Instruction Manual
106 Pages
Preview
Page 1
USER MANUAL
3D OPTICAL COHERENCE TOMOGRAPHY
DRI OCT-1
INTRODUCTION Thank you for purchasing the TOPCON DRI OCT-1 3D Optical Coherence Tomography.
INTENDED USE / INDICATIONS FOR USE This instrument is provided to observe, photograph, record and analyse electric imaging information of eye balls and accessory visual structures.
FEATURES This instrument is a special photographic device used to observe, photograph and record the image and tomogram of the fundus and present its electronic image for diagnosis. After photography, the images and tomograms of the fundus can be recorded on a personal computer connected through a network or a commercial recording device (flash memory, hard disk, etc.) connected to this instrument. This instrument can perform a number of analyses, such as the quantity measurement, by using the built-in computer. This instrument has the following innovative features: • High-quality digital imaging • Easy operation • Enhanced computerized features
PURPOSE OF THIS MANUAL This manual outlines the DRI OCT-1 3D Optical Coherence Tomography, including operating procedures, troubleshooting, maintenance and cleaning. Before using the instrument, carefully read the "DISPLAY FOR SAFE USE" and the "SAFETY CAUTIONS" to familiarize yourself with the features of the TOPCON DRI OCT-1 3D Optical Coherence Tomography and to ensure that you operate it efficiently and safely. Always keep this Instruction Manual at hand.
CAUTION : Federal law restricts this device to the sale by or on the order of a physician.
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1. No part of this manual may be copied or reprinted, in whole or in part, without prior written permission. 2. The contents of this manual are subject to change without prior notice and without legal obligation. 3. The contents of this manual are correct to the best of our knowledge. Please inform us of any ambiguous or erroneous descriptions, missing information, etc. 2012 TOPCON CORPORATION ALL RIGHTS RESERVED
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CONTENTS INTRODUCTION ................................................................................................................. 1 GENERAL SAFETY INFORMATION ................................................................................... 5 HOW TO USE THIS MANUAL ............................................................................................. 7 GENERAL MAINTENANCE INFORMATION ...................................................................... 7 USER MAINTENANCE ........................................................................................................ 7 DISCLAIMERS ..................................................................................................................... 7 DISPLAYS AND SYMBOLS FOR SAFE USE ..................................................................... 8 DISPLAYS ........................................................................................................................... 8 SYMBOL .............................................................................................................................. 8 WARNING DISPLAYS AND POSITIONS ............................................................................ 9
COMPONENTS ...................................................................................................................... 10 COMPONENT NAMES ...................................................................................................... 10 COMPOSITION OF PARTS WHICH CONTACT THE HUMAN BODY ............................. 10 CONTROL PANEL COMPONENTS .................................................................................. 11 SCREEN LAYOUT ............................................................................................................. 12 STANDARD ACCESSORIES ............................................................................................ 30
PREPARATIONS ................................................................................................................... 31 INSTALLING THE INSTRUMENT ..................................................................................... 31 CONNECTING THE POWER CORD ................................................................................ 32 CONNECTING THE EXTERNAL DEVICE ........................................................................ 33 SETTING MENU ................................................................................................................ 34 RESET FROM POWER SAVE STATE .............................................................................. 48
BASIC OPERATIONS ........................................................................................................... 49 FLOW OF OPERATION .................................................................................................... 49 PREPARATION FOR PHOTOGRAPHY ............................................................................ 50 FUNDUS TOMOGRAPHY ................................................................................................. 51 RED-FREE PHOTOGRAPHY ............................................................................................ 67 SAVING DATA ................................................................................................................... 68 PRINTING DATA ............................................................................................................... 68 HOW TO FINISH ............................................................................................................... 68
MAINTENANCE ...................................................................................................................... 69 DAILY CHECKUPS ............................................................................................................ 69 ORDERING CONSUMABLES ........................................................................................... 69 REPLACING THE ILLUMINATION LAMP ......................................................................... 70 CHANGING THE FUSE ..................................................................................................... 71 REFILLING THE CHIN-REST PAPER SHEET ................................................................. 72 ADJUSTING THE MONITOR ............................................................................................ 72 MAINTENANCE BY THE DEALER ................................................................................... 72
CLEANING ............................................................................................................................... 73 CLEANING THE EXTERNAL COVER, CONTROL PANEL AND OTHERS ...................... 73 CLEANING OF THE PARTS WHICH COME INTO CONTACT WITH THE PATIENT ...... 73 CLEANING THE MONITOR SCREEN .............................................................................. 73 CLEANING THE OBJECTIVE LENS ................................................................................. 74
BEFORE REQUESTING SERVICE .................................................................................. 75
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TROUBLESHOOTING ....................................................................................................... 75
SPECIFICATIONS AND PERFORMANCE .................................................................... 79 SYSTEM DIAGRAM .......................................................................................................... 79 SPECIFICATIONS ............................................................................................................. 80 OTHER SPECIFICATIONS ............................................................................................... 81 SPECIFICATIONS OF THE PERSONAL COMPUTER (COMMERCIAL PRODUCT) TO BE CONNECTED .................................................................................... 82
GENERAL INFORMATION ON USAGE AND MAINTENANCE .............................. 83 INTENDED PATIENT POPULATION ................................................................................ 83 INTENDED USER PROFILE ............................................................................................. 83 ENVIRONMENTAL CONDITIONS FOR USE ................................................................... 83 STORAGE, USAGE PERIOD ............................................................................................ 83 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN STORAGE .............................. 83 ENVIRONMENTAL CONDITIONS FOR PACKAGING IN TRANSPORTATION ............... 83 ELECTRIC RATING ........................................................................................................... 84 DIMENSIONS AND WEIGHT ............................................................................................ 84 SYSTEM CLASSIFICATION .............................................................................................. 84 OPERATION PRINCIPLE .................................................................................................. 85 CHECKPOINTS FOR MAINTENANCE ............................................................................. 85 DISPOSAL ......................................................................................................................... 86 PATIENT’S ENVIRONMENT ............................................................................................. 87 Requirements for the EXTERNAL DEVICE ....................................................................... 87 ELECTROMAGNETIC COMPATIBILITY ........................................................................... 88
RELATION BETWEEN THE SETTING OF THE ILLUMINATION LEVEL AND MAXIMUM RADIANCE ......................................................................................................... 92 REFERENCE MATERIAL .................................................................................................... 93 SCAN PATTERN SPECIFICATIONS ................................................................................ 93 TYPE OF PLUG ................................................................................................................. 95
INFORMATION ABOUT THE OPTICAL RADIATION HAZARD FOR THE USER .................................................................................................. 96 END USER LICENSE AGREEMENT ............................................................................... 97
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GENERAL SAFETY INFORMATION CONTRAINDICATIONS This instrument must not be used for the following patients. •Patients who are hypersensitive to light •Patients who recently underwent photodynamic therapy (PDT) •Patients taking medication that causes photosensitivity.
