KLS Martin group LIMAX 120 User manual

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

Operating Instructions
Surgical Laser Unit Limax®120
Table of Contents
1Product Liability and Warranty ...................................................... 6
1.1 General Information ..............................................................................6
1.2 Scope of Delivery..................................................................................6
1.3 Intended Use........................................................................................7
1.4 Warranty .............................................................................................7
1.5 User’s Inspection ..................................................................................7
1.6 Hotline.................................................................................................8
2Notices Concerning these Operating Instructions ............................. 8
2.1 Validity of this User Manual ....................................................................9
2.2 Symbols Used in this Manual ..................................................................9
3Safety Notices & Instructions .......................................................10
3.1 General Regulations ............................................................................ 10
3.2 Installation and Initial Start-Up............................................................. 11
3.3 Laser Safety .......................................................................................12
3.4 Explosion and Fire Hazards................................................................... 13
3.5 Protecting the Patient .......................................................................... 14
3.6Treatment Room Requirements............................................................. 14
3.7 Safety Requirements for the Laser Unit.................................................. 14
3.8 Safety Instructions Relating to the Pilot Laser......................................... 15
3.9 Laser Safety Officer............................................................................. 15
3.10 Treating Physician ............................................................................... 15
3.11 Electrical Safety .................................................................................. 15
3.12 Grounding the Unit.............................................................................. 16
3.13 Fuses ................................................................................................16
3.14 Safety Devices.................................................................................... 16
3.15 Employment Restriction ....................................................................... 17
3.16 Warning & Information Labels............................................................... 18
3.17 Laser Smoke ...................................................................................... 19
3.18 Proper Handling of Laser Fibers............................................................. 19
4Description of the Unit ................................................................20
4.1 General Information on Laser Theory..................................................... 20
4.2 The Nd:YAG Laser...............................................................................21
4.3 Fields of Application ............................................................................21
5Putting the Limax®120 into Operation..........................................23
5.1 General Information ............................................................................ 23
5.2 Setting up the Limax®120 ................................................................... 23
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5.3 Front Side ..........................................................................................24
5.4 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 .........................................................................29
5.4.8 Foot Switch Connector ....................................................................................30
5.4.9 Mains Connector Socket with Cooling System Fuses............................................30
5.4.10 Line Fuses for the Optical System.....................................................................31
5.4.11 Equipotential Bonding Pin ................................................................................31
5.4.12 NIST Socket AIR ............................................................................................31
5.4.13 MCB Interface of the Smoke Evacuator .............................................................32
5.4.14 Information Label...........................................................................................32
5.4.15 Laser Rating Plate ..........................................................................................33
5.4.16 Smoke Evacuator Rating Plate (VAC) ................................................................33
5.4.17 Mains Connection for Smoke Evacuator (VAC)....................................................34
5.5 Initial Instruction by Authorized Person.................................................. 34
5.6 Measures to Be Taken Prior to Using the Laser System ............................ 35
6Operating the Limax®120 ...........................................................36
6.1 Controls, Indicators and Display Elements.............................................. 36
6.1.1 Keylock Switch...............................................................................................37
6.1.2 Emergency Stop Switch ..................................................................................37
6.1.3 STOP Indicator...............................................................................................38
6.1.4 “LASER ACTIVE” Indicator ...............................................................................38
6.1.5 Fiber Connecting Socket..................................................................................39
6.1.6 Keypad .........................................................................................................39
6.1.7 Rotary Switch with Backlighting .......................................................................40
6.1.8 Display .........................................................................................................42
6.1.9 Laser Status Indicator.....................................................................................43
6.1.10 FILTER LIFE ...................................................................................................44
6.2 Connecting the Laser Fiber ................................................................... 45
6.3 Checking the Laser Fiber with the Pilot Laser .......................................... 46
6.4 Replacing the Laser Fiber ..................................................................... 47
6.5 Connecting the Laser Focusing Handpiece / Applicators............................ 47
6.6 Compressed Air Supply........................................................................ 47
6.7Smoke Evacuator (VAC)....................................................................... 49
6.8 Switching on the Unit .......................................................................... 50
6.9 System Test ....................................................................................... 50
6.10 Foot Switch ........................................................................................ 51
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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 ........................................................................................57
6.14.4 Create A/B Mode ............................................................................................58
6.14.5 Saving Modified Programs ...............................................................................59
