KLS Martin group LIMAX 120 Instructions For Use Manual
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KLS Martin group LIMAX 120 Instructions For Use Manual

Surgical laser unit
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Front Cover
English
90-636-52-30
Revision 5
Date of Release: 2017-07
Surgical Laser Unit
Instructions for Use
Valid from software version V3.00,
hardware release HW 04 and software version SW 02

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Summary of Contents for KLS Martin group LIMAX 120

  • Page 1 Front Cover Surgical Laser Unit English Instructions for Use 90-636-52-30 Revision 5 Valid from software version V3.00, Date of Release: 2017-07 hardware release HW 04 and software version 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 Fragile, avoid pressure and shock Arrows pointing up, transport and store upright Date of manufacture Manufacturer Do not use if packaging is damaged Use-by date Latex-free CE marking of conformity This product may not be disposed of as normal household garbage, see section 9.3 “Disposal of the Unit”, page 98 ®...

  • Page 4: Table Of Contents

    Instructions for Use ® Surgical Laser Unit Limax Contents Notices concerning this Document ..........8 Safety ....................8 Terms & Acronyms ................8 Validity of this Document ............... 9 Symbols Used in this Document ............10 Product Liability and Warranty ............. 11 General Information ................
  • Page 5 Instructions for Use ® Surgical Laser Unit Limax 5.12 Safety Devices ..................23 5.13 Warning & Information Labels............... 24 5.14 Laser Smoke ..................25 5.15 Proper Handling of Laser Fibers............. 25 Operation .................. 26 Front Side ..................26 Rear Panel ..................27 6.2.1 Drawer......................
  • Page 6 Instructions for Use ® Surgical Laser Unit Limax 6.6.9 Display ......................50 6.6.10 Laser Status Indicator ..................51 6.6.11 FILTER LIFE ....................52 Applied Parts ..................53 6.7.1 Connecting the Applied Part ................53 Checking the Laser Fiber with the Pilot Laser .......... 54 Replacing the Laser Fiber ..............
  • Page 7 Instructions for Use ® Surgical Laser Unit Limax 6.20.17 Logfile/Save/Reset ..................83 6.20.18 Overview ....................... 84 6.20.19 Display Screen ....................84 6.20.20 Timeouts ....................... 85 6.20.21 Date & Time ....................86 6.20.22 Alerts ......................87 6.20.23 Service ......................87 Cleaning and Disinfecting ............88 Disposal of consumables ..............

  • Page 8: Notices Concerning This Document

    Instructions for Use ® Surgical Laser Unit Limax Notices concerning this Document Safety Non-observance of this document can lead to serious patient injury! Improper handling and care as well as non-intended use can lead to premature wear and/or pose a risk to patients and users! It is the operator’s responsibility to ensure that all personnel handling the product have understood and do observe the notes and instructions in this document.

  • Page 9: Validity Of This Document

    Instructions for Use ® Surgical Laser Unit Limax Designation Description Nominal Ocular Hazard Distance NOHD ® Safety distances applying to accessories used with the Limax Safety check Sub-miniature A, connector; SMAplus socket: mechanically coded SMA socket for laser fibers with ®...

  • Page 10: Symbols Used In This Document

    Instructions for Use ® Surgical Laser Unit Limax Symbols Used in this Document ® Words marked with are trademarks owned by the respective proprietors. Throughout this document, important information (such as general or safety-related notices) is marked with the following symbols and signal words: Life hazard or serious injury! Indicates a situation which, if not avoided, could result in death or serious injury! Danger of minor injury!

  • Page 11: Product Liability And Warranty

    We are the manufacturer of this product: 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 +49 7461 706-193 info@klsmartin.com ·...

  • Page 12: Scope Of Delivery

    Instructions for Use ® Surgical Laser Unit Limax Scope of Delivery ® Limax 120 surgical laser unit with integrated smoke evacuator (VAC) • 2 keys • ® Foot switch with SWAP pedal • ® Mains cable with Europlug for Limax •...

  • Page 13: Intended Use

    Instructions for Use ® Surgical Laser Unit Limax Intended Use Intended Purpose of the medical device ® The Limax 120 is a surgical laser device operating on the basis of a diode-pumped Nd:YAG laser. It is intended to be used for treating biological tissue in the form of hyperthermia •...

  • Page 14: Use Restrictions

    Instructions for Use ® Surgical Laser Unit Limax Use Restrictions ® The Limax 120 should only be used by professional, qualified and skilled medical staff that ® knows safety rules and risks of laser application. The Limax 120 should only be used by staff that has been trained and instructed for it.

