Valon Multispot Laser User manual

User’s Manual
Document No: 3500151-N 08/2012

Table of Contents
1. Introduction 1
2. Technical Specications 2
3. Terms of Use 3
4. Warranty and Service 6
5. System Description 7
5.1. Free standing unit Valon 7
5.2. PC and Touch screen 8
5.3. Foot switch 11
5.4. Slit Lamp Adapter 12
5.4.1. Revolver 12
5.5 Smart Wheel 13
5.6 Laser Aperture 13
5.7. Optical beam path 14
5.7.1. Laser 14
5.7.2. System (normal) 15
5.8. Accessories 16
5.8.1. Eye Safety Filter 16
5.8.2. Eye safety goggles 16
5.8.3. Cables 17
6. Using Valon 18
6.1 Before Use 18
6.1.1. Ensuring the Basic Safety 18
6.1.2. Turning the System on 19
6.1.3. Adjusting the Binocular Lenses 20
6.1.4. Selecting the Spot Size 20
6.2. Using the software 21
6.2.1. Graphical user interface (GUI) 21
6.2.2. Adjusting the Settings 22
(1) Pulse Duration 22
6.2.3.Treatment Mode 24
6.2.4 Before treatment 26
6.2.5 Checking the Spot Focus 26
6.2.6. Treatment Instructions 26
6.2.7. Finishing the treatment 26
6.2.8. Applications of the Smart wheel 27
6.2.8.1. Changing the pattern 27
6.2.8.2. Changing the pattern size 27
6.2.8.3. Using the micromanipulator 27
6.2.8.4. Adjusting the Orientation of the Pattern 28
6.2.8.5. Changing the power 29
6.2.9. Treatment Information 30

6.2.10. Lens Selection 31
6.2.11. Setup 32
6.2.12. Service 33
6.3 Instructions for After Use 34
6.3.1. Turning off the system 34
7. Patterns 35
7.1. Square 36
7.2. Sector 36
7.3. Circle 37
7.4. Arc 37
7.5. Line 38
7.6. Spot repetition 38
8. Safety 39
8.1. Emergency Stop Button 39
8.2. Double Control 39
8.3. Eye Safety Instructions 40
8.3.1. Eye Safety Filter (OD > 5) 40
8.3.2. Laser Safety Eyewear Requirements 40
8.4. Caution for High Power 40
8.5. Prevention of unauthorized use 41
8.6. Requirements for the treatment room 41
9. Maintenance 42
9.1. User Maintenance 42
9.2. Essential performance and maintenance 42
10. Errors 43
10.1. Conrmable Errors 43
10.2. Non-conrmable Errors 44
10.3. Laser Heatsink Overtemperature 44
10.4. Warnings caused by the RTC4 card 44
10.5. Warnings caused by Spot Recognition 44
11. Troubleshooting 46
11.1. System does not turn on 46
11.2. Aiming beam not visible 46
11.3. Aiming beam not in focus 46
11.4. Aiming beam not correctly centered 47
11.5. Smart wheel not active 47
11.6. Foot switch not active 47
11.7. Error messages 47
12. System Labeling 48
Table of Contents

12.1. System name plates and serial numbers 48
12.1.1 Valon 48
12.1.3. Eye safety lter 48
12.2. Warning symbol denitions 49
13. Disposal of Waste 52
14. Electromagnetic compatibility 53
User Manual Revision history 57
Table of Contents