6.14.6 Overwriting Programs .....................................................................................61
6.14.7 Deleting Programs..........................................................................................61
6.14.8 VAC (Smoke Evacuator) ..................................................................................62
6.14.9 AIR (Compressed Air) .....................................................................................64
6.14.10 AIR VAC OFF..................................................................................................65
6.15 Setup ................................................................................................65
6.15.1 Language ......................................................................................................66
6.15.2 Pilot Laser .....................................................................................................66
6.15.3 Logfile / Save / Reset .....................................................................................67
6.15.4 Overview.......................................................................................................68
6.15.5 Display Screen ...............................................................................................68
6.15.6 Timeouts.......................................................................................................69
6.15.7 Date & Time ..................................................................................................70
6.15.8 Alerts............................................................................................................71
6.15.9 Service .........................................................................................................71
7Summary Operating Instructions..................................................72
8Maintenance and Cleaning...........................................................74
8.1 Cleaning and Disinfecting ..................................................................... 75
9Technical Description ..................................................................77
9.1 Technical Data.................................................................................... 77
9.2 Accessories ........................................................................................79
9.2.1 List of Approved Accessories ............................................................................79
9.2.2 Nominal Ocular Hazard Distances (NOHD) .........................................................80
10 Periodic Safety Check .................................................................81
11 Troubleshooting .........................................................................83
11.1 Information Displayed ......................................................................... 83
11.2 Other Malfunction ............................................................................... 83
12 Ecological Information ................................................................83
12.1 Packaging .......................................................................................... 83
12.2 Ecological Aspects of Operation............................................................. 84
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12.3 Disposal of the Unit .............................................................................84
12.4 Guidelines and Manufacturer’s Declaration on Electromagnetic
Compatibility ...................................................................................... 85
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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
Ludwigstaler Str. 132 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. [phone] · Fax [phone]
[e-mail] · www.klsmartin.com
1.2 Scope of Delivery
•Limax®120 surgical laser unit
•Two keys
•Foot switch
•Mains cable
•Mains cable for smoke evacuator
•Equipotential bonding cable
•MCB cable
•Interlock plug
•Smoke filter
•Five sterile AIR filters
•Air hose, sterile
•Two laser warning signs
•Limax®120 Operating Instructions (user manual)
•Medical device logbook
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1.3 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
•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”!
1.4 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.
1.5 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.
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Operating Instructions
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1.6 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: [phone]
Fax: [phone]
•Should you have any technical questions, please do not hesitate to turn to our
Martin Service Center:
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Our service representatives are available Monday through Friday from 8 a.m. to 5 p.m. (CET).
Should you have any questions concerning maintenance contracts or training courses,
please contact our Technical Service Manager at [phone], or send an e-mail to:
[e-mail].
To answer your technical questions as efficiently as possible, our service technicians require
the serial number of the product. Therefore, please have this number at hand when
contacting our hotline. It is part of the information
provided on the rating plate; see
section 5.4.15 “Laser Rating Plate”, page 33.
2Notices Concerning these Operating Instructions
Non
-observance of these Operating Instructions can lead to patient or user injury!
Be sure to read, understand and follow the instructions given below!
•Every user is required to read these Instructions completely and follow them carefully.
•In particular, be sure to heed all cautions, warnings and danger notices.
•Keep this manual accessible to users at all times.
•It is the user’s responsibility to inform the patient about the application notices, cautions,
warnings and danger notices contained herein, making sure that he / she has understood
them.
NOTICE
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2.1 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 & Co. KG. We will be glad to send you the appropriate version of the
user manual.
2.2 Symbols Used in this Manual
Throughout this manual, important information (such as general or safety-related notices) is
marked with the following symbols and signal words:
Danger of death 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.)!
WARNING
CAUTION
NOTICE
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Operating Instructions
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3Safety Notices & Instructions
3.1 General Regulations
MPG (MDA) Medical Devices Act
93/42/EEC (MDD) EU Directive 93/42/EEC concerning medical devices
DIN EN 60825-1: 2008-05 Safety of laser products – Part 1: Equipment classification and
requirements
DIN EN 60601-1: 2007-07 Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
DIN EN 60601-1-1: 2002-08 Medical electrical equipment – Part 1-1: General requirements
for safety
DIN EN 60601-1-2: 2007-12
Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility – Requirements and tests
DIN EN 60601-2-22: 1996-12
Medical electrical equipment – Part 2-22: Particular
requirements for the safety of diagnostic and therapeutic laser
equipment
DIN EN 60601-1-4: 2001-04
Medical electrical equipment – Part 1-4: General requirements
for safety; Collateral standard: Programmable electrical medical
systems
DIN EN 60601-1-6:2010-10
Medical electrical equipment – Part 1-6: General requirements
for basic safety and essential performance - Collateral standard:
Usability
(IEC 60601-1-6:2010
DIN EN 62304: 2007-03 Medical device software – Software life-cycle processes
DIN EN 62353: 2008-08 Medical electrical equipment – Recurrent test and test after
repair of medical electrical equipment
BGI 832
Betrieb von Lasereinrichtungen (Anwendung der
Unfallverhütungsvorschrift “Laserstrahlung” (BGV B2))
(Operation of laser devices – Application of the accident
prevention regulation concerning laser radiation)
Observe national safety regulations!
