Before Use Be sure to read the SOFTWARE LICENSE AGREEMENT (page 2) before using this product. This operator's manual includes information such as the operating procedure, safety precautions, maintenance, and specifications. Be sure to read this operator's manual before using this product. Keep this manual handy for reference.
SAFETY PRECAUTIONS For Safe Use BEFORE USE, READ THIS MANUAL. Be sure to read the operator’s manual prior to operation of the system to understand the safety precautions and operating procedures thoroughly. In this manual, signal words are used to designate the degree or level of safety alert- ing.
SAFETY PRECAUTIONS: Usage Precautions Usage Precautions Before use WARNING • If any serious device-related incident occurs, report it to Nidek and the competent authority in the country where the user or patient, or both reside. • Connect the power plug to a grounded outlet. Electric shock or fire may occur in the event of malfunction or power leakage.
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SAFETY PRECAUTIONS: Usage Precautions CAUTION • Be sure to use a (HOSPITAL GRADE) power outlet which meets the power specification require- ments. The system may not perform properly, or malfunction or fire may occur. • Never use a power strip or extension cable to supply the system with power. The electrical safety may be lowered.
SAFETY PRECAUTIONS: Usage Precautions During use CAUTION • Before use, perform visual and operation checks. If abnormal conditions are encountered, stop using the system. If the system is used under abnormal conditions, intended results may not be achieved. Also unantici- pated malfunctions or health hazards may occur due to improper diagnosis.
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SAFETY PRECAUTIONS: Usage Precautions CAUTION • Equipment connected to the analog or digital interfaces must be certified according to the applicable international standards for safety (such as EN 60601-1 and IEC 60601-1). Furthermore, all configu- rations shall comply with the system standard IEC 60601-1. Anyone who connects additional equip- ment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 60601-1.
SAFETY PRECAUTIONS: Usage Precautions During use of the anterior segment adapter (optional) WARNING • Be sure to set the safety stopper before the anterior segment cross-sectional image capture. The anterior segment adapter may come into contact with the patient's eye and damage the cornea. CAUTION •...
SAFETY PRECAUTIONS: Usage Precautions Maintenance CAUTION • Only service personnel trained by NIDEK can repair the device. NIDEK will not be responsible for accidents caused by improper servicing. • Do not use the system beyond its service life. Even with proper maintenance and check, after time, the system reliability or safety may become degraded and fail to achieve the target values.
SAFETY PRECAUTIONS: Symbol Information Symbol Information Cautionary labels are provided on the system. If the labels are peeling off or the characters are wear- ing off, contact NIDEK or your authorized distributor. Indicates that the operator is advised to refer to the related instructions in the operator's manual.
System Outline The NIDEK Optical Coherence Tomography RS-330 is an ophthalmic camera that allows non-inva- sive and non-contact observation of the shape of the fundus, anterior segment, and retina, and any disease that may be present. The system offers the following features: Capturing of cross-sectional images of the retina (OCT image) using the principle of the optical •...
BEFORE USE: System Outline 2.1.4 Intended use environment Medical facility CAUTION • If the device is used outside the specified use location, intended performance and security level can- not be maintained. 2.1.5 Principles ● Formation of anterior chamber cross-sectional image, retinal cross-sectional image, and fun- dus image To form retinal cross-sectional images (OCT images) and fundus images (OCT Phase Fundus images), the system main body scans light over the eye to obtain interference light.
BEFORE USE: Configuration and Functions Configuration and Functions Touch screen 8.4-inch color touch LCD Pulling the bottom of the touch screen provides an adjustable viewing angle. To lower the touch screen, pull it to the top posi- tion before lowering it. Pilot lamp Illuminates when the power switch of the system is on ( ).
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BEFORE USE: Configuration and Functions Power switch Image capturing unit Hand light Illuminates the buttons around the joystick to facilitate the device operation in a dark room. Main unit Base unit Power inlet Forehead rest Eye level marker The height of the chinrest is adjusted so that the patient's eyes roughly align with this line. Chinrest External fixation lamp connector ...
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BEFORE USE: Configuration and Functions Compensation lens select lever Used to insert the plus or minus compensation lens. It is used when the refractive error of the patient’s eye is out of the range between -12 D and +15 D or when eye front images are to be captured. -: For eyes with refractive error between -33 D and -7 D +: For eyes with refractive error between +11 D and +35 D or when eye front images are to be cap- tured...
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BEFORE USE: Configuration and Functions Locking knob Used to lock the main unit to the base unit. The main unit is locked differently depending on the direc- tion in which the locking knob is rotated. Used to temporarily lock the main unit during image cap- BRAKE side (clockwise) ture.
BEFORE USE: Main Body Screen Description Main Body Screen Description 2.3.1 Eye front observation screen 11111 Combo OCT/FC OCT OCT/FC MACULA MAP + 0.00D +0.00D Start/Stop button Used to start and stop the scanning. The button shows the scan status with blue color. The scanning is being performed.
BEFORE USE: Main Body Screen Description In OCT release mode, only OCT images are captured. By setting up the system so that the optional anterior segment adapter is ready for use, the button for eye front OCT image capture and the but- ton for the retinal OCT image capture are displayed.
BEFORE USE: Main Body Screen Description Menu button Capture Settings Alignment Setting Camera Setting The Capture Settings dialog appears. Auto Shot CAM1 CAM2 CAM3 Operation Mode Focus Bar Standard Professional Fundus Illumination Close Small pupil image capture button Used to capture images of the eye with a pupil smaller than the required pupil diameter mark Pressing this button changes it to orange and enables image capture with a pupil as small as the min- imum pupil diameter mark ...
