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Young INFINITY PL-40 H Instructions For Use Manual

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Summary of Contents for Young INFINITY PL-40 H

  • Page 1 Instructions for use...
  • Page 2 This page left intentionally blank.

  • Page 3: Table Of Contents

    14. Test run ........................................29 15. Hygiene and maintenance ................................30 – 34 16. Replacing the O-ring ....................................35 17. Young Dental accessories and spare parts ............................36 18. Servicing ......................................37 – 38 19. Technical data ....................................39 – 40 20. Disposal ........................................41 Explanation of warranty terms ..................................

  • Page 4: Symbols

    Symbols in the instructions for use WARNING! ATTENTION! General explanations, (risk of injury) (to prevent damage occurring) without risk to persons or property Thermo washer disinfectable Sterilizable Not for re-use up to the stated temperature Call customer service...
  • Page 5 Symbols on the handpiece Follow instructions for use Article number Date of manufacture Serial number Do not dispose of with domestic Non-sterilizable waste Data Matrix code Non-ionizing electromagnetic for product information radiation including UDI (Unique Device Identification) The medical device with reference to electrical safety, mechanical Not suitable for intracardiac safety and fire prevention...
  • Page 6 Symbols on the foot control Do not dispose of with Non-ionizing electromagnetic DC – direct current domestic waste radiation Protection against Data Matrix code Article number IPX1 dripping water for product information including UDI (Unique Device Identification) Serial number Foot control cordless C-NW UL Component Recognition Mark indicates compliance...

  • Page 7: Symbols

    Symbols on the packaging Data Matrix code This way up for product information including UDI (Unique Device Identification) Permitted temperature range Fragile, handle with care +60 °C (+140°F) Max. -20 °C (-4°F) Min. Humidity, 80 % Keep dry limitation Caution! According to U.S. federal »Der Grüne Punkt«...

  • Page 8: Introduction

    1. Introduction For your safety and the safety of your patients These instructions provide recommendations for safe operation of the enclosed medical device and are intended to protect the safety of the operator and patient. Observe the safety notes on pages 12 to 16. Intended use and Operational Contexts of Use Handpiece: Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth...
  • Page 9 > The medical device does not have any components that can be repaired by the user. Assembly, modifications or repairs must only be undertaken by an authorized Young Dental service partner (see page 43). > The electrical installation at the premises must comply with the regulations laid out in IEC 60364-7-710 (»Installation of electrical equipment in rooms used for medical purposes«) or with the regulations applicable in your country.

  • Page 10: Electromagnetic Compatibility (Emc)

    EMC notes included. Young Dental only guarantees compliance of the control unit with the EMC Directives when it is used with original Young Dental accessories and spare parts. The use of accessories and spare parts that have not been approved by Young Dental may lead to increased emission of electromagnetic interference or to reduced resistance to electromagnetic interference.

  • Page 11: Package Contents

    3. Package Contents Description 295721 White Handpiece 295792 Foot Controller incl. Stick 295788 Charger incl. adaptor 295789 Handpiece cradle 295830 Disposable Barrier Sleeve (1 pack of 25 sleeves) 295791 Removable nosecone (3 units - 1 on handpiece and 2 in the box)

  • Page 12: Safety Notes

    > Send the handpiece or foot control to an authorized Young Dental service parnter (see page 43) for replacement of the battery as soon as the charging cycles start to deteriorate. > Defective or worn-out batteries must only be replaced by an authorized Young Dental service parnter (see page 43).
  • Page 13 Safety notes The medical device is classed as »conventional equipment« (closed equipment without protection against the ingress of water). Charger > Only use the charger supplied. System failure A total system failure does not constitute a critical fault. Simply switch the unit off and then on again. Hygiene and maintenance prior to initial use >...
  • Page 14 Safety notes Danger zones M and G The medical device is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide according to IEC 60601-1/ANSI/AAMI ES 60601-1. The medical device is not suitable for use in oxygen-enriched atmospheres. Zone M is defined as a »medical environment«...
  • Page 15 Safety notes 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 patients and users have an implanted device before using the medical device and test the possible applications.

