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KLS Martin MCO 25 plus Instructions For Use Manual

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EN
V. 5.4 (2013-01)
90-238-52-54
CO
Laser System MCO 25 plus
2
Instructions for Use
Valid for software version V. 5.4 and from hardware revision HW 02 on

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Summary of Contents for KLS Martin MCO 25 plus

  • Page 1 Laser System MCO 25 plus Instructions for Use V. 5.4 (2013-01) Valid for software version V. 5.4 and from hardware revision HW 02 on 90-238-52-54...
  • 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: Table Of Contents

    Instructions for Use Laser System MCO 25 plus Contents Product Liability and Warranty ............7 General Information ................7 Scope of Delivery .................. 7 Intended Use ..................8 Safety Checks..................8 Regularly Used Functions ............... 8 Contraindications .................. 8 Warranty ..................... 9 User’s Inspection ..................
  • Page 4 Instructions for Use Laser System MCO 25 plus Commissioning ................25 Set-up Information................25 Front of Device: Overview ..............26 Rear of Device: Overview and Type Plate ..........27 5.3.1 Connecting the Foot Switch ................28 5.3.2 Foot Switch Mounting ..................28 5.3.3...
  • Page 5 Instructions for Use Laser System MCO 25 plus Setting Laser System Parameters............54 6.6.1 Continuous Operation ..................54 6.6.2 Single Pulse Mode ..................54 6.6.3 Multiple Pulse Mode ..................56 6.6.4 Super Pulse Mode ................... 58 Scanner Operations ................59 6.7.1...
  • Page 6 Instructions for Use Laser System MCO 25 plus Cleaning and Sterilization ............87 Cleaning of the Laser Device ..............87 Cleaning of Focusing / Scanner Hand Pieces ........... 87 Angles ....................90 Parts of the ENT Set ................90 Cleaning Process ................. 91 Sterilization Process ................

  • Page 7: Product Liability And Warranty

    Product Liability and Warranty General Information We thank you for having decided to buy a KLS Martin product. This product carries the CE mark, which means that it satisfies the essential requirements laid down in the EC Directive concerning medical devices.

  • Page 8: Intended Use

    Instructions for Use Laser System MCO 25 plus Intended Use 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 9: Warranty

    Instructions for Use Laser System MCO 25 plus Warranty Our Standard Terms and Conditions of Sale as currently valid shall apply. An agreements diverging from these Standard Terms and Conditions shall not limit the statutory rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables.

  • Page 10: Hotline

    Instructions for Use Laser System MCO 25 plus Hotline • Should you have any questions on how to handle the product or use it for clinical applications, please do not hesitate to contact the Product Management: Tel: +49 7461 706-243...

  • Page 11: Notices Concerning This Document

    The software version is shown on the startup screen of the MCO 25 plus. Should the software version of the device not correspond to the software version indicated here, you can order matching documentation from our Martin Service Center (see section 1.9 “Hotline”, page 10).

  • Page 12: 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 Danger of death or serious injury!

  • Page 13: Safety Notes

    Instructions for Use Laser System MCO 25 plus Safety Notes General Specifications Norm Normtitle 93/42/CE EC Directive 93/42/EEC for medical devices Safety of laser products – Equipment classification and IEC 60825-1:2007 requirements IEC 60601-1:1988 Medical electrical equipment – General requirements...

  • Page 14: Information On Initial Commissioning

    Furthermore, the following additional requirements must be observed: The MCO 25 plus laser may be commissioned only by authorized users. The users must be • familiar with the laser device and know the applicable safety precautions. Persons authorized to use the device must be listed in the medical product log.

  • Page 15: Laser Safety

    Instructions for Use Laser System MCO 25 plus The operator must ensure that the following documents are always accessible and updated regularly: Medical product log or device card, respectively • Instructions of use for device and accessory equipment • Accident and damage reports for cases of personal injury must be reported to the relevant authorities immediately.

