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Summary of Contents for KLS Martin group LIMAX 60
- Page 1 Surgical Laser Unit Instructions for Use V. 1.0-EN (03.13) Valid from software version and hardware release 0000...
- 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 Information on minimumand maximum temperature for storage and transportation ® LIMAX 60: 39 °F to 122 °F (+4 °C – +50 °C) Information on minimum and maximum atmospheric pressure for storage and transportation ® Limax 60: 700 hPa – 1,060 hPa Information on minimum and maximum atmospheric humidity for storage and transportation ®...
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Page 4: Table Of Contents
Instructions for Use ® Surgical Laser Unit Limax Contents Product Liability and Warranty ............8 General Information ................8 Scope of Delivery .................. 8 Intended Use ..................9 Frequently Used Functions ..............9 Contraindications .................. 9 Warranty ................... 10 User’s Inspection ................10 Hotline.................... - Page 5 Instructions for Use ® Surgical Laser Unit Limax ® Putting the Limax 60 into Operation ..........27 General Information ................27 ® Setting up the Limax 60 ..............27 Relocating the Unit ................28 Front Side ..................29 Rear Panel ..................30 5.5.1 Loudspeaker ....................
- Page 6 Instructions for Use ® Surgical Laser Unit Limax Switching on the Laser Unit ..............54 System Test ..................54 6.10 Foot Switch ..................55 6.11 Using the Laser ................... 56 6.12 Connecting the Laser Fiber ..............56 ® 6.13 Turning off the Limax 60 ..............
- Page 7 Instructions for Use ® Surgical Laser Unit Limax Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC) ..............85 Ecological Information ..............89 13.1 Packaging ..................89 13.2 Ecological Aspects of Operation ............. 89 13.3 Disposal of the Unit ................89 V.
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Page 8: 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 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·... -
Page 9: Intended Use
Instructions for Use ® Surgical Laser Unit Limax Intended Use ® The Limax 60 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 ... -
Page 10: Warranty
Instructions for Use ® Surgical Laser Unit Limax Warranty Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di- verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. -
Page 11: Hotline
Instructions for Use ® Surgical Laser Unit Limax 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 Fax: +49 7461 706-190 ... -
Page 12: Notices Concerning This Document
Instructions for Use ® Surgical Laser Unit Limax Notices concerning this Document Non-observance of this document can lead to serious or even lethal patient injury! Be sure to read, understand and follow the instructions given below! Every user is required to read this document completely and follow them carefully. ... -
Page 13: Symbols Used In This Document
Instructions for Use ® Surgical Laser Unit Limax 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! Indicates a situation which, if not avoided, could result in death or serious injury! CAUTION Danger of minor injury! -
Page 14: 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 15: Installation And Initial Start-Up
Instructions for Use ® 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 or an authorized service partner. For further information, please refer to section 5.2 “Setting up ®... -
Page 16: Laser Safety
Instructions for Use ® Surgical Laser Unit Limax Moreover, the following supplementary provisions must be observed: ® The Limax 60 laser 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 17: Explosion And Fire Hazards
Instructions for Use ® Surgical Laser Unit Limax Therefore, the following safety measures must be strictly observed: All doors providing access to the laser area must be marked by warning lamps. 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 18: Protecting The Patient
Instructions for Use ® 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 light- / radiation-proof cover, ... -
Page 19: Safety Instructions Relating To The Pilot Laser
Instructions for Use ® Surgical Laser Unit Limax Safety Instructions Relating to the Pilot Laser CAUTION Risk of irritation by pilot laser light! The direct or reflected pilot laser light can have a glaring effect that may temporarily affect the working ability of users. ... -
Page 20: Electrical Safety
Instructions for Use ® Surgical Laser Unit Limax 3.11 Electrical Safety The unit is a Class 1 system (acc. to IEC 60601) and therefore must be connected to a duly grounded power supply system in accordance with the specifications contained herein (see section 9.1 “Technical Data,”... -
Page 21: Safety Devices
Instructions for Use ® Surgical Laser Unit Limax 3.14 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: ... -
Page 22: Warning & Information Labels
Instructions for Use ® Surgical Laser Unit Limax 3.16 Warning & Information Labels Laser class label located on the rear panel, with information on max. laser light power outputs (see also section 5.5 “Rear Panel”, page 30. Laser warning label and ... - Page 23 Instructions for Use ® Surgical Laser Unit Limax 1 Laser warning label and information label 2 Beam exit opening with information label V. 1.0...