  • Page 15: Functional Principle

    Instructions for Use ® Surgical Laser Unit Limax Functional Principle General Information on Laser Theory LASER is an acronym meaning “Light Amplification by Stimulated Emission of Radiation”. The laser (light source) consists of an active medium and an excitation source. This excitation source “pumps”...

  • Page 16: Frequently Used Functions

    Instructions for Use ® Surgical Laser Unit Limax The irradiation intensity achieved on the surface of the tissue depends on the effective distal laser output power (tissue side), • the diameter of the beam hitting the tissue (beam spot size), which in turn is a function of •...

  • Page 17: Safety Notices & Instructions

    Instructions for Use ® Surgical Laser Unit Limax Safety Notices & Instructions General Regulations The following standards, laws, directives and regulations were observed in the design and manufacture of this product: Standard Title MPG (MDA) Medical Devices Act 93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices IEC 60825-1:1993 + A1:1997 + A2:2001 Safety of laser products –...

  • Page 18: Laser Safety

    Instructions for Use ® Surgical Laser Unit Limax Laser Safety ® The Limax is a Class IIb unit acc. to the Medical Devices Act (or MDD, respectively), • is a Class 4 laser unit (acc. to IEC 60825-1), • bears the CE-mark in compliance with EU Directive 93/42/EEC (MDD). •...

  • Page 19: Explosion And Fire Hazards

    Instructions for Use ® Surgical Laser Unit Limax Explosion and Fire Hazards Fire hazard! Class 4 lasers (IEC 60825-1) represent a potential ignition source due to heat building up in ® the tissue or at the fiber ends. When working with the Limax 120, the user therefore is required to observe the following measures in order to prevent laser-induced fires and explosions:...

  • Page 20: Treatment Room Requirements

    Instructions for Use ® Surgical Laser Unit Limax Treatment Room Requirements ® The access doors of all rooms in which the Limax 120 is used must be marked with a • laser radiation warning sign (supplied with the product). A warning lamp must be installed at all doors leading to the laser area. When these lamps •...

  • Page 21: Laser Safety Officer

    Instructions for Use ® Surgical Laser Unit Limax Laser Safety Officer The operator must appoint a Laser Safety Officer in writing, whose responsibilities include the following: carry out all safety measures required • provide instruction, to all persons involved, on required safety measures and the proper •...

  • Page 22: Grounding The Unit

    Instructions for Use ® Surgical Laser Unit Limax 5.10 Grounding the Unit The laser unit is grounded via the ground conductor integrated in the mains cable. This is an important prerequisite for the safe operation of the unit. If the mains cable is correctly connected in accordance with relevant electrotechnical regulations, proper grounding is automatically ensured.

  • Page 23: Safety Devices

    Instructions for Use ® Surgical Laser Unit Limax 5.12 Safety Devices In designing this laser unit, we strictly adhered to the principle of ensuring utmost user and patient safety. As a result, the technical safety devices incorporated in the system (and described in the following) effectively prevent maloperation: Upon turning it on, or when the voltage comes back after a power failure, the unit goes •...

  • Page 24: Warning & Information Labels

    Instructions for Use ® Surgical Laser Unit Limax 5.13 Warning & Information Labels Laser class label located on the rear panel (17, Fig. 6-2) with information on max. laser light power outputs. For further technical data see section 11 “Technical Data”, page 103.

  • Page 25: Laser Smoke

    Instructions for Use ® Surgical Laser Unit Limax 5.14 Laser Smoke 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 26: Operation

    Instructions for Use ® Surgical Laser Unit Limax Operation Front Side Fig. 6-1: Front side 1 Control panel 2 Keylock switch 3 SMAplus laser fiber connecting socket 4 Luer-lock socket for AIR (purge air) 5 VAC (Smoke evacuator) 6 Main filter (VAC), with 2 connectors for suction hoses 7 Cooling air outlet The functions of the controls and indicators (1), the keylock switch (2) and the SMAplus ®...

  • Page 27: Rear Panel

    Instructions for Use ® Surgical Laser Unit Limax Rear Panel 1 Drawer 2 Handle 3 Loudspeaker ® 4 MCB socket Limax 5 Service interface, locked 6 Accessory port 7 Interlock/Warning 8 Foot switch connector ® 9 Fuses Limax 10 Mains connector socket ®...

