Professional Documents
Culture Documents
Instruction Manual 7000
Instruction Manual 7000
INSTRUCTION
MANUAL
7000
LaserStar 532 nm
TABLE OF CONTENTS
SECTION 2 - SAFETY.................................................................................................................................... 7
Standards ................................................................................................................................................. 8
Working with Laser Radiation ................................................................................................................ 9
Labels...................................................................................................................................................... 10
Labels on the Slit Lamp Adapter SLA-BMBQ ..................................................................................... 11
Labels on the User Protection Filter UPF active / passive 532nm.................................................... 12
Labels on the Laser Indirect Ophthalmoscope LIO-500 .................................................................... 12
Labels on the Slit Lamp Adapter UNI-SLA .......................................................................................... 14
Laser Safety Devices ............................................................................................................................. 15
Arrangement of Safety Controls .......................................................................................................... 18
Page 4 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 1 - INTRODUCTION
The D.O.R.C. LaserStar 532 nm is a therapeutic eye laser device with which the
treatment of many ophthalmic indications is possible. The section “Clinical Manual”
within this manual contains information about these applications and their risks.
Treatments are performed with the radiation of a cw (continuous wave), KTP
frequency doubled Nd:YVO laser which is aimed via the red beam of a diode laser.
As listed in section 8 „Accessories“ may be attached. In general only attachments
approved by D.O.R.C. international bv. should be attached to the LaserStar 532 nm.
Do not attach any accessories or attachments to the LaserStar 532 nm, which have
not been approved by D.O.R.C. international bv.
Contact lenses are highly recommended for various tasks (see section 8 „Accessories“
and section 9 „Clinical Manual”).
The device can only be installed and in-serviced at the customers premises by
authorised personnel of D.O.R.C. International bv. or a D.O.R.C. distributor.
Before operating the unit section 2 on „Safety“ must be carefully read and furthermore
the location of installation must be prepared in accordance with the recommendations
in section 6 „Installation“.
All functions are carefully checked at the manufacturers facility.
Unless otherwise agreed, the warranty is 12 months from the date of installation.
The warranty of D.O.R.C. International bv. is limited to the exchange / repair of
defective parts unless otherwise included in the conditions of sale.
WARRANTY
The manufacturer will provide warranty services only in the following cases:
• The device must be operated in conformity with the instructions in this Instruction
Manual.
• All servicing, adjustments and settings, repairs and alterations, etc., must be
carried out by D.O.R.C. International bv. trained and authorised specialists.
LIABILITY
D.O.R.C. International bv. or its representatives are responsible only for the safety and
reliability of the performance of the device if following is provided by the user:
• Installation, repairs and alterations were carried out by persons authorised by
D.O.R.C. International bv.
• Users are informed (have read) about, and act according to, safety regulations
and features described in the manuals. The parameters given in the clinical
manual (section 9 of this Instruction Manual) are guideline values and should be
considered according to the condition of each patient.
• The installation in the laser room is in conformity with the EN 60601-1 and EN
60825-1 requirements.
• The device is used in compliance with the Instruction Manual.
• Changes or modifications to the LaserStar 532 nm not expressly approved by
D.O.R.C. International bv. could void the user’s authority to operate the
equipment.
• The device is periodically serviced for safety and all functions are checked.
• The device only gets used by persons authorized and trained to perform the
specific treatment.
• Only use D.O.R.C. International bv. approved delivery devices with Quattro Quick
Lock connector.
We thank you for your choice and wish you full success with the LaserStar 532 nm.
Phone : ++ 31-181-458080
Fax : ++ 31-181-458090
E-mail : sales@dorc.nl
Web-site : www.dorc.nl
Page 6 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 2 - SAFETY
Introduction
The maximum laser radiation (for values refer to section 7 "Technical Description") is
not exceeded even in the case of a fault.
The LaserStar 532 nm and its delivery devices are safe devices for the physician, the
patient and for third parties, provided the operation is in accordance with this
Instruction Manual. Installation, maintenance, calibration, repairs or alterations may
only be carried out by persons authorised by D.O.R.C. International bv.
Important:
STANDARDS
The LaserStar 532 nm complies with the following technical standards and directives:
* NOTE: This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment generates, uses, and can
radiate radio frequency energy and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct the
interference at his own expense.
