Asclepion MCL 31 Dermablate User Manual
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Asclepion MCL 31 Dermablate User Manual

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User Manual
MCL 31 Dermablate
Dermatological Er:YAG Laser
182099015-V01-10.Juni2013-GA-MCL31-THAI

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Summary of Contents for Asclepion MCL 31 Dermablate

  • Page 1 User Manual MCL 31 Dermablate Dermatological Er:YAG Laser 182099015-V01-10.Juni2013-GA-MCL31-THAI...
  • Page 2 WARNING The MCL 31 Dermablate laser device emits high levels of infrared radiation that may cause serious damage to the eyes if it is used improperly. Further risks are also possible. Therefore, this User Manual must be studied carefully before using the device and all warnings and instructions observed during its operation.
  • Page 3 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 5: Table Of Contents

    Contents Table of contents Introduction ................1 Overview ...................... 1 Symbols in the User Manual ................. 1 Intended use ....................2 Copyright ...................... 3 Safety ..................4 Overview ...................... 4 Electrical hazards ..................5 Biological hazards ..................5 Radio interference ..................5 Laser ......................
  • Page 6 Content Switching on ....................28 Operation of the device ............30 Overview of operation ................. 30 Settings for your laser device ..............31 5.2.1 Parameters ......................32 5.2.2 Special function/Tools ..................33 5.2.3 Activating the laser ready mode and releasing laser beam emission ....34 5.2.4 Changing the handpiece ..................
  • Page 7 Contents Regular maintenance, safety checks and calibrationError! Bookmark n 11.1 Routine maintenance ........Error! Bookmark not defined. 11.2 Regular safety check ........Error! Bookmark not defined. Disposal ......... Error! Bookmark not defined. EC compliance declaration... Error! Bookmark not defined. Appendix: Manufacturer’s EMC declarationError! Bookmark not define 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 9: Introduction

    • In case of malfunctions or errors that are beyond the User's capabilities, contact Asclepion's Engineering Department. Knowledge of this User Manual is required to operate the device. Therefore, please familiarize yourself with the contents and pay special attention to information concerning its safe operation.

  • Page 10: Intended Use

    Recommended use Operating at a wavelength of 2.94 µm, which corresponds with maximum water absorption, the MCL 31 Dermablate Er:YAG laser is perfectly suited for precise superficial skin ablation or cut- ting, skin vaporization and skin coagulation. Typical indications are:...

  • Page 11: Copyright

    Among other institutions, Asclepion Laser Technologies GmbH also offers courses for laser expertise in medical applications. Medical Device Directive/Medical Product Act The MCL 31 Dermablate meets the requirements of EC Medical Device Directive 93/42/EEC and its German equivalent in the form of the German Medical Product Act (MPG).

  • Page 12: Safety

    (93/42/EEC) and the German Medical Product Act (MPG). The MCL 31 Dermablate is a Class IIb medical device as defined in the directive in Annex IX (i.e. a surgical invasive product that is intended to have a biological effect – this must not be confused with the laser class!).

  • Page 13: Electrical Hazards

    The use of accessories and cables not authorized by the manufacturer may result in increased interference emissions or decreased immunity of the device with the above mentioned consequences. Use only accessories and cables that have been authorized by Asclepion Laser Technologies for the purpose 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 14: Laser

    Safety WARNING The device must not be stacked/collocated or in combination with other devices. If the device is operated close to or with other devices, you must check that the device is working properly in this arrangement. Laser 2.5.1 Optical hazards caused by laser emission Lasers are classified in accordance with their potential for danger.
  • Page 15 Safety The NOHD (Nominal Ocular Hazard Distance) of this laser system is extremely large, so the entire laser session room is to be regarded as the laser area. Personal eye protection WARNING Laser radiation can cause serious damage to the eyes. Everyone present in the laser room during a treatment session must wear laser safety goggles and patients an eyeshield! Laser safety goggles and eyeshields must comply with the specifications defined in the...

  • Page 16: Laser-Induced Fire Hazard

    Safety 2.5.2 Laser-induced fire hazard WARNING Because of the laser radiation from the devices, there is a risk of fire or explosion if the laser is used in the presence of flammable materials, solutions or gases or in an environment that is enriched with oxygen. Users should take the following precautions to prevent fires caused by laser radiation: •...

  • Page 17: Technical Data

    Technical data Technical data Device models Part Designation Description Number MCL 31 Dermablate 1820 Er:YAG Laser (main unit) VarioTEAM Handpiece 4075 Standard handpiece for skin ablation (1-6mm) VarioTEAM XL Handpiece 4076 Standard handpiece for skin ablation (8-12 mm) MicroSpot Zoom Handpiece...
  • Page 18 Technical data Classification according to II b directive 93/42/EEC Accessories See chapter 7 Accessories Operating mode The device has been designed for continuous operation Smoke evacuation Inbuilt smoke evacuation with three-stage filter system Specification Laser Laser model Er:YAG laser (solid state laser) Wavelength 2940 nm Laser class...

