KLS Martin group LIMAX 120 Operating Instructions Manual

KLS Martin group LIMAX 120 Operating Instructions Manual

Surgical laser unit
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Surgical Laser Unit
Operating Instructions
V. 2.0-EN (03.12)

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Summary of Contents for KLS Martin group LIMAX 120

  • Page 1 Surgical Laser Unit Operating Instructions V. 2.0-EN (03.12)
  • Page 2: Table Of Contents

    Operating Instructions ® Surgical Laser Unit Limax Table of Contents Product Liability and Warranty ............6 General Information ................6 Scope of Delivery .................. 6 Intended Use ..................7 Warranty ..................... 7 User’s Inspection .................. 7 Hotline....................8 Notices Concerning these Operating Instructions ......8 Validity of this User Manual ..............
  • Page 3 Operating Instructions ® Surgical Laser Unit Limax Front Side ..................24 Rear Panel ..................26 5.4.1 Drawer......................27 5.4.2 Loudspeaker ....................27 5.4.3 Laser MCB Interface ..................28 5.4.4 Service Interface .................... 28 5.4.5 Service Connector ..................28 5.4.6 Accessory Port ....................28 5.4.7 Interlock / Warning Connector .................
  • Page 4 Operating Instructions ® Surgical Laser Unit Limax 6.11 Using the Laser ................... 52 ® 6.12 Turning off the Limax 120 ..............52 6.13 Emergency Shutdown ................53 6.14 Working with Programs ................ 53 6.14.1 Standard Program ..................54 6.14.2 Selecting Programs ..................55 6.14.3 Adjusting Programs ..................
  • Page 5 Operating Instructions ® Surgical Laser Unit Limax 12.3 Disposal of the Unit ................84 12.4 Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility ..................85 V. 2.0...
  • Page 6: Product Liability And Warranty

    We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·...
  • Page 7: Intended Use

    Operating Instructions ® Surgical Laser Unit Limax Intended Use ® 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 8: Hotline

    Operating Instructions ® Surgical Laser Unit Limax Hotline Should you have any questions on how to handle the unit / product or question on its • clinical application, please do not hesitate to contact the Product Management: Tel: +49 7461 706-243 Fax: +49 7461 706-190 Should you have any technical questions, please do not hesitate to turn to our...
  • Page 9: Validity Of This User Manual

    Operating Instructions ® Surgical Laser Unit Limax Validity of this User Manual These Operating Instructions are valid from hardware / software version 0201. ® The software currently installed in your Limax 120 is indicated on the start-up screen (see section 6.9 “System Test” page 50). If the software version indicated on the screen does not comply with the version number specified above, please do not hesitate to contact the Service of Gebrüder Martin GmbH &...
  • Page 10: Safety Notices & Instructions

    Operating Instructions ® Surgical Laser Unit Limax Safety Notices & Instructions General Regulations MPG (MDA) Medical Devices Act 93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices Safety of laser products – Part 1: Equipment classification and DIN EN 60825-1: 2008-05 requirements Medical electrical equipment –...
  • Page 11: Installation And Initial Start-Up

    Operating Instructions ® Surgical Laser Unit Limax Installation and Initial Start-Up The installation and first start-up of the device may only be performed by Gebrüder Martin GmbH & Co. KG or an authorized service partner. CAUTION Danger of injury! Any person involved in any way in the handling of this device must be fully familiar with the contents of these Operating Instructions.
  • Page 12: Laser Safety

    Operating Instructions ® Surgical Laser Unit Limax Operating staff training must be repeated on an annual basis (refresher courses); all • participants in such training must confirm their participation in writing. When the unit is not in use, it must be protected against unauthorized access (e.g. by •...
  • Page 13: Explosion And Fire Hazards

    Operating Instructions ® Surgical Laser Unit Limax At least once a year, the persons working in the laser area must be informed on relevant • safety requirements and measures to be taken, and must be instructed in the correct use of the device.
  • Page 14: Protecting The Patient

    Operating Instructions ® Surgical Laser Unit Limax Protecting the Patient Under any circumstances, the patient must be protected against injuries that could be caused by improper use of the laser. This means in particular: protecting his / her eyes with suitable antilaser goggles or by using a •...
  • Page 15: Safety Instructions Relating To The Pilot Laser

