CA-200 Instruction Manual Rev1 2008

NOTE Selecting externally connected equipment The Topcon CA-200 complies with the CE marking. Before connecting a personal computer to the TOPCON product, make sure that such external equipment is in compliance with EN 60950-1 and CE marking. When the CA-200 is installed inside rooms for medical use, the external personal computer, printer connected to the CA-200 must be powered through an insulation transformer compliant with IEC 60601-1 The CA-200 stand alone installed inside rooms for medical use doesn’t need to be powered through an insulation transformer. For powering the printer connected to the unit is still required insulation transformer, compliant with IEC 60601-1 Manufacturer Hesp Technology S.r.l. Via C. E. Gadda, 15 52027 San Giovanni Valdarno (AR) Italy Distributor TOPCON EUROPE B.V. Essebaan 11 2908 LJ Cappelle A/D Ijseel THE NEDERLAND

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USAGE PURPOSE APPLICATION The CA-200 is a corneal analyser. The instrument captures an image of the cornea and analyses the topography of it and the pupil contour. The computer software selects from a sequence of images the one with the best focus. Inside the image the reflected cone disc rings from the illuminate cone serve to geometrically calculate the topographical map of the cornea. From the topographical map data a series of parameters indices and measurements are elaborated. The principal applications of corneal analysis are in the following fields: • •

corneal data for diagnostic tools corneal data for contact lens selection

USER Ophthalmologists, Oculist, Optometrist, Opticians and contact lens technicians. The instrument must be used only by qualified stuff. WORKING PLACE OF USAGE Medical studios, institutions and surgical clinical rooms. Contact Lens Ophthalmology stores.

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INTRODUCTION Thank you for purchasing the TOPCON Corneal Analyser CA-200. The CA-200 System Corneal Analyser places itself at the apex of its kind with its elevated technological and application content. The Corneal Analyser is an instrument rich in solutions that allows very demanding ophthalmologists and contact lenses specialists a detailed and complete study of the cornea. The instrument processes any type of corneal map: axial and instantaneous curvature with 2D and 3D representation, altimetric maps, curvature and height differences map, corneal wave-front aberrations; it can simulate any type of contact lens: Ortho K, keratoconus and others. Its points of strength are: · a 24 rings Placid disk with a working distance of over 80 mm that guarantees an extremely precise and reproducible corneal topography acquisition while keeping the patient comfortable. · an intuitive and powerful software that allows the complete management of the patient clinical history · the contact lenses management and the application tool. The intuitive and user friendly software and the patient-comfortable hardware, put the CA200 among the most appreciated tools in its field. Thanks to the continuous research and collaboration with important medical and optic experts on the subject, the complex mathematical analysis at the base of the corneal topography have been put to the service of applied medical refractive surgery and contact lens fitting.

This Instructions Manual describes the TOPCON CA-200, including outline, basic operations, troubleshooting, checking, maintenance and cleaning. To get the best use of the instrument, please read the safety Displays and Safety Cautions. Keep this Manual available for future reference.

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PRECAUTIONS

This instrument is an electronic precision unit, so be sure to use and store it in a place controlled under normal living temperature, humidity and atmospheric pressure, and avoid direct exposure to sunlight. To ensure smooth operation, install the instrument on a surface free of vibrations. Also do not put anything on top of the instrument. Connect all cables properly before using. Use the power at a rated voltage. When not in use, switch off the power source and protect the unit from sunlight and dust. For accurate measurement results, keep the examination acquisition cone clean and free of spots and dust. Electromagnetic Compatibility This product conforms to the EMC standard (IEC 60601-1-2:2001). - MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and need to be installed and put into service according to the EMC information provided in the accompanying documents. - Portable and mobile RF communications equipment can effect medical electrical equipment - The use of accessories and cables other than those supplied with the instrument, exception for cables sold by the manufacturer of the equipment as replacement parts, may result in increase emission or decrease immunity of the equipment or system. - The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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EMC Table Emission Test RF Emission Cispr 11

RF Emission

Emission Guidance Compliance Electromagnetic enviroment guide The corneal topographer CA-200 uses RF energy Group 1

Class B

Cispr 11

Harmonic Emission IEC 61000-3-2

Class A Compliant

Voltage Fluctuation/flicker Emission IEC 61000-3-3

Compliant

only for internal functioning. Therefore its RF emissions are very low and most likely these don’t cause interference to the near electronic devices. It is possible to use the device inside all buildings, included the domestic ones and buildings directly connected to public low voltage power supply which powers the buildings for domestic use, taking appropriate measures during installation. It is possible to use the device inside all the buildings, included the domestic ones and the buildings directly connected to a public low voltage power supply which powers the buildings for domestic use.