Page 8 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Caution:
Any use of this device or parts thereof for
procedures other than those specified herein may
result in hazardous exposure to radiation and
electrical danger.
Before releasing any treatment pulses, the user must check that the following points
are being complied with:
• The Laser must only be activated if the user is ready for treatment.
• Laser pulses are only released in the course of applying treatments.
• Monitor the quality (shape and brightness) of the aiming beam before releasing
laser pulses. Round shape and brightness according to previous treatments of
the aiming beam is a first indication of a well functional optical laser beam path. If
one of those parameters is not in order discontinue the use of the laser.
• Do not use the laser if flammable gases might be in the room.
• Persons assisting during the treatment and who are in the range of possible laser
radiation are to be informed about the hazards. Everyone must wear the
appropriate (532 nm) safety goggles.
• During the release of laser pulses no objects should be present in the beam path
with the exception of contact glasses.
• The whole treatment room is under hazard from reflections (e.g. from the contact
glass). It is compulsory to wear appropriate protective glasses in the treatment
room (refer to section 8 "Accessories").
• During the functional checks in accordance with section 5 "Maintenance", all
persons in the laser room must wear appropriate 532 nm protective glasses. The
laser beam may not be directly aimed at persons. The physician must protect
him/herself by using a appropriate laser protection filter in the optical path of
his/her observation system which is approved by D.O.R.C. International bv.
• The following laser protecting glasses can be ordered from D.O.R.C.
International bv.:
In the case of damage to the glasses, or a change in coloration, discontinue their use
and replace them.
LABELS
LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT
ACCORDING TO EN 60825-1:2001-11
Laser Aperture
c) Type label
Location: on the back panel of the unit
Page 10 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
d) Information label
Location: on the left side of the unit
Laser Aperture
b) Type label
Location: on the lower part of the slit lamp interface
UPF 532nm
Page 12 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Laser Aperture
b) Type label
Laser Aperture
b) Type label
Location: on the mounting arm of the slit lamp adapter
Page 14 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
1. Key switch
Without the key turned on it is impossible to emit laser radiation. The persons
authorised to operate the device are responsible for the safe-keeping of the keys
which must be removed after use.
2. Autokey
Associated to the currently used laser delivery device the Autokey (AK) delivers data
regarding the kind of delivery device and current set data. It therefore eliminates user
errors due to faulty inputs.
In order to avoid hazardous situations during treatment, the user is obliged to connect
the remote interlock connector at the door interlock switch.
4. Beam shutter
The beam shutter only opens when the operating elements have been properly
actuated and when no internal faults are present. When no signal has been applied to
the beam shutter it automatically interrupts the laser path by a pre loaded spring.
5. Safety circuit
The device has an internal electrical safety circuit which shuts down the laser power
supply in the case of incorrect operating conditions.
The fiber engaged switch only allows the laser to radiate as long as a fiber has been
inserted and properly locked at the laser aperture.
The physician must protect himself or herself by using a user protection filter for
532 nm within all viewing beam paths while performing laser treatments. Only use
D.O.R.C. international bv. approved user protection filters. The active user protection
filter UPF active 532nm closes before each laser pulse and protect the user by filtering
the laser light during radiation. After the end of the laser pulse the beam path gets
cleared by actively and automatically removing of filter device.
The passive user protection filter UPF passive 532nm is stationary in the beam path
and is filtering the laser radiation constantly.
The red aiming laser radiation at 635 nm is below permissible radiation level and not
dangerous for physician or patient and therefore protection filter for this wavelength is
not required.
The SLA-BMBQ requires mounting of a separate user protection filter. It can be a passive
filter mounted either at the beam entrance of the slit lamp or just before the binocular. An
active filter can be mounted just before the binocular.
Page 16 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Display
• Display, indicating chosen parameters, status of the system, error, messages,
warning messages
Back plane
• Remote Interlock connector
Main cabinet
• Speaker for audible indication of laser radiation as well as critical situations,
errors, status
Page 18 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 3 - DESCRIPTION
OVERVIEW
The LaserStar 532 nm contains a laser generator, a control electronics and a control
panel. All for the user necessary controls are arranged on the front panel.
