ANKYLOS FRIALIT /XiVE FRIOS. Instructions for Sterilization and Instrument Care

ANKYLOS FRIALIT /XiVE FRIOS Instructions for Sterilization and Instrument Care

General Requirements for the Use of Medical Products Annotations for the Preparation of DENTSPLY Friadent CeraMed (DFC) Products All dental implants by DFC are intended for single use only and must not be sterilized. For medical products which are not produced by DFC, please check the manufacturers guidelines regarding preparation and recycling. Please check the product label for further information on the manufacturer. All separatable parts must be disassembled for cleaning and disinfection, prior to reassembly, sterilization, storage, and reuse. If an ultrasonic cleaning solution is used, the drills must be placed in a bur organizer. Please follow legal regulations, as well as the hygienic guidelines for practices and clinics. In particular, please heed the guidelines regarding effective inactivation of prions. The constant risk of contamination and infection must be excluded or reduced through prevention. Judgement of the risks and dangers in connection with the medical treatment and definition of appropriate precautions. Schematization and systematization of work routines with the predominant aim to avoid contamination and injuries. Follow OSHA s universal precautions for cross contamination. Both used and openly displayed medical products/devices should be considered contaminated, and must be sterilized prior to use. During medical product/device transport, care must be taken not to put staff or third parties at risk. For their own safety, staff members must wear appropriate protective clothing and gloves when using and handling medical products/devices. Medical products/devices should not be stored in physiological saline solution, as longer exposure may cause corrosion. Individual parts must be completely submerged in a bubble-free bath during disinfection. Demineralized water is required for the final rinse, after disinfection. Demineralized water can prevent water staining and crystal seeding, which may prohibit the proper sterilization process or accelerate corrosion. Please remember that you are responsible for the sterility of all of your medical products/devices. It is important to only use validated cleaning, disinfection, and sterilization procedures. All equipment you use should be serviced at regular intervals and all validated parameters must be followed during each cleaning, disinfection, and sterilization procedure. Always observe the manufacturers shelf-life for all products/devices. Every cleaned, disinfected, and sterilized package should display the sterilization date.

Validated* Sterilization Procedure for DENTSPLY Friadent CeraMed Medical Products 1. Pre-Disinfection (avoidance of cross contaminations) Place all medical products/devices in an ultrasonic germicidal bath** immediately after use. Remove all residues and disassemble instruments. Refer to pages 11-16 for disassembly instructions.. Cleansing Always use demineralized water and neutral cleansing solutions.** The internal irrigation tube should be cleaned with a Miller needle, and must be rinsed with distilled water at the beginning and the end of the exposure time using a disposable syringe (min. 10ml). Individual parts must be cleaned with a plastic cleaning brush and then rinsed with demineralized water. Please control all products after the cleansing process in order to avoid damage or corrosion. Damaged products must be replaced. 3. Disinfection Place all individual parts in an ultrasonic germicidal bath.** 4. Rinsing and Drying For best results, after removing all individual parts from the ultrasonic germicidal bath, each individual part should be rinsed three times with demineralized water. Dry all individual parts thoroughly with a lint-free, disposable cloth. Use oil-free, compressed air when drying internally irrigated parts. Always check all parts for damage or corrosion after rinsing and drying. 5. Preparation for Sterilization Place all medical products/devices in their designated tray. Seal the sterilizable tray or place the individual parts in a sterile package that is compatible with steam saturation. IMPORTANT! All medical products/devices that are delivered non-sterile must be prepared according to the manufacturers guidelines prior to and after every usage. If a deviating procedure is utilized, it must be validated by the practice or clinic. For information on the reusability of medical products, please check the product label and the following list. Disposable products are marked with on the label. Products which are not suitable for a sterilization in saturated steam due to their composition must be disinfected prior to use. Refer to pages 6-10 for a list of medical products sterilization/disinfection classification, and page 3 for disinfection procedures 1-4 (pre-disinfection Rinse and drying) and procedure 7 (Storage). The disassembly/assembly of products and trays is described on pages 11 to 14. 6. Sterilization The medical products/devices are sterilized in the autoclave for 7 minutes at 13 C (70 F) or for 0 minutes at 11 C (50 F) these are the minimum holding times, the cycle time is longer and may vary depending on the type of device used. 7. Storage Store the dry, sterilized parts at room temperature. * The sterilization procedure was validated according to the following guidelines: 1. DIN EN ISO 1764: Sterilization of medical products. RKI guideline: Hygienic requirements for the preparation of medical products (Bundesgesundheitsblatt 44:1115-116) ** Please observe all manufacturers guidelines for disinfection and cleansing solutions with special regard to the concentration, exposure time, and temperature. Only neutral disinfection solutions without chlorine, ammoniac, and aldehydes and with a proven effectiveness against HBV, HCV, and HIV must be used. The products have to meet the respective national regulations for disinfectants (e.g. FDA approval, DGHM listing, CE marking). If disinfectants containing aldehydes are used, this might lead to a possible fixation of proteins. Please use only freshly prepared solutions. 3

