KLS Martin diomax MDL20 User manual

English
diomax
®MDL20
Surgical diode laser
Service m
anual
90-336-62-30
Revision 3
Date of Release: 2010-10

Service manual
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2 Revision 3
Content
1Product Liability and Warranty ...................................................... 5
1.1 General Information ..............................................................................5
1.2 User’s Inspection ..................................................................................5
1.3 Hotline.................................................................................................5
1.4 Notices concerning the Operating Instructions ..........................................6
2Safety Instructions ...................................................................... 6
2.1 General Provisions ................................................................................6
2.2 Laser safety .........................................................................................8
2.3Explosion and Fire Hazards.....................................................................9
2.4 Safety Instructions Relating to the Pilot Laser...........................................9
2.5 Electrical safety .................................................................................. 10
2.5.1 Grounding the Unit .........................................................................................10
2.5.2 Danger by Voltage..........................................................................................10
2.6 Safety Devices....................................................................................10
2.6.1 Rating Plates and Warning & Information Signs..................................................11
2.6.2 Hard-Software label after service update...........................................................12
3Functional description .................................................................13
3.1 Functional description of the Power supply unit ....................................... 14
3.2 Functional description of the diode module............................................. 15
3.3 Functional description of the cooling unit................................................ 17
3.4 Functional description of the CPU board ................................................. 18
3.5 Functional description of the basis board................................................ 18
3.6 Functional description of the adapter board ............................................ 19
3.7 Functional description of the front panel ................................................ 20
3.8 Functional description of the loudspeaker............................................... 22
3.9 Functional description of the CAN and RS 232 interface ........................... 23
4Disassembly and replacement......................................................24
4.1 Cover removal and replacing ................................................................ 24
4.2 Removal/replace of the front panel........................................................ 26
4.3 Removal/replace of the CPU board ........................................................ 28
4.4 Removal of the CPU board battery ........................................................ 28
4.5 Removal/replace of the basis board....................................................... 29
4.6 Removal/replace of the CFL converter ................................................... 29
4.7 Removal/replace of the TFT display module............................................ 30
4.8 Removal/replace of the complete rotary encoder..................................... 30
4.8.1 Removal/replace of the rotary encoder LED PCB.................................................31
4.8.2 Removal/replace of the rotary knob ..................................................................31

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4.8.3 Removal/replace of the rotary knob center ........................................................32
4.8.4 Removal/replace of the rotary encoder light ring ................................................33
4.8.5 Removal/replace of the rotary switch ................................................................33
4.9 Removal/replace of the laser activating lamp incl. cable........................... 34
4.10 Removal/replace of the cable switch on system ...................................... 34
4.11 Removal/replace of the diode module including sensor board ................... 36
4.12 Removal/replacement of the cooling unit ............................................... 38
4.13 Removal/replace of the junction PCB ..................................................... 40
4.14 Removal/replace of the temperature switch/sensor ................................. 40
4.15 Removal/replace of the fan .................................................................. 41
4.16 Removal/replace of the power supply unit .............................................. 42
4.17 Removal/replace of the Loudspeaker ..................................................... 44
4.18 Removal/replace of the RS 232 and CAN connector with cable.................. 44
4.19 Removal/replace of the adapter board ................................................... 45
4.20 Removal/replace of the plug-in feet....................................................... 45
4.21 Adjusting the SMAX fibre connecting socket ........................................... 46
5Electrical measurements .............................................................48
5.1 diomax®electrical system .................................................................... 48
5.2 Service voltages ................................................................................. 49
5.2.1 +12V ............................................................................................................49
5.2.2 +5V..............................................................................................................50
5.2.3 +12V ............................................................................................................50
5.2.4 -12V .............................................................................................................51
5.3 Component power supply measurements ............................................... 51
5.3.1 Diode module ................................................................................................51
5.4 Testing high current safety shutdowns................................................... 52
5.4.1 Diode module shutdown when subject to current overflow...................................52
5.4.2 Pilot laser shutdown when subject to current overflow ........................................52
6Service Menu.............................................................................53
6.1 Device information ..............................................................................54
6.2 Incident log........................................................................................ 54
6.3 Adjust ...............................................................................................55
6.4 Calibrate............................................................................................ 56
6.5 Cooling ..............................................................................................57
6.6 Reset logfile ....................................................................................... 59
6.7 Reset all settings ................................................................................60
6.8 Activating the TESTIO-display............................................................... 60
7Flash updater by KLS Martin ........................................................61
8diomax®status codes .................................................................62

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9Tools/Spare parts and Accessories................................................69
9.1 Tools .................................................................................................69
9.2 Spare parts and Accessories .................................................................70

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1Product Liability and 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 User’s Inspection
Immediately upon receipt, parts must be checked for completeness and potential damage in
transit. Notice of any such damage must be given immediately.
1.3 Hotline
•Should you have any technical questions, please do not hesitate to turn to our
KLS 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].
NOTICE
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 pr
ovided on the rating plate; see
section 2.6.1.

