W&H Med amadeo M-MH40 Instructions For Use Manual
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W&H Med amadeo M-MH40 Instructions For Use Manual

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Instructions for Use
M-MH40
M-UK1023, M-UK1015, M-UK1010

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Summary of Contents for W&H Med amadeo M-MH40

  • Page 1 Instructions for Use M-MH40 M-UK1023, M-UK1015, M-UK1010...

  • 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....................................... 19 of front panel ....................................... 19 of rear panel ......................................20 of foot control S-N2/S-NW ...................................21 of motor with cable .....................................
  • Page 3 Contents General notes ...................................... 42 Limitations on processing .................................. 43 Initial treatment at the point of use ..............................44 Manual cleaning ....................................45 Manual disinfection .................................... 46 Automated cleaning and disinfection ............................... 47 Drying ........................................48 Inspection, maintenance and testing ............................... 49 Packaging ......................................

  • 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 of the Supply current 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 of the control 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 us. 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 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 M-UK1023 M-UK1015 M-UK1010 Control unit 30387000 30388000 30389000 REF 04005900 Irrigant support Mains cable country-specific Optional included in set REF 30264000 Foot control S-NW REF 30285000 Foot control S-N2 Irrigation tubing set 3,8 m REF 04364100 (6 pcs, disposable) REF 30393000 Motor M-MH40 with 3,5 m cable REF 04006800 Locking pin (2 pcs)

  • Page 12: Safety Notes

    4. Safety notes Control unit / Motor > Before using the medical device for the first time, store it at room temperature for 24 hours > Check the medical device and the motor with cable for damage and loose parts every time before use. >...
  • Page 13 Safety notes Control unit > Use only original W&H fuses. > Never touch the patient and the electrical connections 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 the WS-75 (20:1) ratios exclusively with the contra-angle handpieces approved by W&H.
  • Page 14 Safety notes Control unit / Motor 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 Control unit / Motor Control unit 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 Safety notes Intermittent operating mode S3 (3min/5min) The medical device is designed for intermittent operating mode S3 with an operating time of 3 minutes and an idle time of 5 minutes. If the operating mode specified is observed no overheating of the system and therefore no injury to the patients, users or third parties arises.
  • Page 18 Safety notes Test run Do not hold the motor with transmission instrument at eye level. > Connect the transmission instrument to the motor. Point the transmission instrument with the head facing downwards. > Operate the motor with the foot control. In the event of operating malfunctions (e.g., vibrations, unusual noise, resp.

  • Page 19: Description

    5. Description of front panel Irrigant support locator Pump cover Display (touchscreen) Pump cover OPEN Connection for motor...

  • Page 20: Of Rear Panel

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

  • Page 21: Of Foot Control S-N2/S-Nw

    Description of foot control S-N2/S-NW Locator ORANGE attach/detach Change program YELLOW GREEN Change motor direction Pump Forward operation/reverse operation ON/OFF GREY Start motor (pedal) VARIABLE or ON/OFF (Factory setting = variable)
  • Page 22 Description of foot control S-N2/S-NW ORANGE S-N2 / S-NW: Change program Press the ORANGE button to change programs in ascending order. The motor direction is automatically set to forward operation every time the program is changed. When changing to a program with drilling or sawing function, a longer acoustic signal sounds (risk of injury). GREEN –...

  • Page 23: Of Motor With Cable

    Description of motor with cable The motor with cable must not be disassembled. The motor with cable must not be oiled (pre-oiled for entire service life). To prevent the instrument on the motor attachment from turning during transmission of high torques, the locking pin supplied can be pushed into the designated hole (see illustration).

  • Page 24: Start-Up

    6. Start-up Place the medical device on a flat level surface. Ensure that the medical device can be disconnected from the power supply at any time.  Insert the  Connect the mains cable and foot control. irrigation tubing. S-N2 Pay attention to the >...

  • Page 25: Control Unit

    7. Control unit switching on and off Switching on the control unit Switching off the control unit  Plug the mains cable into an  Switch off the control unit at earthed power socket. the power switch.  Switch on the control unit ...

  • Page 26: Starting Operation

    8. Starting operation Setup wizard The touch screen must only be touched using fingers. Using hard objects on the touch screen may scratch or damage the surface. Setting up control unit Switch on your control unit and follow the directions of the setup wizard. The set-up wizard guides you through the various set-up stages up to the main menu: >...

  • Page 27: Control Unit Operation

    9. Control unit operation Main menu     35 000    max Ncm    Application area  Set speed / torque  Setup  Foot control  Forward/reverse operation mode  Progress display mode ...
  • Page 28 Control unit operation My favorites Select drill protocol group An activated drill protocol cannot be deleted Edit > Adjust factory setting of drill protocol groups. > Create drill protocol Copy Rename Activate Delete...
  • Page 29 Control unit operation Set program max. 50 Ncm Transmission Speed At 40,000 rpm the accuracy of the set speed is ±10 %. Torque Adjustment range 5 – 80 Ncm with WS-75 only. The motor switches off automatically when the set torque is reached in forward and reverse operation modes. The accuracy of the set torque during the P4 (screw function) and P6 (thread cutting function) programs in the 20 –...