  • Page 16: Danger Of Explosion And Fire

    Class 4 lasers (DIN EN 60825-1) can cause fires due to the heating of tissue or fiber ends. Therefore, comply with the following requirements to prevent laser-induced fires and explosions when using the MCO 25 plus: The device must not be used near flammable anesthetics or highly volatile mixtures such •...

  • Page 17: 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 18: 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 who shall also be responsible for the following: Implementation of safety measures •...

  • Page 19: Earthing Of The Device

    Proper earthing is ensured if the mains cable is connected according to the VDE regulations. For use of the MCO 25 plus in certain operation areas (e. g. during intracardiac operations), the device can additionally be earthed at the equipotential grounding pin using the equipotential grounding cable.

  • Page 20: Warning And Information Labels, Key Switch, Emergency-Stop

    Instructions for Use Laser System MCO 25 plus 3.16 Warning and Information Labels, Key Switch, EMERGENCY-STOP Information label on the rear of the device containing the maximum output values for the laser light. Average power 25 W Max power ≤ 250 W Superpuls Pulse 5 ms –...
  • Page 21 Instructions for Use Laser System MCO 25 plus Positions of safety notes, key switch and EMERGENCY-STOP switch 1 Warning label for laser light exit opening 3 EMERGENCY-STOP switch 2 Laser warning label 4 Key switch V. 5.4...

  • Page 22: Fumes

    ® If the external fume suction system marVAC is used together with the MCO 25 plus, the activation of the fume suction system can be controlled by activation of the laser. Do not use laser without working fume suction system! •...

  • Page 23: About This Device

    Instructions for Use Laser System MCO 25 plus About this Device General Information on Laser Theory LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. The laser consists of an active medium and an excitation source. The excitation source “pumps”...
  • Page 24 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 25: Commissioning

    Set-up Information The MCO 25 plus is a state-of-the-art laser surgery device controlled by a microprocessor. The device produces laser light in the infrared wavelength (10,600 nm) with a laser power of up to 25 W that the user can apply via various applicators.

  • Page 26: Front Of Device: Overview

    Instructions for Use Laser System MCO 25 plus All reflecting surfaces must be covered with suitable materials. • All highly flammable liquids and gases must be removed from the laser area. • • All persons in the laser area (incl. patient) must be provided with protective goggles.

  • Page 27: Rear Of Device: Overview And Type Plate

    Instructions for Use Laser System MCO 25 plus Rear of Device: Overview and Type Plate Fig. 5-1: Overview of connections on the rear 1 Mains connection socket 4 Theater door interlock 7 Type plate 2 Mains fuses 5 Equipotential grounding pin...

  • Page 28: Connecting The Foot Switch

    Instructions for Use Laser System MCO 25 plus 5.3.1 Connecting the Foot Switch 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 29: Mains Connection

    Without the theater door interlock or the supplied shorting plug in the corresponding socket (4, Fig. 5-1), the MCO 25 plus cannot be activated. If a door contact switch is connected, the device will stop the laser emission when the door •...

  • Page 30: Equipotential Grounding Pin

    Instructions for Use Laser System MCO 25 plus — Press the key and set device to Laser Ready. Only then can the laser treatment be continued. The theater door contact must be a potential-free (floating) contact. The contact on the theater door must be suitable for 24 V / 0.1 A DC.

  • Page 31: Preparing The Laser Device For Attaching The Mirror Joint Arm

    Instructions for Use Laser System MCO 25 plus Preparing the Laser Device 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). • Turn the clamping (4) that is located under the cap to the left using the 5-mm hexagon •...

  • Page 32: 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 During transport, the mirror joint arm is not mounted to the device; it is supplied with the device in a separate packaging.

  • Page 33: Mounting And Securing The Mirror Joint Arm

    Instructions for Use Laser System MCO 25 plus 5.5.1 Mounting and Securing the Mirror Joint Arm NOTICE Remove latch for removing or mounting the mirror joint arm! Remove the cap (7) from the arm. • Screw mirror joint arm into the connection thread (1, Fig. 5-2) on the laser device.
  • Page 34 Instructions for Use Laser System MCO 25 plus Then connect the flexible plastic air hose to the air outlet for the flushing gas hose (9) • behind the joint arm of the laser. Slide cover ring (6) fully down. •...

