OCULUS C-QUANT User manual

OCULUS
C-QUANT
INSTRUCTION MANUAL

i / iii Instruction Manual C-Quant (G/80000/1007/en)
Notes on this instruction manual
Thank you for your purchase and the trust you have placed in this OCULUS product. The
C-Quant has been manufactured and tested according to strict quality criteria. You have
selected a modern and well-engineered product.
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.
We cooperate with many clinics and practicing physicians and develop performance
specifications for new instruments in close consultation with them.
The C-Quant was developed in cooperation with Dr. Tom van den Berg PhD from the
Netherland Ophthalmic Research Institute of the Royal Academy (NORI, in 2005
merged into the netherlands institute for Neuroscience, www.nin.nl), in Amsterdam.
Dr. Tom van den Berg began his research on light scatter in the human eye in the
mid - 1980s. It was only recently, some 20 years later, that he found in OCULUS a
partner for putting his ideas into practice.
Due to ongoing development, the diagrams shown may depict minor changes to the ac-
tual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us a fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
Management and workers
OCULUS is certified according to DIN EN ISO 9001:2000 and 13485:2003, setting high
standards of quality where development, manufacture, quality assurance and service re-
garding the entire range of products are concerned.

Table of contents
Instruction Manual C-Quant (G/80000/1007/en) ii / iii
Table of contents
1 Scope of delivery........................................................................................................................................................1
2 Safety instructions....................................................................................................................................................1
2.1 Safety instructions concerning organisation .................................................................................1
2.2 Pictogram definitions...............................................................................................................................2
2.3 Safety instructions regarding the use of the C-Quant...............................................................2
3 Proper Usage ...............................................................................................................................................................4
4 Transportation and Disposal.................................................................................................................................4
4.1 Transport and storage instructions ....................................................................................................4
4.2 Disposal of used devices .........................................................................................................................4
5 Electromagnetic Compatibility (EMC) / Cables..............................................................................................5
6 Description of Unit and its Function.................................................................................................................5
7 Operation ......................................................................................................................................................................5
7.1 Before first Use ...........................................................................................................................................5
7.2 Installation and Electrical Connection...............................................................................................6
7.3 Installation of the Software...................................................................................................................6
8 Patient Data Management.....................................................................................................................................7
8.1 Starting Patient Data Management ...................................................................................................7
8.2 Entering new patients ..............................................................................................................................7
8.3 Selecting existing patients .....................................................................................................................8
8.4 Deleting examinations .............................................................................................................................9
8.5 Patient data ..................................................................................................................................................9
8.6 Exporting patient data .......................................................................................................................... 10
8.7 Importing patient data.......................................................................................................................... 11
8.8 Backup (Saving data) ............................................................................................................................. 12
8.9 Settings........................................................................................................................................................ 14
8.9.1 Settings “Main”................................................................................................................... 14
8.9.2 Settings “Devices”.............................................................................................................. 15
8.9.3 Settings “Import/Export”................................................................................................. 17
8.9.4 Settings “Email” .................................................................................................................. 18
8.9.5 Settings “Interface”........................................................................................................... 19
8.9.6 Settings “Smartcardreader” ........................................................................................... 20
8.9.7 Settings “Miscellaneous”................................................................................................. 21
8.10 Starting the C-Quant program.......................................................................................................... 22
9 C-Quant Program ................................................................................................................................................... 22
9.1 Information Boxes (C-Quant Program)..........................................................................................23
9.1.1 Common data...................................................................................................................... 23
9.1.2 Examination specific data .............................................................................................. 23
9.1.3 Result fields.......................................................................................................................... 25
9.1.4 Examination fields............................................................................................................. 26
9.1.5 Examination response chart..........................................................................................27
10 How the C-Quant works...................................................................................................................................... 27
10.1 The measurement principle................................................................................................................. 27
10.2 Compensation comparison method ................................................................................................ 29