1
Valon Multispot Laser is a semi-automated laser system
that enables fast and effective treatment of retinal dis-
eases. Connected to most popular microscopes it offers
variable functions for transpupillary laser photocoagulation.
Aside from standard single shot photocoagulation Valon
also offers varied laser scanning patterns enabling a faster
and high-quality treatment.
The system is composed of a slit lamp adapter integratable
with compatible microscopes. With computer controllable
scanners it produces a variety of different predened spot
patterns to suit several treatment applications. The slit lamp
adapter (SLA) also allows the adjustment of the spot size:
available sizes are (50 µm,) 100 µm, 200 µm, 300 µm and
400 µm. The 532 nm laser beam is produced by a laser
installed in the console and transmitted to SLA by an opti-
cal ber. The system itself is controlled by a PC connected
to a monitor with a touch screen enabling the physician
to adjust suitable settings for the treatment. The available
settings are the shape and size of the gure formed by the
single spots, the duration and intensity of the laser pulse,
the mutual distance of spots and the intensity of the aiming
beam. The program also produces a preview of the spot
pattern to visualize the area to be coagulated in the target
tissue.
To ease the control of the system during treatment, a smart
wheel is also included for manual control. It enables the
physician to change between gures, gure sizes and the
positioning of the gure and also changing the power with-
out looking away from the microscope. The system is de-
signed to suit hospital environment.
Valon provides a safe and costefcient treatment by short-
ening the treatment time and making it more effective. The
short period of time required for the coagulation of a large
amount of spots makes the treatment also more bearable
for the patient. Valon has been developed in collaboration
with medical experts to ensure the optimal properties for
safe and efcient use.
1. Introduction
Caution!
Valon should
only be used
for treatment
purposes
Caution!
This medical
elecrical equip-
ment is in-
tended for use
by healthcare
personnel only
Caution!
U.S. Federal
law restricts
this device to
sale by or on
the order of a
physician

2
Treatment wavelength 532 nm
Spot size (50 μm,) 100 μm, 200 μm,
300 μm and 400 μm
Slit Lamp Integrateable to various up-
pert light source type slits-
lamps e.g. Haag-Streit BM
and BQ and CSO SL 990
Laser Frequency doubled Nd-YVO
532 nm
Laser Power 0-1500 mW (nom. 2500 mW
limited to 1500 mW)
Accuracy of internal pow-
er measuring
±5 %
Laser class (treatment) IV
Pulse duration 10-650 ms, 10-30 ms in pat-
tern mode
Aiming laser 635 nm, adjustable bright-
ness
Laser class (aiming) 3R, limited to class I
Available Patterns Square, Circle, Line, Sector,
Arc, Spot
User Interface Touch screen or smart
wheel
Risk classication IIb
Electrical classication Type 1
NOHD (nominal ocular
hazard distance)
5 m
NA (numerical aperture) 0.075-0.125
Operating room tempe-
rature
+10°C - +30°C
Condition of transport
and storage
+5°C - +60°C
2. Technical Specications

3
The device is designed only for treatment purposes that
are described below.
Functional purpose of the device (intended use)
The Valon-laser proposes a radically different way to per-
form photocoagulation. A concept introduced by Meyer-
Schwickerath for the treatment of diabetic retinopathy in
the 1950s.
Photocoagulation entails the delivery of a laser beam to the
fundus of the eye with the assistance of a slit lamp (mi-
croscope) and a contact lens. A certied physician places
several hundred laser burns (“spots”) in selected areas of
the patients fundus. The burns are used to destroy the ab-
normal blood vessels that form in the retina of the diabetic
patient. This treatment has been shown to reduce the risk
of severe vi-sion loss for eyes at risk by 50%.
The treatment parameters for retinal photocoagulation
have remained relatively constant since the rst descrip-
tion of an argon laser coupled to a slitlamp delivery system
in 1970. The three separate but interdependent variables
available to the clinician are the beam size, power, and
duration of the pulse. Typically, for diabetic retinopathy,
retinal vascular applications, and the treatment of retinal
breaks, the retinal laser spot sizes range from 100 to 500
μm, the pulse durations from 100 to 200 milliseconds, and
the power from 100 to 750 mW.
Intended patient population and medical condition (in-
dication for use)
Photocoagulation has been shown to be effective in the
treatment of proliferative diabetic retinopathy and ad-
vanced forms of nonproliferative diabetic retinopathy
associated with macular edema in large, prospective, multi-
center, randomized trials—the DRS and ETDRS.
3. Terms of Use
Caution!
This medi-
cal electrical
equipment is
inteded for use
by professional
healthcare per-
sonnel only
Caution!
Mobile RF
communica-
tions equip-
ment can effect
medical electri-
cal equipment
Caution!
Medical electri-
cal equipment
needs special
precautions
regarding EMC
and need to
be installed
according to
EMC infor-
mation

