B. Braun Aesculap Spine activ L FW961R Gebrauchsanweisung/Technische Beschreibung Seite 2

®
Aesculap activ L
activ L insertion instrument
Legend
1 Spacer
2 Clamp
3 Clamping sleeve
4 Insertion instrument handle
5 Slotted-hole pin
6 Coupling pin
7 Superior prosthesis plate
8 Polyethylene inlay
9 Inferior prosthesis plate
10 Unlocking button for spacer
11 Twist cap
Symbols on product and packages
Caution, general warning symbol
Caution, see documentation supplied with the product
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 activ L insertion instrument is used for implanting the intervertebral disc prosthesis through anterior (0°) or lat-
eral (approx. 45°) approach. The appropriate color-coded and labeled insertion instrument is used according to the
implant height.
Available sizes
Art. no. Size
FW961R 8.5 mm
FW962R 10 mm
FW963R 12 mm
FW964R 14 mm
Safe handling and preparation
Use of the activ L insertion instrument requires precise knowledge about spine surgery and the stabilization and bio-
mechanical situation at the spine.
Operative use of the activ L insertion instrument is described in detail in the relevant O.R. manual.
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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.
Safe operation
Risk of injury and/or malfunction!
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Always carry out a function check prior to using the product.
WARNING
Coupling the implant
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Select the appropriate insertion instrument according to the height of the intervertebral disc prosthesis.
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Completely assemble the intervertebral disc prosthesis.
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Extend spacer 1 as far as possible. If necessary, change the position of the spacer by turning twist cap 11.
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Put the intervertebral disc prosthesis onto clamp 2 of the insertion instrument, observing the marking on the
insertion instrument. The inferior prosthesis plate 9 must abut the part of the insertion instrument clamp 2
marked "CAUDAL"; the superior prosthesis plate 7 must abut the part marked "CRANIAL".
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Guide the prosthesis plates on the spacer 1 onto coupling pins 5 and 6 of the clamp 2.
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Make certain that the coupling pins of the clamp fully engage in the coupling holes of the prosthesis plates.
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Turn clamping sleeve 3 clockwise until the intervertebral disc prosthesis is securely couples.
Decoupling the implant
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Release clamping sleeve 3.
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Carefully detach the insertion instrument from the implant.
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If the insertion instrument cannot be detached without applying force: Turn twist cap 11 anticlockwise to move
back spacer 1.
Disassembling
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Turn twist cap 11 counterclockwise until it can be removed.
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Hold unlocking button 10 pressed down.
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Pull out spacer 1 to the front.
Assembling
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Insert clamp 1 from the front through clamp 2 and, with unlocking button10 pressed down, push in the clamp
as far as it will go.
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Release unlocking button 10.
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Attach twist cap 11 and screw it on as far as it will go.
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To position spacer 1 as required: Turn twist cap 11 accordingly.
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.
Disassembling the product before carrying out the reprocessing procedure
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Disassemble the product immediately after use, as described in the respective instructions for use.
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Open up instruments with hinges.
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.
Preparation before cleaning
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Dismantle the product prior to cleaning, see Disassembling.
Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
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Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and
high-grade steel, according to the manufacturer's instructions.
CAUTION
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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 60 °C.
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Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
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Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfection.
– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/dis-
infection.
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
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Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.