CenterVue drs User manual

CenterVue
DRS Operating Manual
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OPERATING MANUAL

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DRS Operating Manual
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MANUAL INFORMATION
Date of release: April 18, 2014
Revision number: 18
Reference software version: v2.3.x
Manufacturer:
CenterVue SpA
Via San Marco 9h, 35129 Padova –ITALY
Tel. [phone]
Fax [phone]
SUMMARY
1. INTRODUCTION.....................................................................................................................4
2. SYSTEM..................................................................................................................................5
3. LABELING...............................................................................................................................6
4. SYMBOLS ...............................................................................................................................7
4.1 List of symbols adopted on the device.................................................................................................. 7
4.2 List of symbols 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 Anterior Eye......................................................................................................................................... 17
9.7 Stereo exams ....................................................................................................................................... 18
9.8 Warning messages............................................................................................................................... 19
10. REVIEWING THE IMAGES ...................................................................................................20
10.1 Patient record screen .......................................................................................................................... 20
10.2 Full image screen................................................................................................................................. 22
11. REMOTE VIEWER ................................................................................................................24
12. PRINTOUT ............................................................................................................................26

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12.1 Full image screen................................................................................................................................. 26
12.2 Patient record screen .......................................................................................................................... 26
13. RETINAL FIELDS..................................................................................................................27
14. SETTINGS.............................................................................................................................28
14.1 Fields.................................................................................................................................................... 28
14.2 Exam .................................................................................................................................................... 29
Exam ........................................................................................................................................................ 29
Saving....................................................................................................................................................... 30
Advanced ................................................................................................................................................. 31
14.3 Network ............................................................................................................................................... 32
General .................................................................................................................................................... 33
Wireless ................................................................................................................................................... 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.............................................................................................................................58
24. TROUBLESHOOTING...........................................................................................................59

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1.INTRODUCTION
The Digital Retinography System (DRS) is a fundus camera for the acquisition of digital images of
the retina without the use of a mydriatic agent.
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.
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 (US) restrict this device to sale by or on the order of a physician
or a properly licensed practitioner.

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2.SYSTEM
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

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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;
Hand blower;
Glasses with adjustable prisms;
USB 2.0 extension cord.
3.LABELING

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4.SYMBOLS
4.1 List of symbols adopted on the device
Symbol
Explanation
Manufacturer Data
Manufacturing 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

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5.PREPARING THE DRS
Carefully and thoroughly read paragraph 7 WARNINGS AND PRECAUTIONS before
proceeding with first use.
The test should be performed in conditions of semi-obscurity to facilitate the
dilation of the pupil
To set up your DRS follow these steps:
extract the system from its box;
place the DRS on a suitable electrical table
1
;
connect the power cord provided with the unit to the power inlet (see Figure 2);
optionally connect a compatible printer1to 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 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.
1
Not provided with the DRS

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5.2 Camera autotuning message on first start
After upgrade to latest software version a message could appear:
This message 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.

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6.PREPARING THE PATIENT
Patients with Contact Lenses. Image quality may be affected by contact lenses. It is
recommended to have contact lenses removed before imaging the patient.
This paragraph explains how to prepare a patient for the DRS test.
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.
Before the test 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 starts look straight in front of you and when a small green circle becomes
visible anywhere within the field look steady at it;
5) open your eyes wide so that eyelids do not interfere and try to not blink during the test;
6) do not move during the test;
7) if you follow these instructions the acquisition of a single photo will take less than 30
seconds.

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7.WARNINGS AND PRECAUTIONS
The following precautions are particularly relevant to the device safety:
Federal laws (US) restrict this device to sale by or on the order of a physician or a
properly licensed practitioner.
The clinical interpretation of DRS images is restricted to licensed eye care
practitioners.
A device specific training is required for any operator to become able to use the
system.
Do not open the device: this could lead to electric shocks or damage to the system.
Do not use the instrument in the event that the cover or other parts of the device
have been removed.
Only technicians authorized by CenterVue may service the DRS. CenterVue
cannot be held responsible for system safety should the DRS be opened, repairs
carried out, third parties software be installed, or parts be replaced by unauthorized
persons.
Do not expose the device to water: this could lead to fire or electric shock.
Stand clear from moving parts during operation.
All parts in contact with a patient’s skin need to be disinfected after use
(see par. 17).
The instrument is supplied with an earth ground by means of a protection
conductor contained inside the power supply cable. Before turning on the system,
make sure the power supply socket is correctly grounded to avoid the risk of
electric shock.
The 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 and complying with IEC 60950. Any person
who connects external equipment to signal input, signal output or other connectors
of the DRS has formed a Medical Electrical System according the definition of
IEC 60601-1 and is therefore responsible for the system to comply with the
requirements of IEC 60601-1, § 16. If in doubt, contact the local representative.
Data Backup: DRS contains Patient Health Information. It is strongly
recommended the use of the “backup” utility as indicated at the Chapter “System”.
The following precautions are particularly relevant to prevent use errors:
The device must be placed in a room which is not exposed to adverse chemical-
physical conditions, such as the presence of sulfur, salt, dust, direct sunlight, lack
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
fulfilled.
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° (50 - 104 F°) / Humidity (max): 90% not condensing

