Instructions for Sterilization and Instrument Care by azadf8w

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									Instructions for Sterilization
        and Instrument Care
                                                                                                                                     Validated* sterilization procedure for DENTSPLY Friadent medical devices




General requirements                                                           Annotations for the preparation
for the preparation of medical devices                                         of DENTSPLY Friadent medical
                                                                               devices                                               1. Pre-disinfection (avoidance of cross    3. Disinfection                              6. Sterilization
■   Please pay attention to the valid legal regulations of your country as                                                           contaminations)
                                                                                                                                                                                Place all products in a germicidal bath**.   The materials are sterilized in the
    well as the hygiene guidelines for practices and clinics. In particular,
                                                                                                                                     Place all medical devices in a                                                          autoclave for 7 minutes at 132 °C
    please heed the guidelines regarding and effective inactivation of         ■   All medical devices produced sterile by
                                                                                                                                     disinfectant bath** immediately after                                                   (270 °F) up to 134 °C (273.2 °F) or for
    prions.                                                                        DENTSPLY Friadent are intended for single
                                                                                                                                     use. Remove all residues and               4. Rinsing and Drying                        20 minutes at 121 °C (250 °F) – these
                                                                                   use only and must not be re-sterilized.
                                                                                                                                     disassemble demountable products.                                                       are the minimum holding times, the
                                                                                                                                                                                After removal of the products from the
■   The ever-present risk of contamination and infection must be                                                                                                                                                             time of operation is longer and may
                                                                                                                                                                                desinfectant bath, all components must
    excluded or reduced by specific preventive measures.                        ■   For medical devices which are not                                                                                                         vary depending on the type of device
                                                                                                                                                                                be rinsed 3 times with distilled water
                                                                                   produced by DENTSPLY Friadent please,             2. Cleaning                                                                             used.
                                                                                                                                                                                (e.g. aqua purificata). Please dry all
    Among these are:                                                               check the manufacturers‘ guidelines
                                                                                                                                     Please use distilled water and neutral     components thoroughly with a lint-free
                                                                                   regarding preparation and re-usability.
    • Assessment of the risks and dangers in connection with the                                                                     cleaning agents** only. The internal       disposable cloth. Oil-free compressed
                                                                                                                                                                                                                             7. Storage
      medical treatment and definition of appropriate precautions                                                                     irrigation tube has to be cleaned with     air is mandatory for cleaning the
                                                                               ■   All demountable parts must be disassem-           a Miller needle and must be rinsed         internal irrigation tube. Please re-check    Store the sterilized parts dry and
    • Schematization and systematization of work routines with the
                                                                                   bled for cleaning and disinfection and            with distilled water at the beginning      all parts for damage or corrosion            dust-free at room temperature.
      predominant aim of avoiding contamination and injuries
                                                                                   assembled prior to sterilization. In case of      and the end of the exposure time using     afterwards.
    • Careful anamnesis with special regard to the patient-induced risks           disassembly, please only clean and disinfect      a disposable syringe (min. 10 ml).                                                      * The sterilization procedure was validated according to
      of infection                                                                 the parts of one instrument in a lot.             The products must be cleaned with a                                                     the following guidelines:
                                                                                                                                                                                                                             1. DIN EN ISO 1764: Sterilization of medical devices
                                                                                                                                     plastic instrument cleaning brush and      5. Preparation for sterilization             2. RKI guideline: 2001 Hygienie requirements for the
                                                                                                                                     then rinsed with distilled water. Please                                                preparation of medical devices (Bundesgesundheitsblatt
■   Not only used medical devices have to be considered contaminated           ■   If an ultrasonic cleaning solution is used,                                                  Please place all medical devices in the      (German Federal Health Gazette) 44:1115 – 1126)
                                                                                                                                     check all products after cleaning                                                       ** Please observe all manufacturers‘ guidelines for
    but also those materials which are openly displayed. They must be              the drills must be placed in a drill organizer.                                              tray provided. Weld the sterilizable tray
                                                                                                                                     in order to avoid either damaging and                                                   disinfection and cleaning agents with special regard to the
    prepared hygienically without exception. During transport it has to be                                                                                                      or the single medical devices in a sterile   concentration, exposure time and temperature. Only
                                                                                                                                     corrosion.                                                                              neutral disinfection solutions without chlorine, ammoniac
    assured that neither staff nor third parties are at risk. For their own                                                                                                     bag suitable for saturated steam.
                                                                                                                                     Damaged products must be replaced.                                                      and aldehydes and with a proven effectiveness against
    safety, staff members must wear appropriate protective clothing and                                                                                                                                                      HBV, HCV, and HIV must be used. The products have to
    protective gloves.                                                                                                                                                                                                       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
■   Medical devices should not be stored in physiological saline solution                                                                                                                                                    freshly prepared solutions.
    as a longer exposure might lead to corrosion. The parts must be
    moistened completely and bubble-free in a tub. For the final rinsing
    after disinfection, demineralized water is required in order to avoid
    water stains and crystal seeding which might disturb the subsequent
    process of sterilization.