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BEFORE USE: Main Body Screen Description Focus gauge The gauge moves in accordance with the focus. • The focus adjustment value of the optical system used for color fundus image capture is shown in diopter. For NAVIS-EX, the focus adjustment value of the optical system used for OCT image capture is shown in diopter.
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BEFORE USE: Main Body Screen Description Required pupil diameter mark Indicates the required pupil diameter (pupil diameter required for proper image capture). If the pupil diameter is smaller than this mark, or eyelashes are on this mark, images may not be cap- tured.
BEFORE USE: Main Body Screen Description 2.3.2 Fundus observation screen (Operation mode: Professional) OCT/FC display For the button and icons that are not explained below, see “2.3.1 Eye front observation screen” (page 21). This screen is displayed with the following setting: Menu button Capture Settings dialog Operation Mode...
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BEFORE USE: Main Body Screen Description Scan line Shows the position of the scan line for OCT image capture. Operate the slider or the scan line operation button to move the scan line or change its shape. The scan line cannot extend out of the OCT Phase Fundus image. The position and shape of the scan lines can be changed as shown below.
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BEFORE USE: Main Body Screen Description Slider Used to change the scan line width. It cannot be used for the Disc Circle scan line or Retina Map scan line. Scan line operation button Used to move the scan line or change its shape. The displayed button changes depending on the selected OCT setting.
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BEFORE USE: Main Body Screen Description Focus split Indicates the focus condition on the fundus by the displacement between the upper and lower lines. The focus is optimum when the upper and lower lines form a single line. Orientation tab Used to show the orientation of the captured image.
BEFORE USE: Main Body Screen Description 2.3.3 Fundus observation screen (Operation mode: Standard) OCT/FC display For the button and icons that are not explained below, see “2.3.1 Eye front observation screen” (page 21). This screen is displayed with the following setting: Menu button Capture Settings dialog Operation Mode...
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BEFORE USE: Main Body Screen Description Image capture information Displays the selected OCT setting. OCT image Displays the OCT image of the scan line position. The SSI indication shows the evaluation of the OCT image quality (on a scale of 10 with a bar graph). Eye front image 11111 MACULA MAP...
BEFORE USE: Main Body Screen Description Focus Bar Operates inside the system main body. The focus bar can be either shown or hidden. “3.7.1 Image capture setting” (page 120) FC display For the displayed buttons and icons, see “O OCT/FC 11111 display”...
Displays the captured eye front image. OK button Displays the thumbnail of the captured image in the Release Data tab of RS-330 Capture. The check box shown to the left side of the thumbnail is selected to allow saving of the data.
BEFORE USE: Main Body Screen Description NG button Displays the thumbnail of the captured image in the Release Data tab of RS-330 Capture. The check box shown to the left of the thumbnail is not selected (It can be checked later).
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BEFORE USE: Main Body Screen Description OCT image Displays the OCT image of the scan line position. The arrow at the bottom right of the image corre- spond to the arrow on the OCT Phase Fundus image. In addition, the SSI indication and the image averaging result are displayed.
RS-330 Capture Screen RS-330 Capture is software used to operate the RS-330 from the computer and to transfer the cap- tured images to NAVIS-EX. Most of the operations related to image capture are linked between the system main body and RS-330 Capture, and can be operated using either of them. Use the conve- nient one.
This button can be used only when the scanning is stopped Edit Combo (“Scan Stop” is blue). Setting Allows setting of RS-330 Capture parameters. This button can be used only when the scanning is stopped Setting (“Scan Stop” is blue).
• If the captured image is not registered as the baseline, the Release Data tab is displayed when RS-330 Capture is activated. Past Exam tab By registering an image captured with the RS-330 as a baseline image, the image capture conditions of the baseline image can be copied to the RS-330.
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Close button Closes RS-330 Capture. CAUTION • The thumbnails in the Release Data tab are deleted without being saved. To save the thumbnails, close RS-330 Capture by clicking the “Save & Close” button in the Release Data Save & Close tab.
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BEFORE USE: RS-330 Capture Screen R / L indication Indicates the eye (right or left) being observed in blue. Cornea-reflected spots Eight corneal-reflected spots appear when the patient's eye is displayed in the eye front observation screen. Required pupil diameter mark Indicates the required pupil diameter (pupil diameter required for proper image capture).
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BEFORE USE: RS-330 Capture Screen SSI(10/10) Controller Allows individual adjustment of the focus, Z position, and polarization of the image. of each item changes it to orange Clicking the Auto button and automatically optimizes the image. The items can also be manually adjusted using the sliders.
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BEFORE USE: RS-330 Capture Screen Fundus observation illumination intensity up/down buttons Used to adjust the brightness of the illumination for fundus observation. Reduces the intensity. Increases the intensity. Flash intensity up/down buttons Used to adjust the flash intensity for image capture.
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BEFORE USE: RS-330 Capture Screen Electronic working dot Shown in yellow and used as the reference point for alignment. • If the patient's eyelid is not opened wide enough or their cornea has any lesions or such, the elec- tronic working dot may not be displayed due to improper detection of the cornea-reflected spots.
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BEFORE USE: RS-330 Capture Screen SSI(10/10) 12mm Scan Width Scan line Shows the position of the scan line for OCT image capture. Dragging the scan line moves it or changes its shape. The scan line cannot extend out of the OCT Phase Fundus image.
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BEFORE USE: RS-330 Capture Screen Internal fixation lamp Indicates the current fixation lamp position in green. Dragging the internal fixation lamp moves it. To stabilize the patient's eye fixation, instruct the patient to focus on the fixation lamp during image capture.
