SS-1000 Instruction Manual Rev A

i Important Safety Information ■ Do not install this instrument in a location where explosives or inflammable substances are used or stored. Otherwise, fires or explosion may occur. ■

Do not remove the cover of the instrument. Otherwise, you may be directly exposed to high voltage sections.

■

Do not disassemble or modify the instrument. Otherwise, you may be directly exposed to high voltage sections.

■ Disconnect the power cord from all the connected devices before installing and/or servicing the instrument. Otherwise, you may get an electric shock. ■

Do not place the attached insulation transformer directly on the floor when in use.

■

Do not connect a plug-in socket or extension cord to the attached insulation transformer.

■

Only use the specified terminal for connection of the instrument. Using another type of terminal may result in failure of the instrument.

■

Do not connect electric appliances not provided in the system package to the insulation transformer. Otherwise, failure may occur to the insulation transformer or electric appliances.

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■ Do not place water or chemicals on the instrument. Any water or chemicals entering the instrument may cause an electric shock or failure. ■

This instrument is a diagnostic/measuring device specially designed for ophthalmology. Never use the instrument for other purposes.

■

The external output terminal is not isolated from the internal circuit. Inappropriate wiring may damage the internal circuit. If you wish to connect this instrument to other devices, contact our local distributor or Tomey Corporation.

■

When operating this instrument connected to other devices not described in this document, only use the device that satisfies IEC60601-1 or equivalent safety requirements or that conforms to IEC60950 and whose power source is insulated with the attached insulation transformer, in order to satisfy the safety requirements regarding the medical equipment.

■

The total rated input of devices to be connected to the attached insulation transformer is less than 950 VA. Use the transformer to supply power only to devices intended to consist of a part of the system.

■

Do not connect the power source of the attached computer and computer monitor, which is connected to this instrument for operation, directly to the socket on the wall. Otherwise, an electric shock or failure may occur.

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■

Never mark or damage the caution labels on the instrument. Caution labels are provided on a place on the top of the measuring unit, a place on the side, a place on the right side of the light source unit, and two places on the left side.

■

If a label is damaged or becomes illegible, please contact Tomey Corporation or our local distributor.

Measuring unit

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Light source unit (Front/right side)

Light source unit (Rear/left side)

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ii How to Read This Manual Outline This manual is structured as follows. 1. PRIOR TO USE Describes safety precautions and important information to be understood before installing and using the instrument. 2. NAMES AND FUNCTIONS OF PARTS AND COMPONENTS Describes names and functions of each section of the instrument. 3. OPERATION PROCEDURES Describes information required for installing and using the instrument. 4. TECHNICAL INFORMATION Describes useful technical information about the instrument. 5. INSPECTION AND MAINTENANCE Describes procedures for replacing consumable parts, etc. that the user of the instrument should normally conduct. 6. TROUBLESHOOTING Describes how to solve problems. 7. CONSUMABLES AND OPTIONAL EQUIPMENT Describes consumable parts and optional equipment. 8. SPECIFICATIONS Describes the specifications of the instrument. 9. INDEX Refer to the index when needed.

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SYMBOLS USED IN THIS MANUAL The symbols below indicate the following:

■

This is a precaution that, if unheeded, will result in a hazardous situation where there is an imminent danger of serious injury or death.

■

This is a precaution that, if unheeded, could result in a hazardous situation where there is a possibility of serious injury or death.

■

This is a precaution that, if unheeded, may result in a situation where there is a possibility of minor or moderate injury or damage to property.

■

This is an additional instruction which may contain a special precaution on company policy related, either directly or indirectly, to the safety of personnel or to the protection of property.

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iii Contents i Important Safety Information... i-1 ii How to Read This Manual... ii-1 iii Contents ...iii-1 1.

PRIOR TO USE ...1-1 1.1 Precautions for operation ...1-1 1.2 Checking contents of package ...1-5 1.3 Glossary ...1-6 1.4 Outline of operation ...1-9

2.

NAMES AND FUNCTIONS OF PARTS AND COMPONENTS ... 2-1 2.1 Examination List screen ...2-1 2.1.1 Menu bar ...2-3 2.1.2 Tool bar...2-5 2.1.3 Patient list ...2-6 2.1.4 Examination data display area...2-7 2.2 Main Viewer screen...2-8 2.3 System Setup screen ...2-20 2.3.1 Settings for Main Viewer screen (when [Main Viewer] tab is selected) ...2-20 2.3.2 Setting on 2D analysis screen (when 2D Analaysis tab is selected) ...2-22 2.3.3 Settings on viewer main screen (when Volume tab is selected) ...2-23 2.4 Make Movie screen ...2-24 2.5 CCD image enlargement screen ...2-26

3.