  • Page 28: Drawer

    Instructions for Use ® Surgical Laser Unit Limax ® The Limax 120 is available in 2 versions: Version E (standard version): • Mains cable for 230–240/16 A and mains connector socket provided on unit. Version U: Non-detachable mains cable for 200–240 V/30 A. •...

  • Page 29: Mcb Socket Limax ® 120

    Instructions for Use ® Surgical Laser Unit Limax ® 6.2.4 MCB Socket Limax Using the MCB cable, connect the MCB socket of the ® Limax 120 (4, Fig. 6-2) to the MCB socket of the integrated VAC, see section 6.2.16 “VAC MCB Socket”, page 35.
  • Page 30 Instructions for Use ® Surgical Laser Unit Limax Door Interlock If a door contact switch is connected to this contact (1), the unit automatically stops laser light emission as soon as the door is opened. As a result, the following red message is displayed: •...

  • Page 31: Foot Switch Connector

    Instructions for Use ® Surgical Laser Unit Limax 6.2.7 Foot Switch Connector Socket for connecting the foot switch (8, Fig. 6-2) for ® Limax 120 laser activation and laser light emission. See section 6.15 “Foot Switch with SWAP®”, page 65 for a functional description.

  • Page 32: Disconnection Limax ® 120 From Power Supply

    Instructions for Use ® Surgical Laser Unit Limax ® A safety bracket (2) is provided on the Limax 120 to protect the mains cable from slipping out accidentally. Secure the safety bracket (2) with the screw (1). • Fig. 6-5: Safety bracket ®...

  • Page 33: Connecting The Limax ® 120 U-Version To The Power Supply

    Instructions for Use ® Surgical Laser Unit Limax ® 6.2.11 Connecting the Limax 120 U-Version to the Power Supply The mains connector socket of the U version has a non-detachable power supply cable. It is suitable for a supply voltage of 200–240 V, 50/60 Hz. If current consumption is too high in the laser circuit, 2 fuses rated T 16 AH, 500 V, slow-blow (9, Fig.

  • Page 34: Line Fuses For The Optical System

    Instructions for Use ® Surgical Laser Unit Limax 6.2.13 Line Fuses for the Optical System If current consumption is too high in the laser circuit, the optics line fuses (11, Fig. 6-2) will be tripped. Pushing them back in again reactivates them. 6.2.14 Equipotential Bonding Pin The equipotential bonding pin (12, Fig.

  • Page 35: Vac Mcb Socket

    Instructions for Use ® Surgical Laser Unit Limax 6.2.16 VAC MCB Socket Connect the MCB cable to the MCB socket of the VAC (18, Fig. 6-2) and then to the MCB socket of the ® ® Limax 120, see section 6.2.4 “MCB Socket Limax 120”, page 29.

  • Page 36: Vac Rating Plate

    Instructions for Use ® Surgical Laser Unit Limax 6.2.18 VAC Rating Plate The rating plate of the smoke evacuator (19, Fig. 6-2) is located on the rear side of the smoke evacuator U-version rating plate 6.2.19 Serial Number Structure ® The serial numbers of the Limax 120 and the VAC are part of the information provided on the respective rating plate.

  • Page 37: Vac Mains Connection

    Instructions for Use ® Surgical Laser Unit Limax 6.2.20 VAC Mains Connection The mains connector socket (4) of the VAC is located on the rear panel of the unit (Fig. 6-2). The assembly also includes an ON/OFF switch (3) and 2 line fuses (2).

  • Page 38: Setting Up The Limax ® 120

    Instructions for Use ® Surgical Laser Unit Limax ® 6.3.1 Setting up the Limax The unit must be set up so that the mains cables can be easily disconnected on the rear panel of the unit. Danger of injury from electric shock in the event of incorrect mains connection! ®...

  • Page 39: Relocating The Unit

    Instructions for Use ® Surgical Laser Unit Limax 6.3.2 Relocating the Unit Danger of damage due to shocks and vibrations! Move the unit carefully to prevent the optical components from being exposed to heavy shocks and vibrations. ® If you need to relocate the Limax 120 inside the same building, remove the key and keep •...

  • Page 40: Installation And Initial Start-Up

    Instructions for Use ® Surgical Laser Unit Limax 6.3.3 Installation and Initial Start-Up The installation and first start-up of the device may only be performed by Gebrüder Martin or an authorized service partner. For further information, please refer to section 6.3.1 “Setting up ®...
  • Page 41 Instructions for Use ® Surgical Laser Unit Limax Moreover, the following supplementary provisions must be observed: ® The Limax 120 may be operated only by qualified and duly authorized personnel. These • users must be fully familiar with the laser system and have a complete understanding of all safety measures required.