Table of contents
iii / iii Instruction Manual C-Quant (Version 01 – G/80000/1007/en)
10.3 The psychometric function.................................................................................................................. 31
10.4 Strategy details ........................................................................................................................................ 32
10.5 Examination phases ............................................................................................................................... 32
11 Quick Guide - Performing an examination.................................................................................................. 33
11.1 Before the examination........................................................................................................................ 33
11.2 Starting an examination....................................................................................................................... 34
11.3 Printout ....................................................................................................................................................... 35
12 Practical Guide for operating the C-Quant ................................................................................................. 35
12.1 Measuring procedure............................................................................................................................. 35
12.1.1 Patient instruction............................................................................................................. 36
12.1.2 After the measurement................................................................................................... 38
12.2 Measurement - Examples .................................................................................................................... 40
13 Troubleshooting ...................................................................................................................................................... 49
14 Inserting corrective lenses.................................................................................................................................. 49
15 Cleaning and Care.................................................................................................................................................. 50
16 Terms of Warranty and Servicing .................................................................................................................... 51
16.1 Terms of warranty................................................................................................................................... 51
16.2 Assumption of liability for functions and damage ...................................................................52
16.3 Address of the manufacturer and service department ........................................................... 52
17 Declaration of Conformity.................................................................................................................................. 53
18 Technical Specifications / Minimum PC Requirements ..........................................................................54
19 Bibliography.............................................................................................................................................................. 55

1 Scope of delivery
Instruction Manual C-Quant ( G/80000/1007/en) 1 / 56
1Scopeofdelivery
☞
Note
We reserve the right to change the scope of delivery in line with ongoing technical devel-
opment.
2 Safety instructions
2.1 Safety instructions concerning organisation
The law requires that the manufacturer expressly informs the user about safety aspects
concerning the handling of the C-Quant. This chapter contains a summary of the most
important points regarding these safety matters.
Attention
Do not use the device if you have not understood the instruction manual.
ÎMake sure to keep this instruction manual in a safe place and available to operating
personnel at all times.
ÎObserve the legal regulations with regard to accident prevention.
Component Order Number
C-Quant 80000
Power supply ETH25-12/MED 05150500
Mains cable (EU/USA) 05200320 or 05200210
USB cable 05200560
Dust cover 60100 05 001
Anti-reflex-coated lenses 8003
Instruction Manual G/80000
Setup-CD ROM 05330510

2 Safety instructions
2 / 56 Instruction Manual C-Quant ( G/80000/1007/en)
This unit is a high-quality technical product. To ensure that it functions correctly and
safely we recommend the following: Have the C-Quant checked by our service personnel
or an authorised dealer every two years. If an error occurs which you are unable to cor-
rect, label the device as "out of order" and contact our service department.
2.2 Pictogram definitions
Attention
Identifies a potentially dangerous situation which may cause minor injury or damage to
property.
Note
Instructions for use, and useful or important information.
☞
Note
Identifies important information about the product or on how to use it, which requires
special attention.
2.3 Safety instructions regarding the use of the
C-Quant
☞
Note
Before you use the C-Quant for the first time you must be instructed either by us or an
authorised dealer.
Attention
No modifications may be made to this device without the permission of the
manufacturer.

2 Safety instructions
Instruction Manual C-Quant ( G/80000/1007/en) 3 / 56
ÎOnly operate the C-Quant using original accessory parts supplied by us, and when
the device is in technically correct working order.
ÎNever operate a C-Quant that is damaged. Should such a situation arise, contact the
supplier.
ÎDo not operate the devices included in the delivery in areas where explosions may
occur, where there are inflammable anaesthetics, volatile substances such as alcohol
or petrol nearby.
ÎDo not operate or store the C-Quant in damp rooms.
ÎKeep the C-Quant away from water that may drip, surge or splash and make sure
that no liquids can enter the C-Quant. Do not place any containers with liquid either
close to or on the C-Quant.
ÎWhen cleaning, use a damp cloth and make sure that no liquid enters the C-Quant.
ÎOnly operate the C-Quant in rooms used for medical purposes if VDE 0100 installa-
tion procedures have been observed.
ÎDo not force any plug connections.
If you are unable to make a plug connection, check whether the plug fits the socket.
If you detect damage to the connection, you should let our service personnel repair
the damage.
ÎWhen disconnecting electrical connections, pull on the respective plug instead of
the cable itself.
Attention
Any additional equipment that is to be connected to either analogue or digital interfaces
must verifiably fulfil appropriate EN or IC specifications. Furthermore, all configurations
must comply with the IEC 601 - 1 system norm.
Attention
If you connect the C-Quant with non-medical equipment (e.g. data processing equip-
ment) to a medical electrical system, doing so must not cause patient-relevant safety
levels to fall below IEC 601 - 1. If making this connection leads to the leakage current
threshold being exceeded, protective measures including a circuit breaker must be in
place.

