Manual Usuario VITRA MULTISPOT PDF

APRIL 2016
USER MANUAL
Select a chapter
Introduction
I – Regulatory information and safety
II – Technical information
III – Using the device
2012
IV – Maintenance
V – Clinical information Directive 93/42/EEC
11, rue du bois joli - CS 40015 - 63808 Cournon d’Auvergne Cedex - 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
This QUANTEL MEDICAL equipment is proprietary products of QUANTEL MEDICAL under
international copyright law and all rights are reserved. This manual may only be reproduced in
whole or in part with written permission of QUANTEL MEDICAL. This manual is furnished for
informational use only and QUANTEL MEDICAL reserves the right to modify the equipment
characteristics and manual without previous notice. Photos and diagrams are not contractual.
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 authorized by QUANTEL MEDICAL.
Any question regarding the installation or the use of the VITRA MULTISPOT system should be
directed to the QUANTEL MEDICAL Service Department or to a local distributor:
International U.S.A.
QUANTEL MEDICAL QUANTEL USA MEDICAL UNIT

11, rue du bois joli, CS 40015 601, Haggerty Lane
63808 Cournon d’Auvergne Cedex BOZEMAN MT 59715
FRANCE U.S.A.
Tel.: +33 (0) 473 745 745 Tel.: +1 888 660 6726
Fax: +33 (0) 473 745 700 Fax: +1 (406) 586 2924
E-mail: contact@quantel-medical.fr E-mail: info@quantelmedical.com
Web site: www.quantel-medical.com Web site: www.quantel-medical.com
© 2016 QUANTEL MEDICAL

2012
All rights reserved

Vitra Multispot User Manual
Software version 2.10
International version
Directive 93/42/EEC
(Ref: XL_VMS_ME_AN)
th
APRIL 20 2016
USER MANUAL
INTRODUCTION
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS Rev
2016
1. USER MANUAL DESCRIPTION ............................................................... 1
2. USER MANUAL TERMS AND SAFETY SYMBOLS ................................. 1
3. UNPACKING THE INSTRUMENT ............................................................. 2

3.1. TRANSPORTATION INFORMATION ....................................................................... 2
3.2. PACKING LIST & ACCESSORIES ........................................................................... 3
4. GENERAL LASER SYSTEM DESCRIPTION ........................................... 5

4.1. VITRA MULTISPOT FRONT PANEL FUNCTIONS .................................................. 5
4.2. VITRA MULTISPOT REAR PANEL FUNCTIONS .................................................... 6
4.3. MULTISPOT ADAPTOR DESCRIPTION .................................................................. 7
User manual
Introduction
1. USER MANUAL DESCRIPTION

The Vitra Multispot User Manual is organized into the following chapters:
Introduction
I Regulatory & safety information
II Technical information
III Using the device
IV Maintenance
V Clinical information
Each chapter is saved as a .pdf file.
2. USER MANUAL TERMS AND SAFETY SYMBOLS
WARNING
Potential hazards which, if not avoided, could result in serious injury or death
CAUTION
Potential hazards which, if not avoided, could result in minor or moderate injury and/or product
damage
NOTE
Significant additional information or explanation
1 XL_VMS_ME_AN_160420
User manual
Introduction
3. UNPACKING THE INSTRUMENT

3.1. TRANSPORTATION INFORMATION
To minimize transportation risks, this instrument has been packed with special
care. However, before unpacking the laser, check the packaging for any sign of
damage or improper handling.
2
Expedition label – Acceptable environmental conditions for

1 2
Handling with care transport and storage
Direction of positioning of
Pressure limits.
the parcel.
Fragile.
Relative humidity limits.
To handle with care.
To preserve at dryness. Temperature limits.
Fragile. To preserve safe from the

To preserve at dryness. sunlight.
Consult the instruction

manual.
To preserve at dryness.
XL_VMS_ME_AN_160420 2
User manual
Introduction
3 Reception of equipment label
NOTE: In case of any problem, immediately contact the shipping company. Do only
open the box in the presence of a company representative. Draw up a list of
all damaged parts and ask for it to be signed by the company representative.
CAUTION: If the instrument is at a temperature below 15°C (59°F), switching on the

instrument may cause serious damages. Unpack the instrument and leave it
at normal temperature for at least half a day to ensure that the internal
components warm up gradually.
3.2. PACKING LIST & ACCESSORIES

Before beginning the installation, check the contents of the package against the following list:
Basic configuration Codes

VITRA Multispot laser 532nm including: XLVMS
Power cord
Doorswitch remote (red) + Front filter / lamp remote connectors
Keys (2)
User Manual XL_VMS_ME_AN
GentleFoot TM Footswitch XLAAAPEDALE4
Multispot adaptor kit composed of: XLVMSSC

Scanner delivery system for laser 532nm + Potentiometer (all together linked
to a green connector)
Set of mechanical pieces to adapt the scanner delivery system to the slit
lamp models:
o Short mirror for BM models
o Rising ring for BQ models
User manual
Introduction
VITRA MULTISPOT laser photocoagulator accessories (list and part number)

QUANTEL MEDICAL ordering codes
FOR ANCILLARY PERSONNEL PROTECTION
Laser safety goggles OD 5 for 532 nm XL532PROT
LASER PROBE DELIVERY SYSTEM
Straight laser probe, single-use, sterile - 20 gauge (pack of 10) XLEND20D
Curved laser probe, single-use, sterile - 20 gauge (pack of 10) XLEND20C
Straight laser probe, single-use, sterile - 23 gauge (pack of 10) XLEND23D
Flexible curved laser probe, single-use, sterile - 23 gauge (pack of 10) XLEND23C
Straight laser probe single-use, sterile - 25 gauge (pack of 10) XLEND25D
Flexible curved laser probe, single-use, sterile - 25 gauge (pack of 10) XLEND25C
Steerable laser probe, single-use, sterile - 23 gauge (pack of 10) XLEND23DIR
Steerable laser probe, single-use, sterile - 25 gauge (pack of 10) XLEND25DIR
Straight STM laser probe, single-use, sterile - 20 gauge (pack of 5) XLEND20STM
Curved STM laser probe, single-use, sterile - 20 gauge (pack of 5) XLEND20CSTM
FOR CALIBRATION PURPOSES
Laser power measurement system XLAAAWATTMETRE
SLIT LAMP ADAPTERS
HAAG STREIT TYPE
532 nm Single Spot Slit Lamp Adaptor XL532BMBQMST2
532 nm Single Spot Slit Lamp Adaptor (Retractable) XL532HSDST
532 nm Multispot Slit Lamp Adaptor “SUPRASCAN” XLSUPSC532
ZEISS
532 nm Single Spot Slit Lamp Adaptor for ZEISS 30 SL XL532CZ30
532 nm Single Spot Slit Lamp Adaptor for CSO 980 SL XL532CSO3ST
OPTIMIS II – Combination
532 nm Single Spot OPTIMIS Slit Lamp Adaptor XL532OPT2STD
INDIRECT OPHTHALMOSCOPE
KEELER
532 nm Adaptor for KEELER VANTAGE Plus Indirect Ophthalmoscope (fiber size: 50µ) XL532IOVPLUSST
532 nm Adaptor for KEELER VANTAGE PLUS Indirect Ophthalmoscope fiber size: 100µ) XL810532IOVPST
Option: KEELER VANTAGE PLUS Indirect Ophthalmoscope (incl. one Led and one Bulb) XLLAFVP2
HEINE
Indirect Ophthalmoscope HEINE Omega 180 with Integrated Adaptor 532nm (fiber size: 50µ) XL532CIOH
ndirect Ophthalmoscope HEINE Omega 180 with Integrated Adaptor 532nm (fiber size: 100µ) XL810532CIOH
OPTION
Power supply with power cord 120V XLIOHALIM120
Power supply with power cord 230V XLIOHALIM230
User manual
Introduction
OPERATING MICROSCOPE
LEICA
532 nm Adaptor for LEICA Microscope – spot sizes 250 – 500µ XLMIL1
ZEISS
532 nm Adaptor for ZEISS Microscope – spot sizes 250 – 500µ XLMIZ1
MOLLER WEDEL HIR (XLMIZ1 + XLMIMWSUP)
532 nm Adaptor for ZEISS Microscope – spot sizes 250 – 500µ XLMIZ1
ZEISS Microscope Adaptor Holder for MOLLER WEDEL HIR 900 Microscope Compatibility XLMIMWSUP
DOCTOR’S FILTERS
Fixed Doctor’s filter 532 nm for WILD Microscope XLFW532A
Fixed Doctor’s filter 532 nm for ZEISS Microscope XLFZ532A
Push-pull Doctor’s filter 532 nm for WILD Microscope XLFW532B
Push-pull Doctor’s filter 532 nm for ZEISS Microscope XLFZ532B
Quad Doctor’s filter 532 nm + 810 nm for LEICA/WILD M844 Microscope XLFW810532E
CARRYING CASE
Carrying case for VITRA MULTISPOT XLVITRAMSVALISE
4. GENERAL LASER SYSTEM DESCRIPTION

4.1. VITRA MULTISPOT FRONT PANEL FUNCTIONS
Power
adjustment knob
Control screen
Laser state LED
Fiber connector
Power supply LED

Lighting lamp
power supply or
doctor’s filter security
connector
Key switch Emergency stop Finger positioning

button tabs
User manual
Introduction
4.2. VITRA MULTISPOT REAR PANEL FUNCTIONS
Fuse trap door
Power supply
plug
Multispot adaptor
connector Main switch
Footswitch
connector
Doorswitch
connector
User manual
Introduction
4.3. MULTISPOT ADAPTOR DESCRIPTION
Optical fiber
50µm
Zoom
Supporting plate
Doctor filter
Micromanipulator
Pattern
selection
button
Multispot adaptor
connector (to be
connected to the
Vitra Multispot unit)
Adaptor equipment:
Doctor filter
The doctor filter is positioned in front of the biomicroscope’s head to protect the physician from
any hazardous/harmful laser reflections when the treatment beam is viewed through the
binocular.
Zoom
The zoom is used to select the treatment beam size at the biomicroscope focal point (spot size).
The spot size ranges from 50 to 500 microns. The laser spot is always parfocal on the slit lamp
focal plane.
Micromanipulator
The micromanipulator allows the user to precisely point the aiming and treatment beams
position to the target. It is adjusted to allow sensitive control within a free range of vertical and
horizontal movements.
Pattern selection button

The pattern selecting button allows the user to rotate/resize the patterns.
User manual
Introduction
NOTE
The following mechanical pieces are to be used to adapt the scanner delivery system to the slit
lamp models:
o Short mirror for BM models:
o Rising ring for BQ models:
For more information, please refer to the:

Vitra Multispot user manual: II - Technical information
Section 3.4: Installing the multispot adaptor onto the slit lamp
USER MANUAL
I – REGULATORY INFORMATION AND SAFETY
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS REV
2016
1. INTENDED USE AND CONTRAINDICATIONS.................................... 1

2. CLASSIFICATIONS .............................................................................. 1
3. SAFETY INFORMATION AND PRECAUTIONS .................................. 2
3.1. GENERAL WARNINGS AND SAFETY INFORMATION ......................................... 2
3.2. IMPORTANT RECOMMENDATIONS....................................................................... 4
3.3. LASER SAFETY EYEWEAR & NOHD ..................................................................... 5

3.3.1. SAFETY EYEWEAR ............................................................................................. 5
3.3.2. NOHD .................................................................................................................... 6
3.4. PRECAUTIONS TO TAKE CONCERNING WASTES AND ELIMINATION OF DEVICE

AND ACCESSORIES: .................................................................................................................. 7
User manual
I – Regulatory & Safety information
1. INTENDED USE AND CONTRAINDICATIONS

The Vitra Ophthalmologic Multispot Photocoagulator laser is intended to be used for retinal
photocoagulation with the following features:
• With a slit lamp scanning delivery system adaptor (multispot): it can deliver a full spectrum
of pattern scanning options. This is intended to be used for anterior and posterior segments
ocular pathology treatment including:
o retinal photocoagulation
o retinal vascular, structural abnormalities and choroids pan retinal photocoagulation,
with:
 Proliferative and nonproliferative diabetic retinopathy;
 Choroidal neovascularization;
 Branch retinal vein occlusion;
 Age-related macular degeneration;
 Retinal tears and detachments;
 Macular edema ;
o Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle
glaucoma.
• With an indirect ophthalmoscope or a microscope for peripheral photocoagulation for

the treatment of proliferative diabetic retinopathy and retinal detachments.
• With an laser probe- for intraocular retinal photocoagulation as an adjunct to vitrectomy

surgery (understanding that this not the sole indication for vitrectomy) in the management
of complicated rhegmatogenous, tractional retinal detachments, proliferative
vitreoretinopathy and proliferative diabetic retinopathy.
This user manual is intended to solely be used by trained ophthalmologists for diagnosis and
treatment of ocular pathology.
2. CLASSIFICATIONS
The system is intended for continuous operation and has the following classifications:
Protective class I (Main insulation)

Type BF (Protection against electrical shocks)
Protection degree IP20 (Protection from solid substances: Ø>12.5 mm)
Operation Continuous with short-time loading
User manual
3. SAFETY INFORMATION AND PRECAUTIONS