WARNINGS Ensuring the Safety of Patients and Operators Use this instrument carefully on the following patients. •Patients who have epidemic corneitis, conjunctivitis or any other infectious disease •Patients who are taking medications that cause light hypersensitivity. Be careful not to hit the patient's eyes or nose with the instrument during operation. The patient may be injured. Handling the cord on this product or cords associated with accessories sold with this product, will expose you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after handling. Preventing Electric Shocks and Fires. To avoid fire and electric shock, install the instrument in a place free of water and other liquids. To avoid fire and electric shock, do not put cups or vessels containing liquids near the instrument. To avoid electric shock, do not insert metal objects into any vents and/or slots. To avoid fire in the event of an instrument malfunction, immediately turn OFF ( ) the Power switch and unplug the cable if you see smoke coming from the instrument or if you detect other problems. Don't install the instrument where it is difficult to unplug the cable from the instrument body. Ask your dealer for repairs.
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CAUTIONS Ensuring the Safety of Patients and Operators When operating the chin-rest up/down switch, be careful not to pinch the patient's hand to avoid possible injury. To avoid injury, do not touch the focusing knob in auto focus operation. To avoid injury of the patient, be careful not to bump the patient's eye or nose with the instrument when operating the touch panel.
Preventing Electric Shocks and Burn To avoid electric shock, do not open the instrument. Request service from an authorized Topcon distributor. Electric shock may cause burns or a possible fire. Turn the power switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating. Do not put any substance over the vent on the top surface of the power supply unit. If the vent is covered, the temperature of the power supply unit may rise abnormally to cause a malfunction. To prevent the instrument from malfunction, do not drop any liquid into the vent.
Electromagnetic Compatibility (EMC) This instrument has been tested (with 100V/120V/230V) and found to comply with IEC60601-1-2: 2007. This instrument radiates radio frequency energy within standard and may affect other devices in the vicinity. If you have discovered that turning on/off the instrument affects other devices, we recommend you change its position, keep a proper distance from other devices, or plug it into a different outlet. Please consult the dealer from whom you purchased the instrument if you have any additional questions.
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HOW TO USE THIS MANUAL • Read the instructions on pages 5 to 6 before using the machine. • Regarding connection to various devices, see "CONNECTING THE EXTERNAL DEVICE"on page 33. • If you would like an overview of the system, begin by reading "BASIC OPERATIONS" (page 49).
GENERAL MAINTENANCE INFORMATION USER MAINTENANCE To ensure the safety and performance of the instrument, all maintenance work, unless specified in this manual, shall be conducted by trained service engineers. The following maintenance tasks may be done by the user. For details, see the relevant part of this manual.
Replacing fuses: The fuses on the instrument body may be replaced by the user. For details, see "CHANGING THE FUSE" on page 71.
Cleaning the objective lens: The objective lens may be cleaned by the user. For details, see "CLEANING THE OBJECTIVE LENS" on page 74.
DISCLAIMERS • TOPCON shall not take any responsibility for damage due to fire, earthquakes, actions by third persons and other accidents, or damage due to negligence and misuse by the user and any use under unusual conditions. • TOPCON shall not take any responsibility for damage derived from inability to properly use this instrument, such as loss of business profit and suspension of business. • TOPCON shall not take any responsibility for damage caused from using this instrument in a manner other than that described in this Instruction Manual. • Diagnoses made shall be the responsibility of pertaining doctors and TOPCON shall not take any responsibility for the results of such diagnoses.
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DISPLAYS AND SYMBOLS FOR SAFE USE To encourage safe and proper use and to prevent injury to the operator and others or potential damage to property, important messages are put on the instrument body and inserted in the instruction manual. We suggest that everyone understand the meaning of the following displays, icons and text before reading the "SAFETY CAUTIONS" and observe all listed instructions.
DISPLAYS Display
Meaning
CONTRAINDICATIONS
Situations in which the device should not be used because the risk of use clearly outweighs any possible benefit.
WARNINGS
Incorrect handling by ignoring this display may lead to a risk of death or serious injury.
CAUTIONS
Incorrect handling by ignoring this display may lead to personal injury or physical damage.
NOTES
Useful functions to know. Paying attention to these will prevent the noted problems.
SYMBOL Symbol
8
IEC/ISO Publication
Description
Description (French)
IEC 60417-5032
Alternating Current
Courant alternatif
IEC 60417-5008
Off (power: disconnection from the mains)
Éteint (courant: avec le secteur)
IEC 60417-5007
On (power: connection of the mains)
Allumé (courant: raccordement sur le secteur)
IEC 60878-02-02
Type B applied part
Partie appliquée du Type B
ISO 7010-W001
General warning sign
Symbole d'avertissement général
ISO 7010-M002
Refer to instruction manual/ booklet
Voir le manuel/la brochure
coupure
WARNING DISPLAYS AND POSITIONS To ensure safety, this machine provides warning displays. Use the instrument correctly by observing the display instructions. If any of the following display labels are missing, contact your TOPCON dealer at the address listed on the back cover. 4
4
3 5
1 7 9 10
No.
