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D-0134090-A – 2022/11
VisualEyes™ - Instructions for Use - EN

Page

Protocol management

Clicking on

“Configuration”

from the main

screen, and selecting

“Protocol Management”

will take the operator to the menu shown in

Figure 3.4-1

This menu is used for managing the

protocols in the system. Protocols are

composed of a list of tests and designated to

be performed in a specific order at the

preference of the clinician or clinic. For a

detailed description of each of these menus

and the available settings, refer to the

Additional Information.

Figure 3.4-1: Protocol Management menu

Содержание VisualEyes 505

Страница 1: ...rotationa Instructions for Use EN VisualEyes Micromedical by Interacoustics Science made smarter D 0134090 A 2022 11...

Страница 2: ...out notice No part of this document may be reproduced or transmitted in any form or by any means without a prior written permission of Interacoustics FireWire is a registered trademark of Apple Inc re...

Страница 3: ...3 USB connection 18 Software installation 18 2 5 1 Demo patients 20 2 5 2 Uninstalling VisualEyes 21 Hardware components and installation 21 2 6 1 VNG and vHIT goggles 22 2 6 1 1 Side mount goggles 2...

Страница 4: ...adjustment 70 3 6 1 Eye image centering 70 3 6 2 Focus adjustment 71 3 6 3 Eye tools menu 71 Calibration 72 3 7 1 Standard calibration 73 3 7 2 Torsion calibration 75 3 7 3 EyeSeeCam calibration 76 3...

Страница 5: ...isualEyes system 99 Warranty and service 99 Rotational chair error messages 100 Cameras disconnecting 102 General technical specifications 103 Minimum computer requirements 103 Standards 103 Goggles 1...

Страница 6: ...nuals on the manufacturer s official website Intended use The VisualEyes system is to be used by trained personnel only such as audiologists ENT surgeons physicians hearing healthcare professionals or...

Страница 7: ...t rotary chairs The VisualEyes system is available in a number of different configurations with and without rotary chairs The standard configurations without rotary chairs are VisualEyes 505 VisualEye...

Страница 8: ...Dynamic Visual Acuity o Gaze Stabilization Test VORTEQ Diagnostic VisualEyes 525 VORTEQ Diagnostic is an add on module including the VORTEQ 2nd Generation IMU for head position and velocity tracking...

Страница 9: ...X Smooth Pursuit X Saccade X Ocular Counter Roll w torsional tracking X Saccadometry X EyeSeeCam vHIT X ADD ON VORTEQ Assessment Dynamic Visual Acuity Dix Hallpike Advanced Lateral Head Roll Gaze Sta...

Страница 10: ...Orion Reclining Orion Reclining is a rotary chair that can be reclined for caloric and positioning testing Orion Comprehensive Orion Comprehensive is a rotary chair inside a chair enclosure containing...

Страница 11: ...X X X X Sinusoidal Harmonic Acceleration SHA X X X X X X VOR Suppression X X X X X X Visual VOR X X X X X X Static SVV X X X X Dynamic SVV X X ADD ON VORTEQ Assessment Dynamic Visual Acuity Dix Hallp...

Страница 12: ...ed major parts EyeSeeCam vHIT goggle and camera VisualEyes software Full HD room camera Cleaning cloth Introduction guides Certificates and reports e g test result report license certificate certifica...

Страница 13: ...esktop PC configuration Included major parts Binocular USB goggles 7 port USB 3 0 hub w external power supply Included major parts Adult USBM2 1A Pediatric USBM2 1P mask for monocular USB camera 7 por...

Страница 14: ...Goggle mounts for side mount and top mount goggles VORTEQ 2nd gen sensor Bluetooth dongle USB cable for charging wired connection Goggle mounts for side mount and top mount goggles Headband for Dynam...

Страница 15: ...device to sale by or on the order of a physician 2 Do not disassemble or modify the product as this may impact on the safety and or performance of the device Always refer to qualified authorized pers...

Страница 16: ...14 Do not service any part of the equipment while in use with a patient CAUTION used with the safety alert symbol indicates a hazardous situation which if not avoided could result in damage to the equ...

