Laser Star 532n

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D.O.R.C. International b.v.

INSTRUCTION
MANUAL
7000
LaserStar 532 nm

Manufacturer : Distributor in the USA:

Dutch Ophthalmic Research Center Dutch Ophthalmic USA


International b.v.
Scheijdelveweg 2 10 Continental Drive, Bldg 1
3214 VN Zuidland Exeter, NH 03833
The Netherlands U.S.A.

Phone : +31 181 458080 Phone : 800-75-DUTCH or 603-778-6929


Fax. : +31 181 458090 Fax. : 603-778-0911
E-mail : sales@dorc.nl E-mail : sales@dutchophthalmicusa.com
Website : www.dorc.nl 30312900-C

TECHNOLOGY CREATED BY VISION


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Date issued: April 2009

30312900-C Page 2/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

TABLE OF CONTENTS

SECTION 1 - INTRODUCTION ...................................................................................................................... 5


Warranty.................................................................................................................................................... 5
Liability...................................................................................................................................................... 6

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

SECTION 3 - DESCRIPTION ....................................................................................................................... 19


Overview ................................................................................................................................................. 19
Connector Plate (Back Panel)............................................................................................................... 20

SECTION 4 - OPERATION .......................................................................................................................... 21


Preparation ............................................................................................................................................. 21
Use of Delivery Devices ........................................................................................................................ 22
Error Messages ...................................................................................................................................... 22
Display Screens ..................................................................................................................................... 23
Selecting Treatment Parameters.......................................................................................................... 32
Resetting Counter.................................................................................................................................. 32
System Activation .................................................................................................................................. 32
Aiming ..................................................................................................................................................... 32
Treatment Pulse Release ...................................................................................................................... 33
System Standby ..................................................................................................................................... 33
Switching Off.......................................................................................................................................... 33
Use of Slit Lamp Adapter SLA-BMBQ.................................................................................................. 33
Use of Laser Indirect Ophthalmoscope LIO........................................................................................ 35
Use of Slit lamp Adapter UNI-SLA........................................................................................................ 36
Power adjustment foot switch.............................................................................................................. 37

SECTION 5 - MAINTENANCE ..................................................................................................................... 38


User Maintenance .................................................................................................................................. 38
Cleaning Instructions ............................................................................................................................ 39
Sterilisation ............................................................................................................................................ 39
Authorised service personnel Maintenance ....................................................................................... 40
Fuse Replacement ................................................................................................................................. 40

SECTION 6 - INSTALLATION ..................................................................................................................... 41


Ambient Conditions............................................................................................................................... 41

30312900-C Page 3/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Laser Room Warning Label...................................................................................................................42


Laser Room Remote Interlock ..............................................................................................................42
Foot Switch .............................................................................................................................................42
UPF active / passive 532nm...................................................................................................................43
Service Software (for Authorised Personnel only) .............................................................................43
EQP ..........................................................................................................................................................43
Power Requirements..............................................................................................................................43
Long-term Storage .................................................................................................................................43
Disposal...................................................................................................................................................44

SECTION 7 - TECHNICAL DESCRIPTION..................................................................................................45


Green Laser Radiation ...........................................................................................................................45
Dimensions .............................................................................................................................................45
Weight......................................................................................................................................................45
Specifications .........................................................................................................................................46
Optical Beam Path..................................................................................................................................48
Electrical Interlocks................................................................................................................................49
System Overview ....................................................................................................................................50
Slit Lamp Adapter SLA-BMBQ – Optical Path .....................................................................................52
Laser Indirect Ophthalmoscope LIO – Optical Path ...........................................................................53
Universal Slit Lamp Adapter UNI-SLA – Optical Path.........................................................................54

SECTION 8 - ACCESSORIES ......................................................................................................................55

SECTION 9 - CLINICAL MANUAL...............................................................................................................56


Intended Use ...........................................................................................................................................57
Principles of Operation ..........................................................................................................................57
Laser Features and Operation ..............................................................................................................57
Applications ............................................................................................................................................58
Endophotocoagulation ..........................................................................................................................58
Bibliography............................................................................................................................................59

SECTION 10 - ADDENDUM .........................................................................................................................62


Approved Connections ..........................................................................................................................62
Electromagnetic Compatibility (EMC) ..................................................................................................62
Guidance and Manufacturer’s Declaration ..........................................................................................63

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.

CAUTION: Use of controls or adjustments or performance of procedures other


than those specified herein may result in hazardous radiation exposure.

CAUTION: Federal Law restricts this device to sale by or on the order of a


physician.

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.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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.

In case of technical questions, please contact your responsible service representative


or the service department of D.O.R.C. International bv. directly.