MPG (Medical Devices Act) and BGV (accident prevention rules) specifically refer to
regulations in force in Germany. Be sure to observe your relevant national
/ local regulations
(laws, directives, rules, etc.) as well!
NOTICE
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3.2 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.
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. Improper handling (non
-compliance) can lead to
bodily harm or equipment damage!
Prior to putting the device into service, the operator must ensure the following:
•Acceptance of the unit by the purchasing department.
•Formal appointment of a Laser Safety Officer by the operator of the unit (acc. to
section 6, BGV B2 (Germany), or equivalent national regulations concerning the prevention
of accidents).
•Appointment of a person specifically responsible for the unit; familiarization of that person
and the staff with the unit.
•Setting up the medical device logbook supplied with the product.
•Registration of the unit with the respective employers' liability insurance association and
the official body responsible for labor safety matters (as applicable).
•Handing over of the unit in a ready-for-use condition with appropriate user instruction,
either by Gebrüder Martin or an authorized representative.
•Observance of all safety instructions.
•Observance of the notices on electromagnetic compatibility provided in section 12.4
“Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility”, page 85.
•Making sure that all operational procedures, including measures to be taken in case of
trouble / failure, are fully understood. Please note that when using the unit in medical
practice, all relevant regulations for the prevention of accidents must be strictly observed!
Such medical use includes all diagnostic, surgical or therapeutic applications involving laser
radiation (in the widest sense). The operator of the unit and the Safety Officers
(specifically, the Laser Safety Officer) are responsible for the proper performance of all
required safety measures, thus ensuring that neither the patient, nor the treating
physician, nor any other person present can be endangered during laser operation.
Moreover, the following supplementary provisions must be observed:
•The Limax®120 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. The names of these authorized persons
must be recorded in the medical device logbook.
CAUTION
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Surgical Laser Unit Limax®120
•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
locking it and keeping the key in a safe place).
•The unit must be operated and serviced in accordance with these Operating Instructions;
this includes periodic safety checks as specified.
The operator of the unit is required to keep the following documents accessible at all times and
ensure they are up-to-date:
•medical device logbook or equipment ID card,
•Operating Instructions for the laser and user instructions for accessories used,
In case of accidents or damage involving personal injuries, such incidents must be reported to
the appropriate body immediately.
3.3 Laser Safety
The Limax®120 laser
•is a Class IIb unit acc. to the Medical Devices Act (or MDD, respectively),
•is a Class 4 laser unit (acc. to DIN EN 60825-1),
•bears the CE-mark in compliance with EU Directive 93/42/EEC (MDD).
Danger of damage to eyes, skin and other organs
!
The unit emits radiation in the non
-visible spectral range of 1320 nm. Be aware that such
radiation can cause irreversible damage to the eyes, skin and other organs!
With Class 4 laser units, both the direct laser beam and the laser light reflected diffusely from
surfaces can be dangerous!
Wear protective
goggles!
Protective goggles required (rating):
D 1320 nm L6
The “laser area” is defined as the area in which the maximum permissible exposure (MPE)
values that are normally binding may be exceeded, taking any accidental deflection of the laser
beam into consideration as well.
Therefore, the following safety measures must be strictly observed:
•All doors providing access to the laser area must be marked by warning lamps.
CAUTION
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•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. Such instruction must be recorded in writing, together with a list of all
participants.
•All persons present in the laser area, without exception, must wear protective goggles
when the laser is switched from “STANDBY” to “LASER READY”:
Acc. to DIN EN 207, the goggles required for protection against laser radiation
must be rated “D 1320 nm L6” or higher.
•The patient’s eyes need to be protected as well.
•It is the responsibility of the operator of the unit to provide suitable protective equipment.
•Never stare directly into the red pilot laser light! Be aware that the afore-mentioned
protective goggles do not protect against the red pilot laser radiation.
3.4 Explosion and Fire Hazards
Fire hazard
!