  • Page 42: Measures To Be Taken Prior To Using The Laser System

    Instructions for Use ® Surgical Laser Unit Limax Measures to Be Taken Prior to Using the Laser System Dangerous laser radiation! Guard the laser area against access by unauthorized persons. Install laser warning sign(s) • and warning lamp(s) at all doors leading to the laser area. •...

  • Page 43: Controls, Indicators And Display Elements

    Instructions for Use ® Surgical Laser Unit Limax Controls, Indicators and Display Elements Fig. 6-6: Controls, Indicators and Display Elements 1 Display 2 Emergency Stop switch 3 STOP symbol with indicator 4 SMAplus laser fiber connecting socket 5 Luer-lock socket for AIR (purge air) see section 6.10, page 55 6 LASER ACTIVE indicator 7 Keylock switch 8 Keypad...

  • Page 44: Keylock Switch

    Instructions for Use ® Surgical Laser Unit Limax 6.6.1 Keylock Switch The keylock switch (7, Fig. 6-6) is used to turn the unit on and off. Vertical key position: unit switched off. Horizontal key position: unit switched on. The key can be withdrawn only in vertical position (0). The keylock switch does not disconnect the unit from the power supply system! 6.6.2 Emergency Stop Switch...

  • Page 45: Stop Indicator

    Instructions for Use ® Surgical Laser Unit Limax 6.6.3 STOP Indicator ® To switch on the Limax 120 via the keylock switch, the Emergency Stop switch must be in pulled-out (deactivated) position (see also section 6.6.2 “Emergency Stop Switch”, page 44). If you try to turn on the laser with the keylock switch while the Emergency Stop switch is still activated (button pushed in), the STOP indicator (3, Fig.

  • Page 46: Smaplus Fiber Connecting Socket

    Instructions for Use ® Surgical Laser Unit Limax 6.6.5 SMAplus Fiber Connecting Socket The fiber connecting socket (4, Fig. 6-6) serves to connect laser fibers featuring an SMAplus plug. The fiber plug is constantly monitored for correct connection. Only when a laser fiber has been correctly connected can the unit be switched to LASER READY.

  • Page 47: Keypad

    Instructions for Use ® Surgical Laser Unit Limax 6.6.7 Keypad VAC button (blue LED) Pressing this button switches the smoke evacuator on or off. If the current program includes parameter settings for the smoke evacuator, these will be automatically activated with the program. If no smoke evacuator parameters are stored in the current program and the evacuator is used nonetheless, default settings will be used, see also section 6.20.1 “Standard Program”, page 68.
  • Page 48 Instructions for Use ® Surgical Laser Unit Limax The PILOT and LASER READY buttons are blocked during laser light emission. • All other buttons can be operated also during laser activation. • Pressing the STANDBY button switches the laser from LASER READY mode (yellow LED) to STANDBY mode (green LED).

  • Page 49: Rotary Switch With Backlighting

    Instructions for Use ® Surgical Laser Unit Limax 6.6.8 Rotary Switch with Backlighting ® All settings on the Limax 120 are made with the rotary switch (10, Fig. 6-6) that can be both rotated and operated axially (double-function pushbutton). It is inactive after starting the ®...

  • Page 50: Display

    Instructions for Use ® Surgical Laser Unit Limax 6.6.9 Display Active field (4) – The highlighted field • (orange) shows the parameter which can now be adjusted. Laser status indicator (6) • see section 6.6.10 “Laser Status Indicator”, page 51. Date and time (7) The format of date and time depends on the selected menu language.

  • Page 51: Laser Status Indicator

    Instructions for Use ® Surgical Laser Unit Limax 6.6.10 Laser Status Indicator No laser fiber connected ® The Limax 120 can be set but cannot be activated. LASER STANDBY An appropriate laser fiber has been connected. ® The Limax 120 can be set as well as activated. LASER READY ®...

  • Page 52: Filter Life

    Instructions for Use ® Surgical Laser Unit Limax 6.6.11 FILTER LIFE The FILTER LIFE indicator (11, Fig. 6-6) indicates the residual capacity of the main filter as follows: Indicator, green The main filter is still new and in good working order. Indicator, yellow The residual capacity of the main filter is less than one third.