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1.4 Notices concerning the Operating Instructions
Non
-observance of the Operating Instructions can lead to serious or even lethal
injury!
Be sure to read, understand and follow
the instructions given below and in the operation
instructions of the product!
•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.
2Safety 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 2003-10 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 4th collateral standard: Programmable electrical medical
devices
BGI 832 Betrieb von Lasereinrichtungen (Anwendung der
Unfallverhütungsvorschrift “Laserstrahlung” (BGV B2))
(Operation of laser devices – Application of the accident
prevention regulation concerning laser radiation)

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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 instruct
ions given herein) can result in personal injury
and/or equipment damage!
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 labor 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, the following supplementary provisions must be observed:
•The diomax®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).

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•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.
2.2 Laser safety
The diomax®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).
CAUTION
Danger of damage to eyes, skin or other organs!
The unit emits radiation in the non
-visible spectral range of 980 nm. Be aware that such
radiation could 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!
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 diode laser
radiation must be rated “D 980 nm L4” or higher.
•The patient’s eyes need to be protected as well.

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•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.
2.3 Explosion and Fire Hazards
WARNING
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
diomax®, 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 (benzine).
•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 vapors, 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 las
er protective goggles of type D 980 nm L4 provide adequate
protection only against the infrared laser radiation, but are ineffective with regard to the pilot
laser light!

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2.5 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. Only
the power supply cable 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 voltages are present, which is dangerous.
All applicable safety measurements must be held during service operations.
WARNING
When locating faulty parts, in some cases you must work without covers!
Hazardous voltage is present on the inner parts (contactor, fuses, main switch, and emergency
switch). Do not touch the exposed parts!
2.6 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 optical fibre has been connected.
•As regards laser activation time, the footswitch has absolute priority over set pulse times
for safety reasons. This means that releasing the footswitch interrupts the laser light
emission process at once, even though the preset pulse time may not have elapsed yet.

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•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 irradiation parameters selected cannot 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 held down.
•The laser power is monitored continuously as long as laser light is being emitted.
•A coded SMAX fibre connecting socket ensures that only appropriate laser fibres can be
connected to the diomax®.
•The emergency stop switch ensures that the unit can be immediately disconnected from
the power supply in a case of emergency.
2.6.1 Rating Plates and Warning & Information Signs
Fig. 2.1 and 2.2 shows the rating plates, warning labels and information signs and there
positions at the laser units.
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)
on the left side of diomax®
Fig. 2-2: Labels at the back side of diomax®
1
Type plate with serial number
2 Radiation output and standards information – label according to IEC 60825-1 (DIN EN 60825-1)

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2.6.2 Hard-Software label after service update
After servicing the laser by changing hardware components or/and software changes the
service technician has to adhere a label near by the type plate with new hard-software index.
Only changes of incompatible components to older versions of the diomax®laser make it
necessary to change hard-software index.
The momentary hard-software index is seen in serial number.
The structure of serial no. is: S/N MDL20 AABB CC DDDD
MDL20
device
AA
hardware index, starting with 00
BB
software index, starting with 00
CC year of production, e.g. 09 = 2009
DDDD running number, different for each unit, e.g. 0108
Fig. 2-3:Label position for updating the hard- and software status
3
Serial number including hard- and software status
4 Additional label adhere by service technician with new hard- and software version no.

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3Functional description
Fig. 3-1: Inner components:
1
CPU and basis board
5
Heat sink
9
Loudspeaker
2
CFL converter
6
Sensor board
10
Power supply unit
3
Front panel
7
Connection canal
11
Adapter board
4
Diode module
8
Fan

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3.1 Functional description of the Power supply unit
Fig. 3-2: diomax®power supply unit
1
Mains socket
3
Footswitch connector
5
Accessory port
2
Equipotential bonding pin
4
Interlock connector
The diomax®features a universal power supply unit with a line voltage range of 100–240
volts/ 50–60 Hz. The mains connector socket assembly includes two fuses rated T 6.3 A (slow-
blow) (1, fig. 3.2). The power supply unit delivers the current for the diode module and the
Peltier elements of the cooling unit. It also delivers the service voltage for all other parts of the
electrical system and is connected to the adapter board which is mounted onto the power
supply unit.
The power supply unit features:
•An equipotential bonding pin which is intended for potential equalization as required for
certain diomax®applications (e.g. intracardiac interventions) (2, fig. 3.2).
•A Footswitch connector for laser activation (3, fig. 3.2)
•An interlock connector for door contact switch. Breaking the contact switches the laser
from LASER READY to STANDBY. At the same time, laser light output is blocked. Use of the
door contact cannot be recommended because it might cause an unexpected interruption
of the laser beam when the door is opened during laser application, which could create a
dangerous situation for the patient. Therefore, the corresponding contacts must be bridged
with the shorting plug supplied when installing the unit (4, fig. 3.2).
•An accessory port for external irrigation gas supplies (MY Gas 2) and/or smoke evacuator
(5, fig. 3.2).
The interlock connector, the footswitch connector, and the accessory port are potential-free
isolated. The Main connectors including the fuses, the key switch and the emergency stop
switch are electrically isolated from the remaining parts of the diomax®, so that by turning off
the unit either by using the key switch or the emergency stop switch the unit is dead.

