INSTRUCTIONS FOR USE

CORNEAL ANALYZER

CA-800 CORNEAL ANALYZER

0123 REV. 10 2015

 CA-800 User Manual – Rev.10 – 06/02/2015

Thank you for choosing this product.

Please read the information in this manual carefully. You must be knowledgeable with its contents in order
to work with the device.

The manufacturer has a policy of continuous improvement of its products, so it is possible that some
instructions, specifications and pictures in this manual may differ slightly from the product you purchased.
The manufacturer also reserves the right to make any changes to this manual without notice.

The original text of this manual is in English.

SW v.: 1.0.x

Manufacturer Distributor

VISIA imaging S.r.l. Topcon Europe Medical B.V.

Via Martiri della Libertà, 95/e Essebaan 11
52027 San Giovanni Valdarno (AR) 2908 LJ Capelle a/d IJssel
Italy The Netherlands
www.topcon.eu
medical@topcon.eu

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Contents
1. INTENDED USE ....................................................................................................................................... 6
1.1. Use:.................................................................................................................................................... 6
1.2. Users:................................................................................................................................................. 6
1.3. Facilities: ............................................................................................................................................ 6
1.4. Positioning the patient ....................................................................................................................... 6
1.5. Contraindications ............................................................................................................................... 7
2. INTRODUCTION....................................................................................................................................... 7
2.1. Notes:................................................................................................................................................. 7
3. PRECAUTIONS ........................................................................................................................................ 7
3.1. EMC table .......................................................................................................................................... 8
4. SYMBOLS ............................................................................................................................................... 10
4.1. Device sample labeling .................................................................................................................... 11
5. SAFETY INSTRUCTIONS ...................................................................................................................... 11
5.1. General ............................................................................................................................................ 11
5.2. Electrical safety ................................................................................................................................ 12
5.3. LED emission safety ........................................................................................................................ 12
5.4. Installation with external devices or IT Network .............................................................................. 12
6. TRANSPORT AND PACKAGING ........................................................................................................... 13
7. CLEANING .............................................................................................................................................. 14
8. PACKAGE CONTENTS .......................................................................................................................... 14
9. CHECKING THE MEASUREMENTS ..................................................................................................... 14
10. PRODUCT WARRANTY AND RELIABILITY ...................................................................................... 15
11. LEGAL PROVISIONS .......................................................................................................................... 15
12. USE AND MAINTENANCE.................................................................................................................. 15
12.1. Use ............................................................................................................................................... 15
12.2. Maintenance ................................................................................................................................ 15
12.2.1. Calibration check ..................................................................................................................... 15
12.2.2. Cleaning ................................................................................................................................... 18
13. LIABILITY............................................................................................................................................. 18
14. WARNING LABELS AND PLATES ..................................................................................................... 18
15. COMPONENTS ................................................................................................................................... 19
15.1. Main parts .................................................................................................................................... 19
16. CA-800 STANDARD ACCESSORIES ................................................................................................. 20
17. INSTALLING/UNINSTALLING THE SYSTEM .................................................................................... 21
17.1. Installing the system .................................................................................................................... 21
17.2. Uninstalling the system ................................................................................................................ 24
17.3. Connection modes ....................................................................................................................... 26
18. OPERATING INSTRUCTIONS............................................................................................................ 27
18.1. General description of functions .................................................................................................. 27
18.1.1. General instructions ................................................................................................................. 27
18.2. Checking calibration .................................................................................................................... 27
18.3. Entering/selecting a patient ......................................................................................................... 27
18.3.1. Creating a new patient ............................................................................................................. 28
18.3.2. Selecting or editing a patient ................................................................................................... 28
18.3.3. Open an examination or acquire data for the selected patient ................................................ 29
18.3.4. Managing the selected patient ................................................................................................ 29
18.3.5. Selecting a patient from Server List ......................................................................................... 30
18.4. Acquisition environment: general instructions ............................................................................. 31
18.4.1. Description of the acquisition screen ....................................................................................... 32
18.4.2. Acquisition gallery .................................................................................................................... 33
18.4.3. Acquisition procedure .............................................................................................................. 33
18.5. Topography .................................................................................................................................. 34

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18.6. Pupillometry ................................................................................................................................. 34

18.7. Meibomian ................................................................................................................................... 35
18.8. Fluorescein .................................................................................................................................. 36
18.9. Measurements ............................................................................................................................. 37
18.9.1. MAP-Topographic map ............................................................................................................ 37
18.9.1.1. Topographic map indexes................................................................................. 38
18.9.1.2. Keratometry ...................................................................................................... 38
18.9.1.3. Keratorefractive indexes ................................................................................... 38
18.9.1.4. Keratoconus ..................................................................................................... 41
18.9.1.5. Pupil ................................................................................................................. 42
18.9.1.6. Gallery .............................................................................................................. 43
18.9.1.7. Full screen mode .............................................................................................. 44
18.9.1.8. Profile ............................................................................................................... 44
18.9.1.9. 3D ..................................................................................................................... 45
18.9.1.10. Edit ring ........................................................................................................... 46
18.9.2. OD/OS ..................................................................................................................................... 47
18.9.3. ZER - Zernike........................................................................................................................... 47
18.9.4. HEIGHT ................................................................................................................................... 50
18.9.4.1. Profile ............................................................................................................... 51
18.9.4.2. 3D ..................................................................................................................... 52
18.9.5. COMP - Comparison ............................................................................................................... 52
18.9.5.1. Differential ........................................................................................................ 54
18.9.6. PUP - Pupillometry .................................................................................................................. 54
18.9.6.1. Display.............................................................................................................. 55
18.9.6.2. Sequences........................................................................................................ 55
18.9.6.3. Dynamic ........................................................................................................... 55
18.9.6.4. Photopic, Mesopic, Scotopic ............................................................................. 56
18.9.6.5. Functions .......................................................................................................... 56
18.9.6.6. Graphs.............................................................................................................. 56
18.9.7. FLUO - Fluorescein ................................................................................................................. 59
18.9.8. WTW - White to White ............................................................................................................. 60
18.9.9. MEIB - Meibomian ................................................................................................................... 61
18.10. Report printing ............................................................................................................................. 61
18.11. Saving the examination data ....................................................................................................... 62
18.12. Lenses ......................................................................................................................................... 63
18.12.1. Contact Lenses .................................................................................................................... 63
18.12.1.1. Gallery ............................................................................................................ 63
18.12.1.2. Ref .................................................................................................................. 64
18.12.1.3. K/L .................................................................................................................. 65
18.12.1.4. T/D .................................................................................................................. 66
18.12.1.5. Profile.............................................................................................................. 67
18.12.2. Optional: Oculentis Intraocular Lenses calculation (toric IOL) ............................................ 67
18.12.2.1. Summary of Corneal Data ............................................................................... 69
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18.12.2.2. Biometry Data ................................................................................................. 69

18.12.2.3. Pre Op Data .................................................................................................... 69
18.12.2.4. IOL Calculation results .................................................................................... 69
18.13. Settings ........................................................................................................................................ 71
18.13.1. General ................................................................................................................................ 71
18.13.2. Measurements ..................................................................................................................... 72
18.13.2.1. Scales ............................................................................................................. 72
18.13.2.2. Fluorescein ..................................................................................................... 73
18.13.2.3. Pupillometry .................................................................................................... 73
18.13.2.4. Map Option ..................................................................................................... 73
18.13.3. Lenses ................................................................................................................................. 74
18.13.4. Report .................................................................................................................................. 75
18.13.5 Server .................................................................................................................................. 76
18.13.6 Admin .................................................................................................................................. 77
18.13.4.1. Manual ............................................................................................................ 77
18.13.4.2 Patients Management .......................................................................................................... 78
18.14. Updating the integrated software ................................................................................................. 78
18.15. Backup ......................................................................................................................................... 79
18.16. Shutdown ..................................................................................................................................... 79
19. TROUBLESHOOTING ......................................................................................................................... 80
20. SPECIFICATIONS ............................................................................................................................... 81
21. CHANGING THE FUSES .................................................................................................................... 83

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1. INTENDED USE

1.1.Use:
CA-800 is a corneal analyzer with integrated pupillographer. The instrument acquires images of the cornea
and analyzes its topography. The software selects the image with the best focus out of a sequence of
images. In the image, the rings of the disc reflected by the illuminated cone are used to geometrically
calculate the topographic map of the cornea. From the topographic map data, a set of parameter are
processed for the measurements.
The main applications of the corneal analyzer are the following:
 Cornea measurements for diagnostic instruments
 Cornea and pupil measurements for application of contact lenses
 Fluorescence analysis for contact lens positioning
 Pupil measurements for the identification of specific pathologies

1.2.Users:
Eye specialists, ophthalmologists, opticians and optometrists.
The instrument must be used by qualified persons.

1.3.Facilities:
Health centers, optician shops, eye hospitals and other eye-care related facilities.

1.4.Positioning the patient

The patient must be positioned in such a way that the distance from the device to the eye is 83 mm.
A steady head position and the correct device-to-patient distance are promoted by resting the patient’s
head properly against the chin rest and forehead band.
Correct alignment with the patient’s pupils can be visually inspected by the operator referring to the two
lines on the forehead supports.

