W&H piezomed SA-320 Instructions For Use Manual
  1. Manuals
  2. Brands
  3. W&H Manuals
  4. Medical Equipment
  5. piezomed SA-320
  6. Instructions for use manual

W&H piezomed SA-320 Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Instructions for Use
SA-320

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the piezomed SA-320 and is the answer not in the manual?

Questions and answers

Related Manuals for W&H piezomed SA-320

Summary of Contents for W&H piezomed SA-320

  • Page 1 Instructions for Use SA-320...

  • Page 2: Table Of Contents

    Contents Symbols .......................................... 4 1. Introduction ....................................... 8 2. Electromagnetic compatibility (EMC) ..............................10 3. Unpacking ........................................ 11 4. Scope of delivery ......................................12 5. Safety notes ......................................13 6. Description....................................... 19 of front panel ....................................... 19 of rear panel ......................................20 Foot control S-N1/S-NW ..................................21 Handpiece with cable..................................
  • Page 3 Contents 12. Error messages ...................................... 38 13. Emergency mode ....................................40 14. Hygiene and maintenance ................................... 42 General notes ...................................... 42 Limitations on processing .................................. 43 Initial treatment at the point of use ..............................44 Manual cleaning ....................................45 Manual disinfection .................................... 48 Automated cleaning and disinfection ...............................

  • 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 Suitable for ultrasonic bath the stated temperature Type B applied part (not suitable for intracardiac application)
  • Page 5 Symbols on the control unit Follow Instructions for Use Class II equipment Catalogue number Date of manufacture Foot control Serial number Do not dispose of with On / Off Supply voltage domestic waste DataMatrix Code for product Electric fuse Alternating current information including UDI (Unique Device Identification) Earth...
  • Page 6 Symbols on the packaging CE marking DataMatrix Code for product Catalogue number with identification number information including UDI XXXX of the Notified Body (Unique Device Identification) Serial number This way up Trademark of RESY OfW GmbH for Date of manufacture identification of recyclable transport and outer packaging of paper and Manufacturer...
  • Page 7 Symbols on the irrigation tubing set CE marking Not for re-use Latex-free with identification number XXXX of the Notified Body Batch code Use by Sterilization with ethylene oxide Manufacturer Catalogue number Keep away from heat Do not use when package is DataMatrix Code for product Do not resterilize damaged...

  • 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.
  • Page 9 Introduction Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. 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: >...

  • Page 10: Electromagnetic Compatibility (Emc)

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

  • Page 11: Unpacking

    3. Unpacking  Lift out the insert with the  Remove the irrigation stand and the foot control. tubing set.  Lift out the insert with the  Remove the carton control unit. containing the accessories supplied. W&H packaging is environmentally friendly and can be ...

  • Page 12: Scope Of Delivery

    4. Scope of delivery Control unit 30078000 30078001 30078003 30078004 30078005 30078006 30078007 REF 06985000 Handpiece with 1.8 m cable REF 07159200 Handpiece with 3.5 m cable REF 07004400 Foot control S-N1 REF 30264001 Foot control S-NW REF 07795800 SPI dongle REF 04653500 Handle for foot control Irrigation tubing set 2.2 m...

  • Page 13: Safety Notes

    5. 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 when the medical device is damaged. >...
  • Page 14 Safety notes > Use only original W&H fuses. > Never touch the patient and the electrical contacts on the medical device simultaneously. The control unit is classed as ”conventional equipment” (closed equipment without protection against the ingress of water). 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.
  • Page 15 Safety notes Instruments > Only use instruments approved by W&H and the associated instrument changer. > Make sure that the instrument used complies with the instrument group displayed. > An overview for the correct power setting is included with each instrument. >...
  • Page 16 Safety notes Risks due to electromagnetic fields This handpiece with cable complies with the reference values defined in EN 50527-2-1/2016 for active implantable medical devices (AIMD) and cardiac pacemakers. The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields.
  • Page 17 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 Sterile disposable irrigation tubing sets are supplied with the equipment.
  • Page 18 Safety notes Hygiene and maintenance prior to initial use > Clean the control unit. > Clean and disinfect the handpiece with cable, the universal support, the stand, the instruments and the instrument changer. > Sterilize the handpiece with cable, the universal support, the instruments and the instrument changer. Test run Do not hold the handpiece with cable at eye level! >...

  • Page 19: Description

    6. Description of front panel Pump cover Stand holder Display Shift buttons Pump cover OPEN PLUS / MINUS buttons Connection for handpiece...

  • Page 20: Of Rear Panel

    Description of rear panel Stand holder Connecting socket for foot control Power switch I / O (ON / OFF) Power Fuse holder with 2 fuses socket REF 06661800 (250 V – T1,25AH)

  • Page 21: Foot Control S-N1/S-Nw

    Description Foot control S-N1/S-NW Handle ORANGE attach / detach Change program GREEN Pump YELLOW ON / OFF Activate boost function GREY Start motor (pedal) VARIABLE or ON / OFF (Factory setting = variable)
  • Page 22 Description Foot control S-N1 / S-NW ORANGE S-N1 / S-NW: Changing the program > Press the ORANGE button to select programs 1 to 3 in ascending order. When changing from the last program to the first program a longer acoustic signal sounds (risk of injury). S-N1: Changing the program >...

