Optos California P200DTx rg User manual

optos.com
User Guide
Optos Panoramic Ophthalmoscope
P200DTx rg
P200DTx rgb
P200DTx fa
P200DTx icg
G108025-010-ENG

G108025-010-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.
Page 2 of 76 Part Number: G108025-010-ENG
English Copyright 2015-2022, Optos plc. All rights reserved.

Legal notice
Copyright 2015-2022, 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71).
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, MONACO, 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: G108025-010-ENG
Release Date: 14 November 2022
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 22
2.3 Intended use 22
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 25
2.7.3.1 Multi-mode workflow 26
2.7.4 System software 26
2.7.4.1 Understanding the review software 26
2.7.5 Accessories and detachable parts 27
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
3.2 Switch off at the end of each day 30
3.2.1 How to use standby mode at the end of each day 31
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3.2.2 How to shut down the scan head 31
3.2.3 Install software updates 31
3.2.4 Log off the image server 31
3.2.5 Restart the image server each week 31
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 35
4.1.2 Selecting and editing existing patient 35
4.1.3 Working with Modality Work List (MWL) 35
4.1.4 How to search using MWL 36
4.2 How to prepare for image capture 36
4.3 How to align the patient 36
4.3.1 Patient coaching 36
4.3.2 Align the patient 37
4.4 How to capture SLO images 38
4.4.1 What to do after the image is captured 39
4.5 How to capture SLO eye steered images 39
4.6 How to capture SLO stereo images 40
4.7 How to capture SLO angiography images 41
4.7.1 Control contrast 42
4.8 How to capture using Multi-mode 42
4.9 How to manage the patient session 42
5 Review images 45
5.1 Starting the review software 45
5.1.1 How to start the application 45
5.2 Reviewing patient images and scans 45
5.3 Exiting the review software 46
6 Manage the system 47
6.1 Managing user details 47
6.1.1 How to create user accounts for use on the scan head 47
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6.1.2 How to create user accounts on the image server 47
6.1.3 How to change users 48
6.2 How to change the language on the scan head 48
6.3 How to change the language displayed in the review application 48
6.4 Storing and archiving images 48
6.5 Managing connections 48
6.6 Managing the Modality Work List 48
6.7 Quality checks 49
6.7.1 Self-tests 49
6.7.2 Status indicator 49
6.7.3 Software update 49
7 Maintenance and cleaning 51
7.1 Servicing 51
7.2 Warranty 51
7.3 Cleaning 52
7.3.1 General cleaning 52
7.3.2 Cleaning before each patient 53
7.3.2.1 How to remove the head and chin rests 53
7.3.3 Cleaning the main mirror 53
7.3.4 Disinfection 54
7.4 Battery replacement 55
7.5 Cable management 55
8 Troubleshooting 57
8.1 Why can't Ilogin? 58
8.2 What information do I need when contacting Optos? 59
8.3 How do I image if the alignment system does not recognize the eye? 59
8.4 How do I restart the scan head? 59
8.5 How do I restart the image server? 59
8.6 What should I do if the PC drive on the image server is full? 60
9 Technical Specification 61
9.1 Safety designation (IEC 60601-1) 61
9.1.1 Scan head 61
9.1.2 Connections 62
9.1.3 Scan head dimensions 63
9.1.4 Review client properties 63
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9.1.5 Touch screen properties 63
9.1.6 Table requirements 64
9.1.7 Battery 64
9.1.8 Environmental considerations (ambient) 64
9.2 Laser safety designation (IEC 60825-1) 65
9.2.1 External Laser warning information 65
9.2.2 Internal Laser warning information 65
9.3 Electromagnetic compatibility (EMC) 66
9.3.1 Guidance and manufacturer declaration – electromagnetic emissions 66
9.3.2 Guidance and manufacturer declaration – electromagnetic immunity 66
9.3.3 Recommended separation distances 68
10 Contact us 71
10.1 Global Headquarters 71
10.2 Regional Offices 71
10.2.1 United States and Canada 71
10.2.2 Australia 72
10.2.3 Denmark 72
10.2.4 France 72
10.2.5 Germany and Austria 72
10.2.6 Norway 72
10.2.7 Spain 73
10.2.8 Sweden 73
10.2.9 Switzerland 73
10.2.10 United Kingdom and other European countries 73
10.3 Authorized Representative 74
10.3.1 European Authorized Representative 74
10.3.2 Swiss Authorized Representative 74
Patient Alignment Guide 75
List of Tables
TABLE 1: Network specification 24
TABLE 2: List of parts 27
TABLE 3: Sample list of touch screen icons 32
TABLE 4: List of hand control buttons 33
TABLE 5: Examples of eye steering buttons 40
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TABLE 6: Examples of stereo buttons 41
TABLE 7: List of status indicator lights 49
TABLE 8: List of problems and solutions 57
TABLE 9: Scan head safety designation details 61
TABLE 10: Scan head dimensions 63
TABLE 11: Review client properties 63
TABLE 12: Touch screen properties 64
TABLE 13: Table size requirements 64
TABLE 14: Environmental ranges 65
TABLE 15: List of electromagnetic emission compliance 66
TABLE 16: List of electromagnetic immunity compliance 66
TABLE 17: List of recommended separation distances 68
List of Figures
FIGURE 1: P200DTx device connected to network (P200DTx fa shown) 23
FIGURE 2: Network data flow 25
FIGURE 3: Hand control 33
FIGURE 4: Chin rest and head rest 34
FIGURE 5: Example capture and review workflow 35
FIGURE 6: Position of the canthus mark on the covers 37
FIGURE 7: Aligned patient 38
FIGURE 8: Reviewing images workflow 45
FIGURE 9: Sample of the connection label 62
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