If any incident occurs, QUANTEL MEDICAL shall not be liable if the following safety information
and precautions are not followed.
3.1. GENERAL WARNINGS AND SAFETY INFORMATION
WARNING
This user manual is designed to acquaint the user with the normal operation and maintenance
of the VITRA Multispot ophthalmologic photocoagulator. The manual scope is limited to the
operation, maintenance and controls of the system. It is not intended to be a guide to laser eye
treatment. Laser safety begins with the understanding that the purpose of this device is to
perform controlled destruction of living tissues. Misuse of this system could result in patient,
physician or attendees injuries. QUANTEL MEDICAL consequently strongly recommends the
user to read and understand this entire manual before using the product, especially this section
concerning safety.
WARNING
The American National Standards for the Safe Use of Laser in Health Care Facilities (ANSI Z
136.3-1996 and ANSI Z 136.1-1993) provide guidance to safely use lasers and laser systems in
the diagnostic and therapeutic areas. Those two standards are related to eye and skin hazards
and recommend the use of protective eye wear, clothing, barriers and screens.
WARNING
Any use of controls or performance adjustments for procedures other than those specified
herein may result in hazardous radiation and/or electrical exposure.
WARNING
USA Federal Law restricts this device to sale by, or on the order of, a physician.
WARNING
This user manual is intended to solely be used by trained ophthalmologists for diagnosis and
treatment of ocular pathology.
WARNING
QUANTEL MEDICAL cannot be held responsible for any damage or injury that results from a
failure to follow or incorrect use the instructions contained in this manual.
WARNING
The Vitra Multispot equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
WARNING
To comply with medical electrical equipment safety standard requirements, the laser power plug
must be connected on to a wall grounded single phase power socket on its own The use of an
adaptor (for multiple connections) or a power bar is prohibited.
WARNING
Do not connect the laser power plug (3 pin adaptor) on an ungrounded power socket (2-pin).
WARNING
Do not use an electric cable extension.
User manual
WARNING
Before cleaning the unit, unplug the power cord from the wall mains plug.
Refer to the:
Vitra Multispot user manual: IV – Maintenance
Section 3.1: Cleaning the Vitra Multispot laser system
WARNING
The instrument calibration must be performed every year by a technician authorized by
QUANTEL MEDICAL.
WARNING
Before using the Multispot adaptor delivery system, make sure that the doctor filter is in place
and not damaged (neither scratched, nor broken).
WARNING
In case the laser efficacy is altered and the laser system needs servicing: you must contact
QUANTEL MEDICAL Service Department or your local distributor.
WARNING
Unit servicing must only be performed by Quantel Medical technicians or otherwise technicians
authorized by Quantel Medical (local distributors).
CAUTION
The device's guarantee will be void if the equipment is opened (even partially), modified or
repaired in any way by persons who have not been authorized to do so by QUANTEL
MEDICAL.
CAUTION
To preserve the appearance of the device, do not use abrasive cleaning products, or solvents. If
possible, clean off stains immediately.
User manual
3.2. IMPORTANT RECOMMENDATIONS
WARNINGS
To prevent injury to personnel or damage to the instrument, all operators must fully versed in
the instructions and procedures detailed herein and in the ANSI Standard Z136.3.
1. Never directly look into a laser light source and avoid exposure to reflected or scattered laser
light. This device is classified as Class IV (4) laser product: direct, reflected or scattered light
from this laser may cause injury.
2. The treatment beam emitted from this instrument has the potential to ignite anesthetics or
flammable materials or explosives. Do not use this system in proximity to these materials.
3. Safety goggles or masks are required for anyone who is present during a treatment session,
except for the physician and the patient. During some procedures it may be advisable to shield
untreated eyes. (Please refer to Section 3.3: Laser safety eyewear & NOHD)
4. Never leave the system on when it is unattended or within the reach of unauthorized persons.
Before leaving the vicinity, turn off the system and keep the key with you.
5. When the laser is on, always keep the system in STANDBY mode unless it is used to perform
treatment.
6. Contact lens wearers should use anti-reflection lenses treated for 532nm wavelength. Contact
lenses, particularly those with plano surfaces, can generate dangerous reflections.
7. Never open the laser enclosure as hazardous levels of visible and invisible optical radiations are
present inside. Refer any servicing problem to qualified personnel authorized by Quantel
medical.
8. Observe all DANGER, WARNING or CAUTION labels placed on the device:

An overview of the location and contents of these labels can be found in the:
Section 1: Labels
9. Circuitry is provided for the connection of a remote interlock. When attached to the laser door
room or other actuator, the interlock will prevent the laser from firing if someone enters in the
room while the system is in use. Installation instructions are provided in:
Section 4.5: Door switch & external red lamp installation
10. Regular maintenance, which can be performed by the user, is described in:
Performing regular maintenance, which includes checking the power calibration, will help
ensuring trouble-free operation.
User manual
3.3. LASER SAFETY EYEWEAR & NOHD
3.3.1. SAFETY EYEWEAR

Safety glasses or filters must protect the eyes from the emitted wavelength (spectral response)
and should therefore have a high optical density at the emitted wavelength:
Safety goggles or masks are required for anyone present at a treatment session.
All terminals (including slit lamp accessories such as camera adaptors and co-observation
tubes) must be equipped with filters that guarantee eye protection to the operator. Protection
at an appropriate Optical Density (OD) must also be provided for the eye that is not directly
viewing through the accessory.
WARNING
Safety glasses providing protection to a specific emitted wavelength may not offer any
protection to another wavelength and should absolutely not be used!
WARNING
Appropriate safety glasses should be available before accessing the treatment room. Any
treatment room window or opening should be protected.
WARNING
QUANTEL MEDICAL recommends the use of safety interlocks and warning lamps adapted to
the treatment area.
WARNING
Any reflective instrument should be avoided. All room surfaces should be matt finished to
prevent any potential laser light reflection.
WARNING
Avoid staring into the aiming beam unless under controlled conditions. However, damage to the
retina from the aiming beam is most improbable.
User manual
3.3.2. NOHD
The safety eyewear requirement is based on the Maximum Permissible Exposure (MPE), the
Nominal Ocular Hazard Distance (NOHD) and the Optical Density (OD).
For additional information, please refer to the standard: ANSI Z136.1-1993, ANSI Z136.3-1996,
or European Standard EN 60825: 1992, Appendix A.
The following formula has been used to calculate the NOHD for the worst case scenario for the
VITRA MULTISPOT unit among its compatible delivery systems.
The values specified here meet or exceed the laser safety eyewear requirements for the Indirect
Ophthalmoscope Delivery System:
Where:
a: beam waist diameter;
z: distance between the laser system and the beam waist;
Ø: full angle beam divergence;
Po: maximum laser power available;
Pf: profile correction factor;
EMPE: Maximum Permissible Exposure, in power density units (power per unit area); EMPE =
0.75
18(t )C6 where t = 0.25s is the maximum exposure time at maximum laser power.
NOHD: Nominal Ocular Hazard Distance (measured from laser aperture) the distance required
to reduce the power density to the MPE.
NOHD and MPE calculation are realized with a 50 µm optical fiber connected to the Vitra
multispot.
Parameters:
a = 0.8 mm
Po = 1.5 W
Pf = 1 EMPE = 25.46 W/m²
z = 0.03 m NOHD = 21.88 m
Ø = 0.0125 rad
Safety Eyewear: All personnel who are within the NOHD are considered to be within the
controlled area and should wear eye protection with a minimum optical density (OD) of:
OD = - LOG (EMPE / Power density) = 3.19
Where Power density = 38996.5 W/m² (taking into account the pupil diameter of 7 mm)
WARNING
For a maximum of security, the safety eyewear must have a protection class of:
L4 @ 532nm (EN 207 Standard).
User manual
3.4. PRECAUTIONS TO TAKE CONCERNING WASTES AND ELIMINATION OF

DEVICE AND ACCESSORIES:
Product category: This product complies with the WEEE Directive (2012/19/EU) marking
requirements. The Vitra Multispot is an electrical / electronic product and must not be discarded
with domestic household waste
Do not dispose with domestic household wastes!
With reference to the equipment types in the WEEE Directive annex I, this product is classed as
category 8 among the "Medical devices (with the exception of all implanted and infected
products)".
To dispose completely of the device and its accessories, contact QUANTEL MEDICAL.
USER MANUAL
II – TECHNICAL INFORMATION
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS Rev
2016
1. LABELS ..................................................................................................... 1
1.1. FRONT PANEL LABELS ........................................................................................... 1
1.2. REAR PANEL LABELS ............................................................................................. 2
1.3. UPPER AND LATERAL FACE LABELS ................................................................... 3
1.4. FOOTSWITCH........................................................................................................... 4
1.5. MULTISPOT ADAPTOR ............................................................................................ 5
2. TECHNICAL SPECIFICATIONS ............................................................... 6

2.1. 532 nm LASER BEAM SPECIFICATIONS ............................................................... 6
2.2. LASER CONTROL INTERFACE ............................................................................... 7
2.3. DELIVERY OPTIONS ................................................................................................ 7
2.4. STANDARDS COMPLIANCE.................................................................................... 8
2.5. ENVIRONMENTAL CONDITIONS ............................................................................ 9
3. INSTALLATION ......................................................................................... 9
3.1. INSTALLATION REQUIREMENTS ........................................................................... 9
3.1.1. OPERATING ROOM ............................................................................................. 9
3.1.2. ELECTRICAL REQUIREMENTS .......................................................................... 9
3.2. VITRA MULTISPOT LASER INSTALLATION ......................................................... 10

3.3. MULTISPOT ADAPTOR CONNECTIONS .............................................................. 10
3.4. INSTALLING THE MULTISPOT ADAPTOR ONTO THE SLIT LAMP .................... 11
3.4.1. REMOVING THE SLIT LAMP GENERATOR CENTERING LATCH .................. 11
3.4.2. SLIT LAMP MIRROR EXCHANGE ..................................................................... 12
3.4.3. TONOMETER HOLDER RISING RING FOR BQ MODELS ............................... 13
3.4.4. DOCTOR FILTER POSITION ............................................................................. 13
3.5. DOOR SWITCH & EXTERNAL RED LAMP INSTALLATION ................................. 14

3.5.1. DOOR SWITCH ................................................................................................... 14
3.5.2. RED LAMP .......................................................................................................... 14
User manual
1. LABELS
1.1. FRONT PANEL LABELS
Ref. Label Description
Laser warning label: located next to the laser aperture on the front panel.
General warning sign

2 ISO 7010-W001 General
KEY label:
Indicates the "OFF" and "ON" positions of the key.
"OFF" for a part of equipment

3 IEC 60417 - 5265
Stand-by or preparatory state for a part of equipment

IEC 60417 - 5266
EMERGENCY STOP label:

4 Situated next to the red emergency stop button.
User manual
1.2. REAR PANEL LABELS
Ref. Labels & Description

Identification label: it contains the following information:
Protection against electrical shocks: the applied parts are
classified as “BF Type". The insulated hand piece tip is the
only part in contact with the patient (it is insulated from
ground). IEC 60417-5333
IEC protection class: "Class I” - Main insulation. Accessible
conductive parts are connected to the ground.
IP 20: Protection from solid substances (Diameter >
12,5mm).
Refer to the instruction manual/ booklet

ISO 7010-M002
For indoor use only.

IEC 60417-5957
Electrical/electronic equipment in accordance with the

Directive 2012/19/UE (WEEE)
Do not dispose with domestic household wastes.
EN 50419
General warning sign

ISO 7010-W001 General
This label specifies the manufacturing date indication.

