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KLS Martin MCO 25 plus Instructions For Use Manual

Co2 laser system
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English
90-238-52-55
Revision 5.5
Date of Release: 2015-08
CO
Laser System MCO 25 plus
2
Instructions for Use
Valid from software version V5.40,
hardware release HW 02 and software release SW 02

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Summary of Contents for KLS Martin MCO 25 plus

  • Page 1 Laser System MCO 25 plus English Instructions for Use 90-238-52-55 Revision 5.5 Valid from software version V5.40, Date of Release: 2015-08 hardware release HW 02 and software release SW 02...
  • Page 2 Symbol Explanation Safety alert symbol CAUTION Indicates a situation which, if not avoided, could result in minor or moderate injury. WARNING Indicates a situation which, if not avoided, could result in death or serious injury. DANGER Indicates a situation which, if not avoided, will result in death or serious injury.
  • Page 3 This product may not be disposed of as normal household garbage, see section 16.2 “Ecological Aspects of Operation”, page 117. The packaging of the MCO 25 plus is “non-wood”, i.e. wood packaging material that is not subject to ISPM 15, and is therefore suitable for NON WOOD international shipment.

  • Page 4: Table Of Contents

    Instructions for Use Laser System MCO 25 plus Contents Product Liability and Warranty ............8 General Information ................8 Scope of Delivery .................. 8 Intended Purpose .................. 9 Frequently Used Functions ..............9 Contraindications ................10 Warranty ................... 10 User’s Inspection ................11 Hotline....................
  • Page 5 Cable Clamp ....................33 5.5.8 Interlock Connector Connection................ 33 Preparing the MCO 25 plus Laser for Attaching the Mirror Joint Arm ..34 Unpacking the Mirror Joint Arm and Preparing it for Mounting ....35 5.7.1 Mounting and Securing the Mirror Joint Arm ............36 5.7.2...
  • Page 6 Instructions for Use Laser System MCO 25 plus 6.6.3 Multiple Pulse Mode ..................59 6.6.4 Super Pulse Mode ................... 61 Scanner Operations ................62 6.7.1 Display ......................62 6.7.2 Scanner Mode Parameters ................63 6.7.3 SOFT FRAC ....................65 6.7.4 POWER FRAC ....................
  • Page 7 Instructions for Use Laser System MCO 25 plus Cleaning and Disinfection ............93 Cleaning of Focusing/Scanner Handpieces ..........94 9.1.1 Parts of the focusing handpieces ..............95 9.1.2 Parts of the scanner handpieces ............... 96 Parts of the Angles ................96 Parts of the ENT Set ................

  • Page 8: Product Liability And Warranty

    2 laser warning signs • Instructions for Use MCO 25 plus • Medical product log • Laser surgery device MCO 25 plus/MCO 25 plus HNO with Scanner additionally comprises: Scanner casing Soft Scan Plus R • Connection cable • Scanner handpiece 127 mm •...

  • Page 9: Intended Purpose

    Instructions for Use Laser System MCO 25 plus Intended Purpose The MCO 25 plus is a laser surgery device that is based on a DC-excited gas laser and used for the treatment of biological tissue by: Hyperthermia • Cutting •...

  • Page 10: Contraindications

    Instructions for Use Laser System MCO 25 plus Contraindications Application of the laser surgery device MCO 25 plus is contraindicated where laser-surgical applications are contraindicated. Warranty Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di- verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer.

  • Page 11: User's Inspection

    Instructions for Use Laser System MCO 25 plus User’s Inspection • Immediately upon receipt, the goods must be checked for completeness and potential damage in transit. Notice of any such damage must be given immediately. • Hotline Should you have any questions on how to handle the product or use it for clinical •...

  • Page 12: Notices Concerning This Document

    Instructions for Use Laser System MCO 25 plus Notices Concerning this Document Non-observance of this document can lead to serious or even lethal patient injury! Improper handling and care as well as non-intended use can lead to premature wear and/or...

  • Page 13: Symbols Used In This Document

    Instructions for Use Laser System MCO 25 plus Symbols Used in this Document Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words: WARNING Life hazard or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury!

  • Page 14: Safety Notes

    Instructions for Use Laser System MCO 25 plus Safety Notes General Specifications Standard Title MPG (MDA) Medical Devices Act 93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices IEC 60825-1:2008-05 Safety of laser products – Equipment classification and requirements IEC 60601-1:2007-07 Medical electrical equipment –...

