iCare COMPASS Perimeters and Microperimeter User Manual

COMPASS
User manual
iCare
COMPASS User Manual - EN
Page 1 of 100
MANUAL INFORMATION
The information in this document is subject to change without prior notice and it is correct at revision
date. Devices configuration can change as products improvements are incorporated and this manual
may not exactly depict your device: please contact the local distributor if you have any questions
about differences.
The original language of this User Manual is English. Should a conflict situation arise concerning a
translated document, the English language version shall prevail.
Date of release:
Revision number:
Software Version:
Reference device:
February 16th, 2023
22
3.0
COMPASS (REF: AMGDSME001)
Copyright © 2023 CenterVue Spa. All rights reserved.
CenterVue S.p.A.
Via San Marco 9h, 35129 Padova – ITALY
www.icare-world.com
iCare
COMPASS User Manual - EN
Page 2 of 100
CONTENTS
1.
INTRODUCTION ....................................................................................................................................... 6
1.1
Operating Principles .............................................................................................................................. 6
1.2
Intended purpose ................................................................................................................................... 6
1.3
Indications for Use ................................................................................................................................. 6
1.4
Patient Population .................................................................................................................................. 6
1.5
User Profile ............................................................................................................................................ 7
2.
DEVICE...................................................................................................................................................... 8
2.1
COMPASS ............................................................................................................................................. 8
2.2
The COMPASS Custom Control Interface (tablet) ................................................................................ 9
3.
LABELS, SYMBOLS AND DEFINITIONS ............................................................................................... 10
3.1
Labels .................................................................................................................................................. 10
3.2
Symbols used on the device ................................................................................................................ 11
3.3
Other symbols found in this manual .................................................................................................... 11
3.4
Definitions ............................................................................................................................................ 12
4.
SAFETY INFORMATION ......................................................................................................................... 13
5.
FIRST USAGE ......................................................................................................................................... 16
5.1
Preparation of the device ..................................................................................................................... 16
5.2
Assembling the tablet support bracket ................................................................................................ 16
5.3
Removing the front lens cap ................................................................................................................ 17
5.4
Attaching the Magnetic Light Shield .................................................................................................... 18
5.5
Turning on the Device .......................................................................................................................... 19
6.
PREPARING THE PATIENT ................................................................................................................... 21
7.
DICOM SUPPORT .................................................................................................................................. 22
8.
PATIENT LIST AND PATIENT RECORD ............................................................................................... 23
8.1
Device status ....................................................................................................................................... 23
8.2
Data Security Center ........................................................................................................................... 25
8.3
Adding a new patient ........................................................................................................................... 27
8.4
Deleting patients .................................................................................................................................. 27
8.5
Searching for an existing patient ......................................................................................................... 27
8.6
Selecting an existing patient ................................................................................................................ 27
9.
PERFORMING THE EXAM ..................................................................................................................... 29
9.1
COMPASS test modalities ................................................................................................................... 29
9.2
Initiating a new Visual Field root test ................................................................................................... 30
9.3
Initiating a Visual Field follow-up test .................................................................................................. 30
9.4
Initiating a Supra-Threshold test .......................................................................................................... 30
9.5
Initiating a new Fundus/Fundus Stereo test ........................................................................................ 30
9.6
Choosing test parameters.................................................................................................................... 31
iCare
COMPASS User Manual - EN
Page 3 of 100
9.7
Before starting ..................................................................................................................................... 32
9.8
During the test ..................................................................................................................................... 33
9.9
Auto-alignment ..................................................................................................................................... 36
9.10 Retinal tracking .................................................................................................................................... 36
9.11 Monitoring test progress ...................................................................................................................... 37
9.12 Other exam types: SUPRATHRESHOLD tests ................................................................................... 39
9.13 Other exam types: FUNDUS and FUNDUS STEREO test ................................................................. 40
10. REVIEWING RESULTS ........................................................................................................................... 41
10.1 Individual test results review ................................................................................................................ 43
10.2 Reliability indices ................................................................................................................................. 44
10.3 Creating a Progression Report ............................................................................................................ 46
10.4 SupraThreshold exams review ............................................................................................................ 47
10.5 Fundus exam review and Stereo 3D Viewer ....................................................................................... 49
11. REMOTE VIEWER .................................................................................................................................. 51
11.1 Setting up the Remote Viewer ............................................................................................................. 51
11.2 Using the Remote Viewer .................................................................................................................... 51
11.3 Patient List screen ............................................................................................................................... 52
11.4 Patient Record screen ......................................................................................................................... 52
11.5 Exam review screen ............................................................................................................................ 53
11.6 Perimetry Mode review screen ............................................................................................................ 55
11.7 Dual Image review / Stereo 3D Viewer screen .................................................................................... 56
11.8 Flickering view ..................................................................................................................................... 57
11.9 Cup-to-disc evaluation ......................................................................................................................... 59
12. PRINTING ................................................................................................................................................ 60
12.1 Printer Setup ........................................................................................................................................ 60
12.2 Report for 24-2 test .............................................................................................................................. 62
12.3 Report for 10-2 test .............................................................................................................................. 65
12.4 Report for 30-2 test .............................................................................................................................. 66
12.5 Reports for the SupraThreshold exams ............................................................................................... 67
12.6 Fundus Report ..................................................................................................................................... 69
12.7 Progression report ............................................................................................................................... 70
12.8 Dual printout / Stereo report ................................................................................................................ 74
13. SETTINGS ............................................................................................................................................... 75
13.1 Launching the Configurator ................................................................................................................. 75
13.2 Device lock reset procedure ................................................................................................................ 75
13.3 Date and time ...................................................................................................................................... 75
13.4 User Role ............................................................................................................................................. 75
13.5 Exam parameters ................................................................................................................................ 76
13.6 Remote Viewer .................................................................................................................................... 77
iCare
COMPASS User Manual - EN
Page 4 of 100
13.7 Network configuration .......................................................................................................................... 79
13.8 Backup ................................................................................................................................................. 80
13.8.1
Device tab .............................................................................................................................. 81
13.8.2
Schedule tab .......................................................................................................................... 83
13.8.3
Execute tab ............................................................................................................................ 84
13.9 Restore ................................................................................................................................................ 85
13.10 Shared folder configuration.................................................................................................................. 86
13.11 Custom Printout Header ...................................................................................................................... 88
13.12 Custom control interface setting .......................................................................................................... 88
14. DEVICE SHUTDOWN ............................................................................................................................. 88
15. TECHNICAL SPECIFICATIONS ............................................................................................................. 89
16. CLEANING............................................................................................................................................... 91
17. TROUBLESHOOTING ............................................................................................................................. 92
17.1 REMOTE ASSISTANCE...................................................................................................................... 94
18. MAINTENANCE ....................................................................................................................................... 95
19. ELECTROMAGNETIC COMPATIBILITY ................................................................................................ 96
19.1 Manufacturers EMC Declaration to IEC 60601-1-2 ............................................................................. 96
19.2 Guidance and manufacturers declaration – Electromagnetic Immunity COMPASS devices ............. 97
19.3 Immunity pass criteria .......................................................................................................................... 97
19.4 Wi-Fi Specifications ............................................................................................................................. 98
20. DISPOSAL ............................................................................................................................................... 99
iCare
COMPASS User Manual - EN
Page 5 of 100
1.
INTRODUCTION
Congratulations for choosing COMPASS and its fundus perimetry and confocal retinal imaging capabilities.
1.1
Operating Principles
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 an automatic perimeter1 with fundus imaging capabilities (Fundus Perimeter), that measures
retinal sensitivity, fixation stability and locus of fixation, and allows the acquisition of confocal images of the
retina, thanks to its confocal scanning imaging system which uses infrared and visible light.
COMPASS works with COMPASS Software, and it operates as standalone units.
Each device integrates a Control Interface with multi-touch display and an external power supply.
As automatic perimeter, COMPASS offers full compatibility with standard 24-2, 30-2 and 10-2 visual fieldtesting choosing one of the projection strategies available (ex. 4-2, ZEST).
COMPASS suprathreshold testing is used to perform fast screening for visual field loss.
COMPASS contains age-matched databases of retinal sensitivity in normal subjects.
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.
1.2
Intended purpose
COMPASS is intended for measuring retinal sensitivity, fixation stability and locus fixation as well as for the
acquisition of retinal images with or without2 a mydriatic agent and for their review.
1.3
Indications for Use
COMPASS is intended for taking digital images of a human retina without the use of a mydriatic agent and for
measuring retinal sensitivity, fixation stability and the locus of fixation. It contains a reference database that is
a quantitative tool for the comparison of retinal sensitivity to a database of known normal subjects.
1.4
Patient Population
COMPASS may be used on all human subjects who have the psycho-physical capabilities to undergo the eye
test. In detail, the patient shall be able to:
- Sit upright and place his/her head in place, in contact with the chin rest and forehead rest for the entire
duration of the test.
- Keep the eye under examination open (with or without supplemental human or mechanical support) for the
duration of the test (blinking is allowed) and to try to stare at the internal fixation target.
- Understand how the exam works and what is required from the patient.
- Hold the patient pushbutton and press it whenever he/she perceives a luminous stimulus during the test.
There are no restrictions as to the selection of the patients undergoing testing, but since the test requires the
patient to maintain concentration and to accomplish his tasks for several minutes, very young patients (before
primary school), as well as mentally diseased people may not be able to cooperate appropriately.
ISO 12866: 1999 Ophthalmic instruments — Perimeters
COMPASS works in a non-mydriatic condition for patients with minimum pupil size of 3.0 mm: the decision to use the mydriatic agent on
patient's pupil eye is under the responsibility of the eye care practitioner.
1
2
iCare
COMPASS User Manual - EN
Page 6 of 100
1.5
User Profile
The intended End-users are health care professionals with training in the ophthalmology field (or equivalent).
The clinical interpretation is restricted to licensed eye care practitioners: the process of making a diagnosis is
the responsibility of the eye care practitioner. It is recommended for the end-user to carefully read this User
Manual to be informed and trained before the use.
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 the images is restricted to licensed eye care
practitioners.
COLOR CONFOCAL IMAGING
SLO systems are superior to conventional fundus cameras in many ways, as they exploit a confocal
imaging principle, which limits the effect of backscattered light from deeper layers and provides
enhanced image quality in terms of contrast and resolution. Another advantage of SLO systems is
that they operate with smaller pupils than non-confocal imaging systems. At the same time, though,
SLO systems do not provide color images, as they typically employ monochromatic laser sources,
resulting in black and white or pseudo-color images.
COMPASS uses white light instead of monochromatic lasers, hence providing true color images
and offering high image fidelity, no need for dilation down to 3 mm. pupil, excellent resolution and
contrast, high quality even in presence of media opacities and optimized exposure of the ONH.
iCare
COMPASS User Manual - EN
Page 7 of 100
2.
DEVICE
2.1
COMPASS
Headrest =
contacting part
Chin rest =
contacting part
User Control Interface
(Tablet)
Patient Side
Fig. 1 – COMPASS
The main parts3 of COMPASS consist of:
• The COMPASS Device
• COMPASS Custom Control Interface with multi-touch display (tablet)
• External Power Supply4
• Patient Push Button5
USB ports
LED Device power
status
COMPASS Custom
Control Interface port
Power button
Power supply
connector
Fig. 2 – Detail of connectors panel
Ethernet port
3
For a list of all components included with the COMPASS device, please see the Content List documents in the device package
It is a device component, model MDS-150AAS12-BA manufactured by Delta Electronics. It features 100-240 VAC, 50-60 Hz and a
consumption of 80 W.
5
The Patient PushButton is a device component, manufactured by iCare.
4
iCare
COMPASS User Manual - EN
Page 8 of 100
Fig. 3 – Patient Push Button (contacting part)
2.2
The COMPASS Custom Control Interface (tablet)
The COMPASS Control Interface (from now on, the tablet) is an integral part of the device and
COMPASS cannot operate without it.
The tablet must be connected to COMPASS using the supplied cable6: if the connection is not working an error
message will appear on the screen (see par. 17 for details). The Mini-HDMI-to-HDMI adapter allows the user
to connect the tablet to an external monitor to display the image on a larger screen.
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 than the one intended by the
Manufacturer, as well as any modifications or misuses are exclusively under end-user
responsibility.
6 The COMPASS Custom Control Interface with multi-touch display is equipped with a custom cable permanently connected to it.
iCare
COMPASS User Manual - EN
Page 9 of 100
3.
LABELS, SYMBOLS AND DEFINITIONS
3.1
Labels
Device information such as device identifier (REF), serial number, manufacturing date and UDI barcode are
reported in the labels fixed on the right side of each device as shown in the following figure. Please do not
remove them.
Serial number
Prod. date
UDI barcode
Fig. 4 – Device and warning labels7
7
Labelling might be subject to changes depending on local regulatory requirements. The label QR Code does not contain information for
the end-user, and it is intended for internal use only.
iCare
COMPASS User Manual - EN
Page 10 of 100
3.2
Symbols used on the device
The meaning of the symbols adopted in the device labels is as follows:
Symbol
Explanation
Information about the Manufacturer.
Manufacturing date (year-month).
Device identifier (catalogue number–product code).
COMPASS is a Medical Device.
COMPASS Serial number.
UDI number.
Electrical and electronic waste is destined for separate recycling.
Refer to the User Manual.
CE mark: the device complies with the essential requirements of the
European Medical Devices Directive 93/42/EEC.
Type B Applied Part.
Non-ionizing radiation - ME EQUIPMENT that includes RF transmitters.
Direct current.
Warning, read carefully.
No serviceable parts inside. Internal inspection is allowed to authorized
personnel only.
Warning, read carefully.
Stand clear from moving parts while in operation.
3.3
Other symbols found in this manual
The meaning of the additional symbols adopted in this User Manual is as follows:
Symbol
Explanation
Important Information.