ISO 7000-2497
Rear connections identification label.
Multispot adaptor Footswitch Doorswitch

Fuses and voltage label: indicates Voltage, Current, Frequency, Power and Fuse specifications.
Fuse / IEC 60417 - 5016

3
Alternating current / IEC 60417 – 5032
User manual
Laser radiation label:

4 Indicates the treatment and aiming beam wavelengths and
powers.
1.3. UPPER AND LATERAL FACE LABELS
Internal radiation label:

Indicates existing laser radiations inside the
apparatus.
2 Federal US law label
User manual
1.4. FOOTSWITCH
Footswitch rear view:
Protection degrees: IPX8

The footswitch is protected against submersion.
User manual
1.5. MULTISPOT ADAPTOR
2
3
CE marking for medical device label.
Laser aperture label:

2 Advises the user that a laser beam is emitted from this
output.
Warranty label:
The device's guarantee will be void if the equipment is
3 opened (even partially), modified or repaired in any way
by persons who have not been authorized by QUANTEL
MEDICAL.
Filter label:
4 Located next to the doctor filter. Indicates the filter
optical density for the indicated wavelength.
User manual
2. TECHNICAL SPECIFICATIONS
2.1. 532 nm LASER BEAM SPECIFICATIONS
Parameters Descriptions
Laser class: Class IV (4) laser product
Laser source: Diode pumped, Frequency doubled - Nd: YAG
Wavelength: 532 nm
CHOSEN TERMINAL
Output power: S/L with multispot
(Out of delivery MICRO LIO ENDO
adaptor
system)
Single 50 to
50 to 1300mW (minimum)
CHOSEN Repeat 1500mW
Tolerance: <±20%
MODE Painting
50 to 600mW
Continuous
Power supply: 100-240 Vac, 50/60 Hz, single-phase, 250VA
CHOSEN TERMINAL
Multispot Multispot
MICRO / LIO
adaptor adaptor
ENDO
Single spot Pattern mode
Exposure time: 50 to 600mW 0.02 to 60s 0.01 to 60s
(Pulse duration) POWER 600 to
0.02 to 3s 0.01 to 3s 0.01 to 0.05s
RANGE 1200mW
>1200mW 0.02 to 0.1s 0.01 to 0.1s
When using the Multispot adaptor terminal with a selected pattern (line, square,
circle or triple arc), the available power range is: 50 to 1300mW.
Shot interval:
(Interval time In REPEAT mode: 0.1 to 0.7s
between pulses) In PAINTING mode: 0.02s
Shot counter: Number of delivered shots: from 0 to 9999
Aiming beam: Laser diode: 635 / 650nm; < 1.0 mW; Class 2 laser product
Cooling: Peltier coolers (TEC) and fan
Laser console Footswitch
Height:14,5 cm (5,71 in) 16,5 cm (6,5 in)

Dimensions:
Width: 18,5 cm (7,28 in) 17,5 cm (6,9 in)
Depth: 30 cm (11,81 in 34 cm (13,4 in)
Weight: 4,8 Kg (10,58 lb) 2,7 Kg (6 lb)
User manual
2.2. LASER CONTROL INTERFACE
Key switch: Power supply : ON / OFF

Front panel (screen): Illuminated push buttons
Foot switch: Connected at the back of the unit, redundant switch configuration
In emergency or hazardous situations, this emergency stop allows to
Emergency stop:
cut off power to all user interface controls and disable the laser head.
The pattern selecting button (potentiometer that is part of the multispot
Pattern selecting adaptor).allows the user to select the rotation/resizing function (when
button pushing on the button) and to rotate/resize the patterns (when turning
the button).
2.3. DELIVERY OPTIONS

Only connect delivery systems provided by Quantel medical. The following Quantel Medical
adaptors are available to the user (delivery options for Vitra Multispot laser 532nm):
 Multispot adaptor
 Microscope adaptor
 Indirect ophthalmoscope adaptor
 Laser probes
WARNING
Laser probes are disposable probes: they are not designed to be re-used.
User manual
2.4. STANDARDS COMPLIANCE

The Vitra Multispot laser complies with the following regulatory and technical
standards:
Standards Descriptions
21 CFR 1040.10 and 1040.11 Performance standard for light-emitting products.
except for deviations
pursuant to laser Notice
No.50, dated July 26, 2001.
IEC 60 601-1 Medical electrical equipment-Part 1:

General requirements for basic safety and essential performance.
IEC 60 601-1-1 Medical electrical equipment - part 1:

General requirements for safety 1:
Collateral standard: safety requirements for medical electrical systems
IEC 60 601-1-2 Medical electrical equipment part 1-2:

General requirements for safety – collateral standard: electromagnetic
compatibility - requirements and tests
IEC 60 601-1-4 Medical electrical equipment: part 1:

General requirements for safety 4 - collateral standard: programmable
electrical medical systems
IEC 60 601-1-6 Medical electrical equipment part 1-6:

General requirements for basic safety and essential performance -
collateral standard: usability
IEC 60 601-2-22 Medical electrical equipment - part 2-22:

Particular requirements for basic safety and essential performance of
surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60 529 Degrees of protection provided by enclosure (IP code).
IEC 60 825-1 Safety of laser products - part 1:

Equipment classification and requirements
IEC 62 304 Medical device software –

Software life-cycle processes (IEC 62A/474/CDV).
ISO 14 971 Medical devices –

Application of risk management to medical devices
(ISO/DIS 14971).
93/42/EEC European Medical Device directive.
IEC 62 366 Medical devices –

Application of usability engineering to medical devices
WARNING: All other devices used in conjunction with the VITRA MULTISPOT using power
supplies (other than those provided for the VITRA MULTISPOT) must be
conformed to the IEC standard 60601-1 (electric compatibility).
WARNING: All other devices used in the same room as the VITRA MULTISPOT must be
conformed to the IEC standard 60601-1-2 (electromagnetic compatibility).
User manual
2.5. ENVIRONMENTAL CONDITIONS
Normal operating Storage and shipping
Temperature 15°C (59°F) < T° < 30°C (86°F) -20°C (-4°F) < T° < 60°C (140°F)
Relative humidity 80% 80%
Atmospheric pressure 700 hPa < p < 1060 hPa 700 hPa < p < 1060 hPa
Maximum altitude 2000 m (about 6560 ft)
NOTE: This device is latex free.
3. INSTALLATION
WARNING
No modification of this equipment is allowed.
3.1. INSTALLATION REQUIREMENTS

3.1.1.OPERATING ROOM
The apparatus should be positioned in such way that the laser beam emerging from the terminal
(probe for example) can under no circumstances be directed toward an opening (door, window)
or any kind of light reflecting materials. The instrument must be installed in a dust free room with
no wall-to-wall carpet or rug. When not operating, the system should be covered to protect the
optical lens from dust. The device bottom and rear vent openings allow air flows necessary for
proper functioning: ensure they are not blocked.
3.1.2.ELECTRICAL REQUIREMENTS
The Vitra Multispot is equipped with a standard power plug at the end of its line cord. The user is
responsible for the installation of an adequate power outlet prior to the laser system installation.
Only connect the laser system to a grounded single phase power socket:
Voltage: 100 to 240 Vac
Frequency: 50 / 60 Hz.
Minimum current: 4 A.
WARNING
Protection earth impedance: Ensure that the socket is properly earthed.
WARNING
Do not connect the laser power plug (3 pin adaptor) on an ungrounded power socket (2-pin).
WARNING
Do not use an electric cable extension.
WARNING
Never connect the laser to a multiple-plug outlet or power strip.
WARNING
Use two different power outlets:
One for the slit lamp
Another one for the laser mains connection.
User manual
3.2. VITRA MULTISPOT LASER INSTALLATION

The vitra multispot should be placed on a table. Make sure the table is strong enough to support
the laser weight.
3.3. MULTISPOT ADAPTOR CONNECTIONS
1.
2.
Vitra Multispot
Adaptor socket
Footswitch
socket
Doorswitch
Remote socket
1. Vitra Multispot optical fiber connection
Turn the laser key to the “OFF” position and remove it.
Remove the dust fiber protection from the fiber’s tip and introduce the fiber into its
location at the front of the Vitra Multispot unit (ST/QL connector) (1).
WARNING
Do not touch the fiber’s tip with fingers.
Lock the fiber connector onto the laser by gently turning clockwise while pushing
down.
2. Multispot adaptor connection to the Vitra

Remove the green remote from the laser at the back of the unit.
Connect the Mutlispot adaptor green connector (2) to the green socket on the Vitra
Multispot
User manual
WARNING
Potential hazards may occur when inserting the optical fiber into the Vitra Multispot ST/QL
connector. Make sure it is not steeply bent (minimum allowed bending radius of 10 mm), stressed
or improperly secured. Failure to follow these recommendations may lead to serious damage to
the fiber or delivery system and/or harm to the patient, staff, or laser operator.
WARNING
If the aiming beam spot is not present at the distal end of the delivery system or its intensity is
reduced or looks diffused: do not use the laser & delivery system. This may be an indication of a
dirty, damaged or malfunctioning delivery system. Operating the laser without the aiming beam
may cause accidental laser exposure to the treatment room, patient, staff or laser operator. If the
aiming beam is not correct, you must contact QUANTEL MEDICAL Service Department or your
local distributor.
WARNING
In case the optical fiber is broken or damaged, contact Quantel Medical Service Department or
your local distributor to replace the optical fiber and recalibrate the system.
WARNING
Safety controls: the unit has a fiber detection system on the laser output. Make sure the fiber is
correctly connected before using the system.
3.4. INSTALLING THE MULTISPOT ADAPTOR ONTO THE SLIT LAMP

In case the user wants to adapt the Multispot terminal onto a slit lamp model other than the one
provided by Quantel Medical (Code: XLLAFQL / QLLAFQL2), the following preparations have to
be done, depending on the slit lamp model:
3.4.1.REMOVING THE SLIT LAMP GENERATOR CENTERING LATCH (FOR HAAG STREIT
900BM/BQ MODELS)
WARNING
The presence of the adaptor's final mirror has for consequence to lower the slit lamp intensity. To
avoid this problem, the generator should be shifted a little on the side to allow more light.
However, if the centering latch system is kept in its original position, this little shift is not possible.
As a consequence, the centering latch should be unscrewed and then removed as shown below:
User manual
3.4.2.SLIT LAMP MIRROR EXCHANGE

The installation of a new mirror, shorter than the original may be necessary to set up the multispot
adaptor on some slit lamps models that are similar to the Haag Streit slit lamp model. This short
mirror allows the slit lamp generator to rotate without touching the doctor’s filter:
Remove the original mirror (long) and replace it by the new one (short). The generator mirror must
be completely inserted to be in contact with the down edge inside of its housing.
Mirror
Binocular
User manual
3.4.3. TONOMETER HOLDER RISING RING FOR BQ MODELS

A tonometer rising ring is needed on all BQ models and similar to adapt the Multispot adaptor to
the Haag streit 900BQ slit lamp and allow a correct adaptor installation. Indeed, in case the
adaptation is not enough raised, the slit lamp generator passage may hit the adaptor mechanics.
The multispot adaptor can slide in

position on the 2 cylindrical guides:
NOTE
In case the slit lamp is not equipped with a tonometer holder as explained above, the adaptor
installation will not be possible. Please contact your local distributor to order it.
3.4.4.DOCTOR FILTER POSITION
WARNING
To optimize user’s protection, the doctor filter must be positioned as closed as possible to the
binocular output. On BM models, a filter spacer is mounted on the adaptors by default. However,
for BQ models, this spacer should be removed to bring the doctor filter closer to the binocular.
You must contact Quantel Medical or your local distributor to install the Multispot adaptor and
securely adjust the filter’s position.
User manual
3.5. DOOR SWITCH & EXTERNAL RED LAMP INSTALLATION

3.5.1.DOOR SWITCH
The user has to provide the door switch. The door switch may either be magnetically or
mechanically triggered: it will close the electrical circuit when the door is closed and open the
circuit when the door is opened. The switch (and its wiring) should be chosen to be supplied with:
24 Vac and 500 mA.
WARNING
The transformer used to deliver the 24 Vac from the 110 or 220 Vac must be TBTS (Very Low
Safety Voltage); in compliance with the EN 61 558-2-6 standard.
This door switch must terminate by a SUB - D 9-pin male standard connector, commonly used for
serial port computer connections. One of the contact wires must be connected to pin 1 and the
other one to pin 3. Polarity is not important.
NOTE
In case this door switch option is not used, a red remote that shorts pins 1 and 3 and allows the
device to go to “ready” mode can be connected instead.
Doorswitch installation figure.
To connect the doorswitch to the laser system: simply remove the red remote from the Vitra
Multispot rear panel and replace it with the door switch circuit connector. Make sure it is firmly
connected in order to avoid any unexpected system safety-interlock.
3.5.2.RED LAMP
The red lamp command is controlled via an external relay (as shown in Section 4.5.1: Door switch
installation / “Doorswitch installation figure”). Connect the red lamp external relay to the same
SUB - D 9-pin male standard connector: one of the contact wires must be connected to pin 8 and
the other one to pin 9. Contact between Pin 8 and 9 is established when the laser is operational
(it is controlled by another relay, this one, internal to the laser system).
The external relay coil must be supplied with a maximum of 24Vac / 500mA. The user has to
provide the red lamp power supply circuit.
USER MANUAL
III – USING THE DEVICE
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS Rev
2016
1. PRIOR CHECKS .................................................................................... 1
2. STARTING UP THE SYSTEM ............................................................... 1

2.1. Emergency stop button ........................................................................................ 1
2.2. Main switch .......................................................................................................... 2
2.3. Keyswitch ............................................................................................................. 2
3. ACCESSING THE TREATMENT SCREEN ........................................... 3
4. S/L ADAPTOR TERMINAL ................................................................... 5

4.1. Patient positioning / Preparing for treatment ................................................. 5
4.2. S/L adaptor / Single spot treatment screen ..................................................... 6
4.2.1. Classical “single spot” mode laser treatment (icons and functions) ............. 6
4.2.1.1. Laser status: STANDBY / READY........................................................ 6
4.2.1.2. Spot size ............................................................................................... 7
4.2.1.3. Power selection .................................................................................... 8
4.2.1.4. Pulse duration ....................................................................................... 8
4.2.1.5. Interval time between pulses ................................................................ 8
4.2.1.6. Mode ..................................................................................................... 9
4.2.1.7. Aiming beam ......................................................................................... 9
4.2.1.8. Counter ............................................................................................... 10
4.2.2. Titrate procedure (compulsory before Multispot treatment) ....................... 10

4.2.2.1. STEP 1: Spot size............................................................................... 10
4.2.2.2. STEP 2: Pulse duration ...................................................................... 11
4.2.2.3. STEP 3: Power level ........................................................................... 11
4.3. S/L adaptor / Multispot treatment screen ........................................................... 12

