OCULUS Mesotest II User manual

OCULUS Mesotest II
INSTRUCTION MANUAL
Examination of mesopic vision and glare sensitivity

i / v Instruction Manual Mesotest II (G/62800/0715/en)
Notes on this Instruction Manual
To ensure safe operation, it is essential that you use the device correctly.
For this reason you should familiarize yourself thoroughly with the
contents of this instruction manual before operating the device. In
particular, pay attention to the safety instructions.
The Mesotest II is used for testing the mesopic visual acuity of the human
eye.
Due to ongoing development, the diagrams shown may depict minor
changes to the actual device delivered.
If you have any queries or would like additional information about your
device, do not hesitate to call or send us a mail or a fax. Our service team
will gladly assist.
OCULUS is certified according to DIN EN ISO 13485, setting high stan-
dards of quality for the development, manufacture, quality assurance and
service of the entire range of products.

Instruction Manual Mesotest II (G/62800/0715/en) ii / v
Table of Contens
1 Scope of Delivery.........................................................................................................................1
2 Graphic Symbols on the Equipment ......................................................................................2
3 Information about the Documentation ................................................................................2
3.1 Structure of the Documentation................................................................................2
3.2 Software Version ............................................................................................................3
4 Safety Instructions......................................................................................................................3
4.1 About this Manual .........................................................................................................3
4.1.1 Used Graphic Symbols.................................................................................4
4.2 Safety Instructions for Use..........................................................................................4
5 Intended Use.................................................................................................................................8
6 Device Description ......................................................................................................................9
6.1 Mesotest II Functionality .......................................................................................... 11
6.2 Twilight (Mesopic) Vision.......................................................................................... 14
7 Initial Operation ....................................................................................................................... 16
7.1 Before Initial Operation............................................................................................. 16
7.2 Information About the Room in which the Device is Set Up ......................... 16
7.2.1 Insert Cover ................................................................................................. 17
7.3 Set up and Connection .............................................................................................. 17
7.4 Software Installation.................................................................................................. 19
7.5 Switching the Device On and Off ........................................................................... 19
8 Before Conducting the Examination .................................................................................. 20
8.1 Prepare the Unit for Routine Operation................................................................ 20
8.2 Prepare the Patient for the Examination.............................................................. 20
8.2.1 Patient Adaptation.................................................................................... 21
9 Examination Using the Control Pad.................................................................................... 22
9.1 Control Pad.................................................................................................................... 22
9.2 Filling In the Test Sheet............................................................................................. 25
9.2.1 Starting the Examination ........................................................................ 25
9.3 Test Mesopic Vision .................................................................................................... 26
9.4 Test Mesopic Vision With Glare .............................................................................. 26
9.4.1 Test for Night Myopia (optional)........................................................... 27
9.4.2 Monocular Examinations (optional)..................................................... 27
10 Conducting the Examination with a Computer/Laptop................................................ 28
10.1 Using the Examination Menu .................................................................................. 28
10.1.1 View the Patient’s Information and Enter any Visual Aid.............. 29
10.1.2 Marking the Results in the Test Image Display................................. 30
10.1.3 Present the Next Optotype ..................................................................... 30
10.1.4 Swing in Minus Lenses............................................................................. 31
10.2 Change Settings........................................................................................................... 31
10.3 Conduct the Examination ......................................................................................... 36

