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Summary of Contents for Cheyenne ERA GEM CC0412X004XV

  • Page 2 ERA Gem...
  • Page 3 Nadel- Modul- Antriebs- Verstell- Control Kontakt- Stichzahl Multi- Batterie USB-C Ablage Lade- Verbin- Etui modul aufnah- einheit hülse Unit (CU)- fläche Skala switch Pack Buchse kabel dungs- Con- kabel nector Needle Cartridge Drive unit Adjust- Control Contact Skala Multi- Batterie USB-C jack Tray Charging...
  • Page 4 Nålemo- Modul- Driven- Juste- Control Kontakt- Antal Multi- Batterie USB-C- Holder Ladeka- Tilslut- Etui holder rings- Unit flade penetre- switch Pack stik ningska- muffe (CU)- ringer Con- skala nector Nålmo- Modul- Driven- Juste- Control Kontak- Stick- Multi- Batterie USB-C- Hylla Laddka- Anslut- Etui...
  • Page 5 * Nicht im Lieferumfang enthalten * No incluido en el volumen de suministro * Ei sisälly toimitukseen * Not included in the scope of delivery * Não contido no escopo de fornecimento * Nieobjęty zakresem dostawy * Niet in de leveringsomvang opgenomen * Δεν...
  • Page 6: Table Of Contents

    Instruction for use English Version 1.0 – Table of Contents 01/03/2023 About this Operating Manual Using the product ......... 39 ............. 54 1.1 Depiction of warnings 6.1 Using the machine with Batterie Pack ............39 ......54 Translation of the 6.2 Use at the control unit ............
  • Page 7: About This Operating Manual

    1 About this Operating Manual 1.1 Depiction of warnings Signal Meaning word Warning notices draw attention to the risk This operating manual applies to the listed Indicates a hazard that will of personal injury and damage to materials components within the scope of supply (see definitely lead to death or to Hazard and are structured as follows:...
  • Page 8: Original Instructions 2 Important Safety Information

    ► Disconnect the Batterie Pack from the ► Never attempt to open the Batterie Important safety information drive unit and switch it off (=Stand-By Pack. The user cannot replace the 2.1 General Safety Information mode) whenever you transport or store supplied battery (Li-Po).
  • Page 9: Product-Dependent Safety Information

    ► While working, use the handpiece cover ► Before treatment, follow all the steps Charging will interrupted temperatures exceed the permissible to protect with the handpiece and the required to disinfect the equipment limits. handpiece cable against contamination (chapter 7 on page 59). body fluids substances...
  • Page 10 ► During use, the handpiece, handpiece has not passed. Note the batch number Injuries caused by contaminated needles or (lot number) of the needle cartridges cable device, including needle module may transmit diseases: used in the corresponding client file in integrated handpiece tray, must be ►...
  • Page 11: Contraindications And Side Effects

    The client should avoid these in the first two • Any form of active acne in the treatment • Under the influence of alcohol and/or area drugs to three days after the treatment. • Dermatosis (e.g. skin tumors, keloids or •...
  • Page 12 2.5.2 Side effects • Formation of small pimples or skin 2.5.3 Required qualifications (user eruptions if skin is not cleaned carefully requirements) In some cases, minor side effects can arise before the treatment during and after the micropigmentation The device, including its accessories, may •...
  • Page 13: Purpose, Application Area And Intended Use

    2.6 Purpose, application area and 2.6.2 Application area contraindications is prohibited (see chapter intended use 2.5.1 on page 43). Body tattoos 2.7 Symbols on the product 2.6.3 Intended use - requirements for 2.6.1 Purpose - Indications for use safe use The symbols described below can be found in this operating manual, on the needle The purpose of the device is the minimally...
  • Page 14: Scope Of Delivery

    2 Batterie Packs Puncture frequency 60 to 150 Hz Humidity limit 1 Handpiece tray Stroke CC04xxX004XV = 3,0 1 Charging cable Cannot be used if packaging is 1 Connection cable Needle depth 0,5 – 3,5 mm damaged 1 Case (6 rotations) Drive DC motor Protection class 3...
  • Page 15: Accessories