Label
2
6
8
Meaning WARNING
1
Electric shock may cause burns or a possible fire. Turn the power switch OFF and unplug the power cord before replacing the fuses. Replace only with fuses of the correct rating.
2
To avoid electric shock, do not open the instrument. Request service from an authorized Topcon distributor.
3
When operating the chinrest up/down switch, be careful not to pinch the patient's hand to avoid possible injury.
4
Do not touch the focusing knob while in auto focus mode. You may be injured.
5
To avoid potential injury during operation, do not touch the patient’s eyes or nose with the instrument.
6
To avoid injury of the patient, be careful not to bump the patient's eye or nose with the instrument when operating the touch panel.
WARNING WARNING CAUTION CAUTION CAUTION
7
Do not put any substance over the vent on the top surface of the power supply unit. If the vent is covered, the temperature of the power supply unit may rise abnormally to cause a malfunction. To prevent the instrument from malfunction, do not drop any liquid into the vent.
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CAUTION-CLASS 3B INVISIBLE LASER RADIATION WHEN OPEN AVOID EXPOSURE TO THE BEAM.
9
Degree of protection against electric shock : TYPE B APPLIED PART
10
CLASS I LASER PRODUCT
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COMPONENTS COMPONENT NAMES Main unit
External fixation target Diopter compensation lens selector
Main unit external cover
Focusing knob
Monitor
Brightness volume
Photography switch Control lever
IR filter selector
Vertical position mark Base brake knob Power lamp
Control panel
Sliding board
Power supply unit External connection terminal (left side)
Fixing knob (for carrying)
Forehead rest *1 Objective lens
Canthus marker
Chin-rest unit
Forehead rest base Chin-rest paper pin
Chin-rest *1
Lamp house cover screw *1:Contacting part (class B)
Lamp house cover Power switch Fuse holder External connection terminal (right side)
COMPOSITION OF PARTS WHICH CONTACT THE HUMAN BODY Forehead rest : Silicone rubber Chin-rest : Acrylonitrile butadiene styrene resin Chin-rest paper pin : Polyamide resin
10 COMPONENTS
CONTROL PANEL COMPONENTS
Base brake knob
Chin-rest up/down switch
Photography switch Internal fixation target position move switch (Up/Down/Left/Right/Reset) Power lamp
Chin-rest up/down switch: Adjusts the chin-rest up/down movement. Internal fixation target position move switch: Adjusts the internal fixation target position finely. Power lamp: Displays "power ON" (this lamp is ON) and "power OFF" (this lamp is OFF). Photography switch: Starts photography. Base brake knob: Locks and unlocks the base.
11 COMPONENTS
SCREEN LAYOUT Display areas and functions of monitor screen The monitor screen is a touch panel. The monitor displays information, and you can perform a variety of operations by touching its screen.
Capture icon selection screen Patients ID display area
[Follow-up] button
Capture icon TAB
[SET UP] button
Capture icon display area
Patients ID display area
: Displays the patients ID.
Capture icon TAB
: Select a tab, and the photography icons, which are registered in each tab, are displayed.
[SET UP] button
: Shifts to the setting menu screen.
Capture icon display area
: Displays the capture icon.
[Follow-up] button
: • Each time you press this button, "Follow-up ON" (button is orange) and "Follow-up OFF" (button is black) is changed each other. In case of "ON", Follow-up photography is done. In case of "OFF", it is not done. • Follow-up photography is applied to the following cases. • Line • 5 Line Cross • 12 Radial • When selecting the photography icon to which Follow-up photography is unapplied, Follow-up photography is not done even if this button is set to "ON".
NOTES
12 COMPONENTS
The follow-up photography function is as follows: the system searches the same scan position as the last photographed data by using the live IR image of the present photograph to determine the scan position.
Reading the base line data for Follow-up photography • Click the photography icon (to which the Follow-up mode is applied) on condition that the [Follow-up mode] button is ON (orange). The system reads the photography data in the past (base line data) that is relevant to the entered patient ID and the selected photography icon.
• The following message is displayed when the relevant data does not exist. • One eye data of the relevant data does not exist.
or
• Both eyes data of the relevant data does not exist.
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Photography screen (OCT photography)
Follow up button
Area 1
Area 3
Area 2
Tomogram live image area
Fundus live image area
Area 1
: Displays the operation mode buttons and changes the modes. The current operation mode is highlighted in orange. The mode that cannot be selected according to the current status is displayed in gray unclearly. The mode cannot be selected even if you touch the button in this status.
Area 2
: Displays the message corresponding to the current status.
Area 3
: Changes the data for the small pupil diaphragm or internal fixation target and adjusts the scan position.
Fundus live image area
: Displays the fundus live image and the graphic image of the scan pattern, which is set in the selected capture icon, with an interrupted line. The right/left eye and illumination level are displayed around the live image. You can adjust the illumination level by the touch panel. (Refer to page 20.) Displays the scan position adjustment range and the fine adjustment buttons in the scan position adjustment mode. You can adjust the scan position by the touch panel. (Refer to page 17.) You can enhance the contrast of the fundus live image with the [Enhance] button at the lower right corner. (Refer to page 20.)
Tomogram live image area
: Displays the tomogram live image. You can perform a variety of operations on the live image. (Refer to page 23.)
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Follow-up button
: The button display is changed according to the Follow-up photography status. The button is not displayed: The selected icon is not the object of Follow-up photography. The button is ON (orange): The selected icon is the object of Follow-up photography. So Follow-up photography is done. The button is OFF (black): Indicates one of the following situations: • The selected icon is the object of Follow-up photography but Follow-up photography cannot be done (the relevant data in the past does not exist). • The mode is changed to the normal photography mode by pressing the [Follow-up] button.
Area 1 Area1 displays the operation mode buttons.You can change to each mode.