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Page 24: Laser Smoke
Instructions for Use ® Surgical Laser Unit Limax 3.17 Laser Smoke CAUTION Laser smoke (plume) could contain viable tissue particles! We recommend the use of a fume suction system (e. g. marVAC by KLS Martin) in case of applications during which fumes are generated. 3.18 Proper Handling of Laser Fibers CAUTION... -
Page 25: Description Of The Unit
Instructions for Use ® 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 26: Fields Of Application
Instructions for Use ® Surgical Laser Unit Limax Fields of Application The therapeutic effect produced by the continuous-wave Nd:YAG laser light is based on the conversion of light energy into heat, a process that triggers both reversible and irreversible tissue reactions (hyperthermia, coagulation, vaporization). The specific therapeutic effect of this type of laser light mainly depends on the following four factors: ... -
Page 27: Putting The Limax ® 60 Into Operation
Instructions for Use ® Surgical Laser Unit Limax ® Putting the Limax 60 into Operation General Information ® The Limax 60 is a microprocessor-controlled surgical laser incorporating the latest technology. The unit generates laser light in the infrared wavelength range (1,320 nm) with a maximum laser output power of 60 watts, available to users via different laser fibers and applicators. -
Page 28: Relocating The Unit
Instructions for Use ® Surgical Laser Unit Limax WARNING Danger of injury from electric shock in the event of incorrect mains connection! To prevent the risk of an electric shock, the unit may only be connected to power supply systems that incorporate a protective conductor. -
Page 29: Front Side
Instructions for Use ® Surgical Laser Unit Limax ® Moving the Limax 60 on its castors inside the same building should always be done by two persons for safety reasons. Be sure to avoid any contact with walls, doors or other equipment during transportation. -
Page 30: Rear Panel
Instructions for Use ® Surgical Laser Unit Limax Rear Panel Handle Loudspeaker Laser MCB interface RS 232 service laptop interface Service connector (optional, no function) Accessory port Interlock / Warning Foot switch connector Mains connector socket with cooling system fuses Line fuses for laser optics Equipotential bonding pin NIST socket (AIR) -
Page 31: Loudspeaker
Instructions for Use ® Surgical Laser Unit Limax 5.5.1 Loudspeaker For position on rear side, see Fig. 5.5, (2). Laser activation tone: high harmonic tone sounded during emission of laser radiation (volume adjustable) Operating tone: alert sounded when rotating or pressing the rotary switch (volume adjustable) ... -
Page 32: Interlock / Warning Connector
Instructions for Use ® Surgical Laser Unit Limax 5.5.6 Interlock / Warning Connector Connector for interlock / warning connector (Fig. 5.5, (7)): Interlock / Warning This connector offers you two functions: The illustration shows the soldering side of the 7-pole interlock / warning connector. -
Page 33: Foot Switch Connector
Instructions for Use ® Surgical Laser Unit Limax 5.5.7 Foot Switch Connector Socket for connecting the foot switch (Fig. 5.5, (8)) for laser activation. See section 6.10 “Foot Switch”, page 55 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 34: Connecting U-Version Lasers To The Power Supply
Instructions for Use ® Surgical Laser Unit Limax 5.5.9 Connecting U-Version Lasers 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. The socket assembly includes two fuses rated T 16 A (slow blow) for the cooling system. -
Page 35: Line Fuses For The Optical System
Instructions for Use ® Surgical Laser Unit Limax 5.5.10 Line Fuses for the Optical System If current consumption is too high in the laser circuit, the optics line fuses (Fig. 5.5, (10)) will be tripped. Pushing them back in again reactivates them. 5.5.11 Equipotential Bonding Pin The equipotential bonding pin (Fig. -
Page 36: Laser Rating Plate
Instructions for Use ® Surgical Laser Unit Limax 5.5.13 Laser Rating Plate The rating plate is located on the rear panel of the unit (see also Fig. 5.5, (15)). For technical specifications, see section 9.1 “Technical Data”, page 78. U version rating plate V. -
Page 37: 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 WARNING 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 38: Operating The Limax ® 60
Instructions for Use ® 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 39: Keylock Switch
Instructions for Use ® 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 does not disconnect the unit from the power supply system! 6.1.2... -
Page 40: Stop Indicator
Instructions for Use ® Surgical Laser Unit Limax 6.1.3 STOP Indicator ® To switch on the Limax 60 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 39). 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 41: Smaplus Fiber Connecting Socket
Instructions for Use ® Surgical Laser Unit Limax 6.1.5 SMAplus 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 42: Keypad
