topical oct system instructions for use
TRANSCRIPT
Topical OCT System Instructions for Use
See what we can see.... 1176.DO.104 Issue 2
VivoSight 3 Software
Page 2 22 Feb 2013 1176.DO.104 Issue 2
Table of Contents
1 INTRODUCTION .............................................................................................................................. 5
2 INDICATIONS FOR USE .................................................................................................................. 5
3 CONTRAINDICATIONS ................................................................................................................... 5
4 WARNINGS AND PRECAUTIONS .................................................................................................. 6
5 ICONS AND SAFETY LABELS ....................................................................................................... 8
5.1 Laser safety labels ......................................................................................................................................... 8
5.2 Icons used on the system labels ................................................................................................................. 8
5.3 Icons Used in the VivoSight PC Software ................................................................................................. 10
5.4 Vivosight iPad Buttons and Indicators ...................................................................................................... 11
6 QUICK GUIDE ................................................................................................................................ 12
7 VIVOSIGHT TOPICAL PROBE ...................................................................................................... 13
7.1 Fitting of the Topical probe standoff ......................................................................................................... 14
7.2 Setting the correct working distance ........................................................................................................ 15
8 SYSTEM PREPARATION .............................................................................................................. 16
8.1 System Setup ............................................................................................................................................... 16
8.2 Power On ...................................................................................................................................................... 17
8.3 Power Off ...................................................................................................................................................... 18
8.4 Preparation for Transportation................................................................................................................... 19
9 VIVOSIGHT PC SOFTWARE INTRODUCTION ............................................................................. 20
9.1 Overview ....................................................................................................................................................... 20
9.2 Main Screens ................................................................................................................................................ 20 9.2.1 Patients Management Screen ................................................................................................................... 20 9.2.2 Patient Record Screen .............................................................................................................................. 21
9.2.2.1 Lesion Map Pop-up Window ............................................................................................................. 23 9.2.2.2 Lesion Editor Pop-up Window .......................................................................................................... 24
9.2.3 Scan / Review Management Screen ......................................................................................................... 24 9.2.3.1 Current Tab ....................................................................................................................................... 24 9.2.3.2 Reference Tab .................................................................................................................................. 25 9.2.3.3 Compare Tab .................................................................................................................................... 26
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9.3 Status Line.................................................................................................................................................... 26
9.4 Header Bar .................................................................................................................................................... 27 9.4.1 Header Bar on Patients Management Screen .......................................................................................... 27 9.4.2 Header Bar on Patient Record Screen ...................................................................................................... 28 9.4.3 Header Bar on Scan / Review Management Screen ................................................................................ 29
9.5 Lesion Bar .................................................................................................................................................... 29
9.6 Footswitch Control ...................................................................................................................................... 31
10 USING THE VIVOSIGHT SYSTEM ................................................................................................ 32
10.1 Start Up ......................................................................................................................................................... 32
10.2 Patients Management .................................................................................................................................. 33 10.2.1 Filtering the Patient List ........................................................................................................................ 33 10.2.2 Sorting the Patient List .......................................................................................................................... 35 10.2.3 Adding a New Patient............................................................................................................................ 35
10.2.3.1 Patient Creation without Existence Check ........................................................................................ 35 10.2.3.2 Patient Creation with Existence Check ............................................................................................. 37
10.2.4 Opening a Patient’s Record .................................................................................................................. 38 10.2.5 Exporting a Patient’s Record ................................................................................................................ 38
10.3 Patient Notes ................................................................................................................................................ 40
10.4 Lesion Management .................................................................................................................................... 40 10.4.1 Lesion Creation ..................................................................................................................................... 41
10.4.1.1 Lesion Creation using the New Button in the Lesion Bar ................................................................. 41 10.4.1.2 Lesion Creation using the Lesion Map ............................................................................................. 42
10.4.2 Editing Lesions ...................................................................................................................................... 43 10.4.3 Filtering the Lesion List ......................................................................................................................... 44 10.4.4 Opening a Lesion for Review ................................................................................................................ 45 10.4.5 Exporting Lesions .................................................................................................................................. 46 10.4.6 Lesion Deletion ..................................................................................................................................... 47
10.5 Scan Acquisition .......................................................................................................................................... 48 10.5.1 Free-Run Scan ...................................................................................................................................... 50 10.5.2 Multi-Scan Scan .................................................................................................................................... 52
10.5.2.1 Multi-Scan Scan Parameters ............................................................................................................ 53
10.6 Scan Management ....................................................................................................................................... 54 10.6.1 Opening Scans for Review ................................................................................................................... 55 10.6.2 Scan Editing .......................................................................................................................................... 56 10.6.3 Scan Export ........................................................................................................................................... 56 10.6.4 Scan Deletion ........................................................................................................................................ 59
10.7 Scan Compare .............................................................................................................................................. 59
10.8 Shutdown...................................................................................................................................................... 62
11 VIVOSIGHT IPAD APPLICATION .................................................................................................. 63
11.1 Overview ....................................................................................................................................................... 63
11.2 Main iPad Screens ....................................................................................................................................... 63 11.2.1 Settings Screen ..................................................................................................................................... 63
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11.2.2 Patients Management Screen ............................................................................................................... 64 11.2.3 Patient Record Screen .......................................................................................................................... 64 11.2.4 Scan Review Screen ............................................................................................................................. 65 11.2.5 Scan Replay Screen ............................................................................................................................. 65
12 USING THE IPAD APPLICATION .................................................................................................. 66
12.1 Entering Settings Details and Connecting to Patients’ Database .......................................................... 66
12.2 Using Patients Management Screen .......................................................................................................... 66 12.2.1 Filtering Patient List............................................................................................................................... 66 12.2.2 Open Patient’s Record .......................................................................................................................... 69
12.3 Analyzing Single Patient’s Record ............................................................................................................ 69
12.4 Reviewing a Scan ........................................................................................................................................ 71
12.5 Replaying a Scan ......................................................................................................................................... 72
13 USE WITH OTHER EQUIPMENT ................................................................................................... 73
14 CLEANING AND DISINFECTING .................................................................................................. 74
14.1 Handheld probe, standoff and umbilical ................................................................................................... 74
14.2 Keyboard, pointing device, and footswitch .............................................................................................. 74
14.3 Cart, OPU, OPU power supply, computer, monitor, and laser ................................................................ 74
15 TECHNICAL DATA ........................................................................................................................ 75
15.1 System specification ................................................................................................................................... 75
15.2 EMC Requirements ...................................................................................................................................... 77
15.3 FCC ................................................................................................................................................................ 78
16 TESTING INCLUDING PRE USE CHECKS ................................................................................... 79
16.1 Pre-Use Checks ........................................................................................................................................... 79
16.2 Electrical Safety Testing ............................................................................................................................. 79
17 MAINTENANCE & ACCESSORIES ............................................................................................... 79
17.1 Maintenance ................................................................................................................................................. 79
17.2 Accessories .................................................................................................................................................. 80
18 WARRANTY ................................................................................................................................... 80
19 DISPOSAL ..................................................................................................................................... 80
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1 INTRODUCTION
Optical Coherence Tomography (OCT) is a cross-sectional imaging technique that is applicable to in-vivo medical examination. The technique is analogous to ultra-sound scanning, but because it uses Near Infra-Red (NIR) light it has much finer resolution (<10µm) for the same imaging depth. OCT allows one to see, in-vivo, in real time and non-invasively, tissue microstructure, without exposing the subject or user to ionizing radiation. The VivoSight Topical OCT system will enable the user to:
1. Enter and manage patient and descriptive data
2. Acquire single and multiple 2-dimensional 16 bit OCT images of sub-surface tissue
3. Produce 3D volumes from multiple 2D images which can be rendered using third party software
4. Export OCT images as TIFF and as DICOM compliant image files Expected locations of use are in-patient and ambulatory care settings. The complete system is suitable for use within the patient environment. Users of the equipment need to be computer literate and have undergone the appropriate level of training for the different areas of operation. At a minimum it is expected that the user will be at nurse practitioner level. Ensure that this manual has been read and understood before using the VivoSight Topical OCT system.
2 INDICATIONS FOR USE
The VivoSight Topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
US Federal law restricts this device to sale by or on the order of a physician
3 CONTRAINDICATIONS
The VivoSight Topical OCT system is contraindicated for:
Invasive procedures
Ophthalmic procedures
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4 WARNINGS AND PRECAUTIONS
Ensure that this manual has been read and understood before using the VivoSight Topical OCT system.
If the VivoSight Topical OCT system shows signs of damage or is suspected of malfunction it should be taken out of service immediately and returned to the manufacturer or their authorised service centre for repair.
If the VivoSight Topical OCT system does not operate as expected, consult section 6 "Quick Guide”. If the VivoSight Topical OCT system continues not to operate as expected, stop using the system immediately and contact the manufacturer or their approved agents for service
The VivoSight Topical OCT images may only be used to supplement other clinical information and should NOT be used to replace current clinical information, practice or judgment.
