Optos 200tx User manual

The information contained within this document is subject to change without notice. The latest version of

this information can be found at www.optos.com.

This document should be used in conjunction with the help files supplied in each application and the

Technical Data Specifications supplied with the device. Instructions and service information can be

obtained by contacting the Optos Customer Service Department through the contact details given in this

handbook.

The device is a prescription device.

Caution

Federal law restricts this device to sale by or on the order of a physician or

practitioner. See CFR 801.109(b)(1) for more information.

Optos does not provide, and the optomap® plus guidelines do not constitute advice on making

reimbursement claims. Diagnostic tests should be ordered by the treating physician and this physician is

responsible for appropriate usage, adequate documentation and proper coding. It is the responsibility of

the physician to comply with Medicare regulations, and check with the local insurance carrier for

reimbursement information and instructions. Optos does not accept any liability for reimbursement claims

made while using optomap® plus.

Copyright

This document may only be used for your personal, non-commercial use. This document and all its

contents (including without limitation, all text, formats, graphics and logos) are the property of Optos plc

and are protected from unauthorized copying and dissemination by the Copyright, Designs and Patents

Act 1988 (as amended), by various intellectual property laws and by international conventions.

Trademarks

WINDOWS is a Trademark of Microsoft Corporation.

ADOBE and ACROBATREADER are Trademarks of Adobe Systems Incorporated.

All other trademarks are the property of their respective owners.

Part Number: G-00085/1

Print Date: February 2011

Table of Contents

1 What's New 1

2 Introduction 3

About the device

3

Indications for use

3

About images

3

Image types

5

3 Getting to know the device 7

Understanding the equipment

7

About the head rest

8

Attaching and detaching the Patient Arm Support

9

Attaching and detaching the Head Rest

9

About the detector settings

9

How to use the hand control

11

4 About the software applications 13

Getting Help

13

Admin application features

13

Capture application features

14

Review application features

14

Storage application features

16

Scheduler application features

16

About software updates

17

5 About capturing an image 19

Working with patient records

19

Cleaning before each patient

20

Patient instructions

21

Capturing images

21

Capture Single Eye Image

23

Single Image Preliminary checks

24

Capturing Stereo Images

24

Multiple Image Preliminary Checks

26

How to capture Autofluorescence images

27

Multi-Frame Settings

27

Capturing Multiple Images (Angiography)

28

How to do eye steering

29

View captured image

30

Checking the quality of captured images

30

Patient positioning

30

6 About the Patient History view 35

Using the Patient History window

36

Opening images

36

Selecting images from the Image Series view

38

Opening images using alternative methods

39

Discarding unwanted images

40

7 Using the viewing options 43

Color Channels

43

Review Tools

43

Recommended reading protocol

44

Using the Automated view

45

Using the Magnifier

45

Using the 3D Wrap view

46

Using the Comparison Overlay

47

Simulating a Binocular Indirect Ophthalmoscope (BIO) view

47

Using False Color views

48

Viewing stereo images

48

Comparing with sample disease images

49

Using the Adjustment and Information panels

49

8 Documenting your review 51

About annotations, retinal drawings and measurements

52

Using annotations

52

Using retinal drawings

53

Using measurements

54

About review notes, diagnostic (pathology) codes and procedure codes

55

Using procedure codes

56

Using review notes

57

Using diagnostic codes

58

9 Distributing images 61

Emailing images

61

Exporting images

62

Importing an image to a patient’s record

63

Printing images

64

Changing eye images from Right to Left (and Left to Right)

66

Assigning an image to another patient’s record

66

10 Using the Image Library 67

11 About archiving 69

When to Archive

69

Changing the Archive Task Settings

69

Archiving to disk

71

Archiving to a network

74

Scheduling storage tasks

74

12 Getting help 75

Accessing help from the device

75

Accessing help from the applications

75

Optos on the Web

76

13 Where to find features 77

Capture application user reference

77

Review application user reference

81

Storage application user reference

91

Scheduler application user reference

92

14 Contact us 93

Global Headquarters

93

Regional Offices

93

15 Training Checklist 95

Chapter 1 - What's New

1 What's New

This release supports the display of optomap® af images.