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Immunity Guidance The CA-200 is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is use within those environmental conditions. Test level Conformity Level Electromagnetic Immunity Test EN 60601-1-2 enviroment guide The floor should be in Electrostatic Discharge (ESD) ± 8kV air ± 8kV air wood, concrete or EN 61000-4-2 ± 6kV contact ± 6kV contact

Electrical Fast Transient/Burst EN 601000-4-4

Surge EN 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11

Magnetic field at power frequency EN 61000-4-8

±2 kV high voltage power line

±2 kV high voltage power line

Differential mode: ±1 kV Common mode: ±2kV

Differential mode: ±1 kV Common mode: ±2kV

<5% UT (>95% dip of UT) for 0,5 cycle

<5% UT (>95% dip of UT) for 0,5 cycle

40% UT 40% UT (>60% dip of UT) for 5 (>60% dip of UT) for cycle 5 cycle 70% UT (>30% dip of UT) for 25 cycle

70% UT (>30% dip of UT) for 25 cycle

<5% UT (>95% dip of UT) for 5 seconds 3 A /m

<5% UT (>95% dip of UT) for 5 seconds 3 A /m

ceramic. If the floor is covered with synthetic matherial, relative humidity should be of at least 30% The quality of the power supply should be that one of a typical commercial or clinical environment The quality of the power supply should be that one of a typical commercial or clinical environment

The quality of the power supply should be that one of a typical commercial or clinical environment. If the user requests a continuous functioning during power supply interruptions, it is recommended a backup power supply unit (UPS) or battery.

Magnetic fields with power line frequency should have characteristic levels of a typical commercial or clinical environment.

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Immunity Radio Frequency Guidance The CA-200 is manufactured to work in the electromagnetic environment specified below. The operator or user should make sure it is use within those environmental conditions.. Test level Conformity Level Electromagnetic enviroment Immunity Test EN 60601-1-2 guide The portable and mobile devices with Conducted RF 3 Veff from 150kHz to 3 Veff from 150kHz to RF communication shouldn’t be used EN 61000-4-6 80MHz 80MHz Radiated RF EN 61000-4-3

3 V/m from 80MHz to 2.5GHz

3 V/m from 80MHz to 2.5GHz

near any part of the device, including cables, except when they follow the recommended safety distance for separation, calculated with the equation applicable to the frequency of the transmitter.

Recommended safety distance for separation: D= 1,2 x √P from 150kHz to 80MHz D= 1,2 x √P from 80MHz to 800MHz D= 2,3 x √P from 800MHz to 2,5GHz Where P is the nominal maximum power of the transmitter output expressed in Watt (W) as specified by the transmitter manufacturer and d is the recommended separation distance expressed in meter (m). The field intensity of the hard-set RF transmitters, as checked in an electromagnetic investigation of the locus, should be less than the conformity level for each range of frequency. It is possible to have interference near devices marked with the symbol:

Recommended separation distance between portable or mobile devices for radiocommunication and the device The CA-200 is manufactured to work in an electromagnetic environment in which the radiated RF disturbances are controlled. The operator or user of the device could prevent electromagnetic interferences by assuring a minimal distance between the portable or mobile RF communication devices (transmitter) and the device as recommended in the chart below, in respect of the output maximum power of the radio-communication devices. Separation distance at the transmitter frequency (m) Output maximum nominal power of the transmitter (W) from 150kHz to 80MHz from 80MHz to 800MHz from 800MHz to 2,5GHz D= 1,2 x √P D= 1,2 x √P D= 2,3 x √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 the transmitter with output maximum nominal power not reported above, the separation distance d in meters can be calculated using the applicable equation at the frequency of the transmitter, where P is the output maximum nominal power of the transmitter in Watt specified by the transmitter manufacturer. Notes: (1) At 80 MHz and 800 MHz it is applicable the higher frequency range (2) This line guide could not be applicable in every circumstances. The electromagnetic propagation is affected by the absorption and the reflection of structures, people or objects.

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SAFETY DISPLAYS In order to encourage safe use of the instrument and to avoid danger to the operator and others as well as damage to properties, warnings are described in the Instructions Manual and marked on the instruments body. We suggest you thoroughly understand the meaning of the following displays/icons and Safety Cautions, as well as read the Manual, and strictly observe all instructions.

DISPLAYS

Improper handling or ignoring this display may lead to the danger of death or serious injury.

Improper handling or ignoring this display may cause personal injury or physical damage.

Injury means hurt, burn, electrical shock, etc. Physical damage means extensive damage that may involve building, peripheral equipment and furniture.

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USAGE AND MAINTENANCE Usage: Since the Corneal Analyser is an electronic instrument for medical purposes, the operation should be supervised by an experienced doctor.