General Warning, read carefully.
iCare
COMPASS User Manual - EN
Page 11 of 100
3.4
Definitions
The meaning of the specific words adopted in this User Manual are as follows:
Word
Explanation
The action of moving the top part of the device so that its optics are aligned
Alignment
with a patient’s pupil.
Customer
COMPASS owner (it can be different from the COMPASS device’s end-user)
Device
The synonym of COMPASS device used in this User Manual.
Any Visual Field or Fundus acquisition session performed using the
Exam
COMPASS device for a certain patient on a certain date. In this manual, the
terms “test” and “exam” are used as synonyms.
Field
A portion of the retina visible in a specific image.
The ability of a patient to fix his/her view on a specific point, for example the
Fixation / Fixating
internal fixation target or the external fixation target.
A small bright green circle visible when looking into the front lens of the
Fixation target
COMPASS device, used to move the gaze of the patient and capture different
fields.
The compensation, by means of internal optics, of a patient’s spherical defect
Focusing
(myopia, hyperopia).
Operator
COMPASS devices’ end-user
A specific portion of the retina characterized by a roughly circular shape and
Optic disk
by outgoing / incoming vessels and fibers.
The synonym of the image acquired by COMPASS device used in this User
Picture
Manual
The aperture located in the center of the iris, of variable diameter, which allows
Pupil
light to enter the eyeball. The pupil naturally is open (dilated) and contracts
when struck by light. If the pupil is too small the image quality may be impaired.
Remote viewer
The web application running on an external PC.
The inner layer of the eyeball. It is the main area of interest in the exams
Retina
acquired by COMPASS devices.
Sensitivity
The minimum intensity of a light stimulus that is reliably perceived by a patient
threshold
as emerging from the background.
The examination mode that involves the acquisition of two images of the retina
Stereo exam
taken from different angles, providing a three-dimensional view using suitable
prismatic glasses.
A spot of light, projected for a limited amount of time on a randomly selected
retinal area overlapped on a uniform light background. Analysing the patient’s
Stimulus
responses to multiple projections of stimuli of varying intensity on the same
area allows to determine the Sensitivity threshold (see definition above) for the
tested area.
COMPASS provides capabilities for a fully automated test process. Specific training is required: it is
recommended for the end user (operator) to carefully read this User Manual to be informed and trained
before the use.
In particular, the end user (operator) shall be acquainted with the above concepts.
Acquaintance with the basic concepts of standard automated fundus perimetry is helpful for an
effective use of some of the features of the Device and for the interpretation of its results.
iCare
COMPASS User Manual - EN
Page 12 of 100
4.
SAFETY INFORMATION
The following precautions are important to use the device in safety:
• Do not use COMPASS devices if the covers or other parts of the device have been removed.
• Avoid all contact with water: risk of fire or electric shock.
• Stand clear from moving parts during operation.
• Do not open COMPASS devices: this could lead to electric shocks or damage to the device.
• COMPASS devices are 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.
• COMPASS devices power supply must be connected to a socket with a circuit breaker.
• The use of other cables and accessories on COMPASS devices than ones provided by the
Manufacturer may negatively affect EMC performances.
• External device/s connected to COMPASS devices, into the patient environment, must comply
with IEC 60601-1. Those device/s that do not comply/complies with the IEC 60601-1 must be
kept out of the patient environment and must comply with IEC 60950-1. Any end-user who
connects external devices COMPASS device creates a new Medical Electrical System as
defined by IEC 60601-1 and is therefore responsible of the conformity of such system with the
requirements defined in clause 16 of IEC 60601-1. Please contact the local distributor for any
additional information.
• COMPASS devices must be used in a room with an electrical system that complies with
applicable healthcare environment safety regulations.
• COMPASS devices must NOT be used in an oxygen-rich environment or presence of
flammable anaesthetics.
• COMPASS devices must be placed in a room that is not exposed to adverse chemical-physical
conditions, such as the presence of sulphur, salt, dust, direct sunlight, lack of ventilation, high
humidity, sudden temperature drops or peaks. The safety and/or effectiveness of the device
cannot be guaranteed if these conditions are not met.
• COMPASS devices need to be operated in a semi-dark environment, to ease the natural
dilation of the patient’s pupil.
• The only applied parts of COMPASS device are the chinrest and forehead rest (see Fig. 1)
and the patient pushbutton (see Fig. 3).
• COMPASS devices need to be operated in the following environmental conditions:
o Temperature: +10 °C to +40°C (50°F to 104° F)
o Humidity (max): 90% not condensing
• COMPASS devices need to be stored in the following environmental conditions:
o Temperature: -10 °C to +60°C (14° F to 140° F)
o Humidity (max): 95% not condensing
• Only technicians authorized by the Manufacturer may service COMPASS devices. The
Manufacturer cannot be held responsible for the device safety should COMPASS devices be
opened, repairs carried out (included using of not Manufacturer’s genuine parts), third-parties
software installed, or parts replaced by an unauthorized person.
• The Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions, or other information that will assist authorized Service
technicians to repair those parts of the COMPASS device that are designated by the
Manufacturer as repairable by Service personnel.
• In case an unexpected hardware condition occurs during use, an error message may appear
(see for example Fig. 5) and the device may become temporarily locked. It is possible to reset
this condition by letting the device re-initialize: refer to par. 13.2 for the complete procedure. If
the error persists, please contact an Authorized Service Center.
The following precautions are important to use the device correctly:
• The clinical interpretation of the images acquired by COMPASS is restricted to licensed eye
care practitioners. The process of making a diagnosis using COMPASS devices results is
the responsibility of the eye care practitioner.
iCare
COMPASS User Manual - EN
Page 13 of 100
• Device-specific training is required: it is recommended for the end-user (operator) to
carefully read this User Manual to be informed and trained before use.
• Use the device in dim light, or at least away from direct light to facilitate the natural dilation
of the pupil.
• Provide explanations to patients before placing them in front of the device: refer to par. 6.
• The minimum pupil diameter required to obtain good quality images is 3.0 mm.
• COMPASS devices work in a non-mydriatic condition for patients with a minimum pupil size
of 3.0 mm: the decision to use the mydriatic agent on a patient's pupil eye is under the
responsibility of the eye care practitioner.
• Report any serious incident to the Manufacturer and to the competent authority of the
Member State in which the user and/or patient is established.
When in operation, COMPASS devices contain Personal Data. The following precautions for the
End-users and the Responsible Organization are important to control the risks related to network
interfaces, data protection and cybersecurity.
• It is the end user’s responsibility to keep and maintain an updated copy of the data
generated by COMPASS devices through regular use of the backup facility, thus
preventing the risk of accidental loss of data.
• The Custom Control interface offers Wi-Fi connection (used for remote printing): it is
strongly recommended to connect only to trusted networks protected by an encryption
system, like for example WPA2, and refrain from connecting to unsecured Wi-Fi networks.
• Device offers a Wired Network Connection (via Ethernet cable), used to connect to a
Remote Viewer (accessible with device credentials) and to store and/or backup data on a
Remote Shared Folder (accessible with infrastructure credentials). When setting your
credentials in the device, it is strongly recommended to use complex passwords; refer to
your infrastructure’s policies to create an effective password. If your infrastructure does
not enforce any password policy, we recommend the following:
o a strong password must be at least 8 characters long;
o it should not contain any of your personal information, like your real name,
username or your company name;
o it must be different from your previously used passwords;
o it should not contain any word spelled completely;
o a strong password should contain different types of characters, including
uppercase letters, lowercase letters, numbers and characters;
o don’t write down your password on notes;
o don’t share your password with other people;
o change your password from time to time.
• The Remote Viewer browser runs on your PC/Laptop and allows to locally download
exams reports and patient’s images; reports and images stored in the Remote Shared
Folder can be available also in your PC/Laptop. It is strongly recommended to protect your
computer by:
o applying physical security measures (locks, security alarms, monitoring, etc.) to
prevent unauthorized persons from accessing your computer that stores patients’
personal data files;
o using full disk encryption (Bitlocker) with a strong password to render data
unreadable even if an unauthorized person were to gain access to your computer;
o using firewall and antivirus software to prevent intrusion and to detect infected
files that might compromise the security of your computer, and thereby enable
unauthorized file access;
o installing security patches and updates in a timely manner;
o protect access to your Windows account with a strong password (see indication
above);
o log off or power off when leaving your computer unattended.
iCare
COMPASS User Manual - EN
Page 14 of 100
•
•
DICOM files usually include very sensitive information about the patient (name, age, ID
number, birth date, weight, etc.) and contain the medical images, which itself are of an
extremely sensitive nature. Special care must be taken to ensure that this information
stays private and is not susceptible to unauthorized access. Before taking any further
actions, make sure that you are authorized to view and store specific DICOM files on your
machine.
• DICOM related interfaces (Physical Interfaces used to export DICOM Data) are: Shared
Remote Folder via Ethernet and USB Export via USB ports.
When saving, exporting, or sending DICOM files, please remember that the DICOM protocol
does not encrypt patients’ personal data; for this reason, it is strongly recommended to delete
the DICOM files from your computer when they are no longer necessary.
Fig. 5 – Example of error message
iCare
COMPASS User Manual - EN
Page 15 of 100
5.
FIRST USAGE
5.1 Preparation of the device
We recommend reading carefully and thoroughly par. 4 - SAFETY INFORMATION before
proceeding with the first use.
To make COMPASS functional for the first use:
• extract the device from its box;
• place it on a suitable electrical table8;
• insert the Headrest silicone cushion on the metal support (see Fig. 6);
• mount the support bracket provided for the tablet (see par. 5.2 below);
• connect the Patient Push Button cable to the connector located underneath the device;
• connect the External power supply provided with the unit to the power inlet (see Fig. 2);
• place the tablet on its support bracket and connect it using the cable to its dedicated port (see Fig. 2);
• plug the power supply to the wall socket.
Fig. 6 - Headrest silicone cushion mounted on metal support
5.2 Assembling the tablet support bracket
Fasten the Custom Control Interface to its support bracket using the two dedicated screws.
As an example, Fig. 9 shows the holes to be used for the left-side mount depicted in Fig. 7: to fix the support
bracket use holes marked 1 and 2. Other configurations can be chosen, based on the user’s preferences.
Fig. 7 – COMPASS Custom Control Interface mounted on the left side of the device
8
Not provided with the device. For a list of all components included with COMPASS, see Content List in the package
iCare
COMPASS User Manual - EN
Page 16 of 100
Fig. 8 – COMPASS Control Interface support bracket
Fig. 9 – Device bottom with holes for the control Interface. Only RED positions can be used.
Mounting the support bracket on the back of the device will make access to USB ports
difficult: in such case, use a USB extension cable 9 to make one of the USB ports readily
accessible.
5.3 Removing the front lens cap
Unscrew the device’s front lens cap to remove it, before turning on the device.
9
It is provided with the device. For a list of all components included with COMPASS device, see Content List in the device package
iCare
COMPASS User Manual - EN
Page 17 of 100
5.4 Attaching the Magnetic Light Shield
The Magnetic Light Shield is a device component10 that shields the patient’s eyes from external sources of
light, as a non-invasive alternative to an eye-patch and to improve patient’s comfort during the test. To attach
it, apply it on the front lens frame: the Light Shield will adhere magnetically to the frame (see Fig. 10).
Fig. 10 – Magnetic Light Shield mounted on COMPASS
10
The Magnetic Light Shield is delivered with COMPASS since September 2017. For information about how to purchase these
components, please refer to your local distributor.
iCare
COMPASS User Manual - EN
Page 18 of 100
5.5 Turning on the Device
Turn on the Device by pressing the power button (see Fig. 2), the device will emit a single beep, the LED
Power Status will power on and the Custom control Interface will power on. Then wait for the boot process
to complete, until the Login screen appears (see Fig. 11).
During the power-on, the LED Power Status performs a red/green/blue cycle to test its LEDs
functioning. In addition, the following information are important to understand device messages
emitted from the color LED Power Status (see Fig. 2):
• steady green light means “power on”
• Fast flashing red light means “Reboot”
• Fast flashing red/green light means “Reboot – Over Voltage Protection/Under Voltage
Protection”
• Single red flashlight means “start of error code reporting”
• Single white flashlight means “start of version code reporting”
• Flashing blue light (code reporting) is proportional at tens in the numerical code
• Flashing green light (code reporting) is proportional at units in the numerical code
Fig. 11 – Login screen
From the drop-down menu you can select your user profile choosing between Doctor or Admin:
- Doctor User have only the access to perform exam (§ 9) and review images (§ 10).
- Admin User have the access to the Doctor User function and the device’s setting (§ 13).
iCare
COMPASS User Manual - EN
Page 19 of 100
Type the password11 and click on Login button. If login is successful, the Home screen opens (see Fig. 11).
The session is automatically closed after 10 minutes of inactivity, which means that the user has to perform
the login again.
To modify the login password, see par. 13.4.
Fig. 12 - Home screen
11
Please ask an Authorized iCare representative for the factory password
iCare
COMPASS User Manual - EN
Page 20 of 100
6.
PREPARING THE PATIENT
This paragraph explains how to prepare a patient for the COMPASS exam (in this manual is used as “test”)
COMPASS compensates for a patient’s spherical refractive error in the range -12 to +15 diopters: testing a
patient presenting a spherical error out of the above range may result in inaccurate measurements.
COMPASS does not compensate for a patient’s astigmatism. Patients with astigmatism within ± 4 diopters can
be tested normally. Testing a patient with astigmatism outside of the above range may result in inaccurate
measurements.
The patient can wear contact lenses or spectacles while being examined, although in the latter case artifacts
may appear in the retinal image.
COMPASS is a non-mydriatic device: there is no need to dilate the patient’s pupil unless the pupil is smaller
than 3 mm. The eye which is not examined should be patched.
Patient contacting parts are indicated in Fig. 1.