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BEFORE USE: RS-330 Capture Screen FC display For the button and icons that are not explained below, see “O OCT/FC display” (page 36). Pressing the button shown below in the Basic Setting tab displays this screen. • Combo release mode...
Close button Closes RS-330 Capture. CAUTION • The thumbnails in the Release Data tab are deleted without being saved. To save the thumbnails, close RS-330 Capture by clicking the “Save & Close” button in the Release Data Save & Close tab.
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BEFORE USE: RS-330 Capture Screen SSI(10/10) OK button Displays the thumbnail of the captured image in the Release Data tab of RS-330 Capture. The check box shown to the left side of the thumbnail is selected to allow saving of the data. NG button Displays the thumbnail of the captured image in the Release Data tab of RS-330 Capture.
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Low quality SSI(3/10) Middle quality SSI(6/10) High quality SSI(10/10) Yellow Green *1. Displayed only when the image is captured using the release button of RS-330 Capture. *2. It is not displayed when the image capture is performed with “RETINA MAP” selected.
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BEFORE USE: RS-330 Capture Screen Image averaging result • The number of successfully averaged images out of the number of the specified HD scan images is displayed. As the number of successfully averaged images becomes larger, finer images can be obtained. The color of the image averaging result indication and the color of the frame color of the OCT image change depending on the proportion of successfully averaged images.
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BEFORE USE: RS-330 Capture Screen FC display For the button and icons that are not explained below, see “O OCT/FC display” (page 47). Pressing the button shown below in the Basic Setting tab displays this screen. • Combo release mode...
BEFORE USE: Packed Contents Packed Contents The following are included in the standard configuration. Check the packed contents before use. Product name Quantity Appearance USB 2.0 cable 1 unit USB 3.0 cable 1 unit (Blue connector tip) Power cord (for system main body) 1 unit Dust cover 1 unit...
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Product name Quantity Appearance Spacer for anterior segment image cap- 1 unit ture Operator's manual 1 volume of each Quick reference guide NAVIS-EX 1 set RS-330 Capture installation CD 1 unit Retina map dongle and B-scan Denois- 1 set ing Software...
BEFORE USE: Initial Use Initial Use 2.6.1 System installation Install the system in a location that satisfies the conditions described in “Before Use”. Place the system main body on a stable table. The system main body should be carried by two per- sons holding it at positions (A) and (B) (both right and left sides).
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BEFORE USE: Initial Use Remove the sheet on the back of the cap holder. Adhere the cap holder on the system main body. • Place the objective lens cap on the objective lens when the system is not used, and on the cap holder when the device is used. Attach the magnetic forehead rest pad to the system main body.
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Turn on power to the computer and the computer monitor. Install NAVIS-EX. For details of installation, refer to the NAVIS-EX Operator's Manual. Install RS-330 Capture. For details of installation, see “2.6.3 Installing RS-330 Capture” (page 58). Shut down Windows. Turn off ( ) power to the isolation transformer.
Chipset Intel C226/8 Series or more (Intel chipset only) • Depending on the computer, RS-330 Capture may not work even when the above specifications are satisfied. Before purchasing the computer, contact NIDEK or your authorized distributor. • In order to use the USB 3.0 PCIE ADD IN CARD, the expansion slot of PCI Express Base Specifica- tion Revision 2.0 X 1 Lane or more is required.
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BEFORE USE: Initial Use Click the Next button. The license agreement dialog box appears. Read the contents carefully, check the box for “I accept the terms of the license agreement”, then click the Next button. Click the Install button to start the installation. After confirming that the box for “Always trust software from “NIDEK CO.,LTD.”.”...
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BEFORE USE: Initial Use Click the Finish button to finish the setup. Remove the installation CD from the CD-ROM drive. The software installation is complete. • Store the installation CD in a secure place. It is needed to uninstall the software, or install it again.
2.6.4 Uninstalling RS-330 Capture To uninstall RS-330 Capture, use the RS-330 Capture installation CD. • The software can be uninstalled also with the “Programs (Uninstall a program)” function of Windows. • Before uninstalling RS-330 Capture, close all the related applications.
BEFORE USE: Initial Use 2.6.5 System start-up Turn on ( ) power to the isolation transformer. Turn on ( ) the power switch (*A) of the system main body. Wait without operating the system until the front eye observation screen is displayed. Combo OCT/FC OCT OCT/FC...
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Depending of the condition of the system, it may require about 20 seconds until connec- tion of the computer is complete. The system is ready for use. • Set the parameters to suit the use conditions. “4.5 Setting of RS-330 Capture” (page 134)
OPERATING PROCEDURE Operation Flow Chart Turning on power to the sys- “2.6.5 System start-up” (page 62) “3.2.1 Preparing for image capture” (page 66) Turn on power to the system, and set the system parameters as necessary. Conduct patient preparation. Image capture “3.2 OCT/FC Release Mode”...
The operating procedure using the system main body is explained below. However, most of the oper- ations can also be performed using RS-330 Capture. Use the convenient one. (For details of the oper- ation using RS-330 Capture, see “2.4 RS-330 Capture Screen” (page 36).) 3.2.1...
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OPERATING PROCEDURE: OCT/FC Release Mode Confirm that the main unit can be moved to the edge of the base unit. If the main unit stops halfway, press and hold the safety stopper, then move the main unit to the edge of the base unit. After moving the main unit, release the safety stopper.
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OPERATING PROCEDURE: OCT/FC Release Mode ● Starting and stopping the scanning (only for OCT image capture) to start or stop the scanning. Press the Start/Stop button The button shows the scan status with blue color. The scanning is being performed. Scan Start is blue Scan Stop is blue The scanning is stopped.
