Optos California P200DTx rg User Manual

Panoramic ophthalmoscope

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Optos Panoramic Ophthalmoscope

P200DTx rg

P200DTx rgb

P200DTx fa

P200DTx icg

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Page 1 User Guide Optos Panoramic Ophthalmoscope P200DTx rg P200DTx rgb P200DTx fa P200DTx icg optos.com...
Page 2 In the United States of America, Federal law restricts this device to sale by or on the order of a physician. CAUTION Page 2 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 3 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.
Page 5: Table Of Contents
Switch on browser-based review clients 3.2 Switch off at the end of each day 3.2.1 How to use standby mode at the end of each day Part Number: G108025-010-ENG Page 5 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 6 5.2 Reviewing patient images and scans 5.3 Exiting the review software Manage the system 6.1 Managing user details 6.1.1 How to create user accounts for use on the scan head Page 6 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 7 7.5 Cable management Troubleshooting 8.1 Why can't I login? 8.2 What information do I need when contacting Optos? 8.3 How do I image if the alignment system does not recognize the eye? 8.4 How do I restart the scan head? 8.5 How do I restart the image server? 8.6 What should I do if the PC drive on the image server is full?
Page 8 TABLE 2: List of parts TABLE 3: Sample list of touch screen icons TABLE 4: List of hand control buttons TABLE 5: Examples of eye steering buttons Page 8 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 9 FIGURE 6: Position of the canthus mark on the covers FIGURE 7: Aligned patient FIGURE 8: Reviewing images workflow FIGURE 9: Sample of the connection label Part Number: G108025-010-ENG Page 9 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 11: Warnings And Cautions
Read the warnings and cautions before using your device. If you identify a serious issue related to the safety and performance of your device or a public health risk you should forward the details to the relative authority and your Optos representative (see Contact us on page 71).
Page 12 Remove the fabric cover before operating the scan head. Measurements on Optos UWF optomap and OCT images are based on scale factors derived from the wide-angle schematic eye model published by Navarro et al . This...
Page 13: Laser Safety
Your device will be installed by Optos trained personnel. Do operate the device until they have completed the installation and training. Your Optos representative will configure the settings when the device is installed. These settings should be changed in the course of normal operation.
Page 14: Electrical Safety
Only use peripherals supplied with the device. Independently sourced peripherals may be compatible. Contact your Optos representative for more information on compatible peripherals (see Contact us on page 71). Ordinary equipment without protection against ingress of water.
Page 15: Environmental Safety
Relocate the affected device or devices. Increase the separation between the equipment and the affected device. Consult the Optos service representative for further suggestions. Part Number: G108025-010-ENG Page 15 of 76 Copyright 2015-2022, Optos plc.
Page 16: Device Failure
Follow the advice in this User Guide if you suspect the device may be faulty (see Troubleshooting on page 57). WARNING If the fault still persists, please contact your Optos representative (see Contact us on page 71). The device is isolated from the mains by the main power cable and IEC connector. In an emergency, the device should be isolated by unplugging from the mains power supply.
Page 17 If you believe cleaning sprays or liquids have got into the equipment, disconnect the power supply and have the equipment checked by Optos qualified service personnel. let the cleaning wipes come into contact with the inside of the instrument.
Page 18: Maintaining Information Security
You can install critical Windows Updates and anti-virus signatures on the Image Server PC and Viewing PCs by following the instructions displayed during the update. Page 18 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 19: Software On Optos-Supplied Pcs
Chapter 1 - Warnings and cautions 1.10 Software on Optos-supplied PCs Only install software when supplied and instructed by Optos. Installing new software Contact Optos Customer Support if you need to install other software (see Contact us on page 71). Updating existing software CAUTION Your System Administrator should carry out software upgrades using the software and instructions provided by Optos.
Page 20 Indicates the item is a medical device. Authorized representative in the European Community. Authorized representative in Switzerland. CE Marking. 0197 Consult accompanying documents. Disposal in compliance with WEEE Directive. Page 20 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 21: Introduction
