Optos P200TxE User manual

User Guide
Optos OCT Ophthalmoscope
P200TxE
G110230-003-ENG

G110230-003-ENG
WARNING
Before using this system:
The system should be used by trained professionals. Before using the system, please
read the operating instructions and safety recommendations in this user guide.
Failure to follow the instructions for use and safety recommendations provided in this
user guide can cause injury to the patient, to the operator, or to other persons.
CAUTION
In the United States of America, Federal law restricts this device to sale by or on the
order of a physician.
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Legal notice
Copyright 2019-2021, Optos plc. All rights reserved.
Optos plc. products are protected by patents and patent applications listed at www.optos.com/patents.
The information contained within this document is subject to change without notice. The latest version of
this information can be found at optos.com.
This document should be used in conjunction with the assistance information supplied in each application.
Instructions and service information can be obtained by contacting Optos (see Contact us on page79).
Optos does NOT provide guidelines on making reimbursement claims. Diagnostic tests should be ordered
by the consulting physician and this physician is responsible for appropriate usage, adequate
documentation and accurate coding. It is the responsibility of the physician to comply with reimbursement
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 this device.
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
OPTOS, OPTOMAP, RESMAX, DAYTONA, CALIFORNIA, SILVERSTONE, OPTOS CALIFORNIA,
OPTOS MONACO, OPTOS SILVERSTONE, 3D WRAP, , and optomap are registered trademarks. All
rights reserved.
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: G110230-003-ENG
Release Date: 16Sep2021
0197
Manufacturer
Optos plc
Queensferry House
Carnegie Campus
Enterprise Way
Dunfermline, Fife
KY11 8GR
UK
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Table of Contents
1 Warnings and cautions 11
1.1 General safety 11
1.2 Laser safety 13
1.3 Electrical safety 14
1.4 Environmental safety 15
1.5 EMC safety 15
1.6 Device failure 16
1.7 Cleaning guidelines 16
1.8 Maintaining information security 18
1.9 Data security 18
1.10 Software on Optos-supplied PCs 19
1.11 Symbol and label information 19
2 Introduction 21
2.1 Device description 21
2.2 Clinical benefits statement 21
2.3 Intended use 21
2.4 Intended users 22
2.5 Target environment 22
2.6 Contraindications 22
2.7 System configuration 22
2.7.1 System parts 23
2.7.2 Network specification and characteristics 24
2.7.3 Image modalities 24
2.7.3.1 SLO imaging modalities 25
2.7.3.2 OCT imaging modalities 25
2.7.3.3 Multi-mode workflow 27
2.7.4 System software 27
2.7.4.1 Understanding the review software 27
2.7.5 Accessories and detachable parts 28
3 Get started 29
3.1 Switch on each day 29
3.1.1 Switch on the image server 29
3.1.2 Switch on the scan head 29
3.1.3 Switch on browser-based review clients 30
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3.2 Use standby mode at the end of each day 30
3.2.1 How to shut down the scan head 31
3.2.2 Install software updates 31
3.2.3 Log off the image server each day 31
3.2.4 Restart the image server each week 32
3.3 Use the system 32
3.3.1 Using the touch screen 32
3.3.2 Using the touch screen keyboard 33
3.3.3 Using the hand control 33
3.3.4 Using the chin rest and head rest 34
4 Capture images 35
4.1 Selecting and managing patient details 35
4.1.1 Adding a new patient 36
4.1.2 Selecting and editing existing patient 36
4.1.3 Selecting a Patient Order from MWL 36
4.1.4 Working with Modality Work List (MWL) 36
4.1.5 How to search using MWL 36
4.2 How to prepare for image capture 36
4.3 How to align the patient 37
4.3.1 Patient coaching 37
4.3.2 Align the patient 37
4.4 How to capture SLO images 39
4.4.1 What to do after the image is captured 40
4.5 How to capture SLO eye steered images 40
4.6 How to capture SLO stereo images 41
4.7 How to capture SLO angiography images 42
4.7.1 Control contrast 42
4.8 How to capture OCT images 43
4.8.1 The patient's view of OCT alignment 44
4.8.2 How to optimize OCT scan quality 44
4.8.2.1 Capture scans quickly and recapture if necessary 45
4.8.2.2 Using the auto-routines 45
4.8.2.3 Live OCT positioning 45
4.8.2.4 Minimizing eye dryness 45
4.8.3 How to capture an OCT follow-up scan 45
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4.9 How to check OCT scans 46
4.9.1 Artifacts - Low signal strength 47
4.9.2 Artifacts - Eye movements 49
4.9.3 Artifacts - Blinks 49
4.9.4 Artifacts - Clipping 50