Fig. 1
The patient must be instructed to look permanently at the aiming point in the center of the Placido disk.
The position of the device in relation to the patient’s eye thus found is the starting point for fine
measurement adjustments.
The patient does not use the controls.

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The patient may be an elderly person, an invalid, or a child. In any case, the device is to be controlled by the
aforementioned skilled staff.

1.5.Contraindications

There aren’t any known contraindications to the use of the medical equipment.

2. INTRODUCTION

The intuitive and user-friendly software interface and the hardware, designed for patient comfort, make
the CA-800 one of the most popular corneal analyzers on the market.
The instrument analyzes any type of corneal map: axial and instantaneous with 2D representation.
This instrument also allows you to simulate contact lenses and view the 3D map to analyze the wavefront
corneal aberrations.

2.1.Notes:
This manual describes the CA-800 corneal analyzer, including its functions, basic operations, instrument
cleaning, and instrument storage.
For best use of the instrument, carefully read the instructions provided.
Keep these instructions in a safe place.

3. PRECAUTIONS

This electronic instrument is a precision unit. Use and store it in a suitable place at normal temperature,
humidity and atmospheric pressure conditions and avoid exposure to direct sunlight.
To ensure proper functioning, install the instrument in a place not subject to vibrations.
Connect all the cables correctly before use.
Use the recommended mains voltage.
When the unit is not used, disconnect the power supply and protect it against the sun and dust.
In order to obtain accurate and reliable measurements, keep the measuring cone clean and dust-free.
This product is in compliance with the EMC standards (IEC 60601-1-2:2007).
- ELECTROMEDICAL DEVICES require particular precautions for electromagnetic compatibility and
must be installed and set up based on the EMC information provided in the documents attached.
- Portable RF communication instruments may interfere with medical devices.
- Using accessories and cables other than those provided with the instrument, except for the cables
sold by the equipment manufacturer as spare parts, may result in increased emissions and may
reduce the immunity of the device or system.
- The eventual cables connected to USB and LAN ports must be less than 3 meters length.
- The device must not be used in contact with other equipment.
If the device is to be used in contact with other instruments, check proper functioning in the required
configuration.

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3.1.EMC table
Emission-related aspects
The CA-800 device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should make sure that it is used in the said environment.
Emission test Compliance Electromagnetic environment – guidance
The CA-800 device uses RF energy only for its internal
RF emissions
Group 1 function. Therefore, its RF emissions are very low and are not
CISPR 11
likely to cause any interference in nearby electronic equipment.
The CA-800 device is suitable for use in all establishments,
RF emissions including domestic establishments and those directly connected
Class B
CISPR 11 to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions Class A The device can be used in all buildings, including domestic
IEC 61000-3:2 Compliant buildings and those directly connected to the public low-voltage
Voltage fluctuations/ flicker power supply network that supplies buildings used for domestic
Compliant purposes.
emissions IEC 61000-3:3

Immunity-related aspects
The CA-800 device is intended for use in the electromagnetic environment specified below. The customer or
the user of the CA-800 device should make sure that it is used in the said environment.
EN 60601-1-2 Compliance
Immunity test Electromagnetic environment – guidance
test level level
Floors should be made of wood, concrete or
Electrostatic discharge
 6kV contact  6kV contact ceramic tiles. If floors are covered with
(ESD)
 8kV air  8kV air synthetic material, the relative humidity
EN 61000-4-2
should be at least 30%
The quality of the power mains should be
Electrical fast transient/ 2kV for power 2kV for power
that of a typical commercial or hospital
Burst EN 61000-4-4 supply lines supply lines
environment.
The quality of the power mains should be
Surge 1kV differential 1kV differential
that of a typical commercial or hospital
EN 61000-4-5 mode mode
environment.

< 5% UT < 5% U T
(>95% dip in UT) (>95% dip in UT)
for 0.5 cycle for 0.5 cycle
The quality of the power mains should be
Voltage dips, short 40% U T 40% U T that of a typical commercial or hospital
interruptions and (60% dip in UT) (60% dip in UT) environment. If the user requires continuous
voltage variations on for 5 cycle for 5 cycle device operation during power mains
power supply input lines 70% U T 70% U T interruptions, it is recommended that the
(30% dip in UT) (30% dip in UT) device be powered using an uninterruptible
EN 61000-4-11 for 25 cycle for 25 cycle power supply or a battery.

< 5% U T < 5% U T
(>95% dip in UT) (>95% dip in UT)
for 5 seconds for 5 seconds

Power frequency magnetic fields should be

Power frequency
at levels characteristic of a typical location in
magnetic field 3 A/m 3 A/m
a standard commercial or hospital
EN 61000-4-8
environment.

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Radio frequency immunity-related aspects

The CA-800 device is intended for use in the electromagnetic environment specified below. The customer or
the user of the CA-800 device should make sure that it is used in the said environment.

EN 60601-1-2 test Electromagnetic environment –

Immunity test Compliance level
level guidance

Portable and mobile RF communications

Conducted RF 3 V from 150kHz to 3 V from 150kHz to
equipment should not be used in the
EN 61000-4-6 80MHz 80MHz vicinity of the device, including its cables,
unless the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter is observed.
Recommended separation distance
d = 1.2 P from 150kHz to 80MHz
Radiated RF 3 V from 80MHz to 3 V from 80MHz to d = 1.2 P from 80 MHz to 800 MHz
EN 61000-4-3 2.5GHz 2.5GHz d = 2.3 P from 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).

The fixed RF transmitter field strength, as determined by an electromagnetic site survey, may be lower than
the compliance level in relation to each frequency range.
Interference may occur in the vicinity of any equipment marked with the following symbol:

Recommended separation distances between portable and mobile RF communication equipment and
the surgical Navigation device
The CA-800 device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of device can help prevent electromagnetic interference by keeping a
minimum distance between portable and mobile RF communication equipment (transmitters) and the device as
recommended below, according to the maximum output power of the communication equipment.

Separation distance according to transmitter frequency (m)

Rated maximum output
of transmitter (W) 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2GHz
d = 1.2 P d = 1.2 P d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note:
(1) At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.

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4. SYMBOLS

Symbol IEC Publication Description

CLASS I DEVICE IN ACCORDANCE WITH 60601-1

IEC 60417-5840
APPLIED PART TYPE B

PRODUCT IN ACCORDANCE WITH DIRECTIVE 93/42/EEC

Type A CORNEAL TOPOGRAPHY ACCORDING TO ISO 19980:2005

IEC 60417-5032 ALTERNATE CURRENT

EN 60601-1 FOLLOW THE INSTRUCTIONS FOR USE

EN ISO 15223-1 MANUFACTURER

EN ISO 15223-1 REFERENCE OR MODEL NUMBER

PRODUCT CLASSIFIABLE AS GROUP 1 IN ACCORDANCE

Group 1 EN ISO 15004-2
WITH EN ISO 15004-2

EXEMPT GROUP PRODUCT CLASSIFIABLE AS EXEMPT GROUP IN

EN62471
EN 62471
ACCORDANCE WITH EN 62471

TEMPERATURE LIMITATION
EN ISO 15223-1 Indicate the temperature limits to which the medical device can be
safely exposed.

HUMIDITY LIMITATION
EN ISO 15223-1 Indicate the range of humidity to which the medical device can be
safely exposed.

ATHMOSPHERIC PRESSURE LIMITATION

EN ISO 15223-1 Indicate the range of atmospheric pressure to which the medical
device can be safely exposed.

KEEP DRY
EN ISO 15223-1 Indicates a medical device that needs to be protected from
moisture.

HANDLE WITH CARE

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THIS WAY UP
ISO 780
Indicates correct upright position of the transport package.

This symbol is solely applicable for EC member countries.

To avoid potential negative consequences for the environment and possibly human health,
this instrument should be disposed of (i) for EU member countries – in accordance with
WEEE (Directive on Waste Electrical and Electronic Equipment) or (ii) for all other
countries, in accordance with local disposal and recycling laws.

4.1.Device sample labeling

5. SAFETY INSTRUCTIONS

5.1.General
 CA-800 should be used only for its intended purposes as detailed in this manual.
 It must be installed by qualified staff.
 The device must be used in the environmental conditions as specified in this document.
 The least favorable environment is defined as the maximum values of temperature for the unit to be
operating in, while the unit is consuming the maximum current. The environmental value is stated as
+40°C. The maximum current absorption occurs during topography acquisition.
 The maximum temperature of applied parts (chinrest and headrest) can exceed 41°C when the device is
used at environmental temperature close to 40°C. The device temperature doesn’t exceed 48°C anyway.
Considering the examination duration, the patient condition and the parts that are in contact with the
patient, there aren’t any known contraindications about to the contact with the device.
 The device must be connected to an appropriate power source, otherwise its performance may be
reduced.

 Position the unit so that it is not difficult to disconnect the plug for connection to the supply
main.

