Dentsply Maillefer CALAMUS DUAL Directions For Use Manual
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Dentsply Maillefer CALAMUS DUAL Directions For Use Manual

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A1300
 Directions For Use
 Instructions d'utilisation
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Summary of Contents for Dentsply Maillefer CALAMUS DUAL

  • Page 1 A1300  Directions For Use  Instructions d'utilisation Distributed by...

  • Page 2: Table Of Contents

    Directions For Use Table of Contents INDICATIONS FOR USE ..............4 CONTRAINDICATIONS ................ 4 WARNINGS ..................... 4 PRECAUTIONS ..................4 ADVERSE REACTIONS ................ 5 STEP-BY-STEP INSTRUCTIONS ............6 6.1) PACKAGE CONTENTS ................6 6.2) SETTING UP THE UNIT ................6 6.3) OPERATION ....................

  • Page 3: Indications For Use

    For dental use only 1) INDICATIONS FOR USE Calamus Dual is an integrated obturation device with hand pieces that are used for Downpack (Pack) and Backfill (Flow) of root canals. The Pack hand piece is intended to heat pluggers for warming and softening gutta-percha master cones and searing off gutta-percha cones.

  • Page 4: Adverse Reactions

     Chemclaving is not recommended for sterilization and maintenance of the tips as this would cause corrosion.  Do not stay in the root canal with a heated tip for more than 4 seconds for safety!  Place gutta-percha on the tip of the thermal response tip before applying the tip to the patient’s tooth! Do not place the tip directly on the tooth! ADVERSE REACTIONS Use in patients with a known sensitivity to latex, silver or copper may cause an allergic reaction.

  • Page 5: Step-By-Step Instructions

    STEP-BY-STEP INSTRUCTIONS 6.1) PACKAGE CONTENTS  Calamus Dual obturation device with hand pieces for Downpack (Pack) and Backfill (Flow)  Remote power cord  Cartridge needle bending tool  Flow hand piece cleaning brush  Replacement cartridge nut  Flow hand piece heat shield ...

  • Page 6: Operation

    7. Flow: Remove a cartridge from blister pack and install cartridge into Flow hand piece: Unscrew and remove the cartridge nut from the hand piece. Insert a cartridge into the hand piece, needle facing outward. Slip cartridge nut over needle and screw cap on clockwise lightly - do not tighten. NOTE: Take care when replacing a cartridge during a procedure, the hand piece cartridge nut and the expended cartridge may be hot to the touch.
  • Page 7 3. PACK Side - Program new temperature and volume settings a. Press the Pack Temperature button on the left side of the keypad and then use the up/down buttons to set the desired temperature. Press either button repeatedly to increase/decrease the temperature in 10°C increments, or hold down the button to rapidly scroll through the temperature range (100°C minimum to 400°C maximum).
  • Page 8 11. Cool hand piece cartridge nut before removing any excess gutta-percha. 11. Replacing the fuses NOTE: The Calamus Dual is manufactured with 250V 300mA rated fuses installed for a 230VAC power source. If power source is 115 VAC, ensure that 250V 600mA rated fuses are installed.

  • Page 9: Sterilisation, Desinfection & Maintenance

    Hand piece Cartridge Nut Gutta-Percha Level indicator Ventilation Gap Hand Piece Activation Cuff Figure 5 - FLOW HAND PIECE COMPONENTS Blue Activation Indicator Electrically Heated Plugger Activation Cuff Figure 6 - PACK HAND PIECE COMPONENTS 6.4) STERILISATION, DESINFECTION & MAINTENANCE Control Console –...
  • Page 10 PACK: Pluggers and Thermal Response Tip Keep the connector portion of the plugger clean. Oxidation from repeated autoclaving should be gently removed. This maintenance will insure proper electrical connection to the hand piece. Pluggers and tips must be cleaned, disinfected and sterilized before every use: 1.
  • Page 11 6.5) CLINICAL TECHNIQUE Only use filling materials compatible with this filling technique such as Gutta-percha (for consistency) or root canal sealer. The actual temperature in the root canal largely depends on the amount of filling material used. Although the device is able to precisely control the heat transmission to the tip, it is unable to prevent undesired heating up of the root.
  • Page 12 4. Activate the electric heated plugger and, in one deliberate and continuous motion, press the heated plugger through the thermosoftened gutta-percha until the silicone stop is 2 mm from the reference point. This procedure must be limited to two to four seconds to prevent thermal injury.

  • Page 13: Clinical Technique Troubleshooting

    6.6) TROUBLESHOOTING 1. Device does not turn on: a) Verify that the power cord is plugged into the device and into wall outlet. b) Unplug device and check fuse. If fuse is blown, replace it. See Operation, Replacing the fuses. 2.

  • Page 14: Warranty & Service

    The tips should be used only to transfer heat – not to exert manual force! Our recommendation is that you use a cold manual plugger for that purpose. All tips will gradually lose their heating efficiency over time. This is strongly depending on the user. 6.8) WARRANTY &...

  • Page 15: Certification

    Caution: This device has been tested and found to comply with the emissions requirements of IEC 60601-1-2:2001-09. These requirements provide reasonable protection against harmful electromagnetic interference in a typical medical installation. However, high levels of radio-frequency emissions from electrical devices, such as cellular phones, may disrupt the performance of this device. To mitigate disruptive electromagnetic interference, position this device away from radio frequency transmitters and other sources of electromagnetic energy.

  • Page 16: Disinfection, Cleaning And Sterilisation

    7) DISINFECTION, CLEANING AND STERILISATION Reprocessing procedure for dental instruments and implantable radicular devices. Foreword For hygiene and sanitary safety purposes, all instruments not marked “sterile” must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well as the subsequent ones.
  • Page 17 Step-by-step procedure A. Devices A3. Contra Angle A2. Implantable devices A1. Instruments Following uses First use Operation Operating mode Warning Disassembling - Disassemble the device, Silicone stops have to be removed. if required Pre-Disinfection - Soak all instruments - Follow instructions and observe concentrations and immediately after use in a immersion times given by the manufacturer (an excessive detergent and disinfecting...
  • Page 18 A3. Contra Angle A2. Implantable devices A1. Instruments Following uses First use Operation Operating mode Warning Packaging - Place the devices in a kit, - Avoid any contact between instruments or posts during support or container to sterilization. Use kits, supports or containers. avoid any contact between - Check the validity period of the pouch given by the X X X X...
  • Page 19 Manufactured by : Distributed by : Maillefer Instruments Holding Sarl Aseptico, Inc. Chemin du Verger 3 P.O. Box 1548 - 8333 216 Street SE CH – 1338 Ballaigues Woodinville, WA 98072 - USA Switzerland Advena Ltd. Pure Offices, Plato Close, Warwick CV34 6WE UK Maillefer Ref.

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A1300

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