Menu button
Capture mode button
Preview mode button
Menu button
: Returns to the photography icon selection screen.
Capture mode button
: Decides the input information and shifts to the photography screen to take a picture.
Preview mode button
: Checks the photographed image and shifts to the preview screen. When there is not a photographed image or when the timer is used in FA photography, this button is displayed in gray unclearly.
Area 2 Area 2 displays the message corresponding to the current status. This area displays mainly the messages for the current processing and for the operation guide. • Message for the current processing When a message for the current processing is displayed, wait until the message disappears.
• Message for the operation guide When a message for the operation guide is displayed, operate the instrument according to the message.
15 COMPONENTS
Area 3 In Area 3, set or change the small pupil diaphragm and the internal fixation target and adjust the scan position. Set or change data with the buttons. Internal fixation target shape selector button Auto search button External fixation target selector button
OCT Focus Position selector button Scan position adjustment mode button
Internal fixation target position selector button Small pupil diaphragm selector button
• Auto search selector button <Circle scan> Set the auto search selector button to "ON". The system detects and tracks the optic disc position automatically. Even if the optic disc moves slightly due to the minute fixation move, you can always perform "Circle scan" with the optic disc as the center. Sometimes the optic disc cannot be automatically detected due to the optic disc shape of the patient or the image contrast. In this case, follow the countermeasure (manual photography or optic disc position specification), which is displayed with the error message, and perform photography again. For details of the countermeasure (manual photography or optic disc position specification), refer to "MEMO" on page 65. <"Line" scan/"Radial" scan/"5 Line Cross" scan> Set the auto search selector button to "ON" except Follow-up photography. The system searches the position specified on the fundus lock screen according to the IR image. In Follow-up photography, the auto search selector button is always ON and this status cannot be changed. The system searches the same position as the base line according to the IR image. • OCT Focus Position selector button < Enhanced Choroidal Mode > To obtain a clear tomogram at the inner place from retina(e.g. choroidal or optic disc), you should set to "Choroidal". To obtain a clear tomogram at the epithelium such as retina, you should set to "Vitreous". When you change Choroidal/Vitreous, pull the instrument fully toward the operator.
16 COMPONENTS
• Scan position adjustment mode button The scan position adjustment mode is accessed. The selected scan pattern, the scan position adjustment range, the scan possible range (only in "Radial" and "5 Line Cross" scan), the fine adjustment buttons, the [Refresh] button (when the auto search function is ON), and [Reset] button (when the auto search function is OFF) are displayed on the fundus live image area. When the auto search function is ON, not the live image but the still image is displayed. To update the still image, press the [Refresh] button. When you want to change manually the circle scan position that is automatically detected by the optic disc auto search function to the desired position, use this scan position adjustment button. Fine adjustment button (up) Scan pattern display (green and yellow)
In case of auto search "ON", the button is displayed. In case of auto search "OFF", the button is displayed. Scan position adjustment range (blue)
Fine adjustment button (left)
Fine adjustment button (right) Scan possible range (red) * Displayed only in Cross/Radial/ 5 Line Cross scan. Fine adjustment button (down)
Line scan Rotation button (counterclockwise) * Displayed only in Line scan.
Rotation button (clockwise) * Displayed only in Line scan.
Circle scan (The still image is displayed.)
Optic disc auto search effective range (red) * Displayed only when the optic disc auto search function is ON in "Circle" scan.
17 COMPONENTS
Scan pattern display (green and yellow) Displays the graphic image of the scan pattern kinds. The green line shows the scan position, and the arrow shows the scan advance direction. (In case of "Radial", "Circle" and "5 Line Cross", the arrow direction for the right eye is reversed for the left eye.) The yellow line is displayed for the scan patterns except "Line" and "Circle". For "3D", the yellow line shows the scan range and, for other scan patterns, the scan position in addition to the position indicated by the green line. When scan is performed once, it is done at the positions indicated by the green and yellow lines.
3D
3D (V)
Line
Circle
Radial
5 Line Cross
Scan position adjustment range (blue) Displays the "6.0mm×6.0mm" range at the focal point on fundus. Touch this range, and the scan position is moved to the touched point. For the "5 Line Cross" and "Radial" scan patterns, the intersection (center of the displayed scan pattern) of lines is the limit of the movable range. For other scan patterns, the edge position of lines is the limit of the movable range. In the case of the tomogram within the "6.0mm×6.0mm" range, you can get the detection sensitivity enough. Scan possible range (red) Displayed only for "5 Line Cross" and "Radial" scan patterns. This range shows the "12.0mm× 12.0mm" range on fundus. This is the limit range where you can get a tomogram by using this instrument. If a tomogram exceeds the "6.0mm×6.0mm" range indicated by the blue line, you cannot always get the sufficient detection sensitivity because the pupil and others obstruct the photography. Fine adjustment buttons (up/down/right/left) Each time you touch these buttons, the scan position is moved by about 0.03mm (on fundus) in the arrow direction. RESET button Displayed only when the auto search function is OFF in "Circle" scan. Press this button, and the position is returned to the center of the scan position adjustment range (blue). Rotation buttons (clockwise/counterclockwise) Displayed only for "Line" scan. Each time you touch these buttons, the scan line is rotated by 5° in the arrow direction.