  • Page 16: Safety Notes

    Safety notes The patient environment (see diagram) encompasses the area up to 2.50 m above the patient and 1.83 m in all horizontal directions. 2.5 m The charger must not be used within the patient environment. 1.83 m 1.83 m...
  • Page 17 This page left intentionally blank.

  • Page 18: Description Of Handpiece

    5. Description of handpiece Coupling for doriot style Removable nosecone disposable prophy angle Status LED handpiece (see page 20) Status LED foot control (see page 21) Charging socket ON/OFF button...

  • Page 19: Description Of Foot Control

    6. Description of foot control Stick Charging LED (orange) Status LED (green) (see page 21 - 22) (see page 21, 24) Charging socket Reset button Pairing button...

  • Page 20: Description Status Led - Handpiece

     Battery is 2 – 25% charged  Battery is 1% charged > Complete the treatment > Charge the battery > Do not start any further treatment > Charge the battery  Error message > Contact a Young Dental service parnter...

  • Page 21: Description Status Led - Foot Control

    8. Description status LED – Foot control flashes flashes alternately ORANGE  Battery of foot control is dead  Pairing unsuccessful > Complete the treatment > Troubleshooting with pairing problems > Charge the battery of the foot (see page 25) control Standby mode >...

  • Page 22: Start-Up - Charging The Battery

    9. Start-up – Charging the battery Important! Fully charge the handpiece and foot control before initial use.  Attach the correct plug to the  After the battery of the charger power cord. handpiece is fully charged connect the charger into the foot control charging socket.

  • Page 23: Start-Up - Query Battery Status

    10. Start-up – Query battery status You can query the battery status when the handpiece is switched on and during the charging process. > Briefly press the ON/OFF button: flashes Battery status 3 x green 75 – 100 % 2 x green 50 –...

  • Page 24: Start-Up - Pairing

    11. Start-up – Pairing For your convenience, the handpience and foot control have been paired. To verify that pairing has been activated, look for an illuminated green LED light on the foot control. If the green light is not on, please follow the steps below to pair the devices. Note: Both devices must be within the same vicinity and placed into pairing mode.
  • Page 25 > Use the stick to press the reset button on the foot control and try pairing again. If the pairing problem cannot be remedied using the steps described above, the unit will need to be inspected by an authorized Young Dental service partner (see page 43).

  • Page 26: Start-Up – Attachment & Removal Of Disposable Barrier Sleeve And Doriot Style Disposable Prophy Angle

    12. Start-up – Attachment & removal of disposable barrier sleeve and doriot style disposable prophy angle > The disposable barrier sleeve and doriot style disposable prophy angle are designed for single-patient use and must be discarded after each patient. Disposable barrier sleeve and doriot style disposable prophy angles are not autoclavable or designed to withstand reprocessing agents.

  • Page 27: Start-Up - Attachment & Removal Of Disposable Barrier Sleeve And Doriot Style Disposable Prophy Angle

    Start-up – Attachment & removal of disposable barrier sleeve and doriot style disposable prophy angle Remove handpiece nosecone.  Place disposable barrier sleeve over the internal shoulder of the handpiece.  Place handpiece nosecone over the disposable barrier sleeve.  >...

  • Page 28: Operation - Handpiece

    13. Operation – Handpiece  Press the ON/OFF button  Press the foot control to on the handpiece. activate the handpiece and control the rotation speed of the doriot style disposable prophy angle. Press the foot control as far as it will go to attain the maximum speed of 3,000 rpm. The following flashing signals are shown on the foot control: Foot control pressed Status LED (green) flashes...

  • Page 29: Test Run

    > Attach the doriot style disposable prophy angle to the handpiece. > Start the handpiece and press the foot control. > In the event of malfunctions (e.g. vibrations, unusual noises or overheating), stop the handpiece immediately and contact an authorized Young Dental service partner (see page 43).
  • Page 30 15. Hygiene and maintenance – General Follow your local and country-specific laws, directives, standards and guidelines for cleaning, reprocessing and sterilization. > Wear protective clothing. > Switch the handpiece off. > Remove the doriot style disposable prophy angle from the handpiece. >...