  • Page 35: Mounting The Focusing Hand Piece

    Instructions for Use Laser System MCO 25 plus 5.5.2 Mounting the Focusing Hand Piece WARNING Risk of injury to eyes by laser light! Never start device as long as the protective caps cover the beam path. • Never activate laser without focusing hand piece. The laser light that is emitted from the •...

  • Page 36: 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 balance the higher weight of the scanner hand piece compared to other focusing hand pieces, the tension of the mirror joint arm must be set to the stronger value.

  • Page 37: Mounting A Scanner (Normal Scan)

    Laser System MCO 25 plus 5.6.1 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 hand piece 127 mm...
  • Page 38 Ferrite core on scanner cable Flushing gas hose connection on laser device Flushing gas hose Scanner cable Fixing clip for scanner cable Fixing strap for scanner cable and gas hose Fig. 5-10: Laying the cable for the MCO 25 plus scanner V. 5.4...

  • Page 39: Scanner Hand Piece Standard, 127 Mm

    5.6.2 Scanner Hand Piece 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 hand piece 127 mm (B, Fig. 5-6) included in the delivery after •...

  • Page 40: Mounting A Scanner (Fractionated Scan)

    5.6.4 Mounting a Scanner (Fractionated Scan) Fractionated scanner operation with MCO 25 plus is possible if the laser is equipped with the required accessory equipment. Scanner casing and scanner cable are connected as done for normal scanner operations (see section 5.6.1 “Mounting a Scanner (Normal Scan)”, page 37).

  • Page 41: Relocating The Device

    Instructions for Use Laser System MCO 25 plus Relocating the Device NOTICE Damage may be caused by vibrations! Move device carefully to avoid exposing the optical components to strong shocks or vibrations. NOTICE Risk of damage to property The device may be placed only on floors with a maximum inclination of 5°! Remove key and store safely before transport within the building.

  • Page 42: Upper Parking Position Mirror Joint Arm

    Instructions for Use Laser System MCO 25 plus 5.7.1 Upper Parking Position Mirror Joint Arm Lock arm into blue clip (1) • — The arm with its two branches is held in parallel position. Turn arm in such a way that it tilts slightly forwards.

  • Page 43: Lower Parking Position Mirror Joint Arm

    — The device can now be moved safely. Handover of the Device to the Operator After installation, set-up and functional check by an authorized KLS Martin service partner, the device and all accessory equipment and documents are handed over to the operator. The operator appoints a laser safety officer according to the regional and national regulations.

  • Page 44: Operating The Device

    Instructions for Use Laser System MCO 25 plus Operating the Device WARNING Danger of physical injury 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 45: 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 (see section 5.2 “Front of Device: Overview”, page 26).

  • Page 46: Changing Setup

    Instructions for Use Laser System MCO 25 plus The user can individually select the settings. It is, however, recommended to have a service technician define the default settings upon initial commissioning of the device. Time Setup Time Setup is the default setting when the device is delivered to the customer.

  • Page 47: Control And Display Elements

    Instructions for Use Laser System MCO 25 plus Control and Display Elements 6.5.1 Control Panel Overview Fig. 6-1: MCO 25 plus control panel 1 LCD display 2 Laser activation light 3 Control panel V. 5.4...

  • Page 48: Control Panel Keyboard

    Instructions for Use Laser System MCO 25 plus 6.5.2 Control Panel Keyboard In the following text, the laser keyboard is used with the descriptions below. SELECT (selection) Memory M1 Arrow down (decrease) Memory M2 Arrow up (increase) Memory M3 Standby (laser operation not...
  • Page 49 Instructions for Use Laser System MCO 25 plus Time Mode In Time Mode the following parameters are displayed: Fig. 6-3: Control panel with display in Time Mode (CW and pulse operation) D Display and display elements M Memory keys- L Laser emission display...
  • Page 50 Instructions for Use Laser System MCO 25 plus Frequency Mode In Frequency Mode the following parameters are shown: Fig. 6-4: Control panel with display in Frequency Mode (CW and pulse operation) D Display and display elements M Memory keys L Laser emission display...

