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. +49 7461 706-0 · Fax +49 7461 706-193
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.

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 11
1.8 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
Should you have any technical questions, please do not hesitate to turn to our
Martin Service Center
Tel: +49 7461 706-343
Fax: +49 7461 706-408
E-mail: service@klsmartin.com
Should you have any questions concerning maintenance contracts or training courses,
please contact our Technical Service Manager:
Tel: +49 7461 706-332
E-mail: service@klsmartin.com
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 5.5.13 “Laser Rating Plate”, page 36.
1.9 Safety Check
The operational safety of the unit must be verified at regular intervals, see section 8
“Maintenance and Cleaning”, page 76 and section 10 “Safety Check (SC)”, page 82.
If the device is not functionally reliable and / or safe to operate, it must be marked as such
and withdrawn from service.
NOTICE

Instructions for Use
Surgical Laser Unit Limax®60
12 V. 1.0
2Notices 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.
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.
2.1 Validity of this Document
This document is valid from hardware / software version 0000.
The software currently installed in your Limax®60 is indicated on the start-up screen (see
section 6.9 “System Test”, page 54). 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. We will be glad to send you the appropriate version of the user manual.

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 13
2.2 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:
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

Instructions for Use
Surgical Laser Unit Limax®60
14 V. 1.0
3Safety Notices & Instructions
3.1 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
DIN EN 60825-1:1994 + A1:2002 + A2:2001
Safety of laser products –Part 1: Equipment classification
and requirements
EN 60601-1:1990 + A1:1993 + A2:1995
IEC 601-1:1988 + A1:1991 + A2:1995
Medical electrical equipment –Part 1: General
requirements for basic safety and essential performance
EN 60601-1-1:2001
IEC 60601-1-1:2000
Medical electrical equipment –Part 1-1: General
requirements for safety
EN 60601-2-2:2007
IEC 60601-2-2:2006
Medical electrical equipment –Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility –Requirements and tests
EN 60601-2-22:1996
IEC 601-2-22:1995
Medical electrical equipment –Part 2-22: Particular
requirements for the safety of diagnostic and therapeutic
laser equipment
IEC 60601-1-4:1996 + A1:1999
Medical electrical equipment –Part 1-4: General
requirements for safety; Collateral standard:
Programmable electrical medical systems
EN 60601-1-6:2010
IEC 60601-1-6:2010
Medical electrical equipment –Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
EN 62304:2006
IEC 62304:2006
Medical device software –Software life-cycle processes
EN 62353:2008
IEC 62353:2007
Medical electrical equipment –Recurrent test and test after
repair of medical electrical equipment
EN ISO 15223-1:2012
ISO 15223-1:2012
Medical devices –Symbols to be used with medical device
labels, labelling and information to be supplied –Part 1:
General requirements
BGI 832
Operation of laser devices –(Application of the accident
prevention regulation concerning laser radiation (BGV B2))
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

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 15
3.2 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
the Limax®60”, page 27.
Danger of injury!
Any person involved in any way in the handling of this device must be fully familiar with the
contents of these Instructions for Use. 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
“Guidelines and Manufacturer’s Declaration on Electromagnetic Compatibility (EMC)”,
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
light (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.
CAUTION

Instructions for Use
Surgical Laser Unit Limax®60
16 V. 1.0
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. The names of these authorized persons
must be recorded in the medical device logbook.
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 Instructions for Use; 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,
Instructions for Use 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®60 laser
is a Class IIb unit acc. to the Medical Devices Act (or MDD, respectively),
is a Class 4 laser unit (acc. to IEC 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 1,320 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 1,320 nm L6 / LB6
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.
CAUTION

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 17
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. 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 EN 207, the goggles required for protection against laser radiation must
be rated “D 1,320 nm L6 / LB6” 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 (IEC 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®60,the user therefore is
required to observe the following measures in order to prevent laser-induced fires and
explosions:
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 purging 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

Instructions for Use
Surgical Laser Unit Limax®60
18 V. 1.0
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®60 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 Martin Service Center or an authorized service
technician as soon as possible.

Instructions for Use
Surgical Laser Unit Limax®60
V. 1.0 19
3.8 Safety Instructions Relating to the Pilot Laser
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.
The protective goggles provide protection only against the working laser light, not
however against the pilot laser light.
Never stare directly into 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 goggle;
keep the key to the laser system in a safe plac;
ensure the proper connection of the laser after relocatio;
proper maintenance of the medical device logbook.
3.10 Users
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.
CAUTION

Instructions for Use
Surgical Laser Unit Limax®60
20 V. 1.0
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 78.
Prior to connecting the unit to the power supply, verify that the mains voltage is the
correct one for the laser.
When connecting the 200 –240 V mains cable, be sure to follow the instructions provided
in section 5.5.9 “Connecting U-Version Lasers to the Power Supply”, page 34.
Only the mains cables provided may be used.
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®60 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 5.5 “Rear Panel”,
page 30).
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