Aesculap Implant Systems

Transcription

1 Aesculap Implant Systems Aesculap Implant Systems Spine USA Instructions for Use / Technical Description Arcadius XP C Instruments Page 1 of 28

2 USA Aesculap Implant Systems Arcadius XP C Instruments Page 2 of 28

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5 Legend 1 U-Joint Screwdriver (ME055R) 2 Ball Joint Screwdriver (ME404R) 3 Fixed Angle Screwdriver (ME056R) 4 Straight Screwdriver (ME057R) 5 U-Joint Drill (ME058R) 6 Ball Joint Drill (ME403R) 7 Fixed Angle Drill (ME059R) 8 U-Joint Bone Awl (ME060R) 9 Ball Joint Bone Awl (ME402R) 10 Fixed Angle Bone Awl (ME061R) 11 Straight Bone Awl (ME062R) 12 U-Joint Screw Extraction Tool (ME072R) 13 Soft Tissue Protection Sleeve (ME103) Δ 14 Interbody Inserter (ME063R) 15 All-in-One Guides for Interbody, 5-11mm (ME064R-ME070R) 16 Impactor (ME071R) 17 Tamp (ME073R) 18 Packing Block (ME074R) 19 Slotted Mallet (ME079T) 20 Multi-Tool Handle (ME075T) 21 Jeweler Inline Handle (GREA-HJ0011-S09) 22 Mini Fixed Inline Handle (GREA-HM0012-S09) 23 Modular Jeweler Handle (ME076R) 24 Modular Chuck Handle (ME077R) 25 Modular Rasps, AO, 13x16mm/15x17mm, 4 /7, 5-10mm lengths (US039R, US044R, US054R-US059R, US068R, US069R, US093R, US099R, US139R, US198R, US199R, US211R- US214R, US217R-US220R, US222R)* 26 Modular Trials 13x16mm/15x17mm, 4 /7, 5-11mm heights (ME126R-ME132R, ME142R-ME148R, ME133R-ME139R, ME232R - ME238R) Δ Δ 27 Dual Rasp/Trials 13x16mm/15x17mm, 4 /7, 5-11mm heights (ME096T-ME102T, ME105T-ME125T) Δ Instrument offered upon customer request only. Not included in the instrument set. in Set # ST0652 only in Set # ST0652 and ST0631 Δ Δ in Set # ST0652 and ST0630 in Set # ST0630 only in Set # ST0631 only Page 5 of 28

6 Symbols on product packages Caution, general warning symbol See documentation supplied with the product Indications & Contraindications The Arcadius XP C Instruments are used for the implantation of Arcadius XP C devices into the cervical spine. Indications and contraindications are listed in the Instructions for Use for Implants (SOP-AIS ). Safe Handling and Preparation Risk of injury caused by incorrect operation of the product. Attend appropriate product training before using the product. For information about product training, please contact your national B. Braun/Aesculap agency. CAUTION Federal law restricts this device to sale by, or on order of a physician Always follow the Instructions for Use of the Arcadius XP C Implants (SOP-AIS ) and the respective surgical techniques. Ensure that the products and accessories are operated and used only by persons with the requisite training, knowledge, and experience. Read, follow, and keep the Instructions for Use. Remove the transport packaging and thoroughly clean the new product manually, prior to its initial sterilization, see reprocessing procedure. 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 if available. Safe Operation Risk of injury and/or product malfunction Always carry out a function check before using the product. Selection of Implant Size using Trial Implants The correct final size of Arcadius XP C Implant is determined by using the implant sizing trials (either Modular Trials or Dual Rasp/Trials). Connect the Modular Trial to the desired Handle (ME076R, ME077R, GREA-HJ0011-S09, or GREA-HM0012-S09) prior to advancing the trial into the disc space. Page 6 of 28

7 CAUTION Anterior osteophytes in the surgical site may prevent desired positioning of a trial and will likely prevent desired positioning of the Arcadius XP C Implant. It is recommended to remove interfering anterior osteophytes before implant insertion. Position the trial in the correct cranial/caudal alignment and carefully insert it into the disc space. Although the trials have depth stops, use fluoroscopy to check their position during insertion. Slotted Mallet (ME079T) can be used to aid insertion or removal of the Modular Trials or Dual Rasp/Trials. Do not apply excessive hammering force with the mallet. Risk of over-distraction, damaging the endplates / adjacent vertebral bodies / Modular Trial Implants / Dual Rasp Trials in the course of incorrectly applying the sizing trials. During the trial insertion, do not apply excessive bending / tilting / levering / hammering force to the Modular Trials or Dual Rasp/Trials. Under lateral and anterior-posterior fluoroscopy confirm the: o Trial depth, height, and lordosis o Endplate coverage (anterior-posterior / medial-lateral) o Midline placement o Implant rotation Select the implant size that corresponds with the final trial size chosen. Note Trials are color-coded to match the height of the corresponding Implant: 5mm Yellow 6mm Blue 7mm Red 8mm Green 9mm Natural 10mm Gray 11mm Black Risk of selecting incorrect implant size Fluoroscopy is mandatory to confirm the final trial size. Trials must provide good contact with the inferior and superior endplates. Therefore the proper footprint, height, and lordotic angle should be chosen for the disc space. Filling the Implant The Implant can be filled with bone or bone replacement material by using the Packing Block (ME074R) and Tamp (ME073R). Page 7 of 28