3 Proper Usage
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3 Proper Usage
This unit may be used only for the purposes described in this Instruction Manual. It is de-
signed for tests of the retinal straylight of the human eye.
The unit may be used only by persons whose proper use of the unit is ensured by their
training and practical experience.
Use the unit only with original parts and accessories delivered by us and in a technically
flawless condition.
With the computer controlling the C-Quant it is not permitted to run other software par-
allel to the examination software in the foreground (such as screen saver, user programs,
etc.). Modes to save energy (BIOS or Windows) should be deactivated.
Use the unit only with an electric supply system whose supply voltage is within the range
given on the type plate.
Please take care to observe the safety precautions given above.
4 Transportation and Disposal
4.1 Transport and storage instructions
Great care must be taken when transporting the C-Quant from one location to another.
ÎAvoid operating or storing the device next to heaters/radiators or in damp areas.
ÎCheck the C-Quant for damage every time it has been transported.
The requirements for transporting and storing the device according to IEC 601 - 1 are as
follows:
These levels apply in conjunction with the use of appropriate packaging and for a maxi-
mum period of 15 weeks.
4.2 Disposal of used devices
In accordance with Directive 2002/96/EC of the European Parliament and the Council of
27 January 2003, and in accordance with German law governing the circulation, return
and environmentally friendly disposal of used electrical and electronic devices, such ap-
pliances must be recycled and may not be discarded as household waste.
Ambient temperature: -40 °C to +70 °C
Relative humidity, including condensation: 10% to 100%
Air pressure: 500hPa to 1060hPa

5 Electromagnetic Compatibility (EMC) / Cables
Instruction Manual C-Quant ( G/80000/1007/en) 5 / 56
5 Electromagnetic Compatibility
(EMC) / Cables
Special precautionary measures in respect of EMC apply to electrically operated medical
devices.
No special measures need be observed in respect of OCULUS devices and systems.
Attention
Portable and mobile HF sets can interfere with electrically operated medical devices.
Cables
To minimise emitted interference and to increase interference resistance, the following
types of cables must be used:
6 Description of Unit and its
Function
The C-Quant measures, in an accurate and objective way, the amount of straylight on the
retina caused by light scattering in a patient´s eye. In an ideal eye there would be no light
scattering at all, but because the eye media are not optically ideal, there will always be
some light scattering; which degrades the image projected on the retina, thus the quality
of vision.
The effect of increased straylight can be compared to what would be seen through very
dirty glasses. In short, more straylight means worse vision.
Straylight may be significantly increased above normal values because of cataract,
corneal distrophies, refractive surgery or other pathologies.
It is designed for computer-controlled operation via serial or USB interface.
7Operation
7.1 Before first Use
Please remove the device as well as the accessories from the packaging and keep this. You
can use it for correctly sending or transporting the device in the case of service or repair.
In this way you avoid unnecessary damage and costs.
Read these operating instructions carefully.
05200320 or 05200210 (110 volt) Mains cable 2.5 m in length

7 Operation
6 / 56 Instruction Manual C-Quant ( G/80000/1007/en)
Being an optical device this unit must be handled with care. Do not expose it to any vi-
bration, impacts, contamination and high temperatures.
7.2 Installation and Electrical Connection
ÎPlace the OCULUS-C-Quant on a level surface.
The electrical connectors are on the backside of the device.
ÎLink up the C-Quant with the PC via the serial or the USB-cable.
ÎConnect the low-voltage socket of the supplied desktop power supply to DC input
connector.
ÎConnect the AC power cable to the desktop power supply.
ÎConnect the power plugs C-Quant power supply to a power outlet.
7.3 Installation of the Software
Attention
First install the software before connecting the device to the PC.
Setup the software
ÎInsert the CD C-Quant (80000) into CD-ROM.
ÎThe CD starts automatically. Follow the on-screen installation instructions.
ÎIf the CD does not start automatically, run setup.exe from CD-ROM.