Integrated control panel
Laser generator Key switch
Autokey (AK)
Display
Laser aperture
Idle time setting
(Selection button 2)
EQP SERVICE/USB
Equipotential Point Service terminal connector FUSE: 2x2AT
PWR 90-250V~50/60Hz
Power connector
PRT
Printer connector
Labels
DRS
Remote Interlock
(Door interlock connector)
FSW
SCN Foot switch connector
Scanner connector
(not used in software version 1) UPF
User protection filter connector
COM
Com port connector
(not used in software version 1)
Page 20 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 4 - Operation
PREPARATION
Always make sure that the optical fiber of the delivery device (endofiber, slit lamp
adapter, laser indirect ophthalmoscope) is connected fully and securely by the Quattro
Quick Lock connector. Also always connect the appropriate Autokey of the delivery
device.
• Only use approved Endo Fibers with the LaserStar 532 nm.
• For procedures where the delivery device (e.g.: Endo Fiber) comes into direct
contact with the patient only use latex free devices.
• Endo Fibers have to be used and maintained according to manufacturers
instructions.
• Only use Endo Fibers with D.O.R.C. Quattro Quick Lock connector.
• Only use the D.O.R.C. Slit lamp adapter with the LaserStar 532 nm
• Only use the special LaserStar 532 nm Laser Indirect Ophthalmoscope with the
LaserStar 532 nm.
ERROR MESSAGES
The LaserStar 532 nm display indicates, apart from the selected parameters, any
malfunctions. A full listing, for use by authorised service personnel, is contained in the
service manual.
Page 22 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
DISPLAY SCREENS
The following display screens appear on the control panel while using the
LaserStar 532 nm:
• Start up screen. Indicates that the laser is in its self control mode and the
internal temperature controls are starting up.
• Adapter control screen. Indicates the adapter read out by the Autokey. User
must confirm the automatic selection manually by pushing the button on the
screen before the LaserStar 532 nm continues the start up process.
• Standby screen. Within this screen of the LaserStar 532 nm the parameters for
the future treatment can be set. The parameters for LIO and Endo-Fibers are
described in the following:
Interval duration
indication and adjustment
#1 #2 #3 #4 #5
PRINT: The parameters of the latest treatment will be printed on the attached
printer (button only appears if a printer is connected).
RESET: Sets the treatment parameters of the latest treatment session to zero.
SETUP: Allows to switch over to the parameter screen where further
parameters of the LaserStar 532 nm can be adjusted (see parameter
screen for further reference).
# 1: Number of pulses delivered since the LaserStar 532 nm has been
turned on or since the RESET button has been pushed.
# 2: Total energy delivered since the LaserStar 532 nm has been turned on
or since the RESET button has been pushed.
# 3: Attached delivery device description.
# 4: Selected User.
# 5: Selected treatment Profile setting within the selected User.
LASER ON: Allows to switch over to the treatment screen (see treatment screen
for further reference).
Page 24 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
• Standby screen. Within this screen of the LaserStar 532 nm the parameters for
the future treatment can be set. The extra parameter for Slit Lamp Adapters is
described in the following:
#6
• Treatment screen. By switching over to this screen the laser will be set to the
ready mode. By pushing the foot switch laser radiation gets released trough the
attached delivery device. The parameters selectable in this screen are described
in the following:
Page 26 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
• Define user name screen. If the EDIT button has been pushed the define
user name screen appears. With the lower right dial wheel a letter or a
number on the black rectangle can be chosen. With the upper right dial wheel
the rectangle can be moved to the next position. If the name is fully defined, it
has to be confirmed by pushing the SELECT button on the screen.
• Select profile screen. Each user can preset and name up to 9 personal
profiles with his/her preferred parameter settings for individual treatments. A
profile (e.g. PROFILE 1) has to be selected by use of the upper or lower right
dial wheel. The profile of the previous laser session gets automatically
preselected. To choose and load a profile the LOAD button on the screen
has to be pushed. To edit a profile (name and parameters) the EDIT button
on the screen has to be pushed. If a user chooses parameters which exceed,
the selected values will automatically be limited by the factory preset values.
Page 28 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
• Define profile screen. If the EDIT button has been pushed the define profile
screen appears. With the lower right dial wheel a letter or a number on the
black rectangle can be chosen. With the upper right dial wheel the rectangle
can be moved to the next position. If the profile name is fully defined, with
the upper right dial wheel the cursor can be moved to the next parameter.