Instructions for Use ® Surgical Laser Unit Limax 6.1.7 Keypad STANDBY button (green LED) Pressing this button switches the laser to STANDBY (laser not ready, green LED). While this operating state allows you to set laser parameters, no laser light can be emitted except the pilot laser light. The STANDBY button can also be used to stop the activated laser during laser operation. -
Page 43: Rotary Switch With Backlighting
Instructions for Use ® Surgical Laser Unit Limax 6.1.8 Rotary Switch with Backlighting ® All settings on the Limax 60 are made with the rotary switch (Fig. 6.1, (10)) that can be both rotated and operated axially (double-function pushbutton). It is inactive after starting the ®... -
Page 44: Display
Instructions for Use ® Surgical Laser Unit Limax 6.1.9 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 ... -
Page 45: Laser Status Indicator
Instructions for Use ® Surgical Laser Unit Limax 6.1.10 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. ... -
Page 46: Connecting The Laser Fiber
Instructions for Use ® 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. ®... -
Page 47: 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 “Setup / Pilot”... -
Page 48: Replacing The Laser Fiber
Instructions for Use ® 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 withdraw the fiber plug from the SMAplus socket. -
Page 49: Air (Purge Air)
Instructions for Use ® Surgical Laser Unit Limax AIR (Purge Air) ® At its front, the Limax 60 offers purge air – see “Luer-lock socket (2)”, page 29 – for clearing the plume generated during laser application from the beam path of the laser applicator. 1 Supply fiber 2 Emitted purge air 3 Emitted laser light... -
Page 50: Connecting The Compressed-Air Hose
Instructions for Use ® Surgical Laser Unit Limax 6.6.1 Connecting the Compressed-Air Hose Connect the compressed-air hose (1) first to ® the NIST socket (AIR) of the Limax laser (see section 5.5.12 “NIST Socket (AIR)”, page 35, and observe the notices provided there!) ... -
Page 51: Connecting The Focusing Handpiece / Applicator
Instructions for Use ® Surgical Laser Unit Limax Connecting the Focusing Handpiece / Applicator The procedures for connecting a focusing handpiece or other accessory applicators are basically the same. For more detailed application instructions, please refer to the product- specific Instructions for Use. CAUTION Danger of injury in the event of misuse! AIR (purge air) may only be used if a sterile air filter has been installed! -
Page 52: Connecting The Focusing Handpiece
Instructions for Use ® Surgical Laser Unit Limax 6.7.2 Connecting the Focusing Handpiece 1 Supply fiber 2 SMAplus plug 3 Luer-lock plug of AIR connecting tube 4 AIR connecting tube 5 Luer-lock socket sterile air filter ® The supply fiber (1) connects the Limax 60 to the focusing handpiece. -
Page 53: Connecting Applicators
Instructions for Use ® Surgical Laser Unit Limax 6.7.3 Connecting Applicators Purged laser fiber 1 AIR connecting tube 2 Laser fiber 3 SMAplus plug 4 Luer-lock plug 5 Sterile air filter To use a purged laser fiber (2), the AIR connecting tube (1) attached to the proximal fiber end must be connected to the sterile air filter (5) using the Luer-lock connector (4). -
Page 54: Switching On The Laser Unit
Instructions for Use ® Surgical Laser Unit Limax Switching on the Laser 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 55: Foot Switch
Instructions for Use ® 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 5.5.7 “Foot Switch Connector”, page 33) located on the rear panel of the laser unit (item 8, section 5.5 “Rear Panel”, page 30). -
Page 56: Using The Laser
Instructions for Use ® 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 57: Turning Off The Limax ® 60
Instructions for Use ® Surgical Laser Unit Limax ® 6.13 Turning off the Limax Rotate keylock switch key from horizontal to vertical position. CAUTION 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 58: Working With Programs
Instructions for Use ® Surgical Laser Unit Limax 6.15 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 59: Selecting Programs
Instructions for Use ® Surgical Laser Unit Limax 6.15.2 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 60: Surgical Laser Unit Limax
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. -
Page 61: Adjusting Programs
Instructions for Use ® Surgical Laser Unit Limax 6.15.3 Adjusting Programs The active program can be changed and saved. Select the program you wish to modify (see also section 6.15.2 “Selecting Programs”, page 59). Select the > Laser power field with the rotary switch and adjust as required (5 –... -
Page 62: Saving Modified Programs
Instructions for Use ® Surgical Laser Unit Limax NOTICE The “work airflow AIR” parameter can be adjusted even if the AIR button is off. Even if the AIR (purge air) is deactivated via the button AIR, the parameter Work flow AIR can be modified. - Page 63 Instructions for Use ® Surgical Laser Unit Limax 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 axially. ...