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OPERATING PROCEDURE: OCT/FC Release Mode Conduct patient preparation. (*A) (*B) Wipe the forehead rest and the chinrest with a clean cotton swab or gauze dampened with rubbing alcohol. If the chinrest paper is used, remove a single sheet from the stack of sheets. (*C) Hold the joystick of the system main body, and...
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OPERATING PROCEDURE: OCT/FC Release Mode (*F) If the limit indicator appears in the touch 11111 screen of the system main body, move the chin- Combo OCT/FC OCT OCT/FC rest in the indicated direction. 黄斑マップ MACULA MAP +0.00D...
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.2 Automatic image capture Alignment, focusing, and image capture are automatically performed (when the auto shot function is enabled). Conduct image capture preparation. “3.2.1 Preparing for image capture” (page 66) Give instructions to the patient. “Look into the device.
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OPERATING PROCEDURE: OCT/FC Release Mode Displaying the electronic working dot automatically performs alignment, focusing, and optimization. After that, images are automatically captured (when the auto shot function is enabled). In OCT/FC release mode , images are captured in the order of OCT image capture and color OCT/FC fundus image capture.
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OPERATING PROCEDURE: OCT/FC Release Mode Check the captured image. 11111 MACULA MAP Cross Retry Average Result Cross X Set as Baseline SSI(10/10) (*A) (*B) In addition to the images, check the SSI and image averaging result to evaluate the quality of the OCT image.
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Set as Baseline shot function. • When images are captured using RS-330 Capture, the Exam Confirma- Exam Confirmation tion dialog is displayed in the touch screen of the system main body.
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• Double-clicking a thumbnail enlarges the image. Images can be confirmed before saving them. “3.2.4 Image confirmation” (page 79) • RS-330 Capture can also be closed by clicking the close button at the top right of RS-330 Capture screen.
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.3 If color fundus images cannot be captured properly Depending on conditions such as the positional relationship between the system main body and the patient's eye, a black shadow or such may be captured in the color fundus image. In such a case, per- form the remedies shown below.
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OPERATING PROCEDURE: OCT/FC Release Mode Symptom Cause and remedy • The image capturing unit may be shifted from the patient's eye. Reflected light at the top: Move the image capturing unit up. Reflected light at the bottom: Move the White reflected light is in image capturing unit down.
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OPERATING PROCEDURE: OCT/FC Release Mode Symptom Cause and remedy • The objective lens may be contaminated. “4.6.2 Cleaning the objective lens” (page 156) Center of the image is white. The entire image is white. • A black shadow may appear with eyes with severe myopia.
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.4 Image confirmation With RS-330 Capture, the thumbnails in the Release Data tab can be enlarged. Images can be con- firmed before saving them. Double-click the desired thumbnail in the Release Data tab. The enlarged view of the selected image is displayed.
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.5 Finishing image capture Normal finishing of image capture Close RS-330 Capture and NAVIS-EX. Shut down Windows. After a while, power to the computer is turned off. Turn off power to the computer peripheral devices.
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To move the system to another room or such, securely lock the main unit by rotating the locking knob to the LOCK side (counterclockwise). Close RS-330 Capture and NAVIS-EX. Shut down Windows. Turn off power to the computer peripheral devices.
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OPERATING PROCEDURE: OCT/FC Release Mode Push the compensation lens select lever (*A) to the deep- est position ( position). Turn off ( ) power to the system main body. While pressing and holding the chinrest up/down button , turn on ( ) power to the system main body.
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.6 Manual image capture (Operation mode: Professional) Depending on the status of the patient's eye, automatic image capture may not function. In such a case, images need to be captured manually. Conduct image capture preparation. ...
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OPERATING PROCEDURE: OCT/FC Release Mode Adjust the alignment and focus. Manipulate the joystick to align the electronic working dot to the center of the target mark. (*A) The working distance indicator is displayed. While observing the working distance indicator, manipulate the joystick forward and backward to achieve the optimum condition ( When the optimum condition ( ) is achieved,...
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OPERATING PROCEDURE: OCT/FC Release Mode To capture images of other parts, press the 11111 OCT Phase Fundus image to move the inter- nal fixation lamp. If the alignment and focus become shifted, adjust them MACULA MAP 黄斑マップ 黄斑ライン again. A 512 B 128 Cross x 5 Regular...
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If the SSI is low, or the optimization is interrupted, individually adjust the focus, Z position, and polarization. There are two methods for the adjustment. Operation on RS-330 Capture: • of each item changes it to orange Clicking the Auto button and automatically optimizes the image.
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OPERATING PROCEDURE: OCT/FC Release Mode • Z-Pos (Z position) adjustment: 11111 Press the , and buttons to adjust the Z position (vertical position in the screen) of the OCT image. MACULA MAP 黄斑マップ 黄斑ライン A 512 B 128 Cross x 5 Regular 12.0mm RETINA...
OPERATING PROCEDURE: OCT/FC Release Mode 3.2.7 Manual image capture (Operation mode: Standard) Depending on the status of the patient's eye, automatic image capture may not function. In such a case, images need to be captured manually. Conduct image capture preparation. ...
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OPERATING PROCEDURE: OCT/FC Release Mode Adjust the alignment and focus. Manipulate the joystick to align the electronic working dot to the center of the target mark. (*A) The working distance indicator is displayed. While observing the working distance indicator, manipulate the joystick forward and backward to achieve the optimum condition ( When the optimum condition ( ) is achieved,...
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OPERATING PROCEDURE: OCT/FC Release Mode To capture images of other parts, press the 11111 fundus image to move the internal fixation 黄斑マップ MACULA MAP lamp. B 128 A 512 Cross x 5 Regular 12.0mm RETINA If the alignment and focus become shifted, adjust them again.