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 If the device has just been delivered or underwent thermal shock, wait at least one hour before
making measurements on patients.
 Keep this manual at hand and close to the device at all times.

 The physician or device user must inform the patient of the related safety instructions and ensure
that they are observed.

 Run all the control functions (detailed in the relative section in this document) before carrying out
measurements on patients.

 Only duly trained and experienced staff may use the device and interpret the results obtained.
 Turn off the device if it is not going to be used for a long period of time.
 It is advisable to use the device in an unlit environment

 If the device has been affected by external forces (e.g. if it is knocked or dropped), it must be
thoroughly checked before examining patients. To do this, refer to the relative section in this manual. If
necessary, send the device in for repair.
 Use only genuine CA-800 accessories and spare parts.
 Remove all the covering material (dust sheet) from the device before turning it on.
 Do not use the device in the vicinity of highly flammable materials or in areas with an explosion risk.

 Unauthorized software installation in the device is not permitted.

 After the examination, the patient may be slightly dazzled. It is recommended to advise the
patient to wait a few minutes before driving or doing anything that requires perfect vision.

5.2. Electrical safety

 To avoid the risk of electric shocks, this equipment must only be connected to supply mains with
protective ground.
 CA-800 has an on-board power supply unit installed. For connection to the mains, use only the
manufacturer-approved cables provided with the device.
 Before performing maintenance on the device, turn it off and disconnect the power cable.
 Do not touch the LAN/USB ports contacts and the patient at the same time.

5.3.LED emission safety

CA-800 has a series of LEDs of various types and powers installed. All the characteristics are detailed in the
“SPECIFICATIONS” section.
The device falls within class 1 according to EN 60825-1.
All sources are classifiable as EXEMPT GROUP according to EN 62471.

5.4.Installation with external devices or IT Network

CA-800 complies with the CE marking requirements.

 Before connecting an external device, such as a computer, printer, monitor, keyboard, mouse
or other devices, make sure that they comply with the EN 60950-1 standard and have the CE
marking.

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 Connecting electrical equipment to the device actually results in the creation of medical
equipment, and may jeopardize safety.
 When CA-800 is installed in rooms for medical use, the PC and the connected printer must be
powered using an IEC 60601-1 compliant insulating transformer.
 If CA-800 is installed in rooms for medical use without a computer, it is not necessary to use an
insulating transformer.
 Do not use mobile phones or other devices not compliant with the requirements of class B EMC in
the vicinity of CA-800.

 Every external device that has to be connected to CA-800 must have a connection cable (USB
or LAN) with a maximum length of 3 m.
The purpose of CA-800 connection to an IT network is report printing and remote technical assistance.
The CA-800 USB port must be connected to printer with USB or LAN interface. Ask Topcon technical
assistance for printer driver installation.
The CA-800 can be connected to a Local Area Network (LAN) through the LAN connector. The network must
have Ethernet protocol (IEEE 802.3). Ask Topcon technical assistance and the system administrator for CA-
800 and network settings.
The purpose of CA-800 connection is saving PDF report on an external network folder or technical service
intervention on the machine.
Connection of CA-800 to a computer network that includes other equipment could result in previously
unidentified RISKS; identify, analyze, and control such RISKS (refer to IEC 60601-1:2005).
Subsequent changes to a computer network could introduce new RISKS and require new analysis.
Changes to the computer network include:
 Changes in computer or data network configuration
 Connection of additional items to computer network
 Disconnecting items from computer network
 Update of equipment connected to computer network
 Upgrade of equipment connected to computer network
The term computer network used here corresponds to the term network/data coupling in IEC 60601-
1:2005.

6. TRANSPORT AND PACKAGING

 The device must be transported and stored in its original packaging.

 For storage and transport conditions, refer to the relative section in this document.
 Carefully store the original packaging, in order to use it if you need to transport the device.
 To move the device over short distances (without packaging) and to fit it in and remove it from the
original packaging, grip the device with both hands, one on the front headrest arch and the other in
the recess at the rear of the device (in position with the locking system).

Completely unscrew the two transportation locks and the semi-lock before use.

Lower the instrument to its minimum height using the joystick, then lock CA-800 using the instrument
semi-lock and the two “instrument locking devices” for transportation.

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7. CLEANING

 Regularly clean the device removing dust using a soft cloth. In the case of more persistent surface
dirt, use a soft cloth soaked with water or alcohol (70% max).

 Be careful not to wet the device and clean it only as indicated to prevent damaging it. Never
use solvents or other abrasive agents.
 The device comes with a dust cover to be used to protect it. Cover CA-800 if it is not going to be
used for a long period of time.

 Before turning on the device, remove the cover. Never put the cover on when the device is
on.

8. PACKAGE CONTENTS

 Power cable
 Manual
 Dust cover
 Accessory for calibration check

NOTE: keep the original packaging to store or transport the device.

9. CHECKING THE MEASUREMENTS

 It is absolutely essential to check calibration when the device has been transported from one
place to another and when it has suffered an impact or thermal shocks.

 It is recommended to check the measurements every day when turning on the device using
the instrument provided.
 The user of the device must check that the measurements provided by the device are plausible.
 It is advisable to visually check all the light sources before examining the patients, to make sure
that they illuminate properly.
 In the event of frequent error signals, turn the device off and contact the technical support to have
it inspected.

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10. PRODUCT WARRANTY AND RELIABILITY

 The product warranty is valid only if all the instructions detailed in this document are
followed.
 The product warranty is forfeited in the event of loss or damage due to improper or incorrect use
of the device.
 The product warranty is valid only if it is equipped with its original accessories.

 If the device is opened by unauthorized staff, the manufacturer is relieved of all responsibility
and the warranty will become null and void.
 NOTE: Modifications or repairs to the product, especially where they require opening the device,
may only be carried out by technical staff authorized by the manufacturer.

11. LEGAL PROVISIONS

93/42/EEC – 2007/47/EC:  Class IM medical device

EN 60601-1:  Class I type B continuous operation
EN 60601-1-2:  EMC
EN 15004-2:  Group 1
EN 62471:  All the sources are “EXEMPT GROUP”
UNI EN ISO 19980  Type A

12. USE AND MAINTENANCE

NOTE: the manufacturer shall provide, upon request, circuit diagrams. the list of components, descriptions,
calibration instructions or other information that will assist the technical assistance personnel in the repair
of parts of the device specified by the manufacturer as repairable by the technical support staff.

12.1. Use
As the CA-800 Corneal Analyzer is an electronic instrument for medical purposes, it must be used by
experienced and qualified staff.

12.2. Maintenance
To assure safety and performance of the equipment, it is advisable not to perform any operations other
than those indicated below. For detailed information, please follow the instructions.

12.2.1. Calibration check

Calibration must be checked if the device was transported from one place to another and if it
suffered an impact or thermal shocks.

Check the device calibration every day before starting patient examinations.
Insert the calibration tool provided with the device (Fig. 2) in the special holes in the chin rest and press
until the tool is blocked on the device. Check that the calibration tool is perfectly aligned with the device. If

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the calibration tool is positioned correctly, all the rings of the Placido disk should be seen reflected in the
center on the surface of the hemisphere (Fig. 3).

Fig. 2

CORRECT alignment
WRONG alignment
Fig. 3

To check calibration, turn the instrument on and go to settings, then select the Admin tab and press Check
(Fig. 4).

Fig. 4

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After acquiring the 8 mm sphere eight times, at the end of the acquisitions the calibration check is
complete and, if calibration is correct, the software will display the message “Calibration Check: POSITIVE”
(Fig. 5).

Fig. 5

If calibration is not correct, the software will display the message “Calibration Check: NEGATIVE” (Fig. 6).

Fig. 6

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12.2.2. Cleaning
Do not clean the plastic parts with solvents such as benzene or similar products, as they may cause
discoloring of the parts and decomposition of the material.
If the instrument is dirty, clean the surface with a dry cloth.
If there are permanent stains on the surface of the Placido disc, please contact Topcon Support for
replacement.
Before using the chin rest on another patient, clean and disinfect the mounts that come into contact with
the forehead and chin with neutral detergents.

13. LIABILITY

The manufacturer shall not be held liable for damages caused by fire, earthquakes, actions by third parties
and other accidents, or negligence and misuse of the instrument by the user.
The manufacturer shall in no way be liable for damages caused by the user or by unavailability of the
device, such as a loss of profits or suspension of business.
The manufacturer shall not be held liable for damages caused by use of the device for purposes other than
those described in this instruction manual.
The manufacturer shall not be held liable for the result of the diagnoses performed with this device.

14. WARNING LABELS AND PLATES

In order to safely use the instrument and prevent risks to the operator and other persons as well as damage
to the device, the instruction manual provides a description of the safety warning labels and plates on the
instrument body.
Carefully read the PRECAUTIONS and SAFETY RULES as well as the manual and observe the instructions
contained therein.