We thank you for your choice and wish you full success with the LaserStar 532 nm.

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

Page 6 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Section 2 - SAFETY
Introduction

Two laser types are incorporated in the LaserStar 532 nm:


1. Diode laser (class 2, red 625-645 nm) as an aiming beam.
2. Cw (continuous wave), KTP frequency doubled Nd:YVO laser (class IV, green,
532 nm) as a treatment laser.
There is danger to the eyes and to the skin from direct and indirect radiation.

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.

The LaserStar 532 nm is a device of the protection class I; BF classification


(protection by an additional protective conductor system, i.e. parts that can be
touched are connected to ground).

Important:

All persons in the laser room must protect their


eyes with laser safety glasses or laser filters
appropriate to intensity and wavelength (532
nm) of the LaserStar 532 nm radiation.
The operating physician must protect itself by
using a protection filter in the optical path of
his/her observation system which got approved
by D.O.R.C. International bv.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

STANDARDS

The LaserStar 532 nm complies with the following technical standards and directives:

• EN 1041 (1998) Information supplied by the manufacturer


with medical devices
• EN 980 (2003) Graphical symbols for use in the labelling of medical
devices
• EN 60601-1 (1990-96) Safety of electrical medical devices
• EN 60601-2-22 (1996) Medical electrical equipment
• EN 60601-1-2 (2003) Safety of electrical medical devices
• EN 60601-1-4 (1996-99) Medical electrical equipment
• EN 60825-1 (2001) Radiation safety of laser devices
• EN 14971 (2001) Risk analysis
• ANSI Z136.1 (2000) Standards for the safe use of lasers
• Part 15 FCC* Radio Frequency Devices

* 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

WORKING WITH LASER RADIATION

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.:

Part No. Type of Blocked Optical DIN- / EN-Identification


Laser Wavelength density

7005.F5 Green 532 nm OD 6 D > 315-532 nm L4


IR> 315-532 nm L6

In the case of damage to the glasses, or a change in coloration, discontinue their use
and replace them.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LABELS

a) Laser caution and signs


Location: on the back panel of the unit

LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT
OR SCATTERED RADIATION
CLASS 4 LASER PRODUCT

MAX. LASER RADIATION: 4 W / 5 mW


PULSE DURATION : CW / CW
WAVELENGTH : 532 nm / 635 nm

ACCORDING TO EN 60825-1:2001-11

b) Label for laser emission aperture


Location: next to the laser aperture

Location: below the laser aperture

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

LABELS ON THE SLIT LAMP ADAPTER SLA-BMBQ

a) Label for laser emission aperture


Location: On the slit lamp tube above the laser aperture.

Location: on the slit lamp tube above the laser aperture

Laser Aperture

b) Type label
Location: on the lower part of the slit lamp interface

c) Type label on the package


Location: on the package of the slit lamp adapter

30312900-C Page 11/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LABELS ON THE USER PROTECTION FILTER UPF ACTIVE / PASSIVE 532NM

a) Type labels on the equipment


Location: On the UPF active 532nm

Location: On the UPF passive 532nm

UPF 532nm

b) Type label on the package


Location: on the package of the UPF active 532nm

Location: on the package of the UPF active 532nm

Page 12 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LABELS ON THE LASER INDIRECT OPHTHALMOSCOPE LIO-500

a) Label for laser emission aperture

Location: on the front surface next to the laser aperture

Location; above the laser aperture

Laser Aperture

b) Type label

Location: on the bottom of the laser indirect ophthalmoscope

c) Type label on the package

Location: on the package of the laser indirect ophthalmoscope

30312900-C Page 13/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LABELS ON THE SLIT LAMP ADAPTER UNI-SLA

a) Label for laser emission aperture


Location: on the mounting arm of the slit lamp adapter

Location: on the mounting arm of the slit lamp adapter

Laser Aperture

b) Type label
Location: on the mounting arm of the slit lamp adapter

c) Type label on the package

Location: on the package of the slit lamp adapter

Page 14 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LASER SAFETY DEVICES

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.

3. Remote interlock connector

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.

6. Fiber engaged switch

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.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

7. User protection filters UPF active / passive 532nm

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.

Both types of use protection filters (active and passive) must


be inserted into the beam path of the used microscope during
laser treatment.

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.

Everyone in the room must wear appropriate eye protection


suited for 532 nm during green laser radiation.

8. User protection filters on the SLA-BMBQ

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.

The SLA-BMBQ must only be used if an appropriate user


protection filter is in place

Page 16 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

9. User protection filters on the LIO-500


The LIO-500 is delivered with built in passive user protection filters. The user
protection filters are placed behind the two exchangeable lenses in the eye pieces
of the ophthalmoscope. To enable cleaning of the user protection filters the user
protection filters are mounted in a precision fit holder and are replaceable.

