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OPHTHALMIC PHOTOCOAGULATORS

INDIRECT OPHTHALMOSCOPE HEINE


DELIVERY SYSTEM
FOR 532 nm LASER

USER MANUAL Directive 93/42/EEC

XL IO HEI ME US MARCH 2004

QUANTEL MEDICAL SA
21, rue Newton, Z.I. du BREZET
63039 Clermont-Ferrand Cedex 2 - FRANCE
Tel : +33 (0) 473 745 745 - Fax : +33 (0) 473 745 700
e-mail : contact@quantel-medical.fr
web site : www.quantel-medical.com
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

1 - IWARNINGS AND CAUTIONS


This reference guide is intended to provide specific information and instructions for using
the VIRIDIS or VIRIDIS TWIN with indirect ophthalmoscope HEINE Omega 180 delivery
system for 532 nm laser.

This document is intended to be used in conjunction with the VIRIDIS or VIRIDIS


TWIN ophthalmic photocoagulator user manual.

The safe use of this laser system begins with your understanding that the purpose of this
laser system is to produce controlled destruction of living tissue. Misuse of the laser system
may result in accidental injury to the patient, physician or attendants.
Complete information for the safe use of lasers in health care facilities is published in ANSI
Standard Z136.3.

For specific informations and instructions, refer to the appropriate section of this guide
for the delivery system that will be used with your device.

You are encouraged to forward all comments or questions regarding the operation,
maintenance or the use of this product to Quantel Medical.

In case of service needs or if you notice a change in the laser efficacy, please contact the
Quantel Medical Service Department or your local Distributor

-------------------------------------------------------------------

CAUTION :
Federal (USA) law restricts this device to sale by or on the order of a physician.

CAUTION :
Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.

------------------------------------------------------------------------

Quantel Medical cannot be held responsible for any damage or injury which results from
a failure to follow, or incorrect use of, the instructions contained in this manual.

The guarantee of the equipment will be void if the equipment is opened (even partially),
modified or repaired in any way by persons who are not authorised by Quantel Medical.

CAUTION :
To preserve the finish of the case, avoid the use of abrasive cleaners. If possible, clean
spots before they dry.

P-3
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

1 - WARNINGS AND CAUTIONS


WARNINGS
BEFORE USING THE PHOTOCOAGULATOR, MAKE SURE THAT THE
DOCTOR'S FILTER IS IN PLACE AND NOT DAMAGED.

IF ANY INCIDENT OCCURS, QUANTEL MEDICAL SHALL NOT BE


LIABLE IF THIS SAFETY PROCEDURE IS NOT FOLLOWED.
100- 240V~
50/60 Hz
350 VA in 240V 5 AT
1
230 VA in 100V 240 V
I max = 4.5A DANGER
SURGICAL LASER
LASER CLASS 4 / IV
Nd:YAG Laser : 532nm, 2W Max LASER RADIATION
Avoid eye or skin exposure to
LASER CLASS 2 / II direct or scattered radiation
Laser Diode : 670nm, <1mW Max
VISIBLE AND/OR INVISIBLE LASER RADIATION ND : YAG 532 nm 2 W Avg.
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
Diode 670 nm 1 mW
CLASS IV LASER PRODUCT per 21 CFR 1040 CLASS IV LASER PRODUCT

CAUTION : FEDERAL USA LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE


ORDER OF A PHYSICIAN OR AN OPTOMETRIST LICENCED BY THE LAW OF THE
STATE IN WHICH HE PRACTISES TO USE OR ORDER THE USE OF THIS DEVICE

DANGER : EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF


FLAMMABLE ANESTETICS OR OXIGEN. RICH ATMOSPHERE
CAUTION : ELECTRIC SHOCK HAZARD. DO NOT OPEN. REFER
SERVICING TO QUALIFIED SERVICE PERSONNEL.

------------------------------------------------------------------------

QUANTEL MEDICAL cannot be held responsible for any damage or injury which results
from a failure to follow, or incorrect use of, the instructions contained in this user
manual.

The guarantee of the equipment will be void if the equipment is installed, modified or
repaired in any way by persons who are not authorised by QUANTEL MEDICAL.

