CenterVue COMPASS Manual de usuario
CenterVue
COMPASS Operating Manual
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Operating Manual
CenterVue
COMPASS Operating Manual
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MANUAL INFORMATION
Date of release: March 31st, 2016
Revision number: 11
Reference software version: v2.0
Manufacturer:
CenterVue S.p.A.
Via San Marco 9h, 35129 Padova –ITALY
Tel. +39 049 739 6147
Fax +39 049 739 6148
CONTENTS
1. INTRODUCTION....................................................................................................................................... 4
2. SYSTEM.................................................................................................................................................... 5
2.1 The device ............................................................................................................................................. 5
2.2 The tablet............................................................................................................................................... 6
3. LABELS ..................................................................................................................................................... 7
4. SYMBOLS.................................................................................................................................................. 8
5. PREPARING THE SYSTEM...................................................................................................................... 9
5.1 Assembling the tablet and joystick supports........................................................................................ 10
5.2 Turning on the Device.......................................................................................................................... 11
6. PREPARING THE SUBJECT.................................................................................................................. 12
7. WARNINGS AND PRECAUTIONS ......................................................................................................... 13
8. NOTES FOR THE OPERATOR .............................................................................................................. 14
9. PERFORMING THE TEST...................................................................................................................... 15
9.1 Adding a new patient........................................................................................................................... 15
9.2 Searching for an existing patient ......................................................................................................... 15
9.3 Selecting an existing patient................................................................................................................ 15
9.4 Root test vs. follow-up test................................................................................................................... 17
9.5 Initiating a new root test....................................................................................................................... 17
9.6 Initiating a new follow-up test............................................................................................................... 17
9.7 Choosing test parameters.................................................................................................................... 18
9.8 Before starting ..................................................................................................................................... 19
9.9 During the test ..................................................................................................................................... 20
9.10 Auto-alignment..................................................................................................................................... 21
9.11 Retinal tracking.................................................................................................................................... 22
9.12 Monitoring test progress...................................................................................................................... 23
10. REVIEWING RESULTS........................................................................................................................... 24
10.1 Individual test results review................................................................................................................ 26
10.2 Reliability indices ................................................................................................................................. 27
10.3 Dual image review ............................................................................................................................... 29
10.4 Creating a Progression Report............................................................................................................ 30
10.5 Remote Viewer .................................................................................................................................... 31
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COMPASS Operating Manual
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11. PRINTING................................................................................................................................................ 34
11.1 Printer Setup........................................................................................................................................ 34
11.2 Report for 24-2 test.............................................................................................................................. 35
11.3 Report for 10-2 test.............................................................................................................................. 35
11.4 Progression report ............................................................................................................................... 38
12. SETTINGS............................................................................................................................................... 40
12.1 Launching the Configurator ................................................................................................................. 40
12.2 Password change ................................................................................................................................ 40
12.3 Backup................................................................................................................................................. 41
12.4 Restore ................................................................................................................................................ 42
12.5 Device lock reset procedure................................................................................................................ 42
12.6 Password change for Remote Viewer ................................................................................................. 42
12.7 Network configuration.......................................................................................................................... 43
12.8 Shared folder configuration.................................................................................................................. 44
13. SYSTEM SHUTDOWN............................................................................................................................ 44
14. TECHNICAL SPECIFICATIONS ............................................................................................................. 45
15. CLEANING............................................................................................................................................... 46
16. TROUBLESHOOTING............................................................................................................................. 47
17. ELECTROMAGNETIC COMPATIBILITY................................................................................................ 48
18. DISPOSAL............................................................................................................................................... 53
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COMPASS Operating Manual
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1. INTRODUCTION
Fundus Perimetry is a technique that images the retina during visual field testing, enabling a
correlation to be made between visual function and retinal structure.
COMPASS is a scanning ophthalmoscope combined with an automatic perimeter, also a Fundus
Perimeter, that allows the acquisition of confocal images of the retina, simultaneously to the
measurement of retinal threshold sensitivity and the analysis of fixation. The Device operates in
non-mydriatic conditions, i.e. without the need of pharmacological dilation.
As a perimeter, the system offers full compatibility with standard 24-2 visual field testing and
contains an age-matched database of retinal sensitivity in normal subjects.
