Volk iNview User`s Manual / Instructions for Use
Contents
1. view USER S MANUAL INSTRUCTIONS FOR USE Volk iNview Retinal Camera Product description The Volk iNview is an ophthalmic camera device to be used by healthcare professionals to acquire wide angle digital color images of the retina using an Apple iPhone or iPod Touch Volk iNview is a combination product comprised of a mobile application app and an indirect ophthalmoscopic lens attachment for an Apple iPhone or iPod Touch The Volk iNview mobile app is accessible to users via the Apple App Store Apple Inc for use on select iOS devices specifically iPhone 5s and 6 or iPod Touch 6 Generation The Volk iNview mobile app operating on an iPhone or iPod Touch integrates with a mechanical adaptor with a telescopic feature that houses a high quality glass funduscopic lens The combination of the mobile app powered smartphone camera and the ophthalmoscope provide a clinician with the ability to image the retina of the human eye using the native high resolution camera and white light LED of the iPhone or iPod Touch IM 088 Rev Effective 11 02 15 Page 2 of 34 Table of Contents PRODUCT DESCRIPTION 1 PACKAGE CONTENTS 2 ACCESSORIES PURCHASED SEPARATELY VOLK INVIEW CARRY CASE PRECISION OPTICAL LENS CLEANER VOLK LENS PEN 3 APPLICATION INSTRUCTIONS LOADING THE APPLICATION Personal iOS device Prepackaged iOS device Starting the Application USING THE APPLICATION Instructions for First Use of the Application2. Customers shall be responsible for returning products for warranty service to Volk Optical Inc 7893 Enterprise Drive Mentor Ohio 44060 USA Warranty repairs will include all labor adjustments and replacement parts Replacement parts may be remanufactured or contain remanufactured materials Warranty service may not be provided without proof the product was purchased from Volk Optical Inc or an Authorized Volk Distributor This Warranty becomes null and void if the customer fails to return the product in packaging that is consistent with the original protective packaging and it results in shipping damage This Warranty becomes null and void if the customer fails to follow the recommended cleaning instructions and or cautions contained in the product instruction manual IM 088 Rev Effective 11 02 15 Page 31 of 34 This Warranty does not cover service required because of disassembly unauthorized modifications or service misuse or abuse SELLER MAKES NO OTHER WARRANTY EXPRESS OR IMPLIED OF THE PRODUCT SUPPLIED HEREUNDER INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FORA PARTICULAR PURPOSE AND ALL SUCH WARRANTIES ARE HEREBY EXPRESSLY EXCLUDED SELLER SHALL HAVE NO LIABILITY FOR LOSS OF PROFITS OR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES UNDER ANY CIRCUMSTANCES OR LEGAL THEORY WHETHER BASED ON NEGLIGENCE BREACH OF WARRANTY STRICT LIABILITY TORT CONTRACT OR OTHERWISE SELLER SHALL IN
3. IM 088 Rev Effective 11 02 15 Page 23 of 34 8 Error messages The following table shows the error messages within the Volk iNview application For error messages that concern the iOS device or operating system consult the iPod Touch or iPhone user guide available on the Apple website Description of error message and action to be Message present in application PP taken Application requires calibration before first use Press the calibrate button in the application and point the camera at the floor to start the calibration process Please press the Calibrate Camera button to calibrate your camera before performing an exam for the first time In order to use the patient data function of the application a Patient ID or Patient Name comprised of A Z only is required Alphabetic Patient First Last Name or Patient ID is required IM 088 Rev Effective 11 02 15 Page 24 of 34 9 Device Parts Applies to O VINVIEW TCH Volk iNview for iPod Touch O VINVIEW 5S Volk iNview for iPhone 5S O VINVIEW 6 Volk iNview for iPhone 6 Figure 20 Key Description Indirect Lens Holder Indirect Lens Camera Sleep button iPod Touch Camera Sleep Button iPhone Camera charging port WD gt IM 088 Rev Effective 11 02 15 Page 25 of 34 10 Labeling Part and lot number information is located on the lower portion of the Lens Tube Figure 21 This information is required to complete th
