iCare COMPASS Perimeters and Microperimeter User Manual

COMPASS
Instructions for Use
DOCUMENT INFORMATION
The information in this instruction for use is subject to change without prior notice and it is correct at
revision date. Device configuration can change as products improvements are incorporated and this
instruction for use may not exactly depict your device: please contact the local distributor if you have
any questions about differences.
The original language of this instructions for use is English. Should a conflict situation arise
concerning a translated document, the English language version shall prevail.
Please refer to §23 for information on the Software versions these Instructions For Use refers to.
Date of release:
Revision number:
Software Version:
Reference device:
April 3rd, 2024
24
4.0
COMPASS (REF: AMGSDME001)
Copyright © 2023 CENTERVUE S.P.A. All rights reserved.
CENTERVUE S.P.A.
Via San Marco 9h, 35129 Padova – ITALY
www.icare-world.com
CONTENTS
1.
INTRODUCTION ....................................................................................................................................... 4
2.
OVERVIEW................................................................................................................................................ 8
3.
COMPASS ................................................................................................................................................. 9
4.
LABELS, SYMBOLS AND DEFINITIONS ............................................................................................... 11
5.
SAFETY INFORMATION ......................................................................................................................... 15
6.
FIRST USAGE ......................................................................................................................................... 19
7.
PREPARING THE PATIENT ................................................................................................................... 24
8.
OPTIONAL FEATURES AVAILABLE UNDER LICENSE ....................................................................... 25
9.
DICOM SUPPORT .................................................................................................................................. 25
10. PATIENT LIST AND PATIENT RECORD ............................................................................................... 26
11. PERFORMING THE EXAM ..................................................................................................................... 33
12. REVIEWING RESULTS ........................................................................................................................... 47
13. REMOTE VIEWER .................................................................................................................................. 59
14. PRINTING ................................................................................................................................................ 69
15. SETTINGS ............................................................................................................................................... 93
16. DEVICE SHUTDOWN ........................................................................................................................... 107
17. TECHNICAL SPECIFICATIONS ........................................................................................................... 108
18. CLEANING AND DISINFECTION ......................................................................................................... 110
19. TROUBLESHOOTING ........................................................................................................................... 111
20. MAINTENANCE ..................................................................................................................................... 114
21. ELECTROMAGNETIC COMPATIBILITY .............................................................................................. 115
22. DISPOSAL ............................................................................................................................................. 118
23. LOG OF DOCUMENT CHANGES ........................................................................................................ 119
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1.
INTRODUCTION
1.1
Intended purpose
COMPASS is a peripheral vision analyser, intended for measuring retinal sensitivity, fixation stability and locus
fixation as well as for the acquisition of retinal images with or without1 a mydriatic agent and for their review.
1.2
Indications for Use
COMPASS is indicated to perform Visual Field tests to measure retinal sensitivity, and to provide retinal images
used for diagnosis and monitoring of several retinal pathologies.
There are no surgical or treatment decisions made solely on retinal images and results obtained by the device.
The clinical interpretation of the exams acquired with COMPASS is restricted to eyecare professionals with
training in the ophthalmology field (or equivalent) that hold the responsibility of the diagnosis.
1.3
Indications for use (for FDA only)
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
Clinical benefit
COMPASS does not claim any clinical benefits, i.e. a positive impact on the health of an individual, expressed
in terms of a meaningful, measurable, patient-relevant clinical outcome, as it does not provide any diagnostic
outcome but provide information for the diagnosis only.
The performance of COMPASS expressed as the ability of the device to achieve its intended purpose is to
measure retinal sensitivity and to capture, display and store images to aid in the diagnosis and monitoring of
diseases and disorders occurring in the retina.
1.5
Contraindications
No contraindications and side-effects have been found for fundus perimetry. No contraindications nor sideeffects have been found for fundus photography. There exist rare and discomforts limited in their timespan, as
temporary glare, watery eyes, during and/or during and after performing the exam.
1.6
Ophthalmic Devices Compliance
COMPASS is fully compliant with ISO 15004-1:2020 and ISO 12866:1999 /AMD:2008.
1.7
Optical Safety
According to ISO 15004-2:2007 and ANSI Z80.36, COMPASS is classified as: Group 1 - Ophthalmic
instruments for which no potential light hazard exists.
1
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.
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1.8
RoHS Compliance
The product is RoHS-compliant according to Directive 2011/65/EU and to Directive 2015/863/EU.
1.9
Electrical Safety
The product is compliant with IEC 60601-1:2005+AMD1:2012+AMD2:2020.
The device is classified as Class II, type B applied part.
1.10 Reporting Serious Incidents (only for EU)
Report any serious incident related to the device, the operator, the patient, or anyone else to CENTERVUE
S.P.A. and to the Competent Authority of the Country/State in which the user and/or patient is established.
1.11 Essential Performance
The clinical performance of COMPASS is to measure retinal sensitivity and to capture, display and store
images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina.
Since there are no surgical or treatment decisions made solely on data obtained by the device, it was
determined that COMPASS does not provide Essential Performance as defined in the IEC 60601-1 standard.
1.12 Use Environment
COMPASS is intended for use in professional healthcare facility environment:
- Ophthalmic & Optometrist Offices
- Ophthalmology Clinics
- Hospitals
- Research laboratories
- Medical offices
The device is suitable for use in domestic and home healthcare environment. Consult complete information
about electromagnetic environment requirements in section §0 of this Instruction for Use.
1.13 Patient Profile
The execution of a Visual Field test requires active interaction between the device and the patient, via the
dedicated push-button.
Consequently, COMPASS can be used by clinicians on any adult person that:
- is able to remain seated, with the forehead placed on the forehead rest, alone or with the aid of another
person;
- has the psychophysical capabilities to understand how the exam works and accomplish the tasks required
by the test, i.e. staring at the fixation target and pressing the dedicated pushbutton whenever the subject
is able to detect a circular luminous stimulus.
The decision to use COMPASS on a vulnerable patient is under the responsibility of the eye care practitioner.
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1.14 Intended users
The primary intended users of COMPASS device is healthcare professionals.
The device is not intended for lay users.
Patient’s interaction with the device is limited to clicking on the patient response button following clinician’s
instructions.
Three different user profiles (Roles) are defined in COMPASS:
ROLE and User profile
Operator user (Healthcare
professionals)
Context of use
Characteristics
Operating as per the medical
intended purpose: Image
acquisition and review
Demographic trait: Healthcare professional
with training in ophthalmology or equivalent:
Opticians
Ophthalmic photographers
Optometrists
Ophthalmologists
Clinical researchers
Medical assistants.
Cleaning and disinfection
Troubleshooting
Admin User
Patient
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Configuration and
set up
Operating as per the medical
intend purpose: press the
pushbutton whenever he/she
perceives a luminous stimulus
during the visual field test
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Required knowledge, skills and abilities:
Experience with using medical
imaging system that have an
embedded computer and software
user interface
Basic computer knowledge
Qualified and experienced personnel,
familiarized with the contents of the
Instruction for Use.
Demographic trait:
System administrator.
Required knowledge, skills and abilities:
Experience with desktop-based
camera
Knowledge of operating systems, IT
network,
user
administration,
backup management
Qualified and experienced personnel,
familiarized with the contents of the
Instruction for Use.
Adult subject having the psycho-physical
capabilities to undergo the eye test following
the operator’s instruction for the duration of
the exam.
The decision to use COMPASS on a
vulnerable patient is under the responsibility
of the eye care practitioner.
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1.15 Principles of operation
The device achieves its intended purpose by projecting light stimuli of different intensities together with a
uniform light background and recording the pressures of the pushbutton by the tested patient when he detects
such stimuli, as in standard Visual Field tests. It also acquires confocal retinal images illuminating the retina of
the patient’s eye, with visible light for imaging purposes and with infrared light for imaging purposes, focusing
and retinal tracking.
1.16 Temperature of applied parts
The applied parts of the devices are the forehead rest and the chin rest. When the device is operated at the
upper limit of its operating temperature range (i.e. close to 40°C/104 °F), the temperature of these parts can,
in extreme conditions, reach 46°C/115°C. It is recommended to not exceed the maximum intended duration of
contact of 10 minutes between these parts and the patient skin. It is recommended to advise the patients to
report to you any possible temperature-related discomfort he/she may perceive.
1.17 Content of the device packaging
The device is provided with:
Custom Control Interface with multi-touch display
Prismatic stereoscopic goggles
Support bracket for Control Interface with mounting kit
COMPASS front lens cap
External power supply with power cord
Light shield with magnets
Forehead and chin rest silicone cushions
This Instruction for Use (or Leaflet, in case of
electronic Instruction for Use)
Dust cover
Mini-HDMI-to-HDMI adapter
Patient Push button
USB Extension cable
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2.
OVERVIEW
Congratulations for choosing COMPASS and its fundus perimetry and confocal retinal imaging capabilities.