8 Implant Placement and Positioning Select and connect the appropriate All-in-One Guide (ME064R ME070R) to the Multi-Tool Handle (ME075T) by pressing and releasing the push button. Note All-in-One Guides are color-coded to match the height of the corresponding Implant: 5mm Yellow 6mm Blue 7mm Red 8mm Green 9mm Natural 10mm Gray 11mm Black Incorrect selection of the All-in-One Guide will result in implant damage and malfunction of the locking mechanism during the pilot hole preparation and bone screw insertion surgical steps. Confirm the selected All-in-One Guide corresponds to the selected Arcadius XP C cage. Align distal square of All-in-One Guide with internal square in the middle of the Arcadius XP C cage. Turn the Multi-Tool Handle wheel clockwise to thread inner shaft into the center fixation hole in the middle of the cage. Secure the selected Implant to the distal end of the All-in-One Guide by continuing to turn the wheel until it cannot be rotated any further. Use appropriate care when inserting the Implant. o Drive the Implant into the disc space using a suitable mallet. Note All-in-One Guides have a positive stop at the distal end to ensure the Implant is positioned flush with the anterior portion of the vertebral body. Inaccurate marking of the midline may result in incorrect positioning of the Implant. Always mark the midline under X-Ray visualization. Determine the center of the vertebral disc using the midline marker under X-Ray visualization. The Interbody Inserter (ME063R) with Multi-Tool Handle (ME075T) can be utilized as an alternative means of inserting the Implant into the disc space. Extreme caution must be exercised during Implant insertion due to the absence of a positive depth stop. If the Implant is inserted too far utilizing the Interbody Inserter (ME063R), the spinal canal and other posterior elements may be compressed Always use fluoroscopy to check the implant position during insertion. Excessive hammering may push the implant too far/deep into the disc space. Page 8 of 28

9 Risk of implant breakage Do not use excessive force when striking the implant connected to either the All-in-One Guide or the Interbody Inserter. Confirm an anatomically suitable position and orientation for the implant. o o o Obtain an AP fluoroscopic image to confirm midline placement of the device. Obtain a lateral fluoroscopic image to confirm the anterior edge of the Implant is seated flush with the anterior border of the vertebral body. Observe the X-Ray markers in both the AP and lateral views to ensure the Implant is not rotated within the disc space. Use Impactor (ME071R) to adjust the position (in AP direction) of the Implant as necessary if the All-in-One Guide/ Interbody Inserter was disengaged. Bone Screw Placement The Bone Awls (Fixed Angle Bone Awl (ME061R), U-Joint Bone Awl (ME060R), Ball Joint Bone Awl (ME402R), or Straight Bone Awl (ME062R)) and the Drills (U-Joint Drill (ME058R), Ball Joint Drill (ME403R), or Fixed Angle Drill (ME059R)) can be used to prepare a pilot hole for the bone screws at the intended screw placement site. Attach Bone Awls and Drills to the desired Handle (ME076R, ME077R, GREA-HJ0011-S09, or GREA-HM0012-S09) prior to using the instruments. Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, soft tissues, etc.) and the Arcadius XP C cage if the bone awls and drills are used without the All-in-One Guide It is recommended to use the bone awls and drills with the All-in-One Guide Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, soft tissues, etc.) with the drills and the bone awls, especially if the Arcadius XP C cage is placed off midline The instruments are sharp, always use the bone awls / drills under X-Ray control. Risk of damage to the Arcadius XP C cage in the course of incorrectly advancing the bone awls and drills Do not apply an excessive compressive / hammering / bending / tilting / levering force to the bone awls and the drills. Keep the instrument's tip directly aligned with the hole axis of the All-in-One Guide or the hole axis of the Arcadius XP C cage The bone awls and the drills must be pushed/advanced by hand only Risk of implant rotation Advance the drills and bone awls by hand while securely holding Arcadius XP C cage with either All-in-One Guide or Interbody Insertion Instrument. Don't disengage the All-in-One Guide/Interbody Insertion Instrument prior to fully inserting the bone screws. Attach a bone screw of appropriate length to selected self-retaining screwdriver (U-Joint Screwdriver (ME055R), Fixed Angle Screwdriver (ME056R), Ball Joint Screwdriver (ME404R), or Straight Screwdriver (ME057R)). Page 9 of 28