P-4
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

2 - TABLE OF CONTENTS
PAGES

1-WARNINGS AND CAUTIONS P-3

2- TABLE OF CONTENTS P-5

3- TECHNICAL SPECIFICATIONS P-6


3-1 Ophtalmoscope specifications P-6
3-2 Viridis laser specifications P-6

4- SAFETY PROCEDURES P-7

5- LABEL PLACEMENT P-8

6- INSTALLATION P-9
6-1 Packing list P-9
6-2 Unpacking P-9
6-3 Description P - 10
6-4 Ophtalmoscope connections P - 11
6-4-1 Connect a fiber on Viridis and Viridis twin lasers P - 11
6-4-2 Connect a fiber on the ophtalmoscope P - 12
6-4-3 Connect the illumination lamp power cords P - 12

6-5 Helmet adjustments P - 13


6-6 Position the ophtalmoscope P - 14
6-6-1 Adjust ophtalmoscope on the helmet P - 14
6-6-2 Adjustment of oculars P - 14

7- OPERATING PROCEDURE P - 15
7-1 Position of optical unit P - 15
7-2 Function and formulas P - 15
7-3 Illumination settings P - 17
7-3-1 Illumination intensity P - 17
7-3-2 Illumination spot size P - 17
7-3-3 Illumination filtering P - 17
7-3-4 Illumination beam position P - 17
7-4 Laser beam centering P - 18
7-5 Size spot of Laser beams P - 18

8- MAINTENANCE P - 19
8-1 Cleaning P - 19
8-2 Storage P - 19
8-3 Fuse replacement P - 19
8-4 Illumination lamp replacement P - 20

9- CLINICAL INFORMATIONS P - 21

VALIDATION SHEET P - 23

P-5
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

3 - TECHNICAL SPECIFICATIONS
3-1 OPHTALMOSCOPE SPECIFICATIONS
Electrical requirements:
- Power supply : - 120 Vac ± 10%
- Frequency : 50 to 60 Hz ± 3 Hz.
- Power : 25 VA

- Single phase (earthed socket) :


- The plug must be able to deliver a minimum current of 10 A

3-2 VIRIDIS LASER SPECIFICATIONS


- Laser beam :
- Laser class : Class IV

- Laser source : Frequency doubled Nd : YAG


Pumping system Diode Laser

- Wavelength : 532 nm

- Terminal Output Power : 50 mW to 1.5 W at 532 nm

Note : these features are guaranteed only with adaptors provided by


QUANTEL MEDICAL

- Aiming beam :
- Laser class : - Class II
- Laser source : - Red Diode laser
- Wavelength : - 670 nm
- Max Output Power : - 0.9 milliwatts

The aiming beam is suppressed during firing and for 0.1 second after each shot to allow a
better examination of the burn.

P-6
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

4 - SAFETY PROCEDURES
This section introduces a few elementary steps to follow when using your
photocoagulator.
Understanding of these instructions and compliance with them and procedures
outlined in ANSI Standard Z136.3 is required to prevent injury to personnel or
damage to the instrument.

1. Never look directly into a laser light source, avoid exposure to reflected or
scattered laser light. This is a class IV laser product. Direct, reflected, or
scattered light may produce injury.

2. The treatment beam emitted from this instrument is a possible source of


ignition of flammable materials or explosives. Do not use this system near these
materials.

3. Always require safety glasses for anyone present at a treatment, except for
the physician and patient. During some procedures it may be advisable to shield
untreated eyes.

4. Never leave the system ON when it is unattended. If you must leave, turn the
system OFF and take the key with you.

5. When the laser is ON, keep the system in the standby mode except during
actual treatment.

6. Use anti-reflection contact lenses treated for argon wavelengths. Contact


lenses, particularly those with plano surfaces, can generate dangerous
reflections.

7. Never open the laser enclosure. Hazardous levels of visible and invisible
optical radiation are present inside. Refer service problems to qualified
personnel.

8. Observe warnings on all DANGER, WARNING, or CAUTION labels.

9. Circuitry for connection of a remote interlock is provided. An interlock can be


attached to the laser room door or other actuator and can electronically go in
standby and cannot firing the laser system if the laser room is entered during
use.