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 perimeter 2 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, ZEST Fast).
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.
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.
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.
2
ISO 12866: 1999 Ophthalmic instruments — Perimeters
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3.
COMPASS
3.1
Device description
Headrest =
contacting part
Chin rest =
contacting part
COMPASS Custom
Control Interface with
multi-touch display
Patient Side
Fig. 1 – COMPASS
The main parts3 of COMPASS consist of:
• COMPASS Custom Control Interface with multi-touch display
• 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, see the section “Content of the device packaging” of this Instruction
for Use.
4
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 Push Button is a device component, manufactured by CENTERVUE S.P.A.
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Fig. 3 – Patient Push Button (contacting part)
3.2
The COMPASS Custom Control Interface
The COMPASS Custom Control Interface with color multi-touch display (see Fig. 4) is an integral part of the
device and COMPASS cannot operate without it.
The COMPASS Custom Control Interface must be connected to COMPASS using the supplied cable6: if the
connection is not working an error message will appear on the screen (see § 19 for details). The Mini-HDMIto-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 COMPASS Custom
Control Interface
Fig. 4 – COMPASS Custom Control Interface
with multi-touch display supplied
with each COMPASS
The COMPASS Custom Control Interface with multi-touch display must be used only together
with COMPASS and in accordance with the instructions provided in this Instruction for Use.
Use of the COMPASS Custom Control Interface for other purposes than the one intended by
the Manufacturer, as well as any modifications or misuses are exclusively under end-user
responsibility.
To protect your device against unauthorized access and manipulation, make sure that only
authorized personnel have physical access to the device
6
The COMPASS Custom Control Interface with multi-touch display is equipped with a custom cable permanently connected to it.
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4.
LABELS, SYMBOLS AND DEFINITIONS
4.1
Labels
Device information such as device identifier (REF), serial number, manufacturing date and UDI barcode are
reported in the labels fixed on the right 7 side of each device as shown in the following figure. Please do not
remove them.
Serial number
Prod. date
UDI barcode
Fig. 5 – Device and warning labels8
7
Right and left sides are determined considering patient’s point of view during exam.
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.
8
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4.2
Symbols used on the device
The meaning of the symbols adopted in the device label is as follows:
Symbol
Explanation
Information about the Manufacturer.
Manufacturing date (YYYY-MM).
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.
Class II device, according to IEC 60601-1.
Please refer to the eIFU.
This instructions for use must be read.
Read this instruction for use before starting work or before operating
equipment or machinery.
CE mark: the device complies with the general safety and performance
requirements of the Regulation (EU) 2017/745. CE mark is followed by
Notified Body identifier.
Type B Applied Part.
Non-ionizing radiation - ME EQUIPMENT that includes RF transmitters.
Device consumption.
Power supply.
Warning, closing motion of mechanical parts of equipment.
Take care to avoid injury to hands.
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4.3
Other symbols found on the device packaging
The meaning of the symbols adopted on the device packaging is as follows:
Symbol
Explanation
Information about the Manufacturer.
Fragile. Handle with care.
Kilogram stacking limit because of the nature of the device package.
The acceptable maximum relative humidity for storage and transport.
The maximum and minimum temperatures limits for storage and transport.
Correct upright position of the transport package.
Device package shall be kept away from rain and be kept in dry conditions.
4.4
Other symbols found in this Instruction for Use
The meaning of the additional symbols adopted in this Instruction for Use is as follows:
Symbol
Explanation
Important Information.
General Warning, read carefully.
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4.5
Definitions
The meaning of the specific words adopted in this Instruction for Use 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 Instruction for Use.
Any Visual Field or Fundus acquisition session performed using the
Exam
COMPASS device for a certain patient on a certain date. In this instru, 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.
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).
IFU
Acronym of Instruction for Use
Operator
COMPASS device’ 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 these
Picture
Instructions for Use.
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 device.
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 not required: it is
recommended for the end user (operator) to carefully read this Instruction for Use 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.
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5.
SAFETY INFORMATION
Although great care and diligence has been taken during the design and development of this
device to reduce as far as possible all risks related to the use of the devices, it is important to read
and understand the following precautions to further mitigate all residual risks.
The following precautions are important to use the device in safety:
• The device is for professional use only.
• The device needs to be installed and put into service by Authorized Service Center.
• Do not use COMPASS device 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 device: this could lead to electric shocks or damage to the device.
• No serviceable parts inside. Internal inspection is allowed to authorized personnel only.
• Closing motion of mechanical parts of equipment, take care to avoid injury to hands and finger.
• Do not use the device when there are visible signs of materials degradation.
• COMPASS device is supplied with an earth ground by means of a protection conductor
contained inside the power supply cable. Before turning on the system, make sure the power
supply socket is correctly grounded to avoid the risk of electric shock.
• COMPASS device power supply must be connected to a socket with a circuit breaker.
• The use of other cables and accessories on COMPASS device than ones provided by the
Manufacturer may negatively affect EMC performances.
• COMPASS power supply must be connected to a socket with a circuit breaker.
• The use of other cables and accessories on COMPASS than ones provided by CENTERVUE
S.P.A., may negatively affect EMC performances.
• Power cable shall be properly maintained during use. In case of damage, contact
CENTERVUE S.P.A. for the replacement.
• It is recommended to power off the device according to instructions of section §16; removing
the power cable could result in data loss.
• External device/s connected to COMPASS device, 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 device must be used in a room with an electrical system that complies with
applicable healthcare environment safety regulations.
• COMPASS device must NOT be used in an oxygen-rich environment or presence of
flammable anaesthetics.
• COMPASS device 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 device needs 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 Push Button (see Fig. 3).
• COMPASS device 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 device 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
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•
•
•
•
•
•
Applied parts surface temperature (i.e. head and chin rests) can exceed the value of
41°C/105°F (i.e. maximum 46°C/115°F) when the device is operated at the upper limit of its
use temperature range. Touch time of applied parts when the device is operated is < 10 min.
Only technicians authorized by the CENTERVUE S.P.A. may service COMPASS device. The
Manufacturer cannot be held responsible for the device safety should COMPASS device 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. 6) and the device may become temporarily locked. It is possible to reset
this condition by letting the device re-initialize: refer to §15.2 for the complete procedure. If the
error persists, please contact an Authorized Service Center.
Risks can arise in relation to the biological contamination caused by the environment the
device is operated into, and by the user and the patients. Follow the cleaning and disinfection
instructions provided below in this Instruction for Use.
The device is not supplied sterile, nor is intended to be sterilized prior or after use;
nevertheless, the risks connected to the biocompatibility of the parts that come into contact
with the patient are in relation to severe consequences, including allergic reactions. Contact
material used in COMPASS is biocompatible and safe for the contact with intact skin for limited
exposure.
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 device results is
the responsibility of the eye care practitioner.
• Device-specific training is not required: it is recommended for the end-user (operator) to
carefully read this Instruction for Use to be informed 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 § 7.
• The minimum pupil diameter required to obtain good quality images is 3.0 mm.
• COMPASS device works 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.
Fig. 6 – Example of error message
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5.1
Security Information
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.
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•
When in operation, COMPASS device contains Personal Data. Transferring data via
USB ports (USB export) or via Ethernet (Shared Remote Folder) may result in
compromised patient privacy.
•
It is the end user’s responsibility to keep and maintain an updated copy of the data
generated by COMPASS device through regular use of the backup facility, thus
preventing the risk of accidental loss of data.
•
To protect your device against unauthorized access and manipulation, make sure that
only authorized personnel have physical access to the device.
•
The COMPASS 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.
•
The 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).
•
Connecting the device increases its vulnerability to security risks that could disable
your system. The Responsible Organization should maintain proper IT security
practices like up-to-date virus protection, firewall and data protection in the systems
where the device is used.
•
When setting your credentials in the device and in any connected PC/Laptop/server, 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;
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o
o
o
o
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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;
installing security patches and updates in a timely manner;
protect access to your Windows account with a strong password (see
indication above);
log off or power off when leaving your computer unattended.
•
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.
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6.
FIRST USAGE
6.1 Preparation of the device
We recommend reading carefully and thoroughly §5 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 table9;
• insert the Headrest silicone cushion on the metal support (see Fig. 7);
• mount the support bracket provided for the COMPASS Custom Control Interface (see §6.2 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. 7 - Headrest silicone cushion mounted on metal support
6.2 Assembling the tablet support bracket
Fasten the COMPASS Custom Control Interface to its support bracket using the two dedicated screws.
As an example, Fig. 10 shows the holes to be used for the left-side mount depicted in Fig. 8: to fix the support
bracket use holes marked 1 and 2. Other configurations can be chosen, based on the user’s preferences.
Fig. 8 – COMPASS Custom Control Interface mounted on the left side of the device
9
Not provided with the device. For a list of all components included with COMPASS, see the section “Content of the device packaging”
of this Instruction for Use.