Preparation of Surgical and Prosthetic Kits IMPORTANT! The clear cover in ANKYLOS Surgical Kits should be discarded and must not be sterilized with the surgical kit. The tub-shaped box in FRIALIT and XiVE Surgical Kits is not a sterile container. Surgical kits must be cleaned, disinfected, and sterilized after each use. Please disassemble the kits according to the following instructions: Remove all the instruments from the Surgical/Prosthetic Kits and prepare them accordingly (page 3 and pages 6-16). Remove the aluminum-base plate and any instrument locators from the Surgical/Prosthetic Kit for separate cleaning, following procedures 1-4 (page 3) prior to sterilization. ADDITIONAL NOTES: When using the ANKYLOS Surgical Kit, always disassemble the instrument locators from the aluminumbase plate and follow procedures 1-4 (page 3) prior to sterilization. Remove and replace sterile filter in the ANKYLOS Surgical Kit prior to sterilization. Sterile filter is only required if storing in a pouchless/unwrapped state. Note, sterile filter will maintain a pouch-less sterile state for a maximum of 30 days. After the Surgical/Prosthetic Kit has been prepared (page 3 procedures 1-4), assemble required instruments in kit prior to sterilization. 4

List of Surgical and Prosthetic Kits ANKYLOS ANKYLOS Prosthetic Tray (complete/for Balance or Standard Systems) ANKYLOS Prosthetic Kit Mini Tray ANKYLOS Recovery Tray ANKYLOS Surgery Tray BoneCondenser ANKYLOS Surgery Tray BoneExpander ANKYLOS Surgery Tray Direction Gauge ANKYLOS Surgery Tray for A + B + C Implants ANKYLOS Surgery Tray for D Implants ANKYLOS Trial Abutment Tray Standard Abutments ANKYLOS Tray Sinus Lift Instruments Material Synthetics Aluminum/Stainless Steel/Sterile Filter FRIADENT FRIADENT Prosthetic Set Mini Tray FRIADENT Tray for Torque Ratchet Synthetics Aluminum FRIALIT FRIALIT BoneCondenser Tray FRIALIT BoneExpander Tray FRIALIT Implant Box FRIALIT Prosthetic Tray FRIALIT Select Tray FRIALIT Surgical Tray FRIOS FRIOS BoneCollector Tray FRIOS MicroSaw Tray FRIOS Unit Sterilization Tray Surgical Steel/Synthetics Stainless Steel/Synthetics XiVE XiVE BoneCondenser Tray XiVE Prosthetic Tray XiVE Security Kit Tray XiVE Select Try-in Implant Basic Set Tray XiVE Surgical Tray XiVE Tap Set Tray Aluminum/Silicone/Synthetics 5