If the profile is fully defined it has to be confirmed by pushing the SELECT
button on the screen.
If the sound interrupt is set to ON during interval lasering the LaserStar 532
nm releases a sound signal just if the LaserStar 532 nm is radiating laser
energy. If the sound interrupt is set to OFF the sound signal is released
constantly during the entire time the foot switch is pushed.
• Setup screen. After switching over from the standby screen to this screen
the desired parameter for adjustment can be selected by using the upper or
the lower right dial wheel. To choose the desired parameter setting press the
SELECT button.
Page 30 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
• Sound volume screen. On this screen the sound volume can be selected by
using the upper or the lower right dial wheel. Values from 1 to 9 can be
selected (the sound can not be turned off). After pushing the SELECT button
on the screen the selected value for the sound volume will be saved and the
standby screen will appear.
• Date/Time screen. On this screen the system date and time can be changed
by selecting the desired parameter with turning the upper right dial wheel.
The parameter itself can be changed by turning the lower right dial wheel.
After pushing the SELECT button on the screen the selected value for the
date and time will be saved and the standby screen appears.
After the system has been started up successfully the treatment parameters can
be selected via the standby screen of the control panel.
RESETTING COUNTER
The total sum of laser energy delivered (in J) and number of pulses released is
indicated on the display. These numbers are automatically reset when the laser is
turned off or when the RESET button on the standby screen is pressed.
SYSTEM ACTIVATION
The LaserStar 532 nm can be activated (the aiming beam is turned on and the
LaserStar 532 nm will release laser pulses when the foot switch is pressed) by
pressing the Switch LASER ON button.
AIMING
The aiming beam will be activated as soon as the LaserStar 532 nm switches over
to the treatment screen. Correct aiming is achieved when the aiming beam covers
the desired treatment area for a single pulse and no other areas/obstacles gets
illuminated by the aiming beam. As long as the LaserStar 532 nm is in the
treatment mode the intensity of the aiming beam can be increased or decreased
by INCREASE ▲ and the DECREASE ▼ button.
Never point the aiming beam directly to the macula. Unintended harm to the
macula might occur. The only exemption to this if the intended treatment
requires laser radiation release to the macula.
Page 32 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Treatment pulses (single pulse or a series of pulses) are released by pressing the
foot switch. As soon as the foot switch is released the LaserStar 532 nm
immediately stops the laser radiation.
SYSTEM STANDBY
After the treatment has been completed press the LASER STOP button. The
LaserStar 532 nm then switches over to the standby mode. This can be seen
since the display shows the standby screen.
SWITCHING OFF
After putting the system into the standby mode (pressing the LASER OFF button)
the key switch can be turned to the 0-position to turn the LaserStar 532 nm off.
Now, the attached delivery devices and options can be removed safely.
When installing the slit lamp adapter to the slit lamp, insert the appropriate user
protection filter first. Then remove the blue mirror cover from the slit lamp
interface, insert the slit lamp interface to the slit lamp tube, and lock the slit lamp
adapter to the slit lamp by turning the locking nut clock wise. Make sure the slit
lamp adapter is fully inserted and secured. Remove the plastic protection cap
and insert the fiber connector attached to the fiber running from the slit lamp
adapter as well as the AutoKey attached to the slit lamp adapter to the LaserStar
532 nm. Make sure they are fully attached. Turn on the LaserStar 532 nm and
check for appropriate recognition of the slit lamp adapter by the LaserStar 532
nm.
When removing the slit lamp adapter from the slit lamp, the fiber connector as
well as the AutoKey connector on the side of the LaserStar 532 nm have to be
removed from the laser unit and the fiber end has to be protected by the plastic
protection cap. The turning knob on the slit lamp tube, opposite the slit lamp
interface, has to be turned counter clock wise for unlocking the slit lamp adapter
to the slit lamp. After unlocking the slit lamp adapter the slit lamp interface can be
pulled out of the slit lamp tube. After removal the slit lamp adapter must be
protected by the blue mirror cover and has to be stored together with the user
protection filters in their case.