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If the SSI is low, or the optimization is interrupted, individually adjust the focus, Z position, and polarization. There are two methods for the adjustment. Operation on RS-330 Capture: • Clicking the Auto button of each item changes it to orange and automatically optimizes the image.
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OPERATING PROCEDURE: OCT/FC Release Mode Press the release button to capture the image. In OCT/FC release mode , images are cap- OCT/FC tured in the order of OCT image capture and color fun- dus image capture. • If the patient's eyelid is detected, the pupil diameter is not large enough, or extraneous light (noise) or such is detected, images may not be captured properly.
OPERATING PROCEDURE: OCT Release Mode OCT Release Mode In OCT release mode, only OCT images are captured. For the button and icons that are not explained below, see “2.3.1 Eye front observation screen” (page 21). 11111 Combo OCT/FC OCT 黄斑マップ...
OPERATING PROCEDURE: OCT Release Mode 3.3.1 Retinal cross-sectional image capture The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below. “3.2.2 Automatic image capture” (page 71) “3.2.6 Manual image capture (Operation mode: Professional)” (page 83) ...
OPERATING PROCEDURE: OCT Release Mode 3.3.2 Anterior segment cross-sectional image capture (optional) By attaching the anterior segment adapter (optional) and the spacer for anterior segment image cap- ture to the system main body, eye front images, and OCT images of the anterior segment such as the cornea and the anterior chamber angle can be captured.
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OPERATING PROCEDURE: OCT Release Mode (*F) Push the compensation lens select lever to the deep- est position ( position). Attach the spacer for anterior segment image capture. Wipe the spacer with a clean cotton swab or gauze dampened with rubbing alcohol. Attach the spacer to the forehead rest of the system main body.
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OPERATING PROCEDURE: OCT Release Mode Anterior segment cross-sectional image capture CAUTION • During the anterior segment cross-sectional image capture, pull the joystick toward the operator before adjusting the alignment and focus, or switching the eye to prevent the anterior segment adapter from coming into contact with the patient's face or eyes.
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OPERATING PROCEDURE: OCT Release Mode Observe the distance between the anterior seg- 15mm ment adapter and the patient's eye from the side of the system main body. When the distance becomes about 15 mm, release the safety stop- per. Lightly move the joystick forward and backward to confirm that the anterior segment adapter (Step 2)) cannot be moved to the patient side beyond the limit set with the safety stopper.
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OPERATING PROCEDURE: OCT Release Mode Optimize the image. (*A) Manipulate the joystick forward and backward to display the OCT image 11111 角膜ラジアル CORNEA RADIAL 黄斑マップ 黄斑ライン A 1024 x 10 6.0mm CORNEA SSI(3/10) SSI(10/10) SSI(3/10) -12.00D Press the OPT. button to optimize the image. Only the polarization is optimized in the anterior segment cross-sectional image capture.
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OPERATING PROCEDURE: OCT Release Mode Adjust the intended part to the adjustment target line. Perform the operation while checking RS-330 Capture. The operation differs depending on the OCT setting. Cornea Line, Cornea Cross, Cornea Radial • Manipulate the joystick forward and backward so that the top of the OCT image (corneal surface)
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OPERATING PROCEDURE: OCT Release Mode Check the SSI. As the SSI becomes higher, a finer image can be obtained. 11111 Low quality SSI(3/10) 角膜ラジアル CORNEA RADIAL 黄斑マップ 黄斑ライン Middle quality SSI(6/10) A 1024 x 10 6.0mm CORNEA High quality SSI(10/10) SSI(3/10) SSI(10/10) -12.00D...
OPERATING PROCEDURE: FC Release Mode FC Release Mode In FC release mode, only color fundus images are captured. For the button and icons that are not explained below, see “2.3.1 Eye front observation screen” (page 21). 11111 Combo OCT/FC OCT FC FC + 0.00D +0.00D...
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OPERATING PROCEDURE: FC Release Mode Image capture position select button (for stereo image capture Select the positions for stereo image capture. The selected button is shown in orange. The TEMPO- RAL button is for the temporal side, and the NASAL button is for the nasal side.
OPERATING PROCEDURE: FC Release Mode 3.4.1 Standard image capture The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below. “3.2.2 Automatic image capture” (page 71) “3.2.6 Manual image capture (Operation mode: Professional)” (page 83) ...
OPERATING PROCEDURE: FC Release Mode 3.4.2 Stereo image capture Images of the same fundus are captured from two different positions: one from the temporal side and the other from the nasal side. The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below.
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OPERATING PROCEDURE: FC Release Mode Check the captured image. 11111 STEREO(TEMPORAL) Click the desired button from OK, NG, and Retry. Retry Press the OK button to display the purple 11111 (*B) electronic working dot Combo OCT/FC OCT FC FC Displaying the electronic working dot automatically optimizes alignment, and focusing.
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OPERATING PROCEDURE: FC Release Mode Using stereo gauge (*A) A stereo gauge is displayed in the fundus observation screen for stereo image capture. It is used as a guideline for alignment when the electronic working dot cannot be displayed. (*B) Align the two optical working dots sym- 11111...
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OPERATING PROCEDURE: FC Release Mode Stereo image capture pattern tab When the stereo image capture is started, the stereo image capture pattern tab is displayed in RS-330 Capture. When an image is captured, the image capture advances to the next one. However, the desired image capture can be selected regardless of the preset order by clicking the desired setting in the tab or changing the eye to be captured using the joystick.
OPERATING PROCEDURE: FC Release Mode 3.4.3 Panorama image capture Images of multiple positions of the fundus are captured as specified with two to nine internal fixation lamps in the preset order. With the factory setting, are displayed. The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below.
