KLS Martin group LIMAX 120 User manual

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

2 Revision 5
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.
Instructions for Use
Follow Instructions for Use
Catalog number
Serial number
Production lot number, batch
Store in a place protected from direct sunlight
Store in a place protected from frost
Keep dry
Information on minimum and maximum temperature for storage
and transportation.
Limax®120: See section 11 “Technical Data”, page 103 for valid values.
Information on minimum and maximum atmospheric pressure for storage
and transportation.
Limax®120: See section 11 “Technical Data”, page 103 for valid values.
Information on minimum and maximum atmospheric humidity for storage
and transportation.
Limax®120: See section 11 “Technical Data”, page 103 for valid values.

Revision 5 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
NON WOOD
The packaging of the Limax®120 is “non-wood”, i.e. wood packaging
material that is not subject to ISPM 15 and therefore suitable for
international shipment.

Instructions for Use
Surgical Laser Unit Limax®120
4 Revision 5
Contents
1Notices concerning this Document ................................................. 8
1.1 Safety .................................................................................................8
1.2 Terms & Acronyms................................................................................8
1.3 Validity of this Document .......................................................................9
1.4 Symbols Used in this Document............................................................ 10
2Product Liability and Warranty .....................................................11
2.1 General Information ............................................................................11
2.2 Hotline............................................................................................... 11
2.3 Scope of Delivery................................................................................ 12
2.4 User’s Inspection ................................................................................12
2.5 Warranty ...........................................................................................12
3Intended Use .............................................................................13
3.1 Intended Purpose of the medical device ................................................. 13
3.1.1 Indications for Use of the medical device...........................................................13
3.1.2 Patient Group/Patient Selection........................................................................13
3.1.3 Environmental conditions ................................................................................13
3.1.4 User .............................................................................................................13
3.2 Use Restrictions ..................................................................................14
3.2.1 Contraindications ...........................................................................................14
3.3 Warnings and Precautions .................................................................... 14
4Functional Principle.....................................................................15
4.1 General Information on Laser Theory..................................................... 15
4.2 The Nd:YAG Laser...............................................................................15
4.3 Fields of Application ............................................................................ 15
4.4 Frequently Used Functions ................................................................... 16
5Safety Notices & Instructions .......................................................17
5.1 General Regulations ............................................................................17
5.2 Laser Safety ....................................................................................... 18
5.3 Explosion and Fire Hazards................................................................... 19
5.4 Protecting the Patient .......................................................................... 19
5.5 Treatment Room Requirements............................................................. 20
5.6 Safety Requirements for the Laser Unit.................................................. 20
5.7 Safety Instructions Relating to the Pilot Laser......................................... 20
5.8 Laser Safety Officer.............................................................................21
5.9 Electrical Safety .................................................................................. 21
5.10 Grounding the Unit.............................................................................. 22
5.11 Fuses ................................................................................................22