This allows an image of the natural fluorescence of the eye to be captured. Fluorescent dye is not introduced into the patient when performing autofluorescence imaging. Optos’ technology is designed to operate through a minimum pupil diameter of 2 mm. Although pupil dilation is required, the decision to dilate is a medical decision to be made by the eyecare professional.
Page 22: Clinical Benefits Statement
The system prevents the operator altering laser power or exposure times, therefore no specific pre- requisite training is required prior to receiving Optos training. The review of images, as an assist to diagnosis, may only be conducted by a healthcare professional qualified in optometry or ophthalmology.
Page 23: System Parts
(see Using the chin rest and head rest on page 34). The color changes to show the status of the device (see Status indicator on Status indicator page 49). Part Number: G108025-010-ENG Page 23 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 24: Network Specification And Characteristics
All scan head to server transport HTTPS by default OptosAdvance review connection ports Default 80, or 443 where a transport certificate is applied Unused ports Locked on scan head and image server PC Page 24 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 25: Image Modalities
FIGURE 2: Network data flow 2.7.3 Image modalities Optos multi-modal ultra-widefield retinal imaging enables the capture of posterior images, with a field of view of up to 200 degrees in a single capture, and in an imaging time of less than 0.4 seconds.
Page 26: Multi-Mode Workflow
3D Wrap view displays the current image on a 3D model eye. You can run the animated "Fly-Through" or demonstrate refractive errors and Intraocular Lenses. Page 26 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 27: Accessories And Detachable Parts
The supplied image server depends on your configuration. Mains power cables required for the region will be supplied. Part Number: G108025-010-ENG Page 27 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 29: Get Started
1. Remove the scan head fabric cover. 2. Check the image server is switched and fully started up before switching the scan head. Part Number: G108025-010-ENG Page 29 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 30: Switch On Browser-Based Review Clients
I restart the image server? on page 59). You will be unable to capture images if the self-tests have been successful. Please restart the scan head. If the problem persists please contact your Optos representative (see Contact us on page 71). 3.1.3 Switch on browser-based review clients...
Page 31: How To Use Standby Mode At The End Of Each Day
Restart the image server each week to allow updates to install (see Restart the image server each week below). 3.2.5 Restart the image server each week switch the image server while in use. CAUTION Part Number: G108025-010-ENG Page 31 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 32: Use The System
Displays the images and scan which will be saved at the end of the session. You can change laterality and delete images and scans. Contrast Adjusts the image contrast while capturing angiography images. Cancel Cancels the current action without saving changes. Page 32 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 33: Using The Touch Screen Keyboard
Toggle between angiography light types when capturing angiography images. Lower chin rest. Raise chin rest. Fine adjustment left, right, up and down. Fine adjustment to move the alignment system further from the patient. Part Number: G108025-010-ENG Page 33 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 34: Using The Chin Rest And Head Rest
The head rest comprises a forehead pad that supports the patient's head. The chin rest and head rest should be kept clean (see Cleaning before each patient on page 53). FIGURE 4: Chin rest and head rest Page 34 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 35: Capture Images
4 Capture images These procedures should be used as the basic procedure for all image captures. Please contact your Optos representative if the image modality you want is available (see Contact us on page 71). To achieve optimal patient positioning the patient is typically seated in front of the device. Space may be required to allow the table height to be adjusted while the patient is sitting in the chair.
Page 36: How To Search Using Mwl
Order not being available or the MWL Server being down, may need to be merged by your System Administrator. Note Please contact your Optos representative if introducing MWL to your site. 4.1.4 How to search using MWL 1. Select the MWL Search Parameter for the information type to be searched.
Page 37: Align The Patient
Check: the patient is comfortable. the patient is firmly supported by the head rest and chin rest. Part Number: G108025-010-ENG Page 37 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 38: How To Capture Slo Images
