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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 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
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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.
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Page 4 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
3.1 Get started 3.1.1 Switch on each day 3.1.1.1 Switch on the image server 3.1.1.2 Switch on the scan head 3.1.1.3 Switch on browser-based review clients Part Number: G108707/8GME Page 5 of 75 Copyright 2018, Optos plc. All rights reserved. English...
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3.3.1.1 How to start the application 3.3.2 Reviewing patient images and scans 3.3.2.1 Overview of review screen 3.3.3 Exiting the review software 3.4 Manage the system 3.4.1 Managing user details Page 6 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
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3.4.8 Troubleshooting 3.4.8.1 Why can't I login? 3.4.8.2 What information do I need when contacting Optos? 3.4.8.3 How do I image if the alignment system does not recognize the eye? 3.4.8.4 How do I restart the scan head? 3.4.8.5 How do I restart the image server? 3.4.8.6 What should I do if the PC drive on the image server is full?
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TABLE 7: Scan head safety designation details TABLE 8: Scan head dimensions TABLE 9: Review client properties TABLE 10: Touch screen properties TABLE 11: Table size requirements Page 8 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
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TABLE 13: List of electromagnetic emission compliance TABLE 14: List of electromagnetic immunity compliance TABLE 15: List of recommended separation distances List of Figures FIGURE 1: P200TE device connected to network FIGURE 2: Login page FIGURE 3: Hand control FIGURE 4: Chin rest and head rest...
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Page 10 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
If the device appears faulty or has non-functioning components, please contact your Optos representative, see Contact us on page 71 . If you have any questions regarding the correct use of your device, please contact your Optos representative before attempting to operate the device.
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1. Isabel Escudero-Sanz and Rafael Navarro, "Off-axis aberrations of a wide-angle schematic eye model," J. Opt. Soc. Am. A 16, 1881-1891 (1999). 2. Signal to noise ratio Page 12 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
CAUTION herein may result in hazardous radiation exposure. The P200TE is a Class 1 laser device at the eye, and complies with IEC/EN 60825- 1:2014 and 21 CFR1040.10 and 1040.11 except for deviation pursuant to Laser Notice 50, dated June 24, 2007.
Care must be taken never to touch exposed parts of the device while in physical contact with a patient. If the mains cable is damaged do not use the system and contact your Optos representative, see Contact us on page 71.
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: G108707/8GME Page 15 of 75 Copyright 2018, Optos plc.
If you suspect the device may be faulty see Troubleshooting on page 60. WARNING If the fault still persists, please contact your Optos representative, see Contact us on page 71. Ensure the mains socket is easily accessible.
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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.
PC and Viewing PCs by following the instructions displayed during the update. 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.
Damage to the equipment or loss of data. Interference may occur in the vicinity of equipment marked with this symbol. Laser device present. This symbol is used internally. Only Optos trained personnel are permitted to service the device. Under normal use, operators should never see this symbol.
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Page 20 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Domain processing techniques are applied to construct axial and cross sectional scans. 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.
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.
Chapter 2 - Introduction 2.6.1 System parts FIGURE 1: P200TE device connected to network No. Name of Part Description The scan head comprises the light sources (lasers and ) and electronics Scan head used to capture patient images. The head rest supports the patient's head when the patient is being imaged, see Head rest Using the chin rest and head rest on page 34.
A table may also be supplied. 2.6.2 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.
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Optos OCT raster scan raster Captures a raster scan of OCT images covering a 12 mm x 9 mm central field of view. The Optos OCT scan comprises 65 horizontal line scans. The Optos OCT raster scan moves automatically through the scan volume and lets you capture the macula and optic nerve head within a single OCT volume scan.
Manage and display patient data Store and review images and diagnostic data You can run the review software from the following: Double-click the desktop icon Page 26 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Mains power cable C5881 Network cable 1. Where the OptosAdvance image server software is installed on a compatible virtual machine the physical server will be supplied. Part Number: G108707/8GME Page 27 of 75 Copyright 2018, Optos plc. All rights reserved. English...