10 Engaging the screwdriver incorrectly when turning the bone screw into the Arcadius XP C cage may result in damage to the bone screws Fully insert the tip of the screwdriver into the bone screw. Guide the screw through the All-in-One Guide into the Arcadius XP C cage. Turn the screwdriver in a clockwise motion to advance the bone screw into the vertebral body Risk of damaging biological structures (spinal cord, spinal nerve roots, ligaments, soft tissues, etc.) while advancing incorrectly sized bone screws, especially if Arcadius XP C cage is placed off midline Always advance the bone screws under X-Ray control. Follow surgical technique, or training by Aesculap. Applying too much torque may result in stripping the bone thread by over tightening, damage to the bone screws or the Arcadius XP C cage Always use the screwdrivers with the Jeweler Handles (ME076R and GREA-HJ0011-S09). Adopt a thumb and two finger style grip to reduce the risk of applying too much torque. Risk of damage to the PEEK cage, or the bone screw head in the course of incorrectly driving the bone screw Do not apply an excessive bending/ tilting/ levering force to the Straight Screwdriver (ME057R) or Fixed Angle Screwdriver (ME056R) engaged in the bone screw. Keep the screwdrivers directly aligned with the axis of the bone screws. Insert the bone screws until they reach the final seated position, ensuring full engagement of the two locking mechanisms. Backing out and loosening of the bone screw occurs when the screw is not fully inserted into the cage Insert the bone screw until it gets fully engaged. Follow surgical technique, or training by Aesculap. Repeat the bone screw placement steps outlined above to insert the second bone screw through the Implant. Risk of insufficient stability or implant failure due to using fewer than two internal screw fixation provided Apply all of the screws or use an additional supplemental spinal fixation system that have been cleared for use in the cervical spine, such as cervical plating systems. Revision Locate implant to be revised, then securely engage either the appropriate All-in-One Guide or the Interbody Insertion Instrument (ME063R) with the Multi-Tool Handle (ME075T). Engage selected self-retaining screwdriver (U-Joint Screwdriver (ME055R), Ball Joint Screwdriver (ME404R), Fixed Angle Screwdriver (ME056R) and Straight Screwdriver (ME057R)) in the bone screw head. Retract the bone screw from the vertebral body by turning the screw in a counterclockwise motion. Use the U-Joint Screw Extraction Instrument (ME072R) to retract a free spinning screw. o Thread the instrument to the selected screw to be removed by engaging the internal thread mechanism (left-handed) in the screw head by rotating the instrument in a counterclockwise motion. Page 10 of 28

11 o Apply positive pull force and counterclockwise rotation to remove the screw. Repeat the bone screw removal process with the remaining bone screw in the Arcadius XP C cage. Carefully remove the implant from the disc space. Risk of injury to the patient Remove implant in the direction it was inserted. Excessive force during extraction may cause implant to impact the surrounding tissues. General Caution should be taken while operating the Multi-Tool Handle (ME075T). Activating the PRESS button on the Multi-Tool Handle (ME075T) while actively using the instrument can result in the instrument shaft detaching from the handle Do not cover the PRESS button with hand when utilizing fully assembled instruments. Caution should be taken while operating the instrument handles: the Multi-Tool Handle (ME075T) along with all quick connect handles: Jeweler Inline Handle (GREA-HJ0011-S09), Mini Fixed Inline Handle (GREA-HM0012-S09), Multi-Tool Handle (ME075T), Modular Jeweler Handle (ME076R), and Modular Chuck Handle (ME077R). Danger from improperly engaging the handles Prior to use, ensure that the instruments are securely connected to the handles. Caution should be taken while assembling the following modular instruments: Fixed Angle Screwdriver (ME056R), Fixed Angle Drill (ME059R), U-Joint Screwdriver (ME055R), U-Joint Drill (ME058R), U-Joint Screw Extraction Tool (ME072R), U-Joint Bone Awl (ME060R), and Straight Bone Awl (ME062R). Risk of not being able to securely engage implant or damaging the instruments. Ensure the instruments are correctly assembled prior to use. Danger from improperly assembled U-Joint Drill (ME058R): the drill bit may disengage from instrument shaft Prior to the surgery, ensure the drill bit is secured to the instrument shaft by firmly tightening the nut until it is fully threaded. Danger from improperly assembled U-Joint Screwdriver (ME055R): the screwdriver bit may disengage from the instrument shaft Prior to the surgery, ensure the screwdriver bit is secured to the instrument shaft by firmly tightening the nut until it is fully threaded. Page 11 of 28

12 Disassembly Fixed Angle Screwdriver (ME056R) and Fixed Angle Drill (ME059R) ME056R ME059R Figure 1: Disassembling ME056R and ME059R Unthread the nut [1] from the tube [2]. Pull out the tube [2] from the shaft sub-assembly. Remove the screwdriver bit [3] / drill bit [3] from the tube [2], see Fig. 1. U-Joint Instruments (ME055R, ME060R, ME058R, and ME072R) U-Joint Screwdriver (ME055R) Page 12 of 28