Never touch the mirror within the slit lamp adaptor nor any optical part
within the slit lamp tube. Make sure no impurity gets into the slit lamp
tube. This might cause loss of performance of the slit lamp adapter and
the slit lamp
Selected diameter
Dial wheel
for diameter setting
Locking nut
(not visual within this view)
Page 34 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
After use of the LIO-500 it can be detached from the LaserStar 532 nm by
unscrewing the fiber at the Quattro Quick Lock connector from the LaserStar
532 nm and by removing the auto key connector. The LIO-500 has to be
stored in its plastic case.
Re-attachment of the LIO-500 can be done by attaching the Quattro Quick
Lock connector from the LIO-500 to the LaserStar 532 nm and by plugging in
the auto key connector
After the initial installation of the universal slit lamp adapter UNI-SLA by authorised
personnel of D.O.R.C. International bv. or a D.O.R.C. Distributor, the universal slit
lamp adapter can be used for clinical treatment.
The universal slit lamp adapter UNI-SLA gets mounted to a slit lamp via the
tonometer pin. After securely setting the universal slit lamp adapter on the tonometer
pin the fiber running from the universal slit lamp adapter as well as the auto key
connector can be connected to the LaserStar 532 nm.
The treatment spot diameter can be set to the desired value by turning the diameter
dial wheel. After activating the laser unit the position of the treatment spot can be
preset to the desired location by moving the micromanipulator and watching the
aiming beam spot location.
After use of the UNI-SLA the fiber connector as well as the auto key connector must
be detached from the LaserStar 532 nm. The universal slit lamp adapter can be
detached from the slit lamp unit by lifting it off the tonometer pin. The UNI-SLA has to
be stored in its plastic case
Deflecting mirror
Page 36 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Micromanipulator
With the optional foot switch not only the laser pulses can be released but also the
power can be adjusted. With the main pedal in the centre of the foot switch laser
radiation can be released. Press the foot switch in one move. If the foot switch is
pressed too slow the safety system of the LaserStar 532 nm unit will decline the
laser release command. With the right upper, black button the power adjustment
on the LaserStar 532 nm can be increased in steps of 10mW. With the left upper,
white button the power adjustment on the LaserStar 532 nm can be reduced in
steps of 10mW. This optional power adjustment only works if the LaserStar 532
nm is in the treatment mode.
Section 5 - MAINTENANCE
USER MAINTENANCE
When using contact lenses disinfect them after each treatment. The proper
method is indicated in the instruction sheet accompanying each lens. Endo fibers
have to be treated as indicated by the instructions on the package or in the
accompanying manual. Other accessories have been handled according the
Instruction Manual after each treatment.
Disinfect the user contact areas on the LaserStar 532 nm and its delivery devices.
Commercially available disinfecting agents may be used. Take care not to scratch
the window of the display or to contaminate the opening of the laser aperture by
any kind of debris or fluids.
Weekly
Wipe the surfaces of the instrument, the controls and the display with damp cloth.
Commercially available cleaning agents, ethanol and isopropanol may be used.
Aggressive cleaning agents or abrasives must not be used. Take care not to
scratch the window of the display (clean the equipment with low pressure) or to
contaminate the opening of the laser aperture by any kind of debris or fluids.
Make sure that no humidity enters the equipment or its accessory.
Page 38 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
CLEANING INSTRUCTIONS
The display, the dial wheels and the housing of the LaserStar 532 nm can be
cleaned with a damp cloth. Commercially available cleaning agents, ethanol and
isopropanol may be used. Aggressive cleaning agents or cleaning agents with
abrasive additions must not be used. Take care not to scratch the window of the
display (clean the equipment with low pressure) or to contaminate the opening of
the laser aperture by any kind of debris or fluids.
Make sure that no fluids enter the equipment or its accessory.
STERILISATION
The LaserStar is not sterile and does not have to be sterilised before use. In case of
endo coagulation treatments, sterile endo fibers have to be used.
Only use D.O.R.C. approved endo fibers with Quattro Quick Lock connector. The
endo fibers have to be handled according the instructions of the manufacturer.
Reusable endo fibers have to be disinfected and sterilised according the instructions
of the manufacturer.