After inserting the exchangeable lenses in the eye piece of the


ophthalmoscope always make sure that the user protection
filters are placed correctly behind the two exchangeable
lenses.

The LIO-500 must only be used if the two user protection


filters are placed correctly behind the two exchangeable
lenses.

10. User protection filters on the UNI-SLA


The UNI-SLA is delivered with a built in passive user protection filter. The user
protection filter is placed before the beam entrance of the slit lamp.
The user protection filter must cover the full observation path of the slit lamp in
order to protect the user from the green laser radiation.

The UNI-SLA must only be used if the user protection filter is


placed correctly in front of the beam entrance of the slit lamp.

11. In case of fire or explosion

Switch off the system immediately.

30312900-C Page 17/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

ARRANGEMENT OF SAFETY CONTROLS

Front of laser generator


• Autokey (Labelled: AK)
• Key switch
• Fiber engaged switch

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)

Laser power setting

Display
Laser aperture
Idle time setting
(Selection button 2)

Laser duration setting


(Selection button 1)

30312900-C Page 19/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

CONNECTOR PLATE (BACK PANEL)

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

• Set up the LaserStar 532 nm


• If a slit lamp is used mount the slit lamp adapter to the slit lamp according the
accompanying user manual.
• Connect the fiber of the desired delivery adapter to the main laser console.
• If a slit lamp adapter, a laser indirect ophthalmoscope, or an endo fiber in
cooperation with an optical device such as a microscope is used, attach the user
protection filter to the optical device (follow the specific instructions within the
Instruction Manual of the device) or make sure the built in user protection filter is
in place.
• Plug in the Autokey connector of the desired delivery adapter to the Autokey (AK)
connector of the main laser console.
• Connect the foot switch plug.
• Plug in mains cable.
• Switch on with the key switch. During start-up procedure the status will be shown
at the display.
• Adjust the delivery device according to your needs (follow the specific
instructions within the Instruction Manual of the delivery device).
• Check that the equipment works properly (display, speaker, etc.)
• Make sure that everybody within the room, who is not protected by a user
protection filter attached to a optical device, is wearing appropriate safety
goggles.
• After the treatment has been completed disinfect the user contact area at the
LaserStar 532 nm.

30312900-C Page 21/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

USE OF DELIVERY DEVICES

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 D.O.R.C. International bv. approved delivery devices


with Quattro Quick Lock optical connectors together with the
LaserStar 532 nm.

• 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.

Optical fibers must be treated with up most caution. Bending


or not fully connecting the optical fiber might result in damage
to the fiber and the attached systems. Also unwanted laser
radiation might be released which could harm user or patient.

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.

30312900-C Page 23/66


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 parameters for LIO and Endo-Fibers are
described in the following:

Laser power Pulse duration


indication and adjustment indication and adjustment

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

# 6: Diameter set on the slit lamp adapter.

30312900-C Page 25/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

• 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:

Laser Stop: Allows to switch over to the standby screen.


▲: Increases the aiming beam brightness by one step.
▼: Decreases the aiming beam brightness by one step.

Page 26 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

• Select user screen. With the LaserStar 532 nm it is possible to register 9


different users. The user has to be selected by use of the upper or lower right
dial wheel. The specific user profile can be loaded by selecting the profile
and pushing the LOAD button on the screen. To edit a user (name and
parameters), the user has to be selected by the upper or lower right dial
wheel and the EDIT button on the screen has to be pushed.
If the equipment is switched on either the standby screen is loaded directly (if
the DEFAULT USER was loaded during the previous laser session) or the
user selection of the previous laser session gets automatically preselected
and can be confirmed with the LOAD button on the screen.

Upper right dial wheel

Lower right dial wheel

• 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.

30312900-C Page 27/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

• 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.

30312900-C Page 29/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

• 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.

• Aiming beam brightness screen. On this screen the aiming beam


brightness can be pre selected by using the upper or the lower right dial
wheel. Values from 0 to 9 can be selected. After pushing the SELECT button
on the screen the selected value for the aiming beam brightness will be
saved and the standby screen will appear.

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.

30312900-C Page 31/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

SELECTING TREATMENT PARAMETERS

After the system has been started up successfully the treatment parameters can
be selected via the standby screen of the control panel.

Before the treatment the following parameters must be set:


• The treatment power via the dial wheel on the left side on the control panel
• The pulse length via the upper right dial wheel on the control panel
• The idle time via the lower right dial wheel on the control panel
(if the idle time is set to 0 the pulse repetition will be turned off – this results
in a single pulse released after pushing the foot switch-independent on the
length of pushing action on the foot 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 PULSE RELEASE

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.