13 U-Joint Bone Awl (ME060R) U-Joint Drill (ME058R) U-Joint Screw Extraction Tool (ME072R) Figure 2: Disassembling ME055R, ME060R, ME058R and ME072R Remove the spring [1] covering the U-joint from the distal end of the shaft, see Fig. 2. Straight Bone Awl (ME062R) Figure 3: Disassembling ME062R Unthread the nut [1] from the tube [2]. Pull out the tube [2] from the shaft sub-assembly, see Fig. 3. Page 13 of 28

14 Assembly Fixed Angle Screwdriver (ME056R) and Fixed Angle Drill (ME059R) ME056R ME059R Figure 4: Assembling ME056R and ME059R Figure 5: Correct fully threaded position of the nut for ME056R and ME059R [1] Insert the screwdriver bit [3] / drill bit [3] into the tube [2]. Place the tube [2] over the shaft sub-assembly. Firmly thread the nut [1] over the tube [2] until it is fully threaded, see Fig. 4 and Fig. 5. Page 14 of 28

15 Danger from improperly assembled Fixed Angle Screwdriver (ME056R) or Fixed Angle Drill (ME059R): the screwdriver bit / drill bit may disengage from the instrument during shipment or operation Ensure the screwdriver bit [3] / drill bit [3] is secured to the tube by firmly tightening the nut [1] until it is fully threaded. See Fig. 4 and Fig. 5. U-Joint Instruments (ME055R, ME060R, ME058R, and ME072R) U-Joint Screwdriver (ME055R) U-Joint Bone Awl (ME060R) U-Joint Drill (ME058R) U-Joint Screw Extraction Tool (ME072R) Figure 6: Assembling ME055R, ME060R, ME058R and ME072R Page 15 of 28

16 Figure 7: Correct spring position Slide the spring [1] over the distal end until it is completely covering the U-joint. The end of the spring [2] must sit in the undercut, see Fig. 6 and Fig. 7. Danger from improperly assembled U-Joint Screwdriver (ME055R), U-Joint Bone Awl (ME060R), U- Joint Drill (ME058R), and U-Joint Screw Extraction Instrument (ME072R): The spring may disengage from the instrument shaft during shipment or operation Ensure the end of the spring [2] is seated in the undercut. Page 16 of 28

17 Soft Tissue Protection Sleeve (ME103) The Soft Tissue Protection Sleeve can be assembled to the following instruments: U-Joint Screwdriver (ME055R), U- Joint Bone Awl (ME060R), U-Joint Drill (ME058R) and U-Joint Screw Extraction Instrument (ME072R). Figure 8: Assembling ME103 (U-Joint Screwdriver shown) Figure 9: Correct sleeve position (U-Joint Screwdriver shown) Prior to assembling the Soft Tissue Protection Sleeve the spring [1] must be removed (see Disassembly instructions and Fig. 2) Slide the sleeve [1] over the distal end until hard stop, see Fig. 8 and Fig. 9. The sleeve [1] can be removed by applying force in the opposite assembly direction. Straight Bone Awl (ME062R) Place the tube [2] over the shaft sub-assembly. Figure 10: Assembling ME062R Firmly thread the nut [1] over the tube [2] until it is fully threaded, see Fig. 10. Page 17 of 28

18 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 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 validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for process validation. Note For the latest information on reprocessing and material compatibility, see the reprocessing brochure at Aesculap US website 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 6h. Neither pre-cleaning fixation temperatures >45 C/113 F nor disinfecting fixation agents (active ingredient: aldehydes/alcohols) should be used. Excessive amounts of neutralizing agents or basic cleaners may result in material degradation and/or fading, causing the laser marking to become unreadable on 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 destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water then drying. Only process chemicals that have been tested and approved (e.g. FDA clearance) 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. Page 18 of 28

19 Disassembly of product before reprocessing Disassemble the product (if applicable) immediately after use, as described in the respective Disassembly section of the Instructions for Use. Preparations at the place of use Clean instruments as quickly as possible after usage. Prevent any significant contaminants from drying onto the instrument surface prior to cleaning. If applicable, rinse non-visible surfaces preferably with deionized water, e.g. with a disposable syringe. 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 h. Preparation before cleaning Inspect tray to insure all debris have been removed. Repeat as many times as necessary until no visible debris remains in the tray. Disassemble each product (if applicable) prior to cleaning, see Disassembly section. 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 o are approved for plastics and high-grade steel, o do not degrade softeners (e.g. in silicone). Observe specifications regarding concentration, temperature and exposure time. Do not exceed the maximum allowable washing temperature. Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. Rinse the product thoroughly with water prior to mechanical cleaning and disinfecting in order to prevent foam formation and reduced effectiveness of the process chemicals. Carry out ultrasonic cleaning: o As an effective mechanical supplement to manual cleaning/disinfection. o As a pre-cleaning procedure for encrusted residues, in preparation for mechanical cleaning/ disinfection. o As an integrated mechanical support for mechanical cleaning/disinfection. o For additional cleaning of products with residues left after mechanical cleaning/disinfection. Page 19 of 28

