W&H piezomed PLUS SA-435 M Instructions For Use Manual
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W&H piezomed PLUS SA-435 M Instructions For Use Manual

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Instructions for Use
SA-435 M
SA-430 M

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Summary of Contents for W&H piezomed PLUS SA-435 M

  • Page 1 Instructions for Use SA-435 M SA-430 M...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 4 1. Introduction ....................................... 7 2. Unpacking ........................................9 3. Scope of delivery ....................................10 4. Safety notes ......................................11 5. Description....................................... 16 6. Start-up ........................................19 7. Operation ........................................23 8. Icons ......................................... 26 9. Error messages ......................................29 10.
  • Page 3 Contents 14. Data on electromagnetic compatibility according to IEC/EN 60601-1-2..................49 15. Disposal ......................................... 53 W&H course certificate ....................................54 Explanation of warranty terms ................................... 57 Authorized W&H service partners ................................58...

  • Page 4: Symbols

    Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, without risk to (risk of injury) (to prevent damage occurring) persons or objects Thermo washer disinfectable Sterilizable up to Type B applied part the stated temperature (not suitable for intracardiac application)
  • Page 5 Symbols on the medical device Follow Instructions for Use Foot control Catalogue number Date of manufacture Serial number Manufacturer Do not dispose of with DC – direct current CE marking with domestic waste identification number of XXXX the Notified Body Electric voltage (volt) DataMatrix Code for product information including UDI...
  • Page 6 Symbols on the packaging CE marking with identification DataMatrix Code for product Catalogue number number of the Notified Body information including UDI XXXX (Unique Device Identification) Serial number Trademark of RESY OfW GmbH for This way up Date of manufacture identification of recyclable transport and outer packaging of paper and cardboard.

  • Page 7: 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 8 Introduction Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device when it is used in compliance with the following directions: > The medical device must be used in accordance with these Instructions for Use. >...

  • Page 9: Unpacking

    2. Unpacking  Remove the carton.  Remove the packaging and remove the power supply, irrigation tubing set and accessories.  Lift out the insert with the stand, Instructions for Use, universal support, control unit and mains cable. 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 10: Scope Of Delivery

    3. Scope of delivery Control unit 30406000 30407000 REF 08072750 Irrigation tubing set 2,2 m incl. Y-manifold (6 pcs. disposable) REF 07883900 Power supply REF 07721800 Universal support REF 08067690 Stand Mains cable country-specific Optional included in set REF 30392000 Handpiece SA-40 L with 1,8 m cable (only for SA-435 M) REF 30392001 Handpiece SA-40 L with 3,5 m cable (only for SA-435 M) REF 30408000 Handpiece SA-40 with 1,8 m cable (only for SA-430 M) REF 06369001 Nozzle cleaner...

  • Page 11: 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 12 Safety notes Power failure In the event of a power failure, if the control unit is switched off, or when switching between programs, the last values set are saved and re-activated on power-up. System failure A total system failure does not constitute a critical fault. Mains cable/Power supply >...
  • Page 13 Safety notes Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (ICD) can be affected by electric, magnetic and electromagnetic fields. This medical device is suitable for use on patients with unipolar and bipolar pacemakers or ICD, if a safety distance between the medical device and the cardiac pacemaker or ICD of at least 40 cm (15.75 inch) is maintained.
  • Page 14 Safety notes Coolant supply The medical device is designed for use with physiological saline solution. > Always ensure the correct operating conditions and cooling function. > Use only suitable coolants and follow the manufacturer’s medical data and instructions. > Use the W&H irrigation tubing set or accessories approved by W&H. Irrigation tubing set >...
  • Page 15 Safety notes Hygiene and maintenance prior to initial use > Clean the control unit. > Clean and disinfect the universal support and the stand. > Sterilize the universal support. Test run Do not hold the handpiece with cable at eye level! >...

  • Page 16: Description

    5. Description SA-430 M / SA-435 M Stand holder Connection for power supply Connection cable Connection for handpiece Connection for foot control...
  • Page 17 Description foot control S-N2/S-NW Locator ORANGE attach/detach GREEN YELLOW GREY Start motor (pedal) VARIABLE or ON/OFF (Factory setting = ON/OFF)
  • Page 18 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. When changing from the last program to the first program a longer acoustic signal sounds (risk of injury). S-NW: Switching between multiple control units Press the ORANGE button for 3 seconds.

  • Page 19: 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.  Attach the control unit until it  Connect handpiece cable. engages. Pay attention to the positioning! ...
  • Page 20 Start-up  Attach the universal support and lock it.  Insert the irrigation tubing. > Open the pump cover (a,b). > Insert the irrigation tubing (c). > Close the pump cover (d).
  • Page 21 Start-up Control unit switching on and off  Plug the mains cable/power  Pull the power plug out of the supply into an earthed power socket. socket.  Switch on/off the control unit at the power switch. SA-430 M / SA-435 M Ensure that the SA-430 M / SA-435 M is connected to the power supply before switching on the control unit at the power switch.
  • Page 22 Start-up Coolant filling function operation Make sure that the coolant filling function has been carried out prior to every application. The coolant filling function symbol will only appear on the display if a handpiece is connected. Coolant filling function Start the coolant filling function by confirming the entry. The coolant filling functions lasts for 15 seconds.