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Page 64: Overwriting Programs
Instructions for Use ® Surgical Laser Unit Limax 6.15.5 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 65: Air (Purge Air)
Instructions for Use ® Surgical Laser Unit Limax Acknowledge the confirmation query with > Yes — < BACK or > No returns you to the Programs menu, leaving the existing program unchanged. 6.15.7 AIR (Purge Air) Select > AIR (purge air) >... -
Page 66: Air Off
Instructions for Use ® Surgical Laser Unit Limax NOTICE The AIR button is used to switch the purge air supply ON or OFF completely. The button status is saved as well when creating a program. In other words, it is possible to create programs that do not use the purge air supply function. -
Page 67: Setup
Instructions for Use ® Surgical Laser Unit Limax 6.16 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 >... -
Page 68: Pilot Laser
Instructions for Use ® Surgical Laser Unit Limax 6.16.2 Pilot Laser Select Setup / > Pilot > Pilot brightness The brightness (intensity) of the pilot laser can be set across a range of 1% to 100%. > Pilot flash frequency The pilot laser can be set across a range starting with CW (continuous light) and ending with 5 Hz pulsed mode... -
Page 69: Logfile / Save / Reset
Instructions for Use ® Surgical Laser Unit Limax 6.16.3 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 70: Overview
Instructions for Use ® Surgical Laser Unit Limax 6.16.4 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 71: Timeouts
Instructions for Use ® Surgical Laser Unit Limax 6.16.6 Timeouts Setup / Timeouts Use < BACK to exit the menu. > Menu timeout The menu timeout defines for how long the rotary switch remains active after its last use. Luminous ring white –>... -
Page 72: Date & Time
Instructions for Use ® Surgical Laser Unit Limax 6.16.7 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 73: Alerts
Instructions for Use ® Surgical Laser Unit Limax 6.16.8 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 74: Quick Instructions For Use Instructions For Use
Instructions for Use ® Surgical Laser Unit Limax Quick Instructions for Use Instructions for Use Preparation Read user manual. Connect unit to power supply Connect laser connecting cable to a separate socket. Turn on unit Insert key in vertical position, then turn it to horizontal position and wait until self-test has been completed. - Page 75 Instructions for Use ® Surgical Laser Unit Limax Activate laser unit Operate LASER READY button (LED lights up yellow). Apply laser light Operate foot switch at stage 2 and apply laser light. Deactivate laser unit Operate STANDBY button (LED lights up green). ...
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Page 76: Maintenance And Cleaning
Instructions for Use ® Surgical Laser Unit Limax Maintenance and Cleaning NOTICE 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 accessories prior to each operation hospital staff Checking the laser warning lamp(s) prior to each operation... -
Page 77: Cleaning And Disinfecting
Instructions for Use ® 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 SMA-plus socket). For this reason, never use sprays for cleaning! NOTICE Never sterilize the unit! Always disconnect the unit from the supply before cleaning and disinfecting it. -
Page 78: Technical Description
Instructions for Use ® Surgical Laser Unit Limax Technical Description Technical Data ® Designation Specification Limax 50Type of laser Diode-pumped Nd:YAG laser Laser wavelength 1,320 nm Laser output power 5 – 60 W Pulse types Continuous (cw) Single pulse: pulse on-time: 0.1 s – 10 s Pulse train, adjustable: pulse on-time: 0.1 s –... - Page 79 Instructions for Use ® Surgical Laser Unit Limax ® Designation Specification Limax Width 50 cm Dimensions Height 107 cm Depth 59 cm Weight Laser 115 kg Ambient temperature 5 °F to 122 °F Ambient conditions for (-15 °C to +50 °C) transportation and storage Relative humidity (non-condensing!) 10% to 90%...
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Page 80: Accessories
Instructions for Use ® Surgical Laser Unit Limax Accessories 9.2.1 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 81: Hazard Distances (Nohd)
Instructions for Use ® Surgical Laser Unit Limax Accessory Specifications Item Number Sterile air filter, disposable product, for AIR filter 80-181-90-04 ® connection to LUER output of Limax Connecting tube, 25 cm, for connection to AIR tube focusing handpiece fiber or purged fiber, 79-100-31-04 disposable product Flyer... -
Page 82: Safety Check (Sc)
Instructions for Use ® Surgical Laser Unit Limax Safety Check (SC) 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 IEC 62353 in order to verify that the unit duly conforms to safety regulations. - Page 83 Instructions for Use ® Surgical Laser Unit Limax Checking required monitoring, safety and alarm devices [ ] 3.1 Alert check (acoustic/optical signals) [ ] 3.2 Keylock switch [ ] 3.3 Emergency stop switch [ ] 3.4 Interlock device [ ] 3.5 Connection of ext.
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Page 84: Troubleshooting
Instructions for Use ® 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 6.1.9 “Display”, page 44). 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... - Page 85 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 device Limax 60 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 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 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 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 customer or the user must assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
- Page 88 Instructions for Use ® Surgical Laser Unit Limax Recommended separation distances for portable and mobile RF communication equipment ® and the KLS Martin Limax 60 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 89 Instructions for Use ® Surgical Laser Unit Limax Ecological Information 13.1 Packaging As it is our policy to recycle as many parts of the packaging as possible, Gebrüder Martin offers to take back the entire packaging upon the user’s request. 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.
- Page 90 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 KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com ·...
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