■   As you are responsible for the sterility of the applied medical devices,
    please keep in mind that only validated procedures must be used for                                                                                                         IMPORTANT!                                   product label and the following list.
    cleaning, disinfection, and sterilization. All equipment has to be                                                                                                                                                       Disposable products are marked with
    serviced at regular intervals, and all parameters must be observed in                                                                                                       All medical devices which are supplied          on the label.
    every cycle. Please observe the shelf-life of the sterile packaging of                                                                                                      non-sterile must be prepared according       Products which are not suitable for
    products (see manufacturer‘s instructions). Preparation ends with the                                                                                                       to the manufacturers‘ guidelines prior to    sterilization in saturated steam due
    release for application.                                                                                                                                                    and after every use in patient treatment.    to their components have to be
                                                                                                                                                                                This also applies for the very first use.     disinfected prior to use (see page 4).
                                                                                                                                                                                                                             The disassembly/assembly of products
■   Every sterile packaging should display an indicator of sterilization and                                                                                                    If a deviating procedure is applied, it      and trays is described on page 4 and
    should be marked with the date of sterilization.                                                                                                                            must be validated by the practice or         pages 12 – 15.
                                                                                                                                                                                clinic.

                                                                                                                                                                                For information on the re-usability of
                                                                                                                                                                                medical devices, please check the




2                                                                                                                                                                                                                                                                                  3
Conditioning of trays/kits                                                                                      Special instructions for preparation of plastic trays




Trays/kits have to be conditioned after                               PLEASE CONSIDER:                          Filled trays must not be cleaned or                     1. Pretreatment
every utilization. Please disassem-                                                                             disinfected.
                                                                                                                                                                        Large or visible impurities must be
ble them according to the following                                   ■   When using ANKYLOS® kits please
                                                                                                                                                                        removed from the trays immediately
instructions.                                                             disassemble the plastic straps.       When using the tray collect used
                                                                                                                                                                        after use (no more than two hours
                                                                                                                instruments separately and do not
                                                                                                                                                                        later).
■   Please remove all products from                                   ■   Please replace possible existing      replace them in the tray. This will
    the tray/kit and condition them as                                    sterile filters.                       prevent greater contamination and
                                                                                                                                                                        Remove all instruments from the trays
    described.                                                                                                  avoid having to clean and disinfect
                                                                                                                                                                        (separate cleaning and disinfection as
                                                                      ■   Then prepare all individual           the filled tray.
                                                                                                                                                                        directed by the manual for sterilization
■   Please remove the basic plate and                                     components of the tray/kit.
                                                                                                                                                                        and instrument care).
    the accessory box, if present, from                                   Re-assemble the tray/kit for          Clean and disinfect the used instru-
    the tray/kit.                                                         sterilization and equip it with the   ments, then place them in the tray and
                                                                                                                                                                        Use running water (move the parts back
                                                                          required products..                   sterilize the instrument tray with all the
                                                                                                                                                                        and forth thoroughly for at least one
■   Please remove the aluminum insert                                                                           instruments in their places.
                                                                                                                                                                        minute) or a disinfectant solution (rinse
    for separated cleaning.
                                                                                                                                                                        thoroughly three times). Use only a soft
                                                                                                                The initial disinfection cannot
                                                                                                                                                                        brush or a clean soft cloth, which is
                                                                                                                replace the subsequent disinfection
                                                                                                                                                                        used for this purpose only, for manual
                                                                                                                step required after cleaning.
                                                                                                                                                                        removal of impurities, never metal
                                                                                                                                                                        brushes or steel wool.
                                                                                                                Use only neutral cleaning agents
                                                                                                                and disinfectants without chlorine,
                                                                                                                                                                        Disassemble the trays completely.
                                                                                                                ammonia, phenol, aldehydes that are
                                                                                                                suitable for cleaning and disinfecting
                                                                                                                plastic instruments. Disinfectants must
                                                                                                                                                                        2. Cleaning
                                                                                                                conform to the applicable national
                                                                                                                regulations for disinfectants (such as                  Immerse the disassembled trays in a
                                                                                                                FDA approval, CE mark, DGHM/VAH                         freshly prepared cleaning bath of the
                                                                                                                listing). If disinfectants containing                   specified concentration for the period
                                                                                                                aldehyde are used, they may fi x blood                  specified by the manufacturer.
                                                                                                                or protein. If ultrasonic baths are used,
                                                                                                                non-foaming cleaning agents and                         Clean the surfaces with a soft brush
                                                                                                                disinfectants must be used.                             until there is no visible contamination.
                                                                                                                                                                        Clean the holes separately with a fine
                                                                                                                Use only water with a bioburden                         brush. Clean the bottom of the modules
                                                                                                                ≤ 10 CFU/ml and an endotoxin burden                     thoroughly and also the parts between
IMPORTANT!                                                                                                      ≤ 0.25 IU/ml (e.g. water for cleaning or                the hard and soft plastic parts.
                                                                                                                freshly prepared purifi ed or ultra-
• The clear cover in the ANKYLOS®kits must not be sterilized.                                                   purifi ed water in accordance with the                  After cleaning, rinse all parts
                                                                                                                pharmacopoeia).                                         thoroughly with water at least three
• The tub-shaped insert (small box) in the FRIALIT® and XiVE® trays                                                                                                     times. Move the parts back and forth.
  is no sterile container.




