OPHTHALMIC PHOTOCOAGULATORS

INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM
FOR 532 nm LASER
USER MANUAL

Directive 93/42/EEC

XL IO532 ME AN JULY 2002

QUANTEL MEDICAL
21, Rue Newton - Z.I. du Brézet
63039 CLERMONT-FERRAND CEDEX 2 - FRANCE
Tel : 00 33 (0)4 73 745 745 - Fax : 00 33 (0)4 73 745 700
e-mail: biovisio@quantel-medical.fr
 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

1 - INTRODUCTION
This reference guide is intended to provide specific information and instructions for
using the VIRIDIS or VIRIDIS TWIN or VIRIDIS LITE with the following compatible
delivery system : indirect ophthalmoscope delivery system for 532 nm laser. Ref : IO.

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

TWIN or VIRIDIS LITE ophthalmic photocoagulator user manual.

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

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

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.

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

Rev. 07/2002 P-3

USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

2 - TABLE OF CONTENTS
CONTENTS
Pages Rev. 07/2002

1- INTRODUCTION P-3

2- TABLE OF CONTENTS P-4 X

3- WARNINGS AND CAUTIONS P-5

4- SAFETY PROCEDURES P-6

5- CONNECTION INSTRUCTIONS

5-1 Delivery system connection to VIRIDIS and VIRIDIS TWIN P-7

5-2 Delivery system connection to new VIRIDIS and TWIN P-8 X
5-3 Delivery system connection to VIRIDIS LITE P-9

6- INDIRECT OPHTHALMOSCOPE

6-1 Description P - 10
6-2 Installation P - 10
6-3 Operation P - 13

7- LABELS ON THE DELIVERY SYSTEM P - 14

8- MAINTENANCE

8-1 Operation P - 15

9- PROFESSIONAL CLINICAL INFORMATION P - 16

VALIDATION SHEET P - 18 X

P-4 Rev. 07/2002

 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

3 - 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
230 VA in 100V 240 V
I max = 4.5A
SURGICAL LASER
LASER CLASS 4 / IV
Nd:YAG Laser : 532nm, 2W Max

LASER CLASS 2 / II
Laser Diode : 670nm, <1mW Max
VISIBLE AND/OR INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO
DIRECT OR SCATTERED RADIATION
CLASS IV LASER PRODUCT per 21 CFR 1040

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

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.

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 efficiency, please contact
the QUANTEL MEDICAL Service Department or your local Distributor.

Rev. 07/2002 P-5

USER MANUAL INDIRECT OPHTHALMOSCOPE
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.

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 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

5 - CONNECTION INSTRUCTIONS
5-1- DELIVERY SYSTEM CONNECTION TO VIRIDIS AND VIRIDIS
TWIN
1- Turn the laser key OFF and pull the key out.

2- Open the front door to access the fiber connector (turn the opening handle).

Handle to open
the door

3- Remove the fibre protection and guide the fiber to the screw of the fibersocket
(SMA-connector).

Notch on the
Laser module

532 810
nm nm

532 nm fiber Connection 810nm fiber

Connect the delivery connection
system to this output (Viridis Twin)

4- Screw the fiber to the 532nm laser output by gently turning clockwise.

5- Carefully guide the fiber through the notch on the laser module and close the door. Lock
the door by turning the handle.

CAUTION:

Do not screw the fiber tightly. Too much force may cause misalignment and damage the
fiber. If youtouch 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.

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USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

5 - CONNECTION INSTRUCTIONS

5-2- DELIVERY SYSTEM CONNECTION TO NEW VIRIDIS AND

VIRIDIS TWIN
Each delivery system option has its owm NON removable optical fiber

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
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-8 Rev. 07/2002

 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

5 - CONNECTION INSTRUCTIONS
5-3- DELIVERY SYSTEM CONNECTION TO VIRIDIS LITE
Each delivery system option has its own NON removable optical fiber.
The optical fiber connector is a SMA-905.
Fiber protection
CAUTION : If you touch the fiber tip with
fingers you must clean it (with optical paper
and isopropyl alcohol) to maintain its efficiency.