10. Regular maintenance which can be performed by the user. The performance
of regular maintenance including calibration checking will help to assure trouble-
free operation.

P-7
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

5 - LABEL PLACEMENT

1 LASER
APERTURE
1040-11-a-3
L20 x H11 mm

2 532 nm
OD 3.5+
L23 x H9 mm

3 L22 x H8 mm

4 Indirect
Adaptor
MODEL
IO
L35 x H8 mm
x2

5 0 L14 x H3 mm
PUPIL

Indirect MODEL
Adaptor IO
US Pat. 4.681.413
CE
CE
CE
CE

HEINE
OMEGA 180

2 3
5
x2

532 nm
OD 3.5+ 25387

LASER
APERTURE
1040-11-a-3

74 IIIIIIIIIII
I I 54 54 I I 74

P-8
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION
6 -1 PACKING LIST
Before assembling the system, make sure the package contains all components ordered.

Ophtalmoscope :Omega 180 Power supply: EN 20-1


- Helmet with delivery system - Power supply with its power cord
- 0 dioptry optical (2) - Replacement fuse
- Hat protect - Power cord link lamp/power supply
- Cleaning cloth - Heine using manual
- Heine Instruction manual
- Heine product sheet
- Ranging case
- Power cord link lamp/power supply
- Replacement halogen lamp

HEINE EN 20-1

I
67
45
89
123

10

max. 0
6,5 V / 1,8 A

6 -2 UNPACKING
Prior to delivery, this instrument has been packed with special care in order to minimize
transport risks.
However, before unpacking your laser, check the packaging for signs of damage or
improper handling. If you discover any, contact the shipping company immediately and
only remove the packaging in the presence of a representative of the company. Draw up
a list of all damaged parts and make sure it is signed by the transport company’s
representative.

WARNING : if the ophtalmoscope power supply is at a temperature below 10°C,


switching on it may cause serious damage. Unpack the power supply and
leave it at normal temperature for at least half a day to ensure that the
internal components warm up gradually.

P-9
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION
6-3 DESCRIPTION
INDIRECT OPHTALMOSCOPE WITH ADAPTOR

Lamp power supply


connector

Button to place an Fiber connector


Button to set the
illumination filter illumination
HEINE aperture size
OMEGA 180

Button to position Button to position


the laser beams the illumination
inside illumination beam (on each
spot Size spots
side) x2

0
button

LASER
APERTURE
1040-11-a-3

HELMET OF INDIRECT OPHTALMOSCOPE

Button to set the


helmet height

HELMET

Button to set the


helmet size

Optical unit
support x2

Button to lift up / step down the


ophtalmoscope Button to adjust the
ophtalmoscope

P - 10
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION
6-4- OPHTALMOSCOPE CONNECTIONS
Each delivery system option has its owm NON removable optical fiber
6-4-1 Connect a fiber on the VIRIDIS and VIRIDIS TWIN lasers

1- Turn the laser key OFF.

2- Remove the protections and introduce the fiber in the fiber socket (SMA-connector).

3- Screw completely the fiber connector to the laser by gently turning clockwise.
Connect the fiber to the front
panel of Viridis / Twin.

532 810
LASER APERTURE nm nm

CAUTION:
Do not screw the fiber tightly. Too much force may cause misalignment and damage the fiber.
If you touch the fiber tip with your fingers, you must clean it (with optical paper and
isopropyl alcohol) to maintain its efficiency.
Be sure the fiber is correctly connected before firing.
Verify that the aiming beam from the delivery system is homogeneous. If not, the fiber might be
damaged or dirty.

P - 11
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION
6-4-2 Connect a fiber on the ophtalmoscope

- The laser must be off.

- Remove the protective cap of the fiber.

- Plug in and screw the fiber connector on the


ophtalmoscope fiber plug.

Fiber Do not screw the fiber


connector tightly.
Do not touch the fiber
tip with fingers

Fiber
ophtalmoscope
plug

6-4-3 Connect the illumination lamp power cords

- The power supply must be off. Power cord


connector
- Plug the both power cord together.