4                                                                                                                                                                                                             5
Special instructions for preparation of plastic trays                                                                             List of trays / kits

                                                                                                                                                                                                        Material


                                                                                                                                  ANKYLOS®
                                                                                                                                  ANKYLOS® Prosthetic Kit Mini                                          synthetics
                                                                                                                                  ANKYLOS® Prosthetic Tray (complete/for Balance or Standard Systems)   aluminum/synthetics
3. Disinfection                                                                        Please pack the trays in disposable
                                                                                                                                                  ®
                                                                                       sterilization packs (single or double      ANKYLOS Recovery Tray                                                 aluminum/synthetics
Immerse the disassembled tray into a
                                                                                       packs) and/or sterilization containers     ANKYLOS® Surgery Tray BoneCondenser                                   aluminum/synthetics
freshly prepared disinfectant bath of
                                                                                       that conform to the following require-                     ®
                                                                                                                                  ANKYLOS Surgery Tray BoneExpander                                     aluminum/synthetics
the specified concentration for the
                                                                                       ments:
period stipulated by the manufacturer.                                                                                                            ®
                                                                                                                                  ANKYLOS Surgery Tray Direction Gauge                                  aluminum/synthetics
                                                                                       ■   DIN EN ISO/ANSI AAMI ISO 11607         ANKYLOS® Surgery Tray EA                                              aluminum/synthetics
                                                                                                                                  ANKYLOS® Surgery Tray for A + B + C Implants (metal box)              aluminum/stainless steel/sterile filter
4. Rinsing and drying
                                                                                       ■   suitable for steam sterilization       ANKYLOS® Surgery Tray for D Implants                                  aluminum/synthetics
After disinfection, rinse all parts                                                        (temperatures up to at least
                                                                                                                                                  ®
thoroughly with water as specified by                                                      137 °C (279 °F), adequate steam        ANKYLOS Surgery-Kit (synthetic box)                                   synthetics/silicone
the disinfectant manufacturer. Move                                                        permeability)                          ANKYLOS® Tray Sinus Lift Instruments                                  aluminum/synthetics
the parts back and forth.                                                                                                         ANKYLOS® Trial Abutment Tray Standard Abutments                       aluminum/synthetics
                                                                                       ■   adequate protection of trays and
Dry all parts with lint-free disposable                                                    sterilization packages from mechani-   FRIADENT®
cloths (do not use recycled cloths). Use                                                   cal damage                             FRIADENT® Prosthetic Set Mini                                         synthetics
oil-free compressed air to dry holes.                                                                                                             ®
                                                                                                                                  FRIADENT Tray for Torque Ratchet                                      aluminum
                                               5. Maintenance and assembly             ■   regular maintenance in accordance
                                                                                           with the manufacturer‘s specifi-
                                               Reassemble the trays. Do not use                                                   FRIALIT®
                                                                                           cations (sterilization containers)
                                               instrument oil or damaged trays.                                                   FRIALIT® BoneCondenser Tray                                           aluminum/stainless steel/synthetics
                                                                                                                                              ®
                                                                                                                                  FRIALIT BoneExpander Tray                                             aluminum/stainless steel/synthetics
                                                                                       7. Sterilization                           FRIALIT® Prosthetic Tray                                              aluminum/stainless steel/synthetics
                                               6. Preparation for sterilization
                                                                                       See instructions for sterilization and                 ®
                                                                                                                                  FRIALIT Select Tray                                                   aluminum/stainless steel/synthetics
                                               Place the separately cleaned and
                                                                                       instrument care, page 3, section 6.                    ®
                                                                                                                                  FRIALIT Surgical Tray                                                 aluminum/stainless steel/synthetics
                                               disinfected instruments back into the
                                               trays.
                                                                                                                                  FRIOS®
                                                                                                                                  FRIOS® BoneCollector Tray                                             aluminum/synthetics
                                                                                                                                          ®
                                                                                                                                  FRIOS FixationSet Tray/EasyFix Tray                                   aluminum/synthetics
                                                                                                                                  FRIOS® MicroSaw Tray                                                  med. grade steel/synthetics/aluminum
                                                                                                                                  FRIOS® SinusSet Tray                                                  aluminum/synthetics
                                                                                                                                  FRIOS® Unit Sterilization Tray                                        stainless steel/synthetics
      The internal padded insert is for protection during shipping only and
      must be removed before using the tray for the first time. The padded insert                                                  XiVE®
      must never be sterilized.                                                                                                   XiVE® BoneCondenser Tray                                              aluminum/stainless steel/synthetics
                                                                                                                                  XiVE® Prosthetic Tray                                                 aluminum/stainless steel/synthetics
      All trays must be cleaned, disinfected and sterilized before using them
                                                                                                                                      ®
      for the first time and then after every use and every time they are                                                          XiVE Security Kit Tray                                                aluminum/stainless steel/synthetics
      contaminated. If greater contamination can be avoided (used instruments                                                     XiVE® Select Try-in Implant Basic Set Tray                            aluminum/synthetics
      not returned to tray, no visible contamination on the tray), it is not                                                          ®
                                                                                                                                  XiVE Surgery Tray (metal box)                                         aluminum/stainless steel/synthetics
      necessary to clean and disinfect the trays. In this case the used
                                                                                                                                  XiVE® Surgical Tray (synthetic box)                                   synthetics/silicone
      instruments must be cleaned and disinfected separately and the loaded
                                                                                                                                      ®
      trays sterilized. However, thorough cleaning and disinfection is absolutely                                                 XiVE Tap Set Tray                                                     aluminum/stainless steel/synthetics
      essential for effective sterilization.

