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HD Analyzer

™ Chapter 6: Manufacturer

- 98 -

6 M

ANUFACTURER

VISIOMETRICS, S.L.

C/Argenters, 8. Edifici 3.

Parc Tecnològic del Vallès

E-08290 Cerdanyola del Vallès

Barcelona (Spain)

Tel.: (+34) 935 824 501

Manufacturer number:

5.122-PS

Our website:

www.visiometrics.com

Commercial information:

[email protected]

Technical Support:

[email protected]

Содержание HD Analyzer OQAS

Страница 1: ...USER S MANUAL Version 2 4 English 0318 e tina Deutsch Espa ol Fran ais Italiano Nederlands Portugu s T rk e Magyar Polski...

Страница 2: ...MODEL OQAS HDA Optical Quality Analysis System High Definition Analyzer BRAND HD Analyzer APPLICABLE PARTS Chin guard Type B CODE 2 REVIEW 1 2017 08 PRINTED IN SPAIN...

Страница 3: ...D ANALYZER 22 3 1 USING THE PROGRAM WITHOUT THE HD ANALYZER 22 3 2 USING THE PROGRAM WITH THE HD ANALYZER 22 3 2 1 User guidelines 22 3 2 2 Patient guidelines 23 3 2 2 1 General guidelines 23 3 2 2 2...

Страница 4: ...Purkinje option 65 3 5 5 3 Move the machine away from the patient and focus the eye 65 3 5 5 4 Select the appropriate option 66 3 5 5 5 Focus with the help of the directional arrows 67 3 5 5 6 Automat...

Страница 5: ...5 5 2 WARNING MESSAGES 96 6 MANUFACTURER 98 7 REGULATORY INFORMATION 99 8 SYMBOLS 100 9 ELECTROMAGNETIC IMMUNITY 100...

Страница 6: ...ACCESS TO EQUIPMENT S POWER CONNECTION TO THE ELECTRICAL NETWORK TURN OFF OR UNPLUG THE DEVICE WHEN NOT IN USE TO AVOID THE RISK OF FIRE AND ELECTRIC SHOCK DO NOT EXPOSE THE HD Analyzer UNIT TO RAIN...

Страница 7: ...PARTS INSIDE THE DEVICE THAT CAN BE REPAIRED BY THE USER CONTACT YOUR SUPPLIER OR TECHNICAL SERVICE IN CASE OF BROKEN OR DAMAGED EXTERNAL PARTS PLEASE CONTACT TECHNICAL SERVICES BEFORE USING THE DEVIC...

Страница 8: ...the network If the equipment stops working normally error messages will appear on the computer screen In this case do not try to repair it Refer to your supplier or technical service If the equipment...

Страница 9: ...the eye including high order aberrations and diffuse light which are not usually taken into account by most aberrometric techniques These higher order aberrations can have a major impact on refractive...

Страница 10: ...ough the FC moving head to which two mirrors are attached the correction of the spherical refraction of the eye to be measured is produced This is achieved by modifying the optical paths between lense...

Страница 11: ...calculated from the assessment of the amount of light that is on the outside of the patient s double pass image relative to the amount of light in its central part Accordingly the higher the OSI value...

Страница 12: ...them all having the same definition This agrees with the fact that the more details and contours greater spatial frequency there are in the real scene the more the contrast between those details and...

Страница 13: ...maximum possible As the frequency increases the MTF decreases because the contrast in the system image is increasingly less than the real scene contrast This relationship expressed mathematically is t...

Страница 14: ...easurement with an artificial pupil diameter that is less than the natural pupil diameter so that the measurement conditions are reproducible 1 2 CHARACTERISTICS Quantitative and objective assessment...

Страница 15: ...pseudoaccommodation range Diagnosis of pathologies Precise measurement of the ocular MTF Modulation Transfer Function in all situations The aberrometers overestimate the MTF when there is scattering p...

Страница 16: ...time 240 ms Laser diode wavelength 780 nm Selection of laser power Automatic Maximum laser power in pupil plane 45 39 W Best focus position Automatic Fixation target Landscape with house XY Movement...

Страница 17: ...sta and Windows 7 32 bits Minimum USB ports 1 USB 2 0 port 1 4 3 Accessories 1 4 3 1 Computer PC or laptop Used to run the instrument control program Must meet the following minimum specifications Pro...

Страница 18: ...he HD Analyzer over a 5 year period places the dynamic elements of the equipment below 15 of their service lives 1 6 ACCURACY OF THE MANUAL It is possible that some of the screens shown in the various...

Страница 19: ...part is very fragile and could damage the interior elements If transport to a distant location is necessary you should contact your local distributor or the manufacturer to carry out the packaging pro...

