DEPISTEO VT1 Series User manual

DEPISTEO VT1
USER MANUAL
VT1 Master GT Edition
VT1 Master Edition
VT1 Essential Edition
V04.07.00
March 2018

V04.07.00
March 2018
Contents
1. Introduction ____________________________________________________________________6
1.1. List of supplied elements__________________________________________________________7
1.2. Presentation _____________________________________________________________________7
1.3. Technical features ________________________________________________________________9
1.4. VT1 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 _________________________________________________________15
2.5. Interpretation of results __________________________________________________________15
3. Equipment and Installation _______________________________________________________16
3.1. Installation procedure____________________________________________________________17
3.1.1. Opening the box ________________________________________________________________________17
3.1.2. Nomenclature __________________________________________________________________________ 17
3.1.3. Connection_____________________________________________________________________________19
3.2. Operating systems_______________________________________________________________20
3.3. Software installation (computerized version)_______________________________________20
3.3.1. PC connection __________________________________________________________________________ 21
3.3.2. Uninstallation __________________________________________________________________________ 21
3.3.3. First run _______________________________________________________________________________21
3.3.1. Test before use _________________________________________________________________________22
3.4. Procedure to stop the device _____________________________________________________22
3.4.1. Software version ________________________________________________________________________22
3.4.2. Essential remote control version ___________________________________________________________22
3.4.3. LCD remote control version _______________________________________________________________22
3.5. Backup/restore __________________________________________________________________22
3.5.1. Presentation___________________________________________________________________________22
3.5.2. Backup _______________________________________________________________________________22
3.5.3. Restore_______________________________________________________________________________23
4. Use __________________________________________________________________________25
4.1. Raise/lower VT1 body ____________________________________________________________26
4.2. Software use ____________________________________________________________________26

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4.2.1. Description of menus ____________________________________________________________________26
4.2.2. Manual mode __________________________________________________________________________ 27
4.2.3. Automatic mode ________________________________________________________________________ 32
4.2.4. Parametering ___________________________________________________________________________ 32
4.2.5. Data base_____________________________________________________________________________ 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. VT1 Essential Edition remote control response forms___________________________________________42
4.4. Master Edition LCD 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. Children phorias test_____________________________________________________________51
5.2.1. Purpose _______________________________________________________________________________ 51
5.2.2. Interpretation limits _____________________________________________________________________51
5.2.3. Definition ______________________________________________________________________________51
5.2.4. Patient instructions ______________________________________________________________________51
5.2.5. Expected responses______________________________________________________________________ 51
5.2. Adult phorias test________________________________________________________________53
5.2.1. Purpose _______________________________________________________________________________ 53
5.2.2. Interpretation limits _____________________________________________________________________53
5.2.3. Definition ______________________________________________________________________________53
5.2.4. Patient instructions ______________________________________________________________________53
5.2.5. Expected responses______________________________________________________________________ 53
5.3. Contrast sensitivity test __________________________________________________________55
5.3.1. Purpose _______________________________________________________________________________ 55
5.3.2. Patient instructions ______________________________________________________________________55
5.4. Astigmatism test ________________________________________________________________56
5.4.1. Purpose _______________________________________________________________________________ 56
5.4.2. Definition ______________________________________________________________________________56
5.4.3. Prerequisite ____________________________________________________________________________ 56
5.4.4. Patient instructions ______________________________________________________________________56
5.4.5. Expected responses______________________________________________________________________ 56
5.4.6. Perception example______________________________________________________________________56
5.5. Depth perception test ____________________________________________________________58