  • Page 19: Technical Description

    The beam delivery system is a photo-mechanical assembly consisting of an articulated mirror arm and a handpiece (see Figure 5: ). It transmits laser light to the point of treatment. MCL 31 Dermablate The articulated mirror arm is mechanically attached to the .

  • Page 20: Safety Units

    Technical data Safety units The device is equipped with several safety units that have been provided to avoid maloperation and unintentional activation of the system. All those who operate the laser or assist during treatment should familiarize themselves with these units. Laser emergency STOP switch The red Laser emergency STOP switch at the front of the device (see figure below) is for the purpose of switching off the system immediately in an emergency.
  • Page 21 Technical data Power switch The power switch separates the device from the line voltage. If the device is not in use, the switch should be in the OUT (O) position. Power switch Figure 3: Power switch on the rear panel of the device 182099015-V01-10.Juni2013-GA-MCL31-THAI...
  • Page 22 Technical data Foot switch The foot switch is an electric button that releases the laser emission if the laser is activated and the device is in the READY mode. It is equipped with two redundant switching elements. Always position the foot switch close to the treatment area. Figure 4: Foot switch STANDBY mode The STANDBY mode prevents unintentional or inadvertent activation of the laser.
  • Page 23 Technical data Laser emission is indicated by an acoustic signal during the emission period. Warning labels The device carries several warning labels (see chapter Installation - Labels). These labels must always be clearly readable and replaced immediately when damaged. Contact the Engineering Department immediately in such cases. The manufacturer will only guarantee the safety, reliability and performance of the device, the device has been used in accordance with the instructions given in this manual (on the safety measures and the use of the system),...

  • Page 24: Start Up

    Incompleteness and/or damage in transit are to be claimed immediately from the supplier. Asclepion Laser Technologies does not accept any liability unless a separate explicit agreement has been made. Please keep the packing for future safe consignment of the device.

  • Page 25: Installation

    Start-up Installation 4.2.1 Device design Connector for suction hoses Handpiece connector Speed control for smoke evacuator (retractable) Display with touchscreen Articulated arm Handpiece connector Laser emergency STOP switch Smoke evacuator inside Key switch Handpiece connector Filter package for smoke evacuator behind cover Connector for suction hoses Speed control...

  • Page 26: Labels On The Device

    Start up Vent Service interface Master Power switch interface Power inlet socket Connector for foot switch Connector for remote door interlock contact exhaust for Connection of potential smoke evacuation equalization Figure 6: Connections on the rear panel of the device 4.2.2 Labels on the device WARNING...
  • Page 27 Start-up Figure 7: Laser aperture at distal end of articulated arm Laser emergency STOP switch (Figure 8) Beam exit aperture (Figure 9) Add-on part (Figure 10) 182099015-V01-10.Juni2013-GA-MCL31-THAI...
  • Page 28 Start up Sliding prohibited label (Figure 167) Sliding prohibited label (Figure 117) Safety instruction label Laser warning (Figure 17) label EN 60825-1 (Figure 12) Air out Coolant in Label Coolant out warning against electrical field ( Figure 13) Maker's plate (Figure 18) WLAN antenna label ( Figure 14)
  • Page 29 Laser emergency STOP switch for switching off the laser radiation. interference. Warning: It is essential that only accessories approved by Asclepion Laser Technologies are connected here. Master and Activ Sync are exclusively for authorized personnel. Connector for foot switch...
  • Page 30 Start up Figure 17 : Sliding prohibited Figure 20: Laser warning label DIN EN 60 825-1 This label warns of the dangers, maximum energy emission values and the classification of the laser source. 182099015-V01-10.Juni2013-GA-MCL31-THAI...
  • Page 31 Start-up Figure 21: Laser aperture at distal end of articulated arm 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 32: Overview Of The Installation

    Start up 4.2.3 Overview of the installation Important information After installation and any relocation of the device from a cold to a warm environment with a temperature difference of more than 5°C, allow the device to adjust to the room temperature in the unpacked state before being used for at least the following times: min.

  • Page 33: Door Interlock Connection

    Start-up 4.2.4 Door interlock connection At the rear panel of the device, a connector is provided for a door interlock contact to the device (see Figure 22: Connections for remote door interlock contact and laser warning lamp). The port must be a round screwed plug, type (x)V 40 according to IEC 60130-9, e.g. Lumberg WSV 40 (as delivered).

  • Page 34: Terminals For Spot Identification & Fume Extraction

    The cable must always be connected. Otherwise, the spot cannot be identified. This will trigger an error message. In addition, the MCL 31 Dermablate is equipped with a fume extraction device. In READY mode, particles and aerosols forming in the process of ablation will be exhausted directly at the point of formation as long as the footswitch is depressed.