  • Page 53: Applied Parts

    Instructions for Use ® Surgical Laser Unit Limax Applied Parts ® The defined standard applied part according to IEC 60601-1 for the Limax 120 is the Bare Fiber Universal, 400 µm: REF 79-700-40-04. Other accessories are listed in section 8.4.1 “List of Approved Accessories”, page 94. These parts are “type B”...

  • Page 54: Checking The Laser Fiber With The Pilot Laser

    Instructions for Use ® Surgical Laser Unit Limax Checking the Laser Fiber with the Pilot Laser Before starting the therapy, and also after replacement, the laser fiber must be checked as follows: Press PILOT button and set pilot beam brightness to maximum (100%) using the •...

  • Page 55: Air (Purge Air)

    Instructions for Use ® Surgical Laser Unit Limax 6.10 AIR (Purge Air) ® At its front, the Limax 120 offers purge air, see Luer-lock socket connector (4, Fig. 6-1), for clearing the plume generated during laser application from the beam path of the laser applicator.

  • Page 56: Compressed-Air Hose

    Instructions for Use ® Surgical Laser Unit Limax 6.10.1 Compressed-Air Hose A compressed-air hose with an elbow plug for connection to a central gas supply system of type Dräger (REF 78-215-03-04) is available from the Martin Service Center, see section 2.2 “Hotline”, page 11.

  • Page 57: Testing The Purge Air Flow

    Instructions for Use ® Surgical Laser Unit Limax 6.10.2 Testing the Purge Air Flow Dangerous laser radiation! Be aware that laser light is emitted as soon as the laser pedal is operated beyond the switching point (in LASER READY mode)! Never operate the laser pedal (3, Fig.

  • Page 58: Connecting The Sterile Air Filter

    Instructions for Use ® Surgical Laser Unit Limax 6.11.1 Connecting the Sterile Air Filter Prior to each use of the purge air function, make sure that a sterile air filter has been directly connected ® to the Luer-lock socket of the Limax 120 (see section 6.6.6 “Luer-Lock Socket for AIR (Purge Air)”, page 46).

  • Page 59: Connecting Applicators

    Instructions for Use ® Surgical Laser Unit Limax 6.11.3 Connecting Applicators Purged laser fiber 1 AIR tube 2 Laser fiber 3 SMAplus plug 4 Luer-lock plug 5 Sterile AIR filter To use a purged laser fiber (2), the AIR tube (1) attached to the proximal laser fiber end must be connected to the sterile AIR filter (5) using the Luer-lock connector (4).

  • Page 60: Vac (Smoke Evacuator)

    Instructions for Use ® Surgical Laser Unit Limax 6.12 VAC (Smoke Evacuator) ® The smoke evacuator (VAC) (5, Fig. 6-1) integrated into the Limax 120 eliminates the smoke or plume generated during laser therapy. The VAC includes a high-performance air filter (ULPA standard) to purify the air inside the unit before it is exhausted into the ambient air.

  • Page 61: Replacing The Main Filter

    Instructions for Use ® Surgical Laser Unit Limax 6.12.2 Replacing the Main Filter Note that only Gebrüder Martin main filters (ULPA standard) may be used! The residual capacity of the filter is indicated, as well as the need to replace it, see section 6.6.11 “FILTER LIFE”, page 52.

  • Page 62: Connecting The Suction Hose

    Instructions for Use ® Surgical Laser Unit Limax 6.12.3 Connecting the Suction Hose The main filter has 2 connectors (1, 2) for suction hoses with internal diameters of 10 mm (1) and 22 mm (2). Close the non-used connector with the cap •...

  • Page 63: Vac Performance During Laser Operation

    Instructions for Use ® Surgical Laser Unit Limax 6.12.4 VAC Performance During Laser Operation Operating the laser pedal (3, Fig. 6-18) until it reaches the switching point activates stage 1 along with the work suction mode of the VAC. Pressing the laser pedal further down (beyond the switching point) activates stage 2 and laser light is emitted in addition.

  • Page 64: System Test

    Instructions for Use ® Surgical Laser Unit Limax 6.14 System Test Turn on the laser unit (see section 6.13 • ® “Switching on the Limax 120”, page 63). ® During start-up, the Limax 120 routinely performs a self-test for approx. 10–30 s. The blue start-up screen shows the ®...

  • Page 65: Foot Switch With Swap ® Pedal

    Instructions for Use ® Surgical Laser Unit Limax ® 6.15 Foot Switch with SWAP Pedal The foot switch with guard (1) stands securely on the floor. Use the connecting cable supplied to connect it to the foot switch socket (8, Fig. 6-2). The foot switch has 2 pedals.

