Phelcom Eyer User manual

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CONTENTS
1. Compliance 6
1.1. Safety Guidelines 6
1.2. Indication for use 7
1.3. Intended users 7
1.4. Intended patient population 7
1.5. Clinical benefits 7
1.6. Contraindications and limitations 8
2. Introduction 9
2.1. Usage 9
2.2. Overview 9
2.3. Setup and electrical connections 10
3. Eyer®13
3.1. Device features 13
3.1.1. Operation 14
3.2. Application 15
3.2.1. Device start screen and access 15
3.2.4.1. Patients 25
3.2.4.1.1. Creating patient profiles through Eyer®25
3.2.4.1.2. Patient personal information 27
3.2.4.1.2.1. Info 27
3.2.4.1.2.2. Removing a patient profile through Eyer®28
3.2.4.1.2.3. Exams 29
3.2.4.1.2.4. Creating exams through Eyer®29
3.2.4.1.2.5. Image capture screen 30
3.2.4.1.2.6. Captured images 34
3.2.4.1.2.6.1. Synchronization failure 42
3.2.4.1.2.7. Image analysis and editing through Eyer®43
3.2.4.1.2.7.1. Cropping 43
3.2.4.1.2.7.2. Image Measurement 44
3.2.4.1.2.7.3. Image Rotation 44
3.2.4.1.2.7.4. Levels 45
3.2.4.1.2.7.5. ISNT Function 45
3.2.4.1.2.8. Removing images through Eyer®48
3.2.4.1.2.9. Removing exams through Eyer®48
3.2.4.1.2.10. Creating and editing diagnosis through Eyer®49
3.2.4.1.2.11. Sending files by email 52
3.2.4.1.2.12. Device printer setup 53

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3.2.4.2. Exams 53
3.2.4.3. Options 54
3.2.4.3.1. Clinic 55
3.2.4.3.2. System 55
3.2.4.3.2.1. Logs 56
3.2.4.3.2.2. Defaults 56
3.2.4.3.2.3. Advanced Resources 57
3.2.4.3.2.4. Language 58
3.2.4.3.2.5. Terms and conditions of use 59
3.2.4.3.3. Device 59
3.2.4.3.3.1. Calibration 60
3.2.4.3.3.2. About 60
3.2.4.3.3.3. User Manual 61
3.2.4.3.4. Servers 61
3.2.4.3.4.1. Common server setup 62
3.2.4.3.4.2. DICOM servers setup 63
3.2.4.3.4.3. FTP server setup 64
3.2.4.3.4.4. SMB/CIFS server setup 65
3.2.4.3.4.5. Local Folder 66
3.2.4.3.4.6. DICOM file information 66
4. Carrying out exams 70
4.1. Posterior segment 70
4.2. Anterior segment 72
5. Maintenance, handling and sanitizing 72
6. Packing, storage, transportation, site selection, operation, and environmental
conditions 74
7. Accompanying parts and accessories 75
7.1. Accessories 75
8. Disposal 76
9. Cables and connections 77
9.1. Cables 77
9.2. Connections 77
10. Technical Data 79
10.1. Optical characteristics 79
10.2. Electrical characteristics 80
11. Warning 82
12. Troubleshoot Guide 83
13. Electromagnetic Safety Standards 85
13.1. Supplier declaration and guidelines - Electromagnetic emissions 86
13.2. Supplier declaration and guidelines - Electromagnetic immunity 87

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13.3. Recommended minimum separation distances from mobile RF communication
devices to Eyer®89
13.4. Radio frequency interference 90
14. Biocompatibility 92
15. Glossary and symbols 93
16. Cybersecurity Information 95
16.1. Objective 95
16.2. System overview 95
16.3. General principles 95
16.4. Cybersecurity functions 95
16.5. Data backup 96
17. Term of Warranty 96

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1. Compliance
Phelcom Technologies developed this device according to worldwide quality
standards, prioritizing patient and operator safety, electromagnetic compatibility
and friendly operational flow, thus making Eyer®Retinal Camera safe, reliable and
robust, meeting the most varied demands of fundus imaging for diagnosis and
screening purposes. Main quality standards adopted follow below:
●ISO 13485:2016
●ISO 14971:2019
●IEC 60601-1:2005+AMD1:2012
●IEC 60601-1-2:2014
●IEC 60601-1-6:2011
●IEC 60601-1-9:2014
●IEC 62366:2010
●IEC 62304:2004
●ISO 10993-1
●ISO 15004-1:2020
●ISO 10940:2009
●ANSI Z80.36-2016
1.1.Safety Guidelines
Eyer®Retinal Camera is a low-risk device that complies all requirements of ISO
15004-2020, ISO 10940:2009 and ANSI Z80.36-2016, being classified as Group 1
fundus camera. It means that there is not any risk for the patients related to lighting
during retinal imaging. Even so, we strongly recommend following the guidelines
below:
●Follow the information on labels and read this User Manual carefully before
turning on and using the device. Wherever the symbol is found, read all
suggested recommendations carefully.
●This device is not suitable for use in the presence of flammable mixtures
containing air, oxygen, or nitrous oxide.
●Product must be used as a diagnostic tool for eye diseases, having no
treatment function.
●Device operation does not require the operator to wear an individual
protection device. However, wearing protection device is optional in adverse
conditions.
●Keep the device in a safe location. Avoid shocks and vibrations.
●Do not clean with abrasive solutions. Follow the sanitizing procedure listed in
this manual.
●Avoid seeping of any liquid or any particle material inside the device.

