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Labina PL-500
OPERATING MANUAL

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Summary of Contents for LaBina PL-500

  • Page 1 Labina PL-500 OPERATING MANUAL...
  • Page 2 Needle cartridges "4.3 Accessories and spare parts" on page 18 Handpiece CA-5.1 Handpiece cable GCB-2.1-6 Ink pot E-0552 Handpiece tray FL-A9.2-3 Handpiece cover E-0610 Foot switch E-1010 Power supply E1165 Country-specific adapter EU: E-1154 * Not included with the delivery Labina PL-500...
  • Page 3 Device ON button ( )/Device OFF button ( ) (white LED) Power LED indicator ( ) (white LED) Increase frequency ( ) button / decrease frequency ( ) button Connection for handpiece Connection for foot switch Connection for power supply Labina PL-500...
  • Page 4: Table Of Contents

    Setting the needle protrusion depth...................... 27 Setting the penetration frequency...................... 28 Switching the handpiece on and off...................... 28 7 Cleaning and maintenance ....................... 29 English Version 4.0 – 04/2019 Translation of the original operating manual. The original operating manual was generated in German. Labina PL-500...
  • Page 5 Cleaning surfaces.............................. 30 8 Transport and storage conditions................... 31 Controller, handpiece with handpiece cable, power supply and foot switch ...  31 Needle cartridge ...............................  31 9 Disposal ............................ 31 10 Questions and problems...................... 32 11 Guarantee ............................ 32 12 Declaration of conformity ...................... 34 Labina PL-500...
  • Page 6: About This Manual

    A B O U T T H I S M A N U A L This operating manual applies to the Labina PL-500 (A-9.32-140) and its accessories. It contains important information about setting up, operating and looking after the device safely and as intended for use.
  • Page 7: Important Safety Instructions

    Children must be supervised and prevented from playing with the device. Prevent fluids from getting inside the device, the handpiece, the foot switch or the power supply. Avoid sources of interference by ensuring that portable or mobile radio devices are not operated in the vicinity of the device. Labina PL-500...
  • Page 8: Important Health And Safety Precautions

    (consumables) and are only ever per- mitted to be used once. Dispose of used or faulty needle cartridges as well as needle cartridges whose pack- aging is damaged in a non-penetrable sharps container in accordance with the regula- tions applicable in your country. Labina PL-500...
  • Page 9 Please be sure to inform your customer to avoid contact with recently treated skin. Recently treated areas of skin should also be protected from Contamination and UV and solar radiation. Additional irritants such as Visits to swimming pools or saunas Abrasive or chemical peelings Hair removal at the treated areas or Labina PL-500...
  • Page 10: Contraindications And Side Effects

    Allergy to topical anaesthetics (local anaesthetic) Under the influence of alcohol and/or drugs Pregnancy and lactation The treatment of mucous membrane and eyeballs is strictly forbidden. The treatment must be immediately aborted in the event of: Excessive perception of pain Fainting/dizziness Labina PL-500...
  • Page 11: Required Qualification (User Requirements)

    The device and its accessories may not be used by per- sons with no experience or knowledge unless they are being supervised or instructed (train- ing). The device may only be used by persons trained in the following: Qualification for micropigmentation/PMU Labina PL-500...
  • Page 12: Intended Purpose, Scope Of Application And Proper Use

    There are no open wounds caused in the skin by this thanks to the minimally invasive punc- turing of the epidermis (top skin layer) and the dermis (middle skin layer). Afterwards, the skin requires only a very short regeneration phase in which the epithelial function will be re- stored. Labina PL-500...
  • Page 13 Improper use is when the device or its accessories are used in a manner other than as de- scribed in this operating manual or if the operating conditions have not been complied with. The treatment of contraindications in particular is forbidden (see chapter "2.4.1 Contraindic- ations" on page 10). Labina PL-500...
  • Page 14: Symbols On The Product

    Housing offers protection from jets of water Housing offers protection from foreign objects thicker than 1 mm Handpiece Foot switch DC connection, inner pin positive Observe operating manual! Manufacturer Date of manufacture Catalogue number, order number Serial number Batch code Labina PL-500...
  • Page 15 Air pressure limit Protect from moisture Only use indoors Fragile Do not use if packaging damaged Not for re-use Dispose of in compliance with waste electronic appliances guidelines Do not re-sterilise Warning of cutting or penetrating injuries JAPAN TUV R-PSE Labina PL-500...
  • Page 16 UL certification for components recognised in Canada and the USA Double insulation / device protection class II GHOST-R mark for Russia Device complies with the requirements of RoHS 2 SIQ mark license EN60601-1 Ukraine UKRSepro See operating manual for further information Labina PL-500...
  • Page 17: Scope Of Delivery

    Protection class Penetration frequency 50-140 Hz Drive Precision motor - DC Operating mode Continuous operation Dimensions (W x H x D) 100 mm x 45 mm x 140 mm Handpiece weight approx. 50 g Total weight approx. 1100 g Labina PL-500...
  • Page 18: Operating Conditions

    E-0401N1 - Symphony Nano n1 – E-0401N2 - Symphony Nano n2 – Handpiece cover E-0610 – SCOPE OF SPARE PART ARTICLE DESCRIPTION PIECE/VPE DELIVERY Controller MA-9.32-140 Handpiece CA-5.1 Foot switch E-1010 Handpiece tray FL-A9.2-3 Power supply E1165 Country-specific EU: E-1154 adapter Labina PL-500...
  • Page 19: Getting Started

