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CenterVue 

DRS Operating Manual  

Pg. 53 of 59 

 

19. ELECTROMAGNETIC COMPATIBILITY 

This device is classified in class B according to IEC 60601-1-2.  
This device has been tested and found to comply with the limits for medical devices contained in 
IEC  60601-1-2  and  Medical  Device  Directive  93/42/EEC.  These  limits  are  intended  to  provide 
reasonable protection against harmful interference in a typical medical installation. This instrument 
generates,  uses  and  can  radiate  radio  frequency  energies  and,  if  not  installed  and  used  in 
accordance with these instructions, may cause harmful interference to other devices in the vicinity. 
However,  there  is  no  guarantee  that  interference  will  not  occur  in  a  particular  installation.  If  the 
system does cause harmful interference to other devices, which can be determined by turning the 
system  off  and  on,  try  to  eliminate  the  interference  by  adopting  one  or  more  of  the  following 
measures: 

  reorient and/or relocate the receiving device; 

  increase the distance between the devices; 

  connect the system to an outlet on a different circuit than that to which the other devices is 

connected; 

  consult the manufacturer or field service technician for help. 

 

20. FCC (USA) and IC (Canada) radio certification 

The DRS contains a radio module that complies with regulations of the USA and Canada. 

  FCC ID:   K7T-WIFIHU-A ID  

  IC:  

2377A-WIFIHUA. 

These devices comply with part 15 of the FCC rules. 
Changes  or  modifications  not  expressly  approved  by  the  party  responsible  for  compliance  could 
void user’s authority to operate the equipment. 
Operation  is  subject  to  the  following  2  conditions:  (1)  this  device  may  not  cause  harmful 
interference, and (2) this device must accept any interference received, including interference that 
may cause undesired operation.  

Содержание drs

Страница 1: ...CenterVue DRS Operating Manual Pg 1 of 59 OPERATING MANUAL ...

Страница 2: ...ls adopted in this manual 7 5 PREPARING THE DRS 8 5 1 TIME ZONE SETTING 8 5 2 Camera autotuning message on first start 9 6 PREPARING THE PATIENT 10 7 WARNINGS AND PRECAUTIONS 11 8 NOTES TO OPERATOR 12 9 PERFORMING THE TEST 13 9 1 Adding a new patient 13 9 2 Selecting an existing patient 14 9 3 Starting the image acquisition process 14 9 4 Automated acquisition 15 9 5 Manual alignment 16 9 6 Anteri...

Страница 3: ...less 34 Shared folder 35 Password to protect access from the network 37 14 4 System 38 General 38 Time 39 Backup 39 Printers 43 Service 43 14 5 EKN 46 14 6 About 48 15 AUTOMATIC SOFTWARE UPDATE 49 16 SYSTEM SHUTDOWN 50 17 CLEANING 51 18 MAINTENANCE 52 19 ELECTROMAGNETIC COMPATIBILITY 53 20 FCC USA and IC Canada radio certification 53 21 TECHNICAL SPECIFICATIONS 54 22 DICOM Statement 55 23 DISPOSAL...

Страница 4: ...even different retinal fields can be framed using multiple internal fixation targets The clinical interpretation of the images acquired by the DRS is restricted to licensed eye care practitioners The process of making a diagnosis using DRS results is the responsibility of the eye care practitioner A device specific training is required for any operator to become able to use the system Federal laws...

Страница 5: ...YSTEM Figure 1 DRS right side top and left side bottom views Figure 2 Detail of the device right side Chin rest applied part Forehead rest applied part Patient side Operator side Touch screen USB ports Ethernet port Power switch Power inlet Fuses ...

Страница 6: ... with Power cord Spare fuses This Operating Manual Dust cover Microfiber cleaning tissue for touch screen Front lens photographic cleaning paper pack of single use sheets Silicone forehead rest Hand blower Glasses with adjustable prisms USB 2 0 extension cord 3 LABELING ...

Страница 7: ...acturing Date year week of production Electronic and electric devices must be recycled Refer to Instruction Manual CE mark the device complies with the essential requirements of the European Medical Devices Directive 93 42 EC Warning Do Not Touch Type B Applied Part Generic Warning 4 2 List of symbols adopted in this manual Note Warning ...

