IVVC User Manual

USER MANUAL
InVivoVue Clinic
Release 1.2
QOP-60-05 Revision B August 2008
Customer Support
Sunita Sayeram Applications Engineer & Imaging Specialist Phone: 919-314-5506 Email: ssayeram@bioptigen.com Eric Schneider Director of Operations Phone: 919-314-5500x1216 Email: eschneider@bioptigen.com
General Inquiries
Bioptigen, Inc. 104 T.W. Alexander Drive P.O. Box 13569 Durham, NC 27709 Email: sdoct@bioptigen.com
ii
Table Of Contents
Table Of Contents
Product Information .................................................................................................................... 7 Symbol Explanations .............................................................................................................. 7 Overview of the Hardware ...................................................................................................... 8 Device Description ............................................................................................................. 8 Indications for Use.............................................................................................................. 8 Classification ...................................................................................................................... 8 Contraindications and Warnings ......................................................................................... 8 Safety..................................................................................................................................... 9 Operational Safety.............................................................................................................. 9 Environmental Conditions..................................................................................................10 Electromagnetic Compatibility (EMC) ................................................................................10 General Precautions..........................................................................................................10 Maintenance .........................................................................................................................10 Labeling ................................................................................................................................11 Engine...................................................................................................................................11 Hand Held Probe Interface Box .............................................................................................11 Clinical Retinal Scanner Interface Box ..................................................................................11 Cleaning and Disinfecting......................................................................................................12 The Handheld Probe .........................................................................................................12 The Clinical Scanner .........................................................................................................13 Optical Fibers ....................................................................................................................14 Scanner Start Up and Shut Down .............................................................................................15 Powering Up the Hardware ...................................................................................................15 Checking the Line Spectrum .....................................................................................................16 Creating a Line Spectrum Configuration File .........................................................................18 Shutting Down the Scanner ...................................................................................................18 About Shutting Down the Scanner.....................................................................................18 About Backing Up the System ...........................................................................................18 Performing a Backup .........................................................................................................19 Shutting off the Power .......................................................................................................20 Conducting a Patient Exam .......................................................................................................22 Setting Up a New Patient ......................................................................................................22 Selecting or Adding the Patient .............................................................................................22
iii
InVivoVue Clinic (Release 1.2) Setting Exam Defaults ...........................................................................................................23 Selecting the Types of Scan to Acquire .................................................................................23 Acquiring Images ..................................................................................................................24 An Overview of Acquiring Images......................................................................................24 About the Fixation Control Window ...................................................................................24 Creating Fixation Targets ..................................................................................................25 About the Video Fundus/Scan Control Window .................................................................26 Aiming to Acquire an Image ..............................................................................................26 Using Free Run Mode to Acquire an Image .......................................................................28 Basic Operations.......................................................................................................................30 Creating Customized Scans ..................................................................................................30 Editing Scans ........................................................................................................................31 Deleting Scans ......................................................................................................................31 Exporting Patient Exams .......................................................................................................31 Reviewing Image Scans ........................................................................................................32 Saving Image Scans .............................................................................................................33 Printing Images .....................................................................................................................34 The B-Scan Window..........................................................................................................34 The Volume Intensity Projection Window ..........................................................................34 The Video Fundus/Scan Control........................................................................................35 Generating a Scan Report.....................................................................................................35 Administrative Operations .........................................................................................................37 Setting Up the System...........................................................................................................37 Creating a Study ...............................................................................................................37 Creating a New Scan Protocol...........................................................................................37 Defining a New Treatment Arm .........................................................................................38 Creating a Physician Record .............................................................................................38 Creating an Examiner Record ...........................................................................................39 Maintaining Study Information ...............................................................................................39 Editing a Study ..................................................................................................................39 Deleting a Study ................................................................................................................40 Adding a Scan Protocol to a Study ....................................................................................40 Defining a New Treatment Arm .........................................................................................41 Adding a Treatment Arm to a Study ..................................................................................41 Working with Patient Information ...........................................................................................41
iv
Table Of Contents Working with Patient Records............................................................................................41 Editing a Patient Record ....................................................................................................42 Deleting a Patient Record..................................................................................................42 Working with Exam Records .................................................................................................43 Editing an Exam Record ....................................................................................................43 Deleting an Exam Record..................................................................................................43 Exporting Patient Exams ...................................................................................................44 Importing Patient Exams ...................................................................................................44 Reading Non-Native Site Data...........................................................................................45 Maintaining Physician and Examiner Information ..................................................................47 Creating a Physician Record .............................................................................................47 Editing a Physician Record................................................................................................48 Deleting a Physician Record .............................................................................................48 Creating an Examiner Record ...........................................................................................49 Editing an Examiner Record ..............................................................................................49 Deleting a Examiner Record ..............................................................................................50 Maintaining Image Scans ......................................................................................................50 Creating Preset Scans ......................................................................................................50 Archiving Scans ................................................................................................................51 Retrieving Archived Scans ................................................................................................52 Loading Images from OCT Data ........................................................................................52 Saving Images as OCT Data .............................................................................................53 Loading Images from OCU Data .......................................................................................54 About File Types ...............................................................................................................54 Memory Management .......................................................................................................55 Configuring User Settings .....................................................................................................55 Changing Default User Settings ........................................................................................55 Creating a New User Settings File .....................................................................................57 Loading an Existing Settings File.......................................................................................57 Advanced Operations................................................................................................................59 Optimizing the Reference Arm ..............................................................................................59 Reference Arm Adjustments for Myopes/Hyperopes Imaging ............................................59 Reference Arm Adjustments for Pediatric Imaging ............................................................59 Focus Adjustment..............................................................................................................60 Acquiring Doppler Data .........................................................................................................60
InVivoVue Clinic (Release 1.2) Displaying Scan with Doppler Data .......................................................................................61 Optimizing Image Dispersion.................................................................................................62 Reviewing Image Scans ........................................................................................................63 Playing Back Image Scans ................................................................................................63 Changing B-Scan Window Settings ...................................................................................63 Setting VIP Window Samples ............................................................................................64 Viewing 3-Dimensional Rendering of Image Scans ...............................................................64 About the 3-D Analysis Tool ..............................................................................................64 Loading a Rectangular Volume Scan into the 3-D Analysis Tool .......................................65 Cropping 3-D Image to Displayed Samples .......................................................................65 Registering B-Scans in 3-D Image ....................................................................................66 Changing 3-D Display Options ..........................................................................................66 Cropping the 3-D Image Using Crop Lines ........................................................................67 Slicing the 3-D Image Using Slider Controls ......................................................................68 Capturing the 3-D Image ...................................................................................................68 Resetting the 3-D Image....................................................................................................69 Switching 2-D Windows into Main Window ........................................................................69 Troubleshooting ........................................................................................................................70 Resolving Hardware Problems ..............................................................................................70 Resolving Software Problems ...............................................................................................70 Loss of Fixation Target or Desktop Display ...........................................................................71 Reclaiming the Fixation Target ..........................................................................................72 Setting Up the (840nm) Engine and Probe ............................................................................74 Installing the Clinical Scanner and Chin Rest ........................................................................74 Connecting the Probe Interface Box, the Engine and the Computer ......................................76 Using other Types of Probe ...................................................................................................79 Index .........................................................................................................................................81
vi
Product Information
Symbol Explanations
The following symbols are displayed throughout the User Manual. Warning! Warnings alert about situations that, if not avoided, could result in death or serious injury. Caution! Cautions warn against a potentially hazardous situation that, if not avoided, may result in minor or moderate injury to the user or subject or damage to the equipment or other property. Cautions may also alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse. Note Notes identify technical requirements to which the user should devote special attention, such as remarks on common errors, unusual situations, and tips for optimized use. Alternating Current Symbol: Found on Electrical Safety Label on the back of the Engine and Interface Boxes
Operating Instructions: Found on Manufacturer Label Consult User Manual
Protective Ground Earth: Found inside Engine and Interface Boxes Type B Applied Part: Found on Hand Held Probe and Clinical Retinal Scanner Directional Arrows: Found on front of the Engine; Reference Arm Position and Reference Arm Power
InVivoVue Clinic (Release 1.2)
Overview of the Hardware

Device Description
The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with < 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography. The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).
Indications for Use

The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue. Users of this system should be physicians or technicians with professional training or experience in the use of retinal imaging equipment.
Classification
Medical Device: Class I, Type B, IPXO, Continuous Operation, Not for use in flammable environments, Not provided sterile, Cleaning Instructions provided.
Contraindications and Warnings

This device is a Class I laser product. The power level of the output of this device is well within safety standards, i.e. the typical exposure duration for a standard imaging session is places the total ocular exposure as well below the maximum permissible exposure. Users should not look directly into the output of this device for any longer than necessary for obtaining images. If the imaging is paused for more than 30 seconds, the subject should be instructed to move away from the scanner and rest their eyes. Warning! Explosion Hazard Do not operate the device in an environment where explosive and/or flammable substances are used or stored. In the event of an emergency, disconnect the power cords immediately. Caution! Phototoxicity Because prolonged intense light exposure can damage the retina, the use of the device for ocular examination should not be unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. This device should be used with filters that eliminate UV radiation (< 400 nm) and, whenever possible, filters 8
Safety and Cleaning that eliminate short-wavelength blue light (<420 nm).* Caution! Phototoxicity The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum exposure limit.* Caution! Phototoxicity While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes, it is recommended that the intensity of light directed into the subjects eye be limited to the minimum level which is necessary for diagnosis. Infants, persons with aphakia and other diseases of the eyes will be at greater risk. The risk may also be increased if the person being examined has had any exposure with the same instrument or any other ophthalmic instrument using a visible light source during the previous 24 hours. This will apply particularly if the eye has been exposed to retinal photography.*
*Note: The Phototoxicity cautions listed above are mandatory text as defined in the CDRH guidance document #71, Ophthalmoscope Guidance (Direct and Indirect).
Safety
Operational Safety
Warning! Danger of High Voltage Do not remove component covers. Installation, assembly, service, and maintenance must be performed by the manufacturer or an authorized service representative only. Warning! Patient Contact Do not simultaneously touch the patient and the computer. Caution! Ventilation System requires proper ventilation. Do not block the Front or Back of the Engine! Do not block the Back of Sides of the Interface Boxes. For product liability and/or warranty by the manufacturer the following must be observed:

The device must be used according to this manual, Bioptigen Spectral Domain Ophthalmic Imaging System Users Manual." Installation, assembly, service, and maintenance have been performed by the manufacturer or an authorized service representative only. No modifications to the device are allowed. The electrical installation of the room where the device is used complies with national standards. Do not remove or disable the ground pin of any power connection. Supply cables are for connecting Bioptigen equipment only and may not be used with any other equipment. 9
Environmental Conditions
Warning! Explosion Hazard Do not operate the device in an environment where explosive and/or flammable substances are used or stored. In the event of an emergency, disconnect the power cords immediately. The device is not designed for use in damp or high humidity environments. Do not allow condensation to form on any component. Do not place fluid-filled containers on any surface of the device. Not for use in flammable environments. Operating conditions The system shall be able to operate within a temperature range of 15 to 30 and within a C C relative humidity range of 20% to 85% non-condensing. Transportation and Storage Conditions The system shall be able to transport and store within a temperature range of -10 to 50 C C.
Electromagnetic Compatibility (EMC)

The System has been approved by Underwriters Laboratory Inc for EMC and is currently in the last stages of electrical safety testing. This includes standards UL60601-1:2003; IEC60601-1, 2nd ed; CSA C22.2 No.601.1-M90; IEC60825; and IEC60601-1-2:2001.
General Precautions
Caution! Subject Contact The optimal position of the ocular lens is ~25 mm or ~1 from the corneal surface of the eye. While this should be a long enough working distance to avoid contact with the subjects eyelashes or nose, care should still be taken to prevent this collision.
Maintenance
There are no user maintainable parts in the system. Preventative Inspection The user should check the power level of the system every six months by Checking the Line Spectrum. If the attenuator wheel can no longer be adjusted so that the power level is above 75%, contact Bioptigens Customer Support department.
10
Safety and Cleaning
Labeling
Engine
Reference Arm Power Reference Arm Position
LED indicator for Power LED indicator for Scanning Sample Fiber Connection External Source Connection Avoid Exposure Label
Serial Number Manufacturer Label
Model Number and Date Manufactured
Cautions and Warnings
Hand Held Probe Interface Box
Serial Number
Electrical Safety
Model Number/ Mfg Date
Manufacturer
Clinical Retinal Scanner Interface Box
Serial Number
Electrical Safety
Model Number/ Mfg Date
Manufacturer
11
Cleaning and Disinfecting

The Handheld Probe
To clean the handheld probe lenses, you need the following supplies:

gloves lint-free lens tissue (a nonwoven rayon blend is recommended) methanol
Follow these steps to clean the probe: 1. Wearing gloves, fold one piece of lens tissue in half 4 times in the same direction along the shorter side.
2. Now, fold the lens tissue in half along the longer side.
3. Apply one to two drops of methanol to the tissue at the fold.
12
Safety and Cleaning 4. Wipe the lens straight across, and then roll and rotate the lens tissue off of the lens.
5. Inspect the lens for residue. If the lens is not clean, repeat steps 1-4 above, using a new piece of lens tissue. Note: Never use the same lens tissue twice!
The Clinical Scanner

The head and chin rest should be cleaned with isopropyl alcohol swabs following each imaging session. If accidental contact of the subjects eye or eyelashes occurs with the ocular lens, the lens should be cleaned immediately to avoid potential artifact on the scanned image. To clean, follow the cleaning and disinfecting procedure for The Handheld Probe.
13
Optical Fibers
Follow these steps to clean the unit's optical fibers: 1. Open the fiber cleaner to expose the fiber cleaner ribbon tape. Hold open throughout cleaning process.
2. Place the fiber in first channel, twist left and right, then slide fiber down channel.
3. Place the fiber in second channel, twist left and right, then slide fiber down channel. The fiber is now clean.
4. Release the lever to close the fiber cleaner.
14
Scanner Start Up and Shut Down

Powering Up the Hardware
Begin each day by powering up the hardware for InVivoVue. Before you start the InVivoVue software on the computer, you must turn on the scanner hardware, because it is required for the software to start and run properly. Turn on the scanner hardware in either of two ways:

If you previously shut off the power by turning off the power strip, simply turn on the power strip. If you previously shut off the power of the individual components, turn them on individually, making sure that you have also turned on the power strip.
Here is an illustration of the location of the switches on the two hardware components:
15
Checking the Line Spectrum

To check the line spectrum, select the patient called Bioptigen Diagnostics and select a pending scan to run the test. (If you do not already have such a patient, add a new patient with this name.) Add a new exam with todays date (unless there is an existing one with the current date in this patient record, in which case you may add scans to that exam), and follow the steps outlined below. To can create test records for checking the line spectrum follow the procedures for Creating a Study, Creating a New Patient Record, Setting Exam Defaults, and Selecting the Types of Scan to Acquire. To check the line spectrum follow these steps: 1. Make sure that the Bioptigen Diagnostics patient is selected, and select or add an exam with todays date. Click the Start Exam (or Review Exam) button, and the Imaging folder is displayed. 2. From the Tools menu, select Load Settings..., and the Load Settings File dialog box appears. 3. Navigate to the C:\Program Files\Bioptigen\InVivoVueClinic directory. From the list of files in the dialog box, select the file LineSpectrum.ini, and click the Open button. The settings for checking the line spectrum are loaded into InVivoVue. Note: If you do not find the LineSpectrum.ini file, refer to the procedure Creating a Line Spectrum Configuration file to create the file. Then load the file as described above, and continue with the following steps. 4. On the Imaging tab page, select from the dropdown list the scan preset named OD_Linear_10mm_1000x40x1, and add it to the scan list. 5. At the top of the Capture tab, click the Start Free Run button, and a green curved line appears in the Horizontal B-Scan window. (Depending upon certain properties of the power source in your unit, the line may have a single peak, giving it the shape of a bell curve, or it may have more than one peak. See image below for a good example of the line spectrum.) Note: Regardless of the particular shape of the curve, the peak of it should be no higher and no lower than two thirds (2/3rd) of the B-scan window (y=~250). 6. To adjust the height of the curve, turn the (smaller) Reference Arm Power knob on the front of the engine (hardware), clockwise to raise the peak, or counterclockwise to lower the peak. 7. After adjusting the curve to the proper height, click the Stop Free Run button to end the scanning. 8. Click the Save Scan button to save this scan in the patient record. 9. From the Tools menu, select Load Settings..., and the Load Settings File dialog box opens. 10. In the dialog box, select the appropriate User.ini file. (If you are imaging the retina, load the retina User.ini file; if you are imaging the cornea, load the cornea User.ini file.) The InVivoVue settings for scanning patients are restored and you may resume imaging patients.
16
Process Flow for Checking the Line Spectrum
17
Creating a Line Spectrum Configuration File

