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DRSplus

–

Operating Manual

5/58

Introduction

Congratulations for choosing

drs

plus

and its color confocal retinal imaging capabilities.

The

drs

plus

is intended for the acquisition of colored images of the retina without the use of a

mydriatic agent. More specifically, the

drs

plus

provides colored images of the retina with a field of

view of 45° x 40°, in fully automatic mode. The device includes a dedicated software application and
operates as a stand-alone unit.

The clinical interpretation of images acquired by the

drs

plus

must be carried out

exclusively by ophthalmologists.

The ophthalmologist is responsible for any diagnosis based on

drs

plus

results.

Use of the device is strictly limited to suitably trained operators.

Содержание drs plus

Страница 1: ...DRSplus Operating Manual 1 58 Operating Manual ...

Страница 2: ... Via San Marco 9h 35129 Padova ITALY Tel 39 049 501 8399 Fax 39 049 501 8398 The information in this manual are correct at the date of issue of the manual The device configuration can change as product improvement are incorporated and this manual may not exactly depict your device Please contact the customer service if you have any questions about differences ...

Страница 3: ...tion of images 24 9 3 Fast exam 25 9 4 External eye examination 26 9 5 Stereo modality available under license only 26 10 Patients Database 27 10 1 Adding a new patient 27 10 2 Editing an existing patient 27 10 3 Single and multiple selection of patients 27 10 4 Deletion of patients 28 10 5 Export of all patients images 28 11 Image review 29 11 1 Patient Details screen 29 11 2 Image review 31 11 3...

Страница 4: ...8 Electromagnetic Compatibility 51 18 1 Manufacturers EMC Declaration according to ISO 60601 1 2 51 18 2 Guidance and manufacturer declaration electromagnetic immunity 52 18 3 Immunity tests performance criteria 54 18 4 Wi Fi specifications 55 18 5 FCC USA and IC Canada radio certification 56 19 Technical Specifications 57 20 Disposal 58 20 1 Separate collection for electrical and electronic equip...

Страница 5: ...ically the drsplus provides colored images of the retina with a field of view of 45 x 40 in fully automatic mode The device includes a dedicated software application and operates as a stand alone unit The clinical interpretation of images acquired by the drsplus must be carried out exclusively by ophthalmologists The ophthalmologist is responsible for any diagnosis based on drsplus results Use of ...

Страница 6: ...trical and electronic waste is destined for separate recycling Refer to the Operating Manual CE mark the device complies with the essential requirements of the European Medical Devices Directive 93 42 EC Type B Applied Part Non ionizing radiation ME EQUIPMENT that includes RF transmitters Direct current Power button See the device back panel Fig 7 2 2 Other symbols found in this manual Symbol Expl...

Страница 7: ...DRSplus Operating Manual 7 58 General Warning read carefully ...

Страница 8: ... cap for shipping only Fig 1 Cables protection shell Fig 2 Device stand Fig 3 Headrest with silicon cushion Fig 4 External power supply Fig 5 which includes a country specific power cable Fig 1 drsplus device Fig 2 Cables protection shell Fig 3 Device stand Fig 4 Headrest Fig 5 External power supply ...

Страница 9: ...anual 9 58 Fig 6 drsplus Fig 7 Back Panel Headrest Patient side Operator side Touch screen USB ports Ethernet port Power button Power supply connector LED Device power status Back panel with shell DisplayPort version 1 0 ...

Страница 10: ... fixation light Fig 8 Prismatic goggles for stereo view Fig 9 Fig 8 External fixation light Fig 9 Stereo goggles The drsplus is provided with This operating manual Contents list Unpacking packing and setup manual Climatic preconditioning instructions Electrical test report ...

Страница 11: ...DRSplus Operating Manual 11 58 4 Labels The device label is located on the back side of the display as shown in Fig 10 Fig 10 Device label ...

Страница 12: ...he device check that the power outlet is correctly earthed to avoid the risk of electrocution The drsplus must be used in a room with an electrical system that complies with applicable healthcare environment safety regulations The drsplus power supply must be connected to a socket with a circuit breaker The drsplus must NOT be used in an oxygen rich environment or in presence of flammable anesthet...

Страница 13: ...ck of ventilation high humidity sudden temperature drops or peaks The safety and or effectiveness of the instrument cannot be guaranteed if these conditions are not met The following precautions are important to avoid incorrect use of the device Provide explanations to patients before placing them in front of the device Use the device in dim light or at least away from direct light This will facil...

