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Osstell ISQ Si-SQ Instructions For Use Manual

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Instructions for Use
Edition USA
module
Si-SQ

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Summary of Contents for Osstell ISQ Si-SQ

  • Page 1 Instructions for Use Edition USA module Si-SQ...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 3 1. Introduction ......................................6 2. Electromagnetic compatibility (EMC) ..............................8 3. Scope of delivery ...................................... 9 4. Safety notes ......................................10 5. Description....................................... 11 6. Start-up ........................................12 7. Operation ........................................13 8. Hygiene and maintenance ..................................16 9.

  • Page 3: Symbols

    Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, (if persons could be injured) (if property could be damaged) without risk to persons or property Sterilizable Call customer service up to the stated temperature...
  • Page 4 Symbols on the Osstell ISQ module Follow Instructions for Use Type B applied part (not suitable Catalogue number for intracardiac application) Serial number Date of manufacture CE mark with identification number XXXX of the Notified Body DC – direct current...
  • Page 5 Symbols on the packaging CE mark Data Matrix code with identification number for product information including UDI (Unique XXXX of the Notified Body Device Identification) This way up Data structure in accordance with Health Industry Bar Code Fragile, handle with care Permitted temperature range +70 °C (+158°F) Max.

  • Page 6: Introduction

    Intended use Osstell ISQ is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region Osstell ISQ can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the user.
  • Page 7 > The Osstell ISQ module must be used in accordance with these Instructions for Use. > The Osstell ISQ module has no components that can be repaired by the user. Assembly, modifications or repairs must only be undertaken by an authorized W&H service partner (see page 35).

  • Page 8: Electromagnetic Compatibility (Emc)

    2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.

  • Page 9: Scope Of Delivery

    3. Scope of delivery Description 30210000 Osstell ISQ module 07849900 TestPeg 07721800 Universal support 07460300 SmartPeg mount...

  • Page 10: Safety Notes

    > Before using the Osstell ISQ module for the first time, store it at room temperature for 24 hours. > Check the Osstell ISQ module and the measuring probe with cable for damage and loose parts every time before use.

  • Page 11: Description

    5. Description SmartPeg mount Osstell ISQ module Measuring probe connection TestPeg Measuring probe with cable USB cable...

  • Page 12: Start-Up

    6. Start-up General  Push in the Osstell ISQ module until it locks audibly. Pay attention to the positioning of the USB cable!  Connect USB.  Connect measuring probe. Pay attention to the positioning!

  • Page 13: Operation

     Attach the SmartPeg to the implant or abutment by screwing the SmartPeg mount using finger force of approximately 4-6 Ncm. Do not overtighten the SmartPeg or the SmartPeg thread may be damage * For further information, please contact an authorized W&H service partner or visit osstell.com...
  • Page 14 Operation  Press the foot control pedal once to start the measurement.  Press the foot control pedal again to stop the measurement early.  Hold the measuring probe about 3 to 5 mm from the tip of the SmartPeg until the measured value is displayed.
  • Page 15 The resonance frequency as a measure of implant stability is calculated from the oscillation frequency of the SmartPeg. The results of this calculation are displayed as the ISQ value. The scale from the ISQ value ranges from 1 to 100. * For further information, please contact an authorized W&H service partner or visit osstell.com...

  • Page 16: Hygiene And Maintenance

    8. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying. Cleaning agents and disinfectants >...
  • Page 17 Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.
  • Page 18 Hygiene and maintenance Initial treatment at the point of use Wipe the Osstell ISQ module, the measuring probe with cable and the universal support and the irrigant support with disinfectant. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant...
  • Page 19 > Clean the measuring probe with cable and the universal support under running tap water (< 35°C / < 95°F). > Rinse and brush off all internal and external surfaces. > Remove liquid residues using compressed air. Osstell ISQ module > Do not immerse the Osstell ISQ module in water or clean under running water.
  • Page 20 Hygiene and maintenance Manual disinfection Measuring probe with cable / Universal support > W&H recommends wipe-down disinfection. Evidence of the basic suitability measuring probe with cable and the universal support for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).
  • Page 21 > Cleaning at 55°C (131°F) – 5 minutes > Disinfection at 93°C (200°F) – 5 minutes Osstell ISQ module / Measuring probe with cable The Osstell ISQ module and the measuring probe with cable are not approved for automated cleaning and disinfection.
  • Page 22 Hygiene and maintenance Drying Measuring probe with cable / Universal support > Ensure that the measuring probe with cable and the universal support are completely dry internally and externally after cleaning and disinfection. > Remove any liquid residues using compressed air.
  • Page 23 Hygiene and maintenance Inspection, maintenance and testing Inspection – Measuring probe with cable / Universal support > Check the measuring probe with cable and the universal support after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any measuring probe with cable and the universal support that are still soiled. >...
  • Page 24 Hygiene and maintenance Packaging Measuring probe with cable / Universal support Wrap the measuring probe with cable and the universal support in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization procedure.
  • Page 25 Hygiene and maintenance Sterilization Measuring probe with cable / Universal support W&H recommends sterilization according to EN 13060, EN 285. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the measuring probe with cable and the universal support. Recommended sterilization cycles >...
  • Page 26 Hygiene and maintenance Storage Measuring probe with cable / Universal support > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 27: Servicing

    The inspection must be undertaken by a qualified organization and must include the following procedures: Osstell ISQ module > External visual inspection > Visual inspection of internal components on suspicion of safety interference, e.g., mechanical damage of the enclosure or indicators of overheating The regular inspection must only be performed by an authorized W&H service partner.
  • Page 28 Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it. >...

  • Page 29: W&H Accessories And Spare Parts

    Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners 07721100 07849900 07721800 Measuring probe with cable* TestPeg Universal support 07460300 SmartPeg mount * The measuring probe with cable from Osstell is compatible with the W&H Osstell ISQ module.

  • Page 30: Technical Data

    11. Technical data Osstell ISQ module SI-SQ Voltage from Implantmed: 5.5 V Dimensions in mm (height x width x depth): 79 x 138 x 88 Weight in kg: 0.210 kg TestPeg measured value tolerance: 55 +/-5 SmartPeg measured value tolerance:...
  • Page 31 Technical data Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Equipment according to IEC 60601-1/ANSI/AAMI ES 60601-1 Class II medical electrical equipment Type B applied part (not suitable for intracardiac application) Pollution level: Overvoltage category: Altitude: up to 3,000 m above sea level...

  • Page 32: Disposal

    12. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and country-specific laws, directives, standards and guidelines for disposal. > Waste electrical equipment > Accessories and spare parts > Packaging...

  • Page 34: Explanation Of Warranty Terms

    Ex p la na ti on o f war ranty ter ms This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for Use have been followed.

  • Page 35: Authorized W&H Service Partners

    Authorized W&H service partners Visit W&H on the Internet at http://wh.com You can find your nearest W&H service partner under “Service” in the menu. If you do not have Internet access, please contact: W&H Impex Inc. 33091 W Jefferson Ave Brownstown, MI 48173, USA t +1 800 265 6277 +1 519 944 6739 f +1 519 974 6121...

  • Page 36: Manufacturer's Declaration

    Manufacturer’s declaration...
  • Page 37 Manufacturer’s declaration...
  • Page 38 Manufacturer’s declaration...
  • Page 39 Manufacturer’s declaration...
  • Page 40 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form no. 50875 AAE t +43 (0)6274 6236-0, f +43 (0)6274 6236-55 Rev. 003 / 05.04.2019 office@wh.com wh.com Subject to alterations...

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