The line spectrum configuration file (LineSpectrum.ini) is used for loading the necessary system settings to check the (power) line spectrum of the InVivoVue hardware. If you want to check the line spectrum but find that you do not have the file LineSpectrum.ini, follow these steps to create the file. 1. Select the Imaging tab. 2. On the right side of the tab, between the Volume Intensity Projection and Video Fundus/Scan Control windows, click the Options button. The Edit Options dialog box opens. 3. At the top of the dialog box, click the Options tab. 4. At the top of the Options tab, deselect the Custom check box. 5. In the Display Type group box in the middle of the tab, select the Line option button. 6. Close the Edit Options dialog box. 7. From the Tools menu, select Configure Processing..., and the Image Processing and Resampling Controls dialog box opens. 8. At the top of the Processing tab, click the Clear All button, and close the dialog box. 9. From the Tools menu, select Save Settings..., and the Save Settings File dialog box opens. 10. At the bottom of the dialog box, in the File Name field type LineSpectrum, and click the Save button. The dialog box closes. If you just created this file for checking the line spectrum now, you can return to the topic, Checking the Line Spectrum.
Shutting Down the Scanner

About Shutting Down the Scanner
The light source in the scanner has a limited lifetime, so rather than allowing it to run constantly, you should shut down the scanner at the end of each day. Before you shut down the scanner, it is a good time to consider

exporting patient exams archiving patient exams backing up your system data
About Backing Up the System

As with any computer system, it is a good idea to perform regular backups of data you obtain when working with InVivoVue. Performing a backup makes copies of important files and stores them in another location, making them available in case the original files are lost or corrupted and you need restore these files from the most recent copy. By backing up your data frequently, you are better ensured that you can more fully recover from any loss of data.
18
Scanner Start Up and Shut Down By default, InVivoVue's data is stored on the D:\ partition of your computer's hard drive, along the path D:\Bioptigen\Data\Images. Because of the size of individual image files captured by InVivoVue, the total amount of data is quite large. So to properly backup your data, you should use an external storage device or a network drive if your company has one available for you. You should also consider backing up the InVivoVue application files and data, especially the database that holds all patient and exam data, including 'pointers' to where the patients' scans are stored. The application files, including the database, are stored in C:\Program Files\Bioptigen\InVivoVue Clinic. Once you determine where you want to store data that you backup, you should then devise a regular schedule for backing up data, such as daily at the end of each day or weekly on the same day each week. A number of third party software programs exist for automating and regularly scheduling the backup process. If you use other software to automate your back-up procedures, follow the directions that come with the software to perform successful backups. If you choose to back up your data manually, use the Microsoft Windows Explorer to manage files on your computer. As part of backing up your data, you might want to consider archiving scans, which removes data from your system to another storage location. Bioptigen strongly recommends archiving exams when the available space for storing the image files is less than 10% of the total storage capacity on the disk drive. (The D:\ drive is the default disk drive for storing image files.) To check the amount of available space on the disk drive: 1. Open Windows Explorer. 2. Right-click on the disk drive, and a pop-up menu is displayed. 3. Select Properties, and the Properties dialog box opens. 4. Select the General tab, and verify that the amount of Free Space is greater than 10% of the Capacity of the drive. Now, unless you need to archive scans, you are ready to perform a backup.
Performing a Backup
Perform a backup by copying your InVivoVue Clinic program and data files to a network drive or external storage device for safe keeping. Because of the total size of these files, especially if you have a large number of scans, you should have at least one terabyte of storage space available for the backup files. Overtime, you may need to further increase the available space for backup. Note that, depending upon the number of scan images on your system, the backup procedure could take up to an hour or more to complete. (Remember, you can archive scans to remove them from your system and store them elsewhere; you still need the same amount of storage space, but by archiving, you reduce the amount of data that you regularly back up and shorten the time it takes.) Follow these steps to perform a backup: 1. If you are using an external storage device, connect it to your computer. (Usually, this only requires that you connect the device's USB cable to an available USB port on your computer.)
19
InVivoVue Clinic (Release 1.2) 2. Using Windows Explorer, find the Bioptigen directory in the Program Files on your computer's C:\ drive, at the path C:\Program Files\Bioptigen. Right-click on the Bioptigen folder, and from the pop-up menu, select Copy. 3. With your mouse cursor, point to the area on the network drive or external device where you want to place the copy of the Bioptigen folder. Right-click on that area, and from the pop-up menu, select Paste. In a few seconds, the application files are copied to your backup location. 4. Select the new folder you just created, right-click on it and select Rename. Append the current date to the folder name. For example, the new Bioptigen folder should be named Bioptigen-YYYY-MM-DD,' where YYYY=current year, MM=current month, and DD=current day. 5. Now find the Bioptigen data (image) directory on your D:\ drive, at the path D:\Bioptigen\Data. Right-click on the Data folder, and from the pop-up menu, select Copy. 6. Again, with your mouse cursor, point to the area on the network drive or external device where you want to place the copy of the Data folder. Right-click on that area, and from the pop-up menu, select Paste. The data (image) files are copied to your backup location. Note, however, that depending upon the number of images, this part of the process may take an hour or more. 7. After copying the folders to the back up location, you might want to verify that all of the data was successfully copied, by one or more of the following steps: a. Right-click on both the original and the backup copies of the folders, and from the pop-up menu select Properties. In the Properties dialog box, select the General tab and note the Size of the folders; they should be exactly the same. b. Compare the contents (subfolders) in both the original and backup copies of the folders. (You can open two instances or copies of Windows Explorer for easier side-by-side comparison.) c. Further compare the individual files in both the original and backup copies of files. d. Open randomly selected images in the backup files: From the File menu in InVivoVue, select Load Processed Data or Load Unprocessed Data, and then navigate to select individual .OCT and .OCU files, to verify that the images are displayed correctly. 8. After completing the backup, you can disconnect any external device connected to your computer for purposes of backup. Be sure to follow Windows procedures for safely disconnecting the device.
Shutting off the Power

Once you have completed all activity for the day, you can shut down the scanner in either of two ways:
Turn off the power strip where the hardware is plugged in. Note: In Bioptigen's standard installation, the computer is also plugged into the power strip, so be sure you shutdown the computer before you turn off the power strip.
20
Turn off the two individual components of the scanner hardware, using their power switches on the rear panels.
For illustrations of the location of the switches on the two hardware components, see picture below.
21
Conducting a Patient Exam

Setting Up a New Patient
Whenever a new patient joins your practice or visits your clinic, you need to create a new record for him or her. Follow these steps to set up a new patient: 1. Select the Patient/Exam tab. 2. At the bottom of the tab, click the Add Patient button, and the Add Patient dialog box opens. 3. Enter an ID, First and Last names, the MRN (medical record number), and the DOB (date of birth), and select M or F for the patient's gender. Note: Except for the MRN, all of these fields are required to save the new record, and you must have unique values for ID, MRN and the combination of First and Last name. 4. If you know the values for Refractive Error and Axial Length for the patient's eyes, you can also enter them now, and you can add any Notes for the record. 5. When you finish entering the information, click the Save & Exit button to save the new record and close the dialog box. When you have created the record, you can see the patient information in the View Patient Details group box at the bottom right of the Patient/Exam tab.
Selecting or Adding the Patient

To conduct a patient exam, you must first select an existing patient record or create a new record. To select an existing record, follow the steps below. If you need to create a new patient record, follow the steps in Creating a New Patient Record. 1. At the top of the InVivoVue application window, select the Patient/Exam tab. 2. To select an existing record, you can either use the Find Patient group box at the top of the tab or the List Patients group box below it. 3. To find a patient record, enter part or all of the record information in the Patient ID, Patient MRN, First Name or Last Name fields in the Find Patient group box. As you type in any field, InVivoVue selects the first record it finds in the List Patients group box that matches the information you entered. 4. Alternatively, you can select a record from the List Patients group box. You can find patients by their exam dates. Enter a date (or use the calendar option by clicking the down arrow beside the date text box) in both the From and To date fields. Records that match your selection are displayed in the list below your selection. In the Show Patients group box, select either All Patients, or select In Study and choose a study from the drop-down list. Records that match your selection are displayed in the list below your choice. You can sort the list of records by any of the columns; to sort, simply click on the column heading.
22
Conducting a Patient Exam 5. Select the patient record from the list, and basic information from the record is displayed in the View Patient Details group box at the bottom right of the tab. 6. Next, you must set the exam defaults.
Setting Exam Defaults

Once you select the patient for an exam, you must then set certain 'defaults' for the exam, including the examiner, physician, study and treatment arm. Values for each of these fields are set by default for the current InVivoVue session; however, you can change any of the entries as necessary for the current exam, either by selecting other existing values or by adding a new examiner or physician. Follow these steps to verify or change the defaults for the current exam: 1. On the Patient/Exam tab, locate the Set Exam Defaults/Add Exam group box at the upper right of the tab. 2. Check the entries for Examiner, Physician, Study and Treatment Arm to ensure they are correct for the patient's current exam. 3. If you need to change any of the entries, select a new entry from the drop-down list for that field. 4. If you need to create an entry for a new examiner or physician, select from the related topics below. 5. After selecting all the defaults for this exam, click the Add Exam button, and the exam record is added to the list of exams for the current patient. 6. If you make a mistake or want to change any of the exam defaults, you can edit or delete the exam record 7. When you have successfully added an exam to the patient's record, select the exam from the list in the View Patient Exams group box, and click the Start Exam button. InVivoVue then takes you to the Imaging tab. 8. Now you can select the types of scan for the selected exam.
Selecting the Types of Scan to Acquire

Before you can acquire images for a patient, you must add one or more types of scan to the patient exam. You can select either preset scans associated with a protocol, individual preset scans, or you can create customized scans for the patient. Note: You can only add scans to an exam that has the current (today's) date. For exams dated in the past, you can only delete scans for which the Status is 'Abandoned;' all other functions for adding or editing scans are disabled. Follow these steps to select preset scans: 1. Select the Imaging tab. 2. Verify that you have selected the desired exam at the top of the Review Scans group box, which shows the patient's name, ID, physician and study, as well as the date and time that the exam record was created.
23
InVivoVue Clinic (Release 1.2) 3. To add preset scans from a protocol, choose a protocol from the Select Protocol dropdown list at the top of the tab, and click the Add Scans button. (To add the scans in a randomized order, click the Randomize Scans button instead.) 4. To add individual preset scans (which may or may not be associated with any protocol), choose them from the Select Preset Scan drop-down list, and click the Add Preset Scan button. 5. You can also define custom scans to add to the exam. (Refer to Creating Customized Scans.) 6. After you have added all desired scans to the exam record, select the one you want to conduct first from the Review Scans group box on the left of the Imaging tab. The large green arrow indicates the currently selected scan. You can change the order of scans in the list, for any scan that is 'pending.' To reorder, select the scan, and click the Re-Order buttons to move it up or down in the list, to achieve the order in which you want to conduct the scans. 7. Now you are ready to acquire the images for the exam. Note: If you want to define a new scan protocol comprising the images currently selected for an exam, follow the steps in Creating a New Scan Protocol.
Acquiring Images
An Overview of Acquiring Images
To acquire images, you first seat the patient in front of the slit lamp and position his or her head comfortably in the chin rest. Next you manually adjust the slit lamp so the patient can see the fixation target, and then you are ready to begin aiming to acquire images. During the process, you use the Fixation Control window and the Video Fundus/Scan Control window to help with aiming and acquiring images, so you need to know about them. After you aim the slit lamp and find the target for the scan, you acquire the images selected or defined for the exam, and finally you save them for the patient's exam record. Continue by reading About the Fixation Control window.
About the Fixation Control Window

The Fixation Control window is located on the Capture tab on the Imaging tab. It displays the fixation target that is seen by the patient when looking into the scanner. A circular green target on a red background is located in a default location that is based on your user configuration settings. The Fixation Control window has two sets of buttons: a row of control buttons and a row VCR playback buttons. You can choose whether to show or hide each set and whether to place them at the bottom or the left side of the window. To show or hide the buttons or to change their placement, right-click in the title bar of the Fixation Control window, and a pop-up menu appears. Make your selections for the display and placement of each set of buttons. You can use the default color, shape, size and position of the target, or you can change them as necessary for the patient, to give you the precise view of the anatomy of the eye. 24
Conducting a Patient Exam 1. To change the fixation target color, position the mouse cursor over the fixation target window and right click. Select Target color and the Color dialog box opens. Select a color and click OK. The fixation target color changes to the selected color. 2. To change the fixation target background color, position the mouse cursor over the fixation target window and right click. Select Background color and the Color dialog box opens. Select a color and click OK. The fixation target background color changes to the selected color. 3. To change its shape, click the button to switch between a circle and a cross. button.
4. To switch between hiding and displaying the target, click the 5. To switch between a blinking or still target, click the button.
6. To change its size, place the mouse cursor over the edge of the target, and when the cursor changes to a size. , click and drag the edge of the target to enlarge or reduce the
7. To change its position in the window, place the mouse cursor over the center of the target, and when the cursor changes to a any position in the window. , click and drag the target to move it to
8. You can save changes to the target location (but not the size) as another preset target to use for future scans. Refer to Creating Fixation Targets. As an alternative to the type of target described above, you can select an AVI file by clicking the folder button to open the Open Fixation File dialog box and select one from your computer. Playback of the AVI is controlled with the VCR playback buttons located on the Fixation Control window. The VCR playback button are automatically displayed when an AVI file is opened. (If the playback buttons are not visible, right-click in the title bar of the Fixation Control window, and the Playback Toolbar Visible pop-up menu appears. Check the Playback Toolbar Visible option to see the playback buttons.) To revert back to the original fixation target, click the button.
If you have saved any preset targets, click the button to show a drop-down list and choose between them, to position the fixation target in a different location, for foveal fixation or optic nerve head (ONH) fixation. Now read About the Video Fundus/Scan Control window.
Creating Fixation Targets

You can create new preset fixation targets for alternative locations for the target, rather than having to drag the fixation target each time to a new location. For example, you might want to create preset targets for foveal or optic nerve head (ONH) fixation. To save a new preset target, 1. Click the Save button below the Fixation Control window, and the Define Fixation Preset dialog box opens.
25
InVivoVue Clinic (Release 1.2) 2. Enter a unique name to describe the new preset target. 3. Make any changes you want to the X and Y coordinates (although these are based on the position you defined by dragging the target in the window). 4. Select whether the new target preset is for OD, OS or Any Eye. 5. Click the OK button, and the new preset target is saved. After creating new preset targets, you can select them from a list by clicking the green down arrow below the Fixation Control window.
About the Video Fundus/Scan Control Window

The Video Fundus/Scan Control window, located to the right of the Fixation Control window on the Imaging tab, presents of a view of what the scanner sees in real time. This control is a tool for aligning the scanner to the target in the patient, rather than any substitute for fundus photography. The video image is displayed without the inversion often associated with camera lenses. In most patients with light-colored eyes, the retina lights up under the illumination of the fundus camera, yielding a bright spot in the video image. In such cases, you can use the bright spot for easier alignment, using the joystick to zoom in and narrow the focus as you search for the OCT image. When the fundus video shows the retinal surface in focus, the OCT image is only a few millimeters from coming into focus. Using the joystick to continue to focus for the OCT image, the fundus image loses sharpness as the OCT image becomes sharper. For reference, you can save electronic files of images and print copies from the video image. Click on the Click on the button at the bottom of the video window to save a bitmap (.BMP) image. button to send a copy to your printer. Click the button to show how an
image will look upon printing. Click the the overlay. Click the
button to switch between hiding and displaying
button to toggle the video capture on and off.
Now you are ready for Aiming to Acquire an Image.
Aiming to Acquire an Image