Страница 20: ...on the chin rest and through the hands with which they can grasp the chin rest This risk which can be classified as Non Critical and as a consequence will only require a low level of disinfection is...

Страница 21: ...e when it is not in use This device is not water or splash proof If moisture water or liquid gets inside immediately unplug it and contact technical services or your provider before using the device a...

Страница 22: ...can select the mode chosen for correction from all those available It is important to emphasize the following Purkinje measurements do not require any external correction Therefore when performing a...

Страница 23: ...ectly positioned in the chinstrap of the HD Analyzer and move the mobile part of the device to the position that is farthest from the patient In addition it is recommended that all measurements be tak...

Страница 24: ...ars the sounds If no sound pattern is followed have the patient try not to blink or blink as little as possible during the entire process 20 seconds Also advise the patient to close the eye not being...

Страница 25: ...this occurs contact your distributor to schedule a calibration Figure 6 Home screen Home Most times when running the program after the home screen you head to the Database To save time the program au...

Страница 26: ...database and related images into the desired directory Setup This button displays the setup screen where some of the system parameters can be modified Each parameter is detailed in later chapters 3 4...

Страница 27: ...ioning 27 Figure 7 Patient database The Patient field allows searching patients by name surname patient ID and a range of dates date of birth last measurement or any other measurement Figure 8 Patient...

Страница 28: ...splays all the details for this patient and you can perform new measurements or load and analyze existing data 3 4 2 Working with patients 3 4 2 1 Add data on a new patient To add data on a new patien...

Страница 29: ...data A dialog box asking to confirm the changes will be displayed If confirmed the changes will be saved If not confirmed it will bring you back to the data modification screen Click Cancel to cancel...

Страница 30: ...t Once the patient is selected their previously saved measurements will be displayed Here they can be retrieved for analysis printing comparison etc By default the entire list is shown but you can app...

Страница 31: ...o print a series of measurements at the same time avoiding the need to load each separate measurement manually Simply select those which you would like to print by holding Control and click Once selec...

Страница 32: ...before deleting 3 5 MEASUREMENTS To access the measurements screen you must first access the Database screen Next select the patient you wish to take measurements from and finally click on Measure You...

Страница 33: ...3 Functioning 33 Figure 13 Entering the refraction without information If the patient has been studied before the program will fill in the sphere cylinder and axis fields with the last accepted value...

Страница 34: ...5D to 8D as long as the astigmatism is less than or equal to 0 5D In any other situation the instrument requires external assistance This may be Cylindrical corrective lenses located in the head of th...

Страница 35: ...e being taken You may also enter the best corrected visual acuity BCVA and the uncorrected visual acuity UCVA as additional information to be included in the printed results report via the button loca...

Страница 36: ...oftware version being run B Main functions Using these buttons you can carry out the various operations related to data processing such as accessing the database see section 3 4 and saving or printing...

Страница 37: ...eric results obtained for measurements relating to OSI Light Condition Depth of Focus Tear Film and Purkinje as well as the parameters entered by the user 3 5 3 3 Data on the selected patient also app...

Страница 38: ...f the patient s spherical refraction within a 3D range around the spherical equivalent of the subjective refraction entered by the user If the values entered are incorrect the system will produce an e...

Страница 39: ...this process is taking place the user can see the double pass images that the program records Once finished the program automatically selects the double pass image it considers to most in focus and d...

Страница 40: ...and Light Condition See the indications relating to the patient in section 3 2 The OSI measurement index of scattering or diffuse light by defining the OSI parameter can be carried out using the 4 mm...

Страница 41: ...next screen after capturing the six double pass images This may be The screen to validate each of the six double pass images captured before processing them The screen of the results selected in the u...

Страница 42: ...ttern of sounds The results will display different information depending on whether or not it was guided or through a pattern of sounds To configure the default mode that carries out the tear film seq...

Страница 43: ...change in the tear film The Figure 20 shows how the Tear Film images are being recorded Figure 20 Tear Film measurement 3 5 3 3 Depth of Focus See the indications relating to the patient in section 3...

Страница 44: ...t all times Figure 21 Depth of Focus measurement Ask the patient to try to focus on the stimulus during the Depth of Focus process Otherwise the results may come out incorrect Keep in mind that at tim...

Страница 45: ...asurement entered by the user Measured pupil diameter Patient s pupil diameter measured by the instrument A value of 0 0 indicates that said diameter cannot be measured Best focus position Best spheri...

Страница 46: ...lyzer Chapter 3 Functioning 46 3 5 4 1 OSI and Light Condition The results of these two measurements are shown in Figure 22 and Figure 23 respectively Figure 22 OSI results Figure 23 Light Condition r...

