FIM MEDICAL Visiolite Series User manual

User Manual
Visiolite®
Essential
Modulus
Master and Master-GT
V04.02.00
March 2018

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Contents
1. Introduction___________________________________________________________________6
1.1. List of supplied elements__________________________________________________________7
1.2. Presentation _____________________________________________________________________7
1.3. Technical features ________________________________________________________________9
1.4. Visiolite® range models __________________________________________________________10
1.5. Serial number labels _____________________________________________________________11
2. Safety________________________________________________________________________12
2.1. General _________________________________________________________________________13
2.2. Operator ________________________________________________________________________14
2.3. Medical contraindications ________________________________________________________14
2.4. Precautions before tests _________________________________________________________16
2.5. Interpretation of results __________________________________________________________16
3. Equipment and Installation ____________________________________________________17
3.1. Installation procedure____________________________________________________________18
3.1.1. Opening the box _______________________________________________________________________ 18
3.1.2. Nomenclature _________________________________________________________________________ 18
3.1.3. Connection____________________________________________________________________________20
3.2. Operating systems_______________________________________________________________21
3.3. Software Installation (computerised version) ______________________________________21
3.3.1. PC connection_________________________________________________________________________22
3.3.2. Uninstallation__________________________________________________________________________22
3.3.3. First run_______________________________________________________________________________ 22
3.3.1. Test before use________________________________________________________________________23
3.4. Procedure to stop the device _____________________________________________________23
3.4.1. Software version_______________________________________________________________________23
3.4.2. Essential remote control version _________________________________________________________23
3.4.3. LCD remote control version _____________________________________________________________ 23
3.5. Backup/restore __________________________________________________________________23
3.5.1. Presentation___________________________________________________________________________ 23
3.5.2. Backup _______________________________________________________________________________23
3.5.3. Restore_______________________________________________________________________________24
4. Use__________________________________________________________________________26
4.1. Raise/lower Visiolite® body ______________________________________________________27
4.2. Software use ____________________________________________________________________27
4.2.1. Description of menus ___________________________________________________________________ 27

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4.2.2. Manual mode__________________________________________________________________________ 28
4.2.3. Automatic mode _______________________________________________________________________32
4.2.4. Settings_______________________________________________________________________________32
4.2.5. Database _____________________________________________________________________________ 39
4.3. Essential remote control use _____________________________________________________41
4.3.1. Begin a test ___________________________________________________________________________41
4.3.2. Binocular and monocular mode __________________________________________________________ 42
4.3.3. Visual field ____________________________________________________________________________ 42
4.3.4. Standby_______________________________________________________________________________ 42
4.3.5. Essential remote control response forms__________________________________________________42
4.4. Master model LCD screen remote control use______________________________________43
4.4.1. Keys _________________________________________________________________________________44
4.4.2. Forehead presence ____________________________________________________________________44
4.4.3. Begin a test ___________________________________________________________________________44
4.4.4. Choose a mode________________________________________________________________________ 45
4.4.5. Perform a test _________________________________________________________________________ 45
4.4.6. Visual field ____________________________________________________________________________ 45
4.4.7. Standby_______________________________________________________________________________ 45
4.4.8. Remote control response form___________________________________________________________45
5. Tests Description_____________________________________________________________47
5.1. Visual acuity test ________________________________________________________________48
5.2. Contrast sensitivity test __________________________________________________________50
5.2.1. Purpose ______________________________________________________________________________50
5.2.2. Patient instructions_____________________________________________________________________ 50
5.3. Duochrome test _________________________________________________________________51
5.3.1. Purpose ______________________________________________________________________________51
5.3.2. Definition______________________________________________________________________________51
5.3.3. Patient instructions_____________________________________________________________________ 51
5.3.4. Expected responses____________________________________________________________________ 51
5.3.5. Perception example ____________________________________________________________________ 51
5.4. Astigmatism test ________________________________________________________________52
5.4.1. Purpose ______________________________________________________________________________52
5.4.2. Definition______________________________________________________________________________52
5.4.3. Prerequisite ___________________________________________________________________________ 52
5.4.4. Patient instructions_____________________________________________________________________ 52
5.4.5. Expected responses____________________________________________________________________ 52
5.4.6. Perception example ____________________________________________________________________ 53
5.5. Phorias test _____________________________________________________________________54
5.5.1. Purpose ______________________________________________________________________________54
5.5.2. Interpretation limits_____________________________________________________________________54
5.5.3. Definition______________________________________________________________________________54
5.5.4. Patient instructions_____________________________________________________________________ 54
5.5.5. Expected responses____________________________________________________________________ 54
5.6. Depth perception test ____________________________________________________________56
5.6.1. Purpose ______________________________________________________________________________56