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Fig. 9 – COMPASS Control Interface support bracket
Fig. 10 – 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 10 to make one of the USB ports readily
accessible.
6.3 Removing the front lens cap
Unscrew the device’s front lens cap to remove it, before turning on the device.
10
It is provided with the device. For a list of all components included with COMPASS, see the section “Content of the device packaging”
of this Instruction for Use.
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6.4 Attaching the Magnetic Light Shield
The Magnetic Light Shield is a device component11 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. 11).
Fig. 11 – Magnetic Light Shield mounted on COMPASS
11
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.
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6.5 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. 12).
During the power-on, the LED Power Status performs a red/green/blue cycle to test its LEDs functioning.
After two second LED Power Status turns off, then becomes steady green. The device is turned on.
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. 12 – Login screen
The
button on the top allows to display the electronic Instruction for Use (this Instruction for Use) with
the internal PDF viewer. Pressing the button will display a list of this Instruction for Use translated in all the
languages supported: select the most suitable for your Country to open it.
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 (§ 11) and review exams (§ 12).
- Admin User have the access to the Doctor User function and the device’s setting (§ 15).
Type the password12 and click on Login button. If login is successful, the Home screen opens (see Fig. 12).
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 §15.4.
To modify the standby time, please see §15.12
12
Please ask an Authorized iCare representative for the factory password
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Fig. 13 - Home screen
6.6 Unlock function
When unlock button appears insert password to exit the standby to come back to the latest used page.
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7.
PREPARING THE PATIENT
This paragraph explains how to prepare a patient for the COMPASS exam (in this Instruction for Use is used
as “test”).
COMPASS is a non-mydriatic device12: 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.
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.
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 with the eye mark found
on the sides of the metal frame (see Fig. 14). If this is not the case the chin rest height
needs to be adjusted with the on-screen controls (see § 11.11)
Fig. 14 - Sketch of the eye mark on the metal frame
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.
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8.
OPTIONAL FEATURES AVAILABLE UNDER LICENSE
The following optional features of COMPASS’ software can be enabled by purchasing and installing a
dedicated license13.:
9.
-
Full DICOM communication (MWL and PACS): see also § 9
-
Additional concurrent Clients for the Remote Viewer, for units manufactured with a SW version equal
to or later than 4.0: for more details see § 13
-
SmartMosaic (mosaic of 3 Fundus images): see § 11.14
-
LDAP (Lightwight Directory Access Protocol) support: refer to the COMPASS LDAP User Manual
-
OPI (Open Perimetry Interface): refer to the COMPASS OPI User Manual.
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 14. For info about how to use COMPASS with
DICOM, refer to the COMPASS DICOM Operating Manual.
DICOM support is available only for wired connections.
DICOM communication and LDAP support licenses are not compatible: it is not possible to
install both licenses on the same device.
13
14
Contact your local distributor for information about how to purchase and install any of the above software features.
Ask to your local distributor for purchasing a DICOM license, and for the COMPASS DICOM manual and Conformance Statement.
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10.
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.
15).
Fig. 15 – 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 patient's gender
• the date of the last exam performed
• a button that allows to start a new exam for that patient directly from the Patient List
The following functions and commands are available in the Patient List screen:
• access the Information Center screen (see § 10.1)
• refresh the Patient List
• adding a new patient (see § 10.2)
• deleting a patient (see § 10.3)
• searching for an existing patient (see § 10.4)
• selecting an existing patient (see § 10.5)
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10.1 Information Center
The Information Center 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 five tabs: Backup, Shared folder, Data Storage, Data Security and About.
Each tab title could display a red badge indicating the number of unread notifications related to that tab.
Backup tab
From the Backup tab, it is possible to check the backup progression status, stop a running backup or start a
manual backup. This screen also includes information on the last backup performed, with its status (completed,
cancelled, failed with reason explanation). For more information on Backup, see § 15.8.
Fig. 16 – Information Center screen – Backup status
Shared Folder tab
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 § 15.10. See § 19 for information about
possible error conditions during the export process.
Fig. 17 – Information Center screen – Shared folder status
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Data Storage tab
The Data Storage tab contains information about the capacity and the amount of space available of the internal
data storage, and detects whether the installed storage media (both the memory module for the operating
system and the disk for the exam data) are genuine parts authorized by the Manufacturer.
In case of storage media failure, it is recommended to replace it with a genuine part authorized
by the Manufacturer, to ensure its compatibility and reliability.
Contact your Authorized Service Center in case you need to replace the storage media.
Fig. 18 – Information Center screen – Data Storage tab
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Data Security tab
The Data Security tab lists any unsecure settings detected in the device configuration, and suggests how to
solve them.
Unlike what happens with the other tabs, the notifications displayed on the Data Security tab title badge are
permanent and are not dismissed after being read: the only way to make them disappear is to solve the
detected security threats.
Fig. 19 - Information Center screen - Data Security Center tab, 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 § 15.6), which prevents man-in-the-middle attacks.
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About tab
The About tab contains information about the software release version installed.
It also contains the
button that allows to open the electronic Instruction for Use (this Instruction for Use),
similarly to the Login page (see Fig. 12).
Press the More button to display information on the unit serial number, the device configuration, the status of
optional licenses installed (see § 8) and the maximum number clients that can connect simultaneously to the
Remote Viewer (see § 13 for more details).
Fig. 20 – Information Center screen – About tab expanded
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10.2 Adding a new patient
To create a record for a new patient, click on
and the Patient Editing screen will open (see Fig. 21).
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.
Fig. 21 – Patient editing screen
10.3 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. 22)
and confirm to delete it.
10.4 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
.
10.5 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.
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Once a patient has been selected in any of the above ways, the Patient Record screen opens (see Fig. 22)
and provides information on the selected patient, whose name is shown at the top-left corner of the screen.
Press the
icon next to the patient’s name to edit the patient’s details.
On the left side of the screen the Visit List is present, displaying the exams grouped by visit (i.e., by date).
Select any visit to access the exams taken on that date.
On the central part of the screen the exams taken on the selected visit are listed: the list can be scrolled by
dragging it. Click on the desired exam to review it.
Press the Select button or long-press any exam to select multiple exams to delete or export: a checkbox will
appear next to each exam of the current visit to allow to add or remove the exam to the selection; then, press
the
button to export the selected exams or the
button and confirm to delete them. If no exam is
selected, press the
button and confirm to delete the entire patient.
On the right side of the screen the sequences of Visual Field exams are displayed, grouped by eye and by
grid used. Click on a sequence to expand it as in Fig. 23: this will display a scrollable list containing all the
exams included in the sequence, and a button to start a new Follow-up exam to be added to the sequence.
See § 12 for full details on how to review an exam. Click on the New Exam button to initiate a new Root test
(see § 11.1 for details).
Fig. 22 – Patient Record screen
Fig. 23 – Exam sequence expanded
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11.
PERFORMING THE EXAM
This paragraph explains how to operate COMPASS to perform the test (in this instruction for use the terms
“test” and “exam” are used as synonyms).
11.1 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, ZEST and ZEST Fast
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. 33), 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
• an exam sequence (composed of a root test and its related follow-up tests) is
identified by this graphics, displaying the grid used and the dates of the first and last
exam of the sequence:
• 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
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11.2 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 Exam Mode
selector.
Then, select the desired projection strategy using the Visual Field Strategy selector.
11.3 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.
11.4 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 Exam Mode selector. For a description of the exam flow of the SupraThreshold
test, refer to § 11.12.
11.5 Initiating a new Fundus/Fundus Stereo/SmartMosaic test
To initiate a new Fundus test, click on the New Exam button, and select Fundus using the Exam Mode
selector.
Then, select the desired mode (among SmartMosaic, Fundus and Fundus Stereo) using the Visual Field
Strategy selector
Finally, in case of a Single Field Fundus test, select the desired imaging mode (among IR, COLOR and
IR+COLOR) using the Imaging Modality selector.
For a description of the exam flow of the fundus tests, refer to § 11.13.
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11.6 Choosing test parameters
When the New Exam command is pressed the Test parameters selection screen opens (see Fig. 24),
allowing review and modification of the test parameters.
The following commands / options are available:
1. Exam mode selection: Visual field, SupraThreshold, Quick SupraThreshold, Fundus
2. Eye selection: OD (right eye), OS (left eye), OU (both eyes)
3. Selection of:
• Visual Field strategy (for Visual Field tests only): ZEST, ZEST Fast or “4-2“
• Acquisition Modality (for Fundus tests only): SmartMosaic, Single field or Stereo
• Imaging Modality (for Single field Fundus tests only): IR, COLOR or IR+COLOR
4. For perimetric tests only, 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
5
1
2
3
4
7
8
Fig. 24 – Test parameters selection screen
ZEST vs. 4-2 vs. ZEST Fast
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 4-2 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.
The ZEST Fast strategy adds an advanced projection algorithm to the ZEST strategy, allowing to
reduce the examination time, resulting in a test approximately 30-40% shorter than a regular ZEST
test with the Coherence Check option disabled.