iii / v Instruction Manual Mesotest II (G/62800/0715/en)
10.3.1 Starting Patient Data Management..................................................... 37
10.3.2 Entering a New Patient............................................................................ 38
10.3.3 Selecting an Existing Patient ................................................................. 38
10.4 Select and Start Exam................................................................................................ 39
10.4.1 Conduct the Programm "Mesopic vision bin".................................... 40
10.4.2 Conduct the Programm "Mesopic vision mono"............................... 42
10.4.3 Test for Night Myopia (optional)........................................................... 44
10.5 Display and Print Results........................................................................................... 45
10.6 Finishing the Exam...................................................................................................... 46
10.7 Load Existing Examination........................................................................................ 46
11 Editing the Examination Programmes................................................................................ 47
11.1 Compilation of a Custom Selection List of Examinations ............................... 47
11.2 Create A New Examination Programme ............................................................... 48
11.3 Edit Examination Programme .................................................................................. 51
12 Patient Data Management .................................................................................................... 52
12.1 Rename Patient Data ................................................................................................. 52
12.2 Exporting Patient Data .............................................................................................. 53
12.3 Importing Patient Data.............................................................................................. 54
12.4 Data Backup.................................................................................................................. 55
12.4.1 Backup data................................................................................................. 56
12.4.2 Reconstruct data........................................................................................ 56
12.4.3 Automatic backup ..................................................................................... 57
12.5 Change settings ........................................................................................................... 57
12.5.1 "Main" tab ................................................................................................... 58
12.5.2 "Devices" tab............................................................................................... 60
12.5.3 "Import/Export" tab................................................................................... 62
12.5.4 "Email" tab................................................................................................... 64
12.5.5 "Interface" tab ............................................................................................ 65
12.5.6 "Smartcardreader" tab.............................................................................. 66
12.5.7 "Misc" tab .................................................................................................... 67
12.5.8 "Hecht" and "DICOM" tabs...................................................................... 68
13 Cleaning, Disinfection and Maintenance .......................................................................... 68
13.1 Unplug the Equipment............................................................................................... 68
13.2 Cleaning ......................................................................................................................... 69
13.3 Disinfection ................................................................................................................... 69
13.4 Care and Maintenance............................................................................................... 70
13.4.1 Exchange Viewer Enclosure .................................................................... 71
13.4.2 Replacing the Fuse .................................................................................... 72
13.4.3 Change the Lamp at the Panel Illumination...................................... 73
14 Troubleshooting........................................................................................................................ 74
15 Transport and Storage ............................................................................................................ 75
15.1 Transport and Storage Information........................................................................ 75
15.2 Disassembly and Packing .......................................................................................... 76

Instruction Manual Mesotest II (G/62800/0715/en) iv / v
16 Disposal....................................................................................................................................... 76
17 Terms of Warranty and Service............................................................................................ 77
17.1 Liability for proper function or damages.............................................................. 77
17.2 Address of the manufacturer and service department..................................... 78
18 Declaration of Conformity.....................................................................................................79
19 Technical Data .......................................................................................................................... 80
20 Appendix..................................................................................................................................... 82
20.1 Electromagnetic Compatibility................................................................................ 82
20.2 Guidance and Manufacturer’s Declaration -
Electromagnetic Emmisssions for the Mesotest II............................................. 83

v / v Instruction Manual Mesotest II (G/62800/0715/en)

1 Scope of Delivery
Instruction Manual Mesotest II (G/62800/0715/en) 1 / 86
1 Scope of Delivery
We reserve the right to change the scope of delivery in line with ongoing
technical development.
If you find transport damage upon delivery, immediately file a claim
with the transport company.
Have the damage confirmed on the bill of lading so that an orderly
handling of the complaint for damages is possible.
Keep the packaging in a safe place. You can then ship or transport
the unit in the proper manner for any servicing or repairs that may
arise. You can thus avoid unnecessary damage and costs.
Components Order Number
Mesotest II
or
Mesotest II konkav (minus lenses can be
swung in), with eye occluder
62800
62801
Mains cable 05200320
Test block (100 sheets) 62850
Dust protection cover 026010005001
Cover for back pane of the viewer 016280000002
Instruction Manual Mesotest II G/62800/xxxx/en
Optional:
Control pad with LCD module and
panel illumination
62811
Software module for Windows®-
compatible computers for patient data
acquisition and for control of the Mes-
otest II, incl. interface cable, USB 2.0
adapter and floating license key
62803
Carrying bag 62802

2 Graphic Symbols on the Equipment
2 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
2 Graphic Symbols on the Equipment
3 Information about the Documentation
3.1 Structure of the Documentation
A folder containing a set of documentation is supplied with your Mesotest
II:
Instruction Manual: The design of the unit is described in detail in
this document. The instruction manual also gives you general infor-
mation about working with the Patient Data Management system
and all safety-related instructions for use of the Mesotest II.
Software Installation: The introduction to the Software Installation
describes how to install the Mesotest II software and the associated
drivers.
If you work with a floating license key, the respective instruction manual
explains how you can use the Mesotest II within a network.
1 Company logo + address 7 Protection class
2 Applied part, type B 8 Fuses
3 CE 9 Voltage, frequency
4 Disposal with household waste is
prohibited
10 Electric energy consumption
5 Matrix 11 Serial number of the device
6 Follow operating instructions 12 Device name, Article number
Fig. 2-1: Figure legend
1
8
3
6
10
5
7
9
11
12 2
4