20 Validated Cleaning/Disinfection Procedures Validated Procedure Manual Cleaning with Immersion Disinfection Manual Cleaning with Ultrasound & Immersion Disinfection Mechanical Cleaning with Pre-Rinse Manual Pre- Cleaning with Immersion & subsequent Mechanical Cleaning Manual Pre- Cleaning with Ultrasound & subsequent Mechanical Cleaning Devices Specific Requirements Reference ME056R, ME057R, ME059R, ME061R, ME063R, ME071R, ME073R, ME074R, ME079T, ME103, Dual Rasp/Trials (ME096T-ME102T, ME105T- ME125T), Modular Trials (ME126R-ME132R, ME142R-ME148R, ME133R-ME139R, ME232R- ME238R), Modular Rasps (US039R, US044R, US054R-US059R, US068R, US069R, US093R, US099R, US139R, US198R, US199R, US211R- US214R, US217R-US220R, US222R), All-in-One Guides (ME064R-ME070R), ME075T 1 ME055R, ME058R, ME060R, ME062R, ME072R, ME076R, ME077R, ME402R, ME403R, ME404R, GREA-HJ0011-S09, GREA-HM0012-S09 ME057R, ME071R, ME073R, ME079T, Modular Rasps (US039R, US044R, US054R-US059R, US068R, US069R, US093R, US099R, US139R, US198R, US199R, US211R- US214R, US217R- US220R, US222R) 1 ME056R, ME059R, ME061R, ME063R, ME074R, ME103, Dual Rasp/Trials (ME096T-ME102T, ME105T-ME125T), Modular Trials (ME126R- ME132R, ME142R-ME148R, ME133R-ME139R, ME232R-ME238R), All-in-One Guides (ME064R- ME070R), ME075T 1 Disposable syringe 20ml Cleaning brush: TA011944, TTE654202, or GK When cleaning products with movable hinges, ensure these are in an open position; move joint while cleaning Drying phase: Use lint-free cloth or medical compressed air Disposable syringe 20ml Cleaning brush: TA011944, TTE654202, or GK When cleaning products with movable hinges, ensure these are in an open position; move joint while cleaning Drying phase: Use lint-free cloth or medical compressed air Disposable syringe 20ml Cleaning brush: TA011944, TTE654202, or GK Place products in a tray suitable for cleaning Disposable syringe 20ml Cleaning brush: TA011944, TTE654202, or GK When cleaning products with movable hinges, ensure these are in an open position; move joint while cleaning Place products in tray suitable for cleaning (avoid rinsing blind spots) with any hinges open. Disposable syringe 20ml Cleaning brush: TA011944, TTE654202, or GK Place products in a tray suitable for cleaning (avoid rinsing blind spots) with any hinges open. Chapter: Validated Cleaning/ Disinfection Procedures Sub-Chapter: Manual Cleaning with Immersion Disinfection Chapter: Validated Cleaning/ Disinfection Procedures Sub-Chapter: Manual Cleaning with Ultrasound & Immersion Disinfection Chapter: Validated Cleaning/ Disinfection Procedures Sub-Chapter: Manual Cleaning with Pre-Rinse Chapter: Validated Cleaning/ Disinfection Procedures Sub-Chapter: Manual Pre-Cleaning with Immersion & Subsequent Mechanical Cleaning Chapter: Validated Cleaning/ Disinfection ME055R, ME058R, ME060R, ME062R, ME072R, Procedures ME076R, ME077R, ME402R, ME403R, ME404R, Sub-Chapter: GREA-HJ0011-S09, GREA-HM0012-S09 Manual Pre-Cleaning with Ultrasound & Subsequent Mechanical Cleaning 1 Prior to manual cleaning with immersion, completely immerse parts in an appropriate enzymatic manual cleaning solution and allow to soak for 4 minutes. Prior to manual disinfection, allow water to drip off for a sufficient length of time to prevent dilution of the disinfecting solution. After manual cleaning/disinfection, check visible surfaces visually for residues. Repeat the cleaning/disinfection process if necessary. Page 20 of 28

