Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive


[PDF]Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive...

0 downloads 213 Views 579KB Size

Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive, Thousand Oaks, CA 91362 USA Toll Free: 888-649-6425, Direct: 661-705-4920, www.implantdirect.com

Instructions for Use: SXT - Screw Removal Tool IXT - Implant Removal Tool Caution: Federal law restricts this device to sale by or on the order of a dentist. Disclaimer of Liability: The users of Implant Direct Sybron Manufacturing, LLC. products must determine whether or not a particular product is suitable for a particular application and circumstance. Implant Direct Sybron Manufacturing, LLC. disclaims any liability, express or implied, and shall have no responsibility for any direct, indirect, punitive or other damages arising out of or in conjunction with any errors in professional judgment or practice in the use of Implant Direct Sybron Manufacturing, LLC. products. Users are advised and obliged to study the latest news and developments in implant dentistry, and to frequently review www.implantdirect.com for any updates to products and/or specifications. Implant Direct Sybron Manufacturing, LLC. has no control over the use of its products, which are the responsibility of the user. Implant Direct Sybron Manufacturing, LLC. assumes no liability whatsoever for damage arising thereof. 1. Indications for Use: Removal tools(Stainless Steel) are intended for removal of implants or screws in instances where the engaging feature of the interface no longer functions. 2. Compatibility: ● SXT: Use with damaged internal driving feature of 3.2mmD and 3.7mmD InterActiveTM implants; 3.2mmD LegacyTM2, LegacyTM3, LegacyTM4 implants; 3.3mmD SwishActiveTM, SwishPlusTM and SwishTaperedTM implants; and any Implant Direct fixation screws which have a damaged engaging feature. ●

IXT: Use with damaged internal driving feature of all RePlant®,RePlus®, ReActive®, GoDirect®, ScrewIndirect®, ScrewPlant® and ScrewPlus® implants; 3.7mmD and larger LegacyTM1, LegacyTM2, LegacyTM3, LegacyTM4 implants; 4.1mmD and larger SwishActiveTM, SwishPlusTM, and SwishTaperedTM implants; 4.3mmD and larger InterActiveTM implants.

3. Contraindications: Avoid using excessive torque, which can cause fracturing of surrounding bone, and which can damage anatomy when performing the procedure. Due to the conductive nature of metallic implants, electrosurgery is contraindicated. The IXT or SXT tools are not to be used where broken fixation screw fragments remain inside the implant. The fixation screw fragments are to be removed prior to the implant removal procedure. 4. Surgical Techniques For Implant Removal Removal tools should always be inspected before use and are to be replaced after excessive wear or damage. Do not use if tool is damaged. 4.1 Training: Implant removal procedure involves a complex procedure and should be performed by dental professionals who have been well training in proper surgical techniques. Inadequate training may result in failure to safely remove the implant and further complications. Check tool for excessive wear and replace if damaged. Removal tools are limited use devices provided non-sterile. Page 1 of 4

4.2 Pre-Operative Treatment Planning: Appropriate radiography should be used to determine the amount of osseointegration and implant location to avoid anatomical structures such as the mandibular canal, maxillary sinuses and adjacent teeth. The removal tools are not to be used as the only means to remove an implant from the bone. A torque control tool is recommended to be used. Tool and/or implant interface failure may occur during procedure. Ensure fractured pieces are not aspirated or ingested by patient. IXT - 145 Ncm Maximum SXT - 90 Ncm Maximum 4.3 Removal Process: The following procedures are only to be used as guides and not a substitute for complete implant removal training. There are multiple methods used to remove an implant. Not all necessary steps are included in this instruction. The decision of whether or not to remove bone, the method and type of bone removal tools, and the amount of bone to be removed is to be carefully determined by the clinician. Preserve bone by applying as much torque as possible without removing or damaging surrounding anatomy. An iterative step of counter clockwise torque and bone removal, or vise versa, may be needed. It is the clinician's responsibility to choose the correct procedure for each case. 4.3.1 If implant interface is not damaged 4.3.1.1 If the interface is not damaged, implant drivers can be used to remove the implant. If determined to be necessary, remove bone from around implant. Ensure the axis of tool is aligned with the axis of the implant and apply counterclockwise torque (Fig. 1). Check tool for excessive wear or damage and replace if needed. 4.3.2 If implant interface is damaged: 4.3.2.1 If the interface is damaged, removal tools (IXT, SXT) may be used to attempt removal of the implant. However, success is less likely than in instances in which the interface is not damaged. If determined to be necessary, remove bone from around implant. Insert the removal tool into the implant, ensuring the axis of tool is aligned with axis of the implant, and apply a constant axial force in the apical direction while turning counter clockwise (Fig. 1). Check tool for excessive wear or damage and replace if needed. The approximate torque the tools can fail at are shown below. IXT - 145 Ncm Maximum SXT - 90 Ncm Maximum