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15. COMPONENTS

15.1. Main parts

Placido disk Headrest

NB: The parts in

contact with the
patient (applied parts)
Chinrest are the head rest in
Teflon and the chin
rest in acrylonitrile
butadiene styrene
resin (ABS)

Display with
multi-touch screen

Joystick with
acquisition button

STAND-BY
button
Instrument locking Power connector
devices for transportation (with fuse carrier)
USB ports (2)
LAN port

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16. CA-800 STANDARD ACCESSORIES

The following accessories are included in the package:

 Calibration checking device

The calibration checking device

shows the serial number of the
instrument with which it is associated.
To properly check calibration, the
calibrator provided with the
instrument must always be used.

 Power cable

 Manual

 Touchscreen pen, silicon cloth, chin rest

paper and chin rest pins

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17. INSTALLING/UNINSTALLING THE SYSTEM

CA-800 is packed for shipping in a double cardboard box on a dedicated pallet with specially shaped
cardboard parts inside, to help ensure the instrument is safely handled and transported.

Two special warning labels are applied on the outside of the cardboard box. Please check them as
described below before accepting the instrument on delivery, or accept it only with reserve.

If the circle on the label, shown below, is white, this means that the instrument has not been tilted during
handling. If it is red, the instrument may have been damaged during transport.

If the white rectangle on the label shown above is red in the middle, this means that the instrument may
have been damaged by shocks during transport.

Keep the original packaging for future use. The system must always be handled/shipped in
its original packaging, which is specifically designed to protect it against damages.

17.1. Installing the system

Before installing the system, read the “Safety Instructions” in this manual.
Fig. 7 shows the complete packaging of the instrument.
Cut the extensible film and the packing straps. Open the outer box as shown in Fig. 8.

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Fig. 7

Fig. 8
Remove the manual and the accessories from the dedicated spaces between the two pieces of cardboard
The accessories are:
 “Topcon” box:
o calibration checking device
o chin rest paper
o chin rest pins
o touchscreen pen
o silicon cloth
 Power cable (European cable and Hospital Grade cable)
 CA-800 dust cover
 CA-800 user manual
Open the internal box and remove the specially shaped part that holds the instrument. Remove the Nylon
cover. The instrument can now be taken out of the package. The steps are illustrated in Fig. 9 .

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Fig. 9
Be careful when taking CA-800 out of the box gripping it by the chin rest arch and the base beside the
joystick.
Place the instrument on a flat surface.

Completely unscrew the two transportation locks and the semi-lock.

Connect the power cable provided.

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The instrument is now ready for use.

17.2. Uninstalling the system

Take the original packaging.

Set the instrument to the minimum height using the joystick. Lock the device using the
instrument semi-lock and the two “instrument locking devices” for transportation.

Fig. 10
Insert the instrument in the box, as shown in Fig. 10, and place the Nylon cover on it.
Follow the step sequence shown in Fig. 11.

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Fig. 11
Put the accessories in the dedicated spaces. Close the external box with strong packing tape or use
extensible film and packing straps.

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17.3. Connection modes

LAN port
USB ports (2)

Power connector

STAND-BY button

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18. OPERATING INSTRUCTIONS

CA-800 is designed to work in stand-alone mode. For this reason, all the software functions are
automatically loaded when the device is turned on, enabling the user to control the device and guiding him
or her through the various phases:
- Entering the patient's data
- Different acquisition modes
- Measures display and processing
- Lens selection
More information for each function and the description of all the settings and other functions available is
provided in the following paragraphs of this chapter, to which you should refer for further details.
To interact with the software, the LCD display with touchscreen is used. To activate the button or the
desired function, simply touch the screen at the command. The screen is highly sensitive. Gentle and slight
pressure is required and strongly recommended.

18.1. General description of functions

CA-800 is a corneal analyzer with the following functions:
- Cornea image acquisition and topographic analysis;
- Dynamic pupillometry acquisition: recording of a sequence of pupil images as the light conditions
change. Static pupillometry acquisition in controlled light conditions (photopic, mesopic and
scotopic);
- Fluorescein analysis: picture and/or movie acquisition that allow to check the contact lens
positioning, or to assess cornea's artifacts and the lachrymal film (rupture time);
- Analysis of wavefront corneal aberrations generated by the front surface of the cornea with Zernike
analysis: information on the optical properties of the cornea and the optical problems that may
affect sight;
- Contact lens simulation: the software selects from a database the lens best suited to the eye and
allows different lenses to be compared;
- Optional - Oculentis Intraocular lents calculation (Toric IOL).

18.1.1. General instructions

The follow icons provide access to functions commons to various working environments:
Access to the "Settings" section, described in detail in the dedicated paragraph.
Direct printing of the report or saving a PDF file based on the options selected in the print
section.

18.2. Checking calibration

See 12.2.1- Calibration check.

18.3. Entering/selecting a patient

When the instrument is turned on, the software displays the following screen. To continue the
examination, you must always enter a patient or select one from database or server (if enabled).

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Fig. 12
Fig. 12 shows the section for creating a new patient, entering Last Name, Name and Birth Date (Gender
and ID are optional).

18.3.1. Creating a new patient

To create a new patient, select the “New” tab and enter the data using the on-screen keyboard. Once you
have entered the new patient data, tap on the “Ok” button to confirm the information and continue with
the examination. If you want to clear all the fields tap on the “Clear” button.
A special character can be entered simply by touching and holding the corresponding letter (Fig. 13).

Fig. 13

18.3.2. Selecting or editing a patient

On the input screen, tap on the "List" tab to access all the patients found in the database (Fig. 14).

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Fig. 14
On this screen you can select a previously created patient and the examinations associated with him/her.
If you edit the “Last Name” field, a search is done in the database for patients with the corresponding
surname or whose surname contains the selected key. By pressing the arrow button on the right, the field
and the search are canceled.

18.3.3. Open an examination or acquire data for the selected patient

In the left column, tapping on a patient in the “Exam List” frame, the list of associated examinations will be
displayed. In this list, you can access examinations or delete them, using the “Open” or “Delete” buttons.
After selecting a patient, another examination can be carried out by pressing the "New” button.

18.3.4. Managing the selected patient

From the list of patients, select the patient you want to manage and press the "Action" button. The
application opens a form (Fig. 15) with three buttons, “Delete”, “Export” and “Cancel”. Press “Delete” to
delete the selected patient with all of his exams, press “Export” if you want to export it with all of his exams
or press “Cancel” to abort.
From the list of patients, select the patient you want to edit, a form will be opened to editing it. Press “Ok”
or “Cancel” to confirm or cancel the changes.

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Fig. 15

18.3.5. Selecting a patient from Server List

After enabling the CA-800 Server List integration using the CA-800 settings panel (see Server List
configuration), you can select a new patient from the patient list retrieved from the IMAGEnet i-base or
Corneal Analyzer (Fig. 16). The user can search for a patient either by surname or by ID (only if you have
selected IMAGEnet i-base as active server). A list of patients corresponding to the search criteria will be
created. After selecting a patient, the user can create a new examination in standard mode by tapping on
the “Ok” button.

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Fig. 16
18.4. Acquisition environment: general instructions
Fig. 17 shows the acquisition screen.

Fig. 17
The joystick illustrated in Fig. 18 is the only part the user has to physically control during acquisition. The
button on the top marked "Acquisition button" starts the acquisition of the various measurements.
The thumb wheel marked "Height Regulation" allows you to adjust the instrument height according to the
patient's position.

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On the chin rest there is also a knob for adjusting the height, if the adjuster on the joystick is not enough to
achieve the correct position.
To perform the acquisition, position the patient with his/her chin on the chin rest and forehead on the
forehead rest. This is the correct position for performing the examination.

The position of the chin rest must be

Fig. 18
both comfortable and correct, i.e. it
must allow the person performing the
measurement to correctly focus on the
fixation LED.
Make sure the patient's
forehead is well up
against the forehead rest.

Wheel for chinrest

height adjustment.

Fig. 19

18.4.1. Description of the acquisition screen

The acquisition window (Fig. 17) has the following commands:
 OD and OS: these indicate the eye being acquired (the one highlighted in yellow); they are selected
automatically, depending on the position to which you move the instrument.
 TOPO: gives access to the topographic section.

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 PUPI: gives access to the pupillometry section.

 EXTRA: gives access to the meibomian section.
 FLUO: gives access to the fluorescein section.

18.4.2. Acquisition gallery

A preview of the acquired image is shown in the acquisition gallery (Fig. 20 for topography, pupillometry,
meibomian and fluorescein, respectively).

Fig. 20
The images are numbered progressively and each of them is associated with the eye it refers to and the
type of acquisition.
For topography, you can tap on a preview image to select or deselect it. The selected images are displayed
normally, while those not selected are dark (Fig. 21).
To calculate the topographic map, the software automatically selects the best image for each eye.
The arrow buttons in the gallery frame for each eye are used to scroll the images, as some of these are
hidden if more than three acquisitions per eye are made.

18.4.3. Acquisition procedure

Back-lighting of the Placido disk is automatically activated when you enter the acquisition environment. If
the instrument is not used for a few minutes, the cone turns off; to turn it on again, just press the joystick
button.
To acquire the image or measurements in general, whatever mode you are in, simply proceed as follows:
- Align the live image in the center and focus, and then press the joystick button to start the
acquisition.
- Move the instrument forwards and backwards (following the indications of the red and blue arrows
on the screen) to find the ideal focus.
- When the green indicators are displayed, press the joystick button again and the system will
automatically capture the required image and/or measurements. Do not move the joystick during
acquisition, which lasts just a few seconds.