Before starting the test, please check the following:
•
patient should sit in a comfortable position, with the forehead and chin in firm contact with
the rests
•
height of the table and chair should be adjusted so that the patient can comfortably place
her/his chin on the corresponding rest
•
the patient’s head should be vertical (not tilted forward / backward)
•
chin rest should be positioned so that the patient’s eye is aligned to the eye mark found
on the sides of the metal frame (see Fig. 13). If this is not the case the chin rest height
needs to be adjusted with the on-screen controls (see par. 9.11)
Fig. 13 - Sketch of the eye mark on the metal frame
iCare
COMPASS User Manual - EN
Page 21 of 100
Before the exam, the end-user should inform the patient about the following:
• COMPASS will test your ability to perceive light while looking at a steady target.
• the test is non-invasive, in particular the device will never touch your eye, and you will only
perceive some light;
• find a comfortable position and keep the chin and forehead firmly pressed against the rests;
• at the beginning of each test, the unit will move around to find your pupil: this is absolutely
normal;
• always keep your eyes wide open, so that eyelids do not interfere;
• when the test starts, look straight in front of you and when a small green, circular spot appears
anywhere, look at it;
• do not move, nor speak during the test;
• you can blink whenever you feel necessary, unless instructed not to do so;
• you will be given this push-button: press it when you see, or believe to see, a whitish small
spot appearing anywhere;
• it is normal that you do not see many of the spots.
7.
DICOM SUPPORT
DICOM is a standard for distributing and viewing medical images and related information.
COMPASS can export DICOM files natively.
Purchasing an additional license, COMPASS also supports full DICOM communication, as specified in the
COMPASS DICOM Conformance Statement document 12. For info about how to use COMPASS with
DICOM, refer to the COMPASS DICOM Operating Manual.
DICOM support is available only for wired connections.
12
Ask to your local distributor for purchasing a DICOM license, and for the COMPASS DICOM manual and Conformance Statement.
iCare
COMPASS User Manual - EN
Page 22 of 100
8.
PATIENT LIST AND PATIENT RECORD
Once the Device has been turned on click on the COMPASS button to open the Patient List screen (see Fig.
14).
Fig. 14 – Patient list screen
The different columns in the list indicate respectively (left to right):
• the presence and number of exams (represented by the retinal images) stored for a certain patient
(right and left eye)
• the patient’s full name
• the patient’s date of birth
• the date of the last exam performed
The following functions and commands are available in the Patient List screen:
• checking the Device Status (see §8.1)
• if the Data Security Center icon is present (see Fig. 14), checking security issues (see 8.2)
• adding a new patient (see §8.3)
• deleting a patient (see §8.4)
• searching for an existing patient (see §8.5)
• selecting an existing patient (see §8.6)
8.1
Device status
The Device status screen contains additional information on the COMPASS status and can be accessed
tapping on the
icon. A change in the status will be signaled with a red number on the top right of the icon,
representing the number of new notifications.
This window includes three tabs: Backup status, Shared folder status and About.
Backup status
From the Backup tab, it is possible to see the backup progression status, stop a running backup or start a
manual backup. This screen also includes information on the backup media and on the last backup, with its
status (completed, cancelled, failed with reason explanation). For more information on Backup, see par. 13.8.
iCare
COMPASS User Manual - EN
Page 23 of 100
Fig. 15 – Device status screen – Backup status
Shared folder status
From the Shared Folder tab, it is possible to monitor the progression and see the error messages of the Shared
Folder processes. For more information on the Shared Folder see par. 13.10. See par. 17 for information about
possible error conditions during the export process.
Fig. 16 – Device status screen – Shared folder status
About tab
The About tab contains information about the software release version installed, the unit serial number, the
total disk capacity and the amount of space available.
iCare
COMPASS User Manual - EN
Page 24 of 100
8.2
Data Security Center
The Data Security Center icon
appears on the right of the top bar in the Patient List as in Fig. 14 or in the
Patient Page as in Fig. 19 (and in the DICOM Work List, refer to the DICOM User Manual) if unsecure settings
are detected in the device configuration. Press the icon to display the Data Security Center window (see Fig.
17), which will list the detected cybersecurity threats and suggest how to solve them.
Fig. 17 - Data Security Center window, with 3 security issues detected
In detail, the following settings can be detected as insecure:
Wi-Fi: the tablet is connected via Wi-Fi (using the Android settings) to an access point that uses an insecure
protocol (such as WEP, WPA or open connection), which is a potential cybersecurity threat. Configure the WiFi access point to use the WPA2 protocol to solve this issue.
Control Interface: Compass units equipped with legacy ASUS and Nexus tablets as Control Interface could
be compromised by a malicious user with advanced hacking knowledge and physical access to the tablet. It is
recommended to never leave the Control Interface unattended.
Remote Viewer: the Remote Viewer is configured to use HTTP protocol, which is a potential cybersecurity
threat. Configure the Remote Viewer to use HTTPS (see §13.6), which prevents man-in-the-middle attacks.
iCare
COMPASS User Manual - EN
Page 25 of 100
COMPASS units equipped with legacy ASUS tablet as Control interface need to have
the Location Services enabled under the Android settings to correctly obtain the current
Wi-Fi parameters. It is recommended to manually enable this option within the Android
settings, to correctly detect the Wi-Fi settings and identify whether the device is
connected to an unsecure network. To enable the Location Services, access the
Android settings and enter the Location menu:
Tap the switch on the first row to turn it to “on”: automatically the Location mode
selection will show up. Select “Battery saving” and press the “back” arrow:
The resulting setting will be the following. It is now possible to close the Android settings
and return to the COMPASS application.
iCare
COMPASS User Manual - EN
Page 26 of 100
8.3
Adding a new patient
To create a record for a new patient, click on
and the Patient Editing screen will open (see Fig. 18). Type
the last name, first name and select the date of birth (mandatory fields), optionally select the gender and type
a unique code of your choice. Then click OK to save or Cancel to abort.
If a patient with the same last name, first name and birth date already exists in the unit database, a warning
message will pop-up suggesting to select the existing one instead of the new one, to avoid undesired patient
duplications.
8.4
Deleting patients
To delete one or more patient, long-press on the corresponding row. The patient will be marked as selected
and the
button will appear on the top bar. It is now possible to select/deselect more patients to be deleted
at the same time. Press the trash bin button and confirm to delete the selected patients.
Alternatively, you can press the trash bin button in the Patient Record page of the desired patient (see Fig.
19), and confirm to delete it.
8.5
Searching for an existing patient
To search for an existing patient, click on
and type the initial letters of the name, surname or code of the
patient you are looking for, then click OK. When the desired patient is shown in the list, click on it to select. To
exit the search, click on  to hide the keyboard and then on
8.6
.
Selecting an existing patient
To select a specific patient in the list, click on it. The list is sorted by the date and time of the last exam and
can be scrolled up and down.
Fig. 18 – Patient editing screen
Once a patient has been selected in any of the above ways, the Patient Record screen opens (see Fig. 19)
and provides information on the selected patient, whose name is shown at the top-left corner of the screen.
See par. 10 for full details on how to review a patient’s data. Click on the New Exam button to initiate a new
test.
iCare
COMPASS User Manual - EN
Page 27 of 100
Fig. 19 – Patient Record screen
iCare
COMPASS User Manual - EN
Page 28 of 100
9.
PERFORMING THE EXAM
This paragraph explains how to operate COMPASS to perform the test (in this manual the terms “test” and
“exam” are used as synonyms).
9.1
COMPASS test modalities
COMPASS allows to measure a patient’s visual field in time, hence creating a sequence of tests. It also
provides a true color confocal image of the retinal fundus (see below).
COMPASS provides four different test modalities:
• a Visual Field test allows to determine the sensitivity thresholds for each location identified
by the selected test grid, using the selected projection strategy (4-2 and ZEST are
available). Visual Field (VF) tests allow to monitor the progression of retinal sensitivity by
performing follow-up sequences:
▪ a root test is the first performed on a certain patient and eye, thus it does not require
the existence of a previous test;
▪ follow-up tests require a previous root test of the same eye;
• a SupraThreshold test allows to perform a quick assessment of the retinal sensitivity,
without determining the threshold for each location;
• the Quick SupraThreshold test allows to perform an even faster assessment of retinal
sensitivity, using the same projection strategy of the SupraThreshold test on a smaller grid
(see Fig. 29), and with speed optimizations
• a Fundus/Fundus Stereo test allows to acquire only the fundus color image.
The follow-up modality exploits image registration techniques to accurately match stimuli
locations in the follow-up test with their position in the corresponding root test and ensure
high precision of the results. End users should be fully aware of the difference between
root tests and follow-up tests.
With COMPASS:
• any follow-up test is associated with its root test
• any root test is identified by this graphics:
• it is not possible to generate a progression report using only root tests
• it is only possible to generate a progression report using a root test and its followup tests
iCare
COMPASS User Manual - EN
Page 29 of 100
9.2
Initiating a new Visual Field root test
To initiate a new root test, click on the New Exam button, and select Visual Field using the test type selector.
9.3
Initiating a Visual Field follow-up test
To initiate a new follow-up test, select the desired root test and click on the New Follow Up button.
9.4
Initiating a Supra-Threshold test
To initiate a new SupraThreshold test, click on the New Exam button, and select SupraThreshold or Quick
SupraThreshold using the test type selector. For a description of the exam flow of the SupraThreshold test,
refer to par. 9.12.
9.5
Initiating a new Fundus/Fundus Stereo test
To initiate a new fundus test, click on the New Exam button, and select Fundus/Fundus Stereo using the
test type selector. For a description of the exam flow of the fundus tests, refer to par. 9.13.
iCare
COMPASS User Manual - EN
Page 30 of 100
9.6
Choosing test parameters
When the New Exam command is pressed the Test parameters selection screen opens (see Fig. 20),
allowing review and modification of the test parameters.
The following commands / functions are available:
1. Test type selection (Visual field, Suprathreshold, Quick SupraThreshold, Fundus or Fundus
Stereo);
2. Eye selection (OD, OS, OU). OU option is currently available for Quick SupraThreshold tests only;
3. For Visual Field tests only, selection of the threshold strategy (ZEST or “4-2“);
4. For perimetric tests, the current exam configuration as determined by fixed and configurable settings
(see Table 1);
5. Chin-rest height adjustment;
6. For perimetric tests only, selection of the test grid (or pattern);
7. Test start;
8. Back to Patient Record screen.
6
1
5
4
2
3
7
8
Fig. 20 – Test parameters selection screen
ZEST vs. 4-2
Zippy Estimation by Sequential Testing (ZEST) is an adaptive Bayesian method for determining
sensitivity measures. ZEST, that is similar to SITA algorithms, allows to reduce examination time
while maintaining accuracy.
In terms of threshold, ZEST estimates are on average 0.9 dB higher than those found with the 42 staircase (similarly to SITA algorithms vs. full threshold).
In terms of examination time, the average for a 24-2 test is approximately 40% shorter using ZEST
than using 4-2.
iCare
COMPASS User Manual - EN
Page 31 of 100
The following perimetric parameters are used and cannot be modified:
• background luminance:
31.4 asb
• maximum luminance (0 dB):
10000 asb
• stimulus duration:
200 ms
• stimulus size:
Goldmann III
• fixation target for foveal stimulus:
4 green circles in diamond configuration
• fixation target for non-foveal stimuli:
single green circle
Fixation Target
The standard projection grid used in COMPASS is the “24-2”. This grid has an asymmetric shape
which extends to the temporal peripheral area. In order to project stimuli in the extreme positions,
COMPASS will show a fixation target shifted 3 degrees right when testing OD, and left when testing
OS. For homogeneity, the same happens for any other test grid, except for the “30-2” grid.
The following settings may be fixed or configurable, depending on the selected test type. For a
description of the Reliability indexes refer to par. 10.2. For the settings configuration, refer to
par.13.5.
Quick
Setting
Visual Field
SupraThreshold
SupraThreshold
Coherence Check (CC)
Configurable
Not available
Not available
ON
ON
OFF
ON
ON
Configurable
Blind Spot test (BS)
Configurable
ON
OFF
False Positives (FP)
Configurable
ON
ON
False Negatives (FN)
Configurable
ON
OFF
PRL calculation
Foveal
threshold
ON for VF and
Table 1 – Fixed and configurable Exam settings
9.7
Before starting
Following are some hints to maximize the effectiveness of the test:
• check that the lens cap has been removed;
• check that the room is sufficiently dark;
• patient should sit in a comfortable position, with the forehead and chin in firm contact with
the corresponding rests. Patient’s head should be vertical and not tilted. Chin rest should
be positioned so that eye is aligned to the mark;
• ask the patient to look at the fixation target throughout the test;
• perform a quick training on patients that never had perimetry before.
iCare
COMPASS User Manual - EN
Page 32 of 100
9.8
During the test
The following table describes the test process flow for a Visual Field exam.
#
STEP
PURPOSE
INSTRUCTIONS
1
Autoalignment
Patient should not move and should look for the green fixation target.
For additional details see next paragraph.
2
Auto-focus
Align instrument
to patient’s eye
Correct
for
patient’s spherical
refraction
Patient should not blink and should look at fixation target
The reference image should have good quality, in particular images that
are too dark, or partially occluded by eye lashes or lids should be
3
Reference
IR image
Capture reference
infrared
retinal
image to be used
for eye tracking
retaken. Click the
button on the right of the screen to retake the
reference image if its quality is not satisfactory (see for example Fig. 22).
Click on the
button to proceed.
: a poor-quality reference image may compromise the VF test,
increase its duration, prevent retinal tracking or make follow-up
testing impossible.
4
Blind spot
location
Identify location of
blind spot
5
Detect
fixation
Locate center of
fixation
Fovea Test
Measure
sensitivity at the
fovea
6
7
Perimetry
Measure
sensitivity at all
grid
locations
using
central
fixation target
Drag and center circle over optic disc, then click on the
proceed (see Fig. 23)
: a wrong or imprecise placement of the optic disc marker
results in failure of the BS test, and in a wrong display of the ONH
in the results printout (see par. 12).
Patient should look steadily at fixation target.
: once this step is completed the system will stop and wait for
confirmation: click the forward arrow to proceed with next step
Patient should look at the center of the 4 green dots and press the button
when she/he sees a white spot.