4.3.1. Pattern selection screen ............................................................................. 12
4.3.2. Pattern treatment screen ............................................................................ 13
4.3.2.1. Pattern treatment screen: general functions ...................................... 13 X
4.3.2.2. Available patterns and descriptions .................................................... 15
A. Line pattern ......................................................................................... 15
B. Square pattern .................................................................................... 16
C. Arc / Circle pattern .............................................................................. 17
D. Triple arc pattern................................................................................. 18
5. OTHER TERMINALS: MICRO, LIO AND ENDO ................................. 19

5.1. Treatment screen (for MICRO, LIO and ENDO) icons and functions ................ 20
5.2. Operation ........................................................................................................... 20
5.3. Procedure from which the treatment screen has been called ........................... 20
5.4. Footswitch .......................................................................................................... 21
6. SETTING UP THE VITRA MULTISPOT INTERFACE ......................... 23

6.1. Vitra Multispot interface Set up screen .............................................................. 23
6.2. Setting up the Vitra Multispot interface “Quick Start” option .............................. 25
7. SHUTTING DOWN THE LASER SYSTEM.......................................... 26
8. APPENDIX: VITRA MULTISPOT & DATA FOR CONTACT LENSES 26

User manual
1. PRIOR CHECKS
Carry out the following checks prior to start up and use the Vitra Multispot laser system:
WARNINGS
1) Make sure that all persons attending the laser treatment session (except for the user and
patient) wear adequate laser safety glasses. Refer to:
Vitra Multispot user manual: I - Regulatory & safety information
Section 3.3: Laser safety eyewear & NOHD
2) Check that the laser emergency stop button is released
(as explained in Section: 2.1. Emergency stop button).
3) Make sure the safety interlock is connected.
4) Check that the Multispot adaptor is well connected to the laser unit.
5) Make sure the power supply cable is connected.
2. STARTING UP THE SYSTEM

The Vitra Multispot laser console has 3 power supply control keys:
Emergency stop button on the front panel (section 2.1.).
Main switch on the back panel (section 2.2.).
Keyswitch on the front panel (section 2.3.)
2.1. EMERGENCY STOP BUTTON

When the emergency red STOP button at the front of the unit is pressed, all laser functions
stop instantly:
The following procedure should be followed to restart the laser system after an “emergency”
stop:
1) Press and turn the emergency button clockwise to release it.

2) Turn the keyswitch to the “OFF” position.
3) Restart the system as usual by turning the key to the “ON” position.
NOTE
Timing and counter settings will return to their default values.
WARNING
This emergency switch should ONLY be used in case of an emergency.
User manual
2.2. MAIN SWITCH

The main switch allows the user to supply power to the Vitra Multispot system when it is
turned on (“I” position): the blue LED on the front panel lights on.
2.3. KEYSWITCH
The keyswitch allows the user to start or stop the laser:
When turning the key to the left ("OFF" position),

the laser stops. The screen shuts down.
When turning the key to the right ("ON" position),

the laser starts: the system boots up and the LCD screen lights up
to display the startup screen.
NOTE
The key cannot be removed while the laser is activated (key to "ON" position).
User manual
3. ACCESSING THE TREATMENT SCREEN

After having turned the key to the “ON” position: the system boots up and in a few seconds,
the following Startup screen is displayed:
Press this area for a

few seconds to To access the terminal
display statistical selection screen, select:
information
(Ref NOTE )
1 “QUICKSTART” or
“NAME”
Selecting the arrows Allows the user to access the
allows the user to terminal selection screen by
access pre- default (or, if pre-programmed:
programmed a QuickStart treatment screen
treatment screens common to all users: Section
for each user. 5.3)
(Section 5.3)
Allows the user to program
treatment parameters for up to
5 User’s names.
Allows the user (Section 6.1)
to adjust screen
contrast. Allows the user to
adjust volume.
Screen 1 –Startup screen
1
NOTE
More information about statistical information is available in the:
Section 6: Statistics
Select: “QUICKSTART” or “NAME”: the laser starts warming-up and displays the “terminal
selection” screen:
Escape to
Startup screen
Allows the user to

access the terminal
doctor calibration
screen.
2
(Ref NOTE )
To adjust screen To adjust LIO

contrast lamp intensity
Screen 2 – Terminal selection screen
User manual
The User can choose the delivery system to be used from the following list:
1) Multispot adaptor
(Slit Lamp)
2) Laser probe
3) Operating microscope
4) Indirect ophthalmoscope
NOTE
The Terminal selection screen is displayed by default when “QUICKSTART” is selected from
the Startup screen. However, in the case it has been pre-programmed as explained in:
Section 6.2: Setting up the Vitra Multispot interface “Quick start” option
Then pre-selected Treatment screen with defined parameters will be displayed instead.
2
NOTE
Pressing “c” for a few seconds allows the user to access the doctor calibration screen:
For more information on how to perform the calibration, refer to the:

Section 4: Terminal power calibration
NOTE
For diagnosis use (as opposed to treatment use), the Multispot adaptor should be retracted as
shown on the picture below:
Unretracted position (treatment)
Retracted position (diagnosis)
Check it is not retracted when selecting the Multispot adaptor terminal.
User manual
4. S/L ADAPTOR TERMINAL

4.1. PATIENT POSITIONING / PREPARING FOR TREATMENT
WARNING
Before treatment, check:
• The eyepieces are well adjusted to compensate for variance in individual user’s vision.
• The aiming beam spot (adjusted to 200µm) is clear and well defined with the illuminated slit at
focal distance.
If this not the case, call Quantel Medical Service Department or your local distributor.
WARNING
Ensure the chinrest and headrest are thoroughly cleaned prior to follow the procedure below:
1) Comfortably position the patient behind the slit lamp table. Place his/her chin on the chinrest
and the forehead against the headrest.
2) Select the contact lens taking into account its magnification factor and position the contact
lens on the patient's eye.
WARNING
The spot size (which value is displayed on the treatment screen) has to be adjusted (using the
zoom) taking into account the contact lens laser spot magnification factor. To determine the
spot size at focal distance, please refer to the lens specifications provided in the manufacturer
manual.
WARNING
It is always recommended to use an indirect contact lens such as:
• In periphery: Ocular Mainster PRP 165 (x1.96) / Volk SuperQuad (x2)
• In central area: Ocular Mainster Focal/Grid (x1.05)/Volk Area Centralis (x0.94)
Indeed: direct contact lenses (such as the 3 mirror lens) are strictly not recommended:
- Patient uncomfortable position.

- One of the laser spot could be reflected in another mirror.
NOTE
For more information about contact lenses, please refer to:
Section 8: Appendix – Vitra Multispot & Data for contact lenses.
User manual
4.2. S/L ADAPTOR / SINGLE SPOT TREATMENT SCREEN
Selected the S/L terminal:
The unit will display the “Single spot” treatment screen that corresponds to a single spot pattern. This
treatment screen may be used to:
• Perform a classical “single spot” mode laser treatment (4.2.1)

• Perform a “Titrate” procedure (compulsory before Multispot treatment) (4.2.2)
Escape to the
Terminal
selection screen.
Displays the
selected terminal Select this area to
for treatment access the Pattern
selection screen
(4.3.1)
Screen 3 –S/L adaptor treatment screen
4.2.1.CLASSICAL “SINGLE SPOT” MODE LASER TREATMENT (ICONS AND

FUNCTIONS)
The Vitra Multispot laser interface provides complete control over all the following parameters:
4.2.1.1. LASER STATUS: STANDBY / READY

STANDBY / READY icon:
A LED (located on the left side of the

LCD screen) indicates the laser status
User manual
There are 3 possible modes:
Laser modes: LED color Action

STANDBY Green The laser cannot shoot.
READY Orange The laser is ready to shoot.
SHOOTING Orange The laser is shooting.
Press the
Wait for the footswitch :
Press the “READY”
“Standby” display
icon (+Beep)
Led
Icon
Laser STANDBY 2s READY SHOOTING

mode mode delay mode mode
Release the
Press the “Ready” icon
footswitch :
to go back to
“STANDBY” mode
NOTE
If the footswitch has not been pressed after more than 3 minutes in READY mode: the laser
automatically goes back to STANDBY mode.
4.2.1.2. SPOT SIZE

The Multispot adaptor zoom allows the user to adjust spot size at the biomicroscope focal
point.
The spot size can vary from 50µ to 500µ by

steps of 20µ. It is indicated in μm at the
bottom of the pattern selection square in the
middle of the screen.
NOTE
In Pattern treatment mode, the minimal spot
size is 100μm.
User manual
4.2.1.3. POWER SELECTION

Power display:
The power control knob at the front of the Vitra Multispot system allows the user to adjust the
“Out of delivery” power.
Power
adjustment knob
Laser state led
Fiber connector
4.2.1.4. PULSE DURATION

Pulse duration icon:
This icon allows the user to adjust the pulse duration time: The "+" and "-" buttons may be
used to increase or decrease the duration time.
4.2.1.5. INTERVAL TIME BETWEEN PULSES

Interval time icon:
This icon allows the user to select the time interval between two consecutive pulses in
“REPEAT” mode. The "+" and "-" buttons may be used to increase or decrease the interval
time.
NOTE: Default value: 0,10 s.
User manual
4.2.1.6. MODE
Mode icon:
Pressing the “Mode” icon allows the user to choose the treatment mode as indicated below:
Mode description
Single (default mode)
When pressing the footswitch (no

matter for how long), a single shot is
triggered.
To shoot again, release the footswitch
and press it again.
Repeat
As long as the footswitch is pressed,

the laser shoots repetitively during the
selected duration time at the chosen
time interval.
Painting
As long as the footswitch is pressed,

the laser shoots repetitively during
0,05s (exposure time) at 0.02s time
interval.
Continuous
As long as the footswitch is pressed:
The laser shoots for 60 seconds.
Then, the laser beam is interrupted
for a fraction of a second.
And the laser restarts to shoot for
another 60 seconds or until the
footswitch is released.
NOTE
The single mode is displayed by default
4.2.1.7. AIMING BEAM

Aiming beam icon:
The ’+’ And ’-’ buttons allow to increase or decrease the aiming beam intensity. The laser red
aiming beam (650 nm) power ranges from:
1 (minimum power output) to 9 (maximum power output: 0,6mW).
NOTE
During shooting and for the following 0,1s, the aiming beam is turned off to allow a better burn
result examination.
User manual
NOTE
The aiming beam may be turned off: Set its value to 1 and then press on "-" button for 3
seconds. When the aiming beam is turned off, the laser cannot shoot. To reactivate it, press
"+".
WARNING
The aiming beam passes through the same delivery system as the working beam; therefore,
its appearance provides a good indication regarding the delivery system performance. If the
aiming beam spot is not present out of the delivery system, or if its intensity is reduced or
looks diffused, the delivery system may be damaged or not properly working. In this case, do
not use the laser system and call Quantel Medical Service department or your local distributor.
4.2.1.8. COUNTER
Counter icon:
The counter displays the total number of delivered pulses.
NOTE
Remember to press the RESET button before each treatment.
The counter also resets when the laser is turned off (key switch to OFF position) or with the
main switch at the back of the unit ("0" position).
4.2.2.TITRATE PROCEDURE (COMPULSORY BEFORE MULTISPOT TREATMENT)

The aim of the titrate procedure is to adjust and determine the settings required for the
multispot treatment looking at the effect of a “single spot” impact on tissues.
Properly place the red aiming beam on the patient's retina with the slit lamp joystick. Each
footswitch depression will result in one application. Treatment may be interrupted at any point
by releasing the footswitch.
4.2.2.1. STEP 1: SPOT SIZE
Select spot size (continuous zoom)

As explained in:
Section: 4.2.1.2: Spot size.
WARNING
manual.
User manual
4.2.2.2. STEP 2: PULSE DURATION
Select a very short pulse

0.010s 10ms
duration: 10ms by default.
(always recommended):
4.2.2.3. STEP 3: POWER LEVEL
Select the power level

from and up.
required for treatment:
It should be increased step by step until the doctor is satisfied with the effect on
tissues.
Once the power level selected, the treatment pattern may be chosen from the “Pattern
selection screen” as follows (Section 4.3: S/L adaptor / Multispot treatment screen)
User manual
4.3. S/L ADAPTOR / MULTISPOT TREATMENT SCREEN

4.3.1.PATTERN SELECTION SCREEN
Select the “Pattern selection” square in the middle of the “treatment screen” (Screen 3 –S/L
adaptor treatment screen) to access the Pattern selection screen:
Screen 4 –Pattern selection screen.
Press on the different

Patterns
patterns to access:
Single spot treatment

screen.
Line treatment screen.
Square treatment screen.
Arc / Circle treatment

screen.
Triple arc treatment screen.
User manual
4.3.2.PATTERN TREATMENT SCREEN

Pattern screen example (square pattern):
To adjust Spot spacing
(Section 4.3.2.1 - A)
Cancel the resume

function when a
pattern was Resume function.
interrupted (Section 4.3.2.1 - C)
(Section 4.3.2.1 - C)
To resize / rotate
patterns
(Section 4.2.1 - B)
4.3.2.1. PATTERN TREATMENT SCREEN: GENERAL FUNCTIONS

A. SPOT SPACING AND SPACING COEFFICIENT
On each pattern screen (except for the "Single spot" screen), the user can modify the spacing
between spots. It can vary from 0.0 to 2.0 Ø (spot diameter):
Select this area to Coefficient Select this area to

reduce the value increase the distance
distance between between spots
spots (decreases (increases the coef.
the coef. value) value)
The coefficient value determines the spots spacing as shown in the following equation:
SPOT SPACING = SPOT Ø x COEFFICIENT
NOTE
Spacing coefficients may be chosen from: 0 - 0,25 - 0,5 - 0,75 - 1 - 1,5 – 2
User manual
B. RESIZING / ROTATING PATTERNS
Each pattern screen has dedicated parameter icons that allow to rotate or to resize the
patterns (extend/reduce the patterns – extend/reduce the radius of rounded shape patterns).
They are located at the bottom right of the Pattern screens: Screen 5 - Pattern screen
example.
To be adjusted, the icon (used to extend/reduce a pattern – extend/reduce the radius of a

rounded shape pattern) has to be selected (highlighted and outlined in red) as in the example
below:
Once highlighted, the active parameter can be adjusted using:
the Multispot adaptor knob:
or the following buttons:
NOTE
Pressing on the Multispot adaptor knob allows the user to move the selection from a
parameter icon to another.
C. RESUME FUNCTION
This function, when it is activated, allows to the user to continue the pattern when this
one was interrupted.
The spots executed are displayed on the screen in red.
A canceling tab is displayed at the left-hand of the pattern display.
Activation: Press the function button until it highlights white (about 1s).
Use: After the release of the footswitch.