    CU-Connector 4.2 Accessories Charge cut-off current < 100 mA Model GCC04150007 The following accessories can be purchased Charging cable length GCC06120007 from your local specialist retailer: Connection assign- Diameter Ø 24 mm ment • Handpiece tray Length 31 mm Input •...
  • Page 16: Preparing The Machine For Use

    The manufacturer has designed this 5 Preparing the machine for use 5.1 Checking the equipment permanent make-up machine for use with WARNING the following control unit (PU 2). Use the NOTICE enclosed connection cable and the CU- Danger of Explosion Connector for this purpose.
  • Page 17: Disinfecting Equipment

    ► Make sure that contact surfaces on the 5.2 Disinfecting equipment NOTICE Batterie Pack and on the CU-Connector CAUTION Product damage caused by non-approved are not contaminated or have metallic particles adhering to them. disinfectants Risk of short circuits and risk of minor Disinfectants that are not compatible with electric shocks ►...
  • Page 18: Charging The Batterie Pack

    ► Check whether the drive unit, the CU- ► Charge the Batterie Pack no later than ► Never transport the drive unit with the Connector, or the Batterie Pack are when the LED turns red to avoid dam- Batterie Pack plugged in. Before contaminated.
  • Page 19 • A power bank • The power adapter from among the recommended accessories The information on the output power can generally be found on the nameplate of the ► Plug the USB-A connector of the power adapter or the power bank. If a USB- enclosed charging cable into a suitable A port is available, charging should work source.
  • Page 20: Connecting And Disconnecting The Drive Unit With The Batterie Pack

    ► Disconnect the charging cable from the 5.4 Connecting and disconnecting the 5.5 Pull on the handpiece cover Batterie Pack and the power source. drive unit with the Batterie Pack CAUTION ► If the O-ring of the Batterie Pack is lost NOTICE Infection from contaminated handpiece or worn, replace it as described in...
  • Page 21: Changing The Needle Cartridge

    Use a translucent, color-less handpiece To pull the handpiece cover on correctly: 5.6 Changing the needle cartridge cover. Otherwise, there may be problems ► Switch off the handpiece and remove WARNING with the needle protrusion setting, the the needle cartridge. visibility of the LED, or finding the Risk of injury from needles ►...
  • Page 22: Using The Product

    ► Rotate the needle cartridge clockwise by • Operating mode – Batterie Pack has ► The needle cartridges are delivered in approx. 45°. As you rotate it, the woken up and is waiting for input; the sterile packaging. Do not remove them multiple locating points will engage LED in the Multiswitch is lit or flashing, from their packaging until immediately...
  • Page 23 The Batterie Pack must first be set to 6.1.3 Starting and stopping working mode operating mode so that the motor can be Keep in mind that you cannot start the started. motor unless you have set the Batterie Pack in operating mode as described in chapter ►...
  • Page 24 After it is switched on, the motor rotates Pack does not work as expected. You can Keep in mind that the Batterie Pack can with a frequency of 100 Hz. If you have only find more information on this in chapter 10 provide an additional lower frequency level briefly stopped the motor and resume the on page 63.
  • Page 25: Use At The Control Unit

    ► Only hold the machine by the Batterie ► Keep the Multiswitch pressed for at least Pack so that you can look at the mark on 3 second. the machine from above. The Batterie Pack is set to Stand-By mode and the LED in the Multiswitch turns off.
  • Page 26: Setting The Needle Depth

    ► Connect the socket of the included 6.3 Setting the needle depth Turning counterclockwise (viewing connection cable to the CU-Connector. direction on the needle cartridge) increases CAUTION the needle protrusion depth. ► Connect the plug of the included Risk of injury from excessive needle connection cable to the corresponding Turning clockwise (viewing direction on the Depth...
  • Page 27: Cleaning And Maintaining The Product