PROCEDURE :

1) Remove the fiber protection and put the fiber

guide to the screw of the fibersocket.

2) Screw the fiber guide into the laser connector as far

as possible (finger tight).

Fiber guide

CAUTION :
Do not screw the fiber tightly.Too much force may cause misalignment and damage
the fiber.

Be sure the fiber is correctly connected before firing : verify the aiming beam
from the delivery system is homogeneous. If not the fiber might be damaged or
dirty.

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USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

6 - INDIRECT OPHTHALMOSCOPE
6-1- DESCRIPTION
The indirect ophthalmoscope adaptator for the 532 nm photocoagulator has been
designed to interface or adapt to the Keeler-Fison or Keeler-Vantage or Topcon Indirect
Ophthalmoscope only.

It is a lightweight device which connects via the fibre optic directly to the VIRIDIS or the
VIRIDIS-LITE 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.

6-2- INSTALLATION
The adaptor fits easily within a few seconds to the Keeler Vantage or Keeler Fison or
Topcon Ophthalmoscope.
Located on each side of the indirect adaptator are silver mounting thumbscrews which
are tightened snugly against the indirect. (See following figures).

The laser aiming mirror directs the coaxial aiming and treatment beams to the target.
It can be adjusted by the treating physician, merely by turning the mirror adjustment knob
located on the laser indirect adaptator.

P - 10 Rev. 07/2002
 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

6 - INDIRECT OPHTHALMOSCOPE
INDIRECT OPHTHALMOSCOPE WITH LASER ADAPTOR

Rev. 07/2002 P - 11
USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

6 - INDIRECT OPHTHALMOSCOPE
LASER INDIRECT OPHTHALMOSCOPE ADAPTOR

Fiber input

Mounting screw
LASER APERTURE

Mirror adjustment
knob
Laser mirror

Fiber input

Mounting screw

LA

Laser mirror
OD 3.5 +
532 nm

P - 12 Rev. 07/2002
 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

6 - INDIRECT OPHTHALMOSCOPE
6-3- OPERATION
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.
Taille duspot
Apparent spot size
apparent
Image image
Virtual virtuelle
on
de
thela retina
rétine 30 D

Laser
Taille spotlaser
du spot size
on retina
sur 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.

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USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

7 - LABELS ON THE DELIVERY SYSTEM

7-1- LABELS PLACEMENT

INDIRECT OPHTHALMOSCOPE

LA 1

L42 x H12 mm
OD 3.5+
532 nm

1 LASER APERTURE
1040-11-a-3

2 532 nm
2 L23 x H9 mm
OD 3.5+

3 L22 x H8 mm

L35 x H8 mm
Indirect MODEL
4 Adaptor IO

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 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

8 - MAINTENANCE
8-1- OPERATION
When necessary, remove dust from the indirect ophthalmoscope with an appropriate
lens brush. After dusting, clean the mirrors with Kodak lens tissue and a few drops of
pure acetone. Do not use the tissue dry as this will scratch the mirror. Use a very light
pressure to avoid misaligning the mirrors. Do not rub the mirrors more than once or
twice. Excess rubbing will only redistribute the dirt and cause scratches.

Dust cover

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

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USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

9 - PROFESSIONAL CLINICAL INFORMATION

KEELER FISON - KEELER VANTAGE - TOPCON INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEMS (1/2)

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 model available has 3 possible fixations for :

KEELER-FISON or KEELER VANTAGE or TOPCON Indirect 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 6-3: OPERATION

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.

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 INDIRECT OPHTHALMOSCOPE USER MANUAL
DELIVERY SYSTEM FOR 532 nm LASER

9 - PROFESSIONAL CLINICAL INFORMATION

KEELER FISON - KEELER VANTAGE - TOPCON INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEMS (2/2)

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

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 350 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.

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.
Rev. 07/2002 P - 17
USER MANUAL INDIRECT OPHTHALMOSCOPE
DELIVERY SYSTEM FOR 532 nm LASER

VALIDATION SHEET

Publishing date July 2002

Revision date July 2002

Written by C. TCHA

Checked by C. CHABRIER

Written by P. QUERO

P - 18 Rev. 07/2002