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The red arrows indicate to move the instrument forward towards the patient's eye.

The blue arrows indicate to move the instrument backward, away from the patient.

18.5. Topography
Topography is used to measure the corneal curvature. It is based on the reflection of the Placido disk on the
eye at a controlled working distance for high precision measurement.
CA-800 allows the user to acquire the corneal topography of the eye. The “Corneal Map” is obtained from
the reflection of 24 rings of the Placido disk at a distance of 80 millimeters from the patient's eye. The
position of the device, in relation to the patient’s eye thus found, is used as a starting point for fine
adjustments to be made in the corresponding measurement mode.
By selecting this mode, the acquisition environment shown in Fig. 21 appears.

Fig. 21
In this mode, the topographic map of the cornea is acquired.
Knowing the distance of the corneal apex, with a precision of microns, at the time of acquisition of the
topographical image, the software applies to each of the 256 zero crossing, identified for each of the 24
RINGS, a correction factor given by the ratio between correct mean value and mean radius of the ring.
Concerning the calculation, the software calculates, as standard, 6,144 zero crossing points, identified at
the 24 RINGS along the 256 semi-meridian.

18.6. Pupillometry
Press the “PUPI” button to acquire the Pupillometry images.
By selecting this mode, the acquisition environment shown in Fig. 22 appears on the screen.

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Press the joystick button to start the acquisition and press the button again to stop the acquisition; if the
user does not interrupt the acquisition manually, the software automatically interrupts it when the sliding
bar reaches the end.
As already mentioned in the introductory paragraphs, four types of acquisition can be performed:
- Dynamic pupillometry
- Photopic controlled light conditions (Photopic)
- Mesopic controlled light conditions (Mesopic)
- Scotopic controller light conditions (Scotopic)

Fig. 22
In the case of dynamic pupillometry, recording of the state of the pupil is started, first in scotopic
conditions, then photopic and then scotopic again. The data on the diameters measured are recorded and
shown in the "Measurements" section.
For the dynamic acquisition, a sequence of images is recorded and allows you to "review" the evolution of
the pupil through the various different light conditions applied. In the static pupillometry acquisition made
in controlled light conditions (photopic, mesopic and scotopic) certain frames are saved and can be display
by scrolling the associated gallery in the Pupil  Measurements section.
WARNING: With blue eyes, acquisition of pupillometry in mesopic lighting conditions can be difficult to
accomplish.

18.7. Meibomian
Press the EXTRA button to acquire the meibomian gland images.
By selecting this mode, the acquisition environment shown in Fig. 23 appears on the screen.

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Fig. 23
In this section the user can take pictures of the meibomian gland. The images will be displayed in the
gallery and in the Measurements tab.

18.8. Fluorescein
Press the “FLUO” button to access the fluorescein analysis acquisition environment (Fig. 24).
You can select between picture and movie acquisition.

Fig. 24

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18.9. Measurements
All measurements performed during the examination can be reviewed in detail in the "Measurements"
section.
There are four types of measurement.
 MAP: Keratometry
 ZER: Zernike Analysis
 ALTIM: Altimetric
 PUP: Pupillometry
to which various environments correspond. They are described in detail in the following sections.

18.9.1. MAP-Topographic map

The environment displayed is shown in Fig. 25.

Fig. 25
Tap on the “OD” or “OS” buttons to display the map of the right or left eye. The “OD” and “OS” buttons are
only active if the keratometry of the eye in question has been acquired.
In the right column, you can select the following options:
 Absolute or Normalized: absolute scale or standardized scale with related step.
 Axial or Tangential: axial map or tangential map.
 Display: allows you to choose whether to display or not the image of the eye, the map, the rings,
the numeric values and transparency.
Press on any point on the map to display the following information:
 Diopters (D)
 Radius (r)
 Meridians (θ)
 Altimetry (z)

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18.9.1.1. Topographic map indexes

The diagnostic indexes can be selected with the following buttons (at the top, above the map):
 K: Keratometry
 I: Keratorefractive indexes
 KC: Keratoconus
 P: Pupil

18.9.1.2. Keratometry
Press the “K” button to display the keratometric data on the 3 mm, 5 mm and 7 mm zones, as shown in Fig.
25.

18.9.1.3. Keratorefractive indexes

Press the ”I” button to view the keratorefractive indexes (Fig. 26):

Fig. 26
 Astigmatism: Astigmatism at 3 and 5 mm
 Pupil Avg: Average pupil power for a pupil of 4.5 mm
 Asphericity: Asphericity of the cornea at 8 mm diameter. Pressing the arrow will open a more
detailed set of data. Refer to the corneal asphericity section below for more details.
 Spherical Aberration: Longitudinal spherical aberration of a 4.5mm diameter cornea area
 Curvature Irregularity: Irregularity of curvature calculated on the standard deviation of the
instantaneous readings for a 4.5mm diameter cornea area
 Asymmetry + SAI: Asymmetry between the most curved hemisphere and the flattest one,
calculated for a 4.5mm diameter cornea area and a SAI (Surface Asymmetry Index) which
represents the surface asymmetry index of the 4.5mm diameter cornea area.

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Corneal asphericity
The window is composed by two tabs’ (Asphericity and Peripheral degrees) which specify the corneal
asphericity.
The Corneal Asphericity window could be invoked also from Corneal Height Map environments. In this case,
as in the topographic map, the user should choose the Asphericity Corneal menu item.

Asphericity

Fig. 27

As you can see from (Fig.27) the panel is divided into four parts.
The top-left rectangle (Principal meridian asphericity (8mm)) contains three lines:
 in the first line you can read the apical radius (Ro) and the asphericity (e) along the flattest meridian
(@);
 in the second line there are the same parameters calculated along the steepest meridian; in the
third line there are the average values of the apical radius and of the asphericity. The parameter
calculations are based on a circular area centered in the center of the rings with diameter= 8mm.
The top right rectangle (Peripheral degrees) contains the same parameters as in the top left one, but the
diameter of the circular area is 4.5mm.
The bottom right rectangle contains two parameters: the corneal asphericity referred to as pupillar surface
(4.5mm) and the surface irregularity (SD).
The last parameter measures the difference between the current cornea curvature and related aspherical
best fit surface. In every panel, curvature and asphericity values are formatted according to the settings
chosen with the items Curvature and Asphericity present in the settings environment.

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Peripheral degrees
The table describes the corneal asphericity at the different peripheral degrees. (see Figure 28).

Fig. 28
The first four rows of the table describe the parameter values examined along the nasal, temporal, inferior
and superior emimeridian. The next two rows (horizontal and vertical) represent respectively the average
between nasal and temporal parameter values and between inferior and superior parameter values.
The last row contains the general parameter averages.
The first two columns show the analyzed meridian and the apical radius along that meridian. The successive
rows (R10, R15, R20, R25, R30) indicate the eccentricity value or the sagittal radius at the various peripheral
degrees.

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18.9.1.4. Keratoconus
Press the “KC” button to open Keratoconus screening, this section is divided into two tabs: KC and CLMI.
The KC shows the following information (Fig. 29):

Fig. 29
 AK: Apical curvature.
 Represents the power of the cornea at its apex
 AGC: apical gradient of curvature.
 Represents the average variations per unit of length of the corneal power, taking the apical power
as reference.
 SI: difference between the average power of two circular zones centered on the vertical axis of the
ruler and placed in the lower hemisphere and in the upper hemisphere of the cornea respectively.
 Kpi: Keratoconus diagnosis probability index.
Based on the combined evaluation of the first three indexes with the probability index, three different
possibilities result: topographic picture not compatible with keratoconus (green); suspected keratoconus
(yellow); topographic picture compatible with keratoconus (red).
If the topographic picture is compatible with keratoconus or indicates a suspected keratoconus, the
numerical values of the geometric parameters of the cone are shown at the bottom of the panel. These are:
 A: area of the keratoconus (mm²)
 D: average diameter of the keratoconus (mm)
 r, ø: polar coordinates (mm, °) of the barycenter of the keratoconus in relation to the center of the
map
 RND: circularity factor of the keratoconus
The CLMI shows the following information (Fig. 30):

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Fig. 30
 Axial map CLMI: Cone Location and Magnitude Index based on the axial map.
 Tangential map CLMI: Cone Location and Magnitude Index based on the tangential map.
 DSI: Differential Sector Index.
 PPK: Percent Probability Keratoconus.
 Display CLMI: allows you to choose whether the CLMI map must be shown or not.

18.9.1.5. Pupil
Press the “P” button to open the pupil indexes (Fig. 31):
 Corneal Diameter: represents the diameter of the patient’s cornea in mm.
 KC: KC represents the central keratometry in diopters.
 Avg Pupil Power: Average pupil power for a pupil of 4.5 mm.
 Pupil Dec.: Pupil decentralization from the optical axis.
 Avg Pupil Ø: Mean diameter of the pupil.