4.9.5 Artifacts - Alignment of essential structures 50
4.10 How to capture using Multi-mode 50
4.11 How to manage the patient session 51
5 Review images 53
5.1 Starting the review software 53
5.1.1 How to start the application 53
5.2 Reviewing patient images and scans 53
5.3 Exiting the review software 54
6 Manage the system 55
6.1 Managing user details 55
6.1.1 How to create user accounts for use on the scan head 55
6.1.2 How to create user accounts on the image server 55
6.1.3 How to change users 56
6.2 How to change the language on the scan head 56
6.3 How to change the language displayed in the review application 56
6.4 Storing and archiving images 56
6.5 Managing connections 56
6.6 Managing the Modality Work List 56
6.7 Quality checks 57
6.7.1 Self-tests 57
6.7.2 Status indicator 57
6.7.3 Software update 57
7 Maintenance and cleaning 59
7.1 Servicing 59
7.2 Warranty 59
7.3 Cleaning 60
7.3.1 General cleaning 60
7.3.2 Cleaning before each patient 61
7.3.2.1 How to remove the head and chin rests 61
7.3.3 Cleaning the main mirror 61
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7.3.4 Disinfection 62
7.4 Battery replacement 63
7.5 Cable management 63
8 Troubleshooting 65
8.1 Why can't Ilogin? 66
8.2 What information do I need when contacting Optos? 67
8.3 How do I image if the alignment system does not recognize the eye? 67
8.4 How do I restart the scan head? 67
8.5 How do I restart the image server? 67
8.6 What should I do if the PC drive on the image server is full? 68
9 Technical Specification 69
9.1 Safety designation (IEC 60601-1) 69
9.1.1 Scan head 69
9.1.2 Connections 70
9.1.3 Scan head dimensions 71
9.1.4 Review client properties 71
9.1.5 Touch screen properties 71
9.1.6 Table requirements 72
9.1.7 Battery 72
9.1.8 Environmental considerations (ambient) 72
9.2 Laser safety designation (IEC 60825-1) 73
9.2.1 External Laser warning information 73
9.2.2 Internal Laser warning information 74
9.3 Electromagnetic compatibility (EMC) 74
9.3.1 Guidance and manufacturer declaration – electromagnetic emissions 74
9.3.2 Guidance and manufacturer declaration – electromagnetic immunity 74
9.3.3 Recommended separation distances 76
10 Contact us 79
10.1 Global Headquarters 79
10.2 Regional Offices 79
10.2.1 United States and Canada 79
10.2.2 Australia 80
10.2.3 Denmark 80
10.2.4 France 80
10.2.5 Germany and Austria 80
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10.2.6 Norway 80
10.2.7 Spain 81
10.2.8 Sweden 81
10.2.9 Switzerland 81
10.2.10 United Kingdom and other European countries 81
10.3 European Authorized Representative 82
Patient Alignment Guide 83
List of Tables
TABLE 1: Network specification 24
TABLE 2: List of parts 28
TABLE 3: List of touch screen icons 32
TABLE 4: List of hand control buttons 33
TABLE 5: Examples of eye steering buttons 40
TABLE 6: Examples of stereo buttons 41
TABLE 7: Scan results 46
TABLE 8: List of status indicator lights 57
TABLE 9: List of problems and solutions 65
TABLE 10: Scan head safety designation details 69
TABLE 11: Scan head dimensions 71
TABLE 12: Review client properties 71
TABLE 13: Touch screen properties 72
TABLE 14: Table size requirements 72
TABLE 15: Environmental ranges 73
TABLE 16: List of electromagnetic emission compliance 74
TABLE 17: List of electromagnetic immunity compliance 74
TABLE 18: List of recommended separation distances 76
List of Figures
FIGURE 1: P200TxE device connected to network 23
FIGURE 2: Network data flow 24
FIGURE 3: Optos OCT line scan example position and scan pattern 26
FIGURE 4: Optos OCT raster scan example area, scan pattern and fixed center 26
FIGURE 5: Optos OCT retina scan example scan area and cross hairs 26
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FIGURE 6: Optos OCT optic nerve head scan example target and scan lines 26
FIGURE 7: Hand control 33
FIGURE 8: Chin rest and head rest 34
FIGURE 9: Example capture and review workflow 35
FIGURE 10: Position of the canthus mark on the covers 38
FIGURE 11: Aligned patient 38
FIGURE 12: OCT capture workflow 43
FIGURE 13: Indication of what the patient will see when being aligned for OCT imaging 44
FIGURE 14: Examples of local weak signal strength. 48
FIGURE 15: Example of local weak signal near the fovea. 48
FIGURE 16: Example of local weak signal with acceptable global SNR. 48
FIGURE 17: Possible movement detected. 49
FIGURE 18: Possible blink detected. 49
FIGURE 19: Example of clipped B-Scan. 50
FIGURE 20: Example of clipping near the fovea. 50
FIGURE 21: Example of clipping near the optic disc. 50
FIGURE 22: Reviewing images workflow 53
FIGURE 23: Sample of the connection label 70
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