Braun Aesculap activ L Instructions For Use Manual
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Braun Aesculap activ L Instructions For Use Manual

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Aesculap
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Aesculap Spine
Instructions for use/Technical description
activ L instruments

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  • Page 1 Aesculap ® Aesculap Spine Instructions for use/Technical description activ L instruments...
  • Page 2 Trial Implants Midline marker FW922R-FW928R/ FW955R FW971RFW979R) Wedges Spacers FW941R-FW944R FW951R FW954R Slotted Hammer FW579R Hammer Key for inserter FL045R FW945R 7 8 9 activ L parallel distractor FW970 activ L handle (for chisel guide) Chisel guides FW980R FW981R–FW984R/ FW989R-FW996R Single chisels FW989R–FW992 Double chisels...
  • Page 3 activ L insertion instrument FW961R–FW964R activ L angled distraction forceps FW960R activ L angled revision distraction forceps FW965R activ L revision instrument for PE inlay FW968R activ L revision instrument for endplates FW966R/FW967R activ L handle for revision instrument FW998R...
  • Page 4 ® Aesculap activ L instruments Legend ® activ L instruments Aesculap K activ L angled distraction forceps FW960R 23 Handle parts A Midline marker FW955R 24 Lock B Trial Implants FW922R-FW928R/FW971R- 25 Locking lever FW979R) 26 Working tip C Wedges FW941R-FW944R and shaft for wedge L activ L angled revision distraction forceps FW940R FW965R...

  • Page 5: Intended Use

    L revision instruments and distrac- tion forceps The intended use of the activ L instruments are to allow successful implantation of the Aesculap activ L The activ L revision instruments and distraction forceps device. These instruments aid in selecting, placing, and are used for the distraction/mobilization of two adja- revising the activ L device.
  • Page 6 ® Aesculap activ L instruments Available sizes activ L wedges, spacers, chisels and chisel guides Trial implants Art. no. Designation Size Art. no. Designation Size FW941R Wedge 6 mm FW922R Trial implant caudal S1 S 5° FW942R 8 mm FW923R Trial implant caudal S1 M 5°...
  • Page 7 Safe handling and preparation Note The chisels and chisel guides are used with activ L han- CAUTION dle for chisel guide FW980R. Federal law restricts this device to sale by, or on The wedges are used with activ L shaft for wedge order of a physician! FW940R.
  • Page 8 Aesculap ® activ L instruments Disassembling for reprocessing activ L double chisels FW985R–FW988R & single chisels FW989R–FW992R activ L parallel distractor FW970R ► Slide cage l back and rotate counterclockwise by 90°, see Fig. 3. ► Turn twist cap 10 counterclockwise until scale 4 ►...
  • Page 9 activ L chisel guides FW981R–FW984R/ activ L insertion instruments FW961R– FW989R-FW996R FW964R ► ► Push irrigation tube (outer diameter 7 mm/inner Turn twist cap 21 clockwise until it can be diameter 4 mm) at least 20 mm onto the end of the removed, see Fig.

  • Page 10: Validated Reprocessing Procedure

    Aesculap ® activ L instruments activ L revision instruments for endplates Note Mechanical reprocessing should be favored over man- FW966R & FW967R ual cleaning as it gives better and more reliable results. ► Unscrew handle 39 of revision instrument, see Fig. Note ►...

  • Page 11: Preparation Before Cleaning

    Only process chemicals that have been tested and Cleaning/disinfection approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials Product-specific safety notes on the repro- according to the chemical manufacturers’ recommen- cessing procedure dations may be used for processing the product.