21 Manual Cleaning with Immersion Disinfection ME056R, ME057R, ME059R, ME061R, ME063R, ME071R, ME073R, ME074R, ME079T, ME103, Dual Rasp/Trials (ME096T-ME102T, ME105T-ME125T), Modular Trials (ME126R-ME132R, ME142R-ME148R, ME133R-ME139R, ME232R-ME238R), Modular Rasps (US039R, US044R, US054R-US059R, US068R, US069R, US093R, US099R, US139R, US198R, US199R, US211R- US214R, US217R- US220R, US222R), All-in-One Guides (ME064R-ME070R), ME075T Phase Step T [ F/ C] t [min] Conc. [%] Water Quality I Pre-Cleaning RT (cold) >15 See # 3 D-W Chemical Aldehyde-free, phenol-free, and QUAT-free concentrate, ph II Intermediate rinse RT (cold) 1 - D-W - III Disinfection RT (cold) 15 See # 3 D-W IV Final rinse RT (cold) 1 - Distilled Water Aldehyde-free, phenol-free, and QUAT-free concentrate, ph V Drying RT D-W: Drinking water RT: Room temperature 1 Recommended: Steris Prolystica 2x concentrate enzymatic presoak and cleaner 2 Recommended: Steris Prolystica 2x concentrate neutral detergent 3 Prepare according to manufacturer s instructions Note information on appropriate cleaning brushes and disposable syringes. See Cleaning & Disinfection Procedures section. For ME075T: o Prior to manual cleaning with immersion, completely immerse parts in an appropriate enzymatic manual cleaning solution and allow to soak for 4 minutes. Phase I Fully immerse the product in a prepared room temperature enzymatic detergent solution (Recommended: Steris Prolystica) for at least 15 min. Ensure all accessible surfaces are moistened. Rinse lumens at least five times with disposable syringe (20ml). Ensure that all accessible surfaces are moistened. Thoroughly clean the product with a suitable soft bristled brush in the solution until all discernible residues have been removed from the surface. Brush any non-visible surfaces with a suitable soft-bristled brush for 1 min. Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Thoroughly rinse these components with the cleaning disinfectant solution 5x with 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 III Fully immerse the product in the disinfectant solution (Recommended: Steris Prolystica). Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. Visually inspect all lumens and gaps to ensure there is no remaining contamination. Thoroughly rinse these components with the cleaning solution ( 5 times), using a disposable syringe (20 ml). Ensure all accessible surfaces are moistened. - Page 21 of 28

22 Phase IV Rinse/flush the product thoroughly (all accessible surfaces) under running desalinated water. Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. Rinse lumens with a disposable syringe (20 ml) at least five times. Drain any remaining water fully. Phase V Dry the product in the drying phase with suitable equipment (e.g. lint-free cloth, compressed filtered air), see Cleaning & Disinfection Procedures. Manual Cleaning with Ultrasound & Immersion Disinfection ME055R, ME058R, ME060R, ME062R, ME072R, ME402R, ME403R, ME404R, GREA-HJ0011-S09, GREA-HM0012-S09 T t Conc. Water Phase Step Chemical [ F/ C] [min] [%] Quality I Pre-Cleaning RT (cold) >15 See # 3 D-W Aldehyde-free, phenol-free, and QUAT-free concentrate, ph II Intermediate rinse RT (cold) 1 - D-W - III Ultrasonic Cleaning RT (cold) 15 See # 3 D-W IV Final rinse RT (cold) 1 - Distilled Water Aldehyde-free, phenol-free, and QUAT-free concentrate, ph V Drying RT D-W: Drinking water RT: Room temperature 1 Recommended: Steris Prolystica 2x concentrate enzymatic presoak and cleaner 2 Recommended: Steris Prolystica 2x concentrate neutral detergent 3 Prepare according to manufacturer s instructions - Note information on appropriate cleaning brushes and disposable syringes. See Validated Cleaning/Disinfection Procedures section. Phase I Fully immerse the product in a prepared room temperature enzymatic detergent solution (Recommended: Steris Prolystica) for at least 15 min. Ensure all accessible surfaces are moistened. Rinse lumens at least five times with a disposable syringe (20ml). Ensure all accessible surfaces are moistened. Thoroughly clean the product with a suitable soft bristled brush in the solution until all discernible residues have been removed from the surface. Brush any non-visible surfaces with a suitable soft-bristled brush for 1 min. Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Thoroughly rinse these components with the cleaning disinfectant solution 5x with 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. Page 22 of 28

23 Phase III Prepare neutral detergent (Recommended: Steris Prolystica) in an ultrasonic cleaning bath. Clean the product in an ultrasonic cleaning bath (frequency 35 khz) for at least 15 min. Ensure all accessible surfaces are immersed and acoustic shadows are avoided. Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. Visually inspect all lumens and gaps to ensure there is no remaining contamination. Thoroughly rinse these components 5 times with the cleaning solution, using a disposable syringe (20 ml). Ensure all accessible surfaces are moistened. Phase IV Rinse/flush the product thoroughly (all accessible surfaces) under running desalinated water. Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. Rinse lumens with a disposable syringe (20 ml) at least five times. Drain any remaining water fully. Phase V Dry the product in the drying phase with suitable equipment (e.g. lint-free cloth, compressed filtered air), see Cleaning & Disinfection Procedures. Mechanical Cleaning with Pre-Rinse ME057R, ME071R, ME073R, ME079T, Modular Rasps T Phase Step [ F/ C] t [min] Conc. [%] Water Quality I Wash Phase I 131/55 5 See # 3 D-W II Wash Phase II 131/ T-W II Rinse 194/90 2 See # 3 Distilled Water Chemical Aldehyde-free, phenol-free, QUATfree enzymatic cleaner, ph ,4 Aldehyde-free, phenol-free, QUATfree neutral detergent, ph ,4 IV Drying 194/ D-W: Drinking water T-W: Tap water 1 Recommended: Steris Prolystica 2x concentrate enzymatic presoak and cleaner 2 Recommended: Steris Prolystica 2x concentrate neutral detergent 3 Prepare according to manufacturer s instructions 4 Always follow the manufacturer s specifications for automatic washer-sterilizers and use a free-rinsing, low sudsing detergent with a neutral ph ( ). Due to variations in water quality, the type of detergent and its concentrations may require adjustment for optimal disinfection and cleaning. Before placing in the washer disinfector, immerse products in drinking water and agitate all moving parts (e.g. with a brush) until there is no evidence of soil Place the pre-rinsed products in a tray that is suitable for cleaning (avoiding rinsing blind spots). Place any hinged instruments in the tray with their hinges open. Check visible surfaces for residues after mechanical cleaning/disinfection. - Page 23 of 28