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The DRS needs to be stored under the following environmental conditions:
Temperature: -10 - 60 C° (14 - 140 F°) / Humidity (max): 90% not condensing
A not optimal pupil alignment may cause the acquisition of an image of the retina
that has a growing light crescent on a board. Such growing light should be
considered an artifact and not a feature of the retina under examination.
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 ...”
Automatic alignment of the pupil:
Automatic alignment of the pupil 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 OPERATOR
No specific skills are required to operate the DRS.
A minimal, device specific, training is required to become able to use the system.
The operator needs to be acquainted with the following concepts:
pupil: the central part of the external surface of the eye, through which light goes in;
retina: the internal surface of the eye ball;
fixation / fixating: the ability of a subject to stare at a specific point in space and specifically
the DRS internal fixation targets.

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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
5).
Figure 5 - “Home” screen
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 gender and type a Code of your choice. Then click on
save.

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9.2 Selecting an existing patient
To select an existing patient from the list, click on the PATIENT LIST button: the complete list of
stored patients will show up (see Figure 6).
The following mechanisms are available to find a specific patient:
scroll the list by dragging the screen up or down;
sort the list by one of the available field (the list can be sorted by last name, age or date of
last visit) by clicking on the corresponding arrows (for descending, for ascending)
located at the header of the list (by default patients are sorted by their numeric ID, in
ascending order);
search for a specific patient by typing the initials of the last name or first name in the
search box.
Figure 6 - Patient list screen
Once the desired patient has been identified in the list, click on the corresponding line to select.
9.3 Starting the image acquisition process
Whether a new patient has been created or an existing one selected or none of the above
(anonymous), it is possible to start the image 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 multiple fields at 45° per photo. See par. 14.1 for details on how to configure the
fields acquired in each of the above two options; you can also select ANTERIOR EYE to
acquire the external part of the eye (useful to prove the presence of cataract in case of
impossibility to acquire the retina) or STEREO to acquire a couple of Central Nasal field
images with two different head displacement to produce a Stereoscopic vision of the optic
disc (see details below);
c. Position the patient on the chin rest and head rest and use the CHINREST UP and
CHINREST DOWN buttons to adjust the chin rest position, if needed. When the
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.

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The START button is only enabled if the chin rest is engaged. If the patient is
not properly positioned on the chin rest, the START button will not be enabled
and it will not be possible to start the acquisition process.
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);
b. Move the optical head to center the patient’s pupil to the front lens (see Figure 8); the
system will also display the pupil current diameter and 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 drive (see Figure 10);
f. In case of acquisition of both eyes and/or multiple fields, the acquired images can be
displayed before proceeding to the next one, depending on the settings (see par. 14.2).
At any time during the above sequence it is possible to stop the acquisition process
by pressing the CANCEL button.
Figure 7 - Automatic eye search in progress
Figure 8 - Automatic alignment in progress

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Figure 9 - Auto-focus in progress
Figure 10 - Image processing and storage in
progress
9.5 Manual alignment
If, for some reasons, the automated eye search fails, a message as in 11 shows up. Reasons for
failure include: improper patient positioning, patient not fixating steadily, patient moving the head
and / or the gaze 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
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.

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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 patient’s chin should be placed near the edge of the chin rest (see
Figure 13).
Once 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 pressing it.
Once satisfied with the position and focus, press SHOOT to acquire the image.
Figure 13 - Anterior eye: correct patient position
The room must be sufficiently lit in order to be able to take an Anterior Eye photo.

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Figure 14 - Anterior eye acquisition
Figure 15 - Full screen of the anterior eye
9.7 Stereo exams
If Stereo is selected prior to start the exam, two images of the Central Nasal field will be shot one
after the other, with automatic alignment and focus. A delay between the shots will be applied in
order to let the pupil get back to its normal 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
prismatic goggles that let each eye see only one of the two images. Alternatively, the “crossed-eye”
format, which does not require goggles, can be toggled by clicking on the swap images button.

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9.8 Warning messages
If the lens cap is placed on the front lens when an exam is started, the message reported in Figure
16 will be shown (unless “check lenscap presence” is off, see 14.2 - Exam | Advanced). Press ok
to exit and restart the exam, after having removed 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 about the possible low quality of the image (see Figure 18).
Figure 18 - Warning due to incorrect focusing

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10.REVIEWING THE IMAGES
Once the image(s) has (have) been acquired, the system will open the patient’s individual record
and present a thumbnail 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