Страница 14: ...nation examination mode involving the acquisition of images of the ocular surface instead of the retina Field portion of the retina visible in a specific image Fixation the ability of a patient to fix his her view on a specific point for example the internal fixation target of the drsplus Fixation target small bright green circle visible when looking into the front lens of the drsplus used to move...

Страница 15: ... the device out of its shipping box and place it onto a suitable table Install the headrest included in the package on the device Fig 11 Connect the power supply to the back panel and to the wall socket Optional Connect a printer to one of the USB ports located in the back panel of the device Install the cables protection shell drsplus needs to be operated in a semi dark environment to ease the na...

Страница 16: ...ig 13 Use the button located near the top right corner of the screen to temporarily skip the Configuration Wizard and go straight to the login screen The Configuration Wizard will be shown the next time the device is started To proceed with the Configuration Wizard press the START button In any of the wizard steps it is possible to browse back to the previous interface by pressing the PREVIOUS but...

Страница 17: ...their format Fig 15 Fig 15 Configuration Wizard date and time settings In the following screen Fig 16 the local System Administrator user can be created by selecting user name and password The user name must contain at least 4 characters1 The password must contain at least 6 characters It is possible to select for such user a different language than the one selected in the first step 1 Moreover se...

Страница 18: ... same rules and constraints described for the Administration account Fig 17 Configuration Wizard creation of user accounts 7 3 Login Turn on the device by pressing the power switch button Fig 7 When the boot is completed the Login screen will be shown Fig 18 Select the desired user from the menu input the user password and press the login button The drsplus can now be operated To modify the passwo...

Страница 19: ...the last two images acquired for that patient The total number of images acquired for that patient is superimposed above the thumbnail for the left and right eye respectively Surname Name Code Date of Birth Gender Date of the last examination made with drsplus Fig 19 Patient List To browse back to the Patient List from any other screen press the Patients icon locate on the top left side of the scr...

Страница 20: ...the current username date and time are found Fig 20 Navigation Bar The Navigation Bar functionalities follows Function Command Browse to the Patient List View the USB devices ready for images export if any View the current status of ethernet and wireless connections Open the panel including Configuration 13 and Utilities tools 14 Logout Reboot and Shutdown menu ...

Страница 21: ...e find a comfortable position keeping the forehead well placed on the device head rest 3 Once a good position is found please do not move and do not talk 4 Open your eyes wide 5 At the beginning of the exam the device will move to find your eye Such movement is normal when the device moves please keep looking forward 6 When a small green light appears please look at such light and avoid blinking 7...

Страница 22: ...tient is already included in the local database enter the initial characters of the patient s name surname or code in the search box To add to the local database a new patient press the New Patient button Refer to 10 1 for additional details about the New Patient functionality Upon having saved and located the patient in the Patient List click on the corresponding line the new exam button to start...

Страница 23: ... acquire the available options follow Every selected field corresponds to a specific position of the internal green fixation target Fig 22 Exam configuration screen The following fields can be selected a CENTRAL centered on the foveal pit b NASAL centered approx 19 nasally to the foveal pit c TEMPORAL centered approx 19 temporally to the foveal pit d CENTRAL NASAL centered approx 7 nasally to the ...

Страница 24: ...frontal lens To ensure the correctness and speed of image acquisitions the pupil shall fall in the area delimited by yellow bands When the patient is ready and the acquisition is configured press the START EXAM button to begin the image acquisition procedure 9 2 Automatic acquisition of images drsplus automatically a Aligns the frontal lens toward the patient s pupil b performs the autofocus of th...

Страница 25: ...r the patient Top right text Fig 23 Running examination screen in automatic mode The acquisition process can be interrupted at any moment by clicking the STOP EXAM button Being the acquisition totally automated this is the only available control 9 3 Fast exam This functionality Fig 24 permits to start an examination without the need to add a new patient first When a Fast Exam is started a new pati...

Страница 26: ...will automatically acquire an image of the external surface of the eye see Fig 25 Fig 25 Image of the external surface of the eye zoom 9 5 Stereo modality available under license only When this modality is set drsplus will automatically acquire a couple of retinal images using the nasal fixation target The two acquisitions differ just by a small transverse displacement acquired to add the stereosc...