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Fig. 31

18.9.1.6. Gallery
Press the icon at the top right of the map to enter the gallery (Fig. 32).

Fig. 32
From the gallery, you can change the default image for all the acquisitions made.

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18.9.1.7. Full screen mode

From the map environment (Fig. 25) you can access full screen mode (Fig. 33) by pressing the button
positioned at the bottom right corner of the image.
To close the environment, tap on the X button at the bottom right corner.

Fig. 33

18.9.1.8. Profile
Press the "Profile" button to view the curvature profile along the most curved meridian and the flattest
meridian (red and blue).
The difference is displayed in green (Fig. 34).
By pressing the arrow buttons, you can change the flattest and the most curved meridians.
The graph will be modified accordingly.
Press the “Map” button, to go back to the topographic map.

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Fig. 34

18.9.1.9. 3D
Press the “3D” button to view the 3D map of the keratometric data (Fig. 35):

Fig. 35

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18.9.1.10. Edit ring

In this section the user can edit the 24 rings in order to improve the topographic map (Fig. 36).

Fig. 36
On the right, the navigation tools are available:
 At the top, the thumbnail of the image with a red rectangle inside is displayed. This shows the
current position within the image; it is possible to drag it and move it to see different parts of the
image.
 At the bottom, there is a zoom slide that allows the user to zoom from 100% to 1000%.
The editing tools are found on the left:
 From the top area, you can select the ring you wish to edit;
 In the central area, three buttons are available:
 “Delete Points”, to delete parts of the selected ring;
 “Delete Ring”, to delete all of the selected ring;
 “Delete All”, to delete all the 24 rings.
 “Add Ring”, to choose where the selected ring will be added in the image;
 The four arrows and the central button available at the bottom are active only when the “Add
Ring” button is enabled. These allow the user to move the cursor and to confirm the position.
At the top of the image there are three buttons:
 “Reset”, to reset the original rings;
 “Save”, to save all the changes made by the user;
 “Close”, to close the environment.

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18.9.2. OD/OS
In this section you can compare the OD and the OS data on the same screen (Fig. 37):

Fig. 37
As in the “Map” section, you can switch between the “K”, “I”, “KC” and “P” tabs.
The “DIFF” button is disabled because the “difference map” is allowed only with the same eye.

18.9.3. ZER - Zernike

The Zernike module provides a comprehensive view of the wavefront aberrations generated by the front
surface of the cornea. The results of the Zernike axis are illustrated by means of numerical indexes and
graphic representations (Fig. 38).
Tap on the “OD” or “OS” buttons to view the results of the Zernike analysis for the right or left eye.
On the left the OPD Map is detailed, representing the total aberration that corresponds to the sum of all
the aberration components and the RMS value. This allows you to quantify the deviation with respect to an
ideal wavefront.
On entering the module, the aberration map is displayed (“Maps” section):
 Histograms of the Zernike expansion coefficients: each histogram represents the weight of the
corresponding polynomial.
 Primary aberrations map:
 Astigmatism: the map, the magnitude in diopters, the axis and the RMS value are displayed
 Spherical aberration: the map, the quantity of longitudinal spherical aberration in diopters and
the RMS value are displayed
 Coma: the map, the RMS value and the direction are displayed
 High Order: all the components of an order higher than the primaries are grouped; the map
and the RMS value are displayed.

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Fig. 38
Tap on “Graphs” at the top left to display the vision quality summary (Fig. 39). This section displays:
 Zernike Coefficient pyramid: represents the numerical value of each coefficient by means of a gray
scale; the greater the coefficient, the greater the color contrast with the pyramid background.
 Point Spread Function: represents the intensity of the wavefront in the retina.
 Spot Diagram: represents the spatial distribution of the wavefront over the retina.
 Visus/Visus Low Contrast: represents the patient's real vision with high and low contrast.

Fig. 39

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The data displayed refers only to the component induced by the anterior surface of the cornea, not by the
eye entire optical system.
Press the “Maps” button to return to the maps display.
The “Pupil” button opens a panel (Fig. 40) where you can select the diameter of the pupil (in a range
between 2 mm and 7.5 mm) to see how the aberrations change as the pupil diameter varies.

Fig. 40

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18.9.4. HEIGHT
“Height” environment allows the user to compare the patient’s cornea with a reference surface (Fig. 41):

Fig. 41
In the right column it is possible to:
 Choose between the “Absolute” and “Normalized” scale, with the possibility to change the
normalized scale step.
 Choose the “Best Fit Diameter” and select the best fitting diameter in the range from 3mm to
8mm.
 Choose the “Reference Surface” and select the following surfaces:
 Spherical: the user can change the “Radius Flat”.
 Aspherical: the user can change the “Radius Flat” and Asphericity”.
 Asphero – Toric: the user can change the “Radius Flat”, “Toricity” and “Asphericity”.
 Differential: the user can select the image of another exam of the same patient to compare it
with the current exam (Fig. 42).
By tapping on any point of the map, the software will provide the following information:
 r: the distance of the point from the center of the image in polar coordinates.
 lb: the angle of the distance r.
 Height: the distance between the patient’s cornea point and the reference surface point.
In the altimetric mode, it is still possible to see the “K”, “I”, “KC” and “P” tabs.

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Fig. 42

18.9.4.1. Profile
Press the "Profile" button to view the curvature profile along the steep meridian or the flat meridian (Fig.
43).

Fig. 43
It is possible to scale the graph with the “50μm”, “10μm” and “5μm” buttons found under the graph.
Press the “Close” button to go back to the topographic map.

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18.9.4.2. 3D
Press the “3D” button to view the 3D map of the altimetric data (Fig. 44).

Fig. 44
18.9.5. COMP - Comparison
Comparison mode allows the user to compare the current exam data with the data of another exam for the
same patient (Fig. 45).

Fig. 45

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When you select the “COMP” button, the interface shown in Fig. 46 appears and the software allows you
to choose in a list of exams for the patient currently selected.

Fig. 46
In comparison mode, it is still possible to see the “K”, “I”, “KC” and “P” tabs; in addition, it is possible to
select the “DIFF” button (see the relative paragraph).
The user can also change:
 MAP: it is possible to choose between axial and tangential.
 SCALE: it is possible to choose between absolute and normalized, for the normalized map the user
can set the step.
It is possible to change the comparison exam by tapping on the “X” button at the top right corner of the
comparison exam map.

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18.9.5.1. Differential
By tapping the “DIFF” button in comparison mode, the user switches to differential mode (Fig. 47).

Fig. 47
In this section it is possible to see the differential map between the current exam and the exam selected by
the user.
Under the maps found at the top left and top right there are the main indexes of the respective maps.
Above the differential map there are four differential values that appear after tapping on the differential
map:
 P: is the difference between the dioptric power;
 r: is the difference between the radii of curvature;
 d: is the distance of the cursor from the center of the image;
 g: is the angle of the cursor from the base line.
The user can change the step of the differential map by tapping on the two arrows next to the step label.
Press the “COMP” button to go back to comparison mode.

18.9.6. PUP - Pupillometry

The pupillometry module allows the user to display and analyze the dynamic and static pupillometry (pupil
images acquired in controlled light conditions).
Normally, if pupillometry is acquired, the software switches to dynamic mode (Fig. 48).

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Fig. 48
Tap on “OD” or “OS” to display the pupillometry of the right or left eye, respectively.
With the patient's eye in view, the buttons will be located below the home screen. These buttons are used
to navigate between the acquired frames. The current frame is shown next to the buttons.

18.9.6.1. Display
 Ring Center: Shows the position of the fixation point
 Pupil: Shows the blue ring, which highlights the pupil edges
 Grid: Shows an overlaid grid
 Rulers: Shows calibrated rulers

18.9.6.2. Sequences
The user can select the sequence of images to be displayed using the buttons at the top:
 Dynamic
 Photopic
 Mesopic
 Scotopic
The active buttons are those for which at least one acquisition is available.

18.9.6.3. Dynamic
Tapping on the "Dynamic" button to display the dynamic pupillometry in the left column, the following
information will also be displayed:
 Average: Value of the maximum and minimum pupil diameter measured in all the images acquired
during the sequence.
 Pupil Center: Cartesian coordinates of the average pupil center and its standard deviation.
 Diameter: Pupil diameter for the frame selected.
 Pupil Center (frame): Cartesian coordinates of the center of the pupil for the frame selected.

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18.9.6.4. Photopic, Mesopic, Scotopic

By tapping on the “Photopic”, “Mesopic”, “Scotopic” buttons, static pupillometry acquisitions will be
displayed with the following information:
 Value of the average pupil diameter measured for all the images acquired during the sequence.
The other information is the same as that already described for dynamic pupillometry.

18.9.6.5. Functions
Graphs
Press the “Graphs” button to display the graphs relating to the pupil. This function is explained in the next
paragraph.
Delete
Pressing the “Delete” button, the system deletes the current pupillometry frame and the data it contains.