 The user can finish the pattern by pressing the footswitch again.
 He can cancel the pattern resume by pressing the canceling tab and perform
a new pattern.
User manual
4.3.2.2. AVAILABLE PATTERNS AND DESCRIPTIONS
A. LINE PATTERN
NOTE
Pattern selected by default

Pattern
Number of spots 3
Screen 6 –Line pattern
Adjusting the default pattern:

Action
Adjust
Selected Effect on pattern
+ front
icon
knob
+ To Rotate by steps of 45°:
User manual
B. SQUARE PATTERN
The square pattern is recommended for pan retinal photocoagulation in central area.
NOTE
Pattern
Number of spots 9 (3x3)
Screen 7 –Square pattern
Action
Adjust
+ front
icon
knob
To Rotate by steps of
+
45°:
User manual
C. ARC / CIRCLE PATTERN

This pattern is recommended to treat retina tear.
NOTE

Position
Radius 1000µm
Screen 8 – Circle pattern
Action
Adjust
+ front
icon
knob
+ The pattern rotates by steps of 45°
Increase / reduce the spots number by steps of 1/8
+ Radius adjustment from 800 to 2500μm
User manual
D. TRIPLE ARC PATTERN

The triple arc pattern is recommended for pan retinal photocoagulation in retina's peripheral
areas.
NOTE

Pattern
Number of spots 9
Screen 9 – Triple arc pattern
Action
Adjust
+ front
icon
knob
To Rotate by steps of
+
45°:
User manual
5. OTHER TERMINALS: MICRO, LIO AND ENDO

To use other terminals, choose and select the MICRO, ENDO or LIO terminal from the
Terminal selection screen:
The unit will display the corresponding treatment screen:
Escape to Terminal
selection screen.
Procedure from which the
treatment screen has been
called:
or
For more information, refer

to: Section 5.3
Displays the terminal

chosen for treatment
Screen 10 –Treatment screen (MICRO-LIO-ENDO)
WARNING
When the MICRO or ENDO terminal is selected, and before accessing the treatment screen,
the following message is displayed:
The User has to make sure the protection filter is well positioned before using the laser. Press
“OK” to move on to the “Treatment screen”.
User manual
5.1. TREATMENT SCREEN (FOR MICRO, LIO AND ENDO) ICONS AND
FUNCTIONS
For more information about all treatment screen icons & functions for:
• Power • Interval time between pulses • Counter
• Pulse duration • Aiming beam • Spot size
• Treatment mode
Refer to:
Section 4.2.1: Classical “single spot” mode laser treatment (icons & functions)
5.2. OPERATION
For any delivery system provided as an option (MICRO, LIO or ENDO): please refer to the
dedicated delivery system manual.
5.3. PROCEDURE FROM WHICH THE TREATMENT SCREEN HAS BEEN

CALLED
The following icons indicate the procedure from which the treatment screen has been called:
or
Before using the laser system, the User can set up the Vitra Multispot interface and pre-
program parameters for several laser treatments. They are two ways to pre-program
parameters for an exam:
“QUICKSTART”
The “Quick Start” option allows the user to quickly access the most preferred (mostly used)
treatment screen. It is common to all users. Any of the 4 terminals may be pre-selected.
“NAME” (User Name)

Each of the 5 displayed USER NAME icons in the Startup screen may be selected to
customize up to 12 laser treatments. Any of the 3 terminals: MICRO, LIO and ENDO may be
pre-selected.
In case the procedure has been called:
1) From the “Quick Start”:

The “MEMORY” icon is left blank:
2) From a selected User Name (+ Terminal selection screen): all user customized treatments for
the selected terminal are available by selecting the following icon:
Memory icon:
Successively press on the icon to move from a pre-programmed treatment to another. All
saved parameters for the selected treatment will automatically be displayed in the treatment
screen to be used.
For more information, please refer to:

Section 6: Setting up the Vitra Multispot interface
User manual
5.4. FOOTSWITCH
Footswitch icon
When using the MICRO, LIO or ENDO terminal, three footswitch configurations are available to
the user:
BASIC
BASIC+
ADVANCED
Successively press on the icon to move from a footswitch configuration to another.
Footswitch available functions for each configuration:
Footswitch & functions

Bottom Top
Left switch Right switch Top switch during 3s
switch switch
To To select the
select “Advanced mode”
Decreases Increases Triggers
Using the top switch in
power. power. the shot. -
“Advanced mode”
Standby
allows the user to
or
select parameters
-Ready.
BASIC X X X
MODE
BASIC+ X X X X
ADVANCE
X X X X X
D
Top switch :
Ready / Standby
“Advanced mode” is
selected if the top
switch is pressed >3s
Parameter selection in
Adanced mode
Left switch :
To decrease the
selected parameter.
Right switch :
To increase the
selected parameter.
Bottom switch :
To trigger the shot
User manual
Selecting parameters in ADVANCED mode:
An additional function is available in “ADVANCED”

mode when pressing the switch located at the top
of the footswitch for more than 3 seconds. This
additional “ADVANCED” function allows the user
to select the treatment parameters by repeatedly
pressing on the top switch. Use the lateral
switches or the control screen to modify the
selected parameter settings.
NOTE
When this function is activated, the laser will
automatically turn to “standby” mode.
NOTE
The selected parameter is marked by an icon
located under the power display.
NOTE
If the top switch has not been pressed (activated)
for more than 5 seconds, then the laser leaves the
footswitch “ADVANCED” mode.
NOTE
When using the multispot adaptor, only the BASIC+ footswitch functions are available.
User manual
6. SETTING UP THE VITRA MULTISPOT INTERFACE

6.1. VITRA MULTISPOT INTERFACE SET UP SCREEN
The Vitra Multispot “Setup” screen allows the user to pre-program laser treatment parameters
for each of the 5 user “NAME” icons displayed in the “Startup” screen. Select:
The following screen is displayed:
To access the
keyboard screen
To choose the legend

display from:
Treatment
Parameters
US International
(with words) (with icons)
To control volume
Escape to Reset all fields Save

Startup to default parameters
screen values selection
Screen 11 – VITRA MULTISPOT Setup screen
User manual
Treatment screens icons and functions:

Parameters Description
Allows the user to enter an user name that will be displayed in the Startup
screen. Up to 5 user names can be saved. The user name can be entered using
the following icon:
The keyboard screen will then be displayed::
Type the user name to be saved and select “OK” to validate and return to the
setup screen
Parameters Description
Each user can pre-program parameters for up to 12 laser treatments. As for the
User name selection, press the keyboard screen icon to enter and validate a
treatment name.
Allows the user to choose from:
or BASIC /BASIC + / ADVANCED modes as explained in:
Section 5.4: Footswitch.
Allows the user to choose the pre-programed terminal type for the selected
Treatment name : Micro / Endo / LIO
For more information, please refer to:
Screen 2 – Terminal selection screen
NOTE
The “Slit Lamp” choice is not available from the Terminal selection list
However, it is available from the “QuickStart” setup screen as explained in:
Section 6.2.: Setting up the Vitra Multispot interface “Quick Start” option
Allows the user to select a default “Out of delivery system” Power value for the
or selected treatment name. For more information, please refer to:
Section 4.2.1.3 : Power selection
or Allows the user to select the pulse duration time. Please refer to:
Section 4.2.1.4 : Pulse duration
Allows the user to select the laser shooting mode for the selected Treatment
or name. Choice list: Single, Repeat, Painting or Continuous. For more information,
please refer to:
Section 4.2.1.6: Mode
Allows the user to select the time interval between two consecutive pulses. For
or more information, please refer to:
Section 4.2.1.5: Interval time between pulses
NOTE
To use the pre-selected parameters screens, refer to:
Section 5.3: Procedure from which the treatment screen has been called
User manual
6.2. SETTING UP THE VITRA MULTISPOT INTERFACE “QUICK START”

OPTION
The “Quick Start” option allows the user to quickly access the most preferred (mostly used)
treatment screen. It is common to all users.
From the Vitra Multispot Startup screen (Screen 1 –Startup screen), press on the following
icon for few seconds until the “Quick start” setup screen is displayed:
“Quick Start” setup screen:
To choose the legend

display from:
Treatment
Parameters
US International
(with words) (with icons)
Escape to Save parameters

Startup screen selection
Reset all fields
to default values
Screen 12 – Quick Start setup screen
The treatment parameters for the “Quick Start” setup screen can be adjusted as explained in
the above section:
Section 6.1 : Vitra Multispot interface Set up screen
“SAVE” the new treatment parameters to be used in the “Quick Start” treatment screen and
select “ESC” to go back to the Vitra Multispot Startup scree
NOTE
The Multispot adaptor (Slit Lamp) terminal can be pre-selected in this “Quick Start setup”
screen.
When the “Quick Start” setup screen has been completed and saved: it is possible to directly
access the “Quick Start” treatment screen from the Vitra Multispot Startup screen (Screen 1 –
Startup screen):
Simply select the following icon:
Refer to:
Section 5.3: Procedure from which the treatment screen has been called
NOTE
In case the “Quick start” setup screen with customized treatment parameters has not been
completed and saved or if the “DEL” icon has been used to reset all treatment fields
parameters, then the Vitra Multispot terminal selection screen will be displayed instead of the
treatment screen (Screen 2 –Terminal selection screen).
User manual
7. SHUTTING DOWN THE LASER SYSTEM

At the end of the treatment:
Select or check the unit is in “STANDBY” mode.
Switch off the laser with the key switch (Section 2.3 : Key switch)
Switch off the laser with the main switch (Section 2.2: Main switch).
NOTE
At the end of the day, place a dust cover on all devices (laser, adaptors and slit lamp).
WARNING
The red emergency stop button (on the front panel) must only be used in case of an
emergency situation.
8. APPENDIX: VITRA MULTISPOT & DATA FOR CONTACT LENSES
WARNING
manual.
WARNING
It is always recommended to use indirect contact lenses such as:
• In periphery:
Ocular Mainster PRP 165 (x1.96) / Volk SuperQuad (x2)
• In central area:
Ocular Mainster Focal/Grid (x1.05) / Volk Area Centralis (x0.94)
WARNING
Direct contact lenses (such as the 3 mirror lens) are strictly not recommended:
- Patient uncomfortable position.
- One of the laser spot could be reflected in another mirror.
WARNING
DO NOT use any contact lens with a laser spot magnification smaller than 0.94.
User manual
NON EXHAUSTIVE LIST FOR INDIRECT LENSES
WARNING
The contact lenses non exhaustive lists shown below are not contractual.
OCULAR
User manual
VOLK
USER MANUAL
IV - MAINTENANCE
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS Rev.
2016
1. CLEANING AND DISINFECTION ......................................................... 1

1.1 GENERAL ................................................................................................................. 1
1.2 RESPONSIBILITIES FOR CLEANING AND DISINFECTION ................................. 1
1.3 CLEANING AND DISINFECTION OF PATIENT AREAS......................................... 1
2. SERVICE VISITS ................................................................................... 1
3. ROUTINE MAINTENANCE.................................................................... 2
3.1 CLEANING THE VITRA MULTISPOT LASER SYSTEM ......................................... 2
3.1.1 VITRA MULTISPOT REAR PANEL .................................................................. 2
3.1.2 VITRA MULTISPOT LCD SCREEN (DISPLAY) .............................................. 2
3.1.3 VITRA MULTISPOT HOUSING ........................................................................ 2
3.2 CLEANING THE OPTICS ......................................................................................... 3

3.3 OPTICAL FIBER & AIMING BEAM INSPECTION ................................................... 3
3.4 CHECKING SPOT MOVEMENT LIMITS ................................................................. 4
3.5 AIMING / TREATMENT BEAM COINCIDENCE & PATTERN CHECK UP ............. 5
4. TERMINAL POWER CALIBRATION .................................................... 7

4.1 REQUIRED EQUIPMENT: ....................................................................................... 7
4.2 PREPARATION ........................................................................................................ 7
4.3 CALIBRATION .......................................................................................................... 8
5. TOUCH SCREEN CALIBRATION ......................................................... 9
6. STATISTICS ........................................................................................ 10
7. FUSE REPLACEMENT ....................................................................... 11 X
8. ERROR MESSAGES AND SYMBOLS ............................................... 12