  • Page 51: Description Of Control Keys

    Instructions for Use Laser System MCO 25 plus 6.5.3 Description of Control Keys Name Function Description Emission Indicator lit when laser light is being Function indicator and laser indicator emitted warning indicator lit yellow When this key is pressed, the device...

  • Page 52: Description Of Function Keys

    Instructions for Use Laser System MCO 25 plus 6.5.4 Description of Function Keys Name Function Description Function key, lit yellow, laser stops Continuous laser Selects continuos laser mode (CW). after release of foot switch light Selects single pulse mode, laser...

  • Page 53: Display Description

    Instructions for Use Laser System MCO 25 plus 6.5.5 Display Description Mode Name Function Description 2 W – 25 W cont. (F1), Power, Laser output power in W, maximum F, C 10 W – 25 W pulse and scan Max Power power in pulse or multiple pulse mode (F2, F3, C1…C5)

  • Page 54: Setting Laser System Parameters

    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 55 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 56: 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 power output (MAX POWER), the PULSE and the pause time (PAUSE) or the PULSE RATE, respectively.
  • Page 57 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 LENGTH and CYCLE PAUSE or CYCLE RATE, respectively. Setting ranges for cycle length...

  • Page 58: Super Pulse Mode

    Instructions for Use Laser System MCO 25 plus Fig. 6-10: Display of multiple pulse with cycle function 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 low pulse energy.

  • Page 59: 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 60: 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 61 Instructions for Use Laser System MCO 25 plus NOTICE If the energy density is constant, the thermal strain on the tissue is reduced with increased scan speed. Hand piece versions: Scanner hand piece 127 mm, 200 mm The scanner hand pieces are different from the focusing hand pieces for normal laser applications.

  • Page 62: 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 hand piece 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 63: 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. 6-14: Generation of individual dots in irregular order (example: square) 6.7.4 POWER FRAC...

  • Page 64: Additional Accessory For The Scanner Mode

    Instructions for Use Laser System MCO 25 plus Additional Accessory for the Scanner Mode Via the menu item hand piece selection (D4, see section 6.7.1 “Display”, page 59) you can select the micromanipulators MINI POINT and / or MICRO POINT with their respective selectable focal lengths.

  • Page 65: 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. Selectable laser...
  • Page 66 Instructions for Use Laser System MCO 25 plus The scan shapes can also be selected via the setting MICRO POINT 2 / 2R. Focal length MICRO POINT 2 / 2R Shape 225 mm 300 mm 400 mm 450 mm 500 mm Triangle 1 –...

  • Page 67: 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 68: Line Scanning

    Instructions for Use Laser System MCO 25 plus 6.9.3 Line Scanning The 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 69: Micro Point 2R

    Instructions for Use Laser System MCO 25 plus NOTICE The angle setting of the line on the display does not correspond to that in the operation area. It depends on the position of the laser relative to the user and on the current position of the scanner, as well as on the orientation of the application optics.

  • Page 70: 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 71: 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 super pulse key (F4) and then directly the line key (C5).

  • Page 72: 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 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 73: 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 74 Instructions for Use Laser System MCO 25 plus After holding M1 for several seconds, a menu appears in which you can enter the name for a memory location. The menu allows deleting existing names, changing them or entering a new name for the memory location.

  • Page 75: Loading Of Parameters

    Instructions for Use Laser System MCO 25 plus Display of the memory and the entered text Letter / number field Keys used to move the cursor in the field D7 Key used to confirm a letter or number Key used to delete a letter or number After entry, select the field STORE and confirm by pressing P1 (SELECT).
  • Page 76 Instructions for Use Laser System MCO 25 plus The stored parameters appear on the display when the memory keys (M1…M5, Fig. 6-3) are briefly pressed. The number of the memory location and the saved name of the memory or the application are shown above the symbol of the operating mode (D8).

