W&H implantmed SI-915 Instructions For Use Manual
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W&H implantmed SI-915 Instructions For Use Manual

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Instructions for Use
SI-915 / SI-923

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  • Page 1 Instructions for Use SI-915 / SI-923...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 4 1. Introduction ....................................... 8 2. Unpacking ........................................ 10 3. Scope of delivery ..................................... 11 4. Safety notes ......................................12 5. Description........................................17 of front panel ......................................17 of rear panel ......................................18 of foot control ..................................... 19 6. Start-up ........................................20 7.
  • Page 3 Contents 13. Hygiene and maintenance ..................................31 General notes ...................................... 31 Limitations on processing .................................. 32 Initial treatment at the point of use ..............................33 Manual cleaning ....................................34 Manual disinfection .................................... 35 Automated cleaning and disinfection ............................... 36 Drying ........................................37 Inspection, maintenance and testing ...............................

  • Page 4: Symbols

    Symbols WARNING! Sterilizable up to the stated Consult Instructions for Use (if persons could be injured) temperature ATTENTION! CE marking with identification Do not dispose of with (if property could be damaged) number of the Notified Body domestic waste XXXX Manufacturer General explanations, without DataMatrix code for product...
  • Page 5 Symbols Follow Instructions for Use Power consumption Supply current of the control unit Class II equipment Electric fuse Frequency of the alternating current Foot control Earth MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL 25UX SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601- Supply voltage 1:2005/(R)2012 + A1:2012 +...
  • Page 6 Symbols Revolutions per minute Temperature limitation Caution! According to +70 °C (+158°F) Max. (= rpm) Federal law restricts this device to sale by or on the -40 °C (-40°F) Min. order of a physician, dentist, veterinarian or with the This way up Humidity limitation descriptive designation of any 80 %...
  • Page 7 Symbols Batch code Use by Latex-free Not for re-use Do not use when package is Sterilization with ethylene damaged oxide Do not resterilize Keep away from heat Single sterile barrier system...

  • Page 8: Introduction

    1. Introduction For your safety and the safety of your patients These Instructions for use explain how to use your medical device. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to Observe the safety notes.
  • Page 9 Introduction Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when compliance with the following instructions is ensured: > The medical device must be used in accordance with these Instructions for Use. >...

  • Page 10: Unpacking

    2. Unpacking Lift out the insert with the control unit. Remove the mains cable, irrigant support, universal support and Instructions for Use. W&H packaging is environmentally friendly and can be disposed of by industrial recycling companies. However, we recommend that you keep the original packaging.

  • Page 11: Scope Of Delivery

    3. Scope of delivery SI-923 (230 V) SI-915 (120 V) Control unit 30286000/30286001 30287000/30287001 REF 07721800 Universal support REF 04005900 Irrigant support Mains cable country-specific Optional included in set Irrigation tubing set 2.2 m REF 04363600 (6 pcs, disposable) EM-19 motor without electrical contacts REF 30185000 with 1.8 m cable REF 30285000...

  • Page 12: Safety Notes

    4. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. >...
  • Page 13 Safety notes > Use only original W&H fuses > Never touch the patient and the electrical contacts on the control unit simultaneously. The control unit is classed as “conventional equipment” (closed equipment without protection against the ingress of water). Use the control unit in P4 and P5 programs exclusively with the surgical contra-angle handpieces approved by W&H. Use of other contra-angle handpieces may result in deviation from the indicated torque.
  • Page 14 Safety notes Mains cable / Power switch > Only use the mains cable supplied. > Plug the mains cable only into an earthed power socket. > Set up the control unit so the power switch and the socket are easily accessible at all times. Disconnect the control unit from the power supply in case of danger.
  • Page 15 Safety notes Risks due to electromagnetic fields The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric, magnetic and electromagnetic fields. Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about the risks.
  • Page 16 Safety notes Coolant supply The medical device is designed for use with physiological saline solution. > Always ensure correct operating conditions and that sufficient and adequate coolant is delivered. > Always provide sufficient coolant and ensure the appropriate suction. > Use only suitable coolants and follow the manufacturer’s medical data and instructions. >...

  • Page 17: Description

    5. Description of front panel Program buttons Pump cover Display Irrigant support locator Pump cover OPEN Connection for motor...