OPERATION PROCEDURES...3-1 3.1 Analysis outline ...3-1 3.1.1 Types of analysis ...3-1 3.1.2 Opening analysis screens...3-2 3.2 2D analysis...3-3 3.2.1 Anterior chamber angle...3-6 3.2.2 Central cornea thickness / anterior chamber depth ...3-10 3.2.3 Flap thickness...3-12 3.2.4 Area ...3-14 3.2.5 Manual Measurement ...3-16 3.3 Corneal shape analysis ...3-18 3.3.1 Outline ...3-18

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3.3.2 Map display format ...3-19 Standard format ...3-24 Application format...3-32 3.3.3 Map type...3-39 3.3.4 Map scale ...3-45 3.3.5 Map unit...3-49 3.3.6 Quantitative index ...3-50 3.3.7 Map options ...3-54 3.3.8 Map setting ...3-60 3.3.9 Data Tables...3-65 3.3.10 Other map display modes and applications ...3-66 3.4 Bleb analysis ...3-70 3.5 ITC Analysis ...3-73 3.5.2 Analysis results ...3-77 3.6 Volume analysis ...3-79 3.7 3-D view ...3-82 3.8 Trace correction screen...3-84 3.9 Output of results ...3-87 3.9.1 Printing ...3-87 3.9.2 Saving files ...3-89 3.10 Utilities...3-90 3.10.1 Handling patient ID ...3-90 3.10.2 Exporting/deleting examination data...3-96 3.10.3 Importing examination data ...3-100 3.10.4 Data table ...3-103 3.10.5 Export patient list ...3-106

4.

TECHNICAL INFORMATION...4-1

5.

TROUBLESHOOTING...5-1

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1. PRIOR TO USE ■

Read this manual thoroughly before using the instrument to ensure proper and safe operation.

■

Always

follow

the

operation

procedures

described in this manual. ■

Check that there is no device that generates strong magnetic fields near the instrument. Strong magnetic fields may cause noise and affect measurement.

1.1 Precautions for operation

■

Only allow adequately skilled operators to use the instrument.

■

Precautions for installing the instrument and accessories -

Install the instrument in a location free of water or chemicals. Any water or chemicals entering the instrument or devices may cause an electric shock or failure.

-

Do not install the instrument in a place where chemicals are stored or gases may occur. Spilt chemicals or vapor may enter the instrument or devices and ignite.

-

Check the frequency, voltage, and allowable current (or power consumption) of the power source. Operating the instrument connected to an inappropriate power source may cause fire or an electric shock.

-

Connect the power plug to a grounded 3P-outlet. Otherwise, a short circuit due to failure of the instrument may result in an electric shock.

-

Do not place any heavy object on the power cord or squash the power cord. This may cause fire or an electric shock.

-

Completely insert the power plug into the outlet. Faulty contact, allowing any metal to contact exposed plug terminals, or dust accumulated on exposed plug terminals may result in fire or an electric shock.

-

Ground the instrument appropriately. Otherwise you may get an electric shock.

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-

Do not connect any device with data transmission specifications that are not compatible with the instrument. Connecting such a device may cause a fire or an electric shock. If you wish to connect this instrument to other devices, contact our local distributor or Tomey Corporation.

-

Do not hold the head unit, chin rest, forehead pad, joystick, or cables when lifting the instrument. These components are detachable and the instrument may drop, resulting in injuries.

-

Install the instrument in a location not subject to direct sunlight, high temperature and humidity, or air with significant dust, salt, and/or sulfur content. These may cause failure or malfunction of the instrument.

-

Install the instrument in a level and stable location free of vibration and mechanical impacts to ensure correct capturing, and prevent the instrument from falling or being dropped, which can result in fire or fatal accidents.

-

Install the instrument between the patient and physician so that they can face with each other.

-

Install the instrument in a location that is sufficiently clear of any other equipment that may interfere with the examination when using the instrument.

-

Check the frequency, voltage, and allowable current (or power consumption) of the power source.

■

Precautions before using the instrument

-

Check that the instrument works properly by inspecting switch and button operations, display, and printing.

-

Check that all cables are connected correctly and completely.

-

Since simultaneous use of multiple devices can cause misdiagnosis or result in a hazardous situation, be extremely careful.

-

Check the sections that the patient will directly touch.

-

Peel off the top sheet of chin rest paper and clean the forehead pad with a cloth dampened with alcohol before capturing.

-

Check that the instrument is correctly grounded.

-

Check that the date set in the attached computer conforms to the actual operation date and time.

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■ Precautions during operation -

Do not place any container with liquid in it on the instrument. Any liquid entering the instrument may cause electric shock or failure.

-

Do not use the corneal curvature value or the pachymeter value calculated by this device for refractive surgery, only allow to operate for the surgery with general diagnosis.