: if not properly instructed, patients often miss clicking at this
time.
: once this step is completed the system will stop and wait for
confirmation: click on
to proceed with the next step
Patient should look steadily at the green dot and press the button when
she/he sees a white spot. Patient can blink at any time. Periodically
inform the patient of the progress. See note concerning eye tracking.
: if not properly instructed, patients sometimes get away from
the forehead rest during the test.
: once this step is completed the system will stop and wait for
confirmation: click on
iCare
button to
COMPASS User Manual - EN
to proceed with the next step
Page 33 of 100
Patient should not blink and should look at the green fixation dot until a
light is flashed.
: click on the
quality.
8
Color
image
Capture
color
photo of posterior
pole
button on the right to retake the image if of poor
: the system will try to register (i.e. to match) the acquired Color
image over the Reference IR image. Should the registration fail due to
bad quality of either of the two images, the end user will be prompted to
Retake the image, or to Continue (see Fig. 24). In the latter case, the
Color image will be saved as a separate Fundus exam, and the
Reference IR image will be used for the results printout (see par. 12).
Once the image is satisfying, click on
its results
to finish the exam and store
VISUAL FIELD EXAMS WITH 30-2 GRID
Due to test locations of the 30-2 grid being close to the edges of the field, the exam flow with the
30-2 grid has the following variations:
- Steps 1 to 6 take place as described above, with the IR image and foveal test being
performed with a fixation target in the central position with respect to the field (see Fig. 21,
position 1).
- Step 7 is split in two parts: at the end of the foveal test the fixation target changes from the
central position to a position at about 4° from the center in lower-nasal direction (see Fig.
21, position 2). Allow the patient to locate the fixation target and to start fixating it before
clicking the arrow to proceed.
- The projection takes place only on a subset containing half of the total grid locations (38
out of 76), until all the corresponding thresholds are measured.
- Then, the fixation target changes to a position at about 4° from the center in uppertemporal direction (see Fig. 21, position 3). Allow the patient to locate the fixation target
and to start fixating it before clicking the arrow to proceed; the remaining 38 locations are
then tested.
- Step 8 finally takes place using the central fixation target, in order to make it possible to
register the color image over the IR image.
Fig. 21 – “30-2” grid test locations (left)
and fixation target positions used for OD (center) and OS (right)
iCare
COMPASS User Manual - EN
Page 34 of 100
Fig. 22 – Good (left) and poor quality (right) reference image
Fig. 23 – Marker for optic disc location in Exam screen
Fig. 24 – Message shown in case of Color image registration failure
iCare
COMPASS User Manual - EN
Page 35 of 100
9.9
Auto-alignment
Several hints may be presented on screen by the system to help the end user correct a patient’s position: see
Table 2 below.
Pupils smaller than the minimum required may trouble the auto-alignment and auto-focusing
processes
EYE NOT FOUND: Please make sure patient head is not tilted, eye is open wide
EYE TOO FAR LEFT: Please make sure patient head is well centered in front rest and not tilted
EYE TOO FAR RIGHT: Please make sure patient head is well centered in front rest and not tilted
EYE TOO LOW: Please raise chin rest until alignment process restarts
EYE TOO HIGH: Please lower chin rest until alignment process restarts
PATIENT TOO FAR: Please make sure patient head is not tilted, or detached from front rest
Table 2 – System hints during auto-alignment
9.10
Retinal tracking
Eye tracking is a fundamental component of Fundus Perimetry.
Infrared retinal images, acquired at the rate of 25 images per second, allow for continuous, automated,
tracking of eye movements. Determination of eye movements allows, in turn, active compensation of
fixation losses, with perimetric stimuli being automatically re-positioned prior to and during projection based
on the current eye position. This mechanism reduces test-retest variability and ensures accurate correlation
between function (i.e. retinal threshold values) and structure (retinal appearance). Compensation of eye
movements takes place before and during projection of a certain stimulus. In absence of this mechanism shifts
in eye position occurring at the time of projection of a certain stimulus even in healthy patients easily produce
artifacts in VF results.
Regular operation of the eye tracking is indicated by a GREEN frame surrounding the retinal image (see Fig.
25). A RED frame indicates that eye tracking is NOT operational: in such case stimuli cannot be projected
and the test is paused until the retina can be tracked again. Typical patient position (e.g. far from forehead
rest).
Fig. 25 – Tracking active (left) and on hold (right)
iCare
COMPASS User Manual - EN
Page 36 of 100
9.11
Monitoring test progress
6
1
4
3
2
5
7
10
8
12
11
9
.
Fig. 26 – Exam screen while test is in progress
The following information and functions are available:
1. Pupil images from alignment cameras allow the end user (operator) to check if patient’s eyes are open
2. Pupil size: if smaller than 3 mm a “small pupil” warning is displayed. Pupil size may oscillate during
the test due to accommodation
3. Information about the selected exam parameters: type (Visual Field / SupraThreshold / Quick
SupraThreshold / Fundus), eye (OD / OS) and strategy (ZEST / 4-2)
4. Buttons to adjust the height of the chinrest
5. Live stabilized retinal image (i.e. shifted using the information coming from the eye-tracking) with
stimuli allows the operator to monitor progress. The center of the small orange square displayed on
the stabilized image represents the current fixation point (the point of the retina which is aligned to the
center of the fixation target at every moment). Seen stimuli are shown as filled dots. The stimulus
being projected is shown as an empty circle.
6. Tracking status (circular colored frame)
7. Elapsed test time
8. Reliability indices (False Negatives, False Positives and Blind Spot, see par. 10.2) updated live (caught
occurrences over catch trials)
9. Completed stimuli over total being projected: test proceeds slow at the beginning and turns
progressively faster
10. Buttons that allow to stop (top) or to pause (bottom) the test at any time
11. Information about the exam phases completed (Alignment, Autofocus, Auto-exposure)
12. Button that allows to turn OFF the retinal Tracking
Patients with little experience of COMPASS might take some time to understand how the test
works. If the reliability indices reach high values, it is advised to train the patient better and stop
the test because the current one will result unreliable.
The Pause button allows to suspend the exam for some time to let the patient rest if he/she is
experiencing some fatigue. When resuming from the pause, the projection will restart after 3s of
delay to avoid missing the first stimuli.
iCare
COMPASS User Manual - EN
Page 37 of 100
COMPASS requires a minimum pupil of 3.0 mm: a test with average pupil size smaller than
3.0 mm may be unreliable.
It is possible to turn OFF the retinal Tracking, if the test is taking too long due to highly
unstable fixation or poor image quality. However, the stimuli positioning correction will no
longer take place and this will result in the exam being considered unreliable. The system
will ask for confirmation when pressing the “Turn Tracker OFF” button (see Fig. 27). It is
not possible to re-enable the tracking for the current exam once it has been disabled. The
fact that the retinal Tracking has been disabled during the exam will be displayed both in
the Exam review screen and in the report Printout.
Fig. 27 – Confirmation request to disable tracking
iCare
COMPASS User Manual - EN
Page 38 of 100
9.12
Other exam types: SUPRATHRESHOLD tests
The SupraThreshold and Quick SupraThreshold tests have been developed to provide a quick assessment
of the retinal sensitivity compared to normality values in a reduced examination time, as in SupraThreshold
perimetric tests. Only two intensities are tested: first at a lower intensity and then, if not seen, at a higher
intensity, hence this test does not measure the actual threshold but rather a SupraThreshold response
consisting of one of the following options: “seen at lower intensity”, “seen at higher intensity”, “not seen at
higher intensity” (see Fig. 28). The two intensities used are determined based on average and standard
deviation values from COMPASS normality database and are dependent on the point location and on the
patient’s age. Both Suprathreshold tests are designed to quickly determine whether the retinal sensitivity falls
below or above the 90th and 95th percentile of a reference population of normal subjects, without determining
the actual threshold.
Fig. 28 – SupraThreshold test projection logic
The SupraThreshold test follows the same exam flow of the Visual Field Test and takes approximately 2 to 3
minutes per eye.
The Quick Suprathreshold test is designed to take 30 to 90 seconds per eye to complete, by means of the
following optimizations:
- A reduced test grid: 24 locations instead of 52
- Possibility to select OU: OS test starts right after OD test has completed
- No PRL determination: the grid will not be centered on the PRL
- Reduced Reliability tests (only False Positives are tested)
- Possibility to disable the Fovea threshold measurement
For a complete description of the outcomes of the SupraThreshold and Quick SupraThreshold tests see par.
10.4.
The only grid available for the SupraThreshold test is the “24-2-st”.
The only grid available for the Quick SupraThreshold test is the “24-2-reduced”, which consists
of a reduced subset (24 instead of 52) of the 24-2-st grid locations (see Fig. 29).
Fig. 29 – 24-2-st (standard Suprathreshold) grid compared to 24-2-reduced (Quick Suprathreshold)
iCare
COMPASS User Manual - EN
Page 39 of 100
9.13
Other exam types: FUNDUS and FUNDUS STEREO test
The Fundus test allows to acquire the color photo of the fundus. With respect to the exam flow described at
par. 9.8, only steps 1, 2 and 8 take place, i.e. automatic alignment and focus. During the test, the fixation target
is at the same position as in the Visual Field test, to provide an image of the central field of the retina.
The Fundus Stereo test allows to acquire two images of the nasal field with a slight lateral displacement of
the unit’s head position. A delay between the shots is applied to let the pupil partially recover. To review stereo
images, the end user (operator) should use specific 3D Prismatic stereoscopic goggles13, such as the model
provided with COMPASS starting from September 2017: in this way it will be possible to have a 3D
representation of the optic nerve head. For more information about the stereo feature, refer to par. 10.5.
The Fundus Stereo test takes images of the nasal field, so the fixation target will be
positioned at the far nasal end of the visual field: before starting the test, instruct the patient
where to search in order to locate the target.
Fig. 30 – Example of a Fundus image (left) and of one of a Fundus Stereo image (one of the pair) (right)
13 The Prismatic Stereoscopic Goggles are delivered with COMPASS since September 2017. For information about how
to purchase these components, please refer to your local distributor.
iCare
COMPASS User Manual - EN
Page 40 of 100
10.
REVIEWING RESULTS
Once a test is completed, the system will open the Patient Record screen (Fig. 32) for the selected patient
and present a thumbnail view (Fig. 31) of all tests made on the selected date.
The Visual Field exam thumbnail presents the following information:
•
Red-free retinal image (with overlaid actual test locations) if the Color Image registration was
successful, otherwise the IR retinal image is displayed;
•
Examined eye (OD / OS);
•
Date and time the test was performed;
•
Type (root / follow-up);
•
Pattern used and number of test locations actually completed (incomplete tests will show in yellow);
•
Threshold algorithm (ZEST or 4-2 staircase);
•
Duration (minutes: seconds);
•
Focus index;
•
Average pupil size during test;
•
False Negatives index (FN);
•
False Positives index (FP);
•
Blind Spot index (BS);
•
Mean Deviation index (MD);
•
Pattern Standard Deviation index (PSD);
•
Fundus Perimetry Deviation Index (FPDI);
•
Tracking ON / OFF indicator (will display OFF if the tracking has been disabled during the exam)
The Fundus and Fundus Stereo exam thumbnails present the following information:
•
Color retinal image;
•
Examined eye (OD / OS);
•
Sate and time the test was performed;
•
Type (Fundus / Fundus Stereo);
•
Focus index;
•
Pupil size at time of shooting;
•
Field;
•
Shutter Time (photo exposition in ms).
Fig. 31 – Example of thumbnails for Visual Field (left) and Fundus (right) exams
iCare
COMPASS User Manual - EN
Page 41 of 100
The Fundus Perimetry Deviation Index (FPDI) is a global index that assigns a value between
0% and 100% based on an aggregate percentage of visual function, with 100% being a perfect
age-adjusted visual field. Central visual field points are more heavily weighted, and the percentage
of visual field loss is calculated based on pattern or total deviations depending on the depth of
loss.
The Patient Record screen provides the following commands:
1. modify the patient’s name, birth date, gender, and code;
2. permanently delete the selected patient’s record (any data);
3. shows the Device Status window (see par. 8.1);
4. display the tests performed at a specific date;
5. display the tests performed within a certain sequence identified by a root test;
6. open Exam Review screen (see Fig. 33);
7. start a new root test (do not use this button if you wish to start a follow-up);
8. start a follow-up test within the specified sequence of tests;
9. go back to patient list screen.
1
2
3
7
4
6
5
8
9
Fig. 32 – Patient Record screen
iCare
COMPASS User Manual - EN
Page 42 of 100
10.1
Individual test results review
The Exam Review screen (Fig. 33) provides the following information and functions:
1. Patient name and info
2. Selector for image modality (color, infrared or red-free)
3. Retinal image and visual field data, depending on selected modality (default: red-free, infrared and
red-free images are shown with overlaid VF data). Click on image to open a full screen view and zoom
/ pan the image. Swiping left and right allows to switch to the other image types (same as selector 2)
4. Perimetric test parameters
5. Option to enable / disable display of perimetric results over retinal image (default: yes). Note: this
option is not available on Color images
6. Option to switch ON / OFF fundus mode convention (default: on). See the information box below for
more details
7. (scroll down to see these) Image tools including blue, green, red filters used to display individual
color channels and gamma correction, used to enhance image brightness (see details explained in
Table 3 below)
8. Commands for report generation, storage and printout (see details explained in Table 3 below)
9. Command to go back to Patient record screen.
8
1
3
2
4
5
6
7
9
Fig. 33 – Exam review screen, red-free display modality
iCare
COMPASS User Manual - EN
Page 43 of 100
Top bar button
Description
Export image in JPG format (first icon), fundus report in PDF format (second
icon), image in DICOM format (third icon) or perimetric test report in PDF
format (last icon) to a shared folder (see par. 13.10). These buttons are
enabled only if the shared folder has been previously configured.