  • Page 12: Manual Cleaning/Disinfection

    Aesculap ® activ L instruments Manual cleaning/disinfection Manual cleaning with ultrasound and immersion disinfection Phase Step Conc. Water Chemical [°C/°F] [min] quality Pre-Cleaning RT (cold) >15 D–W Aldehyde-free, phenol-free, and See # QUAT-free concentrate, pH ~ 9 Intermediate rinse RT (cold) D–W Ultrasonic Cleaning RT (cold)

  • Page 13: Inspection, Maintenance And Checks

    Phase II Inspection, maintenance and checks ► Rinse/flush the product thoroughly (all accessible ► Allow the product to cool down to room tempera- surfaces) under running water. ture. ► Mobilize non-rigid components, such as set screws, ► After each complete cleaning, disinfecting and dry- joints, etc.
  • Page 14 ® Aesculap activ L instruments Packaging activ L chisel guides FW981R–FW984R/ FW989R-FW996R ► Appropriately protect products to prevent damage of fine working tips. ► Remove the irrigation tube A∅7/I∅4 from the end ► Place the product in its holder or on a suitable tray. of the guide.
  • Page 15 Sterilization activ L revision instruments for endplates FW966R & FW967R ■ Aesculap advises against sterilizing the device by ► Slide the lock nuts 38 along the anchoring rods 36 immediate use steam sterilization (IUSS) or chem- as far as the threaded rods, see Fig. 10. ical sterilization.
  • Page 16 ® Aesculap activ L instruments Assembling after sterilization activ L insertion instruments FW961R– FW964R activ L parallel distractor FW970R ► Insert spacer 15 from the front through clamp 16 ► Put nuts 8 into nut cage 7. and, with unlocking button 22 pressed down, push ►...

  • Page 17: Safe Operation

    Safe operation Risk of injury and/or malfunc- tion! ► Always carry out a func- WARNING tion check prior to using the product. activ L parallel distractor FW970R Coupling the trial implants for anterior access (0°) ► Turn twist cap 10 counterclockwise until jaw pieces 1 and 2 are in contact with each other and the scale 4 reads less than 8.5 mm, see Fig.
  • Page 18 Aesculap ® activ L instruments ► activ L handle (for chisel guide) FW980R, Insert chisel guide 12 centrally into the disk space and adjust safety stop f to the desired chisel depth double chisels FW985R–FW988R, single while monitoring radiographically. chisels FW989R–FW992 & chisel guides FW981R–FW984R/FW989R-FW996R Risk of injury when using the product beyond the field of...
  • Page 19 Decoupling the implant activ L insertion instruments FW961R– FW964R ► Release clamping sleeve 17. ► Carefully detach the insertion instrument from the Coupling the implant implant. ► ► If the insertion instrument cannot be detached Select the appropriate insertion instrument without applying force: Turn twist cap 21 anti- according to the height of the intervertebral disc clockwise to move back spacer 15.
  • Page 20 Aesculap ® activ L instruments ► Applying the activ L angled revision distrac- Insert the working tip 26 into the intervertebral space, see Fig. 18. When doing so, ensure that the tion forceps FW965R instrument is pushed as dorsally as possible into the intervertebral disk space.
  • Page 21 ► Removing the activ L angled revision distrac- To remove the PE inlay from the revision instru- ment: tion forceps FW965R – Rotate the adjustment knob 33 in a counter- ► Gently press the handle parts 27 together and clockwise direction. actuate locking lever 29.
  • Page 22 Aesculap ® activ L instruments ► Note Push the revision instrument between the end- plates. When doing so, ensure that the hooks 37 The pins 39 on the screw connection of the anchoring reach over the posterior edges of the plates. rods of the revision instrument will point in the same ►...

  • Page 23: Technical Service

    Distributor in the US/Contact in ► For service and repairs, please contact your Canada for product information national B. Braun/Aesculap agency. Modifications carried out on medical technical equip- and complaints ment may result in loss of guarantee/warranty rights Aesculap Implant Systems LLC and forfeiture of applicable licenses.
  • Page 24 - DIR 93/42/EEC Technical alterations reserved Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany Phone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com Aesculap – a B. Braun company TA-Nr. 014275 07/15...

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