ZEST and ZEST Fast strategies are equivalent, which means that it is possible to perform a Follow-up of a
ZEST root test using the ZEST Fast strategy, and viceversa.
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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 § 12.3. For the settings configuration, refer to §15.5.
Quick
Setting
Visual Field
SupraThreshold
SupraThreshold
Configurable,
Coherence Check (CC)
for ZEST
Not available
Not available
strategy only
PRL calculation
ON
ON
OFF
Foveal threshold
ON
ON
Configurable
Blind Spot test (BS)
Configurable
ON
OFF
False Positives (FP)
ON
ON
ON
False Negatives (FN)
Configurable
ON
OFF
Table 1 – Fixed and configurable Exam settings
11.7 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 with 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.
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11.8 During the test
The following table describes the test process flow for a Visual Field exam.
# STEP
PURPOSE
INSTRUCTIONS
1 AutoAlign instrument Patient should not move and should look for the green fixation
alignment
with patient’s eye
target. For additional details see next paragraph.
2 Auto-focus
Correct
for
patient’s spherical Patient should not blink and should look at fixation target
refraction
3 Reference
Capture reference The reference image should have good quality, in particular images
IR image
infrared
retinal that are too dark, or partially occluded by eye lashes or lids should
image to be used be retaken. Click the Prev button on the left of the screen to retake
for eye tracking
the reference image if its quality is not satisfactory (see for example
Fig. 26). Click on the Next button to proceed.
4
5
6
7
Blind spot
location
Identify location of
blind spot
Detect
fixation
Locate center of
fixation
Fovea Test
Measure
sensitivity at the
fovea
Perimetry
Measure
sensitivity at all
grid
locations
using
central
fixation target
: a poor-quality reference image may compromise the VF
test, increase its duration, prevent retinal tracking or make
follow-up testing impossible.
Drag and center circle over optic disc, then click on the Next button
to proceed (see Fig. 27)
: 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 § 14).
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 Next 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 Next to proceed with the next step
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Patient should not blink and should look at the green fixation dot
until a light is flashed.
: click on the Prev button on the left to retake the image if of poor
quality.
8
Color
image
Capture
color
photo of posterior
pole
: 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. 28). 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 § 14).
Once the image is satisfying, click on Next to finish the exam and
store its results
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. 25,
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.
25, 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. 25, 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. 25 – “30-2” grid test locations (left)
and fixation target positions used for OD (center) and OS (right)
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Fig. 26 – Good (left) and poor quality (right) reference image
Fig. 27 – Marker for optic disc location in Exam screen
Fig. 28 – Message shown in case of a Color image registration failure
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11.9 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
11.10
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.
29). 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 causes for this situation might be
wrong patient head position (e.g. far from forehead rest), difficulties in fixation, closing eyes or falling eyelids.
Fig. 29 – Tracking active (left) and on hold (right)
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11.11
Monitoring test progress
7
1
5
2
6
3
10
4
8
12
9
13
11
Fig. 30 – Exam screen while test is in progress
The following information and functions are available:
1. Patient name.
2. Pupil images from alignment cameras that allow the end user (operator) to check if patient’s eyes are
open, overlapped with a live measurement of the pupil size: if smaller than 3 mm a “small” label is
displayed, and its color turns to orange. Pupil size may oscillate during the test due to accommodation.
3. Eye under examination (OD / OS)
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 with
the centre of the fixation target at every moment). Completed stimuli are shown as white, filled dots.
The stimulus being projected is shown as an empty orange circle, that turns to filled if the patient
presses the pushbutton in time.
6. Tracking status (circular coloured frame).
7. Elapsed test time.
8. Reliability indices (False Positives, False Negatives and Blind Spot, see § 12.3) 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. Button that allows to pause the test at any time.
11. Button that allows to stop the exam: the exam will be saved as a partial test, containing the data of the
completed stimuli only.
12. Button to reset the automatic alignment, if the motors’ limits were reached.
13. Button that allows to turn OFF the retinal Tracking.
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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.
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. 31). 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. 31 – Confirmation request to disable tracking
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11.12
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 outcomes: “seen at lower intensity”, “seen at higher intensity”, “not seen at
higher intensity” (see Fig. 32). 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. 32 – 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 §
12.5.
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. 33).
Fig. 33 – 24-2-st (standard SupraThreshold) grid compared to 24-2-reduced (Quick SupraThreshold)
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11.13
Other exam types: FUNDUS and FUNDUS STEREO test
The Fundus test allows to acquire a TrueColor or Infrared photo of the fundus. With respect to the exam flow
described at § 11.8, only steps 1, 2 and 8 take place, i.e. automatic alignment and focus. During the test, the
fixation target is placed at the center of the visual field, to provide an image of the central field of the retina.
If the IR+COLOR option is selected, the two images are acquired in sequence and will be stored as two
different exams.
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. For more
information about the stereo feature, refer to § 12.6.
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. 34 – Example of a Fundus image (left) and of one of a Fundus Stereo image (one of the pair) (right)
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11.13.1 Retaking an image
If the image quality is not satisfying, any Fundus image can be retaken, only within the current day. This can
be done by pressing the
button next to the desired image in the Patient Page (see Fig. 35): the device
will acquire a new image and then the dialog in Fig. 36 will appear, allowing to compare the old and the new
image and to decide whether to keep the old photo, replace it with the new one, or keep both.
Fig. 35 – Fundus exam, with the retake button available
Fig. 36 – Image Retake: choosing which image(s) to keep
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11.14
Other exam types: SMART MOSAIC test
The SmartMosaic is an optional feature that can be activated purchasing a dedicated license: see § 8 for
details.
A SmartMosaic test consists of acquiring up to three Fundus TrueColor images of three pre-determined fields
(Central, Nasal and Temporal), and to merge them into a single, wide-field image sized approximately
100°x60°.
As for the Fundus Stereo test, a delay between the shots is applied to let the pupil partially recover. After each
shot, the fixation target will start blinking and gradually moving to the next position, to help the patient follow it.
After all the images have been acquired, the interface in Fig. 37 will show up, allowing to retake any of the
images that might have been acquired with low quality (typically due to pupil not recovered yet, bad alignment
or blinking). Select the images that you want to re-acquire and press the Retake Images button. This
procedure can be repeated as many times as needed. Press the Create Mosaic button to complete the test
and start the mosaic generation.
After the mosaic has been generated, four Fundus exams will be stored: the three single fields
that can be reviewed individually, and the Mosaic (see § 12.6 for details on reviewing Fundus
images).
It will be possible to retake the single fields’ images individually within the day, but not to regenerate the mosaic after it has been generated.
Fig. 37 - SmartMosaic: retaking the images
The images resulting from the mosaic process may contain artifacts (such as duplicated or
disconnected vessels) that are generated at the transition between two adjacent fields and that are
not present in the original images. Such artifacts can be easily ruled out by comparing the mosaic
image with the original single-field images.
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12. REVIEWING RESULTS
Once a test is completed, the system will open the Patient Record screen (Fig. 22) for the selected patient
and display a thumbnail view (Fig. 38) of all exams taken on the selected date. Press on the desired exam to
open the Test Results Review screen (see § 12.1).
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, ZEST Fast 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);
•
If the exam was taken in the current day, the
button that allows to retake the photo (see §
11.13.1).
Fig. 38 – Example of thumbnails for Visual Field (left) and Fundus (right) exams
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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.
12.1
Individual test results review
The Exam Review screen (Fig. 39) provides the following information and functions:
1. Patient name
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. Image tools including blue, green, red filters used to display individual color channels (for
TrueColor image only) and brightness, contrast and gamma, used to enhance image brightness
(see details explained in Table 3 below)
8. Commands for Single Test Report and Progression Report generation and sharing (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. 39 – Exam review screen, red-free display modality
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Top bar buttons
Description
The following options will appear:
-
Export image to shared folder: will send the displayed image to the
shared folder (only available if the shared folder is set up)
Export DICOM object to shared folder: will send the displayed image
as a DICOM object to the shared folder (only available if the shared folder
is set up)
Create fundus/perimetry report: opens the interface for the report
destination: see § 12.2 below.
Generate the progression report (see § 12.4).
Image tools buttons
Description
Used to display individual colour channels (for TrueColor images). The
green channel provides the red-free image.
Used to enhance image appearance by adjusting brightness, contrast and
gamma. Each image type (Infrared, TrueColor, RedFree) has an
independent set of these parameters. These settings do not alter the
original images, but are applied to that when opened.
The brightness, contrast and gamma settings are persistent, which
means that they are re-applied when the exam review is re-opened (also in
the Remote Viewer) or when generating the exam report. Use this button to
reset the brightness/contrast/gamma parameters to their default values.
Table 3 – Exam Review buttons and related commands
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12.2
PDF report destination
When generating a Perimetry/Fundus/Progression PDF report, the dialog in Fig. 40 will show up. The buttons
on the top bar allow to choose the destination for the generated report.