8.1 WARNINGS ............................................................................................................ 12
8.2 ERROR MESSAGES ............................................................................................. 13
8.3 CALIBRATION ERROR MESSAGES .................................................................... 13
User manual
IV – Maintenance
1. CLEANING AND DISINFECTION

1.1 GENERAL
Although the use of the Vitra Multispot does not involve any skin contact with the patient,
attention should be given to the possibility of cross-contamination between patients via the
system patient contact areas (chinrest, headrest and steadying handles). In addition the entire
system will require routine cleaning as described in the care and maintenance section of this
manual.
1.2 RESPONSIBILITIES FOR CLEANING AND DISINFECTION

The health care facility where the instrument is to be used is responsible for:
1) Determining the level of cleaning and disinfection of patient contact areas required
between patients.
2) Appropriate education and training for staff required to carry out cleaning and
disinfection.
3) Ensuring that routine cleaning and disinfection methods used in the facility are
compatible with the instrument.
4) Routine cleaning of the entire system.
1.3 CLEANING AND DISINFECTION OF PATIENT AREAS

Although cleaning and disinfection procedures and standards within different health care facilities
may vary considerably, the following points are provided as general guidelines:
1) Thorough cleaning of all patient contact areas is recommended for each procedure.
Disposable chinrest papers can also be attached to the chinrest area and changed
between patients.
2) Manual cleaning can be carried out by wiping all contact areas using a suitable liquid
cleaning agent which is non-corrosive, non-toxic and Iow in residue.
3) Chemical disinfection of patient contact areas may be carried out provided that the
method and materials chosen by the health care facility have been shown to be
compatible with the instrument.
4) Steam sterilization and heat disinfection is not recommended and the chinrest
assembly (or any other system components) should not be immersed in liquid.
2. SERVICE VISITS
On a regular basis (at least once a year), you must contact your QUANTEL MEDICAL trained
service representative to undertake the preventive maintenance visits of your Vitra Multispot laser
system. The Vitra Multispot laser system general performance will be checked:
- Touch screen calibration

- Optics external cleaning
- Aiming beam calibration
- Check the optical fiber & terminals calibration
- Cavity calibration & Electronic adjustments (power board) check-up:
Thermistors (Diode, Yag, KTP)
Peltiers boards (temperature)
User manual
IV – Maintenance
3. ROUTINE MAINTENANCE
WARNING
Disconnect AC power before cleaning the case.
Use only a damp cloth for cleaning. Do not use any solvent, nor alcohol.
All surfaces should be thoroughly dried after cleaning.
NOTE
The Vitra Multispot system has been designed to provide a trouble-free operation that minimizes
downtime. As a result very little user maintenance is required.
Maintenance procedure:
1) Turn off the laser system.

2) If necessary, allow the laser system to cool down for several minutes.
There are five routine maintenance tasks that are explained in the following sections:
Cleaning the Vitra Multispot unit (Section 3.1)
Cleaning the optics (Section 3.2)
Optical fiber and aiming beam inspection (Section 3.3)
Checking spot movement limits (Section3.4)
Aiming / treatment beam coincidence & Pattern checkup (Section 3.5)
3.1 CLEANING THE VITRA MULTISPOT LASER SYSTEM

3.1.1 VITRA MULTISPOT REAR PANEL
The air is expelled through the access holes located at the back of the laser console. Any built up
dust should be cleaned as necessary. Use a dry cloth to remove dust from these surfaces.
3.1.2 VITRA MULTISPOT LCD SCREEN (DISPLAY)

Make sure the LCD screen is turned off before cleaning the screen. If the screen is dark, it will be
easier to see the areas that are dirty or oily. Use a dry, soft cloth (ideally the microfiber type of
cloth used to clean eyeglasses) and very gently wipe the screen. Do not press hard on the screen
in an attempt to scrub the dirt off because it could cause pixels to burn out.
3.1.3 VITRA MULTISPOT HOUSING

Clean the rest of the Vitra Multispot system with a cloth dampened with a non-caustic cleaning
solution such as soap and water, isopropyl alcohol, or a "hospital-grade" disinfectant avoiding any
optical surfaces. Do not spray or pour cleaning agents directly on the system. Dry with a clean,
dry cloth or allow to air dry.
User manual
IV – Maintenance
3.2 CLEANING THE OPTICS

Periodically inspect and clean the Vitra Multispot system optics:
Slit lamp optics

The slit lamp lens must be kept clean otherwise performance can be compromised.
Adaptor optics
The reflecting mirror must be kept clean to optimize laser transmission. Output lens and
doctor filter must also be cleaned. After each use, place the dust cover over the slit lamp
to keep all optical surfaces clean.
Required equipment:
- Lint free optical tissues (available from a photographic store)

- Cotton swabs
- Pure or AR grade ethanol or methanol.
Method:
1) Remove dust from the optics with an appropriate lens brush.

2) Moisten the optical tissue or Q-tip in the solvent and gently wipe it across the optical
surfaces in linear strokes. Use a very light pressure to avoid misaligning the mirrors.
Do not wipe the mirrors more than one or two times because excess wiping will only
redistribute the dirt over the optical surface and cause scratches.
3) Use one tissue or one Q-tip per wipe, then discard and use a fresh one for the next
wipe.
CAUTION
Never use dry swabs or tissues to clean an optical surface, as this may damage the surface.
3.3 OPTICAL FIBER & AIMING BEAM INSPECTION

Before beginning a Multispot laser system treatment procedure, check the aiming beam integrity:
it is essential to the laser system safe operation.
WARNING
If the aiming beam is weak (blur / barely or not visible red spot): do not use the laser or delivery
system: the optical fiber may be damaged. Operating the laser without the aiming beam may
result in laser exposure to non-targeted tissue and possible injury. A damaged cable may cause
accidental laser exposure to the treatment room personnel or patient, and/or set fire in the
treatment room. Contact your local distributor or QUANTEL MEDICAL Service Department.
WARNING
When using an optical fiber delivery device, always inspect the optical fiber cable to ensure that it
has not been kinked, punctured, fractured, or otherwise damaged. The optical fiber cable may be
damaged if stepped on, pulled, left lying in a vulnerable position, kinked, or tightly coiled. Do not
clamp the cable with a hemostat or other instruments.
User manual
IV – Maintenance
3.4 CHECKING SPOT MOVEMENT LIMITS

Refer to the following indications to check the spot movement limits:
Preliminary conditions:
Position the focusing bar on the slit lamp.
Position the slit lamp generator at the
center of the oculars.
Switch on the slit lamp, position 8 (longest
slit).
Verify the fiber to laser connection.
When a treatment screen is displayed,
then the laser aiming beam is activated:
project the aiming beam on the focusing
bar.
NOTE
Do not select a multi-spot screen
The aiming beam should be projected on

the focusing bar in the center of the lighted
slit.
The spot movement limits may be

adjusted using the final mirror position.
Spot vertical movement:

± 5mm
Using the micromanipulator, check that the

Focusing bar Spot horizontal aiming beam spot can move likewise in
movement:
± 3mm both horizontal and vertical directions, up
the lighted slit limits.
Aiming beam spot Slit from the slit
lamp generator
WARNING
If this is not the case, you must contact: your
local distributor or QUANTEL MEDICAL
Service Department.
User manual
IV – Maintenance
3.5 AIMING / TREATMENT BEAM COINCIDENCE & PATTERN CHECK UP
WARNING
Wearing appropriate safety glasses is required for all persons present when the laser is in use.
The aiming and treatment Beam (532nm) coincidence should be checked on a regular basis: the
following procedure should be carried out at least every three months or as considered necessary
by the user.
Required materials:
Photographic paper (Kodak linagraph direct printer).
Focal distance adjustment:
1. Attach a photographic paper onto the focusing bar (Fig. 1)
Photographic paper
sheet
Figure 1 - Place the photographic paper in position
2. Turn the slit lamp “ON” to illuminate the paper.

3. Adjust the eyepieces to accommodate the user’s eyes.
4. Adjust the slit width to: “full circle” and “low intensity” illumination.
5. Turn the laser “ON”. Select the S/L adaptor terminal to display the “Single spot” treatment
screen as explained in the:
Vitra Multispot user manual : III – Using the laser system
Section 4.2: S/L adaptor / Single spot treatment screen
The aiming beam is activated.
6. Swing the illumination tower on the side so that it does not obstruct the aiming beam.
7. Adjust the zoom adaptor to 200 μm. Adjust the slit lamp position so that the aiming beam
forms only one clear, well defined spot on the paper attached to the target (focal distance) and
lock the slit lamp in this position.
User manual
IV – Maintenance
Aiming / treatment beam coincidence for a single spot:
8. Switch the laser to “READY” mode.

9. Shoot with minimum power and exposure time. Fire the laser only once to the target paper.
10. Inspect the burn mark through the binoculars to check that the aiming beam spot coincides with
the burn mark.
NOTE
Depending of the photographic type of paper used for the aiming / treatment beam coincidence
checkup: the burn mark might not be clearly distinguished when minimum power has been
used. In this case, power may have to be increased step by step until coincidence can clearly
be checked.
WARNING
In case the aiming beam/treatment beams do not coincide: do not use the system on patients.
Contact your local distributor or QUANTEL MEDICAL Service Department.
Pattern checkup:
11. Exchange the photographic paper for a square target verification paper with the following
dimensions:
Figure 2 - Square pattern verification target
12. Select the “Square pattern” treatment screen as explained in the:

Vitra Multispot user manual: III – Using the laser system
Section 4.3.2.2: Available patterns / B: Square pattern
13. Adjust the zoom adaptor to 500μm (largest spot).
14. Set the parameters: 5x5 square pattern, 500μm zoom and maximum spot spacing (spacing
coefficient = 1.00). (with those settings, the square pattern side distance should be equal to
4,5mm)
15. Verify that the square pattern aiming beam is strictly displayed within the 5mm side target square
(Fig. 2). The pattern must be uniformly distributed within the grey square.
WARNING
In case the pattern spots are not strictly and uniformly distributed within the grey area: DO NOT
use the system on patients. Contact your local distributor or QUANTEL MEDICAL Service
Department.
User manual
IV – Maintenance
4. TERMINAL POWER CALIBRATION

WARNING
The power meter used for calibration should have been calibrated periodically according to the
manufacturer’s recommendations.
WARNING
Do not use Silicone Photocell-type meters.
WARNING
Wearing appropriate safety glasses is required for all persons present when the laser is in use.
WARNING
Only recalibrate the laser system when required by the calibration test result.
4.1 REQUIRED EQUIPMENT:

Ophir laser power meter model DGX 03A P/E, or equivalent (QUANTEL MEDICAL part number:
«XLAAAWATTMETRE»)
4.2 PREPARATION
1) Start the laser by activating the main switch and turning the key to: ’ON’.
2) With an Ophir power meter:
• Select the wavelength (532nm for the Vitra Multispot).
• Set the power meter to operate in “ENERGY” mode.
• Select the caliber corresponding to the energy range delivered by the device.
NOTE
For non-Ophir power meters, set the measurement range as indicated in the power meter
owner’s manual.
3) Direct the optical fiber’s aiming beam into the laser power meter photo detector. Adjust the
distance to obtain a defocused aiming beam spot: it should occupy the largest possible area on
the photo detector sensitive surface. Always ensure that the full diameter of the defocused beam
is striking the active surface of the power meter’s photo detector.
WARNING
A focused beam may damage the photo detector.
4) Select the Vitra Multispot terminal selection screen as explained in the:
Vitra Multispot User Manual: III - Using the laser system
Section 3: Accessing the treatment screen
5) Choose the terminal to calibrate and press >3s on the small letter “C” to access the terminal
calibration screen.
Vitra Multispot terminal selection screen

6) The calibration screen for the chosen terminal is then displayed:
User manual
IV – Maintenance
The calibration is done at:
Power: 500 mW
Exposure time: 1s.
Energy= (Power) x (Exposition).
The nominal value is: 500 mW.

(The Joule meter gives values in mJ)
The allowed maximum power adjustment is ±

20%:
400mW < P < 600 mW.