Страница 8: ... power cord provided with the unit to the power inlet see Figure 2 optionally connect a compatible printer1 to any of the USB ports see Figure 2 attach the silicon forehead rest included in the tool box on the forehead rest frame as shown in the pictures below Figure 3 and Figure 4 Figure 3 Forehead rest patient side Figure 4 Forehead rest rear side 5 1 TIME ZONE SETTING The first time the DRS is ...

Страница 9: ...e appears ONLY ONCE when recent software is started the first time PLEASE APPLY THE LENS CAP AND PRESS OK AND WAIT ABOUT 30 SECONDS UNTIL THE FOLLOWING MESSAGE APPEARS This procedure is not invasive and not essential if the operator forgets to apply the Lens Cap and just presses ok the image quality is not affected and no danger is possible to the patient anyway ...

Страница 10: ...est inform the patient about the following 1 the test is non invasive in particular the system will never touch your eye and you will only see a flash of light when a photograph is taken 2 find a comfortable position keeping the chin and forehead firmly pressed against the rests 3 at the beginning of each test the unit will move around to find your pupil this is absolutely normal 4 when the test s...

Страница 11: ... room where the DRS is operated must respect IEC or ISO safety standards relative to medical use of a room or area The DRS must NOT be used in an oxygen rich environment or in presence of flammable anesthetics External equipment connected to the DRS within the patient environment must be compliant with IEC 60601 Equipment not complying with IEC 60601 1 shall be kept outside the patient environment...

Страница 12: ...is a sophisticated computer algorithm procedure The algorithm may fail in some circumstances such as long eyelashes make up room too bright or presence of breaches of light on patient face very big pupil Under these conditions the alignment may fail and the device could rest on the patient face No safety issue is compromised but the exam should be repeated under better conditions 8 NOTES TO OPERAT...

Страница 13: ...n Several options are available at this point such as adding a new patient see 9 1 below selecting an existing patient from the list see 9 2 below starting the image acquisition process without identifying the patient see 9 3 below 9 1 Adding a new patient To add a new patient to the list type the last name mandatory first name and date of birth in the corresponding boxes Optionally select the gen...

Страница 14: ... acquisition process Before proceeding be sure that the patient received complete explanations concerning the test and what she he is required to do as explained at par 5 1 Then proceed as follows a Select OU to acquire images from both eyes default OD for the right eye only and OS for the left eye only b Select SINGLE FIELD to acquire one 45 image of the retina default or MULTI FIELD to acquire m...

Страница 15: ... which eye is being acquired the red circle in Figure 8 represents the pupil and becomes green when proper centering is achieved In case the auto alignment module fails manual alignment is possible see par 9 5 below for details c Perform auto focus see Figure 9 d Capture an image by flashing the retina This step involves also automatic tuning of the flash level e Store the image in the local hard ...

Страница 16: ...e during eye search If any of the above situations applies try to fix the cause re position the patient instruct her him to steadily fixate at the target and or to not move before proceeding with the manual alignment Use the UP DOWN LEFT RIGHT buttons to adjust the optical head position and align the patient s eye to the instrument front lens As soon as the eye is detected the automated procedure ...

Страница 17: ... started the optical head moves in front of the selected eye for a rough alignment When it reaches the optimal position a live color view of the eye is displayed so that manual alignment and focus can be performed using the on screen buttons The fine manual positioning and focus setting is necessary in order to take a good quality picture The live view can be toggled to full screen just by pressin...

Страница 18: ...l dimensions and have two images as much similar as possible in terms of brightness The delay length can be set in the Settings page Exam Saving Implementing a slight shift between one image and the other the optical head of the DRS will capture a simulated stereoscopic view of the optical disc In order to perceive the 3D vision of the optic disk the images must be watched with a couple of prismat...

Страница 19: ...d the lenscap Figure 16 Message when lens cap is detected When the pupil measured immediately before the snapshot is smaller than 3 8 mm a warning message is shown to inform the operator about the possible low quality of the image see Figure 17 Figure 17 Warning due to small pupil When the auto focus process is not able to find an optical focus a warning message is shown to inform the operator abo...

Страница 20: ...mbnail view of all the available images see Figure 19 10 1 Patient record screen For each image thumbnail the following information is displayed the eye OD OS and field information in the top left corner the image number in the top right corner the acquisition date and time in the bottom right corner Figure 19 Patient record screen Figure 20 Patient record with a stereo couple ...

