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Optos P200TxE User Manual Download Page 2

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.

Page 2 of 84

Part Number: G110230-003-ENG

English

Copyright 2019-2021, Optos plc. All rights reserved.

Summary of Contents for P200TxE

Page 1: ...User Guide Optos OCT Ophthalmoscope P200TxE G110230 003 ENG...

Page 2: ...is 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 Unite...

Page 3: ...tions 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...

Page 4: ...Page 4 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All rights reserved...

Page 5: ...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 i...

Page 6: ...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...

Page 7: ...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 displaye...

Page 8: ...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 inform...

Page 9: ...esignation 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 TAB...

Page 10: ...ng 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 Possib...

Page 11: ...of light Some patients with epilepsy may be sensitive to flashes of light Caution should be exercised for patients who have a history of reaction to camera flashes or strobe lighting Equipment modific...

Page 12: ...mic Photography Image Storage SOP Classes Measurements in third party viewers may not be accurate CAUTION Day to day use patients Patients MUST NOT operate this device The patient should not touch the...

Page 13: ...on hazards have been identified for direct or indirect ophthalmoscopes some patients may be less tolerant to an exposure of light This may be the case for infants aphakic patients and persons with dis...

Page 14: ...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 79 The image server switch and any...

Page 15: ...ission limits CISPR11 Group 1 Class B see Guidance and manufacturer declaration electromagnetic emissions on page 74 Although compliant with all applicable international EMC standards the equipment ge...

Page 16: ...the unlikely event you hear a loud noise from the device see smoke or smell burning stop imaging and isolate the device by unplugging from the mains power supply If you suspect the device may be faul...

Page 17: ...become contaminated they must be replaced immediately Do NOT use lint cloths tissues or other materials that may create dust on or near the scan head Always allow cleaned areas to air dry Improper cle...

Page 18: ...uipment connected to the IT NETWORK DATA COUPLING l upgrade of equipment connected to the IT NETWORK DATA COUPLING CAUTION The scan head and image server should be kept in a secure location You are re...

Page 19: ...echanical fixing and an additional protective earth connection should this be required Danger high voltage warning WARNING Warnings are directions which if NOT followed could cause l Fatal or serious...

Page 20: ...The limits for this are defined in IEC 60601 Serial Number Indicates the item is a medical device Authorized representative in the European Community 0197 In accordance with Directive 93 42 EEC Consul...

Page 21: ...sease earlier when treatment is potentially the most effective 1 l Capturing images in less than half a second improves clinic workflow and efficiency 2 l Motorized head and chin rest to more easily a...

Page 22: ...t environment The device shall be operated in an ophthalmology clinic hospital environment or in an optometrist s commercial premises Operation shall be conducted within a range of lighting conditions...

Page 23: ...es to show the status of the device see Status indicator on page 57 6 Touch screen The touch screen monitor is used to interact with the system It displays alignment feedback and captured images 7 Han...

Page 24: ...tion type LAN TCP IP ipV4 Connection speed 1 Gbps recommended Connection security All scan head to server transport HTTPS by default Connection ports defaults Default 80 or 443 where a transport certi...

Page 25: ...dalities l optomap fa and optomap icg are captured at the optomap plus resolution l optomap plus is captured at resolution x1 5 that of the standard resolution optomap 2 7 3 2 OCT imaging modalities C...

Page 26: ...scans The fovea should be in the center for all macula scans Ensure the cross hairs are centered on the macula FIGURE 5 Optos OCT retina scan example scan area and cross hairs Optos OCT optic nerve he...

Page 27: ...nd review software provided by OptosAdvance l Browser based review clients The image capture software runs on the scan head 2 7 4 1 Understanding the review software OptosAdvance is browser based revi...

Page 28: ...ck the desktop icon 2 7 5 Accessories and detachable parts CAUTION The use of parts and cables other than those specified may result in degraded electromagnetic compatibility of the system TABLE 2 Lis...

Page 29: ...view client 1 Check that the power supply is switched on 2 Switch on the image server Note If it seems the image server is not working check the monitor is switched on then confirm the image server is...

Page 30: ...kely that there is a temporary problem with the image server You can attempt to clear problems by restarting the image server see How do I restart the image server on page 67 l You will be unable to c...