Export image (left icon), fundus report in PDF format (center icon) or
perimetric test report (right icon) to USB. These buttons are enabled only if
a USB storage device is plugged in.
Open the fundus report in PDF format (left icon) or the perimetric test report
PDF (right icon) for viewing in a PDF viewer or printout.
Generate the progression report (see par. 10.3).
Image tools button
Description
Toggles between original image and the filtered image (i.e. the image with
the below filters applied).
Used to display individual color channels (for color images). The green
channel provides the red-free image.
Used to enhance image brightness by adjusting gamma, from 0.5 to 1.8.
This correction does not alter the original image.
Store the selected gamma value in the database. When re-opening the
image in the future this value, will be applied by default. This correction
does not alter the original image, which can always be accessed with
the “filtered” button.
Table 3 – Exam Review buttons and related commands
10.2
Reliability indices
COMPASS provides standard methods to assess the reliability of a patient in performing the visual field test:
• False Positives (FP): these are trials in which no stimulus has been projected, therefore the patient
is not expected to respond. If this index exceeds 25% the number will show in red, indicating possibly
poor reliability.
• False Negatives (FN): during the test, certain stimuli are randomly selected and retested at brighter
level than has been previously seen. If the patient does not respond, a false negative instance is
recorded. If this index exceeds 25%, the number will show in red, indicating possibly poor reliability.
• Blind Spot Test (BS): during the test stimuli are projected with high luminance, at random times, at
the blind spot location that has been selected prior to the start. Index shows the number of positive
responses obtained over the total number of such BS projections. If this index exceeds 25%, the
number will show in red, indicating possibly poor reliability.
Moreover, COMPASS introduces an additional test specific for Visual Field exams performed with ZEST
strategy:
• Coherence Check (CC): this test introduces additional projections (max. 1 per grid location point) to
limit the effect of occasional false responses.
iCare
COMPASS User Manual - EN
Page 44 of 100
Depending on the selected exam type, the four above tests may be individually enabled or disabled in the
Configurator app: see par. 13.5.
COMPASS provides one additional parameter to be considered when assessing the reliability of a certain test:
• Average pupil size: shows the average pupil diameter throughout the test. If this index is below 3.0
mm, the number will show in red, indicating possibly poor reliability.
Fig. 34 – Detail of Exam review screen with reliability indices
Fixation plot / Area
Differently than in non-retinal tracked perimeters, the COMPASS fixation plot shown in a test report
(see par. 0 and Fig. 35 below) is not to be considered a way to assess the reliability of a patient /
test.
In fact, the plot shows fixation losses, as determined by tracking eye movements (see par. 9.10),
but these movements are taken into account and compensated at the time of projection of the
stimuli, therefore they do not necessarily degrade a test reliability.
Fig. 35 – Fixation plot and Area
Fundus Perimetry vs. Standard Perimetry display conventions
In Standard Automated Perimetry, results are always displayed using the patient’s perspective, i.e.
they represent visual field maps, with superior field at the top and inferior field at the bottom: this
convention is used in the Exam Review screen when the Fundus Mode selector is set to OFF
(“Visual Field” convention).
In Fundus Perimetry, results are displayed using the doctor’s perspective, i.e. they represent retinal
sensitivity maps and show properly oriented retinal images: this convention is used when the
Fundus Mode selector is set to ON (“Fundus” convention). Values from the superior field correspond
to the inferior retina and vice versa.
Therefore, the two conventions differ in that they flip the results vertically.
iCare
COMPASS User Manual - EN
Page 45 of 100
10.3
Creating a Progression Report
To create a progression report, select and open any test belonging to the desired series (root or
follow-up), then click the button to view the progression report →
The Progression report test selection screen will open (see Fig. 36), which allows to select / deselect the
tests to be considered to generate the report. For example, some tests may be excluded because of poor
reliability (excess FP, FN, or BS).
•
•
•
•
•
A progression report is created using a root test and its follow-up tests
Only tests that derive from the same root can be included
At least two tests shall be included
The earliest test included in the report acts as the baseline
Either root or follow-up tests can act as baseline
This screen provides the following functions:
1. Include / exclude a certain test from the report
2. Show Progression Report
3. Save Progression Report to USB (requires USB drive)
4. Save Progression Report to shared folder
5. Cancel report generation and go back to Exam Review screen
See par. 12.7 for a description of the Progression report.
1
5
3
4
2
Fig. 36 – Progression Report test selection screen
iCare
COMPASS User Manual - EN
Page 46 of 100
10.4 SupraThreshold exams review
The review window of a SupraThreshold test (Fig. 38 and Fig. 39) is similar to the one of the Visual Field
test, except that the stimuli do not have a numeric representation but an icon whose meaning is as follows:
Fig. 37 – SupraThreshold responses
The MD, PSD and FPDI indices cannot be determined for a SupraThreshold test; instead, the responses at
individual points (seen at lower intensity, seen at higher intensity, not seen) are merged into one global index
called SupraThreshold Response. The foveal threshold is not considered in the calculation of this index but
is displayed on the left panel (if enabled).
Based on the reference database from approximately 400 eyes of normal subjects’ population included in
COMPASS, the SupraThreshold Response index represents the percentage of the population of normal
subjects having the same result as the one being reviewed, and the colors in the underlying bar indicate
whether the value of this index is:
• Above the 10th percentile of normal subjects’ population (GREEN) or
• Between the 10th and 5th percentile (YELLOW) or
• Below the 5th percentile (RED).
A RED outcome indicates in other words that results lower than or equal to the present were found in only 5%
of the reference population of normal subjects. A YELLOW outcome indicates that results lower than or equal
to the present were found in only 10% of the reference of subjects of normal population. Conversely, a GREEN
outcome indicates that results equal to or higher than the present were found in 90% of the reference
population of normal subjects.
Fig. 38 – SupraThreshold exam review window
iCare
COMPASS User Manual - EN
Page 47 of 100
Fig. 39 – Quick SupraThreshold exam review window
iCare
COMPASS User Manual - EN
Page 48 of 100
10.5 Fundus exam review and Stereo 3D Viewer
The review window for Fundus and Fundus Stereo exams is similar to the one for Visual Field exams.
Instead of the Visual Field parameters, image-related information is shown on the left panel (Exam Type,
Focus position, Pupil size, Field and Shutter Time, see Fig. 40).
If the image is part of a Stereo pair of images, a selector on the left panel (see point 1. In Fig. 40) or swiping
left/right on the image allows to switch between the two images of the pair. Moreover, the
button allows
to enter the Stereo 3D Viewer window. It is possible to enter this window also by clicking on the
present on the bottom right of Stereo images in the Patient Record screen (see Fig. 32).
button
1
Fig. 40 – Fundus Stereo exam review window
The Stereo 3D Viewer window (Fig. 41) displays images of the Stereo pair side by side; the images info are
displayed on the top, and the pan and zoom of the two images is linked so they can be adjusted together. In
order to view the 3D reconstruction of the images a pair of Prismatic stereoscopic goggles14 has to be used.
14 The Prismatic Stereoscopic Goggles are delivered with COMPASS since September 2017. For information about how
to purchase these components, please refer to your local distributor.
iCare
COMPASS User Manual - EN
Page 49 of 100
Fig. 41 – Stereo 3D Viewer
On the top bar, the following buttons are available:
Top bar button
Description
Open (first icon), export to USB (second icon) or export to Shared Folder (last
icon) the dual printout of the images of the Stereo pair.
For more info on the dual printout, see par. 12.8.
Swaps left and right image: this function can be used when using a different
method for 3D reconstruction (like crossing eyes), or if the optic nerve head
is perceived as an elevation instead of a cavity.
iCare
COMPASS User Manual - EN
Page 50 of 100
11. REMOTE VIEWER
The Remote Viewer is a browser-based software that allows the review of test results on any computer
connected to COMPASS via a local area network.
The Remote Viewer provides access to the Patient List, individual Patient records, Exam Review screen and
PDF printout. The Remote Viewer only allows to display the data and does not have any patient data editing
function.
Compatible browsers include Google Chrome, Microsoft Edge, Mozilla Firefox and Apple Safari.
To use the Remote Viewer, the device needs to be connected to the local area network via Ethernet
connection.
The Remote Viewer is available for wired connections only.
Since use of the Remote Viewer depletes some computational resources, no more than two
clients can be connected to the unit at the same time.
11.1
Setting up the Remote Viewer
To enable the Remote Viewer, connect the device to the local network by plugging the network cable in the
Ethernet port located on the back of the system (see Fig. 2).
To start using the Remote Viewer it must be enabled by selecting the desired protocol and setting
an access password: see par. 0 for instructions on how to setup the Remote Viewer.
11.2
Using the Remote Viewer
Open the browser and type http://gsd-sssss.domain in the address bar, where sssss is the five digits serial
number of the unit and domain is the local network domain name: this will open the Login screen. If the
selected protocol is HTTPS, the https://gsd-sssss.domain address must be used. In case the device is not part
of a domain, the http(s)://gsd-sssss.local address might work as well.
If you cannot retrieve the network domain name or if the network is using static Ips and not DHCP,
you can retrieve the device IP as follows:
•
launch the Configurator application (see par. 13.1);
•
click on the “NETWORK” tab;
•
•
•
click on the
icon of the “Wired” network;
retrieve the IP;
type http://IP (or https://IP if using HTTPS) in the address bar
Type the password and press Login: this will open the Patient List screen (Fig. 42), which resembles the
corresponding screen in the on-board software.
The Remote Viewer session is automatically closed after 20 minutes of inactivity.
The user is automatically logged out after 20 minutes of inactivity.
iCare
COMPASS User Manual - EN
Page 51 of 100
11.3
Patient List screen
Right and left eye image thumbnails are shown in the first column, followed by the patient name and date of
birth. The right-most column shows the date of the last exam.
Patients in the list are sorted by the date of their last exam.
Patient Search function is available in the top-left corner of the screen.
Click on the desired patient to enter the Patient Record screen (see Fig. 43). Click on Logout to exit the
Remote Viewer.
Fig. 42 – Patient List in Remote Viewer
11.4
Patient Record screen
This screen allows access to all exams and displays the same info present in the Patient Record screen in the
on-board software. The edit/delete patient and New Exam commands are not available in the Remote
Viewer.
In each exam box the following additional buttons are available:
Generate the progression report (see par. 10.3).
Download the perimetric report in PDF format (see par. 12).
Download the fundus report of the Color Image in PDF format.
Fundus exams provide only this button.
Download the fundus report of the Infrared Image in PDF format.
(Fundus Stereo exams only) Downloads the stereo report in PDF format.
Click on the desired image to enter the Exam review screen (see Fig. 44).
iCare
COMPASS User Manual - EN
Page 52 of 100
Fig. 43 – Patient Record screen in Remote Viewer
11.5
Exam review screen
Entering the Exam review screen shows the Color image of the selected Exam (or the IR image if the Color
image is not available).
Fig. 44 – Exam Review screen in Remote Viewer
iCare
COMPASS User Manual - EN
Page 53 of 100
The following functions are available in this screen:
Function
Command
Description
Back
Back to Patient Record Screen
Logout
Logout from the Remote Viewer
Patient Info
Displays all patient related information (full name,
date of birth, gender, code) and gives access to
a thumbnail view of all the images available for
this patient.
Also used to compare the currently displayed
image with any other image in the list click on the
corresponding Compare button: this will open the
Dual Image Review screen (see Fig. 47).
Previous/Next arrows
Switch to IR photo of the same exam, and then to
the next/previous exam.
Exam Info
Displays all exam related information (date and
time of capture, eye, pupil size, field, exposure,
focus)
Image Filters
Provides access to the red, green (i.e. red-free),
blue filters and gamma adjustment (see Fig. 45).
Download
Allows to download the Perimetry report (PDF),
the Progression analysis (PDF) original image
(JPG), the Fundus report of the image (PDF), the
Filtered image (JPG), the Fundus report of the
Filtered image (PDF) or the Dual printout Report
(PDF) on local PC (see Fig. 45)
Stereo 3D Viewer
Enters the Stereo 3D Viewer
Perimetry Mode
Provides access to the Perimetry Mode window,
showing stimuli thresholds overlay on retinal
image (available only for Visual Field exams)
[see below for details]
Additional Tools
Provide access to additional tools like flickering
and cup-to-disc evaluation (see below for
details)
Zoom
Mouse wheel
Pan
Mouse left-click and drag
iCare
Zooms in or out
Moves the image around to frame different
regions
COMPASS User Manual - EN
Page 54 of 100
Fig. 45 – Image Filters, Download options and More Tools in Remote Viewer
The image tools do not alter the original image.
When applying a Gamma value from the Remote Viewer, the same value will be stored and
used also in the on-board software interface, and vice versa.
11.6
Perimetry Mode review screen
This screen allows the review of the perimetric data of a Visual Field exam. When accessing this interface, the
stimuli thresholds are superposed over the red-free (or IR if not available) retinal image. The results of the
Visual Field test are displayed on the left side of the screen.
Fig. 46 – Perimetry Mode Review screen in Remote Viewer
iCare
COMPASS User Manual - EN
Page 55 of 100
The following additional functions are available in the bottom-left side of this screen:
Function
Command
Description
Close
Back to Fundus (image only) review screen.
Image Type
Switch between the red-free and the IR retinal
image for the stimuli overlay.
Hide/Show Thresholds
Hide or show the stimuli threshold overlay over the
retinal image.
Fundus/Standard perimetry
display convention
Switch between Fundus Perimetry and the
Standard Perimetry display conventions, i.e. flips
the results vertically (see par. 10.1)
11.7
Dual Image review / Stereo 3D Viewer screen
The Dual Image review screen (Fig. 47) allows comparison of any pair of images of the selected patient (color
and infrared, left and right eye, same or different dates). The Stereo 3D Viewer screen has a very similar
interface, except that the Lock button is missing (pan and zoom are kept locked), and it is replaced by the
Swap images button.