The VivoSight Topical OCT system is NOT intended to provide direct diagnosis or to make clinical decisions and is not intended to replace trained staff or existing test and assessment procedures.
The VivoSight Topical OCT system should only be cleaned and disinfected as specified in these instructions (section 14).
If the VivoSight Topical OCT system is used in a manner NOT specified by the manufacturer, the protection provided by the equipment may be impaired.
Caution – use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
The VivoSight Topical OCT system is a CLASS 1 Laser Product. Do NOT attempt to stare directly into the beam. Do NOT attempt to insert a mirror or other reflecting device into the beam.
The OPU contains a 660nm 3mW fibre coupled laser. No laser radiation is accessible within the OPU.
NO modification of this equipment is allowed
Connections between the modules of the VivoSight Topical OCT system must NOT be changed: Do NOT disconnect the laser from the Optical Processing Unit (OPU) CLASS 1M INVISIBLE LASER RADIATION WHEN OPEN. DO NOT VIEW WITH OPTICAL INSTRUMENTS
Do NOT modify any connections to the monitor. SPECIFIED SYSTEM CONNECTIONS ONLY
Do NOT modify any connections on the back of the Computer, OPU, or laser. SPECIFIED SYSTEM CONNECTIONS ONLY
Do NOT modify any connections on the cart or isolation transformer. SPECIFIED SYSTEM CONNECTIONS ONLY
Do NOT use a power supply for the OPU, other than the one supplied with the system
Do NOT operate the VivoSight Topical OCT system outside the rated power supply range specified. Ensure the VivoSight Topical OCT system is only connected to an earthed supply.
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Do NOT touch connections to the PC or Monitor and the PATIENT at the same time.
Do NOT touch connections at the rear of the OPU and the PATIENT at the same time.
Do NOT touch connections at the rear of the Santec HSL-2000 Laser and the PATIENT at the same time
Do NOT block the cooling vents on the front of the PC
The VivoSight Topical OCT system is NOT intended to be used with external USB or audio devices with a separate connection to the mains such as printers, external storage devices, routers, powered speaker systems and other accessories that may compromise isolation during clinical procedures. DO NOT CONNECT MAINS POWERED DEVICES.
Only cables <3m long should be used to connect acceptable devices to the front of the computer.
When using the VivoSight Topical OCT system, ensure that the mains lead, umbilical, and footswitch cable are NOT a trip hazard.
The VivoSight Topical OCT system is NOT MRI safe and should NOT be taken into an MRI environment.
The VivoSight Topical OCT system is NOT defibrillator proof.
The VivoSight Topical OCT system must NOT be used in the presence of flammable anaesthetic mixtures with oxygen or nitrous oxide.
The recommended operating temperature range of the VivoSight Topical OCT system is +15°C to +35°C.
The VivoSight Topical OCT system should be placed on a stable level surface, away from direct sunlight.
TURN OFF THE SANTEC HSL-2000 LASER USING THE ‘LD’ BUTTON AND ‘POWER’ KEYSWITCH BEFORE MOVING THE CART OUT OF THE EXAMINATION ROOM; OTHERWISE EXPENSIVE DAMAGE TO THE LASER MAY RESULT.
When moving the VivoSight Topical OCT system or when it is not in use, stow the mains cable, footswitch, and handheld probe.
STOW THE MONITOR INBOARD BEFORE MOVING CART.
Grasp the monitor with both hands when positioning it. Do NOT insert fingers into any potential pinch points on the monitor support arm.
It is recommended that at least two people move the system when the terrain is uneven or inclined, or when moving the system over thresholds.
Do NOT place loads in excess of 10kg on top shelf of the cart.
Do NOT apply loads to the umbilical in excess of 1.5Kg shear force, and 5Kg tensile force.
Antivirus software is installed on delivery. However, it is recommended that the user checks that the software conforms to the user’s IT policy.
Only software specified in this manual may be safely installed on the system without consulting MDL.
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5 ICONS AND SAFETY LABELS
5.1 LASER SAFETY LABELS
Label Description
Laser Classification Location: Top of probe above objective lens
CAUTION - CLASS 1M
INVISIBLE LASER RADIATION
WHEN OPEN
DO NOT VIEW DIRECTLY
WITH OPTICAL INSTRUMENTS
Protective Housing Label Location: Front of Santec HSL-2000 laser
5.2 ICONS USED ON THE SYSTEM LABELS
Icon Description
Attention, consult accompanying documents
Consult Instructions For Use
Type CF Applied Part
Type Number
Serial Number
Date of Manufacture
Manufacturer
OFF (Power: disconnection from Mains)
ON (Power: connection to Mains)
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Icon Description
OFF for a part of equipment
ON for a part of equipment
Input-Output
Direct Current
Protective Earth
Computer Network
Isolation Transformer
Input
Output
Fuse
Alternating Current
Equipotentiality
Temperature Limitation
Fragile
Keep Away from Sunlight
Keep Dry
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5.3 ICONS USED IN THE VIVOSIGHT PC SOFTWARE
Icon Description
Desktop shortcut to start the VivoSight Software
Indicator - the instrument has a temporary fault that prevents normal operation.
Info Button - display VivoSight product information
Settings button – open Tools dialog
Minimize button - minimize the VivoSight window
Close button - close the VivoSight Software
Home button – go to home page with filters unset
Back button – navigate to previous screen
Graphical lesion filter – open Lesion Map with all patient’s lesions
Clear Filter button – remove filters in use
Down Lesion Arrow – open scan list belonging to a particular lesion
Up Lesion Arrow – close scan list belonging to a particular lesion
Scan has been acquired, but not saved.
Scan has been acquired and saved.
Current displayed image
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5.4 VIVOSIGHT IPAD BUTTONS AND INDICATORS
Only buttons and key presses specific for the VivoSight iPad application are described in the following table. Standard iPad controls and indicators are not described in this section.
Graphical Representation
Action Type Key Description
Touch Home
Displays the Patients Management screen.
Touch Back
Navigates to the previous screen.
Touch Settings
Accesses the Settings screen. Displayed in the bottom right corner of the Patients Management screen.
Touch Clear Filter
Removes the filters in use.
Touch Replay
Transits from the Scan Review screen to the Scan Replay screen and starts playing a scan
Touch Play
Plays a new or a paused scan.
Touch Close
Closes the Scan Replay screen.
Touch Pause
Pauses the current scan.
Indicator Not applicable
Indicates that scan is being downloaded from the database
Indicator Not Applicable
Displayed in the place of the first frame of the scan until it has been downloaded from the database.
Also, the default scan image for empty scans.
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6 QUICK GUIDE
The following section is a brief method of use and is intended only as a reminder and checklist for those operators who have read this manual in full, and are conversant with the VivoSight Topical OCT system, its use and all warnings and cautions.
CLEAN PRIOR TO PATIENT USE
SYSTEM SETUP
A0 Move the cart into the patient area and connect the equipotentiality point if required
A1 Move the cart into its final position and apply the cart brakes on the front wheels
B Plug the mains cable into the mains supply
C Position the footswitch
D Position the monitor
E Switch on the cart master switch
F If the cart switch does not illuminate, check the transformer switch indicator is illuminated
G Turn on the OPU illuminated switch
H Turn the laser power key clockwise - The LD light will illuminate and then extinguish
I Press the LD switch to start the laser - The LD light will illuminate
J Turn on the computer
K Turn on the monitor
L Open the cart drawer to access the keyboard and pointing device
M Start up the VivoSight software
N Remove the probe from the holster
SYSTEM SHUTDOWN
N Replace the probe in the holster when all scans are complete
M Shut down the software and computer, ensuring the shutdown process completes
L Close the cart drawer
K Turn off the monitor
I Press the LD switch to stop the laser - The LD light will extinguish
H Turn the laser power key anti-clockwise
G Turn off the OPU
E Switch off the cart master switch
D Stow the monitor inboard
C Stow the footswitch on the bottom shelf
B Unplug the mains cable, stow on the cart, and if appropriate disconnect the equipotentiality point
A2 Release the cart brakes
D
E
B
I
A1
C
K
G
H
L
J
M
N
A2
D
Bottom rear of cart
F
A0
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7 VIVOSIGHT TOPICAL PROBE
The VivoSight hand-held topical probe has a visible red spot to enable the user to position the scan on the required area of skin. It enables X-Y scanning to be performed to produce 2D images, and 3D volume rendered images from multiple 2D images.
. The topical probe has been designed to be held comfortably in either the left- or right-hand, and operates in any orientation for ease-of-access to the region being imaged. A low-power red laser projects light from the scanning lens at all times when the VivoSight system is powered-up. This laser helps the user to position the probe correctly on the region-of-interest.
Laser
X-scan
Y-scan
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7.1 FITTING OF THE TOPICAL PROBE STANDOFF
A probe standoff is provided with the VivoSight Topical OCT system to aid positioning the probe on the skin surface and setting the correct scan distance. The standoff is fitted to the topical probe by clipping it sideways onto the retaining ring on the objective lens mount. The standoff can be removed by doing the reverse, and simply unclipping it from the objective lens mount. The standoff can also be rotated to set the most appropriate orientation for the skin area being scanned.