ANKYLOS List of Medical Products for Sterilization/Disinfection Re-Usability Sterilization/ Material Disinfection ANKYLOS Cutting and Abrasive Instruments ATP Punch Yes 1,4 Sterilization Yes Medical Grade Steel BoneCondenser Yes Sterilization Ti6Al4V BoneExpander Yes Sterilization Ti6Al4V Drills, Milling Tools, Conical Reamers Yes 1 Sterilization Medical Grade Steel Implant Recovery Instruments Yes Sterilization Medical Grade Steel Mucosa Punch Yes 4 Sterilization Yes Medical Grade Steel Sinus Lift Instruments Yes Sterilization Medical Grade Steel Taps Yes 1 Sterilization Medical Grade Steel ANKYLOS Surgical Components Device for Implants Yes Sterilization Titanium Direction Gauges Surgery Yes Sterilization Synthetics Extra Long Instruments Yes Sterilization Medical Grade Steel Parallel Gauges for Drills Yes Sterilization Titanium Surgical Mallet and Chisel Yes Sterilization Medical Grade Steel Trial Abutments Yes Sterilization Synthetics Tweezers Yes Sterilization Titanium ANKYLOS Ratchets, Torque Drivers, Activators, De-activators Activator/De-activator for Matrix of Snap Attachment Yes Sterilization Med. Grade Steel/Synthetics Device Yes Sterilization Stainless Steel Cover Cap for Ratchet Insert Yes Sterilization Medical Grade Steel Handles Yes Sterilization Medical Grade Steel Insertion Instruments for Implants Yes Sterilization Medical Grade Steel Inserts for Prosthetic Ratchet Yes Sterilization Yes Medical Grade Steel Mounting Device Insert for Prosthetic Ratchet Yes Sterilization Medical Grade Steel Open-end Wrench Yes Sterilization Medical Grade Steel Placement Aids Yes Sterilization Medical Grade Steel Prosthetic Ratchet Yes Sterilization Yes Medical Grade Steel 1 All cutting or abrasive products must be replaced after 0 uses or as use demands (e.g. due to bluntness). Resharpen if blunt. 3 Final product can be sterilized (after casting). 4 Disposable product (mucosa punch, center pin). 6

Re-Usability Sterilization/ Material Disinfection Ratchet Inserts for Implants Yes Sterilization Medical Grade Steel Ratchet Inserts for Instruments Yes Sterilization Medical Grade Steel Screwdriver Inserts Yes Sterilization Medical Grade Steel Surgical Ratchet Yes Sterilization Yes Medical Grade Steel Unscrew Instruments for Cover Screws Yes Sterilization Medical Grade Steel ANKYLOS Screws/Sleeves Screws No Sterilization Ti6Al4V Sleeves/Threaded Sleeves No Sterilization Permador PDF ANKYLOS Impression Taking/Abutments Balance Base Abutments No Sterilization Ti6Al4V Balance Posterior/Anterior Abutments No Sterilization Ti6Al4V Drilling Sleeve for SynCone No Sterilization Ti6Al4V Gold Copings/Bars (Standard Abutment) No Sterilization DEGUNORM/Permador Gold Coping DEGUNORM No Sterilization DEGUNORM Gold Coping Permador/Permador PDF No Sterilization Permador/Permador PDF Parallel Gauge Yes Sterilization Ti6Al4V Positioning/Polymerisation Sleeve No Sterilization Synthetics Retention Copings No Sterilization Ti6Al4V Standard Abutments (All) No Sterilization Ti6Al4V Standard Abutments with Snap Attachment No Sterilization Ti6Al4V/Permador Sulcus Former No Sterilization Ti6Al4V SynCone Abutment No Sterilization Ti6Al4V Taper Cap for SynCone No Sterilization Degulor 3406 Temporary Caps No Disinfection Synthetics Transfer Cap No Disinfection Synthetics Transfer Components for the Balance System No Sterilization Medical Grade Steel Wax-Up Copings No Sterilization 3 Synthetics ADDITIONAL NOTES: All materials qualify for medical use. Please contact DENTSPLY Friadent at info@friadent.de for more detailed specifications. 7