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3.2 Functional description of the diode module
The system contains a direct diode laser working in infrared range (980 nm) and a visible red
pilot laser (635 nm). The diode laser provides the energy needed for medical treatment; the
pilot laser provides an aiming beam.
Fig. 3-3: diomax®optical system
A Schematic housing of laser diode module
1 Power laser modules (980 nm modules, 20 W power)
2
Pilot laser module (635 nm module, 3 mW power)
3
Optic for pilot laser beam
4
Beam transformation optic for power laser modules
5
Optical beam combiner
6 Photo diode (control of power beam) (twice)
7
Focussing lens for power beam and pilot beam
8
Contact switch for fibre detection
9 Laser fibre connected to laser diode module
The diode laser module includes the red pilot laser, which is also a low power diode laser. Both
lasers were adjusted together. They are focussed into the centre of a laser fibre connector by a
fixed focussing lens. There are no possibilities to re-adjust or change one of both lasers. The
diode laser module is mounted with extremely high thermal contact to an electro thermal
cooler, which consists of 4 Peltier elements.

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Fig. 3-4: Electrical diagram of optical system of diomax®
1
Current to power diodes
2
Pulse modulated current to pilot diode
3 Photo diode as power meter (twice)
4 Signal from fibre connection switch
The main current of up to 50 A goes to the power diode (1, fig 3.4) to produce light at a
wavelength of 980 nm with up to 20 W power. The power beam is transformed and focussed to
the connected laser fibre and passing the beam combiner (5, fig 3.3). A small part of the
power is reflected to the photo diode resulting in a proportional signal (3, fig 3.4).
A pulse modulated current is applied to the pilot laser diode (2, fig. 3.4) given a low power red
laser beam. Both laser beams are focussed collinear to the laser fibre entrance side. A switch
indicates the connected laser fibre (4, fig. 3.4).

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3.3 Functional description of the cooling unit
The cooling unit is composed of a Peltier element (2, fig. 3.5) that transfers heat from the
diode module (1, fig. 3.5) towards an aluminium heat sink (3, fig 3.5). A connection canal
(4, fig. 3.5) leads the warm air from the aluminium heat sink as well as from the power supply
unit towards the fan (5, fig. 3.5), which leads the heat through cooling slots outside the
diomax®.
Fig. 3-5: diomax®cooling unit
1
Diode module
2
Peltier element
3
Heat sink
4
Connection canal
5
Fan
A Temperature sensor (fig.3.6) and a temperature switch (fig. 3.7) located onto the cooling
unit are monitoring the heat dissipation.
Fig. 3-6: Temperature sensor
1
Temperature sensor
Fig. 3-7: Temperature switch
1
Temperature switch

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3.4 Functional description of the CPU board
The CPU board contains two central processor units operating security and controlling tasks. A
graphic controller operates the graphical output signals. The CPU board features a 3V battery
which can be replaced.
Fig. 3-8: CPU board
1 CFL converter cable 4 CPU
2
3V battery
5
Rotary switch connector
3 12 V cable connector 6 Display connector
3.5 Functional description of the basis board
The basis board is responsible for the conversion of signal towards the CPU board and other
components and is located underneath the CPU board on the front panel. The CFL-converter
(1, fig. 3.9) is mounted onto the basis board and connected to the TFT-display.
Fig. 3-9: Basis board
1
CFL converter
3
Laser signal lamp power supply connector
2
TFT display connector
4
Rotary encoder PCB lamp connector

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3.6 Functional description of the adapter board
The adapter board is mounted onto the power supply unit and is responsible for the allocation
of the service voltages towards the different diomax®components.
Fig. 3-10: Adapter board
1 Power supply unit connector
2 12 V cable
3
Ribbon cable (34-pole)
4
Ribbon cable (40-pole)
5 Ribbon cable from sensor PCB
6
Loudspeaker cable

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3.7 Functional description of the front panel
Fig. 3-11: Front panel outside view
1 Emergency stop switch 5 Display
2
SMAX fibre connecting socket
6
Rotary switch
3 Laser signal lamp/optical fibre status 7 Keylock switch
4
Keypad
The front panel is a support for the CPU board and the basis board including the CFL converter
on the inside. The outer part of the front panel features the main control interfaces (fig. 3.11).
The keylock switch (7, fig. 3.11) turns the power on or off, the emergency stop switch (1, fig.
3.11) interrupts the power supply to the unit and also blocks laser light emission immediately.
The SMAX optic fibre socket (2, fig. 3.11) is monitored electronically. Only when a matching
applicator has been connected can the unit be switched to LASER READY.
The two-color laser signal lamp (3, fig.3.11) can have the following statuses:
•Red: No optical fibre connected
•OFF: Optical fibre correctly connected to the SMAX socket. Footswitch not operated.
•Yellow: Laser ready and footswitch operated: laser light is being emitted
—Continuous yellow light:
As long as the footswitch is operated in continuous (CW) mode.
—Intermittent/pulsing yellow light:
In pulsed mode, the signal lamp lights up during pulse times and remains off during
pulse pauses.