W&H Implantmed Instructions For Use Manual
  1. Manuals
  2. Brands
  3. W&H Manuals
  4. Medical Equipment
  5. Implantmed
  6. Instructions for use manual

W&H Implantmed Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Instructions for Use
SI-915 / SI-923

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Implantmed and is the answer not in the manual?

Questions and answers

Related Manuals for W&H Implantmed

Summary of Contents for W&H Implantmed

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

  • Page 2: Table Of Contents

    ......................................22 of foot control ..................................... 23 of motor with cable ..................................... 24 7. Start-up ........................................25 8. Implantmed ......................................26 9. Control unit operation changing program (P1 – P5) ................................27 change speed (P1 – P3) ..................................28 change torque (P4 –...
  • Page 3 Contents Initial treatment at the point of use ..............................40 Manual cleaning ....................................41 Manual disinfection .................................... 42 Automated cleaning and disinfection ............................... 43 Drying ........................................44 Inspection, Maintenance and Testing ..............................45 Packaging ......................................46 Sterilization ......................................47 Storage ........................................ 48 15.

  • Page 4: 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 Thermo washer disinfectable Sterilizable Call customer service up to the stated temperature...
  • Page 5 Symbols on the control unit Follow Instructions for Use Class II equipment Catalogue number Consult Instructions for Use Foot control Serial number Date of manufacture On / Off Supply voltage of the unit Do not dispose of with Electric fuse Alternating current domestic waste Data Matrix code...
  • Page 6 Symbols on the foot control CE marking Catalogue number with identification number XXXX of the Notified Body Serial number Do not dispose of with domestic waste Date of manufacture Data Matrix code for product information including UDI (Unique Device Identification) Category AP equipment UL Component Recognition Mark indicates compliance...
  • Page 7 Symbols on the packaging CE marking Data Matrix code with identification number for product information including UDI XXXX of the Notified Body (Unique 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 8 Symbols on the irrigation tubing set Consult Instructions for Use Not for re-use Latex-free CE marking Use by Sterilization with with identification number ethylene oxide XXXX of the Notified Body Batch code Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices, and who intends to use or order the use of this medical device.

  • Page 9: Introduction

    Misuse may damage the medical device and hence cause risks and hazards for patients, users and third parties. Qualifications of the user Only suitably qualified medical, technical and specialist trained staff may use the W&H Implantmed. We have based our developmed and design of the Implantmed on the »physician« target group.
  • Page 10 The medical device complies with the regulations of Directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the Implantmed when compliance with the following instructions is ensured: > The Implantmed must be used in accordance with these Instructions for Use.

  • Page 11: Electromagnetic Compatibility (Emc)

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

  • Page 12: Unpacking

    3. Unpacking  Remove the packaging.  Remove the foot control, Instructions for Use and accessories.  Remove the motor with cable.  Lift out the insert with the control unit. Remove the mains cable, irrigant support, universal support, irrigation tubing set and Instructions for Use.

  • Page 13: Scope Of Delivery

    4. Scope of delivery Description 30286000 Control unit SI-923 (230 V) 30287000 Control unit SI-915 (115 V) 30185000 EM-19 motor without electrical contacts with 1.8 m cable incl. 5 hose clips 04363600 Irrigation tubing set 2.2 m (3 pcs, disposable) 07721800 Universal support 04005900...

  • Page 14: Safety Notes

    Control unit / Motor > Before using the Implantmed for the first time, store it at room temperature for 24 hours. > Check the control unit and the motor with cable for damage and loose parts every time before use.
  • Page 15 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 P4 and P5 programs exclusively with the surgical contra-angle handpieces approved by W&H.
  • Page 16 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 17 Safety notes Control unit / Motor / Foot control Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if patient and user have implanted systems before using the medical device and consider the application. >...
  • Page 18 Safety notes Foot control S-N2 Follow the directions and safety notes in the Instructions for Use of the foot control. The foot control is approved for operation in potentially explosive atmospheres (AP). > Note that when using or setting low speeds, the operation or run-down of rotary instruments is more difficult to detect. >...
  • Page 19 Safety notes Coolant supply The Implantmed 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 20 Safety notes Transmission instrument > Follow the directions and safety notes in the Instructions for Use of the transmission instrument. > Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer approved transmission instruments. > Follow the directions of the manufacturer of transmission instrument with reference to transmission ratio, maximum speed and maximum torque.

  • Page 21: Description Of Front Panel

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

  • Page 22: Of Rear Panel

    Description of rear panel Irrigant support locator Connection for foot control Connection for mains cable Fuse holder with 2 fuses REF 06352200 (2 x 250 V - T1.6 AH) Power switch ON / OFF...

  • Page 23: 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 24: 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). The motor with cable is a type B applied part (not suitable for intracardiac application). Temperature information Temperature of the motor on the operator side: max.

