Aesculap
®
Temporary spikes for CASPAR anterior cervical fusion
Symbols on product and packages
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 instruments for anterior cervical fusion have been designed for cervical spine plating with CASPAR plates and
screws for anterior cervical fusion (ACF).
The temporary spikes are used for fixating the titanium cervical spine plates on the vertebral body.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Application of the instruments for anterior cervical fusion requires detailed knowledge of spine surgery and spine
biomechanics. The operating surgeon must be familiar with all theoretical and practical aspects of the operating
technique for the CASPARevolution system.
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The patient must be informed about the advantages and disadvantages of anterior cervical fusion.
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Read and follow the operating manual.
Note
The operating manual can be ordered under article number 043102 from the address given below.
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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).
Safe operation
Fixating the titanium CASPAR ACF plates on the vertebral bodies
To facilitate the intraoperative handling, the titanium CASPAR ACF plates FG420T to FG490T are fixated on the ver-
tebral bodies. This prevents slipping of the plates during the drilling procedure, and it facilitates the positioning of
the drill holes and the insertion of the SPECTRUM screws.
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Position the titanium CASPAR ACF plates on the vertebral body.
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Insert the first temporary spike in special impactor instrument FG315R.
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To secure the temporary spike, push forward and turn the outer sleeve of impactor instrument FG315R.
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To detach the impactor instrument from the temporary spike, turn the ring handle and pull it back as far as it
will go.
For inserting the temporary spikes, there are small holes located on the center line of the titanium CASPAR ACF
plates.
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Insert a temporary spike in one of the small holes in the plate.
Note
At least two temporary spikes have to be inserted to achieve secure temporary fixation of the titanium CASPAR ACF
plates on the vertebral body.
Note
Make certain that the holes for inserting the temporary spikes of the titanium CASPAR ACF plates are in surface con-
tact with the vertebral body. This is necessary to achieve secure fixation of the plates on the vertebral body.
Removing the temporary spikes
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Once the CASPAR ACF plates have been fixated with the screws, remove the temporary spikes, using impactor
instrument FG315R, and set aside for disposal, see Disposal.
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 up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://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 temper-
atures >45 °C nor fixating disinfecting 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 fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
Additional drying, if necessary.
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’ recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
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Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
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Material damage such as corrosion, cracks, fracturing, premature aging or swelling.
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Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
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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
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If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.
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Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
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Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Symbol
Explanation
Not for reuse in intended applications as defined by the manufacturer
Use by
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
WARNING
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.
CAUTION
Damage to the instruments due to incorrect application!
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Use the instruments for anterior cervical fusion only in connection with tita-
nium CASPAR ACF plates FG420T to FG490T.
WARNING
Risk of damage to spinal cord, nerve roots, adjacent intervertebral space or soft
tissue! Breakage of the temporary spike during implantation, due to multiple
bending or bluntness of the spike!
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Use temporary spikes only in connection with titanium CASPAR ACF plates.
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Insert the temporary spikes only by using the appropriate impactor instrument
FG315R.
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The temporary spikes are for single-use only.
CAUTION
Breakage of the temporary spike during implantation, due to multiple bending or
bluntness of the spike!
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The temporary spikes are for single-use only.
CAUTION
Breakage of the temporary spike during removal, due to multiple bending or
bluntness of the spike!
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The temporary spikes are for single-use only.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
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Use cleaning and disinfecting agents according to the manufacturer’s instruc-
tions which
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are approved for use e.g. on aluminum, plastic materials and stainless steel,
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do not attack softeners (e.g. in silicone).
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Observe specifications regarding concentration, temperature and exposure
time.
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Do not exceed the maximum permitted cleaning temperature of 55 °C.