- Plug in connector on the ophtalmoscope lamp plug like


indicate on the opposite figure .

- Plug the other side connector on the power supply like


Illumination
below.
lamp plug
HEINE EN 20-1
I
567
4
8
123

9 10

0
max.
6,5 V / 1,8 A

Power cord
connector

P - 12
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION

6-5 HELMET ADJUSTMENTS

Remove the optical unit by unscrewing the knob on the optical unit attachment.

- To adjust the height of the helmet


on the head, screw or unscrew the
knob at top of the helmet until the
Attachment
height of it is correct.
for optical unit

- To adjust the size of the helmet


to the head, screw or unscrew the
knob at back of the helmet until
the size of it is correct.

When the settings are done, place the optical unit on helmet attachment with its locking knob.

P - 13
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

6 - INSTALLATION
6-6 POSITION THE OPHTALMOSCOPE
- Turn on the illumination by turning on the ophtalmoscope power supply.
- Toggle optical unit support to the work position.

The optical unit must be nearest as possible of eyes.

- Place a target viewing 12 to 16 inches away for the optical unit.


- A light spot is visible through the oculars. It must be centered in the field of view.

6-6-1 ADJUST OPHTALMOSCOPE ON THE HELMET


The positioning of the optical unit on helmet, is possible by
loosening the knob indicated.

In this state, the possible movements are (see figure) :


- up and down
- In and out
- Forward and backward

Position optical unit to have the light spot vertically centered.


Tighten the knob.

6-6-2 ADJUSTMENT OF OCULARS

- The interpupillar distance adjustment


can be set by pushing / pulling the
532 nm
finger tabs under the ocular. OD 3.5+ 25387

74 I I I I I III I I I I I 54 54 I I 74

The light spot must be centered in the field of view: Finger tabs

Close one eye and move the corresponding ocular, with its finger tabs, to have the
light spot in the center of field of view.
Do the same procedure for the other eye.

THE OPTICAL ACCURATE SETTING IS EXTREMLY IMPORTANT


PARTICULARLY FOR EXAM OF NARROW PUPIL

P - 14
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

7 - OPERATING PROCEDURE
7-1 POSITION OF OPTICAL UNIT
Rest position

- To toggle the optical unit to rest


position at work position and vice
versa, push the button to unlock
and handle it to the desired
position.

x2

Work position

7-2 FUNCTION AND FORMULAS

The indirect ophthalmoscope adaptator for the 532 nm photocoagulator has been
designed to interface or adapt to the Heine Omega 180 Indirect Ophthalmoscope only.

It is a lightweight device which connects via the optic fiber directly to the VIRIDIS or the
VIRIDIS-TWIN.
It integrates a fixed non-moving, high visibility eye safety filter for the doctor protection.

FUNCTION

Used mainly for peripheral photocoagulation. The exact factors used will depend on the
nature and size of the vessels being treated.

CAUTION

The usual cautions apply in respect of ancillary personnel having adequate protection. The
precaution applies to the doctor using the apparatus, in that the laser beam aiming is
dependant upon his line of sight.

P - 15
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

7 - OPERATING PROCEDURE

The laser is used in conjunction with an auxiliary lens, as is usual for the indirect
ophthalmoscope ; and the power of this lens will determine the spot size on the retina as
follows :

Since the human eye has an average focusing power of 60 diopters then the ratio
between the condensing lens used and this power will give an enlargement of the
retinal image according to this ratio and the distances between the
ophthalmoscope, the condensing lens, and the eye.
Apparent
Taille duspot
spot size
apparent
Image image
Virtual virtuelle
on
thela retina
de rétine 30 D

Laser
Taille spotlaser
du spot size
sur on retina
la rétine
30-40cm 6cm 6cm

FORMULAS :
- Retinal image Enlargement = ( Ref-Pow ) / ( D ).
- Retinal Spot size (microns) = ( Lbeam-Diam ) x ( D ) / (Ref-Pow )
Where :
- Lbeam-Diam = the laser beam diameter at the focal plane : 400
microns
- D = the power of the condensing lens in Dioptres
- Ref-Pow = the Refractive power of the patient eye

Examples :
- The human eye has an average focusing power of 60 diopters :

E. g. A : for a 20 Diopter lens the enlargement will be 3 times : ( 60 / 20 )


E. g. B : for a 30 Diopter lens the enlargement will be 2 times : ( 60 / 30 )

- Consequently the laser spot size, will be Reduced by the same ratio at the retinal
plane.
- The laser spot size is around 400 microns at the fundus image plane for a
50 microns fiber and the QUANTEL MEDICAL adaptor.