Follow the steps below to aim the scanner and acquire the image. 1. Have the patient place his or her head in the chin rest on the slit lamp. 2. Manually position the slit lamp until the patient can see the fixation target, while observing the image in the Video Fundus/Scan Control window to help you with alignment. 3. If the scan is set up to acquire Doppler data (identified by the letter D in the scan list) you may request to view Doppler data while aiming by checking the Doppler? check box beside the Start Aiming button.
26
Conducting a Patient Exam Note: The Doppler? check box is enabled only when a pending scan that is set up to acquire Doppler data is selected. De-selecting the Doppler? check box stops the display of Doppler data during aiming. 4. Once the patient can see the fixation target (even if it is not yet in focus), click the Start Aiming button at the top of the Capture tab on the Imaging tab, and the system activates two images at the top of the Capture tab: the Horizontal and Vertical B-Scan alignments. (These images show the horizontal and vertical scanning beams, enabling you to more precisely center the image on the feature of interest [fovea, optic nerve head, lesion, etc.] for the scan.) Note: You may use either footswitch on the foot pedal to start aiming. Make sure the Start Aiming button has focus, which is indicated when the button is outlined in blue. 5. Now tilt the joystick forward to further zoom in on the eye for more precise aiming, continuing to observe the image in the Video Fundus/Scan Control window to help you. Note: As you zoom in to find the image, you first come across a couple of faint OCT images of the retina; these are ghost images. As you continue to zoom in, past these images, you come to a very bright retinal image. To verify that you have acquired the real image you want to scan, continue to zoom past the image until you see the blurred, inverted complex conjugate image; there are no further images past this one. Now, tilt the joystick backward until you have the bright real image (not inverted) in focus. 6. Center the image in the horizontal plane by tilting the joystick left or right to move the scanner in the plane that is tangential to the eye, centering horizontally on the feature of interest. 7. To center the image in the vertical plane, twist the joystick left or right to move the scanner up or down, centering vertically on the feature of interest. When you are finished aiming the scanner, the top of the image should be located in the top one third or one half of the Horizontal B-Scan window. (See sample below of a correctly aligned image.)
27
8. To sharpen the image, adjust the diopter on the scanner for the brightest image. As you adjust the diopter, you can ask the patient to indicate when the fixation target appears sharpest. 9. When the image is correctly aligned and in sharpest focus, click the Start Snapshot button, which switches the scanner from aiming mode to scan acquisition mode. Now the Horizontal and Vertical windows display the B-Scans in real time and the volume intensity projection as the image is being generated. Note: You may use either footswitch on the foot pedal to start the snapshot. Make sure the Start Snapshot button has focus, which is indicated when the button is outlined in blue. Note: If InVivoVue cannot allocate sufficient memory to acquire the scan, it will display a message indicating memory allocation failure. When this occurs, reduce the size of the scan by modifying one or more of the following scan parameters: lines, scan, frames, and/or volumes. 10. When the scanning is complete, the Status of the scan changes from Pending to Unsaved and the Save button is enabled. The time the scan was acquired is displayed below the scan status. If you are satisfied with the image, click the Save button, and the Status of the scan changes from Unsaved to Pending. If you are not satisfied with the pending image, repeat the steps above. Note: You may use either footswitch on the foot pedal to save the scan. Make sure the Save Scan button has focus, which is indicated when the button is outlined in blue. Note: InVivoVue checks the default save drive for sufficient space. If there is less than 10% free space available on the default save drive, you will be advised to archive exams in order to free up space; however, you may save the scan. If there is less than 2 gigabytes of free space on the default save drive, you will advised to archive scans and will not be allowed to save any more scans until there is more than 2 gigabytes of free space available to save a scan. 11. If at any time you want to cancel the aiming process, click the Stop Aiming button. You can view the image in the B-Scan window using the VCR playback buttons below the window. Using the slider controls for Rate and Frame number, you can adjust the frame Rate for playback and select individual frames for viewing.
Using Free Run Mode to Acquire an Image

Free Run mode is an alternative to Aiming mode to acquire an image. Free Run mode puts the system in a continuous scan mode and displays the B-Scan image and any volume intensity projection (for Volume images) as they are being acquired. In this mode, the size of the image buffer is determined by the scan definition and is limited to storing one set of frames of image data, so you must choose carefully what you want to save. Follow these steps to acquire an image using Free Run mode: 1. Have the patient place his or her head in the chin rest on the slit lamp.
28
Conducting a Patient Exam 2. Manually position the slit lamp until the patient can see the fixation target, while observing the image in the Video Fundus/Scan Control window to help you with alignment. 3. Click the Start Free Run button. The system begins to scan continuously, and the label on the button changes to Stop Free Run. Note: You may use either footswitch on the foot pedal to Start Free Run. Make sure the Start Free Run button has focus, which is indicated when the button is outlined in blue. 4. Once you start Free Run, the Start Free Run button changes to Stop Free Run, so if you want to stop scanning, click the Stop button, and the scanning stops after completing the current run and filling the buffer. Furthermore, if you click the Stop button, it changes to Abort, allowing you to cancel the scan without waiting for the buffer to fill. 5. Be sure to align the image in the frame so that the top of the image (i.e., the tissue surface) is located in the top one third or one half of the Horizontal B-Scan window. 6. When the system has acquired satisfactory frames for the image, click the Stop Free Run button to end the scanning process. When the scanning is complete, the Status of the scan changes from Pending to Unsaved and the Save button is enabled. The time the scan was acquired is displayed below the scan status. Note: You may use either footswitch on the foot pedal to stop free run mode. Make sure the Stop Free Run button has focus, which is indicated when the button is outlined in blue. Note: If InVivoVue cannot allocate sufficient memory to acquire the scan, it will display a message indicating memory allocation failure. When this occurs, reduce the size of the scan by modifying one or more of the following scan parameters: lines, scan, frames, and/or volumes. 7. If you are satisfied with the pending image, click the Save button, and the Status of the scan changes from Unsaved to Saved. If you are not satisfied with the pending image, repeat the steps above. Note: You may use either footswitch on the foot pedal to save the scan. Make sure the Save Scan button has focus, which is indicated when the button is outlined in blue Note: InVivoVue checks the default save drive for sufficient space. If there is less than 10% free space available on the default save drive, you will be advised to archive exams in order to free up space; however, you may save the scan. If there is less than 2 gigabytes of free space on the default save drive, you will advised to archive scans and will not be allowed to save any more scans until there is more than 2 gigabytes of free space available to save a scan. You can view the image in the B-Scan window using the VCR playback buttons below the window. Using the slider controls for Rate and Frame number, you can adjust the frame Rate for playback and select individual frames for viewing.
29
Basic Operations
Creating Customized Scans
Instead of using any of the preset scans available in your system, you may want to define your own parameters for scans to add to the exam. Note: You can only add customized scans to an exam that has the current (today's) date. For exams dated in the past, you can only delete scans for which the Status is 'Abandoned;' all other functions for adding or editing scans are disabled. Follow these steps: 1. From the Customize Scans group box on the Imaging tab, click the Add Custom Scans... button, and the Select Parameters for New Scan dialog box opens. 2. If you want to base your customized scan on a preset scan, select a scan from the Defined Scan Presets drop-down list, and click the Copy Settings from Selected Preset button. The parameters of the selected preset scan are then loaded into the Select Parameters group box of the dialog box. 3. If you do not want to base your customized scan on a preset scan, then click the button for the type of scan (Annular Volume, Linear B-Scan, etc.) you want to define, and the default parameters for that type are loaded into the Select Parameters group box of the dialog box. 4. Optionally, select a target from the drop-down list in the Select a Fixation Target group box. 5. Make any changes to the parameters (Diameters, Offsets, etc.) of the scan, either by using the scrolling buttons to select values or by selecting the field and typing the value you want. 6. Select whether you want to scan the OD (right), OS (left) or OU (both) eyes. (If you select OU, two scans are added to the exam, one for each eye.) 7. If you want to acquire Doppler data along with the scan data, select the Doppler scan? check box and specify the Number of Samples to acquire. This number indicates the number of Doppler samples that are acquired per B-scan. Note: Bioptigen recommends a number between 2 and 4; otherwise, the scan may be too large for memory allocation. 8. When you have finished setting the parameters for the scan, you can save the parameters as a new preset scan. Enter a unique name for the new preset scan, eye selection and click the Create Preset button. 9. It is a good idea to observe the System Memory bar above the Add to Exam button. The System Memory bar will tell you when the selected scan parameters (lines, scans, and frames, volumes) will result in a scan that may be too large to acquire. The System Memory bar is green when there is sufficient memory to acquire the scan; red, when the computer system may not be able to allocate enough memory to acquire the scan. (For more information on the System Memory bar, see Memory Management.) 10. Click the Add to Exam button to add the scan(s) to the exam and close the dialog box, or click the Cancel button to close the dialog box without adding a scan to the exam.
30
Basic Operations If you want to add additional customized scans to the exam, repeat the steps in this topic for each additional scan.
Editing Scans
You can edit preset or customized scans (but not scans added from a protocol), if the Status of the scan is Pending (you have not acquired an image). For example, you might select a particular preset scan but want to change one or two parameters to suit your needs, such as changing the dimensions of a scan. Follow these steps: 1. From the Review Scans list, select the scan for which you want to change one or more parameters. The green arrow moves to the selected scan. 2. In the Customize Scans group box above the list, click the Edit Selected Scan... button, and the Edit Scan Parameters dialog box opens. 3. In the dialog box, you can select another preset scan, select a different type of scan, or change individual parameters including which eye(s) to scan. 4. If you want to save your changes as a new preset scan, give it a name in the Enter Name for Preset field near the bottom of the dialog box. 5. When you have completed all of your changes, click the Save Changes button at the bottom of the dialog box. Note: If you find you want to change the parameters of a scan after acquiring an image, you can clear the image by selecting another scan or by changing from the Imaging tab. In the message box that appears and asks if you want to save the data, click the No button. Select the scan again, and follow the steps above.
Deleting Scans
You can delete scans from an exam (typically the current exam) , if the Status of the scan is Pending (you have not acquired an image). For example, you might select a group of scans from a protocol but elect not to conduct one or more of them. You might also want to delete Abandoned scans from past exams, to clean up the list of scans you acquired during the exam. Follow these steps: 1. From the Review Scans list, select the scan you want to delete. The green arrow moves to the selected scan. 2. In the Customize Scans group box above the list, click the Delete Selected Scan... button, and the scan is deleted.
Exporting Patient Exams

You can export an exam to make a copy of all patient and image data associated with the exam. In addition, exporting creates files for importing into a central database; these can be used in a read-only version of the program. InVivoVue also provides the choice to export with or without the information that identifies patients, a useful option if you need to store anonymous data for clinical studies. You can export to your computer, a network drive or a DVD. 31
InVivoVue Clinic (Release 1.2) When you export an exam, InVivoVue creates 4 or 5 files (depending upon the type of scan) for each scan saved for the exam. The total amount of disk storage space necessary to store exported exams can be extensive; for example, the files exported for a linear scan can total 170 megabytes (Mb) or more, and the files for a volume scan can exceed 400 Mb. So be sure that you have adequate space on your computer, network drive or (especially) DVD. To export a patient exam, follow these steps: 1. On the Patient/Exam folder, select the patient record for which you want to export data. 2. In the View Patient Exams group box, select the specific exam to export from the current patient record. 3. If you want to include identifying information about the patient, click the checkbox, When Exporting Exam, Include Patient Identifier, located below the list of exams. The patient ID, birth date and name will be included in the exported data. (If you choose to exclude identifying information, the patient's name is withheld, and the birth date defaults to 01 January 1901.) 4. Click the Export Exam button, and the Browse for Folder window opens. 5. In the dialog box, find or create an empty folder on your computer to which you want to export the exam data. (InVivoVue only allows exporting to an empty folder.) If you want to create a folder now, click the Make New Folder button to create a new empty folder for the exam data, and give the folder a name relevant to the information you are exporting. 6. When you have selected the destination folder for the exported data, click the OK button. InVivoVue creates a subfolder and names it PatientID_XXX (where XXX is the patient's ID number from the system). Then within this folder, it also creates a subfolder and names it with the exam's date. InVivoVue then creates some system files in the top-level destination folder, and the exam data is copied to the subfolder with today's date. The dialog box closes. If you want to place a copy of the exam data in the patient's file, you can copy the files you exported to a DVD.
Reviewing Image Scans

At any time, you can review saved scans, provided they have not been archived, which removes them from the system. (You can review scans from archived scans only if you retrieve them from the archive.) You can review saved or unsaved scans from the current exam in progress, or you can load a previous exam. Follow these steps to select scans from the current exam: 1. Locate scans of the current exam in the list in the Review Scans group box on the Imaging tab. 2. If you have just completed a scan to acquire an image, but you have not yet saved it, you can replay this unsaved scan by using the VCR playback buttons located just below Horizontal B-Scan window on the Capture tab. 3. To review a saved scan from the current exam, select it from the list. Note the folder icon in the Details column for the selected scan. Follow these steps to select scans from a previous exam:
32
Basic Operations 1. On the Patient/Exam tab, select the patient record for which you want to review image scans. (If you need help finding a patient, refer to Selecting or Adding the Patient.) When you select the patient record, all exams for that patient are loaded into the list in the View Patient Exams group box on the right. 2. From the list of patient exams, select the exam for which you want to review scans, and click the Review Exam button. (If the selected exam is for the current date and is incomplete, the Review Exam button is instead labeled Continue Exam.) InVivoVue switches to the Imaging tab, and the scans for the selected exam are listed in the Review Scans group box on the left. 3. To review a saved scan, select it from the list. Note the folder icon in the Details column for the selected scan. After you select the saved scan to review, follow these steps: 4. Click on the folder icon in the Details column, and a pop-up menu appears. 5. From the pop-up menu, select Load OCT Data, and InVivoVue loads the image for viewing. 6. Replay the image by using the VCR playback buttons. 7. To adjust the brightness or contrast during playback, click the Options button located below the Volume Intensity Projection window on the right, and the Edit Options dialog box opens. 8. On the Adjustments tab, use the slider controls for Brightness and Contrast to increase or decrease these settings. Click the Reset button to restore these settings to the levels of the image as first captured. 9. To view scan details contained in the OCT header, double-click the file name that is displayed on the Capture tab, above the B-Scan and Volume Intensity Projection windows.
Saving Image Scans

After you have acquired a satisfactory image for a scan, you can save the scan for the patient's current exam record. (Before you save them, you can review image scans to ensure you have acquired satisfactory images.) After you acquire an image, the scan status changes to Unsaved. To save the scan, click the Save Scans button above the Volume Intensity Projection (VIP) window, at the top of the Capture tab. Note: InVivoVue checks the default save drive for sufficient space. If there is less than 10% free space available on the default save drive, you will be advised to archive exams in order to free up space; however, you may save the scan. If there is less than 2 gigabytes of free space on the default save drive, you will advised to archive scans and will not be allowed to save any more scans until there is more than 2 gigabytes of free space available to save a scan. For each saved scan, InVivoVue creates and stores four or five individual files (depending upon the file type), giving them a sequential name based on the patient ID, on which eye is scanned and on certain other parameters from the scan. The five file types are
raw spectral data of the scan, .OCU file extension
33
InVivoVue Clinic (Release 1.2) processed data of the scan, .OCT file extension bitmap image of frame 1 (one) of the B-Scan, .BMP extension bitmap image of the fundus image, .BMP extension bitmap image of the VIP window (for volume scans only), .BMP extension
Note: If you want to save a different bitmap image (other than frame 1) for the B-Scan, you can select it by playing the B-Scan using the VCR playback buttons to review each frame and stopping the playback at the specific frame you want to save. Also, at any time while acquiring or reviewing image scans, you can save copies of images from the VIP and Fundus Video/Scan Control windows. For example, you might want copies of these images for consultation or for later review. To save copies of images in either window, click the Save button below the window.
Printing Images
InVivoVue allows you to print images, as well as to preview them before printing, in a couple of ways. You can preview and print single images of the B-Scan, Volume Intensity Projection and Video Fundus/Scan Control windows. Select from the following sections for instructions about the window you want to print.
The B-Scan Window

Before printing from the B-Scan window, select the frame you want to print. Follow these steps: 1. To select a frame for previewing and printing, click the Frame Advance button repeatedly until the frame you want to print is loaded in the window. Optionally, you can drag the Frame slider control to select a frame. 2. After the frame is selected, from the File menu select Print Preview, and the Print Preview dialog box opens. 3. To change the size of the preview image, click the Zoom button and select an option. 4. To print from the Print Preview window, click the Print button. 5. To print without previewing the image, from the File menu select Print B-Scan Image, and the Print dialog box opens. 6. Select the printer to which you want to print, and adjust other settings as necessary, and then click the OK button.
The Volume Intensity Projection Window

1. To preview before printing, click the Print Preview button below the window, and the Print Preview dialog box opens. 2. To change the size of the preview image, click the Zoom button and select an option. 3. To print from the Print Preview window, click the Print button.
34
Basic Operations 4. To print without previewing the image, click the Printer button under the window, and the Print dialog box opens. (Alternatively, select Print Volume Image from the File menu to open the Print dialog box.) 5. Select the printer to which you want to print, and adjust other settings as necessary, and then click the OK button.
The Video Fundus/Scan Control

1. To preview before printing, click the Print Preview button below the window, and the Print Preview dialog box opens. 2. To change the size of the preview image, click the Zoom button and select an option. 3. To print from the Print Preview window, click the Print button. 4. To print without previewing the image, click the Printer button under the window, and the Print dialog box opens. 5. Select the printer to which you want to print, and adjust other settings as necessary, and then click the OK button.
Generating a Scan Report