  • Page 15: Installation And Initial Start-Up

    Laser System MCO 25 plus Installation and Initial Start-Up Installation and initial commissioning may be performed only by Gebrüder Martin or authorized service partners. For further information see section 5.2 “Setting up the MCO 25 plus”, page 27. CAUTION Danger of physical injury! Any person that handles the device in any way must have fully read and understood the contents of these instructions for use.

  • Page 16: Laser Safety

    Laser System MCO 25 plus Furthermore, the following additional requirements must be observed: The laser surgery device MCO 25 plus may be commissioned only by authorized users. The • users must be familiar with the laser surgery device and know the applicable safety precautions.
  • Page 17 Instructions for Use Laser System MCO 25 plus Therefore, the following safety precautions must be strictly complied with: Accesses to the laser areas must be marked with warning lamps. • • Persons working in the laser area must be informed about safety regulations and precautions and instructed in the operation of the device at least once per year.

  • Page 18: Danger Of Explosion And Fire

    Instructions for Use Laser System MCO 25 plus Danger of Explosion and Fire WARNING Danger of Explosion and Fire! Class 4 laser surgery devices (IEC 60825-1) can act as sources of ignition due to heating of tissue or fiber ends. Therefore, comply with the following requirements to prevent laser-...

  • Page 19: Requirements For Treatment Rooms

    Requirements for Treatment Rooms • Rooms in which the MCO 25 plus is to be operated must be marked with a sign (included in the delivery) at all accesses. All access doors to the laser area must be equipped with a warning lamp. When the •...

  • Page 20: Laser Safety Officer

    Instructions for Use Laser System MCO 25 plus Laser Safety Officer According to the German Accident Prevention Directive BGV B2 (Laser Radiation), the operator must appoint a laser safety officer in writing. This person is also responsible for the following: Implementation of safety measures •...

  • Page 21: Fuses

    Upon activation of the device or return of the operating voltage after a power failure, the • device switches into STANDBY mode – the MCO 25 plus laser cannot be activated. • The laser cannot be activated either as long as the mirror joint arm is not connected (otherwise the message Interlock Error will appear on the display).

  • Page 22: Usage Restrictions

    Instructions for Use Laser System MCO 25 plus 3.15 Usage Restrictions Persons below the age of 16 must not work with laser surgery devices or in laser areas (applies to laser classes 3R, 3B and 4, see BGV B2 §11). Minors above the age of 16 may work with laser surgery devices or in laser areas under supervision and if safety is ensured by a qualified person, and if such work is required in the context of training.

  • Page 23: Positions Of Safety Notes, Key Switch And Emergency Stop Switch

    Instructions for Use Laser System MCO 25 plus 3.16.1 Positions of safety notes, key switch and EMERGENCY STOP switch 1 Information label to indicate the laser exit opening 2 EMERGENCY STOP switch 3 Key switch 4 Laser warning label and information label for class 4 lasers...

  • Page 24: Fumes

    Instructions for Use Laser System MCO 25 plus 3.17 Fumes CAUTION Risk of infection due to viable tissue particles in laser fumes! The fumes that are created in particular by vaporization during the laser treatment can be harmful to health.

  • Page 25: Description Of The Co 2 Laser System

    LASER is an acronym meaning “Light Amplification by Stimulated Emission of Radiation”. The MCO 25 plus laser (light source) consists of an active medium and an excitation source. This excitation source “pumps” the electrons of the active medium from their normal state into a stimulated energy state (high energy level).

  • Page 26: Area Of Application

    There are numerous possible applications for the MCO 25 plus. Apart from its low penetration depth and precise cutting capabilities, other benefits of the MCO 25 plus in laser surgery are reduced stress for the patient and fast healing process.

  • Page 27: Putting The Mco 25 Plus Into Operation

    Instructions for Use Laser System MCO 25 plus Putting the MCO 25 plus into Operation General Information The device is a microprocessor-controlled continuous-wave CO laser with a maximum laser output of 50 W at the handpiece. The entire system including laser tube, high-voltage supply, closed-circuit water cooling, pilot laser, safety shutter and control interface (control panel) is integrated into one single casing.

  • Page 28: Relocating The Device

    — Place a soft pad under the display on the load floor. — Place another pad at the lower end of the laser surgery device over the caster holders. — Place the MCO 25 plus laser with its front on this pad and secure against toppling. Revision 5.5...

  • Page 29: Front Side

    Instructions for Use Laser System MCO 25 plus Front Side 1 Display and control panel 2 EMERGENCY STOP switch 3 Key switch 4 Warning labels 5 Laser surgery device MCO 25 plus 6 Focusing handpiece 7 Mirror joint arm Revision 5.5...

