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Optos P200T E Series User Manual Download Page 20

Chapter 1 - Warnings and cautions

Symbol and label information

Consult accompanying documents.

Disposal in compliance with WEEE Directive.

Page 20 of 72

Part Number: G110230/1ENG

English

Copyright 2019, Optos plc. All rights reserved.

Summary of Contents for P200T E Series

Page 1: ...optos com USER GUIDE Optos OCT Ophthalmoscope P200TxE ...

Page 2: ...n 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 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 3: ... 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 dissem...

Page 4: ...Page 4 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 5: ...ronment 21 2 5 Contraindications 22 2 6 System configuration 22 2 6 1 System parts 22 2 6 2 Network specification and characteristics 23 2 6 3 Image modalities 24 2 6 3 1 SLO imaging modalities 24 2 6 3 2 OCT imaging modalities 25 2 6 3 3 Multi mode workflow 26 2 6 4 System software 26 2 6 4 1 Understanding the review software 27 2 6 5 Accessories and detachable parts 27 3 How to 29 3 1 Get starte...

Page 6: ...e patient 37 3 2 4 How to capture SLO images 39 3 2 4 1 What to do after the image is captured 40 3 2 5 How to capture SLO eye steered images 40 3 2 6 How to capture SLO stereo images 41 3 2 7 How to capture SLO angiography images 42 3 2 7 1 Control contrast 42 3 2 8 How to capture OCT images 43 3 2 8 1 The patient s view of OCT alignment 44 3 2 8 2 How to optimize OCT scan quality 45 3 2 8 2 1 Ca...

Page 7: ...ist 50 3 4 7 Quality checks 50 3 4 7 1 Self tests 50 3 4 7 2 Status indicator 50 3 4 8 Maintenance 51 3 4 8 1 Servicing 51 3 4 8 2 Warranty 51 3 4 8 3 Cleaning 52 3 4 8 3 1 General cleaning 52 3 4 8 3 2 Cleaning before each patient 53 3 4 8 3 3 Cleaning the main mirror 53 3 4 8 3 4 Disinfection 54 3 4 8 4 Battery replacement 54 3 4 8 5 Cable management 55 3 4 9 Troubleshooting 55 3 4 9 1 Why can t...

Page 8: ...Guidance and manufacturer declaration electromagnetic emissions 64 4 3 2 Guidance and manufacturer declaration electromagnetic immunity 64 4 3 3 Recommended separation distances 66 5 Contact us 67 5 1 Global Headquarters 67 5 2 Regional Offices 67 5 2 1 United States and Canada 67 5 2 2 Australia 68 5 2 3 Denmark 68 5 2 4 France 68 5 2 5 Germany and Austria 68 5 2 6 Norway 68 5 2 7 Spain 68 5 2 8 ...

Page 9: ...onnected to network 22 FIGURE 2 Network data flow 24 FIGURE 3 Optos OCT line scan example position and scan pattern 25 FIGURE 4 Optos OCT raster scan example area scan pattern and fixed center 25 FIGURE 5 Optos OCT retina scan example scan area and cross hairs 26 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 F...

Page 10: ...Page 10 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 11: ...xercised for patients who have a history of reaction to camera flashes or strobe lighting Equipment modifications No modification of this equipment is allowed Positioning scan head on table The scan head should be positioned in the middle of the table width The front of the scan head should be inline with the front of the table to allow the patient to get into the correct alignment position The ch...

Page 12: ...ce The patient should not touch the touch screen The patient should only be in contact with the forehead pad chin pad and face pad When angiography images are being captured additional space will be required to allow the injection of the dye and for other individuals involved in the procedure These individuals could include medical staff or patient helper Do not inject the patient until the approp...

Page 13: ... any other ophthalmic device using a visible light source within the previous 24 hours may also be less tolerant to a further exam using light CAUTION The Laser Management System maintains a Class 1 accessible emission limit AEL at the eye for normal operation and under foreseeable fault conditions While the scan head covers are fitted the risks are minimized Images may only be captured when the s...

Page 14: ...e the system and contact your Optos representative see Contact us on page 67 The image server switch and any browser based review clients or monitors must be positioned outside the patient environment more than 1 5 meters 5 ft from the scan head Do not connect any peripherals to the scan head Only use peripherals supplied with the device Independently sourced peripherals may not be compatible Cont...