-

If the corneal curvature value measured with the instrument is used to select interocular lens, further surgery might be required. Please draw a conclusion with the examination result by other devices.

-

When performing diagnosis using a Topographic color map, it is necessary to conduct a careful review by performing multiple measurements and with other methods. Note that error could be caused in analysis by light blockage with eyelashes or eyelids, misalignment of the center due to unstable faulty analysis due to corneal disorder or secretions.

-

Be extremely careful not to take too much time or too many measurements, as this can stress the patient.

-

Always check that the devices operating correctly and the patient to ensure safety.

-

If a problem with any instrument or the patient occurs, take appropriate action such as stopping the machine to ensure the safety of the patient.

-

When moving the head and/or chin rest of the measuring unit, pay attention to the position of the patient's face, hands, and fingers. The patient may be injured by the moving section of the measuring unit.

-

Do not allow any person to place their hands or fingers in the clearance under the head unit or the section under chin rest, measurement window, or moving section. Their hands or fingers may be crushed and injured.

-

Be careful not to touch the patient and the computer or the computer monitor simultaneously. Do not allow the patient to touch the connection terminal.

-

Do not lean on the instrument or press the instrument from the top. The instrument may fall, resulting in mechanical failure or injuries.

-

Peel off the top sheet of chin paper and clean the forehead pad with a cloth dampened with alcohol before the next patient.

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-

If any smoke, offensive odor, or abnormal sound occurs, turn off the instrument immediately, disconnect the power plug from the outlet, and contact our local distributor or Tomey Corporation.

■

Precautions after operation -

Hold the plug when disconnecting the power cord from the outlet to avoid applying excessive force on the cord. Pulling the cord may damage inner core wires, resulting in electric shock or fire.

-

When disconnecting cords, do not apply too much force to them, for example, do not hold and pull the cord.

-

Refer to “5.4 Routine maintenance” and “5.6 Storing” for instructions on the cleaning and storage of the instrument.

■

If any instrument failure occurs, stop operation immediately, indicate the failure , and contact our local distributor to request repairs. -

Never modify the instrument. Doing so may cause electric shock or failure of the instrument. The instrument contains high-voltage sections. Touching these sections will result in death or serious injuries.

-

Disconnect the power plug from the outlet when replacing fuses. Otherwise you may get an electric shock, resulting in death or serious injuries.

-

Use the power cord and fuses provided with the instrument or specified by Tomey to ensure safety. Also, do not use the accessories provided with the instrument for other equipment.

-

Conduct regular inspections of the instrument and components.

-

When the instrument is not used for 1 month or longer, refer to “5.3 Inspection” in this manual and check that the instrument is operating correctly and safely before starting operation.

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1.2 Checking contents of package Open the package and check that the following items are included in the package and are not damaged. If any item is missing or damaged, contact our local distributor as soon as possible. ■

Keep the box and packing materials for use when moving or transporting the instrument.

■

When taking the instrument out of the box, pull the outer box upward and then remove the packing materials. Be careful not to lift the instrument up by directly holding the head unit, chin rest, forehead pad, joystick, or cables. Otherwise, the instrument could be damaged.

● Main unit Cornea/Anterior Segment OCT ·············· 1 ● Light source unit ·············································· 1 ● Power cord (Light source unit) ···························· 1 ● Power cord (Isolation Transformer) ······················ 1 ● Optical fiber cable ············································ 1 ● Stay for the optical fiber ····································· 1 ● LVDS communication cable································ 1 ● Harness cover ················································· 1 ● Stopper for the circular connector ························ 2 ● Fuses (2 fuses are installed in the Light source unit.) · 4 ● Chin rest paper ················································ 1 ● Pins for Chin rest paper ····································· 2 ● Dust cover ······················································ 1 ● Workstation computer (Keyboard, mouse and power cord are contained) ·· 1 ● PC monitor(Video cable and power cord are contained) ··· 1 ● Model eye······················································· 1 ● Fiber cleaner ··················································· 1 ● Isolation Transformer ········································ 1 ● SS-1000 INSTRUCTION MANUAL (this manual) ···· 1 ● SS-1000 INSTALLATION MANUAL······················ 1 ● TB-1000 INSTRUCTION MANUAL ······················ 1 ● TB-1000 INSTALLATION CD······························ 1

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1.3 Glossary [A/B-scan]

:

The number of A-scan lines per B-scan image

[AA]

:

Auto Alignment See [Auto Alignment].

[AS]

:

Auto Shot See [Auto Shot].