  • Page 30: Rear Panel

    Instructions for Use Laser System MCO 25 plus Rear Panel Fig. 5-1: Overview of connections on the rear panel 1 Mains connection socket 5 Equipotential Grounding Pin 2 Mains Fuses 6 Connection socket for foot switch 3 Cable clamp 7 Type plate 4 Socket for interlock connector 5.5.1...

  • Page 31: Mains Connection

    Instructions for Use Laser System MCO 25 plus 5.5.2 Mains Connection NOTICE Use only the supplied mains cable or a replacement cable by Gebrüder Martin with the laser system! Plug mains cable into mains connection socket (1, Fig. 5-1). •...

  • Page 32: Foot Switch Connection

    Instructions for Use Laser System MCO 25 plus 5.5.5 Foot Switch Connection The foot switch cable (8) is to be connected to the 5-pin connection socket (6) and secured by screwing on. The foot switch (9) must be positioned in a way that it is easily accessible for the operator.

  • Page 33: Foot Switch Mounting

    (4, Fig. 5-1) on the rear of the MCO 25 plus. NOTICE The MCO 25 plus cannot be activated without the interlock connector (supplied with bypass). When the OR door is opened, the interlock contact on the OR door is opened. In this case, the MCO 25 plus will immediately stop laser emission and switch into STANDBY mode.

  • Page 34: Preparing The Mco 25 Plus Laser For Attaching The Mirror Joint Arm

    • device to switch into STANDBY mode. The laser treatment can be continued without interruption. • Preparing the MCO 25 plus Laser for Attaching the Mirror Joint Arm Unscrew protection cap from the thread (1). • Remove gray cap from the opening of the 5-mm hexagon spanner (2).

  • Page 35: Unpacking The Mirror Joint Arm And Preparing It For Mounting

    Instructions for Use Laser System MCO 25 plus Unpacking the Mirror Joint Arm and Preparing it for Mounting NOTICE The mirror joint arm is a precision component. Therefore any mechanical loading should be avoided while moving or transporting the device or the mirror joint arm.

  • Page 36: Mounting And Securing The Mirror Joint Arm

    Instructions for Use Laser System MCO 25 plus 5.7.1 Mounting and Securing the Mirror Joint Arm NOTICE Remove latch (4, Fig. 5-2) for removing or mounting the mirror joint arm! Remove the cap (7) from the mirror joint arm. •...
  • Page 37 Instructions for Use Laser System MCO 25 plus Carefully tighten in clockwise direction. Avoid jamming. • — Approximately 15 turns are required until the mirror joint arm is fully inserted into the retainer (8) on the laser surgery device. Then connect the flexible plastic air hose to the air outlet for the flushing air hose (9) •...

  • Page 38: Mounting The Focusing Handpiece

    Never start device as long as the protective caps cover the beam path. • Never activate MCO 25 plus laser without focusing handpiece. The laser light that is • emitted from the mirror joint arm has a divergence that is so low that even in a distance of several meters the laser beam is still focused, which bears significant hazard potential.

  • Page 39: Preparing The Mirror Joint Arm For Use With A Scanner

    Instructions for Use Laser System MCO 25 plus Preparing the Mirror Joint Arm for Use with a Scanner In order to compensate the weight of the scanner handpiece, which is higher than that of other focusing handpieces, the tension of the mirror joint arm must be set to the stronger value.

  • Page 40: Mounting A Scanner (Normal Scan)

    Laser System MCO 25 plus 5.8.1 Mounting a Scanner (Normal Scan) Scanner operations with the MCO 25 plus are possible if the laser is equipped with the required accessory equipment. Scanner casing Soft Scan Plus R Scanner handpiece 127 mm...

  • Page 41: Laying The Cable For The Scanner

    Instructions for Use Laser System MCO 25 plus 5.8.2 Laying the cable for the scanner • First connect flushing air hose (12) to the connection (3) on the scanner handpiece. Connect the other end of the flushing air hose to the connection on the laser surgery •...

  • Page 42: Scanner Handpiece Standard, 127 Mm

    5.8.3 Scanner Handpiece Standard, 127 mm Standard scanner operation with the MCO 25 plus is possible if the laser is equipped with the required accessory equipment. Connect the scanner handpiece 127 mm (B, Fig. 5-7) included in the delivery after •...