Page 15: ...rranty of this device The manufacturer is not responsible for any interference caused by using l Interconnect cables not supplied by Optos l Unauthorized changes or modifications to this equipment Do not use devices which intentionally transmit RF signals cellular phones transceivers or radio controlled devices in the vicinity of this equipment as it may cause performance outside the published spe...

Page 16: ...ning the main mirror The mirror can be damaged during cleaning Preventing mirror contamination reduces the risk of damaging the mirror It is not recommended to routinely clean the main mirror Only clean the mirror if dust particles smudges or spots have accumulated on its surface When cleaning the main mirror do not rub the spots too hard as this may cause damage Do not touch the edges of the main...

Page 17: ... product Be careful not to damage the scan head covers when cleaning Do not use harsh detergent abrasive cleaners or solvents that are not recommended by the manufacturer Do not expose equipment parts to steam or sterilizers as this will damage the device Do not allow liquids to get into the equipment If you believe cleaning sprays or liquids have got into the equipment disconnect the power supply...

Page 18: ...ounts and the maintenance of password security 1 9 Data security CAUTION Your System Administrator is responsible for backing up the image server Backups must be verified regularly to avoid patient data loss Only allow authorized personnel to access the data Changes to data may lead to incorrect diagnosis Implement measures to protect personal patient data from misuse If a critical error occurs du...

Page 19: ...equipment or goods l Environmental pollution CAUTION Cautions are directions which if not followed could cause l A hazardous situation for a user engineer patient or any other person l 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 s...

Page 20: ...rnings and cautions Symbol and label information Consult accompanying documents Disposal in compliance with WEEE Directive Page 20 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 21: ...aser ophthalmoscope and optical coherence tomographer intended for in vivo digital imaging of posterior ocular structures including the vitro retinal interface retina retinal layers optic disc choroid and choroido scleral interface It is indicated for producing high resolution wide field en face reflectance images auto fluorescence images fluorescein angiography images indocyanine green angiograph...

Page 22: ...local or network resources Any browser based review clients connected to your network can be used to review and analyze patient images 2 6 1 System parts 1 2 3 4 5 6 7 8 9 10 FIGURE 1 P200TxE device connected to network No Name of Part Description 1 Scan head The scan head comprises the light sources lasers and swept source and electronics used to capture patient images 2 Head rest The head rest s...

Page 23: ...ment The image server switch and any browser based review clients or monitors must be positioned outside the patient environment more than 1 5 meters 5 ft from the scan head Note The device also includes a user guide power cable and ethernet cable not shown on this diagram A table may also be supplied 2 6 2 Network specification and characteristics The following network specification is recommende...

Page 24: ...ectance images and provides UWF image views from a single capture action l optomap color view an UWF color fundus image combining red and green reflectance images l optomap neurosensory retinal view an UWF green laser reflectance image of the surface retina l optomap choroidal view an UWF red laser reflectance image of the deeper retina optomap af optomap af is an UWF green laser auto fluorescence...

Page 25: ... sectional OCT image The line scan is 48 degrees 14 mm in length The Optos OCT line scan mode lets you capture cross sectional B Scan OCT images of the vitreo retina retina and choroid retina structures This scan is also known as a B scan OCT FIGURE 3 Optos OCT line scan example position and scan pattern Optos OCT raster scan Captures a raster scan of OCT images covering a 48 x 30 degrees 14 mm x ...

Page 26: ...egrees 6 mm x 6 mm field of view Optos OCT ultra widefield HD volume scan HD volume scans can be positioned anywhere within an on axis optomap image The high density scan captures 121 B scans covering a 20 x 12 degrees 6 mm x 3 mm field of view Optos OCT ultra widefield extended line scan The extended line scan can be positioned centrally within an on axis optomap image It generates a cross sectio...

Page 27: ...linked together for simultaneous image viewing l Automatic registration of image features These registered points are used to align images that are viewed together You can also register image reference points manually l Annotation and measurement tools that provide graphical mark ups on the images These mark ups are saved with the patient medical record l Image measurements including distance and ...