  • Page 35: Varioteam Handpiece

    Start-up 4.2.6 VarioTEAM handpiece Spacer Jack for suction hoses Bezel to change the spot size Port on the mirror arm Figure 24: Handpiece The laser spot size is varied by turning the bezel. The system detects the new spot size automatically.

  • Page 36: Switching On

    Start up Switching on Verify that the following requirements have been met before switching on the device: • The device is in perfect condition (no damage). • The voltage specified on the type label is the same as that of the mains supply available at the installation location.
  • Page 37 Start-up Figure 25: Start screen 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 38: Operation Of The Device

    Operation Operation of the device WARNING The laser device emits high levels of radiation in the infrared range. The use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure. This may cause serious damage to the eyes. It is essential to observe the instructions included in this User Manual for equipment and procedures for operating, maintaining, checking or calibrating purposes.

  • Page 39: Settings For Your Laser Device

    Operation Overview of important functions of the device Tools Buttons for Increase choosing the value Value or changing the Decrease Mode Value READY Standby Info line Figure 26: Ablation screen Settings for your laser device mode The parameters that can be set depend on the Ablation mode (with VarioTEAM handpiece): Fluence Time...

  • Page 40: Parameters

    Operation Note that  only the useful modes can be activated for a specific handpiece. That means that not all modes can be set for each handpiece.  most of the parameters technically depend on each other. That means that, for example, the highest fluence is not simultaneously possible with the shortest pulse duration.

  • Page 41: Special Function/Tools

    Operation 5.2.2 Special function/Tools Press the Tools key to open the application's Tools screen). Figure 27: Tools screen Function/ Display Remarks parameter Pilot working mode Pilot (0 = CW, 0.5 Hz, 1Hz) Pilot Pilot brightness (0-100%) Filter End Of Life Remaining lifetime for smoke counter evacuation filter system...

  • Page 42: Activating The Laser Ready Mode And Releasing Laser Beam Emission

    Operation 5.2.3 Activating the laser ready mode and releasing laser beam emission See also chapter 6 Application! After activation the laser is in the STANDBY mode. Standby is highlighted in white on the READY/STANDBY key. Verify again that • the handpiece has been connected correctly, •...

  • Page 43: Changing The Handpiece

    Parameters can be changed in the READY mode; the device will not automatically switch to STANDBY. The MCL 31 Dermablate is equipped with a user-friendly Laser emergency STOP that is located on the front panel of the device (see Figure 5: ). In an emergency, the laser is disabled immediately by holding this key down and thus any laser danger for the user and patient is removed.
  • Page 44 Operation To switch off the laser device, turn the key switch anticlockwise as far as it will go. Only then should switch off the power switch on the rear panel of the device (refer to Figure 3: Connections on the rear panel of the device). Switching the power switch to ‘0’ disconnects the device completely disconnected from the power supply.

  • Page 45: Application

    We would like to assist you in contacting other users. The responsible partner of Asclepion Laser Technologies GmbH will readily inform you accordingly in detail.

  • Page 46: General Treatment Information

    Application General treatment information WARNING Smoke, vapor and tissue particles are produced as by-products of laser treatment. These contaminants can be removed by the internal smoke evacuator to keep the visual field clean for the operator and exhaust any air pollutants. WARNING If the laser is applied, the use of an ear protection is highly recommended for all persons in the treatment room.
  • Page 47 Application WARNING The contact surface of the distance holder of the handpiece is in contact with the patient’s skin during the treatment. There is the risk of micro-organisms being transferred. The selected handpiece must be disinfected before each application and cleaned and disinfected after each application session as described in the chapter ‘Cleaning and disinfection’.

  • Page 48: Advisory Notes On Treatment

    In case of any doubt, you should consult a colleague with practical experience and/or an application specialist of Asclepion Laser Technologies GmbH before you begin with laser treatment. CAUTION...
  • Page 49 Application Clinical experience has shown that optimal ablation of tissue can be achieved by applying energy densities at average levels (about 4 to 10 J/cm²). For initial application sessions, we recommend using an energy density of 4 J/cm². As a general rule, energy density settings between 4 J/cm² and 10 J/cm² are adequate for most indications.

  • Page 50: Typical Indications

    Application 6.2.1.1 Typical Indications Operating at a wavelength of 2.94 µm, which corresponds with the maximum absorption of water, the MCL 31 Dermablate Er:YAG laser is perfectly suited for precise superficial skin ablation and skin coagulation. Typical indications are: •...