4 Safety Instructions
Instruction Manual Mesotest II (G/62800/0715/en) 3 / 86
3.2 Software Version
The instruction manual describes the following versions of the Mesotest
II software as well as the Patient Data Management system:
Laptop/Computer:
Mesotest II software: Version 1.0.4.x
Patient Data Management Version 6.08
☞
Note:
The Patient Data Management software version is displayed on the
„Settings“ screen within the Patient Data Management (sec. 12.5,
page 57).
The software version of the Mesotest II programme is shown on the
“Change Settings” screen within the Mesotest II programme
(fig. 10-11, page 35).
4SafetyInstructions
4.1 About this Manual
Carefully read through the Instruction Manual.
Keep the Instruction Manual in good condition near the device.
If the scope of delivery includes a netbook: Read the operating
manual for the netbook.
Observe the legal regulations with regard to accident prevention.

4 Safety Instructions
4 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
4.1.1 Used Graphic Symbols
Attention
Denotes a potentially hazardous situation which can easily result in minor
physical injury or property damage.
Note:
Identifies situations which can result in property damage, or denotes
application information and useful or other important information.
☞
Identifies important information about the product and its use, which
require special attention.
4.2 Safety Instructions for Use
Attention
Personal injury or property damage due to improper operation
Observe the following safety instructions.
Personal injury or property damage due to equipment modifications that
could jeopardize safety
This equipment may not be modified without the permission of the
manufacturer.
>This symbol denotes menu paths and screen shots. Example for
starting an examination:
Mesotest II > Examination > Load
which means:
Select the “Examination” menu from the menu bar.
Select the menu item “Load”.

4 Safety Instructions
Instruction Manual Mesotest II (G/62800/0715/en) 5 / 86
Instructions for operating personnel
Make certain that the Mesotest II is used exclusively by personnel
that have the training and practical experience to safely and
properly operate the equipment.
Transport and storage instructions
Refer to the notes in sec. 15, page 75.
Instructions for setup and connection
Do not use or store the Mesotest II in rooms that are humid.
Keep the Mesotest II away from water that may drip, surge or splash
on it, and make sure that no liquids can enter the Mesotest II. Do not
place any containers holding liquids in the vicinity of the Mesotest II.
Germany: Only operate the Mesotest II in rooms used for medical
purposes after they have been set up according to the VDE
Regulations 0100-710.
Do not operate the equipment included in the packing list in
explosive environments, in the presence of combustible narcotic
agents or volatile solvents such as alcohol, benzene, etc.
Make sure that the electrical plug of the Mesotest II is easily
accessible so that it can be unplugged easily.
Do not use excessive force when connecting the electrical plug.
If a connection is not possible, check whether the plug fits the jack.
If you find damage to the plug connector, have the damage correct-
ed by our service department.
Information about patient environment
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment.

4 Safety Instructions
6 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Use devices in the patient environment which are in conformity with the
IEC 60601-1 standard. If you use a multiple socket extension cord or a
device which do not comply with the IEC 60601-1 standard, use an
isolation transformer
Instrutions to us a ME system
The Mesotest II and a connected computer are a medical electrical system
(ME system) according to DIN EN 60601-1. If you want to connect further
devices, for example a printer, these devices will be part of the ME system.
Make sure that all devices of the ME system are in accordance with
IEC 60601-1 or IEC 60950-1.
Abb. 4-1: Patient environment

4 Safety Instructions
Instruction Manual Mesotest II (G/62800/0715/en) 7 / 86
Instructions for operation
Never put a damaged Mesotest II into operation.
Only operate the Mesotest II using original accessory parts supplied
by us, and when the device is in technically perfect working order.
Before initial operation: Let OCULUS or an authorized dealer train
you in the operation of the Mesotest II.
Only operate the equipment after you have read and understood the
Instruction Manual.
Do not touch the patient and the device at the same time.
Make sure that the device cannot tip over by leaning against it or
sitting on it.
Do not cover the ventilation openings.
Instructions for maintenance
To ensure satisfactory and reliable operation, we recommend that you
have the Mesotest II checked every two years by our service department
or an authorized dealer. If an error occurs which you are unable to correct,
label the Mesotest II as “out of order” and contact our service department
or an authorized dealer.
Instructions for disassembly and disposal
When disconnecting electrical connections, pull on the respective
plug instead of the cable itself.
Dispose of the equipment in compliance with the corresponding
legal requirements.
Note on electrical safety
Attention
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Mesotest II with non-medical electrical equipment (for
example data processing equipment) to a medical electrical system must
not result in a patient safety level below that prescribed by DIN EN ISO
60601-1. If making this connection leads to the leakage current threshold
being exceeded, protective measures including a circuit breaker must be
in place.
Ensure that connections with non-medical devices are made
correctly.
Use only a computer that meets the specifications given in this
instruction manual, sec. 19, page 80.