USER MAINTENANCE To maintain the safety and performance of the equipment, never attempt to do maintenance except for the items specified here. For details, follow the instructions. Calibration Check: For details, see “Calibration Check” on MAINTENANCE Cleaning of examination cone: For details, see “Cleaning the instrument” on MAINTENANCE

ESCAPE CLAUSES The manufacturer shall not take any responsibility for damage due to fire, earthquakes, actions by third persons and other accidents, or the negligence and misuse of the instrument by the user under unusual conditions. The manufacturer shall not take any responsibility for damage derived from the user or unavailability of this equipment, such as a loss of business profit and suspension of business. The manufacturer shall not take any responsibility for damage caused by usage other than that described in this instructions Manual. The manufacturer shall not take any responsibility for the result of diagnosis using this equipment.

GUARANTEE CONDITION Guarantee would be valid as long as the above clauses are applied and only if the instrument is utilised strictly for the purposes described in this manual. The guarantee condition applied is the minimum prescribed by local regulations.

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WARNING INDICATIONS AND POSITIONS For safety purposes, this equipment includes clearly labelled warnings. Use the equipment following this warning instructions. If any of the following marking labels are missing, please contact your dealer or TOPCON at the address stated on the back cover.

CAUTION To avoid potential electrical injury during operations do not touch the patient’s eyes or nose with the instrument. To avoid electrical shock, do not open the instrument. Refer all servicing to only qualified personnel.

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CONTENTS - Introduction - Safety Display - Safety Cautions - Usage and Maintenance - Escape Clauses - Guarantee Condition - Warnings Indications and Positions

COMPONENT NAMES - Main body components - Control Panel components - Standard accessories

PREPARATIONS - Hardware installation - Software installation

BASIC OPERATIONS - Acquisition - Acquisition settings - Corneal map - Map profile - Corneal map settings - Lenses - Lens profile - Preferred lenses - Lens settings - WiFi connection - Admin tools

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TROUBLESHOOTING - Trouble-shooting operations

REFERENCE - Optional accessories - Specifications

MAINTENANCE - Cleaning the instrument - Fuse change - Calibration Check

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CONTROL PANEL COMPONENTS

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CA-200 HEAD STANDARD ACCESSORIES The following are standard accessories. Make sure that all these items are included.

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PREPARATIONS

Hardware Installation:

Software Installation: See “CA-200 Installation Manual” included in the CA-200 Setup CD.

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BASIC OPERATIONS ACQUISITION Turning on the system the device start acquisition.

Grab procedure Select the eye with R o L button (the system auto-select the eye moving the instrument to the left or to the right); Find the center of the rings; Press joystick button (you ear a single beep) to start procedure; Move the joystick forward and back (according to instruction on the screen) to find the best focus; The best image will be automatically acquired (you ear a multiple beep); for manual acquire press the joystick button again. The gallery The preview of acquired images will be shown in the gallery.

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Clicking on a preview you can select or deselect the image. Selected images are shown normally, while unselected are dark. For map calculating, the software automatically choose the best acquisition between the selected ones. Press arrow buttons to scroll up and down all the previews. Functions Settings Click on “Setting” button to open the settings panel. Send To Click on “Send To” button to send selected previews and images to the remote Corneal Analyser software. Reset The “Reset” button resets all acquisitions and clears the gallery. If the calibration procedure is running, the “Reset” button can stop it. Processing Click the “Processing” button to leave acquisition and calculate the map. All selected images will be evaluated but only the best will generate the map.

ACQUISITION SETTINGS Pressing “Settings” button in acquisition environment opens the settings panel.

Click on “Network Status” button to open the network configuration tool. Click on “Start Calibration Procedure” to perform the system calibration. Click on “Admin Tools” to open the panel for administration actions and maintenance.

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CORNEAL MAP The corneal map is the main processing result.

If both eye are acquired, you can press on the “R” or “L” button to display right eye map or left eye map. You can change the map visualization selecting one or more of the following buttons: • Axl or Tan: for axial or tangential map; • Abs or Nor: for absolute or normalized scale; • Eye and/or map and/or Ring: for eye image, map, and ring points.

Press on a point in the map let you read some point-interesting information, such as • Diopters • Radius • Meridian • Elevation

Profile Press the “Profile” button to display the curvature profile along the steepest and the flattest meridian (red and blue). The difference is shown in green.

Press on “Close” button to close the profile panel. Indices Use the indices button to obtain information you want.

Keratometrics Sim K This command provides a simulation of the readings that would be obtained by using keratometer. The selected zone therefore has an extension that varies according to the curvature of the measured cornea. It is possible to see the steeper and flatter meridians on the map together with the corresponding simulated keratometric data; Meridians This command allows the user to see the steeper and flatter meridians on the map within the zones 3mm, 5mm and 7mm of the cornea, with the corresponding keratometric data, forcing the axis to be perpendicular to each other; Emimeridians This command allows the user to see the keratometric data for each semimeridian.

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