KLS Martin group LIMAX 60 User manual

Surgical Laser Unit
Instructions for Use
V. 1.0-EN (03.13)
Valid from software version and hardware release 0000

2 V. 1.0
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
Observe instructions for use
Item number (Item no.)
Serial number
Lot designation
Not to be reused!
Sterilization by ethylene oxide
Sterilization by irradiation
Store in a place protected from direct sunlight
Store in a place protected from frost
Store in a dry place

V. 1.0 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
Limax®60: 10% –90%, non-condensing
Fragile, avoid pressure and shock
Arrows pointing up, transport and store upright
Manufacturing date
Manufacturer
Do not use if packaging is damaged
Use before
Not to be resterilized!
Latex-free
CE mark of conformity
This product may not be disposed of as normal household garbage
NON WOOD
The packaging of the Limax®60 is “non-wood”, i.e. wood packaging
material that is not subject to ISPM 15, and is therefore suitable for
international shipment.

Instructions for Use
Surgical Laser Unit Limax®60
4 V. 1.0
Contents
1Product Liability and Warranty ...................................................... 8
1.1 General Information ..............................................................................8
1.2 Scope of Delivery..................................................................................8
1.3 Intended Use........................................................................................9
1.4 Frequently Used Functions .....................................................................9
1.5 Contraindications ..................................................................................9
1.6 Warranty ........................................................................................... 10
1.7 User’s Inspection ................................................................................ 10
1.8 Hotline............................................................................................... 11
1.9 Safety Check ...................................................................................... 11
2Notices concerning this Document ................................................12
2.1 Validity of this Document ..................................................................... 12
2.2 Symbols Used in this Document............................................................ 13
3Safety Notices & Instructions .......................................................14
3.1 General Regulations ............................................................................ 14
3.2 Installation and Initial Start-Up............................................................. 15
3.3 Laser Safety....................................................................................... 16
3.4 Explosion and Fire Hazards................................................................... 17
3.5 Protecting the Patient .......................................................................... 18
3.6Treatment Room Requirements............................................................. 18
3.7 Safety Requirements for the Laser Unit.................................................. 18
3.8 Safety Instructions Relating to the Pilot Laser......................................... 19
3.9 Laser Safety Officer............................................................................. 19
3.10 Users................................................................................................. 19
3.11 Electrical Safety.................................................................................. 20
3.12 Grounding the Unit.............................................................................. 20
3.13 Fuses ................................................................................................ 20
3.14 Safety Devices.................................................................................... 21
3.15 Employment Restriction ....................................................................... 21
3.16 Warning & Information Labels............................................................... 22
3.17 Laser Smoke ...................................................................................... 24
3.18 Proper Handling of Laser Fibers............................................................. 24
4Description of the Unit ................................................................25
4.1 General Information on Laser Theory..................................................... 25
4.2 The Nd:YAG Laser............................................................................... 25
4.3 Fields of Application ............................................................................ 26

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 5
5Putting the Limax®60 into Operation............................................27
5.1 General Information ............................................................................ 27
5.2 Setting up the Limax®60..................................................................... 27
5.3 Relocating the Unit.............................................................................. 28
5.4 Front Side .......................................................................................... 29
5.5 Rear Panel ......................................................................................... 30
5.5.1 Loudspeaker ..................................................................................................31
5.5.2 Laser MCB Interface .......................................................................................31
5.5.3 Service Interface............................................................................................31
5.5.4 Service Connector ..........................................................................................31
5.5.5 Accessory Port ...............................................................................................31
5.5.6 Interlock / Warning Connector .........................................................................32
5.5.7 Foot Switch Connector ....................................................................................33
5.5.8 Mains Laser Connector Socket..........................................................................33
5.5.9 Connecting U-Version Lasers to the Power Supply ..............................................34
5.5.10 Line Fuses for the Optical System.....................................................................35
5.5.11 Equipotential Bonding Pin ................................................................................35
5.5.12 NIST Socket (AIR) ..........................................................................................35
5.5.13 Laser Rating Plate ..........................................................................................36
5.6 Measures to Be Taken Prior to Using the Laser System ............................ 37
6Operating the Limax®60.............................................................38
6.1 Controls, Indicators and Display Elements.............................................. 38
6.1.1 Keylock Switch...............................................................................................39
6.1.2 Emergency Stop Switch ..................................................................................39
6.1.3 STOP Indicator...............................................................................................40
6.1.4 “LASER ACTIVE” Indicator ...............................................................................40
6.1.5 SMAplus Fiber Connecting Socket .....................................................................41
6.1.6 Luer-Lock Socket for AIR (Purge Air) ................................................................41
6.1.7 Keypad .........................................................................................................42
6.1.8 Rotary Switch with Backlighting .......................................................................43
6.1.9 Display .........................................................................................................44
6.1.10 Laser Status Indicator.....................................................................................45
6.2 Applied Parts ...................................................................................... 45
6.3 Connecting the Laser Fiber ................................................................... 46
6.4 Checking the Laser Fiber with the Pilot Laser .......................................... 47
6.5 Replacing the Laser Fiber ..................................................................... 48
6.6 AIR (Purge Air) ................................................................................... 49
6.6.1 Connecting the Compressed-Air Hose ...............................................................50
6.7 Connecting the Focusing Handpiece / Applicator ..................................... 51
6.7.1 Connecting the Sterile Air Filter........................................................................51
6.7.2 Connecting the Focusing Handpiece ..................................................................52
6.7.3 Connecting Applicators....................................................................................53