Vitra Multispot Terminal calibration
screen
4.3 CALIBRATION
1) Protect yourself from any laser reflection. Then, press the footswitch and read the power meter
measurement.
2) Calculate the average over 10 measurements. The standard deviation between power result
values should not exceed ±5%.
3) Set the calibration value to the measured average using buttons:
and
This correction will then be applied to the whole power range.
4) Escape from the calibration menu by selecting:
User manual
IV – Maintenance
5. TOUCH SCREEN CALIBRATION

From the Vitra Multispot unit startup screen, turn the power knob at the front of the unit clockwise
until the following calibration screen is displayed:
Vitra Multispot touch screen calibration screen

NOTE
Read the whole “Touch Screen” calibration procedure before starting the calibration
1) Turn the power knob clockwise until the “GO” message is displayed in the yellow rectangle area.
2) Wait for the first beep: it is the beginning of the calibration procedure.
3) Press ’P’ until the second beep can be heard.
4) Successively press on each of the 4 screen corners. Each time a corner is pressed, repetitive
beeps can be heard: it means the pressure applied to the screen is recognized and validated.
5) To complete the calibration procedure and exit the calibration page, select:
The startup screen.is displayed again.
User manual
IV – Maintenance
6. STATISTICS
The statistic screen displays the Number of shots Vs Power.
To access the
statistic screen,
press on this
area until it is
displayed.
VITRA MULTISPOT startup screen
Statistics screen:
User manual
IV – Maintenance
7. FUSE REPLACEMENT
WARNING
Disconnect the power cord before any intervention on the instrument.
Fuse trap door accessible from on the Vitra Multispot rear panel
Specifications:
Manufacturer: LITTLEFUSE
Model: T4AL 250V P
The fuses must comply with

standard EN 60 127-1
User manual
IV – Maintenance
8. ERROR MESSAGES AND SYMBOLS

The warnings and error messages are displayed in the middle of the screens.
8.1 WARNINGS
Icons and information
Icons Messages Cause Action

Close the remote.
The remote is opened or is
Verify the remote control
Remote interlock improperly closed (door or other
connection located at the back of
safety device).
the unit.
The footswitch is pressed while

Footswitch is activated Release the footswitch.
in “STANDBY” mode.
Check the footswitch connection at

Pedal not connected The footswitch is not recognized.
the back of the unit.
Check the filter’s position.

Doctor’s filter not The doctor’s filter is not
Check the filter connection to the
connected / positioned detected.
Vitra Multispot unit (front panel)
Scan pos Adaptor retraction detection Close the multispot adaptor.
The delivery system terminal is

Fiber disconnected not connected or not correctly Check the optical fiber connection.
connected.
Scanner Error Check the laser connection to the

Multispot adaptor is not detected
Scanner com. error Vitra Multispot unit.
Spot size out of range Adjust the spot size by rotating the
Spot size out of range
Must be >100 and <500 optical zoom
User manual
IV – Maintenance
8.2 ERROR MESSAGES

Icons Messages Cause Action
Release the
The footswitch is pressed out of Footswitch.
Footswitch error a treatment screen. Disconnect the footswitch and
(It could be a short circuit). check that the error message
disappears.
Check the environmental
conditions.
Let the laser “run” until the error
Humidity error The cavity environment humidity
message disappears.
Humidity >80% is over 80%.
If the message persists after 4
hours, contact QM Service
Department.
Hard shoot Shoot out of the normal

Contact QM Service Department.
Call Service sequence
Power detected inside cavity

Power detected Contact QM Service Department.
when not in shooting mode.
Shutter1
Shutter 2
Power Supply Error of hardware Contact QM Service Department.
Init Error
Current Error
The instrument must only be used
The cavity temperature is too within the acceptable temperature
Temperature
high or too low. range: 10°C to 30°C (50°F to
95°F)
Last shot power <20% compared

Call Service Power <20% of the desired
to the expected desired power
Soft P<20% power
Call Service Power >20% of the desired

Hard P>20% power
Call Service Power<50% of the desired

Hard P<50% power
Error Requested pattern cannot be

Scanning error realized.
Error
Scanner motor locked Contact QM Service Department.
scanner
8.3 CALIBRATION ERROR MESSAGES

In case the error message: “N/C” appears in red color in a terminal icon in the Vitra Multispot
Terminal selection screen: it means that the laser terminal is not calibrated.
In case the error message: “Cavity not calibrated” appears in red color in the Vitra Multispot
startup screen: it means the cavity is not calibrated.
In both cases, contact your local distributor or QUANTEL MEDICAL Service Department.
USER MANUAL
V – CLINICAL INFORMATION
APRIL 2016
2012
Directive 93/42/EEC
Tel.: +33 (0) 473 745 745 - Fax: +33 (0) 473 745 700
CONTENTS Rev.
2016
1. VITRA MULTISPOT WITH SLIT LAMP ............................................ 1

1.1. CLASSIC USE (SINGLE SPOT) .................................................................................... 1
1.1.1. INDICATIONS .................................................................................................. 1
1.1.2. APPLICATIONS ............................................................................................... 1
1.1.3. BIBLIOGRAPHY .............................................................................................. 1
1.1.4. ROUTES ........................................................................................................... 1
1.1.5. CONTRAINDICATIONS ................................................................................... 1
1.1.6. ADVERSE EFFECTS ....................................................................................... 1
1.1.7. SETTINGS ........................................................................................................ 2
1.1.8. AIMING BEAM ................................................................................................. 2
1.1.9. PRECAUTION FOR PERSONNEL .................................................................. 2
1.2. MULTISPOT USE................................................................................................. 2
1.2.1. TREATMENT PROCEDURE ........................................................................... 2
1.2.2. WARNINGS ...................................................................................................... 3
2. VITRA MULTISPOT WITH OPERATING MICROSCOPE ................ 4

2.1. INDICATION ............................................................................................................. 4
2.2. APPLICATION .......................................................................................................... 4
2.3. ROUTES .................................................................................................................. 4
2.4. CONTRAIDICATIONS ................................................................................................. 4
2.5. PRECAUTION ........................................................................................................... 4
2.6. ADVERSE EFFECTS .................................................................................................. 4
2.7. SETTINGS ............................................................................................................... 4
2.8. AIMING BEAM .......................................................................................................... 4
2.9. PRECAUTION FOR PERSONNEL ................................................................................. 5
3. VITRA MULTISPOT WITH LASER PROBE DELIVERY SYSTEM... 6

3.1. INDICATIONS ........................................................................................................... 6
3.2. APPLICATION .......................................................................................................... 6
3.3. EFFECTS ................................................................................................................. 6
3.4. PREPARATION ......................................................................................................... 6
3.5. ROUTES .................................................................................................................. 6
3.6. TREATMENT METHOD ............................................................................................... 6
3.7. HAZARDS ................................................................................................................ 7
3.8. SIDE EFFECTS ......................................................................................................... 7
3.9. PRECAUTION ........................................................................................................... 7
3.10. CONTRAINDICATIONS ............................................................................................... 7
4. VITRA MULTISPOT WITH INDIRECT OPHTHALMOSCOPE.......... 8

4.1. INDICATIONS ........................................................................................................... 8
4.2. USE ........................................................................................................................ 8
4.3. APPLICATION .......................................................................................................... 8
4.4. ROUTES .................................................................................................................. 8
4.5. CONTRAINDICATIONS ............................................................................................... 8
4.6. PRECAUTION ........................................................................................................... 9
4.7. ADVERSE EFFECTS .................................................................................................. 9
4.8. SETTINGS ............................................................................................................... 9
4.9. AIMING BEAM .......................................................................................................... 9
4.10. PRECAUTION FOR PERSONNEL ................................................................................. 9
4.11. REFERENCES – INDIRECT OPHTHALMOSCOPE ......................................................... 10
User manual
V – Clinical information
1. VITRA MULTISPOT WITH SLIT LAMP

1.1. CLASSIC USE (SINGLE SPOT)
1.1.1. INDICATIONS
The Vitra Multispot adaptor has its own 50 micron optical fiber that connects directly to the
Vitra Multispot. This adaptation provides the laser beam in the same axis and focal plan as the
slit lamp biomicroscope. This non-contact delivery system also incorporates a zoom; which
can continually adjust the spot diameter from 50 to 500 microns. This zoom is parfocal, which
means that for any spot diameter the zoom focal plan coincides with the biomicroscope focal
plan. 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, focal spot size, and exposure duration. The physiologic effect of the Vitra
Multispot Nd:YAG ophthalmic laser is equivalent to that is produced with common continuous
wave Argon lasers that produce radiation in the 488 - 514 nanometer range.
1.1.2. APPLICATIONS
This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic
conditions including: Diabetic Neovascular Retinopathy, Senile Macular Degeneration, and
Retinal Detachments.
1.1.3. BIBLIOGRAPHY
Marjorie A. Mosier, MD, Jean Champion, BA, BS, Lih-Huei Liaw, MS, and Michael W. Berns,
PhD.
Retinal effects of the Frequency-Doubled (532 nm) YAG Laser: Histopathological
Comparison with Argon Laser
Lasers in Surgery and Medicine 5:377-404 (1985)
Rosario Brancato, Francesco Bandello, Guiseppe Trabucchi and Rosangela Lattanzio. Milano.
Frequency-doubled ND:YAG laser versus argon-green laser photocoagulation in
proliferative diabetic retinopathy
Lasers and light in Ophthalmology vol.4 no.2 pp 97-102 (1991)
1.1.4.ROUTES
The laser treatment beam is directed through the cornea to the target tissue. Accessory
contact lenses which consist of special mirrors and lenses may be used to aid in treatment of
particular targets such as the fundus.
1.1.5.CONTRAINDICATIONS
The following situations, which would prevent visualization of the target tissue are
contraindicated for laser treatment:
Cloudy cornea or extreme haze of the aqueous humor of the anterior chamber.
1.1.6.ADVERSE EFFECTS
The following 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 Watt has
caused tissue vaporization in rabbits. Studies indicate that the Vitra Multispot will have similar
adverse effects compared to continuous wave Argon lasers used at the same settings. No
evidence of non-thermal effects has been observed.
User manual
1.1.7.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:
500 microns spot size, 0, 1 second exposure and 50 milliwatts is a low starting combination.
An efficient shot exposure will typically cause a blanching of target tissue. To produce the
desired effect, exposure duration can be adjusted from 0,01 second to continuous.
1.1.8.AIMING BEAM
Even while low power, the aiming beam is an intense light source and retinal exposure should
be limited to that which is required for target acquisition. Proper aiming is aided by low aiming
beam intensity.
1.1.9.PRECAUTION FOR PERSONNEL

Backscattered radiation is of low intensity but can be dangerous, avoid eye exposure:
Protective eyewear designed for the selected wavelength (532nm) and enough Optical
Density (O.D. 4) should be worn by any person present in the room. For more information,
refer to:
Vitra Multispot user manual: I – Regulatory and safety information
Section 3 3 – Laser safety eyewear and NOHD
WARNING
Federal (US) law states that only a physician may buy this device.
WARNING
Making adjustments, or performing procedures other than those specified in the instruction
manual, can result in hazardous radiation exposure.
1.2. MULTISPOT USE

1.2.1.TREATMENT PROCEDURE
1) Adjust the aiming beam intensity
2) To adjust the laser treatment spot size, the exposure time and the power level required for
treatment: it is compulsory to perform a titrate procedure as explained in the:
Section 4.2.2 – Titrate procedure
3) Then, to access the pattern selection screen: press on the “pattern selection” square in the
middle of the titrate screen:
4) Press on the pattern chosen for treatment:
Pattern selection screen.
5) Adjust spot spacing and rotate and/or resize the pattern as required as explained in the:
Section 4.3.2 – Pattern treatment screen
User manual
6) Focus the slit lamp and observe the red aiming beam on the patient's retina. Verify that the
laser spots are round and that the pattern is undistorted. Establish proper placement of the
laser beam with the slit lamp joystick.
7) Before starting the treatment, verify that all parameters are within pre-defined ranges.
8) Depress the footswitch to deliver power energy. Each footswitch depression will result in one
scanned pattern. Treatment may be interrupted at any point by releasing the footswitch.
1.2.2.WARNINGS
WARNING
It is the responsibility of the physician to select the appropriate power and treatment locations.
WARNING
Early release of the footswitch will terminate the treatment beam before the complete pattern
has been delivered. This results in delivery of a partial pattern. In this case, the pattern can be
completed by delivering burns individually. It is recommended that the full pattern be delivered.
WARNING
DO NOT repeat the pattern on the same target tissue as the pattern will start from the
beginning, resulting in overlapping burns.
WARNING
Intraocular pressure elevations have been reported to occur in up to 53 % of eyes when 360°
of the trabecular meshwork has been treated with 100 spots at the initial session. Intraocular
pressure rises occur most frequently from 1 to 2 hours following laser treatment, although they
may occur several hours afterwards. For this reason, it is imperative to monitor patient
intraocular pressure after laser treatment for up to 24 hours. Peripheral anterior synechiae
may occur when the posterior portion of the trabecular meshwork or other structures, posterior
to the meshwork, are treated. These are best avoided by meticulous delivery of a well-focused
laser beam. Transient corneal epithelial burns have reportedly been resolved within 1 week
without scarring. Endothelial burns are rarely encountered when careful focusing is employed.
Rarely, severe iritis may occur, related to either an unusual patient response or improper spot
location.
WARNING
Laser safety eyewear information provided in the:
User manual
2. VITRA MULTISPOT WITH OPERATING MICROSCOPE

2.1. INDICATION
The Zeiss and Leica operating microscopes adaptors have been specially designed for
physicians who are using those types of operating microscopes in conjunction with a slit lamp.
The only Zeiss model available comes with a slit lamp. The adaptor has its own optical fiber to
connect it directly to the Vitra Multispot. The treatment beam will cause photocoagulation of
pigmented tissues within the eye through the burning action of the laser (532 nm). This effect
can be controlled by varying the parameters of beam power, exposure duration and spot
sizes. The physiological effect of the Vitra Multispot 532 nm ophthalmic laser is equivalent to
the effect produced by common continuous wave Argon lasers producing wavelength in the
488 - 514 nanometer range.
2.2. APPLICATION
This system has the same clinical indications as the slit lamp delivery system, but can be used
on recumbent patients.
2.3. ROUTES
The laser treatment beam is directed through the cornea to the target tissue. The laser is used
in conjunction with a focusing lens. The focusing lens will determine the spot size on the
retina.
2.4. CONTRAIDICATIONS
The following situations prevent visualization of target tissue and are contraindicated for laser
treatment:
 Cloudy cornea or extreme haze of the aqueous humor of the anterior chamber.
2.5. PRECAUTION
The laser beam aiming is dependent upon the three-mirror lens, so the doctor operating the
apparatus should take caution.
2.6. ADVERSE EFFECTS