Страница 17: ...y Such products will be marked with the crossed out wheeled bin The cooperation of the user is important to ensure a high level of reuse and recycling of electric and electronic waste Failing to recyc...

Страница 18: ...operator can restart the test from the software Rotational chair has seat belt to secure the patient from falling during the tests Rotational chair tests do not respond to the RF remote as an additio...

Страница 19: ...it Examine the cabinet and accessories for scratches and missing parts Report any concerns immediately Report any missing part or any mechanical or electrical malfunction immediately to your local di...

Страница 20: ...tion EU 2017 745 Approval of the quality system is made by T V identification no 0123 Medical device Manufacturer Date of Manufacture Indicates a component is intended for one use or for use on a sing...

Страница 21: ...16 This product contains a component Orion Comprehensive Auto Traverse chair of Class 2 Laser beam Hence do not look directly into the laser beam Keep dry Transport and storage temperature range Trans...

Страница 22: ...VisualEyes This is especially important to consider in a server client setup with multiple installations of VisualEyes where it is recommended to upgrade all installations to the newest software PC se...

Страница 23: ...and shut down the computer Make sure the power cable and the power supply for PC are disconnected Plug the PCI expresscard into a free PC slot and insert the power adapter F3 14 SATA 16 between the po...

Страница 24: ...If a previous version of VisualEyes has been installed on the computer checking Migrate any existing VisualEyes system settings will transfer any existing system settings during the installation This...

Страница 25: ...store it in a convenient place 2 5 1 Demo patients The VisualEyes software includes demo patients that you can import into OtoAccess Database for demos The demo patients are available at the followin...

Страница 26: ...installer and control panel Hardware components and installation A VisualEyes system can depending on the configuration contain a lot of hardware components and it is important that these are all conn...

Страница 27: ...justable Velcro head strap that comfortably secures the goggles to the patient The side mount goggles come with replaceable foam pads that are meant for single use as reuse of foam pads can cause cros...

Страница 28: ...rizontal camera adjustment 3 camera focus adjustment right Hardware setup 1 Insert the camera s into the camera slot s on the goggle and tighten the fixation screws using the supplied screw driver unt...

Страница 29: ...ect the other end of the USB cables to the supplied USB hub Ensure that the hub is powered through the external power supply If used with a rotary chair the goggles plug in to the connectors on the ch...

Страница 30: ...igured as VisualEyes EyeSeeCam The camera is connected through USB and can be mounted into the spherical socket over the eye A laser stimulus projects from the goggles in the vHIT test Figure 2 6 7 Ey...

Страница 31: ...ensing 6 Ensure that the calibration laser is in horizontal vertical alignment and adjust if necessary 2 6 2 External room camera All VisualEyes systems are delivered with an external room camera This...

Страница 32: ...ase find the below example for better explanation Before calibration you can select the Calibration option which is shown with a white background After calibration you can select the START option whic...

Страница 33: ...d installation instructions please refer to separate documentation for AquaStim or AirFx Setup in software 1 Connect the USB type B connector to the connector on the rear panel of the irrigator Connec...

Страница 34: ...be model DLB7 2 or newer to be compatible with the system Figure 2 6 15 Digital Light Bar Hardware setup 1 Attach the Digital Light Bar to the tripod 2 Connect the USB cable to a USB port on the compu...

Страница 35: ...a side mount goggle left and mounted on the headband for Dynamic Visual Acuity right The VORTEQ 2nd Generation IMU has four LEDs that describe the status of the device ON Flashes yellow when powered o...

Страница 36: ...all the device software from Kvaser AB Check the box to always trust software from Kvaser AB then choose Install 2 6 6 1 Optotype Tests If VORTEQ Assessment is added to the software the stimulus must...

Страница 37: ...tions for the hardware installation please refer to the separate installation instructions Hardware setup 1 Follow the instructions in the separate installation instructions for the specific rotary ch...

Страница 38: ...position left and in reclined position right Reclining chair configuration The VNG goggles can be connected directly to the reclining rotational chair FireWire cards are used with FireWire side mounte...