1. Prepare the device for image capture (see How to prepare for image capture on page 36). 2. Align the patient (see How to align the patient on page 36). Page 38 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 39: What To Do After The Image Is Captured
Depending on the features available on your device, you may be able to capture eye steered images. The eye steered options are selected by touching an option or pushing the control in the required direction. Part Number: G108025-010-ENG Page 39 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 40: How To Capture Slo Stereo Images
Depending on the features available on your device, you may be able to capture stereo pairs. The stereo pair options are selected by touching an option or pushing the control in the required direction. Page 40 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 41: How To Capture Slo Angiography Images
The injection should be administered when the scan head is aligned. If a timer is started accidentally you can reset it by selecting the timer and selecting Reset. Part Number: G108025-010-ENG Page 41 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 42: Control Contrast
Stereo pairs will be shown side-by-side in OptosAdvance. Continue capturing images until you have a good stereo pair, deleting and recapturing as necessary. Patient Session Summary Page 42 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 43 If the session is incomplete or incorrect select outside the summary to continue the session. Part Number: G108025-010-ENG Page 43 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 45: Review Images
Captured images and scans are displayed using the OptosAdvance software. 1. Double-click to run OptosAdvance. 2. Log in using your username and password. 3. Select the patient. Part Number: G108025-010-ENG Page 45 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 46: Exiting The Review Software
6. Compare results across studies if required. Note Detailed instructions can be found in the application help files. 5.3 Exiting the review software To leave OptosAdvance, select Logoff Page 46 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 47: Manage The System
User Management > Accounts. 4. Select Add. 5. Enter the details for the new user and select the privileges to be assigned to them. 6. Select Save. Part Number: G108025-010-ENG Page 47 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 48: How To Change Users
The ability to edit network settings is restricted to System Administrators. If there are any connection problems ask your System Administrator to review your settings and where necessary contact your Optos representative for instructions on how to proceed (see Contact us on page 71).
Page 49: Quality Checks
6.7.1 Self-tests Each time the system starts it runs a series of self-tests. If any problems are identified please follow the on- screen instructions and take appropriate action or contact your Optos representative (see Contact us on page 71). 6.7.2 Status indicator The status of the scan head is identified using different colored lights on the status indicator.
Page 51: Maintenance And Cleaning
Your device will be installed by Optos trained personnel. Do operate the device until they have completed the installation and training. Your Optos representative will configure the settings when the device is installed. These settings should be changed in the course of normal operation.
Page 52: Cleaning
If you believe cleaning sprays or liquids have got into the equipment, disconnect the power supply and have the equipment checked by Optos qualified service personnel. let the cleaning wipes come into contact with the inside of the instrument.
Page 53: Cleaning Before Each Patient
Dispose of the dirty cloth after each wipe to avoid transferring the dust back on to the mirror. You will have to use several wipes to clean the mirror. Part Number: G108025-010-ENG Page 53 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 54: Disinfection
4. Inspect the surface of the mirror for visible dust. Take note of any smudges or spots. 5. Fold an Optos-approved cleaning cloth twice so that it has a number of layers. 6. Use single downward strokes to gently wipe the mirror. Always start from the top of the visible area.
Page 55: Battery Replacement
A 3V Lithium coin battery is embedded in the hardware for the device and does require to be changed by users. If there is a problem, please contact your Optos representative (see Contact us on page 71). 7.5 Cable management Do ...
Page 57: Troubleshooting
Note If you require further assistance, please contact your Optos representative (see Contact us on page 71). When contacting Optos you will need to supply your site number (see What information do I need when contacting Optos? on page 59). TABLE 8: List of problems and solutions...