4. Adjusting Electronic Camera Device Settings Using Application with Patient Information Encryption Summary Checklist for Encrypted vs Unencrypted mode Calibrating the Camera Undertaking an Image Session Imaging Steps Summary DATA EXPORT 4 INDICATIONS FOR USE 5 CONTRAINDICATIONS 6 WARNINGS AND PRECAUTIONS EYE SAFETY 7 IMPORTANT SYMBOLS 8 ERROR MESSAGES 9 DEVICE PARTS 10 LABELING 11 CLEANING INSTRUCTIONS 12 TECHNICAL DESCRIPTION Supported Electronic Camera Devices 13 INTELLECTUAL PROPERTY INFORMATION Patents Trademark 14 DISPOSING OF THE VOLK INVIEW 15 DEVICE CLASS 16 CONTACT 17 WARRANTY Product Warranty 18 ORDERING INFORMATION IM 088 Rev A Effective 11 02 15 ONAA A AAA MAAN Ww WWNN NN NNNNNN ro NNN e nn M RC Oo OW WN NNN WOOD W W Page 3 of 34 1 Package contents Packaging contents will vary by part number VINVIEW TCH iPod Touch None VINVIEW 5S iPhone 5S VINVIEWC TCH iPod Touch iPod Touch 6th Gen Included as part of the electronic camera device if supplied O USB power and sync cord O Apple Wall Power Charger US sockets 2 Accessories purchased separately Volk iNview Carry Case Model Number VINVIEW CASE Official Pelican Watertight and Dustproof Case supplied with fitted foam interior Volk Precision Optical Lens Cleaner Model Number VPOLC Volk Precision Optical Lens Cleaner consists of a highly absorbent lint fre
5. Controls Store Help Mm ngu fe My Music iPhone Figure 9 O Select the Apps menu item on the left side of iTunes Scroll down until the File Sharing section is visible Select the Volk iNview app and the file iNviewDataExport zip will appear under the Volk iNview Documents heading O Now select the Volk iNviewDataExport zip document and click on the Save to button This will open a dialog box that will allow you to navigate to the location of your choosing to save the data cis mem gt g Qy Search File Edit View Controls Store Help nade iNview iNview r 3268 100 M f File Sharing The apps listed below can transfer documents between your iPhone and this computer Hn W A iNview D t A pps INVvVIeW Documents iNviewDataExport zip 5 1 MB Yesterday 3 10 PM Music E Movies iMovie 1 TV Shows vex INview Photos ES Gi Info Keynote f Music Numbers Movies P C TV Shows S AA Books Audiobooks A Tones Add File Save to Y 24 86 GB Free Revert Apply Figure 19 O Once the data is on your computer you can choose to unzip the data by right clicking on it and selecting the Extract All option IM 088 Rev A Effective 11 02 15 Page 21 of 34 4 Indications for Use The Volk iNview ophthalmic camera is intended to take photographs of the retina of the eye for the purposes of general visualiz
6. VINVIEW TCH 2 Volk iNview for iPhone 5s VINVIEW 5S 3 Volk iNview for iPhone 6 VINVIEW 6 Warranty Terms The Seller warrants to the Purchaser that the goods furnished hereunder will for the appropriate periods of product warranties as defined on our user instructions shipped with each product conform to Sellers agreed to specifications The obligation of the Seller and the Purchaser s sole and exclusive remedy hereunder shall be limited at the Seller s option to replacement of defective goods or refund of the purchase price thereof Purchaser shall not return goods unless authorized in writing by Seller Seller shall have the right to inspect the goods at Purchaser s installation Purchaser s failure to give prompt written notice 30 days upon discovery of any alleged defect shall constitute a waiver by Purchaser of all claims with respect thereto Notwithstanding the foregoing warranties and remedies seller shall have no obligation hereunder if the goods become defective as a result of improper storage contamination adulteration improper use or misapplication after delivery thereof to Purchaser If the product fails to function due to defects in either materials or workmanship Volk will at its option either repair or replace the product without charge subject to the Warranty Limitations Volk Optical warrants its iNview Retinal Imager against defects in material or workmanship for a period of 1 year from receipt by end user
7. names here Just tap to share ejz Message Mail Notes Save Image Assign to Contact Figure 8 Transferring Data to a PC or Mac The Volk iNview application can also be used to transfer images with patient information to your PC or Mac using iTunes Before You Start O If it is not installed already download iTunes to your PC by going to www apple com itunes download Follow the instructions to complete the installation process Data Export Process 1 In the Volk iNview app press the Data Export button 2 The first time the Data Export button is pressed Volk iNview will generate a compressed zip file containing all image data Subsequent Data Export operations will give you the following options a Export All Images same as first activation b Export Images Since Last Export creates new export file with only new data Delete Export File d Cancel return to Volk iNview 3 Once you have selected an export option Volk iNview will display a message indicating that a data export file has been created and is available for transfer to a PC Press OK 4 Activate iTunes 5 Connect the Volk iNview device to the PC using a USB cable 6 Select the Volk iNview device by clicking on the iPhone button Figure 18 Note view the tutorial videos and help on the application for further information on using the application IM 088 Rev A Effective 11 02 15 Page 20 of 34 D 44 P bb r yu File Edit View