      Please also follow the relevant instructions on page 3.




6                                                                                                                                                                                                                                                7
List of medical devices for sterilization/disinfection                                                                                  List of medical devices for sterilization/disinfection

                                                                             Sterilization/                                                                                                                                                 Sterilization/
                                                              Re-usability                    Disassembly Material                                                                                                       Re-usability                         Disassembly Material
                                                                             disinfection                                                                                                                                                   disinfection

ANKYLOS® cutting and abrasive instruments                                                                                               ANKYLOS® screws/sleeves
ATP Punch                                                         yes1, 4    sterilization    yes         medical grade steel           Screws                                                                               no             sterilization                   Ti6Al4V

BoneCondenser                                                     yes        sterilization                Ti6Al4V                       Sleeves / Threaded Sleeves                                                           no             sterilization                   Permador® PDF
BoneExpander                                                      yes        sterilization                medical grade steel
                                                                                                                                        ANKYLOS® impression taking / abutments
                                                                        1
Drills, Milling Tools, Conical Reamers                            yes        sterilization                medical grade steel
                                                                                                                                        Balance Anterior Abutments                                                           no             sterilization                   Ti6Al4V
Implant Recovery Instruments                                      yes        sterilization                medical grade steel
                                                                                                                                        Balance Base Abutments                                                               no             sterilization                   Ti6Al4V
Mucosa Punch                                                      yes4       sterilization    yes         medical grade steel
                                                                                                                                        Balance C / Temporary Abutments                                                      no             sterilization                   synthetics
Sinus Lift Instruments                                            yes        sterilization                medical grade steel                        ®
                                                                                                                                        CERCON Balance Abutments                                                             no             sterilization                   ZrO2-TZP/Ti6Al4V
Taps                                                              yes1       sterilization                medical grade steel           Drilling Sleeve for SynCone®                                                         no             sterilization                   Ti6Al4V
           ®
ANKYLOS surgical components                                                                                                             Gingiva Former / Sulcus Former                                                       no             sterilization                   Ti6Al4V

Assembly Device for Implants                                      yes        sterilization                titanum                       Gold Coping DEGUNORM®                                                                no             sterilization                   DEGUNORM®

Cooling Device                                                    yes        sterilization                synth./copper (gold plated)   Gold Coping Permador® / Permador® PDF                                                no             sterilization                   Permador®/Permador PDF

Direction Gauges Surgery                                          yes        sterilization                synthetics                    Gold Copings / Bars (Standard Abutment)                                              no             sterilization                   DEGUNORM®/Permador®

Extra long Instruments                                            yes        sterilization                medical grade steel           Parallel Gauge                                                                       yes            sterilization                   Ti6Al4V

Parallel Gauges for Drills                                        yes        sterilization                titanum                       Positioning / Polymerisation Sleeve                                                  no             sterilization                   synthetics