Страница 47: ...three clearly defined areas in Figure 24 Figure 24 Areas of the result screen A Button area These buttons give access to the different viewing options for the measurement results B Image view area De...

Страница 48: ...alues in red represent eyes with a significant degree of diffusion mature cataract etc The OSI value is colored according to the visible color scale under the value itself Potential Visual Acuity It i...

Страница 49: ...sion of the patient s optical system affect the formation of the image on the retina The patient does not have to see as the screen shows since only the optical quality of the eye is taken into accoun...

Страница 50: ...resented by a color scale By clicking and dragging the mouse over the image on the left you can select the area of the image that will be displayed on the right side where you can apply the desired zo...

Страница 51: ...the retinal image Figure 28 is shown on the right side of the screen The zoom allows you to zoom in and out of the image by pressing the More or Less buttons You can rotate the 3D image by simply dra...

Страница 52: ...s starting from the bottom right The radial profile shows the median profile Choose the Angular display to view the profile at a particular angle Move the cursor in the bar that opens under the image...

Страница 53: ...the measurements by optical constraints whereas in the subjective cases neuronal processing aspects are largely involved This visual acuity is shown on both decimal and Snellen scales The value of the...

Страница 54: ...le which allows a clearer appreciation of the cut off frequency MTF cut off This chart is displayed on the right side of the screen By selecting a specific area of the graph with the mouse cursor you...

Страница 55: ...2 Tear Film are shown Two numerical values can be found at the top of each of them The one on the left represents the moment the image was recorded The one on the right represents the calculated OSI...

Страница 56: ...e results taking into account the corrections provided Figure 32 Modification in the cataloging of images You can export the images by double clicking with the left side of the mouse and specifying th...

Страница 57: ...igure 33 Tear film result screen with sound pattern A Patient History Each time a measurement is guided by a sound pattern it is classified into one of the following 5 groups conveniently defined and...

Страница 58: ...lution over the 20 seconds of a specific measurement is shown assigning it the color associated to the group to which the measurement belongs according to its characteristics In the upper right the gr...

Страница 59: ...at is why the best double pass image detected shows 0 0 D and is marked as Distance vision The image marked Near Vision corresponds to an accommodative demand of 2 0 D Inside the image in the upper le...

Страница 60: ...The OQAS Accommodative Range OAR is considered to be the dioptric range between the BF and the point at which the quality chart decreases to 50 In the event that the program considers that it is possi...

Страница 61: ...an example of each of these screens They all have a similar structure In the lower part the parameters used in each measurement are detailed while in the upper part the results obtained are shown You...

Страница 62: ...HD Analyzer Chapter 3 Functioning 62 Figure 36 Comparison of profiles in Light Condition measurements Figure 37 Depth of Focus measurement comparison...

Страница 63: ...f the mouse and specifying the desired directory You can export it as an image bmp or jpg format or directly save your data in a text file txt 3 5 5 Purkinje Measurement 3 5 5 1 Introducing the subjec...

Страница 64: ...apter 3 Functioning 64 The patient must perform the measurement without correcting their visual impairments Therefore neither test glasses nor the patient s own glasses will be used Figure 39 Subjecti...

Страница 65: ...e option Figure 40 Position of the Purkinje option 3 5 5 3 Move the machine away from the patient and focus the eye Now while the patient is looking at the center of the house in the stimulus move the...

Страница 66: ...MRA inlay implanted Post With inlay for those patients who have the KAMRA inlay implanted At the moment you select one of the 2 options the laser will be activated and the patient will be able to see...

Страница 67: ...to the patient s eye and one yellow pointing to you which will guide your movements Note that these indications will only be displayed when the eye is correctly centered on the image Initially the bl...

Страница 68: ...ppear around the Purkinje image of the laser in a very central area of the image Continue moving at a constant speed keeping that green circle as centered as possible reaching the point of best focus...

Страница 69: ...that it has passed beyond the point of best focus and will replace the blue arrow with a yellow arrow pointing in the opposite direction Reverse the direction of movement of the machine moving it away...

Страница 70: ...and their size to indicate which direction the machine should move to reach the point of best focus and how far it is from that point of best focus the larger the arrow the farther away the machine i...

Страница 71: ...ot move the machine any more Figure 46 Green mark indicating the position of best focus It is advisable during this focusing process that the patient although he she can blink should avoid doing so ex...

Страница 72: ...nt has involuntarily moved the head or you have involuntarily moved the machine the indicating arrows will show you how to reach the best focus point again Similarly if at any time the eye becomes dec...

Страница 73: ...not correct On the enlarged image locate In Pre Without inlay acquisitions the center and the edge of the pupil In Post With inlay acquisitions the center and edges of the KAMRA inlay To locate the c...

