SYMBOLS ..........................7 List of symbols adopted on the device ....................7 List of symbols adopted in this manual ....................7 PREPARING THE DRS ......................8 TIME ZONE SETTING ..........................8 Camera autotuning message on first start .................... 9 PREPARING THE PATIENT ....................10 WARNINGS AND PRECAUTIONS ..................
Page 3
19. ELECTROMAGNETIC COMPATIBILITY ................53 20. FCC (USA) and IC (Canada) radio certification ..............53 21. TECHNICAL SPECIFICATIONS .................... 54 22. DICOM Statement........................55 23. DISPOSAL ..........................58 24. TROUBLESHOOTING ......................59 CenterVue DRS Operating Manual Pg. 3 of 59...
In particular, the DRS allows to acquire color images of the retina over a field of view of 45° x 40°. Seven different retinal fields can be framed using multiple internal fixation targets.
Chin rest applied part Operator side Patient side Touch screen Figure 1 - DRS right side (top) and left side (bottom) views Power switch Power inlet USB ports Fuses Ethernet port Figure 2 - Detail of the device right side...
The DRS system is supplied 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;...
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 CenterVue DRS Operating Manual Pg. 7 of 59...
Figure 4 - Forehead rest rear side 5.1 TIME ZONE SETTING The first time the DRS is powered on, the operator should set the Time zone: see § 14.4 – SYSTEM/TIME. The configuration request will appear every time the DRS is started, until the time zone is set.
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. CenterVue DRS Operating Manual Pg. 9 of 59...
There are no restrictions as to the selection of the patients undergoing DRS testing. The DRS is a non-mydriatic device (minimum pupil diameter 4 mm), so there is no need to dilate the subject’s pupil. Patient contacting parts are indicated in Figure 1.
The DRS needs to be operated in a semi dark room (except when taking Anterior Eye photos). The DRS needs to be operated under the following environmental conditions: Temperature: 10 - 40 C°...
Do not leave the front lens uncovered while the system is not in use. The DRS display is a touch screen panel: wherever this manual says “click on ...” it means “point the finger on the display on ...”...
9. PERFORMING THE TEST This paragraph explains how to operate the DRS to perform a complete test. When the unit is turned on and the boot process is over, the Home screen shows up (see Figure Figure 5 - “Home” screen Several options are available at this point, such as: adding a new patient (see 9.1 below);...
AUTOMATIC CHIN REST flag is selected from the settings menu (see par. 14), the chin rest is automatically adapted to the patient head characteristics. d. Press the START button to start the acquisition procedure. CenterVue DRS Operating Manual Pg. 14 of 59...
9.4 Automated acquisition Once the START button is pressed, the DRS will automatically perform the following steps: a. Move the optical head to locate the patient’s pupil (see Figure 7);...
As soon as the eye is detected the automated procedure will resume. Figure 11 - Failure of automatic eye search The result of the overall acquisition process is one or more retinal images as the one shown below. CenterVue DRS Operating Manual Pg. 16 of 59...
Figure 12 - Retinal image acquired by the DRS 9.6 Anterior Eye In order to shoot a focused image of the anterior part of the eye, the patient’s head must be placed on the chinrest but with a distance of 3-5cm (2-3 fingers) between the patient’s forehead and the instrument forehead rest.
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.
When the auto-focus process is not able to find an optical focus, a warning message is shown to inform the operator about the possible low quality of the image (see Figure 18). Figure 18 - Warning due to incorrect focusing CenterVue DRS Operating Manual Pg. 19 of 59...
the acquisition date and time, in the bottom-right corner. Figure 19 - Patient record screen Figure 20 - Patient record with a stereo couple CenterVue DRS Operating Manual Pg. 20 of 59...
Page 21
3D viewer Print both Click on the printer icon to print two images on a single page. Icon eyes is enabled when a supported printer is connected. Figure 21 - Image retake function CenterVue DRS Operating Manual Pg. 21 of 59...
Only available when showing a stereo image. Clicking on this icon will swap right and left image of a stereo Swap stereo pair (“crossed-eye” format). Only available when showing a images stereo pair. CenterVue DRS Operating Manual Pg. 22 of 59...
Page 23
The photo shows an example of such goggles. “Crossed-eye” format is also supported. CenterVue DRS Operating Manual Pg. 23 of 59...
11. REMOTE VIEWER There are two ways to review DRS data and images remotely from a PC, a tablet or a smartphone. The first is by connecting to an existing network (LAN) and the second is by creating a private network even in absence of an existing network infrastructure.
Page 25
Figure 25 - DRS patient list displayed in remote viewer CenterVue DRS Operating Manual Pg. 25 of 59...