Surgical Mallet and Chisel                                        yes2       sterilization                medical grade steel           Regular C/X Abutments                                                                no             sterilization                   Ti6Al4V
                                                                                                                                        Retention Copings                                                                    no             sterilization                   Ti6Al4V
Try-in Abutments                                                  yes        sterilization                synthetics
                                                                                                                                        Standard Abutments (all)                                                             no             sterilization                   Ti6Al4V
Tweezers                                                          yes        sterilization                titanum
                                                                                                                                        Standard Abutments with Magnetic Attachment                                          no             sterilization                   titanum/Sm2Co17
ANKYLOS® ratchets, torque drivers, activators, deactivators                                                                             Standard Abutments with Snap Attachment                                              no             sterilization                   Ti6Al4V/Permador®
Activator/De-activator for Matrix of Snap Attachment              yes        sterilization                med. grade steel/synthetics   Sulcus Former                                                                        no             sterilization                   Ti6Al4V
Assembly Device                                                   yes        sterilization                medical grade steel           SynCone® Abutment                                                                    no             sterilization                   Ti6Al4V
Cover Cap for Ratchet Insert                                      yes        sterilization                medical grade steel           Taper Cap for SynCone®                                                               no             sterilization                   Degulor® 3406
Handles                                                           yes        sterilization                medical grade steel           Temporary Caps                                                                       no             sterilization3                  synthetics
Insertion Instruments for Implants                                yes        sterilization                medical grade steel           Transfer Cap                                                                         no             disinfection                    medical grade steel
Inserts for Prosthetic Ratchet                                    yes        sterilization                medical grade steel           Transfer Components for the Balance System                                           no             sterilization                   medical grade steel
Mounting Device Insert for Prosthetic Ratchet                     yes        sterilization                medical grade steel           Wax-Up Copings                                                                       no             disinfection                    synthetics
Open-end Wrench                                                   yes        sterilization                medical grade steel
                                                                                                                                        ANKYLOS® Repair Instruments
Placement Aids                                                    yes        sterilization                medical grade steel
                                                                                                                                        Extraction pin                                                                       no             sterilization                   medical grade steel
Prosthetic Ratchet                                                yes        sterilization    yes         medical grade steel
                                                                                                                                        Handle for taper protection                                                          no             sterilization                   medical grade steel
Ratchet Inserts for Implants                                      yes        sterilization                medical grade steel
                                                                                                                                        Rachet insert for extraction pint                                                    yes            sterilization                   medical grade steel
Ratchet Inserts for Instruments                                   yes        sterilization                medical grade steel
                                                                                                                                        Taper protection                                                                     no             sterilization                   medical grade steel
Screwdriver Inserts                                               yes        sterilization                medical grade steel
                                                                                                                                        Taps                                                                                 no             sterilization                   medical grade steel
Surgical Ratchet                                                  yes        sterilization                medical grade steel
                                                                                                                                        Trephine                                                                             no             sterilization                   medical grade steel
Unscrew Instruments for Cover Screws                              yes        sterilization                medical grade steel
                                                                                                                                        Unscrew Instrument                                                                   no             sterilization                   medical grade steel




                                                                                                                                        1
                                                                                                                                            All cutting or abrasive products have to be replaced after 20 usage cycles             PLEASE CONSIDER:
                                                                                                                                            at the most or as occasion demands (e.g. due to bluntness).
                                                                                                                                        2
                                                                                                                                            Resharpen if blunt                                                                     All materials qualify for medical use.
                                                                                                                                        3

                                                                                                                                        4
                                                                                                                                            Final products can be sterilized (after casting)                                       Please contact us for more detailed specifications.
                                                                                                                                            Disposable product (punch cannula)
                                                                                                                                        5
                                                                                                                                            Disposable product (center pin)
                                                                                                                                                                                                                                   IMPORTANT:
                                                                                                                                                                                                                                   Not all products are available in every country!




8                                                                                                                                                                                                                                                                                                    9
              ,                       ,                                                                                                                           ,                                ,                             ,
List of medical devices for sterilization/disinfection                                                                                        List of medical devices for sterilization/disinfection

                                                                                   Sterilization/                                                                                                                                                     Sterilization/
                                                                Re-usability                        Disassembly Material                                                                                                       Re-usability                               Disassembly Material
                                                                                   disinfection                                                                                                                                                       disinfection