    Operating Instructions ® Surgical Laser Unit Limax Safety Instructions Relating to the Pilot Laser CAUTION Danger of eye damage! Upon switching on the unit, visible pilot laser radiation is emitted at the distal end of the applicator system (fiber tip or laser focusing handpiece) unless the pilot laser has been switched off by operating the backlit pilot laser button (yellow LED).
  • Page 16: Grounding The Unit

    Operating Instructions ® Surgical Laser Unit Limax Only the mains cables provided may be used. Note that the mains cables for the laser and • the smoke evacuator (VAC) are not the same. Assign correctly! The mains cables and their connectors must be in perfect working order and may never be •...
  • Page 17: Employment Restriction

    Operating Instructions ® Surgical Laser Unit Limax To ensure that the selected irradiation parameters cannot be accidentally changed during • the laser treatment, all control buttons as well as the rotary switch are blocked (inoperable) as long as the foot switch is held down. Except for VAC, AIR and STAND BY. •...
  • Page 18: Warning & Information Labels

    Operating Instructions ® Surgical Laser Unit Limax 3.16 Warning & Information Labels Label located on the rear panel, with information on max. laser light power outputs (see also section 5.4 “Rear Panel”, page 26. Label located next to the laser exit opening, beside SMAplus fiber connecting socket (see illustration below).
  • Page 19: Laser Smoke

    Operating Instructions ® Surgical Laser Unit Limax 3.17 Laser Smoke CAUTION Laser smoke (plume) could contain viable tissue particles! For applications generating smoke gases, it is mandatory to use the integrated smoke evacuator. 3.18 Proper Handling of Laser Fibers CAUTION Danger of bodily harm as a result of non-observance of the instructions for use! The user instructions supplied with the laser fibers must be carefully read prior to using the products.
  • Page 20: Description Of The Unit

    Operating Instructions ® Surgical Laser Unit Limax Description of the Unit 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 21: The Nd:yag Laser

    Operating Instructions ® Surgical Laser Unit Limax The Nd:YAG Laser The Nd:YAG laser is a solid-state laser which emits high-intensity radiation at a wavelength of 1.320 nm (belonging to the near infrared range of the spectrum). The medium used is a cylindrical YAG (yttrium-aluminum-garnet) crystal doped (mixed) with Nd ions (neodymium ions).
  • Page 22 Operating Instructions ® Surgical Laser Unit Limax ® The application possibilities of the Limax 120 laser are numerous. As the laser light is ® delivered through thin, flexible laser fibers, the Limax 120 can be universally used for open-surgical as well as endoscopic applications. It is particularly useful in cases where difficult anatomical conditions require high-precision work to be performed in highly restricted surgical sites.
  • Page 23: Putting The Limax ® 120 Into Operation

    Operating Instructions ® Surgical Laser Unit Limax ® Putting the Limax 120 into Operation General Information ® The Limax 120 is a microprocessor-controlled surgical laser incorporating the latest technology. The unit generates laser light in the infrared wavelength range (1320 nm) with a maximum laser output power of 120 watts, available to users via different laser fibers and applicators.
  • Page 24: Front Side

    Operating Instructions ® Surgical Laser Unit Limax Front Side 1 Control panel 2 Luer-lock socket (AIR) 3 Smoke evacuator (VAC) ® The functions of all the controls and indicators (1) of the Limax 120 are described in detail in section 6.1 “Controls, Indicators and Display Elements”, page 36. For compressed air (2), see section 6.6 “Compressed Air Supply”, page 47, and detailed information on the smoke evacuator (3) can be found in section 6.7 “Smoke Evacuator (VAC)”, page 49.
  • Page 25 Operating Instructions ® Surgical Laser Unit Limax V. 2.0...
  • Page 26: Rear Panel

    Operating Instructions ® Surgical Laser Unit Limax Rear Panel V. 2.0...
  • Page 27: Drawer

    Operating Instructions ® Surgical Laser Unit Limax Drawer MCB interface Integrated smoke evacuator Loudspeaker Information label Laser MCB interface VAC rating plate RS 232 service laptop interface Laser rating plate Service connector (optional, no function) VAC air discharge Accessory port VAC mains connector socket Interlock / Warning Integrated smoke evacuator (VAC)
  • Page 28: Laser Mcb Interface

    Operating Instructions ® Surgical Laser Unit Limax 5.4.3 Laser MCB Interface This Laser MCB interface (Fig. 5.4, (3)) is intended for connecting the integrated smoke evacuator using the MCB cable. See section 5.4.13 “MCB Interface of the Smoke Evacuator”, page 32. 5.4.4 Service Interface ®...
  • Page 29: Interlock / Warning Connector