  • Page 51: Pre-Therapy Action

    Application 6.2.1.3 Pre-Therapy Action The area to undergo treatment must be carefully cleaned. Depending on the size and/or depth of a lesion to be dealt with, it must be decided if anesthesia is required and what type of anesthesia is appropriate. Therapeutic treatment performed with an Er:YAG laser causes a distinct amount of fume for- mation resulting from photo ablation.
  • Page 52 Application Circular technique • Planarize the rim of a lesion (e.g. acne scar) using overlap technique • Mop debris up • Continue treatment until desired ablation effect is achieved • Stop capillary bleeding if necessary Paintbrush technique: • Paintbrushing can be used to handle ex- tended, area-like lesions (e.g.

  • Page 53: Procedure

    Application 6.2.1.5 Procedure Preparation of patient: • Careful (!) removal of cosmetics • Skin disinfection • Local anesthesia where necessary • Put on laser safety goggles Therapy parameters: Spot size Recommended energy density 1.0 mm – 6.0 mm 4 J/cm² - 10 J/cm² for ablation of lesion 2 J/cm²...
  • Page 54 Application 6.2.2. Fractional treatment with MicroSpot handpiece (optional) As an alternative to area-like removal of tissue, the MicroSpot handpiece allows you to apply a series of micrometer-sized spots arranged in a certain mutual spacing pattern. Because these spots are surrounded by untreated tissue, the method is less harmful and the healing progress distinctly more rapid.
  • Page 55 Application E 10% N 10% N 25 % C 10 % W 25 % Mode Expert Normal Normal Kalt Warm Energy Spot Number Spot Diameter 0.35 0.35 0.56 0.35 Energy per Pulse Fluence J/cm² per Pulse Coverage Pulse Duration µs 1000 2 –...

  • Page 56: Contra-Indications

    Application 6.2.2 Contra-indications CAUTION The intensive laser light in the infrared range can cause thermal damage to skin structures. The contra-indications listed below are based on clinical experience in operating laser devices for said purposes over some 15 years. They do not claim to completeness or unlimited validity.
  • Page 57 Application 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 58: Accessories

    Asclepion Laser Technologies GmbH cannot assume any liability for these products. No further equipment is required for safe operation of the MCL 31 Dermablate . Handpieces are not considered accessories. Part numbers for ordering hand pieces can be found in Chapter 3.1.

  • Page 59: Cleaning, Disinfection And Sterilization

    Cleaning, disinfection and sterilization Cleaning, disinfection and sterilization General Rules Device WARNING The laser is operated with the mains power supply. There is the risk of electric shock! Disconnect the mains lead from the mains socket to break the power supply to the system before you proceed with cleaning.

  • Page 60: General Recommendations For Cleaning, Disinfection And Sterilization Of Handpieces

    Tooling/resources: neutral cleaner (e.g. Edisonite Super), running water or moist, lint- manual free wipe, brush, soft brush, microfiber wipe (provided by Asclepion, or similar glass wipe), alcohol or isopropyl alcohol: 1. Procedure for metal parts WITHOUT optics (e.g. laser handpiece spacer): Rinse the accessory with water to remove contamination from its surface.
  • Page 61 Cleaning, disinfection and sterilization Cleaning: Procedure for metal parts WITHOUT optics ONLY (e.g. laser ) automatic Tooling/resources: tool for cleaning/disinfection, neutral cleaner 1. Load accessory parts into the device in a position such that water can flow out from cannula openings and blind holes, if any. 2.

  • Page 62: Special Recommendations For Cleaning, Disinfecting & Sterilizing Accessories

    Cleaning, disinfection and sterilization Special recommendations for cleaning, disinfecting & sterilizing accessories Basic body Spacer Figure 30: Laser handpiec The spacer is easily removed from the basic body (at the MicroSpot-handpiece screw off). It must be cleaned and disinfected immediately after use and before use on another patient. The spacer (metal part!) can be sterilized.
  • Page 63 Cleaning, disinfection and sterilization 182099015-V01-10.Juni2013-GA-MCL31-THAI...

  • Page 64: Fault Messages And Fault Clearance

    Asclepion Laser Technologies GmbH. Improper use or maintenance of the laser system may void the warranty given by Asclepion Laser Technologies GmbH. Before starting any repair or if you have questions that have not been answered by this manual, contact your service partner (see chapter ‘Customer service’).

  • Page 65: Fault Messages And Fault Clearance

    Fault messages and fault clearance Fault messages and fault clearance The MCL 31 Dermablate is provided with alarm systems. If they are triggered, the system will switch to safe mode and stop any emission of laser radiation. Attempt to remove the fault yourself, following the instructions given in the table below.
  • Page 66 The touchscreen must be calibrated by an authorized service engineer. react (or only Therefore, inform your vendor or the Engineering Department of Asclepion Laser Technologies GmbH directly (see chapter ‘Customer sporadically) service’). No laser emission Check that the foot switch lead is properly connected.
  • Page 67 Appendix 182099015-V01-10.Juni2013-GA-MCL31-THAI...

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