Class 4 lasers (DIN
EN 60825-1) represent a potential ignition source due to heat building up
in the tissue or at the fiber ends. When working with the Limax
®120, the user therefore is
required to observe the following measures in order to prevent laser
-induced fires and
exp
losions:
•
Never use the unit in the vicinity of flammable narcotics or highly volatile mixtures such
as alcohol or petroleum spirit (white gas).
•
There is a fire or explosion hazard if the laser light is used in the presence of flammable
materials, solutions or gases or in an oxygen-enriched atmosphere.
•
The surgical site must be arranged so that neither the patient nor the surgical staff could
be endangered even in the event of an accidental release of the laser beam, and that
ignition of easily flammable materials is prevented at the same time! Consequently, no
oxygen may be used for irrigation during endoscopic interventions.
•
When using laser light in the area of organs, body cavities and tubi that could contain
flammable gases or vapors, protective measures must be taken to prevent fire and
explosion hazards.
WARNING
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3.5 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
•protecting those organs and tissues of the surgical site which must not be exposed to laser
radiation, covering them with diffuse-reflection or light-absorbing materials such as moist
towels or compresses
•preventing laser-induced fires, especially in endolaryngeal interventions
•preventing ignition of intestinal gases, and of tissue when using artificial respiration
techniques involving oxidizing gases.
3.6 Treatment Room Requirements
•The access doors of all rooms in which the Limax®120 is used must be marked with a
laser radiation warning sign (supplied with the product).
•A warning lamp must be installed at all doors leading to the laser area. When these lamps
are on, the laser area may only be entered by authorized persons wearing the prescribed
protective goggles.
•All doors leading to the laser area must be kept shut during use of the laser system.
•Surfaces capable of reflecting laser radiation should not be used in the laser area or must
be adequately covered.
3.7 Safety Requirements for the Laser Unit
•All instruments used must have such a form and surface finish that dangerous reflections
of the laser light are largely prevented.
•Optical equipment used for surgical site observation must have been specially designed for
use with laser systems and may only be used in conjunction with suitable auxiliary filters
meeting the requirements applying to laser protective goggles.
•If the laser is found to be malfunctioning, it must be withdrawn from service at once! The
problem(s) must be entered in the medical device logbook and reported to the Laser
Safety Officer. Make sure to contact either Gebrüder Martin GmbH & Co. KG or an
authorized service technician as soon as possible.
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3.8 Safety Instructions Relating to the Pilot Laser
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)
. To avoid eye damage,
never stare into the beam exit (aperture) of the applicator system when this button is on!
Please note that the laser protective goggles of type D 13
20 nm L6 provide adequate
protection only against the infrared laser radiation, but are
ineffective with regard to the pilot
laser light
!
3.9 Laser Safety Officer
According to the relevant (German) regulations for the prevention of accidents (relating to
laser radiation – BGV B2), the operator of the system is required to formally appoint a Laser
Safety Officer, whose responsibilities include the following:
•carry out all safety measures required
•provide instruction, to all persons involved, on required safety measures and the proper
use and operation of the unit
•mark the laser area
•check the alarm signals for proper functioning
•ensure the availability of laser protective goggles
•keep the key to the laser system in a safe place
•ensure the proper connection of the laser after relocation
•proper maintenance of the medical device logbook
3.10 Treating Physician
The treating physician is responsible for the safe and proper use of the medical laser system.
He / she must check and ensure that all safety measures are duly observed and must be
familiar with laser-specific operating techniques.
3.11 Electrical Safety
The unit is a Class 1 system (acc. to DIN EN 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 77).
•Prior to connecting the unit to the power supply, verify that the mains voltage is the
correct one for the laser and the smoke evacuator (see section 5.4.17 “Mains Connection
for Smoke Evacuator (VAC)”, page 34).
CAUTION
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Operating Instructions
Surgical Laser Unit Limax®120
•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
used if in any way defective.
•Never turn on the laser system if any part of its housing is not fixed in place as intended.
Be aware that laser radiation can be emitted from an open laser unit in an uncontrolled
manner! Moreover, there is a risk of exposure to dangerously high electric voltages or
currents.
3.12 Grounding the Unit
The unit is grounded via the ground conductor integrated in the mains cable. This is an
important prerequisite for the safe operation of the unit. If the mains cable is correctly
connected in accordance with relevant electrotechnical regulations, proper grounding is
automatically ensured.
The yellow-and-green equipotential bonding cable is intended for use in cases where potential
equalization is required for laser operation (e.g. when using the Limax®120 for intracardiac
interventions).