Page 28: ...sAdvance image server 1 C5031 Mains power cable C5881 Network cable 1 Where the OptosAdvance image server software is installed on a compatible virtual machine the physical server will not be supplied Page 28 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 29: ...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 switched on 3 1 1 2 Switch on the scan head CAUTION Only use the fabric cover when the scan head is powered off or in standby mode Remove the fabric cover before operating the scan head The scan head will move when the alignment system is be...

Page 30: ...ikely 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 58 l You will be unable to capture images if the self tests have not been successful Please restart the scan head If the problem persists please contact your Optos representative see Contact us on page 67 3 1 1 3 Switch on brow...

Page 31: ...he end of each day on the previous page 2 When the status indicator has turned blue you can turn off the power supply The power switch is located at the at the back of the scan head The off position is marked 3 Fit the dust cap in the face pad and place the fabric cover over the scan head 3 1 2 2 Log off the image server each day You should log off the image server at the end of each day 1 Exit Op...

Page 32: ...can which will be saved at the end of the session You can change laterality and delete images and scans The image browser can be used to select a suitable SLO image at the start of the OCT capture process Cancel Cancels the current action without saving changes Finished Completes the current action Shut down device 3 1 3 2 Using the touch screen keyboard The touch screen keyboard uses the same lay...

Page 33: ...ve the focus within the OCT scan towards the vitreous Press the top button on the hand control to capture an image Press the top button on the hand control to capture a scan Note When capturing OCT scans always wait for the auto routines position depth and focus to complete before making manual adjustments Allow the system to respond after making each adjustment 3 1 3 4 Using the chin rest and hea...

Page 34: ...ty you want is not available see Contact us on page 67 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 To capture and review images and scans use the procedures below Page 34 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights...

Page 35: ...s details by entering any combination of the patient s first name last name birth date and patient ID The matching patient records are displayed as you type 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 l Sm 1987 l Smith 23 birthday on the 23rd day Part Number G110230 1ENG Page 35 of 72 Copyright 2019 Optos plc All right...

Page 36: ...lable or the MWL Server being down must be reconciled using the admin application 3 2 1 1 1 How to search using MWL 1 Select the MWL Search Parameter for the information type to be searched 2 Enter the Search Criteria 3 Select Enter on the touch screen to search MWL and display the corresponding MWL Work Item Note Please contact your Optos representative if introducing MWL to your site 3 2 2 How t...

Page 37: ...nt should look for the patient alignment target see Patient Alignment Guide on page 71 The alignment colors seen by the patient are also shown on the touch screen so you will see the alignment feedback they can see 5 The patient should choose one of the central corners of the alignment target The patient will be asked to look at their chosen corner when being imaged 3 2 3 2 Align the patient 1 Pre...

Page 38: ...in rest and that their teeth are together and mouth closed FIGURE 11 Aligned patient 6 Check that the pupil is stable in the live view and that the patient s head is not tilted 7 Ask the patient to look at their chosen corner of the alignment target and remain still while you make any final adjustments to the scan head to the correct alignment position 8 Adjust the alignment The alignment target w...

Page 39: ...ollowing list Reference How to capture SLO images 39 How to capture SLO eye steered images 40 How to capture SLO stereo images 41 How to capture OCT images 43 How to capture SLO angiography images 42 3 2 4 How to capture SLO images To capture SLO images use the procedure below FIGURE 12 SLO capture workflow Part Number G110230 1ENG Page 39 of 72 Copyright 2019 Optos plc All rights reserved English...

Page 40: ...an then continue or complete the session 1 The captured image is displayed full screen on the touch screen After a few seconds you are automatically returned to the capture page 2 Check the quality of the captured image and if required continue capturing images 3 If required remove the controls from the view by selecting Declutter 4 If required change the laterality or delete the image 5 The captu...

Page 41: ...ally capture the image Auto capture is turned off after capturing an image l Manual capture Align the scan head into the correct position Press the screen to capture the image when the pupil is in the center of the cross hairs and the patient alignment target is green You can also capture using the hand control 7 Check the quality of the images see What to do after the image is captured on the pre...

Page 42: ...medical staff or patient helper Do not inject the patient until the appropriate point in the angiography procedure Selecting Angiography will allow the manual capture of FA or ICG images In Angiography mode the FA or ICG timers can be configured to run separately or as a single combined timer A timer is started by either selecting the timer or when the initial image captured The injection should b...