Страница 27: ...te Gender and Notes Press SAVE to save the new patient or CANCEL to cancel the operation Fig 26 New Patient dialog 10 2 Editing an existing patient To modify the information of an existing patient open the Patient Details screen see 11 1 and press the Edit Patient button This will open the Edit Patient dialog Fig 27 Fig 27 Edit Patient dialog 10 3 Single and multiple selection of patients To selec...

Страница 28: ...4 Deletion of patients Select the patients to be deleted and click the Delete button on the right panel 10 5 Export of all patients images Select the patients whose images are to be exported and click the Export button in the right panel Refer to 12 for additional information about this feature ...

Страница 29: ...e patient was examined Each row includes the thumbnails of the last acquired images both OD and OS and the number of images for that date OD and OS Left panel Thumbnails of the images acquired in the selected date including additional information eye retinal field estimated pupil size acquisition date and time Center of the screen Fig 28 Patient Details screen Available functionalities Function Co...

Страница 30: ...creen review of a single image Click on the image thumbnail Retake an image5 Press the icon on the bottom right corner 2 Available under license only 3 Function is active only upon selection of two images 4 It is not possible to delete an image that has been mounted in a mosaic Operator shall delete the mosaic before deleting its images 5 It is not possible to delete an image that has been mounted...

Страница 31: ...vious next image buttons located on the left right edge of the screen Browse back to the patient details screen button top right Open the list of images for quick access Fig 30 button bottom left Open the toolbar that includes image adjustment export print and deletion button bottom right Fig 30 Image review screen Here the list of images for quick access is shown on the left panel and the toolbar...

Страница 32: ...tionalities Function Command Enable Disable the zoom and pan synchronization any zoom and pan operation done on an image will immediately will replicated on the fellow image Swap the images Close the side by side review screen Open the toolbar that includes right image adjustments export print and deletion button bottom right Open the toolbar that includes left image adjustments export print and d...

Страница 33: ... included in the drsplus software Fig 33 Visual flickering screen Available functionalities Function Command Start or pause the image flickering Show the other image Change the flickering speed Cursor on the right side Close the image flickering screen 11 5 Mosaic The drsplus includes a special software algorithm that stitches together two or more photos of a retina to obtain an image with wider f...

Страница 34: ... of a new mosaic is possible only under certain conditions a The selected retinal fields belong to the same eye b The selected retinal fields have been acquired in the same date c At least one CENTRAL field has been selected A maximum of 9 images can be stitched together into a mosaic The drsplus cannot be used to acquire images during a mosaic creation The creation of a mosaic with 9 images takes...

Страница 35: ...f the ethernet cable to the Ethernet port located on the back panel of the device the network connection might require additional configuration 13 3 Once the connection is up and running open a browser in the remote PC and insert the address of the device http nnnnn domain into the address bar Here nnnnn are the 7 characters which compose the serial number of the drsplus as reported in the device ...

Страница 36: ...re 13 6 one or more destinations including USB and network drives choose export parameters Fig 36 o select one or more of the following export formats JPEG PDF DICOM o in the case of the PDF format various parameters can be selected including the orientation of the paper vertical horizontal sheet size A4 A5 Letter and number of images per page Once the export parameters have been defined click on ...

Страница 37: ...ation panels described below Some configuration panels are accessible or restricted according to the user level 13 1 Account The Account panel Fig 37 allows users to change their password Fig 37 Account panel You must know the current password in order to be able to change it 13 2 Users This panel Fig 38 is only accessible to the Administrator and enables management creation modification and delet...

Страница 38: ...arameters required for the network connection and specify the primary network using the selector Fig 39 Network panel Ethernet connection wired DHCP manual setting can be configured In this latter case the IP address and DNS must be configured manually Fig 40 Ethernet connection settings Wi Fi connection The network parameters can be configured as per the Ethernet The following functionalities are...

Страница 39: ...wired and Wi Fi network connection status 13 4 Date and time This panel Fig 42 allows you to configure the parameters relating to the date and time formats offering the following functions Automatic requires Internet connection or manual date and time settings Time zone settings Date and time format settings Fig 42 Date Time panel 13 5 Security This panel Fig 43 allows you to configure the securit...

Страница 40: ... signed HTTPS certificate that must be accepted into your browser in order to dismiss the standard warning issued by all browsers Fig 43 Security panel 13 6 Export This panel Fig 44 Fig 45 allows you to configure the parameters relating to the export function Fig 44 Export panel ...