Страница 39: ...D 0134090 A 2022 11 VisualEyes Instructions for Use EN Page 34 Figure 2 6 21 Configuration of Nydiag 200 Reclining Chair Figure 2 6 22 Configuration of System 2000 Reclining Chair...

Страница 40: ...p test by combining the VisualEyes system with Orion Auto Traverse Comprehensive or System 2000 Auto Traverse Comprehensive rotary chairs The chair is enclosed in a light tight booth The laser project...

Страница 41: ...ear the operator This allows the operator to monitor the patient inside the booth via the observation monitor screen The video from the observation camera is not recorded or saved in the software Figu...

Страница 42: ...D 0134090 A 2022 11 VisualEyes Instructions for Use EN Page 37 Figure 2 6 27 Configuration of Orion Auto Traverse Comprehensive Figure 2 6 28 Configuration of System 2000 Auto Traverse Comprehensive...

Страница 43: ...crew the head support on the chair to remove it 2 Slide the hook through the seat belt slot of the safety seat so that a hook is available on each side of the infant seat 3 Secure the infant seat and...

Страница 44: ...atible with the below tests if licensed Spontaneous Nystagmus Gaze Smooth Pursuit Saccade Optokinetic Step Velocity Sinusoidal Harmonic Acceleration Hardware setup 1 Ensure the EOG board is registered...

Страница 45: ...slowly Watch the sine wave There should be two colored sine waves that are superimposed into one curve If the curves match there is no need to calibrate Figure 2 6 32 Sine Wave Validation If the curve...

Страница 46: ...centered laterally on the chair base If the scale shows the chair is off center enter the current chair off center position under Current Lateral Position cm then select the direction the chair is fro...

Страница 47: ...e Y Axis and observe if the laser moves in a smooth pattern Click Stop to stop the Sine Wave Test Under SVV Angle Test click Go to check that the SVV line is rendered Use the left right arrow buttons...

Страница 48: ...drum on the Auto Traverser Comprehensive chair Safety checks Before beginning the test in the chair system certain safety tests must be done as described below Safety checks for for Orion Auto Traver...

Страница 49: ...le to the EOG connector on the rear panel of the DataLink 2 Connect the USB type B connector to the USB PC port on the back of the DataLink and connect the other end to the computer or the USB hub The...

Страница 50: ...000 Comprehensive Reclining chair To solve this change the board number by right clicking on the board in Instacal and click Change Board Configure instacal so the DataLink miniLAB 1008 is Board 1 and...

Страница 51: ...be installed choose the default option to install the Universal Library Examples During installation Windows Security may request permission to install the device software from Measurement Computing...

Страница 52: ...the default selections for installing the drivers 32 64 bit x86 Start Menu Shortcuts and GUI tools When asked for the destination folder for installing the drivers choose the default location of C Pr...

Страница 53: ...hardware will then function using the same license as entered for the VNG goggle After registering and licensing the VNG goggle any additional hardware can be registered This can be done by restarting...

Страница 54: ...D 0134090 A 2022 11 VisualEyes Instructions for Use EN Page 49...

Страница 55: ...e used Wireless HDMI connections are not supported When setting up the TV this should be set to Computer or Game mode to correct for HDMI scaling and digital image processing potentially delaying the...

Страница 56: ...during installation it is highly recommended to remeasure the display size Different versions of VisualEyes have used different measurement methods It is therefore important to validate the dimension...

Страница 57: ...ing the sliders determining the maximum angle that can be used for the visual stimuili 2 9 3 2 Hardware delay In order to compensate for any potential delay for the presentation of the visual stimuli...

Страница 58: ...elay can be found under System Default Settings Stimuli Clicking Reset Delay will set the hardware delay to 0 ms To adjust the hardware delay for the connected monitor for visual stimuli the below ins...

Страница 59: ...e test click on the subtest 3 Go to Temporary Setup 4 From Temporary Settings click on Hardware Delay in the left panel 5 The suggested adjustment for the hardware delay will be presented as Current D...

Страница 60: ...ured under System Default Settings DVA Stimulus The DVA Stimulus settings screen provides the separate screen measurements for the stimulus used for the DVA tests If the TV screen is too large for DVA...