4
In addition to proliferative and non proliferative diabetic reti-
nopathy, other treatments and pathologies that may benet
from laser photocoagulation include:
• Choroidal neovascularization
• Branch and central retinal vein occlusion
• Age-related macular degeneration
• Lattice degeneration
• Retinal tears and detachments
• Iridotomy
• Iridectomy
• Trabeculoplasty in angle closure and open angle glau-
coma
Valon is solely intended for treating the lesions mentioned
above.
Complications (reasonable foreseeable)
Properly conducted laser photocoagulation rarely causes
serious complications. The adverse effects of PRP include
visual eld constriction, night blindness, color vision chang-
es, inadvertent laser burn, macular edema exacerbation,
acute glaucoma, and traction retinal detachment.
Contraindications
Contraindications for using the laser include opacities in
the cornea or lens, or blood in the vitreous humor that may
interfere with the delivery of laser energy to the desired
structure.
3. Terms of Use

5
Explanation of any novel features
Valon delivers patterns of several laser spots with a pulse
duration that is ve times shorter than that of a conven-
tional laser. The Valon method of photocoagulation has the
following advantages when compared to a conventional,
single spot treatment:
• Minimized thermal damage leading to homogenous and
predictable burns.
• Less total energy required
• Less discomfort for the patient
In addition to the conventional single shot setting, Valon
can deliver several different patterns including sectors,
squares, arcs and circles.
These modes of operation are a new approach to the treat-
ment of diabetic retinopathy, retinal tears, vascular occlu-
sions and other retinal pathologies.
The laser is operated via a touch screen and a smart wheel
wheel, which gives the physician the freedom to choose a
pat-tern without removing their eyes from the oculars.
The user is allowed to perform only the maintenance or
service operations that are described in this manual. Fur-
ther operations might damage the device and the user.
Such service operations may be performed solely by quali-
ed maintenance personnel.
Before performing treatment operations with Valon, the
user must receive user training.
3. Terms of Use

6
The warranty of Valon is 12 months for the entire system
excluding ber and optics. Painted surfaces are not cov-
ered by warranty if the system is left in direct sunlight or
subjected to other UV radiation for long periods of times.
System does not contain components that could be ser-
viced by the user. In case the system needs service,
please contact the manufacturer or an authorized service
representative.
Manufactured by:
Valon Lasers Oy
Merimiehenkuja 5
01670 Vantaa
FINLAND
tel. [phone]
4. Warranty and Service

7
5.1. Free standing unit Valon
The Valon Laser Free Standing Unit (STA) consists of the
trolley with the computer, the laser console and the elec-
tronics of the device. The monitor with touch screen is xed
to the trolley. The trolley is on wheels and is easily mov-
able. The foot switch is connected to the laser console.
Functions and connections between different parts of the
trolley are described in the following sections.
5. System Description
Warning!
Handle with
extreme care
when moving
the system to
protect espe-
cially the opti-
cal ber
Warning!
The system
should not
be stacked or
located close
to other equip-
ment

8
5.2. PC and Touch screen
The system is equipped with a medical grade PC, medical
grade touch screen and suitable programs. Some speci-
cations are presented below.
PC specications
PC model Osbourne mini PC
Touch screen 1528L medical LCD desk-
top touch screen
Max. screen resolution 1024 x 768
Operating system Windows XP embedded +
sp2
Software MultiSpot 1.05 / 1.06
d2x Driver versio 3.01.0
RBC9 driver for smart wheel
Laser service software 3.06
Elo touch screen driver
RTC4 Drivers
Cute PDF 2.8
GPL Ghostscript 8.15
SLP 440 driver
5. System Description
Warning!
Never use the
PC to any oth-
er than treat-
ment purposes
or connect to
the internet.
The PC con-
tains no anti-
virus software.
Also, the use
of any external
equipment is
not allowed