Страница 41: ...ig 45 Configuration of export destination 13 7 Printers This panel Fig 46 allows you to configure the printing subsystem Refer to the on line documentation for details of how to configure the CUPS printing system Fig 46 Printers panel ...

Страница 42: ...established the panel will show the Authorization Code that the remote operator will need in order to connect to the device Function Command Open a Remote Assistance RA session Upload diagnostic data to a CenterVue server Export diagnostic data to USB Fig 47 Assistance Utilities The current status of the Remote Assistance session is always available through the service icon on the top bar Pressing...

Страница 43: ...up configuration The Operator user can only execute an already configured backup job The panel displays the date and time of the last successful backup HARD DISK FAILURES ARE UNPREDICTABLE AND MAY CAUSE IRREVERSIBLE LOSS OF DATA IN THE EVENT OF LOSS OF DATA IT CAN BE EASILY RECOVERED FROM THE LAST BACKUP PERFORMED IT IS THE OPERATOR S RESPONSIBILITY TO KEEP AN UPDATED BACKUP OF THE DATA GENERATED ...

Страница 44: ...formed automatically destination Configuration of external storage units USB keys and discs on which backup is performed automatically destination 14 3 Restore This panel Fig 49 provides the utility to restore from a backup The panel displays a list of available destinations that contain a compatible backup image that can be restored Only the Administrator user is allowed to perform a restore oper...

Страница 45: ...of all patients and examination data On resetting to factory settings all data will be erased and all settings returned to initial values Installed licenses are not affected Fig 50 Reset panel 14 5 Licenses This panel Fig 51 can be used to manage optional licenses It shows the list of licenses installed on the device and allows to either revoke a license or to install a new one ...

Страница 46: ... folder of a USB flash memory which then must be plugged into one of the three USB ports The device will detect the installation package and prompt the operator for a confirmation before proceeding with the installation Fig 52 Update panel 14 7 More This panel Fig 53 provides a few utilities that can be used to Enable or disable the demo dataset Move the optical head to positions that are suitable...

Страница 47: ...led with no restrictions by the Administrator 14 9 Optical head position Except during startup and when an exam is in progress the optical head is always positioned in the lens cap position where the back of the headrest protects the front lens To clean the front lens the operator can press the Lens cleaning position button to move the optical head to a position that exposes the front lens to the ...

Страница 48: ...lect the Logout option to close the current session or select Reboot to restart the device or select Power off to initiate the shutdown procedure and power off the device Wait a few seconds after the on board display goes dark before removing the power cord of switching off the power source for example by turning the main switch on the electric table ...

Страница 49: ... Do not attempt to clean the front lens with a dry cloth as this may scratch the surface The headrest silicon cushion is the only part in direct contact with the patient it should be sanitized with a disinfecting wipe after each use and allowed to dry prior to reuse Take care not to sprinkle parts not belonging to the patient rest The headrest silicon cushion can also be removed and washed with lu...

Страница 50: ...y by personnel authorized by CenterVue Maintenance frequency recommended by CenterVue Safety electric tests according to IEC 60601 1 once a year Comprehensive system verification every two years Inquire with your local distributor or Authorized Service Center for service contracts and warranty extensions ...

Страница 51: ... other devices are connected contact the manufacturer or field service technician for help This device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided within this document Portable and mobile RF communications equipment can affect the readings made by this device 18 1 Manufacturers EMC Declaration according to ISO 606...

Страница 52: ...ment guidance Electro static discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Avoid touching the exposed conductive parts of connectors when handling the device or connecting cables Electrical fast transient burst IEC 61000 4 4 2 kV for p...

Страница 53: ...equency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level ...

Страница 54: ... NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcasts and TV br...

Страница 55: ...ing to frequency of transmitter 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800MHz to 2 5 GHz d 1 17 P 0 01 0 12 0 12 0 12 0 1 0 37 0 37 0 37 1 1 17 1 17 1 17 10 3 70 3 70 3 70 100 11 70 11 70 11 70 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the tran...

Страница 56: ...otected Management Frames 18 5 FCC USA and IC Canada radio certification drsplus contains a radio module that complies with regulations of Canada and the USA and in particular with Part 15 of FCC regulation 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...

Страница 57: ...contact the equipment manufacturer Users play a major role in contributing to the reuse recycling and recovery of WEEE The potentially dangerous substances contained in WEEE can pollute the environment and produce harmful effects on human health Below is a list of specific hazards related to some substances which may leach in the environment and in the water system Lead damages the nervous system ...

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