8. 0 00 AM 89 MN Feedback Information New Patient Existing Patient Quick Image Data Export Complete Exam Figure 9 At this distance it is easy to keep the eye centered in display If the patient s eye is dilated sufficiently bmm diameter or greater a red reflex should be visible At this distance the red reflex is slit like in nature not circular The width of the slit will be dependent on the diameter of the patient s pupil The greater the pupil size the greater the width of the red reflex With a red reflex present the user is further instructed to smoothly move the Volk iNview Retinal Imager towards the patient s eye while attempting to keep the red reflex centered on the display Figure 10 shows the image seen as the user pushes closer to the eye IM 088 Rev Effective 11 02 15 Page 12 of 34 No SIM gt 10 00 AM 89 Feedback Information New Patient Existing Patient Quick Image Data Export Complete Exam Figure 10 Note the most effective way to align the Volk iNview Retinal Imager is to rely on the lead hand to make the necessary positioning adjustments At the sweet spot of operation the red reflex will quickly expand from a slit to fill the entire field of view FOV of the Primary Lens Element This action is similar to how a properly aligned indirect BIO behaves as it is aligned with an eye Figure 11 IM 088 Rev Effective 11 02 15 Page 13 of 34 No SIM 90 MN Fee
9. 02 15 Page 6 of 34 12 30 PM 1 50 PM Settings Volk iNview Airplane Mode Wi Fi Bluetooth Notifications Control Center Do Not Disturb 3 oe General Settings Apps Figure 3 Summary Check List 1 Turn device to airplane mode 2 Adjust Screen Brightness setting to maximum 3 Disable Auto Brightness Using Application with Patient Information Encryption Display amp Brightness No SIM 1 24 PM 100 mum lt Settings Display amp Brightness BRIGHTNESS ce e i Auto Brightness Text Size Bold Text On first startup of the application you will be presented with the choice to use the application in either encrypted mode or unencrypted mode Figure 4 IM 088 Rev A Effective 11 02 15 Page 7 of 34 Create Encryption Key To encrypt all patient data please enter an encryption key Press the Cancel button if you do not want to encrypt patient data If you choose to encrypt patient data you will be required to enter this key when you launch the iNview app CIT MEA Cancel OK gqiwieiritiylulilolp alsidifigihij kJ EN zixicivibinim m 123 space Figure 4 IMPORTANT NOTE THERE IS NO PASSWORD RESET AVAILABLE SHOULD THE ENCRYPTION KEY BE FORGOTTEN ALL DATA STORED WITHIN THE APPLICATION WILL BE LOST This is an important decision for the user In the encrypted mode all of the patient imagery and data is stored
10. 4 12 30 PM Volk iNview EG Na e A a Settings Apps Figure 2 Using the application Instructions for First Use of the Application This section contains instructions for setting up the Volk iNview application for the first time It is strongly recommended that this section is read entirely before using your new Volk iNview Adjusting Electronic Camera Device Settings During normal operation of the Volk iNview Retinal Imager the electronic camera device display iPod Touch iPhone 5s or iPhone 6 is used to help the user to align the device with the patient s eye as well as to review acquired retinal images To aid in these functions it is recommended that the display brightness setting of the electronic camera device be set to a fixed full brightness setting This can be done by accessing Settings Display amp Brightness where one could then turn Auto Brightness Off and position the brightness slider on High Figure 3 It is advantageous to restrict calls and texts from being pushed onto the electronic camera device while it is being used to acquire retinal images This can be accomplished by placing the electronic camera device in Airplane Mode prior to taking retinal images Note to receive access to software updates the electronic camera device needs to establish occasional access to the internet This cannot be done while the device is in Airplane Mode unless WiFi is enabled IM 088 Rev Effective 11
11. Lens that is used within the Volk iNview Retinal Imager is a 25D lens and it has a working distance of approximately 50mm The large end of the Lens Tube is fashioned like an indirect BIO lens with the intention that the user position and stabilize the device using the patient s forehead as a steady reference as illustrated in Figure 8 below view Figure 2 IM 088 Rev Effective 11 02 15 Page 11 of 34 Note the Volk iNview Retinal Imager should not come into contact with the patient The working distance of the Primary Imaging Lens is approximately 50mm This ensures that there is always a comfortable amount of distance between the device and patient The most effective way of properly aligning the Volk iNview Retinal Imager is to use the lead hand the one in contact with the patient s forehead to make all the required adjustments in space The hand closer to the electronic camera device should be held reasonably stable as the positioning adjustments are being made with the lead hand When an imaging session is underway the operator uses the live video displayed on the electronic camera device to align the device with the patient s eye Within a couple of seconds from the time the imaging session is initiated the user is instructed to position the Volk iNview Retinal Imager about 100mm in front of the eye to be imaged Atthis distance the eye socket should fill the display as illustrated in Figure 9 below No SIM 1
