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Page 3 of 60

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Part

Number:

G102748/11_ENG

Release

Date:

January

2021

0197

Manufacturer

Optos

plc

Queensferry

House

Carnegie

Campus

Enterprise

Way

Dunfermline,

Fife

KY11

8GR

UK

Part

Number:

G102748/11_ENG

Copyright

2021

,

Optos

plc.

All

rights

reserved.

English

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Содержание P200T

Страница 1: ...optos com User Guide P200T Optos Panoramic Ophthalmoscope G102748 11_ENG...

Страница 2: ...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 Un...

Страница 3: ...mation 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 doc...

Страница 4: ...Page 4 of 60 English Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved...

Страница 5: ...2 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 4 System software 24 2 6 4 1 Understanding...

Страница 6: ...o capture stereo images 35 3 3 Review images 35 3 3 1 Starting the review software 36 3 3 1 1 How to start the application 36 3 3 2 Reviewing patient images and scans 36 3 3 3 Exiting the review softw...

Страница 7: ...4 9 5 How do I restart the image server 46 3 4 9 6 What should I do if the PC drive on the image server is full 46 4 Technical Specification 47 4 1 Safety designation IEC 60601 1 47 4 1 1 Scan head 4...

Страница 8: ...Network specification 23 TABLE 2 List of parts 25 TABLE 3 List of touch screen icons 30 TABLE 4 List of status indicator lights 38 TABLE 5 List of problems and solutions 44 TABLE 6 Scan head safety d...

Страница 9: ...twork Daytona shown 22 FIGURE 2 Network data flow 24 FIGURE 3 Example capture and review workflow 31 FIGURE 4 Sample of the connection label 48 Page 9 of 60 Part Number G102748 11_ENG Copyright 2021 O...

Страница 10: ...Page 10 of 60 English Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved...

Страница 11: ...e scan head should be inline with the front of the table to allow the patient to get into the correct alignment position Suitability of images The suitability of using an image or print for viewing is...

Страница 12: ...sentative will configure the settings when the device is installed These settings should NOT be changed in the course of normal operation Please consult your Optos representative before changing the s...

Страница 13: ...r exposure Using the controls adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure All P200T product variants are Class 1 laser devices...

Страница 14: ...e 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 55 The image server switch browser based rev...

Страница 15: ...emission limits CISPR11 Group 1 Class B Guidance and manufacturer declaration electromagnetic emissions on page 51 Although compliant with all applicable international EMC standards the equipment gen...

Страница 16: ...In order to prevent any contamination always clean and disinfect parts of the equipment which will be in contact with the patient see Cleaning before each patient on page 41 Adequate cleaning and disi...

Страница 17: ...equipment 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 Do NOT let the cleaning...

Страница 18: ...an head and image server should be kept in a secure location You are responsible for maintaining the security of information stored on the scan head and image server You are responsible for the securi...

Страница 19: ...warning WARNING Warnings are directions which if NOT followed could cause l Fatal or serious injury to a user engineer patient or any other person l Damage to the equipment described in this manual a...

Страница 20: ...ge which can flow from the applied part The limits for this are defined in IEC 60601 SN Serial Number In accordance with Directive 93 42 EEC Consult accompanying documents Disposal in compliance with...

Страница 21: ...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 NOT required the decision to dilat...

Страница 22: ...Administrators can also manage images located on 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 par...

Страница 23: ...includes a user guide dust cap 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...

Страница 24: ...p color reflectance and optomap af modalities l optomap plus is generally used for medical imaging optomap is captured at a standard resolution and is typically used for healthy eye exams or screening...

Страница 25: ...rea measurements and cup to disk ratio l You can also use the 3D Wrap view for patient education purposes The 3D Wrap view displays the current image on a 3D model eye You can run the animated Fly Thr...

Страница 26: ...Page 26 of 60 English Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved...

Страница 27: ...e switched on 1 Check that the power supply is switched on 2 Switch on the image server Your image server may also be used as a browser based review client Note If it seems the image server is not wor...

Страница 28: ...ad If the problem persists please contact your Optos representative see Contact us on page 55 3 1 1 3 Switch on browser based review clients Captured images can be reviewed using the OptosAdvance soft...

Страница 29: ...te l Your device communicates with Optos overnight and will need to access the image server PC l Image files cannot be viewed on browser based review clients when the image server has been shut down l...