18 COMPONENTS
Optic disc auto search effective range (red) Displayed only for "Circle" scan. This indicates the "4.0mm×4.0mm" range at the focal point on fundus. Use this range to adjust the "Circle" scan position manually to the optic disc center. To put the patient's optic disc into this range, move the fixation position (move the optic disc) by the internal fixation target position move switch on the control panel. The circle center may be aligned with the optic disc center. When the optic disc is put into this range, the optic disc is automatically detected by the optic disc auto search function thereafter • Small pupil diaphragm selector button Displays the small pupil diaphragm status (ON/OFF). You can change ON/OFF of the small pupil diaphragm. When the pupil diameter of the patient is small (pupil diameter is approx. φ4.0mm or less), set to ON and take a picture. (Refer to P.59.) • Internal fixation target position selector button When selecting the fundus capture icon, the internal fixation target position (one of "D", "C" and "M") is displayed according to the setting. The fixation target position is changed to "D", "C" and "M" in turn by touching this button. D (Disc): Optic disc is the center of the screen. C (Center): The middle position between macula and optic disc is the center of the screen. M (Macula): Macula is the center of the screen. • external fixation target selector button Displays the status (ON/OFF) of the external fixation target. You can change ON/OFF of the external fixation target by this button. When the external fixation target is ON, the internal fixation target shape selector button and the internal fixation target position selector button are displayed in gray unclearly. The shape or position of the internal fixation target cannot be changed even if you touch the button in this status. Displays the status of the internal fixation target. (Background is gray.)
Displays the status of the external fixation target. (Background is orange.) • Internal fixation target shape selector button Displays the selected internal fixation target shape. You can select the internal fixation target shape among the following five shapes by pressing this button. • 1 dot/4-dot rectangle/4-dot rhomb/×/cross
19 COMPONENTS
Fundus live image area This area displays the fundus live image, the right/left eye, illumination level and besides, the graphic image of the scan pattern, which is set on the selected capture icon, with an interrupted line. You can set ON/OFF of the illumination level and the "Enhance" function for the live image by the touch panel. When the optic disc auto search function is ON in "Circle" scan, the range frame where the optic disc can be automatically tracked (optic disc tracking frame (blue)) is displayed and when the scan size is not "3×3" in the 3D optic disc scan, optic disc tracking frame (red) is displayed. In the scan position adjustment mode, the selected scan pattern is displayed with a solid line, and the scan position adjustment range and fine adjustment buttons are displayed. You can adjust the scan position by the touch panel. Scan pattern display (green and yellow) * Interrupted line
Right/left eye display
Live image
[Enhance] button Illumination level display
• Live image: Displays the fundus live image. • Scan pattern display (green and yellow): Displays the graphic image of the scan pattern, which is set on the selected capture icon. The green line shows the scan position, and the arrow shows the scan advance direction. (The arrow direction for the right eye is reversed for the left eye.) The yellow line is displayed for the scan patterns except "Line" and "Circle". For "3D", the yellow line shows the scan range and, for other scan patterns, the scan position in addition to the position indicated by the green line. When scan is performed once, it is done at the positions indicated by the green and yellow lines. The length and size of the lines are changed according to the set value of scan size.
3D
3D (V)
Line
Circle
Radial
5 Line Cross
20 COMPONENTS
• Right/left eye display: In the case of left eye, "OS(L)" is displayed at the upper right position of the live image. In the case of right eye, "OD(R)" is displayed at the upper left position. • Illumination level display: Displays the illumination level (level) by five steps (value: 1 to 5). You can adjust the illumination level by touching the screen. (Refer to P.57.) • Optic disc tracking frame (blue) Displayed only when the optic disc auto search function is ON in "Circle" scan. This frame shows the optic disc auto search possible range. Put the patient's optic disc into this frame by operating the internal fixation target position move switch on the control panel. So, the optic disc auto search function works to detect the optic disc automatically.
Optic disc tracking frame (blue)
21 COMPONENTS
• Optic disc tracking frame (red): Displayed when the scan size is not "3×3" in the 3D optic disc scan. Put the patient's optic disc into this frame by operating the internal fixation target position move switch on the control panel. Then, take a picture.
Optic disc tracking frame (red)
• Follow-up photography When Follow-up photography is executed in "Line", "Radial" and "5 Line Cross" scan, alignment starts according to the base line IR image and the system is under the fundus lock condition.
Fundus lock condition
22 COMPONENTS
Tomogram live image area This area displays the tomogram live image. Perform the operation on the live image. Warning line (orange) for the tomogram display position
Z lock position display bar
Live image
Z lock position
[Manual] button [Image Quality] level meter
[Optimize] button
Image Quality value (IQV)
• Z lock position : Displays the center position of the displayed tomogram. After the processing of "Auto Z (Z lock)" and "Auto Polarization", the tomogram live image is always displayed on the 2/3 position at the upper side on the bar. • Z lock position display bar : Indicates the Z lock position changeable range. By touching an optional position on the bar, you can move the center position of the displayed tomogram to the touched position.
Z lock position is moved.
23 COMPONENTS
• Image Quality value (IQV) : Displays the "Image Quality" level with a value.
NOTES
Image Quality value (IQV) is the image quality evaluation standard peculiar to TOPCON. IQV shows the image quality of the tomograms obtained by DRI OCT-1 with a value quantitatively. When you need a tomogram applicable to image analysis or other processing, IQV must be 45 or higher. If IQV is 45 or higher, the tomogram has a proper image quality. If IQV is 70 or higher, the tomogram has an excellent image quality. If IQV is less than 45, image analysis can be performed for the tomogram but the reliability on the analysis result is reduced. So the tomogram is not applicable for analysis.
• [Image Quality] level meter
: Displays the "Image Quality" level with meter.
• Live image
: Displays the live tomogram image.
• [Optimize] button : Starts "Auto Z (Z Lock)" and "Auto Polarization" and detects the retina position automatically. Then, this button optimizes the image output sensitivity to display a clear tomogram. : This is displayed when part of the tomogram overlaps the top edge of the • Warning line tomogram live image area. If you take a picture in the condition that this (orange) for the tomogram display line (orange) is displayed, analysis after photographing may not be successful. Therefore, lower the Z lock position until this line disappears. position Then, take a picture. • [Manual] button
24 COMPONENTS
: If the image is not found by the [Optimize] button, press the [Manual] button and operate the Z lock tab and [Rough operation] button to perform optimizing.
Preview screen (OCT photography) After OCT photography, the preview screen shown below appears.