9
Screen settings
The basic screen settings are adjusted with the buttons
on the right side panel of the monitor. To enter the setting
mode press the Menu button (1) and choose the setting
you want to change by the Select button (2). Use the arrow
buttons (3) to adjust.
The side panel also contains the Power button (4) of the
moni-tor. If the screen is not activated when the system is
turned on (from the key switch), use the Power button to
activate the screen.
5. System Description

10
Monitor connections
The connections of the monitor are presented in image 1.
(1) Power cable
(2) Monitor cable
(3) USB-cable for touch screen
5. System Description
The connections the monitor (viewed from below)

11
5.3. Foot switch
When the foot switch is
pressed the system starts
the process of coagulat-
ing the dened spot pat-
tern with the 532 nm laser
beam. The laser emission
can always be interrupt-
ed by releasing the foot
switch if the patient´s eye
has moved or there is any doubt about the function of the
system. The system terminates the drawing of the pattern
instantly when the foot switch is released.
If the foot switch stays pressed after the pattern is drawn,
the system does not continue the coagulation. To produce
a new laser gure, the foot switch must be released and
repressed.
The foot switch is solidly connected to the laser console
box.
Connecting the foot switch:
5. System Description
Valon STA

12
5.4. Slit Lamp Adapter
The slit-lamp adapter contains the scanners that deect the
laser beam delivered from the laser console by an optical
ber. The SLA case envelopes the focusing optics and the
scanner electronics. The SLA is intergratable to various
upper light source type slit lamps e.g. Haag-Streit slit lamp
models 900BM and 900BQ and CSO SL 990.
5.4.1. Revolver
The SLA also includes a focusing unit that enables the
adjustment of the spot size. Available spot sizes are 50μm,
100μm, 200μm, 300 μm and 400μm.
5. System Description
Warning!
Sharply bend-
ing or improp-
erly securing
the ber may
lead to da-
mage of the
ber or beam
delivery sys-
tem and/or
harm to the
patient or laser
operator.

13
5.5 Smart Wheel
The smart wheel is a manual control button that allows the
user to change gure, gure size, gure position, gure
orientation and power during the treatment without having
to use the touch screen.
The smart wheel is connected to the USB-port of the com-
puter which is located under the screen.
5.6 Laser Aperture
Laser aperture is situated on the slit lamp and it is marked
with laser aperture sticker.
5. System Description
Note
The applica-
tions of the
smart wheel
are presented
in section
6.2.8.

14
5.7. Optical beam path
5.7.1. Laser
1. Green power laser generator 532nm
2. Green beam path 532nm
3. Collimating lens
4. Red aiming beam path 635nm
5. Red aiming beam laser 635nm
6. Beam splitter
7. Coupling lens
8. Fiber connector
9. Fiber of delivery device
10. Output beam 532 nm + 635 nm aiming beam
11. Green power laser measuring diode
12. Frequency doubling crystal
13. Laser crystal (Nd:YVO)
14. Laser Diode
5. System Description

15
5.7.2. System (normal)
1. Laser unit 7. Scanner No 2
2. Fiber 8. Focusing lens
3. Collimating lens 9. Slit lamp
4. Scanner No 1 10. Beam splitter
5. Slit lamp adapter 11. Slit lamp optics
6. Transferring lenses 12. Slit lamp mirror
5. System Description

16
5.8. Accessories
5.8.1. Eye Safety Filter
The eye safety lter protects the eyes of the user. The opti-
cal density of the lers is OD>5 which is a standard value
in this eld.
The shape and location of the lter depends on the slit
lamp model. In Haag-Streit BM the lter is located as
shown in image below.
In Haag-Streit BQ (left) and CSO 990 (right) the ring-
shaped lter is located between microscope and binocu-
lars.
5.8.2. Eye safety goggles
A pair of goggles (OD > 5 for 532nm) is delivered with each
Valon unit.
5. System Description
Warning!
Use of any oth-
er accessories
may result in
noncompliance
of standards
Warning!
Never use any
other eye safe-
ty lters with
the system
Caution!
Do not touch
the lter plates!
The plates
may become
scratched