  • Page 43: Mounting Scanner Soft Frac / Power Frac

    5.8.5 Mounting Scanner SOFT FRAC / POWER FRAC Fractionated scanner operation with MCO 25 plus is possible if the MCO 25 plus laser is equipped with the required accessory equipment. Scanner casing and scanner cable are connected as done for normal scanner operations, see section 5.8.1 “Mounting a Scanner (Normal Scan)”, page 40.

  • Page 44: Upper Parking Position Mirror Joint Arm

    Instructions for Use Laser System MCO 25 plus 5.8.6 Upper Parking Position Mirror Joint Arm Lock arm into blue clip (1). • — The arm with its 2 branches is held in parallel position. Turn arm in such a way that it tilts •...

  • Page 45: Lower Parking Position Mirror Joint Arm

    (longer break) or if the MCO 25 plus laser is to be transported over longer distances. Loosen rotary fixation (2) and then first turn the arm as is done for the upper parking •...

  • Page 46: Operating The Mco 25 Plus

    Instructions for Use Laser System MCO 25 plus Operating the MCO 25 plus WARNING Danger of injury by operating errors! There is the danger of severe injury by laser light if the device is not used in accordance with these instructions for use, or if settings are changed in a manner contrary to what is explained in the listed instructions.

  • Page 47: Emergency Stop Switch

    Laser System MCO 25 plus EMERGENCY STOP Switch NOTICE Do not use the EMERGENCY STOP switch for normal shutdown of the MCO 25 plus. The EMERGENCY STOP switch immediately stops the emission of laser light, section 5.4 “Front Side”, page 29.

  • Page 48: Changing Modes

    • Press SELECT to confirm your selection. • — The display shows the starting screen and the software version of the MCO 25 plus. Further control panel operations are described in section 6.5.2 “Control Keys and Display Field”, page 54.

  • Page 49: Language Selection

    Instructions for Use Laser System MCO 25 plus 6.4.2 Language Selection The user can select from among the following languages: German, English, French, Spanish, Italian Language Selection When switching on the device with the key switch, keep the SELECT key pressed until a •...

  • Page 50: Control Elements And Display

    Operating panel with display (showing starting screen) and key pad After turning the key switch, the MCO 25 plus shows a starting screen on the display. It displays the KLS Martin logo and the software version of the laser surgery device MCO 25 plus.

  • Page 51: Key Pad

    Instructions for Use Laser System MCO 25 plus 6.5.1 Key Pad The key pad of the MCO 25 plus comprises the following keys: SELECT Memory M1 (selection) Arrow down Memory M2 (decrease) Arrow up Memory M3 (increase) STANDBY Memory M4...
  • Page 52 Instructions for Use Laser System MCO 25 plus TIME SETUP (Time Mode) In Time Mode (TM) the following parameters are displayed: Fig. 6-3: Control panel with display in Time Mode (CW and pulse operation) D Display and display elements P Keys for parameter pre-settings and navigation...
  • Page 53 Instructions for Use Laser System MCO 25 plus Frequency Mode In Frequency Mode (FM) the following parameters are shown: Fig. 6-4: Control panel with display in Frequency Mode (CW and pulse operation) D Display and display elements P Keys for parameter pre-settings and navigation (arrow keys)

  • Page 54: Control Keys And Display Field

    Button lit yellow, flashing in MCO 25 plus is ready and laser light can be LASER READY alternation with S1 during activated by pressing the foot switch power check...

  • Page 55: Function Keys And Scanner Control Keys

    Observe Fig. 6-3, page 52. Name Function Description Function key, lit yellow, Selects continuous laser Continuous laser MCO 25 plus laser stops after mode (CW). light release of foot switch Selects single pulse mode, Function key, lit yellow, laser stops Single pulse...

  • Page 56: Display Fields On The Display

    Instructions for Use Laser System MCO 25 plus 6.5.4 Display Fields on the Display Observe Fig. 6-3, page 52. and Fig. 6-4 page 53. Mode Name Function Description 2–25 W cont. (F1), Power, Laser output power in W, maximum F, C 10–25 W pulse and...

  • Page 57: Selecting The Operating Mode

    This operating mode works with continuous laser light at continuous laser output as long as the foot switch is activated. This mode is only available for CO lasers with direct current excitation, which is possible with the MCO 25 plus. This laser mode is often called “CW” (continuous wave). Parameters in Continuous Operation Power output (average power) Use the SELECT key to select the field POWER.
  • Page 58 Instructions for Use Laser System MCO 25 plus Parameters in Single Pulse Mode Power output (POWER) Use the SELECT key to select the field POWER. • Increase or decrease the power output value using the arrow keys. • Both keys have an automatic repetition function which increases or decreases the value repeatedly when the key is held down.