Page 31: ...OFF the power supply The power switch is located at the at the back of the scan head The OFF position is marked Note It can take up to one minute from the touch screen turning black to the status ind...

Page 32: ...options are selected by touching an option or pushing the control in the required direction TABLE 3 List of touch screen icons Icon Description Accept laterality Confirms the laterality of the captur...

Page 33: ...adjust the scan see How to optimize OCT scan quality on page 44 The retina view will update in real time to show the location of the scan FIGURE 7 Hand control TABLE 4 List of hand control buttons Co...

Page 34: ...ity if more complex adjustments are required l Always wait for the auto routines position depth and focus to complete before making manual adjustments l Allow the system to respond after making each a...

Page 35: ...le the patient is sitting in the chair To capture and review images and scans use the procedures below FIGURE 9 Example capture and review workflow 4 1 Selecting and managing patient details Patients...

Page 36: ...te 4 1 4 Working with Modality Work List MWL When enabled the scan head supports the selection of patients from a DICOM MWL Server Searching patient orders in MWL mode supports the following Name Pati...

Page 37: ...then the chin rest Both may be adjusted before the image is captured but it is better to get comfortable and firmly supported from the start 4 The patient should look for the patient alignment target...

Page 38: ...he head rest The patient s mouth should be closed to reduce movement during image capture e Use the hand control to adjust the chin rest height to support the patient s chin see Using the hand control...

Page 39: ...on the patient being imaged 10 Capture the required image modality from the following list Reference How to capture SLO images 39 How to capture SLO eye steered images 40 How to capture SLO stereo ima...

Page 40: ...imaging each patient 4 5 How to capture SLO eye steered images Depending on the features available on your device you may be able to capture eye steered images The eye steered options are selected by...

Page 41: ...iption Mode selector Changes the control to display either eye steering or stereo directions Stereo 1 Stereo 1 selected The next image captured will be a Stereo 1 image Stereo 2 Stereo direction captu...

Page 42: ...ion 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 You may manually switch between FA and ICG Note...

Page 43: ...ired location 5 Re align the patient if required see How to align the patient on page 37 6 Select the live SLO image on the touch screen or press the top button on the hand control to set up the OCT T...

Page 44: ...er of the green alignment target Ask the patient to keep their head still in the standard alignment during OCT imaging FIGURE 13 Indication of what the patient will see when being aligned for OCT imag...

Page 45: ...sensitivity l Adjust the focus control to increase the signal strength see Using the hand control on page 33 Multiple or extended focus adjustments should not be required l If the auto focus result is...

Page 46: ...likely to be acceptable Scans with SNR indications of SNR of 6 10 are marginal You should consider repeating the scan trying to achieve a higher level of SNR Scans with SNR indications of 5 10 or low...

Page 47: ...with all retinal imaging devices ocular opacity may block the transmission of light and view of the retina which can then impact the SNR Overall signal strength The overall signal strength is measure...

Page 48: ...ocument the image as non evaluable If a local weak signal does not cover essential parts of the image the operator should document the image as evaluable FIGURE 14 Examples of local weak signal streng...

Page 49: ...vements see How to check OCT scans on page 46 You should replay the frames and assess if the movement is significant FIGURE 17 Possible movement detected 4 9 3 Artifacts Blinks The patient may blink m...

Page 50: ...tructures Depending on the structure being imaged the essential structure at the center of the scan will change l The fovea should be in the center for all macula scans l The optic disc should be in t...

Page 51: ...red images and scans have been captured Image Browser The Image Browser can be accessed after the first image has been captured You can check the images and scans which will be saved at the end of the...

Page 52: ...Page 52 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All rights reserved...

Page 53: ...to start the application 1 Use your web browser to go to the address provided by your System Administrator 2 Enter your username and password then select Login 3 You can now search for a patient You c...

Page 54: ...ews as required 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 P...

Page 55: ...n head 1 Login to the scan head 2 Select To admin 3 Select Users 4 Select New user 5 Enter the details for the new user and select if they will be an Administrator or Operator 6 Return to the admin me...

Page 56: ...ttings Device Dicom 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 repre...

Page 57: ...ifferent colored lights on the status indicator For more information see System parts on page 23 TABLE 8 List of status indicator lights Status color Description White Switching on and running self te...