E. g. A : 400 / 3 = 133 microns.


E. g. B : 400 / 2 = 200 microns.

P - 16
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

7 - OPERATING PROCEDURE

7-3 ILLUMINATION SETTING


7-3-1 Illumination intensity

HEINE EN 20-1
I
67
45
89
123

- Increase or decrease the


10

0
max.
6,5 V / 1,8 A intensity of illumination by turning
this knob.

7-3-2 Illumination spot size

- 4 possibilities are availlable to


set the illumination spot :
- 3 size spot positions
- 1 scattered spot position

- To select these positions, use


the lever indicated.
HEINE
7-3-3 Illumination filtering OMEGA 180

- It 's possible to filter the


illumination. 4 filtering are
availlable:
- Green
- No filter
- Blue
LASER
- Yellow APERTURE
1040-11-a-3

- To select these filter, use the


lever indicated. Finger tabs

7-3-4 Illumination beam position

- To center vertically the illumination beam within the vision field turn one of these knobs.

- To center horizontally the illumination beam, move the finger tabs to a side or to the
other

P - 17
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

7 - OPERATING PROCEDURE

7-4 LASER BEAM CENTERING

x2

x2

- To center the aiming and


0

treatment beams on illumination


spot, turn this button.

7-5 SIZE SPOT OF LASER BEAMS

-The laser spot size can be


increased until 2 times
approximatively.
The size depends also on the
work distance.

x2
- To increase/decrease laser spot
size, turn the knob indicated.
0

x2

P - 18
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

8 - MAINTENANCE
8-1 CLEANING
WARNING :
Disconnect AC power before cleaning the case :

When necessary, remove dust from the indirect ophthalmoscope with an


appropriate lens brush. After dusting, clean the opticals with Kodak lens tissue and
a few drops of alcohol. Do not use the tissue dry as this will scratch the opticals. Do
not rub the opticals more than once or twice. Excess rubbing will only redistribute
the dirt and cause scratches.

The hat protections of the helmet can be cleaned with soap solution.

In any case, do not use corosive products.

8-2 STORAGE
After each use, place the indirect ophthalmoscope in its case to keep all optical
surfaces clean.

8-3 FUSE REPLACEMENT OF POWER SUPPLY

Disconnect the power cord before any intervention on the instrument.

Spécifications : glass fuse


0.25 AT - 250 V
Fuse

Fuse holder

P - 19
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

8 - MAINTENANCE
8-4 ILLUMINATION LAMP REPLACEMENT

Before any intervention, the laser


and the power supply of the
ophtalmoscope must be off.

Power supply - Unplug the power supply lamp


Lamp connector
connector

Lamp cap - Unscrew the lamp cap

- Remove the old lamp from his


housing.
Lamp
Do not touch the lamp with fingers.
# 068
HEINE
XHL
6V

- Clean the glass lamp with a soft


swab moistened with ethanol.
- Place the new lamp in its housing
taking care to place tappet in groove
Ophtalmoscope

- screw the lamp cap on


ophtalmoscope and replace the lamp
connector

P - 20
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

9 - CLINICAL INFORMATIONS
HEINE OMEGA 180 INDIRECT OPHTHALMOSCOPE DELIVERY SYSTEM

Indications :
The Indirect ophthalmoscope adaptator for the 532 nm photocoagulators has been designed for
physicians who are already currently using this type of Ophthalmoscope.

The adaptator is easily removable. It has an integrated non-moving, eye safety filter for the treating
physician.
The adaptator has its own 50 micron optic fiber, to connect directly to the device.