Fig. 47 – Dual Image Review screen in Remote Viewer
The following additional functions are available in this screen, in addition to those described above for the
Single Image review screen:
iCare
COMPASS User Manual - EN
Page 56 of 100
Function
Command
Description
Lock
(Dual Image review only) Allows to “lock”/”unlock”
the two images so that the same region gets
zoomed and panned in both images.
Swap images
(Stereo 3D Viewer only) Swaps left and right
image, to be used if the optic nerve head is
perceived as an elevation instead of a cavity.
Close
Goes back to the Exam Review screen.
11.8
Flickering view
COMPASS allows to compare two images one by one, by switching manually or automatically between the
two. This feature is called flickering. To access the flickering window, press the Additional Tools button in the
Single Image review screen, then click on Select image for flickering: the remote viewer will show a window
(see Fig. 48) with all the pictures available for flickering (i.e. all of the Color and IR images of the same patient
and same eye). The software automatically registers the two images to overlap them (compensating shift,
rotation and Color/IR distortion).
Fig. 48 – Flickering image selection
Select the image to flicker with, then click Done.
iCare
COMPASS User Manual - EN
Page 57 of 100
Fig. 49 – Flickering review window
On the left side of the image the date and time of the 2 selected pictures are displayed. The small circle
indicates the date and time of the currently displayed image.
Fig. 50 – Currently active picture: “2016-09-09 17:28”
The following features are available in this screen:
Function
Command
Description
Close
Goes back to the Exam Review screen.
Play/Pause
Play/pause the automatic flickering.
Next image
Toggle manually between the two images.
Animation speed
Flickering frequency selection (from 1 to 10Hz).
The 2 images are “locked”: zooming and dragging will act on both images.
iCare
COMPASS User Manual - EN
Page 58 of 100
11.9
Cup-to-disc evaluation
The cup-to-disc ratio (CDR) is the ratio between the optic cup and the neuroretinal rim diameters. To evaluate
it, draw the two diameters: click over the picture to start the first segment drawing, then click to define the end.
Do the same for the second diameter. The segments can be modified by clicking and dragging the segment
endpoints.
Fig. 51 – Flickering review window
The following buttons are available in this screen:
Function
Command
Description
Cancel
Discard drawings and return back to the Exam
review window.
Accept
Save cup-to-disk drawings and return back to the
Exam review window.
COMPASS is not a cup-to-disc ratio measurement equipment.
Its calculation is determined by how the diameters are drawn by the user and so it is subject to
the error introduced by the end user (operator): the CDR in COMPASS shall be considered as a
qualitative indication only.
Moreover, COMPASS does not provide CDR values comparison with normative data, so the
clinical interpretation of the CDR measurements obtained with COMPASS is the sole
responsibility of the eye care practitioner.
iCare
COMPASS User Manual - EN
Page 59 of 100
PRINTING
12.
Printer Setup
12.1
COMPASS supports wireless connection to most Android-compatible printer. Printing apps from the most
common manufacturers come pre-installed into COMPASS tablet (see Table 4). Before choosing a printer,
please check if the model is included in the compatibility list issued by the printer manufacturer for every app.
Brand
Description
Mopria
Multi-brand printer app
HP
HP Android ePrint
Samsung
Samsung Mobile Print App
Lexmark
Lexmark Mobile Printing
Canon
Canon Mobile Printing, Canon Easy-PhotoPrint, PIXMA/MAXIFY PrintingSolutions
Epson
Epson iPrint, Seiko Epson Corporation
Konica Minolta
Konica Minolta Printers, Page Scope Mobile
Table 4 – Printing apps
There are two possible network setups for printers, depending on whether a wireless Access Point (e.g.
Wireless router) is available or not.
Infrastructure Mode
In this configuration, both COMPASS tablet and the printer are connected to an Access Point, such as a
wireless router.
Access Point
(e.g. Wireless router)
Wi-Fi Direct Mode
COMPASS connects directly to the printer via wireless, without the need of an Access Point: please note that,
to setup this configuration, printer must support Wi-Fi Direct.
Wi-Fi Direct
To connect the printer in Wi-Fi Direct mode, enter the “Advanced Wi-Fi” menu of the tablet settings and select
the “Wi-Fi Direct” item (see Fig. 52), and proceed with pairing with the printer following the instructions provided
by producer.
iCare
COMPASS User Manual - EN
Page 60 of 100
Fig. 52 – Item “Wi-Fi Direct” within “Advanced Wi-Fi” menu
Alternatively, it is possible to pair with the printer directly within the Adobe Acrobat Reader app, using the
Mopria Print Service (see Fig. 53).
Fig. 53 – Connection to the printer in Wi-Fi Direct mode via Mopria Print Service
It is preferable to avoid connecting directly to the printer in Wi-Fi Infrastructure mode, as the tablet
cannot be connected to another Wi-Fi data network at the same time. As a result, it will not
automatically reconnect to the printer after reboot (as it does not provide internet access), so it is
recommended to connect in Wi-Fi Direct mode instead of Wi-Fi Infrastructure.
iCare
COMPASS User Manual - EN
Page 61 of 100
12.2
Report for 24-2 test
The printout for an exam performed with the 24-2 grid is a one-page layout presenting the following information
(see Fig. 55):
1.
Patient information (name, date of birth, age when test was performed);
2.
Examined eye (OD, OS);
3.
Test parameters (date, time, duration, test pattern, threshold strategy, average pupil size during test,
BS, FP, FN, foveal threshold);
4.
Color image of the ONH;
5.
Threshold values (dB) over red-free image, using the Fundus Perimetry display convention (see info
box below for information about the colors used and previous info box for details about the various
display convention);
6.
Mean Deviation (MD), Pattern Standard Deviation (PSD) and Fundus Perimetry Deviation (FPDI)
indices, plus information if the Tracking and CC were enabled during the exam
7.
Cluster MDs (dB) (see clusters identification in Fig. 56);
8.
Grayscale VF map (see Fig. 57 for the gray tone symbols adopted), using the Standard Perimetry
display convention;
9.
Total and Pattern deviation maps and related significance levels, using the Standard Perimetry
display convention;
10. Tracking Performance Indices: TPI0.5° and TPI1° measure the rate of occurrence, during stimuli
projections, of eye movements compensated by the tracking within respectively 0.5° and 1.0° in
amplitude. The numbers between brackets report the corresponding values in (simulated) absence
of retinal tracking, for comparison
11. Fixation Area: this index reports the area (and its semi-axis between brackets) of the 95th percentile
fitting ellipse of the fixation points recorded during the test; the higher this index the more dispersed
fixation and the wider eye movements;
12. Fixation plot, describing the amplitude of eye movements in time, relative to the PRL;
13. Glaucoma Staging System 2;
14. Software version used to generate the report;
15. Custom printout header (see Par. 13.11 for how to configure it).
Fig. 54 – Example of Tracking Performance Indices
The colors used in the Fundus Perimetry map (5) and symbols used in the Total and Pattern
Deviation maps (9) are derived from normative values:
red is used for points having a total deviation with p < 0.5%
dark orange is used for points having a total deviation with p < 1% and  0.5%
light orange is used for points having a total deviation with p < 2% and  1%
lime is used for points having a total deviation with p < 5% and  2%
green is used for points having a total deviation with p  5%
white is used for the foveal and optic disc locations
iCare
COMPASS User Manual - EN
Page 62 of 100
15
1
2
3
6
5
4
7
9
8
10
11
13
12
14
Fig. 55 – COMPASS report for a test with 24-2 grid
iCare
COMPASS User Manual - EN
Page 63 of 100
Fig. 56 – Stimuli of the 24-2 pattern (left) and 30-2 pattern (right) grouped in clusters15
Fig. 57 – Symbols used for the grayscale map and related dB intervals
15
Garway-Heath et al; Mapping the Visual Field to the Optic Disc; Ophthalmology Volume 107, Number 10, October 2000
iCare
COMPASS User Manual - EN
Page 64 of 100
12.3
Report for 10-2 test
The printout for an exam performed with the 10-2 grid is similar to the one of a 24-2 grid, with the following
differences (see Fig. 58):
• The cluster analysis (7) is not available;
• The Glaucoma Staging System (13) is not available and is replaced by the color photo;
• As the projection grid is smaller, the retinal image shows a zoomed view of the projected area.
Tests performed with the “small test grid” are solely for training and not suitable for generating a
report.
Fig. 58 – COMPASS report for a test with 10-2 grid
iCare
COMPASS User Manual - EN
Page 65 of 100
12.4
Report for 30-2 test
The printout for a test performed with the 30-2 grid (Fig. 59) is similar to the one of a 24-2 grid, with the following
difference:
• the cluster analysis (7) displays the Cluster MDs only for the subset of locations that are in common
with the 24-2 grid (see Fig. 56).
Fig. 59 – COMPASS report for a test with 30-2 grid
iCare
COMPASS User Manual - EN
Page 66 of 100
12.5
Reports for the SupraThreshold exams
The printout for a SupraThreshold exam displays the following information (see Fig. 60):
1.
Patient information and exam data, among which the foveal threshold measurement
2.
Red-free retinal image with overlapped 3 symbols representation (seen at lower intensity, seen at
higher intensity, not seen)
3.
Color image of the ONH detail
4.
Tracking performance indices and Fixation plot
5.
Color image of the entire retina
6.
Suprathreshold Response index, with reference to delimiting percentiles
Fig. 60 – COMPASS report for a SupraThreshold test
iCare
COMPASS User Manual - EN
Page 67 of 100
The printout for a Quick SupraThreshold exam contains the same information (Fig. 61). The only differences
are:
- a wider ONH detail image;
- the BS reliability index is N/A;
- the Fovea threshold might be Disabled.
Fig. 61 – COMPASS report for a Quick SupraThreshold test
iCare
COMPASS User Manual - EN
Page 68 of 100
12.6
Fundus Report
The Fundus Report printout can be generated and exported for both Fundus / Fundus Stereo and Visual
Field / SupraThreshold tests (both Color and Infrared image).
It is a one-page layout presenting the following information (see Fig. 62):
1. Patient information (name, date of birth, age when test was performed);
2. Exam date and time;
3. Examined eye (OD, OS);
4. Pupil size during photo shoot;
5. Type of image (Color / Infrared);
6. Cup-to-disc ratio (if previously set by the end user).
Fig. 62 – Fundus report examples: for Color Image (left) and for Infrared Image (right)
iCare
COMPASS User Manual - EN
Page 69 of 100
12.7
Progression report
The Progression Report provides information on a series of tests (24-2, 10-2 or 30-2) pertaining to the same
patient and eye.
It is a one-page layout presenting the following information (see Fig. 63):
1. Patient information (name, date of birth)
2. Examined eye (OD, OS)
3. Baseline Test parameters (date, time, duration, test pattern, threshold strategy, average pupil size
during test, BS, FP, FN, foveal threshold, MD and PSD);
4. Color image of the ONH at baseline
5. Grayscale map, Total and Pattern deviation maps and related significance levels at baseline
6. Last follow-up parameters (date, time, duration, test pattern, threshold strategy, average pupil size
during test, BS, FP, FN, foveal threshold, MD and PSD)
7. Color image of the ONH at last follow-up
8. Grayscale map, Total and Pattern deviation maps and related significance levels at last follow-up
9. Dates of intermediate follow-up tests included in the MD progression plot
10. Point-wise differences (dB) between last follow-up and baseline
11. Differences in cluster MDs between last follow-up and baseline (for 24-2 and 30-2 tests only)
12. MD progression plot for all included tests
13. FPDI progression plot for all included tests (for 24-2 and 30-2 tests only)
14. Software version used to generate report
15. Custom printout header (see Par. 13.11 for how to configure it).
iCare
COMPASS User Manual - EN
Page 70 of 100
15
1
2
3
5
4
6
7
8
9
10
11
13
12
14
Fig. 63 – Progression report for 24-2 series
iCare
COMPASS User Manual - EN
Page 71 of 100
15
1
2
3
5
4
6
7
8
9
10
12
14
Fig. 64 – Progression report for 10-2 series
iCare
COMPASS User Manual - EN
Page 72 of 100
15
1
2
3
5
4
6
7
8
9
10
11
13
12
14
Fig. 65 – Progression report for a 30-2 series
iCare
COMPASS User Manual - EN
Page 73 of 100
12.8
Dual printout / Stereo report
The Dual printout and the Stereo report have the same layout and they display the two images selected (or
the pair of Stereo images) on a single page, in landscape format. The header displays info of the patient
(Name, code, and date of birth) and of each image (date/time, Pupil size, field and Image Type).
Fig. 66 – Example of a Dual printout Report
iCare
COMPASS User Manual - EN
Page 74 of 100
SETTINGS
13.
COMPASS provides access to settings by means of a separate application called “Configurator”.
The Configurator app can be accessed by the Admin user only.
13.1 Launching the Configurator
To access the Configurator:
• Press the “back” icon at the bottom of the screen to go to the Home screen
• Press the logout icon
• Select user “Admin” from the drop down menu
• Type the corresponding password and click Login
•
Enable tethering by clicking
•
Click the App icon
•
Start the Configurator by clicking
;
.
13.2 Device lock reset procedure
In case COMPASS raises error codes ranging from “117” to “121”, or from “124” to “130”, entering in a locked
state, the Configurator can be used to reset this condition. In such case a warning icon is shown on the top
right bar of the Configurator.
To reset the error condition, click on the warning icon: a confirmation message will appear. After clicking the
OK button COMPASS will re-initialize. Upon completion of the re-initialization procedure it is possible to restart
using COMPASS normally. If the error condition keeps occurring, please contact an authorized Service center.
13.3 Date and time
This page allows to set the date, time, and time zone of the system. The setting will affect the date and time
of the tablet and the main unit’s internal PC. In order to store the new setting, press the Apply button (see Fig.
67): device will request to power off in order to apply the new settings.
Fig. 67 – Configurator – DATE/TIME settings
13.4 User Role
Passwords for both the “Admin” and “Doctor” users can be changed in the “User role” tab of the Configurator
by clicking the
iCare
icon (see Fig. 68). Shutdown and restart the device to make the new passwords effective.