3.13 Fuses
Defective fuses may be replaced only by authorized service personnel.
The fuses are installed on the rear panel of the unit. They include two line fuses located in the
mains connector socket assembly plus two overcurrent fuses (see section 5.4 “Rear Panel”,
page 26).
The smoke evacuator has two line fuses of its own. The fuse ratings are indicated on the rear
panel of the unit, see also section 5.4.17 “Mains Connection for Smoke Evacuator (VAC)”,
page 34.
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:
•Upon turning it on, or when the voltage comes back after a power failure, the unit goes
into STANDBY mode – the laser beam cannot be activated.
•Similarly, laser beam activation is impossible if no laser fiber has been connected.
•As regards laser activation time, the foot switch has absolute priority over set pulse times
for safety reasons. This means that releasing the foot switch interrupts the laser light
emission process at once, even though the preset pulse time may not have elapsed yet.
•The foot switch has two pedals: the right one is used for laser activation and activation of
accessory components, whereas the left one is intended for switching between programs
(SWAP mode).
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•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.
•The laser power is monitored continuously as long as laser light is being emitted.
•The coded SMAplus fiber connecting socket ensures that only appropriate laser fibers can
be connected to the Limax®120.
•The emergency stop switch ensures that the unit immediately stops emitting laser light in
a case of emergency. However it is not disconnected from the power supply
3.15 Employment Restriction
Young persons below the age of 16 years are not permitted to work with lasers or in laser
areas (this applies to laser classes 3R, 3B and 4, as specified in Sect. 11 of BGV B2, the
German accident prevention regulation). Young persons above that age are permitted to work
with lasers or in laser areas if this is necessary for training purposes and provided that safety
is ensured by a qualified supervisor.
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Operating Instructions
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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).
Laser warning label and information label for Class 4
lasers.
Beam exit opening with
information label
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Surgical Laser Unit Limax®120
3.17 Laser Smoke
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
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. Please note that non
-observance of the laser fiber handling recommendations can
result in fiber damage and
/ or patient or user injury.
Dangerous laser radiation
!
Dangerous laser radiation may be released if laser fibers are overbent (lateral beam exit due
to fiber breakage).
Take special care with laser fibers
inserted into the patient’s body!
Note also that insufficiently fixed laser fibers could get displaced and slip away from the
surgical site due to internal stress, with radiation being emitted in unintended directions.
Laser light delivery system
!
As the aiming beam (pilot laser) takes the same path through the laser light delivery system
as the working beam, it is perfectly suited for checking the delivery system for integrity.
Damage or malfunction in the laser delivery system should be suspected
if no aiming spot at
all is visible at the distal end of the delivery system, if spot intensity is low or if the spot has a
diffuse, irregular shape (see
section 6.3 “Checking the Laser Fiber with the Pilot Laser”,
page 46).
CAUTION
CAUTION
CAUTION
NOTICE
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Operating Instructions
Surgical Laser Unit Limax®120
4Description of the Unit
4.1 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" the electrons of the active medium from their normal state into a stimulated
energy state (high energy level). The medium then starts to return to its normal state
(transition to lower energy levels). In this process, photons are emitted. The light is then
reflected multiply in an optical resonator (laser cavity) consisting of a highly reflecting mirror
and a partially transparent one. At the same time, it is amplified by induced emission while
traveling back and forth between the mirrors. Through the semitransparent mirror, part of the
laser light is coupled out and subsequently used for medical purposes.
Main characteristics of laser light:
•Highly parallel beams – very little beam divergence / spread.
•Monochromaticity – light of a very narrow wavelength range, equivalent to a single color in
the spectrum of electromagnetic radiation.
•Coherence – all photons emitted are in phase (in terms of both space and time).
The active medium (lasing material) can either be a gas, a liquid dye or a solid. Most gas
lasers consist of atoms or small molecules or a mixture of both. In the case of the solid-state
laser, the active medium consists of atoms or ions doped (bound) in a solid-state host crystal.
In the case of the dye laser, the active medium consists of molecules of a relatively high
molecular weight, dissolved in a liquid.
For the pumping energy that is needed, either direct current, high-frequency energy or – as in
the case of the solid-state laser – light is used. Under specific pumping energy conditions, the
so-called "population inversion" phenomenon can be observed with all of the above media.
This means that it is possible to induce laser light emission at a specific wavelength that is
characteristic for the active medium used. The high light intensity gain is achieved through
optical feedback by the mirrors of the laser resonator and through amplification by induced
emission each time the beam passes through the resonator.
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