FRIALIT /XiVE and FRIADENT List of Medical Products for Sterilization/Disinfection Re-Usability Sterilization/ Material Disinfection FRIALIT/XIVE, and FRIADENT Cutting and Abrasive Instruments Drills, Stepped Drills, Depth Stops, and Fitting Tools Yes 1 Sterilization Yes Medical Grade Steel FRIADENT BoneProfiler Yes 1 Sterilization Medical Grade Steel FRIADENT Periotome/Periotome Blades Yes/Yes 1 Sterilization Yes Medical Grade Steel FRIADENT Tissue Punch Yes 1 Sterilization Medical Grade Steel FRIALIT/XiVE BoneCondenser Yes 1 Sterilization Med. Grade Steel/Synthetics FRIALIT/XiVE BoneExpander Yes Sterilization Med. Grade Steel/Synthetics FRIADENT Trephine Drills Yes 1 Sterilization Medical Grade Steel XiVE Taps Yes 1 Sterilization Ti6Al4V FRIALIT/XiVE, and FRIADENT Surgical Components FRIADENT Depth Gauges, Gingiva Measuring Devices Yes Sterilization Titanium FRIADENT Drill Extensions Yes Sterilization Medical Grade Steel FRIADENT Implant Forceps Yes Sterilization Titanium FRIADENT Implant Mallet Yes Sterilization Med. Grade Steel/Synthetics FRIADENT Radiographic Balls Yes Sterilization Medical Grade Steel FRIADENT Seating Instruments, Paralleling Pins Yes Sterilization Titanium FRIALIT/XIVE, FRIADENT Select Components Yes Sterilization Titanium FRIALIT/XiVE, and FRIADENT Ratchets, Screwdrivers, Implant Drivers, Activators, Deactivators FRIADENT Activator/Deactivator for Attachments Yes Sterilization Med. Grade Steel/Synthetics FRIADENT Bar Clip Activator Yes Sterilization Medical Grade Steel FRIADENT Drivers (Handpiece/Ratchet) Yes Sterilization Medical Grade Steel FRIADENT Ratchet Yes Sterilization Yes Medical Grade Steel FRIADENT Ratchet Inserts Yes Sterilization Medical Grade Steel FRIADENT Seating Instruments Yes Sterilization Titanium FRIADENT Torque Drivers Yes Sterilization Yes Medical Grade Steel FRIALIT/XiVE, FRIADENT Implant Drivers Yes Sterilization Medical Grade Steel FRIALIT/XiVE, FRIADENT Screws/Sleeves FRIADENT Cover Screws/MP Cover Screws No Sterilization Titanium FRIADENT Fixation Screws No Sterilization Ti6Al4V FRIADENT Standard Abutment Screws No Sterilization Ti6Al4V 1 All cutting or abrasive products must be replaced after 0 uses or as use demands (e.g. due to bluntness). Resharpen if blunt. 3 Final product can be sterilized (after casting). 4 Disposable product (mucosa punch, center pin). 8

Re-Usability Sterilization/ Material Disinfection FRIADENT Thread Sleeves No Sterilization High-Nobel Alloy FRIADENT Transfer Screws No Sterilization Ti6Al4V XiVE TG Abutment Screws No Sterilization Ti6Al4V XiVE TG Coping Screws No Sterilization Ti6Al4V XiVE TG Cover Screws for Implants No Sterilization Titanium XiVE TG PickUp Guide Pins No Sterilization Ti6Al4V FRIALIT/XiVE, FRIADENT Impression Taking, Abutments FRIADENT CeraBase No Sterilization Al O 3 /Ti6Al4V/Titanium FRIADENT EstheticBase No Sterilization Ti6Al4V/Titanium FRIADENT AuroBase No Sterilization 3 High-Nobel Alloy/Synthetics FRIADENT EstheticCap No Sterilization Synthetics FRIADENT Gingiva Formers (All) No Sterilization Titanium FRIADENT Gold Round Bars No Sterilization High-Nobel Alloy FRIADENT MP Abutments No Sterilization Ti6Al4V/Titanium FRIADENT MP Classic Abutments No Sterilization Ti6Al4V/Titanium FRIADENT ProTect No Disinfection Synthetics FRIADENT Telescopic Abutments No Sterilization Ti6Al4V/Titanium FRIADENT TempBase No Sterilization Ti6Al4V FRIADENT TempBase Cap No Disinfection Synthetics FRIADENT Titanium Round Bars No Sterilization Titanium FRIADENT TransferCap No Disinfection Synthetics FRIADENT Transfer Coping Basic No Sterilization Titanium FRIADENT Transfer Copings No Sterilization Titanium FRIADENT, XiVE TG Attachment No Sterilization Ti6Al4V/High-Nobel Alloy FRIADENT, XiVE TG AuroBase No Sterilization 3 High-Nobel Alloy/Synthetics FRIADENT, XiVE TG Castable Waxing Sleeves No Sterilization 3 Synthetics FRIADENT, XiVE TG Cast-to Waxing Sleeves No Sterilization 3 HSL/Synthetics FRIADENT, XiVE TG Gold Bar Copings No Sterilization High-Nobel Alloy FRIADENT, XiVE TG Impression Copings No Sterilization Titanium FRIADENT, XiVE TG Titanium Bar Copings No Sterilization Titanium XiVE TG Abutments No Sterilization Titanium ADDITIONAL NOTES: All materials qualify for medical use. Please contact DENTSPLY Friadent at info@friadent.de for more detailed specifications. 9