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• When the panorama image capture is started, the panorama image capture pattern tab is displayed in RS-330 Capture. When an image is captured, the image capture advances to the next one. How- ever, the desired image capture can be selected regardless of the preset order by clicking the desired setting in the tab or changing the eye to be captured using the joystick.
OPERATING PROCEDURE: FC Release Mode 3.4.4 Eye front image capture Attaching the spacer for anterior segment image capture to the system main body enables color eye front image capture. Only manual image capture is available to capture eye front images. Preparing for eye front image capture Pull out the compensation lens select lever (*A)
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OPERATING PROCEDURE: FC Release Mode Eye front image capture CAUTION • To capture eye front images, be sure to attach the spacer for anterior segment image capture. Without the spacer, sufficient working distance cannot be secured, and image capture becomes difficult. Conduct image capture preparation.
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OPERATING PROCEDURE: FC Release Mode Manipulate the joystick forward and backward to display the eye clearly. Press the release button to capture the image. Check the captured images and save them. 11111 ANTERIOR “3.2.2 Automatic image capture” (page 71) (Step 5) to (Step 8) Retry...
OPERATING PROCEDURE: Combo Image Capture Combo Image Capture By setting combinations of various release modes in advance, images can be captured in the desired modes in the preset order without changing the setting. The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below.
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OPERATING PROCEDURE: Combo Image Capture Move the main unit and the image capturing 11111 unit so that the patient's eye is displayed in Combo OCT/FC OCT the center of the screen, and that the elec- MACULA MULTI 黄斑マルチ (*A) tronic working dot is displayed.
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OPERATING PROCEDURE: Combo Image Capture • When the combo image capture is started, the combo image capture pattern tab is displayed in RS- 330 Capture. When an image is captured, the image capture advances to the next one. However, the desired image capture can be selected regardless of the preset order by clicking the desired set- ting in the tab or changing the eye to be captured using the joystick.
OPERATING PROCEDURE: Other Image Capture Other Image Capture 3.6.1 Small pupil image capture This function allows image capture of eyes with the pupil smaller than the required pupil diameter mark The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below.
OPERATING PROCEDURE: Other Image Capture 3.6.3 Fundus autofluorescence image capture (optional) Fundus images can be captured using the characteristic reaction of lipofuscin in the retinal pigment epithelium to autofluoresce. With the system, green light is used for excitation. The image capture procedure is the same as that in OCT/FC release mode except the steps OCT/FC described below.
OPERATING PROCEDURE: Setting Image Capture Conditions Setting Image Capture Conditions 3.7.1 Image capture setting Press the menu button 11111 Combo OCT/FC OCT OCT/FC 黄斑マップ MACULA MAP +0.00D The Capture Settings dialog appears. Capture Settings Alignment Setting Camera Setting Set the parameters as desired. Auto Shot CAM1 CAM2...
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OPERATING PROCEDURE: Setting Image Capture Conditions Parameter Explanation Camera Setting CAM1 / CAM2 / CAM3 The conditions for the color fundus image capture such as the ISO speed and con- trast are changed. “4.5.3 Color fundus image capture setting” (page 147) Operation Mode Standard / Professional Screen for fundus observation (in Combo release mode...
OPERATING PROCEDURE: Setting Image Capture Conditions 3.7.2 OCT image capture setting Press the OCT setting button MACULA MAP 11111 Combo OCT/FC OCT OCT/FC MACULA MAP 黄斑マップ +0.00D The OCT Base/Detail Settings dialog appears. OCT Base/Detail Settings OCT Setting OCT Detail A Point B Point Set the parameters as desired.
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OPERATING PROCEDURE: Setting Image Capture Conditions ● OCT detailed settings Parameter A Point B Point Cross HD Count Scan Type 1 / 5 / 10 / 15 / 20 / MACULA LINE 512 / 1024 30 / 50 1 / 5 / 10 / 15 / 20 / MACULA CROSS 512 / 1024 30 / 50...
OPERATING PROCEDURE: Copying Image Capture Conditions (for OCT images only) Copying Image Capture Conditions (for OCT images only) By registering an image captured with the RS-330 as a baseline image, the image capture conditions of the baseline image can be copied to the RS-330. This function facilitates follow-up examinations.
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However, some scan line positions, widths, and fixation lamp positions may not be directly compatible with the RS-330 due to differences of the product specifications. In this case, values are automatically converted so that they can be copied to the RS-330.
SYSTEM SETTINGS AND MAINTE- NANCE Troubleshooting If the system does not function properly, check the table below before asking NIDEK or your autho- rized distributor for repair. Symptom Remedy • The power cord may not be connected. Check the connection of the power cord. The touch screen does not turn •...
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Set the Tracking Position Offset parameter. Optic disc images are dark. “4.5.1 Setting of RS-330 Capture” (page 134) • The tracking position offset may be working to prevent the iris from block- Electronic working dots and ing the image capture optical path.
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SYSTEM SETTINGS AND MAINTENANCE: Troubleshooting Symptom Remedy • The auto shot may not be enabled. Enable the auto shot. “3.7.1 Image capture setting” (page 120) • The patient's eyelid may be detected or the pupil diameter may not be large enough for image capture.
SYSTEM SETTINGS AND MAINTENANCE: Error Messages and Remedies Error Messages and Remedies If one of the following error codes is displayed on the screen or printed out, follow the suggestions in the cause and remedy column. The error code, detailed indications, and serial number of your system are helpful for proper servicing. Message Cause and remedy •...