12. NO EVENT BE LIABLE IN RESPECT OF THIS ORDER AND OR PRODUCT DELIVERED ON ACCOUNT OF THIS ORDER FOR ANY AMOUNT GREATER THAN THAT PAID TO SELLER ON ACCOUNT OF THIS ORDER THE PURCHASER ACKNOWLEDGES THAT IT IS PURCHASING THE GOODS SOLELY ON THE BASIS OF THE COMMITMENTS OF THE SELLER EXPRESSLY SET FORTH HEREIN IM 088 Rev Effective 11 02 15 Page 32 of 34 18 Ordering Information Orders may be placed with an Authorized Volk Optical Distributor in your region Authorized Distributor contact information is available directly from Volk Optical Inc For Volk iNview Camera devices purchased including camera the warranty covers the external indirect lens attachment iOS application and iOS device Volk Optical Inc 7893 Enterprise Drive Mentor Ohio 44060 USA Toll free within the United States 1 800 345 8655 Phone 440 942 6161 Fax 440 942 2257 Email volk volk com Website www volk com EU REPRESENTATIVE The Volk authorized representative based in the European Union EU is Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA UK Tel 44 0 1753 857177 Members of the European Union should contact their authorized Volk Distributor for disposal of this unit Conseil canadien des normes Registraire accr dit Certificate FM 71461 IM 088 Rev Effective 11 02 15 Page 33 of 34 the leader in aspheric optics A HALMA COMPANY Volk Optical Inc 7893 Enterprise Drive Mentor
13. Ohio 44060 USA Toll free within the United States 1 800 345 8655 Phone 440 942 6161 Fax 440 942 2257 Email volk volk com Website www volk com IM 088 Revision A Effective November 2 2015 IM 088 Rev A Effective 11 02 15 Page 34 of 34
14. a area 100 Kbyte compressed file size JPEG 50 iPod Touch 70 iPhone 5s 85 iPhone 6 Downloaded from App Store Both automatic capture and forced capture modes supported 180mm 134mm iPod Touch 135mm iPhone 5s 149mm iPhone 6 94mm 325g lens tube case only 413g integrated iPod Touch system 16 Gbyte integrated iPod Touch system Lightning type to USB cable Internal electronic camera device battery operates all imager functions 100 240VAC 50 60 Hz input 5 VDC output Lightning connector type Integrated iPod Touch system only 0 to 35 C 20 to 45 C 5 to 95 non condensing Up to 3000m Page 28 of 34 13 Intellectual Property Information Patents The Volk iNview Retinal Imager is protected by international patents Patents have been issued in Japan and China Patents are pending in the US India and the EU Trademark Volk iNview is a registered trademark of Volk Optical Inc iPod Touch iPhone 5s and iPhone 6 are registered trademarks of Apple Inc 14 Disposing of the Volk iNview Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment Therefore when disposing of this product be absolutely certain to follow the procedure which conforms with the laws and regulations applicable to your area 15 Device Class This product has been tested to meet the requirements under ISO 15004 2 2007 E as a Group I exempt product Thi
15. ation and patient education NOTE The Volk iNview can either be supplied as a complete ophthalmic camera device or can be used with an existing iPod Touch 6 Generation iPhone 55 or iPhone 6 5 Contraindications Because prolonged intense light exposure can damage the retina the use of the device for ocular examination should not be unnecessarily prolonged and the brightness setting should not exceed what is needed to provide clear visualization of the target structures The Volk iNview is deemed to have a maximum Safety exposure for use on a patient of two hours The Volk iNview is not intended to provide visualization for the purposes of diagnosis 6 Warnings and Precautions Use only Apple products that are listed as compatible with the Volk iNview No modifications to the Volk iNview hardware are permitted The Volk iNview application cannot be used unless the device is within the Volk iNview camera system The Volk iNview must be used in adherence to the daily maximum exposures listed in Eye Safety below Eye Safety All versions of the Volk iNview retinal imager iPod Touch iPhone 5s iPhone 6 have been tested against ISO 15004 2 2007 Ophthalmic Instruments Fundamental requirements and test methods Part 2 Light hazard protection The illumination levels of all supported Volk iNview implementations have been shown to comply with Group 1 classification as per the referenced standard Group 1 classification of the Volk iN