USE OF SLIT LAMP ADAPTER SLA-BMBQ


After the initial installation of the slit lamp adapter SLA-BMBQ by authorised
personnel of D.O.R.C. International bv. or a D.O.R.C. Distributor, the slit lamp
adapter and its user protection filter can easily be removed and re-attached to the
slit lamp by the user. Due to the precision locking mechanism of the slit lamp
adapter re-adjustment of the spot position at the slit lamp adapter is not
necessary after removal and re-insertion by the user. Whenever using the SLA-
BMBQ the appropriate user protection filter must be used. The user protection
filter for the BQ model slit lamp is inserted between the binocular and the
magnification changer and for the BM model slit lamp in front of the magnification
changer. The user protection filters are clearly marked with “UPF – 532 nm”. Only
use D.O.R.C. approved user protection filters with the appropriate wavelength
specification as described in Section 8 of this document.

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

30312900-C Page 33/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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

Always use the appropriate D.O.R.C. user protection filter when


operating the slit lamp adapter. Only use the D.O.R.C. user protection
filter delivered with the slit lamp adapter and the LaserStar 532 nm

Indicator for selected


diameter

Selected diameter

Dial wheel
for diameter setting
Locking nut
(not visual within this view)

Slit lamp tube

Slit lamp interface

Page 34 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

USE OF LASER INDIRECT OPHTHALMOSCOPE LIO-500

After the initial installation of the laser indirect ophthalmoscope LIO-500 by


authorised personnel of D.O.R.C. International bv. or a D.O.R.C. Distributor the laser
indirect ophthalmoscope can be used for clinical treatment.

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

Upper adjustment knob


for vertical beam
dj t t

Lower adjustment knob for Laser aperture


horizontal beam adjustment

30312900-C Page 35/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

USE OF SLIT LAMP ADAPTER UNI-SLA

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

Dial wheel for diameter


setting

Tonometer pin mount

User protection filters

Deflecting mirror

Page 36 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Micromanipulator

POWER ADJUSTMENT FOOT SWITCH

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.

To safely adjust the power with the optional foot switch


make sure to place your foot on the appropriate guide rail
next to the centre main pedal in order to increase or
decrease the power on the LaserStar 532 nm unit.

30312900-C Page 37/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Section 5 - MAINTENANCE

All work not explicitly permitted


has to be carried out by service
personnel authorised by
D.O.R.C. International bv.
Opening of covers or housings
secured by screws is also
exclusively limited to service
personnel authorised by
D.O.R.C. International bv.

USER MAINTENANCE

After each treatment

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.

30312900-C Page 39/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

AUTHORISED SERVICE PERSONNEL MAINTENANCE

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 the users responsibility to ensure that the LaserStar


532 nm laser is operated and maintained in accordance
with 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.

If during checks users determine that there is a fault with a


unit, the faulty unit must immediately be taken out of
service and certified D.O.R.C. service personnel must be
contacted. Under no circumstances any attempt to readjust
or repair the equipment themselves must be taken.

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:

operating temperature ...........................+ 15 – +28°C (59°F to 82°F)

relative humidity.....................................up to 85%

atmospheric pressure ............................700 – 1200 hPa

b) Transport / Storage:

temperature ...........................................+ 5 – +60°C (41°F to 140°F)

relative humidity.....................................max. 90%

atmospheric pressure ............................700 – 1200 hPa

Rooms containing hazardous materials are not suitable as laser rooms.

Small water / fluid spills will not affect the LaserStar 532 nm.

The LaserStar 532 nm is a device of protection class I type BF.

The LaserStar 532 nm must not be placed on an inclined surface without an


appropriate locking mechanism.

Medical electrical devices require special attention regarding EMC. Such devices
have to be set up and operated according to the accompanying documents.

Portable and mobile HF communication devices can affect medical electrical


devices.

30312900-C Page 41/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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.

LASER ROOM WARNING LABEL

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.

LASER ROOM REMOTE INTERLOCK

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

UPF ACTIVE / PASSIVE 532NM

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.

SERVICE SOFTWARE (FOR AUTHORISED PERSONNEL ONLY)

In order to perform service a PC can be attached to the service terminal connector


of the LaserStar 532 nm. On the PC the LaserStar 532 nm service software has to
be installed and must be active. Parameters and service relevant data can be up
and downloaded and the LaserStar 532 nm can be diagnosed, repaired and
adjusted.

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.

Operating Supply Current supply


voltage frequency

90 – 250 V 50/60 Hz 2.0 A

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“.