  • Page 31: Hygiene And Maintenance

    Hygiene and maintenance – General > The charger must not be connected. > Do not immerse the handpiece and the foot control or clean them under running water. Warnings The handpiece cradle, handpiece and foot control are not sterilizable by autoclave, but can be reprocessed following the procedures listed below: >...
  • Page 32 Hygiene and maintenance – Handpiece, Foot Control, Charger/Adapter, and Cradle Manual cleaning and reprocessing Point of Use Remove nosecone and process under guidelines outlined on Page 33. Remove excess soil with disposable cloth or paper wipe. Discard wipe after use. Containment and Transportation Handle with care.
  • Page 33 Hygiene and maintenance – Handpiece Nosecone Maintenance Visually inspect to ensure that all contamination has been removed. Visually inspect power supply and cords for damage. Do NOT add lubricant to the handpiece. Point of Use Remove excess soil with a disposable cloth of paper wipe. Discard wipe after use.
  • Page 34 The standard ISO 14457 stipulates a durability of at least 250 sterilization cycles. In the case of the handpiece nosecone from Young Dental, we recommend you to have regular service carried out after 600 sterilization cycles or one year. > The reprocessing and sterilization procedures above have been validated to destroy viable microorganisms, but given that the handpiece cannot be sterilized, and that the device is used outside of a sterile field, the device should be considered non-sterile during use.

  • Page 35: Replacing The O-Ring

    16. Replacing the O-ring Do not use sharp tools!  Remove the nosecone from the handpiece. Hold the O-ring between your thumb and index finger and apply firm pressure to disengage  the ring from the metal channel. Pull the old O-ring off. ...

  • Page 36: Young Dental Accessories And Spare Parts

    17. Young Dental Accessories and spare parts Use only original Young Dental accessories and spare parts or accessories approved by Young Dental. Supplier: Young Dental partners 295721 295791 295790 295789 White Handpiece Removable nosecone O-ring (3 pcs) Handpiece cradle To maximize performance,...

  • Page 37: Servicing

    > Function test with check to see if the maximum speed can be reached The regular inspection must only be performed by an authorized Young Dental service partner (see page 43). Defective or disused batteries must only be replaced by an authorized Young Dental service partner (see page 43).

  • Page 38: Servicing

    Servicing Repairs and returns In the case of a fault or malfunction send the complete medical device to an authorized Young Dental service partner (see page 43) for repair. Always return equipment in the original packaging!

  • Page 39: Technical Data

    19. Technical data Handpiece PL-40 H Battery type: Li-ion Rated voltage: 3.7 V Rated capacity: 680 mAh Max. speed 3,000 rpm Max. torque 2 Ncm Dimensions (WxDxH): 160 x 25 x 28 mm Weight: 118 g Foot control C-NW Battery type: Li-ion Rated voltage: 3.7 V...
  • Page 40 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 Charger power cord: Class II medical electrical equipment Handpiece: Internally powered Type BF applied part (not suitable for intracardiac application) The C-NW foot control is protected against vertically falling drops of water (IPX1 as per IEC 60529) Pollution level: Overvoltage category:...

  • Page 41: Disposal

    18. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Waste electrical equipment > Accessories and spare parts > Packaging...

  • Page 42: Explanation Of Warranty Terms

    Young Dental! Claims under warranty – accompanied by proof of purchase – must be sent to the vendor or to an authorized Young Dental service partner. The provision of service under warranty extends neither the warranty period nor any other guarantee period.

  • Page 43: Authorized Young Dental Service Partners

    Authorized Young Dental service partners Find your nearest Young Dental service partner at http://www.youngdental.com Simply go to the menu option »Service« for full details. Alternatively please contact: W&H Impex Inc., 14300 Henn Rd., Dearborn, MI 48126, USA t + 1 800 2656277, 1 519 9446739, f + 1 519 9746121, E-Mail: service.us@wh.com...
  • Page 44 Manufacturer YOUNG Young Dental Manufacturing Co. 13705 Shoreline Court East Form-Nr. 50938 AEN Earth City, MO 63045 USA Rev. 004 / 22.01.2019 Subject to alterations t + 1(847)458-5400 295886B customerservice@youngdental.com www.youngdental.com...

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