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7.2 SETTING THE CORRECT WORKING DISTANCE
The correct working distance is set as follows: 1. Set the software to capture a scan (see section 9 for a detailed description of software operation).
2. Position the probe so that the patient-facing edge of the standoff is gently pressing against the patient’s skin around the region-of-interest (see figures below); use the red laser light to guide the position of the imaged section.
3. By observing the image in the VivoSight software, adjust the working distance so that the region of skin you wish to see is within the region demarcated by the four right-angled guide lines (see figures below). The image of the skin is moved vertically within the frame by:
i. Changing the fitted stand-off for a different length (see 7.1 for the correct procedure).
ii. Twisting the probe and/or detachable stand-off to adjust the way it fits the contours of the patient’s skin.
iii. Varying the angle at which the probe is pressed onto the patient’s skin.
iv. Varying the pressure applied to the probe.
4. Ensure that the patient is comfortable before proceeding with the scan.
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8 SYSTEM PREPARATION
8.1 SYSTEM SETUP
The cart should be kept stationary with the brakes applied within one minute of powering-on, and for one minute after powering-off the equipment. Otherwise damage may occur to the VivoSight Topical OCT System.
The procedure for setting up the Michelson Diagnostics VivoSight Topical OCT system is as follows:
1. Move the cart into the patient area and connect the equipotentiality point if required. Move the cart into final position on a level floor, away from sources of heat or moisture in a room conforming to the environmental conditions set out in section 15.1.
2. Apply the cart brakes by moving the foot-operated levers on the two front wheels to the down position (A).
H
H
E
B
I
C
K
G
H
L
J
M
D
N
A1
Released Applied
Bottom rear of cart
F
A0
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8.2 POWER ON
To power on the system and make it ready for normal use, follow the instructions below:
1. Plug the power cable (B) into a suitable mains-power supply (see section 15.1 for power requirements).
2. Position the footswitch (C) and monitor (D) so that they are convenient for the operator and unlikely to constitute a trip or collision hazard.
3. Switch on the cart master switch (E), located on the right-hand side of the cart between the first and second shelves. If the cart master switch is not illuminated, check that the isolation transformer (F), located under the rear of the cart, is switched on and the “ON” indicator is illuminated.
4. Turn on the Optical Processing Unit (G). A lamp on the switch illuminates to indicate the unit is on.
5. Insert the laser power key (H) and turn it 90 degrees clockwise to the on position. The light in the centre of the “LD” button (I) will illuminate for a few seconds.
6. Press the “LD” button (I) to turn on the laser, the light in the centre of the button will illuminate.
7. Turn on the computer by briefly pressing the power button (J).
8. Turn on the monitor by briefly pressing the power button located on the bottom right-hand corner
(K).
9. Open the cart draw (L) to access the keyboard and pointing device.
10. When the computer has booted-up and the familiar Windows desktop is visible on the monitor, start the VivoSight software by double-clicking the VivoSight icon using the keyboard or attached pointing device.
11. Remove the probe (N) from the holster
The system is now ready for normal use
H
I
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8.3 POWER OFF
The VivoSight application software should be closed and Windows shutdown before power is turned off.
After using the VivoSight Topical OCT system, it should be shut down in the following way:
Select the Close button in the top right of the screen to close the VivoSight application software.
Select the Windows Start button in the bottom left corner of the screen.
Select the Shut Down option from the menu.
When the power indicator on the front of the system computer (J) has turned off, the components of the VivoSight Topical OCT system should be turned off in the following manner:
1. Turn off the system monitor by briefly pressing the power button on the bottom right-hand corner of the panel (K).
2. On the front of the laser unit, press the “LD” button (I) once, the light in the centre of the button will extinguish.
3. Turn the laser power key 90 degrees counter-clockwise and remove it. The power light will turn
off.
4. Turn off the Optical Processing Unit (G), the power lamp on the switch will extinguish.
5. Switch off the cart master switch (E), located on the right-hand side of the cart between the first and second shelves.
I
H
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6. Close the drawer containing the keyboard and pointing device (L) and re-stow the foot switch (C).
8.4 PREPARATION FOR TRANSPORTATION
The cart should be kept stationary with the brakes applied within one minute of powering-on, and for one minute after powering-off the equipment. Otherwise damage may occur to the VivoSight Topical OCT System.
It is recommended that at least two people move the system when the terrain is uneven or inclined, or when moving the system over thresholds. Ensure that the system does not experience any excessive vibration or shock.
Ensure the monitor is stowed inboard before moving the system.
When moving the system through small gaps, care should be taken to ensure that the probe and probe holster are not damaged by knocks on hard surfaces.
Preparation for movement of the VivoSight Topical OCT system over short distances (within the same facility) is detailed in the steps below:
1. Power off the system as described in the preceding section 8.3.
2. Remove the mains plug from the mains socket and stow the mains cable.
3. Disconnect the equipotentiality point if appropriate.
4. Stow the monitor is inboard to prevent it from catching on doorways etc.
5. Ensure the probe is correctly and securely placed in the holster and the probe umbilical neatly hanging by the side of the cart with no kinks or twists.
6. Release the brakes on the cart front wheels (A).
The VivoSight Topical OCT system is now ready to be safely moved
Applied Released
A1
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9 VIVOSIGHT PC SOFTWARE INTRODUCTION
9.1 OVERVIEW
The VivoSight PC software provides the means to capture; store and review OCT. Acquired images can also be exported for review and processing by external applications. When images are no longer required, they can be deleted. Images are stored in a database on the computer’s internal disk, along with all related information, in the following manner:
A ‘Patient’ consists of complete record of ‘Lesions’ and associated ‘Scans’ attached to one person registered through a unique identifier called Patient ID
A ‘Lesion’ or group of lesions associated with a ‘Patient’ is a record of written descriptions and/or associated scans belonging to a particular ‘Patient’. One ‘Lesion’ can be associated with number of different scans.
A ‘Scan’ consists of one image frame or sequence of image frames that have been acquired, as well as details of the scan parameters.
Each ‘Patient’ may have one or more ‘Lesion’ records and/or ‘Scans’ taken for that lesion. The VivoSight PC software supports two basic patterns of use:
Patient details may be defined in advance of the examination procedure. The patient details are entered before the patient arrives. Patient personal details, as well as a list of lesions to be examined can be pre-populated before the examination. In this scenario only scans are acquired and additional lesion and scan notes can be added during the examination.
Patient, lesion and scan details may be entered during the examination procedure or after it is complete. A new blank ‘Patient’ is created and default values for all the user-defined fields such as patient identity, lesion description and scan notes are initially used and filled as appropriate. Following scan acquisition, it is possible to fill-in the patient’s data, lesion, and scan description following the exam.
The VivoSight PC software displays information and controls on screens that are appropriate for the main tasks that can be performed by the VivoSight topical probe.
9.2 MAIN SCREENS
There are three main screens in the VivoSight PC software; navigation between the screens is performed by clicking the appropriate buttons.
9.2.1 Patients Management Screen
The Patients Management screen is the first screen to be displayed when VivoSight starts. It allows management of all patients held in the database.
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On this screen it is possible to:
- filter the patient list at various criteria - sort patients in ascending / descending order - add new patients - open patient’s record for review - export one or more patient’s record
Selecting a patient enables either his / her record to be opened for review, or to Export the record. Selecting two or more patients enables Exporting of their records. Double-clicking on a single patient’s record will open the Patient Record screen for that patient. It is possible to add a new patient in two different ways: by creating a new patient explicitly, or by searching through the database for a patient and, in case that he / she is not found, create a new entry pre-populated with data used by the search filters.
9.2.2 Patient Record Screen
The second screen is the Patient Record screen. It allows management of a particular patient: editing of his / her data, managing his / her lesions (creation, editing and deletion of lesions, as well as exporting) and entering important notes related to the patient. The Patient Record screen holds all scans recorded for a particular patient, and is the base screen for scan acquisition.
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Initially, scans are grouped by lesions,
They can also be grouped by the date they were taken:
Lesions can be filtered by various criteria using textual and graphical filter. The textual filter is based on the same concept of an alphanumeric search through the list of lesions, similar to patient filtering on the
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Patients Management screen. The visual filter has the same functionality as the textual filter; however it provides a quick overview of all lesions belonging to a patient.
9.2.2.1 Lesion Map Pop-up Window
The Lesion Map provides quick overview of all patient lesions. It is used for the graphical filtering of lesions.
It also provides quick way to acquire a scan. The user can create a new lesion and start a scan immediately in a single step by double-clicking on a particular location.
Using a right click, it is possible to point to a specific lesion in a graphical view and select its record for editing and further manipulation. In the case no specific lesion is selected, a new lesion located at the selected position can be created.
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9.2.2.2 Lesion Editor Pop-up Window
The Lesion Editor pop-up window allows management of lesions – creation and editing.
It allows a user to enter all data relevant for the particular lesion and start the scan in Free-Run mode immediately.
