Hulaser K2 Mobile User Manual

Dental diode laser

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1370
Publishing
date: Jan.02.2020
En
Document No: PK2M-02

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Summary of Contents for Hulaser K2 Mobile

  • Page 1 1370 Publishing date: Jan.02.2020 Document No: PK2M-02...
  • Page 2 No information contained herein may be copied, translated, transcribed or duplicated for any commercial purposes or disclosed to the third party in any form without the prior written consent of Hulaser. This user manual should be read and used as a guideline for properly installing and operating the device.
  • Page 3: Table Of Contents

    TABLE OF CONTENTS 6-2. Starting the device 1. Safety information 6-3. Selecting the procedure 1-1. Safety information 6-4. Function settings 1-2. Precaution 6-5. Custom settings 2. Product overview 6-6. Presets settings 6-7. Tip initiation 2-1. Unpacking 6-8. Firing the laser 2-2.
  • Page 4: Safety Information

    1. SAFETY INFORMATION The purpose of the safety information is to ensure the safety of users and prevent property damage. Please read this document carefully for proper use. 1-1. Safety information Danger DANGER indicates a hazardous situation which, if not avoided, could result in serious injuries.
  • Page 5 If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment. [Note] In the event of an accident, the incident must be reported to a HULASER, Inc. or a European representative or the competent authority.
  • Page 6: Precaution

    1-2. Precaution ● This device must be purchased by an authorized person like a dentist, physician. ● This user manual must be understood to the user who is licensed before using this device. ● Adjust the device’s setting based on your clinical experience. Start the laser treatment from the lowest level and increase gradually.
  • Page 7: Product Overview

    When unpacking the shipping package, check that any components are damaged or missing. Contact the Hulaser Service Representative immediately for any damage or missing. [Note] The shipping container might be needed when you return the device to the Hulaser Service Representative for repair.
  • Page 8: Components

    2-2. Components Description Model Picture K2 Mobile battery charger K2 Mobile battery charger and cradle AC/DC Adapter TRG30R050V K2 mobile Main body K2 Mobile Thin Tip for K2 Mobile General Tip for K2 Mobile Fiber stripper Fiber stripper...
  • Page 9 2-2. Components Description Model Picture K2 Rechargeable Battery KL2-0006 Model: 0282 Laser protective eyewear 890~1070nm : D LB6+I LB7+RM LB8, OD 6-8 User manual PK2M-02 warning Use of accessories, adapter other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Page 10: Specifications

    2-3. Specifications ● Classifications MFDS Device Class III Laser Surgical Unit : Diode CE Device Class IIb Medical Device FDA Device 79GEX Class II Medical Device CDRH Laser Class IV (4) Laser ● Charging Station Size(WxDxH) 160mm x 90mm x 38mm Weight 150 g Voltage Input...
  • Page 11: Product Layout

    2-4. Product Layout All the names of devices must be understood before read this user manual. ● Device This device is used for a variety of dental soft tissue treatments. Laser diode is used as a source of invisible infrared radiation for this device and delivered to the treatment area through the Tip. ●...
  • Page 12: Clinical Use

    The charging indicators on the front of the charging station display the charging status. -Up to four batteries are able to be charged at one time. -If one battery is fully charged, the indicator turns blue half-round. -If the indicator doesn’t turn half-round after charging for more than three hours, the battery might be damaged and need to be replaced.
  • Page 13: Cleaning And Sterilization

    3. CLEANING AND STERILIZATION 3-1. Cleaning The device must be cleaned prior to use on every patient. Use dry gauze on the device’s surfaces that are exposed to contaminant. To clean the main body, follow the instruction: 1. Ensure that the device is turn off. 2.
  • Page 14: Sterilizing

    3-2. Sterilizing The Tip must be sterilized in an autoclave before use. Warning Although the recommended autoclave sterilization procedure is specified by Hulaser, users have a responsibility to validate the autoclave sterilizer properly. [Note] The recommended autoclave cycle: Temperature: 250℉(121℃) | Time cycle: 20 minutes * Conducted for the steam sterilization method and the sterilization assurance level in the test was not less than 10 killed organisms in one cycle.
  • Page 15: Charging