  • Page 23: Operation

    7. Operation Main menu      Instruments library  Setup   Coolant filling function  Coolant volume    Foot control  Power  Instrument group  Information  Bone quality In instrument group 3, the power settings are displayed according to bone quality (D1, D2, D3). D3 >...
  • Page 24 Operation “Auto Detection” > Instrument detection assists the user and helps to avoid incorrect settings. > Only deactivate the „Auto Detection“ if instrument detection fails during treatment. > The instrument’s maximum power setting is shown on the instrument card. My instruments “My instruments”...
  • Page 25 Operation Navigation * Only visible when using the foot control S-NW. ** Visible in Piezo mode / *** visible in Implant mode...

  • Page 26: Icons

    8. Icons User Foot control ON/OFF An activated user cannot be deleted System Add user Implant mode > Switch from Piezo mode to Implant mode Manage user Piezo mode User settings: Copy, Rename, Activate, Delete > Switch from Implant mode to Piezo mode Coolant filling function Confirm/save Grey = Coolant volume set, inactive...
  • Page 27 Icons Module info > Activating / deactivating Fade-out time Reset Select time SOUND Software Update > Activating/deactivating Language Reset > Select “Auto detection” Import user settings > Activating/deactivating “Auto detection OFF” Export user settings Change application Device info > Activating/deactivating Switch only between Service Implant/Piezo mode...
  • Page 28 Icons red = replace batteries Setting selected black = Information Foot control S-NW green = Information with selection option Foot control S-N2 red = error message, work cannot be continued orange = error message, work can be continued Reduce/increase parameters >...

  • Page 29: Error Messages

    9. Error messages Icon Description of error Solution WARNING NO HANDPIECE DETECTED > Unplug the handpiece and plug it back in again > Deactivate AUTO DETECTION If the error message appears again, contact an authorized W&H service partner immediately. WARNING NO INSTRUMENT DETECTED >...
  • Page 30 Error messages Icon Description of error Solution WARNING INSTRUMENT DETECTION ERROR > Check LED socket (correctly attached, defective) > Deactivate AUTO DETECTION WARNING SURGERY SCALER > Check the plug contacts of the handpiece > Allow handpiece 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...

  • Page 31: Hygiene And Maintenance

    10. 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 universal support and the stand with disinfectant. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfection step after cleaning.

  • Page 34: Manual Cleaning

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

  • Page 35: Manual Disinfection

    Hygiene and maintenance Manual disinfection Universal support/Stand W&H recommends wiping down with disinfectant. Evidence of the basic suitability of the universal support and the stand for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozid® AF wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”...

  • Page 36: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Universal support/Stand 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 37: Drying

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

  • Page 38: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, maintenance and testing Universal support/Stand > Check the universal support and the stand after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any universal support and stand 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 Sterilisation Evidence of the universal support’s basic suitability 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: Service

    11. Service 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 Service 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 45: W&H Accessories And Spare Parts

    12. 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 (Link: https://www.wh.com) 30392000 06205600 07945930 07172900 Handpiece SA-40 L with 1,8 m cable LED socket Transportation case Cassette incl.
  • Page 46 W&H accessories and spare parts 00636901 07721800 08067690 07883900 Nozzle cleaner Universal support Stand Power supply 08072750 07233500 Irrigation tubing set 2.2 m incl. W&H Adapter kit Y-manifold (6 pcs, disposable item) 08041710 Irrigation tubing set 3.8 m incl. Y-manifold (6 pcs, disposable item)

  • Page 47: Technical Data

    13. Technical data Control unit SA-430 M SA-435 M Supply voltage: 100 – 240 V Operating voltage: 30 – 32 V DC Frequency: 50 – 60 Hz Maximum power output (ultrasonic): 18 W 24 W Operating frequency: 22 – 35 kHz Coolant flow rate at 100 %: at least 50 ml/min S3 (80s on/330s off)
  • Page 48 Technical data Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport: 8 % to 80 % (relative), non-condensing Temperature during operation: +10°C to +35°C (+50°F to +95°F) Humidity during operation: 15% to 80% (relative), non-condensing 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 I medical electrical equipment (to avoid the risk of electric shock, the power supply must only be connected to a supply mains...

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

    14. 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. The customer and/or the user should assure that this medical device is set up and used in an environment of the specified type and/or in accordance with the specifications of the manufacturer.
  • Page 50 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 (11.8 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 Class B [150 kHz – 30 MHz] Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011 Class B [30 MHz –...
  • Page 52 Results of the electromagnetic tests Proximity fields from RF wireless communications equipment 385 MHz 27 V/m IEC/EN 60601-1-2 Table 9 450 MHz 28 V/m IEC/EN 61000-4-3 710 / 745 / 780 MHz 9 V/m 810 / 870 / 930 MHz 28 V/m 1720 / 1845 / 1970 MHz 28 V/m...

  • Page 53: Disposal

    15. 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 54: 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 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51029 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 004 / 27.09.2021 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

Piezomed classic sa-430m

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