COMPASS User Manual - EN
Page 75 of 100
•
•
•
Always keep passwords in a safe place.
It is not possible to operate COMPASS if the passwords are lost.
If both passwords are lost, or to reset the “Admin” password, contact your Authorized
Service Center for support.
Fig. 68 – Configurator – USER ROLE tab
13.5 Exam parameters
This tab is divided in two sections.
The top section allows to choose which reliability tests to perform during Visual Field exams (see Fig. 69). All
the tests are enabled by default. For a detailed description of the reliability indices, see par. 10.2.
The bottom section allows to enable or disable the Fovea threshold measurements for Quick Suprathreshold
tests. This option is disabled by default being of little interest for a Suprathreshold test, to reduce test time.
This setting only applies to Quick Suprathreshold tests (and not to regular Suprathreshold tests).
Fig. 69 – Configurator – EXAM PARAMETERS tab
Disabling reliability tests reduces the examination time but it may also lead to less
reliable results.
The reliability tests can be configured for Visual Field exams only. In Supra Threshold exams,
instead, only FP and BS tests are performed (FN is disabled, and CC is not applicable, since
ZEST strategy is not used).
iCare
COMPASS User Manual - EN
Page 76 of 100
13.6 Remote Viewer
This tab allows to enable the Remote Viewer and configure its parameters.
To change the password used to access the Remote Viewer, type the new password and press Apply.
It is possible to select the protocol used by the Remote Viewer web server (HTTP, HTTPS, or both) or to
completely disable the Remote Viewer functionality.
Fig. 70 – Configurator - REMOTE VIEWER screen
For cybersecurity reasons, it is recommended to configure the Remote Viewer to use HTTPS.
If the HTTPS protocol is selected, a warning message like the following one might appear on
the browser when connecting. This is due to the browser not being able to verify COMPASS’
self-signed certificate but it is not a real security threat. Click on “Advanced” and then on
“Proceed to gsd-sssss (unsafe)” to access the Remote Viewer.
iCare
COMPASS User Manual - EN
Page 77 of 100
The Privacy mode checkbox allows to hide all patient names from the Patient List view of the Remote
Viewer. To find a patient, enter part of its name or code in the Search box: only the patient names that match
the search criteria are shown.
Fig. 71 - Remote Viewer's search interface if Privacy Mode is enabled
iCare
COMPASS User Manual - EN
Page 78 of 100
13.7 Network configuration
COMPASS supports either Ethernet connection or wireless connection. However, Remote Viewer, Shared
Folder export, DICOM and service access are available only through wired network connection.
The wireless connection is available only through the Control Interface and is intended only for printing and
service access.
The Ethernet port is located on the back of the system (see Fig. 2).
The Control Interface Wi-Fi should be enabled to connect the COMPASS to a wireless
network.
Click on the “Network” tab in the Configurator app to access the Network configuration window.
Fig. 72 – Configurator - NETWORK screen
The wireless network parameters are set directly using the tablet’s Android Wi-Fi Settings panel, while the
Ethernet network is configured by clicking on the
icon, near the “Wired” label.
Fig. 73 – Configurator - Network configuration screen
iCare
COMPASS User Manual - EN
Page 79 of 100
The COMPASS wired interface supports either DHCP or static profiles: to use DHCP, switch ON the DHCP
button. Otherwise, type the IP, Network Mask, Gateway, and DNS: you may need to contact your system
administrator to obtain these details.
After configuration, press OK button to store the parameters.
To switch between Ethernet and wireless connection, click on the Advanced button on the Network
configuration window (Fig. 72): the following window appears.
Fig. 74 – Primary Network settings
The window shows the current configured network interface, called active interface, and allows to select the
connection to be used as network connection. By pressing OK, the Control Interface prompts a message if the
configured interface was modified.
13.8 Backup
COMPASS allows the backup of data to a USB media or to a Network folder. The backup can be automatic
(i.e. periodically scheduled) or manual.
The backup is an incremental backup and will be saved in a subfolder called cv_backup: this means that
COMPASS will back up only the data added or modified since the last completed backup.
COMPASS supports backup to more than one device media. Moreover, the same device media can be used
as backup for different COMPASS units.
To access the Backup window, press Backup on the Configuration app. The backup configurator contains
three screens: Device, Schedule, Execute.
Although COMPASS uses Solid State Drive (SSD) technology for data storage, performing
periodic backups is critical for maintaining the safety of your data against unpredictable
hardware failures.
Manual modifications to the backup folders will damage the backup data.
Use a media formatted with the NTFS filesystem. External media formatted with different
filesystems might lead to data loss.
iCare
COMPASS User Manual - EN
Page 80 of 100
13.8.1 Device tab
This screen allows to select the device used for backup. The backup can be performed to a USB media or to
a network folder: select the desired backup device by clicking on USB or NETWORK at the top of the screen.
When all the parameters are defined for the selected device, press Apply to store the device parameters and
move to the Schedule screen.
Backup to USB
Fig. 75 – Configurator - BACKUP screen - USB-media backup selected
When the device is connected and ready for backup, the
icon changes to green.
The USB media used for backup should be formatted as NTFS, with enough free space to store the backup
file.
USB sticks are less reliable than USB disks: in case of backup to USB media, consider using
USB disks instead of USB sticks.
iCare
COMPASS User Manual - EN
Page 81 of 100
Backup to Network
Fig. 76 – Configurator - BACKUP screen - Network backup selected
The network parameters to be set are the following:
• Server: network name or IP address of the remote host.
•
Folder: name of the shared folder in the server.
•
Username: if you’re not in a Windows Domain network, this field contains the username used in the
remote server; if you’re in a Windows Domain network, the format of this field is: DOMAIN\USERNAME
•
Password: this field contains the password used by the user in the remote server
All these fields are mandatory.
Empty passwords (e.g. guest accounts) are not supported.
If a Windows-based system is used as backup destination, the Username should be different
from Guest, because of Windows Guest user restrictions.
iCare
COMPASS User Manual - EN
Page 82 of 100
13.8.2 Schedule tab
Turn ON the Automatic backup button in the Schedule tab to allow periodic backup.
At the scheduled time, COMPASS will try to contact the selected media. If the media is not ready (e.g. network
disk not available or USB not connected), COMPASS will temporarily suspend the backup procedure and will
keep retrying for one hour.
The backup will be performed regularly on the next scheduled occurrence even if the last backup attempt
failed.
Fig. 77 – Configurator – BACKUP screen – Schedule tab with automatic backup enabled
The backup will be performed starting on the date set in the Starts on field with the frequency configured in
the Execute every field.
By pressing the Apply button, COMPASS stores the backup configuration.
iCare
COMPASS User Manual - EN
Page 83 of 100
13.8.3 Execute tab
This screen shows the backup status and allows to perform a manual backup.
To perform a backup, press on the Execute button.
Once the backup has started, COMPASS can be used regularly except for the impossibility to
delete images.
Fig. 78 – Configurator - BACKUP screen - Execute tab
If a manual or automatic backup is in execution, this screen shows the progression status with an estimation
of the remaining time.
iCare
COMPASS User Manual - EN
Page 84 of 100
13.9 Restore
This feature allows to restore a backup from the selected media.
The backup to be restored can come from the same unit or from another COMPASS: the Restore window will
show a list of available backups.
To restore a database:
• Be sure that the USB media or the Network folder used as backup are available, then select the right
device in the Device tab and press Apply.
Fig. 79 – Configurator - RESTORE screen - Network folder selected
•
Click Apply: the screen shows the list of available backups in the selected media.
Fig. 80 – Configurator - RESTORE screen - List of available archives to be restored
•
•
Tap on the backup to be restored to select the backup. The screen switches to the Execute tab. Press
the Execute button: all the data contained in the backup media will be uploaded to the device.
Wait until the message “Restore completed successfully” is displayed.
The restore function will not erase the COMPASS database: patient data will be
appended.
The backup/restore system is NOT compatible with backup archives generated with versions
older than 2.2.0. So, after upgrading from a version older than 2.2.0, it is strongly advised to
perform a new full backup of the unit data right after the software upgrade in order to prevent
any loss of data in case of any unpredictable hardware failure.
iCare
COMPASS User Manual - EN
Page 85 of 100
13.10 Shared folder configuration
COMPASS exams can be exported to a network shared folder, in different formats. The Shared Folder
configuration tab in the Configurator app allows to edit the export parameters. Press Apply when the
modification process has been completed.
Status
Switch to “Enabled” to activate data export to a shared folder and configure the relevant options, including
server, destination folder, username, and password.
Mode
If the “Manual” option is selected, data is exported using the export icon located in the exam review screen
(see Par. 10.1, Table 3). If “Auto” is selected, data is exported automatically to the selected shared folder
upon acquisition and can also be exported manually.
Connection parameters
-
SERVER: network name of the remote host shall be inserted. The IP of the server may also be used
in this field if the network does not have a DNS.
-
FOLDER: this field shall contain the name of the shared folder in the server.
-
USERNAME: if you are not in a Windows Domain network, this field contains the username used in
the remote server; if you are in a Windows Domain network, the format of this field shall be:
DOMAIN\USERNAME
-
PASSWORD: this field contains the password used by the user in the remote server
Image/Visual Field Format
Select the file format desired for the export. Images can be exported in JPG, PDF or DICOM format; Visual
Field report only in PDF format.
Fig. 81 – Configurator - SHARED FOLDER configuration
iCare
COMPASS User Manual - EN
Page 86 of 100
To check the Shared Folder connection status, check the Device Status window from the Patient List or the
Patient Page interfaces (see par. 8.1).
See par. 17 for information about possible error conditions during the export process.
COMPASS Shared Folder connectivity uses SMB/CIFS protocol, up to ver. SMBv3. COMPASS
supports SMB/CIFS connection to hosts running the following operating systems: Windows 7, 8,
10, Server 2012, and Linux.
COMPASS natively stores all images using jpg compression. A 95% quality factor is used.
Exported images are identical to those stored in the device, i.e. they retain the same
resolution, quality factor and size.
iCare
COMPASS User Manual - EN
Page 87 of 100
13.11 Custom Printout Header
COMPASS report printouts can be customized with personal information: it is possible to add a custom logo
and custom text to the header.
The logo must be a JPG or PNG image, up to 1024x1024 pixels size, and must be named
custom_header_image.jpg (or .png in case of a PNG image).
The text information must be up to 5 lines and must be stored in a file named custom_header.txt.
To set the custom header, save the two files above in a USB storage device and plug it into COMPASS when
the configurator is in the Custom Printout tab: the device will recognize the presence of the above files in the
USB and it will be possible to import the new header with the button Apply header on the USB device.
If a custom header has been previously imported, the header is shown in the upper part of the screen. The
custom header can be removed from the printouts using the Remove current header button.
Fig. 82 – Configurator - CUSTOM PRINTOUT header configuration
13.12 Custom control interface setting
From the Home screen of Fig. 12 press
to enter the menu. Click on the Settings Icon to enter the menu
and select the desired standby time for the Custom Control Interface Display.
Extending the display standby time, the patient data will be more exposed to unwanted
visualization.
14.
DEVICE SHUTDOWN
To shut down the device, go back to the Home screen and press the power off icon
twice then turns off.
iCare
COMPASS User Manual - EN
: the device beeps
Page 88 of 100
15.
TECHNICAL SPECIFICATIONS
Fundus Automated Perimetry Features
Projection field:
Background luminance and color:
30° (radius)
31.4 asb, white
Maximum luminance:
10000 asb
Dynamic range:
0 - 50 dB
Stimulus size, shape and color:
Stimulus duration:
Test strategies:
Goldmann III, round, white
200 ms
ZEST
4-2
Suprathreshold testing
Quick Suprathreshold testing
Test patterns:
Fixation control:
24-2, 30-2, 10-2
25 Hz automated retinal tracking
Fundus Imaging Features
Field of view:
Sensor resolution:
Light sources:
Imaging modalities:
iCare
60° (diameter)
5 Mpixel (2592x1944)
infrared (825-870 nm) and white LED (440-650 nm)
color, infrared, red-free, stereoscopic
Resolution:
17 μm
Minimum pupil size:
3 mm
Working distance:
28 mm
COMPASS User Manual - EN
Page 89 of 100
Other features and characteristics
Class and type of applied part:
IP classification:
Class I, Type B according to the IEC 60601-1
IPX0 according to the degree of protection provided by the enclosure with respect to
harmful penetration of particulate matter or water
Automatic operation:
Automatic pupil size measurement
auto-alignment, auto-focus, auto-exposure, auto-capture
Auto-focusing adjustment range:
COMPASS Control Interface:
Connectivity:
- 12 D to + 15 D
10.1” multi-touch, color display control interface
Wi-fi and Ethernet connection
Hard disk:
SSD, 480 GB or higher
DICOM16:
DICOM support, modality worklist
Size:
Weight:
Power supply:
360 mm x 590 mm x 620 mm (14.2” x 23.2” x 24.4”)
25 kg (55 lb)
Rated voltage 100-240VAC,
Frequency 50-60 Hz
Power Consumption 80W
Service life (lifetime):
The service life (lifetime) of the devices is five (5) years from the date of
manufacturing.
COMPASS is equipped with17:
Accessories:18
•
Custom Control Interface with multi-touch display
•
Support bracket for Control Interface with mounting kit
•
External power supply with power cord
•
Forehead and chin rest silicone cushions
•
Dust cover
•
Patient push button
•
Prismatic stereoscopic goggles
•
COMPASS front lens cap
•
Light shield with magnets
•
This User Manual
•
Mini-HDMI-to-HDMI adapter
•
USB Extension cable
No Accessories
Specifications are subject to change without notice for improvement, as the result of ongoing technical development.
16
Available under additional license only: please refers to your local distributor for further and detailed information including for DICOM
Conformance Statatement
17
COMPASS is always equipped with all the device components (definition = any raw material, substance, piece, part, software, firmware,
labelling, or assembly which is intended to be included as part of the finished, packaged, and labelled device
18
Accessory = a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
iCare
COMPASS User Manual - EN
Page 90 of 100
16.
