BBraun
Temporary spikes for CASPAR anterior cervical fusion
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Aesculap® Temporary spikes for CASPAR anterior cervical fusion Symbols on product and packages Symbol
Explanation Not for reuse in intended applications as defined by the manufacturer
Use by
Breakage of the temporary spike during implantation, due to multiple bending or bluntness of the spike! ► The temporary spikes are for single-use only. CAUTION ► Position the titanium CASPAR ACF plates on the vertebral body. ► Insert the first temporary spike in special impactor instrument FG315R. ► To secure the temporary spike, push forward and turn the outer sleeve of impactor instrument FG315R. ► 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. ► 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 contact with the vertebral body. This is necessary to achieve secure fixation of the plates on the vertebral body.
Caution, general warning symbol Caution, see documentation supplied with the product
Removing the temporary spikes Breakage of the temporary spike during removal, due to multiple bending or bluntness of the spike! ► The temporary spikes are for single-use only.
Date of manufacture CAUTION
► 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.
Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
Validated reprocessing procedure
at https://extranet.bbraun.com
General safety instructions
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. ► The patient must be informed about the advantages and disadvantages of anterior cervical fusion. ► Read and follow the operating manual. Note The operating manual can be ordered under article number 043102 from the address given below. ► 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. ► 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).
Safe operation 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! ► Apply the product only under visual control. WARNING
Damage to the instruments due to incorrect application! ► Use the instruments for anterior cervical fusion only in connection with titanium CASPAR ACF plates FG420T to FG490T. CAUTION
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 vertebral 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.
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! ► Use temporary spikes only in connection with titanium CASPAR ACF plates. ► Insert the temporary spikes only by using the appropriate impactor instrument FG315R. ► The temporary spikes are for single-use only.
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 operator/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 temperatures >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. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► 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
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for use e.g. on aluminum, plastic materials and stainless steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 55 °C.
Risk of damage to, or destruction of the temporary spikes due to reuse! The temporary spikes are intended for single use only. ► Do not reuse the temporary spikes. CAUTION ► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product. ► 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. ► Carry out ultrasound cleaning:
– As an effective mechanical supplement to manual cleaning/disinfection – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfection. ► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the positioning aids.
Mechanical cleaning/disinfecting Note It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (with FDA approval or a CE marking, for instance). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase
step
T [°C/°F]
t [min]
Water quality
Chemical/Note
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
Validated cleaning and disinfection procedure
– pH = 13 – <5 % anionic surfactant
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion disinfection
■ Do not reprocess the product
Chapter Manual cleaning/disinfection and sub-chapter:
after use in the body.
■ Drying phase: Use a lint-free
– pH = 11*
■ Chapter Manual cleaning with immersion disinfection
cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection
■ Do not reprocess the product after use in the body.
■ Place the instrument in a tray
■ 0.5 % working solution
Chapter Mechanical cleaning/disinfecting and sub-chapter:
■ Chapter Mechanical alkaline cleaning and thermal disinfecting
that is suitable for cleaning (avoiding rinsing blind spots).
Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfection
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for the cleaning and disinfection device
D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline
Inspection, maintenance and checks
infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary. CAUTION
Manual cleaning with immersion disinfection Phase
step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemicals
I
Disinfectant cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT (cold)
1
-
D–W
-
III
Disinfection
RT (cold)
15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT (cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).
► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Check for compatibility with associated products.
Packaging
D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 minute. ► Mobilize non-rigid components, such as set screws and hinges, during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a suitable disposable syringe. Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws and hinges, during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the instrument in the disinfectant solution. ► Mobilize non-rigid components, such as set screws and hinges, during disinfection. ► Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the instrument thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws and hinges, during final rinsing. ► Rinse lumens at least five times using an appropriate disposable syringe. ► Drain any remaining water fully. Phase V ► In the drying phase, dry the product via appropriate means (e.g., wipes, compressed air), see Validated cleaning and disinfection procedure.
► Appropriately protect products with fine working tips. ► Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets). ► Validated sterilization process
– Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.
Sterilization for the US market ■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization. ■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/275 °F
4 min
20 min
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.
Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Technical Service Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.
Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 008349
2017-11
V6
Änd.-Nr. 58002