  • Page 59: Multiple Pulse Mode

    Instructions for Use Laser System MCO 25 plus 6.6.3 Multiple Pulse Mode When the foot switch is activated, the laser emits a sequence of laser pulses until the foot switch is released. The display also shows the average laser output (AVERAGE POWER) that is derived from the output power (MAXIMUM POWER), the PULSE DURATION and the pause time (PAUSE) or the PULSE RATE, respectively.
  • Page 60 Instructions for Use Laser System MCO 25 plus CYCLE In CYCLE mode, the CYCLE key is pressed in addition to the MULTIPLE PULSE key. The display shows the parameters CYCLE DURATION and CYCLE PAUSE or CYCLE RATE, respectively. Setting ranges for cycle length...

  • Page 61: Super Pulse Mode

    Instructions for Use Laser System MCO 25 plus 6.6.4 Super Pulse Mode In super pulse mode, the laser generates very short laser light pulses that have enhanced intensity due to the physical process in the laser tube. This enables the user to work very athermally thanks to the high maximum power output and concomitantly low pulse energy.

  • Page 62: Scanner Operations

    Instructions for Use Laser System MCO 25 plus Scanner Operations 6.7.1 Display When any of the scanner keys C1...C5 is pressed, the display switches to the screen shown below: D Display L1 Laser emission display D1 Maximum power P1 Select key...

  • Page 63: Scanner Mode Parameters

    Instructions for Use Laser System MCO 25 plus 6.7.2 Scanner Mode Parameters Setting range for maximum power from 10–25 W in steps of 1 W. Figure size Use the SELECT key to select the field FIGURE SIZE. Now increase or decrease the value using the arrow keys.
  • Page 64 Instructions for Use Laser System MCO 25 plus Scanner handpiece options Scanner handpieces 127 mm, 200 mm The scanner handpieces are different from the focusing handpieces for normal laser applications. To avoid confusion, the scanner handpieces are color-coded. In addition, the connection threads differ to avoid connecting the focusing handpiece to the scanner.

  • Page 65: Soft Frac

    Instructions for Use Laser System MCO 25 plus 6.7.3 SOFT FRAC For a surface scanning effect with low penetration depth, connect the scanner handpiece SOFT FRAC to the scanner and select the setting SOFT FRAC in the menu HAND PIECE. Via control of the scanner, the laser generates a surface-filling number of spots with a diameter of 0.8 mm.

  • Page 66: Power Frac

    Instructions for Use Laser System MCO 25 plus The order in which the laser dots are generated is irregular, which minimizes the thermal strain on the tissue. Fig. 6-9: Generation of individual dots in irregular order (example: square) 6.7.4 POWER FRAC...

  • Page 67: Additional Optical Application Parts For The Scanner Mode

    Instructions for Use Laser System MCO 25 plus Additional optical application parts for the Scanner Mode As an option, it is possible to use the micromanipulators MINI POINT and / or MICRO POINT 2 / 2R. Connection adapters for surgical microscopes and colposcopes by various manufacturers can be ordered via the Martin Service Center upon request, see section 1.8...

  • Page 68: Mini Point Micromanipulator

    Instructions for Use Laser System MCO 25 plus 6.8.1 MINI POINT Micromanipulator By selecting the MINI POINT in D4, see section 6.7.1 “Display”, page 62, and its focal length, this micromanipulator can be used with the scanner. The following shape sizes can be selected...

  • Page 69: Micro Point 2/2R Micromanipulator

    Instructions for Use Laser System MCO 25 plus 6.8.2 MICRO POINT 2/2R Micromanipulator By selecting the MICRO POINT 2/2R in D4 (Fig. 6-3) and its focal length, this micromanipulator can be used with the scanner. The following laser power settings can be selected depending on focal length.
  • Page 70 Instructions for Use Laser System MCO 25 plus The following shape sizes can be selected depending on focal length: Focal length MICRO POINT 2/2R 225 mm 300 mm 400 mm 450 mm 500 mm Shape Triangle 1–5 mm 2–6 mm 2–8 mm...

  • Page 71: Special Scanner Functions

    Instructions for Use Laser System MCO 25 plus Special Scanner Functions 6.9.1 Continuous Scan CYCLE PAUSE/CYCLE RATE • Setting: OFF When setting a cycle pause of less than 10 ms or a cycle rate of more than 5 Hz, OFF appears on the display and continuous scanning without pause is activated as long as the foot switch is pressed.