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5.6.2. Interpretation limits_____________________________________________________________________56
5.6.3. Definition______________________________________________________________________________56
5.6.4. Patient instructions_____________________________________________________________________ 56
5.7. Fusion test______________________________________________________________________57
5.7.1. Purpose ______________________________________________________________________________57
5.7.2. Definition______________________________________________________________________________57
5.7.3. Patient instructions_____________________________________________________________________ 57
5.7.4. Expected responses____________________________________________________________________ 57
5.8. Age-related macular degeneration (ARMD) / Amsler grid____________________________58
5.8.1. Purpose ______________________________________________________________________________58
5.8.2. Definition______________________________________________________________________________58
5.8.3. Prerequisite ___________________________________________________________________________ 58
5.8.4. Patient instructions_____________________________________________________________________ 58
5.8.5. Expected responses____________________________________________________________________ 58
5.8.6. Perception examples ___________________________________________________________________ 58
5.9. Colour perception test ___________________________________________________________59
5.9.1. Purpose ______________________________________________________________________________59
5.9.2. Definition______________________________________________________________________________59
5.9.3. Prerequisite ___________________________________________________________________________ 59
5.9.4. Patient instructions_____________________________________________________________________ 60
5.9.5. Interpretation limits_____________________________________________________________________60
5.10. External and central visual field test_____________________________________________61
Definitions ______________________________________________________________________________________ 61
5.10.1. External visual field ____________________________________________________________________61
5.10.2. Central visual field _____________________________________________________________________62
5.10.3. Patient instructions_____________________________________________________________________ 62
5.10.4. Significance of stimuli in the test window__________________________________________________63
5.10.5. Results _______________________________________________________________________________63
5.10.6. Limits_________________________________________________________________________________ 63
5.11. Glare sensitivity test (Master-GT version)________________________________________64
5.11.1. Purpose ______________________________________________________________________________64
5.11.2. Principle ______________________________________________________________________________ 65
5.11.3. Operator and patient instructions_________________________________________________________65
5.12. Glare resistance test (Master-GT version)________________________________________65
5.12.1. Purpose ______________________________________________________________________________65
5.12.2. Principle ______________________________________________________________________________ 65
5.12.3. Patient instructions_____________________________________________________________________ 65
6. Cleaning and Maintenance ____________________________________________________68
6.1. Removable forehead rest cleaning ________________________________________________69
6.1.1. Remove forehead rest __________________________________________________________________ 69
6.1.2. Replace forehead rest __________________________________________________________________69
6.2. Clean the housing _______________________________________________________________69
6.3. Clean the lenses_________________________________________________________________69
6.4. Clean the peripheral field holes ___________________________________________________69

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6.5. Annual service __________________________________________________________________70
6.6. Guarantee_______________________________________________________________________70
7. What To Do If? _______________________________________________________________71
7.1. No noise when switched on ______________________________________________________72
7.2. Normal switch-on noise but screen light remains grey______________________________72
7.3. Error message appears at recording ______________________________________________72
7.3.1. “Identification incomplete” _______________________________________________________________ 72
7.3.2. “Operation must use updateable query”___________________________________________________72
7.4. Patient identification file found but not the tests ___________________________________72
7.5. Visiolite® light does not come on _________________________________________________72
7.6. Glare and motor drive seem weak_________________________________________________72

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1.Introduction

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1.1. List of supplied elements
The following elements should be found inside the packaging:
Visiolite®
External medical power plug IEC60601 (reference: GTM41060-2512 GLOBTEK manufacturing, UL
certification: E175861)
USB lead (for computerised versions only)
Visiolite® software installation CD with user manual included (for computerised versions only)
Driver remote control (for remote control versions only)
Cloth for cleaning lenses
Forehead rest
Response forms CD (for remote control versions only)
Information sheet
1.2. Presentation
We recommend reading these instructions thoroughly before use.
This user manual is intended for Visiolite® operators, whatever the chosen model (Essential, Modulus, Master or
Master-GT).
Only a practitioner can direct a patient to an ophthalmologist in order to confirm the Visiolite® results obtained.
The ophthalmologist will perform further tests to prescribe visual correction or surgical intervention.
The Visiolite® is a screening device designed by FIM MEDICAL for the exploration of visual function. The
Visiolite® currently operates with two driving modes, depending on the model (refer § 1.4):
Remote control version
Computerised version
Designed for maximum ergonomics, the Visiolite® is equipped with a detector that detects the position of the
patient’s forehead. Once the patient is correctly positioned, the test begins.
The Visiolite® is designed to progressively adapt the patient to different light levels depending on the type of
test performed. Tests can be performed on three light levels:
High photopic
Low photopic
Mesopic
Depending on the version, the practitioner can parameter sequences in order to define which tests are to be
performed systematically, depending on needs. The Visiolite® is equipped with several optical effects and
mirrors to perform near (33cm/13inches), intermediate (60cm/23.6inches) and far (5m/16.4ft) vision tests.
Tests can also be performed in monocular or binocular vision. For computerised versions, results are recorded
directly onto the computer. For remote control versions, results are recorded on response forms.
Innovative solutions have considerably reduced the weight of the device and expanded the range of available
tests requiring no operator manipulation of the device. The device also integrates the latest high technology: a
lighting principle that preserves slide quality over time.