Tomogram preview area
Photographed image
Scanned range
Tomogram preview area
Scan position (icon)
Red-free image
: Previews the photographed tomograms up to three. When there are four or more images in "3D" or "Radial" scan, the typical image is displayed in this area. In "3D" scan, the three images at the center and both ends are regarded as the typical images and, in "Radial" scan, the two images (vertical and horizontal) are regarded so. For each image, an icon and a value that indicate the scan position are displayed.
Scan position (value)
: Displays the image taken by each photographing action.
25 COMPONENTS
Menu screen Set many kinds of data for this instrument on this screen. On the capture icon selection screen, which is the initial screen, press the [SET UP] button. This screen appears. • Capture select screen Set the icon display on the capture select screen and the parameters for each capture icon. Function button
[Edit Tab Name] button
Page name
Page number
Capture icon Tab
Capture Icon List
Icon layout setting area
Page forward/ backward button
[Delete] button [Edit ] button
[Default] button
[Add] button
Function button
: Saves and cancels the setting.
Page name
: This is the name of the current setting menu page.
Capture icon LIst
: Displays all the Capture icon. Display the hidden Capture icon with the scroll bar at the rightmost.
Page number
: Displays the current setting menu page's number in the page order.
Icon layout setting area
: Sets the icons that will be displayed on the Capture icon selection screen, which is the initial screen.
Page forward/backward button [Edit] button
: Shifts to other pages in the setting menu.
Capture icon Tab
: Select a tab, and the photography icons, which are registered in each tab, are displayed.
[Edit Tab Name] button
: You can change capture icon Tab name.
26 COMPONENTS
: Shifts to the parameter setting screen to check and change the parameters for the capture icon selected in the icon layout setting area.
[Add] button
: Adds the icon, which is selected on the capture icon list, to the upper left of the icon layout setting area. When you select a capture icon in the icon layout setting area, the icon is added to the left side or upper right corner of the capture icon.
[Default] button
: Resets all the icons, which are displayed on the icon layout setting area, to the initial status. The message for rechecking is displayed.
[Delete] button
: Deletes the capture icon, which is selected in the icon layout setting area. After deleting, the remaining capture icon are placed in order from the left.
27 COMPONENTS
• Parameter setting screen Set the parameters for the capture icon selected in the icon layout setting area. Function button
Capture icon name Display of the icons
Page number
Item name Page forward/backward button
Item value display area
Item value selector button
Function button
: Saves and cancels the setting.
Display of the capture icon name
: Displays the selected capture icon name.
Display of the icons
: Displays the icons of the selected capture icon.
Item name
: Displays the objective items of the parameters for the selected capture icon. Select the desired item.
Item value display area
: Displays the current set status of the item buttons.
Item value selector button
: Displays the items to be set for each item button. Select the desired item.
Page number
: Displays the number of the current parameter setting page in the page order.
Page forward/backward button
: Shifts to other pages for setting parameters.
28 COMPONENTS
• Photography setting screen - Auto operation setting screen - Memory screen Set a variety of photography data and removal of USB memory. Function button
Page name
Page number
Utility button
Page forward/backward button
Item button
Item value display area
Function button
: Saves and cancels the setting.
Page name
: This is the name of the current setting menu page.
Page number
: Displays the current setting menu page's number in the page order.
Utility button
: Displays the objective items on the current setting menu page. Select the desired item.
Page forward/backward button
: Shifts to other pages in the setting menu.
Item button
: Displays the objective items of the parameters for the selected capture icon. Select the desired item.
Item value display area
: Displays the current set status of the item buttons.
29 COMPONENTS
STANDARD ACCESSORIES Upon unpacking, make sure that all the following standard accessories are included. Figures in ( ) are the quantities. Power cord (1)
Fuses (5)
Chin-rest paper sheet (1)
External fixation target (1)
Monitor cleaner (1)
User manual and Unpacking and assembly manual (1 each)
UNPACKING AND ASSEMBLY MANUAL
3D OPTICAL COHERENCE TOMOGRAPHY
USER MANUAL
OCT-1
3D OPTICAL COHERENCE TOMOGRAPHY
DRI OCT-1
Dust cover (1)
Spare parts case (1)
Chin-rest paper pins (2)
Rail covers (2)
Phillips screwdriver (1)
LAN cable (1)
30 COMPONENTS
PREPARATIONS INSTALLING THE INSTRUMENT
CAUTIONS
1 2
• To prevent the instrument from falling and to avoid injury during carrying, be sure to secure the instrument with the fixing knob at the bottom. • To avoid injury or damage, two people should be employed for supporting the instrument from the underside. Carrying by one person may result in personal injury and/or damage to the instrument should the person slip or fall. If you support any other part except the underside, you may be pinched by the instrument or injured by falling. • To avoid falling and injury while moving the table with the instrument on top of it, be sure to use an approved automatic instrument table. • To prevent the instrument from falling and to avoid injury, install the instrument on a level surface.
Fasten the fixing knob. Firmly hold the instrument body at the specified positions, and put it on the automatic instrument table.
Holding positions
3 4
Fixing knob
Holding the instrument body
After installing the instrument, fully loosen the fixing knob. The instrument body is free to move. If the instrument body is slightly unlevel, fine-adjust the height by properly operating the four adjusters. Do not extend the adjuster past 1cm.
Adjuster
31 PREPARATIONS
CONNECTING THE POWER CORD To avoid fire and electric shock in case of leakage, be sure to use a
WARNINGS power supply equipped with a 3-pin plug AC receptacle for proper grounding.
CAUTIONS
1 2
3
To avoid electric shock, do not handle the plugs with wet fingers.
Make sure that the POWER SWITCH of the instrument body is OFF ( Attach the power cord to the instrument body.
Plug the power cord into the 3-pin plug AC receptacle.
32 PREPARATIONS
).
CONNECTING THE EXTERNAL DEVICE CAUTIONS
NOTES
To avoid electric shock, do not touch the external connection terminal, the cable terminal from the external device and the patient at the same time. Use the external device complying with IEC60950-1 or UL60950/ UL60950-1. Do not connect any device that is not specified as a system. For details about connecting the external devices, contact your dealer or TOPCON (see the back cover).