9.2.3 Scan / Review Management Screen
The Scan / Review Management screen allows management of the scans of a particular lesion. It is separated into three tabs: Current, Reference and Compare.
9.2.3.1 Current Tab
The Current tab enables scans to be acquired. Scan width can be adjusted if required. Preset scans can be made. Acquired images can be previewed and either stored or re-acquired. Important scans can be exported for archiving or for analysis and manipulation using appropriate third-party software. Unwanted scans can be deleted.
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9.2.3.2 Reference Tab
The Reference tab enables selection of a previously acquired scan as a reference for comparison with the current scan. Images on this screen can only be reviewed using the frame selector.
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9.2.3.3 Compare Tab
The Compare tab enables comparison of scans. The user can compare a scan from the Current tab side-by-side with a scan selected in the Reference tab.
The upper image area contains the scan selected on Reference Tab and can be reviewed using the upper Frame Selector. The lower image area is occupied by the current view from the Current Tab. It can be replayed / paused and reviewed using the lower Frame Selector. Export, Scan and Replay related to this scan are available from this screen as well.
9.3 STATUS LINE
The Status Line is displayed at the top of the first two VivoSight screens, Patients Management and Patient Record. It contains a summary of the system status, resource and system information.
The Status Line is divided into four sections:
System Status
Indicates if the instrument has a temporary fault or has a serious fault requiring calibration or repair. For normal operation this section is blank.
Resources
Indicates the proportion of computer disk space used and the current computer processing unit (CPU) load.
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A warning is displayed if the disk is more than 90% full.
Information
Identifies the VivoSight PC software version and current date and time. Selecting the information button provides further details about the system and software, including the manufacturer.
Settings
Identifies the current database being used. Selecting the Settings button opens the Tools dialog, providing the option to connect to local (default setting) or remote database.
The System Status area displays the following indications.
Indication Condition Recommended Action
Warning: Missing Triggers Ensure that the laser is powered on and that the LD light is illuminated.
The Resources area displays an indication of the available disk space.
Status Line Condition Recommended Action
Disk more than 90% full
When convenient and when a scan is not in progress, delete unwanted data so that the disk is less than 90% full.
9.4 HEADER BAR
The Header Bar is displayed on all VivoSight screens. It has different functionality depending on currently opened screen.
9.4.1 Header Bar on Patients Management Screen
On this screen, the Header Bar is displayed right beneath the Status Line, on top of the patients table.
It contains: search boxes (Patient ID, First Name, Last Name, Gender, Date of Birth, Last Scan Date and Clinician ID) used for filtering the patient list, Clear Filter button (on the left), and buttons on the right used for opening an existing patient’s record, exporting a patient’s record and creation of a new patient. The Open button is available if only one patient is selected in patient list, and opens the Patient Record screen. The Export button is available if one or more patients is selected, enabling the export of several patient records at once.
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The New button is always available, allowing creation of a new patient’s record at any time.
Button Description Availability
Clear Filter button – removes filter(s) in use Always
Creation of a patient – opens Patient Record screen
Always
Opening of a patient’s record for review – opens Patient Record screen
One patient selected
Export of patient record(s) – opens Export dialog One or more patients selected
9.4.2 Header Bar on Patient Record Screen
As on the previous screen, the Header Bar is displayed right beneath the Status Line, on top of the Lesion management area.
It contains patient details belonging to the selected patient, arranged in the same way as they were on Patients Management screen (Patient ID, First Name, Last Name, Gender, Date of Birth, Last Scan Date and Clinician ID). Note: In case the user gets confused about the patient data being displayed, he / she can get a quick
hint by double-clicking on the Header Bar somewhere between the fields with patient data. Double-clicking once more brings back the fields containing the real patient data.
The Patient data is contained in editable text boxes allowing data modification. The only non-editable field is Last Scan Date text box, since it holds the date of the last scan acquired for the selected patient. (Last Scan Date is automatically set when the scan is acquired.)
If patient data is changed, the Save button is available for recording the changes.
If the Patient Record screen is entered to create a new patient, the Create button is displayed instead of Save.
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The Navi-buttons are located on the left:
The Home button opens the Patients Management screen with all filters cleared, giving the full patient list. The Back button navigates back to the Patients management screen with the filters set as they were, giving filtered patient list.
9.4.3 Header Bar on Scan / Review Management Screen
The Header Bar on the Scan / Review management screen is displayed on top of the screen, as this screen does not have a Status Line.
The Header Bar is divided into several sections: navi-buttons, patient and lesion identification, system status and scan controls.
Navi-buttons
The Home button opens the Patients Management screen with all filters cleared, giving the full patient list. The Back button navigates back to the Patient Record screen.
Patient Identification
Patient identification information is available for the current selected patient: Patient ID, First Name and Last Name.
Lesion Identification
Lesion identification information is available for the current selected lesion: Lesion ID.
System Status
Indicates if the instrument has a temporary fault or has a serious fault requiring calibration or repair. If instrument is working normally, this section is blank.
Scan controls are displayed on the right half of the Header Bar.
Scan acquisition can be started or stopped (Scan / Stop button); scan width can be modified. Preset scans can be acquired (Multi1 and Multi2 buttons). Scans can be saved - single frames can be recorded (Save Frame) as well as whole scans (Save All). Scans can be exported (Export button) or discarded (Discard). Scans just acquired or previously recorded can be replayed (Replay button).
9.5 LESION BAR
The Lesion Bar is displayed only on the Patient Record screen, right beneath the Header Bar. It enables simple lesion / scan management.
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If the Patient Record screen is entered to create a new patient, the Lesion Bar is not displayed. The Lesion Bar is present only when the patient record already exists. Patient’s scans can be grouped by the lesions they belong to, or by the date they were taken, using the scan grouping buttons: Lesions and Dates. The default view is by Lesions – every time the Patient Record screen is entered from the first Patients Management screen, the scan view is set to Lesion.
Button Description
Group scans by the lesion they belong to
Group scans by the date they were taken
The Lesion list can be filtered textually, using the Lesion ID and Lesion Description search boxes, or graphically using the Graphical Lesion Filter. Filters can be removed using the Clear Filter button, on the left.
Button Description
Graphical Lesion Filter – opens Lesion Map pop-up window providing quick overview of all lesions belonging to a patient
Clear Filter button – removes filter(s) in use
When a patient has no lesions in his / her record, or none of the existing lesions is selected, the New button is available to create a new lesion. If the patient has lesions in his record and a particular lesion is selected, the lesion can be deleted, exported, opened for review, scanned and edited. If two or more lesions are selected, they can be deleted at once or exported.
Button Description Availabiity
Creation of a lesion – opens Lesion Editor pop-up window
- No existing lesions - Lesions exist, none selected
Opening of a lesion for review – opens Scan / Review Management window
One lesion selected
Opening of a lesion for scanning, automatically starts Free-Run acquisition – opens Scan / Review Management window
One lesion selected
Lesion editing – opens Lesion Editor pop-up window
One lesion selected
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Button Description Availabiity
Deletion of a lesion – opens Confirmation dialog One or more lesions selected
Export of lesion(s) – opens Export dialog One or more lesions selected
9.6 FOOTSWITCH CONTROL
A three pedal footswitch can be used to provide hands free operation of some VivoSight operations.
The following action types are defined for use with the footswitch. To activate the action, press the pedal until it “clicks” and then release it Each footswitch pedal has an equivalent keyboard key which can be used as an alternative if required.
Graphical Representation
Equivalent Key
Pedal Operation
F6 Left, Blue Multi 1 scan acquisition
F7 Middle, Yellow Start / Stop Free-Run scan acquisition
F8 Right, Green Multi 2 scan acquisition
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10 USING THE VIVOSIGHT SYSTEM
10.1 START UP
After turning on the system PC (as described in section 8.2), the Windows 7 desktop is displayed.
VivoSight
To start the VivoSight software, double-click the VivoSight shortcut on the windows desktop.
Alternatively, use the Windows start menu to navigate to the Michelson Diagnostics program group. Select VivoSight to start the application software.
As the VivoSight application starts, an information window is displayed identifying the VivoSight system and software version. A start-up message confirms the correct initialisation of hardware and software subsystems.
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10.2 PATIENTS MANAGEMENT
The Patients Management screen is the first screen to be displayed when VivoSight starts. It lists all patients held in the database.
It allows the patient list to be filtered using various criteria or sorted in ascending / descending order. It also allows creation of new patients. From this screen it is possible to open patient’s record for review and scanning afterward. Records of patients (including all scans of a particular patient) can be exported.
10.2.1 Filtering the Patient List
The Patient list can be filtered using the search boxes in the Header Bar by: Patient ID, patient’s First Name, Last Name, Gender, Date of Birth, Last Scan Date and Clinician who did the examination. While the filter is being entered in a particular search box, only the entries that fulfil the filter condition are presented from the top of the table. As long as filters are used, they are displayed in search boxes. The Patient ID entry filters the patient list so that entries that contain the entered filter condition, regardless of the position, are left in the list.