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The Visiolite® offers the following assets:
Compact size
Light-weight equipment
Portability
Ergonomic use
Quick testing
Programming and automation to create test sequences according to patient risk
Elimination of yellowing of slides
Optimization of computer connectivity
Option of performing several visual acuity tests to avoid voluntary or involuntary memorizing of
optotypes
Device set-up for vehicle-driver tests
Performing visual tests with corrective or progressive lenses
Performing tests in low photopic light for photo-sensitive patients
Creating/modifying test sequences
Performing far, near and intermediate vision tests

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1.3. Technical features
Technical features
Storage temperature
0 - 50°C (32 - 122°F)
Operating temperature
15 - 35°C (59 - 95°F)
Humidity
75% maximum
Altitude of operation
< 2000m (6561.7ft)
External power plug
Input: 100-240VAC 50-60Hz 0.6A Output: 12VDC 2.08A (medical class)
Power supply
12VDC from an external power medical supply (refer § 1.1)
Power absorbed
24W
Standard
EN 60601-1, EN 60601-1-2
Medical class
Class I
Applied part
Type B
Marking
CE
Dimensions
50x27x25 cm (19.7x10.6x9.8 inches)
Weight
4.850 kg (10.7lb)
Optical features
Lighting system
16 white LEDs and diffuser system
Lenses
Far vision: (5.0 ± 0.1)m (16.4 ± 0.3)ft
Intermediate vision: (60.0 ± 0.5)cm (23.6 ± 0.2)inches
Near vision: (33.00 ± 0.25)cm (13.0 ± 0.1)inches
Hyperopia lenses: +1 dioptre
Lighting conditions (nominal
values)
High photopic (160 candelas)
Low photopic (80 candelas)
Dusk mesopic (3 candelas)
Conform to NF EN ISO 8596 standard
Test features
Reactivity
Time between 2 neighbouring tests: 700ms
Time to pass from one slide to another: 1 sec
Average test time
Routine test: 3 mins
In-depth test: 5 mins

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1.4. Visiolite® range models
ACUITY TESTS
ESSENTIAL
MODULUS
MASTER
Landolt rings
•
•
•
Numbers
•
•
Letters
•
•
•
Low vision letters
•
•
SUPPLEMENTARY TESTS
Astigmatism
•
•
•
Red/green duochrome
•
•
•
Depth perception
•
•
Vertical and horizontal
phorias
•
•
•
Fusion
•
Ishihara type colours test
•
•
•
Amsler grid
•
•
Contrast sensitivity
•
Hyperopia test (+1dioptre)
•
•
•
Horizontal et vertical visual
field
•
•
•
Glare sensitivity
• (GT option)
Glare resistance
(educational test)
• (GT option)
DISTANCES
Far vision 5m/16.4ft
•
•
•
Intermediate vision
60cm/23.6inches
•
•
Near vision
33cm/13.0inches
•
•
•
LIGHTING
High photopic
•
•
•
Low photopic
•
•
Mesopic (night vision)
•
•
DRIVER MODE
Computer
•
•
Remote control
•
•

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1.5. Serial number labels
Serial number labels display the following information:
CE marking Directive 93/42/EEC
Type B applied part
The device should not be discarded with general household waste. Return it to the
manufacturer for disposal
Consult the accompanying documents
SN
Serial number
Manufacturer identification

