunction with the reamer guide or the chisel guide to prepare
the fin bed for the inferior implant plate of the activC intervertebral disk prosthesis.
Available sizes
Art. no. Designation
Trial implant size XS, H5
FW789R 1
1 Trial implant size XS, H6
FW790R
1 Trial implant size S, H5
FW791R
Trial implant size S, H6
1
FW792R
1 Trial implant size M, H5
FW793R
Trial implant size M, H6
FW794R 1
1 Trial implant size L, H5
FW790R
1 Trial implant size L, H6
FW790R
Trial implant size XL, H5
1
FW797R
1 Trial implant size XL, H6
FW798R
1 Trial implant size XXL, H5
FW799R
1 Trial implant size XXL, H6
FW800R
1 Handle
FW8701
2
Reamer guide (with mounting block)
FW871R
2 Hi-Line XS handpiece angled XL-I
GB771R
4 Hi-Line XS activC drill XL-I D1, 5
GE700SU
3 activC chisel guide
FW784R
3 activC chisel holder
FW786R
activC chisels
FW787R 4
1 Trays FW645R and FW647R
2
only tray FW647R
3
only tray FW645R
4
single-use products
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Risk of injury caused by incorrect operation of the product!
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Attend appropriate product training before using the product.
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For information about product training, please contact your national
B. Braun/Aesculap agency.
WARNING
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Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
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Read, follow, and keep the instructions for use.
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Use the product only in accordance with its intended use, see Intended use.
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Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
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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.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Replace any damaged components immediately with original spare parts.
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To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
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!
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Do not reprocess the product.
DANGER
Art. no. Designation
GE700SU Hi-Line XS activC drill XL-I D1, 5
FW787R activC chisels
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
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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.
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Use the product only in accordance with its intended use, see Intended use.
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Do not use products from open or damaged sterile packaging.
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Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Do not use the product after its use-by date.

Safe operation

Risk of injury and/or malfunction!
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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
Note
Follow OP-Manual no. O31302 and instructions for use "activC intervertebral disk prosthesis", see TA011995.
Mounting the trial implant of the selected size on the handle
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Turn locking pipes 11 of handle 2 to "open" position
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Mount the trial implant with the selected size, height and shape onto the handle 2. Note the "CRANIAL" and
"CAUDAL" markings on the handle and on the trial implant.
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Turn locking pipes 11 of handle 2 to "closed" position .
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Check the trial implant for firm seating.
Compression of the spinal canal and of other posterior elements caused by trial
implants inserted too deeply!
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Prior to insertion of trial implants, adjust the depth stop to minimum insertion
depth.
WARNING
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Insert trial implants in the intervertebral space under X-ray control.
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Use adjusting wheel 12 to set the depth stop of the trial implant to minimum insertion depth.
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Insert the trial implant in the intervertebral space under X-ray control. Ensure correct cranial and caudal align-
ment of the trial implant.
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Align the markings of the trial implant center to the midline marking.
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If necessary, correct the position of the depth stop with adjusting wheel 12 until the intended position is reached.
Ensure that depth stop abuts to the anterior edge of the vertebral body.
Increased risk of migration if the selected implant size is too small!
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Select the trial implant or implant size, respectively, to achieve maximum cov-
erage of the vertebral body endplates.
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On the X-ray, in AP and lateral view, check to ensure that the size, position
WARNING
and alignment of the trial implant are correct.
Irritation of the facet joints and strain on spinal cord and nerve roots due to
excessive or insufficient distraction!
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Select the correct trial implant/ implant height.
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Check for correct height of the trial implant in a lateral X-ray.
WARNING
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On the intraoperative X-ray image, in AP and lateral view, check the size, height and position of the trial implant.
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With the trial implant properly positioned, turn locking pipes 11 to "open" position
fully in axial direction from the trial implant.
The trial implant remains in the intervertebral space.
Note
The fin bed can either by prepared by reaming or chiseling. This can be carried out either with the reamer guide with
handpiece or the chisel guide with chisel holder, depending on which set is used.
, see Fig. 1.
and pull off handle 2 care-