8 Patient Data Management
Instruction Manual C-Quant ( G/80000/1007/en) 7 / 56
8 Patient Data Management
8.1 Starting Patient Data Management
After you have switched on the PC, it first loads the operating system. It then displays the
user interface for "Patient Data Management".
In case the user interface does not start automatically:
ÎClick the C-Quant icon on the desktop.
Fig. 8-1: Patient Data Management
☞
Note
To enter the C-Quant program, you must either enter a new patient into the "Patient
group box" or select an existing patient from the list.
8.2 Entering new patients
ÎTo enter a new patient in Patient Data Management, click [New].

8 Patient Data Management
8 / 56 Instruction Manual C-Quant ( G/80000/1007/en)
ÎEnter the patient’s last name, first name and date of birth completely in the patient
window.
Fig. 8-2: Entering new patients
ÎOptionally you can enter an ID number for the patient.
ÎTo accept the entries you have made, click [Save]. The patient you have just entered
now appears in the patient list.
ÎSelect this new patient from the patient list and start the C-Quant program.
8.3 Selecting existing patients
The patient list on the left-hand side of the screen displays all previously examined
patients in alphabetical order.
ÎClick [Search] to quickly find the patient you require from the list.
ÎEnter the patient’s name or the first letter of the name in the "Last name" field.
ÎOptionally you can search for the patient by entering his or her ID number, assuming
that patient was assigned one when first entered.
ÎClick the appropriate entry in the list to transfer that patient’s name to the patient
window. This also brings up a list of any previous examinations for that patient in
the examination window (bottom right-hand side).
Extended patient search: [Extended] checkbox
ÎActivate the [Extended] checkbox.
The screen displays additional search parameters which reference previous examinations,
for example. The procedure is similar to entering a new patient name.
Fig. 8-3: Extended search

8 Patient Data Management
Instruction Manual C-Quant ( G/80000/1007/en) 9 / 56
"Invert result”
If this option is activated, all data that do not meet the selected search criteria are dis-
played.
When the [Search] button is activated, all other buttons are deactivated (greyed out).
ÎTo exit search mode, you must press the [Quit Search] button. The other buttons are
then reactivated.
8.4 Deleting examinations
This function makes it possible to delete individual examinations from the patient data.
ÎClick [Delete exam.] underneath the list of examinations.
You will be asked if you really want to delete the examination.
Fig. 8-4: Delete individual examination
ÎConfirm your selection by clicking [Yes].
8.5 Patient data
Renaming patients
Patient data can be changed later by activating [Change] (under the patient
directory).
The input fields for entering the patient data are now activated (white background)
and the cursor jumps directly into the top field.
ÎActivate the [Save] button.
The changes are recorded.
Deleting patient data
Patient data can be deleted via [Delete patient].

8 Patient Data Management
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Attention
Before data are actually deleted, one must confirm twice that all the examinations per-
formed on the patient, as well as all patient data from the patient data administration,
are to be removed.
8.6 Exporting patient data
Content
Saving patient and examination data in a different directory.
Transferring measurement data to another storage medium (e.g. USB drive).
Sending stored data by e-mail.
ÎIn Patient Data Management, select the patient you require.
You can select a patient’s entire data master or individual examinations.
ÎClick [Export].
The following dialog box appears:
Fig. 8-5: Exporting patient data
ÎSelect "Single File (U12)".
ÎYou can open the "Directory" by clicking the button.
ÎSpecify the name and destination of the file you are saving.
ÎClick [Export].
The patient and examination data have now been saved at the destination specified.
You can send data stored on the hard drive as an e-mail attachment.

8 Patient Data Management
Instruction Manual C-Quant ( G/80000/1007/en) 11 / 56
Note
Requirements for transferring data to another PC:
A software licence purchased from an authorised dealer. This licence includes instal-
lation instructions and a Licence-Key.
The C-Quant program must be installed on the other PC. If the program is updated
on the C-Quant PC (sender), the program on the other PC (recipient) must also be
updated.
8.7 Importing patient data
Import the patient and examination data you have received into your C-Quant software.
ÎIn Patient Data Management, click [Import]
The following dialog box appears:
Fig. 8-6: Import-Box
ÎSelect the option "U12".
ÎClick the button under "File".
ÎLook for the exported file in the selected folder.
ÎOpen the exported file.
ÎClick [Import].
The imported files are marked in the Patient Data Management menu.