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2.Safety

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2.1. General
CAUTION:
Never dismantle or interfere with the device without the authorisation of the manufacturer. Only
FIM MEDICAL After Sales Service and trained distributors are qualified to work on the equipment
The Visiolite® should be returned regularly for annual maintenance to FIM MEDICAL After Sales or
your distributor
Use only the leads and power plugs supplied by FIM MEDICAL
It is highly recommended to store and transport the Visiolite® at a temperature of 0 -40°C (32 -
104°F). If a change in atmospheric conditions occurs, wait a while until there is no condensation on
the optics before using the device
Do not expose the device to vibrations or excessive shocks
Do not wet the device. Protect it from all liquid projections. Never wash the Visiolite® under running
water or spray directly with liquids
If accidentally damaged (fall or shock), send the device to FIM MEDICAL After Sales Service, or to
your distributor, if trained by FIM MEDICAL for maintenance
If the device no longer maintains a stable position, or has degraded, return it to FIM MEDICAL After
Sales Service, or to your distributor, if trained by FIM MEDICAL for maintenance
If any elements of the device degrade, the device should be returned for checking, to FIM MEDICAL
After Sales Service, or to your distributor, if trained by FIM MEDICAL for maintenance
Repetitive visual defects appearing in every patient should signal a possible problem with the device
The device should not be used in the presence of anaesthetic gases
The Visiolite® remote controls should only be used with the device, and vice-versa
If the device or its accessories degrade visibly, contact FIM MEDICAL After Sales Service or your
distributor
The device should sit on a flat and stable surface
If a multi-adaptor is used, no other electrical device or multi-adaptor should be connected to the
device
The device should be positioned so as to leave the power plug free, in case of emergency

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2.2. Operator
The Visiolite® is reserved for the use of health professionals.
For computerised versions, the operator must be trained in the basic rules of computers and shall take all
precautions against the risk of software pirating, disclosure of confidential data, viral attacks or incorrect
handling.
Particular care shall be taken to back up recorded data as often as possible, on a reliable support. FIM MEDICAL
recommends daily back up.
As a reminder to operators, the Visiolite® software is delivered with a licence contract stating the software
conditions of use. This licence is granted for the installation and use at one work station. All new installations
require the purchase of extra licences.
2.3. Medical contraindications
Patients suffering from the following medical contraindications are not permitted to perform vision tests:
General contraindications: photosensitive persons should not perform screening tests in high photopic
Contraindications related to glare: all photosensitising medication
All persons performing the glare test must be informed of the risks related to certain photosensitising
medication. Ensure the patient does not suffer from the following pathologies (non-exhaustive list):
albinism
cystinosis
keratoconjunctivitis
surgery
inflammation
traumatism
Ensure the patient has not undergone refractive surgery less than three months previously.
Example of list (non-exhaustive) of photosensitising medications in France (see next page).

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Non-steroidal anti-inflammatories
Antibiotics
Cardiology - Angiology
Neurology - Psychiatry
Acide tiaprofénique
Artotec (Diclofenac)
Cyclines
Antiarrhythmic
Neuroleptics
Brexin
Doxy (Doxycycline)
Amiodarone
Largactil
Butazolidine
Doxycycline
Bi-tildiem (Diltiazem)
Modecate
Cycladol
Granudoxy (Doxycycline)
Corbionax (genAmiodarone)
Moditen
Diclofenac
Lysocline
Cordarone (Amiodarone)
Neuleptil
Feldene
Mestacine (Minocycline)
Deltazen (Diltiazem)
Nozinan
Ketoprofene
Minocycline
Diacor (Diltiazem)
Tercian
Ketum (ketoprofene)
Minolis (Minocycline)
Dilrene (Diltiazem)
Trilifan
Indocid (Indométhacine)
Mynocine
Diltiazem
Zyprexa
Indocollyre (Indométhacine)
SpanorGén (Doxycycline)
Monotildiem (Diltiazem)
Inflaced
Tetralysal
Serecor
Antidepressants
Mobic
Tolexine (Doxycycline)
Tildiem (Diltiazem)
Floxyfral (Flutamide)
Nabucox
Vibramycine (Doxycycline)
Naprosyne (Naproxène)
Antihypertensives
Hypnotics
Nifluril Gélule
Macrolides
Co-renitec
Noctran
Piroxicam (ketoprofene)
Disulone
Furosemide
Theralene
Profenid (ketoprofene)
Pediazole
Korec (Quinaprilchlorhyd.)
Proxalyoc (Piroxicam)
Zithromax
Koretic (Quinaprilchlorhyd.)
Sedatives
Surgam
Lasilix (Furosemide)
Mépronizine (Méprobamate)
Topfena (ketoprofene)
Quinolones
Logimax
Tegretol
Voldal
Ciflox
Logroton
Voltarene (Diclofenac)
Decalogiflox
Moducren
XenidGén (Diclofenac)
Enoxor
Moduretic
Zofora
Logiflox
Moex
Monoflocet (Ofloxacine)
Piportyl
Negram Forte
Prestole
Noroxine
Prinzide
Pipram fort
Renitec
Uniflox
Sulphamides
Adiazine
Allergology (anti-histamines)
Metabolism and Nutrition
Infectiology, Parasitology
Cancerology and Haematology
Algotropyl (Promethazine)
Oral Antidiabetics
Antituberculosis drugs
Eulexine (Flutamide)
Istamyl
Amarel
Adiazine (Sulfamide)
Flutamide
Fluisedal (Promethazine)
Daonil
Rifater (Rifampicine)
Prostadirex (Flutamide)
Phenergan (Promethazine)
Hémidaonil
Primalan
Minidiab
Antimalarials
Otorhinolaryngology
RhinathiolPromethazine
Quinimax (Pipotiazine)
Oflocet (Ofloxacine)
Theralene
Hypolipidemics
Quinine
Toplexil
Lipanor
Savarine
Gynaecology
Apaisyl
Lodales
Duphaston (Dydrogestérone)
Zocor
Antileprosy drugs
Lamprene (Clofazimine)
Gastroenterohepatology
Disulone
Dipentum
Systemic antivirals
Rheumatology
Cymevan
Neuriplege
Zelitrex
Quinisedine