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Entries in the next three search boxes (First Name, Last Name and Gender) and the last one (Clinician ID), filter patient list in a way that only entries that start with entered filter condition are displayed in the list.
As for the remaining two search boxes (Date of Birth and Last Scan Date), the patient list is filtered by each field separately (date, month, year), meaning that only entries that contain the entered filter condition are left in the list. Entries in a year field will accept two digit entries. Two digit entries are processed assuming that they are a date in the last 100 years.
If Gender, Date of Birth, and Clinician ID are blank, they will always be displayed in the patient list when filters are being used.
The Patient list can be filtered using multiple filters as well. Entries that fulfil all entered filter conditions concurrently are displayed in the list.
The Clear Filter button in the Header Bar, on the left, removes filters in use and brings back the full patient list. When this button is clicked, all search boxes are cleared i.e. contain only watermarks.
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10.2.2 Sorting the Patient List
The Patient list can be sorted by selecting any column heading. Selecting the column heading again reverses the sort order. A triangle symbol next to a column heading indicates the column by which the patients are currently ordered; the orientation of the triangle indicates either ascending or descending sort-order.
10.2.3 Adding a New Patient
A New patient can be added in two ways: 1. Without checking for his / her existence in database 2. From a previous check of his / her existence in the database
10.2.3.1 Patient Creation without Existence Check
Selecting the New button on the Patients Management screen, while the patient list is fully displayed (no filters are set), opens the Patient Record screen enabling the creation of a new patient.
Patient data can be entered in text-boxes on the Header Bar of the Patient Record screen.
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All text-boxes are available, except Last Scan Date, since that information is automatically set when scans are acquired. The new data entry is coloured orange until the Create button is selected i.e. a new patient created.
Every patient is uniquely identified with his / her Patient ID. If during the input, the Patient ID becomes dark violet, it means that the entered ID is already used by another patient i.e. the patient with that ID already exists in database.
In that case duplication of a patient is prevented by disabling the Create button.
After creation the entered data is coloured in black, Create button changes to Save, and the Lesion Bar is displayed.
If no patient data is entered and the Create button clicked, a new patient will be created with default values:
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Field Value
Patient ID “Pat_dd/mm/yyyy_hh:mm“ – where date_time is the moment of creation
First Name “Unknown_First”
Last Name “Unknown_Last”
Gender blank
Date of Birth blank
Last Scan Date blank
Clinician ID blank
10.2.3.2 Patient Creation with Existence Check
A New patient can be created from a previous check of his / her existence in the database, using filters on the Patients Management screen.
After the search, selecting the New button will open the Patient Record screen enabling the creation of a new patient. All data previously entered on Patients Management screen will be displayed in the text-boxes ready for amendments and patient creation.
Listed below are the possible results of the patient search on Patients Management screen:
Filtered Patient List Meaning Patient Creation
Blank Patient with entered data doesn’t exist in database
Possible
One entry – Patient ID exact match
Patient with entered data already exists in database
Impossible, unless Patient ID is changed
One entry – Patient ID partial or no match
Patient with entered data exists in database, but has different ID
Possible
More than one entry Several patients exist in database with matching data
Possible
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If Patient ID on Patient Record screen is dark violet, it means that patient identified by that ID already exists, and creation of the patient is prohibited (The Create button is disabled).
10.2.4 Opening a Patient’s Record
Selection of a patient on the Patients Management screen and clicking on the Open button opens the patient’s record for review or scanning afterward.
Double-clicking on a patient entry opens his / her record.
10.2.5 Exporting a Patient’s Record
The Patients Management screen a patients’ record to be exported i.e. all scans belonging to a particular patient. One record can be exported at a time or several at once. In order to export one patient’s record, select the patient entry by clicking on it or using check box on the right, and click the Export button.
The Export dialog will appear offering different export options. For detailed explanation on exporting see section 10.6.3.
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In order to export several records at once, select multiple patient entries and click Export button. Multiple patient entries can be selected in several ways:
1. Using check-boxes on the right 2. Holding the Ctrl key on the keyboard while clicking on the patient entries 3. Holding the Shift key on the keyboard while clicking on the patient entries. It will select all
consecutive patients between first and second mouse click 4. Using so-called ‘Sticky’ selection, moving over the patient entries while holding left mouse button.
It will select all consecutive patients between mouse button presses and releases. When multiple patients are selected for exporting, the Export dialog displays Patient IDs of all selected patients in the Patients section:
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10.3 PATIENT NOTES
Patient’s notes can be entered in the Notes section located at the bottom of the Patient Record screen.
This section is present in order to keep important notes relating to the patient, his / her lesions and scans.
10.4 LESION MANAGEMENT
The main screen for lesion management is the Patient Record screen. Lesions can be created, edited, filtered, exported and deleted. All controls are on Lesion Bar. Scans of a particular patient can be grouped by the lesion they belong to or by the date they were taken. The initial view is Lesion-based and is obtained through the Lesions button:
Every lesion in the list has a Lesion Pictogram, a picture indicating the lesion position, a Lesion ID identifying the lesion, and a Lesion Description describing the lesion nature or position. Scans belonging to a particular lesion are displayed in the list when the entire lesion row area or Down Lesion Arrow button is clicked. The Lesion arrow changes its direction to Up. Every scan in the list has Scan ID, Scan Date, Scan Mode and Scan Note.
The Scan list belonging to a particular lesion is closed when the Up Lesion Arrow button or lesion row area between Lesion Pictogram, Lesion ID and Lesion Description is clicked. The Lesion arrow changes its direction to down.
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The Date-based view of scans is obtained through the Dates button:
Similar to the Lesion-based view, scans made on the same date can be displayed / closed using the Arrow button, or by left-clicking on the date. Every scan in the list has a Lesion Pictogram and Lesion ID, as well as Scan ID and Scan Note.
10.4.1 Lesion Creation
10.4.1.1 Lesion Creation using the New Button in the Lesion Bar
A New Lesion can be created using the New button in the Lesion Bar.
When the New button is clicked, the Lesion Editor window pops up, allowing the user to set the lesion position and enter all data relevant that lesion (Lesion ID and Lesion Description) through a dedicated button (Scan), and start scan acquisition immediately.
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The Orange dot on the body chart indicates the lesion position.
If the Lesion ID text-field is left blank, a Lesion ID will automatically be generated with the format “Les_dd/mm/yyyy_hh:mm”, where date_time is the moment of lesion creation. If the Lesion Description is left blank it will remain blank after Lesion creation. If the OK button is clicked on the Lesion Editor, an empty lesion is created and added to the list of patient’s lesions. If the Scan button is clicked, the Scan / Review Management screen is opened and scan acquisition started in Free-Run mode. A new lesion is created with an automatically assigned scan. If The Cancel button is clicked, the changes are rejected and lesion is not created.
10.4.1.2 Lesion Creation using the Lesion Map
A New Lesion can be created using the Graphical Lesion Filter i.e. Lesion Map.
When the Graphical Filter button is clicked, the Lesion Map window pops up. All lesions belonging to a particular patient are marked with orange dots.
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In order to create a new lesion and start scanning immediately, double-click the body chart where you want lesion to be. This action will create a new lesion at the selected location, and open the Scan / Review Management screen with acquisition started in Free-Run mode. The Lesion data will be blank i.e. the Lesion Pictogram will be set according to the position selected on Lesion Map, Lesion ID will be automatically generated, and Lesion Description will be left blank.
10.4.2 Editing Lesions
Existing lesions and data related to them can be modified using the Lesion Editor pop-up window.
There are two possibilities for opening the Lesion Editor:
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1. It can be opened if a particular lesion is selected using the lesion check box, and the Edit button in the Lesion Bar is clicked:
2. It can be opened if the Lesion Pictogram is clicked once:
The Lesion ID and Lesion Description can be quickly modified directly in the lesion list. One click on these text boxes will open the lesion (if it is not already opened) and allow editing.
10.4.3 Filtering the Lesion List
The Lesion list can be filtered both graphically and textually. The Textual filter is based on the same concept of alphanumeric searching through the list of lesions, similar to patient filtering. Search boxes available for textual filtering are Lesion ID and Lesion Description, located in the Lesion Bar. The Lesion list is filtered in a way that only entries that contain the entered filter condition, regardless of position, are left in the list.
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The Graphical filter has the same functionality as the textual filter, however it provides a quick overview
of all lesions belonging to one patient. It is accessible through a single mouse click on button on the Lesion Bar. When it is clicked, the Lesion Map pop-up window appears.
In order to filter the lesion list, right-click on the area of interest on the body chart, and lesion list will be filtered by lesions whose position is near the selected area. The Graphical Filter button will have an Orange dot displayed indicating the selected filtered lesion.
The Clear Filter button on the left of the Lesion Bar removes any filter(s) in use and brings back the full lesion list. When this button is clicked, all search boxes are cleared i.e. contain only watermarks.