Страница 61: ...te language in the drop down selection menu see Figure 2 6 2 The software will have to be restarted when the program language is changed The languages available in the software are below English Unite...

Страница 62: ...ase 2 11 2 Video recordings VisualEyes can record videos from the VNG or vHIT goggles as well as the video from the external room camera These video files will be linked to the specific patient and se...

Страница 63: ...archiving PDF prints outside of OtoAccess Database This is possible from System Default Settings Print under PDF Configuration From here set Save PDF Document to ON and specify the storage location fo...

Страница 64: ...onfiguration section in System Default Settings Print After following above instructions a new Create PDF button will appear in the Session Review after a completed session Clicking Create PDF will ge...

Страница 65: ...ockwise to disengage the button DataLink optional Ensure that the DataLink is connected to power and connected to the computer through the USB connection Power on the device using the power switch on...

Страница 66: ...rmation on testing see sections 3 8 and 3 9 4 Patient Sessions This will take the operator to an overview of previous patient sessions that can be reviewed in detail exported or printed For further in...

Страница 67: ...D 0134090 A 2022 11 VisualEyes Instructions for Use EN Page 62 Figure 3 2 1 VisualEyes main screen...

Страница 68: ...3 3 1 This menu is used for setting up the system components and accessories and general software settings such as language and Video Storage Location Figure 3 3 1 System Default Settings menu The Sy...

Страница 69: ...or to the menu shown in Figure 3 4 1 This menu is used for managing the protocols in the system Protocols are composed of a list of tests and designated to be performed in a specific order at the pref...

Страница 70: ...re the test can be divided in different sections for Sitting and Supine positions Table 3 4 1 Default protocols with VisualEyes systems VisualEyes 505 VisualEyes 515 VisualEyes 525 VORTEQ Assessments...

Страница 71: ...sequence can be customized by the operator by adding or removing tests using the buttons below the list of tests The order of the tests can also be altered by clicking and holding on a test in the li...

Страница 72: ...back on the goggles Confirm with the patient that there is no light leakage If the patient still sees light adjust the goggles position and tightness of the strap as needed 8 Headband straps should b...

Страница 73: ...ither of the recline handles found on the sides of the chair frame and this is up to the operator to decide considering the test requirements The footrest should not be used as a step to enter the cha...

Страница 74: ...the booth enclosure Unscrew the head support and remove it Slide the hook through the seat belt slot of the safety seat so that a hook is available on each side of the infant seat Secure the infant s...

Страница 75: ...ately Ensure that the goggle cover is taken off while you place the goggle on the patient s face Adjust the strap for a snug fit For vision denied testing place the cover on the goggles Confirm with t...

Страница 76: ...camera rotations 3 6 2 Focus adjustment To optimize the pupil detection the camera should be focused This is done by turning the knobs lens as described for the selected goggles in section 2 6 1 and...

Страница 77: ...r is required to perform the calibration When using the Orion Comprehensive or Auto Traverse chairs the built in laser will be used for the calibration For EyeSeeCam it is recommended to always use th...

Страница 78: ...impaired and not able to see the default target size Start the calibration by pressing Start Calibration 4 in Figure 3 7 1 Refer to the instructions in sections 3 7 1 3 7 4 for performing the calibra...

Страница 79: ...et positions After completion of the calibration the check marks will turn green if the calibration values are within acceptable ranges Figure 3 7 3 If the calibration values are not acceptable the ch...

Страница 80: ...n tracker is to be utilized in the dark with dilated pupils it is very important to perform the torsion calibration in the dark with dilated pupils If possible ask the patient to look slightly up this...

Страница 81: ...bration must be performed Whenever EyeSeeCam is selected as input source the Head Calibration button will appear Figure 3 7 7 Clicking this will open the Head Calibration screen Figure 3 7 7 Head Cali...

Страница 82: ...the impedance is measured as 10 kOhm or less the electrode will be marked as Good indicated by green coloring If the impedance is between 11 kOhm and 15 kOhm the electrode will be marked as Medium in...

Страница 83: ...erformed by following the procedure in section 3 7 1 If the electrode traces for horizontal and vertical traces show drift the traces can be manually centered using the Center Traces button If the pat...