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2.4. Precautions before tests
The device operates on the basis of binocular fusion. The operator must ensure the patient has adequate fusion
to perform the test. Before all tests, the operator should ask the patient if he or she generally wears glasses or
contact lenses. Photosensitive patients may perform the tests in low photopic, for more comfort during the
tests.
The patient should be placed in an environment adapted to tests. Ensure there is no intense lighting that may
reflect on the Visiolite® optics, particularly for the glare test, where strong lateral light sources would disrupt the
test. Do not place the device near a window. For the glare test, the user must inform the patient of the test
procedure. During the test, always explain to the patient which optotypes he or she is in the process of studying
(eg: number of lines, letters, etc.).
The medical personnel must ensure the patient is calm when performing the test and that he or she has
understood the aim of the screening. The operator controls the Visiolite® back-lighting, which progressively
increases in intensity to enable the patient to become accustomed to the light levels. The operator may drive
the Visiolite® in low photopic for patient comfort. The operator should ensure the patient leaves the room
safely after performing the glare test (no visual problems, headache or fatigue).
2.5. Interpretation of results
Patient results should always be accompanied by an explanation from the practitioner
The Visiolite® may not be used for medical treatment. It can under no circumstances be used as the
basis for medication prescriptions, pre- or post-surgical diagnoses, or any other type of prescription
The Visiolite® may not be used to determine the aptitude of an individual to perform a certain task. This
can only be established by the doctor responsible for the tests, in conjunction with other medical
expertise
The Visiolite® is a screening device for visual problems. Only an ophthalmologist is qualified to confirm
Visiolite® results, in conjunction with other tests, to prescribe correction or surgical intervention

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3.Equipment and Installation

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3.1. Installation procedure
3.1.1. Opening the box
After removing the compartment containing the accessories, lift the Visiolite® by the handle as indicated below.
We strongly advise conserving all the original packaging of the Visiolite® for maintenance operations.
3.1.2. Nomenclature
1 Body
The Visiolite® body contains all the functional elements.
2Mask
Far and near vision lenses are integrated into the mask, which is adapted to the average patient morphology.
3Base
The Visiolite® base is ballasted to ensure stability of the instrument whatever the inclination of the body.
The elastomer gum coating prevents the Visiolite® slipping, and avoids scratching the table surface.
2
1
3

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Face mask
1Far vision lenses
2Near vision lenses
3Removable forehead rest piece
A removable elastomer piece is positioned on the forehead rest. An electro-sensitive sensor indicates the
patient’s forehead is in contact with the forehead rest, via a Visiolite® light display. When the forehead is
correctly positioned on the forehead rest, the patient should not feel any discomfort.
4Peripheral field
A number of small holes are visible around the lenses. These light guides are for the visual peripheral field test.
5Nose position
Back –Connection support
1RS232 connector lead or remote control
2 USB lead
3Power supply
3
1
2
4
5
3
2
1

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3.1.3. Connection
Incline the device to the connection position.
Thread the leads via the back of the Visiolite® between the base and the body.
Firstly connect the control leads (USB lead or remote control) then the mains adaptor lead.
Reposition the Visiolite® to work mode, taking care not to jam the leads.
Plug the mains adaptor into the wall socket.
Caution, for computerised versions:
Do not connect the Visiolite® to the computer before the software is installed (refer § 3.2).