  • Page 77: Pilot Laser

    Instructions for Use Laser System MCO 25 plus 6.12 Pilot Laser The red pilot laser light is used to mark the spot where the CO laser beam will be applied. The protective laser goggles do not protect against pilot laser light! Do not directly look into the pilot laser! •...

  • Page 78: Pilot Laser In Flashing Mode

    Instructions for Use Laser System MCO 25 plus Deactivation while in active 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 hand piece.
  • Page 79 Instructions for Use Laser System MCO 25 plus CAUTION Danger of fire! Do not press the key Laser Ready before the focusing hand piece is pointed at the operation area and all measures to avoid laser-induced fires and explosions described above are complied with.

  • Page 80: System Check

    The originally set pulse time will be used again if the foot switch is pressed again. 6.14 System Check When the MCO 25 plus is switched on, the display shows the starting screen for some ten seconds. It shows the KLS Martin logo and the software version number. Check the blue display for screen errors.

  • Page 81: Lcd Contrast Adjustment

    Instructions for Use Laser System MCO 25 plus 6.14.1 LCD Contrast Adjustment 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 82: Quick Instructions For Use

    Instructions for Use Laser System MCO 25 plus Quick Instructions for Use Preparation Read the instructions for use • Connection Connect the device to the mains power using • the original cable Check Unlock EMERGENCY STOP switch • Put on protective goggles Protect the eyes of the patient •...
  • Page 83 Instructions for Use Laser System MCO 25 plus Activate the device Press the key Laser Ready (LED lit yellow) • Activate foot switch Apply laser light Switch off the device Turn key switch to vertical position. • Remove key and store it in a safe location.

  • Page 84: Maintenance

    Instructions for Use Laser System MCO 25 plus Maintenance When contacting Gebrüder Martin in regard to repairs and maintenance work on the laser device, always indicate the model and the complete serial number. This information can be found on the type plate. The current software version is displayed under the logo when the device is switched on.

  • Page 85: Check Of The Optical System

    Instructions for Use Laser System MCO 25 plus 8.1.2 Check of the Optical System • Use laser with focusing hand piece f = 127 mm. Set device to single pulse mode, 10 W, pulse duration 50 ms – 0.1 s.

  • Page 86: Maintenance

    Instructions for Use Laser System MCO 25 plus Maintenance Inspection Maintenance Frequency To be performed by Inspection of accessory equipment before every surgery Hospital staff Inspection of the pilot beam for coaxial exit from the focusing hand before every surgery...

  • Page 87: Cleaning And Sterilization

    Instructions for Use Laser System MCO 25 plus Cleaning and Sterilization Cleaning of the Laser Device All outer surfaces of the device including the front plate can be cleaned with commercial cleaning agents that do not contain alcohol. NOTICE Damage to the device! Make sure that no liquids can enter the device openings.
  • Page 88 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 89 Instructions for Use Laser System MCO 25 plus Parts of the scanner hand pieces 1 Tip 2 Tube 3 Optics Description Item no. 1: Tip 2: Tube 3: Optics – A: Scanner 127 mm 76-500-50-04 76-500-51-04 76-500-52-04 – B: Scanner 200 mm...

  • Page 90: Angles

    Instructions for Use Laser System MCO 25 plus Angles Description Backstop 127 mm 76-100-20-04 Backstop 200 mm 76-100-25-04 Adapter 76-200-15-04 Angle 120° 76-200-10-04 Angle 90° 76-200-05-04 Parts of the ENT Set ENT set Illustration Item number 3: Optics 76-600-06-04 2: Tube 76-600-01-04 Attachment 0°...

  • Page 91: Cleaning Process

    Instructions for Use Laser System MCO 25 plus Cleaning Process Item number Name Tube Focusing hand piece 50 mm 76-100-06-04 76-100-07-04 Focusing hand piece 127 mm 76-100-11-04 76-100-12-04 Focusing hand piece 200 mm 76-100-16-04 76-100-17-04 Scanner hand piece 127 mm...