    Operating Instructions ® Surgical Laser Unit Limax 5.4.7 Interlock / Warning Connector Connector for door interlock and warning lamps (Fig. 5.4, (7)): Interlock Breaking the contact switches the laser from LASER READY to STANDBY. At the same time, laser light output is blocked.
  • Page 30: Foot Switch Connector

    Operating Instructions ® Surgical Laser Unit Limax 5.4.8 Foot Switch Connector Socket for connecting the foot switch (Fig. 5.4, (8)) for laser activation. See section 6.10 “Foot Switch”, page 51 for a functional description. Position the foot switch next to the surgical site in such a way that the user can easily reach it with his / her foot, then plug the connecting cable with the black connector into the foot switch connecting socket (guide lug must...
  • Page 31: Line Fuses For The Optical System

    Operating Instructions ® Surgical Laser Unit Limax 5.4.10 Line Fuses for the Optical System If current consumption is too high in the laser circuit, the optics line fuses (Fig. 5.4, (10)) will be tripped. Pushing them back in again reactivates them. 5.4.11 Equipotential Bonding Pin The equipotential bonding pin (Fig.
  • Page 32: Mcb Interface Of The Smoke Evacuator

    Operating Instructions ® Surgical Laser Unit Limax 5.4.13 MCB Interface of the Smoke Evacuator The MCB interface of the smoke evacuator (Fig. 5.4, (13)) must be connected with the MCB interface of the laser (see section 5.4.3 “Laser MCB Interface”, page 28) using the MCB cable.
  • Page 33: Laser Rating Plate

    Operating Instructions ® Surgical Laser Unit Limax 5.4.15 Laser Rating Plate The rating plate is located on the rear panel of the unit (see also Fig. 5.4, (15)). For technical specifications, see section 9.1 “Technical Data”, page 77. U version rating plate 5.4.16 Smoke Evacuator Rating Plate (VAC) The rating plate of the smoke evacuator (Fig.
  • Page 34: Mains Connection For Smoke Evacuator (Vac)

    Operating Instructions ® Surgical Laser Unit Limax 5.4.17 Mains Connection for Smoke Evacuator (VAC) The mains connector socket assembly of the smoke evacuator (Fig. 5.4, (18)) includes an ON / OFF switch (3) and two line fuses (2). The evacuator must be connected to a separate –...
  • Page 35: Measures To Be Taken Prior To Using The Laser System

    Operating Instructions ® Surgical Laser Unit Limax Measures to Be Taken Prior to Using the Laser System CAUTION 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. Provide protective goggles for all persons present in the laser area (incl.
  • Page 36: Operating The Limax ® 120

    Operating Instructions ® Surgical Laser Unit Limax ® Operating the Limax CAUTION Potential hazard due to maloperation! Using the controls or adjusting functions of the laser in ways other than those described in this user manual can lead to dangerous irradiation! Controls, Indicators and Display Elements Display “LASER ACTIVE”...
  • Page 37: Keylock Switch

    Operating Instructions ® Surgical Laser Unit Limax 6.1.1 Keylock Switch The keylock switch (Fig. 6.1, (7)) 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). NOTICE The keylock switch disconnects the unit all-pole from the power supply network! 6.1.2...
  • Page 38: Stop Indicator

    Operating Instructions ® Surgical Laser Unit Limax 6.1.3 STOP Indicator ® To switch on the Limax 120 via the keylock switch, the emergency stop button must be in pulled-out (deactivated) position (see also section 6.1.2 “Emergency Stop Switch”, page 37). 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 (Fig.
  • Page 39: Fiber Connecting Socket

    Operating Instructions ® Surgical Laser Unit Limax 6.1.5 Fiber Connecting Socket The fiber connecting socket (Fig. 6.1, (4)) 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 40: Rotary Switch With Backlighting

    Operating Instructions ® Surgical Laser Unit Limax LASER READY button (yellow LED) Pressing this button switches the unit to LASER READY (yellow LED), provided a suitable laser fiber has been connected. The pilot laser is activated automatically in this state. PILOT button (yellow LED) Pressing this button activates the pilot laser (aiming beam) in STANDBY mode, provided a laser fiber has been...
  • Page 41 Operating Instructions ® Surgical Laser Unit Limax OFF (ring not illuminated) Rotary switch inactive. This is the initial state after turning on the unit, and it is the state into which the laser automatically lapses if it has not been operated for some time (menu timeout).
  • Page 42: Display