Страница 84: ...e EN Page 79 Figure 3 7 11 Standard calibration with ENG The test screen When the system and the patient have been prepared the tests can be performed To enter a test session select the desired protoc...

Страница 85: ...ins buttons for operator controls The buttons in the panel vary for each test Some of the most general controls are the following t Test menu opens the session tree allowing the operator to view the c...

Страница 86: ...the test can be performed on an examination table reclining chair With the patient seated in the upright reclining chair remove the Orion or System 2000 head support and set it aside Unlock the chair...

Страница 87: ...nd physically lift the chair back with the patient into an upright position Figure 3 9 2 Supine positional test 3 9 1 5 Caloric test Caloric testing is performed with the goggle cover on for vision de...

Страница 88: ...y degrees above horizontal using the angle marker below the seat before performing the test Orion Reclining chair Recline the chair to thirty degrees above horizontal using the angle marker below the...

Страница 89: ...The Velocity Step Test is vision denied test This involves rotating the patient in one direction at a constant velocity for several seconds then stopping the chair while recording continues The same p...

Страница 90: ...izontal testing or up and down for vertical testing 3 9 2 2 Lateral Head Roll The Lateral Head Roll test is performed to identify horizontal canal BPPV and includes the 3D head model guide to assist i...

Страница 91: ...otype character without shaking the head In the GST test the optotype size remains the same but the head velocity changes The head velocity is measured in degrees per second The results are plotted as...

Страница 92: ...nt s head Practice a few impulses before recording This will also familiarize the patient with the stimulus Do not allow the hands to touch or move the goggles during head impulses as that movement wi...

Страница 93: ...the operator performs the head impulse the software will display the head and eye movements in the appropriate impulse graph depending on the impulse direction If the head movement fits the swoosh ve...

Страница 94: ...9 8 The analysis displayed is defined by the page navigation at the top of the screen Once the Lateral LARP and RALP tests have been performed the EyeSeeSix report can be created from the vHIT for Ey...

Страница 95: ...ction This test resembles the lateral vHIT test and assesses the lateral semicircular canals A laser target is used as the suppression medium for the SHIMP test The vHIT goggle is placed on the patien...

Страница 96: ...sitioned center laser dot The VOR gains should be similar in the vHIT and SHIMP tests However the pattern of saccades generated is different vHIT rarely generates compensatory saccades in normal patie...

Страница 97: ...recordings are played synchronously from the Test Review screen The playback will begin by clicking on the play button in the playback menu As the test plays back a yellow circle will show the current...

Страница 98: ...sualEyes system easily allows for reviews of current and or previous sessions for the selected patient After selecting the desired patient profile the operator can select the Patient Sessions button f...

Страница 99: ...esults can be reviewed by selecting the test menu button in the top left corner of the test screen A drop down menu will appear with the Review Session button displayed at the bottom Figure 3 11 4 Rev...

Страница 100: ...ower left corner of the Session Review screen to return to the main screen Review patient videos If video recording has been enabled during the patient sessions the videos may be reviewed after testin...

Страница 101: ...atible video player Video of eye recordings no raw data Video of room recording By selecting the Enable Selection Mode in the left side panel it is possible to select videos to be deleted or exported...

Страница 102: ...test protocol For a detailed description of each of these menus and the available settings refer to the Additional Information 3 13 2 Data export When you have completed your testing you can export r...

Страница 103: ...ower switch on the back of the controller If the DataLink is used turn off the power using the power switch on the back of the device If the AirFx air irrigator or AquaStim water irrigator is used ver...

Страница 104: ...een on PC can be cleaned by the microfiber lens cleaning cloth when the monitor is turned off If the touch screen needs further cleaning use a Sani Cloth AF3 disinfectant wipe to clean the surface All...

Страница 105: ...lity and performance of the equipment if Assembly operations extensions readjustments modifications or repairs are carried out by authorized persons A 1 year service interval is maintained The electri...

Страница 106: ...otary chair reclined position error applicable for Orion and System 2000 reclining chair If the Orion Reclining or System 2000 Reclining chair is reclined during a rotary chair test the software will...