5 Intended Use
8 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Attention
Use of a multiple socket extension cord
Risk of personal injury or material damage caused by unsafe multiple
socket extension cord
If you are using a multiple socket extension cord to connect the Mesotest
II to the power supply, you must heed the following information:
Use an extension cord strip that complies with the requirements of
DIN EN ISO 60601-1: 20005, section 16.
Do not place the multiple socket extension cord on the floor.
Do not use more than one multiple socket extension cord.
Plug only the Mesotest II and the computer that is being used with
the unit (if applicable) into the multiple socket extension cord.
If you are using a multiple socket extension chord it has to be supplied
with a isolation transformer.
If you are using a new computer for the Mesotest II:
Check the electrical safety. Call OCULUS Service for this purpose.
Electromagnetic Compatibility (EMC) / cables
Risk of personal injury or damage to property due to electromagnetic in-
terference
Portable and mobile RF communications equipment can affect medical
electrical equipment sec. 20, page 82.
Make sure that portable and mobile RF communications equipment
do not cause interference.
Recommendation: Maintain a minimum distance of 4 m. If the
distance is shorter, you must ensure that the Mesotest II functions
correctly.
5 Intended Use
The Mesotest II is intended for the use described in this Instruction
Manual.
The Mesotest II is used for testing the mesopic visual acuity of the human
eye.
Heed the safety instructions listed above.
Contraindication
None known

6 Device Description
Instruction Manual Mesotest II (G/62800/0715/en) 9 / 86
6 Device Description
,
1 Viewer enclosure 4 Yoke spring
2 Device viewer 5 Air vents
3Housing
Fig. 6-1: Front view of the Mesotest II
3
1
5
4
2

6 Device Description
10 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
1 Back of the viewer with grey pane 5 Serial interface port
2Housing 6On/Offswitch
3 Control pad 7 Nameplate
4 Device plug with fuse holder
Fig. 6-2: Back view of the Mesotest II
2
3
1
654
7

6 Device Description
Instruction Manual Mesotest II (G/62800/0715/en) 11 / 86
6.1 Mesotest II Functionality
Description
The Mesotest II is a PD-independent, freespace instrument for testing
mesopic vision and glare sensitivity.
Freespace means that the tests are conducted under natural visual
conditions in an open space.
The device myopia is more or less eliminated, as the eyes accommodate
and converge in the same way as for natural vision.
The flexible viewer enclosure facilitates relaxed viewing and provides an
optimal fit for every patient. The enclosure completely shuts out all
extraneous light, thus allowing correct examinations to be conducted,
even in just moderately dark room conditions.
The air vents in the enclosure prevent the patient’s glasses or the unit’s
viewer glass from fogging.
Use
In Germany: The Mesotest II is used for testing mesopic vision and glare
contrast sensitivity as required by driver’s license issurance regulations
and it meets the requirements of DIN 58220, Part 7.
Testing of mesopic vision and glare contrast sensitivity is an important
supplement to photopic vision testing, especially for the assessment of
night driving ability. Pre- and post-operative testing of the mesopic vision
and glare sensitivity of patients with intraocular lenses, or those who
have undergone refractive surgery is recommended, as well as for
prescription of tinted lenses.
The device is dimensioned such that the patients’ differing inter-pupillary
distance does not affect the results.
Setup
The focussing screen of the test field is viewed through a lens via a
semi-reflector viewer mirror. The optotypes are presented in front of this
focussing screen. Their virtual image appears 5 meters away from the eye.
The optotypes are vapour-deposited on a glass substrate.
The glare light is located at the left of the test field at a visual angle of
3°. Depending on the test that has been selected, this is activated
automatically.
The glare light simulates the glare situation of an oncoming vehicle with
dimmed headlights. The glare illuminance at pupil level is 0.35 lux.
White light emitting diodes are used as the light source. It is thus
unnecessary to change lamps
The ambient light and the glare light are illuminated separately by one
light emitting diode each.