    Operating Instructions ® Surgical Laser Unit Limax 6.1.8 Display The laser display (Fig. 6.1, (1)) consists of the following elements: Name (1) of the currently set laser • program – with notice “modified” (5) if the stored program has been changed in any Information line (2) for notices or actions •...
  • Page 43: Laser Status Indicator

    Operating Instructions ® Surgical Laser Unit Limax 6.1.9 Laser Status Indicator No laser fiber connected The laser can be set but cannot be activated. LASER STANDBY An appropriate laser fiber has been connected. The laser can be set as well as activated. LASER READY The laser has been activated and is ready for light emission.
  • Page 44: Filter Life

    Operating Instructions ® Surgical Laser Unit Limax 6.1.10 FILTER LIFE Filter indicator, green The filter is still new and in good working order. Filter indicator, yellow The residual capacity of the filter is less than one third. A new filter should be kept available for replacement. Filter indicator, red The filter is heavily soiled / clogged already.
  • Page 45: Connecting The Laser Fiber

    Operating Instructions ® Surgical Laser Unit Limax Connecting the Laser Fiber NOTICE The laser features a coded SMA (SMAplus) socket which ensures that laser activation is possible only if a laser fiber with an SMAplus plug has been connected. ® Remove the laser fibers and applicators permitted for use with the Limax 120 (see •...
  • Page 46: Checking The Laser Fiber With The Pilot Laser

    Operating Instructions ® 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 47: Replacing The Laser Fiber

    Operating Instructions ® Surgical Laser Unit Limax Replacing the Laser Fiber To replace the laser fiber, proceed as follows: Set laser to STANDBY: Press STANDBY button to deactivate laser (LED of STANDBY button • must light up green!) At the proximal end of the laser fiber, loosen the screw cap of the SMAplus plug, then •...
  • Page 48 Operating Instructions ® Surgical Laser Unit Limax Sterile air filter In any case, a sterile air filter must be directly connected to the Luer-lock connector of the laser. The filter features a Luer-lock connector as well. Depending on the fiber used, different connection options are available: Irrigated fiber ®...
  • Page 49: Smoke Evacuator (Vac)

    Operating Instructions ® Surgical Laser Unit Limax Smoke Evacuator (VAC) The integrated smoke evacuator is intended for removing the smoke (surgical plume) generated during operations. An external suction hose is connected to the smoke filter on the front panel of the ®...
  • Page 50: Switching On The Unit

    Operating Instructions ® Surgical Laser Unit Limax Switching on the Unit The red emergency stop switch must be in pulled-out position. • Insert key, then rotate it clockwise to horizontal position. It is not possible to remove the key when set to horizontal position.
  • Page 51: Foot Switch

    Operating Instructions ® Surgical Laser Unit Limax 6.10 Foot Switch The foot switch with its housing (1) stands securely on the floor. Use the connecting cable supplied to connect it to the foot switch socket (see section 5.4.8 “Foot Switch Connector”, page 30) located on the rear panel of the laser unit (item 8, section 5.4 “Rear Panel”, page 26).
  • Page 52: Using The Laser

    Operating Instructions ® Surgical Laser Unit Limax 6.11 Using the Laser CAUTION 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 53: Emergency Shutdown

    Operating Instructions ® Surgical Laser Unit Limax 6.13 Emergency Shutdown Push red emergency stop switch axially. • — This blocks light emission at once. Set keylock switch to vertical position. • ® Prior to restarting the Limax 120, make sure that the emergency stop button is in •...
  • Page 54: Standard Program

    Operating Instructions ® Surgical Laser Unit Limax 6.14.1 Standard Program The standard program is a basic program that can neither be deleted nor overwritten. If you wish to use this program in a modified form, you need to save it under a new name. These are the settings of the standard program: Laser power 10 W...
  • Page 55: Selecting Programs

    Operating Instructions ® Surgical Laser Unit Limax 6.14.2 Selecting Programs List of last-used programs (LUPs) A maximum of four program names plus the standard program are directly displayed in the main menu. The four program names are always identical with the four last-used programs. The currently selected program is always displayed in top position.
  • Page 56 Operating Instructions ® 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 screen.
  • Page 57: Adjusting Programs