16. dback Information New Patient Existing Patient Quick Image Data Export Complete Exam Figure 11 During the entire time the Volk iNview Retinal Imager is being aligned with the eye the video stream is being analyzed When an aligned and focused retina is detected retinal images are automatically acquired and saved by the Volk iNview software application Acquisition is demonstrated through a camera shutter click audio notification and flashing screen Image Capture During an imaging session a total of up to 9 images will automatically be captured and saved by the device These images will be automatically acquired and saved based on an internal algorithm that grades the quality of the image Using the auto acquisition functionality of the Volk iNview Retinal Imager proper alignment between the device and the patient s eye only has to be maintained for a fraction of a second in order for high quality images to be acquired and saved In addition to the auto acquisition feature the Volk iNview Retinal Imager always gives the user the option of capturing an image on command The user can capture a retinal image by touching anywhere in the Image Display Section of the Main Program Display Figure 12 IM 088 Rev Effective 11 02 15 Page 14 of 34 No SIM 10 02 AM 838 Feedback Information Press for manual image New Patient Existing Patient Quick Image Data Export Complete Exam Figure 3 All user captu
17. e Product Registration Card that is supplied with the Volk iNview Retinal Imager Figure 10 IM 088 Rev Effective 11 02 15 Page 26 of 34 11 Cleaning instructions The Volk iNview Retinal Imager is a precision medical device that should be handled with care Only manual non immersion cleaning as described should be used for this instrument Do not autoclave or immerse in cleaning fluids Always disconnect power supply from source before cleaning Do not use synthetic fiber lens cleaning cloths e g microfiber on optical surfaces 1 Remove the electronic camera device from the external indirect lens attachment 2 Shut down electronic camera device 3 Wipe the external surface with a clean absorbent non shedding cotton cloth dampened with a water detergent solution 2 detergent by volume or water isopropyl alcohol solution 70 IPA by volume 4 The Primary Imaging Lens can be cleaned using Volk Precision Optical Cleaner or the Volk Optical LensPen Note further instructions and cleaning options can be found in the Volk Cleaning and Care guide on the Volk website Methods A and B are applicable to the Volk iNview 5 Ensure that excess solution does not enter the instrument Use caution to ensure cotton cloth is not saturated with solution 6 Surfaces must be carefully hand dried using a clean non shedding cotton cloth 7 Safely dispose of used cleaning materials 8 The electronic camera device can be cleaned
18. e optical towellete moistened to an exact saturation level with a unique combination of oil removers and cleaning agents http www volk com index php volk products accessories lens cleaner precision optical lens cleaner html Volk Lens Pen Model Number VLENSPEN Volk LensPen ophthalmic lens cleaning instrument utilizes a remarkable lens cleaning compound which removes finger prints smudges and grease marks with ease http www volk com index php volk products accessories lens cleaner lens pen html IM 088 Rev Effective 11 02 15 Page 4 of 34 3 Application Instructions This section contains instructions for setting up your new Volk iNview Retinal Camera capturing images and exporting the images from the device Loading the application Personal iOS device 1 Visit the App Store on your Apple device and download the application Volk iNview 2 Place your device into the Volk iNview indirect lens holder as pictured in Figure 1 below Figure 1 Prepackaged iOS device 1 Charge the device fully before use 2 Power on the iPod Touch using the Sleep button located on top of the electronic camera device 3 Connect the camera WiFi your local network Note Full instructions to connect to WiFi can be found on the Apple website Starting the Application The Volk iNview software application is launched by selecting the Volk iNview application icon Figure 2 IM 088 Rev A Effective 11 02 15 Page 5 of 3
19. ex fills the Primary Imaging Lens FOV stabilize the device as the auto acquisition capability begins to acquire and save retinal images indicated by momentary flash of the screen and or audible snap dE mE od ow 7 After auto acquisitions start to occur Quick Image memory will quickly fill with up to 9 aligned and focused retinal images 8 At the user s discretion user acquired images can be obtained by touching anywhere in the Image Display Section of the Main Program Display see Figure 12 9 Select Complete Examination from the Main Program Display Quick Image Pressing the Quick Image button will start an imaging session and provide the user with a quick way to conduct an imaging session However the images that are stored during a Quick Image session have no patient information attached Every time a Quick Image session is run it writes over previously acquired Quick Image results Data Export Note Exporting data from the application may not comply with current HIPAA regulations Although data stored in the encrypted mode conforms to HIPAA requirements exported data is not necessarily HIPAA compliant Sharing an Image Individual images can be shared using the Share button from the image viewing gallery IM 088 Rev Effective 11 02 15 Page 19 of 34 95 E No SIM gt AirDrop Share instantly with people nearby If they turn on AirDrop from Control Center on iOS or from Finder on the Mac you ll see their