  • Page 72: Line Scanning

    6.9.3 Line Scanning The MCO 25 plus laser has the function key C5 for line scanning that is especially intended for surgical laser applications of the scanner. The line can be straight, curved or strongly curved. You can switch between the selections by pressing the key C5.
  • Page 73 Instructions for Use Laser System MCO 25 plus NOTICE No energy area density is shown during the line scanning process. These scan shapes are intended for surgical cutting procedures and have a high energy density. HIGH is shown on the display.

  • Page 74: Micromanipulator Micro Point 2R With Micro Switch

    Instructions for Use Laser System MCO 25 plus 6.10 Micromanipulator MICRO POINT 2R with MICRO SWITCH 6.10.1 Connection Fig. 6-12: Connection of micromanipulator MICRO POINT 2R to scanner casing Soft Scan Plus R 1 MICRO POINT 2R 4 MICRO SWITCH connector...

  • Page 75: Line Control

    Instructions for Use Laser System MCO 25 plus 6.10.2 Line Control When using the micromanipulator MICRO POINT 2R with MICRO SWITCH, the selection of the straight or curved line and its orientation can be done via the micromanipulator. Key for clockwise rotation...

  • Page 76: Line Scanning With Super Pulse

    Instructions for Use Laser System MCO 25 plus 6.10.3 Line Scanning with Super Pulse When using the line scanning shapes you can also use the super pulse mode instead of continuous laser light. Press the SUPERPULSE key (F4) and then directly the line key (C5).

  • Page 77: Super Pulse Line Scanning With Cycle

    Instructions for Use Laser System MCO 25 plus 6.10.4 Super Pulse Line Scanning With Cycle By pressing the key CYCLE (F5), you can activate the repetition function for the super pulse line scan The line is scanned cyclically as long as the foot switch is activated.

  • Page 78: Overlap

    Instructions for Use Laser System MCO 25 plus 6.10.6 Overlap Using the parameter OVERLAP you can adjust the effect of the super pulse line scan. A stronger overlap results in a higher power density and a stronger effect. Effect of the overlap parameter used with line scanning...

  • Page 79: Adapting The Name And Number Of The Memory Cell

    Instructions for Use Laser System MCO 25 plus 6.11.2 Adapting the Name and Number of the Memory Cell Display of the memory location whose name can be entered or changed Selection of NO or YES P2, P3 Button SELECT to confirm NO...
  • Page 80 After entry, select the field STORE and confirm by pressing SELECT key (P1). • The MCO 25 plus laser accepts the name and the parameters and saves them in the • selected storage location (M1 in the example).

  • Page 81: Recalling Parameters

    Instructions for Use Laser System MCO 25 plus 6.11.3 Recalling Parameters NOTICE If no scanner is connected and you try to load a memory location in which a scanner setting is stored, the display will show the message PLEASE CONNECT SCANNER.

  • Page 82: Checking The Laser Light Using The Pilot Laser

    Instructions for Use Laser System MCO 25 plus 6.12 Checking the Laser Light Using the Pilot Laser Before starting treatment, emission of CO -laser light must be checked on the focusing handpiece. CAUTION Possible distraction by pilot laser light! Direct or reflected pilot laser light can blind the user and temporarily impair his or her working ability.

  • Page 83: Activating The Pilot Laser

    Sometimes it may be necessary to deactivate the pilot laser either in STANDBY or in active mode. Deactivation while in STANDBY S1 STANDBY S2 PILOT MCO 25 plus is set to STANDBY • S3 LASER READY Press the PILOT key twice within 3 s. •...

  • Page 84: Pilot Laser In Flashing Mode

    Deactivation of the pilot laser in active mode is permissible only if the location of the laser application is clearly indicated by the needle-shaped tip of the focusing handpiece. Set MCO 25 plus to LASER READY. • Press the PILOT key twice within 3 s.

  • Page 85: Applying Laser Light

    Instructions for Use Laser System MCO 25 plus 6.13 Applying Laser Light CAUTION Risk of injury to eyes if used without protective goggles! Ensure that all persons present in the room including the patient are wearing protective • laser goggles.
  • Page 86 Press the key LASER READY (S3) to set the laser to readiness. • The MCO 25 plus laser now internally checks the selected laser power. During this check, the lamps of the keys STANDBY (S1) and LASER READY (S3) flash in alternating fashion.