  • Page 92: Sterilization Process

    Instructions for Use Laser System MCO 25 plus NOTICE After the cleaning process, the angular pieces and the ENT attachments must be checked for proper function. Sterilization Process Item number Name Tube Focusing hand piece 50 mm 76-100-06-04 76-100-07-04 Focusing hand piece 127 mm...

  • Page 93: Troubleshooting

    Instructions for Use Laser System MCO 25 plus Troubleshooting 10.1 Messages on the Display An automatic self-test routine permanently monitors the system and ensures the safety of patients, surgical team and device. Operational and functional faults are indicated by messages on the display.

  • Page 94: Temperature Error

    Instructions for Use Laser System MCO 25 plus 10.2.3 Temperature Error The message TEMPERATURE ERROR appears if the cooling water temperature is too high. Check if the ventilation slots on the side of the laser device are blocked. • 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 laser can be activated again after pressing the Standby key.

  • Page 95: Other Messages

    Instructions for Use Laser System MCO 25 plus The display then shows ACTUAL AVERAGE POWER that may differ from the selected power output. Maximum power actual power Fig. 10-1: Actual 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 96: Faults Without Display Messages

    Instructions for Use Laser System MCO 25 plus 10.4 Faults 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, contact the technical service (see section 1.9 “Hotline”, page 10.).

  • Page 97: Accessories

    Instructions for Use Laser System MCO 25 plus Accessories Use only the original accessory equipment listed below. The list may be updated and changed. The current list can be requested from Gebrüder Martin. 11.1 Focusing Hand Pieces and Tips Name...

  • Page 98: Micromanipulators

    Adapter, Leica M650 / 651 / 655 for MICRO POINT 2 / 2R 76-401-01-04 11.3 Scanner Name Item number 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...

  • Page 99: Protective Goggles

    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...

  • Page 100: Technical Data

    Instructions for Use Laser System MCO 25 plus Technical Data Name Data MCO 25 plus Laser type: laser Laser wavelength: λ = 10,600 nm Laser power output 2 – 25 W Laser class: Device class: IIb acc. to MPG Protection class:...
  • Page 101 Instructions for Use Laser System MCO 25 plus Name Data MCO 25 plus Cooling, heat exchange closed water cycle, air Temperature, 10 – 45 °C (50 – 113 °F), 10 – 95 % (no condensed moisture) relative humidity Control panel...

  • Page 102: Safety Check

    Instructions for Use Laser System MCO 25 plus Safety Check NOTICE Performance of the safety check must be entered into the medical product log, and the results are to be documented! The compliance of the laser device with the safety requirements must be checked annually by a safety check according to DIN EN 62353.
  • Page 103 Instructions for Use Laser System MCO 25 plus Check of the required monitoring / safety display and message system Shutter (protection against laser beams) Laser protection goggles Emission control (acoustic, visual) Power measuring device (Comparison of internal / external power) Interlock system (functional check) ext.

  • Page 104: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)

    Instructions for Use Laser System MCO 25 plus Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) Guidance and manufacturer’s declaration according to DIN EN 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emissions This device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment.
  • Page 105 Instructions for Use Laser System MCO 25 plus Guidance and manufacturer’s declaration according to DIN EN 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emissions The device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment.
  • Page 106 Instructions for Use Laser System MCO 25 plus Guidance and manufacturer’s declaration according to DIN EN 60601-1-2, clause 6.8.3.201 b) Table 204: Electromagnetic immunity The device is intended for operation in an electromagnetic environment as specified below. The user must ensure that it is used in such an environment.
  • Page 107 Laser System MCO 25 plus Recommended safety distances between portable and mobile HF-telecommunications devices and the KLS Martin MCO 25 plus according to DIN EN 60601-1-2 clause 6.8.3.201 b), Table 206 The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 108: Ecological Information

    If the treatment is interrupted and the unit is not being used for an extended period, we recommend you to switch it off for safety as well as economic reasons (energy saving). The MCO 25 plus is low-maintenance. There are such wastes produced as can be disposed of as household waste or waste water.
  • Page 109 Instructions for Use Laser System MCO 25 plus V. 5.4...
  • Page 110 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: 01.13 ·...

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