Fig. 1 Page 2 of 4

5: Cleaning and Disinfection: Prevent body fluids, hard and soft tissues from drying on the instruments and drills by cleaning as soon as possible after use. 5.1: Preparation: Automated cleaning may not be effective. Thorough manual cleaning process is recommended. When applicable, disassemble trays, instruments and drills prior to cleaning. 5.2: Cleaning and Disinfection 5.2.1: Agents: Cleaning agents containing hydrogen peroxide, chlorine or chloride must not be used as the active agents are corrosive to stainless steel. Ensure instruments made with different materials are not placed together in liquid during cleaning. 5.2.2: Preliminary Manual Cleaning: For heavily soiled instruments and drills, or for instruments and drills that have accumulated organic debris, a preliminary manual cleaning is advised. Use a soft brush (no metal bristles) so as to completely remove residue. 5.2.2.1: Wipe instruments using a soft, disposable non-shedding wipe. 5.2.2.2: Soak in lukewarm enzymatic solution for 20 minutes. 5.2.2.3: Universal precautions for the handling of contaminated or biohazardous materials should be observed. 5.3: Routine Cleaning 5.3.1: Wash the instruments using a broad spectrum cleaning solution. Rinse in water and dry thoroughly. 5.3.2: Prepare a neutral pH enzyme cleaning detergent solution per manufacturer’s instructions and place in a sonication unit. 5.3.3: Completely submerge instrument in cleaning solution and sonicate for 10 minutes, preferably at 45-50kHz. 5.3.4: Rinse instrument in purified (de-ionized) water thoroughly for at least 3 minutes. 5.3.5: Repeat above two steps with freshly prepared cleansing solution. 5.3.6: Dry the instrument with a clean, disposable, and absorbent non-shedding wipe. 5.3.7: If soil or tissue or fluid is visible on the device, repeat the cleaning and disinfection steps above. 6: Packaging For Sterilization: Enclose the product in an FDA cleared steam sterilizable wrap and sterilize in an FDA cleared sterilizer. Check the sterilization packaging is compatible with the sterilization parameters for the device.

7: Sterilization of non-sterile instruments: Steam sterilize using a gravity cycle for 15 minutes at a temperature of 132°C (270°F) with a dry cycle of 30 minutes. Steam sterilize using a pre-vacuum cycle for 4 minutes at a temperature of 132°C (270°F) with a dry cycle of 20 minutes. To avoid deformation, surgical tray should not touch walls of steam sterilizer. When sterilizing multiple instruments in one steam sterilization cycle, ensure that the sterilizer manufacturer’s maximum load requirements are followed. Clean and sterilize the surgical devices using the allowable parameters. Not following the cleaning and sterilization instructions may accelerate normal product aging. Ensure instruments made with different materials are not touching during sterilization. Page 3 of 4

8: Storage: It is recommended to use the devices immediately after sterilization. Keep tools in their sterilization packaging and in a dry and clean environment. Maintain packaging integrity. Check before usage. Please refer to the sterilization packaging's instructions for use. 9: Instructions: Users are advised to consult instructions for use and the technical support sections of our website (www.implantdirect.com) for assistance. Implant Direct offers training for implantology and additional information is available on Implant Direct website.

Manufacturer’s symbol

CE mark Caution: Federal law restricts this device to sale by or on the order of a dentist Consult instructions for use

Do not use if packaging is damaged Caution

Reference/Product Code number

Caution: Not Sterilized

Authorized Representative in Europe

Authorized Representative in Europe Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands IFU-009 Rev.03 CO:5287

Page 4 of 4