24 Manual Pre-Cleaning with Immersion & Subsequent Mechanical Cleaning ME056R, ME059R, ME061R, ME063R, ME074R, ME103, Dual Rasp/Trials (ME096T-ME102T, ME105T-ME125T), Modular Trials (ME126R- ME132R, ME142R-ME148R, ME133R-ME139R, ME232R-ME238R), All-in-One Guides (ME064R-ME070R), ME075T Phase Step T [ F/ C] t [min] Conc. [%] Water Quality I Pre-Cleaning RT (cold) >15 See # 3 D-W Chemical Aldehyde-free, phenol-free, and QUATfree concentrate, ph II Intermediate rinse RT (cold) 1 - D-W - III Disinfection RT (cold) 15 See # 3 D-W IV Rinse RT (cold) 1 - Distilled Water V Wash Phase I 131/55 5 See # 3 D-W VI Wash Phase II 131/ T-W VII Rinse 194/90 2 See # 3 Distilled Water Aldehyde-free, phenol-free, and QUATfree concentrate, ph Aldehyde-free, phenol-free, QUAT-free enzymatic cleaner, ph ,4 Aldehyde-free, phenol-free, QUAT-free neutral detergent, ph ,4 VIII Drying 194/ D-W: Drinking water T-W: Tap water RT: Room temperature 1 Recommended: Steris Prolystica 2x concentrate enzymatic presoak and cleaner 2 Recommended: Steris Prolystica 2x concentrate neutral detergent 3 Prepare according to manufacturer s instructions 4 Always follow the manufacturer s specifications for automatic washer-sterilizers and use a free-rinsing, low sudsing detergent with a neutral ph ( ). Due to variations in water quality, the type of detergent and its concentrations may require adjustment for optimal disinfection and cleaning. Prior to pre-cleaning with immersion, the Multi-Tool Handle (ME075T) instrument must be completely immersed in an appropriate enzymatic manual cleaning solution and allowed to soak for 4 minutes. Protective sleeve on tip of the Bone Awl (ME061R) must be fully retracted to expose groove and ensure all evidence of soil is removed from the groove during the manual cleaning process (refer to Phase I below). Phase I Fully immerse the product in a prepared room temperature enzymatic detergent solution (Recommended: Steris Prolystica) for at least 15 min. Ensure all accessible surfaces are moistened. Rinse lumens at least five times with disposable syringe (20ml). Ensure that all accessible surfaces are moistened. Thoroughly clean the product with a suitable soft bristled brush in the solution until all discernible residues have been removed from the surface. Brush any non-visible surfaces with a suitable soft-bristled brush for 1 min. Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Thoroughly rinse these components with the cleaning disinfectant solution 5x with 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. - Page 24 of 28

25 Phase III Fully immerse the product in the disinfectant solution (Recommended: Steris Prolystica). Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. Visually inspect all lumens and gaps to ensure there is no remaining contamination. Thoroughly rinse these components with the cleaning solution ( 5 times), using a disposable syringe (20 ml). Ensure all accessible surfaces are moistened. Phase IV Rinse/flush the product thoroughly (all accessible surfaces) under running desalinated water. Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. Rinse lumens with a disposable syringe (20 ml) at least five times. Drain any remaining water fully. Phases V-VIII (Washer Disinfector) Place the products in a tray that is suitable for cleaning (avoiding rinsing blind spots). Place any hinged instruments in the tray with their hinges open. Check visible surfaces for residues after mechanical cleaning/disinfection. Manual Pre-Cleaning with Ultrasound & Subsequent Mechanical Cleaning ME076R, ME077R Phase Step T [ F/ C] t [min] Conc. [%] Water Quality I Pre-Cleaning RT (cold) >15 See # 3 D-W Chemical Aldehyde-free, phenol-free, and QUAT-free concentrate, ph II Intermediate rinse RT (cold) 1 - D-W - III Ultrasonic Cleaning RT (cold) 15 See # 3 D-W Aldehyde-free, phenol-free, and QUAT-free concentrate, ph IV Rinse RT (cold) 1 - Distilled Water - V Wash Phase I 131/55 5 See # 3 D-W Aldehyde-free, phenol-free, QUATfree enzymatic cleaner, ph ,4 VI Wash Phase II 131/ T-W VII Rinse 194/90 2 See # 3 Distilled Water Aldehyde-free, phenol-free, QUATfree neutral detergent, ph ,4 VIII Drying 194/ D-W: Drinking water T-W: Tap water RT: Room temperature 1 Recommended: Steris Prolystica 2x concentrate enzymatic presoak and cleaner 2 Recommended: Steris Prolystica 2x concentrate neutral detergent 3 Prepare according to manufacturer s instructions 4 Always follow the manufacturer s specifications for automatic washer-sterilizers and use a free-rinsing, low sudsing detergent with a neutral ph ( ). Due to variations in water quality, the type of detergent and its concentrations may require adjustment for optimal disinfection and cleaning. - Page 25 of 28