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Page 28 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
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: G108707/8GME Page 29 of 75 Copyright 2018, Optos plc. All rights reserved. English...
I restart the image server? on page 62 . 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 . 3.1.1.3 Switch on browser-based review clients...
3.1.2.3 Restart the image server each week Exit OptosAdvance before turning the image server. CAUTION You should restart the image server each week to allow updates to install. Part Number: G108707/8GME Page 31 of 75 Copyright 2018, Optos plc. All rights reserved. English...
The touch screen keyboard uses the same layout as a standard keyboard in your language. As needed, accented or special characters may be available by pressing and holding keys with a symbol in the upper right corner. Page 32 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Press the top button on the hand control to Press the top button on the hand control to capture an image. capture a scan. Part Number: G108707/8GME Page 33 of 75 Copyright 2018, Optos plc. All rights reserved. English...
FIGURE 4: Chin rest and head rest 3.2 Capture images These procedures should be used as the basic procedure for all image captures. Please contact your Optos available, see Contact us on page 71 . representative if the image modality you want is To achieve optimal patient positioning the patient is typically seated in front of the device.
For example, to search for John Smith, who was born on 23 May 1987 and who has a patient ID of 456789 you could enter: by name: Sm 1987 Smith 23 (birthday on the 23rd day) Part Number: G108707/8GME Page 35 of 75 Copyright 2018, Optos plc. All rights reserved. English...
. 2. Select the patient record, see Working with patient details on the previous page . 3. Select the options for the images being captured. Page 36 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Ensure the patient blinks before capturing the image so that the cornea is lubricated. 1. The inner or outer corner of the eye where the upper and lower eyelids meet. Part Number: G108707/8GME Page 37 of 75 Copyright 2018, Optos plc. All rights reserved. English...
8. Capture the required image modality from the following list: Capturing instructions How to capture SLO images How to capture eye steered images How to capture stereo images Capturing OCT images 1. Intraocular lens Page 38 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
You can also capture using the hand control. 6. Check the quality of the images, see What to do after the image is captured on page 41 . Part Number: G108707/8GME Page 39 of 75 Copyright 2018, Optos plc. All rights reserved. English...
The stereo pair options are selected by touching an option or pushing the control in the required direction. Description Mode selector Changes the control to display either eye steering or stereo directions. Page 40 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
5. The capture session can be completed at this stage if no scans or additional images are needed. 6. Select Finished patient if the quality of all captured images is acceptable. Part Number: G108707/8GME Page 41 of 75 Copyright 2018, Optos plc. All rights reserved. English...
Image Browser Displays the images and scan which will be saved at the end of the session. You can change laterality and delete images and scans. Page 42 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
FIGURE 11: List of OCT scan types No. Description Live external view. Primary scan type selector. OCT scan type options. Save and recapture. Image Browser displays all the captured images and scans. Part Number: G108707/8GME Page 43 of 75 Copyright 2018, Optos plc. All rights reserved. English...
OCT adjustment controls How to optimize OCT scan quality How to capture OCT images What to do after OCT image capture SNR and OCT scan quality Page 44 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Ask the patient to look off center towards a suitable reference point on the alignment target and recapture the opto map image. For more information on the alignment targets, see Patient Alignment Guide on page 75 . Part Number: G108707/8GME Page 45 of 75 Copyright 2018, Optos plc. All rights reserved. English...
Tracking displayed the scan location is aligned with the planned location 1. Signal to noise ratio Page 46 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Ensure the patient blinks before capturing the image so that the cornea is lubricated. Adjust the patient's head to ensure that the scan is not tilted. Part Number: G108707/8GME Page 47 of 75 Copyright 2018, Optos plc. All rights reserved. English...
