KLS Martin LIMAX 120 User manual

LIMAX® 120
SURGICAL Nd:YAG-LASER
Service manual
From MDP120 0100 10 0100
MDP120 0200 13 0157
Software version 1.XX-1.41
REF 90-561-62-10 • REV 1 • Release Date 2016-12

Service manual LIMAX 120
Service manual version 1.00
page I
Table of Contents
Table of Contents ...................................................................................................I
1
Product Liability & Warranty.................................................................. 1
1.1 General information ............................................................................. 1
1.2 Hotline ............................................................................................... 1
2
Safety Instructions............................................................................... 2
2.1 General Provisions ............................................................................... 2
2.2 Laser safety ........................................................................................ 4
2.3 Explosion and Fire Hazards ................................................................... 5
2.4 Safety Instructions Relating to the Pilot Laser.......................................... 5
2.5 Electrical safety ................................................................................... 6
2.5.1 Grounding the Unit .............................................................................. 6
2.5.2 Danger by Voltage............................................................................... 6
2.6 Safety Devices..................................................................................... 7
2.6.1 Rating plates and warning & information labels........................................ 8
2.6.2 Hardware-Software label after service update.......................................... 9
3
Transport and packaging .................................................................... 10
3.1 Transportation................................................................................... 10
3.2 Opening the carrier box...................................................................... 11
3.3 Packaging......................................................................................... 11
4
Functional description......................................................................... 12
4.1 Front................................................................................................ 12
4.2 Backside........................................................................................... 13
4.3 Opto-mechanical unit ......................................................................... 14
4.4 Gas flow controller............................................................................. 19
4.5 PCB stack ......................................................................................... 20
4.6 Front panel ....................................................................................... 21
4.7 Power supply unit .............................................................................. 22
4.8 Cooling unit ...................................................................................... 23
4.8.1 Cooling unit connectors ...................................................................... 24
4.9 VAC ................................................................................................. 25
4.9.1 VAC filter.......................................................................................... 26
4.9.2 Special voltages ................................................................................ 27
4.10 Footswitch ........................................................................................ 27
4.10.1 Footswitch wiring diagram .................................................................. 28
5
Disassembly and replacement ............................................................. 29
5.1 Removal of the front cover.................................................................. 29
5.2 Removal of the back cover .................................................................. 30
5.3 Removal of the opto-mechanical unit.................................................... 32
5.4 Removal of the gas flow controller ....................................................... 33
5.5 Removal of the front panel.................................................................. 34
5.6 Removal of the PCB stack ................................................................... 35
5.6.1 Replacing the CPU board battery.......................................................... 35
5.7 Removal of the power supply unit ........................................................ 36

Service manual LIMAX 120
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5.8 Removal/ replace of the cooling unit..................................................... 39
5.8.1 Removal/ replace of the de-ionization cartridge...................................... 40
5.9 Removal/ Replace of the particle filter .................................................. 41
6 Filling the water cooling unit ............................................................... 42
6.1 First water fill in ................................................................................ 42
6.2 De-ionized water ............................................................................... 43
6.3 Second step to fill in the de-ionized water............................................. 44
6.4 Control of water level ......................................................................... 45
7 Draining the water cooling system ....................................................... 45
7.1 Seasonal draining of cooling water....................................................... 45
7.2 Draining for temperature > 0 °C, frost free .......................................... 46
7.2 Draining for frost transport ≤0 °C ....................................................... 47
8 Electrical diagram .............................................................................. 48
9 Service Menu .................................................................................... 51
9.1 Device information............................................................................. 52
9.2 Incident log....................................................................................... 53
9.3 Calibrate........................................................................................... 54
9.4 Cooling............................................................................................. 56
9.5 VAC ................................................................................................. 58
9.6 Reset log file..................................................................................... 62
9.7 Reset all settings ............................................................................... 63
9.8 Activating the TESTIO-display ............................................................. 64
10 Martin flash updater........................................................................... 66
11 LIMAX® 120 status codes.................................................................... 67
12 Tools / Spare parts and Accessories...................................................... 81
12.1 Tools................................................................................................ 81
12.2 Spare parts and Accessories................................................................ 82