  • Page 18: Of Rear Panel

    Description of rear panel Irrigant support locator Connection for foot control Connection for mains cable Fuse holder with 2 fuses (2 x 250 V - T1.6 AH) Power switch ON / OFF...

  • Page 19: Of Foot Control

    Description of foot control Locator ORANGE attach / detach Change program Programs 1 to 4 Program 5 (torque 20 – 60 Ncm) GREEN Pump ON / OFF YELLOW Change motor direction forward / reverse operation mode GREY Start motor (pedal) VARIABLE or ON / OFF (Factory setting = variable)

  • Page 20: Start-Up

    6. Start-up General Place the medical device on a flat level surface. Ensure that the medical device can be disconnected easily from the power supply.  Connect the mains cable and  Attach the universal support foot control. and lock it. Pay attention to the positioning! ...

  • Page 21: Control Unit

    7. Control unit Switch on / switch off Switch on Control unit Switch off Control unit  Connect the control unit  Switch off the control unit to the power supply. at the power switch.  Switch on the control unit ...

  • Page 22: Control Unit Operation

    8. Control unit operation Changing program (P1 – P5) Activate the desired program (P1 – P5) by pressing the corresponding program button. During selection an audible signal can be heard and the Program button lights up. The selected program appears on the display with the adjusted range in rpm, e.g. for P1: Pump function ON / OFF Display settings...

  • Page 23: Changing Speed (P1 - P3)

    Control unit operation Changing speed (P1 – P3) Pressing and holding PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased.  Press program button (P1–P3)  Increase speed  Decrease speed At 40,000 rpm the accuracy of the speed set is ± 10%.

  • Page 24: Changing Torque (P4 - P5)

    Control unit operation Changing torque (P4 – P5) Program P4: range 5 – 70 Ncm, intermediate stage 32 Ncm. The motor switches off automatically when the set torque is reached in forward and reverse operation modes. Program P5: range 20 – 60 Ncm. The control unit automatically switches to reverse operation when the set torque is reached.

  • Page 25: Changing Coolant Volume (P1 - P5)

    Control unit operation Changing coolant volume (P1 – P5) Factory setting 100 % Range 65 %, 80 % and 100 %. Press and hold the PLUS / MINUS button to continuously increase or decrease the values. Press and hold program button P2 during this procedure. ...

  • Page 26: Operation

    9. Operation foot control Change program Press the ORANGE button to select programs 1 – 4 in ascending order. In program 5 switch the torque steps from 20 – 60 Ncm. The motor direction is automatically set to forward operation every time the program is changed. When changing from program 4 to program 1 and in program 5 from 60 Ncm to 20 Ncm, a longer acknowledgment signal sounds (risk of injury).
  • Page 27 Operation foot control To change from VARIABLE to ON / OFF Keep program button P3 depressed throughout this procedure.  Keep P3 depressed for approx. 4 seconds  Continue to keep P3 depressed and simultaneously press the PLUS and MINUS buttons ...

  • Page 28: Restoring Factory Settings

    10. Restoring factory settings The factory setting always starts with program 1 (P1).  Switch off the control unit  Press and hold P1 and simultaneously switch on the control unit...

  • Page 29: Thread Cutter Function (Chip Breaker Mode)

    11. Thread cutter function (chip breaker mode) When the thread cutter function (P5) is activated, the speed in both forward and reverse operation modes is 20 rpm and can no longer be changed. When the motor button (grey) on the foot control is pressed, the thread cutter rotates inwards until the set torque is reached.

  • Page 30: Error Messages

    12. Error messages Error no. Description Solution Switch off device, allow device to cool for at least Electronics overheated – safety shutdown 20 minutes, re-start Switch off device, allow device to cool for at least Electronics overloaded 10 minutes, re-start Voltage too high Switch off device, check voltage, re-start Switch off device, re-start, do not actuate foot control...

  • Page 31: Hygiene And Maintenance

    13. 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 32: Limitations On Processing

    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 33: Initial Treatment At The Point Of Use

    Hygiene and maintenance Initial treatment at the point of use > Clean the medical device immediately after every treatment. > Wipe the control unit, 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 step after cleaning.

  • Page 34: Manual Cleaning

    Hygiene and maintenance Manual cleaning Universal support / Irrigant support Do not immerse the universal support or the irrigant support in liquid disinfectant or in an ultrasonic bath. Universal support / Irrigant support > Clean the universal support and the irrigant support under running tap water (< 35°C / < 95°F). >...