Check that the patient is still correctly aligned and select Save and recapture . For more information see How to capture OCT images above . Delete the scan and recapture. Finished OCT Page 48 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
OCT image quality and therefore could determine the ability CAUTION to distinguish the retinal layers. 1. Signal to noise ratio Part Number: G108707/8GME Page 49 of 75 Copyright 2018, Optos plc. All rights reserved. English...
You can change laterality and delete images and scans. You can review stereo paired images. Continue capturing images until you have a good stereo pair, deleting and recapturing as necessary. Page 50 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
You can get help reviewing images in the software help files. Part Number: G108707/8GME Page 51 of 75 Copyright 2018, Optos plc. All rights reserved. English...
After you have selected your study you can see the images captured as a series of thumbnails down the side of the screen. Position your mouse over a thumbnail to display more details about the specific image modality. Select Help to get more information. Page 52 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
CAUTION You need a user account on the scan head and on OptosAdvance. The ability to create a user account is restricted to System Administrators. Part Number: G108707/8GME Page 53 of 75 Copyright 2018, Optos plc. All rights reserved. English...
Your Administrator is responsible for maintaining the storage and archive settings. You can get help storing and archiving in the OptosAdvance help files or contact your Optos representative, see Contact us on page 71 . You should back-up your image server data at least once a week. Page 54 of 75...
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 . 3.4.6 Quality checks Your system automatically runs specific checks during start up and shut down.
Chapter 3 - How to... 3.4.7.1 Servicing open the scan head covers. There are no user serviceable or replaceable parts inside. Only Optos trained personnel are permitted to install and service the device. CAUTION service the device when imaging a patient. 3.4.7.2 Warranty The details of your warranty are included in your contract.
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2. When the head or chin rest reaches the stops, gently lift the head or chin rest and pull to remove it from the casing. 3. After cleaning, slot the head or chin rest back into the casing and gently push back into position. Part Number: G108707/8GME Page 57 of 75 Copyright 2018, Optos plc. All rights reserved. English...
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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.
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 . 3.4.7.5 Cable management Do ...
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 the facing page .
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 . 3.4.8.2 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. 3.4.8.6 What should I do if the PC drive on the image server is full?
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 .
570 mm (23 inches) including chin rest Height 608 mm to 632 mm (24 inches to 25 inches) Weight 40 kg (89 lbs) Door access width 760 mm (30 inches) Page 64 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
Dimension Details Width 887 mm (35 inches) Depth 600 mm (24 inches) including chin rest Height 725 mm (29 inches) to 1205 mm (47 inches) Part Number: G108707/8GME Page 65 of 75 Copyright 2018, Optos plc. All rights reserved. English...
Device is DEHP free. 4.2 Laser safety designation (IEC 60825-1) The P200TE is a Class 1 laser device at the eye, and complies with IEC/EN 60825- 1:2014 and 21 CFR1040.10 and 1040.11 except for deviation pursuant to Laser Notice 50, dated June 24, 2007.
CLASS 3B LASER PRODUCT 4.3 Electromagnetic compatibility (EMC) The P200TE is intended for use in the electromagnetic environment as specified in the following tables. The customer or the user of the device should assure that it is used in such an environment.
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Conductive RF 3Vrms distance calculated from the equation applicable to the frequency of the transmitter. IEC61000-4-6 150kHz to 80MHz Recommended separation distance d=1.2√P Page 68 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
This section lists the recommended separation distances between portable and mobile communication equipment and the device. The P200TE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the P200TE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the P200TE as recommended below, according to the maximum output power of the communications equipment.
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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. Page 70 of 75 Part Number: G108707/8GME English Copyright 2018, Optos plc. All rights reserved.
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. 5.2 Regional Offices Please check optos.com for new or updated regional office information.
When capturing OCT modalities the operator may choose to capture an image when you are aligned slightly off center. 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: G108707/8GME Page 75 of 75 Copyright 2018, Optos plc. All rights reserved. English...
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