Service manual LIMAX 120
Service manual version 1.00
page 1
1 Product Liability & Warranty
1.1 General information
KLS Martin will accept no responsibility for the safety, reliability and proper functioning of the
equipment unless:
• All readjustments, modifications or repairs that become necessary are carried out by
persons authorised to perform such work,
• All electrical installations of the respective room are in conformity with the
requirements provided by pertinent IEC regulations,
• The unit is used in accordance with the Operating Instructions provided.
• Any modification or repair work performed on the unit by persons who have not been
specially authorised by the manufacturer to perform such work shall void the warranty
given.
• The user is strictly required to duly observe the handling instructions and the
applicators; accordingly, the manufacturer will assume no liability - whether within or
after the period of warranty - for any damage done to optical components caused by
improper handling.
1.2 Hotline
Should you have technical questions or require spare parts, please contact our hotline for
support:
Tel.: [phone]
Fax: [phone]
[e-mail]
Ourservice 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 under [phone], or send an e-mail to:
[email protected]

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2 Safety Instructions
2.1 General Provisions
MPG (MDA)
Medizinproduktegesetz (German Medical Devices Act)
93/42/EEC
EC Directive 93/42/EEC concerning medical devices (MDD)
DIN EN 60825-1: 2008-05 Safety of laser products – Part 1: Equipment classification,
requirements and user’s guide
DIN EN 60601-1: 2007-07 Medical electrical equipment: General requirements (basic
standard)
DIN EN 60601-1-1: 2002-08 Medical electrical equipment – Part 1: General
requirements for safety
DIN EN 60601-1-2: 2007-12 Medical electrical equipment – Part 1–2: 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 collateral standard: Programmable electrical medical
devices
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)
Installation and initial start-up of the unit may only be carried out by Gebrüder Martin or an
authorized service partner.
Caution!
Any person who is in any way involved in the operation or maintenance of this unit
must be fully familiar with these Operating Instructions. Please note that improper
handling (i.e. any action not in compliance with the instructions given herein) can
result in personal injury and/or equipment damage!

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Before putting the unit into operation, the following steps must have been carried out:
• Acceptance of the unit by the purchasing department
• Formal appointment of a Laser Safety Officer by the operator of the unit (see § 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 laboratories safety matters (if 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
• Making sure that all operational procedures, as well as 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 the patient, the
treating physician or any other person present cannot be endangered during laser
operation.
Moreover, thefollowing 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.
• 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 maintain the following documents and keep them
accessible at all times:
• medical device logbook or equipment ID card
• Operating Instructions (regarding the unit itself as well as accessories used)
In case of accidents or damage involving personal injuries, such incidents must be reported to
the appropriate body immediately.

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2.2 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)
• carries the CE-mark in compliance with EU Directive 93/42/EEC (MDD).
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.
• 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, 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 LIMAX® 120
laser radiation must be rated “D 1318 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.
Caution!
Danger of damage to eyes, skin or other organs!
The unit emits radiation in the non-visible spectral range of 1318 nm.
Be aware that such radiation could cause irreversible damage to the
eyes, skin and other organs!

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2.3 Explosion and Fire Hazards
• Never use the unit in the vicinity of flammable narcotics or highly volatile mixtures such
as alcohol or petroleum spirit.
• The surgical site must be arranged so that neither the patient nor the surgical staff
could 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! For this reason, it
is not permitted to use oxygen as an irrigation medium!
• When using laser light in the area of organs, body cavities and tubular structures that
could contain flammable gases or vapours, protective measures must be taken to
prevent fire and explosion hazards.
2.4 Safety Instructions Relating to the Pilot Laser
Notice!
Upon switching on the unit, visible pilot laser radiation is emitted at the
distal end of the applicator system (fibre end or focusing hand piece)
unless the pilot laser has been switched off by operating the yellow-
backlight pilot laser button. 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 1318 nm L6
provide adequate protection only against the infrared laser radiation,
but are ineffective with regard to the pilot laser light!
Danger!
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 fibre 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
explosions:

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Service manual version 1.00
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2.5 Electrical safety
The unit is a Class 1 system (acc. to DIN EN 60601) and must therefore be connected to a duly
grounded power supply system in accordance with the specifications contained herein. Only the
power supply cables provided may be used.
• The power supply cable and its connector 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 in place as intended. Be
aware that laser radiation could 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.
2.5.1 Grounding the Unit
The unit is grounded via the ground conductor integrated in the power cable. This is an
important prerequisite for the safe operation of the unit. So if the power cable is connected in
accordance with pertinent electro technical regulations, proper grounding is automatically
ensured.
The yellow-and-green potential equalization cable must be connected to the equipotential
bonding conductor provided in rooms for cardiac interventions (standard relating to rooms
used for medical purposes).
2.5.2 Danger by Voltage
In the laser system mains voltage is present, which is dangerous.
All applicable safety measurements must be held during service operations.
Hazardous voltage is present on the inner parts (contactor, fuses, and main switch). Do not
touch the exposed parts!
Warning:
When locating faulty parts, in some cases you must work without
covers!