Instructions for Use
Surgical Laser Unit Limax®120
Revision 5 5
5.12 Safety Devices.................................................................................... 23
5.13 Warning & Information Labels............................................................... 24
5.14 Laser Smoke ...................................................................................... 25
5.15 Proper Handling of Laser Fibers............................................................. 25
6Operation..................................................................................26
6.1 Front Side .......................................................................................... 26
6.2 Rear Panel ......................................................................................... 27
6.2.1 Drawer..........................................................................................................28
6.2.2 Handle ..........................................................................................................28
6.2.3 Loudspeaker ..................................................................................................28
6.2.4 MCB Socket Limax®120..................................................................................29
6.2.5 Accessory Port ...............................................................................................29
6.2.6 Interlock/Warning Connector ...........................................................................29
6.2.7 Foot Switch Connector ....................................................................................31
6.2.8 Fuses Limax®120, Version E ...........................................................................31
6.2.9 Mains Connector Socket Limax®120, Version E..................................................31
6.2.10 Disconnection Limax®120 from Power Supply ...................................................32
6.2.11 Connecting the Limax®120 U-Version to the Power Supply .................................33
6.2.12 Disconnecting the Limax®120 U-Version from the Power Supply..........................33
6.2.13 Line Fuses for the Optical System.....................................................................34
6.2.14 Equipotential Bonding Pin ................................................................................34
6.2.15 NIST Socket (AIR)..........................................................................................34
6.2.16 VAC MCB Socket ............................................................................................35
6.2.17 Limax®120 Rating Plate .................................................................................35
6.2.18 VAC Rating Plate ............................................................................................36
6.2.19 Serial Number Structure..................................................................................36
6.2.20 VAC Mains Connection ....................................................................................37
6.3 Putting the Limax®120 into Operation................................................... 37
6.3.1 Setting up the Limax®120 ..............................................................................38
6.3.2 Relocating the Unit .........................................................................................39
6.3.3 Installation and Initial Start-Up ........................................................................40
6.4 Measures to Be Taken Prior to Using the Laser System ............................ 42
6.5 Operating the Limax®120.................................................................... 42
6.6 Controls, Indicators and Display Elements.............................................. 43
6.6.1 Keylock Switch...............................................................................................44
6.6.2 Emergency Stop Switch ..................................................................................44
6.6.3 STOP Indicator...............................................................................................45
6.6.4 LASER ACTIVE Indicator..................................................................................45
6.6.5 SMAplus Fiber Connecting Socket .....................................................................46
6.6.6 Luer-Lock Socket for AIR (Purge Air) ................................................................46
6.6.7 Keypad .........................................................................................................47
6.6.8 Rotary Switch with Backlighting .......................................................................49

Instructions for Use
Surgical Laser Unit Limax®120
6 Revision 5
6.6.9 Display .........................................................................................................50
6.6.10 Laser Status Indicator.....................................................................................51
6.6.11 FILTER LIFE ...................................................................................................52
6.7 Applied Parts ...................................................................................... 53
6.7.1 Connecting the Applied Part.............................................................................53
6.8 Checking the Laser Fiber with the Pilot Laser .......................................... 54
6.9 Replacing the Laser Fiber ..................................................................... 54
6.10 AIR (Purge Air) ................................................................................... 55
6.10.1 Compressed-Air Hose .....................................................................................56
6.10.2 Testing the Purge Air Flow ...............................................................................57
6.11 Connecting the Focusing Handpiece/Applicator ....................................... 57
6.11.1 Connecting the Sterile Air Filter........................................................................58
6.11.2 Connecting the Focusing Handpiece ..................................................................58
6.11.3 Connecting Applicators....................................................................................59
6.12 VAC (Smoke Evacuator)....................................................................... 60
6.12.1 Turning VAC on/off with Mains Switch...............................................................60
6.12.2 Replacing the Main Filter .................................................................................61
6.12.3 Connecting the Suction Hose ...........................................................................62
6.12.4 VAC Performance During Laser Operation..........................................................63
6.13 Switching on the Limax®120................................................................ 63
6.14 System Test ....................................................................................... 64
6.15 Foot Switch with SWAP® Pedal .............................................................. 65
6.16 Using the Laser Light........................................................................... 66
6.17 Connecting the Laser Fiber ................................................................... 66
6.18 Turning off the Limax®120 .................................................................. 67
6.19 Emergency Shutdown.......................................................................... 67
6.20 Working with Programs........................................................................ 68
6.20.1 Standard Program ..........................................................................................68
6.20.2 Selecting Programs.........................................................................................69
6.20.3 Adjusting Programs ........................................................................................71
6.20.4 Laser power...................................................................................................71
6.20.5 Operating modes............................................................................................71
6.20.6 Creating a SWAP®A/B Program .......................................................................73
6.20.7 Saving Modified Programs ...............................................................................74
6.20.8 Overwriting Programs .....................................................................................76
6.20.9 Deleting Programs..........................................................................................77
6.20.10 VAC program .................................................................................................77
6.20.11 AIR program..................................................................................................79
6.20.12 Setting the Work Flow AIR...............................................................................79
6.20.13 AIR/VAC OFF .................................................................................................80
6.20.14 Setup ...........................................................................................................81
6.20.15 Language ......................................................................................................81
6.20.16 Pilot Laser .....................................................................................................82