For any saved scan, you can generate a report that contains information from the patient record and copies of images from the scan. The information includes the patient's name, age, medical record number, notes associated with the exam, exam date, print date, and the eye that is scanned. For the scan image, the report contains the scan type and parameters, the selected B-scan frame and the volume intensity projection (for volume images). Here is an image of a sample report.
35
You must have Microsoft Word 2007 to generate reports, and your InVivoVue installation must have the template file SimpleReport.dot in the application directory. (Bioptigen provides this file with its default installation.) To print or save a patient report, first select the patient and the exam for which you want to generate a report, and follow these steps: 1. On the Imaging tab, select a saved scan from the Review Scans group box. 2. In the Details column for the selected scan, click the folder icon, and a pop-up menu appears. 3. In the pop-up menu, select Load OCT Data. 4. Play back the OCT image stopping on the frame to be included in the report. 5. To generate and print a report, click the Print button in the Report group box on the right of the Imaging tab. InVivoVue creates a Microsoft Word document containing the report, and sends it to your computer's default printer. It also saves an electronic copy of the report in Word's .DOC format, storing it in the folder that contains the exam data. 6. If you only want to save a copy of the report, then click the Save button instead. Report files are named in a manner similar to the data files for the scan. The file name is a string of numbers and letters that begins with the patient ID and includes references to the eye that is scanned, the scan type, the scan dimensions and angle, the B-scan frame number, plus a random, sequential number to ensure the uniqueness of the file name. If InVivoVue was not able to generate a VIP bitmap due to insufficient available memory, the report displays No volume bitmap saved image too large for memory. You may open the report template (SimpleReport.dot) and move or resize the VIP and/or OCT image placeholders. Note: First open MS Word 2007, and then open the simpleReport.dot file to make modifications to the report template. It is a good idea to make a copy of the report template prior to modify it.
36
Administrative Operations
Setting Up the System
Creating a Study
Because exams must be associated with a study record, you must create at least one study record before conducting exams with InVivoVue. 1. At the top of the InVivoVue application window, select the Clinical Study tab. 2. Search or browse the list of studies in the List Clinical Studies group box, to ensure that the study you intend to create is not already on the system for your site. (To find a study by searching, begin typing the Study ID or Name, and InVivoVue finds the next study that matches the number or name you enter.) 3. Below the list of studies, click the Add Study... button, and the Add Study dialog box opens. 4. In the Study Details group box, enter a unique Study Name and Study ID (both are required), and enter any details in the Description text box. 5. If you want to associate one or more treatment arms with the study, select one or more of the Available Treatment Arms, and click the Add >> button to add it to the Treatment Arms in Study list. The default value of 'Uncategorized' is always added to the study record, to allow you to conduct individual exams in a study without associating them with a treatment arm. 6. If you want to add default scans for the study, select one or more of the Available Scan Protocols in the Scan Protocols group box, and click the Add >> button to move them to the Scan Protocols in Study list. 7. When you are finished defining the parameters for the study, click the Save Changes button to close the dialog box and add the new study to the list of studies on the tab.
Creating a New Scan Protocol

You can create a new scan protocol using the collection of scans for an exam, whether a current exam or an exam from the past. If your objective is simply to create a new scan protocol, regardless of any actual exam, you can do that, too. If there are no patient exams from which you want to create a scan protocol, you might want to create a test patient record and an exam solely for creating the new scan protocol; in this way, you avoid altering actual patient records. In the following procedure, you will create a patient record and an exam record and add scans to the exam, all for the purpose of creating a new scan protocol. After creating the scan protocol, you will delete the information, to eliminate any false information from the system. 1. From the Patient/Exam tab, create a new patient record using false information. 2. Add an exam to the patient record, and click the Start Exam button. InVivoVue takes you to the Imaging tab. 3. Add the scans for your new scan protocol to the exam, by creating customized scans or adding preset scans.
37
InVivoVue Clinic (Release 1.2) 4. If you have an existing scan protocol that contains scans similar to the new one you want to create, add the scans from that existing protocol. 5. For any scans you add from preset scans or another scan protocol, edit them to define the correct scan parameters for the new scan protocol. 6. Delete any unwanted scans if you added the scans of an existing scan protocol. 7. Re-order the list of scans as appropriate for the new scan protocol. 8. In the Define Protocol group box at the bottom of the tab, enter a unique name for the new scan protocol, and click the Save Protocol button. Note: If the name you enter is not unique, a "!" symbol appears to the right of the name field, and the Save Protocol button is not enabled. 9. After saving the new scan protocol, delete all scans from the exam, and return to the Patient/Exam tab. 10. On the Patient/Exam tab, delete the exam and the patient record that you created for this procedure.
Defining a New Treatment Arm

Typically, you define a new treatment arm when you are creating or editing a study record; however, you can only define a new arm in the Edit Study dialog box. If you are setting up a new study, but you do not find the treatment arm you want to add, you must first go to the Edit Study dialog box to define it. Follow these steps: 1. Select the Clinical Study tab. 2. Select the study for which you want to define a new treatment arm, and click the Edit Study... button to open the Edit Study dialog box. 3. In the middle of the dialog box, click the New Treatment Arm button to display the Add Treatment Arm group box. 4. Enter a Name and a Description for the new arm. 5. Click the Create Treatment Arm button, and the new arm is added to the Study record.
Creating a Physician Record

Physician records are associated with exams, and one is selected each time you create a new exam. If the physician record you want is not in the system, you can create the record at the same time you add an exam to a patient's record. You can also create a physician record apart from any exam, as an administrative function; for example, if a new physician is joining your clinic or practice, you can add the record so that it is available when you are ready to conduct exams for his or her patients. Follow these steps to create a physician record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens.
38
Administrative Operations 2. In the Physician group box at the bottom of the dialog box, select <NEW PHYSICIAN>. 3. Enter the First Name and Last Name of the physician for the new record. (The combination of the First Name and Last Name must be unique in your system.) 4. Click the Create New Physician button. 5. If you need to create another physician record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the new record is available to select for new exams.
Creating an Examiner Record

Examiner records are associated with exams, and one is selected each time you create a new exam. If the examiner record you want is not in the system, you can create the record at the same time you add an exam to a patient's record. You can also create an examiner record apart from any exam, as an administrative function; for example, if a new examiner is joining your clinic or practice, you can add the record so that it is available when you are ready to conduct exams. Follow these steps to create an examiner record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Examiner group box at the top of the dialog box, select <NEW EXAMINER>. 3. Enter the Name of the examiner for the new record. (The Examiner name must be unique in your system.) 4. Click the Create New Examiner button. 5. If you need to create another examiner record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the new record is available to select for new exams.
Maintaining Study Information

Editing a Study
You may find occasionally that you need to update or otherwise change a study record. You can change the name or the study number, update the description, add and remove treatment arms and add and remove protocols; however, you cannot remove a treatment arm if scans are associated with it. Follow these steps to edit an existing study record: 1. At the top of the InVivoVue application window, select the Clinical Study tab. 2. Search or browse the list of studies in the List Clinical Studies group box, to find the study you want to edit. (To find a study by searching, begin typing the Study ID or Name, and InVivoVue finds the next study that matches the number or name you enter.)
39
InVivoVue Clinic (Release 1.2) 3. Below the list of studies, click the Edit Study... button, and the Edit Study dialog box opens. 4. In the Study Details group box, enter a unique Study Name and Study ID (both are required), and enter any details in the Description text box. 5. To add or remove Treatment Arms, select them in the appropriate list, and click the Add >> and <<Remove buttons. The default value of 'Uncategorized' cannot be removed from the study record. (You can also create a new treatment arm from this dialog box to add to the study.) 6. To add or remove Scan Protocols, select them in the appropriate list, and click the Add >> and <<Remove buttons. (Removing scan protocols has no effect on any scans derived from those protocols and already associated with an exam; instead, removing a protocol only eliminates it from the list of protocols available when adding scans to future exams.) 7. When you are finished editing the parameters for the study, click the Save Changes button to close the dialog box.
Deleting a Study
You can delete a study record provided that no exams are associated with the study. If you want to delete a study that does have associated exams, you must first delete those exams. However, you can only delete exams that do not have saved image scans, but you cannot delete saved images. To delete a study record that meets the criteria above, follow these steps: 1. In the InVivoVue application window, select the Clinical Study tab. 2. Search or browse the list of studies in the List Clinical Studies group box, to find the study record you want to delete. (To find a study by searching, begin typing the Study ID or Name, and InVivoVue finds the next study that matches the number or name you enter.) 3. Below the list of studies, click the Delete Study button, and the selected study record is removed from the system.
Adding a Scan Protocol to a Study

You can add one or more scan protocols to a study when you create the study record or later by editing the study record. If the protocol you want to add does not already exist, you first need to define a new one. For more information, select from list of Related Topics below. To add an existing scan protocol to a study, follow these steps: 1. On the Clinical Study tab, select the study for which you want to add a scan protocol, and click the Edit Study... button. The Edit Study dialog box opens. 2. In the Scan Protocols list at the bottom of the dialog box, select one or more items from the Available Protocols list, and click the Add>> button. The selected protocols are moved to the Scan Protocols in Study list. 3. When you are finished adding protocols to the study, click the Save Changes button at the bottom of the dialog box, to close it and save your changes. 40
Administrative Operations
Defining a New Treatment Arm

Typically, you define a new treatment arm when you are creating or editing a study record; however, you can only define a new arm in the Edit Study dialog box. If you are setting up a new study, but you do not find the treatment arm you want to add, you must first go to the Edit Study dialog box to define it. Follow these steps: 1. Select the Clinical Study tab. 2. Select the study for which you want to define a new treatment arm, and click the Edit Study... button to open the Edit Study dialog box. 3. In the middle of the dialog box, click the New Treatment Arm button to display the Add Treatment Arm group box. 4. Enter a Name and a Description for the new arm. 5. Click the Create Treatment Arm button, and the new arm is added to the Study record.
Adding a Treatment Arm to a Study

You can add one or more treatment arms to a study when you create the study record or later by editing the study record. If the treatment arm you want to add does not already exist, you first need to define a new one. For more information, refer to the list of topics below. To add an existing treatment arm to a study, follow these steps: 1. On the Clinical Study tab, select the study for which you want to add a scan protocol, and click the Edit Study... button. The Edit Study dialog box opens. 2. In the Treatment Arm list in the middle of the dialog box, select one or more items from the Available Treatment Arms list, and click the Add>> button. The selected treatment arms are moved to the Treatment Arms in Study list. 3. When you are finished adding treatment arms to the study, click the Save Changes button at the bottom of the dialog box, to close it and save your changes. Refer also to Defining a New Treatment Arm Creating a Study Editing a Study
Working with Patient Information

Working with Patient Records
As your database of patients grows over time, it can become increasingly difficult to find the records you need; however, InVivoVue has several tools to help you find and work with patient records. Follow these steps to find, filter and sort patient records: 1. Select the Patient/Exam tab. 41
InVivoVue Clinic (Release 1.2) 2. Determine whether you want to search among all patients in the database or filter the list to show only those associated with a specific study. 3. In the Show Patients group box, select either All Patients or [Patients] In Study. 4. If you select [Patients] In Study, drop down the list of studies, and select the one for which you want to find patient records. Only those patients with one or more exams associated with the selected study are shown in the list below. Note: The function is not yet enabled to narrow the list of patients in a study by selecting a treatment arm. 5. To sort the list of patients, click on any of the column headings to sort the list by the values in that column. Click on the column heading again to toggle between ascending and descending order. 6. After selecting and sorting the list of patients to work with, you can find individual records directly, by entering identifying information in any field in the Find Patient group box. As you enter the Patient ID, MRN, First Name or Last name, InVivoVue selects the first record that matches your entry, and the more detailed your entry, the more precise is the match. For example, if you search for a patient with the last name 'Smith,' when you enter an 'S' InVivoVue selects the first patient whose last name begins with 'S.' As you continue typing in the name, InVivoVue finds a better match until it selects the first 'Smith' if finds; if there a large number of Smiths in the database, refine your search by entering the patient's first name. For more information about working with patient records, select from the list of Related Topics.
Editing a Patient Record

From time to time, you will need to update patients' records, to include information from recent exams or to add notes to their files. Follow these steps to update patient records: 1. Select the Patient/Exam tab. 2. Find and select the patient record you want to change. 3. At the bottom of the tab, click the Edit Patient button, and the Edit Patient dialog box opens. 4. Enter new information and update existing information as needed for the record. 5. When you finish updating the information, click the Save & Exit button to save the new record and close the dialog box. When you have updated the record, you can see your changes in the View Patient Details group box at the bottom right of the Patient/Exam tab.
Deleting a Patient Record

You can delete a patient record provided that no exams are associated with it. (If associated exams have no saved image scans, you can delete abandoned scans and then delete the exams before deleting the patient record.) Follow these steps to delete patient records:
42
Administrative Operations 1. Select the Patient/Exam tab. 2. Find and select the patient record you want to delete. 3. At the bottom of the tab, click the Delete Patient button, and the Confirm Delete message box opens. 4. If you are sure you want to delete the record, click the Yes button, and the record is deleted from the database.
Working with Exam Records

Editing an Exam Record
You can edit an exam record only on the day it is created. You can change the physician and examiner, as well as the associated study and treatment arm. Follow these steps: 1. On the Patient/Exam tab, select the patient record containing the exam you want to edit. 2. In the View Patient Exams group box, select the exam you want to edit, and the Edit Exam button is enabled. 3. Click the Edit Exam button to open the Exam for [Patient Name] dialog box. 4. In the dialog box, select a different Study or Treatment Arm, and enter any Notes about the exam. Select a different Examiner or Physician. You can even enter the name of a new Examiner or Physician in the Add New... fields. If you do enter new names for either, click the Create... button to save the name and select it for the current exam. 5. When you have completed your changes to the exam record, click the Save Changes button at the bottom of the dialog box.
Deleting an Exam Record

You can delete an exam record only if no saved scans are associates with it. If the exam has pending or abandoned scans, you can first delete them before deleting the exam. Follow these steps to delete an exam that meets the criteria: 1. On the Patient/Exam tab, select the patient record containing the exam you want to delete. 2. In the View Patient Exams group box, select the exam you want to delete. If the exam meets the criteria for deleting, the Delete Exam button is enabled. 3. If the exam has any pending scans, click the Continue Exam button to view the details on the Imaging tab. (If the exam date is in the past, click the Review Exam button.) 4. Select each pending exam in turn, and click the Delete Selected Scan button to remove the scan from the list. 5. When all scans are deleted, return to the Patient/Exam tab. 6. Click the Delete Exam button, and the Confirm Delete message box opens.
43
InVivoVue Clinic (Release 1.2) 7. If you are sure you want to delete the record, click the Yes button, and the record is deleted from the database.
Exporting Patient Exams

You can export an exam to make a copy of all patient and image data associated with the exam. In addition, exporting creates files for importing into a central database; these can be used in a read-only version of the program. InVivoVue also provides the choice to export with or without the information that identifies patients, a useful option if you need to store anonymous data for clinical studies. You can export to your computer, a network drive or a DVD. When you export an exam, InVivoVue creates 4 or 5 files (depending upon the type of scan) for each scan saved for the exam. The total amount of disk storage space necessary to store exported exams can be extensive; for example, the files exported for a linear scan can total 170 megabytes (Mb) or more, and the files for a volume scan can exceed 400 Mb. So be sure that you have adequate space on your computer, network drive or (especially) DVD. To export a patient exam, follow these steps: 1. On the Patient/Exam folder, select the patient record for which you want to export data. 2. In the View Patient Exams group box, select the specific exam to export from the current patient record. 3. If you want to include identifying information about the patient, click the checkbox, When Exporting Exam, Include Patient Identifier, located below the list of exams. The patient ID, birth date and name will be included in the exported data. (If you choose to exclude identifying information, the patient's name is withheld, and the birth date defaults to 01 January 1901.) 4. Click the Export Exam button, and the Browse for Folder window opens. 5. In the dialog box, find or create an empty folder on your computer to which you want to export the exam data. (InVivoVue only allows exporting to an empty folder.) If you want to create a folder now, click the Make New Folder button to create a new empty folder for the exam data, and give the folder a name relevant to the information you are exporting. 6. When you have selected the destination folder for the exported data, click the OK button. InVivoVue creates a subfolder and names it PatientID_XXX (where XXX is the patient's ID number from the system). Then within this folder, it also creates a subfolder and names it with the exam's date. InVivoVue then creates some system files in the top-level destination folder, and the exam data is copied to the subfolder with today's date. The dialog box closes. If you want to place a copy of the exam data in the patient's file, you can copy the files you exported to a DVD.
Importing Patient Exams

You can import into your site an exam that was exported from another InVivoVue site (at Release 1.1 and higher) and view the imported exam and its associated scans and reports.
44
Administrative Operations When you import an exam, InVivoVue copies to your site all of the patient information associated with the exam. This includes information on the following entities, as they are related to the imported exam: Site (including hardware and software installation information) Study and study category Patient Exam (including physician and examiner) Protocol (if scans in the exam were part of a scan protocol) Image files (.oct, .ocu., .bmps, reports) Fixation target (if a scan was added with preset fixation target) InVivoVue will detect when a patient exam and image files already exist on your site and will ask you if you want to continue with the import, thereby overwriting the existing files, or cancel the import. To import a patient exam, follow these steps: 1. From the Tools menu, select Import Exam, and the Browse for Folder dialog box opens. 2. In the dialog box, find the exam folder on your computer that contains the exam you wish to import. Do not expand the exam folder to select the sub-folder that is named PatientID_XXX (where XXX is the patients ID number). The import will fail if you select the Patient ID folder. 3. Click the OK button. InVivoVue inserts the contents of the exam folder into your sites database and stores the exams scans and reports on your default save drive. The dialog box closes. When an exam that was created on another InVivoVue site is imported into your site, a Switch Sites button appears on the Capture tab. Clicking on this button opens a dialog box that allows you to switch to the site associated with the freshly imported exam so that you may review it. (Refer to the information in Reading Non-Native Site Data to learn more about the using the InVivoVue application as a reader application.)
Reading Non-Native Site Data