30312900-C Page 43/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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:

material / components location in the LaserStar 532 nm

backup battery electronic board


TFT Display display
electrolyte capacitors power supply and electronic board

No other material requiring special handling is used in the construction of


LaserStar 532 nm. Optics are made of conventional BK7 glass or quartz.
The conventional electronics can be disposed of via the normal electronic
disposable system. The housing is made of metal (steel, aluminium).

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

Section 7 - TECHNICAL DESCRIPTION

GREEN LASER RADIATION

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

30312900-C Page 45/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

SPECIFICATIONS

Treatment Laser

Laser type.............................................. Diode pumped and frequency doubled


Nd:YVO

Laser class ............................................ IV

Wavelength ........................................... 532 nm

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

Laser type.............................................. Diode Laser

Laser class ............................................ II

Wavelength ........................................... 625 – 645 nm

Attenuation ............................................ 0 – 1 mW

Slit Lamp Adapter SLA-BMBQ

Diameter range...................................... 50 – 5000 µm

Laser Indirect ophthalmoscope LIO-500

Spot diameter ........................................ 1000 µm

Universal Slit Lamp Adapter UNI-SLA

Diameter range...................................... 50 – 1000 µm

Page 46 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Symbols used

Address of the manufacturer

Attention, consult accompanying documents

Type BF equipment

Dispose of equipment and parts properly

30312900-C Page 47/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

OPTICAL BEAM PATH

3 4
2 5
6
1 7
8
9

810 nm 1064 nm 532 nm


532 + 635 nm

10
11
14 13 12

(1) Green power laser generator 532 nm


(2) Green beam path 532 nm
(3) Collimating lens
(4) Red aiming beam path 635 nm
(5) Red aiming beam laser 635 nm
(6) Beam splitter
(7) Coupling lens
(8) Quattro Quick Lock connector
(9) Fiber of delivery device
(10) Output beam 532 + 635 nm
(11) Green power laser measuring diode 532 nm
(12) Frequency doubling crystal (KTP)
(13) Laser crystal (Nd:YVO)
(14) Laser diode

Page 48 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

ELECTRICAL INTERLOCKS

+ 24 V

Beam switch ---

Main processor laser enable ---

Supervisor processor system OK ---

Key switch ---

Door interlock ---

Fiber engaged ---

GND

30312900-C Page 49/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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

ADD Adapter detection


CAV Laser cavity
COM Communication interface
COP Communication print
DRS Door switch / door interlock
EFS Engaged fiber switch
ELB Electronic board
FRM Frame including Covers
FSW Footswitch interface
GND Grounding pin
HMI Human machine interface
KSW Key switch
LSL Laser light
LSW Laser switch

Page 50 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

MED Measuring diode


NTW Network interface
PCD Peltier cooling diode
PCK Peltier cooling KTP
PCY Peltier cooling Nd:YVO
PLD Power laser diode
PRT Printer
PSU Power supply
PWR Power connection
SCN Scanner interface
SPK Speaker
TLD Target laser diode
TMD Temperature measuring diode
TMH Temperature measuring heat sink
TMK Temperature measuring KTP
TMY Temperature measuring Nd:YVO
UPF User protection filter
USB USB interface
VAC Voltage AC

30312900-C Page 51/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

SLIT LAMP ADAPTER SLA-BMBQ – OPTICAL PATH

2
3

7 5
8

10 9 12
11

(1) Fiber

(2) Laser beam path

(3) Collimating lens

(4) Focusing lens

(5) Mirror

(6) Slit lamp illumination beam path

(7) Mirror

(8) Slit lamp illumination focus lens

(9) Mirror

(10) Treatment point on retina

(11) User protection filter

(12) Viewing beam path to slit lamp binocular

Page 52 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

LASER INDIRECT OPHTHALMOSCOPE LIO – OPTICAL PATH

2 1

6 5

(1) Fiber

(2) Laser beam path

(3) Mirror

(4) Focusing lens

(5) Mirror

(6) Treatment point on retina

(7) Binocular lens

(8) User Protection Filter

(9) Viewing beam path to binocular

30312900-C Page 53/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

UNIVERSAL SLIT LAMP ADAPTER UNI-SLA – OPTICAL PATH

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)