Instructions for Use
Surgical Laser Unit Limax®120
Revision 5 7
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
7Cleaning and Disinfecting ............................................................88
7.1 Disposal of consumables ...................................................................... 89
8Maintenance ..............................................................................90
8.1 Periodic Maintenance ........................................................................... 90
8.2 Troubleshooting ..................................................................................91
8.2.1 Information Displayed.....................................................................................91
8.2.2 Other Malfunction...........................................................................................91
8.3 Safety Check (SC)............................................................................... 92
8.4 Accessories ........................................................................................94
8.4.1 List of Approved Accessories............................................................................94
8.4.2 Hazard distances (NOHD)................................................................................97
9Ecological Information ................................................................98
9.1 Packaging .......................................................................................... 98
9.2 Ecological Aspects of Operation............................................................. 98
9.3 Disposal of the Unit .............................................................................98
10 Guidelines and Manufacturer’s Declaration on Electromagnetic
Compatibility (EMC)....................................................................99
11 Technical Data ......................................................................... 103
12 Quick Instructions for Use .........................................................105

Instructions for Use
Surgical Laser Unit Limax®120
8 Revision 5
1Notices concerning this Document
1.1 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 responsibili
ty to ensure that all personnel handling the product have
understood and do observe the notes and instructions in this document.
•Every user is required to read this document completely and follow it carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this document accessible to users at all times.
•Observe the Instructions for Use supplied with the focusing handpiece or other accessory
applicators.
1.2 Terms & Acronyms
Designation Description
AIR Purge airflow
AIR Medical compressed-air
CGS Central gas supply system
CW Continuous wave, pulse type
EMV Electromagnetic compatibility
HT High temperature
IP X1 Protection against dripping water falling vertically
LASER Light Amplification by Stimulated Emission of Radiation
LED Light-emitting diode
marTray®Product name of a Gebrüder Martin tray
marVac®Product name of the Gebrüder Martin external smoke evacuator
MCB Martin Communication Bus, enables communication between the
Limax®120 and the integrated smoke evacuator (VAC)
MPR Maximum Permissible Radiation
Nd:YAG laser Neodymium-doped yttrium-aluminum-garnet laser
NIST Gas type-specific screw connector acc. to the National Institute of Standards
and Technology

Instructions for Use
Surgical Laser Unit Limax®120
Revision 5 9
Designation Description
NOHD Nominal Ocular Hazard Distance
Safety distances applying to accessories used with the Limax® 120
SC Safety check
SMA
Sub-miniature A, connector;
SMAplus socket: mechanically coded SMA socket for laser fibers with
SMAplus plugs, which allow activation of the Limax®120
VAC Smoke evacuator integrated into the Limax®120
1.3 Validity of this Document
These instructions for use are valid for software version V3.00, hardware release HW 04 and
software release SW 02.
The software currently installed in your Limax®120 is indicated on the start-up screen, see
section 6.14 “System Test”, page 64. If the software version indicated on the screen does not
comply with the version number specified above, please do not hesitate to contact the
Martin Service Center, see section 2.2 “Hotline”, page 11. We will be glad to send you the
appropriate version of the Instruction of Use.

Instructions for Use
Surgical Laser Unit Limax®120
10 Revision 5
1.4 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!
Indicates a situation which, if not avoided, could result in minor or moderate injury!
Risk of material damage
Indicates a situation which, if not avoided, could lead to material damage (loss of time, data
loss, device/machine failure, etc.)!