Страница 21: ...a USB key only available if a USB key is plugged in any of the USB ports Retake images Clicking on this icon will select one or more images to be retaken see Figure 21 When all images have been selected click on NOTE images can be retaken within 5 minutes after they have been captured Open full image screen Click on the corresponding thumbnail this command will open the full image screen shown in ...

Страница 22: ...Clicking on this icon will export the selected image as a high quality jpg file on any USB key only available if a USB key is plugged in any of the USB ports Image print Clicking on this icon will print the current image only available if a compatible USB printer is connected Image delete Clicking on this icon will permanently delete the selected image Move to next previous image Clicking on these...

Страница 23: ...Images 3D viewer Figure 24 To perceive the 3D vision of the optic disk the images must be watched with a couple of prismatic goggles that let each eye see only one of the two images The photo shows an example of such goggles Crossed eye format is also supported ...

Страница 24: ...guration and configure the remote PC with a different IP 4 Retrieve the DRS IP as displayed in the Settings Network screen see par 14 3 Figure 33 5 Type the DRS IP in the URL box of the remote PC s Internet browser Remote visualization through a private network To configure the DRS for a private network access see par 14 3 To use the viewer in wireless mode proceed as follows 1 Enable the wireless...

Страница 25: ...CenterVue DRS Operating Manual Pg 25 of 59 Figure 25 DRS patient list displayed in remote viewer ...

Страница 26: ... to print two images on the same printout Once the button is pressed a dialog box appears prompting for the selection of two images The image list can be scrolled in order to select the images to be printed by clicking on the print icon that is placed on the top right corner of each image Once two images are selected the printout can be printed by clicking on the Print button Figure 26 Double prin...

Страница 27: ...orally to the foveal pit d SUPERO TEMPORAL centered 12 superiorly and 12 temporally to the foveal pit e PERI CENTRAL centered 5 nasally to the foveal pit f SUPERIOR centered 17 superiorly to the foveal pit g INFERIOR centered 17 inferiorly to the foveal pit Figure 28 DRS retinal fields The field s acquired respectively when using the SINGLE FIELD or MULTI FIELD acquisition modes described previous...

Страница 28: ...cord screen Once in the settings page the following tabs are available 14 1 Fields This page allows configuring the fields acquired by the SINGLE and MULTI acquisition modes any 45 field among the 7 available ones see par 13 can be associated to the SINGLE mode while up to seven 45 fields can be associated to the MULTI mode Figure 29 Fields menu in settings page single field ...

Страница 29: ...Y Image Processing Strategy It is possible to select between two different Image Processing Strategy Uniformity and Contrast This setting affects the internal gains and color tunings of the Camera The final retina image has different color balance and luminosity but the original image details are the same One Strategy is not better than other and mostly depends on personal taste and habit UNIFORMI...

Страница 30: ...saved in the DICOM tag 0008 0080 Institution name It is also possible to choose to automatically create a folder for each patient name and or a folder for each exam ID when saving on USB key it is possible to enable the function for DICOM export of images from the Remote Viewer The DICOM file format contains both the retina image and some corollary field for example exam date time patient name typ...

Страница 31: ...scription this value is saved in the DICOM tag 0008 1030 Enter the Series Description this value is saved in the DICOM tag 0008 103e find the option to disable the lens cap detection at the start of the exams control the threshold of the auto exposure meter Exposure Value box The higher the value specified the brighter the flash level The value can be set from 0 5 to 5 0 The default button sets th...

Страница 32: ...s label The result can be any of the following see Figure 33 Internet connection fully available on address xxx xxx xxx xxx the DRS is fully connected to the Internet required for EKN connection and support purposes LAN working on IP xxx xxx xxx xxx a valid network is set and the local network is ready No working connection the DRS is not connected to any network Figure 33 Network General tab in s...

Страница 33: ...lick on Private Network button see Figure 34 The Private Network allows the use of the DRS remote viewer without using existing networks It can be used both in wired and wireless configuration To go back and use an existing network click on Set Network The Private Network always enables the wireless interface If the DRS is plugged into an existing network where another DHCP server is active unplug...