XiVE®, FRIALIT®, FRIADENT® cutting and abrasive instruments                                                                                   XiVE®, FRIALIT®, FRIADENT® impression taking, abutments
                                                                          1
Drills, Stepped Drills, Depth Stops and Depth Stop Tools            yes            sterilization    yes         medical grade steel           FRIADENT® Gingiva Formers (all)                                                      no                 sterilization                   titanum
FRIADENT® BoneProfiler                                               yes1           sterilization                medical grade steel           FRIADENT® Gold Round Bars                                                            no                 sterilization                   Noble metal alloy
FRIADENT® Periotome/Periotome Blades                                yes/yes1       sterilization    yes         medical grade steel           FRIADENT® MP Abutments                                                               no                 sterilization                   Ti6Al4V/titanum
FRIADENT® Tissue Punch                                              yes1           sterilization                medical grade steel           FRIADENT® ProTect                                                                    no                 disinfection                    synthetics
XiVE® / FRIALIT® BoneCondenser                                      yes1           sterilization                med. grade steel/synthetics   FRIADENT® TempBase                                                                   no                 sterilization                   Ti6Al4V
                                                                                                                                                             ®
     ®        ®
XiVE / FRIALIT BoneExpander                                         yes            sterilization                med. grade steel/synthetics   FRIADENT TempBase Cap                                                                no                 disinfection                    synthetics
XiVE® / FRIALIT® Trephine Drills                                    yes1           sterilization                medical grade steel           FRIADENT® Titanum Round Bars                                                         no                 sterilization                   titanum
     ®                                                                    1                                                                                  ®
XiVE Taps                                                           yes            sterilization                medical grade steel           FRIADENT Transfer Copings                                                            no                 sterilization                   titanum
                                                                                                                                              FRIADENT® TransferCap                                                                no                 disinfection                    synthetics
XiVE®, FRIALIT®, FRIADENT® surgical components
                                                                                                                                              FRIADENT®, XiVE® TG Attachment                                                       no                 sterilization                   titanum
FRIADENT® Depth Gauges, Gingiva Measuring Probes                    yes            sterilization                titanum
                                                                                                                                                             ®        ®                                                                                               3
                                                                                                                                              FRIADENT , XiVE TG AuroBase                                                          no                 sterilization                   Noble metal alloy/syn.
FRIADENT® Drill Extensions                                          yes            sterilization                medical grade steel
                                                                                                                                              FRIADENT®, XiVE® TG Castable Waxing Sleeves                                          no                 sterilization3                  synthetics
FRIADENT® Implant Forceps                                           yes            sterilization                titanum
                                                                                                                                                             ®        ®                                                                                               3
                                                                                                                                              FRIADENT , XiVE TG Cast-to Waxing Sleeves                                            no                 sterilization                   Noble metal alloy/syn.
FRIADENT® Implant Mallet                                            yes            sterilization                med. grade steel/synthetics
                                                                                                                                              FRIADENT®, XiVE® TG Gold Bar Copings                                                 no                 sterilization                   Noble metal alloy
FRIADENT® Radiographic Balls                                        yes            sterilization                medical grade steel
                                                                                                                                                             ®        ®
                                                                                                                                              FRIADENT , XiVE TG Impression Copings                                                no                 sterilization                   titanum
FRIADENT® Seating Instruments, Paralleling Pins                     yes            sterilization                stainless steel
                                                                                                                                              FRIADENT®, XiVE® TG Titanum Bar Copings                                              no                 sterilization                   titanum
XiVE® / FRIALIT®, FRIADENT® Select Components                       yes            sterilization                titanum
                                                                                                                                              XiVE® TG Abutments                                                                   no                 sterilization                   titanum
     ®        ®            ®
XiVE , FRIALIT , 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® Handpiece/Ratchet Hex/Slot Screwdrivers                   yes            sterilization                medical grade steel           FRIOS®
FRIADENT® Placement Instruments                                     yes            sterilization                titanum                       Bone Stud Remover                                                                    yes1               sterilization                   medical grade steel
                                                                                                                                                                       ®                                                                 1
          ®
FRIADENT Ratchet                                                    yes            sterilization    yes         medical grade steel           Drill Set for FRIOS SinusSet                                                         yes                sterilization                   medical grade steel
FRIADENT® Ratchet Inserts                                           yes            sterilization                medical grade steel           FRIOS® BoneCollector (case))                                                         yes                sterilization       yes         titanum
                                                                                                                                                        ®
          ®
FRIADENT Torque Drivers                                             yes            sterilization    yes         medical grade steel           FRIOS BoneShield FormSet                                                             yes                sterilization                   titanum/syn./aluminum
     ®        ®            ®
XiVE / FRIALIT , FRIADENT Implant Drivers                           yes            sterilization                medical grade steel           FRIOS® Drilling and Positioning Tool for Membrane Tacks                              yes                sterilization                   medical grade steel
                                                                                                                                                        ®
                                                                                                                                              FRIOS EasyFix                                                                        yes                sterilization       yes         med. grade steel/titanum
XiVE® TG, FRIADENT® screws/sleeves
                                                                                                                                              FRIOS® Holder for Membrane Tacks                                                     yes                sterilization                   titanum
FRIADENT® Cover Screws / MP Cover Screws                            no             sterilization                titanum
                                                                                                                                              FRIOS® MicroSaw Chisel                                                               yes2               sterilization                   medical grade steel
FRIADENT® Fixation screws                                           no             sterilization                Ti6Al4V
                                                                                                                                                        ®
                                                                                                                                              FRIOS MicroSaw Protector                                                             yes                sterilization                   med. grade steel/nickel silver
FRIADENT® Standard Abutment Screws                                  no             sterilization                Ti6Al4V
                                                                                                                                              FRIOS® Seating Instruments for Membrane Tacks                                        yes                sterilization                   medical grade steel
FRIADENT® Thread Sleeves                                            no             sterilization                noble metal alloy
                                                                                                                                                        ®
                                                                                                                                              FRIOS Sinus instruments                                                              yes                sterilization                   Ti6Al4V/surgical steel
FRIADENT® Transfer Screws                                           no             sterilization                Ti6Al4V
     ®
XiVE TG Abutment Screws                                             no             sterilization                Ti6Al4V                       FRIOS® Trephines for Bone Removal                                                    yes1               sterilization                   medical grade steel
                                                                                                                                                                                                                                         1
XiVE® TG Coping Screws                                              no             sterilization                Ti6Al4V                       Trephine Drill                                                                       yes                sterilization                   medical grade steel
     ®
XiVE TG Cover Screws for Implants                                   no             sterilization                titanum
XiVE® TG PickUp Guide Pins                                          no             sterilization                Ti6Al4V