20. he application Patient information and images are encrypted Data is stored within the application Data storage is not HIPAA Data is stored in a HIPAA compliant compliant manner Calibrating the Camera The camera must be calibrated before imaging a patient for the first time After software initialization has taken place and the user has moved past Data Encryption Selection the user is presented with the Main Program Display Figure 5 No SIM 98 Feedback Information New Patient Existing Patient Quick Image Data Export Calibrate Camera Figure 5 Before the Volk iNview Retinal Imager can be used to acquire retinal images the camera must first be calibrated The camera calibration process aligns the smart device field of view FOV and the point of focus with the Primary Imaging Lens Note the Volk iNview software application will only operate if the smart device in which it is installed is used with calibrated to a Volk supplied iNview retinal imaging attachment IM 088 Rev A Effective 11 02 15 Page 9 of 34 To calibrate the camera the user selects the Camera Calibration icon from the Main Program Display No SIM 98 NI Feedback Information New Patient Existing Patient Quick Image Data Export Calibrate Camera Figure 6 A dialog box then instructs the user to point the Volk iNview Retinal Imager camera at the ground from at least 2 feet away After a few seconds a sec
21. ient information entered during a previous imaging session an imaging session is started by selected Existing Patient from the Main Program Display This loads the Patient Record Identifier Display The existing patient can be searched by either Patient Birth Date and Name or Patient ID Number whichever is applicable Reaching the Patient Exam Date Display Figure 14 the user has the option of reviewing images from previous imaging sessions or performing a New Exam Left Eye or New Exam Right Eye IM 088 Rev Effective 11 02 15 Page 16 of 34 No SIM gt 100 No SIM 7 Back Back Back Patient Record Identifier Patient Last Name Patient Exam Date Patient Birth Date amp Name Smith New Exam Left Eye Patient ID Number New Exam Right Eye Quick Image Exams Oct_14_2015 Oct 15 2015 Figure 5 Once an imaging session is selected the internal illumination source is turned on and the device is made ready to acquire retinal images A total of up to 9 images will automatically be captured and saved by the device during each imaging session These images will be automatically acquired and saved based on an internal algorithm that grades the quality of the image The auto acquisition feature of the Volk iNview Retinal Imager is a powerful capability that makes the product unique within the marketplace It greatly eases the job of acquiring high quality retinal images using a hand held device Using the auto acquisition functionalit
22. in the following fashion a Unplug all cables and turn off iOS device press and hold the Sleep Wake button and then slide the onscreen slider b Using a soft slightly damp lint free cloth wipe the external surface Avoid getting moisture in openings Do not use window cleaners household cleaners compressed air aerosol sprays solvents ammonia abrasives or cleaners containing hydrogen peroxide to clean the iPhone or iPod Touch Note the Volk iNview Retinal Imager is not intended to be disinfected Note the Volk iNview Retinal Imager is not intended to be sterilized IM 088 Rev Effective 11 02 15 Page 27 of 34 12 Technical description Supported Electronic Camera Devices iPod Touch 6th Gen O iPhone 5s O iPhone 6 Patient Pupil Size Field of View Illumination Working Distance Diopter Correction Operating Modes Image Size Image Format Battery Life Qty of 2 minute exams Software Image Capture Modes Lens Tube Length Camera Case Length Overall Width Weight Camera Memory Image Export Power Source Battery Charger Operating Temperature Non Operating Temperature Relative Humidity Operating Altitude IM 088 Rev Effective 11 02 15 5mm diameter or greater 50 White light LED provided by electronic camera device 50mm 20D to 20D autofocus accommodation User selectable either Encrypted Unencrypted Data Mode 918 x 918 Pixels 843 Kpixel total 466 Kpixel retin