    Operating Instructions ® Surgical Laser Unit Limax 6.14.3 Adjusting Programs The active program can be changed and saved. Select the program you wish to modify (see • also section 6.14.2 “Selecting Programs”, page 55) Select the > Laser power field with •...
  • Page 58: Create A/B Mode

    Operating Instructions ® Surgical Laser Unit Limax NOTICE The “work suction” and “work airflow” parameters can be adjusted even if the VAC and / or AIR buttons are off. However, they can be activated only if the respective button is ON. 6.14.4 Create A/B Mode ®...
  • Page 59: Saving Modified Programs

    Operating Instructions ® Surgical Laser Unit Limax The large part (left) of the parameter section shows the active part of the program (here: A). The active program can now be modified by selecting the parameter of your choice. The < SWAP A/B menu item enables you to exchange (swap) the two parts of the program.
  • Page 60 Operating Instructions ® 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 •...
  • Page 61: Overwriting Programs

    Operating Instructions ® Surgical Laser Unit Limax 6.14.6 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 62: Vac (Smoke Evacuator)

    Operating Instructions ® Surgical Laser Unit Limax Acknowledge the confirmation query with • > Yes — < BACK or > No returns you to the Programs menu, leaving the existing program unchanged. 6.14.8 VAC (Smoke Evacuator) Select > VAC (smoke evacuator) •...
  • Page 63 Operating Instructions ® Surgical Laser Unit Limax > Delay basic suction The (stop) delay time for the “basic suction” parameter can be set in steps across a range of 5 to 20 seconds. It can also be switched off completely (0 s) or set to “infinite” (∞). (The basic suction process is running continuously, starting after first foot switch release).
  • Page 64: Air (Compressed Air)

    Operating Instructions ® Surgical Laser Unit Limax 6.14.9 AIR (Compressed Air) Select > AIR (compressed air) • > Basic flow The “basic airflow” parameter can be set across a range of 0 % to 40 %. > Work flow The “work airflow” parameter can be set across a range of 10 % to 100 %.
  • Page 65: Air Vac Off

    Operating Instructions ® Surgical Laser Unit Limax 6.14.10 AIR VAC OFF If the VAC and / or AIR buttons are deactivated, the Work SUCTION VAC and / or Work FLOW AIR parameter fields are grayed out. Pressing the AIR / VAC buttons reactivates these functions.
  • Page 66: Language

    Operating Instructions ® Surgical Laser Unit Limax 6.15.1 Language Setup / Language Select the interactive language of your • choice. — Once you have made a selection, the screen will immediately be shown in the newly selected language. The > Setup menu will remain open.
  • Page 67: Logfile / Save / Reset

    Operating Instructions ® Surgical Laser Unit Limax 6.15.3 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 68: Overview

    Operating Instructions ® Surgical Laser Unit Limax 6.15.4 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 69: Timeouts

    Operating Instructions ® Surgical Laser Unit Limax 6.15.6 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 >...
  • Page 70: Date & Time

    Operating Instructions ® Surgical Laser Unit Limax 6.15.7 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 71: Alerts

    Operating Instructions ® Surgical Laser Unit Limax 6.15.8 Alerts Setup / Alerts Select > Alert and set operating tone • volume. Select > Laser activation tone and set • volume. DIN EN 60601 specifies a minimum loudness level for the laser activation signal. This level can be increased at your choice.
  • Page 72: Summary Operating Instructions

    Operating Instructions ® Surgical Laser Unit Limax Summary Operating Instructions Preparation Read user manual. • Connect unit to power supply • Laser cable: 230 V, 16 A, 50 / 60 Hz • VAC cable: 230 V, 10 A, 50 / 60 Hz Turn on unit Insert key in vertical position, then turn it to horizontal •...
  • Page 73 Operating Instructions ® Surgical Laser Unit Limax Activate laser unit Operate LASER READY button (LED lights up yellow) • Apply laser radiation Operate foot switch at stage 2 and apply laser light • Deactivate laser unit Operate STANDBY button (LED lights up green) •...
  • Page 74: Maintenance And Cleaning

    Operating Instructions ® Surgical Laser Unit Limax Maintenance and Cleaning NOTICE Repairs may only be carried out by service technicians specially authorized by Gebrüder Martin GmbH & Co. KG. Inspection & Maintenance Frequency / Interval To Be Carried out by: Checking the accessories prior to each operation hospital staff...
  • Page 75: Cleaning And Disinfecting