Fig. 40 - Dialog for the PDF report destination selection
Top bar button
Description
Send the report directly to the printer.
Store the report on the attached USB device. This button is only available when a
USB device is plugged in.
Send the report to the shared folder. This button is only available when a shared
folder is set up (see § 15.10).
Display the report in the onboard PDF viewer app.
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12.3
Reliability indices
COMPASS provides standard methods to assess the reliability of a patient in performing the visual field test:
• False Positives (FP): this value represents the occurrences in which the patient has pressed the
pushbutton when no stimulus had been projected, and therefore he was 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.
Depending on the selected exam type, the four above tests may be individually enabled or disabled in the
Configurator app: see § 15.5.
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. 41 – Detail of Exam review screen with reliability indices
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Fixation plot / Area
Differently than in non-retinal tracked perimeters, the COMPASS fixation plot shown in a test report
(see § 14.2 and Fig. 42 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 § 11.10), but
these movements are considered and compensated at the time of projection of the stimuli, therefore
they do not necessarily degrade a test reliability.
Fig. 42 – 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.
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12.4
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 generate the Progression Report.
SupraThreshold and Quick SupraThreshold tests cannot generate a Progression Report.
The Progression report exam selection screen will open (see Fig. 43), 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 of FP, FN, or BS indices).
Two different types of Progression Reports are available:
1) the Comparison Report (see § 14.6), that allows to compare any two exams, or a series of exams with
4-2 strategy.
2) the Smart Progression Analysis Report (see § 14.7), that provides the output of the Smart
Progression Analysis on a series of exams taken with the ZEST or ZEST Fast strategy.
The Smart Progression Analysis Report is available for the ZEST and ZEST Fast strategies
only.
The selected series can contain a mix of exams performed with any of the two strategies, which
are considered equivalent. In detail, also the Baseline exams can be taken both with the same
strategy or with different strategies (i.e., one ZEST and one ZEST Fast).
Exams where the FP index is higher than 15% are marked as Unreliable.
Note 1: unreliable exams are de-selected by default but can be selected on operator’s choice
(even to be used as Baseline exams). In both report types, they appear in the Global Trend
Analysis graph with a different marker (grey instead of black) to identify them.
Note 2: incomplete tests are not selectable and will not be displayed in the Progression Report.
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 complete tests shall be included.
• If only two complete tests are selected, a Comparison Report is generated.
• If three or more ZEST/ZEST Fast tests are selected, a Smart Progression Analysis Report
is generated: the two oldest complete tests selected will be marked as BASELINE (see Fig.
43), and they will constitute the base for the Smart Progression Analysis.
It is important to select two Baseline exams with similar results and close in time to produce a
robust Smart Progression Analysis. To aid in this selection, two parameters are calculated:
1) the Baseline Similarity Index (BSI): this index quantifies how similar the results of the
selected exams are, in percentage. It is advised to select two exams with more than 52.5% of
BSI.
2) the Time Interval: this value represents how distant in time the two exams are. It is advised
to select two exams with less than 6 months of Time Interval.
It is possible to select two Baseline exams that do not fulfill these two conditions and proceed
anyway; however, this situation will be highlighted both during the selection (with a
marker
next to the related parameter, displayed in orange) and in the Smart Progression Report, where it
will be printed in orange color (see § 14.7).
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The Progression Report Exams Selection screen provides the following functions:
1. Checkboxes to select/deselect each exam, and one at the top to select/deselect all.
2. The Date column header allows to order the exams by date in ascending or descending order.
3. When two or more exams are selected, the two oldest are identified as BASELINE, and at the top right
their Similarity Index and Time Interval values are displayed.
4. A checkbox that allows to hide/show Incomplete exams, that in any case cannot be selected.
5. A toggle button that allows to choose whether to use the MD or FPDI for the Global Trend Analysis
chart in the Progression Report; the FPDI index is not available for 10-2 series.
6. A text comment will suggest how to proceed with the exam selection and which type of Report is going
to be generated.
7. Press GENERATE to proceed with the Report creation or cancel to go back.
3
2
1
4
5
6
7
Fig. 43 – Progression Report exams selection screen
After pressing the GENERATE button, the report is created and the Progression Report destination
selection screen appears (see Fig. 44), that allows to select whether to print the report directly, store it on a
USB drive (if already plugged in), send it to the Shared Folder (if configured) or opened with the internal PDF
Viewer.
Fig. 44 – Progression Report destination selection screen
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12.5
SupraThreshold exams review
The review window of a SupraThreshold test (Fig. 46 and Fig. 47) 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. 45 – 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. 46 – SupraThreshold exam review window
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Fig. 47 – Quick SupraThreshold exam review window
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12.6
Fundus exam review and Stereo 3D Viewer
The review window for Fundus, SmartMosaic 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. 48 and Fig. 49).
It is possible to zoom and move the image by pinching and dragging it as desired.
On the left side, the Image tools are available to adjust the image display parameters (brightness, contrast,
channels, etc.).
Stereo images are stored and displayed as two single Fundus exams.
If the image is part of a Stereo pair of images, the
to review the stereo pair it belongs to.
button allows to enter the Stereo 3D Viewer window
Fig. 48 – Fundus exam review window
Fig. 49 – SmartMosaic exam review window
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The Stereo 3D Viewer window (Fig. 50) 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.
To review stereo images, the end user (operator) should use specific 3D Prismatic stereoscopic goggles 15,
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.
Fig. 50 – Stereo 3D Viewer
On the top bar, the following buttons are available:
Top bar button
Description
Allows to view, print or export on USB or Shared Folder the report for the selected
image (Fundus review) or pair of images (Stereo 3D Viewer).
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.
Displays the Image Tools interface to change the display parameters for the related
image, such as brightness, contrast, etc. (see Table 3).
15
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.
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13. 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.
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.
Compatible browsers include Google Chrome, Microsoft Edge, Mozilla Firefox and Apple
Safari. Make sure you are accessing the Remote Viewer with the most up-to-date version of your
browser.
Starting from the COMPASS serial number 03000, by default only one client can connect to
the Remote Viewer. Additional concurrent clients can be added by purchasing a licence:
contact your local distributor for more info on how to purchase such license.
Units with serial number below 03000 can have up to 11 clients simultaneously connected,
instead.
13.1
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 § 15.6 for instructions on how to setup the Remote Viewer.
13.2
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 § 15.1);
•
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. 51), which resembles the
corresponding screen in the on-board software.
The user is automatically logged out after 20 minutes of inactivity.
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13.3
Patient List screen
The left-most column shows the patient’s name, gender and date of birth. The right-most column shows the
date of the last exam and two icons representing the number of Visual Field and Fundus exams.
Patients in the list are sorted by the date of their last exam.
Patient Search function is available at the top of the screen, as well as the function to add a new patient
clicking on the
icon.
Click on the desired patient’s row to enter the Patient Record screen (see Fig. 52). Click on
Logout to exit the Remote Viewer.
and then
Fig. 51 – Patient List in Remote Viewer
13.4
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
button beside the patient name allows to enter the interface to edit the patient's details.
On the right side of the screen, the following additional buttons are available:
Command
Description
Select: start the multiple selection of exams, to be exported using the button below.
Export: opens the export options interface (see Fig. 53) to export all the patient’s exams,
or the selected exams if the multiple selection was initiated. The buttons on the left allow
to choose whether to download the files or print directly. It is possible to choose whether
to export the Perimetry report and/or the Fundus report of the exams. For the Fundus
reports, it is possible to select the output format (JPEG or PDF), page orientation and
how to regroup the images.
Compare: opens the image selection screen for the Dual Image review screen (see §
13.8).
Flicker: opens the image selection screen for the Flickering review screen (see § 0).
Click on the desired exam’s box to enter the Exam review screen (see Fig. 54).
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Fig. 52 – Patient Record screen in Remote Viewer
Fig. 53 – Export Options interface in Remote Viewer
When exporting a single or dual images being zoomed using the mouse scroll, the
button allows to choose whether to export the current zoomed view or the full
image in the PDF report.
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13.5
Exam review screen
Entering the Exam review screen of a VF exam opens the interface shown in Fig. 54.
Fig. 54 – Exam Review screen in Remote Viewer
On the left side of the screen the patient’s details, the exam details and the main results of the Visual Field
test are displayed.
The dates buttons on the bottom allow to quickly open other exams of the same Baseline – Follow-up series.
In the middle of the screen, all the graphs present also in the exam PDF report are displayed. Clicking on any
graph will display it in a magnified view.
Clicking on the retinal image with the thresholds overlapped will open the Perimetry Mode Review screen (see
§ 13.6).
The following functions are available in this screen:
Command
Description
Allows to choose which retinal image to display with the
thresholds overlapped. Among RedFree, Infrared and
TrueColor.
Hides/shows the thresholds overlapped to the retinal image.