Страница 34: ...Ethernet port this could create problems in wireless connection Press RESCAN to refresh the list of available networks then select the network to which you want to connect to Enter the WiFi password key and click Connect to establish the wireless connection In Figure 35 an example of a wireless networks found Figure 35 Wireless menu when a wireless network is going to be set up ...

Страница 35: ...e Full image screen This button allows you to save the exam in the shared folder Figure 36 Figure 36 Menu in Settings page Shared Folder As shown in Figure 36 you can set the export function to save the images in a folder inside the DRS by pressing the INTERNAL button or in a remote folder by pressing the REMOTE button When INTERNAL is selected data is saved in a folder inside the DRS This folder ...

Страница 36: ...l be validated and stored in your DRS configuration Figure 39 Remote Folder Configuration Connection Successful The most important difference between the two type of shared folder internal and remote is where the data is store and therefore how it can be accessed The Internal option is the easiest to set up but the data is available only as long as the DRS is powered on and connected to the networ...

Страница 37: ...AL shared folder is active Password to protect access from the network Figure 41 LAN Access submenu in Settings page The LAN ACCESS sub tab lets you set a password for the Remote Viewer access to the DRS to prevent access to the exams data to unauthorized people in your local network ...

Страница 38: ...ure the screensaver the delay can be between 5 min and 60 min If the screensaver is enabled it can be protected by a password the operator will also be prompted for the password when the DRS starts Third party EMR systems can interface to the DRS using its web programming interface This feature can be enabled only if a valid license is installed Enable or disable the DARK MODE a configuration that...

Страница 39: ...igure 44 To restore data from an existing backup press the button Restore Data see Figure 44 A wizard will let you choose between a full restore existing data are replaced with the ones contained in the backup or a fusion of the data the imported data are merged with the ones present in the DRS The restore has a same patient recognition and in case of doubt the wizard asks for confirmation of dupl...

Страница 40: ... new backup This warning permit to cancel the operation by pressing the Cancel button see the dialog boxes here below and afterwards plug another external device and launch the backup operation again A manual modification of the backup data over your external device prevents the ability to restore that backup Remember to never modify your exams when reviewing them Figure 45 This view is shown when...

Страница 41: ...ode selection view Figure 48 Restore mode Using the first mode ERASE button the current DRS exams and patient s data are overwritten by data of the selected backup source In the second mode APPEND button the system properly recognizes identical patients and exams and executes a restoration into the DRS of the differences only Only in case of ambiguity the system asks the operator to select from a ...

Страница 42: ...ts dialog An ambiguity between patients arises when they have the same name no other useful information like birth date etc and they do have different database creation dates For both backup and restore a progress percentage informs the operator about the operation status ...

Страница 43: ...rvice menu allows using some service functionalities In particular Reset Robot will force a reset of the robot motor positions the same procedure is performed by the system at startup Service will give access to a special password protected panel available for authorized personnel only Image rebuild allows rebuilding the images thumbnails in case some of them have disappeared as a consequence of a...

Страница 44: ...nction with caution The Reset Patients button is disabled when the DRS is connected to the EKN cloud The Remote assistance button opens a remote connection that allows authorized service technicians to connect to the DRS Once pressed the following disclaimer appears informing the operator that he she is authorizing the access to all the data present on the device for servicing purposes Figure 52 R...

Страница 45: ...ct to These parameters must be sent to the service operator in order to connect Figure 53 Remote Assistance result The connection can be closed using the same button which now has changed to Close Remote Assistance Please note that as stated in the disclaimer the remote assistance is closed automatically if the machine is restarted Figure 54 Remote assistance status ...

Страница 46: ...y web browser from anywhere in the world It can be used as a system of telemedicine the operator and the doctor can be situated in different places It is possible to easily share some of the images with who you desire For more detailed information on this new feature please refer to https www eyeknowledge net about Figure 55 EKN sync submenu in Settings page HOW TO REGISTER YOUR DRS ON THE EKN CLO...

Страница 47: ...ercase characters Then carefully type the One Time Secret Key shown on your DRS You need to do this operation only once 4 Start viewing Go back to your DRS and keep it connected to the internet After less than half an hour you can go back to Settings EKN and the device will display registered After a while all the patients and the exams will be available on your EKN account The upload time depends...

Страница 48: ...Vue DRS Operating Manual Pg 48 of 59 14 6 About This screen shows the DRS serial number the software and firmware version the OS version and the Ethernet WiFi MAC address Figure 56 About menu in Settings page ...