XiVE®, FRIALIT®, FRIADENT® impression taking, abutments                                                                                       1
                                                                                                                                                  All cutting or abrasive products have to be replaced after 20 usage cycles                 PLEASE CONSIDER:
FRIADENT® CeraBase                                                  no             sterilization                Al2O3/Ti6Al4V/titanum             at the most or as occasion demands (e.g. due to bluntness).
                                                                                                                                              2
                                                                                                                                                  Resharpen if blunt                                                                         All materials qualify for medical use.
FRIADENT® CERCON® Abutments                                         no             sterilization                ZrO2-TZP                      3

                                                                                                                                              4
                                                                                                                                                  Final products can be sterilized (after casting)                                           Please contact us for more detailed specifications.
                                                                                                                                                  Disposable product (punch cannula)
FRIADENT® Telescopic Abutments                                      no             sterilization                Ti6Al4V/titanum               5
                                                                                                                                                  Disposable product (center pin)
                                                                                                                                                                                                                                             IMPORTANT:
          ®
FRIADENT EstheticBase                                               no             sterilization                Ti6Al4V/titanum                                                                                                              Not all products are available in every country!
FRIADENT® EsthetiCap                                                no             sterilization                synthetics



10                                                                                                                                                                                                                                                                                                             11
Disassembly/assembly of DENTSPLY Friadent medical devices                                                                                    Disassembly/assembly of DENTSPLY Friadent medical devices



ANKYLOS® Surgical Ratchet / XiVE® Ratchet                                                                                                    ANKYLOS® ATP Punch
Disassembly                                                                                                                                  Disassembly                                  Assembly
■   First please twist the reverse button     ■   Remove the sprocket with the return       ■   Prior to sterilization, please lubricate     ■   The ATP Punch is held together by a      ■   Please slide the punching sleeve for
                                                  spring from the ratchet (2)                   the components with a thin layer of              bayonet fitting and can be                    the ATP Punch onto the milling tool
■   Then press it down and loosen it
                                                                                                resin-free oil and let excess oil drip off       disassembled by just twisting
    by turning counter-clockwise. Now         ■   Remove the return spring from the                                                                                                       ■   Then turn the sleeve and the milling
    please release the milled ring                sprocket (3)                                                                               ■   Hold the housing of the ATP Punch and        tool clockwise
                                                                                            Assembly
    nut from the ratchet by turning it                                                                                                           turn the milling tool (1) clockwise
                                                                                                                                                                                          ■   Now slide the spring and the housing
    counter-clockwise (1)                                                                   ■   Please assemble the ratchet in reverse
                                                                                                                                             ■   Now remove housing (2) and spring            onto the milling tool
                                                                                                order
                                                                                                                                                 (3) from the milling tool
                                                                                                                                                                                          ■   Finally please turn housing and
1                                             2                                                 3                                            ■   Finally the punching sleeve (4) can be       milling tool clockwise
                                                                                                                                                 slid from the milling tool




                                                                                                                                                                                   1                  4         3           2

                                                                                                                                             PLEASE CONSIDER::
                 ®                                                  ®                                                                        The punching sleeve is disposable and
ANKYLOS Prosthetic Ratchet / FRIADENT Ratchet                                                                                                has to be replaced after use


                                              Disassembly                                   ■   Now please remove the return spring
                                                                                                from the sprocket
                                              ■   First unscrew the ratchet head (1) from
                                                  the handle (5)                            ■   Prior to sterilization, please lubricate
                                                                                                                                             ANKYLOS® Mucosa Punch
                                                                                                the components with a thin layer of
                                              ■   Then please remove the ratchet insert                                                      Disassembly                                  4                                                 length of the center pin and insert it
                                                                                                resin-free oil and let excess oil drip off
                                                  for implant driver or the torque driver                                                                                                                                                   back into the mucosa punch (Please
                                                                                                                                             ■   Loosen the cover screw with the
                                                  from the ratchet head                                                                                                                                                                     consider the pinpoint!)
                                                                                            Assembly                                             screwdriver counter-clockwise from
                                              ■   Now remove the guide jacket (2),                                                               the large milled ring nut (1/2)                                                        ■   When screwing in the cover
                                                                                            ■   Please assemble the ratchet in
                                                  sprocket (3) and ratchet spring (4)                                                                                                                                                       screw, please avoid pinching of the
                                                                                                reverse order                                ■   Now please remove the center pin
                                                  from the ratchet head                                                                                                                                                                     compression spring
                                                                                                                                                 with the spring (3)

                                                                                                                                                                                          ■   Loosen the small milled ring nut by       5
                                                                                                                                             1                                                turning it counter-clockwise
                                                   1            2                   3       4                               5                                                             ■   Now remove the punching cannula
                                                                                                                                                                                              from the clamping chuck