Yearly Maintenance
Authorised, trained service personnel must carry out a yearly maintenance
programme during which they must check, at least, the following points:
a. Power level of laser beam
b. Functional check of the LaserStar 532 nm and the delivery systems
c. Safety check
According to the regulations governing medical products, this safety check must
be performed by authorised and trained personnel only. Their check, and its
results, must be recorded by using D.O.R.C. approved forms. The interval of one
year may vary from country to country according to local regulations.
It is possible for the user to check the aiming and treatment beams as well as the
function of the LaserStar 532 nm and the delivery systems.
FUSE REPLACEMENT
• Switch off the key switch and unplug the mains cable.
• Open the fuse holders next to the mains cable connector on the back panel
and check the two fuses (use fuses type 2AT).
• Only replace broken fuses with fuses of exactly the same size and values as
indicated on the back panel next to the fuse holder.
Page 40 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 6 - INSTALLATION
The initial installation and introduction into the use of the system must be carried
out by specialised service personnel authorised by D.O.R.C. international bv.
For the initial installation of the system or after a change in the configuration of the
system a D.O.R.C. Field Maintenance Protocol, appropriate for the system, must
be completed by a service engineer authorised by D.O.R.C. International bv.
AMBIENT CONDITIONS
Ensure that the ambient conditions as specified below are met during transport
and operation of the laser.
a) During Operation:
b) Transport / Storage:
Small water / fluid spills will not affect the LaserStar 532 nm.
Medical electrical devices require special attention regarding EMC. Such devices
have to be set up and operated according to the accompanying documents.
Note:
The LaserStar 532 nm must not be exposed to atmospheric pressures or
temperatures exceeding the values mentioned above. Transport in aeroplanes
should be under thermal and pressure adapted conditions.
A laser warning label is to be placed on the outside of the entrance door to the
laser room in a position where it is well visible.
Other requirements for the safe installation of the LaserStar 532 nm laser system
may be found in the Standard „Safety of laser products“, EN 60825-1 (latest
version) and in the respective domestic regulations.
U = 24 VDC
I = 100 mA
Legend:
(1) Plug socket of the door interlock connector of the LaserStar 532 nm
(2) Plug
(3) Connecting cable
(4) Safety switch
(5) Entrance door to the room
FOOT SWITCH
Connect the foot switch to the foot switch connector on the back of the
LaserStar 532 nm.
Page 42 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Affix the user protection filter in the beam path of the microscope which is used for
the laser treatment. For installation of the user protection filters refer to the
Instruction Manual of the microscope.
EQP
The Equipotential Point of the LaserStar 532 nm must be connected to the mains
installation ground.
POWER REQUIREMENTS
The house installation of the customer must be in accordance with the IEC
requirements.
LONG-TERM STORAGE
The LaserStar 532 nm can be turned off and remain unoperated for a few months
without any detrimental consequences. Keep the unit dust free (use the case) and
clean the system before use as described in section 5 „Maintenance“.
DISPOSAL
The user (owner) of the LaserStar 532 nm is responsible for a safe and
environmental conform disposal of the LaserStar 532 nm after its service life.
Do not dispose of as a normal domestic refuse. In order to prevent environmental
risks, please address yourself to specialized companies for the disposal of the
device and of all its accessories.
Dispose the unit according Directives 2002/96CE and 2003/108/CE.
The following material and components used in the construction of
LaserStar 532 nm needs special treatment according to the 2002/96/CE directive
Annex II:
Please note that the product does not contain any dangerous material. Its disposal
will not damage the environment and will not put at risk staff charged with the
disposal itself. As an extra safety precaution, we recommend to contact the waste
local services and/or the competent authorities in order to be properly informed
about the disposal of the device.
Page 44 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
The laser radiation of the LaserStar 532 nm is generated by using a laser diode for
stimulating the Nd:YVO solid state laser crystal. This Nd:YVO crystal generates
laser radiation in the infrared range. This infrared laser radiation is transformed to
visible green laser radiation by the use of a frequency doubling element – the KTP
(potassium titanyl phosphate).
The intensity of the green laser radiation can be adjusted by varying the
stimulating current of the laser diode. An integrated measuring system constantly
monitors the delivered green laser radiation power and therefore controls the
delivered output.
If any problems during the laser radiation is detected the LaserStar 532 nm turns
off the stimulating effect of the laser diode and obstructs the laser path by
activating the internal beam switch.