Allows to display the retinal image in Fundus (default) or
Perimetry convention.
Export: opens the export options interface (see Fig. 53) for
the Perimetry report of this exam.
Progression analysis: open the exams selection window for
the generation of a Progression or Comparison report.
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13.6
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. The image can be zoomed scrolling with the
mouse and then panned dragging it with the mouse.
Fig. 55 – Perimetry Mode Review screen in Remote Viewer
The following additional functions are available in the bottom-left side of this screen:
Function
Close
Command
Description
Back to the Exam review screen.
Previous/next item
Switch to the Infrared/TrueColor image of the same
exam, or to the previous/next exam.
Image tools
Displays the Image tools to adjust the image display
parameters (see § 13.7).
Export
Opens the export options interface (see Fig. 53) for
the Fundus report of this image.
Hide/Show Thresholds
Hide or show the stimuli threshold overlay over the
retinal image.
Fundus/Standard
perimetry display
convention
Cup-to-disc evaluation
iCare
Switch between Fundus Perimetry and the
Standard Perimetry display conventions, i.e. flips
the image and results vertically (see § 12.1)
Allows to set the markers for the cup-to-disc ratio
evaluation (see § 13.10). Hides/shows the markers
once they’ve been set.
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13.7
Image tools/Visits dialog
This dialog has 2 tabs: Filters and Visits (see Fig. 56).
Fig. 56 – Image tools dialog: Filters (left) and Visits (right) tabs
The Filters tab allows to adjust the display parameters for the image, to enhance its appearance and/or to
select the desired color channel, in the same way as can be done on the onboard application (see § 12.1).
The RESET button reverts all the parameters to their default values.
The Filters do not alter the original image.
Once set, the visualization parameters are stored on the device, and are shared with the
onboard application. This means that the most recent parameters applied are used both on
the onboard application and on the Remote Viewer.
The Visits tab allows to view all the images of the patient (regardless whether they are included in a Visual
Field or Fundus exam), and to select one to be used for comparison in the Dual Image review (see § 13.8)
using the
button and clicking on COMPARE, or in the Flickering view (see § 0) clicking on FLICKER
(available only if the two images are related to the same eye).
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13.8
Dual Image review / Stereo 3D Viewer screen
The Dual Image review screen (Fig. 57) allows comparison of any pair of images of the selected patient (color
and infrared, left and right eye, same or different dates), and can also be used as a Stereo 3D Viewer.
Fig. 57 – 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:
Function
Image tools
Lock
Swap images
Export
iCare
Command
Description
Displays the Image tools to adjust the related image
display parameters, which can be done for each
image independently (see § 13.7).
Allows to “lock”/”unlock” the two images so that the
same region gets zoomed and panned in both
images.
Swaps left and right image.
Opens the export options interface (see Fig. 53) for
the Fundus report of this image.
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13.9
Flickering view
COMPASS allows to compare two images one by one, by switching manually or automatically between the
two. This feature is called flickering, and allows to compare any two images (Color or IR) of the same patient
and same eye. It is possible to access the flickering window from the Patient record screen (see § 13.4) or
from the Visits tab of the Image tools dialog (see § 13.7).
The software automatically registers the two images to overlap them (compensating shift, rotation and Color/IR
distortion).
Fig. 58 – Flickering review window
On the left side of the image the date and time of the 2 selected pictures are displayed. The bar on the left
indicates which image is currently displayed.
Fig. 59 – Currently active picture: “2020-02-29 11:51”
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The following features are available in this screen:
Function
Close
Command
Description
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 10
Hz).
The 2 images are “locked”: zooming and dragging will act on both images.
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13.10
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. 60 – Cup-to-disc ratio evaluation
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.
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14. PRINTING
14.1
Printer Setup
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. 61), and proceed with pairing with the printer following the instructions provided
by producer.
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Fig. 61 – 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. 62).
Fig. 62 – 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.
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14.2
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. 64):
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. 65);
8.
Grayscale VF map (see Fig. 66 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. TrueColor retinal image;
14. Serial number of the unit that generated the report, software version used to generate the report, and
the version of the normative DB
15. Custom printout header (see § 15.11 for how to configure it).
Fig. 63 – 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
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15
1
2
3
6
5
4
7
9
8
10
11
13
12
14
Fig. 64 – COMPASS report for a test with 24-2 grid
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Fig. 65 – Stimuli of the 24-2 pattern (left) and 30-2 pattern (right) grouped in clusters16
Fig. 66 – Symbols used for the grayscale map and related dB intervals
16
Garway-Heath et al; Mapping the Visual Field to the Optic Disc; Ophthalmology Volume 107, Number 10, October 2000
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14.3
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. 67):
• The cluster analysis (7) is not available;
• 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. 67 – COMPASS report for a test with 10-2 grid
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14.4
Report for 30-2 test
The printout for a test performed with the 30-2 grid (Fig. 68) 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. 65).
Fig. 68 – COMPASS report for a test with 30-2 grid
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14.5
Reports for the SupraThreshold exams
The printout for a SupraThreshold exam displays the following information (see Fig. 69):
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. 69 – COMPASS report for a SupraThreshold test
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The printout for a Quick SupraThreshold exam contains the same information (Fig. 70). The only differences
are:
- a wider ONH detail image;
- the BS reliability index is N/A;
- the Fovea threshold might be Disabled.
Fig. 70 – COMPASS report for a Quick SupraThreshold test
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14.6
Comparison Report
The Comparison Report provides information on a Baseline-Follow-up pair 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. 71):
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 Follow-up and Baseline
11. Differences in cluster MDs between 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 § 15.11 for how to configure it).
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15
1
2
3
5
4
6
7
8
9
10
11
13
12
14
Fig. 71 – Comparison report for 24-2 exams
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1
2
3
5
4
6
7
8
9
10
12
14
Fig. 72 – Comparison report for 10-2 exams
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1
2
3
5
4
6
7
8
9
10
11
13
12
14
Fig. 73 – Comparison report for 30-2 exams
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14.7
Smart Progression Analysis Report
The Smart Progression Analysis (also called “SPA”) analyzes a series of Root-FollowUp COMPASS exams
to detect whether a retinal damage is progressing, locally or globally. It provides a detailed report, showing a
comparison between two initial exams (identified as Baseline exams) and the last Follow-up of the series, and
the outcomes of two analysis: the Event Analysis and the Trend Analysis.
The Progression Event Analysis detects whether single or consecutive progressing events have occurred
in each single tested location, also providing a global Event assessment. The detection of the Events is based
on test-retest variability levels obtained from patients followed over relatively short periods of time, in whom
there is reasonable assurance that the disease has not progressed.
The Global Trend Analysis allows to assess whether there is a progression of the damage (both locally and
globally), it calculates the rates of Visual Field progression over time (i.e., the speed of progression) and, if
enough data is available, extrapolates the progression from 3 to 5 years in the future.
Finally, the comparison of the TrueColor image of the ONH of the Baseline and last Follow-up exams allows
qualified eye care practitioners to qualitatively appreciate whether structural changes have occurred over time
and their relationship with sensitivity loss at corresponding regions of the visual field.
The Smart Progression Analysis Report is available for the ZEST and ZEST Fast strategies
only.
The selected series can contain a mix of exams performed with any of the two strategies, which
are considered equivalent. In detail, also the Baseline exams can be taken both with the same
strategy or with different strategies (i.e., one ZEST and one ZEST Fast).
The SPA Report (see Fig. 74) is divided into 6 sections:
1) the Report header
2) the Baseline exams analysis
3) the Last Follow-up analysis
4) the Progression Event Analysis
5) the Trend Analysis
6) the Report footer
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1
3
2
4
5
6
Fig. 74 – Smart Progression Analysis Report for a 24-2 series of exams
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14.7.1 Report header
This section contains info about the Patient (name, code, date of birth, gender, notes) and the exam series
(eye, grid and strategy used).
The Custom header is also present at the top (see § 15.11 to learn how to setup the Custom header).
14.7.2 Baseline exams analysis
This section shows a side-by-side comparison of the two Baseline exams. From top to bottom, the following
data are displayed:
TrueColor images of the ONH of the two
exams
Grayscale VF maps,
measured thresholds.
representing
the
Pattern Deviation charts, with separation of the
locations in clusters
Exam data (date and time, FN, FP, BS, MD,
PSD, FPDI indices)
The Baseline Similarity index (marked in
orange if below 52.5%) and the Time Interval
(marked in orange if higher than 6 months)
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14.7.3 Last Follow-up exam analysis
This section shows the same data as the Baseline exams (excluding the Baseline Similarity index and the
Time Interval), but related to the last Follow-up.
Moreover, the ONH color image is divided into 6 sectors, indicated with different colored patterns on the image
frame. These colored patterns allow to relate each sector (and its RNFL bundles, see note below) to the
correspondent cluster in the Cluster MDs chart in the Trend Analysis at the bottom of the page (see § 14.7.5).