Once two images are selected the printout can be printed by clicking on the “Print” button. Figure 26 - Double printout images selection Figure 27 - Single and double images printout CenterVue DRS Operating Manual Pg. 26 of 59...
INFERIOR: centered 17° inferiorly to the foveal pit; optic disk Figure 28 - DRS retinal fields The field(s) acquired respectively when using the SINGLE FIELD or MULTI FIELD acquisition modes described previously can be configured in Settings (see par. 14).
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) CenterVue DRS Operating Manual Pg. 28 of 59...
Micro aneurisms and macula details may appear more visible with this setting CONTRAST strategy - this selection returns an image with more contrast and luminosity difference. Details may appear more evident but image has a more grainy aspect, especially at high zoom levels. CenterVue DRS Operating Manual Pg. 29 of 59...
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, type of medical instrument, etc.) CenterVue DRS Operating Manual Pg. 30 of 59...
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 the value to the default level (2.0). CenterVue DRS Operating Manual Pg. 31 of 59...
Current network status 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). ...
General To enable a wired connection, plug a network cable into the DRS and wait a few seconds. Press “SET NETWORK” to refresh the network configuration. Most networks do not require the operator to set the IP address manually, but in case it’s needed, click on the Manual button and enter the IP address (mandatory), netmask (mandatory), gateway (optional) and DNS (optional).
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 CenterVue DRS Operating Manual Pg. 34 of 59...
(e.g. \\drs-0010\shared). In case of complex networks, it may be necessary to insert the IP address of the DRS instead of its name (e.g. \\192.168.1.10\shared). In this case you might need to seek the support of your local IT staff.
Page 36
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 network. The Remote option might require additional information and special permissions (especially in complex networks) but the data is available even when the DRS is powered off or disconnected.
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.
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. ...
Backup tab allows full management of backup and restoration of the DRS entire database. To perform a data backup, simply connect a USB key or hard disk to the DRS and start the backup operation by pressing “Backup Data” button (see Figure 44).
Page 40
Remember to never modify your exams when reviewing them. Figure 45 - This view is shown when a previously stored backup is found. Note how the button is labeled “UPDATE BACKUP” instead of “START BACKUP”. CenterVue DRS Operating Manual Pg. 40 of 59...
Page 41
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.
Page 42
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. CenterVue DRS Operating Manual Pg. 42 of 59...
Reset Patients will erase all the patients and their data exams, while Reset Parameters will erase all the settings to Factory defaults (selected fields, network configuration, shared folder, preferences, etc.). CenterVue DRS Operating Manual Pg. 43 of 59...
Page 44
NO WAY to restore the data. Use this function 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.
Page 45
Once confirmed with the OK button, the device contacts CenterVue servers and generates a random password and a port to connect 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.
Figure 55 - EKN sync submenu in Settings page HOW TO REGISTER YOUR DRS ON THE EKN CLOUD To start browse your DRS through the EKN platform you need to first register the instrument on the EKN. 1. First time registration with the One Time Secret Key Go to Settings, then EKN;...
Page 47
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".
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 CenterVue DRS Operating Manual Pg. 48 of 59...
15. AUTOMATIC SOFTWARE UPDATE When a new software update is released by the manufacturer and the DRS is connected to the 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.
Always put back the cap on the front lens. Do not leave the front lens uncovered while the system is not in use. CenterVue DRS Operating Manual Pg. 50 of 59...
When cleaning the rest of device, the device must be powered off, and the power cord shall be disconnected from mains. If needed, the external covers of the unit can be cleaned by means of a slightly damp cloth. CenterVue DRS Operating Manual Pg. 51 of 59...
•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 ...
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 ...
Voltage: 100-240 VAC, 50-60 Hz, fuse 3.15 A (T type) Power consumption: 100 VA 22. DICOM Statement DRS can export a DICOM-compliant file format. Refer to the table below for the list of supported tags. Description Value (0002,0000)
Page 56
(0010,0030) Patient's Birth Date of birth fields Value entered in the patient’s (0010,0040) Patient's Sex gender field Value entered in the patient’s (0010,1000) Other Patient IDs “code” field (0018,7004) Detector Type CMOS CenterVue DRS Operating Manual Pg. 56 of 59...
23. DISPOSAL The DRS is made of different materials, such as plastics, aluminum, electronic parts. In case of instrument disposal, please separate the various materials and follow the laws and regulations regarding disposal or recycling for each material effective in your own country.
If any problem occurs, check the following table and try to apply the proposed solution. If this does not solve the problem, immediately stop the unit operation, switch off the main power, disconnect the power supply cord and contact CenterVue authorized personnel. Issue...