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3-Xl Io Hei Me An 03-2004
3-Xl Io Hei Me An 03-2004
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
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
------------------------------------------------------------------------
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
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
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
- Wavelength : 532 nm
- 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.
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.
7. Never open the laser enclosure. Hazardous levels of visible and invisible
optical radiation are present inside. Refer service problems to qualified
personnel.
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.
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.
P-9
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER
6 - INSTALLATION
6-3 DESCRIPTION
INDIRECT OPHTALMOSCOPE WITH ADAPTOR
0
button
LASER
APERTURE
1040-11-a-3
HELMET
Optical unit
support x2
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
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
Fiber
ophtalmoscope
plug
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
Remove the optical unit by unscrewing the knob on the optical unit attachment.
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.
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.
P - 14
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER
7 - OPERATING PROCEDURE
7-1 POSITION OF OPTICAL UNIT
Rest position
x2
Work position
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 :
- 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.
P - 16
INDIRECT OPHTHALMOSCOPE HEINE USER MANUAL
DELIVERY SYSTEM
FOR 532 nm LASER
7 - OPERATING PROCEDURE
HEINE EN 20-1
I
67
45
89
123
0
max.
6,5 V / 1,8 A intensity of illumination by turning
this knob.
- 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
x2
x2
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 :
The hat protections of the helmet can be cleaned with soap solution.
8-2 STORAGE
After each use, place the indirect ophthalmoscope in its case to keep all optical
surfaces clean.
Fuse holder
P - 19
USER MANUAL INDIRECT OPHTHALMOSCOPE HEINE
DELIVERY SYSTEM
FOR 532 nm LASER
8 - MAINTENANCE
8-4 ILLUMINATION LAMP REPLACEMENT
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.
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.
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.
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
Written by F. LOYAL
Checked by C. CHABRIER
Validated by P. QUERO
P - 23