[A-scan]

:

Scan to obtain depth information for the patient's eyes by irradiating the patient's eyes with light

[B/C-scan]

:

The

number

of

B-scan

images

used

to

create

three-dimensional image data [B-scan]

:

Scan to obtain a tomographic image by repeating A-scan along the patient’s eyes

[B-scan image]

:

Tomographic image obtained by B-scan

[CCD view]

:

Screen that displays the CCD image

[CCD/OCT view]

:

Screen that displays the CCD image and the tomographic image simultaneously

[CCD image]

:

Image with the anterior segment of the eye captured from the front

[C-scan image]

:

Tomographic image of the slice plane perpendicular to the depth direction

[En-face image]

:

Projected image of the front

[Horizontal image]

:

Tomographic image of the slice plane in the horizontal direction

[Intel]

:

Intel and Intel Core are registered trademarks of United States Intel Corporation in United States and

other

countries. [ITC]

:

Contact between the iris and Trabecular meshwork or rear of the cornea

[Rotation image]

:

Tomographic image of the slice plane in an optional direction

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[SE]

:

Spherical Equivalence See [Spherical Equivalence].

[TOMEY Link]

:

Digital medical record system to control the data measured with Tomey products

[VD]

:

Vertex Distance [mm] Represents the distance between corneal vertex and posterior surface of the lens.

[Vertical image]

:

Tomographic image of the slice plane in the vertical direction

[Windows]

:

Intel and Intel Core are registered trademarks of United States Intel Corporation in United States and

other

countries. [Z-Off]

:

Function

to

automatically

align

the

sight

in

the

up/down/right/left directions Sight alignment is not performed in the back/forth (depth) directions. [Auto Alignment]

:

Function

to

automatically

up/down/right/left

directions

align

the

sight

and

back/forth

in

the

(depth)

directions. Selecting [Z-Off] allows you to perform [Auto Alignment] in the up/down/right/left directions only. [Auto Shot]

:

Function to automatically start measurement when the patient's eyes are within the measuring range

[Auto power off]

:

Function to automatically turn off the main unit monitor, with only the power lamp flashing, when the instrument is not used for a specified time (Auto Power Off mode). Touch any button to return to Normal mode.

[Shift average]

:

Function to reduce random noise by superimposing the adjacent tomographic images in a three-dimensional image to form an average

[Periphery fixation target]

:

Target to direct the patient’s eye sight in the fixation direction (up/down/right/left).

[Scan direction]

:

Scan direction of B-scan

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[Slice plane]

:

Plane cut from a three-dimensional image

[Zero point]

:

Reference

position

in

the

depth

direction

on

a

tomographic image Sensitivity is higher as the measurement object is nearer to the zero point. [Touch panel]

:

Allows you to make various settings and execute the touch alignment function by directly touching the screen of the measuring unit.

[Accommodation target]

:

Target to encourage accommodation ability of the patient’s eyes

[Spherical Equivalence]

:

Calculated from the refractometer value SPH+CYL/2

[Live image]

:

CCD image and tomographic image displayed in real time before starting measurement

[Radial scan]

:

Scan method to obtain a three-dimensional image by repeating B-scan along the circumference

[Raster scan]

:

Scan method to obtain a three-dimensional image by repeating B-scan horizontally or vertically

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1.4 Outline of operation This instrument is a three-dimensional OCT (optical coherence tomography) image diagnosis unit that captures three-dimensional image of the anterior segment of the patient’s eye by high-speed scanning without making a contact with the eye. In addition to the 3D mode to obtain a three-dimensional image, this instrument also has a 2D mode to obtain a high-resolution two-dimensional tomographic image and a Movie mode to obtain an animated image of a two-dimensional tomographic image. The patient places their chin on the chin rest and looks into the fixation light in the measurement window. When the joystick button is pressed, infrared measurement laser is emitted to the patient's eye and the tomographic image of the eye is displayed on the monitor. While monitoring the front image and tomographic image of the patient’s eye, adjust the position in the up/down/right/left directions and back/forth (depth) directions using the joystick. After alignment is completed, press the joystick button to start measurement. This instrument is also equipped with the Auto Alignment function that performs alignment automatically, facilitating the entire process up until measurement. It also has the Auto Shot function which starts measurement automatically if the patient's eyes are within the measuring range. After measurement is completed, the data is automatically transferred to the computer. The three-dimensional image of the anterior segment can be analyzed in various ways using the dedicated software.

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2. NAMES AND FUNCTIONS OF PARTS AND COMPONENTS 2.1 Examination List screen

6

7

8

5

1 2

3

4

(1) Menu bar Displays menu names. Each menu consists of hierarchical options in a pull-down menu. (2) Tool bar Frequently used menu items are displayed using icons. Each function can be executed by simply clicking the icon. (3) Patient list Set conditions to search for a patient. A list of patients that match the set conditions is displayed. Also, register new patient or modify information for an existing patient. (4) “Do Exam” button area This area contains buttons to recall measurements and capture screens of the instrument to take measurements and capture images by connecting to the PC. (5) Examination data display area Displays the examination data.

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