The treatment beam will cause photocoagulation of pigmented tissues within the eye through the
burning action of the laser.
This effect can be controlled by varying the parameters of beam power and exposure duration.
The physiologic effect of the device Nd:YAG doubled Ophthalmic 532 nm laser is equivalent to
that produced with common continuous wave Argon Lasers producing radiation in the 488 - 514
nanometer range.

Applications :
This system has the same clinical indications as the Slit Lamp delivery system, but is used for
peripheral photocoagulation or photocoagulation of recumbent patient.

Routes :
The laser treatment beam is directed through the cornea to the target tissue.
As it is usual for the indirect ophthalmoscope, the laser is used in conjunction with an auxiliary lens.
The power of this lens determine the enlargement of the fundus image :
it will determine also the laser spot size on the retina.
For an eye with an average focusing power of 60 Diopters :
Two examples :
* For a 20 Diopter lens, the spot size will be 133 microns
* For a 30 Diopter lens, the spot size will be 200 microns
See the formulas for spot size calculation in the chapter 7-2

Contraindications :
Patients in following situations which prevent visualization of target tissue are contraindicated for
laser treatment :

- Cloudy cornea or extreme haze of the aqueous humor of the anterior chamber.
- Cases involving laser photocoagulation within the arcades.
- Albino patients.

Precaution :
The precaution applies to the doctor using the apparatus, in that the laser beam aiming is
dependant upon his line of sight.

P - 21
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER

9 - CLINICAL INFORMATIONS
HEINE OMEGA 180 INDIRECT OPHTHALMOSCOPE DELIVERY SYSTEM
Adverse Effects :
Adverse effects may occur as a result of laser treatment :
- Corneal burns and inflammation
- Transient elevations in intraocular pressure.
Excessive combinations of power and exposure can cause undesirable tissue vaporization and
charring.
The combination of a 200 micron spot, 0.05 second exposure, and 0.40 Watts has caused tissue
vaporization in rabbits.
Studies indicate these hazards are no different from adverse effects from continuous wave argon
lasers used at these same settings. No evidence of non-thermal effects has been observed.

Settings :
The desired treatment parameters of power, exposure duration, and spot size are selected as
required.
If unsure which settings are required, select a low power, short duration, and large spot size. Increase
power and duration or decrease spot size as necessary :
- 0.1 second exposure, and 150 milliWatts is a low starting combination.

An efficient shot exposure will typically cause a blanching of target tissue.


Exposure duration can be adjusted by the adjustment knob as required to result in the desired effect.

Shorter pulse durations require higher power densities to create a burn; However , very short pulse
durations can be potentially dangerous. Longer pulse durations may be safer to use, but it may be
more difficult to keep the head steady in an effort to create a round spot.

Tissue response to laser light is primarily determined by power density. Power density (W/cm²) is
laser power (W) divided by the area (cm²) of the illuminated spot; therefore, you can increase power
density either by increasing the laser power or by decreasing the spot size.

IT IS IMPORTANT TO REMEMBER THAT CHANGING THE ASPHERIC LENS AFFECTS SPOT


SIZE, POWER DENSITY AND THE FIELD OF VIEW.

Aiming beam :
The aiming beam, while low power, is still an intense light source and retinal exposure should be
limited to that required for target acquisition.
Proper aiming is aided by a low aiming beam intensity.

Precaution for personnel :


Backscattered radiation is not harmful when viewed through the protective filter.
Protective eyewear designed for the selected wavelength (532 nm) should be worn by the doctor and
all ancillary personnel.
Wave length range : 180 - 532 nm / OD > 3.5 ; Reference (EN 207) : D 180 - 315 L6

CAUTION:

Federal (USA) law restricts this device to sale by or on the order of a physician.

CAUTION:
Use of controls or adjustments, or performance of procedures other than those specified in the
Instruction Manual, can result in hazardous radiation exposure.

P - 22
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER

VALIDATION SHEET

Publishing date March 2004

Revision date March 2004

Written by F. LOYAL

Checked by C. CHABRIER

Validated by P. QUERO

P - 23

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