FRIOS List of Medical Products for Sterilization/Disinfection Re-Usability Sterilization/ Material Disinfection FRIOS BoneCollector (Case) Yes Sterilization Yes Titanium FRIOS BoneShield Form Set Yes Sterilization Titanium/Synthetics FRIOS MicroSaw Chisel Yes Sterilization Medical Grade Steel FRIOS MicroSaw (Protector) Yes Sterilization Medical Grade Steel FRIOS Trephines for Bone Removal Yes 1 Sterilization Medical Grade Steel Trephine Drill Yes 1 Sterilization Medical Grade Steel 1 All cutting or abrasive products must be replaced after 0 uses or as use demands (e.g. due to bluntness). Resharpen if blunt. 3 Final product can be sterilized (after casting). 4 Disposable product (mucosa punch, center pin). ADDITIONAL NOTES: All materials qualify for medical use. Please contact DENTSPLY Friadent at info@friadent.de for more detailed specifications. 10

/ of DENTSPLY Friadent CeraMed Medical Products ANKYLOS Surgical Ratchet 1 Twist the directional knob at the end of the Ratchet to ensure the drive is engaged. Press direction knob down while rotating it slowly counter-clockwise. A slight click or change in rotational resistance is felt. Pull directional knob away from Surgical Ratchet (1). Unscrew the Knurled Handle (). Remove the return spring and the central direction shaft from the Surgical Ratchet body. Prepare disassembled components per direction on page 3 procedures - 4. Prior to assembly and sterilization, cover the components with a thin layer of resin-free oil and let excess oil drip off. Assemble instruments in reverse order and sterilize as described on page 3 procedures 5-7. ANKYLOS Prosthetic Ratchet/ FRIADENT Ratchet 3 Unscrew the head of the Prosthetic Ratchet (1) from the Ratchet s body (5). While holding the Ratchet head, remove inner mechanics. Disassemble the guide jacket (), sprocket (3), and ratchet spring (4). Prepare disassembled components per direction on page 3 procedures - 4. Prior to assembly and sterilization, cover the components with a thin layer of resin-free oil and let excess oil drip off. Assemble instruments in reverse order and sterilize as described on page 3, procedures 5-7. ANKYLOS/FRIADENT Torque Driver Inserts for Prosthetic Ratchet Using the nipple at the end of the Prosthetic Ratchet, align with the recess of the torque drivers and push together. This action will disengage inner mechanics from the outer case of torque driver. Prepare disassembled components per direction on page 3 procedures - 4. 1 3 4 5 Insert the torque driver s inner mechanics to outer case(when assembling an ANKYLOS 1mm or 1.8mm hex torque driver instrument, first engage the hex drive into the Fitting Aid for Prosthetic Ratchet Inserts). Holding the torque driver, rotate the outer case clockwise while pushing both parts together until they lock (click). Sterilize assembled instruments as described on page 3 procedures 5-7. 11