Dimensions
250 mm
105 mm
220 mm
Weight
7 kg
SPECIFICATIONS
Treatment Laser
Laser power........................................... 50 mW up to 2 W
Pulse length........................................... 10 ms up to 5 s
Idle time................................................. 10 ms up to 5 s
NOHD.................................................... 10 m
Accuracy of internal
treatment power measuring................... ± 5 %
Aiming Laser
Attenuation ............................................ 0 – 1 mW
Page 46 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Symbols used
Type BF equipment
3 4
2 5
6
1 7
8
9
10
11
14 13 12
Page 48 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
ELECTRICAL INTERLOCKS
+ 24 V
GND
SYSTEM OVERVIEW
Front cover
LSL
KSW
ADD
PLD
Back plane
COM
TLD
USB
COP
NTW MED
PRT PCD
SCN PCY
ELB CAV
PCK
FSW
TMD
UPF
DRS TMY
VAC*
TMK
GND EFS
LSW
PWR
TMH
SPK
HMI
PSU FRM
HMI
Page 50 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
2
3
7 5
8
10 9 12
11
(1) Fiber
(5) Mirror
(7) Mirror
(9) Mirror
Page 52 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
2 1
6 5
(1) Fiber
(3) Mirror
(5) Mirror
7
1
9 8 11
6 10
(1) Fiber
(2) Laser beam path
(3) Collimating lens
(4) Diffuser lens
(5) Collimating lens
(6) Mirror
(7) Slit lamp illumination beam path
(8) Mirror
(9) Treatment point on retina
(10) User protection filter
(11) Viewing beam path to slit lamp binocular
Page 54 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Section 8 - ACCESSORIES
The system must only be used with accessories, spares and consumables which
have been listed in this Instruction Manual.
Parts other than these have to be first approved by D.O.R.C. international bv. Those
system parts have to be tested as a complete unit including the additional options.
PARTS (OPTIONAL)
Most Ophthalmologists today are now very familiar with the use of a variety of
laser wavelengths and laser products from different manufacturers, nonetheless it
is extremely important that every new laser is approached as though it were
completely different to the one that the user previously gained their experience on
- it usually is.
As a result of this, all settings given in this clinical handbook are meant only as
guidelines and it remains, as always, the responsibility of the operating
Ophthalmologist to ensure that they establish the optimal settings for each and
every case that they treat. With a new laser, one must be prepared to forget
previously learned settings and work gradually upwards until one has established
optimal settings and thresholds relative to the new laser.
This clinical handbook provides a summary of guidelines for the most common
applications. Please note that although these applications have all received FDA
and other approvals, their inclusion does not guarantee that the application has
received approval in your country.
Additionally, we recommend that the reader refers to textbooks and literature for a
more comprehensive description of contemporary surgical laser techniques. A
bibliography is included at the back of this handbook, but we especially
recommend :
Laser Surgery of the Posterior Segment (Second Edition up). Steven M.Bloom,
Alexander J. Bruckener : Lippincott-Raven, 1997.
or :
Laser Jahrbuch der Augenheilkunde 1992
Kampik, A. : Biermann Verlag, Zülpich, D-5352
There are many more applications currently under investigation and, as and when
these new applications receive approval, we will update this handbook. It is
expected that your local supplier will keep you informed about this but, should you
hear about any new application and wish to ask us about it, please contact us at
the address shown on the last page of this manual. Additionally, should you
develop a new application, or have any queries or amendments which you would
like to suggest to applications already in this manual, we will be more than happy
to hear from you.
Finally we would like to thank you for taking the decision to purchase a
D.O.R.C. International bv. product. If at any time you feel that our support, or that
of your supplier, falls beneath your expectations, please do not hesitate to contact
us directly.
Page 56 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
INTENDED USE
PRINCIPLES OF OPERATION
The LaserStar 532 nm is mobile and can be used either coupled through a variety
of intraocular probes for endo.
APPLICATIONS
Laser Surgery of the Posterior Segment (Second Editiotn up). Steven M.Bloom,
Alexander J. Bruckener : Lippincott-Raven, 1997.
ENDOPHOTOCOAGULATION
This procedure, although in use for sometime now, requires a few words.
Used mainly in conjunction with argon, as an auxiliary procedure in vitro retinal
surgery, may be performed equally well with the cw frequency doubled Nd:YVO.