  • Page 30: Menue Navigation

    Control unit operation Menue Navigation...
  • Page 31 Control unit operation User System An activated user cannot be deleted Add user Set screen lock Activating / deactivating screen lock Manage user Screen lock User settings: Copy, Rename, Activate, Delete Interval Interval: Select time Foot control Sound Pairing – S-NW Activating/deactivating Language Properties...
  • Page 32 Control unit operation Device info Software update Service Reset Restore factory settings Licenes Restart GPL: GNU General Public License Control unit restarts automatically LGPL: GNU Lesser General Public License Import user settings Module info User interface Export user settings Motor control unit Foot control...
  • Page 33 Control unit operation Program 1 (P1) Confirm/save drill function Program 2 (P2) Favorite selected drill function Program 3 (P3) black = information drill function green = Information with selection option Program 4 (P4) red = error message, work cannot be continued screw function orange = error message, work can be continued Program 5 (P5)

  • Page 34: Factory Settings

    Control unit operation Factory settings ENT Surgery Transmission WS-75 (20:1) WS-75 (20:1) Speed rpm 80.000 2.000 Setting range rpm 400 – 80.000 10 – 2.000 10 – 50 Motor direction of rotation forward forward forward Pump Torque Ncm 40 (5-80) (Setting range Ncm)
  • Page 35 Control unit operation Factory settings CMF Surgery Transmission Speed rpm 10.000 40.000 80.000 40.000 Setting range rpm 200 - 40.000 200 - 40.000 400 - 80.000 200 - 40.000 Motor direction forward forward forward forward of rotation Pump Torque Ncm...
  • Page 36 Control unit operation Factory settings Ribs and Thorax Transmission WS-75 (20:1) WS-75 (20:1) WS-75 (20:1) Speed rpm 1.000 Setting range rpm 10 – 50 10 – 2.000 10 – 200 Motor direction of rotation forward forward forward Pump Torque Ncm 30 (5-80) 70 (5-80) (Setting range Ncm)
  • Page 37 Control unit operation Factory settings Orthopedics Transmission Speed rpm 40 000 5.000 8.000 Setting range rpm 200 – 40.000 200 – 40.000 200 – 40.000 Motor direction forward forward forward of rotation Pump Torque Ncm...
  • Page 38 Control unit operation Factory settings Spine Surgery Transmission Speed rpm 40.000 80.000 Setting range rpm 200 – 40.000 400 – 80.000 Motor direction of rotation forward forward Pump Torque Ncm...
  • Page 39 Control unit operation Factory settings The thread cutter function can be selected when creating a new drill protocol. Thread-cutter function (chip breaker mode) When the pedal (grey) on the foot control is pressed, the thread cutter rotates inwards until the set torque is reached. The control unit automatically switches to reverse operation when the set torque is reached.

  • Page 40: Error Messages

    10. Error messages The error message disappears when it is clocked or when the pedal (grey) on the foot control is released. Icon Description of error Solution WARNING FOOT CONTROL > Check plug contacts of foot control > Check the plug contacts of the dongle WARNING MOTOR >...
  • Page 41 Error messages Icon Description of error Solution WARNING TIME-OUT > Release the pedal (grey) on the foot control > Allow motor to cool for at least 10 minutes SYSTEM ERROR > Switch the control unit off and back on again If the error message appears again, contact an authorized W&H service partner immediately.

  • Page 42: Hygiene And Maintenance

    11. 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 43: 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 44: 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 motor with cable 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 45: Manual Cleaning

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

  • Page 46: Manual Disinfection

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

  • Page 47: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Motor with cable / 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 48: Drying

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

  • Page 49: Inspection, Maintenance And Testing

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

  • Page 50: Packaging

    Hygiene and maintenance Packaging Motor with cable Pack the motor with cable 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 51: Sterilization

    Hygiene and maintenance Sterilization Motor with cable 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 motor with cable. Recommended sterilization procedures >...
  • Page 52 Hygiene and maintenance Sterilization Evidence of the basic suitability of the motor with cable 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).

  • Page 53: Storage

    Hygiene and maintenance Storage Motor with cable > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 54: Servicing

    12. 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 55 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 56: Accessories, Consumables, Spare Parts And Other Recommended Medical Devices By W&H

    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 07962790 07721800 04364100 Transportation case Universal support Irrigation tubing set 3,8 m (6 pcs) 04005900 06352200 04006800...
  • Page 57 Accessories, consumables, spare parts and other recommended medical devices by W&H 30285000 04653500 30393000 Foot control S-N2 Locator for foot control Motor M-MH40 with 3,5 m cable 30264000 Foot control S-NW Scan the QR code to find accessories, consumables and spare parts for this medical device.

  • Page 58: Technical Data

    14. Technical data Control unit M-UK1023 M-UK1015 M-UK1010 Mains voltage: 230 V 120 V 100 V Permissible voltage fluctuation: 220 – 240 V 110 – 130 V 90 – 110 V Rated current: 0.3 – 0.8 A 0.3 – 1.6 A 0.3 –...
  • Page 59 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 60: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    15. 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 61 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 62 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 63: Disposal

    16. 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 64: 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 65 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 67: 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 68: 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 70 W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form Nr. 51015 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 005 / 15.11.2023 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Amadeo m-uk1023Amadeo m-uk1015Amadeo m-uk1010303870003038800030389000

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