/ of DENTSPLY Friadent CeraMed Medical Products ANKYLOS ATP Punch The ATP Punch is held together by a bayonet fitting and can be disassembled by twisting. Hold the case of the ATP Punch and turn the milling tool (1) clockwise. Remove case () and spring (3) from the milling tool. The sleeve for the ATP Punch (4) can be slid from the milling tool. Prepare disassembled components per direction on page 3 procedures -4. Replace sleeve with new. 3 4 1 Slide the sleeve for the ATP Punch on the milling tool. Turn the sleeve and milling tool clockwise. Insert the spring and case on the milling tool. Turn case and milling tool clockwise. Sterilize prior to use as described on page 3 procedures 5-7. IMPORTANT! The sleeve (4) for the ATP Punch is disposable and must be replaced after use. 1 ANKYLOS Mucosa Punch 3 Loosen the cover screw with the screwdriver counter-clockwise from the large milled ring nut (1/). Remove the center pin with the spring (3). Loosen the small milled ring nut by turning it counter-clockwise. Remove the punching canula from the clamping chuck. Prepare disassembled components per direction on page 3 procedures - 4. Replace center pin and Punching Canula with new. Assemble in reverse order. Sterilize prior to use as described on page 3 procedures 5-7. Changing the Length of the Mucosa Punch 4 Turn the cover screw on the large milled ring nut with the screwdriver of the mucosa punch. When removing the screw, mind the compression spring of the punch (spring load!). Remove the center pin with the compression spring, insert the compression spring on the required length of the center pin, and insert it back into the mucosa punch (be aware of the pinpoint). When screwing in the cover screw avoid pinching the compression spring. Changing the Punching Cylinder Turn the small milled ring nut against the large one and unscrew it. Remove the punching canula from the chuck and turn or replace it (5). Please pay attention to the pinpoint when inserting the punching canula. 5 IMPORTANT! The center pin and the punching canula are disposable and must be replaced. 1

1 FRIALIT Drill DepthStop Tool Place the shaft end of the drilling instrument on a soft pad (1/). Remove the depth stop tool from the drilling instrument with the long-fitting aid. Prepare disassembled components per direction on page 3 procedures - 4. 3 4 Assemble the depth stop tool with the short-fitting aid on the drilling instrument. Sterilize prior to use as described on page 3 procedures 5-7. IMPORTANT! The depth stop tools of the FRIALIT Drills.0, 3.4 & 3.8 are not pre-assembled. The depth stop tools of the FRIALIT Drills 4.5, 5.5 & 6.5 are pre-assembled. ADDITIONAL NOTES: The D.0 pilot drill placement and removal of depth stops is opposite of above. XiVE Drive Stops for Twist Drills Place the tip of the drilling instrument on a soft pad (e.g. OR-Sheet). Remove the depth stop manually over the tip of the drilling instrument. Prepare disassembled components per direction on page 3 procedures - 4. Push the depth stop manually over the tip of the drilling instrument. Sterilize prior to use as described on page 3 procedures 5-7. IMPORTANT! The depth stops for XiVE Twist Drills are not pre-assembled. FRIADENT Periotome Loosen the head of the instrument counter-clockwise from the handle. Remove the blade. Prepare disassembled components per direction on page 3 procedures - 4. Assemble in reverse order. Sterilize prior to use as described on page 3 procedures 5-7. IMPORTANT! During assembly, the driving stud of the blade must be inserted in one of the notches at the working part. 13

/ of DENTSPLY Friadent CeraMed Medical Products FRIOS BoneCollector Remove the disposable suction tube (1) from the particulate container (). Strip the suction unit adapter (3) from the suction unit. Unscrew the particulate container from the suction unit (4). Remove the titanium filter (5) from the suction unit adapter. Prepare disassembled components per direction on page 3 procedures - 4. Assemble in reverse order. Sterilize prior to use as described on page 3 procedures 5-7. 1 4 5 3 IMPORTANT! The suction tube and titanium filter have to be disposed after use. The sterile titanium filter and the sterile suction tube are inserted in the BoneCollector case immediately prior to use. 14

FRIADENT Class I Medical Devices In terms of the Directive 93/4/EEC Class I Medical Devices are: Non-active hand-held surgical and prosthetic instruments for implant placement and augmentation Components for impression technique, which do not remain in the patient s mouth Non-active components for the planning stage FRIADENT Class IIa, IIb and III Medical Devices In terms of the Directive 93/4/EEC Class IIa, IIb, and III Medical Devices are: Dental Implants, membranes, membrane nails, as well as bone reconstruction materials Active surgical and prosthetic instruments for implant placement and augmentation Components for impression technique and prosthetic overdenture, which remain in the patient s mouth Manufacturer: FRIADENT GmbH P.O. Box 71 01 11 681 Mannheim/Germany Phone: + 49 61 430-188 Fax: + 49 61 47 13 06 E-mail: info@friadent.de Internet: http://www.friadent.de 15

Order No. ML-064 15Dec05. Distributor North America: DENTSPLY Friadent CeraMed Lakewood, CO 808 (800) 46-7836 www.dentsplyfc.com Manufacturer: DENTSPLY Friadent GmbH D-681 Mannheim/Germany