As a retinal imager, COMPASS uses a confocal optical design, similarly to SLO systems, to
capture color as well as red-free images of superior quality. In addition, a high resolution live image
of the retina obtained using infrared illumination is available throughout the test.
COMPASS is intended for use as a diagnostic device to aid in the detection and management of
glaucoma. The device is indicated for measuring retinal sensitivity, for a quantitative assessment of
fixation characteristics, as well as to capture infrared and color images of the retina without the use
of a mydriatic agent.
The Device integrates a tablet and is provided with an external power supply. The device works
with a dedicated software application and operates as a standalone unit.
The clinical interpretation of the results obtained with COMPASS is restricted to licensed eye care
practitioners. The process of making a diagnosis using COMPASS 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.
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COMPASS Operating Manual
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2. SYSTEM
2.1 The device
Fig. 1 - COMPASS
Fig. 2 –Detail of connectors side
Fig. 3 –Patient push button
3 USB ports
Ethernet port
Main switch
12V power inlet
Tablet (example)
Digital joystick
(not used)
Forehead rest =
contacting part
Chin rest =
contacting part
Patient Side
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COMPASS Operating Manual
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COMPASS is provided with:
dedicated tablet with USB cable and related support
external power supply and related power cord
digital, USB powered, joystick and related support
this operating manual
removable forehead rest
patient push button
front lens cap
2.2 The tablet
The tablet is an integral part of the system and COMPASS cannot operate without it.
The tablet must be connected to COMPASS using the supplied USB cable: if the connection is not
working an error message will appear on the screen (see par. 16 for details).
Use the USB port next to the power inlet to connect the tablet: this is the only port that will
also recharge the tablet.
The tablet is equipped with a color, multi-touch display.
More than one model is supported: the tablet power switch, volume control and USB port
are located on the tablet frame and vary depending on the specific model.
Patient data and images are not stored on the tablet.
The tablet must be used only together with COMPASS and in accordance with the
instructions provided in this manual. Use of the tablet for other purposes, as well as
any modifications of the tablet settings other than indicated in this manual may
result in the COMPASS to become unusable.
Charging the tablet
COMPASS cannot be used if the tablet is not sufficiently charged. The tablet is charged via the
USB port of the device.
To maximize the duration of the charge:
Set the screen brightness to “Auto” or anyway not to maximum;
Plug the tablet in the left-most USB port, near the power switch;
Keep COMPASS powered and the tablet connected when the device is off;
Turn off the screen when the device is not in use.
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COMPASS Operating Manual
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3. LABELS
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COMPASS Operating Manual
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4. SYMBOLS
The meaning of the symbols adopted in this manual is as follows:
Symbol
Explanation
Manufacturer Data
Manufacturing Date (year/month 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
Type B Applied Part
Non-ionizing radiation - ME EQUIPMENT that include RF transmitters
Generic Warning
Important information
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COMPASS Operating Manual
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5. PREPARING THE SYSTEM
We recommend to read carefully and thoroughly par. 7 WARNINGS AND
PRECAUTIONS before proceeding with first use.
To make COMPASS functional for the first use:
extract the system from its box;
place it on a suitable electrical table
1
;
insert the soft forehead rest on the metal support (see Fig. 4);
mount the supports provided for the tablet and the joystick (see par. 5.1 below);
connect the patient push button cable to the connector located underneath the device;
connect the power supply provided with the unit to the power inlet (see Fig. 2);
place the tablet on its support and connect it using the cable to the left-most USB port;
place the joystick on its support, connect it using the cable to any of the free USB ports and
check for its correct orientation;
plug the power supply to the wall socket.
Fig. 4 - Forehead rest mounted on metal support
1
Not provided with the system
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COMPASS Operating Manual
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5.1 Assembling the tablet and joystick supports
The tablet and joystick are mounted, using the included supports (see Fig. 6), towards the posterior
part the device, on any side. Both supports are fixed with screws to the bottom of the device.
As an example, Fig. 7 shows the holes to be used for the left-side mount depicted in Fig. 5: to fix
the supports use holes marked 1 and 2 for the tablet and those marked 3 and 4 for the joystick.
Other configurations can be chosen, based on a user’s preferences.
The joystick is not used in the current software version.
Fig. 5 –Tablet mounted on the left side of the device
Fig. 6 –Support for the tablet
Fig. 7 –Instrument bottom with holes for tablet and joystick supports
4
3
1
2
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