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: November 6th, 2015
Revision number: 21
Reference software version: v2.4
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 Symbols adopted on the device ............................................................................................................ 7
4.2 Symbols adopted in this manual............................................................................................................ 7
5. PREPARING THE DRS............................................................................................................................. 8
6. PREPARING THE PATIENT..................................................................................................................... 9
7. WARNINGS AND PRECAUTIONS......................................................................................................... 10
8. NOTES TO OPERATOR......................................................................................................................... 11
9. PERFORMING THE TEST...................................................................................................................... 12
9.1 Adding a new patient........................................................................................................................... 12
9.2 Selecting an existing patient................................................................................................................ 12
9.3 Starting the image acquisition process................................................................................................ 13
9.4 Automated acquisition ......................................................................................................................... 14
9.5 Manual alignment ................................................................................................................................ 15
9.6 Anterior Eye......................................................................................................................................... 16
9.7 Stereo exams....................................................................................................................................... 17
9.8 Warning messages.............................................................................................................................. 17
10. REVIEWING THE IMAGES..................................................................................................................... 19
10.1 Patient record screen........................................................................................................................... 19
10.2 Full image screen ................................................................................................................................ 20
11. REMOTE VIEWER.................................................................................................................................. 23
12. PRINTOUT............................................................................................................................................... 25
12.1 Single image printout........................................................................................................................... 25
12.2 Dual image printout.............................................................................................................................. 25
13. RETINAL FIELDS.................................................................................................................................... 27
14. SETTINGS............................................................................................................................................... 28
14.1 Fields ................................................................................................................................................... 28
14.2 Exam.................................................................................................................................................... 28
14.3 Network................................................................................................................................................ 30
14.4 System................................................................................................................................................. 34
14.5 EKN...................................................................................................................................................... 41
14.6 About.................................................................................................................................................... 42
15. AUTOMATIC SOFTWARE UPDATE ...................................................................................................... 43
16. SYSTEM SHUTDOWN............................................................................................................................ 44
17. CLEANING............................................................................................................................................... 45
17.1 Front lens............................................................................................................................................. 45
17.2 Patient cushions .................................................................................................................................. 46
17.3 Touch screen panel............................................................................................................................. 47
17.4 Plastic shells........................................................................................................................................ 47

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DRS Operating Manual
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18. MAINTENANCE....................................................................................................................................... 48
19. ELECTROMAGNETIC COMPATIBILITY................................................................................................ 49
20. FCC (USA) and IC (Canada) radio certification....................................................................................... 49
21. TECHNICAL SPECIFICATIONS ............................................................................................................. 50
22. DISPOSAL............................................................................................................................................... 51
23. TROUBLESHOOTING............................................................................................................................. 52
APPENDIX A - DICOM Statement .................................................................................................................. 53
APPENDIX B –AUTOMATED MOSAIC FUNCTION ..................................................................................... 55
APPENDIX C –EYE KNOWLEDGE NETWORK (EKN)................................................................................. 57

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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°,
in a fully automatic mode. 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 left side view
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;
Hand blower;
Glasses with adjustable prisms;
USB 2.0 extension cord.
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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3. LABELING

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DRS Operating Manual
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4. SYMBOLS
4.1 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 Symbols adopted in this manual
Note
Warning

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DRS Operating Manual
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5. PREPARING THE DRS
Read carefully and thoroughly paragraph 7WARNINGS AND PRECAUTIONS before
proceeding with first use.
The test should be performed in conditions of semi-obscurity to facilitate natural
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
Time zone configuration
The first time the DRS is powered on, the operator is requested to set the time zone. The
configuration request (Figure 5) will appear every time the DRS is started, until the time zone is set
(see §14.4).
Figure 5 –Request to configure time zone
Request for camera auto-tuning
After a software upgrade to the latest version a message as in Figure 6 may appear. Such
message appears only once when a new software is started for the first time: please apply the lens
cap and press ok, then wait until the completion message (Figure 7) appears.
1
Not provided with the DRS

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DRS Operating Manual
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Figure 6 –Request to perform camera auto-tuning
Figure 7 –Camera auto-tuning completion message
6. PREPARING 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 3.8 mm), so there is no need to dilate the subject’s pupil. Patient contacting parts
are indicated in Figure 1.
Patients wearing Contact Lenses: image quality may be affected by contact lenses. It is
recommended to have contact lenses removed before imaging the patient.
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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DRS Operating Manual
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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.
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: the DRS contains Patient Health Information. It is strongly
recommended the use of the “backup” utility. See par. Settings >> 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
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