  • Page 23: Handpiece With Cable

    Description Handpiece with cable The handpiece with cable must not be disassembled. The handpiece with cable must not be oiled. Coolant tube The handpiece with cable is a type B applied part (not suitable for intracardiac application). Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Temperature of the medical device on the patient side (front area of the handpiece): maximum 48°C (118.4°F)

  • Page 24: Start-Up

    7. Start-up Place the control unit on a flat, level surface. Ensure that the control unit can be disconnected from the power supply at any time.  Connect the mains cable and  Insert the stand. Pay attention to the the foot control.
  • Page 25 Start-up Switching on and off  Insert the irrigation tubing.  Connect the control unit to the power supply. > Open the pump cover. Disconnect the control unit from > Fit the irrigation tubing the power supply. Follow the same sequence when removing the irrigation tubing.
  • Page 26 Start-up Coolant filling function Make sure that the coolant filling function has been carried out prior to every application. The coolant filling function will only appear on the display if a handpiece is connected.  Coolant filling function  Press the PLUS/MINUS buttons at the same time to activate the coolant filling function.

  • Page 27: Instruments

    8. Instruments Insert/remove Inserting an instrument Removing an instrument  Position the instrument on the  Attach the instrument handpiece thread. changer to the instrument.  Turn the instrument changer  Twist off the instrument with until it snaps into place. the instrument changer.

  • Page 28: Setup Settings

    9. Setup settings Control unit Calling up the setup settings Press the  and  buttons at the same time to access the setup options. Press the  or button to select the setup setting. The selected Setup setting is framed green. Operating hours counter Variable or ON / OFF Foot control...

  • Page 29: Foot Control S-N1

    Setup settings Foot control S-N1 To change from VARIABLE to ON / OFF  Foot control  Select setting = VARIABLE (factory setting) Stepless power regulation of the instrument (up to the power set in the respective program) = ON / OFF...

  • Page 30: Volume

    Setup settings Volume  Volume  Increase volume  Decrease volume Mute...

  • Page 31: Reset Factory Settings

    Setup settings Reset factory settings The control unit will restart after the factory settings have been reset.  Reset  Start reset countdown  The reset countdown can be interrupted within 5 seconds...

  • Page 32: Operation

    10. Operation Main menu settings Calling up the main menu settings Press the  or  button to select the required menu. The selected menu is framed green. Instrument display Programs (1 – 3) Power Coolant Operating mode Boost function Press the ...

  • Page 33: Changing The Program (P1 - P3)

    Operation Changing the program (P1 – P3)  Program  Next program  Previous program...

  • Page 34: Changing Power

    Operation Changing power The power range can be set from 5 – 100. Each change is immediately saved in the selected program.  Power  Increase power  Reduce power By keeping the PLUS / MINUS button pressed you can continuously increase / decrease the power. The instrument’s maximum power setting is shown on the instrument card.

  • Page 35: Changing The Coolant Flow

    Operation Changing the coolant flow The coolant quantity can be set from 10 – 100. Each change is immediately saved in the selected program. You can also change the coolant quantity during use.  Coolant  Increase flow rate in 10 % steps ...

  • Page 36: Changing The Operating Mode

    Operation Changing the operating mode Each change is immediately saved in the selected program. You cannot change the operating mode during application.  Changing the operating mode > Basic: The handpiece power remains the same irrespective of the load on the instrument. >...

  • Page 37: Factory Settings

    11. Factory settings Instrument group 1 – 3 Group 1 Group 2 Group 3 Program Power Coolant Operating mode *Boost function * Using the boost function, you can boost performance by 20% of the set value for 15 seconds. Activate the boost function by pressing the yellow button on the foot control.

  • Page 38: Error Messages

    12. Error messages Error Description Solution > Connect foot control correctly Foot control not recognized > Connect correct foot control > Connect foot control correctly Foot control error > Connect correct foot control Info: Foot control recognized > Connect handpiece >...
  • Page 39 Error messages Error Description Solution > Check LED socket (correctly attached, defective) Instrument detection error (Activate emergency mode [see pages 40–41] or change the LED socket) Button (keypad) pressed > Switch off the device and restart during power-on > Switch off device and allow to cool down Error electronics temperature >...

  • Page 40: Emergency Mode

    13. Emergency mode Only activate the emergency mode if instrument detection fails during treatment. Press the  and  buttons at the same time to access the setup settings.  Press the PLUS/MINUS button to deactivate instrument tip detection.  Instrument tip detection deactivated. using the shift button ...
  • Page 41 Emergency mode In emergency mode, it is not possible to switch between programs, change the mode or activate the boost function. Instrument display Power Coolant The power range can be set between 5 and 70. The coolant quantity can be set between 10 and 100. The coolant quantity cannot be deactivated in emergency mode.