The InVivoVue Clinic application provides the ability to view imported patient exam data acquired on other InVivoVue Clinic scanners (at Release 1.1 and higher). When an exam is imported, all information associated with the exam is imported as well. This includes the: Site information The site identifies the InVivoVue scanner on which the image was acquired. The hardware and software in use at the time of the image acquisition is imported along with general site information, like site name and site description. Bioptigen refers to other InVivoVue sites as non-native sites and the site into which exams are being imported as the native site.
45
InVivoVue Clinic (Release 1.2) Study and Treatment Arm information This is the study and treatment arm information associated with the exam, including protocol information if the exams scans were loaded from a scan protocol. Patient information The patient information is limited to the information at the time of the export. If the exporter requested to omit patient identifiers, then the actual patient name and date of birth are omitted. Exam information This includes all information about the exam, including the physician and examiner. Image scans and reports This includes all of the image files and patient reports that were saved with the exam Fixation Presets This includes any fixation presets that were explicitly associated with a scan.
After an exam that was created on another InVivoVue site is imported into your site, InVivoVue displays the name of the site you are currently viewing at the top of the Clinical Study tab and a Switch Sites button. Clicking on Switch Sites button opens a dialog box that allows you to switch to the site associated with the freshly imported exam so that you may review it. To view an imported exam, follow these steps: 1. From the Clinical Study tab, click on Switch Sites button and the Display Data From Which Site? dialog box opens. Select the site from which the imported exam originated and click on Choose Other Site button. 2. The selected site is made the current site and the site name is displayed on the Windows Title Bar and at the top of the Clinical Study tab to the right of the Viewing Data From label. The study associated with the imported exam is displayed in the list of Clinical Studies. 3. Click on Patient/Exam tab to see a list of patients associated with exams that have been imported into the selected site. You can either use the Find Patient group box at the top of the tab or the List Patients group box below it to locate the patient that is associated with the imported exam you want to view. 4. Select the imported patient record from the list, and basic information from the record is displayed in the View Patient Details group box at the bottom right of the tab. Imported exams that are associated with the patient are displayed in the Patient Exams group box above the View Patient Details group box. 5. Select the imported exam from the Patient Exams list and click on Review Exam button to view the scans associated with the imported patient exam. (Or, you may select the exam and click on Imaging tab to review the scans.) 6. Refer to the information in Reviewing Image Scans to learn more about using the InVivoVue application to view image scans. 7. To return to the native site, open the Display Data From Which Site? dialog box (by clicking the Switch Sites button on the Clinical Study tab) and click the Choose Native Site button. When working with a non-native site you may view all imported information associated with that site. Specifically, InVivoVue will allow you to:
46
Administrative Operations View all imported study information associated with the non-native site. View all imported patient information associated with the non-native site. View all imported exam information associated with the non-native site, including the physician that presided over the exam and the examiner that acquired the images. Export imported exams associated with the non-native site. View imported image scans associated the non-native site. This includes the ability to: o Load the .oct file and play it back. o Load the .ocu file and reprocess it. o Save the .oct and/or .ocu file(s) using the Save As function from the Tools menu. o View the image scan in 3D View (must be rectangular volume scan). o Print the B-scan and VIP windows. o Print and save patient reports. Archive imported exams associated with non-native site exams. In fact, Bioptigen recommends archiving both native and non-native site exams to manage disk storage. Retrieve imported archived exams.
When working with a non-native site you cannot modify any of the information that is displayed. Specifically, InVivoVue will not allow you to: Add a study and/or treatment arm to a non-native site; nor can you modify or delete a study and/or treatment arm associated with a non-native site. Add a patient to a non-native site; nor can you modify or delete a patient associated with a non-native site. Add an exam to a non-native site; nor can you modify or delete an exam associated with a non-native site. Add an examiner or a physician to a non-native site; nor can you modify or delete an examiner or a physician associated with a non-native site. Add a scan to an exam that is associated with a non-native site; nor modify or delete a scan that is associated with a non-native site. Acquire a scan when working with a non-native site.
Maintaining Physician and Examiner Information

Creating a Physician Record
Physician records are associated with exams, and one is selected each time you create a new exam. If the physician record you want is not in the system, you can create the record at the same time you add an exam to a patient's record. You can also create a physician record apart from any exam, as an administrative function; for example, if a new physician is joining your clinic or practice, you can add the record so that it is available when you are ready to conduct exams for his or her patients.
47
InVivoVue Clinic (Release 1.2) Follow these steps to create a physician record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Physician group box at the bottom of the dialog box, select <NEW PHYSICIAN>. 3. Enter the First Name and Last Name of the physician for the new record. (The combination of the First Name and Last Name must be unique in your system.) 4. Click the Create New Physician button. 5. If you need to create another physician record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the new record is available to select for new exams.
Editing a Physician Record

You can edit a physician record regardless of whether it is associated with any exams. You might want to edit the record if the physician changes his or her name. Follow these steps to edit a physician record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Physician group box at the bottom of the dialog box, select the name of the physician whose record you want to change. 3. Change the First Name and Last Name of the physician as necessary for the record. (The combination of the First Name and Last Name must be unique in your system.) 4. Click the Save Changes button. 5. If you need to change another physician record, repeat the preceding steps; otherwise, click the OK button to close the dialog box. The changes are reflected on all existing exams, and the updated record is available to select for new exams.
Deleting a Physician Record

You can delete physician records from the database provided that no exams are associated with that physician. InVivoVue warns against and prevents you from deleting a physician record with associated exams. Follow these steps to delete a physician record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Physician group box at the bottom of the dialog box, select the name of the physician whose record you want to delete. 3. Click the Delete Physician button.
48
Administrative Operations 4. If you need to delete another physician record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the old record is no longer available to select for exams.
Creating an Examiner Record

Examiner records are associated with exams, and one is selected each time you create a new exam. If the examiner record you want is not in the system, you can create the record at the same time you add an exam to a patient's record. You can also create an examiner record apart from any exam, as an administrative function; for example, if a new examiner is joining your clinic or practice, you can add the record so that it is available when you are ready to conduct exams. Follow these steps to create an examiner record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Examiner group box at the top of the dialog box, select <NEW EXAMINER>. 3. Enter the Name of the examiner for the new record. (The Examiner name must be unique in your system.) 4. Click the Create New Examiner button. 5. If you need to create another examiner record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the new record is available to select for new exams.
Editing an Examiner Record

You can edit an examiner record regardless of whether it is associated with any exams. You might want to edit the record if the examiner changes his or her name. Follow these steps to edit an examiner record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Examiner group box at the top of the dialog box, select the name of the examiner whose record you want to change. 3. Change the Name of the examiner as necessary for the record. (The Examiner name must be unique in your system.) 4. Click the Save Changes button. 5. If you need to change another examiner record, repeat the preceding steps; otherwise, click the OK button to close the dialog box. The changes are reflected on all existing exams, and the updated record is available to select for new exams.
49
Deleting a Examiner Record

You can delete examiner records from the database provided that no exams are associated with that examiner. InVivoVue warns against and prevents you from deleting an examiner record with associated exams. Follow these steps to delete an examiner record: 1. From the Tools menu, select Setup Examiner/Physician..., or from the Patient/Exam tab, click the Add Examiner/Physician button. The Edit Examiner or Physician dialog box opens. 2. In the Examiner group box at the top of the dialog box, select the name of the examiner whose record you want to delete. 3. Click the Delete Examiner button. 4. If you need to delete another examiner record, repeat the preceding steps; otherwise, click the OK button to close the dialog box, and the old record is no longer available to select for exams.
Maintaining Image Scans

Creating Preset Scans
If you use certain scan definitions frequently, you can create your own preset scan definitions, which allows you to select scans from a list rather than define them each time you use them. When you create customized scans, you have the option to save them as preset scans. You must first start an exam before creating scans; then follow these steps to create preset scans: 1. From the Customize Scans group box on the Imaging tab, click the Add Custom Scans... button, and the Select Parameters for New Scan dialog box opens. 2. If you want to create a new preset scan based on an existing preset scan, select the existing scan from the Defined Scan Presets drop-down list, and click the Copy Settings from Selected Preset button. The parameters of the selected preset scan are then loaded into the Select Parameters group box of the dialog box. 3. If you do not want to base your new preset scan on another, then click the button for the type of scan (Annular Volume, Linear B-Scan, etc.) you want to define, and the default parameters for that type are loaded into the Select Parameters group box of the dialog box. 4. Optionally, select a target from the drop-down list in the Select a Fixation Target group box. 5. Make any changes to the parameters (Diameters, Offsets, etc.) of the scan, either by using the scrolling buttons to select values or by selecting the field and typing the value you want. Note: InVivoVue does not allow you to enter values outside of allowable ranges. If you enter a value beyond the range, InVivoVue automatically reverts to the value at the nearest end of the range and converts the characters to red font, to alert you to the condition.
50
Administrative Operations 6. At the bottom of the dialog box, select whether you want to scan OD or OS. (You cannot create a preset scan for OU. Instead, you must create separate preset scans for OD and OS.) 7. When you have finished setting the parameters for the scan, enter a name for the new preset scan in the field near the bottom of the dialog box, and click the Create Preset button. (InVivoVue does not force you to enter a unique name for the scan, but it is usually a good idea to do so.) 8. If you want to add the new preset to the current exam, click the Add to Exam button, or click the Cancel button to close the dialog box without adding the scan to the exam. Now you can add the new preset to any exam by selecting it from the Select Preset Scan list on the Imaging tab.
Archiving Scans
InVivoVue allows you to archive scans from patient exams, which removes the image and report files from your system to another file storage location. You might want to archive scans to conserve storage space on your system's computer. Bioptigen strongly recommends archiving exams when the available space for storing the image files is less than 10% of the total storage capacity on the disk drive. (The D:\ drive is the default disk drive for storing image files.) Because of the large size of images, you need a storage location with large amounts of available storage, such as a network drive or some external storage device, such as an additional hard drive. Note: Bioptigen does not support archiving to DVD or CD, because certain characteristics of the Microsoft Windows operating system make it impossible to retrieve files from them. Archiving locks your computer system, preventing you from performing any other tasks, and depending upon how many exams you archive, the process can take quite a while. So you should not archive scans at any time that you need your system for other tasks, such as examining patients. Follow these steps: 1. From the Tools menu, select Archive Scans..., and the Archive Exams dialog box opens. 2. In the Archivable Data group box is listed (by date, in reverse chronological order) all data that is available for archiving. 3. For each date that you want to archive data, select it and double-click the date or click the >> button to move it to the list in the Selected Exams group box. 4. If you only want to archive data for individual patients, click the + button to drop down a list of patients with archived scans from that date, and select the ones to archive. 5. As a further alternative to selecting individual dates for archiving, you can select all exams prior to a given date. At the bottom of the dialog box, enter a date or select it from the calendar, and click the Select All Exams Prior To button. All exams in your system that are dated before the date you selected are then copied to the list in the
51
InVivoVue Clinic (Release 1.2) Selected Exams group box. At the bottom of the window, the Required Space field shows how much storage space is required to store the selected exams. 6. At the top right of the dialog box, select the destination where you want to archive exams. Click the Browse button to open the Browse for Folder dialog box on your system, and find the folder in which you want to save the archived data. At the bottom of the window, the Available Space field shows how much space is available for storage on the volume (network drive, external device, etc.) you selected. 7. Click the Start Archiving button, and InVivoVue begins moving the image files for the exams you selected to the archiving location. Remember, the process can take many minutes to complete, so be sure you have enough time available without interrupting patient exams.
Retrieving Archived Scans

Archived scans and reports are removed from the system and stored in another location. If you find that you need to refer to archived scans and reports, InVivoVue allows you to retrieve them. The Retrieve Archived Scans function moves selected scans and reports from the archive and restores them to the original location on your system. Like archiving, retrieving scans locks your computer system, preventing you from performing any other tasks, and depending upon how many scans you retrieve, the process can take quite a while. So you should not retrieve scans at any time that you need your system for other tasks, such as examining patients. Follow these steps: 1. From the Tools menu, select Retrieve Archived Scans..., and the Retrieve Exams dialog box opens. 2. In the Retrievable Data group box, all data available for retrieving is listed alphabetically by patients' names. 3. Select each patient for whom you want to retrieve data, and double-click the name or click the >> button to move it to the list in the Selected Exams group box. 4. If you only want to retrieve data for individual exams, click the + button to drop down a list of exams by date for each patient, and select the ones to retrieve. 5. As you select exams to retrieve, they are moved to the Selected Exams list, and for each exam is shown the file path to the original location where the data will now be restored. In addition, the Space Needed field shows how much total space is needed for the retrieved images and how much is available on your system. 6. Click the Start Retrieving button, and InVivoVue begins moving the image files for the exams you selected to the original location. Remember, the process can take many minutes to complete, so be sure you have enough time available without interrupting patient exams.
Loading Images from OCT Data

Typically, you load images for viewing during the course of an exam; however, you might want to view images outside of your database and not associated with any of your patients' exams.
52
Administrative Operations For example, a colleague might want to share an image with you during the course of research, in which case you might need to load an image from another location, such as a shared network drive. In these cases, you can load the OCT (processed) file from a scan to view the image, and similarly you can share your images with others. When images are shared in this way, they do not contain any patient information. Follow these steps to load images outside of your database: 1. Select the Imaging tab. 2. From the File menu, select Load..., and the Load OCT Data dialog box opens. 3. Navigate or browse to the location containing the image file you want to view. 4. Select the file from the list, and click the Open button. The image is displayed on the Imaging tab. After reviewing the image, you can save a copy in another location for later reference. If you want to save a copy, refer to Saving Images as OCT Data.
Saving Images as OCT Data

Typically, images are saved when you save the scans of an exam; however, you might sometimes want to save images apart from patient exams. For example, you might want to share an image with a colleague during the course of research. InVivoVue allows you to save images in other locations outside of your database such as a shared network drive, without any patient information. In these cases, you save the OCT (processed) file from a scan. Follow these steps to save images outside of your database: 1. On the Patient/Exam tab, select the patient record containing the exam with images you want to save elsewhere. 2. In the View Patient Exams group box, select the exam, and click the Review Exam button. InVivoVue displays the Imaging tab, which contains the list of scans for the selected exam. 3. From the list of scans, select the one you want to save. 4. In the Details column, click on the folder icon, and a pop-up menu appears. 5. From the pop-up menu, select Load OCT Data, and InVivoVue loads the image for viewing. 6. Navigate or browse to the location where you want to store the image. 7. From the File menu, select Save As..., and the Save OCT Data dialog box opens. 8. In the File Name field, enter a name for the file. (If the file was loaded from the File menu, then by default InVivoVue enters the current name of the file; however, you might want to change the name to something more meaningful, to help identify the image once it is stored outside of your database.) 9. Click the Save button to save the image and close the dialog box.
53
Loading Images from OCU Data

On occasion, you may want to load the OCU (raw spectral data) file for an image; for example, you might want to use InVivoVue's algorithm to optimize image dispersion to improve the quality for viewing. Whatever the reason, you can load OCU data in either of two ways: You can select an image outside of your own database, or you can load OCU data for any saved image in your database. To load OCU data for images in your database, follow these steps: 1. Select the Imaging tab. 2. Either select a saved image from the current exam, or select another patient's exam from which to select an image for loading OCU data. 3. In the Review Scans group box, select the image to load. 4. For the selected image, right-click on the folder icon in the Details column, and a popup menu appears. 5. From the pop-up menu, select Load OCU Data. To load OCU data for images outside of your database, follow these steps: 1. Select the Imaging tab. 2. From the File menu, select Load..., and the Load OCT Data dialog box opens. 3. At the bottom of the dialog box, drop down the list for Files of Type, and select OCT Unprocessed Data Files (*.OCU). 4. Navigate or browse to the location containing the image file you want to load. 5. Select the file from the list, and click the Open button. The image is displayed on the Imaging tab.
About File Types