  • Page 35: Manual Disinfection

    Hygiene and maintenance Manual disinfection Control unit / Universal support / Irrigant support W&H recommends wipe-down disinfection. Evidence of the basic suitability of the control unit, motor with cable and the irrigant support for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozidR AF wipes” (Schulke & Mayr GmbH, Norderstedt) and “CaviWipes™”...

  • Page 36: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Universal support / Irrigant support W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. The control unit is not approved for automated cleaning and disinfection.

  • Page 37: Drying

    Hygiene and maintenance Drying Universal support / Irrigant support > Ensure that the universal support and the irrigant support are completely dry internally and externally after cleaning and disinfection. > Remove liquid residues using compressed air.

  • Page 38: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, maintenance and testing Inspection – Universal support / Irrigant support > Check the universal support and the irrigant support after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any universal support and irrigant support that are still soiled. >...

  • Page 39: Packaging

    Hygiene and maintenance Packaging Universal support Pack the universal support in sterilization packages that meet the following requirements: > The sterilization procedure must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >...
  • Page 40 Hygiene and maintenance Sterilization Universal support 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. > The program selected must be suitable for the universal support. Recommended sterilization procedures >...

  • Page 41: Sterilization

    Hygiene and maintenance Sterilization Evidence of the basic suitability of the universal support for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)), the Systec VE-150* steam sterilizer (Systec) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun). “Dynamic-air-removal prevacuum cycle”...

  • Page 42: Storage

    Hygiene and maintenance Storage 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 43: Servicing

    14. 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 44 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. Always return equipment in the original packaging.

  • Page 45: Accessories, Consumables, Spare Parts And Other Recommended Medical Devices By W&H

    15. Accessories, consumables, spare parts and other recommended medical devices by W&H Use only original W&H accessories and spare parts or accessories approved by W&H. Suppliers: W&H partners (Link: https://www.wh.com) 04013500 07948730 Cassette Transportation case 04005900 06352200 07721800 Universal support Irrigant support Fuse (250 V - T1.6AH)
  • Page 46 Accessories, consumables, spare parts and other recommended medical devices by W&H 30185000 30285000 04653500 EM-19 motor without Foot control S-N2 Locator for foot control electrical contacts and 1.8 m cable 04363600 04719400 06290600 Irrigation tubing set 2.2 m (6 pcs) Irrigation tubing set 2.2 m Hose clips (5 pcs)

  • Page 47: Technical Data

    16. Technical data Control unit SI-923 SI-915 Mains voltage: 230 V 120 V Permissible voltage fluctuation: 220 – 240 V 110 – 130 V Rated current: 0.3 – 0.8 A 0.3 – 1.6 A Frequency: 50 – 60 Hz Mains fuse (2 pcs): 250 V –...
  • Page 48 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 (protective earth conductor used for functional earth connection only!) Pollution level: Overvoltage category: Altitude: up to 3,000 m above sea level...

  • Page 49: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    17. 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 high-intensity may occur.
  • Page 50 Data on electromagnetic compatibility according to IEC/EN 60601-1-2 RF communication equipment 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 51 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Mains terminal disturbance voltage (Conducted Emissions) Group 1 CISPR 11/EN 55011 [150 kHz – 30 MHz] Class B Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 [30 MHz – 1000 MHz] Class B Harmonic distortion IEC/EN 61000-3-2 Class A...

  • Page 52: Disposal

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

  • Page 53: W&H Course Certificate

    W&H course certificate for the user The user has been trained to use the medical device correctly in accordance with the legal regulations (medical devices marketing regulations, medical devices act). Particular attention has been paid to the chapters on safety notes, start-up, operation, hygiene and maintenance, and service (regular inspections). Product name Serial number (SN) Manufacturer with address...
  • Page 55 W&H course certificate for the instructor The user has been trained to use the medical device correctly in accordance with the legal regulations (medical devices marketing regulations, medical devices act). Particular attention has been paid to the chapters on safety notes, start-up, operation, hygiene and maintenance, and service (regular inspections). Product name Serial number (SN) Manufacturer with address...

  • Page 57: Explanation Of Warranty Terms

    Ex p la na ti on o f war ranty ter ms This W&H medical device 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 58: 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 60 W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form Nr. 50874 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 008 / 22.03.2023 office@wh.com wh.com Subject to alterations...

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Implantmed si-923

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