BBraun
Tibial and distal femoral cutting guide
40 Pages
Preview
Page 1
For unilaterally deeper incisions at the tibia (step incisions)
Aesculap® Tibial and distal femoral cutting guide
► Use cutting guide D and E. ► Apply the primary incision and remove the converging fixation pins. ► Move cutting guide D and E in the row of parallel holes in 4-mm steps distally. ► Resect again, applying the step incision. ► Remove the fixation pins and detach cutting guide A-E and universal alignment system NP608R from the bone. ► Remove the resected bone.
Legend A B C D E F G 1 2 3 4 5
Distal femoral cutting guide Tibial cutting guide left Tibial cutting guide right Tibial revision cutting guide right Tibial revision cutting guide left Tibial cutting guide left Tibial cutting guide right Holes for fixation pin Compression spring Push buttons Cutting slot Laser marking
Symbols on product and packages
For unilaterally deeper incisions at the femur (step incisions) ► Use distal femoral revision cutting guide A. ► Perform the primary incision through the cutting guide(marked with 0). ► Perform step incisions 4 or 8 mm deep in the marked slot without moving the cutting guide.
Disassembling Remove push buttons 3 from cutting guide A-G in the following way: ► Insert a hexagon socket key size 3.5 mm (e.g. NP618R) into push-button 3 to be removed. ► Push the push button 3 against compression spring 2 into the cutting guide and turn it clockwise as far as it will go. ► Remove pushbutton 3, with compression spring 2 attached, from the cutting guide.
Assembling
Caution, general warning symbol Caution, see documentation supplied with the product
Damage to cutting guide or push button due to incorrect assembling! ► Carefully slide the push button into the cutting guide. CAUTION ► Insert push button 3 on hexagon socket key size 3.5 mm. ► Position push button 3 on the cutting guide
Applicable to ► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at www.extranet.bbraun.com
The positioning is correct if the laser markings 5 are in matching positions. ► Slide in push button 3 against the pressure of compression spring 2 into the hole provided in the cutting guide,
and turn it clockwise as far as it will go. ► Extract the hexagon socket key from push button 3.
Intended use
Compression spring 2 slightly pushes out push button 3 from the cutting guide.
The asymmetric tibial cutting guide and the distal femoral cutting guide are used to ensure correct bone resection at the distal femur and the proximal tibia in endoprosthetic knee procedures. The distal femoral cutting guide is used for the resection of the distal femur. The asymmetric tibial cutting guides, left and right, are used for resecting the proximal tibia in the medial approach at the left or right knee, respectively.
Validated reprocessing procedure
Safe handling and preparation
Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.
CAUTION Federal law restricts this device to sale by, or on order of a physician! ► 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.
Safe operation Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.
General safety instructions
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 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.
General information
WARNING Risks due to imprecise resections! ► The cutting guide must be stable while being inserted saw blade into the cutting guide Do no bend the saw blade during the sawing procedure. WARNING
For navigated alignment using the OrthoPilot® navigation system ► Connect cutting guide A-E to the universal alignment system NP608R, using mounted push buttons 3. ► Fasten the universal alignment system NP608R on the bone. ► Align cutting guide A-C on the bone, using the OrthoPilot® navigation system and universal alignment system
NP608R.
For manual alignment ► Connect the cutting guide B-G to alignment system NE477R (part of the external tibial alignment system) and
align manually.
For intramedullary alignment ► Connect cutting guide B-G with adapter NE195R. ► Use components NP677R and NP678R to connect to the intramedullary rod or the reamer in the medullary cavity
(see operating manual).
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.
Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the respective instructions for use.
Fixation ► Fasten the aligned cutting guide A-G on the bone with the fixation pins ∅ 3.2mm (e.g. NP582R/NP583R)
inserted through the parallel holes marked 0. Note Aesculap recommends additional fixation through the lateral, converging holes (see operating manual for the knee endoprosthesis). ► Resect the bone through cutting guide 4 in cutting guide A-E.
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.
Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.
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, for example, on aluminum, plastic materials, and high-grade 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 134 °C.
► Carry out ultrasound cleaning:
– as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/ disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.
Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► 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 product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.
Mechanical cleaning/disinfecting Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Validated cleaning and disinfection procedure Mechanical alkaline cleaning and thermal disinfecting Validated procedure
Specific requirements
Reference
Machine type: single-chamber cleaning/disinfection device without ultrasound
Manual cleaning with ultrasound and immersion disinfection
■ Cleaning brush:, e.g. TA011327 ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free
Chapter Manual cleaning/disinfection and sub-chapter:
Phase
Step
T [°C/°F]
t [min]
Water quality
Chemical/Note
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline:
■ Chapter Manual cleaning with ultrasound and immersion disinfection
cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection
■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
Chapter Mechanical cleaning/disinfecting and sub-chapter:
– pH = 13 – <5 % anionic surfactant
■ Chapter Mechanical alkaline
■ Connect components with
■ 0.5 % working solution
cleaning and thermal disinfecting
lumens and channels directly to the rinsing port of the injector carriage.
– pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
■ Keep working ends open for cleaning. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection
■ Cleaning brush:, e.g. TA011327 ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).
■ Connect components with
Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:
■ Chapter Manual pre-cleaning with ultrasound and brush
■ Chapter Mechanical alkaline
lumens and channels directly to the rinsing port of the injector carriage.
cleaning and thermal disinfecting
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
■ Keep working ends open for cleaning.
Mechanical cleaning/disinfection with manual pre-cleaning
Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning /disinfection process if necessary.
Manual pre-cleaning with ultrasound and brush Manual cleaning with ultrasound and immersion disinfection Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic 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
-
-
-
-
D–W: FD–W:
Drinking water 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 dis-
infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.
Phase
Step
T [°C/°F]
t [min]
Conc. [%]
Water quality
Chemical
I
Ultrasonic cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► 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 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
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
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant
■ 0.5 % working solution – pH = 11* III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning and disinfection device
D–W: FD–W:
Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.
Inspection, maintenance and checks
CAUTION
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. 020011
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 product 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 Tech-
nical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.
Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile 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
– Disassemble the product – 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 products 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.
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.
01/13
V6
Änd.-Nr. 45662