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8.8 Backup (Saving data)
Saving data
ÎIn Patient Data Management, click [Backup].
The following dialog box appears:
Fig. 8-7: Backup - Box
The dialog box consists of two fields: „Backup“ and „Restore“.
In these fields, the directory can be marked in which the data are to be saved or from
which they are to be loaded, e.g. "F:\"; for a network drive.
Saving data can be done in a number of ways:
“Save all data”
If this option is selected, all examination and patient data are saved.
“Changed and new data only”
If this option is selected, only data that have been changed, or newly entered data
are saved.
Note
Saving data can be time-consuming depending upon the amount of data. It is therefore
advisable to use this function when the PC (or the device) will not be needed for some
time.
ÎTo initiate data storage, activate the button [Save].
OCULUS Optikgeräte GmbH recommends making a periodical backup of patient data.

8 Patient Data Management
Instruction Manual C-Quant ( G/80000/1007/en) 13 / 56
Reconstructing patient data
The [Restore] button is used to reconstruct or restore saved data. The directory from
which the data are to be reconstructed must be selected first.
“Backup-directory”
This field is for entering the letter, which designates the drive, and, if it exists, the
subdirectory of the source from which the data are to be restored.
ÎClick on the button to select the drive and directory from which the data are
to be restored.
ÎClick the [Restore] button for uploading the data from the backup data carrier into
the system.
Automatic backup
It is also possible to save backup data automatically. When exiting an examination
program, the new examination data are always saved automatically.
ÎActivate this function in the “Settings” menu (see next paragraph).
This function should only be used if an additional drive with replaceable data carriers
is available.

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8.9 Settings
The Patient Data Management system can be customized in the “Settings” menu. This
menu consists of six tab panels, into which the required settings are entered.
ÎTo activate this menu, press the button [Settings].
8.9.1 Settings “Main”
When the menu is opened, the “Main” tab panel always initially appears in the fore-
ground. General settings are made here
Fig. 8-8: Main - Setting
Language
Specify the language which the program should use.
Optional items for patient
Optional information can be entered here.
Such information can then be activated or deactivated in the patient list context
menu and also appear when an extended search is performed under the name spec-
ified here.
ÎBy activating [Save] the selected setting can be saved.
This setting will be loaded every time the program is restarted.
ÎThe button [Cancel] deletes the selected alterations and deactivates the function.
The Patient Data Management software version is displayed at the bottom right.

8 Patient Data Management
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8.9.2 Settings “Devices”
Fig. 8-9: Devices -Box
ÎUse the mouse or the cursor keys on your PC- keyboard to activate the next tab pan-
el, “Devices”.
The paths for the database and for all connected devices are entered here.
Settings for storing the database are made in the “Database” field.
The database storage can be set up for different configurations.
The settings in the following fields can then be set separately for each configuration.
The user is then selected from the drop-down menu and is activated by clicking on
the checkbox [Active].
“Database-folder”
Here you enter the drive and path in which the database is located.
Alternatively the drive and the directory can be searched for by pressing the
button.
“Data-folder”
Here you enter the drive and sub-directory in which the data are located.
Alternatively the drive and the directory can be searched for by pressing the
button.

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☞
Note
Settings for the selected device are made in the „Devices“ field.
You select the device for which the settings are to be made from the drop-down menu.
Switch the device to active, if it is connected.
“File”
Here, you enter the drive and sub-directory in which the application file is located.
Alternatively the drive and the directory can be searched for by pressing the but-
ton.
“Transfer-folder”
A directory or folder for storing the patient data is always created locally on your PC
and is used as a „transfer folder“ for transfer of the data to the database.
Here again, the name is always the name of the device followed by the
extension .DAT.
Here, you enter the drive and sub-directory for the “transfer folder”.
Alternatively the drive and the directory can be searched for by pressing the but-
ton.
Write permisson
Because the settings for all devices can be made from a PC workstation without the
devices actually being connected, you must specify for each PC workstation, whe-
ther the respective device is actually connected or not.
If it is connected, activate the write permission checkbox. The write permission must
be deactivated for all other devices.