  • Page 42: Hygiene And Maintenance

    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. The instruments can be reprocessed in the instrument stand (REF 07134900).

  • 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 handpiece with cable immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. > Operate the coolant fill function for at least 10 seconds. >...

  • Page 45: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the handpiece with cable, the universal support, the stand and the instrument changer in liquid disinfectant or in an ultrasonic bath. Handpiece with cable / Universal support / Stand / Instruments / Instrument changer >...
  • Page 46 Hygiene and maintenance Manual cleaning Disassembling the handpiece / Replacing of the LED socket  Unscrew the handpiece cap.  Pull out the LED socket. Cleaning of the coolant tubes / spray nozzles Clean and disinfect the nozzle cleaner in an ultrasonic bath / a washer-disinfector. Clean outlets carefully with the nozzle cleaner to remove dirt and deposits.
  • Page 47 Hygiene and maintenance Manual cleaning Cleaning of the light source Avoid scratching the light source! Wash the light source with cleaning fluid and a soft cloth. Blow the light source dry using compressed air or dry it carefully with a soft cloth. >...

  • Page 48: Manual Disinfection

    Hygiene and maintenance Manual disinfection Handpiece with cable / Universal support / Stand / Instruments / Instrument changer > W&H recommends wiping down with disinfectant. Evidence of the basic suitability of the handpiece with cable, the universal support, the stand, the instruments and the instrument changer for effective manual disinfection was provided by an independent test laboratory using the ”mikrozid®...

  • Page 49: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection Handpiece with cable / Universal support / Stand / Instruments / Instrument changer 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 50: Drying

    Hygiene and maintenance Drying Handpiece with cable / Universal support / Stand / Instruments / Instrument changer > Ensure that the handpiece with cable, the universal support, the stand, the instruments and the instrument changer are completely dry internally and externally after cleaning and disinfection. >...

  • Page 51: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, maintenance and testing Inspection – Handpiece with cable / Universal support / Stand / Instruments / Instrument changer > Check the handpiece with cable, the universal support, the stand, the instruments and the instrument changer after cleaning and disinfection for damage, visible residual soiling and surface changes.

  • Page 52: Packaging

    Hygiene and maintenance Packaging Handpiece with cable / Universal support / Instruments / Instrument changer Pack the handpiece with cable, the universal support, the instruments and the instrument changer 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 method.
  • Page 53 Hygiene and maintenance Sterilization Handpiece with cable / Universal support / Instruments / Instrument changer 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 54: Sterilization

    Hygiene and maintenance Sterilization Evidence of the basic suitability of the handpiece with cable, the universal support, the instruments and the instrument changer 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)) and the Systec VE-150* steam sterilizer (Systec).

  • Page 55: Storage

    Hygiene and maintenance Storage Handpiece with cable / Universal support / Instruments / Instrument changer > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 56: Service

    15. 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 57 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 58: 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 (Link: https://www.wh.com) 07945930 07172900 04653500 07004400 Foot control S-N1 Transportation case Sterilization cassette Handle for foot control 30264001 Foot control S-NW 06985000 06205600...
  • Page 59 W&H accessories and spare parts 00636901 07721800 04005900 07233500 Nozzle cleaner Universal support Stand W&H Adapter kit 07795800 04363600 04719400 Irrigation tubing set 2.2 m SPI dongle Irrigation tubing set 2.2 m (3 pcs, disposable item) 04364100 Irrigation tubing set 3.8 m (3 pcs, disposable item)

  • Page 60: Technical Data

    17. Technical data Control unit SA-320 Supply voltage: 100 – 130 V / 220 – 240 V Frequency: 50 – 60 Hz Permitted voltage fluctuation: ±10 % Nominal current: 0.1 – 1.0 A / 0.1 – 0.5 A Mains fuse: 2 x 250 V –...
  • Page 61 Technical data Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Devices 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-N1 / S-NW are waterproof according to IPX8, 1 m depth of immersion, 1 hour (water-tight in accordance with IEC 60529)

  • Page 62: Disposal

    18. 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 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 69: Open Source Software

    Open Source Software The software running this product was developed by utilization of the library QT of Digia. As kernel Linux is applied, the initial starting sequence is carried out by using the bootloader U-Boot. For CANopen communication CanFestival is applied. These and all other software components are copyrighted by W&H Dentalwerk Bürmooos GmbH or third parties.

  • Page 70: Manufacturer's Declaration

    Manufacturer’s declaration...
  • Page 71 Manufacturer’s declaration...
  • Page 72 Manufacturer’s declaration...
  • Page 73 Manufacturer’s declaration...
  • Page 74 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50756 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 022 / 19.02.2021 office@wh.com wh.com Subject to alterations...

Table of Contents