Part Number Part


7010.DORC Laser probe curved with DORC connector, 20G / 0.9mm (Box/6, sterile)
7011.DORC Laser probe straight with DORC connector, 20G / 0.9mm (Box/6, sterile)
7220.DORC Directional laser probe, with DORC connector, 20G / 0.9mm (Box/6, sterile)
(not available in the U.S.A.)
7123.DORC Laser probe straight with DORC connector, 23G / 0.6mm (Box/6, sterile)
7223.DORC Directional laser probe, with DORC connector, 23G / 0.6mm (Box/6, sterile)
(not available in the U.S.A.)
7025.DORC Laser probe straight with DORC connector, 25G / 0.5mm (Box/6, sterile)
7225.DORC Directional laser probe, with DORC connector, 25G / 0.5mm (Box/6, sterile)
(not available in the U.S.A.)
7410.DORC Illuminated laser probe, curved with DORC laser & light connector, 20G /
0.9mm (Box/6, sterile)
7411.DORC Illuminated laser probe, straight with DORC laser & light connector, 20G /
0.9mm (Box/6, sterile)
7510.DORC Illuminated laser probe, curved with tapered tip for use in combination with
23G vitrectomy system, 23G / 0.6mm (Box/6, sterile)
7005.F1 Safety filter for Zeiss/Möller-Wedel Microscopes, Active
7005.F2 Safety filter for Leica Microscopes, Active
7005.F3 Safety filter for Zeiss/Möller-Wedel Microscopes, Passive
7005.F4 Safety filter for Leica Microscopes, Passive
7005.F5 Safety Goggles, 532nm
7005.F6 Slit Lamp Adapter SLA-BMBQ
7005.F7 Laser Indirect Ophthalmoscope LIO-500
7005.F9 Universal Slit Lamp Adapter UNI-SLA
7005.F10 Safety filter for BQ900, Active
7005.F11 Safety filter for BQ900, Passive
7005.F12 Safety filter for BM900, Passive

30312900-C Page 55/66


D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Section 9 - Clinical Manual

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

The intended treatments for the LaserStar 532 nm are:


• Photocoagulation By radiating the tissue with the laser the temperature of
the tissue can be increased. This, due to the effect of absorption of radiation
in the tissue and the transformation of laser energy into thermal energy.
Depending on the intensity of the laser radiation the tissue shrinks, is
coagulated, burned, or vaporized. Based on those effects healing effects
result in the eye.

PRINCIPLES OF OPERATION

The cw frequency doubled Nd:YVO laser systems LaserStar 532 nm performs


coagulations at 532 nm.
The physiological mechanism of photocoagulation is based on a thermally-induced
denaturation of macro-molecular proteins. The transformation of light energy into
heat results mainly from the absorption of the chromophores xantophyll, melanine
and haemoglobin. Depending on the intensity of the irradiation, the tissue can be
caused to shrink, coagulate, carbonise or even evaporate. Certain beneficial
therapeutic effects are based on healing processes and scar formation.
CW frequency doubled Nd:YVO, at 532 nm, generates exactly the same laser light
such as the cw frequency doubled Nd:YAG laser and requires also exactly the
same energy. Compared to argon the cw frequency doubled Nd:YVO requires
about the same energy as argon to achieve photocoagulation because it’s green
light is better absorbed by haemoglobin and less by xantophyll and there is a
resultant reduction in scattering. The clinical results are about the same as with
argon photocoagulation - if not better. The harmful side lines (like blue) as they get
produced by the argon laser are not present with the frequency doubled Nd:YVO
laser. By putting less energy into the eye, it reduces the post-operative
complications. As it is a solid state, rather than gas tube, laser it also offers clear
economic advantages over conventional argon systems and is much easier to
maintain.
Whereas cw diode lasers at 810 nm has a much deeper penetration, cw frequency
doubled Nd:YVO at 532 nm has a similar depth of penetration to argon and is
therefore suitable for all retinal procedures currently performed by argon lasers.
The lower scattering and lesser absorption by xantophyll makes it safer to use in
the area of the macula.
In general one can summarize that the laser treatment should be started with
rather low power and short pulse length and those parameters are increased step
by step according to the desired and achieved effect.

LASER FEATURES AND OPERATION

The LaserStar 532 nm is mobile and can be used either coupled through a variety
of intraocular probes for endo.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

APPLICATIONS

The cw frequency doubled Nd:YVO can, as has been previously mentioned, be


used as an alternative to argon in all of its traditional applications. As these are
already very well established and documented, it is not our intention here to go
through of all the indications, contraindications and procedures. However, should
the reader be interested, we especially recommend the following book :

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:

Power (mW) Exposure duration (ms) Energy (J)

300 200 0.06

If there is no effect, the exposure duration or power should be increased.

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.

Safety with Lasers and Other Sources - A Comprehensive Handbook.


Sliney, D. and Wolbarsht, M. : Plenum Press, New York, 1980.

Ophthalmic Lasers : Current Clinical Uses.


March, W. F. : Slack, Inc., Thorofare, New Jersey, 1984.

Anterior Segment Surgery, IOL's Lasers and Refractive Keratoplasty.