26 Phase I Fully immerse the product in a prepared room temperature enzymatic detergent solution (Recommended: Steris Prolystica) for at least 15 min. Ensure all accessible surfaces are moistened. Rinse lumens at least five times with a disposable syringe (20ml). Ensure all accessible surfaces are moistened. Thoroughly clean the product with a suitable soft bristled brush in the solution until all discernible residues have been removed from the surface. Brush any non-visible surfaces with a suitable soft-bristled brush for 1 min. Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Thoroughly rinse these components with the cleaning disinfectant solution 5x with 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 III Prepare neutral detergent (Recommended: Steris Prolystica) in an ultrasonic cleaning bath. Clean the product in an ultrasonic cleaning bath (frequency 35 khz) for at least 15 min. Ensure all accessible surfaces are immersed and acoustic shadows are avoided. Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. Visually inspect all lumens and gaps to ensure there is no remaining contamination. Thoroughly rinse these components 5 times with the cleaning solution, using a disposable syringe (20 ml). Ensure all accessible surfaces are moistened. Phase IV Rinse/flush the product thoroughly (all accessible surfaces) under running desalinated water. Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. Rinse lumens with a disposable syringe (20 ml) at least five times. Drain any remaining water fully. Phases V-VIII (Washer Disinfector) Place the products in a tray that is suitable for cleaning (avoiding rinsing blind spots). Place any hinged instruments in the tray with their hinges open. Check visible surfaces for residues after mechanical cleaning/disinfection. Inspection, Maintenance, and Functional Checks CAUTION Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication Prior to functional checks, lubricate moving parts (e.g. joints, pusher components, and threaded rods) at the marked lubrication points, using maintenance oil suitable for the respective sterilization process. Allow the product to cool to room temperature. After each complete cleaning, disinfection, and drying cycle, check that the product is: clean, dry, operational, and damagefree (e.g. no broken insulation or loose, bent, broken, cracked, worn, or fractured components). Dry the product if it is wet or damp. Repeat cleaning and disinfection if product still has visible impurities or contamination. Check that the product functions correctly. Page 26 of 28

27 Immediately put aside damaged or inoperable products and send them to Aesculap Technical Service, see Technical Service section. Assemble any disassembled products, see Assembly section. Check for compatibility with associated products. Packaging Appropriately protect products to prevent damage of fine working tips. Those instruments are: ME055R, ME056R, ME057R, ME058R, ME059R, Me060R, ME061R, ME062R, ME402R, ME403R, and ME404R. Place the product in its holder or in a suitable tray. Ensure all cutting edges are protected. Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers). Ensure the packaging provides sufficient protection against recontamination of the product during storage. Steam Sterilization Aesculap advises against sterilizing the device by immediate use steam sterilization (i.e. flash sterilization) or chemical sterilization. Sterilization may be accomplished by a standard pre-vacuum cycle in a steam autoclave. Do not stack containers during sterilization. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga TM Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization Temp. Time Minimum Drying Time Method F/ C Pre-vacuum 270/132 4 min 30 min *Aesculap has validated the above sterilization cycles and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by the FDA for 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. When sterilizing several products at the same time in a steam sterilizer, ensure the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded. Disposal 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 cross contamination. Adhere to national regulations when disposing of or recycling the products, their components and all packaging Page 27 of 28

28 Technical Service Risk of injury and/or product malfunction Do not modify the product. If any Arcadius XP C Spinal System instrument or its components require repair or maintenance, return the entire instrument set in a sturdy box with adequate foam, bubble wrap, or other packaging material to protect it. Instruments returned to Aesculap Implant Systems for repair must have a statement which testifies that each instrument has been thoroughly cleaned and disinfected. Failure to supply evidence of cleaning and disinfection will result in a cleaning charge and delayed processing of your instrument repair. Send the packaged instrument to: Aesculap Implant Systems, LLC. Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, St. Louis, MO Aesculap Repair Hotline Phone: +1 (800) Fax: +1 (314) CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Product information and complaints Aesculap Implant Systems, LLC Corporate Parkway Center Valley, PA SOP-AIS Rev. 2 02/18 Page 28 of 28