10.4.4 Opening a Lesion for Review
Lesions can be opened for review in two ways: 1. By selecting a particular lesion on the Patient Record screen using the Lesion check box, and
selecting the Open button
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2. By double-clicking on the Lesion row area in lesion list
Whichever approach is applied, the Scan / Review Management screen is opened with Current tab displayed. All scans belonging to the selected lesion are present and can be reviewed, exported or deleted. New scans can also be acquired.
10.4.5 Exporting Lesions
The Patient Record screen allows scans belonging to a particular lesion to be exported. One lesion can be exported at a time, or several at once. In order to export one lesion, select a particular lesion using check box on the right, and click on the Export button.
The Export dialog will appear offering different export options. For detailed explanation on exporting, see section 10.6.3
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In order to export several lesions at once, select lesions using the check boxes and click Export button.
10.4.6 Lesion Deletion
Lesions and all scans belonging to them can be deleted. One lesion can be deleted at a time, or several at once. In order to delete a lesion, select a particular lesion using the check box on the right, and click on the Delete button.
A Delete confirmation dialog will pop-up. “Yes” removes the lesion and all associated scans. “No” retains the lesion and associated data.
In order to delete several lesions at once, select lesions using the check boxes and click the Delete button.
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10.5 SCAN ACQUISITION
Scan acquisition can be started in several ways: 1. Selecting a particular lesion on the Patient Record screen using the lesion check box, and selecting
the Scan button
2. Using the Lesion Editor pop-up window and Scan button.
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3. Using the Lesion Map pop-up window and double-clicking on the lesion.
4. Selecting the Scan button on the Scan / Review management screen.
Whichever approach is applied, the Scan / Review Management screen is opened with the Current tab displayed and the scan being acquired in Free-Run mode.
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10.5.1 Free-Run Scan
Free-Run scans continuously acquire and display “live” OCT images. In this mode, only the most recent 5-10 seconds of captured images are held in memory. When the scan is stopped, the images in memory can be viewed and stored, if required. Alternatively, the scan can be acquired again. The intended use of this mode is for freehand examination and identification of skin features relevant to the examination. Once an image of the relevant feature has been captured, the user should stop the scan in order to review and store the images that are in memory.
Free-Run scan images are not stored automatically. The user must choose to store or discard captured images.
When the Free-Run scan acquisition is started, the scan list shows all of the scans defined for the current lesion along with the newly created one being acquired.
The Scan Width can be changed while scanning is in progress.
The Discard button is available to abort the scan
The Discard button can be used to abort acquisition and discard any data held in the buffer.
The red triangular Frame Selector shows the OCT image frames being acquired into memory and moves from left-to-right across the Frame Buffer until the computer memory is full.
When the red triangular frame indicator reaches the right-hand end of the screen, after about 5-10 seconds, older image frames are discarded so that the most recent images can be retained. At this time, the blue Frame Buffer shading begins scrolling to the left, indicating the rate at which the oldest frames are being discarded.
Position the probe to obtain the required image and then select Stop to cease image capture and retain the current Frame Buffer for review and storage.
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Select the Stop button to stop acquiring images for the Free-Run scan.
Only the Save Frame, Save All, Discard and Replay buttons are now active. The Home and Back buttons are unavailable.
This indicates that the user must decide whether to store or discard the frames currently held in the Frame Buffer. At this time, no images have been permanently stored and all other buttons are disabled until an explicit decision is made to store at least one frame or discard the entire scan. The Frame Buffer indicates the frames that are held in memory and the currently displayed OCT frame (red triangle). The frames are indicated in the order that they are acquired from left to right: the left-hand frame is the oldest frame and the right-hand is the most recent frame. Click any frame in the Frame Buffer using the left mouse button to display the corresponding image frame. Subsequently, you may use the keyboard Left Arrow and Right Arrow keys to move through the frames.
Select Replay to automatically play all frames held in memory.
Select Replay to play all recent images held in memory.
Select Pause to stop play for the scan.
If the images acquired are satisfactory then the Save Frame and Save All buttons can be used to store the required data.
Store the currently displayed image frame (repeat as necessary)
Store all of the image frames currently held in memory.
Discard the acquired data if the images are not satisfactory or there is a need to perform a different scan.
When images are stored, the Scan entry in the Scan list is updated to show the acquisition date and time and the total number of frames stored for the scan.
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Once stored, another scan can be captured by pressing the Scan button.
Select the Scan button to start the Free-Run scan. A live OCT image is displayed in the centre of the screen.
A new scan is added to the list with the same settings as the previous one. The new scan is started automatically. An indication of distance can be obtained by pressing and holding down the right mouse button over the image and dragging it to the position required. The approximate distance between the ends of the measurement graphic is displayed in millimetres.
The measurement can be repositioned or adjusted by pressing and holding down the left mouse button over either end of the measurement graphic and dragging it to the position required. Multiple measurements can be created, if required. A measurement can be removed by selecting the graphic with the left mouse button and pressing the keyboard Delete key.
The distance measurement is for indication purposes only.
10.5.2 Multi-Scan Scan
Multi-Scan scans acquire a sequence of image frames, either at equally spaced positions or at regular time intervals. Multi-Scan image frames are stored as they are acquired, allowing more frames to be acquired over a longer period than during Free-Run scans. The scan can be stopped at any time and the stored images can be viewed. If required, the scan can be acquired again. Unwanted scans can be deleted.
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Pressing Scan will begin a new scan in the Free-Run mode; the live images can be used to correctly position the probe and find the region to be imaged. Place the probe on the area of interest and adjust the working distance so that the object is optimally positioned (see Section 7.2 for details). When the correct view is established, the desired Multi-Slice scan is started by pressing Multi 1 or Multi 2 buttons. When a Multi-Scan scan is selected, the Free-Run scan is discarded and a Multi-Scan scan begins.
At the commencement of the Multi-Scan acquisition, the current Free-Run scan will be abandoned and the contents of the Frame Buffer will be discarded.
Start a Multi-Scan scan using pre-set scan parameters 1 (see section 10.5.2.1, below).
Start a Multi-Scan scan using pre-set scan parameters 2 (see section 10.5.2.1 below).
10.5.2.1 Multi-Scan Scan Parameters
The Multi-Scan scans, Multi 1 and Multi 2, capture a predefined number of frames at predefined intervals.
Parameter Multi 1 Multi 2 Description
Scan Width 6.0 mm 2.0 mm The width of the OCT image to be acquired.
Narrow images are acquired at a faster rate than wide images.
Frames 60 500 The total number of image frames to acquire.
Y Start -3 mm -1 mm The Y start position of the first frame relative to the centre position.
Step 0.1 mm 0.004 mm The Y distance to step between each image frame.
As the Multi-Scan scan is acquired, the Scan entry in the Scans list is updated to show the acquisition date and time and the total number of frames stored for the scan.
During the Multi-Scan acquisition the pre-defined number of image frames will be automatically acquired and stored. If required, the Stop button can be selected to interrupt the Multi-Scan scan before the
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defined number of image frames is acquired. In this situation, the frames that have been acquired before the scan was stopped will be stored.
If a Multi-Scan scan is stopped it cannot be continued. If necessary, select Scan and reselect the appropriate Multi-Scan button.
The number of Multi-Scan frames that can be reviewed is limited by the available storage space on the system hard drive or to a maximum of 10,000 frames (whichever of these is smaller).
10.6 SCAN MANAGEMENT
The main screen for scan management is the Scan / Review Management screen.
Scans can be created, edited, replayed, exported and deleted. All the controls, with the exception of Delete, are placed into the Header Bar.
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10.6.1 Opening Scans for Review
While on the Patient Record screen, scans can be opened for review. Open a lesion using the Lesion Arrow button (or click on the lesion row), and double-click on the scan you want to open for review.
If view is set to Date-based, the scan can be opened in two ways: 1. By selecting a particular scan using check box, and click on the Open button:
2. By double-clicking on the scan:
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The Scan / Review screen opens in the Current tab, displaying all scans associated to the previously opened lesion. Previously selected scan is highlighted. Export, Scan and Reply buttons are available, as well as Delete Scan.
10.6.2 Scan Editing
The only data associated to a scan that can be modified is Scan Note. Select the scan you want to modify, by clicking on the Scan Notes field of scan entry. Enter the new note.
Pressing the Enter key on keyboard to saves the scan note and moves the highlight to the following scan.
10.6.3 Scan Export
The Scan / Review Management screen allows exporting of scans. Single frame can be exported, whole scan or several scans at once. The Export button is available when scan acquisition is not in progress and a scan containing image frames is selected in the scan list. At other times, the Export button is disabled.
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To select multiple scans for export to multiple files, hold the Ctrl key on the keyboard whilst selecting the scans.
Selecting Export brings up the export data window where the export parameters can be changed if required.
Images are exported to files in the specified directory with unique filenames derived from the Patient ID, Scan ID, scan notes and scan date and time.
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The following parameters are available in the Export Data window:
Field Choice Description
Frames
All Exports all the frames in the current scan to a single file.
Selected Exports the selected frame in the current scan to a single file.
Data
Both Exports Visual and OCT frames to separate files.
OCT Exports OCT frames to a single file.
Visual Exports Visual frames to a single file.