    4. CHARGING You must charge the batteries before using the device. Follow the instructions to charge the batteries. Caution Use only Hulaser-approved power adapter. [Note] ● Place the charging station on a surface not to be interfered or contaminated. ●...
  • Page 16 1. Plug the power adapter into an AC outlet and connect it to the charging station as below. 2. Open the cover of the charging station. 3. Place the batteries into the battery container in either orientation. 4. When the charging indicator turns blue, the battery is charging.
  • Page 17: Installation

    5. INSTALLATION You must install the battery first and then Tip properly as the following instructions before use the device. 5-1. Installing the battery and Tip (Including the Front Cap) 1. Open the battery cover and insert a battery into the socket at the end of the main body. To remove a battery, open the battery cover and gently pull out the battery from the socket.
  • Page 18 4. Insert Tip into the front of the main body until the magnet inside the main body holds the Tip. 5. Secure the Front Cap to the main body passing through the fiber carefully. 6. Check that the cannula comes out straight from the main body as below. If it comes out bended or the Tip is encumbered, straighten the cannula and re-install the Front Cap.
  • Page 19: Adjusting The Tip Length

    5-2. Adjusting the Tip length You can adjust the Tip length for the procedure appropriately. To extend the Tip, move the Tip handle forward. To shorten the Tip, move the Tip handle backwards. If you move the sliding bar back and forth by force, the rail of the sliding bar might be damaged. 5-3.
  • Page 20: Cleaving The Tip

    5-4. Cleaving the Tip As the Tip deteriorates, it might cause the fracture. Cleave the discolored Tip using the cleaver. 1. Put the cleaver at approximately 3-5 mm from the previous cleave to remove the discolored Tip. 2. Engrave a line across the surface of the Tip using the cleaver lightly. 3.
  • Page 21: Operating

    All persons in the room are wearing the laser protective eyewear. Caution Ineffective removal of tissue may be caused by improper Tip initiation or reduction in the power output. Check with the Hulaser Service Representative to make sure that the device is functioning properly. Caution Use a bite block to prevent accidental biting and breakage of the Tip;...
  • Page 22: Starting The Device

    6-2. Starting the device 1. Turn on the power switch to start the device. The OELD display will show as below and the device will guide by voices. 2. When “Enter Key” appears on the screen, enter the key to activate the device. If the key is not entered properly, turn off the device and restart.
  • Page 23 3. Change the settings of the energy power, emission mode, and auto/manual mode by pressing the up and down button and press the enter button to confirm the settings. Mode Output power Step CW, Pulse 0.1~2.0W 0.1W Laser power CW, Pulse 2.0~3.0W 0.2W CW, Pulse...
  • Page 24: Function Settings

    6-4. Function settings 1. Press up or down button to select the function in the main screen. 2. Adjust the laser beep volume, voice volume, or aiming beam, and each function has each different level to adjust. Each setting has 5 levels. (Level 1 is the lowest and level 5 is the highest. Except voice) -Aiming Beam: To modify the aiming beam brightness.(Level 1 to 5) -Voice: To modify the voice sound (Level 0 to 5) (You may mute the voice.) -Beep Sound: To modify the beep sound (*you cannot turn off beep, Level 1 to 5)
  • Page 25: Custom Settings

    6-5. Custom settings You can customize and preset the frequently used setting condition for daily use. Up to 4 settings are able to be customized upon your selection. 1. Press the enter button on the memory screen to select a memory number. 2.
  • Page 26: Presets Settings