Page 43: ...nt 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 The OCT set up auto routines will run Ask the patient to keep their eyes wide open at the start of the auto routines During OCT set up the patient will see the alignment target tracking scan and scan pattern see The patient s view of O...

Page 44: ...facts the patient should maintain focus on the center of the green alignment target Ask the patient to keep their head still in the standard alignment during OCT imaging FIGURE 14 Indication of what the patient will see when being aligned for OCT imaging Note In some instances you may choose to ask the patient to align slightly off center For example when capturing an ONH scan where the fovea to O...

Page 45: ...nt process l Adjust the position of the OCT to the upper half of the window but not touching the top of the view The higher the position the higher the sensitivity l Adjust the focus control to increase the signal strength see Using the hand control on page 32 Multiple or extended focus adjustments should not be required l If the auto focus result is not close to best then use the drop down contro...

Page 46: ...d attempt to capture the OCT image at the highest possible SNR level from the captured image A SNR level of 6 10 is a marginal level of SNR In this case you should consider repeating the scan trying to achieve a higher level of SNR Averages Where image averaging is applied the scan result shows the number of scans included For example 20 25 indicates 20 scans were included from 25 captured Movemen...

Page 47: ...g the patient session you should check the required 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 session You can change laterality and delete images and scans You can review stereo paired images Continue capturing images until you have a good stere...

Page 48: ...2 Log in using your username and password 3 3 2 Reviewing patient images and scans Captured images and scans are displayed using the OptosAdvance software Refer to the help files for details on using the applications 1 Double click to run OptosAdvance 2 Log in using your username and password 3 Select the patient 4 Select the image or scan to be reviewed 5 Adjust the study layout and views as requ...

Page 49: ...for the new user and select if they will be an Administrator or Operator 6 Return to the admin menu Note User accounts can be made inactive 3 4 1 2 How to create user accounts on the image server 1 Login to OptosAdvance 2 Select Settings 3 Select 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 3 4 1 3 How to ...

Page 50: ...see Contact us on page 67 3 4 6 Managing the Modality Work List Where MWL 1 is available a traffic light system indicates if the scan head is connected to the server The traffic light icon is displayed on the search page on the touch screen Selecting the traffic light icon will display the network status and confirm if any patient details need to be reconciled with the server This screen will also...

Page 51: ...l operation Please consult your Optos representative before changing the settings 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 carry the unit You should be aware of your contractual obligations before disposing of any equipment 3 4 8 1 Servicing CAUTION Do...

Page 52: ... 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 cleaners or solvents that are not recommended by the manufacturer Do not expose equipment parts to steam or sterilizers as this will damage the device Do not allow liquids to get into the equipment If you belie...

Page 53: ...est 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 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 3 4 8 3 3 Cleaning the...

Page 54: ...nfirm all smudges or spots have been removed 9 Refit the face pad 10 Take another image and compare it to the original reference eye image to determine if the image quality has been sufficiently improved 3 4 8 3 4 Disinfection CAUTION Wear powder free gloves at all times when cleaning the device including the scan head and main mirror If the gloves become contaminated they must be replaced immedia...

Page 55: ...owing table and instructions Additional information and resources are available on the Optos website Go to optos com and register to access the information and resources Detailed instructions on using OptosAdvance can be found in the help files for each application Note If you require further assistance please contact your Optos representative see Contact us on page 67 When contacting Optos you wi...

Page 56: ...rror see Cleaning the main mirror on page 53 If the issue persists contact your Optos representative I see a bright reflex above the optic nerve head Patient is too close Image with the patient further out OCT images show horizontal line artefacts Excessive time spent in the OCT imaging mode 5 minutes for 1 OCT capture Exit and re enter the OCT capture mode to ensure dark frame processing is re ap...

Page 57: ... Number on your Optos documentation System Administrators can also find the Site Number on the scan head Diagnostic page 3 4 9 3 How do I image if the alignment system does not recognize the eye In some circumstances the device may not recognize the patient s eye When this happens the alignment system will not display the blue green or red indicators which show how close the scan head is to the pa...

Page 58: ... when prompted 4 You can now login to the scan head and re open any Optos applications on the other PCs 3 4 9 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 l Archive and clear archived studies to recover disk space If the image server is full it is likely that the system needs to be ar...