23. locally within the memory of the electronic camera device as encrypted data The encryption method that is used is sufficient to allow the Volk iNview Retinal Imager to meet HIPAA requirements To operate in an encrypted mode the user is required to provide a password Once an encryption password has been entered the user is then required to enter that same password every subsequent time the Volk iNview software application is launched Failure to enter the proper password will lock out non authorized users Note users who choose to operate the Volk iNview Retinal Imager in an encrypted mode need to take care ensuring that the entered password is securely retained If an encryption password is ever forgotten the only recourse is to first delete the Volk iNview software application and all the patient data contained within the application and then reload the Volk iNview application It is not possible to change from encrypted or unencrypted mode without deleting the application from the iOS device This will remove all images and patient data located in the application Use the data export function see page 19 IM 088 Rev Effective 11 02 15 Page 8 of 34 Summary Checklist for Encrypted vs Unencrypted mode Encrypted Unencrypted A password will be required each time the application is started No password will be required when using the application Patient information and images are not encrypted Data is stored within t
24. ond dialog box will be presented that indicates that the camera calibration has been successfully completed After successful calibration the Volk iNview software application will be automatically exited The iNview software application needs to be re launched for the camera calibration parameters to be successfully applied Note contact Volk if the camera calibration process fails to calibrate with your Volk iNview device Undertaking an Image Session Note the Volk iNview Retinal Imager requires that the patient s pupil diameter be 5mm or greater The larger the patient pupil size the easier it is to properly align the Volk iNview device to the patient s eye Imaging Technique Utilizing the correct technique will make a great difference to the ease of imaging The method of holding the Volk iNview Retinal Imager when it is being used during an imaging session is illustrated in Figure 7 below IM 088 Rev Effective 11 02 15 Page 10 of 34 Figure 7 This method allows access to the screen of the device while providing the best control of the device to capture images The device be used with either the left or right hand at the front The front hand should be placed on the lens grip at the very front of the device for the best control Anyone trained to perform an eye examination using a Volk indirect BIO lens will be able to quickly master operation of the Volk iNview Retinal Imager The Primary Imaging
25. red images are retained within the Volk iNview image memory space not the device s DCIM memory space which is accessed through the Photos App Auto acquired images do not over write any images specifically taken by the user Patient Imaging New Patients The Volk iNview software application allows the user to attach the patient s name first and last name or unique patient ID to the retinal images that are taken When a new patient is to be imaged and archived using the Volk iNview Retinal Imager the user selects New Patient from the Main Program Display This enables the Patient Information Display Figure 13 IM 088 Rev Effective 11 02 15 Page 15 of 34 10 29 AM Patient Information Image Left Eye Image Right Eye Cancel Figure 4 Two different methods are available to attach patient information to the images taken using the Volk iNview Retinal Imager One method is to enter a unique patient ID for every new patient being imaged and managed Alternately patient images can be managed by entering the patient s first and last name and birth date It is not possible for the Volk iNview application to simultaneously accommodate both a first and a last name and a patient ID Once the appropriate patient data has been entered the imaging session is started by selecting either Image Left Eye or Image Right Eye from the Patient Information Display Existing Patients For existing patients patients who have had their pat
26. s product is registered in the US with the FDA as a general use ophthalmic camera under the following proprietary names iNview for iPod Touch VINVIEW TCH iNview for iPhone 5s VINVIEW 5S iNview for iPhone 6 VINVIEW 6 iNview Touch Camera VINVIEWC TCH O ux This product is self declared in the EU as a Class I Accessory in accordance with Council Directive 93 42 EEC Article 1 IM 088 Rev A Effective 11 02 15 Page 29 of 34 16 Contact Information on the Volk iNview Retinal Camera can be found on the Volk website at www volk com If you have any questions or require service contact us at volk volk com for service or call us at 1 800 345 8655 Feedback on the application is always appreciated and any suggested improvements can be made using the Feedback button shown in Figure 22 No SIM 98 Feedback Information New Patient Existing Patient Quick Image Data Export Calibrate Camera Figure 22 IM 088 Rev A Effective 11 02 15 Page 30 of 34 17 Warranty Volk Optical provides a 1 year warranty as standard with the Volk iNview For Volk iNview Camera devices purchased including camera the warranty covers the external indirect lens attachment iOS application and iOS device 1 Volk iNview Touch Camera VINVIEWC TCH For Volk iNview Attachment devices purchased excluding camera the warranty covers the external indirect lens attachment and iOS application 1 Volk iNview for iPod Touch