  • Page 66: Using The Laser Light

    Instructions for Use ® Surgical Laser Unit Limax 6.16 Using the Laser Light Danger of injury! All persons present in the room, including the patient, must now wear laser protective goggles. It is highly advisable to check, prior to operating the LASER READY button, that everyone present complies with this requirement.

  • Page 67: Turning Off The Limax ® 120

    Instructions for Use ® Surgical Laser Unit Limax ® 6.18 Turning off the Limax Rotate keylock switch key from horizontal to vertical position. • Danger of injury! A laser unit that is not being used must be protected against unauthorized use. To comply with this requirement, remove key and store it in a safe place.

  • Page 68: Working With Programs

    Instructions for Use ® Surgical Laser Unit Limax 6.20 Working with Programs Setting each parameter individually prior to each operation would be a cumbersome and time- consuming process, given the multitude of setting options. Creating and storing programs facilitates your setting procedures a lot. Settings used repeatedly can be easily saved as a ®...

  • Page 69: Selecting Programs

    Instructions for Use ® Surgical Laser Unit Limax 6.20.2 Selecting Programs List of last-used programs (LUPs) A maximum of 4 program names plus the standard program are directly displayed in the main menu. The 4 program names are always identical with the 4 last-used programs. The currently selected program is always displayed in top position.
  • Page 70 Instructions for Use ® Surgical Laser Unit Limax The Programs menu appears and the notice “Edit program” is displayed in the information line. Activate the Select function. • This creates a list of all stored programs that is displayed in the menu section of the screen. When navigating through the list of programs, a preview of the currently highlighted program will always be offered in the left part of the...

  • Page 71: Adjusting Programs

    Instructions for Use ® Surgical Laser Unit Limax 6.20.3 Adjusting Programs The active program can be changed and saved. Select the program you wish to modify (see also section 6.20.2 “Selecting Programs”, • page 69) As soon as a laser parameter of the current program has been changed, the notice modified will be displayed to the right of the name of the program.
  • Page 72 Instructions for Use ® Surgical Laser Unit Limax Depending on the selected operating mode, up to 2 pulse parameters can be set: Pulse duration (0.1–10 s) • Sets the length of one laser pulse Pulse pause (0.1–10 s) • Sets the pause between 2 pulses in pulse mode In addition, both the “WORK SUCTION VAC”...

  • Page 73: A/B Program

    Instructions for Use ® Surgical Laser Unit Limax ® 6.20.6 Creating a SWAP A/B Program ® The Limax 120 allows you to change a program into an A/B program, in which case you can ® select among 2 parameter sets. This is called SWAP mode.

  • Page 74: Saving Modified Programs

    Instructions for Use ® Surgical Laser Unit Limax The large part (left) of the parameter section shows the active parameter set (here: A). These parameters can now be modified as required. The inactive parameters are highlighted in green and cannot be selected. To switch between the 2 parameter sets (A and B) of the program, select SWAP A/B...
  • Page 75 Instructions for Use ® Surgical Laser Unit Limax Save under Select Programs/Save under • — This opens the Text Editor. Use the Text Editor to adjust the name of the program: To select letters/characters, turn the rotary • switch as required. To enter characters, press the rotary switch •...

  • Page 76: Overwriting Programs

    Instructions for Use ® Surgical Laser Unit Limax 6.20.8 Overwriting Programs Overwrite Select Programs/Overwrite • A confirmation query is displayed before the stored program can be overwritten with new parameters. Acknowledge the confirmation query • with Yes. This saves the program with the new parameters.

  • Page 77: Deleting Programs

    Instructions for Use ® Surgical Laser Unit Limax 6.20.9 Deleting Programs Delete always relates to the currently active program. Select Programs/Delete • — A confirmation query is displayed before the current program can be deleted. Acknowledge the confirmation query with •...
  • Page 78 Instructions for Use ® Surgical Laser Unit Limax Basic suction The “basic suction” parameter can be set across a range of 0–45%. Work suction The “work suction VAC” parameter can be set across a range of 30–100%. However, the “work suction VAC” setting can never be lower than the “basic suction”...

  • Page 79: Air Program

    Instructions for Use ® Surgical Laser Unit Limax 6.20.11 AIR program Select AIR (purge air) • 6.20.12 Setting the Work Flow AIR Basic flow The “basic flow AIR” parameter can be set across a range of 0–40%. Work flow The “work flow AIR” parameter can be set across a range of 10–100%.