18.9.6.6. Graphs
In this section, three types of graph are displayed:
 Decentralization (Fig. 49)
 Latency (Fig. 50)
 Statistics (Fig. 51)
In all these graphs you can select the eye you wish to analyze by tapping on “OD” or “OS”.
The “Close” button closes the graphs.
Decentralization

Fig. 49
The green concentric circles identify the decentralization of the pupil center with respect to the fixation
point. The red line, on the other hand, represents the coordinate variations during acquisition of dynamic
pupillometry.

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Latency

Fig. 50
The graph shows the time in seconds on the abscissa and the pupil diameter in mm on the ordinate, in a
scale standardized based on the maximum and minimum value recorded. The progression of the pupil
diameter over time is represented in the following.
Taking into account that dynamic pupillometry consists in acquiring various images under variable light
conditions, from scotopic to photopic and back to scotopic, on the "Settings" screen you can set the
acquisition times for each mode (explained later). The left column shows the key to the graph.
Red: for acquisition in scotopic light conditions.
Green to indicate the pupil contraction phase following a change in brightness brought about by the LEDs
coming on.
Blue: for the pupil dilation phase following the change from LEDs on to LEDs off.

NB: These graphs are only available if dynamic pupillometry has been acquired.

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Statistics

Fig. 51
The graph represents the percentile static value of the sample for each acquisition under controlled light
conditions.
As indicated in the key on the right-hand side and by the values detailed on the left, the red line represents
the average value of the sample, the blue frame the value interval between the 25% and 75% percentiles,
the green line the value interval between the 10% and 90% percentiles, and the red circle the values
outside this interval.
The graph is displayed only if images of the pupil have been acquired in photopic, mesopic or scotopic
conditions.

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18.9.7. FLUO - Fluorescein

The fluorescein module (Fig. 52) allows you to assess the physical condition of the cornea and to verify the
contact lens position and fitting towards the cornea.

Fig. 52
The pictures and movies acquired can be viewed in the gallery.
When the fluorescein module is started, the first acquisition in the gallery is displayed in the main window.
Tapping on a picture, this is displayed in the main window.
Tapping on a movie, its reproduction starts automatically.
Depending on the selection, the eye the picture or movie refers to will be highlighted.
The two numbers at the bottom right indicate the number of the image displayed in the main window and
the total number of images in the gallery.

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18.9.8. WTW - White to White

The White to White section allows you to view the value of the corneal diameter calculated from limbus
(Fig. 53).

Fig. 53
Tapping on the Open button in the Edit menu (Fig. 54), the user can manually reposition positional
indicators in order to refine the diameter measurements.

Fig. 54
Next to the image, obtained by automatic white to white calculation, you can see:
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 Corneal diameter.
 Decentralization: deviation from the center of the iris with respect to the fixation point.
By changing the indicators position also values of corneal diameter and offset of the visual axis x and y are
updated.
The Reset button resets all the values to the ones obtained by the automatic system calculations.

18.9.9. MEIB - Meibomian

In the meibomian section, the user can check all the images that have been taken in the meibomian gland
acquisition section (Fig. 55).

Fig. 55

18.10. Report printing

In the measurements section, the user can print all the measurements made in the current exam.

In the top-right corner of the screen, press on the button to open the report printing panel (Fig. 56).
Three sections are available in the report printing panel:
 Report selection: the user can select the type of report he/she wants to print; the height map,
comparison and contact lens report are available only in the related sections.
 Report settings: the user can change the settings for report printing.
 Output devices: the user can choose where he/she wants to export the selected report; both
options refer to printer and USB drive export.
It is also possible to take a screen-shot of the current view.

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Fig. 56

18.11. Saving the examination data

After completing some acquisitions, in order to save the data from the examination, tap on the home
button. As shown in Fig. 57, the software will prompt the user to confirm the action.
If the user presses the “Cancel” button, the software will remain on the current screen.

Fig. 57

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18.12. Lenses

The lenses module has two sections:

Contact Lenses: simulate contact lens fitting.
Intraocular Lenses, that simulate the intraocular lenses positioning and calculation of lenses parameters.

18.12.1. Contact Lenses

The contact lenses module (Fig. 58) simulates contact lens positioning.

Fig. 58
Tap on the "OD" or "OS" button to view the lens in the right or left eye.
There are four main sections in the contact lenses module:
 Gallery
 Ref
 K/L
 T/D

18.12.1.1. Gallery
From this section, is possible to select the brand, the model, the diameter and the base curve of the lenses
(Fig. 58) and to add the favorite ones to the gallery on the right.
To add the favorite lenses, press the “Add” button. To cancel all the lenses shown in the gallery, press the
“Reset” button. Instead if you want to delete a single lens, you must tap on “Recycle Bin” icon.
If more than three lenses are shown in the gallery, it is possible to scroll them using the arrows above and
under the gallery.

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18.12.1.2. Ref
In the ref section the user can see the sphere, the cylinder, the axis and the VD of the selected lens (Fig.
59).

Fig. 59
In this section it is also possible to edit these values by pressing the button found under the values: a tab
will appear (Fig. 60) and the user will be able to edit the values by pressing the relative arrows found at the
right of the value.

Fig. 60
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18.12.1.3. K/L
This section displays information about the patient's eye (Fig. 55), and namely:
 Keratometric data.
 Corneal diameter

Fig. 61
In this section it is also possible to edit the limbus by tapping on the “Edit” button. Pressing this button the
user will be required to select three points of the limbus; after selecting these points the limbus line will be
created.

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18.12.1.4. T/D
This section displays tilting and decentralization of the selected lens (Fig. 62).

Fig. 62
The user can edit the tilt values by tapping on the yellow squares found around the lens, and the
decentralization values by dragging (using their fingers) the lens to the desired position.

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18.12.1.5. Profile
In the profile section, the user can see the distance between the selected lens and the patient’s cornea in a
graph (Fig. 63).

Fig. 63
The user can select the meridian where the distance is displayed by tapping on the arrows found above and
under the meridian value.

18.12.2. Optional: Oculentis Intraocular Lenses calculation (toric IOL)

The Toric IOL software module is the tool to calculate Oculentis Toric intraocular lenses.
The first window (Fig.64) shows the “Summary of Corneal Data”, the second one shows report the biometry
data on the left, and the pre-operative data on the right (Fig. 65)

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Fig. 64

Fig. 65
Tap on the "OD" and "OS" buttons to go from the right to the left eye and vice versa.
Tap on the "Reset" button to erase all the data that have been insert by the user.

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18.12.2.1. Summary of Corneal Data

In this section the user can review the corneal data of current eye. There are a few numbers of sub-
sections, for example “Astigmatism”, “Irregularity”, “Asymmetry”, “Keratometry” and “Keratoconus”.

18.12.2.2. Biometry Data

In this section the user can enter the following data:
 Axial Length (AL);
 Anterior Chamber Depth (ACD);
 The acquisition procedure, choosing between “Optical” and “Acoustical”;
 K1 value: the software enters this value automatically, but the user may edit it;
 K2 value: the software enters this value automatically, but the user may edit it;
 Cylinder value (CYL).

18.12.2.3. Pre Op Data

In this section the user can enter the following data:
 Surgically Induced Astigmatism (SIA);
 Incision Location (IL);
 Spherical Equivalent (SEQ);
 The formula used by the software to calculate Oculentis Toric IOL between Haigis, Hoffer Q, SRK II,
SRK T and Holladay I;
 Toric Lenses, among those available.

The toric lenses available are the following:

o LS – 313 Tx;
o LU – 313 T (X);
o LU – 313 Ty (X);
o LU – 313 MF30T (X);
o LU – 313 MF30TY (X);
o LU – 313 MF30T;
o LU – 313 MF30TY;
o LU – 313 MF20T;
o LU – 313 MF20TY;
o LU – 313 MF15T;
o LU – 313 MF15TY.

18.12.2.4. IOL Calculation results

Once all the Biometry Data and Pre Op Data are provided, it is possible to tap on the "Next" button to
access the second step for toric calculation (Fig. 66).

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Fig. 66

In the second step, the software provides a summary of the data entered by the user and further
information:
 Spherical Power;
 Cylinder Power;
 IOL Axis;
 Residual Astigmatism.

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18.13. Settings

To access the “Settings” section, press the button.

Fig. 67
The settings screen is divided into the following categories.
 General
 Measurements
 Lenses
 Report
 Server
 Admin
From each setting environment, you can close and return to the previous activity by selecting the "Close"
button.

18.13.1. General
Refer to Fig. 67:
 Language: The first time the program is started, the default language is set to English and the
keyboard layout is "QWERTY". To change the language settings, select the desired language from
those that appear by tapping on the  button, press “Set” to set the chosen language for
automatic starting. It is recommended to reboot the device to apply all the settings.
 Keyboard Layout: To change the keyboard layout, select the desired layout and press "Set". You
can display the updated layout in the personal details window ("Main").
 Date: Choose the desired date format and press the “Set” button. You can also set the current
system date and time by tapping on the “Edit” button.
 Pointing Devices: Toggles the mouse cursor on or off.