Instructions for Use
Surgical Laser Unit Limax®60
6 V. 1.0
6.8 Switching on the Laser Unit.................................................................. 54
6.9 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 .................................................................... 57
6.14 Emergency Shutdown.......................................................................... 57
6.15 Working with Programs........................................................................ 58
6.15.1 Standard Program ..........................................................................................58
6.15.2 Selecting Programs.........................................................................................59
6.15.3 Adjusting Programs ........................................................................................61
6.15.4 Saving Modified Programs ...............................................................................62
6.15.5 Overwriting Programs .....................................................................................64
6.15.6 Deleting Programs..........................................................................................64
6.15.7 AIR (Purge Air) ..............................................................................................65
6.15.8 AIR OFF ........................................................................................................66
6.16 Setup ................................................................................................ 67
6.16.1 Language ......................................................................................................67
6.16.2 Pilot Laser .....................................................................................................68
6.16.3 Logfile / Save / Reset .....................................................................................69
6.16.4 Overview.......................................................................................................70
6.16.5 Display Screen ...............................................................................................70
6.16.6 Timeouts.......................................................................................................71
6.16.7 Date & Time ..................................................................................................72
6.16.8 Alerts............................................................................................................73
6.16.9 Service .........................................................................................................73
7Quick Instructions for Use Instructions for Use...............................74
8Maintenance and Cleaning ...........................................................76
8.1Cleaning and Disinfecting ..................................................................... 77
9Technical Description ..................................................................78
9.1 Technical Data.................................................................................... 78
9.2 Accessories ........................................................................................ 80
9.2.1 List of Approved Accessories ............................................................................80
9.2.2 Hazard distances (NOHD) ................................................................................81
10 Safety Check (SC) ......................................................................82
11 Troubleshooting .........................................................................84
11.1 Information Displayed ......................................................................... 84
11.2 Other Malfunction ............................................................................... 84

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 7
12 Guidelines and Manufacturer’s Declaration on Electromagnetic
Compatibility (EMC)....................................................................85
13 Ecological Information ................................................................89
13.1 Packaging .......................................................................................... 89
13.2 Ecological Aspects of Operation............................................................. 89
13.3 Disposal of the Unit ............................................................................. 89

Instructions for Use
Surgical Laser Unit Limax®60
8 V. 1.0
1Product Liability and Warranty
1.1 General Information
We thank you for having decided to buy a KLS Martin product. This product carries the
CE mark, which means that it satisfies the essential requirements laid down in the EC Directive
concerning medical devices.
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. [phone] · Fax [phone]
[email protected] · www.klsmartin.com
1.2 Scope of Delivery
Limax®60 surgical laser unit
Two keys
Foot switch
Mains cable
Equipotential bonding cable
MCB cable
Interlock plug
Smoke filter
Five sterile AIR filters
Air tube, sterile
Two laser warning signs
Limax®60 Instructions for Use (user manual)
Medical device logbook

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 9
1.3 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
hyperthermia
cutting
coagulating
vaporization
To this end, the electric energy input from the supply system is converted into infrared laser
light that is subsequently used for the above-mentioned surgical applications.
The safe surgical use of laser light requires users to be fully familiar with the respective
techniques and forms of applications.
The surgical laser may only be operated in medically used rooms specifically marked as “laser
rooms”!
The operator may operate the device only if an on-site functional test has previously been
performed by Gebrüder Martin or a person authorized by Gebrüder Martin. In addition, a
responsible person designated by the operator must have been instructed in the proper
handling, application and operation of the unit, as well as in its permissible combination with
other medical devices, objects and accessories. This duly instructed officer shall subsequently
be responsible for familiarizing the operator’s staff with the unit as the need arises.
We recommend documenting all user instructions in a medical device logbook. A copy of the
logbook is available from Gebrüder Martin.
1.4 Frequently Used Functions
Section 6.15 “Working with Programs”, page 58, provides applications which explain frequently
used functions of the laser on the basis of stored programs.
1.5 Contraindications
No contraindications limiting the use of the Limax®60 are currently known.

Instructions for Use
Surgical Laser Unit Limax®60
10 V. 1.0
1.6 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.
Important Notices
The product may only be repaired by Gebrüder Martin or a qualified person or firm expressly
authorized by Gebrüder Martin to perform such work.
If the repair is carried out by a person or firm specially authorized by Gebrüder Martin, the
operator of the product is required to obtain from the repairer a certificate with details about
the nature and scope of the repair work done. This certificate must be dated and signed and
include the firm’s details.
In all cases where a party other than the product manufacturer performed the work, repaired
products must be additionally marked with the repairer’s ID label.
Improper interventions or alterations performed by third parties during the period of limitation
shall void any and all warranty claims. Unauthorized actions performed on the product shall
invalidate any liability claims vis-à-vis Gebrüder Martin.
1.7 User’s Inspection
Immediately upon receipt, the goods must be checked for completeness and potential damage
in transit. Notice of any such damage must be given immediately.