InVivoVue uses files of several types, some proprietary and others that are in common use, to store data and images for the software. Here is a list of those file types along with a brief definition of each: .OCT: A Bioptigen proprietary file format containing processed, viewable images with a file header. .OCU: A Bioptigen proprietary file format containing raw spectral data of the scan as unprocessed images. .RAW: A file containing the .oct image data in a raw array of bytes without a header. .UNP: A file containing unprocessed, viewable images as a raw array of bytes without a header. .AVI: A multimedia file that contains audio and video. InVivoVue uses .a vi files to store alternatives to .BMP files for the fixation target. .BMP: A device-independent file for storing and rendering viewable images, especially on the Microsoft Windows operating system. InVivoVue uses .BMP files to store single-frame images of the B-Scan, Volume Intensity Projection and Video Fundus windows.
54
Administrative Operations Whenever InVivoVue saves an image scan, it saves the following files:

raw spectral data of the scan, .OCU file extension processed data of the scan, OCT file extension bitmap image of frame 0 (zero) of the B-Scan, .BMP extension bitmap image of the fundus image, .BMP extension bitmap image of the VIP window (for volume scans only), .BMP extension
Memory Management
InVivoVue display a graphical system memory bar on the Select Parameters for New Scan dialog to provide information on the memory footprint of a custom scan. The memory bar is green when it is likely that there is sufficient memory to acquire the scan; red, when the computer system may not be able to allocate enough memory to acquire the scan. Reading the System Memory bar from right to the left:

The solid green area indicates the estimated percentage of memory in currently in use The hatched area to the right of the solid green area indicates the estimated percentage of the remaining system memory that is needed to acquire the scan. If there is sufficient system memory available to acquire the scan the hatched area is green; otherwise, the hatched area is red. Estimated percentage of memory currently in use Estimated percentage of remaining memory needed to acquire the scan Memory requirements of the custom scan (in MB)
In addition, InVivoVue displays textual information that corresponds to the graphical display:

InVivoVue will allow you to add the scan to the exam, even when there may not be sufficient system memory to acquire the scan. If there is not sufficient system memory to acquire the scan, InVivoVue will notify you and suggest you reduce the size of the scan by modifying the lines, scans, frames and/or volumes parameters.
Configuring User Settings

Changing Default User Settings
As you work with InVivoVue over time, you may want to change some of the default settings of the system, so that these settings match more closely those you typically work with. For example, you might enter into a new phase of a study, in which the types and settings of scans change from those of a previous phase. In these situations, you can change some of the default settings for scan types, so that they more nearly represent your current typical scans. InVivoVue retains default settings for the following areas of the system that you can change:

display of image scans (brightness, contrast, Doppler adjustments, etc.) fixation target (size and position of the target)
55
InVivoVue Clinic (Release 1.2) image processing (processing and resampling controls such as dispersion correction and optimization and resampling parameters) scan types (linear B-Scan, annular volume, mixed volume, etc.)
Generally and at any time, you can save the current settings in the areas list above as defaults by following these steps: 1. From the Tools menu, select Save Settings... to open the Save Settings File dialog box. 2. In the dialog box, select the User file. 3. Click the Save button to save your settings, and a message opens for you to confirm that you want to replace the existing User.ini file. 4. Click the Yes button to close the message window and the dialog box. The settings you save become your default settings until you change them again. For more specific information on how to change settings in individual areas of the system, follow the steps below. After making any of the changes below, follow the preceding steps to save your changes as system defaults. To change default settings for the image display 1. Select the Imaging tab. 2. On the right, below the Volume Intensity Projection window, click the Options button to open the Edit Options dialog box. 3. In the dialog box, make the desired changes on the Adjustments and Options tabs. 4. Close the dialog box. 5. Save your settings as described above. To change default settings for the fixation target 1. Select the Imaging tab. 2. In the Fixation Control window, resize the target and drag it to the desired position in the window. 3. Save your settings as described above. To change default settings for image processing 1. From the Tools menu, select Configure Processing... to open the Image Processing and Resampling Controls dialog box. 2. In the dialog box, make the desired changes on the Processing and Resampling tabs. 3. Close the dialog box. 4. Save your settings as described above. To change the settings for scan types, you must first create a custom scan of type you want to change. To create a custom scan, you must add it to an exam in order to save its settings as your default for that type of scan. You can create the custom scan during the course of an actual exam or by creating a 'dummy' exam that you then delete from the system. In either case, follow these steps.
56
Administrative Operations 1. On the Patient/Exam tab, create an exam or select a current exam from today, and click the Start/Continue Exam button. InVivoVue displays the exam on the Imaging tab. 2. Click the Add Custom Scan... button, and the Select Parameters for New Scan dialog box opens. 3. In the dialog box, select the type of scan for which you want to change the default values. 4. Click the Add to Exam button. 5. Save your settings as described above. The values you saved now become the default values for exams of that type.
Creating a New User Settings File

As discussed in the topic, Changing Default User Settings, a variety of system settings are stored by default in the file, User.ini. These stored settings ensure that each time you start InVivoVue, the system begins with these customary settings in place, as you have set them up according to your typical use of the system. Some users might find it helpful to store more than one set of default system settings; for example, if you are conducting multiple studies with markedly different protocols, you might want to create different default values for the various scan types. If so, you can change the defaults accordingly and store them in a different .ini file, allowing you to load these alternate settings whenever the need arises. To create a new settings file, follow these steps: 1. Refer to the information in Changing Default User Settings to learn what settings you can change and how to change them. 2. After you complete any changes you want you want to make, from the Tools menu, select Save Settings... to open the Save Settings File dialog box. 3. In the dialog box, enter a file name for the new settings file. 4. Click the Save button to save your settings. You can create as many of these alternate settings files as you need and switch between them whenever the need arises. To switch from the current settings to another set of default settings, follow the steps in Loading an Existing Settings File.
Loading an Existing Settings File

From time to time, you may need to load or reset the default settings for various areas of the system. For example, if you find that default values have changed for such things as the display of image scans, the processing of image scans, or the fixation, you can restore them. Or if you have previously created an alternate settings file, you can then switch between existing settings files. In either case, follow these steps to load or restore the values from a system settings file: 1. From the Tools menu, select Load Settings... to open the Load Settings File dialog box.
57
InVivoVue Clinic (Release 1.2) 2. In the dialog box, select the name of the file containing the settings you want to load or restore. Note: Your system defaults are typically stored in the file, User.ini. Alternate settings are stored in a separate file by another name in the form [file name].ini. You may want to avoid selecting the LineSpectrum.ini, because this file pertains only to the specific function of checking the line spectrum. 3. Click the Open button to load the settings file and close the dialog box. The Image Processing, Fixation, and Display Option settings you load become the default settings for the system until you change them again. The default scan parameter settings (dimensions, angle, lines, scans, frames, etc.) are not restored when dynamically loading a systems settings file.
58
Advanced Operations
Optimizing the Reference Arm
The system reference arm is set up for the normal adult eye, with a working distance roughly around 20 mm (except in specially-designed shorter working-distance bores) with the adult retinal bore. However, you may need to change the working distance while imaging a patient with myopia or hyperopia; or, when you image a pediatric patient.
Reference Arm Adjustments for Myopes/Hyperopes Imaging

The system reference arm is set up for the normal adult eye. When imaging myopic or hyperopic patients, you may occasionally need to change the working distance, as one diopter of increased spherical equivalent refraction is associated with a change of about 1 mm in axial length in the eye, and using the standard setting for the reference arm length may result in a blurred image on a patient who is not emmetropic. You may find that the image improves by increasing or reducing the reference arm length to better match the eye length in myopes and hyperopes. You can approximate the number of turns on the reference arm by using the following equation: Turns_CW = (L_normal_adult_eye L_myope/hyperope_eye) * 1.3/0.8, where Turns_CW indicates full clockwise rotations of the reference knob, eye lengths (L) are in mm. (Keep in mind that myopia is associated with increased eye length while shorter eye lengths are seen in hyperopia so factor in the sign change accordingly.) The refractive index of the ocular tissue is 1.3, and the mm per turn of the reference knob is 0.8. When there is either minimal or no clipping at the edges of the image, you may be assured the reference arm position is precise.
Reference Arm Adjustments for Pediatric Imaging

The system reference arm is set up for the normal adult eye. To optimize for the pediatric eye without adjusting the reference arm, you should be positioned to have a longer working distance between the lens and the cornea. The working distance will be in the range of 20 40 mm. You may find that the image improves by reducing the reference arm length to better match the pediatric eye length. A starting point for turns on the reference arm can be found with the following equation: Turns_CW = (L_adult_eye L_ped_eye) * 1.3/0.8, where Turns_CW indicates full clockwise rotations of the reference knob, and eye lengths (L) are in mm. The refractive index of the ocular tissue is 1.3, and the mm per turn of the reference knob is 0.8. For a pediatric eye of length 16 mm, expect to turn the reference arm 14-15 turns clockwise. Then the working distance will be around 20-25 mm between the lens and the cornea. When
59
InVivoVue Clinic (Release 1.2) there is either minimal or no clipping at the edges of the image, you may be assured the reference arm position is precise.
Focus Adjustment
The lens system is set at 0 diopter with the lens in the middle of the available focus range. This allows the system to focus normally in an emmetropic eye. The range of adjustment available in the lens is from +10 to -12 diopters. You may turn the barrel of the bore to factor in the refractive correction for any patient, using the guide below. Maximum image brightness is the indicator that the focus is correct.
Focusing the Hand Held Probe
Acquiring Doppler Data

InVivoVue allows you to acquire Doppler data for images, which comes in the form of multiple lines of information for each A-Scan. Doppler data is then overlaid on the B-Scan image as it is displayed. If you decide to acquire Doppler data, first consider whether the parameters of your scan will leave sufficient additional memory for this data. The amount of memory used scales with the number of A-scans x (1 + the number of Doppler lines). The System Memory bar and Scan Memory Requirements provide feedback on available system memory and scan size. Follow these steps to acquire Doppler data on a custom scan: 1. From the Imaging tab, click on Add Custom Scan button, and the Select Parameters for New Scan dialog box opens. 2. Select a scan type and set the scan parameters (dimension, angle, lines, scans, frames, etc.) and the eye selection. 3. Select the Doppler scan? check box and set the number of Doppler lines you want to acquire per A-Scan in the Number of Samples text box. Although you may specify a
60
Advanced Operations number between 1 and 10, Bioptigen recommends setting the Number of Doppler Samples between 2 and 4. 4. Observe the System Memory bar located below the Eye Selection group box. If it is green, there is likely to be sufficient system memory to acquire the scan. Add the scan to the exam. (Refer to Memory Management to learn more about managing the memory footprint of a scan.) If it is green and red, the scan may be too large to acquire. You may add the scan to the exam; however, when you attempt to acquire the scan, the amount of system memory available for allocation may be insufficient, in which case, InVivoVue will not will not be able acquire the scan. If this occurs, InVivoVue will display a message box advising that you reduce the size of the scan.
5. Close the Select Parameters for New Scan dialog box. 6. If you want to see the Doppler information overlaid on the image during Aiming mode, select the Doppler? check box located between the Start Aiming and Start Free Run button on the Capture tab. This check box is displayed only when a scan is set up to acquire Doppler data. De-selecting the check box turns off the Doppler display during aiming mode. 7. You are now ready to acquire the scan. (Refer to Acquiring Images to learn more about acquiring a scan.)
Displaying Scan with Doppler Data

InVivoVue displays Doppler data when a scan has acquired it, provided the Display Doppler option has been selected. Doppler data is displayed in the B-scan window along with the OCT image. A Doppler signal scale indicating the intensity of the Doppler signal is displayed on the right side of the B-scan window. The direction of blood flow is assigned the color red or blue, indicating flow away from or towards the transducer. You can adjust the display of the Doppler data by changing the scaling, transparency, and threshold for OCT and Doppler data. You can turn off the Doppler display or reset the Doppler display settings to their original values. Follow these steps to adjust the Doppler data display in the B-scan window: 1. From the Imaging tab, load a scan that has acquired Doppler data. (Refer to the information in Acquiring Doppler Data to learn how to acquire Doppler data along with the scan.) 2. Use the VCR playback buttons to view the scan. Allow the scan to play continuously while adjusting the Doppler display. 3. Click on Display Options button below the VIP window and the Edit Display Options dialog box opens. 4. Click the Options tab. 5. Verify that the Display Doppler check box is selected. De-select the check box if you wish to turn off the Doppler display. 6. Use the Doppler Scaling slider control to adjust the signal scaling, intensifying or diminishing the Doppler display. 61
InVivoVue Clinic (Release 1.2) 7. Use the OCT Level threshold slider control to set the threshold of OCT data that must be present in order to display Doppler data. This adjustment is used to suppress Doppler noise on a B-scan. It controls where you see Doppler and requires the OCT data level to be above the percentage of the maximum level in order for the Doppler data to be displayed. 8. Use the Doppler Level Threshold slider control to set the threshold for the Doppler signal. This adjustment requires the Doppler level to be above the threshold in order to display Doppler data. 9. Use the Doppler Transparency slider control to set the relative transparency of the OCT and Doppler signals so that both OCT and Doppler data may be seen, depending on the transparency setting and the relative values of each. 10. Click on Reset button in the Doppler Adjustments group box if you wish to set the Doppler adjustments to their original default values. 11. Close the Display Options dialog box.
Optimizing Image Dispersion

InVivoVue contains an algorithm for optimizing the dispersion of an image. By applying this algorithm, you can sharpen the image significantly. (Note that before optimizing you must first ensure that the reference arm is in the right place.) You can optimize an image that you just acquired (which is thus in the playback buffer), or you can load the .OCU file (which contains the raw spectral data for an image) of another image to optimize. Once you have selected the image to work with, follow these steps: 1. Ensure that the B-Scan window displays a frame with the features you want to view. (You can either pause at that frame during playback, or you can use the Frame slider control to select the frame.) 2. Ensure that the retinal image fills the entire display. (If a significant amount of dark space exists at the top or the bottom of the image, you can alter the display options to eliminate those dark areas.) 3. From the Tools menu, select Configure Processing..., and the Image Processing and Resampling Controls dialog box opens. 4. Select the Resampling tab, and then click the Optimize Frame button. The number of the frame you selected above is displayed on the button. 5. Close the dialog box. 6. On the Capture tab, click the Reprocess Data button located above the Volume Intensity Projection window. 7. Optionally, as the image is played back (and reprocessed using the displayed Dispersion Constants), you can click the Optimize button when the frame you are most interested is displayed in the B-Scan window. 8. After the process of optimization is complete, you must click the Reprocess Data button again, to ensure that the new Dispersion Constants are applied to all the frames preceding the one selected above.
62
Advanced Operations
Reviewing Image Scans

Playing Back Image Scans
For image playback, several controls are available to stop and start playback, to select and few frames individually or play them in succession and to adjust the rate of playback. The primary playback controls are modeled after those of a video or music player: displays the first frame of the scan moves backward to the previous frame plays all frames in succession, looping through the scan repeatedly until another button is clicked stops playback moves forward to the next frame displays the last frame of the scan Two slider controls, which you can drag with the mouse, allow you to set the rate of playback and to select individual frames: Rate allows you to select the number of frames per second for playback, and the numeric value shows the current selected rate. Frame allows you to select individual frames in the sequence, and the numeric value shows the number of the current frame of the total number of frames. The Focus Control is currently not functional.
Changing B-Scan Window Settings

You can make several adjustments for the B-Scan window to alter or improve the display of images. You can adjust brightness and contrast, display Doppler and change its settings, select beginning and ending line samples to eliminate insignificant parts of the image and change the type and color map of the display. Follow these steps to adjust these settings: 1. Click the Options button below the Volume Intensity Projection window to open the Edit Options window. 2. Select the Adjustments tab. a. Use the slider controls to adjust the Brightness and Contrast of the image in the B-Scan window. (Note that the image responds while you make adjustments.) b. If you are viewing Doppler data, click the check box Display Doppler, and then use the slider controls to adjust Scaling, OCT and Doppler Level Threshold and Transparency. c. Click the Reset button in either group box to restore the original settings in that group.
63
InVivoVue Clinic (Release 1.2) 3. Select the Options tab. Controls in the Display Options group box allow you to narrow the number of line samples to view, to magnify or focus in on a particular area along the vertical dimension of the image. a. Click the Custom check box to enable the Display Options. b. Slide the Start control from left to right to exclude line samples from the top; for example, you might select line 10 for the Start of the image, to hide the DC? line that typically appears at the top of an image. c. Slide the End control from right to left to include or exclude line samples from the bottom of the image. d. Click the Reset button to restore the default settings for the image. e. Click the Invert check box to flip the image along its horizontal axis. 4. In the Display Type group box, select Frame to see the entire B-Scan image, or select Line to display individual line samples from the image. Click and drag the slider control, or click on the arrow buttons at either end, to display the individual lines. (If you click and hold an arrow button, lines are displayed in rapid succession throughout the image.) 5. In the Display Color Map group box, select the option buttons to view the image in Gray scale or Color.
Setting VIP Window Samples