Export Format
Tiff Exports to the Tagged Image File format. Scans containing multiple frames are exported to single multipage TIF files.
DICOM Exports all images in a scan to a DICOM part 10 compliant file.
Hard Copy Prints the current OCT frame on a Canon CP800 SELPHY Printer
Output Directory Type an Output Directory in the available box or Browse for a directory using the […] button.
Anonymous output Removes any data which identifies the patient from the exported filenames and file headers.
The progress of the export procedure stages are detailed within the area labelled “Status” once exportation of the file has commenced.
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10.6.4 Scan Deletion
The Scan / Review management screen allows deletion of scans. Select a scan from the list, and click on the Delete Scan button.
The Delete Confirmation dialog will pop-up. Delete button removes scan and all associated images. The Cancel button retains the scan and associated data.
10.7 SCAN COMPARE
The screen that enables scan comparison is the Scan / Review Management screen. It is separated into three tabs: Current, Reference and Compare.
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These tabs allow the user to: 1. Current: View the scans of the currently selected lesion and select particular ones for
comparison 2. Reference: View the scans of the currently selected lesion and select a particular one as a
reference for comparison with the scan selected in the Current Tab 3. Compare: Compare a scan in the Current Tab side-by-side with scan selected in Reference Tab
To select a scan in the Current Tab for comparison, click on the scan entry in the scan list. Selecting a scan in this list displays the images in the lower half of the screen. These images can be reviewed using the Replay button (see section 10.5.1) and Frame Selector.
To select a scan on the Reference Tab for comparison, click on the scan entry in the scan list. Selecting a scan in this list displays the images in the lower half of the screen. These images can be reviewed using the Frame Selector only.
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To compare selected scans, select the Compare Tab. The upper image area contains scan selected on the Reference Tab and the lower image area is occupied by the current view in the Current Tab.
The upper scan can be reviewed using upper Frame Selector.
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The lower scan can be replayed / paused and reviewed using the lower Frame Selector. Export, Scan and Replay related to this scan are available from this screen as well.
10.8 SHUTDOWN
The VivoSight PC software should be closed and Windows shutdown before power is turned off.
Select the Close button in the top right of the screen to close the VivoSight application software.
Select the Windows Start button in the bottom left corner of the screen.
Select the Shut Down option from the menu.
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11 VIVOSIGHT IPAD APPLICATION
11.1 OVERVIEW
The VivoSight iPad application can be used to review patients’ records. It is possible to view patient’s records, search and find particular records of an interest, and review acquired scans.
11.2 MAIN IPAD SCREENS
There are four main screens in the Pad application. Navigating between screens is done through touchpad key presses on the table and menu items, as well as the Home and Back buttons at the bottom of the screen. The VivoSight iPad application follows standard behaviour for iPad applications.
11.2.1 Settings Screen
The Settings screen is the first screen displayed when the VivoSight iPad application starts for the first time (it is the only situation when this screen is automatically displayed). The Settings screen is used to specify the server settings for accessing the patients’ database. This screen also contains the version number for the VivoSight iPad software.
The Settings screen is accessible through Settings button located at the bottom of the Patients Management screen.
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11.2.2 Patients Management Screen
The Patients Management screen presents a list of all patients’ records in the database. This screen is the first screen to be displayed when the VivoSight iPad application is re-started.
From this screen it is possible to enter the Patient’s Record screen, or to search through the database by using filters and quickly access particular patient’s record.
11.2.3 Patient Record Screen
The Patient Record screen is used to view all lesions and associated scans for a particular patient.
Selecting a particular scan from the list will open the Scan Review screen.
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11.2.4 Scan Review Screen
The Scan Review screen is used to preview a recorded scan belonging to a particular lesion. The scan selected on the previous screen has its first frame displayed on the bottom half of the screen.
The Replay button located at the bottom right corner of the screen opens the Scan Replay screen. The scan can also be replayed by tapping on the scan image.
11.2.5 Scan Replay Screen
The Scan Replay screen is used to review a recorded scan for a particular lesion in detail.
It is possible to play, and pause, the scan to review scan frame by frame.
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12 USING THE IPAD APPLICATION
12.1 ENTERING SETTINGS DETAILS AND CONNECTING TO PATIENTS’ DATABASE
The iPad application communicates with the patients’ database remotely, through a Wi-Fi connection. It is necessary to enter the server settings in order for the patients’ database to be accessed.
The Settings screen is used for entering the remote Host’s IP address with the name of the VivoSight application running on the server (vs3), and the Maximum Cache Size in GB. The last setting is related to the memory allocated for local storage. For example, if an average scan size is 100MB, and the maximum cache size is defined as 8GB, then it is possible to store 80 scans. Newly acquired scans will override the oldest accessed scans. It is possible to specify a Maximum Cache Size of 32 GB, on a 64GB iPad 3.
12.2 USING PATIENTS MANAGEMENT SCREEN
The Patients Managements screen is used to review records from the patients’ database and access patient data.
12.2.1 Filtering Patient List
The Patient list can be filtered using alphanumeric and search by date filters, similar to the PC application, through search boxes in the Header Bar. As long as filters are used, they are displayed in search boxes. Letters at the bottom of the screen can be used for filtering based on the first character of the column entry. One ‘touch’ on a particular column will highlight that column and prepare it for aplphabetical filtering. Selecting letter at the bottom of the screen will filter out patient’ list:
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Filtering by Patient ID works in such a way that those patient entries that contain an entered condition (regardless the position) are left in the patient list. All items beginning with the entered filter are displayed on top of the list followed by items containing the filter condition.
With the next three search boxes (First Name, Last Name and Gender) and the last one (Clinician ID), the patient list is filtered in a way that only entries that start with entered filter condition are displayed in the list.
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For the remaining two search boxes (Date of Birth and Last Scan Date), the patient list is filtered through calendar:
The Filter button filters the list according to the selected date. Only entries that match the selected date are left in the list. The Clear button removes the filter in use.
If Gender, Date of Birth, and Clinician ID are blank, they will always be displayed in the patient list when filters are being used.
If the Last Scan Date doesn’t exist, it will not be displayed in filtered list.
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The Patient list can be filtered using multiple filters as well. Entries that fulfil all the entered filter conditions concurrently are displayed in the list.
The Clear Filter button on the left of the Header Bar removes the filters in use and brings back the full patient list. When this button is clicked, all search boxes are cleared i.e. contain only watermarks.
12.2.2 Open Patient’s Record
Two ‘touch’ actions on patient entry will open the patient’s record. The first ‘touch’ will highlight the selected column and row, and the second ‘touch’ on the highlighted row will open the Patient Record screen for the selected patient.
12.3 ANALYZING SINGLE PATIENT’S RECORD
In the Patient Record screen all data related to one patient can be reviewed, all lesions with associated scans and patient notes.
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Similar to the PC application, every lesion in the list has a Lesion Pictogram, picture with the orange marker indicating the lesion position, the Lesion ID identifying the lesion, and Lesion Description describing the lesion or its position.
Scans belonging to one lesion are displayed on a ‘touch’ action and the lesion becomes highlighted.
The ‘Touch’ action on a scan opens the Scan Review screen.
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12.4 REVIEWING A SCAN
The Scan Review screen will display the scan selected on the Patient Record screen at the bottom of the screen. A transitional default image will be displayed until the first frame has been transferred. A progress indicator notifies the user that the scan is being downloaded. The scan download can be cancelled at any time
Once the downloaded is complete, the notification dialog disappears allowing user to replay scan.
The ‘Touch’ action on the Replay button or scan image will open the Scan Replay screen and will play currently selected scan.
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12.5 REPLAYING A SCAN
The ‘Touch’ action on the Replay button or scan image in Scan Review screen will open the Scan Replay screen and will play the currently highlighted scan. It is possible to ‘play’, ‘pause’ and ‘close’ the scan, as well as review the scan frame by frame (swipe the image). Closing the scan will close the Scan Replay window and return back to the Scan Review screen.
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13 USE WITH OTHER EQUIPMENT
The VivoSight Topical OCT system may only be used with the following items:
Additional Software such as: Microsoft Office OpenOffice Tiff compatible image viewers Anti-virus software
Antivirus software is installed on delivery. However, it is recommended that the user checks that the software conforms to the user’s IT policy. Only software specified in this manual may be safely installed on the system without consulting MDL.
External USB devices that do NOT require additional drivers or a separate connection to the mains may be connected to the USB ports on the front of the computer. These include:
USB flash drives (Including U3) USB powered disk drives USB wireless receivers for use with remote keyboards, mice, and printers.
External audio devices that do NOT require a connection to the mains may be connected to the front of the computer. These include:
Microphones Headphones
A network connection with galvanic isolation is provided on the back of the cart to connect the VivoSight Topical OCT system to your local area network. Consult your IT department for connection and configuration.
Do NOT connect external USB or audio devices with a separate connection to the mains including:
Printers External storage devices Routers Powered speaker systems Any other accessories that may compromise isolation during clinical procedures
Only cables <3m long should be used to connect acceptable devices to the front of the computer.