Page 58: ...Page 58 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All rights reserved...

Page 59: ...ttings Do NOT remove the scan head covers Only Optos trained technical personnel are permitted to service the device The scan head weighs 45 kg 100 lbs maximum This requires two people to lift or carr...

Page 60: ...safe use of the product Do NOT use lint cloths tissues or other materials that may create dust on or near the scan head Always allow cleaned areas to air dry Do NOT use harsh detergent abrasive cleane...

Page 61: ...d chin rest may be removed for periodic cleaning by following these steps 1 Stand in front of the device hold both sides of the head or chin rest and pull towards you 2 When the head or chin rest reac...

Page 62: ...these areas and NOT the rest of the mirror c Inspect the mirror surface and confirm all smudges or spots have been removed 9 Refit the face pad 10 Take another image and compare it to the original re...

Page 63: ...ed l Mains supply must be earthed l The device may only be serviced by Optos trained personnel l Care must be taken never to touch exposed parts of the device while in physical contact with a patient...

Page 64: ...Page 64 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All rights reserved...

Page 65: ...rd see Why can t I login on the next page Check the image server is switched on and running see How do I restart the image server on page 67 Check the image server network address and ensure the scan...

Page 66: ...rver disk is full Storage provisions on the image server need to be extended Contact Optos for assistance Cannot locate images just taken of patient Images taken under wrong patient Confirm the patien...

Page 67: ...estart the scan head Scan head problems are often temporary and can usually be resolved by restarting the scan head following these steps 1 End the current session and shut down the device see How to...

Page 68: ...Cs 8 6 What should I do if the PC drive on the image server is full Ask your System Administrator to l Empty the PC Recycle Bin l Empty the Temporary Internet files If you still experience problems or...

Page 69: ...emissions on page 74 Operation is subject to the following two conditions 1 This device may NOT cause harmful interference 2 This device MUST accept any interference received including interference t...

Page 70: ...tinuous Touch screen voltage 12V 9 1 2 Connections These connections are NOT intended to be detached by the user FIGURE 23 Sample of the connection label No Description 1 Mains power cable and switch...

Page 71: ...to 707 mm 27 inches to 28 inches Weight 45 kg 100 lbs maximum Door access width 760 mm 30 inches 9 1 4 Review client properties Browser based review clients let you review and analyze patient images T...

Page 72: ...orrect alignment position The chin rest should slightly overhang the edge of the table The scan head and touch screen must be positioned on a table that meets the necessary safety standards The table...

Page 73: ...AEL at the eye for normal operation and under foreseeable fault conditions Based on current scientific knowledge a Class 1 laser device can be considered as safe by engineering design Wavelengths SLO...

Page 74: ...ic emission compliance Emissions test IEC60601 compliance test level Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The P200TxE uses RF energy only for its internal function Theref...

Page 75: ...erruptions it is recommended that the device be powered from an uninterruptible power supply 5 UT 95 dip in UT for 5 seconds If the user of the device requires continued operation during mains interru...

Page 76: ...survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal...

Page 77: ...ration distance d in meters 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 tran...

Page 78: ...Page 78 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All rights reserved...

Page 79: ...access their details You can find the site number on the documentation received from Optos 10 2 Regional Offices Please check optos com for new or updated regional office information 10 2 1 United St...

Page 80: ...Cedex France Telephone 0 805 119499 All inquiries ics optos com Customer Support 0 805 119499 10 2 5 Germany and Austria Optos GmbH Tiefenbroicher Weg 25 D 40472 D sseldorf Deutschland Telephone DE 0...

Page 81: ...o eMBe Finanz GmbH Bahnhofstrasse 20 Schweiz Telephone 41 0 43 277 07 37 Fax 41 0 43 277 07 38 All inquiries ics optos com Customer Support 0800 55 87 39 10 2 10 United Kingdom and other European coun...

Page 82: ...act us 10 3 European Authorized Representative EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands Page 82 of 84 Part Number G110230 003 ENG English Copyright 2019 2021 Optos plc All ri...

Page 83: ...stances the operator may choose to capture an image when you are aligned to the blue or red target or when only the center is visible When capturing OCT modalities the operator may choose to capture a...

Page 84: ...G110230 003 ENG English...

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