Endophotocoagulation of Chorio-Retina
The straight probe is used for endophotocoagulation of the chorio retina,
particularly for scatter treatment of diabetic retinopathy, with recommended
starting values as per the following table:
Endocyclophotocoagulation
The curved probe is used for endocyclophotocoagulation in cases of a
concomitant glaucoma, using the same recommended starting values as in the
previous table for endophotocoagulation. The probe should be directed against the
ciliary body. if there is no whitening of the ciliary body, increase the exposure
duration.
In both procedures the dosage depends very strongly on the distance of the probe
from the retina or ciliary body - the intensity of the impact may be varied simply be
varying the distance.
Page 58 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
BIBLIOGRAPHY
General Reading
Laser Surgery of the Posterior Segment (Second Edition up). Steven M.Bloom,
Alexander J. Bruckener : Lippincott-Raven, 1997.
Integrated Optical Fiber Systems for Laser Treatment of Some Structures of the
Anterior Segment.
Rol P., Fankhauser F. and Kwasniewska S.
Current Therapy in Ophthalmic surgery (Eds : Spaeth G, Katz L. J and Parker K.
W.). :
B.C. Decker Inc, Burlington, Ontario and Philadelphia, PA: 167-170, 1989.
Glaucoma Surgery,
Spaeth G. L.
Section 11, Ophthalmic surgery: Principles & Practice (Ed : Spaeth G. L.). :
W.B. Saunders Company, Philadelphia, PA, 1990.
Clinical studies on high and low power laser radiation upon some structures of the
anterior and posterior segments of the eye.
Fankhauser, F., Lörtscher, H. P. and van der Zypen, E. : Int. Ophthalmol. 5 (1)
:15-32, 1982.
Contact glass for use with high power lasers - Geometrical and optical aspects.
Roussel, P. and Fankhauser, F. : Internat Ophthalmol 6: 183-190, 1983.
Iridectomy
Outpatient argon laser iridectomy for angle closure glaucoma: A two year study.
Abraham R. K. and Miller G. L. : Trans American Acad . Ophthalmology and
Otolaryngology 1975; 79:
Changes in the ultrastructure of the iris after irradiation with intense light. A study
of long term effects after irradiation with Argon ion, Nd: YAG and Q-switched ruby
lasers.
van der Zypen E., Fankhauser F. and Bebie H., et al. : Adv Ophthal 1979; 39:59-
180.
Contact glasses for use with high power lasers. Two new contact glasses for
microsurgery at the iris in the pupillary and retropupillary space.
Riquin D., Fankhauser F. and Lörtscher H. P. : Internat Ophthal 1983; 6:191-200.
Laser iridectomy.
Schwartz L. in : Laser Therapy of the Anterior Segment: A Practical Approach. (
Eds: Schwartz L., Spaeth G. and Brown G.) Thorofare NJ: Slack, 1984; 46-52.
Page 60 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Weiblinger RP: Clinical literature highlights on argon and neodymium: YAG laser
iridectomy. Ophthalmic Laser Therapy 1986; 1:237-244.
Miscellaneous
Laser Trabeculoplasty
Section 10 - Addendum
APPROVED CONNECTIONS
Do not stack or put this system in direct contact with other systems. If operation in
such a manner is required do constantly monitor the system regarding its correct
function.
NOTE: This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference when the
equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required
to correct the interference at his own expense.
Page 62 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Fixed strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To access the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey
should be considered. If the measured field strength in the location in which the LaserStar 532 nm is used exceeds the
applicable RF compliance level above, the LaserStar 532 nm should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
LaserStar 532 nm.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Page 64 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual
Recommended separation distances between portable and mobile RF communications equipment and the
LaserStar 532 nm
The LaserStar 532 nm is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the LaserStar 532 nm can help prevent electromagnet interference by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the LaserStar 532 nm
as recommended below, according to the maximum output power of the communications equipment.
Distributor:
Manufacturer:
D.O.R.C. international bv.
Scheijdelveweg 2
3214 VN Zuidland
The Netherlands
Phone : ++ 31-181-458080
Fax : ++ 31-181-458090
E-mail : sales@dorc.nl
Web-site : www.dorc.nl
0344
Page 66 of 66