6 Device Description
12 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Controls
You can operate the Mesotest II either via the control pad or via a
computer/laptop.
Control Pad: The integrated panel illumination allows testing to be done
in a darkened room, also see sec. 9.1, page 22.
Operation via computer/laptop: You can also operate the Mesotest II via
a computer/laptop. You then need the Mesotest II software (available as
an optional extra), also see sec. 10, page 28.
Testing wit landolt rings
Testing is conducted under natural vision conditions, without device
accommodation.
Testing is done with a Landolt ring of the visual acuity level 0.1 in acc.
with DIN 58220, Part 1 (in Germany). The Landolt ring can be presented
in six different positions. Four contrast levels without glare (ambient
luminance 0.032 cd/m²) and four contrast levels with glare (ambient
luminance 0.10 cd/m²) are tested.
The optotypes can be presented in six different positions, whereby one
position is prespecified at the beginning of the test.
Four different contrast levels are available:
1:23 / 1:5 / 1:2.7 / 1:2
The contrast level 1:23 is the strongest contrast, i.e. this level is the
easiest to see.
Contrast 1:23 is the ratio of
Ambient luminance: Luminance of the optotype.
Glare light
The glare light is located on the test field.
The glare light simulates the glare situation of an oncoming vehicle with
dimmed headlights in the twilight (glare sensitivity). The glare
illuminance at pupil level is 0.35 lux.
White light emitting diodes are used as the light source. It is thus
unnecessary to change lamps.
1 Landolt ring
2 Ambient light
3 Glare light
Fig. 6-3: Glare light
1
3
2

6 Device Description
Instruction Manual Mesotest II (G/62800/0715/en) 13 / 86
The ambient light and the glare light are illuminated separately by one
light emitting diode each.
A stand-by function switches off the illumination after a certain time if
no entries are made by the operator.
Fixation aid
A projection device for a fixation aid is located over the test field. Two red
dots can be projected onto the test field with this device, if necessary.
If the patient looks directly into the glare light when the switch-over to
mesopic vision is made, he will no longer be able to see the optotypes, to
begin with. This can lead to a delay in the examination procedure, as he
needs some time (approx. 10-30 seconds) to readapt.
Test procedure
Control Pad: The contrast levels are each presented with and without
glare. As such, a total of eight consecutive tests are conducted.
The visual requirement is deemed to be met when the patient has
recognised at least 3 of 5 positions of the Landolt ring (60% criterion).
Mark this accordingly on the test sheet.
Fig. 6-4: Fixation aid
Test no. 1 2 3 4 5 6 7 8
Contrast 1:23 1:5 1:2.7 1:2 1:23 1:5 1:2.7 1:2
Glare light off off off off on on on on
Prespecified position of
the Landolt ring
TL TR T B BR BBL T
Function Test mesopic vision Test mesopic vision with glare

6 Device Description
14 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Computer/Laptop:
With the examination program „Mesopic vision bin“, you can examine
mesopic vision binocularly.
It consists of 10 test steps.
Test 1 and Test 6: Facilitate the fixation, as here the fixation marks are
displayed
Test 2-5: Are used to test mesopic vision
Test 7-10: Are used to test mesopic vision with glare.
With the examination program „Mesopic vision mono“ (optional with
Mesotest II konkav), you can examine mesopic vision monocularly, for the
right and for the left eye. It consists of 20 test steps.
Test 1, 6, 11 and 16: Facilitate the fixation, as here the fixation marks are
displayed.
Test 2-5 and 12-15: Are used to test mesopic vision
Test 7-10 and 17-20: Are used to test mesopic vision with glare.
5 Landolt rings are presented for each contrast level. The visual
requirement is deemed to be met when the patient has recognised at least
3 of 5 positions of the Landolt ring (60% criterion). Mark this in the
software accordingly (sec. 10.1.2, page 30). The results are saved and you
can print them out. You can also compile your own tests.
6.2 Twilight (Mesopic) Vision
Tests for determining mesopic visual acuity and glare contrast sensitivity
were developed, among other things, to test the visual functions that a
driver must have for driving at night.
How do we see in twilight? The transition between daytime (photopic) vision and night (scotopic)
vision is referred to as twilight vision (mesopic vision).
Twilight vision has considerable differences compared to daytime vision.
Daytime vision and cone vision (also known as photopic vision) are the
terms used for luminances greater than 3 cd/m², night vision and rod
vision (also known as scotopic vision) for luminances below 0.03 cd/m² ,
and mesopic vision for luminances in the range between 0.03 and 3 cd/
m².