    6-6. Presets settings This device has 30 pre-programmed settings upon your selection. Preset the setting for the appropriate procedure. Preset Name Tip Initiation Pulse Laser endodontical procedures, including: 0.3W±0.5 •Root Canal Sterilization 0.3W±0.5 •Pulpotomy 0.5W±0.1 •Direct Pulp Capping •Apical Abscess Treatment 1.0W±0.3 Laser periodontal procedures, including: •post Scaling...
  • Page 27 Preset Name Tip Initiation Pulse Laser Other procedure, including: •Hemostasis 2.0W±0.5 •Laser Troughing 1.0W±0.5 2.4W±1.0 •Gingiva Depigmentation 1.0W±0.5 2.0W±1.0 •Biostimulation 2.0W •TMJ Pain Relief 2.0W •orthodontic pain relief 2.0W •Laser Sedation 2.0W 1.0W •Bactericidal effect 2.0W •Hypersensitivity 1.5W±1.0 •Tooth Whitening 2.0W±1.0 •Aphthous Ulcer 0.2W±0.3...
  • Page 28: Tip Initiation

    6-7. Tip initiation [Note] Before using the device, the Tip initiation is required for majority of the procedures once. However, you can bypass this operation if it is already done or not required. Caution Use gauze moistened with water to clean the Tip. Do not use flammable materials when cleaning a hot Tip.
  • Page 29: Firing The Laser

    6-8. Firing the laser EMERGENCY STOP To stop firing laser immediately, open the battery cover and remove the battery to power off the device. 1. The OLED display turns green in ready mode and the red aiming beam also turns on at the end of the Tip.
  • Page 30: Turning Off The Laser

    6-9. Turning off the laser Press the power button to turn off the device. The screen and led light will turn off. 6-10. Calibrating the laser An internal verification for your laser is recommended at least once a year based on the average use. You may purchase a calibrated hand-held power meter approved for use with 980 nm devices to check power output.
  • Page 31: Maintenance

    A medical device needs to be disposed as directed by your local solid waste handling regulations. Contact Hulaser or the Hulaser Service Representative for instructions on returning the device to Hulaser for disposal. Do not dispose of this device or its components in any place. ●...
  • Page 32 ● Laser aperture Check the laser aperture for contamination periodically. If the aperture is contaminated, wipe with cotton swab moistened with isopropyl alcohol until clean. The Tip must be removed from the main body prior to cleaning. Warning Failure to clean the aperture when contaminated, will lead to reduced optical power efficiency and permanent damage to the system.
  • Page 33: Troubleshooting And Repairs

    When the program works incorrectly, remove the battery to restart the device. Wait for 5 seconds and then re-install the battery. If the problem is not solving after restarting the device, the system cannot be used until the cause of the error has been remedied. Call Hulaser or the Hulaser Service Representative. 8-2 Malfunctions and Error messages...
  • Page 34: Label

    9. LABEL Refer the location of the labels on the device indicated as the following table. 9-1. Labels Description on the package Laser aperture Manufacturer Date of manufacture Authorized representative in the European Community Manufacture serial number General warning sign Refer to user manual Type B applied part WEEE sign.
  • Page 35 2. Battery Label symbol Description Lithium ion Battery rechargeable 3. Box Label symbols description This Side Up Commodity inside the box is fragile, Keep dry Should be stored at a temperature between 0 and 50 degrees Professional use only Do not use if package is damaged...
  • Page 36: Labels Description On The Device

    9-2. Labels Description on the device 1. Device and Charger Label symbols Description NO. Label Description Location Product ID label Handpiece, side. Charging station, underside. Charger ID label Laser Warning Handpiece, side. label Laser aperture Handpiece near Laser Aperture end. Battery label Middle of the battery...
  • Page 37: Labels Location

    9-3. Labels location Instruction and warning labels are affixed to the device in the locations shown. <Outer package underside>...
  • Page 38: Limited Warranty

    Hulaser reseller. You may also be directed to an authorized reseller or a person authorized by Hulaser to repair the product. If it is decided that this product should be returned directly to Hulaser, this product should be properly packed, preferably in the original carton, for shipping.
  • Page 39 Contact information Hulaser, Inc KTR EUROPE GmbH 1110, DAERUNG TECHNOTOWN 17,25, GASAN DIGITAL 1-RO, Mergenthalerallee 77, GEUMCHEON-GU, SEOUL 08594, KOREA. 65760 Frankfurt/Eschborn, Germany Tel: +82-2-3012-5678 Fax : +82-2-544-6540 Tel: +49-6196-8871720 Fax : +49-6196-8871728...

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