  • Page 25: Start-Up

    7. Start-up General Always place the Implantmed on a flat level surface. Ensure that the Implantmed can be disconnected easily from the power supply.  Connect the mains cable and  Attach the universal support foot control. and lock it.

  • Page 26: Implantmed

    8. Implantmed Switch on / switch off Switch on Implantmed Switch off Implantmed  Connect the control unit  Switch off the control unit to the power supply. at the power switch.  Switch on the control unit  Disconnect the control unit at the power switch.

  • Page 27: Control Unit Operation

    > P1 – P3 speed in rpm Error messages > Motor temperature too high > Motor push-in connection Always make sure that the LED displays on the buttons and the display itself are all on when switching on the Implantmed.

  • Page 28: Change 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 29: Change Torque (P4 - P5)

    Control unit operation Changing torque (P4 – P5) Program P4: range 5 – 70 Ncm, intermediate stage 32 Ncm. Program P5: range 20 – 60 Ncm. Pressing and holding PLUS / MINUS depressed activates the repeat function and the values are continuously increased / decreased.

  • Page 30: Change 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 31: Operation

    10. 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 32 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 33: Restore Factory Settings

    11. 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 34 Factory settings (P1 – P3) Transmission 20:1 20:1 Speed rpm 35,000 1,200 Setting range rpm 300 – 40,000 15 – 2,000 15 – 2,000 Motor direction of rotation forward forward forward Pump Torque Ncm 100 % 100 % 100 %...
  • Page 35 Factory settings (P4 – P5) P4 forward P4 reverse P5 forward P5 reverse Transmission 20:1 20:1 20:1 20:1 Speed rpm Motor direction forward reverse forward reverse of rotation Pump Torque Ncm Setting range Ncm 5 – 70 5 – 70 20 –...

  • Page 36: Thread Cutter Function (Chip Breaker Mode)

    12. 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 37: Error Messages

    13. Error messages Error no. Description Solution Switch off device, allow device to cool for at least Electronics overheated – safety shutdown 10 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 38: Hygiene And Maintenance General Notes

    14. 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 39: 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 40: Initial Treatment At The Point Of Use

    Hygiene and maintenance Initial treatment at the point of use > Clean and disinfect the medical device immediately after every treatment. > Wipe the control unit, the motor with cable, the universal support and the irrigant support with disinfectant.Wipe the entire surface of the instrument with disinfectant.

  • Page 41: Manual Cleaning

    Hygiene and maintenance Manual cleaning Motor with cable / Universal support / Irrigant support > Do not immerse the motor with cable, the universal support or the irrigant support in liquid disinfectant or in an ultrasonic bath. Motor with cable / Universal support / Irrigant support >...

  • Page 42: Manual Disinfection

    Hygiene and maintenance Manual disinfection Motor with cable / Universal support / Irrigant support > W&H recommends wipe-down disinfection. Evidence of the basic suitability of the motor with cable, the universal support and the irrigant support for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).

  • Page 43: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Motor with cable / 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.

  • Page 44: Drying

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

  • Page 45: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, maintenance and testing Inspection – Motor with cable / Universal support / Irrigant support > Check the motor with cable, the universal support and the irrigant support after cleaning and disinfection for damage, visible residual soiling and surface changes. >...

  • Page 46: Packaging

    Hygiene and maintenance Packaging Motor with cable / Universal support Wrap the motor with cable and 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 47: Sterilization

    Hygiene and maintenance Sterilization Motor with cable / Universal support W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. >...

  • Page 48: Storage

    Hygiene and maintenance Storage Motor 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 49: Servicing

    15. Servicing Regular checks Regular servicing of function and safety including the accessories is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organization and must include the following procedures: Control unit >...
  • Page 50 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 51: W&H Accessories And Spare Parts

    16. 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 04013500 07948730 Sterilization cassette Transportation case 04005900 06352200 07721800 Universal support Irrigant support Fuse (250 V - T1.6AH)
  • Page 52 W&H accessories and spare parts 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 53: Technical Data

    17. Technical data Implantmed 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 54 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!) Type B applied part (not suitable for intracardiac application) S-N2 (REF 30285000) is approved for operation in potentially explosive atmospheres.

  • Page 55: 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 57: 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 59 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 61: 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 62: 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 authorized W&H service partner under “Service” in the menu. If you do not have Internet access, please contact: W&H (UK) LIMITED, 6 Stroud Wood Business Centre, Park Street, St Albans, Hertfordshire AL2 2NJ, United Kingdom t + 44 1727 874990, f + 44 1727 872254, E-Mail: technical.uk@wh.com W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t + 1 800 2656277, 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com...
  • Page 64 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form no. 50874 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 004 / 22.06.2018 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Implantmed si-1010Implantmed si-1015Implantmed si-1023

Table of Contents

Save PDF