Stark, H. J., Maumenee, A. E. and Terry A. C. (eds.) : Williams and Wilkins,
Baltimore, Maryland. 1986.

Ophthalmic Lasers (3rd ed.)


L'Esperance, F. A. Jr., : C.V. Mosby Company, St.Louis Missouri, 1989.

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.

Spectral transmittance of intraocular lenses and damage from intense light


sources.
Mainster, M. A. : J. Opht. Soc. Am. 60 : 848-855, 1970 and American J.
Ophthalmol 85 :167-170, 1978.

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.

Sicherheitsprobleme für die Augen beim Umgang mit Laserstrahlen


(Safety problems for the eye in connection with laser radiation)
Lörtscher, H. P. and Fankhauser, F. : Klin. Mbl. - Augenheilk. 180:360-362, 1982.

Contact glass for use with high power lasers - Geometrical and optical aspects.
Roussel, P. and Fankhauser, F. : Internat Ophthalmol 6: 183-190, 1983.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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:

Continuous wave argon laser iridectomy in angle-closure glaucoma.


Podos S. M., Kels B. D. and Moss A. P. et al. : Am J Ophthalmol 1979; 88:863-
42.

Use of argon laser energy to produce iridectomies.


Pollack I. P. : Trans Am Ophthalmol Soc 1979; 77:674-706.

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.

Lasereffekte in der Iris (Laser effects on the iris).


van der Zypen E. and Fankhauser F. in: Wundheilung des Auges und ihre
Komplikationen. (Eds : Naumann + Gloor), J.F. Bergmann-Verlag München 1980;
337-341. 529-38.

Long-term follow-up of laser iridectomies.


Quingley H. A. : Ophthalmology 1981; 88:218-24.

Argon laser peripheral iridectomies in the treatment of primary angle closure


glaucoma: Long-term follow-up.
Robin A. L. and Pollack I. P. : Arch Ophthalmol 1982; 100:919-23.

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.

A comparison of Nd: YAG and argon laser iridectomies.


Robin A. l. and Pollack I. P. : Ophthalmology 1984; 91:1011-16.

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.

Argon laser iridectomy.


Harrad R. A., Stannard K. P. and Shilling J. S. : Brit J Ophthalmol 1985; 69:368-
372.

Retinal damage after argon laser iridectomy.


Karmon G. and Savir H. : Am J Ophthalmol 1986; 101:554-560.
Laser iridectomy: A controlled study comparing argon and neodymium: YAG.

Page 60 of 66
D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Moster M. R., Schwartz L. W. and Spaeth G. L., et al. : Ophthalmology 1986:20-


24.

Weiblinger RP: Clinical literature highlights on argon and neodymium: YAG laser
iridectomy. Ophthalmic Laser Therapy 1986; 1:237-244.

Miscellaneous

Direkte Ziliar-körperkoagulation mit dem Argonlaser


Bartl, G., Hofmann, H. and Wocheslaender, E. : Fortschr. Ophthalmol 79 :
438,1983

Laser shrinkage of ciliary processes: a treatment for malignant (ciliary block)


glaucoma
Herschler, J. : Ophthalmology 87 : 1155, 1980

Argon laser photocoagulation of the ciliary processes in the management of


aphakic glaucoma
Lee, P. F. : Arch Ophthalmol 97 : 2135, 1979
Transpupillary photocoagulation of the ciliary processes,
Merrit, J. C. : Ann. Ophthalmol 8 : 325, 1976

Transpupillary argon laser cyclophotocoagulation


Klapper, R. M. and Dodick, J. : Doc. Ophthalmol. Proc. Ser 36 : 197, 1984

Laser Trabeculoplasty

Comparison of ARGON and CW Nd:YAG Laser Trabeculoplasty.


Belgrado, G., Brihaye-van Geertuyden, M. and Herzel, R. : Laser Technology in
Ophth. :45-52. Kugler & Ghedini Publications, 1988.

Comparison of Argon and Nd:YAG Laser Trabeculoplasty.


Mermoud , A., Herbort, C.P., Schnyder, C. and Pittet, N. : Klin.Mbl. Augenheilk.
200 1992

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Section 10 - Addendum

APPROVED CONNECTIONS

The following connections to the LaserStar 532 nm supplied by D.O.R.C.


International bv. have been approved:

Connection Type Length


Foot Switch Shielded connection 3.5 m
User Protection Filter Shielded connection 3.5 m
Door Interlock Shielded connection NA (in house installation)
AutoKey Shielded connection NA (connected directly to
delivery fiber)
COM Shielded connection 2m

NOTE: Only connections approved and supplied by D.O.R.C. International bv.


must be used on the LaserStar 532 nm.
The use of connections or accessories not approved by D.O.R.C.
International bv. can cause increased electromagnetic emission as well as
reduced electromagnetic immunity.