  • Page 80: Air/Vac Off

    Instructions for Use ® Surgical Laser Unit Limax 6.20.13 AIR/VAC OFF If the AIR and/or VAC buttons are deactivated, the Work SUCTION VAC and/or Work FLOW AIR parameter fields are grayed out. Pressing the AIR and/or VAC buttons reactivates these functions, see section 6.6.7 “Keypad”, page 47.

  • Page 81: Setup

    Instructions for Use ® Surgical Laser Unit Limax 6.20.14 Setup The Setup menu enables you to adjust certain device settings. Select Setup • — This displays the Setup menu. Settings can be made via the following submenus: Language Pilot Logfile Screen Timeouts Date &...

  • Page 82: Pilot Laser

    Instructions for Use ® Surgical Laser Unit Limax 6.20.16 Pilot Laser Select Setup/Pilot • Pilot brightness The brightness (intensity) of the pilot laser can be set across a range of 1– 100%. Pilot flash frequency The pilot laser can be set across a range starting with CW (continuous wave) and ending with 5 Hz pulsed mode (pulse frequency range: 0.5–5 Hz).

  • Page 83: Logfile/Save/Reset

    Instructions for Use ® Surgical Laser Unit Limax 6.20.17 Logfile/Save/Reset Select Logfile/Save/reset • This function registers the current counter readings in the logfile and resets the counters to zero. The log entry is marked with the date and time when the summation process started.

  • Page 84: Overview

    Instructions for Use ® Surgical Laser Unit Limax 6.20.18 Overview Select Logfile/Overview • — The logfile is displayed. It enables you to check how much laser energy and how many laser pulses have been applied. These parameters are saved manually or automatically for each treatment together with the corresponding starting time and can be accessed by the user at any time.

  • Page 85: Timeouts

    Instructions for Use ® Surgical Laser Unit Limax 6.20.20 Timeouts Setup/Timeouts Menu timeout The menu timeout defines for how long the rotary switch remains active after its last use. Luminous ring white > timeout (30 s – 5 min) > luminous ring off Setting timeout The setting timeout defines the period of time...

  • Page 86: Date & Time

    Instructions for Use ® Surgical Laser Unit Limax 6.20.21 Date & Time Setup/Date & Time As date and time are used as logfile entries for the recorded laser applications, it is necessary to keep both settings current. Following selection of Date & Time, the dialog Set date/time is displayed.

  • Page 87: Alerts

    Instructions for Use ® Surgical Laser Unit Limax 6.20.22 Alerts Setup/Alerts Select Alert and set operating tone volume. • Select Laser activation tone and set • volume. IEC 60601-1 specifies a minimum loudness level for the laser activation signal. This level can be increased at your choice.

  • Page 88: Cleaning And Disinfecting

    Instructions for Use ® Surgical Laser Unit Limax Cleaning and Disinfecting The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to observe your local cleaning and hygiene regulations! Danger of serious injury when using defective accessories! Using a unit that is not in perfect working order or using defective accessories can pose a hazard to patients or users and compromise the proper functioning of the device.

  • Page 89: Disposal Of Consumables

    Instructions for Use ® Surgical Laser Unit Limax Disposal of consumables Disposable products such as single-use fibers, sterile air filters and air tubes must be handled as infectious materials after use and disposed of accordingly. VAC main filters must also be disposed of as infectious materials once their operating hours have elapsed.

  • Page 90: Maintenance

    Instructions for Use ® Surgical Laser Unit Limax Maintenance Periodic Maintenance Repairs may only be carried out by service technicians specially authorized by Gebrüder Martin. Inspection & Maintenance Maintenance interval To Be Carried out by Checking the Emergency Stop prior to the first operation on hospital staff switch for proper functioning each day of use...

  • Page 91: Troubleshooting

    Instructions for Use ® Surgical Laser Unit Limax Troubleshooting 8.2.1 Information Displayed Process-related information is displayed in the information line of the screen (2, Fig. 6-9). Example: “Connect fiber”. 8.2.2 Other Malfunction To alert the user to system troubles that cannot be displayed on the screen, a malfunction indicator is provided in the bottom right corner of the control panel.

  • Page 92: Safety Check (Sc)

    Instructions for Use ® Surgical Laser Unit Limax Safety Check (SC) Safety checks may only be performed by Gebrüder Martin or by service partners specially authorized by Gebrüder Martin. The results of each check must be documented in the medical device logbook, and the proper working condition of the unit confirmed, by the person performing the check.
  • Page 93 Instructions for Use ® Surgical Laser Unit Limax Functional safety check is shown in IEC 62353 section 5 ] Check calibration with external power meter (acceptable tolerance: ±20%): 5 W/10 W/60 W/120 W Add on: Battery ] Check internal battery (U ≥2.8 V);...