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SYSTEM SETTINGS AND MAINTENANCE: Error Messages and Remedies ERROR:217 OCT compensation motor stop error ERROR:221 OCT X galvano driver error ERROR:222 OCT Y galvano driver error ERROR:223 OCT galvano mirror error ERROR:225 OCT shutter error ERROR:226 SLD initialization error ERROR:227 SLD power1 over error ERROR:228 SLD power2 over error...
SYSTEM SETTINGS AND MAINTENANCE: Attaching the Chinrest Paper Attaching the Chinrest Paper Pull out the two fixing pins from the chinrest. Remove a proper amount of chinrest paper from a whole pad. A whole pad of chinrest paper cannot be attached to the chinrest at a time. Be sure to use a pad of 6 mm or less removed from the whole pad.
SYSTEM SETTINGS AND MAINTENANCE: Forehead Rest Pad Replacement Forehead Rest Pad Replacement Magnetic forehead rest pad (30611-1520) The forehead rest pad (made of ABS resin) included in the standard configuration is magneti- cally attachable. Attach or remove it in the orienta- tion as shown to the right.
SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Setting of RS-330 Capture 4.5.1 Setting of RS-330 Capture Set the parameters for the system and image capture. The changed parameters are saved and used as the default settings from the next system start-up.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation Operation Mode Standard / Professional Screen for fundus observation (in Combo release mode [during OCT image Combo capture], OCT/FC release mode , or OCT release mode OCT/FC 11111 11111 MACULA MAP 黄斑マップ...
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture ● OCT tab Parameter Explanation OCT Color Positive (B/W) / Negative (B/W) / Color Color setting of OCT image OCT Polarization Auto / On Condition to execute polarization for optimization Optimize Auto: Executes polarization when the SSI is below the threshold value.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation Camera CAM1 / CAM2 / CAM3 Clicking any button shows a dialog. Photography Setting “4.5.3 Color fundus image capture setting” (page 147) Option On / Off Automatic detection of the pupil diameter and automatic transition to small pupil...
SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture 4.5.2 OCT image capture setting at system start-up OCT image capture parameters at system start-up can be set. The parameters at system start-up can only be set with RS-330 Capture. Open the pull-down menu from “Setting” in the menu bar.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameters • Underlined options indicate factory settings. • Parameters may become unavailable depending on the image capture conditions. ● Default Pattern Parameter Explanation Retinal cross-sectional MACULA LINE / MACULA CROSS / MACULA MAP / MACULA MULTI / MACULA...
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation Scan Width 3.0 mm / 6.0 mm / 9.0 mm Scan line width OCT Sensitivity Regular / Fine / Ultra Fine Adjustment of the exposure time for OCT image capture When Fine or Ultra Fine is selected, image capture takes longer than when Regular is selected.
SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation Auto Segmentation Checked (ILM, IPL/INL, RPE/BM) / Not checked Automatic detection of layer borderlines after image capture Checked: Automatic detection is performed. Not checked: Automatic detection is not performed. The numbers of A Point and B Point can be set in the combinations shown below.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture ● MACULA RADIAL Parameter Explanation A Point 512 / 1024 The number of A-scan points HD Count 1 / 5 / 10 / 15 / 20 (15 / 20 are only for when “6” is selected for “Scan Type”.) The number of images captured by scanning.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture ● DISC MAP Parameter Explanation A Point 256 / 512 / 1024 The number of A-scan points B Point 64 / 128 / 256 The number of images captured by the repeated scanning along the line orthogonal to the scan line.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation Scan Width 3.0 mm / 6.0 mm / 9.0 mm Scan line width OCT Sensitivity Regular / Fine / Ultra Fine Adjustment of the exposure time for OCT image capture When Fine or Ultra Fine is selected, image capture takes longer than when Regular is selected.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture ● CORNEA LINE (for anterior segment cross-sectional image capture [optional]) Parameter Explanation A Point 512 / 1024 The number of A-scan points HD Count 1 / 5 / 10 / 15 / 20 / 30 / 50 The number of images captured by scanning.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameter Explanation OCT Sensitivity Regular / Fine / Ultra Fine Adjustment of the exposure time for OCT image capture When Fine or Ultra Fine is selected, image capture takes longer than when Regular is selected.
SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture 4.5.3 Color fundus image capture setting Parameters of the color fundus image capture can be set. The changed parameters are saved and used as the default settings from the next system start-up. The parameters of the color fundus image capture can only be set with RS-330 Capture.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Parameters • Underlined options indicate factory settings. The initial settings of CAM1, CAM2, and CAM3 are the same. • Parameters may become unavailable depending on the image capture conditions. Parameter Explanation ISO Speed...
Panorama fixation lamp setting Parameters of the fixation lamps at two to nine positions are set for the panorama image capture. The panorama fixation lamp parameters can only be set with RS-330 Capture. Open the pull-down menu from “Setting” in the menu bar.
Edit Combo The settings for the combo image capture can be created, edited, and deleted. • The combo image capture settings can only be edited with RS-330 Capture. • The following parameters can be set for the combo image capture.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Up button Moves the selected combo setting or combo pattern one place up in the list. Down button Down Moves the selected combo setting or combo pattern one place down in the list.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Press the Enter key of the keyboard, or press any blank position in the Combo Explorer to determine the title. A new combo setting is created. A combo pattern is shown in the expanded tree view.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture (*C) A new combo pattern is added. Other combo patters can be edited and added in the same manner. Click the OK button Editing combo setting Open the pull-down menu from “Setting” in the menu bar. Then click “Edit Combo”.
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SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Deleting combo settings and combo patterns Open the pull-down menu from “Setting” in the menu bar. Then click “Edit Combo”. The Combo Edit dialog appears. Delete the desired combo settings and combo patterns.