CLEANING
This paragraph explains how to clean the device.
The chinrest and the Headrest silicone cushion should be wiped with an alcohol wipe before each use and
allowed to dry prior to reuse. Painted parts of the chin rest, such as the twist grip, should not be cleaned by
means of aggressive solutions.
Fig. 83 - Removal of the chin rest silicone pad
Gently pull up and slide the chin rest pad to avoid breaking the retaining peg.
The front lens should be cleaned using a small hand pump air blower, to blow away dust. Only if really needed,
for instance due to the presence of a fingerprint, the objective lens can be cleaned by means of photographic
cleaning paper and a suitable lens cleaning fluid.
The tablet display should be cleaned only with a cloth damped in water.
When cleaning the rest of the device, the device must be off, and the power cord should be disconnected from
mains. If needed, the external covers of the unit can be cleaned using a slightly damp cloth.
iCare
COMPASS User Manual - EN
Page 91 of 100
17.
TROUBLESHOOTING
Symptom
1.
Possible cause(s)
COMPASS does not power on (no
COMPASS is not powered
green LED)
System keeps failing alignment with
message “Eye not found”
3. Message "Disconnected: machine
turned off or not responding" appears
when trying to access the instrument
4. Message "Disconnected: cable not
connected" appears when trying to
access the instrument
5. Message "Disconnected: tethering not
enabled" appears when trying to
access the instrument
6. Bluish artifacts as in this example
appear in all newly acquired images
2.
Solution
Plug the power supply into a
properly working socket then
press the power button for at
least 3 seconds
Front lens cap is in place
Remove front lens cap
COMPASS is off
Turn COMPASS on and login
again
USB cable is disconnected from Connect USB cable and login
tablet and/or from device
again
Login was made with “Admin”
Enable tethering or switch to
user and tethering was not
“Doc” user and login again
enabled
Front lens is dirty
Clean the front lens (see par.
16)
Patient blinked during image Repeat capture and ask
capture
patient not to blink
See par. 12.5 to reset the lock
8. System is not usable with message Malfunction of the rotating
condition. If the condition
“internal error: device temporarily mirror or of the infrared LED
occurs frequently, contact
locked”
board for pupil illumination
authorized service center
Use the wall charger found in
Tablet is fully discharged and the components box to
9. Tablet does not turn on and does not
current from device is not charge the tablet for at least
recharge
sufficient to initiate recharge
one hour, then connect it
normally to the system
7.
Captured image is totally white
iCare
COMPASS User Manual - EN
Page 92 of 100
Symptom
Possible cause(s)
Solution
Pupil is too small (< 3.0 mm)
Dark adapt or dilate patient’s
pupils.
10. One or more dark areas appear in
color and/or IR pictures
11. The fixation target appears decentered approx. 3 degrees to the
left/right
12. Export to the remote shared folder
fails with message “The selected host
is not reachable” or “Timeout”
13. Export to the remote shared folder
fails with message “Unknown error”
14. Export to the remote shared folder
fails with message “The shared disk is
full.”
15. The system reports the message
“Unable to get feedback from
stimulus” (Code 227)
iCare
This is normal and is due to the
asymmetric shape of the “24-2”
grid, which extends to the
temporal peripheral area. To
project stimuli in the extreme
This condition is normal.
positions, the fixation target is
shifted 3 degrees right when
testing OD and left when testing
OS. The same happens for any
other test grid.
• Check that the network
cable is correctly plugged
• Network connection to the
remote shared folder not • Check that the local area
working
network is available
• Write access to the • Check that the remote
selected remote folder not
folder is shared with write
granted
permissions
host computer is not • Check that the computer
reachable
hosting the shared folder
is reachable
The remote export folder was
Re-configure the export
renamed after the export
destination
destination was configured
Empty some space on the
The computer hosting the
host computer or change the
shared folder has a full hard
export destination to another
disk
computer
The stimulus position check
failed.
COMPASS User Manual - EN
Contact an Authorized
Service representative.
Page 93 of 100
17.1 REMOTE ASSISTANCE
If an issue cannot be solved with the basic troubleshooting, please contact an Authorized Service
representative explaining the problem.
The Service technician might require a remote connection to the unit to perform a thorough analysis:
COMPASS includes a Remote Assistance feature by means of a separate application called “Service”.
Remote Assistance allows authorized service technicians to connect to the COMPASS.
Establishing a Remote Assistance session will authorize the remote access to the unit, including
access to images, patient-related information, and device logs.
Remote access is temporary and will expire when the connection is closed or when the device
is shut down.
Remote Assistance requires the unit to be connected to the Internet
The following steps should be performed to establish a Remote Assistance session:
• Press the “back” icon at the bottom of the screen to go to the Home screen
• Press the logout icon.
• Select user “Admin” from the drop down menu.
• Type the corresponding password and click Login.
• Enable Tethering by clicking its icon on the top bar:
Tethering OFF
Tethering ON
Tethering enabled notification
•
Click the App icon:
•
Start the Service application and toggle the Remote Assistance button to “ON”:
•
Provide “PORT” and “PASSWORD” numbers to the Authorized Service personnel to allow them to
connect remotely to the unit.
iCare
COMPASS User Manual - EN
Page 94 of 100
18.
MAINTENANCE
The Manufacturer recommends the periodic maintenance of the components listed in the following table.
Only properly qualified Authorized Service Technicians can perform calibration activities. Contact your local
Authorized Distributor or Service Center if you think your COMPASS requires calibration.
ACCEPTANCE
CRITERIA
TEST
FREQUENCY
Press the Patient
Push Button at least
10 times, moving the
cable, once every 2
seconds.
A beep can be heard
anytime the button is
pressed
Before
performing any
test
Patient Push Button is
not working, and no
patient response is
detected. Test results
are
affected.
Check proper insertion
of the Patient Push
Button connector in the
COMPASS
unit.
If connection is OK and
the problem persists,
contact
Technical
Support.
Front lens
Visual check of front
lens external surface.
No presence of dust or
stains detected
Daily
Image
quality
is
adversely
affected.
Clean the lens as
explained at section 16
of this Manual.
Patient data
Backup the patient
database
on
an
external USB media.
The backup procedure
completes
successfully.
Weekly
External media could
be corrupted (use a
different media) or USB
connection is faulty. If
problem
persists,
contact
Technical
Support.
TEST ITEM
TEST DESCRIPTION
Patient Push
Button
iCare
COMPASS User Manual - EN
IN CASE OF FAILURE
Page 95 of 100
19.
ELECTROMAGNETIC COMPATIBILITY
COMPASS Devices have been tested and found to comply with the limits for medical devices contained in IEC
60601-1-2 and Medical Device Directive 93/42/EEC. These limits are intended to provide reasonable
protection against harmful interference in a typical medical installation. COMPASS Devices generates, uses
and can radiate radio frequency energies and, if not installed and used in accordance with these instructions,
may cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If the COMPASS Devices does cause harmful interference
to other devices, which can be determined by turning the COMPASS Devices off and on, try to eliminate the
interference by adopting one or more of the following measures:
• Reorient and/or relocate the receiving device.
• Increase the distance between the devices.
• Connect the system to an outlet on a different circuit than that to which the other devices are
connected.
• Contact the Manufacturer or field service technician for help.
COMPASS Devices need 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 these COMPASS Devices.
19.1 Manufacturers EMC Declaration to IEC 60601-1-2
The following tables provide specific information regarding compliance of COMPASS Devices
COMPASS Device is intended for use in the electromagnetic environment specified in the below
tables. The customer or the end-user of COMPASS Device should ensure that it is used in such
an environment. Other cables and accessories not provided with the devices may negatively
affect EMC performance.
IEC 60601-1-2 EMISSION TEST for COMPASS models
Test Result
Compliance
Electromagnetic environment - Guidance
B
Yes
COMPASS uses RF energy for its internal
function. Therefore, its RF emissions are very low
1
Yes
and not likely to cause any interference in nearby
CISPR 11
Yes
electronic equipment.
CISPR 11
Conducted RF emissions
Yes
COMPASS is suitable for use in all establishments,
Class B
including domestic and those directly connected to
CISPR 11
Radiated RF emissions
Yes
the public low-voltage supply network that supplies
Class B
buildings used for domestic purposes, providing
Disturbance Power (if applicable)
N/A
N/A
the following warning is heeded:
Harmonic Distortion IEC 61000-3-2
Class A
Yes
(Class A, B, C, D)
COMPASS is intended for use by healthcare
professionals only. COMPASS may cause radio
interference or may disrupt the operation of nearby
Voltage Fluctuations and Flicker
Passed
Yes
equipment. It may be necessary to take mitigation
IEC61000-3-3
measures, such as re-orientating or re-locating
COMPASS or shielding the location.
Test Requirements
Class A or B
Group
CISPR 11, 14-1, 32 or ISO 7137
Table 5 - Electromagnetic Emissions for COMPASS models
iCare
COMPASS User Manual - EN
Page 96 of 100
19.2 Guidance and manufacturers declaration – Electromagnetic Immunity COMPASS devices
IEC 60601-1-2 ELECTROMAGNETIC IMMUNITY FOR COMPASS devices
Compliance
Electrostatic Discharges
Passed
Yes
Radiated RF EM Fields
Professional Healthcare
and Proximity Wireless field
Facility Environment
Yes
(IEC 60601-1-2)
Electrical Fast Transients and bursts
Passed
Yes
Surges Conducted Disturbances,
Passed
Yes
induced by RF fields
Voltage Dips and Interruptions
Passed
Yes
Rated Power-frequency Magnetic Field
Passed
Yes
Table 6 - Electromagnetic Immunity (IEC 60601-1-2:2014) for COMPASS Devices
19.3 Immunity pass criteria
IMMUNITY
Function
System functioning – main unit
System functioning – connection between
Control Interface and main unit
IMMUNITY pass criteria
During the applied testing stimulus, temporary cessation or
interruption of any intended operation is acceptable
During the applied testing stimulus, temporary cessation or
interruption of any intended operation is acceptable
Table 7 - Electromagnetic Immunity (IEC 60601-1-2)
COMPASS devices are intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the end-user of COMPASS devices can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and COMPASS devices as recommended below, according to the maximum output power of
the communications equipment.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the COMPASS devices, including cables
specified by the Manufacturer. Otherwise, degradation of the performance of this equipment could result.
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800MHz to 2.5 GHz
d = 1.17√P
d = 1.17√P
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 transmitter, where P is the maximum power rating
of the transmitter in (W) according to the transmitter manufacturer.
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.
Rated maximum output power of
transmitter
Table 8 - Recommended Separation Distances
iCare
COMPASS User Manual - EN
Page 97 of 100
Wi-Fi Specifications
19.4
Model name:
WL18MODGI (Texas Instruments Incorporated)
Main Chipset:
WL1807MODGIMOC (Texas Instruments Incorporated)
Tx/Rx:
Standard
Conformance:
Interface:
Operation Voltage:
Maximum RF
Power:
Security:
20- and 40-MHz SISO
IEEE 802.11 b/g/n
IEEE 802.11 a/n
Dual-Band (2.4 and 5 GHz)
4-Bit SDIO Host Interface Support
DC 1.8V ±8%
According to EMF Exposure Evaluation Report:
2.4GHz Avg power: 17.5dbm (56.2mW)
5GHz Avg power: 19.5dbm (89.1mW)
Hardware-based encryption-decryption using 64-, 128-, and 256-bit WEP, TKIP,
or AES keys
Requirements for Wi-Fi-protected access (WPA and WPA2.0) and IEEE Std
802.11i (includes hardware-accelerated Advanced Encryption Standard AES)
FCC (USA) radio certification
The COMPASS devices contain a radio module that complies with regulations of the USA and Canada.
FCC ID: ID-Z64-WL18DBMOD
IC ID:
451I- WL18DBMOD
These devices comply with part 15 of the FCC rules. 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) this device may not cause harmful interference, and (2)
this device must accept any interference received, including interference that may cause undesired operation.
iCare
COMPASS User Manual - EN
Page 98 of 100
20.
DISPOSAL
This device is made of different materials, such as plastics, aluminum, electronic parts. In case of instrument
disposal, please separate the various materials and follow the laws and regulations regarding disposal or
recycling for each material effective in your own Country.
Separate collection for electrical and electronic equipment
The European Directive 2012/19/EU establishes separate collection for Waste Electrical and Electronic
Equipment (WEEE). Users of Electrical and Electronic Equipment (EEE) must not dispose of WEEE as
unsorted municipal waste but collect such WEEE separately. The available return and collection system is
defined by the local public administration, or alternatively an authorized company can recycle the WEEE.
Please refer to public administration about separate collection; if this information is not available, 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 of humans, it affects the endocrine system, the cardiovascular system,
and kidneys. It accumulates and is very toxic for animals, plants, and micro-organisms.
Cadmium: accumulates with a half-life of 30 years and can damage the kidneys and cause cancer.
Mercury: is easily accumulated in organisms and concentrates through the food chain. It has chronic effects
and can cause brain damage. Chromium (Hexavalent): easily absorbed into cells with toxic effects. The results
can be allergic reactions, asthma, and it is genotoxic (damages the DNA). Especially dangerous when
incinerated.
Brominated Flame Retardants: widely used to reduce flammability (e.g. cables, connectors, and plastic cases).
iCare
COMPASS User Manual - EN
Page 99 of 100
CenterVue S.p.A.
Via San Marco 9h, 35129 Padova – ITALY
Ph.: +39 049 5018399
Fax: +39 049 5018398
[email protected]
www.icare-world.com
iCare is a registered trademark of iCARE FINLAND OY. CENTERVUE S.P.A., iCARE FINLAND OY and iCARE
USA INC. are parts of REVENIO GROUP and represent the brand iCare.
iCare
COMPASS User Manual - EN
Page 100 of 100
">