    7 Cleaning and maintaining the product NOTICE Damage to product from liquid CAUTION If cleaning fluid or disinfectant gets inside the product components, this can corrode Risk of short-circuit the electrical and mechanical components. If components of the machine are dis- ►...
  • Page 28: Disinfecting Surfaces

    • Aromatic/halogenized hydrocarbons they do not break off or become Manufacturer Product Exposure time (e.g. phenol, chloroform) damaged. Schülke & Mikrozid 1 to 2 mins Mayr Liquid ► Keep in mind that due to the surface • Acetone and benzene finish of the case components, there Based on the material compatibility, you may be color streaks on the product.
  • Page 29: Cleaning Or Replacing O-Rings

    7.4 Cleaning or replacing o-rings 8 Operating, loading, transport, and ► Never store the Batterie Pack at storage conditions The O-rings on the Batterie Pack and CU- temperatures exceeding 60° C (e.g. in a Connector provide a smooth "snap" car at high exterior temperatures). This might result in significant damage.
  • Page 30: Operation

    ► We recommend Activity Temperature Relative using the cover NOTICE range humidity included for transport and storage so Damage to product caused by dropping it (non-con- that your product is kept safe. densing) If the product or one of its components ►...
  • Page 31: Disposal Of Equipment

    9 Disposal of equipment (sharps container) in accor- (working mode), the motor shuts down. For safety reasons, you must then dance with the regulations that restart the motor as described in apply in your country. Have a Dispose product ► chapter 6.1.3 on page 55.
  • Page 32: Operation At The Control Unit

    ► Contact your specialist retailer if the ► If the problem continues, this indicates a „CONNECT HANDPIECE” indicates an error problem continues. in the connection between the drive unit problem with the motor. In this case, and the control unit. Take the following contact your specialist retailer.
  • Page 33 We do not provide warranty cover in respect of the following types of damage: • Damage and secondary damage arising from unintended use or failure to comply with the operating manual. • Damage arising from the ingress of fluids or dirt into the drive •...
  • Page 34: Declaration Of Conformity

    11.2 Declaration of Conformity Declaration of Incorporation (in accordance with 2006/42/EC, Annex II A) Manufacturer MT.DERM GmbH Blohmstr. 37–61 12307 Berlin, Germany Authorized representative for compiling the relevant technical documentation: MT.DERM GmbH Blohmstr. 37–61 12307 Berlin, Germany Description of the machine Product designation: Permanent Make-Up Machine with Batteriepack Product name:...
  • Page 35 The following harmonized standards were applied: EN 60335-1:2012 + AC:2014 + A11:2014 + Household and similar electrical appliances – Safety – Part 1: General requirements A13:2017 + A15:2021 EN 55014-1:2017 + A11:2020 Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission EN 55014-2:1997 + AC:1997 + A1:2001 + A2:2008 Electromagnetic compatibility –...
  • Page 36: Declaration Of Conformity

    11.2 UK-Declaration of Conformity (acc. 2008 No. 1597 Annex II A) Manufacturer MT.DERM GmbH Blohmstr. 37–61 12307 Berlin, Germany Authorized representative for compiling Dr. Andreas Pachten the relevant technical documentation: MT.DERM GmbH Blohmstr. 37–61 12307 Berlin, Germany Description of the machine Product designation: Permanent Make-Up Machine with Batteriepack Product name:...
  • Page 37 The following designated standards have been applied: EN 60335-1:2012 + AC:2014 + A11:2014 + Household and similar electrical appliances – Safety – Part 1: General requirements A13:2017 + A15:2021 EN 55014-1:2017 + A11:2020 Electromagnetic compatibility – Requirements for household appliances, electric tools and similar apparatus – Part 1: Emission EN 55014-2:1997 + AC:1997 + A1:2001 + A2:2008 Electromagnetic compatibility –...

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Era gem cc0415x004xv

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