Note that the corresponding clusters appear vertically swapped because the Cluster MDs chart is represented
in Standard perimetry convention (see § 12.3). A symbol on any image sector/cluster shows its trend in terms
of MD, i.e., whether the cluster is improving, worsening or whether the worsening cannot be assessed due to
floor effect (too low values for the MD).
Fig. 75 - ONH sectors (left) and their related clusters (right), with the symbols legend (center)
The RNFL (Retinal Nerve Fiber Layer) is formed by bundles of nerve fibres coming out from the
ONH and spreading below the retinal surface. An increased intra-ocular pressure (IOP) can
damage some of these bundles resulting in reduced sensitivity in the VF test outcomes in the
related areas identified by the clusters. This damage can also be visible as a reduced
translucency of the fibres and/or an increase of optic nerve head cupping in the TrueColor image.
The division of the locations in clusters is available for the 24-2 and 30-2 grids only.
The report for the 10-2 grid does not provide this grouping, nor the related division in sectors for
the ONH (see Fig. 67).
Furthermore, this section includes the Threshold variation graph: a grayscale VF map, representing the
difference between the last Follow-up thresholds and the average of the Baseline exams. Only negative
differences (i.e., only the points where the VF is worse in the Follow-up) are displayed, as shown in the legend
above the chart.
Fig. 76 – Threshold variation chart, with its grayscale above
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14.7.4 Progression Event Analysis
The Progression Event Analysis detects the number of consecutive, significant progression Events that have
occurred in each location within the exam series, based on COMPASS test-retest clinical database of a
population of stable glaucoma patients. A progression Event is a decrease in sensitivity for a certain exam,
that is below the 5th percentile of expected test-retest variability in such a population (p < 5%). This section
reports the following outcome data:
Progression Event analysis: for each location, a triangular symbol
represents whether an Event has occurred in the last Follow-up. A
black dot means that no Event has occurred in that location, because
the change does not exceed the test-retest variability observed in the
reference population.
Legend: the triangles have different filling depending on the number
of consecutive exams (including the last) that have detected an Event
If the average Baseline threshold for a location is lower than 15 dB,
no Events are detectable for that location and it is marked as Out of
range.
Event assessment: based on the number and type of detected
events, an overall Event assessment is reported among
Likely/Possible/Suspect/No Progression, or No Event Analysis
Possible (if all locations are marked as Out of range).
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14.7.5 Trend Analysis
This section provides an analysis on the trend for the progression, which represents the speed (expressed as
the Rate in dB/yr for MD, or %/yr for FPDI) at which the sensitivity is decreasing in time.
Global trend Analysis: a chart representing the linear
trend of the MD or FPDI (depending on what was selected,
see Fig. 43) over time. Unreliable exams are represented
using a grey dot instead of a black dot.
If enough exams are available (at least 5 exams within 3
years), the progression is linearly extrapolated from 3 to 5
years into the future (see the column “Prediction after N yr”).
At the bottom of the chart, the linear progression rate is
displayed, in dB/year.
The symbol possibly present beside the Rate of
progression represents the degree of significance of the
variation, according to this legend. For example, a double
exclamation mark means that the worsening is highly
significant (p-value < 0.01). The Floor effect symbol is
displayed when the MD difference between the Last Followup and the Baseline average exceeds 20 dB.
Cluster MDs trend: this chart (available for 24-2 and 30-2
grids only) displays the linear variation rate of the MD in
each cluster, in dB/year. In case of significant variation, a
symbol is present within the cluster, according to the same
legend above.
Pointwise trend analysis: this chart displays the linear
variation rate of the sensitivity thresholds in each location
of the grid, in dB/year (rounded to integer values). Only
statistically significant variations (p-value < 0.05) are
displayed: a dot instead of the value means that the
variation is positive or non-significant.
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In the Global trend Analysis chart, the Progression Prediction requires the following conditions to
be met for the calculation:
-
At least 5 exams selected
-
A minimum span of 3 years between the first Baseline and the last Follow-up exam
-
The MD of the average of the two Baseline exams shall be > -20dB, to avoid floor effects
If any of the above conditions is not met, the Progression Prediction is not displayed, and a banner
above the Global Trend Analysis chart will provide an explanation, such as:
Similarly, in case the time span between the first Baseline and the last Follow-up exam is less than
6 months, the following banner will inform that the Progression rate values might be affected by
such a short interval; therefore, the resulting values must be evaluated carefully:
14.7.6 Report footer
This section provides info about the report generation date, the COMPASS serial number that generated it and
the SW version installed, together with the version of the Normative Database.
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14.7.7 30-2 and 10-2 reports
Below are report samples for series of exams taken with the 10-2 grid (see Fig. 77) and with the 30-2 grid (see
Fig. 78).
In the 10-2 report, note that the clusters are not displayed, the Cluster MDs chart is missing and that the
FPDI values are not available:
Fig. 77 – Smart Progression Analysis Report for a series of exams with the 10-2 grid
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In the 30-2 report, note that the clusters contain only the points in common with the 24-2 grid, as for the single
Exam printout (see § 14.4).
Fig. 78 – Smart Progression Analysis Report for a series of exams with the 30-2 grid
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14.8
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. 79):
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. 79 – Fundus report examples: for a Color Image (left) and for an Infrared Image (right)
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14.9
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. 80 – Example of a Dual printout Report
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15.
SETTINGS
COMPASS provides access to settings by means of a separate application called “Configurator”.
The Configurator app can be accessed by the Admin user only.
15.1 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
;
.
15.2 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.
15.3 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.
81): device will request to power off in order to apply the new settings.
Fig. 81 – Configurator – DATE/TIME settings
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15.4 Users
Passwords for both the “Admin” and “Doctor” users can be changed in the “Users” tab of the Configurator
by clicking on the desired user (see Fig. 82). Shutdown and restart the device to make the new passwords
effective.
•
•
•
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. 82 – Configurator – USERS tab
15.5 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. 83). All
the tests are enabled by default. For a detailed description of the reliability indices, see § 12.3.
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. 83 – 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 SupraThreshold exams,
instead, only FP and BS tests are performed (FN is disabled, and CC is not applicable, since
ZEST strategy is not used).
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15.6 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. 84 – Configurator - REMOTE VIEWER screen
For cybersecurity reasons, it is recommended to configure the Remote Viewer to use HTTPS.
When using HTTPS protocol, the server authentication is carried on by means of an SSL certificate.
COMPASS provides a default, self-signed built-in certificate for such authentication. It is however possible to
generate and use a custom certificate instead of the default one: to install it, rename it to custom_cert.pem
and store it into a USB device and plug it into COMPASS, then press the Install custom_cert.pem from
USB device button.
When a custom certificate has been installed, press the Remove custom certificate button to uninstall it
and revert back to the default COMPASS certificate.
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A custom certificate must fulfill the following conditions to be installed on COMPASS:
• It must be an SSL certificate generated in PEM format
• The private key must not be protected by a passphrase
• It must contain the private key within the certificate file, like in the example file below:
-----BEGIN RSA PRIVATE KEY----MIIEogIBAAKCAQEAvmKAUWO/Z0YJu8PMqOOOn1zTp9xHsJp4IRyytS9eMsTIJdxR
[...]
sfJw7OZ5bFPCBU+OfSEs24W4W/0Zad8xBveLSMt1jO45sfOPATI=
-----END RSA PRIVATE KEY---------BEGIN CERTIFICATE----MIIDlTCCAn2gAwIBAgIJAM9S1YMXAf/RMA0GCSqGSIb3DQEBCwUAMGExCzAJBgNV
[...]
3F5jTQf4s6+C
-----END CERTIFICATE-----
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.
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 will be shown.
Fig. 85 - Remote Viewer's search interface if Privacy Mode is enabled
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15.7 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.
Required characteristics and peripheric of the IT-network are:
•
•
•
•
•
•
Printers: compatible printers are listed in section §14.1
Compatible browsers for Remote Viewer: Google Chrome, Microsoft Edge, Mozilla Firefox, Apple
Safari
Supported wireless protocols: Open, WEP, WPA, WPA2
Supported Shared Folder protocols: SMB/CIFS protocol, up to ver. SMBv3, connecting to hosts
running the following operating systems: Windows 7, 8, 10, 11, Server 2012, and Linux.
DICOM: DICOM compatibility is described in the COMPASS - DICOM IFU and DICOM Conformance
Statement
LDAP: LDAP compatibility is described in COMPASS - LDAP Instruction for Use
The Intended Information Flows from the device to the IT infrastructure are:
• Printing of exam reports via a compatible printer
• Storing exams’ and patients’ data to an external USB Data Storage
• Exporting exams’ and patients’ data to a configured remote Shared Folder
• Remote Viewer: view and export exams’ and patients’ data from a personal computer connecting to
the device via a web browser
• DICOM
The responsible organization is strongly recommended to keep virus protection up to date on
the computers used. The responsible organization is also recommended to install security
updates to the used web browsers and computers when available.