Note:

optomap® af images are captured using a green laser light for illumination. This contrasts with the

traditional use of blue illumination or white light for autofluorescence imaging. Green light

autofluorescence differs, and allows a different visualization of macular pathologies since macular

pigment does not interfere. Also the Optic Nerve Head is clearly visible when green laser light is used

for autofluorescence imaging.

Reference Materials

About the device 3

Checking the quality of captured images 30

How to capture Autofluorescence images 27

Selecting images from the Image Series view 38

Using the Automated view 45

Using the Magnifier 45

Using the 3D Wrap view 46

Using the Comparison Overlay 47

Using False Color views 48

Comparing with sample disease images 49

Using measurements 54

Using the Image Library 67

Scheduling storage tasks 74

Capture application user reference 77

Review application user reference 81

Scheduler application user reference 92

Storage application user reference 91

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Chapter 1

Chapter 2 - Introduction

2 Introduction

Your device will be installed by Optos trained personnel. Do not operate the device until they have

completed the installation and training.

Warning

Please read the Safety Guidelines in the Introductory Handbook before using the

device.

About the device

This scanning laser ophthalmoscope is a widefield digital imaging device capable of capturing from the far

periphery of the retina. The retinal images are captured in an automated, patient friendly way without

scleral depression or contact with the cornea.

The 200Tx uses red, green and blue lasers to produce a digital, high-resolution image, which is displayed

on a PC monitor screen. This device can be used to capture angiography images. Red and green lasers

are used for digital color imaging. These laser wavelengths penetrate the retinal structures to different

depths, each wavelength providing information for interpretation and diagnosis.In autofluorescence mode,

the device uses the green laser to illuminate the eye. This allows an image of the natural fluorescence of

the eye to be captured. optomap® af images are captured using a green laser light for illumination. This

contrasts with the traditional use of blue illumination or white light for autofluorescence imaging. Green

light autofluorescence differs, and allows a different visualization of macular pathologies since macular

pigment does not interfere. Also the Optic Nerve Head is clearly visible when green laser light is used for

autofluorescence imaging. No fluorescent dye has to be introduced into the patient.The blue laser is used

when capturing angiography images. A series of images is captured as the fluorescein flows through the

retinal vessels.

Optos’ technology is designed to operate through a minimum pupil diameter of 2mm. Although pupil

dilation is not required, the decision to dilate is a medical decision to be made by the eyecare professional.

Images are captured on the scan head and then viewed, magnified, annotated and separated into their

color components in the Review application.

Indications for use

The 200Tx scanning laser ophthalmoscope is intended to be used as a wide field and retinal fluorescence

imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases or disorders that manifest in

the retina. Depending on the enabled options, some devices are capable of autofluorescence imaging.

Note:

Depending on the enabled options, the device may have a subset of the above indications.

About images

The device can be used in many clinical areas and can assist in disease detection, monitoring and

treatment.

The images can be separated to present distinct retinal sub-structures and can be used to assist in the

assessment and recognition of different retinal pathologies.

Traditional ophthalmoscopes produce a reddish picture derived from a white light source. The Optos

devices use red and green lasers to compose the retinal images.

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Chapter 2 - Introduction

Sample image from 200Tx device.

The composite image supports analysis of the retinal image by allowing individual review of the green and

red channel information.

l

The Green Channel image contains information from the sensory retina through the pigment

epithelium layers of the retina.

l

The Red Channel image contains information from the deeper structures of the retina, from the

pigment epithelium through the choroid.

Compare the green and red channels derived from the composite image shown above.

Sample image from 200Tx device.

Green Channel view Red Channel view

The diagram below summarizes the retinal layers and structures reached by the lasers. These laser

wavelengths penetrate the retinal structures to different depths, each wavelength providing information for

interpretation and diagnosis.

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Chapter 2 - Introduction

Image types

There are different types of image for each type of procedure:

l

optomap® – captures a retinal image. The standard optomap® procedure is a wellness exam. This

procedure captures a standard optomap® retinal image.

l

optomap® plus – captures a medical retinal image. The optomap® plus procedure is a medical

retinal exam. Following this procedure will allow the use of the enhanced features in the Review

application.

l

optomap® fa – some systems are capable of capturing fluorescein images. The optomap® fa

medical procedure allows the capture of fluorescein optomap® fa images. Following this

procedure will allow the use of the enhanced features in the Review application. These images are

captured at a higher resolution than standard optomap® images. The image capture rate for the

early-phase images can be set in the Capture application settings. You must ensure that the

necessary resources are available to administer the fluorescein.