SYSTEM SETTINGS AND MAINTENANCE: Setting of RS-330 Capture Factory-set combo setting Macular Disease Scan Width Scan Pitch Scan Angle Fundus Cross HD No. OCT Setting A Point B Point HD Count Scan Type Count (mm) (mm) (°) Sensitivity Fundus Mode...
SYSTEM SETTINGS AND MAINTENANCE: Cleaning Cleaning 4.6.1 Cleaning the system exterior If the system cover or the touch screen becomes stained, wipe them with a soft cloth. For severe stains, wipe it off with a soft cloth dampened with neutral detergent diluted with water and wrung well, then dry the wet part with a soft cloth.
SYSTEM SETTINGS AND MAINTENANCE: Cleaning 4.6.3 Cleaning the anterior segment adapter (optional) Fingerprints or dust on the anterior segment adapter compromises the quality of captured images. Check the lenses for cleanliness before image capture. If necessary, clean them. CAUTION • The anterior segment adapter or its peripheral parts may come into contact with the patient's eye- lashes.
SYSTEM SETTINGS AND MAINTENANCE: List of Consumables List of Consumables Product name Product number Remarks Chinrest paper 32903-M047 1 stack 1 unit Magnetic forehead rest pad 30611-1520 Made of ABS resin 1 unit Forehead rest pad 15411-M752 Made of polyester elastomer * After using the consumables, prepare spare ones.
SYSTEM SETTINGS AND MAINTENANCE: Optional Accessories Optional Accessories 4.8.1 External fixation lamp The external fixation lamp is an optional accessory used for patients who are unable to focus on inter- nal fixation lamp properly. The fixation of the eye that is subject to image capture can be stabilized by having the patient focus on the external fixation lamp with the other eye.
SYSTEM SETTINGS AND MAINTENANCE: Optional Accessories 4.8.2 Anterior segment adapter The anterior segment adapter is attached over the objective lens of the system main body to capture anterior segment cross-sectional images. It is removed for retinal cross-sectional image capture and color fundus image capture.
SPECIFICATIONS AND TECHNICAL INFORMATION Specifications • OCT specifications Image capture principle Fundus observation OCT Phase Fundus, CCD camera and image capture Retinal cross-sec- Spectral domain OCT tional image observa- tion and image capture Eye front observation CCD camera screen Anterior segment Spectral domain OCT cross-sectional image capture (optional)
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SPECIFICATIONS AND TECHNICAL INFORMATION: Specifications • Fundus camera specifications Type Non-mydriatic fundus camera Image capture angle of 45° (33° for small pupil image capture) view Image capture magnifica- x0.42 tion Resolution Central area:60 line pairs/mm or more Middle area: 40 line pairs/mm or more Peripheral area: 25 line pairs/mm or more Dot pitch on fundus 4.4 µm...
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Operator's Manual, Quick Reference Guide, NAVIS-EX set, RS-330 Capture installation CD, USB 3.0 PCIE ADD IN CARD, retina map dongle and B-scan Denoising Software •...
SPECIFICATIONS AND TECHNICAL INFORMATION: Glossary and Abbreviations Glossary and Abbreviations The following terms and abbreviations are used in the system and operator's manual. Glossary Term Explanation ACA LINE A type of scan line that scans the anterior chamber angle once along a straight line This scan line can only be used when the anterior segment adapter (optional) is used.
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SPECIFICATIONS AND TECHNICAL INFORMATION: Glossary and Abbreviations Term Explanation External fixation lamp The external fixation lamp is an optional accessory used for patients who are unable (optional) to focus on internal fixation lamp properly. The fixation of the eye that is subject to image capture can be achieved by having the patient focus on the external fixation lamp with the other eye.
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SPECIFICATIONS AND TECHNICAL INFORMATION: Glossary and Abbreviations Term Explanation Optical working dots Bright spots displayed on the right and left sides of the screen They are used for fine alignment or focusing, or when the electronic working dot cannot be displayed. For the alignment, the optical working dots need to be brightly displayed and aligned symmetrically to the optical working dot charts.
SPECIFICATIONS AND TECHNICAL INFORMATION: Light Hazard Light Hazard Provision of information on the avoidance of light hazard from the optical device is required in ISO 15004-2 (2007) “Ophthalmic instruments - Fundamental requirements and test methods”. CAUTION • The light emitted from this system is potentially hazardous. The longer the duration of exposure and the greater the number of pulses, the greater the risk of ocular damage becomes.
• Wireless power transfer charging systems for electrical vehicles Specified cable Part name Cable Shielded Ferrite Core Length (m) Power cord for RS-330 USB 2.0 cable USB 3.0 cable External fixation lamp (optional) Specified multimedia equipment Name Standard compliance Computer...
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SPECIFICATIONS AND TECHNICAL INFORMATION: EMC (Electromagnetic Compatibility) Compliance for Emission Standard Product family standard Phenomenon Compliance Group 1 Conducted and radiated RF emissions CISPR 11 Class B Harmonic distortion IEC 61000-3-2 Voltage fluctuations and flicker IEC 61000-3-3 For the regions where the rated voltage is 220 V to 240 V, this device complies with this standard. For the regions where the rated voltage (line to neutral) is 220 V to 250 V, this device complies with this standard.
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SPECIFICATIONS AND TECHNICAL INFORMATION: EMC (Electromagnetic Compatibility) Compliance for Standard Immunity Phenomenon Basic EMC standard Immunity test levels ±8 kV contact Electrostatic discharge IEC 61000-4-2 ±2 kV, ±4 kV, ±8 kV, ±15 kV air 3 V/m Radiated RF IEC 61000-4-3 80 MHz - 2.7 GHz electromagnetic field 80% AM at 1 kHz...
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