Страница 30: ...pture 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 NOT available see Contact us on pa...

Страница 31: ...Chapter 3 How to FIGURE 3 Example capture and review workflow Page 31 of 60 Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved English...

Страница 32: ...e the following information l Patient name l Patient ID l Patient date of birth l Patient gender l Patient notes optional Depending on the features available on your device you may be able to record p...

Страница 33: ...duration of the session if possible There will be opportunities for the patient to rest and blink You will tell the patient when they can rest and blink and when they should try to stay still 2 The p...

Страница 34: ...eing imaged 8 Capture the required image modality from the following list Reference How to capture SLO images 34 How to capture eye steered images 35 How to capture stereo images 35 3 2 4 How to captu...

Страница 35: ...l 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 7 Check the q...

Страница 36: ...s as required 6 Compare results across studies if required Note Detailed instructions can be found in the application help files 3 3 3 Exiting the review software To leave OptosAdvance select Logoff 3...

Страница 37: ...scan head by following these steps 1 Log in to the scan head using the touch screen 2 Select To admin 3 Select Language 4 Select a language from the list 5 Select X to set the language and close the...

Страница 38: ...ecks during start up and shut down 3 4 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 approp...

Страница 39: ...remove the scan head covers Only Optos trained technical personnel are permitted to service the device The scan head weighs 28 kg 62 lbs maximum This requires two people to lift or carry the unit You...

Страница 40: ...se 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...

Страница 41: ...The following cleaning procedures should be carried out before each session 1 Clean the eye piece and dust cap with an individually sealed 70 IPA isopropyl alcohol wipe The eye piece and dust cap can...

Страница 42: ...s to remember when cleaning the main mirror l To prevent contamination take care NOT to touch the surface of the cloth that will be used to clean the mirror l Only hold the cloth by the corners 1 Capt...

Страница 43: ...e A 3V Lithium coin battery is embedded in the hardware for the device and does NOT require to be changed by users If there is a problem please contact your Optos representative see Contact us on page...

Страница 44: ...server is switched on and running see How do I restart the image server on page 46 Check the image server network address and ensure the scan head is on the same network and configured to connect to...

Страница 45: ...r and see Why can t I login below Multiple failed login attempts will result in the user account being locked until a System Administrator unlocks the account 3 4 9 1 Why can t I login This is usually...

Страница 46: ...o I restart the image server Software problems are often temporary and can be resolved by restarting the PC Note When restarting the image server l Ask scan head users to logout before shutting down t...

Страница 47: ...ge 51 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 un...

Страница 48: ...ontinuous Touch screen voltage 12V 4 1 2 Connections These connections are NOT intended to be detached by the user FIGURE 4 Sample of the connection label No Description 1 Mains power cable and switch...

Страница 49: ...ew clients let you review and analyze patient images TABLE 8 Review client properties Review clients Display properties for browser based review clients The minimum recommended monitor resolution 1280...

Страница 50: ...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 considerations ambient Do NOT operate the...

Страница 51: ...Electromagnetic compatibility EMC The P200T 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...

Страница 52: ...cycles Mains power quality should be that of a typical commercial or hospital environment If the user of the device requires continued operation during mains interruptions it is recommended that the...

Страница 53: ...e 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 operation If abn...

Страница 54: ...mitter where P is the maximum output power of the transmitter in watts W according to the transmitter manufacturer Note l At 80MHz and 800MHz the higher frequency range applies l These guidelines may...

Страница 55: ...tion received from Optos Alternatively open the Vantage Admin application and select System menu Set Site Information to display the Practice Information dialog box 5 2 Regional Offices Please check o...

Страница 56: ...e Cedex France Telephone 0 805 119499 All inquiries ics optos com Customer Support 0 805 119499 5 2 5 Germany and Austria Optos GmbH Tiefenbroicher Weg 25 D 40472 D sseldorf Deutschland Telephone DE 0...

Страница 57: ...c 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 5 2 10 United Kingdom and other European cou...

Страница 58: ...Page 58 of 60 English Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved...

Страница 59: ...te In some instances the operator may choose to capture an image when you are aligned to the blue or red target Page 59 of 60 Part Number G102748 11_ENG Copyright 2021 Optos plc All rights reserved En...

Страница 60: ...G102748 11_ENG English...

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