Страница 74: ...mouse and the program will show the partial results of the acquisition 3 5 5 7 Validating a partial image Evaluate how good the image captured and proposed by the program is assessing how well the bo...

Страница 75: ...the optical axis or the lens in case of post operative measurements is not good enough select the Discard image button and the program will return to the point again 3 5 5 63 5 5 6 Automatic capture...

Страница 76: ...mode once you ve reached this point you have already captured and validated a complete partial image But due to the precision that is demanded of the program one image is not sufficient enough to guar...

Страница 77: ...ss since the eye is in a state of constant change it is possible that it has lost its best focus For the second image onward the program automatically discards those that stray too far from the image...

Страница 78: ...e among all the captured and validated images 1 in Manual mode or 5 in Automatic Statistically speaking they are the images closest to the reality of the patient For image results of pre operative mea...

Страница 79: ...or the other may be printed depending on the view option being used when clicking Print When printing you are given the option to either print the report view a print preview or export the report as...

Страница 80: ...HD Analyzer Chapter 3 Functioning 80 Figure 54 Example of a printed OSI report...

Страница 81: ...HD Analyzer Chapter 3 Functioning 81 Figure 55 Example of a printed Light Condition report...

Страница 82: ...HD Analyzer Chapter 3 Functioning 82 Figure 56 Example of a printed Depth of Focus report...

Страница 83: ...HD Analyzer Chapter 3 Functioning 83 Figure 57 Example of a printed Tear Film report double pass images...

Страница 84: ...HD Analyzer Chapter 3 Functioning 84 Figure 58 Example of a printed Tear Film report sound patterns...

Страница 85: ...HD Analyzer Chapter 3 Functioning 85 Figure 59 Example of a printed pre operative Purkinje report...

Страница 86: ...ng 86 Figure 60 Example of a printed post operative Purkinje report Finally you can also generate a report for each of result comparison screens via the Compare option in Database Click Print in these...

Страница 87: ...1 Setup screen 3 6 1 Identification Company refers to the name of the clinic or hospital where the equipment is installed User refers to the name of the doctor or person in charge The information ente...

Страница 88: ...in the fourth option Figure 62 Screen to set the name format The fifth and sixth options allow automatic exportation to an xml file used by IFA Systems AG servers 3 6 4 Visual options for OSI The firs...

Страница 89: ...when performing the Tear Film measurement 3 6 6 Visual options for Purkinje Indicates whether the program should show the pupil in the Post With inlay measurements 3 6 7 Modify and Cancel buttons Onc...

Страница 90: ...d measurements taken This includes the Microsoft AccessTM database file as well as all recorded images If you ve chosen a location where a backup copy already exists the program will overwrite the exi...

Страница 91: ...le pass image is very small and rounded that is the degradation of the retinal image due to both aberrations and intraocular diffusion is very small This can be verified with the very high value of th...

Страница 92: ...that spreads in all directions As a result a high OSI value can be expected as it is At the same time the AV Potential would be low Taking note of the simulation of the projected image on the retina...

Страница 93: ...the operation has been a success Figure 65 is an example of a report of the measurement results of an eye after LASIK surgery You can see how the quality of vision is very satisfactory since the doub...

Страница 94: ...diffusion The OSI value is more significant than in the previous case major diffusion and the AV Potential is minor In the simulations of the projected image on the retina you can also see a more noti...

Страница 95: ...ld not be completed Check the subjective refraction entered and try again 25 27 29 26 28 30 The program has detected a problem with the hardware A hardware error has occurred in the internal spherical...

Страница 96: ...t credit Contact Visiometrics 5 2 WARNING MESSAGES Message Cause The device has not been detected The software will run in read only mode To run in normal mode check the connection cables and restart...

Страница 97: ...Files x86 Visiometrics HD_Analyzer log error log If an error occurs please exit the program turn off the instrument and restart them both again If the error persists check the connections between the...

Страница 98: ...ers 8 Edifici 3 Parc Tecnol gic del Vall s E 08290 Cerdanyola del Vall s Barcelona Spain Tel 34 935 824 501 Manufacturer number 5 122 PS Our website www visiometrics com Commercial information custome...

Страница 99: ...HD Analyzer Chapter 7 Regulatory information 99 7 REGULATORY INFORMATION Australian sponsor Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia...

Страница 100: ...throw out as miscellaneous urban waste but rather dispose of it at a recycling point destined for electrical and electronic equipment CE Brand Serial number Applicable part Laser radiation Class II eq...

Страница 101: ...z and 800 MHz NOTE 2 These guidelines cannot apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM Industrial Scient...

Страница 102: ...7 For assigned transmitters with a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the transmitter frequency...

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