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5.5.1. Purpose _______________________________________________________________________________ 58
5.5.2. Interpretation limits _____________________________________________________________________58
5.5.3. Definition ______________________________________________________________________________58
5.5.4. Patient instructions ______________________________________________________________________58
5.6. Fusion test______________________________________________________________________59
5.6.1. Purpose _______________________________________________________________________________ 59
5.6.2. Definition ______________________________________________________________________________59
5.6.3. Patient instructions ______________________________________________________________________59
5.6.4. Expected responses______________________________________________________________________59
5.7. Age-related macular degeneration (ARMD) / Amsler grid____________________________60
5.7.1. Purpose _______________________________________________________________________________ 60
5.7.2. Definition ______________________________________________________________________________60
5.7.3. Prerequisite ____________________________________________________________________________ 60
5.7.4. Patient instructions ______________________________________________________________________60
5.7.5. Expected responses______________________________________________________________________ 60
5.7.6. Perception examples _____________________________________________________________________ 60
5.8. Color perception test ____________________________________________________________61
5.8.1. Purpose _______________________________________________________________________________ 61
5.8.2. Definition ______________________________________________________________________________61
5.8.3. Prerequisite ____________________________________________________________________________ 61
5.8.4. Patient instructions ______________________________________________________________________62
5.8.5. Interpretation limits _____________________________________________________________________62
5.9. External and central visual field test_______________________________________________63
Definitions ______________________________________________________________________________________ 63
5.9.1. External visual field ____________________________________________________________________ 63
5.9.2. Central visual field _____________________________________________________________________64
5.9.3. Patient instructions_____________________________________________________________________64
5.9.4. Significance of stimuli in the test window__________________________________________________65
5.9.5. Results _______________________________________________________________________________65
5.9.6. Limits_________________________________________________________________________________65
5.10. Glare sensitivity test (Master GT version)________________________________________66
5.10.1. Purpose _______________________________________________________________________________ 66
5.10.2. Principle _______________________________________________________________________________ 67
5.10.3. Operator and patient instructions __________________________________________________________67
5.11. Glare resistance test (Master GT version)________________________________________68
5.11.1. Purpose _______________________________________________________________________________ 68
5.11.2. Principle _______________________________________________________________________________ 68
5.11.3. Patient instructions ______________________________________________________________________68
6. Cleaning and Maintenance _______________________________________________________71
6.1. Removable forehead rest cleaning ________________________________________________72
6.1.1. Remove forehead rest____________________________________________________________________72
6.1.2. Replace forehead rest ____________________________________________________________________72
6.2. Clean the housing _______________________________________________________________72
6.3. Clean the lenses_________________________________________________________________72

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6.4. Clean the peripheral field holes ___________________________________________________72
6.5. Annual service __________________________________________________________________73
6.6. Warranty________________________________________________________________________73
7. What To Do If? _________________________________________________________________74
7.1. No noise when switched on ______________________________________________________75
7.2. Normal switch-on noise but screen light remains grey______________________________75
7.3. Error message appears at recording ______________________________________________75
7.3.1. “Identification incomplete” _______________________________________________________________75
7.3.2. “Operation must use updateable query” _____________________________________________________75
7.4. Patient identification file found but not the tests ___________________________________75
7.5. VT1 light does not come on_______________________________________________________75
7.6. Glare and motor drive seem weak_________________________________________________75
8. Declaration of Conformity ________________________________________________________76

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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:
VT1
External medical power plug
USB lead (for computerized versions only)
VT1 software installation CD with user manual included (for computerized 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
Scoring pad (for remote control versions only)
1.2. Presentation
We recommend reading these instructions thoroughly before use.
This user manual is intended for VT1 operators, whatever the chosen model (VT1 Master GT Edition, VT1 Master
Edition and VT1 Essential Edition).
Only a practitioner can direct a patient to an ophthalmologist in order to confirm the VT1 results obtained. The
ophthalmologist will perform further tests to prescribe visual correction or surgical intervention.
The VT1 is a screening device designed by DEPISTEO for the exploration of visual function. The VT1 currently
operates with two driving modes, depending on the model (refer § 1.4):
Remote control version
Computerized version
Designed for maximum ergonomics, the VT1 is equipped with a detector that detects the position of the
patient’s forehead. Once the patient is correctly positioned, the test begins.
The VT1 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 (dusk light)
Depending on the version, the practitioner can parameter sequences in order to define which tests are to be
performed systematically, depending on needs. The VT1 is equipped with several optical effects and mirrors to
perform near (13in/33cm), intermediate (23.6in/60cm) and far (20ft/6m) vision tests. Tests can also be
performed in monocular or binocular vision. For computerized 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 VT1 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 vol untary 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
Parametering test sequences to customize tests
Performing far, near and intermediate vision tests

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1.3. Technical features
Technical features:
Storage temperature
32 - 122°F (0 –50°C)
Operating temperature
59 - 95°F (15 –35°C)
Humidity
75% maximum
Altitude of operation
<6561.7ft/ <2000m
External power plug
Input: 100-240VAC 50-60Hz 0.6A Output: 12VDC 2.08A (medical class)
Power supply
12VDC from supplied external medical plug (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
19.7x10.6x9.8 in (50x27x25cm)
Weight
10.7 lb/4.850kg
Optical features:
Lighting system
16 white LEDs and diffuser system
Lenses
Far vision: (20 ± 0.3)ft (6.0 ± 0.1)m
Intermediate vision: (23.6 ± 0.2)in (60.0 ± 0.5)cm
Near vision: (13.0 ± 0.1)in (33.00 ± 0.25)cm
Hyperopia lenses: +1 diopter
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 neighboring tests: 700ms
Time to pass from one slide to another: 1sec
Average test time
Routine test: 3 mins
In-depth test: 5 mins