Страница 107: ...or go to the home screen and restarting the test will reset the watchdog timer This is indicated by the Emergency Stop lighting up again Cameras disconnecting If unusual behavior is experienced such a...

Страница 108: ...indows 11 64 bit Standards IEC 60601 1 2005 AMD1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 2 2014 Medical electrical equipmen...

Страница 109: ...ge Environment Transport Temperature Storage Temperature Relative Humidity 20 50 C 0 50 C 30 80 Non condensing Interface FireWire USB 2 0 Cable Length 4 5m 3m for Orion Reclining Camera Configuration...

Страница 110: ...Transport Temperature Storage Temperature Relative Humidity 20 50 C 0 50 C 30 80 Non condensing Interface USB 2 0 Cable Length 4 5m 3m for Orion Reclining 0 9m for Orion Auto Traverse Comprehensive C...

Страница 111: ...15 35 C 30 90 Transport Storage Environment Transport Temperature Storage Temperature Relative Humidity 20 50 C 0 50 C 30 80 Non condensing Interface USB 2 0 Cable Length 4 5m 3m For Rotary Chair Ver...

Страница 112: ...ive Humidity Ambient Pressure 15 35 C 30 90 98 104 kPa Transport Storage Environment Transport Temperature Storage Temperature Relative Humidity 10 50 C 10 35 C 30 80 Interface USB 2 0 Cable Length 2...

Страница 113: ...used for EOG ENG measurements Is available as the DataLink through the EOG Accessory kit for VNG or built into the Orion Auto Traverse Orion Comprehensive chairs through the EOG Accessory kit for Orio...

Страница 114: ...Use EN Page 109 DIGITAL LIGHTBAR Quick Description Digital Lightbar presenting visual stimuli for oculomotor testing Technical Specifications Interface USB 2 0 Dimensions L x W x H 83 8 x 8 9 x 4 4 c...

Страница 115: ...on Environment Temperature Relative Humidity 5 40 C 30 90 Transport Storage Environment Transport Temperature Storage Temperature Relative Humidity 15 40 C 15 40 C 30 80 Rotation Control Mechanical In...

Страница 116: ...rotary tests on top of standard VisualEyes Tests Step Rotation up to 200 s Sinusoidal Harmonic Acceleration 0 01 0 64 Hz VOR Suppression 0 01 0 64 Hz Interface USB USB Cable Length 3m Power Cable Leng...

Страница 117: ...ing Rotation Control Software controlled Available rotary tests on top of standard VisualEyes Tests Step Rotation up to 350 s Sinusoidal Harmonic Acceleration 0 01 1 28 Hz VOR Suppression 0 01 1 28 Hz...

Страница 118: ...ries PEDIATRIC OBSERVATION CAMERA Quick Description Camera mounted on a unipod that can be attached to the Orion Auto Traverse Comprehensive Can be used when doing measurements in babies who can t wea...

Страница 119: ...fied by the manufacturer Otherwise degradation of the performance of this equipment could result in improper operation This equipment complies with IEC60601 1 2 2014 AMD1 2020 emission class B group 1...

Страница 120: ...switch Interacoustics Emergency switch Goggle EyeSeeCam USB cable Interacoustics EyeSeeCam Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601...

Страница 121: ...environment in which radiated RF disturbances are controlled The customer or the user of the ORION can help prevent electromagnetic interferences by maintaining a minimum distance between portable and...

Страница 122: ...e that of a typical commercial or residential environment Surge IEC 61000 4 5 1 kV Line to line 2 kV Line to ground 1 kV 2 kV Mains power quality should be that of a typical commercial or residential...

Страница 123: ...culated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms IEC EN 61000 4 6 150kHz to 80 MHz 6 Vrms in ISM bands 150kHz to 80 M...

Страница 124: ...eration If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ORION b Over the frequency range 150 kHz to 80 MHz field strengths should be less...

Страница 125: ...Returned according to agreement with Interacoustics Other Date Person Please provide e mail address or fax No to whom Interacoustics may confirm reception of the returned goods The above mentioned ite...

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