ELECTROMAGNETIC COMPATIBILITY (EMC)

Changes or modifications to this system not approved by D.O.R.C. International


bv. could cause EMC issues with this or other equipment.

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.

This system is designed and tested to comply with applicable regulations


regarding EMC and needs to be installed and put into service according to the
EMC information stated as follows.

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

GUIDANCE AND MANUFACTURER’S DECLARATION

Guidance and manufacturer’s declaration – electromagnetic emissions


The LaserStar 532 nm is intended for use in the electromagnetic environment specified below. The customer or the
user of the LaserStar 532 nm should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment -
guidance
RF emissions CISPR 11 Group 1 The LaserStar 532 nm uses RF
energy only for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions CISPR 11 Class A The LaserStar 532 nm is suitable
for use in all establishments other
Harmonic emissions IEC 61000-3-2 Class A than domestic and those directly
Voltage fluctuations/flicker Complies connected to the public low-
emissions IEC 61000-3-3 voltage power supply network that
supplies buildings used for
domestic purposes.

Guidance and manufacturer’s declaration – electromagnetic immunity


The LaserStar 532 nm is intended for use in the electromagnetic environment specified below. The customer or the
user of the LaserStar 532 nm should assure that it is used in such an environment.
Immunity test IEC 60601 Test level Compliance level Electromagnetic
environment - guidance
Electrostatic discharge +/-6 kV contact +/-6 kV contact Floors should be wood,
(ESD) IEC 61000-4-2 concrete or ceramic tile. If
+/-8 kV air +/-8 kV air floors are covered with
synthetic material, the
relative humidity should be
at least 30 %.
Electrical fast +/-2 kV for power +/-2 kV for power Mains power quality should
transient/burst IEC supply lines supply lines be that of a typical
61000-4-4 commercial or hospital
+/-1 kV for input/output +/-1 kV for input/output environment.
lines lines
Surge IEC 61000-4-5 +/-1 kV differential +/-1 kV differential Mains power quality should
mode +/-2 kV common mode +/-2 kV common be that of a typical
mode mode commercial or hospital
environment.
Voltage dips, short < 5 % UT (> 95 % dip < 5 % UT (> 95 % dip Mains power quality should
interruptions and in UT ) for 0,5 cycle in UT ) for 0,5 cycle be that of a typical
voltage variations on commercial or hospital
power supply input 40 % UT (60 % dip in 40 % UT (60 % dip in environment. If the user of
lines IEC 61000-4-11 UT ) for 5 cycles UT ) for 5 cycles the LaserStar 532 nm
70 % UT (30 % dip in 70 % UT (30 % dip in requires continued operation
UT ) for 25 cycles UT ) for 25 cycles during power mains
interruptions, it is
< 5 % UT (> 95 % dip < 5 % UT (> 95 % dip recommended that the
in UT ) for 5 sec in UT ) for 5 sec LaserStar 532 nm be
powered from an
uninterruptible power supply
or a battery.
Magnet fields at 3 A/m Magnetic fields at low
supply frequency frequency should not exceed
(50/60Hz) according to the typical value as seen in
IEC 61000-4-8 business and hospital
environments.
Note: UT is the a.c. mains voltage prior to application of the test level.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

Guidance and manufacturer’s declaration – electromagnetic immunity


The LaserStar 532 nm is intended for use in the electromagnetic environment specified below. The customer or the
user of the LaserStar 532 nm should assure that it is used in such an environment.
Immunity tests IEC 60601 Test level Compliance level Electromagnetic
environment -guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the LaserStar
532 nm, including cables,
than the recommended
separation distance
calculated from the equation
applicable to the frequency
of the transmitter.
Recommended separation
distance:

Conducted RF IEC 3 V rms 150 kHz to 80 3 V rms d = 1,2 root P


61000-4-6 MHz outside ISM 80 MHz to 800 MHz
bands
Radiated RF IEC 3 V/m 80 MHz to 2.5 3 V/m d = 1,2 root P
61000-4-3 GHz 800 MHz to 2,5 GHz
where P is the maximum
output power rating in the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
a
survey, should be less than
the compliance level in each
b
frequency range.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:

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.

Separation distance according to frequency of transmitter


m
Rated maximum output
power of transmitter (P) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d= 1.2 root P d= 1.2 root P 2,3 root P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the higher frequency range applies.
Note 1: At 80 MHz and 800 MHz, the separation distance fort he 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.

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D.O.R.C. International b.v. LaserStar 532 nm Instruction Manual

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

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