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2.6 Safety Devices
In designing this laser unit, we strictly looked out for utmost safety for user and patient. As a
result, the technical safety devices incorporated in the system (and described in the following)
effectively prevent misuses:
• When laser device is switched 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 not possible if no fibre is connected.
• As regards laser activation time, the footswitch has absolute priority to the set pulse
time. That means by stop pressing the footswitch the emission of laser light interrupts,
even though the pre-set pulse time has not elapsed yet.
• The footswitch has two switching points, one for activating accessories and a second
one for activating the laser itself. This ensures that laser radiation can only be emitted
as long as both switches are operated.
• To ensure that the set parameters can’t be accidentally changed during the laser
treatment, all control buttons, as well as the rotary switch, are blocked (inoperable) as
long as the footswitch is pressed.
• The laser power is controlled continuously as long as the laser light is emitted.
• A coded SMA-plus fibre plug ensures that only appropriate laser fibres can be connected
to the LIMAX® 120.
• The emergency stop ensures that the unit can be immediately disconnected from the
power supply if necessary.

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2.6.1 Rating plates and warning & information labels
Fig 2.1 warning label “Laser Star”,
explanatory label “VISIBLE AND INVISIBLE LASER RADIATION…LASER CLASS 4”,
and aperture label “LASER APERTURE…”
according to IEC 60825-1 (DIN EN 60825-1)
Fig 2.2 Radiation output and standards information – label
according to IEC 60825-1 (DIN EN 60825-1)

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2.6.2 Hardware-Software label after service update
After servicing of the laser where hardware components are changed and/or software updates
are carried out, the service technician has to adhere a label near by the type plate with a new
hard-software index. Only changes of incompatible components to older versions of the
LIMAX® 120 laser make it necessary to change the hard-software index.
The momentary hard-software index is seen in the serial number.
The structure of serial no. is: SN MDP120 AABB CC DDDD
MDP120 device
AA hardware index, starting with 00
BB software index, starting with 00
CC year of production, e.g. 11 = 2011
DDDD running number, different for each unit, e.g. 0101
Fig. 2.3 Device label LIMAX Device label VAC

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Service manual version 1.00
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3 Transport and packaging
3.1 Transportation
When preparing the LIMAX 120 for transport always drain the cooling unit.
Depending on the transport conditions, different measures have to be taken
referring to chapter 7.
Laser must be transported in upright position. The laser cooling unit consists of a compressor
cooler which is not allowed to be transported on the side. Therefore use a carrier box where
the laser stands in an upright position and make sure that the forwarding company is not
turning the box. The box is signed to be transported in upright position, signed to be handled
carefully, protected against rain and to be protected against frost (Fig. 3.1).
Fig. 3.1 transport label
Do not place the Limax® 120 on its side. Do not place on the head!

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3.2 Opening the carrier box
The LIMAX® 120 is transported in a carrier box.
Size of the box is 130 cm height, 88 cm depth, and 73 cm width. The weight of the empty box
is 78 kg. The Box can be transported in an upright position by using a forklift or a hand pallet
truck.
Open the carrier box by removing eight clamps securing the front (1,Fig. 3.2). Use the front
foam pad (1, Fig. 3.3) to stabilize the front (2, Fig. 3.3) while unloading the LIMAX® 120.
Fig. 3.2 release the securing clamp
1 securing clamps Fig. 3.3 unloading the LIMAX® 120
1 front foam pad 2 fron
t
3.3 Packaging
When preparing the carrier box for transport always verify that the foam pads on each side of
the inner walls are present (Fig. 3.3). These foam pads are essential to secure the LIMAX® 120
and dampen shocks. The front of the carrier box should always be secured with the delivered
clamps (1, Fig. 3.2).

