W&H OSSTELL ISQ Instructions For Use Manual
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W&H OSSTELL ISQ Instructions For Use Manual

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Summary of Contents for W&H OSSTELL ISQ

  • Page 1 Instructions for Use module SI-SQ...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 3 1. Introduction ....................................... 6 2. Scope of delivery ....................................... 8 3. Safety notes ......................................9 4. Description....................................... 10 5. Start-up ........................................11 6. Operation ........................................12 7. Hygiene and maintenance ..................................15 8. Servicing ........................................26 9. W&H accessories and spare parts ................................. 28 10.

  • 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 Thermo washer disinfectable Type B applied part (not suitable for up to the stated temperature intracardiac application)
  • Page 4 Symbols on the Osstell ISQ module Follow Instructions for Use CE marking Catalogue number with identification number XXXX of the Notified Body Manufacture Medical Device Serial number Date of manufacture Data Matrix code DC – direct current for product information...
  • Page 5 Symbols on the packaging Trademark of RESY OfW GmbH CE marking Data Matrix code for identification of recyclable with identification number for product information XXXX transport and outer packaging of the Notified Body including UDI (Unique of paper and cardboard Device Identification) Consult Instructions for Use Medical Device...

  • Page 6: Introduction

    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.
  • Page 7 > Unauthorized opening of the unit invalidates all claims under warranty and any other claims. In addition to unauthorized assembly, installation, modification of or repairs to the Osstell ISQ module and measuring probe with cable, transmission instrument and non-compliance with our instructions, improper use will invalidate all claims made under warranty or otherwise.

  • Page 8: Scope Of Delivery

    2. Scope of delivery Osstell ISQ module 30210000 07849900 TestPeg 07721800 Universal support 07460300 SmartPeg mount 07721100 Measuring probe with cable...

  • Page 9: Safety Notes

    The medical device is classed as “conventional equipment” (closed equipment without protection against the ingress of water). Hygiene and maintenance prior to initial use > Clean and disinfect the Osstell ISQ module and the measuring probe with cable. > Sterilize the measuring probe with cable.

  • Page 10: Description

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

  • Page 11: Start-Up

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

  • Page 12: Operation

    6. Operation > The TestPeg is for testing only and for teaching in the function. > You can purchase SmartPegs from smartpegs.wh.com or osstell.com. > SmartPegs are for single use only. > SmartPegs are available for a range of different implant systems and can be used in combination with all conventionally available implants.* >...
  • Page 13 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 14 Operation Measurement result* The measurement result can be used as part of a general assessment program. The user bears the ultimate responsibility for the decision for implant treatment. Low Stability Medium Stability High Stability Yellow Yellow Green ISQ <60 ISQ 60 – 64 ISQ 65 –...

  • Page 15: Hygiene And Maintenance

    7. 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 16 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 17 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 18 > 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 them under running water.
  • Page 19 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 20 > 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 21 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 liquid residues using compressed air.
  • Page 22 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 23 Hygiene and maintenance Packaging Measuring probe with cable / Universal support / SmartPeg mount Pack the medical device 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 24 Hygiene and maintenance Sterilization Measuring probe with cable / Universal support / SmartPeg mount W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST55 > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. >...
  • Page 25 Hygiene and maintenance Storage Measuring probe with cable / Universal support / SmartPeg mount > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 26: Servicing

    8. Servicing Periodic inspection Regular periodic inspection of the function and safety of the medical device is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The periodic inspection covers the complete medical device and must only be performed by an authorized service partner.
  • Page 27 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 28: 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 29: Technical Data

    10. 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 30 Technical data Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Device according to IEC 60601-1/ANSI/AAMI ES 60601-1 Class II medical electrical device (protective earth conductor used for functional earth connection only!) Type B applied part (not suitable for intracardiac application) Pollution level: Overvoltage category: Altitude:...

  • Page 31: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    11. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 Operating environment and EMC warning notes This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of highintensity may occur.
  • Page 32 Data on electromagnetic compatibility according to IEC/EN 60601-1-2 Portable RF communication devices Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result.
  • Page 33 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 Class B [30 MHz – 1000 MHz] Immunity to electromagnetic interference Electrostatic discharge (ESD) Contact discharge: ± 2 kV, ± 4 kV, ± 6 kV, ± 8 kV IEC/EN 61000-4-2 Air discharge: ±...
  • Page 34 Results of the electromagnetic tests Electrical fast transient/burst IEC/EN 61000-4-4 ±2 kV Conducted disturbances induced by RF fields IEC/EN 61000-4-6 6 V in ISM bands 6 V in amateur radio bands Power frequency magnetic field 30 A/m IEC/EN 61000-4-8 – Surges IEC/EN 61000-4-5 Voltage dips, voltage interruptions...

  • Page 35: Disposal

    12. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...

  • Page 36: Explanation Of Warranty Terms

    As manufacturer, W&H is liable for material or manufacturing defects within a warranty period of 12/24 months from the date of purchase. 12 months: Measuring probe with cable 24 months: Osstell ISQ module We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by W&H! Claims under warranty –...

  • Page 37: Authorized W&H Service Partners

    Authorized W&H service partners Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option “Service” for full details. Or simply scan the QR code.
  • Page 38 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50875 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 005 / 01.10.2021 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Si-sq30210000

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