Page 58: Why Can't I Login
1. End the current session and switch off the power. 2. Restart the image server. 3. Switch the power back on to the scan head. If you still experience problems please contact your Optos representative (see Contact us on page 71). Page 58 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc.
Page 59: What Information Do I Need When Contacting Optos
PC. Exit any programs if prompted. 3. Log on PC when prompted. 4. You can now login to the scan head and re-open any Optos applications on the other PCs. Part Number: G108025-010-ENG Page 59 of 76 Copyright 2015-2022, Optos plc.
Page 60: What Should I Do If The Pc Drive On The Image Server Is Full
Empty the Temporary Internet files. If you still experience problems or need to increase your storage capacity, either locally available or with OptosCloud, then please contact your Optos representative (see Contact us on page 71). Page 60 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc.
Page 61: Technical Specification
User Guide. Read the warnings and cautions before using your device (see Warnings and cautions on page 11). If you have any questions regarding the correct use of your device, please contact your Optos representative (see Contact us on page 71).
Page 62: Connections
Description Mains power cable and switch. Protective earth must be fitted. U.K. Power Cable Fuse: 13A. Network cable. Hand control. Optos Service use. Touch screen. Page 62 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 63: Scan Head Dimensions
The touch screen is powered from the scan head at +12V. disconnect or connect the touch screen while the scan head is in use. WARNING Part Number: G108025-010-ENG Page 63 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 64: Table Requirements
725 mm to 1205 mm (29 inches to 47 inches) Where wheelchair accessibility is required the table must meet wheelchair accessibility standards. 9.1.7 Battery remove the scan head covers. Only Optos trained technical personnel are permitted to service the device. CAUTION The device contains a 3V Lithium coin battery.
Page 65: Laser Safety Designation (Iec 60825-1)
Location of Laser warning Warning information VISIBLE AND INVISIBLE LASER RADIATION Positioned on the laser cover AVOID DIRECT EXPOSURE TO BEAM CLASS 3B LASER PRODUCT Part Number: G108025-010-ENG Page 65 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 66: Electromagnetic Compatibility (Emc)
±1 kV line to line Surge Mains power quality should be that of a typical IEC 61000-4-5 commercial or hospital environment. ±2 kV line to earth Page 66 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 67 810, 870, 930,1720, 1845, less than the compliance level in each frequency 1970, 2450, 5240, 5500, range. 5785 Interference may occur in the vicinity of equipment marked with: Part Number: G108025-010-ENG Page 67 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 68: Recommended Separation Distances
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power of the transmitter in watts (W) according to the transmitter manufacturer. Page 68 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 69 At 80MHz and 800MHz the higher frequency range applies. These guidelines may apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Part Number: G108025-010-ENG Page 69 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 71: Contact Us
Fax: +44 (0) 1383 843 333 All inquiries: ics@optos.com Website: optos.com Existing customers will need to provide their site number to allow Optos to access their details. You can find the site number on the documentation received from Optos. 10.2 Regional Offices Please check optos.com...
Page 72: Australia
Customer Support (DE): (0) 800 723 6805 Customer Support (AT): (0) 800 24 48 86 10.2.6 Norway Telephone: +47 800 16711 All inquiries: ics@optos.com Customer Support: +47 800 16711 Page 72 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 73: Spain
Telephone: +44 (0) 1383 843 300 Fax: +44 (0) 1383 843 333 All inquiries: ics@optos.com Customer Support Freephone: 0808 100 45 46 Customer Support: +44 (0) 1383 843 350 Part Number: G108025-010-ENG Page 73 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 74: Authorized Representative
10.3.1 European Authorized Representative EMERGO EUROPE Prinsessegracht 20 2514 AP, The Hague The Netherlands 10.3.2 Swiss Authorized Representative MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland Page 74 of 76 Part Number: G108025-010-ENG English Copyright 2015-2022, Optos plc. All rights reserved.
Page 75: Patient Alignment Guide
Optos Inc Optos plc Optos Australia Tel: 800-854-3039 Tel: +44 (0) 1383 843 300 Tel: +61 8 8444 6500 usinfo@optos.com ics@optos.com auinfo@optos.com Part Number: G108025-010-ENG Page 75 of 76 Copyright 2015-2022, Optos plc. All rights reserved. English...
Page 76 G108025-010-ENG English...

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