Страница 49: ...he internet a new icon will appear on the Home screen at the top bar notifying availability of the update If you click on the icon the message shown in Figure 57 will appear To download and install the new software version click Install otherwise to keep the current version click Cancel Figure 57 Message to confirm the installation of the new software version ...

Страница 50: ...tient list or Patient record screen and click on the power off button Wait for the progress bar to completely roll back A message on the screen will inform you when it is safe to turn off the main switch Always put back the cap on the front lens Do not leave the front lens uncovered while the system is not in use ...

Страница 51: ...gents Extreme care should be given to always protect the front lens The front lens should be cleaned by using a small hand pump air blower to blow away dust Only if really needed for instance due to the presence of a fingerprint the front lens should be cleaned using photographic cleaning paper and a suitable lens cleaning fluid The touch screen panel should be cleaned only with a cloth damped in ...

Страница 52: ...replace fuses see section Technical specifications Insert fuse holder Connect power cord to mains All service interventions not included in this chapter should be carried out by authorized CenterVue personnel It is warmly recommended to provide a service to the instrument in order to check the electrical safety IEC 60601 1 every year the general functionality test and measurement tests every 5 yea...

Страница 53: ... which can be determined by turning the system off and on try to eliminate the interference by adopting one or more of the following measures reorient and or relocate the receiving device increase the distance between the devices connect the system to an outlet on a different circuit than that to which the other devices is connected consult the manufacturer or field service technician for help 20 ...

Страница 54: ...ize 5 MPixel 2592 x 1944 Resolution 48 pixels deg Resolution on retina 15 µm Pixel pitch on retina 6 µm Other features Patient presence sensor Motorized chin rest Automatic alignment Auto focus adjustment range from 15D to 15D Auto flash level adjustment Touch screen color display Embedded PC Ethernet connectivity Dimensions Weight 19 Kg 42 lbs Size 55 55 33 cm 22 22 13 in Accessories Power cord S...

Страница 55: ... UID UI 22 2 16 840 1 114496 6 4 0002 0010 Transfer Syntax UID UI 20 1 2 840 10008 1 2 1 0002 0012 Implementation Class UID UI 26 1 2 826 0 1 3680043 8 641 0002 0013 Implementation Version Name SH 8 CVUEDRS 0002 0016 Source Application Entity Title AE 10 RUBY_DICOM 0008 0016 SOP Class UID UI 32 1 2 840 10008 5 1 4 1 1 77 1 5 2 0008 0018 SOP Instance UID UI 22 CenterVue ANSI registration code uniqu...

Страница 56: ...Coding Scheme Designator SH 4 SRT 0008 0104 Code Meaning LO 14 Fundus Camera 0008 1030 Study Description LO 2 Value entered in Settings Exam Advanced Study Description 0008 103E Series Description LO 2 Value entered in Settings Exam Advanced Series Description 0010 0010 Patient s Name PN 10 Value entered in the patient s Last Name and First Name fields last first 0010 0020 Patient ID LO 2 Value en...

Страница 57: ...mber IS 0 This tag is always empty 0020 0020 Patient Orientation CS 2 LF 0020 0062 Image Laterality CS 2 R or L left or right eye 0022 000C Horizontal Field of View FL 4 45 000000 0028 0002 Samples per Pixel US 2 3 0028 0004 Photometric Interpretation CS 4 RGB 0028 0006 Planar Configuration US 2 0 0028 0010 Rows US 2 1944 0028 0011 Columns US 2 2592 0028 0030 Pixel Spacing DS 6 0 0064 0028 0100 Bi...

Страница 58: ... contact the manufacturer of the equipment Users have a fundamental role in contributing to reuse recycling and recovery of WEEE The potentially dangerous substances contained in the WEEE can pollute the environment and produce harmful effects to the human health Below there are a few indications of specific dangers of some substances which may leach in the environment and in the water system Lead...

Страница 59: ...or with the control board Robot initialization error or Unable to connect to control board The control board is not powered with 12V or there is no USB connection between the computer and the control board or the BIOS of the embedded PC is set not to power control board logic Contact an Authorized Service Center The retinal image is blurred defocused The motor of the focus LED doesn t move The mot...

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