The connection terminals for external devices are arranged at the right and left of the base unit. External connection terminals (Right side)
USB terminal 2 USB terminal 3
USB terminal 1
External connection terminals (Left side)
Digital video terminal (Spare) Trigger terminal
USB terminal 4 (spare)
LAN terminal
Video terminal
Connecting to the monitor
1
Connect the VGA cable from the monitor to the Video terminal of the instrument.
Connecting to the external memory
1
Connect the external memory such as the USB storage to the USB terminals 1-3 of the instrument.
Connecting to a personal computer
1
Connect the LAN cable, which is the accessory of the instrument, from the personal computer to the LAN terminal of the instrument.
NOTES
You must install the analysis software,which is the accessory of the instrument, to the connected personal computer.
Connecting to LAN This instrument can be connected to Local Area Network through the LAN terminal.
1
Using the LAN cable, which is the accessory of the instrument, connect the Local Network to the LAN terminal of the instrument.
33 PREPARATIONS
SETTING MENU On the setting menu screen, you can set a variety of data.
Preparation for setting
1 2
Check the power cord connection. For details, see "CONNECTING THE POWER CORD" on page 32. Turn ON (I) the POWER SWITCH of the instrument.
Displaying the setting menu screen
1 2
Check the capture icon selection screen, which is the initial screen. Press the SET UP button on the capture icon selection screen.
[SET UP] (setting menu) button
3
Check the setting menu screen.
Returning to the capture icon selection screen
1 2
Press the Cancel button. Return to the capture icon selection screen.
34 PREPARATIONS
PAGE 1: Capture Setting On the "PAGE 1" screen, set the icon display for the capture icon, which is displayed on the capture icon selection screen, and the parameters for each capture icon. For the details of the buttons, refer to page 26 and page 28. • PAGE 1: Initial screen
• How to delete the displayed icon
1
Touch and select the capture icon to be deleted in the icon layout setting area. (It is highlighted.)
35 PREPARATIONS
2
3
Press the Delete icon button.
Make sure that the icon is deleted. The remaining icons are moved to the left side or upper right corner.
36 PREPARATIONS
• How to add the displayed icon
1
2
Touch and select the capture icon to be added from the capture icon list. (It is highlighted.)
To specify the position of the icon to be added, select the icon of the desired position in the icon layout setting area.
37 PREPARATIONS
3
4
Press the Add icon button.
Make sure that the icon is added. The icon that was in the position of the added icon is moved to the right side or lower left corner. Other icons are also moved to the right side or lower left corner in turn.
38 PREPARATIONS
• How to check and change the parameters for the icons
1
2
Touch and select the icon of the capture icon for which the parameters should be checked and changed in the icon layout setting area. (It is highlighted.)
Press the
Edit
button at the bottom of the screen.
39 PREPARATIONS
3
4
The parameter setting screen appears.
Touch the item button whose setting should be changed. The selectable item values are displayed. Touch and change the value to the desired one. Press the [OK] button to decide the change. If you press the Cancel button, the value before changing is set again and the system exits from the parameter setting screen.
40 PREPARATIONS
Item buttons for setting parameters (1) Scan Pattern Scan pattern means the shape or kind to be scanned. It is classified into the following 7 kinds. 3D: You can scan horizontally set the range (Scan Size) with the set resolution (Scan Resolution) and display the scanned object as a stereograph. 3D (V): You can scan vertically set the range (Scan Size) with the set resolution (Scan Resolution) and display the scanned object as a stereograph. Line: Scans linearly. Cross: Scans in a horizontal or vertical cross shape. Radial: Scans radially with the set radial lines (Radial Scan Count). Circle: Scans circumferentially. (2) Scan Size "Scan Size" means the length or range to scan. (3) Scan Resolution "Scan Resolution" means the data quantity to be read by scanning. In the "Line", "Radial" and "Cross" scan, it is the data for one line. In the "Circle" scan, it is the data for one circumference. In the "3D" scan, it is the data for each side of "Length×Breadth". As the scan resolution is higher, a more detailed tomogram can be obtained and at the same time the data quantity is increased. So, it takes a longer time to process the read data and the saved data are increased. (4) Fixation Position Set the fixation position of the patient. There are three selectable items, "Disc", "Center" and "Macula". When "Disc" is set, the optic disc is positioned at the center of the photography screen for the fixation position. When "Center" is set, the middle position between the optic disc and macula is positioned at the center, and when "macula" is set, macula is positioned at the center. (5) Over Scan Count "Over Scan Count" means the following function: The data are read several times at one position for one scanned line. Two or more tomograms at one position are obtained and are displayed in the overlapped status. Consequently the tomogram with better contrast than usual can be obtained. (6) OCT Focus Position There are the following selectable items according to the capture icon for which parameters should be set. Vitreous and Choroidal: For some capture icons, there are two selectable items,”Vitreous” (vitreous body) and “Choroidal” (choroid). When you set "Vitreous", you can obtain a tomogram with the reduced noise at the vitreous body side from the retina epithelium. When you set "Choroidal", you can obtain a tomogram with the reduced noise at the choroid side which is inner from retina. To obtain a clear tomogram at the epithelium such as retina, you should set to "Vitreous". To obtain a clear tomogram at the inner place from retina (e.g. choroid or optic disc), you should set to "Choroidal". In the initial setting of this instrument, "Vitreous" is set.