  • Page 87: System Check

    Laser System MCO 25 plus 6.14 System Check When the MCO 25 plus is switched on, the display shows the starting screen for about 10 s. It shows the KLS Martin logo and the software version. Check the blue display for screen errors.

  • Page 88: Adjusting The Display Contrast

    Instructions for Use Laser System MCO 25 plus 6.14.1 Adjusting the Display Contrast NOTICE If you cannot see the symbols properly after switching on the display, adjust the contrast until the display appears correctly. The contrast of the LCD display can be adjusted and adapted to the ambient conditions.

  • Page 89: Quick Instructions For Use

    Quick Instructions for Use Preparation Follow Instructions for use • Connect laser unit to power supply Connect mains cable of the MCO 25 plus to a • separate mains socket. Put on protective goggles Protect the eyes of the patient •...
  • Page 90 Apply laser light Setting laser unit to STANDBY Press STANDBY key • MCO 25 plus is not ready, LED is lit green Switch off laser unit Turn key switch to vertical position. • Remove key and store it in a safe location.

  • Page 91: Maintenance

    Instructions for Use Laser System MCO 25 plus Maintenance Periodic Maintenance NOTICE Repairs may be performed solely by authorized service technicians of Gebrüder Martin. Inspection/Maintenance Maintenance interval To be performed by Control of the EMERGENCY STOP prior to the first surgery...

  • Page 92: Functional Checks

    Instructions for Use Laser System MCO 25 plus Functional Checks The checks described below were performed by the technical service as part of the system check after installation of the device. On occasion, they can be repeated by an experienced user in order to confirm the proper condition of the laser surgical unit and the optical components.

  • Page 93: Checking The Flushing Air Flow

    • To check the correct release of flushing air, follow the steps below: • Set the MCO 25 plus to single pulse mode (10 W, pulse duration 8 ms). Press the key LASER READY. • — You can feel a slight air flow at the end of the focusing handpiece.

  • Page 94: Cleaning Of Focusing/Scanner Handpieces

    Instructions for Use Laser System MCO 25 plus If accessories are to be disinfected (surface disinfection or immersion), the information of • the manufacturer of the disinfectants concerning material compatibility, dosage, and exposure time must be respected. • Non-sterilizable accessories, such as foot switches, must be subjected to disinfecting cleaning.

  • Page 95: Parts Of The Focusing Handpieces

    Instructions for Use Laser System MCO 25 plus NOTICE If the optical surface is wiped properly, it is cleaned without visible drying edges or streaks. Wipe in one direction only. • Do not wipe in a circle. • Clean both sides in the same manner.

  • Page 96: Parts Of The Scanner Handpieces

    Instructions for Use Laser System MCO 25 plus 9.1.2 Parts of the scanner handpieces 1 Tip 2 Tube 3 Optics Scanner 1: Tip 2: Tube 3: Optics handpiece A: Scanner 127 mm 76-500-50-04 76-500-51-04 76-500-52-04 76-500-53-04 B: Scanner 200 mm...

  • Page 97: Parts Of The Ent Set

    Instructions for Use Laser System MCO 25 plus Parts of the ENT Set Illustration ENT set A: Optics 76-600-01-04 B: Tube 76-600-11-04 Attachment 0° 76-600-02-04 Attachment 90° 76-600-03-04 Attachment 120° 76-600-04-04 Revision 5.5...

  • Page 98: Cleaning Process

    Instructions for Use Laser System MCO 25 plus Cleaning Process Due to the better results regarding efficacy and repeatability, machine cleaning should be preferred to manual cleaning. Description Tube Focusing handpiece 50 mm 76-100-06-04 76-100-07-04 Focusing handpiece 127 mm 76-100-11-04...

  • Page 99: Sterilization

    The responsibility for proper cleaning, disinfection and sterilization of components of the • Laser System MCO 25 plus rests with the operator/user. Be sure to observe your national/local regulations, including potential restrictions. Use appropriate and approved sterile packaging (e.g. in accordance with EN 868, •...
  • Page 100 Instructions for Use Laser System MCO 25 plus Description Tube Focusing handpiece 50 mm 76-100-06-04 76-100-07-04 Focusing handpiece 127 mm 76-100-11-04 76-100-12-04 Focusing handpiece 200 mm 76-100-16-04 76-100-17-04 Scanner handpiece 127 mm 76-500-51-04 76-500-52-04 Scanner handpiece 200 mm 76-500-61-04 76-500-62-04...