The following adverse effects may occur as a result of laser treatment:
 Corneal burns and inflammation.
 Transient elevations in intraocular pressure.
Undesirable vaporization and charring of tissue due to excessive combinations of power and
exposure.
2.7. SETTINGS
Select the desired treatment parameters of power, exposure duration, and spot size (from 250
to 500 microns) as required. If unsure of the required setting, select a low power, short
duration, and large spot size. Then increase the power and duration or decrease the spot size
as necessary. 0,1 second exposure and 150mW is a low starting combination. An efficient
exposure will typically cause an immediate blanching of target tissue. Exposure duration can
be adjusted to achieve the desired effect by using the touch screen as required.
2.8. AIMING BEAM

Even while low power, the aiming beam is an intense light source and retinal exposure should
be limited to that which is required for target acquisition. Proper aiming is aided by low aiming
beam intensity.
User manual
2.9. 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: 450 - 532 nm / OD > 3.5;
Reference (EN 207): D 450 - 532 L5
For more information, refer to:

NOTE
A doctor’s filter must be affixed onto the microscope for the both operating physician and
assistant.
WARNING
WARNING
Making adjustments or performing procedures other than those specified in the instruction
User manual
3. VITRA MULTISPOT WITH LASER PROBE DELIVERY SYSTEM

Pre-Sterilized Disposable laser probe for use with the Vitra Multispot laser
Photocoagulator:
DESCRIPTION CODE
Straight laser probes (5) sterile sold for single use (20 Gauges) XLEND20STM
Straight laser probes (10) sterile sold for single use (20 Gauges) XLEND20D
Curved laser probes (5) sterile sold for single use (20 Gauges) XLEND20CSTM
Curved laser probes (10) sterile sold for single use (20 Gauges) XLEND20C
3.1. INDICATIONS
The laser probe has been designed to provide a means for intraocular photocoagulation as an
adjunct to vitrectomy surgery.
3.2. APPLICATION
Specific indications for use of the laser probe include treatment of complicated
rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy,
proliferative diabetic retinopathy, and various retinal vascular tumors.
NOTE
The laser probe should only be used in conjunction with vitrectomy surgery, but should not be
the sole indication for vitrectomy.
3.3. EFFECTS
The instrument causes photocoagulation of the target tissue within the eye through the
thermal action of the laser beam. This effect can be controlled by adjusting the beam power
and exposure duration. The spot size of the treatment burn can be varied from 200 microns to
1000 microns by varying the distance between the probe tip and the target tissue.
3.4. PREPARATION
Put the laser in STANDBY mode. Only the red aiming beam is ON. To attach the probe, first
remove the protective cap, which may be on the laser end of the laser probe.
Screw the fiber connector onto the receptacle (finger tight). If the laser probe is not fully
inserted and screwed into the receptacle, the terminals internal safety shutter will not open
and allow the laser probe to operate. Check for the presence of the red aiming beam at the
laser probe output by directing the tip of the probe’s handpiece towards a diffused target such
as a piece of paper. By pressing the. +. and "-" buttons, adjust the AIMING BEAM INTENSITY.
3.5. ROUTES
The laser probe is inserted into the vitreous cavity through the sclerostomy incision made for
the vitrectomy instruments. No separate incision is necessary.
3.6. TREATMENT METHOD

A single treatment exposure should produce a blanching of the target tissue. To achieve the
desired effect, exposure duration can be adjusted from 0,01 seconds to continuous. Power
settings can be varied from 50 milliwatts up to the desired treatment levels. If unsure what
settings are required, select a low power and short duration and increase each as necessary.
User manual
3.7. HAZARDS
Even while low power, the aiming beam is an intense light source and retinal exposure
(particularly in the macular region) should be limited to that which is required for target
acquisition.
3.8. SIDE EFFECTS

Corneal burns, inflammation, choroidal detachment, and transient elevation of intraocular
pressure can occur as a result of laser treatment. Unintentional retinal burns can occur if
excessive beam power or duration is used.
3.9. PRECAUTION
Backscattered radiation is of low intensity and is not harmful when viewed through the
protective filter. Protective eyewear designed for the emitted wavelength and power density
should be worn by all ancillary personnel.
3.10. CONTRAINDICATIONS
Use of the laser probe is contraindicated except when used in conjunction with vitrectomy.
WARNING
Contents are sterile unless package is opened or damaged. Sterilized with Ethylene Oxide
Gas. Use once and discard. Use only with viewing optics that have been fitted with appropriate
protective filters.
WARNING
Federal (USA) law restricts this device to sale by, or on order of, a physician.
WARNING
The laser probe is a single-use, disposable component. It is shipped prepackage and sterilized
from the factory. It must not be reused or re-sterilized.
WARNING
If reused or re-sterilized, the laser probe may not perform to specifications and sterility may be
compromised. Reuse or re-sterilization of the system probe may jeopardize safe operation and
may nullify your QUANTEL MEDICAL warranty or service contract.
User manual
4. VITRA MULTISPOT WITH INDIRECT OPHTHALMOSCOPE

4.1. INDICATIONS
The indirect ophthalmoscopes adaptations for the Vitra Multispot photocoagulator have been
designed for physicians who are already currently using those types of ophthalmoscopes. The
adaptations are easily removable. They have an integrated non-moving, eye safety filter for
the treating physician. An adaptation has its own 50 microns optical fiber, which is directly
connected to the Vitra Multispot. The burning action of the treatment beam will cause
photocoagulation of pigmented tissues within the eye. This effect can be controlled by varying
the beam power and the exposure duration. The physiologic effect of the Vitra Multispot
Nd:YAG ophthalmic laser is equivalent to that produced with common continuous wave Argon
lasers producing radiation in the 488 - 514 nanometer range.
4.2. USE
The laser’s indirect opthtalmoscope is indicated to be used for:
1) Any eye requiring laser treatment out to the ora serrata.
2) Any eye with rubeosis iridis from central vein occlusion.
3) Any eye undergoing a pneumatic retinopexy retinal reattachment procedures.
4) Any time laser energy must be delivered through any eye with focal lens opacity or with a
small pupil.
5) Laser treatment of the eye with the patient in the supine position.
4.3. APPLICATION
This system has the same clinical indications as the Slit Lamp delivery system, but only when
used for peripheral photocoagulation.
4.4. 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 determines the enlargement of the fundus image; it will also
determine 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
4.5. CONTRAINDICATIONS
The indirect ophthalmoscope should not be used in or near the macula, or in other areas of
the eye where an accuracy of greater than 300μm is required. The Indirect Ophthalmoscope
has instabilities inherent in the aiming beam of the laser that preclude its use in these areas.
The doctor should always hold the viewing lens so that his view of the target is free of
aberrations when the laser is fired. Aberrations can affect the size of the laser spot and will
change the power density delivered to the retina. Aberrations can also produce a non-uniform
power density (or "hot-spots") in the laser spot.
It is recommended that the condensing aspheric lens used to view the retina have a power of
20 diopters. Lenses with powers other than 20D may be used as long as the physician
understands the relationship between hand-held lens power, position-sensitivity of the optical
elements, and final retinal spot size. The condensing lens used with the indirect
ophthalmoscope should be clear and should have an anti-reflective coating. Although
condensing lenses are available with yellow tints to reduce the amount of short wavelength
light which reaches the retina, these tinted lenses should not be used with the indirect
ophthalmoscope because a large percentage of the laser energy is absorbed by this type of
lens.
The indirect ophthalmoscope should not be used if there is blood in the vitreous that obstructs
the view of the retina. If blood is presents, its absorption of laser wavelengths may preclude
User manual
the indirect ophthalmoscope’s use. The following situations prevent visualization of target
tissue and are therefore contraindicated for laser treatment:
Cloudy cornea or extreme haze of the aqueous humor of the anterior chamber.
Laser photocoagulation within the arcades
Albino patients.
4.6. PRECAUTION
Laser beam aiming is dependent upon the doctor’s line of sight.
4.7. ADVERSE EFFECTS

These adverse effects may occur as a result of laser treatment:
Corneal burns and inflammation
Transient elevations in intraocular pressure.
Undesirable tissue vaporization and charring caused by excessive combinations of power and
exposure. The combination of a 200 micron spot, 0,05 second exposure and 0,40 Watt has
caused tissue vaporization in rabbits. Studies indicate that these hazards are no different from
the adverse effects from continuous wave argon lasers used at these same settings. No
evidence of non-thermal effects has been observed.
4.8. 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 from 0,01
second to continuous.
4.9. AIMING BEAM

Even, while at low power, the aiming beam is an intense light source; retinal exposure should
be limited to that required for target acquisition. Proper aiming is aided by a low beam
intensity.
4.10. PRECAUTION FOR PERSONNEL

Backscattered radiation is of low intensity but can be dangerous, so avoid eye exposure.
Protective eyewear designed for the selected wavelength (532nm) and with enough Optical
Density (O.D. 4) should be worn by any person in the room.
WARNING
WARNING
Making adjustments or performing procedures other than those specified in the instruction
User manual
4.11. REFERENCES – INDIRECT OPHTHALMOSCOPE

Friberg T.
Clinical Experience with a Binocular indirect.
Retina 7: 28-31, 1987
Friberg T.
Principles of Photocoagulation using Binocular Indirect Ophthalmoscope Laser
Delivery Systems.
International Ophtalmology Clinics 30(2) : 89-94, 1990.
Friberg T, Eller A.
Pneumatic repair of Primary and Secondary Retinal Detachments Using a Binocular
Indirect Ophthalmoscope Laser Delivery System.

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APRIL 2016

QUANTEL MEDICAL QUANTEL USA MEDICAL UNIT

© 2016 QUANTEL MEDICAL

All rights reserved

1. USER MANUAL DESCRIPTION ............................................................... 1

2. USER MANUAL TERMS AND SAFETY SYMBOLS ................................. 1

3. UNPACKING THE INSTRUMENT ............................................................. 2

4. GENERAL LASER SYSTEM DESCRIPTION ........................................... 5

1. USER MANUAL DESCRIPTION

Each chapter is saved as a .pdf file.

2. USER MANUAL TERMS AND SAFETY SYMBOLS

3. UNPACKING THE INSTRUMENT

Expedition label – Acceptable environmental conditions for

To preserve at dryness. Temperature limits.

Fragile. To preserve safe from the

Consult the instruction

3 Reception of equipment label

CAUTION: If the instrument is at a temperature below 15°C (59°F), switching on the

3.2. PACKING LIST & ACCESSORIES

Basic configuration Codes

Multispot adaptor kit composed of: XLVMSSC

VITRA MULTISPOT laser photocoagulator accessories (list and part number)

4. GENERAL LASER SYSTEM DESCRIPTION

Power supply LED

Key switch Emergency stop Finger positioning

4.2. VITRA MULTISPOT REAR PANEL FUNCTIONS

Fuse trap door

4.3. MULTISPOT ADAPTOR DESCRIPTION

Pattern selection button

o Short mirror for BM models:

o Rising ring for BQ models:

For more information, please refer to the:

1. INTENDED USE AND CONTRAINDICATIONS.................................... 1

3.2. IMPORTANT RECOMMENDATIONS....................................................................... 4

3.3. LASER SAFETY EYEWEAR & NOHD ..................................................................... 5

3.4. PRECAUTIONS TO TAKE CONCERNING WASTES AND ELIMINATION OF DEVICE

1. INTENDED USE AND CONTRAINDICATIONS

• With an indirect ophthalmoscope or a microscope for peripheral photocoagulation for

• With an laser probe- for intraocular retinal photocoagulation as an adjunct to vitrectomy

Protective class I (Main insulation)

3. SAFETY INFORMATION AND PRECAUTIONS

3.1. GENERAL WARNINGS AND SAFETY INFORMATION

3.2. IMPORTANT RECOMMENDATIONS

8. Observe all DANGER, WARNING or CAUTION labels placed on the device:

3.3. LASER SAFETY EYEWEAR & NOHD

3.3.1. SAFETY EYEWEAR

OD = - LOG (EMPE / Power density) = 3.19

L4 @ 532nm (EN 207 Standard).

3.4. PRECAUTIONS TO TAKE CONCERNING WASTES AND ELIMINATION OF

Do not dispose with domestic household wastes!

2. TECHNICAL SPECIFICATIONS ............................................................... 6

3.2. VITRA MULTISPOT LASER INSTALLATION ......................................................... 10

3.5. DOOR SWITCH & EXTERNAL RED LAMP INSTALLATION ................................. 14

Ref. Label Description

General warning sign

"OFF" for a part of equipment

Stand-by or preparatory state for a part of equipment

EMERGENCY STOP label:

1.2. REAR PANEL LABELS

Ref. Labels & Description

Refer to the instruction manual/ booklet

For indoor use only.

Electrical/electronic equipment in accordance with the