Page 59: ...etic emissions on page 64 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 that may cause undesired operation 4 1 1 Scan head TABLE 9 Scan head safety designation details Feature description Compliance Type of protection against electrical shock Class 1 Degree of protecti...

Page 60: ...RE 16 Sample of the connection label No Description 1 Mains power cable and switch l Protective earth must be fitted l U K Power Cable Fuse 13A 2 Network cable 3 Hand control and Optos Service use 4 Touch screen 4 1 3 Scan head dimensions The scan head hand control and touch screen should be placed on a table which meets the table specification see Table requirements on page 62 There should be ade...

Page 61: ...y properties for browser based review clients The minimum recommended monitor resolution 1280 x 1024 pixels 16 7 million colors Recommended browsers for OptosAdvance Google Chrome 46 0 and higher Internet Explorer 11 0 and higher Apple Safari 6 0 and higher 4 1 5 Touch screen properties The touch screen is powered from the scan head at 12V WARNING Do not disconnect or connect the touch screen whil...

Page 62: ...nches Depth 600 mm 24 inches including chin rest Height 725 mm 29 inches to 1205 mm 47 inches Where wheelchair accessibility is required the table must meet wheelchair accessibility standards 4 1 7 Battery CAUTION Do not remove the scan head covers Only Optos trained technical personnel are permitted to service the device The device contains a 3V Lithium coin battery 4 1 8 Environmental considerat...

Page 63: ...the rear scan head cover CLASS 1 LASER DEVICE 4 2 2 Internal Laser warning information Location of Laser warning Warning information Positioned on the laser module BDIO VISIBLE AND INVISIBLE LASER RADIATION AVOID DIRECT EXPOSURE TO BEAM CLASS 3B LASER PRODUCT Positioned on the swept source cover WARNING LASER RADIATION AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT Positioned of the fiber network c...

Page 64: ...ssions IEC61000 3 2 Class A Voltage fluctuations flicker emissions IEC61000 3 3 Pst Dmax 4 3 2 Guidance and manufacturer declaration electromagnetic immunity TABLE 16 List of electromagnetic immunity compliance Immunity test IEC60601 compliance test level Electromagnetic environment guidance Electrostatic discharge IEC61000 4 2 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile I...

Page 65: ...characteristic of a typical location in a typical commercial or hospital environment Note UT is the a c mains voltage prior to the application of the test level Conductive RF IEC61000 4 6 3Vrms 150kHz to 80MHz Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation appl...

Page 66: ...le and mobile communication equipment and the device The P200TxE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the P200TxE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment transmitters and the P200TxE as recommended below accordi...

Page 67: ...os 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 5 2 1 United States and Canada Optos Inc 500 Nickerson Road Suite 201 Marlborough MA 01752 United States of America Sales Marketing and Customer Support call toll free 800 854 3039 Outside continental US Canada 1...

Page 68: ... 0 805 119499 5 2 5 Germany and Austria Optos GmbH Tiefenbroicher Weg 25 D 40472 Düsseldorf Deutschland Telephone DE 0 800 723 6805 Telephone AT 0 800 24 48 86 Fax 49 0 211 9414 301 All inquiries ics optos com Customer Support DE 0 800 723 6805 Customer Support AT 0 800 24 48 86 5 2 6 Norway Telephone 47 800 16711 All inquiries ics optos com Customer Support 47 800 16711 5 2 7 Spain Telephone 44 0...

Page 69: ...7 38 All inquiries ics optos com Customer Support 0800 55 87 39 5 2 10 United Kingdom and other European countries Optos plc Queensferry House Carnegie Campus Enterprise Way Dunfermline Fife KY11 8GR UK 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 G110230 1ENG Page 69 of 72 Cop...

Page 70: ...Page 70 of 72 Part Number G110230 1ENG English Copyright 2019 Optos plc All rights reserved ...

Page 71: ...me instances 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 an image when you are aligned slightly off center Part Number G110230 1ENG Page 71 of 72 Copyright 2019 Optos plc All rights reserved English Optos Inc Tel 800 854 3039 usinfo optos com Optos plc ...

Page 72: ...G110230 1ENG ...

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