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1.4. VT1 range models
VT1 Master GT Edition
VT1 Master Edition
VT1 Essential Edition
Acuity
Landolt rings



Letters



Children acuity

Supplementary Tests
Glare Sensitivity

Glare Resistance

Contrast Sensitivity


Children Vertical and
Horizontal Phorias

Adult Vertical and
Horizontal Phorias



Fusion



Astigmatism


Depth Perception



Ishihara Type Colors
Test



Amsler Grid



Hyperopia Test



Horizontal and Vertical
Visual Field



Features/ Functions
Distance
Far Vision



Intermediate Vision



Near Vision



Luminosity
High Photopic



Low Photopic



Mesopic (dusk vision)


Operating Mode
Computerized


Remote controlled



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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 authorization of the
manufacturer. Only DEPISTEO After Sales Service and trained distributors are qualified
to work on the equipment
The VT1 should be returned regularly for annual maintenance to DEPISTEO After Sales
Service or your distributor
Use only the leads and power plugs supplied by DEPISTEO
It is highly recommended to store and transport the VT1 at a temperature of 32 - 104°F
(0 - 40°C). 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 VT1 under
running water or spray directly with liquids
If accidentally damaged (fall or shock), send the device to DEPISTEO After Sales Service,
or to your distributor, if trained by DEPISTEO for maintenance
If the device no longer maintains a stable position, or has degraded, return it to
DEPISTEO After Sales Service, or to your distributor, if trained by DEPISTEO for
maintenance
If any elements of the device degrade, the device should be returned for checking, to
DEPISTEO After Sales Service, or to your distributor, if trained by DEPISTEO 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 anesthetic gases
The VT1 remote controls should only be used with the device, and vice-versa
If the device or its accessories degrade visibly, contact DEPISTEO 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 VT1 is reserved for the use of health professionals.
For computerized 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. DEPISTEO
recommends daily back up.
As a reminder to operators, the VT1 software is delivered with a license contract stating the software conditions
of use. This license is granted for installation and use at one work station. All new installations require the
purchase of extra licenses.
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 photosensitizing medication
All persons performing the glare test must be informed of the risks related to certain photosensitizing
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 illnesses requiring photosensitizing medications:
Non-steroidal anti-inflammatories
Antibiotics: Cyclines, Macrolides, Quinolones, Sulphamides
Cardiology –Angiology: Antiarrhythmics, Antihypertensives
Neurology –Psychiatry: Neuroleptics, Antidepressants, Hypnotics, Sedatives
Allergology (anti-histamines)
Metabolism and Nutrition: Oral Antidiabetics, Hypolipidemics
Infectiology, Parasitology: Antituberculosis drugs, Antimalarials, Antileprosy drugs, Systemic antivirals
Cancerology and Hematology
Otorhinolaryngology
Gynecology
Gastroenterohepatology
Rheumatology

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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 comfortable testing.
The patient should be placed in an environment adapted to tests. Ensure there is no intense lighting that may
reflect on the VT1 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 which optotypes the patient is in the process of studying (e.g.
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 VT1 back-lighting, which progressively increases
in intensity so the patient becomes accustomed to the light levels. The operator may drive the VT1 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 VT1 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 VT1 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 VT1 is a screening device for visual problems. Only an ophthalmologist is qualified to confirm VT1
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 VT1 by the handle as indicated below.
We strongly advise conserving all the original packaging of the VT1 for maintenance operations.
3.1.2. Nomenclature
1Body
The VT1 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 VT1 base is ballasted to ensure stability of the instrument however the body is inclined.
The elastomer gum coating prevents the VT1 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 VT1 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 VT1 between the base and the body.
Firstly connect the control leads (USB lead or remote control) then the mains adaptor lead.
Reposition the VT1 to work mode, taking care not to jam the leads.
Plug the mains adaptor into the wall socket.
Caution, for computerized versions:
Do not connect the VT1 to the computer before the software is installed (refer § 3.2).

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3.2. Operating systems
Windows XP, Windows Vista, Windows 7, Windows 8
3.3. Software installation (computerized version)
For computerized versions, the operator must have administration rights on the workstation. From the CD Rom
root directory, run the “SetupVT1.exe” file; not necessary if it is set-up for automatic running.
1. Temporary Welcome Screen
2. Recommendation Screen
3. Enter serial number
from the back of the CD jacket
4. License agreement
5. User information
6. Enter software installation destination
7. Enter database destination
8. Validate Finish