  • Page 94: Accessories

    Instructions for Use ® Surgical Laser Unit Limax Accessories 8.4.1 List of Approved Accessories Accessories and disposable products may only be used with CE-marked laser equipment whose radiation safety complies with ISO 60825 requirements. Only original accessories as specified in the following list are permitted for use. This list of approved accessories is subject to revision and modification.
  • Page 95 Instructions for Use ® Surgical Laser Unit Limax Accessory Specifications Modular system for bare-fiber applications with suction connection Handle 79-311-00-04 Tuohy-Borst-Adapter, single use, sterile 79-311-03-04 Tip for Clip-on Smoke Evacuation Handle 79-311-01-04 Fiber holder Flexpen 2.0 Clip-on Smoke Evacuation Handle, 80-060-02-04 single use, sterile 10-cm tip with bending mandrel...
  • Page 96 Instructions for Use ® Surgical Laser Unit Limax Accessory Specifications ® Cable linking Limax 120 interface and MCB connecting cable 08-507-00-81 interface of integrated VAC Main filter for integrated VAC (ULPA standard); residual capacity and Main filter for integrated VAC 80-060-01-04 need for replacement are indicated on ®...

  • Page 97: Hazard Distances (Nohd)

    Instructions for Use ® Surgical Laser Unit Limax Accessory Specifications Washing tray for autoclavable Washing tray consisting of: 55-803-72-04 focusing handpiece and ® Tray basket marTray 55-804-24-01 autoclavable supply fiber, fully 240 × 251 × 44 mm (size ½) assembled Tray basket cover, 243 ×...

  • Page 98: Ecological Information

    Instructions for Use ® Surgical Laser Unit Limax Ecological Information Packaging Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many parts of the packaging as possible. If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or domestic garbage.

  • Page 99: Guidelines And Manufacturer's Declaration On Electromagnetic Compatibility (Emc)

    Instructions for Use ® Surgical Laser Unit Limax Guidelines and Manufacturer’s Declaration on 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 Limax 120 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 100 Instructions for Use ® Surgical Laser Unit Limax Guidance and manufacturer’s declaration according to IEC 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emissions The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment.
  • Page 101 Instructions for Use ® Surgical Laser Unit Limax Guidance and manufacturer’s declaration according to IEC 60601-1-2 clause 6.8.3.201 b) Table 204: Electromagnetic emissions The device is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
  • Page 102 Instructions for Use ® Surgical Laser Unit Limax Recommended separation distances for portable and mobile RF communication equipment ® and the Gebrüder Martin Limax 120 surgical laser unit according to IEC 60601-1-2, clause 6.8.3.201 b), Table 206 The device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 103: Technical Data

    Instructions for Use ® Surgical Laser Unit Limax Technical Data ® ® Designation Specification Limax 120/Limax Type of laser Diode-pumped Nd:YAG laser Laser wavelength 1,320 ±10 nm Laser output power 5–120 W Operating modes Continuous wave (cw) Single pulse: pulse on-time: 0.1–10 s Pulse train, adjustable: pulse on-time:...
  • Page 104 Instructions for Use ® Surgical Laser Unit Limax ® ® Designation Specification Limax 120/Limax Smoke evacuator (VAC) integrated ® MCB (Martin Communication Bus), control via Limax VAC control VAC mains connection, 220–240 VAC; 50/60 Hz (100/110/120/127/220–240 VAC; 50/60 Hz) version E (U) VAC mains current, max.

  • Page 105: Quick Instructions For Use

    Instructions for Use ® Surgical Laser Unit Limax Quick Instructions for Use This summary is not intended as a substitute for this user manual, which must be observed and followed in its entirety! Preparation Read user manual. • ® Connect Limax 120 and VAC to power supply ®...
  • Page 106 Instructions for Use ® Surgical Laser Unit Limax Select program Use rotary pushbutton to set laser power, • operating mode, pulse parameters, work suction VAC and work airflow AIR Check Inspect laser fiber for cleanness and connect it to • laser unit Activate laser unit Operate LASER READY button (LED lights up...
  • Page 107 Instructions for Use ® Surgical Laser Unit Limax Revision 5...
  • Page 108 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 +49 7461 706-193 info@klsmartin.com ·...

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