    There is a risk of damage to electronics if there is visible damage to cables or cable con- nections. Check the device and the cables by visually checking for damage such as a defective cable connection for example. Never kink the product's cable. Labina PL-500...
  • Page 20: Positioning The Device

    Place the device on a clean, firm and level surface. Ensure that the buttons and the display of the device remain freely accessible during use. Never place the device on or underneath other devices. Place the device on a clean, firm and level surface. Labina PL-500...
  • Page 21: Connecting The Power Supply

    To insert the desired country-specific adapter: Place the country-specific adapter in the recess of the power supply as shown below. Press the adapter into the plug-in power unit until the catch can be heard to engage. Fig. 2: Inserting country-specific adapter Labina PL-500...
  • Page 22: Connecting The Foot Switch (Optional)

    Insert the RCA plug of the foot switch into the socket for the foot switch ( ) on the rear of the controller. Fig. 4: Socket for the foot switch Connecting the handpiece Connect the FireWire jack plug of the handpiece cable to the socket on the controller. Fig. 5: Output socket Labina PL-500...
  • Page 23: Cleaning And Disinfecting The Equipment

    Wipe the controller, the handpiece cable, the handpiece and the handpiece tray with a soft cloth moistened with cleaning product. Wipe the handpiece, the controller, the handpiece cable and the handpiece tray with a soft cloth moistened with disinfectant. Labina PL-500...
  • Page 24: Inserting Or Replacing The Needle Cartridge

    Switch the handpiece off. Insert the needle cartridge into the threaded connection of the handpiece. Turn the needle cartridge clockwise until you can feel resistance. The needle cartridge is now firmly seated in the handpiece. Fig. 6: Tightening the needle cartridge Labina PL-500...
  • Page 25: Pulling The Handpiece Cover On

    Observe the applicable directives for your country when selecting the micropigmenta- tion inks. Observe the accompanying information for the micropigmentation inks used. Use suitable applicators when introducing the micropigmentation inks to the needle cartridge in order to guarantee the sterility of the substances. Labina PL-500...
  • Page 26: Checking Equipment

    The Power LED indicator ( ) illuminates white. The controller is in standby mode. Switch the controller on with the Device ON button ( ) on the top of the controller. You will hear a brief signal tone. The Power LED indicator ( ) illuminates white. Labina PL-500...
  • Page 27: Setting The Needle Protrusion Depth

    Set the needle protrusion depth by turning the moving part of the handpiece (1). A com- plete revolution has the effect of changing the needle protrusion depth by ± 0.5 mm, de- pending on the direction of rotation. Fig. 9: Setting the needle protrusion depth Labina PL-500...
  • Page 28: Setting The Penetration Frequency

    Ensure that the controller is switched on (see chapter "6.1 Switching the control unit to operating mode or standby mode" on page 26). Ensure that the handpiece is correctly connected (see chapter "5.4 Connecting the handpiece" on page 22). Press the Treatment ON/OFF button ( ) on the controller. Labina PL-500...
  • Page 29: Cleaning And Maintenance

    It is recommended that the device is handed over to a specialist retailer for inspection in ac- cordance with manufacturers instructions, at regular 24 month intervals. Material compatibilities To clean the device, use a mild soap detergent authorised in your country, or 50% di- luted 1-propanol solution. Labina PL-500...
  • Page 30: Disinfecting Surfaces

    Disinfect the handpiece cable, the handpiece and the handpiece tray as described in chapter "5.5 Cleaning and disinfecting the equipment" on page 23. Cleaning surfaces External soiling: Wipe the device and its accessories with a soft cloth moistened in the cleaning product or disinfectant. Labina PL-500...
  • Page 31: Transport And Storage Conditions

    Dispose the products showing this symbol in compliance with applicable regula- tions on the disposal of electronic waste. If necessary, ask your specialist retailer or competent authorities about the applicable regulations. Place a container at your workplace for the proper disposal of contaminated parts. Labina PL-500...
  • Page 32: Questions And Problems

    If malfunctions persist or if you have any questions or complaints, please contact your specialist retailer. G U A R A N T E E This device is a high-quality purchase. The product is covered by the statutory 2-year warranty against malfunctions due to mater- ial failure or production defects. Labina PL-500...
  • Page 33 Damage and consequential damage caused by improper use or failure to comply with the operating manual. Damage caused by the ingress of fluids or dirt into the inside of the handpiece, the con- troller or the power supply. Labina PL-500...
  • Page 34: Declaration Of Conformity

    The manufacturer MT.DERM GmbH Gustav-Krone-Str. 3 D-14167 Berlin Hereby declares under their own responsibility that the following product: Product: Micropigmentation system Product name: Labina PL-500 Article description: A-9.32-140 Complies with the following directives: EMC directive: 2014/30/EU Machinery directive: 2006/42/EU RoHS directive:...
  • Page 36 Manufactured by: MT.DERM GmbH | Gustav-Krone-Str. 3 | 14167 Berlin fon +49 (0)30 845 88 54 | fax +49 (0)30 84 58 85 55 | info@mtderm.de | mtderm.de...

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