41 PREPARATIONS
PAGE 2: Photography Setting On the "PAGE 2" screen, set a variety of data for photography. For the details of the buttons, refer to page 29. • PAGE 2: Initial screen
On PAGE 2, the items shown in the following table are assigned to the buttons on each layer. Page name Utility button Picture SetUp
Fixation
42 PREPARATIONS
Item button
Item selector button Type CONSTANT • Changes lighting/blinking of the internal fixation (Lighting) FLICKERING target. (Blinking) Speed Normal (Hz) 1-8 • This is valid when the internal fixation target is set to "FLICKERING" (Blinking). • Set the blinking speed for other status except when photographing. Speed Measure (Hz) 1-8 • This is valid when the internal fixation target is set to "FLICKERING" (Blinking). • Set the blinking speed for photographing. Brightness 1-10 • Changes the brightness of the internal fixation target. Shape 1 dot • Changes the shape of the internal fixation target. 4-dot rectangle 4-dot rhomb X cross
At shipment
1
2
3
Page name Utility button
Item button
Picture SetUp
Fundus Photo
Fundus Photo: Enhance
OCT Scan
Z Lock Position(Vitreous) Z Lock Position(Choroidal) Z Lock Position-3D Wide(Vitreous) Z Lock Position-3D Wide(Choroidal) OCT Scan (Normal) OCT Scan (Auto Search)
Illumination Level
Item selector button ON OFF 0 - 9, BS, AC 0 - 9, BS, AC 0 - 9, BS, AC 0 - 9, BS, AC 1-5 1-5
At shipment
400 450 400 450 3 3
43 PREPARATIONS
PAGE3: Follow-up capture On PAGE 3, set Follow-up photography. • PAGE 3: Initial screen
On PAGE 3, the items shown in the following table are assigned to the buttons on each layer. Page name Utility button
Item button
Follow-up capture
ON/OFF
ON/OFF
Search baseline
Scan Resolution Over Scan Count OCT Focus Position
Capture param
44 PREPARATIONS
Over Scan Count
Item selector button ON OFF Have to same Free Have to same Free Have to same Free Use Baseline Use Current
At shipment
PAGE 4: Auto Operation On the "PAGE 4" screen, set the Auto functions. For the details of the buttons, refer to page 29. • PAGE 4: Initial screen
On PAGE 4, the items shown in the following table are assigned to the buttons on each layer. Item selector At button shipment
Page name
Utility button
Item button
Auto Operation
Focus • Sets the focus automatically.
ON/OFF
Auto Z (Z Lock) • Detects the retina position automatically, and always displays the fundus tomogram clearly during observation. (After displaying, the photographed fundus image is automatically fixed.)
OCT Auto OFF Optimize ON
OFF ON
OFF Z Lock After Auto Z ON
Auto Pola (Auto Polarization) ON/OFF • Adjusts the output sensitivity of the fundus tomogram to the optimum automatically.
OFF ON
45 PREPARATIONS
Item button
Item selector At button shipment
Page name
Utility button
Auto Operation
Auto Search Cricle Scan OFF • Circle Scan: ON/OFF Detects and tracks the optic disc position automatically. Even if the optic disc moves slightly due ON to the minute fixation move, it is always possible to perform "Circle scan" with the optic disc as the center. • Others exc. Circle Scan (Line, Radial, 5 Line Others exc. OFF Cross): Circle Scan Searches the position specified on the fundus lock ON / OFF screen according to the IR image except Followup photography. ON In Follow-up photography, the auto search selector button is always ON and this status cannot be changed. The system searches the same position as the base line according to the IR image. • Auto IR Lock Auto When optimizing is finished, you can obtain the IR Lock observed image as a still image and instruct the ON/OFF shooting position on the still image.
46 PREPARATIONS
OFF ON
Capture icon protocol The following table shows the parameters in each capture icon. : Initial set value Capture Icon
Capture Icon name
Scan Pattern
Scan Size
Scan Resolution
Fixation Position
Over Scan Count
OCT Focus Position
Step
Line H
Line
6.0mm 9.0mm 12.0mm
1024H 1024V
Macula Center Disc External
Not 4 32 48 96
Vitreous Choroidal
-
3.0mm
512H 512V
6.0mm 9.0mm 12.0mm
1024H 1024V
Vitreous Choroidal
-
3.0mm
512H 512V
Line V
Line
32 48 96 Macula Center Disc External
Not 4 32 48 96 32 48 96
Circle
Circle
3.4mm
1024
Disc External
Not 4 16 32
Vitreous
-
Radial
Radial
6.0mm 9.0mm 12.0mm
1024×12
Macula Center Disc External
4 16 32
Vitreous Choroidal
-
5 Line Cross
5 Line Cross
12.0mm 9.0mm 6.0mm
1024
Macula Center Disc External
4 16 32
Vitreous Choroidal
0.05 0.10 0.25 0.50 1.00 1.50
3D (H)
3D
12.0×9.0mm
512×256
Macula Wide Disc External
Not
Vitreous Choroidal
-
Vitreous Choroidal
-
512×64 6.0×6.0mm
512×256 512×128 512×64
3D (V)
3D
4
Macula Center Disc External
Not 4
3.0×3.0mm
512×256
Macula Disc External
Not
12.0×9.0mm
512×256
Macula Wide Disc External
Not
512×64 7.0×7.0mm
512×256
Macula Center Disc External
4 Not
* The item button that has no selectable items is not displayed.
47 PREPARATIONS
RESET FROM POWER SAVE STATE This machine adopts the power save method for power saving. When the instrument body (excluding the chin-rest up/down switch) is not operated for a period of time, the power save function stops power supply to the monitor, illumination light source and photography light source. When power save mode sets in, the power lamp on the control panel flickers and the monitor screen goes off.
1
Press the PHOTOGRAPHY SWITCH . In 10-odd seconds, the instrument recovers from the pause condition and is ready for photography.
NOTES
48 PREPARATIONS
When shipped, the power save set time is 5 minutes.
BASIC OPERATIONS FLOW OF OPERATION
Turning on the power (P.50)
Preparation for personal computer (P.50) • Inputting the patient information (P.51)
Setting the capture icon (P.51)
Setting the patient (P.53)
Setting the illumination level (P.57)
Changing the diopter compensation lens (P.57)
Alignment and photography (P.58)
Transferring to the data to the external personal computer
Saving data Printing data (P.68) *by the external personal computer
Finish procedure (P.68)
49 BASIC OPERATIONS