Note

l

Some systems are capable of capturing autofluorescence images, How to capture

Autofluorescence images on page 27.optomap® af images are captured using a green laser

light for illumination. This contrasts with the traditional use of blue illumination or white light for

autofluorescence imaging. Green light autofluorescence differs, and allows a different

visualization of macular pathologies since macular pigment does not interfere. Also the Optic

Nerve Head is clearly visible when green laser light is used for autofluorescence imaging.

l

Some image types offer additional options, for example, eye steering, ResMax™, images

optimized for the periphery or central pole. These options vary depending on the device being

used and the image type selected. All available options are displayed in the Procedure Selection

dialog box.

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Chapter 2

Chapter 3 - Getting to know the device

3 Getting to know the device

The device comprises the scan head module, Image Server PC, and Viewing PC. For more information,

please refer to the Technical Data Specification supplied with the device.

Images are captured on the scan head. The scan head runs the Capture application. The Image Server PC

runs the Storage application. Admin application, and Scheduler application. The Review application is run on the

Viewing PCs. In a typical installation, the images and database will be stored on the Image Server PC. You

can review captured images at any Viewing PC that is connected to the Image Server PC across the

network.

Understanding the equipment

The device is part of a system of networked PCs.

Scan Head Module

The Scan Head module runs the Capture application. This application lets you select and perform the

required patient imaging procedure.

Caution

The scan head monitor should not be used to review images for diagnostic

purposes.

l

Scan Head – Comprises the lasers and electronics used to capture patient images.

l

Scan Head table – Supports the adjustment of the scan head height. The table can be raised or

lowered using the hand control.

l

Face Pad – The face pad supports the patient’s face when the patient is being imaged. The face

pad can be removed for cleaning.

l

Scan Head monitor arm – Links the monitor to the scan head.

l

Scan Head monitor – Displays the Capture application. The touch screen monitor is used to interact

with the Capture application. It displays alignment feedback and captured images.

l

Hand Control – Comprises buttons used to raise and lower the scan head table, align the patient,

and capture images.

l

Head Rest - Comprises the head support and adjustable chin cup. The head rest can be removed

for cleaning.

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Chapter 3 - Getting to know the device

l

Patient arm support and table wings (if supplied) – Devices used to capture optomap® fa images

may be fitted with a patient arm support and table wings. They are used to support the patient when

the injection is administered. The patient arm support can be removed for cleaning.

Viewing PCs

Viewing PCs run the Review application. The Review application lets you analyze patient images. You can

review images in a variety of ways. You can add annotations to highlight areas of interest, add diagnostic

codes, add notes, and email images to third parties.

Image Server

The Image Server PC runs the management applications:

l

The Admin application lets you configure the network and data management environment. You can

define security levels, create and modify users, and set a variety of system configuration options.

l

The Storage application lets you archive and protect database and patient image files. It is essential

to archive regularly. For further information refer to the Storage application help file.

Depending on your network configuration you may also run the Review application and Scheduler application

from the Image Server PC. When the Review application has been installed on an Image Server PC, the

Image Server PC may be used as an additional Viewing PC.

The Scheduler application lets you schedule patient appointments and manage patient details. The Scheduler

application may be installed on any PC on the same network as the device.

About the head rest

The head rest supports the patient's head while images are being captured. It is made up of a forehead

strap and a chin cup.

The head rest can be removed for cleaning and should be cleaned between patients.The full instructions

can be found in the Introductory Handbook.

Moving the chin cup

l

The chin cup height can be altered by turning the knobs on the side of the head rest.

l

The chin cup should be slid into position for the eye being imaged. When imaging the left eye slide

the chin cup to the first position on the right. When imaging the right eye slide the chin cup to the

first position on the left. There is an additional position on each side if the patient's features require

the chin cup to move further.

l

Release the chin cup by pulling the lever and slide the chin cup into position.

l

The chin cup should be turned to ±15°.

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Chapter 3 - Getting to know the device

Attaching and detaching the Patient Arm Support

The patient arm support is fitted with a clamp and can be attached and removed from the table wings.