27. tos To Delete Done gt 9 Press to view image capture gallery inh New Patient Existing Patient Quick Image Data Export Complete Exam Figure 6 To delete one or more of the images the user marks images by selecting the small circle positioned in the right upper quadrant of the image and then selects Done Alternately a full screen display of any of the images can be commanded by simply selecting that image The user can move through the complete image memory simply by swiping the display side to side From the full screen display the user can choose to upload the image to various destinations by selecting the upload icon Figure 16 Swipe left or right to navigate through images 15926 37686007Right jpg gt Figure 7 IM 088 Rev Effective 11 02 15 Page 18 of 34 Imaging Steps Summary 1 Select either New Patient or Existing Patient from the Main Program Display a If New Patient enter either the patient ID or first name last name and birth date of the patient b If Existing Patient select patient starting from the Patient Record Identifier Display Select Image Left Eye New Exam Left Eye or Image Right Eye New Exam Right Eye Position the Volk iNview Retinal Image approximately 100mm from the patient s eye Center the red reflex on the display Move the Volk iNview Retinal Imager towards the patient keeping the red reflex centered on the display 6 When the red refl
28. view product assumes a continuous light exposure time of less than 2 hours Group 1 ophthalmic instruments require no external product labeling for light hazards IM 088 Rev Effective 11 02 15 Page 22 of 34 7 Important Symbols Caution Consult the instructions for use for important cautionary information The user is advised of important operating and maintenance instructions Consult the instructions for use Indicates that important operating instructions are included in this User Manual Failure to follow these instructions could place the patient or operator at risk Do not operate or leave this assembly in any environment that may exceed 10 C to 40 C Dispose of device in the proper manner and ensure to comply with all laws and regulations applicable to your area The CE mark on this product indicates it has been tested and conforms to the provisions noted within the 93 42 EEC Medical Device Directive Indicates the medical device manufacturer as defined in the EU Directive 93 42 EEC Indicates the Authorized representative in the European Community Indicates the manufacturer s lot number so that the lot can be identified Indicates the manufacturer s product code so that the medical device can be identified Symbols found in the electronic camera device are not included Please visit www apple com to learn how to use your device The iPod Touch and iPhone user guides are available on the Apple website
29. y of the Volk iNview Retinal Imager proper alignment between the device and the patient s eye only has to be maintained for a fraction of a second for high quality images to be acquired and saved In addition to the auto acquisition feature the Volk iNview Retinal Imager always gives the user the option of capturing an image on command The user can capture a retinal image by touching anywhere in the Image Display Section of the Main Program Display Figure 12 All user acquired images are retained within a 9 image memory space Auto acquired images are not allowed to over write any images specifically taken by the user To end an imaging session select Complete Exam from the Main Program Display The user should always remember to select Complete Exam as soon as possible following completion of the session Completing the session turns off the high power illumination and processing functions and this in turn maximizes battery lifetime Additional imaging sessions can be started by repeating the Image Left Eye Image Right Eye selection To review the retinal images obtained during a Quick Image session the user touches on the User Display Section of the Main Program Display This will bring up a thumbnail display of all of the images collected during the just concluded Quick Image session shown below in Figure 15 IM 088 Rev Effective 11 02 15 Page 17 of 34 No SIM 90 NoSIM 1 07 PM 100 P4 Feedback Information Select Pho
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