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●Use no component parts not mentioned in this manual, since their use may
damage the device, causing warranty void.
●Avoid exposing the device to sudden changes of temperature and humidity,
since it may cause condensation on lenses, which compromises optical
performance.
●A fragile part of the system is exposed when the smartphone is disengaged.
Be extra careful to avoid damage of optical components, such as scratches,
dust, oil, or any other dirt that compromises the device performance.
●User is entirely responsible for using any non-specified part, accessory, or
material.
●Avoid falls and shocks, extending the service life of the device. Damages
caused by falls or shocks are not covered by warranty.
●Device shall not be used in case any component part is damaged. Contact
Phelcom technical staff to request repair.
●Never disassemble the device, since it may damage optical and electronic
parts, as well as fragile mechanisms.
●Contact Phelcom technical support in case there are any problems related to
the device.
●Device must be used either in clinical/hospital locations or on-field itinerary
campaigns with a trained operator.
1.2. Indication for use
Eyer®Retinal Camera is a medical non-mydriatic digital camera, a Samsung Galaxy
S10 smartphone to capture digital images and videos of the fundus of the human
eye, surface of the human eye and surrounding areas.
1.3. Intended users
The device may only be operated by persons who have been properly trained, who
are familiar with fundus cameras, ophthalmoscopes, etc., or who have the required
knowledge to operate the device or a similar device. This device may only be used in
accordance with its intended use.
1.4.Intended patient population
All patients may be imaged with Eyer®Retinal Camera.
1.5.Clinical benefits
Eyer®Retinal Camera can be operated non-mydriatically. Whit Eyer®Retinal
Camera digital images can be stored for follow-up or consultation purposes. The
field of view is 45 degrees allowing a detailed diagnosis. The operation of Eyer®
Retinal Camera can be learned quickly, and even an inexperienced camera operator
can capture images with sufficient quality for quick screening purposes.
Eyer®Retinal Camera provides versatility for diagnosing different patient groups

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that are not able to sit in front of desk-top fundus cameras (e.g., supine patients,
wheelchair patients).
Due to small size and portability Eyer®Retinal Camera can also be used for
homecare visits and remote screening camps.
1.6.Contraindications and limitations
Because prolonged intense light exposure can damage the retina, the use of the
device ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization
of the target structures.
The retinal exposure dose for a photochemical hazard is a product of the radiance
and the exposure time. If the value of radiance were reduced in half, twice the time
would be needed to reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscope, it is recommended that the intensity of light directed into the
patient's eye be limited to the minimum level which is necessary for diagnosis.
Infants and persons with aphakia or diseased eyes will be at greater risk. The risk
may also be increased if the person being examined has had any exposure with the
same instrument or any other ophthalmic instrument using a visible light source
during the previous 24 hours. This will apply particularly if the eye has been exposed
to retinal photography.
Eyer®Retinal Camera is classified as Group 1 based on standard ANSI Z80.36:2016.
The daily usage time and maximum allowed number of pulses is calculated based on
optical classification results according to standard ANSI Z80.36:2016.

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2. Introduction
By acquiring Eyer®Retinal Camera you opted for modern, precise, and reliable
device to carry out high-quality ophthalmological exams, in accordance with most
rigorous safety regulations.
2.1.Usage
Eyer®Retinal Camera is a device that provides lighting of the posterior and anterior
portions of the human eye. It enables imaging of such structures to diagnose
diseases in those regions. There are three available exams: color retinography, red-
free retinography and anterior segment imaging.
Eyer®advantage, compared to conventional devices, is mobility, usage, quality
exams and extremely high connectivity.
This device is designed for clinical/hospital locations, as well as on-field patient
screening. Its use does not imply secondary, side, or adverse effects.
This User Manual contains information on assembling, connections, adjustments,
operation, and maintenance, to enable full use of the device. Look forward to
reading all the contents and keeping the manual reachable for reference and
checking.
In case of any information, doubt, suggestion, or complaint about device
components, please contact Phelcom. Always count on the technical staff to help
and guide you, maximizing device usefulness.
2.2.Overview
Eyer®can be used in clinic/hospital locations and on-field. Room temperature must
not exceed 40°C (104oF). To assure Eyer®appropriate functioning, it must be
correctly installed according to the conditions below:
Fundus imaging requires equipment operation by
trained and skilled personnel. Operator is
responsible for learning the techniques applied to
this system.
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●Device must not be exposed to heat sources or put in areas subject to water
or humidity.
●Avoid long permanence under direct solar ray incidence.
2.3.Setup and electrical connections
Eyer®is supplied separately from the smartphone. Before first use, qualified and
supplier-authorized technicians must install smartphone and application to assure
the device works perfectly. Contact Phelcom for further information on initial setup.
Phelcom staff may also provide remote access to make maintenance and application
troubleshooting possible.
Eyer®power source is the smartphone battery. It does not have a connection to the
power grid. When not in use for imaging, the smartphone can be attached to a
passive mechanical-support base and connected to its original charger, facilitating
battery recharge.
For charge procedures, use only original charger
supplied with the smartphone, or a compliant one
which follows all the applicable safety directives.
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It is not possible to access the examination operation
screen while the battery charges.
If the battery is completely discharged, it may be
necessary to remove the battery and charge it externally
with its original charger.
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