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4 Functional description
4.1 Front
Fig. 4.1 Front
1 front panel 4 SMA-plus fibre connecting socket
2 keyswitch 5 VAC filter and connector
3 luer lock connector (AIR)

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4.2 Backside
Fig. 4.2 LIMAX® 120 backside
1 drawer 11 equipotential bonding pin
2 laser MCB connector 12 NIST connector
3 RS 232 connector 13 cable strap
4 service port 14 exhaust port VAC
5 accessory port 15 type plate with serial number
6 interlock connector 16 radiation label
7 footswitch connector 17 VAC MCB port
8 cooling fuses 18 type plate VAC
9 laser fuses 19 VAC mains socket and fuses
10 laser mains socket

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4.3 Opto-mechanical unit
Fig 4.3 overview of the opto-mechanical unit outside
Fig 4.3a overview of the opto-mechanical unit inside
All components of the opto-mechanical unit are installed in a fully closed, dust protected,
distortion-resistant metal housing. The lid consists of three elements: the front (fig. 4.3, 1)
and the back lid (2) and the cooling plate of the pump chamber (3).
• The pump chamber and the Nd:YAG cristal are cooled by the DI-water cooling system
(fig. 4.3, 4). Usually it suffices to remove the front lid for repairing. In case of
suspected defects of the pump chamber the cooling plate will not be changed on
location because of the sensitive of laser diodes which are arranged beneath.
Fig. 4.3 b cooling plate above the
pump chamber
The pump chamber generates the laser beam with a wave length of 1320nm. It is reflected
between the high reflector mirror (fig. 4.3a, 4) and the output mirror (5). Parallelism of the
laser and the pilot beam is reached by deflecting mirrors.

Service manual LIMAX 120
Service manual version 1.00
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The laser power supply cables which connect the anode and cathode with the power supply
unit are connected together when the laser is delivered to prevent damaging of the pump
diodes (fig. 4.3, 7). The ribbon cable connects the opto-mechanical unit to the PCB stack (fig.
4.3, 8).
• The high reflector mirror is adjusted with two setscrews. Therefor the two cover
screws (fig. 4.3c, 6) have to be removed before.
Fig. 4.3c cover screws adjustment of the high-reflector mirror
• The laser shutter is located between pump chamber and output mirror (fig. 4.3d). It is
put into the plug and fixed with one screw (fig. 4.3e). It is important that the shutter
flag doesn’t touch the chassis but is free to move.
Fig. 4.3d position of the Fig. 4.3e laser shutter
laser shutter
Between laser shutter and pump chamber outlet
a protection plate (fig.4.3f) is inserted to isolate
scattered radiation.
Fig. 4.3 f protection plate

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• The output mirror is arranged in the lense corpus and fixed with a clamping plate (fig.
4.3f).
Fig. 4.3f clamping plate
• The pilot beam (635nm) marks the spot where the laser beam hits the tissue. That’s
why it is very important that the pilot and
the laser beam are exactly adjusted. The plate of the pilot is put into the plug to the left
of the light trap (fig. 4.3g) and clamped with a set screw fig. 4.3h). It is important that
the direction is to the light trap. That means that the cable faces towards the light trap
(fig. 4.3i). With the adjustment screws, the pilot beam is superposed with the laser
beam.
Fig. 4.3g fitting of the
pilot plate Fig. 4.3h clamping of the pilot Fig. 4.3i cable faces towards the light trap
• The intern measurement unit controls continuously the power output and is located
between safety shutter and output mirror (fig. 4.3 j). Not until the laser beam hits the
internal measurement unit which controls if power output is in the acceptable tolerance
of ±20% the shutter flag of safety shutter opens.
Fig. 4.3j position of the intern
measurement

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Use the slotted screws at potentiometers (fig. 4.3k) to adjust the offset and amplifying
parameters of the two photodiodes.
Fig. 4.3k Potentiometer screws
Adjustment of photodiodes pre-amplifier
• The 3-dimensional adjusting unit (between
pilot laser and applicator contact) helps
focussing the laser beam onto the the fibre
coupling point.
• The lens tube has to be positioned so that the flute locks with the brad of the
adjustment unit (fig. 4.3p). The plastic wheel is turned as long as the distance of its
outer edge to the lens tube amounts 9.5mm (fig. 4.3q). This is just an approximate
presetting, the rest happens by adjustment.
Fig. 4.3p flute of the lens tube
has to lock with the brand of
the adjustment unit
Fig. 4.3q distance of 9.5mm