Warning

Some devices are supplied with a patient arm support. The patient arm support

supplied with the device is designed to support the weight of a resting arm. Do not

exceed the weight indicated on the patient arm support. When in use, ensure the

patient arm support is securely clamped to the table wing, and that it is covered

with a piece of absorbent paper.

Attaching and detaching the Head Rest

To remove the head rest for cleaning, pull the head rest bolt down and turn one-quarter turn to lock it open.

You can then remove the head rest by sliding it toward you.

When attaching the head rest, push the head rest back in place and then turn the head rest bolt a quarter

turn to release the lock.

About the detector settings

There are a several factors to be considered when selecting the appropriate detector settings:

l

The patient

l

The system response

l

The operator

The patient

When meeting a patient at the start of the imaging session, it is important to assess the amount of

pigmentation in the patient's iris.

Less laser light is reflected by the retina in patients who have a greater amount of pigmentation. This can

result in dark images being captured because less light has been returned from the eye. You should select

the appropriate iris category setting to suit the patient's pigmentation levels.

Small pupil size can also restrict the amount of laser light returned from the retina. Since less laser light is

returned through the smaller pupil, the captured image may seem dark. To minimize this, you should

capture images in a dimly lit room.

Working in Low Light Conditions

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Chapter 3 - Getting to know the device

Warning

The device requires low levels of room light to operate efficiently. Take care to

avoid accidents when working under low light conditions.

Media opacities also absorb or scatter laser light and can block retinal structures.

System response

The device has a laser power of 4mW at the patient's eye and includes a laser safety system that would

prevent the system being used if the lasers were operating at unsafe levels. If the power drops, perhaps

due to a build up of dust, the amount of light returned from the eye will be reduced and will impair image

quality. The accumulation of dust and debris in the return path will also impair image quality.

Detector gains

As the laser power at the eye is a fixed value, the returned retinal information will vary depending on the

amount of light reflected by the pigmentation in the patient's retina. To ensure the greatest amount of

information is detected and that the image quality is optimum, the red and green detectors are set to a

specific gain level. This gain level is initially set when the patient's iris category is entered into the patient

details.

The iris category sets the detectors to expect a certain amount of light back from the patient's retina. You

should assess the patient's hair color, eye color and skin tone to determine the most appropriate iris

category. You can create your own iris categories if you need to.

l

In patients who have high pigmentation levels the "dark" iris category is selected. This sets the

detectors to expect less light back from the patient's retina.

l

In patients who have medium pigmentation levels the "medium" iris category is selected.

l

In patients who have low pigmentation levels the "light" iris category is selected. This sets the

detectors to expect a greater amount of light back from the patient's retina.

The detector gains can be adjusted and used when the next image is captured.

Note

l

Clicking the Optimize button will optimize the current image and sets the detector gains to give a

balanced image of the central pole and periphery in the next image.

l

Review application optimization - maximizes the range of pixel levels displayed on the screen

and adjusts the gamma setting, so that the average intensity of the display matches an ideal

value.

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Chapter 3 - Getting to know the device

How to use the hand control

200Tx Hand Control Hand Control table height buttons

Use these buttons to adjust the table height.

Hand Control eye position buttons

Use these buttons to move the pupil circle to

the center of the patient's eye.

The patient's eye should be displayed inside

the target shown on the External Eye

Camera view. Use the up, down, left and right

buttons on the hand control to align the pupil

circle within the patient's pupil. When the eye

is close to the correct position the system will

indicate which fine alignment button needs to

be pressed to set the distance.

Hint: You can select the eye to be captured

using the Hand Control. Press the left button

to select Right Eye (OD) and the right button

to select Left Eye (OS). Once the eye has

been selected this button reverts back to the

alignment functionality.

Hand Control in and out fine alignment

buttons

Fine adjustment feedback (either - or +) will

be shown on the External Eye Camera view.

These fine adjustment symbols correspond to

the in and out buttons on the hand control.

Press the button indicated to align the limbus

circle on the patient's limbus. When the

patient is close enough the symbol will

change to a filled in circle. The rings change

color, from red to green, when the patient is

correctly aligned.

Hand Control Capture button

Once the patient's eye has been correctly

aligned press the capture button to capture

the image.

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Chapter 3

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Optos 200tx User manual

Optos 200tx User manual

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