                                                                                                                                                                                          Assembly
                 ®                   ®
ANKYLOS / FRIADENT Torque Driver Inserts for Prosthetic Ratchet                                                                              2
                                                                                                                                                                                          ■   Please assemble in reverse order
                                                                                                                                                                                                                                        Changing the punching cylinder
Disassembly                                   Assembly                                                                                                                                    Altering the working length                   ■   Turn the small milled ring nut against
                                                                                                                                                                                                                                            the large one and unscrew it
■   Press the rod at the end of the ratchet   ■   Insert the blade of the torque driver     ■   Now turn the blade in                                                                     ■   Loosen the cover screw on the large
    handle into the recess at the housing         carefully while turning it clockwise          the housing and press                                                                         milled ring nut with the screwdriver of   ■   Then please remove the punching
    of the torque driver until the blade          into the housing                              it until it locks with an                                                                     the mucosa punch                              cannula from the clamping chuck and
    detaches from the housing                                                                   audible “click”.                                                                                                                            turn or replace it (5)
                                                                                                                                             3                                            ■   When removing the screw, please be
                                                                                                                                                                                              careful with the compression spring       ■   Please pay attention to the pinpoint
                                                                                                                                                                                              of the punch (spring loaded!)                 when inserting the punching cannula
                                                                                                                                                                                          ■   Now remove the center pin with the        PLEASE CONSIDER:
                                                                                                                                                                                              compression spring, place the             The center pin and the punching
                                                                                                                                                                                              compression spring onto the required      cannula are disposable.


12                                                                                                                                                                                                                                                                                   13
Disassembly/assembly of DENTSPLY Friadent medical devices                                                                                 Disassembly/assembly of DENTSPLY Friadent medical devices



XiVE® Depth Stops for Twist Drills                                                                                                        FRIOS® BoneCollector
Disassembly                                                                                                                               Disassembly
                                                                                                                                                                                                                                          1
■   Place the tip of the drill on a soft pad                                                                                              ■   First remove the disposable
    (e.g. surgical cloth)                                                                                                                     suction tube (1) from the particulate
                                                                                                                                              container (2)
■   Now please remove the depth stop
    manually over the tip of the drill                                                                                                    ■   Then strip the suction unit adapter (3)
                                                                                                                                              from the suction unit (4)
Assembly                                                                                                                                  ■   Now please unscrew the particulate                                    2
                                                                                                                                              container from the suction unit
■   Please push the depth stop manually                                                       PLEASE CONSIDER:
    over the tip of the drill                                                                 The depth stops of XiVE® twist drills are   ■   Please remove the titanium filter (5)                                      PLEASE CONSIDER:
                                                                                              not pre-mounted                                 from the suction unit adapter                         5                   The suction tube and titanium filter
                                                                                                                                                                                                                        have to be disposed after use.
                                                                                                                                                                                            4                           The sterile titanium filter and the
                                                                                                                                          Assembly
                                                                                                                                                                                                                        sterile disposable suction tube are
                                                                                                                                          ■   Please assemble in reverse order                                          inserted into the BoneCollector
FRIALIT® Drill Depth Stop Tool (from D 3,4 on)                                                                                                                                          3                               housing immediately prior to use

Disassembly                                     1                    2                    3                       4
■   Place the tip of the drill on a soft
    surface (1/2)
■   Now please remove the depth stop
    from the drill using the long depth
    stop tool                                                                                                                             FRIOS® EasyFix
                                                                                                                                          Disassembly
Assembly
                                                                                                                                          ■   Remove the protective cap (1)
■   Please mount the depth stop onto the
    drill using the short depth stop tool                                                     PLEASE CONSIDER:                            ■   Now please unscrew the tip (2) of the
    onto the drill                                                                            The depth stops of the FRIALIT® stepped         centerpiece (3) and remove the
                                                                                              drills universal are not pre-mounted.           working part with the return spring
                                                                                                                                          ■   Then unscrew centerpiece and end
                                                                                                                                          ■   Please unscrew the sphere (5) from
                                                                                                                                              the retracting handle (6) and remove
FRIADENT® Periotome                                                                                                                           the clamp pin (7) from the end
                                                                                                                                          ■   Let the trigger drop from the end
Disassembly
                                                                                                                                          ■   Finally please remove the securing
■   Please loosen the head of the
                                                                                                                                              ring from the end
    instrument counter-clockwise from
    the handle
                                                                                                                                          Assembly
■   Then please remove the blade from
    the working part                                                                                                                      ■   Please assemble in reverse order
                                               PLEASE CONSIDER:
                                               During assembly, the driving stud of
Assembly
                                               the blade must be inserted in one of the                                                                                                                     8
■   Please assemble in reverse order           notches at the working part

                                                                                                                                                                                                5       7       6         3           4       2               1




14                                                                                                                                                                                                                                                            15
Order no. 6-002025/005


Friadent GmbH · P. O. Box 71 01 11 · 68221 Mannheim/Germany
Phone +49 621 4302-1288 · Fax +49 621 47 13 06
e-mail: info@friadent.de
                                                               1109/3.0/WPC




     for FRIADENT Class I Devices
               for FRIADENT Class II a, II b and III Devices

www.dentsply-friadent.com

								
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