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 OD/OS Notation: To select how to indicate the eye being acquired in two different notations. The
option OD/OS shows the Latin notation. The local language option shows the terms used for the
left and right in the language set for the device.

18.13.2. Measurements
The acquisition settings panel allows you to set the parameters for displaying the corneal map and
acquiring and displaying fluorescein and pupillometry (Fig. 68).

Fig. 68

18.13.2.1. Scales
Map
Select a unit of measure:
 Diopters
 Millimeters
This option is activated both for the acquisition screen and for the topographic map.
Type
Select a scale type:
 Absolute
 Normalized
Asphericity
Select an asphericity unit of measure:
 e
 SF
 p
 Q
Cylinder Notation
Select a notation for cylinder calculation:

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 Positive
 Negative

18.13.2.2. Fluorescein
Fluo Draw
Select one or more items with to customize the fluorescein display:
 Ruler
 Grid
Led Brightness
Select the led power in a range from 1 to 15.

18.13.2.3. Pupillometry
Display
Select one or more items with to customize the pupillometry display:
 Grid
 Ruler
 Ring center
 Pupil
Time intervals
Select the time intervals, in a range from 500ms to 5000ms, of the scotopic and the photopic phase during
the pupillometry acquisition.

18.13.2.4. Map Option

Map Draw
Select one or more items to customize the map display:
 Meridians
 Zones
 Ruler
 Grid
Keratometry
Select one of the keratometric indexes:
 Sim-K
 Meridians
 Emimeridians

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18.13.3. Lenses
Allows you to manage your own lenses database (Fig. 69).

Fig. 69
A brand list is displayed to the left.
Tap on the “Import” button to add new manufacturers to the database. You can import new manufacturers
using a USB pen-drive.
Check the manufacturers you want to include in the list of available lenses for contact lens fitting module.
Select the desired brand and press "Set" to set the favorite manufacturer. When you enter the lenses
module, this will be the default manufacturer.
Set the apical clearance using the up/down arrows.
The right panel allows you to enable or disable the optional feature for the intraocular toric lenses
calculation (Oculentis Toric IOL Calculation).

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18.13.4. Report
Clinical Information
Allows the user to edit the header and the logo that will be printed at the top of the report page (Fig. 70).

Fig. 70
Report Settings
Allow the user to set the default paper type and to choose whether the report will be for one eye or both.
Network Folder
Allows the user to configure and use a remote network folder to store CA-800 reports.
This resource will then become selectable as destination in the report print form.
To allow CA-800 to connect to the remote network folder, you must configure the CA-800 settings with the
correct access credentials for the remote resource.
Configuration parameters:
 Network folder path: the path to access the network folder location (without trailing backslashes)
e.g.,
\\server\path_on_server
 User name: specify the domain name if needed
e.g.,
domain_name\user name
 Password: for the specified user name
Tapping on the “Verify” button, the system starts searching for the network resource. This procedure may
take some time, depending on the network. Failure or success to connect to the network resource will be
reported as shown in Fig. 71 and Fig. 72. A connection failure may be due to an unreachable resource path
or to wrong credentials.

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Fig. 71

Fig. 72

18.13.5 Server
Server List
Allows the user to enable or disable the server list and to set the maximum number of patients in the list.
It is possible to select between the corneal analyzer and the ibase server and to set the ibase IP address.

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18.13.6 Admin
This is the instrument administration panel (Fig. 73).

Fig. 73
It provides information on the system, such as: serial number (S/N) and software version (S/V).
The “Check” button starts the calibration check procedure.
Checking calibration
See the paragraph on the procedure.

Calibration must be checked if the device was transported from one place to another and if it
suffered an impact or thermal shocks.

Check the measurements every day when turning on the device.

The “Application” frame manages the behavior of the integrated software:
Upgrade  Updates the integrated software
Backup  Starts the backup procedure on a USB driver
Shut Down  Power off the machine
Manual  Opens the device manual
Reboot App.  Reboot the application

18.13.4.1. Manual
Directly from the CA-800 software, it is possible to open the instrument manual (Fig. 74).
From this environment, you can browse the manual:
 using the arrows at the top left, you can move to another page;
 using the plus and minus buttons, you can zoom in/out the page;
 using the double-arrow button, you can auto zoom to the page size;
 using the button at the top right, you can return to default zoom of 100%.
To close the manual, just press the “Close” button.

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Fig. 74

18.13.4.2 Patients Management

With “Import” and “Export” buttons, users can respectively import and export the entire patient’s
examinations data to USB drive.

18.14. Updating the integrated software

This section describes the software upgrade procedure.
To update the software, perform the following operations:
1. Unpack the update package in the root (main card) of an empty FAT32-formatted USB external
drive.
2. Switch on CA-800.
3. Tap on the settings icon.
4. Tap on the “Admin” tab.
5. Insert the USB stick with the “CA-800 upgrade” files into one of the USB ports (Fig. 75).

Fig. 75
6. Tap on the “Upgrade” button.
7. Tap on “Ok” to reboot the system and start the upgrade procedure.

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8. The system will reboot and start the “CA-800 application”.

9. After restarting, the software updates the system; this operation may take some minutes: do not
restart the machine during this procedure.
10. Your CA-800 is now upgraded.

18.15. Backup
It is recommended that you perform a backup to have a safety copy of every patient's data stored.
Depending on the expected size of the entire archive, we suggest that you use an external USB disk rather
than a USB pen with lower storage space:
1. Insert the empty and FAT32-formatted USB drive into the CA-800 device.
2. Tap on the “Backup” button.
3. Wait until the procedure has been completed.

18.16. Shutdown
Press the "Shutdown" button to close the application and go back to the Windows desktop. You will be
prompted to confirm this operation.
Press the stand-by button to shutdown the device.

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19. TROUBLESHOOTING

Problem Solution
Calibration check has failed Repeat the measurement, and if the problem
persists, contact TOPCON Technical Service to have
the instrument re-calibrated
The standard deviation after an acquisition session is Repeat the measurement
greater than 0.12 D
The CA-800 display is black Check that the CA-800 device is on
Check that the power cables are properly connected

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20. SPECIFICATIONS

Technical Specifications
Keratoscopic Cone 24 rings equally distributed on a 43D sphere
Points Analyzed over 100.000
Points Measured Over 6.200
Cornea Coverage Up to 9.8 mm on a sphere of radius 8mm (42.2 diopters with n = 1.3375)
Focus System Guided focus
Pupillometry Integrated
Fluorescence Integrated
Output Ports USB, LAN

Range and Accuracy of measurements

Corneal Topography units of meas. Min Max precision
Radius of curvature mm 3.3 37.5 +- 0.02 mm
Radius of curvature D (n=1.3375) D (diopters) 9.00 101.5 +- 0.12

Pupillometry units of meas. Min Max precision

Pupillometry mm 0.5 10 +- 0.05 mm

Environmental conditions
Operation: Storage:
Temperature 10 - 40° C Temperature 0 - 45° C
Relative humidity 8-75% (no condensate) Relative humidity 8-75% (no condensate)
Atmospheric pressure 700-1060 hPa Atmospheric pressure 700-1060 hPa

Transport
Temperature -20 - 70° C
Relative humidity 8-75% (no condensate)
Atmospheric pressure 700-1060 hPa

Electrical specifications
Power source AC 100-240V 50/60 Hz
Power consumption 80 VA

NOTE: For the isolation of the device from the supply mains power, the device is provided with a removable
power cable.

Mechanical specifications
width:320mm
height:490mm
CA-800
length:470mm
weight:15 Kg

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Optical radiations
Central fixation LED
Source: Yellow green LED
Wavelength: 572 nm
Power on patient's eye: <0.01 mW

Illumination of Placido disk for topographic analysis

Source: Red LED Type 1
Wavelength: 633 nm
Power on patient's eye: <0.02 mW
Source: Red LED Type 2
Wavelength: 615-630 nm
Power on patient's eye: <0.02 mW

Pupilometric analysis
Source: White LED
Blue Green Red
Wavelength: 473 nm 532 nm 630 nm
Power on patient’s eye: 0.03 cd 0.005 cd 0.008 cd
Source: IR LED
Wavelength: 940 nm
Power on patient’s eye: 0.3 mW
Source: Red LED Type 1
Wavelength: 633 nm
Power on patient’s eye: <0.02 mW
Source: Red LED Type 2
Wavelength: 615-630 nm
Power on patient’s eye: <0.02 mW

Fluorescein analysis
Source: Blue
Wavelength: 475 nm
Power on patient's eye: 0.207 mW

Onboard PC
Operating system WINDOWS 8 Embedded
Processor AMD G-T56N
RAM 2GB
Hard disk At least 250 GB
External connections LAN integrated, 2x USB

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21. CHANGING THE FUSES

Step 1
Open the fuse box cover
using a screwdriver

Step 2
Take out the fuse box (use a
screwdriver to release it)

Step 3
Remove the blown fuse
from its seat and replace it
with an identical one, as
indicated in the table below
and on the instrument label.

Step 4
Push the fuse box carefully
back into position

Fuse type Fuse value

20 x 5 mm T 2.5 A L 250 V anti-surge

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