The en face image for volume scans is displayed in the Volume Intensity Projection (VIP) window. By default, this image is produced by projecting or summing the image intensities through the entire range of depth as displayed in the B-Scan window. However, you can change the settings to sum through a narrower range at any chosen depth of scan. To change the sample summation range, you use the two slider controls to the right of the VIP window. The control immediately to the right of the window affects the center of image, and the number below it indicates the depth from the zero position, which is the top of the B-Scan window. (Note that this is not the true depth, which can only be calculated by factoring in the refractive index of the tissue.) The control on the far right affects the thickness of the summation window, and the number below it shows the thickness in microns. To change the position of the slider controls, click and hold them with the mouse, and then drag them to the desired position. A triplet of horizontal lines is displayed on the B-scan window. The center line indicates the window center and the upper and lower lines indicate the sample width. If you prefer that the horizontal lines remain visible on the B-scan window, check the Windowing Display On checkbox below the two VIP slider controls. To turn the horizontal line display off, uncheck the checkbox.
Viewing 3-Dimensional Rendering of Image Scans

About the 3-D Analysis Tool
You can view a 3-dimensional (3-D) rendering of a rectangular volume scan by loading a rectangular volume scan into the 3-D analysis tool on the 3-D View tab. The 3-D View tab
64
Advanced Operations displays four windows. The main window, labeled 3D, displays a high resolution 3-D rendering of the rectangular volume scan. The three smaller windows display 2-D renderings of the scan. The three smaller windows are used for slicing and/or cropping the scan along the axial, coronal, and sagittal planes. While working with the 3-D image, you have access to a full set of tools you can use to manipulate (rotate and/or tilt) the image, render the image in high or medium resolution, crop and/or slice the image along various planes, register the B-scans and custom your default settings for the 3-D analysis tool. To start working with the 3-D analysis tool, you will need to load a saved rectangular volume scan.
Loading a Rectangular Volume Scan into the 3-D Analysis Tool

Follow these steps to load a rectangular volume scan into the 3-D analysis tool: 1. Click on Imaging tab. From an exam scan list on the Imaging tab (or the File Load Menu option), load a rectangular volume .oct file. 2. Click on 3-D View tab. The Load Rectangular Volume button is enabled. (If you did not load an .oct file, the Load Rectangular Volume button is disabled.) 3. Click on Load Rectangular Volume button. InVivoVue begins loading the (full and unregistered) .oct file into the 3-D analysis tool. A progress bar below the large 3D window tracks the progress of rendering the .oct data into a 3-D image. To the right of the progress bar is text that indicates the name of the process the 3-D tool is performing as it completes the load. When the 3-D tool has completed the rendering of the 3-D image, the progress bar is cleared and the text is set to Ready. 4. Place the mouse cursor in the main 3-D window. a. Left-click anywhere in that area and drag the mouse to view the 3-D image from different angles. b. Right-click anywhere in that area and drag the mouse to move the 3-D image up or down, or to the right or left. c. Use the mouse wheel to zoom in and out of the 3-D image.
Cropping 3-D Image to Displayed Samples

When an .oct file is loaded into the 3-D analysis tool, the .oct file is loaded in its entirety. That is, the .oct file is not automatically cropped to the displayed line samples as defined on the Options tab of the Display Options dialog box, as it is in the B-Scan window. (Refer to Changing B-Scan Window Settings for more information on the display options.) Follow these steps to crop the 3-D image to the sample size defined on the Options tab of the Display Options dialog box: 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Click on Crop to Displayed Samples button. InVivoVue begins cropping the.oct file to the custom sample size defined on the Options tab of the Display Options dialog box. A progress bar below the large 3D window tracks the progress of cropping and re65
InVivoVue Clinic (Release 1.2) rendering the .oct data. To the right of the progress bar is text that indicates the name of the process the 3-D tool is performing as it completes the crop request. When the 3-D tool has completed the cropping and re-rendering of the 3-D image, the progress bar is cleared and the text is set to Ready. 3. Place the mouse cursor in the main 3-D window. a. Left-click anywhere in that area and drag the mouse to view the 3-D image from different angles. b. Right-click anywhere in that area and drag the mouse to move the 3-D image up or down, or to the right or left. c. Use the mouse wheel to zoom in and out of the 3-D image. 4. To restore the image to its pre-cropped state, re-load the rectangular volume scan into the 3-D view (by clicking the Load Rectangular Volume button).
Registering B-Scans in 3-D Image

When an .oct file is loaded into the 3-D analysis tool, the B-scans in the .oct file are not automatically registered to correct for eye movement, for example. Once the rectangular volume scan is rendered in the 3-D analysis tool, you may want to refine the image by registering the B-scans. Follow these steps to register the B-scans in the .oct file and re-render the 3-D image: 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Click on Register button (or Registration Register b-scans mouse menu option). InVivoVue begins registering the B-scans in the.oct file. A progress bar below the large 3D window tracks the progress of registering the B-scans and re-rendering the .oct data. To the right of the progress bar is text that indicates the name of the process the 3-D tool is performing as it completes the registration request. When the 3-D tool has completed registration and re-rendering of the 3-D image, the progress bar is cleared and the text is set to Ready. 3. Place the mouse cursor in the main 3-D window. a. Left-click anywhere in that area and drag the mouse to view the 3-D image from different angles. b. Right-click anywhere in that area and drag the mouse to move the 3-D image up or down, or to the right or left. c. Use the mouse wheel to zoom in and out of the 3-D image. 4. To restore the image to its pre-registered state, hold the mouse still and right-click to display the mouse menu. Select the Registration Restore Original Data Image option. (Or, you may restore the image to its pre-registered state by re-loading the rectangular volume scan into the 3-D view (by clicking the Load Rectangular Volume button).
Changing 3-D Display Options
66
Advanced Operations You may change the display options in the 3-D analysis tool by placing the mouse cursor over any of the 4 windows that make up the 3-D viewing area. Hold the mouse very still and rightclick to access the mouse menu. You may change the following display options: Color Map: To change the color map, select the Show Color Map mouse menu option. The Color Map dialog box opens. Select a color map from the drop down list of color maps on the bottom right side of the dialog box. The color map you chose will persist across active sessions of InVivoVue until you select a different color map. Close the Color Map dialog box. View Options: To change the View options, select the View Options mouse menu. There are several viewing options you may change: o Black background: White is the default color of the 3-D image background. To change the background to black, select Black Background. The background color you choose (white or black) will persist across active sessions of InVivoVue until you change it. High Quality 3-D (slower): The High Quality 3-D option is a default setting. When set, the 3-D Analysis tool produces a high resolution image when the .oct file is loaded into the 3-D Analysis tool and when the image is still. Producing a high resolution image slows down the rendering. If you dont want a high resolution image you can de-select this option. Whichever you chose, the setting will persist across active sessions of InVivoVue until you change it. Adaptive Rendering (faster): The Adaptive Rendering option is a default setting. When set, the 3-D Analysis tool uses a low resolution copy of the image for faster rendering while the image is being moved. If you dont want faster rendering as the image is moved you can de-select this option. Whichever you chose, the setting will persist across active sessions of InVivoVue until you change it. Show Floor: The Show Floor is a default setting. When set, the 3-D Analysis tool displays a grid below the 3-D image. Showing the floor improves image orientation. If you dont want to see the floor you can de-select this option. Whichever you chose, the setting will persist across active sessions of InVivoVue until you change it. Flip A-scan Axis: This Flip A-Scan Axis setting will flip the image along the Ascan axis. This setting does not persist across InVivoVue sessions. Stretch A-Scan: Use this feature to stretch the 3-D image in increments of 100 up to 800%. This setting does not persist across InVivoVue sessions.
o o
Summed Intensity Projection: This feature is available only when the mouse menu is displayed from the Coronal window. Place the mouse cursor over the Coronal window and right-click to display the mouse menu. Select the Summed Intensity Projection option. The summed (or volume) intensity projection of the rectangular volume scan is displayed in the Coronal window. De-select the Summed Intensity Projection to revert back to the original image.
Cropping the 3-D Image Using Crop Lines

In addition to cropping the 3-D image to displayed samples, you may also crop or slice the 3-D image along the axial, coronal and sagittal planes.
67
InVivoVue Clinic (Release 1.2) Follow these steps to crop the image along the axial, coronal and/or sagittal planes: 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Place the mouse cursor over the main 3-D window or over one of the smaller windows. Hold the mouse still and right click to display the mouse menu. 3. Select Crop Show Crop Lines. Dashed lines are displayed along the adjustable edges of the image in each of the 3 smaller windows. 4. Working in Axial, Coronal or Sagittal window, place the mouse cursor on one of the dashed lines and move the line in (if in Axial or Sagittal window) or up or down (if in Coronal window). Notice how the image is changed in the large 3D window. 5. To set the 3-D image to the cropped image that is displayed in the 3-D window, rightclick to display the mouse menu. Select Crop Crop Image. 6. The 3-D image is now cropped based on the position of the crop lines within the Axial, Coronal and Sagittal windows. 7. To restore the image to its pre-cropped state, hold the mouse still and right-click to display the mouse menu. Select the Crop Restore Original Data Image option. (Or, you may restore the image to its pre-registered state by re-loading the rectangular volume scan into the 3-D view (by clicking the Load Rectangular Volume button).
Slicing the 3-D Image Using Slider Controls

You may slice through the 3-D image along the axial, coronal and sagittal planes. Follow these steps to display a slice the 3-D image: 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Axial Slice: Position the mouse cursor on the slider control beside the 2-D Axial window and move the slider control in either up or down direction. As you move the slider control, the 3-D analysis tool slices through the series of B-scans; each slice representing a single B-scan. 3. Coronal Slice: Position the mouse cursor on the slider control beside the 2-D Coronal window and move the slider control in either up or down direction. As you move the slider control, the 3-D analysis tool slices through a collection of A-scans along the coronal plane of the rectangular volume. 4. Saggital Slice: Position the mouse cursor on the slider control beside the 2-D Sagittal window and move the slider control in either up or down direction. As you move the slider control, the 3-D analysis tool slices through a collection of A-scans along the sagittal plane of the rectangular volume.
Capturing the 3-D Image

At any point you may save the 3-D image (or any of the three 2-D images) as a .jpeg file (or as a .pbm file). Capturing an image in the 3D analysis tool does not alter the.oct file. Follow these steps to save the 3-D image as a .jpeg file (or as a .pbm file):
68
Advanced Operations 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Place the mouse cursor over the main 3-D window or over one of the 2-D windows. Hold the mouse still and right click to display the mouse menu. 3. Select Capture Capture 3D Image and the Save As dialog box opens. 4. In the Save in: drop down list, specify where to save the file. 5. In the File Name field, enter a name for the file. 6. Select the Save as type (either .jpeg or .pbm). 7. Click the Save to save the image and close the dialog box.
Resetting the 3-D Image

There are several ways to reset the 3-D image to its original state. Re-load the rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). Hold the mouse still and right-click to display the mouse menu. Select one of the following options: o o o Reset 3D View Crop Restore Original Data Image Register Restore Original Data Image
Switching 2-D Windows into Main Window

You may want to view an image in one of the small 2-D windows in the larger main window. Follow these steps to view a 2-D image in the main window: 1. Load a rectangular volume scan into the 3-D analysis tool (see topic, Loading a Rectangular Volume Scan into the 3-D Analysis Tool). 2. Click on the label of the 2-D window that contains the image you want to view in the main window. For example, if you want to move the 2-D image in the Axial window to the main window, click on the button labeled Axial. 3. The Axial window is moved to the main window and the 3-D image is moved from the main window to the space vacated by the Axial window. The Axial image remains a 2D image. 4. Click on the label 3D, to move the 3-D image back to the main window.
69
Troubleshooting
Resolving Hardware Problems
This topic describes several hardware problems and suggests ways to correct them.
If you have this problem . . .
Try this . . . Check to ensure that all the connectors are in place and that the engine is plugged into the power outlet. Check to ensure that the connectors are in place, that the scanner is plugged into the power outlet and that it is turned on. Turn off the engine, and restart it after one minute. Check to see that the engine is turned on. Ensure that all cables and connectors are in place. Check that the correct configuration file has been loaded.
The engine does not start.
Scanners do not scan, and there is no motion of the galvos. The engine is emitting a high-pitched whine.
The error message Scan driver not found displays.
Resolving Software Problems

This topic describes several software problems and suggests ways to correct them. For some symptoms, an advanced level of training is required for the necessary actions to resolve the problems.
If you have this problem . . . The scan image appears dim.
Try this . . . Check the line spectrum and optimize it; the reference arm power may be too low. Optimize dispersion settings to sharpen the image. If this does not resolve the problem, change the focus and check to see if the reference arm position is off. Change the image display scale in the application window. If this does not resolve the issue, adjust the path length of the
The scan image appears blurred.
The depth seems inadequate.
70
Troubleshooting
reference arm. Part of the scan image is not visible, or the image fades at the beginning or end of the scan. "Ghost" images appear in the display. No image appears in the display. Expand the horizontal and vertical offset parameters that are associated with the scan.
Change the path length of the reference arm. Move the sample to see if an image comes into focus. If this does not resolve the problem, telephone Bioptigen customer support. Move the sample to see if an image comes into focus. If this does not resolve the problem, optimize the line spectrum. Check that the connectors are firmly in place. If this does not resolve the problem, check the line spectrum and optimize it. Also try setting the DC offset to either Auto or Manual mode (this option can be found in the Configure Processing dialog that is an option under the Tools menu). Change the image display scale.
The image is distorted or 'garbled.'
There is background noise
The scan image is either too small or too large. The scan image oscillates abnormally.
Close InVivoVue, and restart it. If this does not resolve the problem, contact Bioptigen customer support. Check the line spectrum and optimize the height. Check the DC Removal option and set it to Auto or Manual.
Vertical striations appear in the scan image. Horizontal striations appear in the scan image.
Loss of Fixation Target or Desktop Display

This problem typically occurs only for users who employ multiple scanning instruments with a single engine. For example, those who use a retinal scanner unit in conjunction with a handheld probe may encounter one of the scenarios described in this topic if they do not accurately follow the procedure described in Using Other Types of Probe. When the clinical retinal scanner (CRS) is reconnected to the engine after using the handheld probe, the display configuration is automatically changed by the computer when booting, because one of the displays is powered off or disconnected. Windows may not detect and
71
InVivoVue Clinic (Release 1.2) configure the display properly if the internal display becomes disconnected from the interface box or the interface box is powered off. This situation will result in the fixation target being displayed on the main monitor. The opposite situation can also occur, if the main monitor becomes disconnected or is powered off. The Windows desktop may be displayed inside the retinal scanner head while the main monitor displays a blank screen. Because of the ways in which Windows interacts with displays, a simple restarting of the computer may not correct these problems. To avoid these problems, check all video connections and ensure that all Bioptigen hardware is powered on and connected properly before turning on the computer.
Reclaiming the Fixation Target

Follow the steps below if you experience a loss of the fixation display, the appearance of the primary display in the retinal scanner head or the appearance of the fixation target on the main monitor. 1. Shut down all Bioptigen software and hardware, and shut down your computer. 2. After everything has completely shut down, turn on the Bioptigen hardware. (If you are uncertain whether the units are on, check that the fans are blowing air through the vent in the back of each.) 3. At the back of the computer, check that the RCA cable is connected to the adapter and that the adapter is connected to the computer as shown:
4. At the back of the probe interface box, disconnect the RCA cable, which is shown in this illustration:
72
Troubleshooting 5. Ensure that the main computer monitor is connected to the computer, and then turn on the monitor. 6. Start the computer, making certain to wait for it to start completely. 7. Reconnect the RCA cable to the probe interface box. (Refer to step 4 above for illustration.) 8. Using the Windows Restart command, restart the computer. 9. After the computer has restarted completely, right click on the desktop, and from the pop-up menu, select Properties to open the Display Properties dialog box. 10. In the dialog box, select the Settings tab. 11. On the Settings tab, select the graphical image for display 1. The Display field below the image should show that it is connected to "Plug and play monitor on NVIDIA," and the Screen resolution should be 1650 x 1080 or some similar high resolution. 12. Select the graphical image for display 2. The Display field should show that it is connected to "Default monitor on NVIDIA," and the resolution should be 800 x 600. Also, ensure the box is checked for "Extended my Windows desktop onto this monitor." 13. At the bottom of the dialog box, click the Advanced button to open the Plug and Play Monitor... dialog box. 14. In the dialog box, click the Quadro FX 560 tab.
15. Verify that the nView Display Mode is set to dualview, that the Primary display is set to Samsung Syncmaster and that the Secondary display is set to TV. 16. Select display 1, and check to box for 'Make this my Primary Display.' 17. Click OK to close the Default Monitor and NVIDIA Quadro FX 560 Properties dialog box. 73
InVivoVue Clinic (Release 1.2) 18. Restart the Bioptigen InVivoVue software. 19. Open the fixation control, and click the monitor icon in the tool bar. You should now have regained control of the fixation target.Setting Up the Engine and Probe
Setting Up the (840nm) Engine and Probe