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14 CLEANING AND DISINFECTING
The VivoSight Topical OCT system including, cables and or other parts may NOT be immersed in water or other liquids.
Do NOT use solvents or abrasive cleaners on plastic parts or the display screen
Cleansers and disinfectants must be CE marked indicating an intended purpose of medical devices & specified for use on plastics. Before cleaning, disconnect from the mains electrical supply.
14.1 HANDHELD PROBE, STANDOFF AND UMBILICAL
The Handheld probe, standoff and umbilical should be cleaned and disinfected prior to patient use with Tristel or other standard hospital disinfectant appropriate to the materials. Ensure all joints on the probe are disinfected thoroughly. Contact cleaning of the objective lens should be minimised. However, if it is required, use a lens cloth or clean air duster. Should further cleaning be required, use a soft cloth moistened in Isopropyl alcohol.
14.2 KEYBOARD, POINTING DEVICE, AND FOOTSWITCH
The Keyboard, pointing device, and footswitch should be cleaned and disinfected at regular intervals in line with your establishments infection control policy
14.3 CART, OPU, OPU POWER SUPPLY, COMPUTER, MONITOR, AND LASER
All accessible surfaces on the Cart, OPU, OPU power supply, computer, monitor, and laser may be cleaned regularly using a cloth dampened with water and detergent that is indicated for use on plastic. Apply the liquid to the cloth and squeeze out surplus liquid. Do NOT apply liquid to the system or its cables. Alcohol lens wipes may be used to clean the screen. The cart, OPU, OPU power supply, computer, monitor, and laser are NOT intended to be disinfected regularly. Only disinfect when required due to contamination of external surfaces.
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15 TECHNICAL DATA
The following technical data relates to the VivoSight Topical OCT system
15.1 SYSTEM SPECIFICATION
Performance
System Type Swept-source Fourier-Domain OCT
Light Source Santec HSL-2000-11 wide sweep laser
Laser Peak Power ≥25 mW
Laser centre wavelength 1305 ± 15 nm
Laser frequency sweep range (>3 mW) ≥ 150 nm
Axial optical resolution (in tissue) < 10 μm
Lateral optical resolution < 7.5 μm
Maximum scan width 6mm x 6mm to a depth of ~2mm
A-line rate 10 kHz
Frame rate >6 fps (5 mm scan width / 1,250 A-lines) >20 fps (1 mm scan width / 250 A-lines) >35 fps (0.2 mm scan width / 50 A-lines)
Mode of Operation
Continuous operation NOT suitable for use in the presence of flammable anaesthetic mixtures with oxygen or nitrous oxide.
Safety
Type of Protection against Electric shock Class I (Safety Earth)
Degree of Protection against Electric shock Type CF Applied Parts
Water & Dust Protection
The handheld probe and umbilical have been designed to reduce ingress of liquids. However do NOT place under running water or immerse in liquids.
All parts of the system are IPX0. No water or dust protection is claimed.
Power (EU)
Supply Voltage 216-264V AC 50/60Hz Nom. (Earthed supply)
Maximum Power 2100VA
Mains Input Connector IEC 320 C19 Socket 16A
Fuse T10A Antisurge
8 Way IEC Socket Maximum Load 6 x 1.4A (Total 8.6A)
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Power (US)
Supply Voltage 110-132V AC 50/60Hz Nom. (Earthed supply)
Maximum Power 1500VA
Mains Input Connector IEC 320 C19 Socket 16A
Fuse T15A Antisurge
8 Way IEC Socket Maximum Load 6 x 1.4A (Total 8.6A) Weight and dimensions
Dimensions (W x D x H) 0.65 x 0.7 x 1.65 m (Monitor at maximum height)
Weight 105kg Environmental
Operating
Temperature of 15C to 35C
Humidity of 20% to 80% non-condensing
Height above sea level to be less than 2000m
Floor to be level to within 10° of horizontal during use
Movement and storage between use
Temperature of 10°C to 40°C
Humidity of ≤ 80% non-condensing
Atmospheric Pressure 50kPa - 106kPa
Floor to be level to within 10° of horizontal when being moved
Thresholds should be less than 20mm in height during transport conditions
Initial Transport and Storage in original packaging
Temperature of 0°C to 40°C
Humidity of ≤ 80% non-condensing
Atmospheric Pressure 50kPa - 106kPa
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15.2 EMC REQUIREMENTS
Guidance and manufacturer's declaration - electromagnetic immunity
The VivoSight Topical OCT system is intended for use in the electromagnetic environment specified below. The customer or the user of the VivoSight Topical OCT system should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 TEST LEVEL
Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to any part of the VivoSight Topical OCT System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
d = 1,2√P
d = 1,2√P80 MHz to 800 MHz
d = 2,3√P800 MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,
a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the VivoSight Topical OCT System is used exceeds the applicable RF compliance level above, the VivoSight Topical OCT System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the VivoSight Topical OCT System.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Recommended separation distances between portable and mobile RF communications equipment and the VivoSight Topical OCT System
The VivoSight Topical OCT System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VivoSight Topical OCT System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VivoSight Topical OCT System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1,2√P
80 MHz to 800 MHz
d = 1,2√P
800 MHz to 2,5 GHz
d = 2,3√P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
15.3 FCC
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. this device may not cause harmful interference, and
2. this device must accept any interference received, including interference that may cause undesired operation.
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16 TESTING INCLUDING PRE USE CHECKS
16.1 PRE-USE CHECKS
Before each use the VivoSight Topical OCT system, including cables must be inspected for wear & damage. Systems showing wear or damage should NOT be used. If in doubt, contact the manufacturer or authorised service representative for advice.
16.2 ELECTRICAL SAFETY TESTING
Electrical safety tests should be performed using a Rigel Medical or similar test system to the requirements of BS EN 62353 including.
Earth Bonding Insulation Patient applied parts leakage Type CF Signs of damage which may lead to the exposure of live parts
After testing check the VivoSight Topical OCT system for correct operation. Frequency of the electrical safety tests should be at least annual or more frequently in the event of actual or potential damage or if your establishment's code of practice specifies.
17 MAINTENANCE & ACCESSORIES
17.1 MAINTENANCE
The VivoSight Topical OCT system does NOT include any user serviceable parts. Therefore the manufacturer or their approved agents for service should be contacted in the event of damage, malfunction or change in performance. If the VivoSight Topical OCT system does not operate as expected, consult section 6 “Quick Guide”. If the VivoSight Topical OCT system continues not to operate as expected, stop using the system immediately and contact the manufacturer or their approved agents for service.
Repair of the VivoSight Topical OCT system is to only be carried out by the manufacturer or their approved agents for service.
Test system performance at least every year or shorter period if specified in your medical establishment's code of practice. Annual calibration is recommended to be carried out by the manufacturer or their approved agents for service. The preventative maintenance of cleaning the objective lens should be carried out as and when required to maintain system performance. Refer to section 14 for details. Before cleaning, disconnect from the mains electrical supply.
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17.2 ACCESSORIES
Probe standoffs are provided with the VivoSight Topical OCT system to aid in positioning the probe on the skin surface at the correct scan distance. Other types may become available. Please consult the manufacturer or distributor with your requirements.
18 WARRANTY
The manufacturer warrants the product, when new, to be free from defects in materials and workmanship and to perform in accordance with manufacturers specification for a period of one year from the date of purchase. The manufacturer will repair or replace at their discretion any components found to be defective or at variation from the manufacturers specification within this time at no cost to the purchaser. Your original supplier will administer this warranty on behalf of the manufacturer; and initial contact relating to a claim under this warranty must be made to the distributor. After contacting your original supplier to agree warranty cover it shall be the purchaser’s responsibility to return the product. The warranty does not include breakage or failure due to tampering, misuse, neglect, accidents or modifications. This warranty is also void if the product is not used in accordance with the manufacturer’s instructions or is repaired during the warranty period by any person other than the manufacturer or their approved service agent. The date of purchase / delivery determines the commencement of this warranty. No other expressed or implied warranty is given and no consequential claims will be accepted.
19 DISPOSAL
Information on Disposal of Waste Electrical & Electronic Equipment (Europe Only)
This symbol on the products and / or accompanying documents means that used electrical and electronic products should not be mixed with general waste. Disposing of this product correctly will save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling. If you are unsure of your national requirements with respect to disposal please contact your local authority, dealer or supplier for further information.
Penalties may be applicable for incorrect disposal of this waste, in accordance with national legislation.
The above information is based on the European waste electrical and electronic equipment directive 2002/96/EC
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US Federal law restricts this device to sale by or on the order of a physician
Michelson Diagnostics Ltd 11A Grays Farm Production Village Grays Farm Road, Orpington Kent BR5 3BD, UK Tel: +44 (0)20 8308 1695 Email: [email protected] 0086
Compliant with Medical Device Directive 93/42/EEC
The Michelson Diagnostics logo and the VivoSight name are the trademarks of Michelson Diagnostics Ltd and are registered in the UK, the US & throughout the European Union
Copyright © Michelson Diagnostics Ltd 2013