  • Page 101: Troubleshooting

    (4, Fig. 5-1, page 30) on the rear of the laser surgical unit. — Check door contact switch. — Check the interlock connector on the rear of the MCO 25 plus. The mirror joint arm is not connected or not fully screwed on. This is controlled by a micro •...

  • Page 102: Temperature Error

    Leave the device switched on until it has cooled down, but do not activate it. As soon as the temperature in the device has reached permissible values, the MCO 25 plus can be activated again after pressing the STANDBY key.

  • Page 103: Other Messages

    Instructions for Use Laser System MCO 25 plus The display then shows CURRENT AVERAGE POWER that may differ from the selected power output. Maximum power current power Fig. 11-1: Current average power output after confirmation The current power output is used for the application as usual. Should the message that prompts the user to confirm the current power output appear more often than expected, contact the Martin Service Center.

  • Page 104: System Troubles Without Display Messages

    Instructions for Use Laser System MCO 25 plus 11.4 System Troubles without Display Messages In case of the following fault symptoms, proceed as described in the right column. If the fault cannot be fixed by the recommended measures, please contact Martin Service Center, see section 1.8 “Hotline”, page 11.

  • Page 105: Accessories

    Instructions for Use Laser System MCO 25 plus Accessories 12.1 List of Approved Accessory Equipment Accessory equipment and single use articles may be used only if radiation safety of laser products is guaranteed according to IEC 60825 and if they are CE-marked.

  • Page 106: Foot Switch

    Foot Switch Description Foot Switch for CO -Laser system MCO 25 plus 77-200-00-04 12.5 Scanner Description Add-on kit scanner Soft Scan Plus R for MCO 25 plus 76-500-00-04 Scanner installation 76-500-20-04 Scanner head complete 76-500-31-04 Scanner connection cable 76-500-40-04 Scanner handpiece 127 mm...

  • Page 107: Special Accessories (Ent Set)

    Attachment 0°for optics 76-600-02-04 Attachment 90°for optics 76-600-03-04 Attachment 120°for optics 76-600-04-04 Brush for attachments 76-600-05-04 Connection adapter for MCO 25 plus to Storz laparoscope 76-300-20-04 Storz coupler laparoscope 76-301-00-04 Olympus coupler laparoscope 76-302-00-04 Storz coupler MCO 76-303-00-04 Connection adapter for scanner to Storz laparoscope 76-500-43-04 12.7...

  • Page 108: Fume Extraction System Marvac

    12.9 Safety Distances (NOHD) For the accessory equipment used with the MCO 25 plus laser, the following safety distances (NOHD = nominal ocular hazard distance) must be observed. If these distances are exceeded, the allowed limit values for laser treatment and radiation intensity are not complied with. The table also contains the ray divergences for each handpiece.

  • Page 109: Technical Data

    Instructions for Use Laser System MCO 25 plus Technical Data Designation Specifications MCO 25 plus Type of laser laser Laser wavelength λ = 10,600 nm Laser output power 2–25 W Laser class Device class IIb acc. to MPG Protection class...
  • Page 110 Instructions for Use Laser System MCO 25 plus Designation Specifications MCO 25 plus Control panel Bluemode LCD display, integrated scanner functions Program memory locations 5 freely assignable memory locations; can also be used for scanner Mains connection 220–240 VAC; 50/60 Hz Mains power max.

  • Page 111: Safety Check (Sc)

    Instructions for Use Laser System MCO 25 plus Safety Check (SC) NOTICE Compliance of the laser surgery device with the safety requirements must be verified annually by a technical safety check according to IEC 62353. Technical safety checks may be performed only by service technicians authorized by Gebrüder Martin.
  • Page 112 Instructions for Use Laser System MCO 25 plus Check of the required monitoring/safety display and message system ] 3.1 Shutter (protection against laser beams) ] 3.2 Laser protection goggles ] 3.3 Emission control (acoustic, visual) ] 3.4 Power measuring device (Comparison of internal/external power) ] 3.5 Interlock system (functional check)

  • Page 113: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)

    Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device MCO 25 plus is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 114 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device MCO 25 plus is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 115 Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 b) Table 204: Electromagnetic immunity The device MCO 25 plus is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 116 Gebrüder Martin MCO 25 plus according to IEC 60601-1-2 clause 6.8.3.201 b), Table 206 The device MCO 25 plus is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a...

  • Page 117: Ecological Information

    (energy saving). The MCO 25 plus is a low-maintenance laser device. All waste products created during its operation can be disposed of as normal waste or waste water.
  • Page 118 Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com · www.klsmartin.com Date of Release: 2015-08 ·...

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