This section describes how to set up the Bioptigen 840nm OCT engine and probe. First, you mount the scanner and chin rest on the table, and then you connect the probe interface and the computer to the engine. This section contains the following topics:

installing the scanner and chin rest connecting the probe interface, engine and computer using other types of probe
Installing the Clinical Scanner and Chin Rest

The clinical scanner unit and the chin rest are installed on the table. The joystick base for the scanner unit fits onto a set of tracks on the table top, and once the base is installed, the scanner is attached to it. The chin rest faces the scanner and is attached at the sides of the table. Follow these steps to install them: 1. Parallel tracks are affixed on the top of the table for attaching the joystick base of the scanner unit:
2. Position the joystick base on top of the tracks:
74
Troubleshooting 3. Place the track covers in position flush against the table and slide them into place over the tracks and wheels of the base, snapping them into place as shown above. 4. Roll the base all the way to the rear position, ensuring that both wheels make contact with the track covers:
This position ensures that the base is precisely perpendicular to the chin rest. 5. Now place the scanner unit onto the joystick base, ensuring that the large hole in the bottom, front of the scanner slides over the shaft in the joystick base:
Ensure that the scanner is lowered fully onto the base. 6. Install the chin rest by placing the two bars into the brackets on the sides of the table:
7. After ensuring that the chin rest faces the scanner (from the patient's perspective), tighten the two set screws in each bracket. (Use a 3/32" hex key or Allen wrench to tighten the hexagonal slotted screws.)
75
Connecting the Probe Interface Box, the Engine and the Computer
To set up the OCT engine and probe, you should place the probe interface box on or next to the engine, to facilitate the connections between them. As you move the interface box, avoid tight bends or kinks in the probe umbilical cord, as they may damage the optical fiber in the cord. Coaxial connections between the engine and probe are color coded, with zip ties applied to the cables. All coaxial connections are made with BNC type connectors. You attach these connections by lining up the key ways with the posts on the engines coaxial port with the slots on the cable end. You then insert the cables and twist them in the clockwise direction until they lock in place. Follow these steps: 1. Place the probe interface box on top of, or vertically next to, the engine so that the probe umbilical is located near the left front of the engine as illustrated:
2. From the back of the units, connect the cables labeled white and black to the corresponding terminals on the engine:
Spectrometer Cable Connection Coaxial Cable Connections
Drive Cable Connection AC Power Connection
3. Now connect the other ends of the black and white cables to the corresponding terminals on the back of the probe interface box:
76
Troubleshooting
Fixation Video RCA Connection

Note: Only used for Clinical Retinal Scanners
AC Power Connection
Fundus Video Coaxial Connection

Note: Only used for Clinical Retinal Scanners
4 Coaxial Cable Connections
4. Connect the green and blue cables to the terminals on the back of the engine. (See the illustration above.) 5. Connect the other ends of the green and blue cables to the computer interface cable:
6. Connect the other end of the computer interface cable to the back of the computer:
7. Connect the small, black, multi-pin interface cable between the spectrometer cable connection on the back of the engine (see above) and the back of the computer:
77
InVivoVue Clinic (Release 1.2) 8. Connect the large, blue multi-pin interface cable between the drive cable connection on the back of the engine (see above) and the back of the computer:
9. After cleaning the yellow optical fiber cable, connect it between the probe interface box and the sample port on the front of the OCT engine.
Note: These connections are keyed to ensure proper alignment of the optical fiber, so ensure that the keys on the fiber cable are aligned to the key-ways on the engine and interface box connectors. Furthermore, tighten these connections only with your fingers, and avoid bending or making kinks in the fiber cable. 10. If your system has a retinal scanner, connect the remaining coaxial cable between the fundus video coaxial connection on the interface box (see above) and the back of the computer:
11. Connect the fixation RCA video cable between the RCA connector on the interface box (see above) and the RCA-to-S-video adaptor:
78
Troubleshooting 12. Connect the other end of the video adaptor to the back of the computer:
13. Connect the AC power cords to the backs of the engine and interface box, and then plug them into AC power outlets. 14. Connect the keyboard and mouse to the back of the computer, and connect the DVI video cable between the back of the computer and the computer monitor:
Using other Types of Probe

The Bioptigen 840nm OCT engine allows for the use of a clinical retinal scanner (CRS) probe, a handheld probe and a microscope. This section describes the process for changing from one to another. For illustrations of components in the following procedure, refer to the topic, Connecting the Probe Interface Box, the Engine and the Computer. Follow these steps to switch from one of the devices above to another: 1. Using the standard Microsoft Windows Shut Down procedure, turn of the system computer. 2. After the computer is completely turned off, turn off the OCT engine and the probe interface box. 3. Disconnect the AC power cord from the interface box. 4. Disconnect all coaxial connections on the back of the interface box. 5. If you are now disconnecting a CRS probe, also disconnect the RCA cable from the back of the interface box. 6. Remove the interface box out of the way, and replace it with the interface box of the device you now want to connect. 7. For any probe, reconnect the black and white coaxial connections; then reconnect the red and yellow connections.
79
InVivoVue Clinic (Release 1.2) 8. If you are now connecting a CRS probe, also connect both the fundus video coaxial cable and the RCA video fixation cable to the back of the interface box. Note: It is very important to connect the RCA video fixation cable before the computer is powered on. Failure to do so may result in the loss of the internal fixation display. If this occurs refer to the troubleshooting topic, Recovering from the Loss of Fixation Target. 9. Connect the AC power cord to the interface box. 10. Turn on the interface box and the OCT engine. 11. Turn on the computer. 12. After the computer has started, start the InVivoVue software, using the desktop shortcut that is defined for the particular probe you have just connected. Note: It is very important to use the correct shortcut for the particular probe, because shortcuts refer to specific hardware settings for each type of probe, and they are not interchangeable.
80
Index
A acquiring an image................................... 26 aiming .................................................. 26 Aiming ...................................................... 28 archiving ............................................ 18, 51 before backup ...................................... 51 exams .................................................. 18 scans ................................................... 51 archving ................................................... 19 AVI ........................................................... 24 B backup ......................................... 18, 19, 51 computer .............................................. 19 data ...................................................... 19 performing ............................................ 19 system ................................................. 19 bitmap .......................................... 26, 54, 55 save ..................................................... 26 bitmap image ........................................... 33 B-Scan ............................................... 26, 63 color map ............................................. 63 color ................................................. 63 grayscale .......................................... 63 Doppler data ........................................ 63 invert image ......................................... 63 settings ................................................ 63 window ................................................. 63 C Checking the Line Spectrum .................... 16 Chin Rest ........................................... 13, 74 installing ............................................... 74 cleaning ................................................... 14 optical fibers .........................................14 Clinical Scanner ................................. 13, 74 Installing ...............................................74 Clinical Study ...........................................40 computer ............................................ 71, 74 connecting ............................................74 configuration file ................................. 57, 70 loading .................................................57 Creating ............................................. 38, 47 Physician Record ........................... 38, 47 D Data ................................................... 18, 19 backing up ...................................... 18, 19 Deleting ....................................................40 studies ..................................................40 Desktop Display .......................................71 Diopter .....................................................26 adjust ...................................................26 dispersion........................................... 54, 62 image ............................................. 54, 62 optimizing ................................... 54, 62 Display .....................................................71 Doppler ........................................ 59, 60, 61 data .......................................... 59, 60, 61 acquiring ............................... 59, 60, 61 Doppler data ............................................63 displaying .............................................63 scaling ..................................................63 threshold ..............................................63 transparency ........................................63 dualview ...................................................71 set ........................................................71
81
InVivoVue Clinic (Release 1.2) E Editing Scans ........................................... 31 Electromagnetic Compatibility .................. 10 EMC......................................................... 10 Engine ......................................... 71, 74, 76 connecting...................................... 74, 76 Exam Record ..................................... 23, 43 Editing .................................................. 43 Examiner.................................................. 23 Examiner Record ......................... 39, 49, 50 Creating ......................................... 39, 49 deleting ................................................ 50 editing .................................................. 49 exams 18, 22, 23, 24, 33, 37, 39, 40, 42, 43, 48, 50, 51, 52 archived ............................................... 52 retrieving .......................................... 52 archiving ........................................ 18, 52 deleting ................................................ 43 exporting ............................ 18, 31, 44, 45 patient ...................................... 31, 44, 45 record................................................... 43 editing .............................................. 43 select for archiving ............................... 51 setting defaults ..................................... 23 viewing ..................................... 31, 44, 45 exporting .................................................. 18 exams .................................................. 18 F file types............................................. 54, 55 .avi ................................................. 54, 55 .bmp ............................................... 54, 55 .oct ................................................. 54, 55 .ocu ................................................ 54, 55 .raw ................................................ 54, 55 .unp ................................................ 54, 55 about .............................................. 54, 55 Find ..........................................................22 patient record .......................................22 Finding a Patient Record ..........................41 fixation control .................................... 26, 55 Fixation Control window ...........................25 Fixation Target 24, 25, 26, 28, 30, 50, 55, 71 Creating ...............................................25 loss of ...................................................71 reclaiming or restoring ..........................71 Select ...................................................30 selecting ...............................................50 Free Run ..................................................28 Fundus Video ..................................... 26, 33 H Handheld Probe .......................................12 Hardware .................................................15 Powering Up .........................................15 I image dispersion ................................ 54, 62 optimizing ....................................... 54, 62 Image Processing .............................. 55, 62 images18, 19, 24, 26, 28, 33, 34, 52, 53, 54, 62, 63, 64, 65, 66, 67, 68, 69 acquiring................................... 24, 26, 28 aiming ..................................................26 backing up ............................................19 dispersion .............................................62 optimizing .........................................62 loading .................................................52 loading, from OCU data ........................54 optimizing .............................................54 optimizing dispersion ............................62 playback ........... 63, 64, 65, 66, 67, 68, 69
82
Index printing ................................................. 34 review .............. 63, 64, 65, 66, 67, 68, 69 saving .................................................. 53 as OCT data ..................................... 53 indications for use ...................................... 8 Interface Box ............................................ 76 connecting............................................ 76 L line spectrum ............................... 16, 18, 57 checking ................................... 16, 18, 57 configuration file ................................... 18 creating ............................................ 18 power ................................................... 18 selecting ............................................... 57 by .ini file .......................................... 57 LineSpectrum.ini ...................................... 18 O OCT ................19, 26, 52, 53, 59, 60, 61, 79 OCT Data........................................... 52, 53 saving images as ................................. 53 OCU......................................................... 19 OCU data ................................................. 54 OD ............................................... 25, 30, 50 Optical Fibers ........................................... 14 cleaning ............................................... 14 optimizing................................................. 54 image dispersion .................................. 54 Optimizing Image Dispersion ................... 62 OS ............................................... 25, 30, 50 OU ..................................................... 30, 50 P Patient ............................. 22, 23, 35, 42, 43 ID 22 MRN..................................................... 22 name .................................................... 43 new ......................................................22 record ............................................. 22, 42 deleting .............................................42 editing...............................................42 finding...............................................42 new...................................................22 report....................................................35 generating ........................................35 patient record ...........................................22 creating ................................................22 patient records .........................................41 filtering .................................................41 finding ..................................................41 sorting ..................................................41 working with .........................................41 patients ....................................................22 adding ..................................................22 finding records for.................................22 selecting ...............................................22 pending ....................................................26 scan .....................................................26 saving ...............................................26 Physician ................................ 23, 38, 43, 47 Physician Record ......................... 38, 47, 48 Creating ......................................... 38, 47 deleting ................................................48 editing ..................................................48 power .......................................................18 line spectrum ........................................18 printing .....................................................34 images .................................................34 scans....................................................34 Probe ............................... 12, 71, 74, 76, 79 connecting ...................................... 74, 76 handheld ..............................................12 83
InVivoVue Clinic (Release 1.2) processing ............................................... 55 protocol .................................................... 37 scan ..................................................... 37 R records ..................................................... 41 patient .................................................. 41 Reference Arm ......................................... 16 Report ...................................................... 35 generating ............................................ 35 Resampling ........................................ 55, 62 S safety ......................................................... 8 contraindications .................................... 8 laser ....................................................... 8 warnings ................................................ 8 Scan ........................................................ 23 types .................................................... 23 Scan Control ............................................ 26 scan protocol ............................... 37, 39, 40 adding to a study .................................. 40 creating ................................................ 37 new ...................................................... 37 Scanner ........................... 15, 18, 20, 74, 76 installing ............................................... 74 powering up ......................................... 15 Shutting Down ................................ 18, 20 scans . 18, 19, 23, 24, 26, 28, 30, 31, 32, 33, 34, 35, 39, 43, 50, 51, 52, 55, 59, 60, 61, 62, 64, 70 abandoned ........................................... 30 acquire ................................................. 23 adjusting .............................................. 32 archived ............................................... 52 retrieving .......................................... 52 archiving ........................................ 51, 52 bitmap of ..............................................33 creating ................................................50 preset ...............................................50 customized ............................... 30, 31, 50 deleting ................................................31 editing ..................................................31 new ......................................................30 pending ................................................26 preset ....................................... 23, 31, 50 printing .................................................34 reviewing ........................................ 31, 32 save .....................................................26 saving ...................................................33 selecting ...............................................31 types .............................................. 23, 30 viewing ........................................... 32, 64 settings............................................... 55, 57 user ................................................ 55, 57 changing ...........................................55 settings file ...............................................57 loading .................................................57 shut down.................................................20 Site...........................................................40 Software Problems ...................................70 Resolving .............................................70 Study ................................ 37, 38, 39, 40, 41 creating .......................................... 37, 41 Deleting ................................................40 editing ...................................... 38, 39, 41 finding ..................................................39 scan protocol ........................................40 adding ..............................................40 System .....................................................18 Backing Up ...........................................18
84
Index T Treatment Arm ........... 23, 37, 38, 39, 41, 43 adding ............................................ 38, 41 adding to a study .................................. 41 new ................................................ 38, 41 troubleshooting ........................................ 70 hardware .............................................. 70 U user settings ...................................... 55, 57 changing ........................................ 55, 57 display of image scans ..................... 55 V Video Fundus ............................... 24, 26, 28 VIP ..................................................... 33, 64 VIP window ........................................ 33, 64 settings .................................................64 Volume Intensity Projection .......... 26, 33, 64 settings .................................................64 Volume Intensity Projection window ... 32, 62 fixation target ....................................55 image processing .............................55 scan types ........................................55
85

IVVC User Manual

Cargado por

Información del documento

Derechos de autor

Formatos disponibles

Compartir este documento

Compartir o incrustar documentos

Opciones para compartir

¿Le pareció útil este documento?

¿Este contenido es inapropiado?

Copyright:

Formatos disponibles

IVVC User Manual

Cargado por

Copyright:

Formatos disponibles

USER MANUAL

Operating Instructions: Found on Manufacturer Label Consult User Manual

InVivoVue Clinic (Release 1.2)

Overview of the Hardware

Indications for Use

Contraindications and Warnings

InVivoVue Clinic (Release 1.2)

Electromagnetic Compatibility (EMC)

Safety and Cleaning

Serial Number Manufacturer Label

Model Number and Date Manufactured

Cautions and Warnings

Hand Held Probe Interface Box

Model Number/ Mfg Date

Clinical Retinal Scanner Interface Box

Model Number/ Mfg Date

InVivoVue Clinic (Release 1.2)

Cleaning and Disinfecting

gloves lint-free lens tissue (a nonwoven rayon blend is recommended) methanol

3. Apply one to two drops of methanol to the tissue at the fold.

The Clinical Scanner

InVivoVue Clinic (Release 1.2)

4. Release the lever to close the fiber cleaner.

Scanner Start Up and Shut Down

InVivoVue Clinic (Release 1.2)

Checking the Line Spectrum

Scanner Start Up and Shut Down

Process Flow for Checking the Line Spectrum

InVivoVue Clinic (Release 1.2)

Creating a Line Spectrum Configuration File

Shutting Down the Scanner

About Backing Up the System

Shutting off the Power

Scanner Start Up and Shut Down

Conducting a Patient Exam

Selecting or Adding the Patient

Setting Exam Defaults

Selecting the Types of Scan to Acquire

About the Fixation Control Window

Creating Fixation Targets

About the Video Fundus/Scan Control Window

button to switch between hiding and displaying

button to toggle the video capture on and off.

Now you are ready for Aiming to Acquire an Image.

Aiming to Acquire an Image

InVivoVue Clinic (Release 1.2)

Using Free Run Mode to Acquire an Image

InVivoVue Clinic (Release 1.2)

Exporting Patient Exams

Reviewing Image Scans

Saving Image Scans

raw spectral data of the scan, .OCU file extension

The B-Scan Window

The Volume Intensity Projection Window

The Video Fundus/Scan Control

Generating a Scan Report

InVivoVue Clinic (Release 1.2)

Creating a New Scan Protocol

Defining a New Treatment Arm

Creating a Physician Record

Creating an Examiner Record

Maintaining Study Information

Adding a Scan Protocol to a Study

Defining a New Treatment Arm