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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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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DRS Operating Manual
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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.