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.
The responsible organization should identify, analyze, evaluate, and control any additional risks
resulting from the EIDON device connected to IT networks including other equipment.
Changes to the IT network could introduce new risks requiring additional analysis by the
responsible organization. The changes include:
- changes in the IT-network configuration
- connection of additional items to the IT-network
- disconnecting items from the IT-network
- update or upgrade of equipment connected to the IT-network
Potential Hazardous situations resulting from the failure of the IT-network
If the connection is lost during data transfer, no data is lost from the device. The images are
still stored in the device and can be transferred once the connection is re-established.
Failure or misconfiguration of the IT-network may result in data not being transferred causing
inconvenience to the operators.
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The Ethernet port is located on the back of the system (see Fig. 2).
The COMPASS Custom Control Interface Wi-Fi must 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. 86 – 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. 87 – Configurator - Network configuration screen
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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. 86): the following window appears.
Fig. 88 – 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.
15.8 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.
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15.8.1 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. 89 – 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.
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Backup to Network
Fig. 90 – 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.
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15.8.2 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. 91 – 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.
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15.8.3 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. 92 – 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.
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15.9 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. 93 – Configurator - RESTORE screen - Network folder selected
•
Click Apply: the screen shows the list of available backups in the selected media.
Fig. 94 – 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.
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15.10 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 § 12.1, 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. 95 – Configurator - SHARED FOLDER configuration
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To check the Shared Folder connection status, check the Information Center (see § 10.1).
See § 19 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.
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15.11 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. 96 – Configurator - CUSTOM PRINTOUT header configuration
15.12 Custom control interface setting
From the Home screen of Fig. 13 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.
16.
DEVICE SHUTDOWN
To shut down the device, go back to the Home screen and press the power off icon
twice and then turns off.
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: the device beeps
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17.
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, ZEST Fast
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:
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60° (diameter)
5 Mpixel (2592x1944)
Light sources:
infrared (825-870 nm) and white LED (440-650 nm)
Imaging modalities:
color, infrared, red-free, stereoscopic, SmartMosaic
Resolution:
17 μm
Minimum pupil size:
3 mm
Working distance:
28 mm
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Other features and characteristics
Class and type of applied part:
IP classification:
Class II, Type B according to 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
DICOM17:
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 with18:
Accessories:19
•
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 Instruction for Use (or Leaflet, in case of electronic Instruction for Use)
•
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.
17
Available under additional license only: please refers to your local distributor for further and detailed information including for DICOM
Conformance Statatement
18
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
19
Accessory = a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
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18.
CLEANING AND DISINFECTION
This section explains how to clean and disinfect the device.
The cleaning process is described as follows:
1. Turn off the device and disconnect the power cord from mains.
2. Clean the Custom Control Interface display and the device’s exteriors: use a clean lint-free microfiber
tissue dampened with small amount of water (i.e. tap-water);
3. Clean the headrest and chinrest silicone cushions with a clean lint-free microfiber tissue dampened
with small amount of water after each use. Both cushions can also be removed and washed with water
and/or a mild hand detergent;
4. Clean the other possible contact parts of the device with the user or patient (e.g. plastic covers, frame,
any aluminum parts, Patient Push-button, Custom control Interface display and any other components)
using a clean lint-free microfiber tissue dampened with small amount of water or a mild hand detergent
5. Clean the front lens (only if really needed) using a clean lint-free microfiber tissue or photographic
cleaning paper dampened with a standard lens cleaning solution. Start from the center of the lens,
wipe it with a circular movement, very slowly, only for one complete rotation. The exiting movement
(i.e. moving away from the lens) has to be made radially, towards the border. Do not reuse the same
wiping cloth area after one pass;
6. Allow all surfaces to dry for 5 minutes before turning on the device.
The disinfection process should be done after each use and is described as follows:
1. Turn off the device and disconnect the power cord from mains;
2. Clean the headrest and chinrest silicone cushions with a disinfecting wipe with 70% isopropyl alcohol
(IPA);
3. Disinfect all the other contact parts using a disinfecting wipe with 70% IPA (or a soft clean disposable
tissue damped with 70% IPA solution): plastic covers, frame and back panel of the tablet, any
aluminum parts, touch screen and components if present.
4. Clean the front lens: use a disinfecting wipe with 70% IPA (or a soft clean disposable tissue damped
with 70% IPA solution). Starting from the centre of the lens, wipe it with a circular movement, very
slowly, only for one complete rotation. The exiting movement (i.e. moving away from the lens) has to
be made radially, towards the border. Do not reuse the same wipe area after one pass.
5. Allow all surfaces to dry for 5 minutes before turning on the device.
Fig. 97 - Removal of the chin rest silicone pad
Gently pull up and slide the chin rest pad to avoid breaking the retaining peg.
Do not reuse the same area of the wiping tissue after one pass.
Do not use disinfectant wipes containing bleach.
Do not allow the liquid from the disinfecting wipe to sit or pool on the area being disinfected for
a long amount of time.
Do not use rough towels or cloths to dry the area.
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19.
TROUBLESHOOTING
Symptom
1. COMPASS does not power on (no green LED)
2. 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
Possible cause(s)
Solution
COMPASS is not powered
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 tablet
and/or from device
Login was made with “Admin” user and
tethering was not enabled
Connect USB cable and login again
Enable tethering or switch to “Doc” user
and login again
Front lens is dirty
Clean the front lens (see § 18)
7. Captured image is totally white
Patient blinked during image capture
8. System is not usable with message “internal error:
device temporarily locked”
Malfunction of the rotating mirror or of the
infrared LED board for pupil illumination
9. Tablet does not turn on and does not recharge
Tablet is fully discharged and current
from device is not sufficient to initiate
recharge
Repeat capture and ask patient not to blink
See §15.2 to reset the lock condition. If the
condition occurs frequently, contact
authorized service center
Use the wall charger found in the
components box to charge the tablet for at
least one hour, then connect it normally to
the system
10. One or more dark areas appear in color and/or IR
pictures
11. The fixation target appears de-centered approx. 3
degrees to the left/right
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Pupil is too small (< 3.0 mm)
Dark adapt or dilate patient’s pupils.
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
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.
This condition is normal.
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•
•
12. Export to the remote shared folder fails with
message “The selected host is not reachable” or
“Timeout”
•
Network connection to the remote
shared folder not working
Write access to the selected
remote folder not granted
host computer is not reachable
13. Export to the remote shared folder fails with
message “Unknown error”
The remote export folder was renamed
after the export destination was
configured
14. Export to the remote shared folder fails with
message “The shared disk is full.”
The computer hosting the shared folder
has a full hard disk
15. The system reports the message “Unable to get
feedback from stimulus” (Code 227)
The stimulus position check failed.
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•
•
•
Check that the network cable is
correctly plugged
Check that the local area network is
available
Check that the remote folder is
shared with write permissions
Check that the computer hosting the
shared folder is reachable
Re-configure the export destination
Empty some space on the host computer
or change the export destination to another
computer
Contact an Authorized Service
representative.
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19.1 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.
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20.
MAINTENANCE
The Manufacturer recommends the periodic maintenance of the device once per year.
Only properly qualified Authorized Service Technicians can perform maintenance activities 20. Contact your
local Authorized Service Center if you think your COMPASS requires maintenance.
To clean the front lens in case of dirt, refer to §19. To check the disk space, refer to §10.1.
20 Note: COMPASS has no user-serviceable internal parts.
Only CENTERVUE S.P.A. authorized personnel may perform maintenance or repair procedures other than those described in this
manual.
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21.
ELECTROMAGNETIC COMPATIBILITY
COMPASS device has been tested and found to comply with the limits for medical devices contained in IEC
60601-1-2. These limits are intended to provide reasonable protection against harmful interference in a typical
medical installation. COMPASS device 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 device does cause harmful interference to other devices, which can be determined by turning the
COMPASS device 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 device needs 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 this COMPASS device.
21.1 Manufacturers EMC Declaration to IEC 60601-1-2
The following tables provide specific information regarding compliance of COMPASS device.
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
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21.2 Guidance and manufacturers declaration – Electromagnetic Immunity COMPASS device
IEC 60601-1-2 ELECTROMAGNETIC IMMUNITY FOR COMPASS
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
21.3 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 device is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the end-user of COMPASS device can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and COMPASS device 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 device, 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
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21.4
Wi-Fi Specifications
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 device contains 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.
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22.
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).
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23. LOG OF DOCUMENT CHANGES
IFU version
23
24
iCare
Description
Introduction of new features: SPA ZEST, Smart
Progression, SmartMosaic.
Introduction of electronic IFU, added 12 languages for IFU,
bugfixes.
COMPASS IFU rev. 24 - US
IFU Release date
Software version
2023-10-10
4.0.1
2024-01-23
4.0.2
Page 119 of 120
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.
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COMPASS IFU rev. 24 - US
Page 120 of 120
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