    Operating Instructions ® Surgical Laser Unit Limax Cleaning and Disinfecting Be sure to observe all local hygiene and processing regulations. NOTICE Never allow liquids to enter the unit through its openings (e.g. the SMAplus socket). For this reason, never use sprays for cleaning! NOTICE ®...
  • Page 76 Operating Instructions ® Surgical Laser Unit Limax Disposal of consumables Disposable products such as single-use fibers, sterile filters and air hoses must be handled as infectious materials after use and disposed of accordingly. VAC filters must also be disposed of as infectious materials once their operating hours have elapsed.
  • Page 77: Technical Description

    Operating Instructions ® Surgical Laser Unit Limax Technical Description Technical Data ® Designation Specification Limax Type of laser Diode-pumped Nd:YAG laser Laser wavelength 1.320 nm Laser output power 5 – 120 W Pulse types Continuous (cw) Single pulse: pulse on-time: 0.1 s –...
  • Page 78 Operating Instructions ® Surgical Laser Unit Limax ® Designation Specification Limax 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 79: Accessories

    Operating Instructions ® Surgical Laser Unit Limax Accessories 9.2.1 List of Approved Accessories The use of accessories and disposable products is restricted to items marked with the CE label and contained in the following list. This list of approved accessories is subject to revision and modification.
  • Page 80: Nominal Ocular Hazard Distances (Nohd)

    Operating Instructions ® Surgical Laser Unit Limax 9.2.2 Nominal Ocular Hazard Distances (NOHD) The accessories are subject to the following safe clearances or hazard distances (NOHD = Nominal Ocular Hazard Distance). The specified minimum distances ensure that the maximum permissible exposure (MPE) limits are not exceeded. Accessory Item Number Specifications...
  • Page 81: Periodic Safety Check

    Operating Instructions ® Surgical Laser Unit Limax Periodic Safety Check NOTICE All safety checks must be documented in the medical device logbook together with the inspection and test results! Once a year a safety check must be carried out acc. to DIN EN 62353 in order to verify that the unit duly conforms to safety regulations.
  • Page 82 Operating Instructions ® Surgical Laser Unit Limax Checking required monitoring, safety and alarm devices Alert check (acoustic / optical signals) Keylock switch Emergency stop switch Interlock device Connection of ext. warning lamps / signs Electrical safety (DIN EN 60601) Protective conductor resistance: ≤...
  • Page 83: Troubleshooting

    Operating Instructions ® Surgical Laser Unit Limax Troubleshooting 11.1 Information Displayed Process-related information is displayed in the information line of the screen (see item 2, section 6.1.8 “Display”, page 42). Example: “Connect fiber”. Information line 11.2 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 84: Ecological Aspects Of Operation

    Operating Instructions ® Surgical Laser Unit Limax If you do not wish to make use of this offer, you can dispose of the packaging material through the normal waste paper or domestic garbage collection channels. 12.2 Ecological Aspects of Operation Whenever the unit is not used for an extended period of time due to treatment pauses, we recommend you to switch it off for safety as well as economic reasons (energy saving).
  • Page 85 Operating Instructions ® Surgical Laser Unit Limax 12.4 Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility Guidance and manufacturer’s declaration according to DIN EN 60601-1-2, clause 6.8.3.201 a) 3) Table 201: Electromagnetic emission The device is intended for use in an electromagnetic environment as specified below. The customer or the user of the device must assure that it is used in such an environment.
  • Page 86 Operating Instructions ® Surgical Laser Unit Limax 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 intended for use in an electromagnetic environment as specified below. The customer or the user must assure that it is used in such an environment.
  • Page 87 Operating Instructions ® Surgical Laser Unit Limax Guidance and manufacturer’s declaration according to DIN EN 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 customer or the user must assure that it is used in such an environment. IEC 60601 Compliance test...
  • Page 88 Operating Instructions ® Surgical Laser Unit Limax Recommended separation distances for portable and mobile RF communication equipment ® and the Limax 120 according to DIN EN 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 89 Operating Instructions ® Surgical Laser Unit Limax V. 2.0...
  • Page 90 Operating Instructions ® Surgical Laser Unit Limax V. 2.0...
  • Page 91 Operating Instructions ® Surgical Laser Unit Limax V. 2.0...
  • Page 92 Tel. +44 (0) 1189 000 570 info@klsmartin.com info.uk@klsmartin.com Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group Ludwigstaler Str. 132 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com ·...

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